Research Insights

Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030

The first monoclonal antibody, Orthoclone OKT3®, was approved in 1986 by the FDA. Since then, a number of antibody therapeutics (more than 100) have been marketed for the treatment of patients suffering from various disease indications, primarily malignant tumors and other rare disorders. Despite the success, these drugs are associated with several limitations, such as increased patient resistance and a general lack of understanding of in vivo mechanisms of action. The aforementioned challenges and impending patent expiries of some of the blockbuster monoclonal antibodies have compelled the researchers and pharmaceutical companies to redesign these drugs and / or find new analogues. To further improve the specificity, efficacy and safety of monoclonal antibodies, the focus has gradually shifted towards the development of next generation recombinant antibodies, such as antibody-drug conjugates (ADCs), bispecific and multispecific antibodies, and antibody fragments and antibody-like proteins (ALPs). Bispecific antibodies are a novel class of antibody therapeutics that act by simultaneously binding two separate and unique antigens (or different epitopes of the same antigen). The primary mechanism of action of these therapeutics involves redirection of immune effector cells for effective killing of cancer cells by antibody-dependent cell mediated cytotoxicity (ADCC) and other cytotoxic mechanisms, such as antibody dependent cellular phagocytosis (ADCP) and complement dependent cytotoxicity (CDC). Having unique biological and pharmacological properties, as well as their availability in different formats, bispecific antibodies have emerged as promising agents for therapeutic use. Advancements related to protein and antibody engineering techniques have led to the production of close to 50 new formats in the recent years.  Till date, two bispecific antibodies, namely Blincyto® (2014) and Hemlibra® (2017), have been approved for therapeutic use. It is worth mentioning that, in 2019 (till September), Blincyto® and Hemlibra® generated revenues worth USD 232 million and USD 930 million, respectively. The growing popularity and therapeutic potential of bispecific antibodies can also be correlated to an exponential increase in the number of clinical trials; the cumulative count of trials has increased from 51 studies in 2014 to over 300 studies in 2019 (till September). More than 300 bispecific drug candidates are currently in clinical / preclinical stages. In fact, multiple licensing agreements, between drug developers and technology providers, have also been inked in the past few years to advance the development of pipeline drug candidates. Scope of the Report The “Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. The study features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report includes: A detailed review of the overall landscape of bispecific antibody therapeutics, including information on drug developers, phase of development (marketed, clinical, and preclinical / discovery) of the pipeline candidates, target antigen, type of antibody format, mechanism of action, target disease indication(s), therapeutic area, broader disease segment, route of administration, mode of administration and patient segment.  A comprehensive list of novel technology platforms that are either currently available or being developed by various firms for the generation of bispecific antibody therapeutics, along with detailed profiles of key technologies. The chapter also includes an insightful competitiveness analysis, featuring a three-dimensional bubble representation that highlights the key technologies that are being used for the development of bispecific antibodies, taking into consideration the development activity based on the technology (in terms of the number of drugs across different phases of development), number of partnerships established related to the technology and size of the developer company. In addition, it consists of a schematic world map representation, highlighting the geographical locations of technology developers engaged in this domain. Detailed profiles of marketed and clinical stage (phase II and phase III) bispecific antibody therapeutics. Each profile features an overview of the drug, details of the developer, along with its financial performance, mechanism of action and targets, dosage information, current clinical development status, development process, as well as details on annual sales (wherever available). Key takeaways from the bispecific antibody therapeutics pipeline, featuring a [A] grid analysis, representing the distribution of the pipeline (on the basis of mechanisms of action of product candidates and antibody formats) across different therapeutic areas and stages of development and [B] a five-dimensional spider-web analysis, highlighting the most popular mechanisms of action based on a number of relevant parameters, including number of bispecific antibodies, number of ongoing clinical trials, target disease indications, number of publications and the number of companies that are developing these molecules.  An analysis of the big biopharma players engaged in this domain, featuring a heat map based on various parameters, such as number of bispecific antibody therapeutics under development, target antigen, type of antibody format, mechanism of action, target therapeutic area and partnership activity. An analysis of recent partnerships and collaboration agreements inked in this domain since 2016, covering research collaborations, product and technology licensing agreements, product development and commercialization agreements, manufacturing agreements, mergers / acquisitions, joint ventures, product development agreements and other deals. A review on the key steps involved and challenges associated with the manufacturing of bispecific antibodies. In addition, it includes a list of contract manufacturing organizations (CMOs) and contract research organizations (CROs). The chapter also highlights the key considerations for bispecific antibody developers while selecting a suitable CRO / CMO. A clinical trial analysis of ongoing and planned studies related to bispecific antibody therapeutics, taking into consideration a number of relevant parameters, including trial registration year, trial recruitment status, trial phase, trial design, disease indication(s), focus therapeutic area, most active industrial and non-industrial players, and geographical location of the trial. A review of the key promotional strategies that have been adopted by the developers of the marketed bispecific antibodies, namely Blincyto® and Hemlibra®. It includes a detailed comparison of both the drugs based on the information available on their respective websites, such as patient support offerings, informative downloadable content, and product visibility in scientific conferences. A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market. One of the key objectives of the report was to estimate the existing market size and the future opportunity for bispecific antibody therapeutics, for the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (solid tumors, hematological malignancies, genetic disorders, autoimmune disorders, infectious diseases, inflammatory disorders, metabolic disorders, eye disorders, skin diseases and others), [B] different mechanisms of action (T-cell retargeting / activation, checkpoint immunomodulation, cytokines retargeting / neutralization, NK-cell retargeting / activation and others), [C] key targets (CD19 x CD22, CD3 x CD19, CD3 x CD20, CD30 x CD16A, Factor IXa x Factor X, HER2 x HER2, ICOS x BAFF, IL-13 x IL-4, IL-17A x Albumin, IL-17A x IL-17F and others), [D] type of antibody formats (asymmetric, fragments, symmetric and others), [E] key players, and [F] key geographical regions (North America, Europe, Asia Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in the report were also influenced by discussions held with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order): Martin Steiner (Chief Executive Officer, Synimmune) Ludger Große-Hovest (Chief Scientific Officer, Synimmune)  Jane Dancer (Chief Business Officer, F-Star) Siobhan Pomeroy (Senior Director, Business Development, Cytom X) Yinjue Wang (Associate Director, Process Development, Innovent Biologics) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell Therapy Manufacturing Market (3rd Edition), 2019 - 2030

Till date, more than 20 cell-based therapies have been approved (recent examples include Zynteglo® (2019), Alofisel® (2018), YESCARTA® (2017) and Kymriah® (2017)), while over 500 product candidates are under development. In fact, there are over 1,000 active clinical studies of cell therapies, worldwide. Over the last few years, such therapies have garnered significant attention within the biopharmaceutical industry. Several companies and venture capital funds / investors have already invested a lot of capital towards the development and commercialization of this emerging class of therapeutics. Despite the optimism, the growth in this domain is still hindered by various development and manufacturing related challenges, primarily due to the limited availability of expertise and infrastructure to produce cell-based therapies, such as CAR-T cell therapies. The growing number of product development initiatives in this domain, coupled to the fact that there are multiple marketed products, have led to a substantial rise in the overall cell therapy manufacturing demand. As a result, developers have turned to contract manufacturing organizations (CMOs) to fulfil their cell therapy development and production requirements.  A wide array of industry players, including well-established companies, mid-sized firms and start-ups, as well as academic institutes, are contributing towards fulfilling the aforementioned demand, offering GMP grade manufacturing services for cell therapies. In addition to cell therapy manufacturing companies, there are several other players that claim to have developed novel technology solutions, aimed at improving the existing cell therapy manufacturing process. Many CMOs are also actively expanding their cell therapy manufacturing capacity either through collaborations or acquisitions, in order to offer a wide range of services to their respective clients. As a result of the ongoing efforts aimed at mitigating the existing challenges in this domain, the cell therapy manufacturing market is expected to witness significant growth in mid-long term. Scope of the Report The “Cell Therapy Manufacturing Market (3rd Edition), 2019-2030” features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions. Amongst other elements, the report includes: A detailed review of the overall landscape of companies that are engaged in the manufacturing of cell-based therapies, including information on the type of cells manufactured (including immune cells (including T cells, dendritic cells, NK cells), stem cells (including adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), source of cells (autologous and allogeneic), scale of manufacturing, type of cell cultures (adherent and suspension), purpose of production (fulfilling in-house requirements and contract services), manufacturing capabilities / services offered (including R&D, cell culture development, quality testing, packaging, labelling, cell banking, cryopreservation, fill / finish services, and regulatory affairs management), location of headquarters and location of their respective manufacturing facilities.  An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective cell therapy manufacturing capabilities, over the period 2015-2019 (till October), taking into consideration parameters, such as year of expansion, type of cells, scale of operation, purpose of expansion (facility expansion and new facility), location of manufacturing facility, and most active players (in terms of number of expansion initiatives undertaken). An analysis of the recent partnerships focused on the manufacturing of cell-based therapies, which have been established in the period 2014-2019 (till November), based on various relevant parameters, such as the year of agreement, type of partnership, type of cells, and scale of operation (preclinical, clinical and commercial). Informed estimates of the annual commercial and clinical demand for cell therapies (in terms of number of cells produced and area dedicated to manufacturing), which were further analyzed based on type of cells.  An estimate of the overall, installed capacity for manufacturing cell-based therapies based on information reported by industry stakeholders in the public domain, highlighting the distribution of the available capacity on the basis of scale of operation (clinical and commercial), size of the organization (small, mid-sized and large firms) and key geographical regions (North America, EU and Asia Pacific). An in-depth analysis of cell therapy manufacturers using three versatile representations, namely [A] a three dimensional grid analysis, presenting the distribution of companies on the basis of type of cells manufactured, scale of operation and purpose of production, [B] a logo landscape based on the type of cells manufactured, geographical location of manufacturer (North America, Europe and Asia Pacific) and type and size of organization (non-industry players, and small, mid-sized and large companies), and [C] a schematic world map representation, highlighting the geographical locations of cell therapy manufacturing facilities of both industry and non-industry stakeholders. A detailed analysis of the various factors that are likely to influence the pricing of cell-based therapies, featuring different models / approaches that may be adopted by manufacturers while deciding the prices of their proprietary offerings. An elaborate discussion on the role of automation technologies in improving current manufacturing methods, along with a comparative (qualitive) analysis of cost differences between manual and automated processes. A qualitative analysis, highlighting the various factors that need to be taken into consideration by cell therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO. A discussion on cell therapy manufacturing regulations across various geographies, including the North America (focusing on the US), Europe and Asia (focusing on Japan), featuring an analysis of the diverse certifications / accreditations awarded to manufacturing facilities by important regulatory bodies across the globe. Elaborate profiles of key players (industry and non-industry) that offer contract manufacturing services for cell-based therapies; each profile includes an overview of the company / organization, information on its manufacturing facilities, service portfolio details, recent partnerships and an informed future outlook.  A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry’s evolution, under a comprehensive SWOT framework, which includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall market dynamics. Insights generated in a market-wide survey, featuring inputs solicited from experts who are directly and indirectly involved in the development and / or manufacturing of cell-based therapies. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the cell therapy manufacturing market. Based on parameters, such as number of ongoing / planned clinical studies, cell therapy manufacturing costs, target patient population, and anticipated adoption of such products, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2019-2030. In addition, to account for the uncertainties associated with the manufacturing of cell-based therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with the following individuals: Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR)  Tim Oldham (Chief Executive Officer, Cell Therapies) Gerard MJ Bos (Chief Executive Officer, CiMaas) Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies) Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics)  Arik Hasson (Executive VP Research and Development, Kadimastem) Gilles Devillers (General Manager, Bio Elpida)  Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy)  Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Fiona Bellot (Business Development Manager, Roslin CT)  Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, Yposkesi) David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Prefilled Syringes Market (5th Edition), 2019-2030

According to experts in the healthcare industry, one in three adults are estimated to be suffering from some type of chronic clinical condition, such as multiple sclerosis, diabetes, rheumatoid arthritis and cardiovascular diseases. Chronic clinical conditions are considered to be among the leading causes of death and disability across the world.  Typically, in such cases, individuals are required to medicate on a daily basis. In addition to the cost of medication, such individuals are also burdened with a deteriorating quality of life, and often struggle with medication adherence.  According to the US Centers for Disease Control (CDC), the overall annual expense incurred by those living with chronic diseases is steadily growing and is currently estimated to be more than USD 3 trillion.  The development and commercialization of self-administrable dosage forms of drugs indicated to treat chronic clinical conditions has made a significant positive impact not only on the healthcare expenses borne by patients but also on compliance to prescribed therapeutic regimens. As the number of patients suffering from such disorders increase, the demand for more convenient and patient friendly drug delivery solutions is also on the rise.  Most self-injection devices / systems, such as autoinjectors and pen-injectors,  rely on prefilled syringes, which serve as primary drug containers in the aforementioned products. Moreover, despite having been in the market for more than three decades now, the overall interest in prefilled syringes continues to grow. In fact, the recent increase in use of biologics, which are usually administered via parenteral routes, has had a significant impact on the demand for prefilled syringes.  Over the years, significant improvements have been made to conventional prefilled syringes in order to further expand the scope of their applications. In this context, it is worth mentioning that dual / multi chambered syringes designed for the administration of lyophilized drugs are already available in the market. In such products, the syringe barrel is divided into two chambers, one of which contains the appropriate diluent for the prefilled (lyophilized) drug formulation. Likewise, there are multiple types of specialty syringes, including contrast agent containing syringes and flush syringes. Further, since the introduction and enforcement of the Needlestick Safety and Prevention Act in 2000, several medical device manufactures have developed add-on or integrated safety devices for prefilled syringes. In fact, by 2020, the incorporation of safety features in prefilled syringes is anticipated to be made mandatory across the world.  We are led to believe that the aforementioned developments are likely to fuel innovation and subsequent future growth in this market. Scope of the Report The ‘Prefilled Syringes Market (5th edition), 2019-2030’ report features an extensive study of the current market landscape of prefilled syringes and the likely future opportunities associated with such devices, over the next 10-12 years. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes: An overview of the current market landscape of companies engaged in manufacturing prefilled syringes, providing information on year of establishment, company size, geographical location of the headquarters and manufacturing facilities, type of material used (glass and plastic), number of barrel chambers (single chamber and dual chamber), type of needle system (fixed needle system, luer lock and luer cone) and syringe volume.  An overview of the current market landscape of companies that are developing drugs in combination with prefilled syringes, featuring information on year of establishment, company size, geographical location of the developers, target indication, phases of development, type of drug molecule, route of administration, approval year (for marketed products), dosage details (for marketed products) and other approved dosage forms (for marketed products).  A detailed competitiveness analysis of the various prefilled syringes that we came across, taking into consideration the supplier power (based on the employee size of developer / manufacturer and their respective annual revenues) and key product specifications, such as number of chambers in the barrel, number of needle systems, volume of the barrel, technological advancement / user-friendliness and other distinguishing features. A list of marketed drugs / therapies and pipeline candidates that are likely to be developed in combination with prefilled syringes in the near future, shortlisted based on an in-depth analysis that takes into consideration various relevant parameters, such as route of administration, type of drug molecule, target indications, other available dosage forms (for approved drugs) and historical annual sales information (for approved drugs). An analysis presenting potential strategic partners (primarily drug developers) for prefilled syringe manufacturers (with regard to likely collaboration opportunities for combination product development) based on different parameters, such as pipeline strength, target therapeutic indication(s) and developer strength. An analysis of the various prefilled syringe combination product-related initiatives of big pharma players, based on parameters, such as current adoption (based on number of approved and under development prefilled syringe combination products) and likely future adoption (based on potential injectable product candidates in the pipeline that are likely to be delivered via prefilled syringes), target therapeutic area(s) and type of drug molecule. A review of the landscape of contract fill / finish services providers that offer services for prefilled syringes, featuring a list of active (large-sized) service providers and analysis based on a number of relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), type of drug molecule (biologics and small molecules), and geographical location of the service provider.  A detailed discussion on various safety features (add-on and integrated devices) installed in recent versions of prefilled syringes and the companies involved in developing and manufacturing such solutions. An informative summary of various guidelines established and issued by major regulatory bodies for the approval of prefilled syringes, across different countries / geographical regions.   Brief discussions of currently available specialty syringes, which include prefilled flush syringes, prefilled diluent syringe systems and prefilled contrast agent delivery systems.  A case study on companies that are engaged in the manufacturing of autoinjectors, featuring brief profiles of key players in this domain; each profile includes an overview of the firm, and information on its respective product portfolio. Elaborate profiles of prominent prefilled syringe manufacturers engaged in this domain, featuring a brief overview of the company, its financial information (if available), information on product portfolio, recent developments and an informed future outlook. Elaborate profiles of prominent prefilled syringe component manufacturers, featuring a brief overview of the company, its financial information (if available), information on product portfolio, recent developments and an informed future outlook. One of the key objectives of the report was to evaluate the current market size and the future opportunity within the prefilled syringes market. Based on various relevant parameters, such as the number of commercialized combination products, annual adoption rate, and expected pricing, we have provided an informed estimate of the likely evolution of the market over the period 2019-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] therapeutic area (blood disorders, infectious diseases, autoimmune disorders, oncology disorders, neurological disorders, ophthalmic diseases and others), [B] type of syringe, [C] type of material (glass and plastic), [D] number of chambers (single chamber and dual chamber),  [E] type of drug molecule (antibodies, proteins, vaccines, small molecules, peptides, and others), and [F] key geographies (North America, Europe (the UK, France, Italy, Spain, Germany and the rest of Europe), Latin America (Brazil, Mexico, Argentina and the rest of Latin America), Asia Pacific (Japan, China, India, South Korea and the rest of Asia Pacific), and the Middle East and Africa (Saudi Arabia, UAE, Africa and the rest of the Middle East)).  The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The opinions and insights presented in the report were influenced by discussions held with several players in this industry. The study includes detailed transcripts of discussions held with the following individuals: Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies) Kirti Maheshwari (Chief Technical Officer, Intas Pharmaceuticals) Gregor Kawaletz (Chief Commercial Officer, IDT Biologika) Kevin Cancelliere and Tibor Hlobik (Marketing Directors, West Pharmaceutical Services) Marco Pederiva (Marketing & Sales Director, Lonstroff) Anonymous (Chief Executive Officer, Small-sized Medical Device Company) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030

According to the World Bank, more than 50,000 different types of medical devices are currently being used on a daily basis in healthcare facilities across the globe. In 2018, the global medical devices market was estimated to have reached a net worth of approximately USD 450 billion. It is also worth noting that, since January 2018, the USFDA approved over 130 medical devices. However, a relatively large proportion of developers lack the resources and technical expertise required to handle regulatory filings and effectively manage the processes associated with procuring marketing authorizations from regional regulators. Moreover, keeping up with evolving regulatory guidelines, rising costs of legal advice and increasing effort required for preparing of technical documentation, is difficult for companies with limited finances. In addition, establishing reimbursement strategies for medium to high-risk devices is also a complicated process and innovator companies usually do not have the expertise to deal with payers and insurance providers. According to a recent report, 68% of medical device companies reports prepared and submitted by in-house players are either rejected or were reported to have multiple major gaps in their clinical evaluation report (CER) and supporting evidences by the notified bodies. In fact. in a survey published in the 2016 edition of Global Medical Device Supply Chain, regulatory requirements were highlighted among the primary areas of concern within the medical device value chain. Furthermore, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments.  The aforementioned challenges have led many medical device developers, especially the smaller players and certain established companies as well, to outsource parts of their regulatory operations to capable contract research organizations (CROs). Generally, CROs are known to offer a number of benefits, which include cost benefits, reductions in time-to-market and, in this specific case, an in-depth and up-to date regulatory support. Given that the global demand for medical devices is increasing at a substantial pace, the opportunity for CROs with expertise in regulatory affairs management is also on the rise. In the foreseen future, the growing complexity of regulatory processes across various developing and developed geographies is likely to prompt more developers to outsource various aspects of their dealings with regulatory authorities. Moreover, in order to cope up with latest changes in medical device-related regulations, several legacy CROs are re-evaluating their operational models and business strategies. Owing to the anticipated rise in demand for such services, the contract regulatory services domain is likely to witness the entry of a number of new players in the foreseen future. Scope of the Report The ‘Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030’ report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe. Amongst other elements, the report includes: A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap analysis, technical dossier set-up, vigilance & medical device report, risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training)), region(s) of operation wherein the company is offering regulatory management services, and popular therapeutic area(s).  A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others). An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe. Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific). Each profile features a brief overview of the company, including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook. A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry. An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner. An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research. A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.  One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device regulatory affairs outsourcing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] types of regulatory affair management service offered (legal representation, project registration and clinical trial application, regulatory writing and publishing  and 6+ categories) [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the growth of the medical device regulatory affairs outsourcing CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders (in alphabetical order of company name):  Tania Persson, Business Development Manager, A+ Science Alexa Foltin-Mertgen, Business Development Manager, AtoZ-CRO Troy Mccall, Chief Operating Officer, CROMSOURCE Christian Wolflehner, Managing Director, Clinical Trial Specialist, CW Research & Management Antal Solyom, Director, Medical Device Unit, HungaroTrial Nazish Urooj, Senior manager, Medical & Clinical Operations, Metrics Research C Omprakash, Technical Director and Partner, Vyomus Consulting  All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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The Human Microbiome Market: Focus on Therapeutics (including gut-brain axis targeting drugs), Diagnostics and Fecal Microbiota Therapies (3rd Edition), 2019-2030

The human body is known to harbor numerous communities of microbes, including both beneficial and harmful species, which are collectively referred to as the microbiota. Likewise, the ecological system of commensal, symbiotic, and perhaps pathogenic microorganisms that reside within a host system is called the microbiome.  Research insights, generated primarily  from the Human Microbiome Project (2009) and other independent studies, have demonstrated that an imbalance in the microbiome (also known as dysbiosis) may lead to the development of several chronic clinical conditions, including Clostridium difficile infections (CDIs), irritable bowel syndrome (IBS), diabetes, Crohn’s disease and ulcerative colitis.  Given the role of the microbiota in both disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, defining a new frontier in the field of medicine. The growing popularity and interest in the therapeutic potential of the microbiome is evident across scientific literature; commonly cited terms in this context include microbiome, microflora, microbiota, fecal microbiota therapy (FMT), microbiome diagnostics, or human microbiome, as observed on the NCBI’s PubMed portal, over the last three years.  Over time, the efforts of industry stakeholders and clinical researchers in this domain have led to the discovery of novel therapeutic strategies, including the establishment of a gut-brain axis, involving the human microbiome. Despite the evident increase in interest (of therapy developers and investors alike) in this field of research, there are currently no approved microbiome-based drugs / therapy products available in the market. However, there is a FMT in the market that is designed to modulate the microbial population within the gut for the treatment of recurrent CDIs. This treatment has been shown to be particularly beneficial to those who are non-responsive to standard-of-care therapies. In addition, a number of microbiome diagnostic tests are available for the detection of digestive and gastrointestinal disorders, inflammatory diseases and certain oncological indications. Further, several technology developers have started using next-generation sequencing techniques and other versatile bioinformatics tools for the characterization of important species of gut microflora. It is also worth mentioning that, in the last 4-5 years, there has been a marked rise in the number of new entrants in this field. Interestingly, several big pharma players have also become actively involved in this domain. Given the fact that there are several candidate therapies in late phases of clinical development, the microbiome-based medical products market can be expected to witness substantial growth over the coming decade. Scope of the Report ‘The Human Microbiome Market: Focus on Therapeutics (including gut-brain axis targeting drugs), Diagnostics and Fecal Microbiota Therapies (3rd Edition), 2019-2030’ report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of microbiome-based medical products (including therapeutics, diagnostics and FMTs), over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape of microbiome therapeutics, providing information on drug / therapy developer(s) (such as year of establishment, location of headquarters and company size), clinical study sponsor(s) or collaborators, phase of development (clinical, preclinical, and discovery stage) of product candidates, type of molecule (small molecule and biologic), type of therapy (prebiotic, probiotic, and prescription drug), target indication(s), key therapeutic area(s), molecular / biological target (if available), mechanism of action (if available), route of administration, type of drug formulation (tablet, capsule, gel, lotion, cream, ointment, nasal spray and 4+ categories), dosing frequency (reported for clinical candidates only), and information on special drug designations (if any). In addition, the chapter highlights the various technology platforms that are being actively used for the development of microbiome therapeutics. Elaborate profiles of key players (established after 2005) that are engaged in the development of microbiome therapeutics (which are presently in both preclinical and clinical stages of development); each profile features a brief overview of the company, its financial information (if available), microbiome-based product portfolio, information on advanced stage (phase II and above) pipeline candidates (featuring a drug overview, current status of development, clinical trial information, and clinical trial end-point analysis) and an informed future outlook.  A discussion on the various types of diagnostic tests, specifically highlighting the importance of next-generation sequencing within this field of research, along with [A] a detailed review of the current market landscape of microbiome diagnostic tests, including the information on the developer(s) (such as year of establishment, location of headquarters and company size), stage of development (commercialized and under development), type of sample used (blood, feces, saliva and vaginal swab), target indication(s), key therapeutic area(s), result turnaround time, and purpose of diagnosis, [B] brief profiles of popular diagnostic developers, and [C] an indicative list of screening and profiling test kits, including information on the developer(s) (such as year of establishment, location of headquarters and company size), type of sample used (blood, feces, saliva and vaginal swab), key therapeutic area(s), and result turnaround time. A review of the historical evolution and other relevant aspects of FMT therapies, including details on the process of donor selection, therapy procedure, route of administration, important clinical guidelines, regulatory guidelines and insurance coverage, along with [A] a detailed assessment of the current market landscape of FMT therapies, providing information on FMT developer(s) (such as year of establishment, location of headquarters and company size), status of development (commercialized, clinical, and preclinical stage), target indication(s), key therapeutic area(s), and route of administration, [B] a geographical clinical trial analysis of ongoing / planned / completed studies of FMTs sponsored by non-industry players, featuring details related to specific FMT therapies and analysis based on relevant parameters, such as the number of registered trials, year of registration, current status, phase of development, study design, type of sponsor(s), target indication(s), key therapeutic area(s), key focus areas, number of patients enrolled and leading non-industry player(s), and [C] information on various stool banks (including year of establishment and location of headquarters), along with brief profiles of the most prominent stool banks located across the globe.   A detailed business portfolio analysis based on an attractiveness and competitiveness (AC) framework, highlighting the current market attractiveness and existing competition across the most popular disease indication(s) for which microbiome therapeutics are under investigation. An analysis of the varied microbiome-focused initiatives of big pharma players (out of top 20 established pharmaceutical players), featuring a [A] heat map representation that highlights microbiome therapeutics under development (in partnership with core microbiome product developers), along with information on funding, partnership activity,  and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), and [B] a spider web representation of the individual competitiveness of the initiatives of big pharma players based on multiple relevant parameters. An analysis of the start-ups / small-sized players (established in the last seven years, with less than 50 employees) engaged in the development of microbiome therapeutics and diagnostics, featuring heat map representation based on parameters, such as number of microbiome therapeutics under development, diversity of product portfolio, funding information (including funding amount, number of investors and evolution of investment activity), partnership activity, disease indication(s) being treated and focus therapeutic area(s), and strength of intellectual property portfolio. An assessment of the most commonly targeted therapeutic indications and details of microbiome-based drugs that are being developed against them, highlighting key epidemiological facts about specific diseases, available methods of diagnosis, and currently available treatment options and their side effects. An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in start-ups / small-sized companies (established in last seven years, with less than 50 employees) that are focused on developing microbiome therapeutics and diagnostics. An elaborate discussion on the various steps involved in the development and manufacturing of microbiome therapeutics, along with [A] an indicative list of contract manufacturers, along with details on year of establishment, location of headquarters, company size, scale of operation, facility location and microbiome production capacity, [B] an indicative list of companies with in-house manufacturing facilities for microbiome therapeutics, along with details on year of establishment, location of headquarters, and company size, [C] an indicative list of CROs that currently claim to have the necessary capabilities to offer various research services (such as screening, sequencing, characterization, analytical), along with details on year of establishment, location of headquarters, company size, and service portfolio details, and [D] an insightful Harvey ball analysis of key considerations that need to be taken into account by industry stakeholders while selecting a suitable CMO / CRO partner. An assessment of the emerging role of big data, highlighting efforts focused on the development and implementation of various algorithms / tools to analyze data generated from microbiome research along with [A] an insightful google trends analysis to demonstrate the rising interest of stakeholders in using big data tools to support microbiome research over the past decade, [B] a list of companies offering big data-related services / tools to support microbiome research, and [C] brief profiles of some of the popular companies that are engaged in this field of research. An informative case study on the various other applications of microbiome products, such as agriculture, animal health, plant health, food products, featuring a list of nearly 80 products, including probiotic supplements, cosmetics, and over-the-counter (OTC) products that are being used as dietary supplements. One of the key objectives of the report was to estimate the existing market size and identify the future opportunity for microbiome therapeutics, diagnostics and FMTs, over the next decade. The research, analyses and insights presented in this report are based on revenue generation trends based on the sales of approved / late stage (estimated) microbiome therapeutics, diagnostic products and FMTs. The report also features the likely distribution of the current and forecasted opportunity within microbiome therapeutics market across [A] type of therapy (prescription drugs, prebiotics, and probiotics), [B] type of molecule (small molecules and biologics), [C] target indication (acne vulgaris, atopic dermatitis, CDI, Crohn’s disease, diabetes, irritable bowel syndrome, lactose intolerance, nonalcoholic steatohepatitis (NASH), ulcerative colitis, and 5+ categories), [D] therapeutic area (autoimmune disorders, dental disorders, digestive and gastrointestinal disorders, dermatological disorders, infectious diseases, metabolic disorders, oncology, and others), [E] supply channel (hospital pharmacies, retail pharmacies, and online pharmacies), [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world), [G] leading drug developers, and [H] leading therapeutic products. In addition, it also features the likely distribution of the current and forecasted opportunity within microbiome diagnostics market across [A] target indication (Crohn’s disease, colorectal cancer, diabetes, irritable bowel syndrome, lung cancer, NASH, obesity, and ulcerative colitis), [B] therapeutic area (digestive and gastrointestinal disorders, metabolic disorders and oncology), [C] supply channel (hospital pharmacies, retail pharmacies, and online pharmacies), and [D] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for the uncertainties associated with the growth of microbiome market and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.       The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company / organization names): Lee Jones (President and Chief Executive Officer, Rebiotix) Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic) Colleen Cutcliffe (Co-founder and Chief Executive Officer, Whole Biome) Nikole E Kimes (Co-founder and Vice President, Siolta Therapeutics) James Burges (Executive Director, OpenBiome) JP Benya (Vice President, Business Development, Assembly Biosciences) Debbie Pinkston (Vice President, Sales and Business Development, List Biological Laboratories) Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)  Mark Heiman (Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics)  Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies) Assaf Oron (Chief Business Officer, BiomX) Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra) Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical) Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Novel Vaccine Delivery Devices Market, 2019-2030

According to experts, the global vaccines market is anticipated to generate revenues worth USD 100 billion by 2025.  Data presented by the WHO indicates that the current global vaccination coverage is nearly 85%; this is believed to be responsible for preventing close to three million deaths from diseases, such as diphtheria, tetanus, whooping cough and measles.  Recent global immunization records indicate that more than 115 million children were immunized against diphtheria, tetanus and pertussis in 2018.  Given the rate at which the global population is growing, the demand for vaccines is likely to increase significantly. However, biopharmaceutical developers are plagued by concerns related to storage and handling of such preventive / therapeutic products.  One commonly reported issue is related to vaccine administration. Despite the success of conventional delivery approaches, which rely on the intramuscular and subcutaneous routes of administration, the present scenario dictates that further improvements are required in order to deal with challenges related to large scale immunization initiatives. Some of the commonly reported disadvantages of the conventional (parenteral) mode of delivery include pain during administration, risk of cross contamination, needlestick injuries, and inaccurate dosing.  Of late, there has been an evident shift in interest to non-invasive immunization methods, which include oral, intranasal and transdermal modes of administration. Currently, many biopharmaceutical companies and clinical research institutes are engaged in the development of novel vaccine delivery systems, taking into consideration the specific requirements of large scale immunization initiatives. As a result, significant efforts have been put into the development of drug delivery technologies / devices, such as microneedle patches, electroporation-based needle free injection systems, jet injectors, inhalation-based delivery systems, biodegradable implants and certain novel types of oral delivery systems. It is worth highlighting that most of the aforementioned systems are specifically being designed to facilitate pain-free administration of vaccines and allow self-administration. Vaccine developers are also attempting to devise ways to make such products more stable so as to eliminate the need for cold chain in transporting such products. Given the pace of innovation in this field, it is anticipated that the novel vaccine delivery devices market is likely to witness radical changes in the coming years.  Scope of the Report The “Novel Vaccine Delivery Devices Market, 2019-2030” report features an extensive study of the current landscape and the likely future opportunities associated with novel vaccine delivery devices, over the next 10-12 years. Amongst other elements, the report includes: A detailed assessment of the overall novel vaccine delivery devices market landscape, featuring an elaborate list of device developers and analysis based on a number of relevant parameters, such as year of establishment, company size, geographical location, type of device (autoinjectors, microneedle patches, jet injectors, dry powder inhalers, microinjectors, nasal delivery systems, pen injectors, biodegradable implants, electroporation-based needle free injection systems and novel oral delivery systems), route of administration (subcutaneous, transdermal, intramuscular, intradermal, inhalation, intranasal, and oral), drug delivery mechanism (mechanical, electrical and miscellaneous), nature of vaccine administration (invasive and non-invasive), speed of administration (fast, moderate and slow), self- administration potential, provisions for audio / visual feedback, device usability (disposable and reusable), type of needle (needleless, fixed needle, detachable needle, and hidden needle), and current development status of novel vaccine delivery systems (preclinical / discovery, clinical and marketed). A detailed competitiveness analysis of novel vaccine delivery devices, taking into consideration the supplier power (based on the year of establishment of developer company) and key product specifications (such as route of administration, device usability, drug delivery mechanism, availability of needle safety system, speed of administration, self-administration potential, provisions for audio / visual feedback, nature of administration, cold chain requirement and current status of development). An analysis evaluating the effectiveness of various vaccines delivery devices in order to compare their respective strengths and capabilities based on a variety of relevant parameters, such as type of active ingredient, dosage form, route of administration, target disease indication and target patient population. A detailed list of marketed and pipeline vaccine candidates that are anticipated to be developed in combination with novel vaccine delivery devices in the near future, featuring analysis based on parameters, such as type of active ingredient, dosage form, route of administration, target disease indication and target patient population.  Elaborate profiles of prominent product developers engaged in this domain; each profile features a brief overview of the company, its financial information (if available), information on its product portfolio, recent developments and an informed future outlook. An analysis of recent collaborations and partnership agreements inked in this domain since 2014, including details of deals that were / are focused on novel vaccine delivery devices. The partnerships captured in the report were analyzed on the basis of year of establishment, type of agreement, type of device, type of vaccine, type of active ingredient and target disease indication. A discussion on important, industry-specific trends, key market drivers and challenges, under a comprehensive SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market. One of the key objectives of the report was to estimate the existing market size and assess potential future growth opportunities for novel vaccine delivery devices. Based on various parameters, such as number of marketed / pipeline products, price of devices (for commercially available products only) and estimated annual adoption rate, we have developed an informed estimate on the likely evolution of the market over the period 2019-2030. In addition, we have provided the likely distribution of the current and forecasted opportunities across [A] type of device (electroporation-based needle free injection systems, oral delivery systems, nasal delivery systems, jet injectors, microneedle patches and microinjectors), [B] route of administration (oral, intramuscular, intranasal, intradermal and subcutaneous), [C] type of vaccine (Bivalent Oral Polio Vaccine, BCG Vaccine, DTP-HepB-Hib Vaccine, Pneumococcal Conjugate Vaccine, Influenza Vaccine, Measles Vaccine, Tetanus-Diphtheria Vaccine and Others) and [D] key geographical regions (North America, Europe, Asia and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Michael Schrader, Chief Executive Officer and Founder, Vaxess Technologies Mikael Ekstrom and Roger Lassing, Vice President, Business Development, Iconovo Henry King, Market Intelligence and Business Development Manager, Innoture All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Liquid Biopsy and Other Non-Invasive Cancer Diagnostics Market (3rd Edition), 2019-2030: Focus on Circulating Tumor Markers such as CTCs, ctDNA, cfDNA, Exosomes and Other Biomarkers

Cancer is known to be one of the leading causes of death worldwide. In 2019, 0.6 million deaths due to cancer are estimated in the US alone.  Moreover, the World Health Organization has estimated the number of new cancer cases to rise by 70% over the next 20 years.  One of the primary reasons for the high mortality associated with this condition is believed to be late diagnosis. This results in delayed treatment, which severely compromises chances of survival. For many years, tissue biopsy has been considered the gold standard for cancer diagnosis. However, owing to the invasive nature of the test, biopsies cannot be repeated frequently to assess / measure disease progression or monitor therapeutic outcome. In fact, in some cases, it is not possible to carry out a biopsy because the affected tissue / organ is not amenable to undergo such a painful and traumatic procedure. This has resulted in a significant unmet need for safer and more patient friendly cancer diagnostics that are capable of offering accurate test results.  Advances in the field of biotechnology have enabled the establishment of several minimally invasive / non-invasive approaches for disease diagnosis. Amongst other promising diagnostic tools, liquid biopsy has emerged as a versatile and promising non-invasive cancer diagnostic tool. This procedure is based on the analysis of biofluids (such as blood, urine and / or plasma) in order to detect rare forms of biomarkers / tumor markers, such as circulating tumor cells (CTCs), circulating tumor DNA / RNA (ctNAs), circulating free DNA (cfDNA) and exosomes. Moreover, liquid biopsies have been demonstrated to be capable of assessing the stage of tumor at the time of sample extraction. Additionally, owing to the non-invasive nature of the test, it can be actively used to monitor / track changes in tumors, both before and during the course of treatment. Other than liquid biopsy, the cancer diagnostics market has witnessed the emergence of several other non-invasive diagnostic technologies, which are based on analytes that are either superficially located (such as skin lesions) and / or are expelled from the body (such as bronchial fluids and exhaled breath). Most of the non-invasive diagnostic techniques mentioned above are backed by clinical data, validating their relevance and applicability across several types of solid tumors (such as breast cancer, lung cancer, ovarian cancer and pancreatic cancer) and hematological malignancies (such as leukemia and lymphoma). In future, non-invasive cancer diagnosis methods, particularly liquid biopsies, are anticipated to replace the existing invasive diagnostic techniques.  Scope of the Report The 'Liquid Biopsy and Other Non-Invasive Cancer Diagnostics Market (3rd Edition), 2019-2030: Focus on Circulating Tumor Markers such as CTCs, ctDNA, cfDNA, Exosomes and Other Biomarkers' report provides an extensive study on liquid biopsy kits / assays that are either commercialized or are under development for diagnosis and / or monitoring of different types of cancer. In addition, it features an elaborate discussion on the likely future opportunity associated with such tests, over the next 10 years. Amongst other elements, the report includes: A detailed review of the overall landscape of the non-invasive cancer diagnostics market, featuring information on the developers of such products and analyses based on a number of relevant parameters, such as year of establishment, company size, geographical location, current development status of proprietary liquid biopsy test (under development, research use only, and available), type of product (assay kit, software / algorithm and device), type of tumor marker analyzed (CTCs, ctDNA, cfDNA, exosomes, and others), key applications (early diagnosis, treatment selection, patient monitoring and recurrence monitoring), type of analyte used (blood, urine and others) and target cancer indications. An analysis of the various partnerships pertaining to non-invasive cancer diagnostics, which have been established between 2016 and 2019, based on various parameters, such as type of partnership, year of partnership, type of tumor marker, target cancer indications and the most active players. An analysis of the investments made in companies engaged in the development of non-invasive cancer diagnostics, including details of seed financing, venture capital financing, debt financing, grants, and capital raised via IPOs and subsequent public offerings. An analysis of the initiatives of big pharma players , highlighting the key focus areas of such companies and analysis based on various relevant parameters, such as stage of development of their proprietary non-invasive cancer diagnostic test(s), key applications, type of tumor marker and target disease indications. A detailed acquisition target analysis, taking into consideration the historical trend of the activity of the companies that have acquired other firms since 2016, and offering a means for other industry stakeholders to identify potential acquisition targets. Elaborate profiles of the key players engaged in this domain, featuring a brief overview of the company, its financial information (if available), a detailed description of its product portfolio, recent developments and an informed future outlook. One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for non-invasive cancer diagnostics. Based on various parameters, such as number of available / under development products and estimated annual adoption rates, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] type of tumor marker (ctDNA, cfDNA, CTCs, exosomes, and others), [B] key applications (early diagnosis, patient monitoring and recurrence monitoring), [C] target disease indications (breast cancer, lung cancer, colorectal cancer, prostate cancer, bladder cancer, melanoma, gastric cancer, pancreatic cancer, ovarian cancer, and others), [D] end users (hospitals, research institutes and others), and [E] key geographical regions (the US, the UK, Germany, Italy, Spain, France, Japan, Australia, China, India, and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Shibichakravarthy Kannan, Founder and CEO, Theranosis Life Sciences Abizar Lakdawalla, Founder, ProXeom Philippe Nore, CEO and Co-founder, MiNDERA Corporation Frank Szczepanski, President and CEO, IVDiagnostics Mark Li, CEO, Resolution Bioscience Brad Walsh, CEO, Minomic International Joachim Fluhrer, Founder and Medical Director, GenosticsAnton Iliuk, President and Chief Technology Officer, Tymora Analytical Operations Burkhard Jansen, Chief Medical Officer, DermTech Christer Ericsson, Chief Scientific Officer, iCellate Medical Jake Micallef, Chief Scientific Officer, VolitionRx Nathalie Bernard, Marketing Director, OncoDNA Riccardo Razzini, Sales and Marketing Manager, LCM Genect Peter French, Strategic Technology Advisor, Sienna Cancer Diagnostics All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell and Advanced Therapies Supply Chain Management Market, 2019-2030: Focus on Technological Solutions (Cell Orchestration Platforms, Enterprise Manufacturing Systems, Inventory Management Systems, Laboratory Information Management Systems, Logistics Management Systems, Patient Management Systems, Quality Management Systems, Tracking & Tracing Systems, and Other Software)

Advanced therapy medicinal products, such as cell and gene therapies, have revolutionized healthcare practices. The introduction of such treatment options has led to a paradigm shift in drug development, production and consumption. Moreover, such therapies have actually enabled healthcare providers to treat several difficult-to-treat clinical conditions. In the past two decades, more than 30 such therapy products have been approved; recent approvals include Zolgensma® (2019), RECELL® System (2018), AmnioFix® (2018), EpiFix® (2018), EpiBurn® (2018), Alofisel® (2018), LUXTURNA™ (2017), Yescarta® (2017), and Kymriah® (2017). Further, according to a report published by The Alliance for Regenerative Medicine in 2019, more than 1,000 clinical trials are being conducted across the globe by over 900 companies. In 2018, around USD 13 billion was invested in this domain, representing a 73% increase in capital investments in this domain, compared to the previous year.  It is worth highlighting that, based on an assessment of the current pipeline of cell therapies and the historical clinical success of such products, it is likely that around 10-20 advanced therapies are approved by the US FDA each year, till 2025.  The commercial success of cell and advanced therapies is not only tied to whether they are capable of offering the desired therapeutic benefits, but also on whether the developers are able to effectively address all supply chain requirements. The advanced therapy medicinal products supply chain is relatively more complex compared to the conventional pharmaceutical supply chain. As a result, there are a number of risks, such as possible operational inefficiencies, capacity scheduling concerns, process delays leading to capital losses, and deliverable tracking-related issues, which need to be taken into consideration by therapy developers. This has generated a need for bespoke technological solutions, which can be integrated into existing processes to enable the engaged stakeholders to oversee and manage the various aspects of the cell and advanced therapies supply chain, in compliance to global regulatory standards. Over the years, several innovative, software-enabled systems, offering supply chain orchestration and needle-to-needle traceability, have been developed. The market has also recently witnessed the establishment of numerous partnerships, most of which are agreements between therapy developers and software solutions providers. Further, given the growing demand for cost-effective personalized medicinal products, and a myriad of other benefits of implementing such software solutions, the niche market is poised to grow significantly in the foreseen future. Scope of the Report The ‘Cell and Advanced Therapies Supply Chain Management Market: Focus on Technological Solutions, 2019-2030’ report features an extensive study of the growing supply chain management software solutions market. The focus of this study is on software systems, including cell orchestration platforms (COP), enterprise manufacturing systems (EMS), inventory management systems (IMS), laboratory information management systems (LIMS), logistics management systems (LMS), patient management systems (PMS), quality management systems (QMS), tracking and tracing software (TTS), and other such platforms that are being used to improve / optimize various supply chain-related processes of cell and advanced therapies. Amongst other elements, the report features: A detailed assessment of the current market landscape, featuring a comprehensive list of over 160 technological platforms that are being used to manage the cell and advanced therapies supply chain, along with information on the different types of software systems (COP, EMS, IMS, LIMS, LMS, PMS, QMS, TTS, and others), their key specifications and benefits (chain of identity and custody, compatibility and integration, data management and analytics, regulatory compliance, reliability and security, scalability, software-as-a-service, traceability, user-friendliness, workflow management, and others), affiliated modes of deployment (cloud and on-premises), scale of management (small enterprise, mid-size enterprise and large enterprise), end users (biobanks, cell therapy labs, hospitals, research institutes, commercial organizations, and others), applications (ordering and scheduling, sample collection, manufacturing, logistics, and patient verification and treatment follow-up), regulatory certifications / accreditations (21 CFR Part 11, CLIA, FACT-JACIE, GAMP 5, GDPR, HIPAA, and others), and key support services offered (customization, installation / implementation, maintenance, training / technical support, upgradation, validation and testing, and others). An insightful company competitiveness analysis, taking into consideration the supplier power (based on their employee base and years of experience in the industry) and portfolio-related parameters, such as number of software solutions offered, affiliated modes of deployment, scale of management, end users, applications, regulatory certifications / accreditations, support services offered, and key platform specifications and benefits. Comprehensive profiles of industry players that are currently offering software solutions for supply chain management, featuring an overview of the company, its financial information (if available), and a detailed description of its software system(s). Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth, in the foreseen future. A detailed review of the cell and advanced therapies supply chain, offering insights on the processes associated with various stages, such as donor eligibility assessment, sample collection, manufacturing, logistics, and patient verification and treatment follow-up, along with information on cost requirements and existing opportunities for improvement in the supply chain management practices. A qualitative assessment of the current and long-term needs of different stakeholders (patients, healthcare providers, collection centers, manufacturers, logistics service providers and regulators / payers) involved in the cell and advanced therapies supply chain, featuring a summary of the diverse needs and areas of concern, along with our opinion (based on past and prevalent trends) on how the industry is preparing to address such issues.  An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are engaged in this field. An analysis of the partnerships that have been established in the domain, in the period between 2014 and Q3 2019, covering software licensing agreements, mergers and acquisitions, product development agreements, product integration agreements, distribution agreements, asset purchase agreements, and other relevant deals. A detailed analysis of the platform utilization use cases where aforementioned software systems were leveraged by various stakeholders in the domain, in the period between 2014 and Q3 2019, highlighting the ways in which companies have implemented such systems to improve / optimize various supply chain-related processes of cell and advanced therapies. An in-depth analysis of the cost saving potential across various processes of the cell and advanced therapies supply chain that can be brought about by the implementation of bespoke and integrated technological solutions / software systems. A case study on COPs, featuring insights on their key functions and implementation strategies, while also considering their strategic position and connectivity with other adjacent systems within the cell and advanced therapies supply chain. In addition, it provides a brief discussion on the growing popularity of COPs on the social media platform, Twitter. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the supply chain management software solutions market. Based on multiple parameters, such as number of cell and advanced therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different software systems, we have developed informed estimates of the evolution of the market, over the period 2019-2030. In addition, we have provided the likely distribution of the current and forecasted opportunity across [A] different software systems (COP, EMS, IMS, LIMS, LMS, PMS, QMS, and TTS), [B] applications (donor eligibility assessment, sample collection, manufacturing, logistics, and patient verification and treatment follow-up), [C] modes of deployment (cloud and on-premises), [D] end users (biobanks, cell therapy labs, hospitals, research institutes, and commercial organizations), and [E] key geographical regions (North America, Europe and Asia-Pacific). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:  Bryan Poltilove (Vice President and General Manager, Thermo Fisher Scientific) Jacqueline Barry (Chief Clinical Officer, Cell and Gene Therapy Catapult) Jill Maddux (Director, Cell and Gene Therapy Product Strategy, McKesson) and Divya Iyer (Senior Director, Corporate Strategy and Business Development, McKesson) Martin Lamb (Chief Business Officer, TrakCel) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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RNAi Therapeutics Market (2nd Edition), 2019 - 2030

The concept of RNA interference (RNAi) was identified in the 1980s. It is based on the selective silencing of specific sequences of mRNA, thereby, inhibiting the ability to translate into disease causing proteins. This phenomenon was first demonstrated in the petunia flower and later studied in C. elegans. Interestingly, the discovery was awarded the Nobel Prize in 2006.  Even though the technique was discovered less than two decades ago, RNAi has had a significant impact within the pharmaceutical domain, and currently there is a robust pipeline of drug candidates based on this principle. The approval of the first RNAi therapeutic, ONPATTRO® (developed by Alnylam Pharmaceuticals), in August 2018 by the USFDA and the EMA, has led to a rise in the interest in this field. ,   In fact, the growing popularity of this upcoming class of targeted therapeutics can also be validated by the substantial increase (more than 85%) in the number of patents that have been filed / granted between the period 2014-2019.  It is worth noting that a variety of RNAi therapeutics, targeting a wide range of therapeutic areas, have already been discovered / developed. However, certain challenges exist; these include concerns related to renal and reticuloendothelial clearance, low extravasation and tissue perfusion and cellular update of nucleic acid-based payloads. Presently, various technology developers are actively engaged in the development of novel technologies and improvement of existing platforms, thereby, attempting to enhance and optimize both RNAi payloads and affiliated excipients. Experts believe that some of the more complex and technical challenges in this domain may need the combined efforts of both synthetic chemists and biologists. In this context, it is important to highlight that substantial collaboration activity, related to RNAi, has been reported in the recent past. Several big pharma players have also demonstrated renewed interest in this field of research. Moreover, during the same time period, more than USD 5.5 billion in capital has been invested by various private and public investors to fund research activities in this domain. Given the pace of innovation and developments in this upcoming market, we can expect RNAi therapeutics to become a major therapeutic modality in the foreseen future. Scope of the Report The “RNAi Therapeutics Market (2nd Edition), 2019-2030: Focus On siRNA, miRNA, shRNA and DNA” report features an extensive study of the current market landscape and future opportunities associated with RNAi therapeutics. The study also features a detailed analysis of key drivers and trends within this evolving market. Amongst other elements, the report includes: A detailed review of the overall landscape of companies developing RNAi therapeutics, including information on phase of development (marketed, clinical, and preclinical / discovery stage) of pipeline candidates, target disease indication(s), key therapeutic areas (oncological disorders, infectious diseases, genetic disorders, ophthalmic diseases, respiratory disorders, hepatic disorders, metabolic disorders, cardiovascular disorders, dermatological disorders, and others),  type of RNAi molecule (siRNA, miRNA, shRNA, sshRNA and DNA), target genes, type of delivery system used, route of administration and special drug designations (if any). A competitiveness analysis of key players engaged in this domain, evaluating their respective product portfolios, type of RNAi molecule, target therapeutic areas, company size and year of establishment. An analysis of completed, ongoing and planned clinical studies for different types of RNAi molecules. The trials were analyzed on the basis of various relevant parameters, such as registration year, current status, phase of development, type of RNAi molecule, regional distribution of clinical trials and enrolled patient population. An in-depth analysis of the various patents that have been filed / granted related to RNAi therapeutics, since 2014. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, regional applicability, CPC symbols, emerging focus areas, leading industry / non-industry players (in terms of the number of patents filed / granted), and patent valuation. An analysis of the various partnerships pertaining to RNAi therapeutics, which have been established till August 2019, based on various parameters, such as the type of partnership, year of partnership, target disease indications, therapeutic area, type of RNAi molecule, financial details (wherever applicable), focus area of collaboration and most active players. An analysis of the investments made at various stages of development in companies engaged in this domain, between 2014-2019, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other offerings. An analysis of the key promotional strategies that have been adopted by developers of marketed oligonucleotide therapeutics, namely Defitelio®, Exondys® and Onpattro®. A review of emerging technology platforms and delivery systems that are being used for targeted therapeutic delivery, featuring detailed profiles of technologies.  Detailed profiles of drug candidates that are in the advanced stages of development (phase II/III and above), including information on their current development status, mechanism of action, route of administration, affiliated delivery technology, dosage, recent clinical trial results along with information on their respective developers. An elaborate discussion on the use of miRNA as a potential biomarker, along with a list of diagnostic kits that are either available in the market, or likely to be approved in the foreseen future. One of the key objectives of the report was to estimate the existing market size and the future growth potential within the RNAi therapeutics market, over the coming decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the financial evolution of the market for the period 2019-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (oncological disorders, genetic disorders, metabolic disorders, hematological disorders, ophthalmic disorders and others), [B] route of administration (subcutaneous, intravenous, topical and intradermal),  [C] share of leading industry players, [D] type of RNAi molecule and [E] key geographical regions (US, Europe and Asia-Pacific). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interview(s) held with Amotz Shemi, CEO, Silenseed. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Genome Editing Services Market-Focus on CRISPR 2019-2030

The 1970s witnessed the introduction of one of the most revolutionary advances in biotechnology, when Hamilton Smith (a molecular biologist at Johns Hopkins University School of Medicine) purified the first site-specific restriction enzyme, called Hind II. This development enabled the scientific community to devise the means to manipulate living organisms at the genetic level, opening up a plethora of opportunities in fundamental and applied life science research. Soon after, in the 1980s, the US FDA approved the world’s first genetically engineered drug, which was human insulin marketed under the brand name HUMULIN®. Genetic engineering and genome editing concepts have evolved significantly over the last two decades, with the development of a variety of versatile DNA modulation technologies including zinc finger nucleases, transcription activator-like effector-based nucleases (TALENs), and the clustered regularly interspaced short palindromic repeats (CRISPR). These developments have enabled medical researchers to perform an array of gene / cell line engineering experiments, including gene knockdowns, gene overexpressions and single base editing, for a variety of R&D applications. It is worth highlighting that, of all the available genome manipulation technologies, CRISPR is currently considered to be the most popular tool, owing to its fast, accurate, and cost-effective approach. In fact, in 2018, scientists Emmanuelle Charpentier, Jennifer Doudna, and Virginijus Siksnys were felicitated for their pioneering efforts on the CRISPR-Cas9 technology, with the prestigious Kavli Prize in Nanoscience.   Currently, there is an evident increase in demand for complex biological therapies (including regenerative medicine products), which has created an urgent need for robust genome editing techniques. The biopharmaceutical pipeline includes close to 500 gene therapies, several of which are being developed based on the CRISPR technology. Recently, in July 2019, a first in vivo clinical trial for a CRISPR-based therapy was initiated. However, successful gene manipulation efforts involve complex experimental protocols and advanced molecular biology centered infrastructure. Therefore, many biopharmaceutical researchers and developers have demonstrated a preference to outsource such operations to capable contract service providers. Consequently, the genome editing contract services market was established and has grown to become an indispensable segment of the modern healthcare industry, offering a range of services, such as gRNA design and construction, cell line development (involving gene knockout, gene knockin, tagging and others) and transgenic animal model generation (such as knockout mice). Additionally, there are several players focused on developing advanced technology platforms that are intended to improve / augment existing gene editing tools, especially the CRISPR-based genome editing processes. Given the rising interest in personalized medicine, a number of strategic investors are presently willing to back genetic engineering focused initiatives. Prevalent trends indicate that the market for CRISPR-based genome editing services is likely to grow at a significant pace in the foreseen future. The “Genome Editing Services Market: Focus on CRISPR, 2019-2030” report features an extensive study of the current landscape of CRISPR-based genome editing service providers. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographical regions. Amongst other elements, the report includes: A detailed assessment of the current market landscape, featuring an elaborate list of over 80 companies that offer CRISPR-based genome editing services, and analyses based on a number of relevant parameters, such as type of gRNA service, availability of gRNA format, type of endonuclease, type of Cas9 endonuclease format, type of cell line engineering offering, type of cell line, type of animal model generation offering, availability of CRISPR libraries and important service provider details (year of establishment, company size and location of headquarters).   An insightful 2X2 representation, highlighting the competitiveness of various CRISPR-based genome editing service providers captured in our database (segregated across various peer groups based on company size), taking into consideration the supplier power and the specific genome editing capabilities (which include gRNA service(s), endonuclease service(s), cell line engineering service(s), animal model generation service(s) and availability of CRISPR library(s)) of different companies. Elaborate profiles of key players (shortlisted based on strength of service portfolio), featuring a brief overview of the company, its financial performance (if available), a detailed description of its genome editing service offerings, recent developments and an informed future outlook. An in-depth analysis of over 10,000 patents related to CRISPR technology that have been filed / granted, since 2006, highlighting key trends associated with these patents, across type of patent, publication year and application year, regional applicability, CPC symbols, emerging focus areas, leading patent assignees (in terms of number of patents filed / granted), patent benhcmarking and valuation.   A detailed analysis of close to 2,000 grants that have been awarded to support research projects related to CRISPR, between 2015 and 2019 (till September), highlighting important parameters, such as year of award, amount awarded, administring institute center, support period, funding mechanism, type of grant application, grant activity, type of recipient organization, regional distribution of recipient organization, prominent project leaders and emerging focus areas. It also features a detailed multivariate grant attractiveness analysis based on the amount awarded, support period, grant type and funding mechanism. A discussion on the advanced technologies and systems that have been developed to improve CRISPR-related processes. It includes a list of companies that have developed such innovative technology platforms, along with details on a number of relevant parameters, such as year of establishment, company size, core expertise, location of headquarters and important technology specifications (including technology name, focus area and key features). In addition, it includes short profiles of key technology providers. Further, the chapter highlights a list of companies that offer CRISPR kits and CRISPR design tools. An analysis highlighting potential strategic partners, segregated based on likelihood of entering into collaboration with CRISPR-based genome editing services providers. The analysis takes into consideration multiple relevant parameters, such as type of therapy, pipeline strength, pipeline maturity, company strength and therapeutic area. A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market. One of the key objectives of the report was to evaluate the current opportunity and the future potential of CRISPR-based genome editing services market. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have segmented the future opportunity across [A] type of services offered (gRNA construction, cell line engineering and animal model generation), [B] type of cell line used (mammalian, microbial, insect and others) and [C] different geographical regions (North America, Europe, Asia Pacific and rest of the world). To account for the uncertainties associated with the CRISPR-based genome editing services market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.      The research, analysis and insights presented in this report are backed by a deep understanding of key insights generated from both secondary and primary research. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Microneedles and Needle-Free Injection Systems / Jet Injectors (Devices based on Spring, Gas and Other Mechanisms) Market, 2019-2030

Chronic clinical conditions, such as diabetes, cardiovascular disorders, certain types of neurological disorders, and cancer, are considered to be among the leading causes of death and disability across the world.  The Center for Managing Chronic Disease at the University of Michigan recently reported that over 50% of the global population is suffering from some form of chronic disease.  Despite significant advances in drug / therapy development for the treatment of chronic diseases, there are several concerns related to the delivery of such therapeutics. Since most medications are developed for parenteral delivery, dosing errors and accidental needlestick injuries are some of the primary areas of concern. In fact, needle phobia is officially recognized as a medical condition by the American Psychiatric Association in its Diagnostic and Statistical Manual of Mental Disorders and is known to affect nearly 10% of the population.  The Needlestick Safety and Prevention Act, which was signed into law in the US in November 2000,  encouraged the development of a variety of needleless syringes / safety syringes, such as needle-free injection systems, microneedle patches and microneedle pens. A sustained focus towards self-injection has also facilitated significant advances in drug development and administration. In fact, the self-injection devices market is characterized by the presence of a myriad of advanced and innovative drug delivery solutions, such as (in alphabetical order) autoinjectors, jet injectors, large volume wearable injectors, microneedles, pen injectors, needleless syringes and prefilled syringes.  The concept of needle free drug delivery is realized using a variety of actuation mechanisms (such as spring- or gas-powered devices) that are capable of facilitating the delivery of therapeutic interventions without the use of needles. On the other hand, microneedles are extremely minute needles (of the order of a few micrometers), which are designed to deliver drugs across the dermis. It is worth highlighting that such delivery systems are primarily based on the subcutaneous / intradermal and transdermal routes. The field of needleless drug delivery continues to witness significant advances, in terms of innovation in drug / therapy administration (such as dose tracking and real-time updates) and the development of compatible drug formulations.  As a result, several stakeholders in the healthcare industry have developed interest in this upcoming field, and have launched product development / commercialization initiatives in the recent past.  Scope of ther Report The “Microneedles and Needle-Free Injection Systems / Jet Injectors (Devices based on Spring, Gas and Other Mechanisms) Market, 2019-2030” report features an extensive study of the current landscape and the likely future opportunities associated with the needle-free injection systems and microneedles market, over the next 10-12 years. Amongst other elements, the report includes: A detailed review of the overall landscape of the needle-free injection systems market, featuring a comprehensive list of device developers and analysis based on a number of parameters, such as year of establishment, company size, geographical location, current development status of various products (under development and commercialized), details on intellectual property portfolio, route of administration (subcutaneous, intramuscular, intradermal and others), type of load (solid and liquid), usability (disposable and reusable), actuation mechanism (spring-based, gas-powered and others), capacity of the device (in terms of volume of drug delivered) and target disease areas.    An overview of the current market landscape of microneedle devices, featuring a comprehensive list of device developers and analysis based on a number of parameters, such as year of establishment, company size, geographical location, current development status of various products (under development and commercialized), details on intellectual property portfolio, type of microneedle device (hollow, solid and dissolving), route of administration (subcutaneous, transdermal, intradermal and others), microneedle length and target disease areas. A detailed product competitiveness analysis of both needle-free injection systems and microneedle devices, taking into consideration the supplier power (based on the year of establishment of developer company) and key product specifications. For needle-free injection systems, specifications, such as therapeutic area, route of administration, maximum device volume, usability, size of intellectual property portfolio, and commercial availability, were considered. For microneedles, specifications, such as therapeutic area, route of administration, length of microneedle, and size of intellectual property portfolio, were considered. A list of marketed drugs / therapies and pipeline candidates that are anticipated to be developed in combination with needle free injectors and microneedles in the near future; the analysis is based on a variety of relevant parameters, such as (in alphabetical order) current status of development, dose concentration, dosing frequency, route of administration, type of dose (standard / weight dependent), expected patent expiry (relevant only for marketed drugs) and information on product sales (relevant only for marketed drugs). An informed business portfolio analysis based on an attractiveness and competitiveness (AC) framework, highlighting the current worth of different types of needle-free injection systems and microneedle devices. Elaborate profiles of prominent product developers engaged in this domain. Each profile features a brief overview of the company, its financial information (if available), information on its product portfolio and recent developments. A case study on the role of contract manufacturing organizations within the medical device industry. It includes a brief description of the various regulatory guidelines for medical devices and highlights the challenges associated with the manufacturing of such products. In addition, it features a list of contract manufacturers that claim to offer services for drug delivery devices and their geographical landscape.  One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for needle-free injection systems and microneedle devices. Based on various parameters, such as number of marketed / pipeline products, existing price of devices (for commercially available products only) and estimated annual adoption rate, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. For needle-free injection systems, the report also features the likely distribution of the current and forecasted opportunity across [A] different types of actuation mechanisms (spring-based, gas powered and others), [B] routes of administration (subcutaneous, intramuscular and intradermal), [C] target disease indication (infectious diseases, diabetes, pain disorders and others), [D] product usability (disposable and re-usable) and [E] key geographical regions (North America, Europe, Asia and Rest of the World). Similarly, the projected future opportunity for microneedle devices has been analyzed across [A] various types of microneedle devices (hollow, solid and dissolving), [B] target disease indication (infectious diseases, osteoarthritis, pain disorders, cancer, and others), [C] type of intervention (vaccines, therapeutic agent and others), and [D] key geographical regions (North America, Europe, Asia and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Michael Schrader, CEO and Founder, Vaxess Technologies Patrick Anquetil, CEO, Portal Instruments Henry King, Market Intelligence and Business Development Manager, Innoture All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Generics Market: Focus on Value-Added Medicines / Supergenerics, 2019-2030

In 2018, it was estimated that the availability of low-cost, generic versions of pharmaceutical interventions saved nearly USD 1.6 trillion in healthcare costs in the US over the last decade.  Given the cost benefits offered, generic medicines usually have high adoption rates. Moreover, upcoming patent expiries of several blockbuster drugs, such as LYRICA®, Cialis®, Advair® and Sensipar®, have intensified the interest of several drug manufacturers in the development of generics. As more generic drugs get approved by regulators across the globe, the competition in the industry has steadily increased. Interestingly, in 2018, the US FDA approved more than 780 generic products, which represented more than 90% increase in the number of such drug approvals since 2014.  The most evident impact of the growth in competition in this domain is deflation of cost of generics, resulting in diminished profit margins for the developers of such products. Therefore, to ensure sustainable growth within the off-patent drug products market, companies are gradually adopting innovative drug alteration techniques in order to develop value added medicinal products, which offer better commercial benefits.  The availability of several advanced drug development and technology platforms have enabled the fabrication and formulation of improved versions of existing drug products. Such modified pharmacological interventions are commonly referred to as supergenerics / complex generics / value-added generics. Although supergenerics are based on the same mechanism of action as that of the original drug, these versions usually have certain additional attributes, such as a new active ingredient, improved manufacturing process, alternative dosage regimen, modified release properties or different formulation. Typically, such drugs are granted a form of marketing exclusivity (for a period of 3-7 years ), enabling their developers to generate relatively higher profit margins, compared to conventional generics. Moreover, the development of value added generics is generally directed at certain unmet clinical needs, which may have been unaddressed by previous versions of the drug. In addition, the approval process for such products is not as complicated; in the US, value added medicines are evaluated under the FDA’s 505(b)(2) pathway. This evolving segment of the pharmaceutical industry has also witnessed a surge in the availability of technology providers, offering a diverse range of platforms / solutions to support the development of supergeneric drugs. After a detailed analysis of prevalent trends, we are led to believe that value-added generic products market is poised to witness significant growth over the coming years. Scope of the Reports The ‘Generics Market: Focus on Value-added Medicines / Supergenerics, 2019-2030’ report features an extensive study of supergenerics, as well as the current landscape and future potential of technology providers that are offering innovative platforms / solutions to supergeneric drug developers. Amongst other elements, the report features: An overview of recently approved supergenerics (over the period 2016-2018), featuring information on route of administration, target disease indication(s), target therapeutic area(s), approval timeline, submission classification code and most active drug developers (in terms of number of product approvals). Additionally, it provides a detailed assessment of technology providers, offering platforms / solutions for supergeneric drug development, including information on year of establishment, company size and geographical location. An informed competitiveness analysis of the technologies captured in our database, taking into consideration relevant parameters, such as supplier power (based on company size of technology provider) and other important technology-related specifications, such as the type of molecule, impact on drug properties and route of administration. Elaborate profiles of prominent technology developers engaged in this domain, featuring an overview of the company, its financial information (if available), a detailed description of its technology platform(s), recent developments and a comprehensive future outlook. A list of marketed generics that, we believe, are likely to be developed as supergenerics in the near future, based on an in-depth analysis taking into consideration multiple relevant parameters, such as the current annual cost of treatment of the parent drug, year of patent expiry, revenues generated in the year before patent expiry, target therapeutic area and number of competitor (generic) drugs available in the market. Detailed case studies on five approved supergeneric drugs, including an overview of the product along with information on the original / parent drug, value proposition offered by the supergeneric version, pricing strategies adopted by the developer (if available), annual revenues of the supergeneric and parent drug (if available) and the key learnings / takeaways from individual case studies. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall supergenerics industry. One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity within the market. Based on several parameters, such as size of the generic drugs market, share of supergenerics within the generic drugs market and expected annual growth rate across various geographies, we have provided an informed estimate of the likely evolution of the market, in the mid to long term, for the period 2019-2030. The chapter also presents a detailed market segmentation across [A] different therapeutic areas (autoimmune disorders, cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, pain disorders, respiratory disorders and others), [B] routes of administration (parenteral, intravitreal, oral, topical and others) and [C] key geographical regions (North America, Asia-Pacific, Europe, South America, and Africa and Middle East). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market (3rd Edition), 2019-2030 (Focus on AAV, Adenoviral, Lentiviral, Retroviral, Plasmid DNA and Other Vectors)

Over the last 12 months, the pharmaceutical industry reported a year-on-year increment of nearly 75% in funding to support the development of various cell and gene therapies. In fact, close to USD 5 billion has been invested into research on gene-based therapies in the previous two decades. Interestingly, over 2,600 clinical studies have been initiated in this field of research, since 1989. The aforementioned numbers are indicative of the rapid pace of development in this upcoming segment of the biopharmaceutical industry. The development of such therapy products require gene delivery vehicles, called vectors, to desired locations within the body (in vivo) / specific cells (ex vivo). The growing demand for such therapies and the rising number of clinical research initiatives in this domain has led to an increase in demand for preclinical and clinical grade gene delivery vectors. Fundamentally, genetic modifications can be carried out using either viral (such as adenovirus, adeno associated virus (AAV), lentivirus, retrovirus, Sendai virus, herpes simplex virus, vaccinia virus, baculovirus and alphavirus) or non-viral (such as plasmid DNA) vectors. Moreover, recent advances in vector research have led to the development of several innovative viral / non-viral gene delivery approaches. At present, 10+ genetically modified therapies have received approval / conditional approval in various regions of the world; these include (in the reverse chronological order of year of approval) Zynteglo™ (2019), Zolgensma® (2019), Collategene® (2019), LUXTURNA™ (2017), YESCARTA™ (2017), Kymriah™ (2017), INVOSSA™ (2017), Zalmoxis® (2016), Strimvelis™ (2016), Imlygic® (2015), Neovasculagen® (2011), Rexin-G® (2007), Oncorine® (2005) and Gendicine® (2003). In addition, over 500 therapy candidates are being investigated across different stages of development. The growing number of gene-based therapies, coupled to their rapid progression through the drug development process, has created significant opportunities for companies with expertise in vector manufacturing. Presently, a number of industry (including both well-established companies and smaller R&D-focused initiatives), and non-industry players (academic institutes) claim to be capable of manufacturing different types of viral and non-viral vectors. In addition, there are several players offering novel technology solutions, which are capable of improving existing genetically modified therapy products and upgrading their affiliated manufacturing processes. Considering prevalent and anticipated future trends, we believe that the vector and gene therapy manufacturing market is poised to grow steadily, driven by a robust pipeline of therapy candidates and technical advances aimed at mitigating existing challenges related to gene delivery vector and advanced therapy medicinal products. Scope of the Rpeort The “Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market (3rd Edition), 2019-2030 (Focus on AAV, Adenoviral, Lentiviral, Retroviral, Plasmid DNA and Other Vectors)” report features an extensive study of the rapidly growing market of viral and non-viral vector and gene therapy manufacturing, focusing on contract manufacturers, as well as companies with in-house manufacturing facilities. The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different regions of the globe. Amongst other elements, the report includes: An overview of the current status of the market with respect to the players involved (both industry and non-indutry) in manufacturing viral vectors, non-viral vectors and other novel types of vectors. It features information on the year of establishment, scale of production, type of vectors manufactured, location of manufacturing facilities, applications of vectors (in gene therapy, cell therapy, vaccines and others), and purpose of production (fulfilling in-house requirements / for contract services). An informed estimate of the annual demand for viral and non-viral vectors, taking into account the marketed gene-based therapies and clinical studies evaluating vector-based therapies; the analysis also takes into consideration various relevant parameters, such as target patient population, dosing frequency and dose strength. An estimate of the overall, installed vector manufacturing capacity of industry players based on information available in the public domain, and insights generated via both secondary and primary research. The analysis also highlights the distribution of the global capacity by vector type (viral vector and plasmid DNA), scale of operation (clinical and commercial), size of the company / organization (small-sized, mid-sized and large) and key geographical regions (North America, Europe, Asia Pacific and the rest of the world). An in-depth analysis of viral vector and plasmid DNA manufacturers, featuring three schematic representations; namely [A] a three dimensional grid analysis, representing the distribution of vector manufacturers (on the basis of type of vector) across various scales of operation and purpose of production (in-house operations and contract manufacturing services), [B] a logo landscape of viral vector and plasmid DNA manufacturers based on the type (industry and non-industry) and the size of the industry player (small-sized, mid-sized and large companies), and [C] a schematic world map representation, highlighting the geographical locations of vector manufacturing hubs. An analysis of recent collaborations  and partnership agreements inked in this domain since 2015; it includes details of deals that were / are focused on the manufacturing of vectors, whihc were analyzed on the basis of year of agreement, type of agreement, type of vector involved, and scale of operation (laboratory, clinical and commercial).  An analysis of the various factors that are likely to influence the pricing of vectors, featuring different models / approaches that may be adopted by product developers / manufacturers in order to decide the prices of proprietary vectors. An overview of other viral / non-viral gene delivery approaches that are currently being researched for the development of therapies involving genetic modification. Elaborate profiles of key players based in North America, Europe and Asia-Pacific (shortlisted based on scale of operation). Each profile features an overview of the company / organization, its financial performance (if available), information on its manufacturing facilities, vector manufacturing technology and an informed future outlook. A discussion on the factors driving the market and the various challenges associated with the vector production process. One of the key objectives of this report was to evaluate the current market size and the future opportunity associated with the vector manufacturing market, over the coming decade. Based on various parameters, such as the likely increase in number of clinical studies, anticipated growth in target patient population, existing price variations across different vector types, and the anticipated success of gene therapy products (considering both approved and late-stage clinical candidates), we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of  [A] type of vectors (AAV vector, adenoviral vector, lentiviral vector, retroviral vector, plasmid DNA and others), [B] applications (gene therapy, cell therapy and vaccines), [C] therapeutic area (oncological disorders, inflammation & immunological diseases, neurological disorders, ophthalmic disorders, muscle disorders, metabolic disorders, cardiovascular disorders and others), [D] scale of operation (preclinical, clinical and commercial) and [E] geography (North America, Europe, Asia Pacific and rest of the world). The research, analysis and insights presented in this report are backed by a deep understanding of key insights generated from both secondary and primary research. For the purpose of the study, we invited over 160 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. Our opinions and insights presented in this study were influenced by discussions held with several key players in this domain. The report features detailed transcripts of interviews held with the stakeholders: Menzo Havenga (Chief Executive Officer and President, Batavia Biosciences) Nicole Faust (Chief Executive Officer & Chief Scientific Officer, CEVEC Pharmaceuticals) Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences) Olivier Boisteau, (Co-Founder / President, Clean Cells), Laurent Ciavatti (Business Development Manager, Clean Cells) and Xavier Leclerc (Head of Gene Therapy, Clean Cells) Joost van den Berg (Director, Amsterdam BioTherapeutics Unit) Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital) Colin Lee Novick (Managing Director, CJ Partners) Cedric Szpirer (Executive & Scientific Director, Delphi Genetics) Semyon Rubinchik (Scientific Director, ACGT) Alain Lamproye (President of Biopharma Business Unit, Novasep) Astrid Brammer (Senior Manager Business Development, Richter-Helm) Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing) Marco Schmeer (Project Manager, Plasmid Factory) and Tatjana Buchholz (Marketing Manager, Plasmid Factory) Nicolas Grandchamp (R&D Leader, GEG Tech) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Automotive Lithium-ion Battery Market: Global Opportunity and Trend Analysis, 2019-2030

The global automotive lithium-ion battery market was $17.4 billion in 2019 and is expected to reach $95.3 billion by 2030, growing at an estimated CAGR of 17.1 % during the forecast period. Lithium-ion batteries are advanced rechargeable batteries that are used in portable consumer electronic products and in electric vehicles, such as e-bikes, e-rickshaws, and e-cars. In the last few years, lithium-ion batteries have been able to effectively penetrate into the automotive market due to its long life and low maintenance costs as compared to traditional batteries, such as lead-acid and nickel-metal hybrid batteries. Growing demand for electric vehicles, compact size, less charging time and low maintenance cost are some of the factors that are driving the global automotive lithium-ion battery market. In addition, the regional government’s push towards the adoptability of electric vehicles (green vehicles), in order to, reduce the carbon footprint, is further, propelling the growth for the automotive lithium-ion market. However, factors such as high cost, due to the limited number of automotive lithium-ion battery manufacturing players and the limited number of charging stations are restricting the growth of the market. Specifically, in 2019, the automotive lithium nickel manganese cobalt batteries (NMC) are anticipated to capture the highest share of about 35.3% in the global automotive lithium-ion battery market; these batteries are likely to continue leading throughout the forecast period as well. NMC chemistries are known to increase the energy density and lifespan of lithium-ion batteries. Hence, players are investing in NMC batteries. For example, Tesla ‘s top-selling car models, Model S and Model X, are equipped with NMC batteries and the company is now focusing on developing an NMC battery that can run over 1lakh km in a single charge. In addition, it is estimated that globally, more than 28 million lithium-ion batteries equipped electric four-wheelers will be sold by 2030. Since, in Q3, 2019, Tesla and Chevy bolt sold more than 50,000 electric cars in the US. The global automotive lithium-ion battery market has been segmented into four regions, namely, North America, Europe, Asia-Pacific and the Rest of the world. Specifically, lithium-ion batteries in the automotive sector are witnessing significant growth in countries, such as China, the US, and certain European regions. At present, China is the biggest market for both in terms of manufacturing lithium-ion batteries for electric vehicles and their consumption. At present, partnerships are one of the key business strategies of the players. For instance, in September 2019, Maruti Suzuki partnered with Toshiba and Denso to set up the world’s largest automotive lithium-ion battery manufacturing unit in Gujrat (India). Some of the leading players of the automotive lithium-ion battery market are Denso Corporation, Toshiba Corporation, Exicom Power Solutions, Johnson Controls Inc., A123 Systems Inc. LG Chem Ltd., Contemporary Amperex Technology Ltd. (CATL), BYD Company Ltd., Panasonic Corporation, and Samsung SDI Co. Ltd. among others.  The automotive lithium-ion battery market is segmented based on battery type, vehicle type, capacity type, and region. Based on battery type, the market is classified into Lithium Titanium Oxide (LTO), Lithium Nickel Manganese Cobalt Oxide, and Lithium Iron Phosphate. Based on vehicle type, the market is categorized into Two-wheeler EVs, Three-wheeler EVs, and Four-wheelers EVs. On the basis of capacity type, the market is bifurcated into 5-47 Wh, 48-99 Wh, 100-250 Kwh and more than 250 kWh. Based on geography, the market is categorized in North America, Europe, Asia-Pacific and the Rest of the World. Scope of the Report The ‘Automotive Lithium-Ion Battery' report features an extensive study of the current landscape of industry players that are offering various types of lithium-ion batteries to the automotive industry. Amongst other elements, the report features: Detailed quantitative analysis of the market in terms of market size and forecast 2019-2030 An in-depth qualitative analysis of the automotive lithium-ion market in terms of key market trends, market drivers, restraints, and opportunities Key insights into the competitive landscape of the market.

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Medical Device Labels Manufacturing Market, 2019 - 2030

As of August, over 30 medical devices were approved by the US FDA alone, in 2019.  Given recent technological advances and the increasing complexity of such products, the need for proper medical device labels has become a concern that is being addressed by both label manufacturers and regulators. In this context, it is worth highlighting that more than 10% of product recalls observed in this market are attributed to medical device labeling related issues. Labels ensure that a product is used according to the manufacturer’s instructions and also serve to protect the developer from litigation pertaining to off-label use / abuse of a marketed device.  Over the years, medical device packaging and labeling operations have evolved significantly. Presently, a variety of novel label designs, equipped with advanced features (such as traceability, tamper-evident sealing provisions and environmental resistance), are available. In addition, there have been significant upgrades pertaining to medical device label materials and label printer technologies.   As the demand for innovative medical devices continues to grow, we believe that innovator companies are more likely to outsource certain aspects of their business operations, such as label manufacturing. Owing to the expertise and infrastructure required to develop and produce certain advanced types of pharmaceutical labels, the demand for contract service providers has increased substantially in this domain. Moreover, in order to cope up with the innovation in this domain, service providers are actively engaged in improving their core capabilities, procuring necessary certifications (such as ISO 13485), and optimizing business strategy. As a result, the industry has witnessed notable consolidation in the last five years, with many of the smaller players being acquired by more established businesses in efforts to augment the latter companies’ offerings. Scope of the Report The “Medical Device Labels Manufacturing Market, 2019-2030” report features an extensive study of the current market landscape of companies offering manufacturing services for medical device labels. The study also features detailed analysis and an elaborate discussion on the future potential of this evolving market. Amongst other elements, the report includes: A detailed review of the overall landscape of companies offering manufacturing services for medical device labels, along with information on location of headquarters, year of establishment, company size, details related to regulatory certification / accreditation, types of label printing technologies used (digital, flexographic, screen, foil stamping, embossing, thermal, offset and others), types of labels manufactured (glue-applied, pressure sensitive, shrink-sleeve, in mold, custom die-cut, cut and stack and others), additional label-related features (extended content, external conditions proof, traceability and tamper-evident),  type of material used (paper, plastic and film) and the manner in which the labels are folded (map fold, fan fold, mini fold, booklets, folding cartons and roll fed). An analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the key value drivers of such deals inked between 2014 and 2019 (till June).  A detailed acquisition target analysis, which takes into consideration the historical trend of activity of top acquirers, providing a means for industry stakeholders to identify potential acquisition targets.  An industry-wide benchmark analysis, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective (geography-based) peer groups. A detailed business portfolio analysis based on the 9-box attractiveness and competitiveness (AC) matrix framework, highlighting the current market attractiveness and competitive strength of different printing technologies used by label manufacturers. An elaborate discussion on the various guidelines established by major regulatory bodies, governing medical device labeling-related practices and product approval, across different countries.  Elaborate profiles of key players that claim to have a diverse range of capabilities for the manufacturing of different types of labels for medical devices; each profile includes an overview of the company, its financial performance (wherever available), information on its label manufacturing capabilities and an informed future outlook.  A discussion on important industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall medical device labels market.  A review of the various upcoming opportunities and anticipated future trends related to medical device label manufacturing that are expected to influence the evolution of this industry over the coming years. One of the key objectives of this report was to evaluate the current opportunity and the future growth potential within the medical device labels manufacturing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] types of labels (glue applied, pressure sensitive, in mold, sleeve and others), [B] type of material (paper, plastic and film), [C] application areas(therapeutic devices, diagnostic devices, drug delivery devices and other devices), [D] device classes (class I devices, class II devices and class III devices), and [E] geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the growth of medical device labels market and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Stem Cell Therapy Contract Manufacturing Market, 2019-2030

Advances in the fields of cell biology and regenerative medicine have led to the development of a variety of stem cell-based therapies for many cardiovascular, oncological, metabolic and musculoskeletal disorders. Driven by the revenues generated from stem cell therapies, the regenerative medicine market is anticipated to generate revenues worth USD 100 billion by 2030. With a promising pipeline of over 200 stem cell therapy candidates, it has become essential for developers to scale up the production of such therapeutic interventions. Given that stem cell therapy manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies. As a result, stem cell therapy developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs) . Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical and commercial-scale manufacturing processes to contract service providers. In addition, even big pharma players, with established in-house capabilities, are gradually entering into long-term business relationships with CMOs in order to optimize resource utilization and manage costs. According to a recent Nice Insight CDMO survey, about 55% of 700 respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development requirements. Considering the prevalent trends, we believe that the stem cell therapy manufacturing market is poised to grow at a steady pace, driven by a robust pipeline of therapy candidates and technological advances aimed at mitigating challenges posed by conventional methods of production. Amidst tough competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor and is likely to grant a competitive advantage to certain CMOs over other players in the industry. Scope of the Report The “Stem Cell Therapies Contract Manufacturing Market, 2019 – 2030” report features an extensive study on contract service providers engaged in the development and manufacturing of stem cell therapies. The study features in-depth analyses, highlighting the capabilities of various stem cell therapy CMOs. Amongst other elements, the report includes: A detailed review of the contract manufacturing landscape for stem cell therapies, featuring a comprehensive list of active CMOs and analysis based on a number of parameters, such as year of establishment, company size, geographical location, number of stem cell therapy manufacturing facilities, source of stem cells (allogenic and autologous), types of services offered (culture development, stem cell identification / validation, stem cell banking, cryopreservation, logistics, fill / finish and regulatory filings), scale of operation (preclinical, clinical and commercial), types of stem cells (adult, embryonic and induced pluripotent) and therapeutic area (oncology and non-oncology).  An elaborate discussion of the various guidelines laid down by regulatory bodies related to stem cells and other cell-based therapies across various geographies, such as the North America (primarily the US), Europe and other regions. Elaborate profiles of the key players based in North America, Europe and Asia-Pacific that have a diverse range of capabilities for the development, manufacturing and packaging of stem cell therapies. Each profile includes an overview of the company, its financial performance (if available), information on service portfolio, stem cell therapy manufacturing facilities, and details on partnerships, recent developments and an informed future outlook.  An analysis of the recent collaborations (signed since 2015) focused on the contract manufacturing of stem cell therapies, based on various parameters, such as year of agreement, type of agreement, scale of operation, source of stem cells used, types of stem cells and location of companies entering the partnership. An informed estimate of the annual demand for stem cell therapies in terms of area (in square feet) dedicated to stem-cell related operations, based on various parameters, such as target patient population, price of the therapy, dosing frequency and dose strength. A detailed capacity analysis, taking into consideration the manufacturing capacities of various stakeholders (small-sized, mid-sized and large CMOs) in the market, based on data gathered via secondary and primary research. It also provides the distribution of global stem cell therapy manufacturing capacity by company size (small-sized, mid-sized and large), and geography (North America, Europe and Asia-Pacific) and scale of operation (preclinical / clinical and commercial). A detailed analysis to understand the relationship between the demand and supply in this field, comparing the presence of stem cell therapy developers and the availability / capability of contract manufacturers across different geographies. An analysis to identify the key performance indicators for service providers active in the domain, based on the information gathered via secondary research and primary research. One of the key objectives of the report was to estimate the future size of the market. Based on parameters, such as increase in number of clinical studies, target patient population, anticipated adoption of stem cell therapies and expected variation in manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the period 2019-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] source of stem cells (autologous and allogenic), [B] types of stem cells (adult, embryonic and induced pluripotent), [C] size of contract service provider company (small-sized, mid-sized and large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America, Europe and Asia and rest of the world). To account for the uncertainties associated with the manufacturing of stem cell therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.  The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Arik Hasson, Executive VP Research and Development, Kadimastem Brian Dattilo Manager of Business Development, Waisman Biomanufacturing David Mckenna, Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota Fiona Bellot, Business Development Manager, Roslin Cell Therapies   Gilles Devillers, General Manager, Bio Elpida Mathilde Girard, Department Leader, Cell Therapy Innovation and Development, YposKesi All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.  

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Antibody Drug Conjugates Market (5th Edition), 2019-2030

With six approved and marketed drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), antibody drug conjugates (ADCs) have become recognized as a potent class of targeted therapeutic agents catering to oncology and hematological diseases markets. The success of such conjugated products can be attributed to their ability to effectively identify and eliminate disease associated cells / pathogens, while limiting off target toxicities. Presently, ADCs are considered a part of mainstream healthcare regimens, having generated significant enthusiasm within the medical science community across the world.  The growing popularity and therapeutic potential of ADCs can also be correlated with an exponential increase in the number of patents that have been filed / granted; the cumulative patent count has increased from 1,395 in 2009 to over 16,500 in the first half of 2019. With more than 200 ADCs in clinical / preclinical stages of development, the industry is gradually shifting from relying on conventional technologies to newer and more robust approaches to conjugate such complex biomolecules. Over the years, a number of well-funded start-ups / small companies, offering novel conjugation technologies, more potent warheads and advanced linker technologies, have been established. In fact, multiple licensing agreements / collaborations have been inked in the past few years between drug developers and technology providers to advance the development of pipeline ADC candidates.   Using ADCs in combination with other drug / therapy classes is an emerging concept and multiple companies are evaluating their proprietary ADC candidates in combination with other established therapeutic classes, such as immune checkpoint inhibitors, epigenetic modulators and monoclonal antibodies. In addition, several other companies have introduced certain novel types of conjugated drug molecules; example of such companies include Bicycle Therapeutics (bicycle drug conjugate), BlinkBio (tunable drug conjugates), Cellectar Biosciences (phospholipid drug conjugate), Centrose (extracellular drug conjugate), Esperance Pharmaceuticals (peptide conjugate) and Nordic Nanovector (radionucleotide conjugate). We expect the ADC therapeutics market to growth at a healthy rate in the mid to long-term, driven by the introduction of new combination therapies involving ADCs, innovative ADC development and conjugation technologies, applications beyond oncology and the expansion of existing marketing authorizations to newer geographies across the world. Scope of the Report The ‘Antibody Drug Conjugates Market (5th Edition), 2019-2030’ report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape of ADCs, providing information on drug developer(s) and technology provider(s), phase of development (marketed, clinical and preclinical / discovery stage) of lead candidates, target antigen, type of linker, type of payload / warhead / cytotoxin, type of antibody, antibody origin, antibody isotype, type of therapy (monotherapy and combination therapy), combination drug (if being evaluated as combination therapy), target indication(s), line of treatment, route of administration and dosing frequency. Elaborate profiles of the clinical stage companies (shortlisted based on phase of development of the lead drug) and their respective product portfolios; each profile features an overview of the company, its financial information (if available), detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical development plan and key clinical trial results) and an informed future outlook. An analysis of the most commonly targeted therapeutic indications and details of ADC candidates being developed against them, highlighting key epidemiological facts about the diseases and currently available treatment options, other than ADCs. A list of key opinion leaders (KOLs) within this domain, featuring detailed 2X2 matrices to assess the relative experience of key individuals, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field. It also includes a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers engaged in this domain. In addition, it presents an analysis assessing the credibility and (relative) level of expertise of different KOLs, based on number of publications, number of citations, number of clinical trials, number of affiliations and strength of professional network (based on information available on LinkedIn). An insightful competitiveness analysis of biological targets, featuring a [A] three-dimensional bubble representation that highlights the targets that are being evaluated for ADC development, taking into consideration the number of lead molecules based on a particular target, phase of development of candidate therapies, number of clinical trials and number of target disease indications, and [B] a five-dimensional spider-web analysis, highlighting the most popular biological targets based on a number of relevant parameters, including affiliated publications, grants received to support research on a particular target, number of industry players involved in drug development efforts based on a singular target and geographical distribution of associated clinical trials.  An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, licensing agreements (specific to technology platforms and product candidates), product development and commercialization agreements, clinical trial agreements, manufacturing agreements, mergers and acquisitions, manufacturing and service agreements, and other relevant agreements.  An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in companies that are focused on developing ADCs. An in-depth analysis of the various patents that have been filed / granted related to ADCs till May 2019. It includes information on key parameters, such as patent type, publication year, geographical location, issuing authority, assigned CPC symbol, emerging focus areas and leading industry / academic players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis. A study of the various grants that have been awarded to research institutes engaged in projects related to ADCs, between 2011 and 2019 (till April), highlighting various important parameters, such as year of award, support period, amount awarded, funding institute, grant type, focus area, type of recipient organization, key project leaders, key regions and leading recipient organizations. An elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch, during / post launch, including a timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products.  An analysis of the key promotional strategies that have been adopted by the developers of marketed products, namely POLIVY™, LUMOXITI™, BESPONSA®, MYLOTARG™, KADCYLA® and ADCETRIS®. An assessment of the various therapeutics that are being evaluated in combination with ADCs. The study also presents the likely evolution of these therapeutics across different indications.  A review of the evolution of ADC conjugation technologies, highlighting the various approaches that have been adopted across different generations; in addition, it presents a review of the existing competition between various conjugation approaches that are available / under development. An overview of the studies conducted to better analyze non-clinical data and support first-in-human (FIH) dose selection in ADCs. The study presents findings from various ADC studies in different animal models. It also includes an analysis of the different methods used in estimating FIH doses. In addition, it highlights the possible FIH starting doses and estimated dose escalations required to reach human maximum tolerated dose (MTD). An elaborate discussion on various factors that form the basis for the pricing of ADC products, featuring different models / approaches that pharmaceutical companies may choose to adopt while deciding the price of their respective lead therapy candidates that are likely to be marketed in the coming years. A case study on manufacturing of ADCs, highlighting the key challenges, and a list of contract service providers that are involved in this domain. A case study on companies offering companion diagnostics that can potentially be used to make treatment related decisions involving ADCs, providing information on the geographical location of key diagnostic developers, affiliated disease biomarkers, assay technique involved, target indication(s), the type of sample required (tumor tissue, blood, bone marrow and others) and the drug candidates for which a particular test was developed. One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for ADCs, over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market for the period 2019-2030. The report includes potential sales forecasts of ADCs that are currently marketed or are in late stages of development. Additionally, it provides forecasts of the overall ADCs market, wherein the current and upcoming opportunity is segmented across [A] type of payload (MMAE, DM4, camptothecin, DM1, MMAF and others), [B] type of linker (VC, Sulfo-SPDB, SMCC, VA, hydrazone linker and others), [C] target indications (breast cancer, lymphoma (HL, NHL, ALCL), leukemia (AML, ALL), urothelial cancer, lung cancer (NSCLC, SCLC), ovarian cancer and others), [D] target antigens (CD30, HER2, CD22, CD33 and others (HER4, TROP-2, EGFR, FOLR1, MSLN, CD142, CD79b, DLL3, CD37, Nectin – 4, LIV-1, c-MET, BCMA, CD25, CD19 and ENPP3)), [E] technology providers (Seattle Genetics, ImmunoGen, StemCentRx, Immunomedics and others), and [F] key geographies (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of these novel therapeutics and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals: Alan Burnett (Professor, School of Medicine, Cardiff University) Aldo Braca (President and Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Senior Manager, BSP Pharmaceuticals) Anthony DeBoer (Director, Business Development, Synaffix) Christian Bailly (Director of CDMO, Pierre Fabre) Christian Rohlff, (Chief Executive Officer and Founder, Oxford BioTherapeutics) Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma) John Burt (Chief Executive Officer, Abzena) Jennifer L. Mitcham (Director,  SMARTag ADCs and Bioconjugates, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions) Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza) Mark Wright (Site Head, Piramal Healthcare) Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia) Tatsuya Okuzumi (Associate General Manager, Ajinomoto Bio-Pharma Services) Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai) Wouter Verhoeven (Chief Business Officer, NBE-Therapeutics) Anonymous (Director, Business Development, Leading CMO) Anonymous (Chief Executive Officer, Leading CMO) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Gene Therapy Market (3rd Edition), 2019 - 2030

Since the approval of the first therapy, Genedicine® in 2003, the gene therapy domain has evolved significantly. Specifically, in 2019, three gene therapies, namely Zolgensma® (US), Zynteglo™ (Europe) and Beperminogene Perplasmid (Japan), have received approval / conditional approval, leading to a marked upward surge in the interest in this field. In fact, the growing popularity can be correlated to the substantial increase (more than 90%) in the number of patents that have been filed / granted in the last three years. Moreover, in the same time period, more than USD 12.5 billion in capital has been invested by various private and public investors to fund research activities. Presently, there are more than 10 approved gene therapies in the market, while many others are being investigated across various phases of clinical research.  Over time, the efforts of industry stakeholders and clinical researchers have led to the discovery of novel molecular targets, thereby, strengthening the research pipelines of companies involved in the development of gene therapies. Further, several technology developers have designed innovative ways to improve the efficacy and safety of gene therapies and introduced advanced therapy development and vector engineering platforms. It is also worth mentioning that, in the last 4-5 years, there has been a marked rise in the M&A activity in this domain, including the involvement of several big pharma players as well. The capability of such therapies to target diverse disease indications is considered to be amongst the most prominent growth drivers of this market. Backed by promising clinical results and several therapy candidates in late phases of development, we believe that the overall market is expected to witness tremendous growth in the coming decade. Scope of the Report The “Gene Therapy Market (3rd Edition), 2019-2030” report features an extensive study of the current market landscape of gene therapies, primarily focusing on gene augmentation-based therapies, oncolytic viral therapies and genome editing therapies. The study also features an elaborate discussion on the future potential of this evolving market. Amongst other elements, the report features: A detailed review of the overall landscape of gene therapies and genome editing therapies, including information on various drug / therapy developer companies, phase of development (marketed, clinical, and preclinical / discovery stage) of pipeline candidates, key therapeutic areas (cardiovascular disorders, muscular disorders, neurological disorders, ocular disorders, oncology and others) and target disease indication(s), information on gene type, type of vector used, type of therapy (ex vivo and in vivo), mechanism of action, type of gene modification (gene augmentation, oncolytic viral therapy and others) and special drug designation (if any). A discussion on the various types of viral and non-viral vectors, along with information on design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vectors. A world map representation, depicting the most active geographies, in terms of the presence of companies engaged in developing gene therapies, and a bull’s eye analysis, highlighting the distribution of clinical-stage pipeline candidates by phase of development, type of vector and type of therapy (ex vivo and in vivo). A discussion on the regulatory landscape related to gene therapies across various geographies, namely North America (the US and Canada), Europe and Asia-Pacific (Australia, China, Japan and South Korea), providing details related to the various challenges associated with obtaining reimbursements for gene therapies.  Detailed profiles of marketed and phase II/III and gene therapies, including a brief history of development, information on current development status, mechanism of action, affiliated technology, strength of patent portfolio, dosage and manufacturing details, along with information on the developer company. An elaborate discussion on the various commercialization strategies that can be adopted by drug developers for use across different stages of therapy development, namely prior to drug launch, at / during drug launch and post-marketing.  A review of various emerging technologies and therapy development platforms that are being used to design and manufacture gene therapies, featuring detailed profiles of technologies that were / are being used for the development of four or more products / product candidates.  An in-depth analysis of the various patents that have been filed / granted related to gene therapies and genome editing therapies, since 2016. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, regional applicability, CPC classification, emerging focus areas, leading industry / non-industry players (in terms of the number of patents filed / granted), and patent valuation. A analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019. The analysis also provides information on the key value drivers and deal multiples related to the mergers and acquisitions that we came across. An analysis of the investments made at various stages of development in companies that are focused in this area, between 2014-2019, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other offerings. An analysis of the big biopharma players engaged in this domain, featuring a heat map based on parameters, such as number of gene therapies under development, funding information, partnership activity and strength of patent portfolio.  A case study on the prevalent and emerging trends related to vector manufacturing, with information on companies offering contract services for manufacturing vectors. The study also includes a detailed discussion on the manufacturing processes associated with various types of vectors. A discussion on the various operating models adopted by gene therapy developers for supply chain management, highlighting the stakeholders involved, factors affecting the supply of therapeutic products and challenges encountered by developers across the different stages of the gene therapy supply chain. An analysis of the various factors that are likely to influence the pricing of gene-based therapies, featuring different models / approaches that may be adopted by manufacturers to decide the prices of these therapies. One of the key objectives of the report was to estimate the existing market size and the future opportunity for gene therapies, for the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (cardiovascular disorders, muscular disorders, neurological disorders, ocular disorders, oncology and others), [B] various types of vectors used for therapy development (adeno associated virus, adenovirus, lentivirus, plasmid DNA, retrovirus and others), [C] type of therapy (ex vivo and in vivo), [D] type of gene modification (gene augmentation, oncolytic viral therapy and others) and [E] key geographical regions (US, EU5 and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order): Adam Rogers (CEO, Hemera Biosciences) Al Hawkins (CEO, Milo Biotechnology) Buel Dan Rodgers (Founder & CEO, AAVogen) Cedric Szpirer (Executive & Scientific Director, Delphi Genetics) Christopher Reinhard (CEO and Chairman, Cardium Therapeutics) Jeffrey Hung (CCO, Vigene Biosciences) Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory) Michael Triplett (CEO, Myonexus Therapeutics) Robert Jan Lamers (CEO, Arthrogen) Ryo Kubota (Chairman, President and Chief Executive Officer, Acucela) Tom Wilton (Chief Business Officer, LogicBio Therapeutics) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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CAR-T Therapies Market (2nd Edition), 2019-2030

CAR-T cell therapies are based on the principle of harnessing the innate potential of the immune system to selectively target and destroy diseased cells. Encouraging clinical results reported across several completed and ongoing trials, coupled to lucrative financing, have inspired many biopharmaceutical developers and academic research groups to focus their efforts on this relatively novel class of cell-based immunotherapies. With two approved products, namely KYMRIAH® (Novartis) and YESCARTA® (Gilead Sciences), CAR-T cell therapies are presently considered among the most promising anticancer therapeutics available, with potential applications in treating other diseases as well. It is worth highlighting that 66% of the pipeline therapies are presently in the clinical stage.  Over 100 companies and 85 academic / research institutes are actively involved therapy development initiatives in this domain. The ongoing research activity in this domain has led to the discovery of several novel molecular targets, which can be exploited for cell therapy development. Further research and characterization of these targets has significantly strengthened the pipelines of stakeholder entities engaged in this market. Driven by the availability of innovative technology platforms, the CAR-T therapies market is poised for success in the long-run as several therapeutic leads have recently entered mid to late-stage (phase II and above) trials and are anticipated to enter the market over the next 5-10 years.   Scope of the Report The “CAR-T Therapies Market, 2019-2030 (2nd edition)” report features an extensive study of the current market landscape and the future potential of CAR-T cell therapies. The report highlights the efforts of both industry players and academic organizations working in this domain. Amongst other elements, the report features the following: An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, highlighting the yearly trend of tweets, most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers. A detailed assessment of the current market landscape of CAR-T cell therapies with respect to type of developer (industry / non-industry), phase of development, target therapeutic indication(s), key target antigen(s), source of T-cells (autologous / allogenic), route of administration, type of therapy (monotherapy / combination therapy) and patient segment (children / adults / seniors). Comprehensive profiles of marketed and mid to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan and key clinical trial results. An analysis of the CAR constructs of clinical-stage CAR-T therapies based on the generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector and type of co-stimulatory domain used. A detailed analysis highlighting several key opinion leaders (KOLs) in this domain. It features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, indicating the geographical locations of eminent scientists / researchers involved in the development of CAR-T cell therapies. An analysis of the various CAR-T cell therapy focused clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend of initiation of such studies and distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies, especially in China. An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications. A detailed discussion on innovative technology platforms that are being used for the development of CAR-T cell therapies, along with profiles of key technology providers. Further, it includes a relative competitiveness analysis of different CAR-T cell therapy-based gene editing platforms, based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology. A case study on manufacturing cell therapy products, highlighting the key challenges, and a list of contract service providers and in-house manufacturers that are involved in this space. An elaborate discussion on various factors that form the basis for pricing of cell therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a CAR-T cell therapy that is likely to be marketed in the coming years.  A review of the key promotional strategies that have been adopted by the developers of the marketed CAR-T cell therapies, namely KYMRIAH® and YESCARTA®.  One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for CAR-T cell therapies over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such therapies, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report includes potential sales forecasts of CAR-T cell therapies that are currently marketed or are in late stages of development. Additionally, it provides forecasts for the overall CAR-T cell therapy market, wherein both the current and upcoming opportunity is segmented across [A] target indications (acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, multiple myeloma, chronic lymphocytic leukemia, hepatocellular carcinoma and colorectal cancer), [B] important target antigens (CD19, BCMA, GPC3 and EGFR) and [C] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Tim Oldham (Chief Executive Officer, Cell Therapies) Vincent Brichard (Vice President, Immuno-Oncology, Celyad) Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital) Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics) Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies) Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) Miguel Forte (Chief Operating Officer, TxCell) Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Synthetic Lethality-based Drugs and Targets  Market, 2019-2030: Focus on DNA Repair (including PARP Inhibitors) and Other Novel Cellular Pathways

Cancer is known to be one of the leading causes of death worldwide. In the US, 0.6 million deaths were reported to have been caused due to cancer in 2018 alone. Further, according to the International Agency for Research on Cancer (IARC), close to 17 million new cancer cases were reported in 2018, worldwide. By 2040, it is estimated that the aforementioned number is likely to grow to 27.5 million.  It is worth mentioning that in the past five years, the United States Food and Drug Administration (USFDA) has approved more than 100 drugs for the treatment of different types of cancer. However, as the growing global population is gradually being exposed to a growing list of risk factors and cancer causing agents, there is a pressing need for more specific and potent drugs / therapies to combat this complex, life threatening clinical condition.  Over time, conventional treatment options, such as chemotherapy, surgery and radiation therapy, have shown limited efficacy in treating late-stage cancers. In addition, the non-specific and highly toxic nature of these therapies have severe detrimental effects on patients’ quality of life.  Defects in deoxyribonucleic acid (DNA) repair have been shown to be one of the primary causes of cancer. Moreover, tumor cells that are characterized by impaired DNA repair pathways typically become reliant on alternative DNA repair pathways for survival. This phenomenon is commonly referred to as oncogene addiction.  Inhibitors of such compensatory repair pathways have the potential to sensitize cancer cells to DNA damaging agents and other therapeutic regimens. On the other hand, the simultaneous inactivation of certain pairs of genes have been shown to cause cell death. This phenomenon is known as synthetic lethality. In cancers, where mutations have led to the loss of function of one gene, using a drug molecule that specifically targets the corresponding gene of the synlet pair has been demonstrated to be a viable and effective therapeutic regimen. Recent advances in biomarker research, including the development of companion diagnostics, in combination with modern molecular screening platforms, which include clustered regularly interspaced short palindromic repeats (CRISPR)- and RNA interference (RNAi)-based screening techniques, have led to the identification of a number of synthetically lethal gene pairs. Currently, there are four approved (and marketed) poly-ADP ribose polymerase (PARP) inhibitor drugs, which have been shown to operate based on the concept of synthetic lethality. Further, several such drugs are being investigated for the treatment of a myriad of advanced oncological and non-oncological indications. A number of companies are engaged in this domain; moreover, both venture capital (VC) firms and government bodies are actively funding such research initiatives. Scope of the Report The ‘Synthetic Lethality-based Drugs and Targets Market, 2019-2030: Focus on DNA Repair (including PARP Inhibitors) and Other Novel Cellular Pathways’ report features an extensive study of the current market landscape and the future potential of the synthetic lethality-based therapeutics. It features an in-depth analysis, highlighting the capabilities of various companies engaged in this domain. In addition to other elements, the study includes:  A detailed assessment of the current market landscape, providing information on drug developer(s) (year of establishment, headquarters and size of the company), phase of development (marketed, clinical, preclinical, and discovery stage) of lead candidates, type of molecule (small molecule and biologic), type of therapy (monotherapy and combination therapy), type of synlet target, target patient segment, key therapeutic area(s), target indication(s), and route of administration. In addition, the chapter includes a list of screening platforms that are being used by industry players to study synlet interactions between gene pairs. Detailed profiles of large players that are engaged in the development of synthetic lethality-based drugs (shortlisted on the basis of phase of development of pipeline products), featuring a brief overview of the company, its financial information (if available), detailed profiles of their respective lead drug candidates, and an informed future outlook. Additionally, each drug profile features information on the type of drug, route of administration, target indications, current status of development and an excerpt on its developmental history. In addition, the chapter includes tabulated profiles of small-sized and mid-sized players (shortlisted on the basis of the number of pipeline products), featuring details on the innovator company (such as location of headquarters, year of establishment, number of employees, and key members of the executive team), recent developments, along with descriptions of their synthetic lethality-based drug candidates.  An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, posted during the period 2010-2019 (till May), highlighting the historical trend of tweets, most prolific contributors, frequently discussed synlet targets, popular disease indications and a multivariate tweet benchmark analysis.  An analysis of close to 700 peer-reviewed scientific articles related to synthetic lethality, published during the period 2017-2019 (till May), highlighting the research focus within this niche industry segment. It includes an informed opinion on the key trends observed across the aforementioned publications, including information on target disease indications, synlet targets, and analysis based on various relevant parameters, such as study type (review article, research article and case report), research objective, year of publication, key research hubs, most popular authors, provision of grant support, and most popular journals (in terms of number of articles published in the given time period and journal impact factor). An analysis of various abstracts presented at the American Society of Clinical Oncology (ASCO) in the time period 2013-2019 (till May), highlighting several parameters, such as year of (abstract) publication, popular drugs, synlet targets, target cancer indications, popular authors, author designations, industry type (industry and academia) and most active organizations (in terms of number of published abstracts). In addition, this analysis features a multi-dimensional bubble chart analysis to assess the relative level of expertise of the key authors / researchers based on the number of publications, citation count and research gate score. An in-depth analysis of close to 750 grants that have been awarded to research institutes engaged in projects related to synthetic lethality, between 2014 and 2019 (till May), highlighting various important parameters associated with grants, such as year of award, support period, amount awarded, funding institute, administration institute center, funding institute center, funding mechanism, spending categorization, grant type, responsible study section, focus area, type of recipient organization and prominent program officers. It also features a detailed analysis on most popular synlet targets and target indications, along with a multivariate grant attractiveness analysis based on parameters, such as amount awarded, support period, grant type, number of synlet targets and number of indications under study. An analysis of the investments made into companies that have proprietary synthetic lethality-based drugs / screening platforms, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings.  An in-depth benchmark analysis of over 230 synlet targets identified from various credible sources (research publications, government fundings, clinical studies, recent news / tweets and abstracts presented in global conferences), highlighting targets that have already been validated in clinical studies, preclinical studies and early-stage research (cases where there is no lead (therapeutic) candidate being investigated). Further, it highlights the long-term opportunities (for drug developers) associated with individual targets, based on their popularity across different portals. An analysis of the role of innovative companion diagnostics in synthetic lethality on the basis of several parameters, such as synlet target, drug candidate(s) being investigated, target biomarker(s), target disease indication(s) and assay technique used. It also includes case studies, highlighting those companion diagnostic tests that are available and are being used to evaluate the therapeutic efficiency of approved PARP inhibitors using the principle of synthetic lethality. One of the key objectives of the report was to estimate the existing market size and identify the future opportunity for synthetic lethality-based drugs, over the next decade. Based on multiple parameters, such as target consumer segments, region-specific disease prevalence, anticipated adoption of the marketed and late stage drugs and the likely selling price, we have provided informed estimates on the evolution of the market over the period 2019-2030. The report includes potential sales forecast of drugs that are currently marketed or are in late stages of development (phase II and above). The report also features the likely distribution of the current and forecasted opportunity across [A] type of molecules (small molecule and biologic), [B] different target indications (breast cancer, colorectal cancer, fallopian tube cancer, gastric cancer, head and neck cancer, lung cancer, ovarian cancer, peritoneal cancer and others), [C] synlet targets (APE1 / Ref-1, Chk1, GLS1, PARP, Pol θ, PP2A and Wee1), [D] route of administration (oral and intravenous), and [E] key geographical regions (North America, EU5, Asia-Pacific and Rest of the World). To account for the uncertainties associated with the growth of synthetic lethality-based drugs market and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):  Simon Boulton (Vice President, Science Strategy, Artios Pharma) Yi Xu (Associate Director, Business Development, IMPACT Therapeutics) Norbert Perrimon (Professor, Department of Genetics, Harvard Medical School) Vivek Dharwal (Professor, Department of Biochemistry, Panjab University) Alfred Nijkerk (Chief Executive Officer, UbiQ) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.  

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Novel Cell Sorting and Separation Market: Focus on Acoustophoresis, Buoyancy, Dielectrophoresis, Magnetophoretics, Microfluidics, Optoelectronics, Traceless Affinity and Other Technologies, 2019-2030

Advances in the fields of cell biology and regenerative medicine have led to the development of various cell-based therapies, which, developers claim, possess the potential to treat a variety of clinical conditions. In 2018, it was reported that there were more than 1,000 clinical trials of such therapies, being conducted across the globe by over 900 industry players. Moreover, the total investment in the aforementioned clinical research efforts was estimated to be around USD 13 billion. Given the recent breakthroughs in clinical testing and the discovery of a variety of diagnostic biomarkers, the isolation of one or multiple cell types from a heterogenous population has not only become simpler, but also an integral part of modern clinical R&D. The applications of cell separation technologies are vast, starting from basic research to biological therapy development and manufacturing. However, conventional cell sorting techniques, including adherence-based sorting, membrane filtration-based sorting, and fluorescence- and magnetic-based sorting, are limited by exorbitant operational costs, time-consuming procedures, and the need for complex biochemical labels. As a result, the use of such techniques has, so far, been restricted in the more niche and emerging application areas. Over the years, extensive research in the field of flow cytometry has enabled the development of a variety of novel technologies that are capable of efficiently isolating cells from tissue samples and / or heterogenous cell populations. In fact, since 2014, over 3,000 patents were reported to have been filed / granted related to such advanced techniques, indicating the rapid pace of innovation in this domain. Developers of the aforementioned technologies claim that these new techniques offer numerous benefits, including fast and precise cell sorting, reduced sample requirement, improved portability, reduced risk to cell viability, and negligible need for expensive biochemical / magnetic labels. Moreover, they have been shown to be compatible for use across a myriad of applications, including research studies (bacteriology, immunology, stem cell research, and viral titering and infectivity), biomedical diagnostics (circulating tumor cell detection, in vitro fertilization, and non-invasive prenatal diagnosis), biological therapy-related process operations (bio-banking, drug discovery, sample preparation, single cell sequencing, and tumor cell characterization), and cell-based therapeutics (B- or T-cell immunotherapies). Consequently, these techniques have captured the interest of several stakeholders in the biopharmaceutical industry. It is also worth highlighting that stakeholders in this domain have received significant support from both private and public investors.  Scope of the Report The ‘Novel Cell Sorting and Separation Market: Focus on Acoustophoresis, Buoyancy, Dielectrophoresis, Magnetophoretics, Microfluidics, Optoelectronics, Traceless Affinity, and Other Technologies, 2019-2030’ report features an extensive study of the current landscape and future outlook of the growing market for novel cell sorting and separation technologies (beyond conventional methods). The study presents detailed analyses of cell sorters, cell isolation kits, and affiliated consumables and reagents, that are based on the aforementioned technologies. Amongst other elements, the report features: A detailed assessment of the current market landscape, featuring a comprehensive list of over 220 innovative cell sorters, cell isolation kits, and affiliated consumables and reagents, along with information on their respective specifications (such as size, weight, cell flow rate, cell sort rate, cell analysis rate, cell purity and viability, process time, and operating temperature and pressure), cell sorting technology (acoustophoresis, buoyancy-activated, dielectrophoresis, magnetic levitation, microfluidics, optoelectronics, photoacoustics, traceless affinity, and others), type of cell (animal cells, cancer cells, immune cells, microbial cells, red blood cells / platelets, stem cells, and others), cell separation approach (positive selection, negative selection and depletion), basis for separation (cell morphology and physiology, cell size and density, surface biomarkers, surface charge and adhesion, and others), and end use / application (research studies, biomedical diagnostics, biological therapy-related process operations, and cell-based therapeutics). An insightful company competitiveness analysis, taking into consideration the supplier power (based on size of employee base and experience in this segment of the industry) and portfolio-related parameters, such as number of products offered, number of target cells, end use(s) / application(s), and key product specification(s).   Comprehensive profiles of key industry players (shortlisted on the basis of company competitiveness analysis scores) that are currently offering novel cell sorters / consumables and cell isolation kits, featuring an overview of the company, its financial information (if available), and a detailed description of its proprietary product(s). Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. An in-depth analysis of the patents that have been filed / granted related to novel cell sorting and separation technologies, since 2014. It highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading industry players (in terms of number of patents filed / granted), and current intellectual property-related benchmarks and valuation. A detailed publication analysis of more than 200 peer-reviewed, scientific articles that have been published since 2014, highlighting the research focus within the industry. It also highlights the key trends observed across the publications, including information on innovative technologies, potential application areas, target disease indications, type of cell, and analysis based on various relevant parameters, such as year of publication, and most popular journals (in terms of number of articles published in the given time period) within this domain.  An analysis of the partnerships that have been established in the domain, in the period 2014-Q1 2019, covering R&D collaborations, licensing agreements, distribution agreements, mergers / acquisitions, asset purchase agreements, product development agreements, product utilization agreements, and other relevant deals. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants / awards, capital raised from IPOs and subsequent offerings, by companies that are engaged in this field. An analysis to estimate the likely demand for novel cell sorting products and solutions across key application areas, including research studies, clinical diagnostics, cell-based therapeutics, and other applications, in different global regions for the period 2019-2030. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the novel cell sorting and separation market. Based on multiple parameters, such as potential application areas, likely adoption rate and expected pricing, we have provided an informed estimate on the likely evolution of the market, over the period 2019-2030. In addition, we have provided the likely distribution of the current and forecasted opportunity across [A] potential application areas (research studies, clinical diagnostics, cell-based therapeutics, and other applications), [B] end users (academic institutes, clinical testing labs, hospitals, and commercial organizations), [C] type of offering (cell sorters, and consumables and isolation kits), [D] cell sorting technology (buoyancy-activated, magnetophoretics, microfluidics, optoelectronics, and other advanced technologies), [E] type of cell (adult stem cells, CAR-T cells, circulating fetal cells, circulating tumor cells, dendritic cells, embryonic stem cells, insect cells, induced pluripotent stem cells, microbial cells, sperm cells, TCR cells, TILs, and tumor cells / cancer cells), [F] size of cell (< 5 µm, 5-10 µm, 10-15 µm, 15-25 µm, and > 25 µm), and [G] key geographical regions (North America, Europe and Asia-Pacific). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of organization names): John Younger (Co-founder and Chief Technology Officer, Akadeum Life Sciences) Sean Hart (Chief Executive Officer and Chief Scientific Officer, LumaCyte) Soohee Cho (Product Manager, Namocell) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Mitochondrial Disease Therapies Market, 2019-2030

Mitochondrial diseases are characterized by chronic, genetic and progressive medical symptoms that arise due to inherited or spontaneous mutations in mitochondrial DNA (a small, circular, double-stranded with ~16,500 base pairs that exists outside of the nucleus), or in some cases, nuclear DNA, which adversely alter the function of mitochondria. Such clinical conditions are rare and are known to affect multiple parts of the body, including neurons and nerves, kidneys, heart, liver, eyes, ears, and pancreas. It is worth highlighting that over 300 mutations have been identified and are associated with various mitochondrial diseases.  Examples of diseases that are caused due to mutations in mitochondrial DNA include Leber's hereditary optic neuropathy (LHON), Leigh syndrome, mitochondrial DNA depletion syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS), and myoclonic epilepsy with ragged red fibers (MERRF). In the US, mitochondrial diseases are known to annually affect 1 in 5,000 individuals. It is also estimated that 1,000-4,000 children are born with a mitochondrial disease every year, in the same region.  Primary mitochondrial diseases are usually difficult to diagnose. In many cases, clinicians and medical professionals are compelled to use the term possible mitochondrial disease, indicating that based on the presenting symptoms they suspect a patient to be suffering from a mitochondrial disease. However, they are unable to confirm the condition via genetic diagnosis. Such instances are further complicated by the aforementioned uncertainty, leading to delays in treatment and subsequent deterioration in the patient’s quality of life.  Currently, several industry stakeholders are engaged in efforts to develop disease modifying interventions for treating different mitochondrial diseases, in addition to drug / therapy candidates that offer symptomatic relief. There are several non-profit organizations that have been established across the globe to support individuals suspected / diagnosed with mitochondrial diseases and also fund research / clinical studies being conducted for treatment of such conditions. In the coming years, the market is anticipated to grow at a significant pace as more novel therapy solutions are approved by regulatory authorities and enter the market. Scope of the Report The “Mitochondrial Disease Therapies Market, 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of therapeutics designed to treat mitochondrial diseases. It features an in-depth analysis, highlighting the capabilities of stakeholder companies / organizations engaged in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage) of lead candidates, type of molecule (small molecule and biologic), type of therapy (monotherapy and combination therapy), path to clinic (dedicated, repurposed and repositioned), target disease indication, and route of administration of the drugs / therapies that are being developed for the treatment of different mitochondrial diseases. Detailed profiles of the players that are engaged in the development of therapies for mitochondrial diseases (shortlisted on the basis of the number / phase of products), featuring an overview of the company, its financial information (if available), a description of its product portfolio, recent collaborations and an informed future outlook. An analysis of close to 200 peer-reviewed, scientific articles published during the period 2014-2019 (till February), highlighting the research focus within this niche industry segment. It includes an informed opinion on the key trends observed across the aforementioned publications, including information on target disease indications, target mutations across different indications, and analysis based on various relevant parameters, such as study type (review article, research article and case report), year of publication, and most popular journals (in terms of number of articles published in the given time period). A list of key opinion leaders (KOLs) within this domain, featuring detailed 2X2 matrices to assess the relative experience of key individuals, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field. It also includes a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers engaged in this domain. In addition, it presents an analysis assessing the credibility and (relative) level of expertise of different KOLs, based on number of publications, number of citations, number of clinical trials, number of affiliations and strength of professional network (based on information available on LinkedIn). A study of the various grants that have been awarded to research institutes engaged in projects related to different types of mitochondrial diseases, between 2015 and 2019 (till May), highlighting various important parameters, such as year of award, support period, amount awarded, funding institute, grant type, responsible study section, focus area and type of recipient organization. One of the key objectives of the report was to estimate the existing market size and the future opportunity of therapies for mitochondrial diseases, over the next decade. Based on multiple parameters, such as disease prevalence, anticipated adoption of the forecasted therapies and the likely selling price of such therapeutic products, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] different target indications (Leigh syndrome, LHON, MELAS, mitochondrial DNA depletion syndrome, mitochondrial myopathy and others), [B] type of therapy (combination and monotherapy), [C] route of administration (oral, intravenous, and others) and [D] key geographical regions (the US, EU5 and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.   All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Abuse Deterrent Formulation Technologies Market, 2019-2030

Although the healthcare industry relies on patient to take medications responsibly, in 2017, close to 18 million individuals were reported to have misused prescription drugs, in the US. In fact, data from a National Survey on Drug Use and Health conducted in the same year, showed that an estimated 2 million Americans misused prescription pain relievers for the first time in the previous year. Moreover, the same study reported 1.5 million people abusing tranquilizers, over 1 million abusing prescription stimulants and more than 270,000 abusing sedatives, for the first time, in the same time period. Owing to a rapid onset of medicinal effect, which offers immediate relief (with high efficacy), opioids are still considered to be one of the most widely used pharmacological interventions for pain management. However, these drugs are known to induce a euphoric state upon consumption, often causing patients to abuse them; increased recreational use of opioids is known to lead to addiction. Moreover, over-prescription of such medicinal products, which promotes their misuse, is considered as one of the root causes of the opioid crisis (increasing number of deaths involving misuse and addiction to opioids), in the US. According to the Centers for Disease Control and Prevention (CDC), more than 72,000 overdose-related deaths were reported in 2017, of which close to 50,000 involved the use of an opioid. Moreover, opioid abuse was estimated to have been responsible for an economic deficit of over USD 500 billion, related to loss of productivity and healthcare costs, in the US. Other drug classes that are prone to abuse include antidepressants and central nervous system (CNS) stimulants. In 2017, close to 17,000 deaths were reported to have been the result of an overdose of prescription antidepressants. Most of these deaths (~11,500) involved the misuse of benzodiazepines, such as VALIUM® (diazepam) and XANAX® (alprazolam). CNS stimulants are usually indicated for the treatment of patients suffering from attention-deficit / hyperactivity disorder (ADHD). Among the various overdose-related deaths which took place in 2017, it is worth highlighting that over 12% involved the use of psychostimulants. Prescription drug abuse has prompted pharmaceutical developers to devise various strategies to prevent misuse. Some of the commonly used approaches to abuse deterrence include limiting use of opioids post-surgery, implementing stringent medicine prescribing guidelines and conducting prescription drug monitoring programs, and creating abuse deterrent formulations (ADFs) of drugs that are likely to be misused. Drug formulations that are designed to prevent an active pharmacological substance from being abused have been identified as a viable and sustainable alternative to limiting recreational / off-prescription use of the abovementioned drug classes and its consequences. Over the years, several different types of abuse deterrent formulation technologies have been developed; these include physical / chemical barriers that prevent drugs from being manipulated for recreational use, addition of chemical agents that interfere with the effects of the drug upon improper use and abuse-resistant drug delivery / administration technologies. Specifically, for opioids, market experts believe that in the foreseen future, ADFs of such drugs are likely to replace conventional forms of such products. However, there are concerns regarding how this transition can be made in a responsible and economically feasible manner. Scope of the Report The 'Abuse Deterrent Formulation Technologies Market, 2019-2030' report features an extensive study of the current market landscape and the future potential of industry players that are offering various abuse deterrent formulation technologies to different pharmaceutical companies. Amongst other elements, the report features: A detailed assessment of the current market landscape of companies offering technologies for the development of abuse deterrent formulations of prescription drugs that are prone to be misused, including information on key technology developers (such as year of establishment, company size, and geographical location), and their respective technologies, offering insights on current status of development (available for use and under development), target drug class (opioids, antidepressants and CNS stimulants), abuse deterrence approach (physical and chemical barriers, prodrug approach, use of agonist / antagonist, aversion, use of specific drug delivery systems, and others), disrupted route of abuse (parenteral, insufflation, covert administration, oral, and others), type of end product (tablets, capsules, transdermal patches, thin films, and others), and release characteristics (delayed / extended, controlled, immediate, and others). An informed competitiveness analysis of the various abuse deterrent drug formulation technologies captured in our database, taking into consideration the supplier power (based on year of establishment) and key technology-related specifications, such as the abuse deterrent approach, disrupted route of abuse, number of products available / under development using a particular technology and strength of intellectual property portfolio (in terms of number of affiliated patents).  Elaborate profiles of prominent technology developers engaged in this domain, featuring an overview of the company, its financial information (if available), and a detailed description of proprietary technology / technologies. Each profile also includes a list of recent developments, highlighting the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the in the foreseen future. An in-depth analysis of the patents that have been filed / granted related to abuse deterrent formulation technologies, from 2000 to 2019 (till April). The analysis also highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading patent assignees (in terms of number of patents filed / granted), and patent benchmarking.    An analysis of the partnerships that have been established in the domain in the period 2013-2019, covering product commercialization and licensing agreements, product development agreements, licensing agreements, mergers / acquisitions, service agreements, research agreements, and others. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on likely licensing deal structures and agreements that are expected to be signed between drug and technology developers in the foreseen future, we have provided an informed estimate on the likely evolution of the market for the period 2019-2030. The report features likely distribution of the current and forecasted financial opportunity across [A] target drug class (opioids, antidepressants and CNS stimulants), [B] abuse deterrence approach (physical / chemical barriers, agonist / antagonist combinations, aversion approach, prodrug approach, abuse deterrent drug delivery systems and others),  [C] type of end product (tablets, capsules, transdermal patches, thin films and others), and [D] geography (North America, Europe, Asia Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:  Greg Sturmer (President and Chief Executive Officer, Elysium Therapeutics)  Aia Malik (Commercial Development Manager, Healthcare, Lucideon) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Vaccine Contract Manufacturing Market (2nd Edition), 2019-2030

The global vaccines market is anticipated to generate revenues worth USD 100 billion by 2025. According to the WHO, the global vaccination rate is nearly 85%, demonstrating the high clinical demand for vaccines.  In addition to meeting the growing demand for vaccines, the developers of these pharmacological interventions are also plagued by high costs of development and complex production protocols. Given that vaccine manufacturing requires highly regulated, state-of-the-art technologies, it has become increasingly difficult for stakeholders to establish in-house expertise for large-scale manufacturing of vaccines. As a result, vaccine developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs). Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical development and commercial-scale manufacturing processes to contract service providers. In addition, even big pharma players, with established in-house capabilities, are gradually entering into long-term business relationships with CMOs in order to optimize resource utilization and manage costs. It is worth highlighting that the contemporary contract services market for vaccines is highly fragmented. Having said that, numerous stakeholders are actively striving to expand their respective service portfolios through substantial acquisition activity. As a result, these CMOs have developed the capabilities to offer end-to-end services, ranging from vaccine development (including preliminary R&D, preclinical studies and clinical trials), to regulatory filings, and commercial scale production. In future, we expect the demand for core competencies to continue to drive sponsor companies to rely on contract service providers for various aspects of product development and manufacturing. Amidst tough competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor and is likely to grant a competitive advantage to certain CMOs over other players in the industry.  Scope of the Report The “Vaccine Contract Manufacturing Market (2nd Edition), 2019 – 2030” report features an extensive study on contract service providers engaged in the development and manufacturing of vaccines. The study features in-depth analyses, highlighting the capabilities of various vaccine CMOs. Amongst other elements, the report includes: A detailed review of the contract manufacturing landscape for vaccines, featuring a comprehensive list of active CMOs and analysis based on a number of parameters, such as year of establishment, company size, geographical location, number of vaccine manufacturing facilities, types of services offered (cell / virus banking, analytical development / testing, formulation, process development, fill / finish and regulatory filings), scale of operation (preclinical, clinical and commercial), type of expression systems used (mammalian, microbial and others) and type(s) of vaccines manufactured.  A region-wise, company competitiveness analysis, highlighting prominent vaccine contract manufacturers based on supplier strength (considering the experience of the contract manufacturer), and service strength (which takes into account the count of service offerings, number of expression systems used and scale of operation). Elaborate profiles of the key players based in North America, Europe and Asia-Pacific that have a diverse range of capabilities for the development, manufacturing and packaging of vaccines. Each profile includes an overview of the company, its financial performance (if available), information on service portfolio, vaccine manufacturing facilities, and details on partnerships, recent developments (expansions), and awards and accolades received, as well as an informed future outlook.  An analysis of the recent collaborations (signed since 2013) focused on the contract manufacturing of vaccines, based on various parameters, such as year of agreement, type of agreement, scale of operation, types of services mentioned in the deal, types of vaccines manufactured, types of therapeutic area and location of facility where the project is to be executed.  A detailed analysis of the expansions undertaken (since 2013) by various service providers within vaccine contract manufacturing industry, based on a number of parameters, including year of expansion, type of expansion (capacity expansion, capability expansion and new facility), geographical location of facility, scale of operation, types of services involved, expansion details (in terms of new area added to existing facilities, if available) and most active players (in terms of number of instances). An informed estimate of the annual commercial and clinical demand for vaccines (in million litres), which was further segmented on various types, such as types of vaccines, types of indications and geography. A detailed capacity analysis, taking into consideration the manufacturing capacities of various stakeholders (small-sized, mid-sized, large / very large CMOs) in the market, based on data gathered via secondary and primary research. It also provides the distribution of global vaccine manufacturing capacity by company size (small-sized, mid-sized, large / very large), and geography (North America, Europe and Asia-Pacific) and scale of operation (preclinical / clinical and commercial). A detailed capacity analysis, taking into consideration the manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs) in the market, based on data gathered via secondary and primary research. It also provides the distribution of global vaccine manufacturing capacity by company size (small-sized, mid-sized, large and very large), and geography (North America, Europe and Asia-Pacific) and scale of operation (preclinical / clinical and commercial). A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.  A discussion on the potential market drivers, such as the growing vaccines pipeline, increasing outsourcing of vaccine operations and opportunities in Asia-Pacific region, which are likely to present in the coming years. One of the key objectives of the report was to estimate the future size of the market. Based on the parameters, such as growth of the overall vaccine market, cost of goods sold, and direct manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period, 2019-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] types of expression systems (mammalian, microbial and others), [B] size of contract service provider company (small-sized, mid-sized and large / very large), [C] scale of operation (preclinical, clinical and commercial) and [D] key geographical regions (North America (US,), Europe (UK, France, Germany, Italy and Spain), Asia (China, India and Japan) and rest of the world. To account for the uncertainties associated with the manufacturing of vaccines and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.  The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Menzo Havenga, CEO, Batavia Biosciences and Claire Otjes, Marketing Manager, Batavia Biosciences David C Cunningham, Director Corporate Development, Goodwin Biotechnology Ingrid Cromann, Director - Vaccine Development, Statens Serum Institut Kevin Daley, Director Pharmaceuticals, Novasep Synthesis Oliver Schub, Senior Business Development Manager, ProBioGen Sebastian Schuck, Head of Business Development, Wacker Biotech  All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (4th Edition), 2019 – 2030

The cancer therapeutics market is considered to be one of the most active segments within the pharmaceutical industry. In the past five years, the USFDA has approved more than 100 drugs for the treatment of different types of cancer. However, there is still a pressing need for more specific and potent drugs / therapies to combat this complex, life threatening clinical condition. It is also worth highlighting that, in the coming years, the number of cancer patients is anticipated to increase substantially along with the growing global population. According to the International Agency for Research on Cancer (IARC), close to 17 million new cases of cancer were diagnosed in 2018, worldwide. By 2040, it is estimated that the aforementioned number is likely to grow to 27.5 million. In fact, the global cancer burden is anticipated to increase by 70% in the next 20 years. Among the current initiatives focused on developing targeted anti-cancer therapies, T-cell therapies (specifically CAR-T, TCR and TIL therapies) have emerged as a promising option owing to their capability to eradicate tumor cells from the body with minimal treatment-related side effects. These adoptive T-cell therapies (ACT) are based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. With the recent approval of KYMRIAH® (Novartis) and YESCARTA® (Gilead Sciences) for the treatment of CD19-positive relapsed / refractory leukemias and lymphomas, such ACTs have become a part of mainstream healthcare solutions. Encouraging clinical trial results and therapeutic response rates achieved across various hematological cancers and solid tumors have further inspired research groups to focus their efforts on the development of these novel therapies. So far, more than 150 academic and research institutes across the globe have made significant contributions to this field, mostly by convening the initial research on potential therapy candidates. In fact, multiple collaborations have been inked in the past decade between various therapy developers and academic / research institutes to advance the development of various pipeline candidates. The ongoing research activity in this field has also led to the discovery of several novel molecular targets. Further research and characterization of the aforementioned targets have significantly strengthened the research pipelines of companies engaged in this market. Driven by the availability of innovative technology platforms, lucrative funding and encouraging clinical trial results, the T-cell immunotherapies market is poised for success in the long-run as multiple product candidates are expected to be approved over the coming decade.  Scope of the Report The “Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (4th Edition), 2019 – 2030” report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies (focusing particularly on CAR-T therapies, TCR therapies and TIL therapies). The report highlights the efforts of both industry players and academic organizations. Amongst other elements, the report features the following: An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, highlighting the yearly trend of tweets, most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers. A detailed assessment of the current market landscape of T-cell immunotherapies with respect to type of therapy, type of developer (industry / non-industry), phase of development, target therapeutic indication(s), key target antigen(s), source of T-cells (autologous / allogenic), and route of administration. In addition, we have provided an overview of the competitive landscape, key challenges and anticipated future trends associated with CAR-T, TCR and TIL-based therapies. Comprehensive profiles of marketed and mid to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results. An analysis of the CAR constructs of clinical-stage CAR-T therapies based on the generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector and type of co-stimulatory domain used. A detailed analysis highlighting several key opinion leaders (KOLs) in this domain. It features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, indicating the geographical locations of eminent scientists / researchers involved in the development of T-cell therapies. An analysis of the various CAR-T cell therapy focused clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend of initiation of such studies and distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies, especially in China. An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications. A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers. Further, it includes a relative competitiveness analysis of different T-cell immunotherapy-based gene editing platforms, based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology. An analysis of the partnerships that have been established in the recent past, covering R&D agreements, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures and others. An analysis of the investments that have been made into companies that have proprietary T-cell based products / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants and debt financing. A case study on other T-cell based therapies, apart from CAR-Ts, TCRs and TILs. It presents a detailed analysis of the approved / pipeline products in this domain, including information on the current phase of development, target therapeutic area(s), type of T-cells used and source of T-cells. A case study on manufacturing cell therapy products, highlighting the key challenges, and a list of contract service providers and in-house manufacturers that are involved in this space. An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a T-cell based immunotherapy that is likely to be marketed in the coming years. A review of the key promotional strategies that have been adopted by the developers of the marketed T-cell therapies, namely KYMRIAH® and YESCARTA®. One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for T-cell immunotherapies over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report includes potential sales forecasts of T-cell immunotherapies that are currently marketed or are in late stages of development. Additionally, it provides forecasts for the overall T-cell immunotherapies market, wherein both the current and upcoming opportunity is segmented across [A] type of therapy (CAR-T, TCR and TIL), [B] target indications (acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, melanoma, bladder cancer, lung cancer, head and neck cancer, multiple myeloma, sarcoma, chronic lymphocytic leukemia, ovarian cancer, esophageal cancer, colorectal cancer, nasopharyngeal carcinoma, hepatocellular carcinoma, acute myeloid leukemia, and renal cell carcinoma), [C] target antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-1 and others) and [D] key geographies (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individualss: Tim Oldham (Chief Executive Officer, Cell Therapies) Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics) Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies) Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) Miguel Forte (Chief Operating Officer, TxCell) Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) Vincent Brichard (Vice President, Immuno-Oncology, Celyad) Peter Ho (Director, Process Development, Iovance Biotherapeutics) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital) Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Natural Killer Cell Therapies: Pipeline Review

Natural killer (NK) cells, or killer (K) cells, represent an important subset of cellular mediators of the innate immune system. These cells are known to be instrumental in containing viral infections and regulating tumor development, while the adaptive immune system generates an antigen-specific response.  Technically, they are classified as group I innate lymphocytes. Although they share a common progenitor, NK cells are very different from B-lymphocytes and T-lymphocytes,  and do not require specific antigen-based activation in order to function. The cytotoxic effects of these cells are mediated using perforin and granzymes, which is somewhat similar to the mode of action of cytotoxic T cells. Additionally, studies have demonstrated that NK cells can also secrete certain cytokines and chemokines, such as IFNγ and TNFα, through which they can recruit other immune components to augment and sustain an immune response. For instance, IFNγ secreted by NK cells has been shown to be involved in T-helper (TH1) cell based immune response, and the activation of certain antigen-presenting cells and macrophages. Alternatively, NK cells have been shown to respond to certain types of interferons and macrophage-derived cytokines.   Several studies have demonstrated the various benefits of NK cells as a therapeutic tool. Currently, these cells are being evaluated across multiple clinical trials to treat various types of cancer and infectious diseases. Further, the genetic modification of NK cells has demonstrated additional benefits, and many companies are also working on developing allogenic product candidates that can be used as off-the-shelf therapies. Scope of the Report The “Natural Killer Cell Therapies: Pipeline Review” report features an extensive study of the current market landscape and clinical research scenario related to all NK cell-based products / product candidates. The information in this report has been presented in the form of interactive dashboards, aiming to provide a comprehensive overview of the ongoing activity in this domain, and offering insights on a number of important parameters, including: An analysis of the contemporary developer landscape, providing information on key innovator companies and their respective NK cell therapies, current (highest) phase of development, source of NK cells (autologous and allogenic), target disease indication (hematological malignancies, solid tumors and others), type of therapy (monotherapy and combination therapy), route of administration and other relevant details (if available). Analysis of both completed and active clinical trials, initiated from January 2009, featuring details on (primary) developer company (year of establishment, location of headquarters, and company size), type of developer (industry and non-industry), name of therapy, source of NK cells (autologous and allogenic), and other trial related details (collaborating sponsors, trial title, study objectives, location of trial, current status, availability of results, target therapeutic indication, study type, current / anticipated enrolment, study start / end date and key outcomes / results). Analysis of terminated clinical trials, highlighting the developer company, type of developer (industry and non-industry), name of therapy, source of NK cells (autologous and allogenic), other trial related details (collaborating sponsors, trial title, study objectives, target therapeutic indication and study type) and reason for termination. All information has been sourced and analyzed from company websites, press releases, reliable clinical trial data repositories (such as clinicaltrials.gov), and other publicly available information platforms.

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Medical Device Contract Manufacturing Market, 2019-2030

Recent advances in data science technology solutions, such as Internet of Things, machine learning, artificial intelligence and real world evidence-based solutions, have enabled medical device developers to digitize and automate a number of product development and manufacturing processes. In 2020, the global medical devices market is estimated to reach a net worth of approximately USD 430 billion.  However, most developers lack adequate resources and the necessary expertise to manufacture medical devices and related components. Moreover, given the rapid rate of evolution, the costs associated with acquiring the necessary infrastructure and capabilities in this field are high; therefore, it is difficult for companies with limited finances to acquire such resources and carry out such operations by themselves. In addition, the evolving regulatory guidelines and complicated pathways to establishing reimbursement strategies render medical devices subject to rigorous quality assessments, especially for medium and high risk devices. The aforementioned constraints have led many of the smaller players and certain established players to outsource a significant part of their manufacturing operations to capable contract manufacturing organizations (CMOs). CMOs are known to offer significant cost-benefits, access to sophisticated / up-to-date infrastructure, large production capacities and reduction in time-to-market. Given the demand for medical devices, the opportunity for CMOs with expertise in medical devices is steadily rising. In fact, in 2018 alone, the USFDA approved over 100 medical devices. It is worth highlighting that, since 2000, more than 65 CMOs have been established. The demand for one-stop-shops and versatile supply chain management solutions have fuelled consolidation activity in this domain. Contemporary contract service providers have been focusing on bolstering in-house capabilities to offer a wider range of services to their clients, covering product design to distribution and marketing, along with regulatory assistance. The medical device sector is among the most highly regulated industries, and we expect the demand for core competencies, such as design and engineering, prototype development and high volume manufacturing, to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations to capable contract service providers. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor; CMOs that invest in such upgrades are likely to gain a competitive edge.   Scope of the Report The “Medical Device CMOs Market, 2019-2030” report features a comprehensive study on the current landscape of contract manufacturing service providers focused on medical devices (specifically for drug-delivery devices, diagnostic devices and therapeutic devices). The scope of the report primarily includes those manufacturers that offer finished product services for medical devices (excluding medical equipment, such as X-ray machines, ultrasound machines, operating tables and other similar products).  The study features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe. Amongst other elements, the report includes: A detailed review of the overall landscape of the medical device contract manufacturing market, featuring a list of CMOs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, manufacturing facilities, geographical location, type of device manufactured (drug-delivery devices, diagnostic devices, therapeutic devices and others), scale of operation (precommercial and commercial) and types of services offered ([A] production services (such as design services, prototyping, component manufacturing, packaging, and sterilization), [B] post-production services (such as supply chain management services, labeling services, logistics, and shipping services) and [C] other services (such as regulatory services, project management services and documentation services). An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful multi-dimensional bubble analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe. A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry. An analysis of the medical device supply-chain, highlighting the role of CMOs engaged in this domain and analysis based on services offered, such as supply chain management services, logistics services, shipping services and warehousing services, to medical device companies.  Elaborate profiles of popular players that specialize in providing services for both precommercial and commercial scale manufacturing of medical devices. Each profile features an overview of the company, its service portfolio, details on manufacturing facilities, as well as an informed future outlook. A geographical clinical trial analysis of ongoing and planned studies related to medical devices, featuring details related to medical devices being investigated across various geographies, based on the number of registered trials, current status of trials, phase of development, type of sponsor, therapeutic area(s) and target disease indication(s), and number of patients enrolled. A detailed analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019. The analysis provides information on the key value drivers for these mergers and acquisitions and the corresponding acquisition deal multiples. In addition, the analysis features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain. An elaborate discussion on the future opportunities / trends related to the medical device contract manufacturing market that are likely to influence the growth within this domain over the coming years. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical device CMO industry. One of the key objectives of this report was to evaluate the current opportunity and the future market potential of the medical device CMOs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] type of devices (drug-delivery, therapeutic and diagnostic devices), [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world) and [E] leading players. To account for the uncertainties associated with the growth of the medical device CMO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Neoantigen Targeted Therapies Market, 2019-2030

Cancer is known to be one of the leading causes of death worldwide, accounting for 0.6 million deaths in 2018, in the US alone.  The World Health Organization has estimated the number of new cancer cases, reported across the globe, to rise by 70% over the next 20 years.  Conventional treatment options, such as chemotherapy, surgery and radiation therapy, continue to demonstrate limited efficacy in late-stage cancers. Moreover, the non-specific and highly toxic nature of chemotherapy and radiation therapy, have severe detrimental effects on patients’ quality of life. Amongst the targeted anti-cancer therapies, immunotherapy has emerged as a potent option, capable of eliminating tumor cells with minimal side effects. For instance, the introduction of the immune check point inhibitors (such as PD-1/PD-L1 and CTLA-4 inhibitors) enabled healthcare providers to offer long term clinical benefit to patients suffering from metastatic tumors. However, these therapies have been reported to generate variable / inconsistent immune responses across different patients and, as a result, only a fraction of patients have actually ended up benefiting from such treatments. In fact, it is estimated that close to 70% of treated patients do not respond to single-agent immune checkpoint therapy.  Recent developments in genomic analysis and advances in bioinformatics have enabled the adoption of more personalized treatment approaches, such as neoantigen targeted therapies. Cancer neoantigens is a term used to refer to a subset of antigens encoded by tumor-specific, mutated genes, which have not previously been recognized by host’s immune system. These are considered to be potential biological targets that can be used to augment the therapeutic value of a number of cancer immunotherapies, including immune checkpoint inhibitors and cancer vaccines, having demonstrated the capability to elicit strong T-cell mediated immune response. Currently, several neoantigen-based therapies are being investigated in combination with various immune checkpoint inhibitors, such as atezolizumab, durvalumab, ipilimumab and nivolumab. In fact, multiple such initiatives by start-ups are backed by venture capital firms and other strategic investors.  Scope of the Report The “Neoantigen Targeted Therapies Market, 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage) of lead candidates, type of molecule (small molecule and biologic), type of treatment (personalized and off-the-shelf), type of therapy (monotherapy and combination therapy), type of immunotherapy, target indication, line of treatment, and route of administration of the drugs / therapies that are being developed for the treatment of cancer. Detailed profiles of developers of neoantigen targeted therapies (shortlisted on the basis of the number of pipeline products), featuring an overview of the company, its financial information (if available), a detailed description of its product portfolio and recent collaborations. In addition, each profile includes an informed future outlook. A detailed publication analysis of close to 300 peer-reviewed, scientific articles published during the period 2015-2019 (till February), highlighting the research focus within the industry. It also highlights the key trends observed across the publications, including information on target disease indications, affiliated cancer immunotherapies, and analysis based on various relevant parameters, such as study type (review article, research article and meta-analysis), year of publication, and most popular journals (in terms of number of articles published in the given time period) within this domain. An in-depth analysis of the various patents that have been filed / granted related to neoantigens till April 2019. It includes information on key parameters, such as patent type, publication year, issuing authority, assigned CPC symbol, emerging focus areas and leading industry / academic players (in terms of size of intellectual property portfolio). An analysis of the various partnerships pertaining to neoantigen targeting therapies, which have been established till March 2019, based on various parameters, such as the type of partnership, year of partnership, target disease indications, type of immunotherapy and the most active players. An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in companies that are focused on developing neoantigen targeted therapies. One of the key objectives of the report was to estimate the existing market size and the future opportunity for neoantigen targeted therapies, over the next decade. Based on multiple parameters, such as disease prevalence, anticipated adoption of neoantigen targeted therapies and the likely selling price of such therapeutic products, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] different target indications (bone and cartilage cancer, colorectal cancer, head and neck cancer, renal carcinoma, hepatocellular carcinoma, lung cancer, gynecological cancer and others) [B] type of treatment (personalized and off-the-shelf), [C] type of immunotherapy (dendritic cell vaccine, DNA / RNA-based vaccine, protein / peptide-based vaccine and TIL-based therapy), [D] route of administration (intradermal, intravenous, subcutaneous, and others) and [E] key geographical regions (US, EU5 and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.   The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Gabriel Nistor (Chief Scientific Officer, AIVITA Biomedical) Ella Sorani (Vice President Research and Development, BioLineRx) Heinz Lubenau (Chief Operating Officer and Co-Founder, VAXIMM) All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Biologics Fill / Finish Services Market, 2019 - 2030

Biologics constitute a majority of the top selling drugs and presently represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, since the launch of recombinant protein-based therapies around three decades earlier, the overall biologics market has grown at an annualized rate of over 12%. It is also worth highlighting that more than 5,000 biopharmaceutical product candidates are currently under development.  Despite the fact that biopharmaceuticals offer significant profit margins, the sponsors of such pharmacological interventions are plagued by high costs of development and complex production protocols. As a result, several start-ups / small-sized companies and certain pharma giants have begun outsourcing different aspects of their business operations to contract service providers. According to the 2017 Nice Insight CDMO survey, about 54% of 700 respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development projects.  Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant benefits, such as reduction in capital investment, access to larger production capacities, reductions in time-to-market and reduced commercialization risk.  Specifically, fill / finish is the final step in the production process and is considered among the most crucial stages of drug product manufacturing. Biologics drug products require special procedures and equipment for fill / finish operations in order to ensure product integrity and safety. As this operation is heavily outsourced, the rise in demand for biologics has resulted in an equivalent need for flexible aseptic fill / finish technologies. Pharmaceutical drug manufacturers have not hesitated to collaborate with contract service providers to leverage the latter’s experience and expertise in the latest fill / finish technologies. Currently, over 115 companies are actively providing fill / finish services for biologics. In the recent past, many service providers have also forged alliances / acquired other players in order to enhance their service offerings.  Scope of the Report The ‘Biologics Fill / Finish Service Providers, 2019-2030’ report features an extensive study on the contract service providers offering drug product manufacturing services within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of companies that claim to specialize in fill / finish operations. Amongst other elements, the report includes:  A detailed review of the overall landscape of contract fill / finish services market for biopharmaceuticals, featuring a list of active service providers and detailed analysis based on a number of relevant parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics filled (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), year of establishment, company size and geographical location of the service provider, count and location of affiliated fill / finish facilities, number of additional services offered (lyophilization, labelling, quality testing, storage and distribution services), dosage forms handled (liquid and lyophilized), and types of primary packaging containers handled (ampoules, cartridges, syringes and vials),  including details on fill / finish capacity and fill volume range. A region-wise, company competitiveness analysis, highlighting prominent fill / finish service providers across various packaging types, based on supplier strength (considering experience and company size of the service provider), service strength (considering number of fill / finish facilities, number of continents where the aforementioned facilities are located, number of additional services offered and scale of operation) and types of biologics handled.      Elaborate profiles of key players across key geographies (North America, Europe and Asia-Pacific), which were shortlisted based on our proprietary company competitiveness analysis. Each profile provides an overview of the company, information on its overall service portfolio, fill / finish facilities, financial performance (if available), and details on partnerships, expansions and recent awards and accolades, as well as an informed future outlook.  An analysis of the recent collaborations (signed since 2013) focused on the contract fill / finish services for biologics, based on various parameters, such as year of agreement, type of agreement, scale of operation of the project, focus area, types of services mentioned in the deal, types of biologics involved and location of facility where the project is to be executed.  A detailed analysis of the expansions undertaken (since 2013) by various service providers for augmenting their respective fill / finish service portfolios, based on a number of parameters, including year of expansion, type of expansion (capacity expansion and new facility), geographical location of facility, type of packaging container involved, scale of operation (as mentioned in the expansion terms), types of services and biologics involved, expansion details (in terms of new area added to existing facilities, if available) and most active players (in terms of number of instances). An estimate of the global, contract fill / finish capacity, by taking into consideration the capacities of various fill / finish service providers (as available on respective company websites), collected via secondary and primary research. The study examines the distribution of number of packaging units and volume of biologics filled, across various types of packaging containers (ampoules, cartridges, syringes, and vials), based on the size of the company / organization (small-sized, mid-sized and large)  and geography (North America, Europe and Asia Pacific). An informed estimate of the annual demand for fill / finish of biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency, dose strength, type of packaging container and volume of the packaging container of the abovementioned products.  An analysis to identify the key performance indicators for service providers active in the domain, based on information gathered via secondary research (for top-ten pharmaceutical players) and primary research. A case study to highlight the benefits of using robotic / automated equipment for aseptic fill / finish processes; the study provides a list of equipment manufacturers providing robots suitable for pharmaceutical operations. A case study to highlight the role of ready-to-use packaging containers in aseptic fill / finish operations; the study provides a list of suppliers providing the ready-to-use components. A discussion on the potential growth areas, such as growing biopharmaceutical pipeline, increasing outsourcing of fill / finish operations, rising focus on self-administration enabling drug delivery devices and growing opportunities in Asia-Pacific region, which are likely to present in the coming years. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, direct manufacturing costs, share of drug product manufacturing costs, and outsourcing trends related to fill / finish operations, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the period 2019-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] types of primary packaging containers used for fill / finish (ampoules, cartridges, syringes and vials), [B] types of biologics (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), [C] company size (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial), [E] key therapeutic areas (cancer, infectious diseases, autoimmune diseases, cardiovascular diseases and other indications), and [F] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy, Spain and rest of the Europe), Asia-Pacific (Japan, China, South Korea, India and Australia)). To account for the uncertainties associated with the fill / finish of biopharmaceuticals and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.   The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Ales Sima, Business Development Manager, oncomed manufacturing  Gregor Kawaletz, Chief Commercial Officer, IDT Biologika Jos Vergeest, International Business Developer, HALIX Purushottam Singnurkar, Research Director and Head of Formulation Development, Syngene International All actual figures have been sourced and analysed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Elastomeric Closure Components Market For Vials, Cartridges and Syringes, 2019-2030: Focus on Caps, Needle Shields, Plungers, Stoppers, Seals, Tip Caps and Other Closures

Pharmaceutical packaging plays a crucial role in ensuring the sterility and quality of a drug product, while also providing information related to its identity and, in certain cases, dosing instructions. Primary packaging material, owing to the fact that it is in immediate contact with the drug / therapy formulation, is considered to be extremely important when it comes to preserving the stability, efficacy and safety of the packaged drug product. Further, given the growing complexity of modern pharmacological interventions, especially biologics, it has become imperative for drug / therapy packaging considerations to be re-evaluated, taking into consideration the evident shift from large batches of one remedy for everyone to smaller batches of more personalized therapeutic solutions. In addition to optimizing drug-packaging compatibility, stakeholders in the pharmaceutical packaging industry have also adopted a number of other flexible solutions to reduce the overall cost and expedite time to market.  The use of elastomeric materials, along with various types of coatings (such as FluoroTec® and Teflon®), has emerged as a promising alternative to conventional, non-coated closures used for primary packaging containers, which were prone to leaching and shedding of particulate contaminants. The advantages of using elastomeric materials in manufacturing container closures are many, including low leaching potential, minimal chemical interaction with the pharmacological formulation, and the fact that they can be used to make waterproof and airtight closures. Moreover, such closures can also be manufactured in the ready-to-use (RTU) format, which saves a significant amount of time by eliminating the need for multiple steps in the overall fill / finish process. Owing to the aforementioned benefits, the industry has witnessed an evident growth in preference for elastomeric container closures.  Scope of the Report The ‘Elastomeric Closure Components Market For Vials, Cartridges and Syringes, 2019-2030: Focus on Caps, Needle Shields, Plungers, Stoppers, Seals, Tip Caps and Other Closures’ report features a comprehensive study of the current scenario and future potential of the elastomeric, primary packaging closure market. It features an in-depth analysis, highlighting the various types of elastomeric closures including stoppers, needle shields and plungers, available in the market for various types of primary packaging containers, such as cartridges, syringes and vials. In addition to other elements, the study includes:  A detailed assessment of the current market landscape of companies manufacturing elastomeric container closures, featuring information on the type of closure (cap, needle shield, plunger, seal, stopper, and tip cap), type of respective primary container(s) (vial, syringe, and cartridge), elastomeric material(s) used for fabricating the aforementioned closures (such as bromobutyl, chlorobutyl, and others), drug type(s) that are compatible with elastomeric closures, sterilization status of closures (pre-sterilized and unsterilized), affiliated sterilization technique (if the closure(s) is available in the pre-sterilized format), scale of production (small scale, and large scale), type of customization (if available), affiliated dimensions, along with compliance certifications of the product.  A comprehensive analysis on the packaging trends of over 230 drug products (including both biologics and small molecule drugs) that were approved over the last five years (beginning 2014), featuring an assessment of the packaging requirements of various container-closure systems based on parameters, such as year of approval of drug, type of molecule, dosage form, route of administration, holding temperature, type of packaging material(s) used for manufacturing primary container and affiliated closure, and leading drug developers (in terms of number of drugs packaged using elastomeric closures).  An analysis of various developments / recent trends related to elastomeric packaging materials, offering insights on [A] partnerships and collaborations established within the industry, and [B] recent global conferences related to pharmaceutical packaging industry. Elaborate profiles of key players in this domain (shortlisted on the basis of size of product portfolio), featuring a brief overview of the company (including information on company headquarters, year of establishment, number of employees, and key members of the executive team), financial information (if available), detailed description of proprietary elastomeric closures, recent developments, and an informed future outlook. A case study on the role of robotics in pharmaceutical manufacturing and fill / finish operations, highlighting the advantages of using automation / automated technologies in such processes. It includes profiles of industry players offering such equipment for the aseptic processing of pharmaceutical products.  An elaborate discussion on emerging trends (such as focus on personalized therapies, shift towards more flexible packaging, upgrading packaging components to enhance drug product safety, and growing adoption of smart packaging solutions) that are likely to have an impact on the future adoption of elastomeric container-closure components in the pharmaceutical packaging industry. It also features a Harvey ball analysis, highlighting the relative effect of each trend on the overall pharmaceutical packaging industry. An in-depth analysis to estimate the current and future demand for elastomeric closures across key primary packaging containers, including vials, syringes and cartridges, in different regions for the period 2019-2030. Input parameters considered for this analysis include current supply of different primary packaging components and their respective closures and the estimated the proportion of elastomeric closures that are likely to be supplied, which is indicative of the demand.  One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for elastomeric closures over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report provides sales forecasts for the overall elastomeric closure market, wherein both the current and upcoming opportunity is segmented across [A] type of packaging container(s) (vials, syringes and cartridges), [B] type of closure(s) used (seal, stopper, cap, plunger, barrel, and needle shield), [C] sterilization status (pre-sterilized and unsterilized), and [D] key geographies (North America, Europe, Asia-Pacific, and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):  Julien Maréchal (Business Development and Technology Director, Aseptic Technologies) Malcolm Gilmore (Facilitator, BioPhorum Operations Group) Marco Pederiva (Marketing and Sales Director, Lonstroff) Konstantin Kazarian (Project Manager of Business Development, PYRAMID Laboratories) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019 – 2030

Over the last couple of decades, the healthcare market has witnessed the entry of several advanced and effective treatment options for cancer; these include a variety of targeted therapies, immunotherapies and certain anti-cancer vaccines as well. However, clinical cancer research is still plagued by high failure rates, various drug / therapy-related limitations, and treatment-based adverse effects, some of which have proven to be fatal. A prominent concern is associated with deciding the type of treatment option to be used for a specific cancer. Patients suffering from a singular type of cancer, who may be at the same stage of the disease, have been demonstrated to exhibit different molecular profiles, and thereby, may respond differently to recommended drug / therapy types. In order to address this concern, pharmaceutical developers and healthcare professionals have adopted a more personalized approach to disease diagnosis and treatment. Over time, several molecular markers have been identified and characterized, and many have been validated for use in making important treatment-related decisions. The role of single analyte biomarkers, such as PD-L1, BRAF, and EGFR, has been well-established across multiple cancer indications. However, due to subtle differences in genomic makeup of individual patients, these biomarkers alone have been shown to be insufficient in determining how patients are likely to respond to various drug / therapy types. Advances in biotechnology have enabled the development of several high throughput tools, which have led to the establishment of better biomarkers, based on genome / exome profiles. Novel cancer biomarkers, such as tumor mutation burden (TMB), microsatellite instability (MSI) / mismatch repair (MMR) deficiency, tumor infiltrating lymphocytes (TILs) and certain others, are presently being investigated across numerous clinical studies. Presently, several diagnostics-focused companies have developed / are developing analytical tests for these biomarkers, which are intended to assist physicians in making personalized treatment-related decisions. It is worth highlighting that many big pharmaceutical players have demonstrated interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of multiple novel biomarkers. Scope of the Report The ‘Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030’ report features an extensive study of the current landscape and future outlook of the immuno-oncology biomarkers testing market (focusing particularly on TMB, MSI and TILs (CD3+, CD4+, CD8+, FOXP3+)). It provides an in-depth analysis, highlighting the capabilities of the various companies engaged in this domain. Amongst various elements, the report includes: A detailed analysis of ongoing, biomarker-based clinical trials initiated by big pharmaceutical companies, featuring details on immuno-oncology biomarkers and disease indications being investigated, based on trial registration year, phase of development, recruitment status, therapy design and type of cancer therapy. An analysis of the landscape of companies offering testing services for cancer biomarkers, namely TMB, MSI / MMR and TILs (including CD3+, CD4+, CD8+ and FOXP3+),  based on a number of relevant parameters, such as year of establishment, size of employee base, location of headquarters, availability status of the test, biomarkers analyzed, application areas, disease indication(s) evaluated, analytical techniques utilized, turnaround time, sample input and others. An insightful 2X2 representation of the results of a detailed competitiveness analysis of various tests (segregated across different biomarker groups), taking into consideration the supplier power (size of employee base) and specific test related parameters, such as, application area of the test, turnaround time and other key specifications. Elaborate profiles of leading analytical testing service providers focused on immuno-oncology biomarkers (shortlisted based on strength of service portfolio), featuring a brief overview of the company, its financial information (if available), information on biomarker testing related service(s), recent developments and an informed future outlook. A detailed publication analysis of over 180 research articles that have been published since 2016, highlighting the key focus areas of ongoing research activity related to immuno-oncology biomarkers, namely TMB, MSI / MMR and TILs. It highlights the prevalent research trends related to the year of publication, disease indications, analytical technique used for biomarker assessment, and type of cancer therapy evaluated. A comprehensive clinical trial analysis of completed, ongoing and planned studies, focused on the assessment of cancer biomarkers, namely TMB, MSI / MMR and TILs, based on various parameters, such as trial registration year, trial recruitment status, trial phase, trial design, indication(s) evaluated, leading industry and non-industry players, and geographical locations of trials. A discussion on the upcoming opportunities (such as development of companion diagnostics, emerging technologies for biomarker assessment, and others) that are likely to impact the evolution of this market over the coming years. A discussion on various steps involved in development operations of companion diagnostics, namely R&D, clinical evaluation, manufacturing and assembly, negotiations with payers / insurance providers and marketing / sales activities, and the cost requirements across each of the aforementioned stages. A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in the development of companion diagnostic products. One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for cancer biomarkers market over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the future opportunity based on [A] biomarker (MSI / MMR, TILs, TMB), [B] disease indications (blood cancer, blood cancer, colon cancer, colorectal cancer, lung cancer, melanoma, prostate cancer and others), [C] analytical technique used (immunohistochemistry, next generation sequencing, polymerase chain reaction and others), [D] application area (research use, clinical use, commercial use), and [E] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Novel Clinical Trial Service Providers: Focus on Real World Data Based Trial Services, Virtual Trials, Adaptive, Umbrella and Basket Design, 2019-2050

The process of developing novel and effective healthcare products is both cost and time intensive. Studies suggest that each prescription drug requires around 10 years and over USD 2.5 billion in working capital before it reaches the market. Further, it is estimated that, in the US, 40% of the pharma industry’s R&D budget is spent solely on conducting clinical trials.  In addition to excessive capital requirement, clinical research is fraught with various other challenges, such as inefficient data handling, risk of failure / termination and a myriad of difficulties associated with patient recruitment and retention. Estimates suggest that nearly 85% of clinical trials fail to retain enough patients for successful study conduct. Patient recruitment and retention-related concerns have been associated with massive delays, with over 90% of clinical trials failing to comply to predetermined completion dates, due to poor participant accrual and excessive subject dropout. Such delays are estimated to result in capital losses of USD 8 million, per day, for a blockbuster drug.   Another prominent area of concern is related to the handling of clinical data, which results in delays in data analysis and preparation of outcome reports. Over the years, the pharmaceutical industry has leveraged technological advances to address several of the aforementioned clinical trial-related constraints / challenges. In fact, the clinical research segment has recently witnessed a surge in the availability of vendors, offering a diverse range of services and solutions for conducting and managing various aspects of trials. Apart from novel clinical trial designs, other advances in this domain include the application of decentralized clinical trial models, use of real-world evidence for clinical research, adoption of advanced clinical supply management solutions and introduction of various patient engagement tools. Many of the aforementioned concepts / solutions have demonstrated the potential to disrupt the conventional method of conducting trials, enabling the establishment of a more patient centric approach to drug development research. Such novel initiatives have also received significant funding from both private and public investors. We are led to believe that the ongoing efforts to improve drug / therapy development research are likely to boost the overall growth of the pharmaceutical market in the coming years. The ‘Novel Clinical Trial Service Providers: Focus on Real World Data Based Trial Services, Virtual Trials, Adaptive, Umbrella and Basket Design, 2019-2050’ report features an extensive study of the current landscape of industry players that are offering various types of innovative clinical research platforms / solutions to the pharmaceutical and life sciences industries. Amongst other elements, the report features: An overview of the current market landscape of companies offering solutions for virtual clinical trials, adaptive trial designs, clinical operations management and real-world evidence based clinical trials, featuring information on year of establishment, geographical location, company size and type of offerings. It also includes a list of virtual clinical trials, clinical studies that have used / are using innovative designs (adaptive trials, basket trials and umbrella trials), and a case study on clinical trials being conducted in real-world settings; the studies are analyzed on the basis of various parameters, such as location of the trial site, target indication, trial phase and study start-date. Brief profiles of companies offering solutions for virtual clinical trials, adaptive trial designs, clinical operations management and real-world evidence based clinical trials, featuring information on their year of establishment, respective headquarters, company size, key executives, service / technology portfolio, recent developments and an informed future outlook. A study of prevalent and emerging trends in the domain, as observed on the social media platform, Twitter. The analysis takes into consideration tweets posted on the platform, between 2013 and 2019 (till March), related to virtual trials, innovative trial designs and patient centricity.  A case study on the initiatives of big pharma players related to virtual clinical trials, offering insights on such clinical studies that have been conducted / planned by the aforementioned players, along with details on associated constraints and the future plans of players engaged in this domain. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity of the market for virtual clinical trial services, adaptive trial design services, real-world evidence based clinical trial services and clinical operations management services. Based on parameters, such as number of pre- or post-approval studies conducted annually, capital investments made in these studies, and the likely cost and time saving opportunities, we have provided an informed estimate of the likely evolution of the market for virtual clinical trials, adaptive trial designs, clinical operations management and real-world evidence based clinical trials, in the short to mid-term and mid to long term, for the period 2019-2050. The report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (cardiovascular disorders, infectious disorders, metabolic disorders, neurological disorders, oncological disorders and others), [B] end-users (small-sized players, mid-sized players, large players and academia / others) [C] phase of development (phase I, phase II, phase III and phase IV) and [D] key geographical regions (US, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. In addition, the report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Phillipe Lemmens (Chief Operating Officer, Andaman7) Himanshu Verma (Founder and Chief Executive Officer, ConsilX) and Rajesh Jain (Co-Founder, ConsilX) Greg Erman (President and Chief Executive Officer, EmpiraMed) Jonathan Moshinsky, Head of Market Strategy, uMotif All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Depressive Disorders (Major Depression, Bipolar Disorder, Postpartum Depression, Treatment-Resistant Depression and Others): Pipeline Review, Developer Landscape and Competitive Insights, 2019

Depression is a chronic medical condition characterized by a persistent feeling of sadness and lack of interest in external stimuli. It is a commonly diagnosed mental health disorder and is considered among the leading causes of disability across the globe. It has been estimated that over 300 million people (considering all age groups) suffer from depression worldwide. Further, depression and other depressive disorders are projected to be responsible for an economic burden of up to USD 210 billion per year in the US. Despite the high prevalence and significant impact of this disease, less than 50% of affected individuals receive treatment in high-income countries; this figure stands at less than 10% for low-income countries. According to the World Health Organization, barriers to effective care for depression and other depressive disorders, include lack of resources, lack of trained healthcare professionals, inaccurate diagnoses of the condition and the social stigma associated with to mental health disorders. A number of blockbuster drugs are available to treat depression; these include Prozac and Celexa (approved in 1980s), Paxil and Zoloft (approved in 1990s), and Lexapro and Cymbalta (approved in 2000s). These drugs work by modulating monoamine levels in the brain, a mechanism that has been re-evaluated and improved across the last six decades. Since the 1950s, around 30 branded drugs and more than 150 generic products have been approved by the FDA to treat various forms of depression. Currently, selective serotonin reuptake inhibitors (SSRIs) form the mainstay of treatment options for depression. Despite the availability of generics and other branded drugs, patients have voiced the need for better antidepressants as currently available SSRIs take a long time (few weeks) to demonstrate therapeutic benefit. In addition, around 50% of treated patients do not respond to the first prescribed antidepressant and need to go through months of trial and error-based therapy regimens before an appropriate drug is identified to treat their underlying condition. Further, there are many patients who never respond to any of the available therapeutic strategies, highlighting an urgent need for effective treatment solutions for depression. Several stakeholders in the pharmaceutical industry are currently engaged in efforts to develop various types of interventions and drug / therapy candidates with novel mechanisms of action to treat depression.    Scope of the Report The “Depressive Disorders Market: Pipeline Review, Developer Landscape and Competitive Insights” report provides an extensive study on the marketed (approved post 2010), clinical and preclinical molecules available / being developed, for the treatment of depressive disorders. Figure 1.1 summarizes the scope of the report and the specific modules that have been covered in detail, in the document. Amongst other elements, the report includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), type of therapy (monotherapy, adjunctive therapy or combination therapy), type of depression (major depressive disorder, bipolar disorder, postpartum depression, treatment-resistant depression and depression (type unknown)), type of drug class (anti-depressant and anti-psychotic), mechanism of action, dosing frequency (twice daily, once daily, twice weekly, once weekly, once in 28 days, twice yearly and once only) and route of administration (oral, nasal and parenteral) of the drugs / therapies being developed for the treatment of depressive disorders. A detailed assessment of discontinued drugs / trials, featuring information on the number of discontinued drug development programs, year of discontinuation, geographical location (of discontinued trial), phase at which the development program was discontinued, mechanism of action of discontinued drug, disease indication (for which the drug was being investigated), reason(s) for discontinuation and information on affiliated developer companies. An analysis of the partnerships that have been established between 2012 and 2019 (till March), covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, clinical trial agreements, and other relevant deals. An analysis of the investments (between 2010 and 2019 (till March)) made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other offerings. A comprehensive clinical trial analysis of completed, ongoing and planned studies for different types of depressive disorders. For the purpose of this analysis, we considered the clinical studies registered till February 2019, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, type of depressive disorder, mechanism of action, leading industry and non-industry players with highest number of completed / ongoing trials, regional distribution of clinical trials, and enrolled patient population across different geographies.  An insightful analysis on clinical end-points being evaluated in late-stage ongoing and planned studies, for various types of depressive disorders. For the purpose of this analysis, we considered the phase III clinical studies registered till February 2019, and identified the most important, primary endpoints being evaluated. An insightful market assessment summary, highlighting the clinical and commercial attractiveness of pipeline molecules (phase II and phase III), taking into consideration size of enrolled patient population (for the trial in the highest phase of development), route of administration, therapy type and dosing frequency (for quantifying clinical attractiveness), and target patient population, expected launch date and size of developer company (for quantifying commercial attractiveness). An elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch, post-marketing, and near patent expiry, including a timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products.  A case study on the upcoming digital health solutions for the management / treatment of depression, featuring information on the various product development pathways adopted by companies involved in this segment of the market; it includes brief descriptions of popular digital solutions as well. The insights presented in this report are backed by a deep understanding of data gathered from secondary sources. The opinions generated over the source of the study, were influenced by inputs from key players in this domain. All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.   

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Companion Diagnostics Market (2nd Edition), 2019-2030

The introduction of personalized medicine has brought about a paradigm shift within the healthcare sector. Over the years, many cases have been identified where conventional treatment options have failed to demonstrate any therapeutic benefit. It is estimated that nearly 50% of prescribed drugs / therapies fail to show adequate clinical benefits. In fact, adverse drug-related reactions / side effects are reported to be the fourth leading cause of death in the US.  To mitigate challenges associated with adverse drug reactions, there are multiple therapeutic products in the market, and many more under development, which have been tailored to effectively treat disease with unique molecular / genetic signatures.  Personalized therapies demand companion diagnostics to make physicians aware of patients’ unique genetic profiles, thereby, enabling them to make informed decisions. A study of nearly 200 unique pharmacological interventions, across 670 clinical trials, concluded that the likelihood of a lead compound passing through all the phases of clinical development and eventually getting approved is only 11%. The same study highlighted that correlating disease-specific biomarker data with therapeutic susceptibility and using this information to recruit patients for clinical research demonstrated a six fold increase in trial success rates.  It is also worth highlighting that companion diagnostic guided drug development efforts have been estimated to help reduce clinical trial costs by almost 60%.   Since the approval of the HercepTest™ (in 1998) for identifying patients for treatment with trastuzumab, over 50 companion diagnostics have been developed for various drugs. Further, several companies have also undertaken initiatives to develop biomarker-based therapeutics for other disease indications, such as infectious diseases, neurological disorders and metabolic disorders.  Industry stakeholders are forging strategic alliances with diagnostic developers to develop diagnostic solutions for a diverse array of drugs / therapies. Such initiatives are focused on improving clinical trial success rates, and subsequently optimizing R&D expenditure in the pharmaceutical industry. Scope of the Report The “Companion Diagnostics Market (2nd Edition), 2019-2030” report features an extensive study of the current market landscape and the likely adoption of these diagnostic tests over the next decade. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, corresponding drug(s) / drug class, affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry  (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others) and the type of sample required (tumor tissue, blood, bone marrow and others). Detailed profiles of developers of companion diagnostics (shortlisted on the basis of the strength of product portfolio), featuring an overview of the company, its financial information (if available), a detailed description of companion diagnostics available / under development and recent collaborations. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth. A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands, taking into consideration several relevant aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic focus and overall market position of each company. An analysis of the partnerships and collaborations pertaining to companion diagnostics, featuring a comprehensive set of analyses based on various parameters, such as the type of partnership, affiliated biomarkers, therapeutic areas and the most active players. A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing / sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages. A comprehensive analysis of completed, ongoing and planned clinical trials featuring the key biomarkers across different type of therapies and cancer indications. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials. One of the key objectives of the report was to estimate the existing market size and the future opportunity for companion diagnostics developers, over the next decade. Based on multiple parameters, such as the disease incidence, adoption of companion diagnostic tests and the likely prices, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV/AIDs), [B] important assay techniques (in situ hybridization (ISH), immune histochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others) and [C] key geographical regions (US, EU5, Japan, China and Australia). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.   The opinions and insights presented in this study were also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Biopharma Contract Manufacturing Market (3rd Edition), 2019 - 2030

Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Characterized by a number of blockbuster therapies (Humira,  Rituxan,  Lantus,  Avastin,  Herceptin  and Remicade ) and a robust pipeline of product / therapy candidates, the market is poised for significant growth in the coming years. It is worth mentioning that much of the anticipated success of the biopharmaceutical market is dependent on new biologics currently under development and biosimilars. The impending growth also indicates the rising importance of manufacturing capacity within the industry. The costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. These constraints have led many of the smaller players in the industry and, at times, certain pharma giants as well, to outsource a significant part of their business operations to contract service providers. Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant cost-benefits, access to larger production capacities and reductions in time-to-market. Owing to the growing number of start-ups that are engaged in R&D of novel biologics, there is significant opportunity for the CMOs in this domain. It is worth highlighting that, since 2000, more than115 new CMOs have been established in order to cater to the growing demand for novel biologics that have specific manufacturing requirements. The contemporary contract services market features a mix of large and small-sized CMOs and is characterized by multiple mergers and acquisitions as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to offer end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings. Despite the fact that the biopharmaceutical sector is amongst the most highly regulated industries, we expect the demand for core competencies to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor and is likely to grant a competitive edge to certain CMOs over other stakeholders.   Scope of the Report The “Biopharmaceutical Contract Manufacturing Market (3rd edition), 2019 – 2030” report features an extensive study on the contract service providers within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of biopharmaceutical CMOs and CDMOs. Amongst other elements, the report includes: A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring a comprehensive list of active CMOs and detailed analysis of the manufacturing service providers based on a number of parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), type of expression systems used (mammalian, microbial and others), year of establishment, employee size, geographical location of the CMO, number of manufacturing facilities, as well as the location of these facilities, GMP compliance, affiliations to regulatory agencies, type of bioreactors used (single-use bioreactors and stainless steel bioreactors), mode of operation of bioreactors (batch, fed-batch and perfusion) and bioprocessing capacity.  Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing and packaging of biologics. Each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on partnerships, recent developments (expansions), as well as a comprehensive future outlook.  A detailed discussion on the key enablers in this domain, including certain niche product classes, such as antibody drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market. A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs.  A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.  A discussion on challenges related to in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource. An analysis of the recent collaborations (signed since 2013) focused on the contract manufacturing of biologics; the analysis is based on various parameters, such as the year in which the agreement was signed, type of agreement, focus area and type of biologics.  A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2013-2018, along with the geographical distribution of this activity. The analysis also depicts the relationship between important deal multiples based on the revenue, number of employees and experience of the acquired company.  An analysis on the recent trends within biopharmaceutical contract manufacturing industry, highlighting various facility and capability expansions. In addition, it provides information on the technology advancements related to biomanufacturing.  A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs / CDMOs) in the market, using data from both secondary and primary research. The study examines the distribution of global biopharmaceutical manufacturing capacity by scale of operation (preclinical / clinical, commercial), size of company (small-sized, mid-sized, large and very large), and geography (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia and Middle East (China, India, Japan, South Korea and rest of the Asia and Middle East), and rest of the world (including Australia).  An informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on a various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry.  A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CMO services to medical device developers. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, and direct manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2019-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), [B] types of expression systems (mammalian, microbial and others), [C] size of the company (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia)). To account for the uncertainties associated with the manufacturing of biopharmaceuticals and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.  The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Astrid Brammer, Senior Manager Business Development, Richter-Helm Birgit Schwab, Senior Manager Strategic Marketing, Rentschler Biotechnologie Christian Bailly, Director of CDMO, Pierre Fabre Claire Otjes, Assistant Marketing Manager, Batavia Biosciences David C Cunningham, Director Corporate Development, Goodwin Biotechnology  Dietmar Katinger, Chief Executive Officer, Polymun Scientific Denis Angioletti, Chief Commercial Officer, Cerbios-Pharma  Jeffrey Hung, Chief Commercial Officer, Vigene Biosciences Kevin Daley, Director Pharmaceuticals, Novasep  Mark Wright, Site Head, Grangemouth, Piramal Healthcare Nicolas Grandchamp, R&D Leader, GEG Tech Raquel Fortunato, Chief Executive Officer, GenIbet Biopharmaceuticals  Sebastian Schuck, Head of Business Development, Wacker Biotech  Stephen Taylor, Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies  Tatjana Buchholz, Marketing Manager, PlasmidFactory and Marco Schmeer, Project Manager, PlasmidFactory Tim Oldham, Chief Executive Officer, Cell Therapies All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030

Chronic disorders, such as diabetes, cancer, heart disease, obesity, and certain types of mental health problems, are considered among the leading causes of death and disability across the globe. According to a report published by the Center for Managing Chronic Disease at the University of Michigan in 2018, more than 50% of the global population lives with some form of chronic illness. In 2018, the global prevalence of diabetes (considered to be one of the fastest-growing clinical conditions) was estimated to be around 425 million; likewise, around 450 million people worldwide are suffering from some form of mental health problem and / or neurological disorder. In addition, the World Health Organization (WHO) reported that different forms of cancers account for about 0.6 million deaths annually in the US alone. Over the years, advances in cell biology and regenerative medicine have led to the development of various cell-based therapies, which claim to possess the potential to address several unmet needs related to the treatment of different chronic clinical conditions. However, there are certain evident challenges, such as scarcity of viable donors, inherent immunogenicity, complications related to supply of oxygen / essential nutrients to grafted cells, drug delivery limitations, and the need for frequent re-administration of cells, which have so far restricted the use of cell-based interventions. Extensive research on cell encapsulation strategies have enabled the development of a variety of technologies capable of confining therapeutic entities within biocompatible matrices / carriers. Encapsulated therapy products offer a myriad of advantages, and have been shown to be capable of addressing existing concerns related to cell sourcing, obviating the need for complex surgical procedures, and enabling targeted drug delivery without the need for immunosuppressive follow-on regimens. In fact, since 2013, over 3,000 patents have been published related to the aforementioned type of therapy, indicating the rapid pace of R&D activities in this domain. Stakeholders have also received significant support from both private and public investors. However, the commercial success of such products is still dependent on ongoing clinical studies, as no such therapy has yet been approved.   Scope of the Report The ‘Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030’ report features an extensive study of the current market landscape and the future potential of encapsulated cell therapies and affiliated technologies. It is worth mentioning that the study also provides insights on therapy products wherein other active drug substances have been encapsulated within living cells. Amongst other elements, the report features: A detailed assessment of the current market landscape of encapsulated cell therapies and affiliated technologies, highlighting various target disease indications, phase of development, encapsulation method, type of cells / API, and route of administration, along with information on various stakeholder companies that are developing novel encapsulation methods / techniques for use in storage and transportation of cells, as well as other applications.  Comprehensive profiles of industry players that are currently engaged in the preclinical / clinical development of their proprietary encapsulated cell therapies, featuring an overview of the company, its financial information (if available), and a detailed description of its product(s), highlighting mechanism of action, current development status, and key preclinical / clinical trial results. Each profile also includes a list of recent developments, highlighting the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the in the foreseen future. An in-depth analysis of the patents that have been published related to cell encapsulation technologies, since 2013. The analysis also highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading industry players (in terms of number of patents filed / granted), and current intellectual property-related benchmarks and valuation. A comprehensive clinical trial analysis of completed, ongoing and planned studies of various encapsulated cell therapies. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, leading industry and non-industry players (in terms of number of trials conducted), study design, target therapeutic area, key indications, study focus, clinical endpoints, and enrolled patient population and regional distribution of trials. An analysis of the partnerships that have been established in the domain in the period 2013-2018, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, process development agreements, and other relevant deals. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are focused in this area. The report also features a detailed study on the various grants that have been awarded to research institutes in this field. An analysis highlighting potential strategic partners (for instance, manufacturers) for encapsulated therapy developers based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing collaborations, and developer strength One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on likely licensing deal structures and agreements that are expected to be signed in the foreseen future, we have provided an informed estimate on the likely evolution of the market for the period 2019-2030. In addition, we have provided information on (potential) sales-based revenues generated by encapsulated cell therapies that are currently in late stages of development for the treatment of different chronic disorders, based on parameters, such as target consumer segments, likely adoption rates and expected pricing. The report features likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (eye disorders, metabolic disorders, neurological disorders, and oncological disorders), [B] target disease indications (ataxia telangiectasia, breast cancer, diabetes, glaucoma, head and neck cancer, macular telangectasia, pancreatic cancer, Parkinson's disease, and retinitis pigmentosa), [C] type of encapsulation material used (alginate-based microcapsules, cellulose hydrogels, medical-grade plastics, and red blood cells), and [D] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of novel therapy products and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.  The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: Alexander Scheer (Chief Scientific Officer, Erytech Pharma) Manuel Pires (Business Developer, Defymed) Michel Revel (Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem) Mick McLean (Chief Executive Officer, Atelerix) Quinton Oswald (Former President and Chief Executive Officer, Neurotech Pharmaceuticals) William L Rust (Founder and Chief Executive Officer, Seraxis) Yuval Avni (Former Chief Executive Officer, Beta-O2 Technologies) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Bone Cement Delivery Systems Market, 2019-2030

According to a study conducted by the International Osteoporosis Foundation (IOF), more than 200 million individuals around the world suffer from osteoporosis. In fact, a total of 8.9 million fractures per year are attributed to osteoporosis, implying that an osteoporotic fracture (of the hip, knee, spine, shoulder, or wrist) occurs after every three seconds. The annual socioeconomic burden associated with this condition is estimated to be around USD 19 billion and EUR 37 billion, in the US and Europe, respectively. Further estimates suggest that, by 2030, nearly 3.5 million knee replacements and 572,000 hip replacements are likely to be performed every year in the US alone. A recent United Nations’ study projected the global elderly population (aged 60 years and above) to rise to 1.3 billion by 2030; given the susceptibility of this population segment to developing osteoporosis, the global burden related to this particular disease is anticipated to increase significantly in the foreseen future. Over time, bone cement delivery systems have become widely popular in diverse types of orthopedic surgeries / procedures. There are many benefits of using such devices, including ease-of-use, targeted and controlled delivery of bone cements, integrated safety mechanisms, and an almost negligible risk of injury to patients. Companies involved in the development / manufacturing of bone cement delivery systems have also captured the interest of several stakeholders / bone cement developers that are looking for novel ways to deliver various types of bone cements to target sites during surgical procedures. In fact, since 2010, over 6,000 patents have been published in this domain, indicating the rapid pace at which research is being carried out. It is anticipated that such efforts are likely to boost the overall growth of this market in the coming years. Scope of the Report The ‘Bone Cement Delivery Systems Market, 2019-2030’ report features an extensive study of the current landscape and the likely future evolution of such systems in the next twelve years. The study features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different global regions. Amongst other elements, the report includes: A detailed assessment of the current landscape of bone cement delivery systems market, highlighting the contributions of industry players engaged in this domain, along with key system specifications. It features information on the type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), compatibility with different types of bone cements (polymethyl methacrylate, calcium phosphate and others), viscosity of bone cements delivered (high, medium and low), system functionality (delivery and mixing), approval date of various products, and maximum capacity. An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, including bone cement delivery systems, across different countries. It also includes an insightful multi-dimensional heat map analysis, featuring a review of the contemporary regulatory scenario in key geographies across the globe. Elaborate profiles of large companies offering bone cement delivery systems (shortlisted on the basis of the number of systems), featuring an overview of the company, its financial information (if available), detailed descriptions of their bone cement delivery systems, and a comprehensive future outlook. In addition, the chapter features tabulated profiles of small-sized and mid-sized bone cement delivery system providers (shortlisted on the basis of number of systems), featuring details on company headquarters, year of establishment, number of employees, executive team, recent developments, along with detailed descriptions of their proprietary bone cement delivery systems. A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2018, based on parameters, such as year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, key value drivers, and financial details of the deal (if available). The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain. In addition, the chapter evaluates the deal multiples of acquisitions specifically focused on bone cement delivery systems, analyzing them based on a number of parameters, namely annual revenues, number of employees and the experience of the acquired company. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals. An in-depth analysis of the various patents that have been filed / granted related to bone cement delivery systems since 1976. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, CPC classification, emerging focus areas (in terms of number of patents filed / granted), type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), industry type and leading industry / non-industry players (in terms of size of intellectual property portfolio). It also features a valuation analysis taking into consideration older patents, which have expired, highlighting the upcoming opportunity for generic product developers and manufacturers in this domain. A comprehensive clinical trial analysis of completed, ongoing and planned studies of different types of bone cements and associated delivery systems for various surgical procedures. For the purpose of this analysis, we considered the clinical studies that started in 1997, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, study design, type of surgical procedure, study focus, leading industry and non-industry players, regional distribution, and enrolled patient population across different geographies. In addition, it features an insightful clinical end-points analysis of ongoing and planned studies. A detailed study on the various grants that have been awarded to research institutes conducting projects related to different types of bone cements, between 2010 and 2018. The analysis highlights various important parameters associated with grants, such as year of award, support period, amount awarded, type of surgical procedures, grant type, responsible study section, focus area and type of bone cements. An analysis to estimate the likely demand for bone cement delivery systems across key surgical procedures, including kyphoplasty, vertebroplasty, hip arthroplasty and knee arthroplasty, in different global regions for the period 2019-2030. One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for bone cement delivery systems over the coming decade. Based on several parameters, such as prices of systems, surgical procedure / region specific adoption trends, and competitive landscape, we have provided an informed estimate on the likely evolution of the market, over the period 2019-2030. The report provides sales forecasts for the overall bone cement delivery systems market with the current and upcoming opportunity segmented across [A] surgical procedure(s) (hip arthroplasty, knee arthroplasty, kyphoplasty and vertebroplasty), [B] type of end-user(s) (ambulatory surgery centers, hospitals and specialty clinics), and [C] key geographies (North America (the US, Canada and Mexico), Europe (EU5 countries), Asia-Pacific and Rest of the World (Australia, China, India, and Japan)). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of organization names): Soren Toksvig-Larsen (Associate Professor, Department of Orthopedics, Lund University) Francesco De Paola (International Product Manager, Medacta International) Ana Bettencourt (Associate Professor, University of Lisbon) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Alzheimer's Disease: Pipeline Review, Developer Landscape and Competitive Insights

Alzheimer’s disease is a neurodegenerative condition characterized by progressive memory loss, cognitive dysfunction anddementia. Currently, it is the most commonly reported neurodegenerative disorder across the world, and the sixth leading cause of death in the US. It was estimated that, in 2018, nearly 5.7 million Americans (considering all age groups) were living with Alzheimer’s disease. During the same year, Alzheimer’s disease and other dementias were projected to be responsible for a healthcare burden amounting to USD 277 billion, in the US. Considering that only a limited range of diagnosis, treatment and disease management solutions are presently available, this segment of the healthcare industry is presently faced with a pressing need for accurate diagnostic (predictive) tests, and efficient treatment options that have the capability to slow the progression of the condition. Despite extensive research aimed at comprehending the etiopathogenesis of Alzheimer’s disease, only six drugs have been approved since 1996 for treatment. The rate of failure of drugs being developed for treating Alzheimer’s disease is alarming (~99.6%) and is even higher than that reported for cancer (~81%). Most of the existing therapeutic options have proven inadequate in arresting the progression of the disease and long term management of associated symptoms. Currently, several stakeholders in the pharmaceutical industry are engaged in efforts to develop various types of disease modifyinginterventions and drug / therapy candidates that offer symptomatic relief. In fact, multiple initiatives by start-ups are being backed by venture capital and other strategic investors. In the coming years, the market is anticipated to grow at a significant pace as more novel solutions clear clinical evaluation and get commercialized.   Scope of the Report The “Alzheimer’s Disease Market: Pipeline Review, Developer Landscape and Competitive Insights” report provides an extensive study on the marketed, clinical and preclinical molecules available / being developed for the treatment of Alzheimer’s disease. Figure 1.1 summarizes the scope of the report and the specific modules that have been covered in detail in the document. Figure 1.1 Alzheimer’s Disease: Scope and Competitive Insights Amongst other elements, the report includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), type of treatment (disease modifying agents or drugs offering symptomatic relief), target stage of the disease (early, mid and late stages), type of therapy (monotherapy or combination therapy), path to clinic (dedicated, and repositioned / repurposed), mechanism of action, and route of administration of the drugs / therapies being developed for the treatment of the condition. An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a representation, highlighting the distribution of the marketed and development stage molecules based on the mechanism of action, [B] a 2X2 grid analysis, representing the distribution of drug candidates across type of therapy, path to clinic and stages of development, and [C] a diagrammatic representation of the regional landscape of industry players involved in the development of drugs in this domain, distributed based on the location of their headquarters. An analysis highlighting the key unmet needs across Alzheimer’s disease, featuring insights generated through data captured from 5000+ social media posts, 250+ recent scientific publications, 100+ patient blogs and the views of key opinion leaders expressed by both patients and industry experts. A detailed assessment of discontinued drugs / trials, featuring information on the number of discontinuations, year of discontinuation, phase of discontinuation, mechanism of action of the terminated drug, target stage of disease and the reason(s) for discontinuation. A detailed publication analysis of close to 300 articles, highlighting the therapeutic areas of focus within the industry. The analysis also highlights the key trends observed across the publications, including information on popular biological targets being investigated, study type (review article, research article and meta-analysis), year of publication, and the most popular journals (in terms of number of articles published within our dataset) within this domain. An analysis of the partnerships that have been established till 2019 (February), covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, manufacturing agreements, and other relevant deals. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered from secondary sources. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company name): Kenneth Moch (President and Chief Executive Officer, Cognition Therapeutics) Ram Bhatt (Chief Executive Officer, Chairman and Founder, ICB International) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Global Stem Cell Therapy Market: Focus on Cardiovascular and Metabolic Disorders, 2019-2030

Cardiovascular disorders and metabolic disorders are considered to be amongst the leading causes of death worldwide. In fact, approximately one-third of the annual number of deaths across the globe are attributed to cardiovascular disorders.  In the US, the annual economic burden associated with these disorders is estimated to be over USD 500 billion. According to a study conducted by RTI International for the American Heart Association, the prevalence of cardiovascular diseases is expected to rise to 45% of the overall US population, while affiliated costs are expected to be over USD 1 trillion by 2035. Despite considerable advances in healthcare, most of the currently available treatment options for cardiovascular disorders focus on palliative care and cannot actually repair damaged cardiac tissue. Although heart transplant is a viable option to treat complex cardiovascular conditions, the waiting time associated with this alternative is excruciatingly long. Likewise, a significant proportion of the global population suffers from diabetes or some form of metabolism related clinical condition. As per IDF Diabetes Atlas, the treatment of diabetes and related complications incurred USD 727 billion in global healthcare expenditure in 2017. In 2017, it was estimated that 425 million individuals, between the ages 20 years to 79 years, were living with diabetes across the globe, and this number is expected to increase substantially in the foreseen future. Similar to cardiovascular diseases, most of the current treatment options for metabolic disorders are indicated for only controlling / managing disease related symptoms. Advances in cell biology and regenerative medicine have led to the development of stem cell therapies that can potentially address several unmet needs and potentially offer a cure for various cardiovascular and metabolic disorders. The field of regenerative medicine has evolved substantially in the recent past; the first stem cell therapy, called Cellgram®-AMI (2011), was approved by the Ministry of Foods and Drug Safety of Korea, for the treatment of acute myocardial infarction. Presently, two other stem cell-based treatment options, namely HeartSheet (heart failure, 2015) and Stempeucel (critical limb ischemia, 2017), are commercially available for cardiovascular disorders. For metabolic disorders, most stem cell therapy candidates are still under development. However, there is one approved product, called Strimvelis for ADA-SCID (2016). Several stakeholders are engaged in efforts to advance the development of regenerative therapies for both cardiovascular and metabolic disorders. In fact, venture capital (VC) firms and government bodies are actively funding several such ongoing research initiatives. Scope of the Report The “Global Stem Cell Therapy Market: Focus on Cardiovascular and Metabolic Disorders, 2019-2030” report features an extensive study of the current market landscape and the future potential of stem cell therapies in treating the aforementioned clinical conditions. The study includes all stem cell therapies that are being developed for the treatment of cardiovascular and metabolic disorders. In addition, we have provided a list of stem cell therapies being developed for stroke, a condition associated with vasculature in the brain. Amongst other elements, the report features the following: A detailed assessment of the current market landscape of stem cell therapies with respect to target therapeutic area (cardiovascular and metabolic), phase of development (approved, phase III, phase II, phase I and preclinical / discovery), target disease indications (Cardiovascular: heart failure, myocardial infarction, critical limb ischemia, angina, peripheral arterial / vascular diseases, myocardial ischemia, myocardial fibrosis, cardiomyopathy and coronary microvascular dysfunction; Metabolic: diabetes, mucopolysaccharidosis type III, ADA-SCID, obesity, mitochondrial disorders and metachromatic leukodystrophy), source of cells (autologous and allogenic), type of stem cells (adult multipotent, adult pluripotent, embryonic multipotent and embryonic pluripotent), stem cell lineage (bone marrow, peripheral blood, adipose tissue, cardiosphere, muscle, Wharton's jelly, umbilical cord, placenta, dental pulp, cord blood and pancreas), and route of administration (intramyocardial, intramuscular, intravenous, intracoronary and implantation). An analysis highlighting the key unmet needs across cardiovascular and metabolic disorders, featuring insights generated from social media posts, recent scientific publications, patient blogs and the views of contemporary key opinion leaders as expressed on online platforms. An overview of the focus areas of therapy developers, including an assessment of the existing opportunity for stem cell therapies across diverse therapeutic indications. An insightful company competitiveness analysis featuring a three-dimensional bubble representation, highlighting the key players in this domain on the basis of the strength of their respective product portfolios, taking into consideration the number of therapies under development, phase of development of these therapies, number of disease indications being targeted and geographical distribution of affiliated clinical trials. An analysis of the partnerships that have been established in the domain in the period 2012-2018, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, process development agreements, and other relevant deals. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, capital raised from IPOs / secondary offerings, debt financing and grants. An analysis of contemporary peer-reviewed scientific research articles published during the period 2013-2018, highlighting the key focus areas of the ongoing research activity, in terms of therapeutic area, target disease indication, and stem cell lineages. Comprehensive profiles of approved and late stage clinical products; each profile features an overview of the therapy, its mechanism of action, history of development, current development status, key clinical trial results, details on recommended dose, price and manufacturing process (wherever available). One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. The report includes information on (potential) sales-based revenues generated by stem cell therapies that are currently marketed or are in late stages of development for the treatment of cardiovascular and metabolic disorders. Additionally, it presents details on the likely distribution of the current and forecasted opportunity across [A] target therapeutic areas (cardiovascular and metabolic), [B] target disease indications (myocardial infarction, heart failure, critical limb ischemia, diabetes, ADA-SCID,  metachromatic leukodystrophy, and other cardiovascular and metabolic disorders ), [C] type of stem cells (adult multipotent, adult pluripotent and embryonic multipotent), [D] source of cells (autologous and allogenic), [E] stem cell lineage (bone marrow, peripheral blood and others), [F] route of administration (intramyocardial, intracoronary, intramuscular, intravenous and implantation) and [G] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of novel therapy products and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals: Michel Revel (Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem) Dr. William L. Rust (Founder and Chief Executive Officer, Seraxis) Xuejun H. Parsons (Chief Executive Officer, Xcelthera) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Patient Recruitment and Retention Services Market, 2019-2030

Clinical trials represent an arduous step in the drug development process and are crucial to understanding the safety and efficacy profiles of novel therapeutic interventions. As these trials are prone to delays, and can even fail altogether, they impose an immense financial pressure on sponsors. Amongst several known challenges, patient recruitment is considered to be one of the rate limiting steps when it comes to getting drugs to the market. It is estimated that 80% of clinical trials do not meet their designated patient enrolment deadlines. In fact, around 37% of research sites fail to meet their subject accrual goals, while more than 10% don’t even enroll a single patient. In addition, retaining patients is also a matter of concern, considering that the approximate dropout rate across clinical studies is around 30%. Delays in product launch, due to inability of the sponsors to recruit / retain patients, are highly common and are estimated to result in an average loss of USD 8 million per day in opportunity costs, for a blockbuster drug. The abovementioned challenges have led several players in the pharmaceutical industry to outsource their patient recruitment-related needs to capable, specialty service providers. Employing contract service providers has been shown to expedite the patient recruitment process. Such service providers employ a variety of outreach methods, such as social media, mobile technologies, electronic health records (EHRs) and real-world evidence (RWE), and, over time, have attained a vital role in the successful conduct of clinical research. Although some big pharma players carry out patient recruitment in-house, the growing complexity of clinical trials and demand for niche patient populations for studies evaluating orphan drugs / personalized medicines is likely to prompt more developer companies to outsource various aspects of their clinical research-related operations in the foreseen future. In fact, the market has recently witnessed the establishment of several partnerships, which include agreements between study sponsors and patient recruitment firms (outsourcing deals) and partnerships between stakeholders aimed to combine their respective services portfolios related to patient recruitment and retention (service alliances). This niche services industry has also witnessed some consolidation as multiple smaller players have been acquired by more established entities, in an effort to expand geographical reach.   Scope of the Report The ‘Patient Recruitment and Retention Services, 2019-2030’ report offers a comprehensive study of the current scenario and future potential of the players providing patient enrollment and retention services. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape of companies offering patient recruitment and retention services, including information on over 10 types of patient outreach methods employed, types of services offered ([A] patient recruitment (including pre-screening and Institutional Review Board (IRB) / Ethics Committee (EC) submission), [B] patient retention (considering various strategies, such as the use of study-branded gifts, study-branded reminders, providing education and support materials, reimbursement programs, transportation programs, patient engagement web site, patient reconnect programs, mobile applications to track patient engagement and others) and [C] other associated services (including site identification and selection,study feasibility / protocol development, project management, clinical trial monitoring and other services), year of establishment, geographical location, and size of company. The chapter also covers an analysis of the geographical reach and therapeutic expertise of service providers, along with details on the payment model, patient recruitment platforms / technologies used, and the various certifications / accreditations awarded by regulatory bodies. An analysis of the most active regions (in terms of patient recruitment activity), based on the locations of headquarters of companies engaged in this domain, featuring schematic world map representations that highlight key hubs across the globe. An insightful 2X2 representation of the results of a competitiveness analysis of various service providers (segregated into three peer groups based on their employee count (small-sized (1-50 employees), mid-sized (50-200 employees) and large (>200 employees)), highlighting capable players in this domain, based on their respective capabilities. Comprehensive profiles of patient recruitment and retention service providers, featuring information on the location of their headquarters, year of establishment, patient recruitment services / platforms portfolio, recent developments and a comprehensive future outlook. An analysis of the partnerships that have been established in the recent past, covering outsourcing agreements, service alliances, acquisitions, joint ventures, mergers, technology licensing and development agreements, and other forms of partnerships. A review of emerging trends in the industry, including the use of social media, mobile technologies, EHRs and RWE, to overcome the challenges associated with patient recruitment and retention. One of the key objectives of the report was to estimate the existing market size and review the potential growth opportunities for patient recruitment service providers over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2019-2030. In addition, we have segmented the future opportunity across [A] therapeutic area (oncology, infectious diseases, cardiovascular diseases, CNS disorders, respiratory disorders, metabolic disorders, and others), [B] steps in patient recruitment process (pre-screening and screening), [C] phases of development (phase I, phase II, phase III and phase IV), and [D] different global regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Simon Klaasen (Co-founder and Managing Director, Link2Trials) Hagit Nof (Chief Operation Officer and Business Development, nRollmed) Paul Ivsin (Managing Director, Seeker Health) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Next Generation Contact Lenses and Visual Prostheses Market, 2019-2030

For more than five decades, contact lenses have primarily been used to correct vision-related disorders. The existence of several unmet needs in the field of ophthalmology, recent technological advances and the availability of new biomaterials, have substantially expanded the range of potential application areas for contact lenses. It is estimated that close to 2.4 million eye injuries occur every year in the US. In order to cater to this demand, a myriad of therapeutic contact lenses have been developed specifically for treating / protecting the eye. The efficient delivery of drugs / other therapeutic substances to the eye is also deemed to be an area for improvement. It is presently characterized by low bioavailability and limited exposure time to pharmacological interventions; for instance, in the case of eye drops, 95% of the active therapeutic ingredient is assumed to be lost / wasted post dose administration. A variety of drug-eluting contact lenses have been / are being developed to address the aforementioned challenges. The potential of contact lenses is being explored for diagnosis and disease monitoring purposes as well. Diabetes and glaucoma are key clinical conditions for which contact lenses are being developed to assess and track various disease related parameters. In fact, 10 contact lenses have already been approved for purposes other than vision correction; recent examples include CUSTOMFLEX® ARTIFICIALIRIS (aniridia, 2018) and EYEMATE® (glaucoma, 2017). On the other hand, according to the National Eye Institute, nearly 1.3 million people are blind, while 2.9 million individuals have poor vision, in the US. It is estimated that the number of cases for blindness and poor vision are likely to reach 2.2 million and 5 million, respectively, by 2030, in the same region. Visual prosthetics, such as bionic eyes, represent the next generation of solutions for vision restoration. Their unique mechanism of action leverages electrical pulses to stimulate optic nerves and bypass damaged segments of region in the eye. Pharmaceutical companies and academic institutions have already invested a significant amount of capital in the development and commercialization of the abovementioned products. The ongoing efforts to innovate in this domain are evident from the fact that more than 7,500 patents have been granted / filed since 2013. In the coming years, the market is anticipated to grow at a significant pace as more novel solutions clear clinical evaluation and get commercialized. Scope of the Report The “Next Generation Contact Lenses and Visual Prostheses Market, 2019-2030” report features an extensive study of the current market landscape of therapeutic contact lenses, drug-eluting contact lenses, diagnostic / monitoring contact lenses and visual prostheses. The study lays emphasis on the novel products and technologies that are being developed for the treatment of ocular disorders, which generally cause severe visual impairment or blindness. Amongst other elements, the report includes: A detailed review of the landscape of novel ophthalmic products, highlighting the different categories of contact lenses and visual prostheses (bionic eye technologies) developed / being developed by various players across the world. It features information on the purpose of development (therapeutic, drug delivery, and diagnosis / monitoring), current development status, target indication(s), type of product, type of organization (industry or non-industry) and location of company headquarters. An analysis of the key promotional strategies that have been adopted by the developers of marketed products, namely ChromaGen™, CUSTOMFLEX® ARTIFICIALIRIS, EYEMATE®, Hyper-CL™, Implantable Miniature Telescope and SENSIMED Triggerfish®. Brief profiles of the novel technologies that are being developed to expand the functionality of contact lenses; each profile features an overview of the technology, along with details on its working mechanism, information on application areas, type of products, key benefits, technical specifications and important details related to the developer company. An in-depth analysis of the various patents granted / filed related to next generation contact lenses and visual prostheses since 2013, highlighting the prevalent and emerging related to the innovation in this domain. The analysis takes into consideration the type of patent, regional applicability, CPC classification, emerging focus areas, leading industry / non-industry players (in terms of the number of patents filed / granted), and patent valuation. An analysis of the partnerships that have been established in this domain, covering R&D agreements, product development agreements, product commercialization agreements, service alliance and acquisitions; the analysis is based on multiple parameters, such as the type of agreement, type of organization, and focus area in terms of product application and target indication. A study of prevalent and emerging trends, and the popularity of next generation contact lenses and visual prostheses, as observed on the social media platform, Twitter. The analysis takes into consideration the tweets posted on the platform, between 2013 and 2018 (till mid-October). A list of key opinion leaders (KOLs) in this domain, featuring a 2X2 analysis to assess the relative experience of certain individuals, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field. It includes a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers engaged in this domain. In addition, it presents an analysis assessing the credibility and (relative) level of expertise of different KOLs based on number of publications, number of citations, number of clinical trials, number of affiliations and extent of professional network. One of the key objectives of the report was to determine the existing market size and develop estimates of future growth opportunities for next generation contact lenses and visual prostheses. Based on parameters, such as the target patient population, price of the lenses and the likely adoption rates, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report also features a detailed segmentation of the present and anticipated future opportunity based on [A] type of product (contact lenses and visual prostheses) [B] purpose of development of contact lenses (therapeutic, drug delivery and diagnosis / monitoring) [C] key disease indications (glaucoma, diabetes, AMD, retinitis pigmentosa and others) and [D] geography (North America, EU5 and Asia-Pacific). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely the conservative, base and optimistic scenarios, which represent different tracks of the industry’s evolution. The opinions and insights presented in this study were also influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with Mark E Byrne (Co-Founder and Chief Technical Officer, OcuMedic), Michal Shavit (Head of Sales and Marketing, EyeYon Medical and Praful Doshi (Founder, Chief Executive Officer and Chief Technical Officer, Leo Lens Technology). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Novel Technologies for Delivery of Proteins, Antibodies and Nucleic Acids, 2019-2030

Given their high target specificity and limited toxicity compared to small molecule drugs, biotherapeutics have revolutionized treatment paradigms across a myriad of clinical conditions, including metabolic disorders, cancers, neurological disorders and autoimmune disorders. In fact, the extent of growth of such therapies can be gauged from the fact that more than 300 biopharmaceuticals have been approved between 2002 and 2018. In 2018, over 15 biological license applications (BLA) received approval. Previously, in 2017, 12 new biologics were approved by the US FDA, which included antibodies (9), antibody-drug conjugates (1), and enzymes (2). Such products are inherently complex, and their full potential continues to remain untapped owing to an array of concerns associated with their development, manufacturing and administration. Specifically, the challenges associated with the delivery of such drugs can be attributed to their large molecular weight, short half-lives, and instability in the gastrointestinal (GI) tract and intestinal lumen. Owing to their susceptibility to enzymatic degradation, the parenteral route of administration is considered to be the most acceptable mode of delivery, enabling such drugs to directly enter systemic circulation. However, parenteral administration often requires patients to visit healthcare centers / clinics for dosing. As a result, non-adherence to prescribed therapeutic regimens is rampant among end-users. Despite these challenges, the demand for biologics is high because of their favorable safety profiles, greater systemic compatibility and fewer side effects. As a result, medical researchers and therapy developers are actively attempting to identify and exploit alternative delivery strategies for such products; examples include aerosol generation systems, lipid nanoparticles, DNA-based delivery technologies, and brain shuttles (designed to facilitate increased drug penetration across the elusive blood-brain barrier). Currently, several biopharmaceutical companies have undertaken initiatives to develop cell-specific drug delivery technologies and have superior formulation technologies, imparting improved release properties to drugs being delivered. Consequently, pharmaceutical developers are likely to witness a rise in available options for the delivery of their respective products in the foreseen future.   Scope of the Report The “Novel Technologies for Delivery of Proteins, Antibodies and Nucleic Acids, 2019-2030” report features an extensive study of the current market landscape and the likely future adoption of such technologies, over the next twelve years.  The study features an in-depth analysis, highlighting: A detailed assessment of the current market landscape of companies offering technologies for delivery of biotherapeutics, including information on their geographical location, types of biologics delivered (proteins, peptides, antibodies and nucleic acids), routes of administration used (parenteral, oral, transdermal / topical, inhalation and others) and impact on drug properties / patient compliance. A comprehensive competitiveness analysis of the drug delivery technologies captured in our report database, taking into consideration the supplier power (based on year of establishment) and key technology-related specifications, such as the type(s) of biologics delivered, extent of impact on drug properties / patient compliance and the route of administration.  Elaborate profiles of prominent technology developers engaged in this domain, featuring a brief overview of the company, its financial performance (if available), information on its product portfolio, recent developments and a comprehensive future outlook. Additionally, the report includes profiles of certain technologies that emerged as relatively superior in our proprietary competitiveness analysis. An in-depth analysis of the various patents that have been filed / granted related to novel drug delivery technologies, till November 2018. It includes information on key parameters, such as patent type, publication year, issuing authority, CPC classification, emerging focus areas and leading industry / academic players (in terms of size of intellectual property portfolio). A detailed analysis of the partnerships and collaborations focused on technologies for the delivery of biotherapeutics, featuring a comprehensive set of analyses based on various parameters, such as the year of establishment, type of partnership, type of therapeutic areas, most active players and geographical location. A discussion on the upcoming opportunities in the field of biotherapeutic drug delivery that are likely to impact the evolution of this market in the coming years. One of the key objectives of the report was to estimate the existing market size and identify potential future growth opportunities for novel technologies designed for the administration of proteins, antibodies and nucleic acids. Based on likely licensing deal structures and agreements that are expected to be signed in the foreseen future, we have provided an informed estimate on the evolution of the market over the period 2018-2030. The report features likely distribution of the current and forecasted opportunity across the [A] type of therapeutic area (oncology and non-oncology), [B] route of administration (parenteral and non-parenteral), [C] key contributing technologies and [D] key geographical regions (North America, Europe, Asia Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Mathias Schmidt (Chief Executive Officer, ArmaGen) Ram Bhatt (Chief Executive Officer, Chairman and Founder, ICB International) Donovan Yeates (Chief Executive Officer and Chief Scientific Officer, Chairman and Founder, KAER Biotherapeutics) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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In Vitro ADME Testing Services Market, 2019-2030

The early stages of drug discovery research, which include the identification of a relevant biological target and a viable lead compound with therapeutic potential, play a crucial role in the overall success of a drug candidate in both preclinical and clinical studies. It is also important to note that the process of drug discovery is extremely demanding, both in terms of capital and time. In fact, the overall amount spent in R&D initiatives in the pharmaceutical / biotechnology sector has increased from around USD 128 billion in 2008 to USD 165 billion in 2018. Moreover, only a small fraction of early stage therapeutic candidates are able to make it past preclinical evaluation. According to a study conducted on terminated drug development programs, the high rate of failure of drugs in clinical trials was primarily attributed to problems associated with their pharmacokinetic profiles, absorption, distribution, metabolism and excretion (ADME) properties and inherent toxicity. As a result, the industry is currently under tremendous pressure to not only meet the expectations of a growing patient population, but to also identify ways to mitigate the risks associated with discovery programs of novel drug / therapy molecules. Specifically, ADME studies are considered to be critical in establishing the safety and efficacy of drug candidates. Currently, there are a number of contract research organizations (CROs) that claim to have the necessary capabilities to offer in vitro ADME services. Over time, such service providers have grown to become an indispensable part of the pharmaceutical / biopharmaceutical market. Moreover, advances in combinatorial chemistry and high throughput screening in the last decade have made it possible to carry out early stage ADME screening for a large number of compounds in a more cost and time efficient manner. In less than a decade, the ADME services industry has witnessed noteworthy consolidation, with many of the smaller players being acquired by more established firms in efforts to augment services portfolios and widen geographical reach. Further, given the growing demand for high quality pharmacological interventions, and the cost and time-related benefits of outsourcing in vitro ADME research, the demand for CROs is projected to grow significantly in the foreseen future.   Scope of the Report The "In Vitro ADME Testing Service Market, 2019-2030" report features a comprehensive study of the current landscape of in vitro ADME testing service providers. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders across different global regions. Amongst other elements, the report includes: A detailed assessment of the current market landscape, featuring a comprehensive list of over 90 CROs that offer in vitro ADME testing services, and analyses based on a number of parameters, such as year of establishment, headquarter location(s), company size, type of additional service(s) offered (in vivo ADME, in silico ADME and toxicology testing), range of assays offered within in vitro ADME service portfolio (blood to plasma ratio, Caco-2 permeability, cytochrome (CYP) enzyme induction / inhibition, metabolic stability, plasma protein binding, reaction phenotyping and others), type of molecule(s) (biologics and small molecules), and type of clientele (pharmaceutical / biotechnology companies and academic / research institutes). A schematic logo landscape of in vitro ADME service providers, highlighting their geographical distribution (on the basis of location of headquarters) and company size (small-sized (1-50 employees), mid-sized (51-200 employees), large (201-1,000 employees), and very large (>1,000 employees)). A discussion on the various outsourcing business models adopted in this domain, along with a list of key considerations that need to be taken into account by industry stakeholders while selecting a CRO partner. Elaborate profiles of popular in vitro ADME testing service providers, featuring a brief overview of the company, its financial information (if available), information on in vitro ADME service(s) capabilities, and a comprehensive future outlook. A comprehensive benchmark analysis, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, and thereby, providing a means for stakeholders to identify ways to gain a competitive edge in the industry. A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2005-2018, along with the geographical distribution of this activity. The analysis also features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain. A detailed discussion on the various regulatory guidelines related to in vitro ADME testing, which have been laid down by major international / regional regulatory bodies (namely European Medicine Agency (EMA), US Food and Drug Administration (USFDA), Ministry of Health, Labor and Welfare (MHLW), International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use, the Organisation for Economic Co-operation and Development (OECD), and World Health Organization (WHO)). One of the key objectives of the report is to evaluate the current opportunity and the future potential of the in vitro ADME testing services market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have segmented the future opportunity across [A] different global regions (North America, Europe, Asia-Pacific and rest of the world), [B] type of services (absorption, distribution, metabolism and excretion), [C] type of assays (across 5+ categories), [D]  type of molecule(s) (biologics and small molecules), [E] type of sponsor company (pharmaceutical / biotechnology companies and academic / research institutes) and [F] therapeutic areas (across 10+ categories). To account for the uncertainties associated with the in vitro ADME testing services market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions conducted with several stakeholders in this industry. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.​​​

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Large Volume Wearable Injectors Market (4th Edition), 2018-2030

Chronic clinical conditions, such as diabetes, cardiovascular disorders, neurological disorders, autoimmune disorders and various types of cancer, are considered to be among the leading causes of death and disability across the world. Recently, the Center for Managing Chronic Disease at the University of Michigan reported that over 50% of the global population is currently suffering from some form of chronic disease. The past few years have witnessed ground breaking advances in the process of drug development and introduction of several innovative pharmaceutical interventions for the treatment of a number of chronic diseases. However, majority of the available treatment options require parenteral administration, frequent dosing, involve repeated hospital visits and are associated with multiple other concerns, such as dosing and medication errors, risk of microbial contamination and needlestick injuries. These challenges represent a substantial threat to medication adherence and, thereby, are likely to significantly impact therapeutic outcomes. Over the past few years, a number of companies have developed advanced therapeutic delivery solutions to alleviate the pressing concerns associated with the administration of both conventional and novel drug / therapy molecules. Amongst modern drug delivery practices, the concept of self-injection has facilitated advanced medications to be administered beyond the clinical setting. This has also served to reduce healthcare costs, improve therapy adherence and optimize the utilization of healthcare resources per treatment. The self-injection devices market is currently characterized by the presence of a myriad of advanced and innovative drug delivery solutions, equipped with a variety of user-friendly features. Notable examples of such products include prefilled syringes, reusable and disposable pen injectors, autoinjectors and large volume wearable injectors. Large volume wearable injectors are capable of drug delivery primarily via the subcutaneous route and have become a preferred choice for administration of drugs in the home-care setting. Variants of these wearable devices have been designed to administer highly viscous drugs (such as most biologics) in large volumes (more than 1 ml), offering numerous benefits, such as ease-of-use, reduced chances of dosing-related errors, integrated safety mechanisms, and an almost negligible risk of needlestick injuries. It is worth highlighting that such devices have captured the interest of several stakeholders in this industry to deliver various insulin and non-insulin drugs. Moreover, the field is witnessing emergence of other technological advancements, such as integrated mobile applications with smart health monitoring and other interesting features (such as provisions for reminders, and the ability to connect to web-based portals for sharing medical data with the concerned healthcare providers), visual / audible drug delivery confirmation notifications, automatic drug reconstitution, and error alerts.   Scope of the Report The “Large Volume Wearable Injectors Market (4th Edition), 2018-2030” report features an extensive study of the current market landscape and the likely future evolution of self-injection devices, over the next twelve years. It specifically lays emphasis on the emergence of patient-centric, convenient, cost-effective and user-friendly wearable drug delivery solutions that are capable of administering large volumes of a drug subcutaneously, in the home-care setting. Amongst other elements, the report includes: A detailed review of the overall landscape of the large volume wearable injectors market, highlighting the contributions of industry players related to the delivery of both insulin and non-insulin drugs, along with key device specifications. It features information on current development status of various products (under development and  commercialized), type of device (patch pump / injector and infusion pump / injector), type of dose administered (continuous and bolus), route of administration (subcutaneous and others), usability (disposable and reusable), mechanism of action (driving force), mode of injection (needle, needle / cannula and needle / catheter), maximum volume of the device and availability of connected mobile application. A comprehensive product competitiveness analysis of all large volume wearable injectors that we came across, taking into consideration the supplier power (based on the year of establishment) and product specifications, such as type of device, type of dose, maximum volume of the device, usability, allowed route of administration, connectivity with the mobile application and availability of an integrated continuous glucose monitoring / blood glucose monitoring (CGM / BGM) system in case of insulin devices. Elaborate profiles of prominent product developers engaged in this domain, featuring a brief overview of the company, its financial information (if available), information on its product portfolio, recent developments and a comprehensive future outlook. Additionally, the report includes tabulated profiles of wearable drug device combination products. An in-depth analysis of the various patents that have been submitted / filed related to large volume wearable injectors, since 1984. It also highlights the key parameters associated with the patents, including information on patent type, patent offices, CPC classification, emerging areas (in terms of number of patents filed / granted) and leading industry players (in terms of size of intellectual property portfolio). A social media analysis depicting prevalent and emerging trends, and the popularity of large volume wearable injectors, as observed on the social media platform, Twitter. The analysis was based on tweets posted on the platform from 2013 to 2018 (till September). A comprehensive clinical trial analysis of completed, ongoing and planned studies of various large volume wearable injector products. For the purpose of this analysis, we considered the clinical studies that started in 2010, and analyzed them on the basis of various parameters, such as trial start year, current trail status, current trial phase, study design, targeted therapeutic area, study focus and clinical outcomes. A case study on the role of contract manufacturing organizations in the overall manufacturing process / supply chain of wearable injectors. It includes short descriptions of the manufacturing services provided by contract service providers in the making of various device components (primary containers), infusion sets, adhesives, closures and injection moldings. A list of marketed drugs / therapies and pipeline candidates that are likely to be developed in combination with large volume wearable injectors in the near future, based on an in-depth analysis of potential candidates, taking into consideration multiple parameters, such as stage of development, dosage, dose concentration, route of administration, type of dose and drug sales (in case of marketed drugs). One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for large volume wearable injectors. Based on parameters, such as the number of commercialized devices, number of devices under development, price of the device and the annual adoption rate, we have provided an informed estimate on the likely evolution of the market over the period 2018-2030. The report also features sales forecasts for the overall large volume wearable injectors market with a detailed market segmentation on the therapeutic area, geographical distribution of the market (North America / Europe / Asia Pacific / RoW), type of device (patch pump / injector and infusion pump / injector) and usability (reusable / disposable). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent different tracks of the industry’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (alphabetical order of companies): Menachem Zucker (VP and Chief Scientist, Elcam Medical) Michael Hooven (CEO, Enable Injections) Mark Banister (CEO, Medipacs) Pieter Muntendam (President and CEO, scPharmaceuticals) Mindy Katz (Director of Product, Sorrel Medical) Jesper Roested (CEO, Subcuject) Graham Reynolds (VP and GM, Biologics, West Pharmaceutical Services) Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Chronic Kidney Disease Market: Pipeline Review, Developer Landscape and Competitive Insights

Chronic kidney disease (CKD) is characterized by progressive loss of kidney function over a period of time. In most patients suffering from CKD, symptoms (such as swollen ankles, blood in urine and foamy urine) are rarely observed until kidney function has declined by 75%. It is worth highlighting that over 90% of the patients suffering from reduced kidney function are unaware of their medical condition.In the US, 15% of adults are reported to be suffering from mild or severe forms of CKD.In fact, the mean global prevalence of CKD, across all five stages of the disease, is estimated to be 13.4%. Limited availability of epidemiological data, lack of awareness, late diagnosis and inappropriate / incorrect treatment are some of the factors responsible for elevating disease incidence. It is also worth noting that developed nations spend over 2-3% of their annual healthcare budget on the treatment of end-stage renal disease (ESRD); however, the economic burden associated with milder forms of CKD is almost double the total costs incurred in the treatment of ESRD. Further, in the US, the disease has been estimated to incur combined direct and indirect costs ranging of USD 14,545 per patient. Existing therapeutic options have already been proven to be inadequate in containing the progression of the disease and its symptoms in the long term. Currently, several stakeholders in the pharmaceutical industry are engaged in efforts to advance the development of various types of disease modifying pharmacological interventions and therapies that offer symptomatic relief. In fact, multiple initiatives by start-ups are being backed by venture capital funding in order to expedite the development of potential therapeutic options for better disease management.   Scope of the Report The “Chronic Kidney Disease Market: Pipeline Review, Developer Landscape and Competitive Insights” report provides an extensive study on the marketed, clinical and preclinical molecules available / being developed for the treatment of chronic kidney disease. Figure 1 summarizes the scope of the report and the specific modules that have been covered in detail in the document. Amongst other elements, the report includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), treatment type (disease modifying agent or drugs offering symptomatic relief), mechanism of action, and route of administration of the drugs being developed for the treatment of chronic kidney disease. An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a heptagon representation, highlighting the distribution of the marketed and development stage molecules based on the target clinical condition, [B] a 2X2 grid analysis, representing the distribution of drug candidates across various disease indications, dosing frequencies and stages of development, and [C] a diagrammatic representation of the regional landscape of industry players involved in the development of drugs in this domain, distributed based on the location of their headquarters. An insightful market assessment summary, highlighting the clinical and commercial attractiveness of pipeline molecules (phase II and phase III), taking into consideration size of enrolled patient population (for the trial in the highest phase of development), route of administration, treatment type (disease modifying agent and drugs offering symptomatic relief) and dosing frequency (for quantifying clinical attractiveness), and target patient population, expected launch date and size of developer company (for quantifying commercial attractiveness). An analysis highlighting the key unmet needs across chronic kidney disease, featuring insights generated from real-time data on unmet needs as identified from social media posts, recent publications, patient blogs and the views of key opinion leaders expressed on online platforms. An insightful competitive analysis, highlighting the key players in the domain on the basis of the strength of their respective development portfolios, taking into account company size and the stage of development of lead molecules in their respective pipelines. A detailed analysis identifying the key opinion leaders (KOLs), featuring a 2X2 analysis to assess the relative experience of certain KOLs who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field. An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, manufacturing agreements and others An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered from secondary sources. The opinions and insights presented in this study were influenced by inputs of several key players in this domain. All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Blockchain in Genomic Data Management: Market Landscape and Competitive Insights, 2018-2030

The success of the Human Genome Project resulted in the generation of large volumes of genomic data, which is extensively used in biotechnology and medical research. Further, advancements in high throughput gene sequencing technologies have enabled scientists to expedite the genome sequencing process, and achieve significant cost benefits as well. In fact, it is estimated that, by 2025, around 15% of the world’s population will have had their genomes sequenced, resulting in the generation of several zettabytes of data. However, currently, there are not many reliable and secure data management resources that offer secure storage, seamless exchange of information, and a reliable transaction platform, for large volumes of genomic and clinical data. Therefore, at this stage, it has become important to develop and establish the necessary tools and technologies to effectively help with the processing and analysis of the aforementioned information and for making it easily accessible to practicing physicians, scientists, pharmaceutical companies and other stakeholders. The blockchain technology has emerged as a viable option to store / exchange genomic data. The decentralized information management model used in blockchains has demonstrated significant benefits in banking and the fintech industry. Moreover, cryptocurrencies, which are based on the blockchain technology, are considered to be a powerful tool for peer-to-peer transactions without involving a third party to track the exchange. In the field of genomics, blockchain can act as a trusted means of carrying out transactions between data owners and data users (research groups / pharmaceutical companies). Moreover, such platforms enable easy access to genomic datasets, thereby, significantly improving the information procurement process for research studies related to personalized drugs / therapies. As a result, many companies have undertaken initiatives to promote the use of the blockchain technology for genomic data management. In fact, the growing importance of blockchain for managing genetic information and using it in healthcare decision-making is also evident in the number of tweets (~1,750) posted on the social media platform, Twitter, in the recent years. In the past few years, recent activities in this domain, such as the establishment of strategic partnerships (involving pharmaceutical players and relevant government bodies) and investments by venture capital / other stakeholders, indicate that the concept of using blockchain platforms for the storage and management of genetic information is gaining traction in the healthcare industry. We believe that such efforts are likely to boost the overall growth of this market in the coming years.   Scope of the Report The ‘Blockchain in Genomic Data Management: Market Landscape and Competitive Insights, 2018-2030’ report features an extensive study on the industry players that are offering blockchain platforms for the storage and management of genomic data. Amongst other elements, the report features: An overview of the current status of the market with respect to companies providing blockchain platforms, along with information on year of establishment, geographical location, company size, type of business model used, types of services offered to data owners and data users (pharmaceutical companies / research institutes), proprietary blockchain platforms and utility tokens, and end-users (pharmaceutical companies, research institutes, genomic data providers (patients and healthy individuals), software developers, and insurers). Tabulated profiles of all the players engaged in this field, featuring a brief overview of the company, and details on funding (if available), types of service(s) offered, proprietary blockchain platforms and utility tokens, key historical milestones, information on partnership(s) (if available), recent development(s) and roadmaps / future plans (if available). An analysis of the prevalent and emerging trends related to this domain as represented on the social media platform, Twitter, highlighting the most frequently talked about utility tokens, active players, and influential authors. It includes an insightful sentiment analysis, summarizing the impact / influence of various tweets posted on the platform. A comparative analysis of the needs of different stakeholders (pharmaceutical companies, research institutes, patients, healthy individuals, insurers and government agencies) in this industry. A detailed analysis highlighting the various business models and go-to-market strategies adopted by companies involved in this space. It features details on the various channels adopted / being adopted by companies to raise awareness and promote the use of their proprietary products / services. An informative bubble analysis, highlighting the market capitalization of the utility tokens of different companies engaged in this domain, based on total maximum supply, circulating supply and token price. A list of recent use cases of blockchain platforms, by pharmaceutical companies, highlighting the ways in which such tools / services have been used to manage and analyze genomic data. An insightful opportunity analysis, featuring an estimation of the existing market size; based on multiple parameters, we have also provided an informed estimate on the potential growth opportunities for companies engaged in this domain over the period 2018-2030. An analysis of various developments / recent trends related to companies offering blockchain platforms for genomic data management, offering insights on [A] instances wherein companies have raised funds to support their respective initiatives, [B] partnership and collaborations established within the industry, [C] other initiatives undertaken by different companies, [D] recent global events (summits, conferences and annual meetings), and [E] views expressed / opinions of selected key opinion leaders / industry experts on social media platforms, such as YouTube. The opinions and insights presented in this study were also influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: David Koepsell (Chief Executive Officer, EncrypGen) Jake Dreier (Director of Growth and Operations, SimplyVital Health) Aldo de Pape (Chief Executive Officer, Genomes.io) and Louis Gooden (Analyst, Genomes.io) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Global Drug Adherence Market: Focus on Smart Delivery Devices (Smart Inhalers, Injectors, Wearable Injectors, Pills) and  Smart Accessories (Medication Dispensers, Pill Bottles / Boxes, Blister Packs)

Poor adherence to prescribed medications is a growing concern in the healthcare industry and is believed to be associated with negative health outcomes, inflated medical expenses, loss in productivity and, in certain cases, proves fatal as well. It has been estimated that, of the ~4 billion annual prescriptions filled by the retailers in the US, approximately 50% are not taken by patients in accordance to physicians’ instructions. According to the US Centers for Disease Control and Prevention (CDC), failure to comply to prescribed treatment regimens has been identified as the cause of 125,000 premature deaths, up to 69% of all rehospitalizations, and results in approximately USD 100-300 billion worth of avoidable annual healthcare spending. Further, the US pharmaceutical industry alone is estimated to suffer a loss of approximately USD 188 billion per year, due to low adherence to prescribed medications. Lack of compliance to therapy is particularly prevalent among elderly patients suffering from chronic clinical conditions, such as cardiovascular disorders, metabolic disorders (e.g., diabetes), neurological and central nervous system related disorders (e.g., multiple sclerosis and Parkinson’s disease) and respiratory disorders (e.g., asthma and chronic obstructive pulmonary disease). It is estimated that overall cost of treatment for non-adherent patients is at least twice as high as patients who adhere to recommended therapy regimens. Studies have demonstrated that every one percent improvement in medication adherence can help the US healthcare industry save up to USD 2 billion, resulting in an increase in pharmaceutical revenues by ~USD 4 billion. As a result, several strategies have been / are being developed by pharmaceutical developers and healthcare providers to improve medication adherence. Such initiatives have been strengthened owing to the availability of connected devices and other digital solutions, which allow patients / healthcare providers to closely monitor and improve drug adherence.   Scope of the Report The ‘Global Drug Adherence Market: Focus on Smart Delivery Devices (Smart Inhalers, Injectors, Wearable Injectors, Pills) and Smart Accessories (Medication Dispensers, Pill Bottles / Boxes, Blister Packs)’ report features an extensive study of the current landscape and future outlook of the growing market for smart medication adherence devices that are either already commercialized or under development. This burgeoning field presently offers a lot of opportunities to innovation-driven start-ups and investors. Amongst other elements, the report features: A discussion on the current market landscape of smart drug delivery devices for medication adherence (which include smart inhalers, smart injectors, smart wearable injectors and smart pills), featuring information on the developers, along with details on key product specifications, namely audio / visual reminders, connectivity features (USB connection, Bluetooth and / or cellular network), availability of companion mobile application(s) and / or  web portal(s), data storage / cloud platform options, and availability of battery backup / rechargeable batteries. A discussion on the current market landscape of smart accessory devices for medication adherence (including smart medication dispensers, smart pill bottles / caps, smart pill boxes and smart blister packs), featuring information on the various developers, along with details on key product specifications. The section also presents a list of compliance packaging systems, along with information on their developers. A summary of the various guidelines issued by regulatory authorities to govern the development and approval of combination products (drugs and smart devices) across different geographical regions. Detailed profiles of some of the leading players in the industry (based on a proprietary shortlisting criteria), highlighting a brief overview of the company, financial information (if available), details related to its products / offerings, clinical trial results, recent developments and a comprehensive future outlook. Detailed case studies on the most common chronic disease indications, featuring disease epidemiology, an overview of the economic burden imposed due to non-adherence to prescribed treatment regimens and a history of drug development efforts along with details on the evolution of delivery devices / strategies for improving therapy adherence. A comprehensive competitiveness analysis of connected smart drug delivery systems and smart accessory systems on the basis of supplier power and key product specifications. An analysis of funding and investments made in companies focused in this domain; the analysis covers information on seed financing, venture capital financing, debt financing, other equity financing and grants / awards received by these companies. An analysis of the partnerships that have been forged between companies in the recent past, covering acquisitions, treatment optimization agreements, distribution agreements, manufacturing and supply agreements, product improvement agreements, product development agreements, product commercialization agreements, licensing agreements, service alliances and other relevant deals inked in the period 2010-2018. It also highlights the number of intercontinental and intracontinental deals signed in the aforementioned time period. A list of standalone mobile applications that have been developed / are being developed to enable patients to adhere to prescribed medication regimens, along with the USFDA’s regulations related to such applications. It also includes details on the various articles / publications that have reported the results achieved by using mobile applications for improving medication adherence among patients. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on various parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. We have segmented the market by type of solution (smart drug delivery devices and smart accessory devices), type of product (smart inhalers, smart injectors, smart wearable injectors, smart pills, smart medication dispensers, smart pill bottles / caps and boxes, smart blister packs and others), therapeutic areas (metabolic disorders, cardiovascular disorders, neurological and central nervous system related disorders, respiratory disorders, and others), route of administration (oral, injectable, inhalable and others) and geography (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following individuals: Bernard Vrijens (Chief Executive Officer, AARDEX Group) Spencer Waugh (Chief Executive Officer, AceAge) Josh Stein (Chief Executive Officer, AdhereTech) Duilio Macchi (Chief Executive Officer, Amiko Digital Health) Gaurav Patel (Chief Technical Officer, Cognita Labs) Tina Valbh (Strategy and Business Development (Advisor), etectRx) Jonathan Sacks (Chief Executive Officer and Chairman, PharmAdva) Timo Heikkilä (Co-Founder and Chief Operating Officer, Popit Technologies) Moore Greenberg (Founder, Wealth Taxi) Anonymous (Small-sized company) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell and Gene Therapy CROs Market, 2018-2030

In the recent past, cell and gene therapies have emerged as promising treatment options for a myriad of complex clinical conditions, including cancers and inherited disorders. Currently, more than 25 such advanced therapy medicinal products are available in the market; examples of recently approved therapies include Alofisel (2018), LUXTURNA™ (2017), YESCARTA™ (2017), Kymriah™ (2017) and INVOSSA™ (2017). In addition, over 500 cell and gene therapy candidates are being investigated in different stages of clinical development, across various geographies. In fact, in the past five years alone, more than 1,000 clinical trials that are currently active were initiated to evaluate the potential of these therapies across multiple therapeutic indications. Due to several development challenges, such as fragile nature of cells being used, safety and efficacy issues, laborious procedures for conducting clinical studies, complex regulatory framework and exorbitant costs, it is difficult for the companies with limited expertise and finances to successfully develop these therapies in-house. The aforementioned challenges have led several players to outsource a significant part of their clinical stage research to capable contract research organizations (CROs), which claim to offer cost-efficient solutions as well as intellectual and operational expertise. In fact, various therapy developers have partnered with CROs to seek their support in advancing product candidates towards approval. Moreover, contract service providers have formed alliances to enhance their capabilities and provide an integrated suite of services. It is also worth highlighting that the industry has witnessed some consolidation in the last five years as smaller players have been acquired in an effort to widen the parent company’s geographical reach. Furthermore, service providers have invested in developing / adopting advanced tools, technologies and platforms in order to provide robust and evidence based clinical data for approval. Given these technological advancements, the cost and time-related advantages of outsourcing research and the expanding pipeline of cell and gene therapy candidates, the demand for CROs is projected to grow in the foreseen future.   Scope of the Report The ‘Cell and Gene Therapy CROs Market, 2018-2030’ report features a comprehensive study on the current landscape of contract research service providers in the cell and gene therapy sector. The study presents an in-depth analysis, highlighting the capabilities of stakeholders engaged in this domain, across different regions of the globe. Amongst various elements, the report includes: An assessment of the current market landscape, featuring a comprehensive list of more than 70 active CROs and a detailed analysis based on a number of parameters, such as the company size, location of their headquarters, year of establishment, type of therapy (cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operations (scale and preclinical) and types of services offered including [A] clinical services (clinical trial management, clinical trial monitoring, data management and project management, clinical safety and quality studies, regulatory services, consultancy services and IT / informatics services) and [B] preclinical services (bioanalytical services, toxicology studies, in vivo studies, preclinical safety and quality studies and support services). A comprehensive discussion on the various outsourcing business models adopted in this field, along with a list of key considerations that need to be taken into account by therapy developers while selecting a CRO partner. Elaborate profiles of prominent players that offer contract research services for cell and gene therapies; each profile provides an overview of the company, its financial status (if available), information on its service(s) portfolio and a detailed future outlook. A comprehensive benchmark analysis, highlighting the key focus areas of small, mid- and large companies, comparing their existing capabilities within and beyond their respective peer groups, and providing a means for stakeholders to identify ways to gain a competitive edge in the industry. A comprehensive clinical trial analysis of ongoing studies related to the cell and gene therapy candidates in order to estimate the total number of product candidates under clinical evaluation. It provides detailed information related to clinical trials based on various parameters, such as geography, current status of trials, type of cell therapies (stem cells, T cells, dendritic cells, NK cells and tumor cells), key therapeutic area(s), disease indication(s) and number of patients enrolled. A detailed analysis of the recent collaborations (since 2013) focused on the contract services signed for cell and gene therapies based on various parameters, such as the year of establishment, type of agreement, type of services for which the companies partnered, type of cell and gene therapy and geographical location. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuringa Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall cell and gene therapy CRO market. One of the key objectives of this report is to evaluate the current opportunity and the future potential of the cell and gene therapy CROs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on [A] type of therapy (cell therapy and gene therapy) [B] scale of operation (clinical and preclinical), [C] type of therapeutic areas (oncology and non-oncology) and [D] geographical region regions (covering North America, Europe, Asia Pacific and rest of the world). To account for the uncertainties associated with the growth of cell and gene therapy CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Pharmaceutical and Life Sciences Real World Evidence: Market Landscape and Competitive Insights, 2018-2030

The process of developing new and disruptive medical products involves heavy investments, both in terms of time and cost. Estimates suggest that each prescription drug requires an average of about 10 years and over USD 2.5 billion in working capital before it gets commercialized. In order to gain regulatory approval and establish standards for the safety and efficacy of these products, randomized clinical trials (RCTs) are conducted; these account for a staggering 40% of the pharmaceutical industry’s budget.In addition to excessive R&D costs, these trials are fraught with various other challenges, such as prolonged delays and risk of failure / termination. It is also worth highlighting that most clinical trials are conducted under controlled conditions and involve a fairly homogenous patient population; however, when such products are approved, there are a variety of factors (both genetic and environmental) that need to be considered while treating individual patients. Data generated from real world applications of drug / therapy products partly addresses the aforementioned complexities and serves to complement the insights derived from controlled RCTs. Real world evidence has demonstrated the potential to validate the therapeutic value of pharmaceutical products and help customize product development in a more patient centric manner. In December 2016, the 21st Century Cures Act was passed directing the FDA to evaluate the applications of real world evidence in supporting healthcare decision-making. Its numerous applications have further encouraged pharmaceutical companies and health economists to utilize it in the evaluation of product candidates targeting even the rarest of medical conditions. In fact, it is estimated that, on an average, a big pharmaceutical company spends nearly USD 20 million annually for generating real world evidence-based insights. The growing importance of real world evidence in healthcare decision-making is also evident from the number of tweets (~4,400) posted on the social media platform, Twitter, in recent years. It is also worth noting that, since 2017, close to 75 global events (which include summits, forums, conferences and annual meetings) have been organized to discuss different aspects of real world evidence. Further, in the past few years, more than 1,000 studies have been initiated by stakeholders in real world setting to assess the impact of pharmacologic / non-pharmacologic treatment on patients and healthcare systems. Various initiatives are underway to further explore the potential of real world evidence in different stages of drug development. We believe that such efforts are likely to boost the overall growth of this market in the coming years.   Scope of the Report The ‘Pharmaceutical and Life Sciences Real World Evidence: Market Landscape and Competitive Insights, 2018-2030’ report features an extensive study on the industry players that are offering real world data / analytics / services to the pharmaceutical and life sciences industries. Amongst other elements, the report features: An overview of the current status of the market with respect to the companies providing real world evidence related solutions. It features information on their year of establishment, geographical location, size of the company, type of offering (real world data, analytics, and services), real world data sources (medical claims, clinical trials, clinical setting, pharmacy, patient-powered and others), and intended application areas (early stage research, clinical development, regulatory submission / reimbursement / market access, and post-approval studies). An elaborate discussion on data governance and the existing regulatory framework related to real world evidence across various geographies, namely North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific (Australia, China and Japan). A detailed publication analysis of close to 500 articles that have been published since 2016, highlighting the key focus areas of ongoing real world evidence-based research activity in the pharmaceutical and life sciences industries. The analysis also highlights the key prevalent trends associated with these publications, including information on the types of real world data sources utilized, leading indications, active stakeholders, and the most popular journals within this domain. A comprehensive analysis of completed, ongoing and planned studies conducted in the real world setting. For the purpose of this analysis, we considered only those studies that have been last updated since 2013, and analyzed them on the basis of various parameters, such as current trial status, regional distribution, type of sponsor, target indications, and enrolled patient population across different geographies. An analysis depicting the prevalent and emerging trends related to this domain as represented on the social media platform, Twitter. In addition to providing information on yearly trends related to the volume of tweets since 2013, the analysis highlights the most frequently talked about real world data sources, applications, therapeutic areas, active players, and influential authors. An in-depth analysis of recent events (summits / forums / conferences / annual meetings) that were organized for stakeholders in this domain, highlighting the evolution of discussion topics related to real world evidence. The analysis also provides details on event type, regional distribution, emerging agendas, popular organizers, active industry and non-industry players, and a schematic mapping of upcoming planned events. A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall real world evidence market. A comparative analysis of the needs of different stakeholders (manufacturers, regulators, payers, providers and patients) involved in this domain. A list of recent use cases where real world evidence was leveraged by pharmaceutical / medical device companies, highlighting the ways in which companies have utilized such information to support regulatory decisions, advance disease understanding, and develop outcome-based reimbursement model. An insightful opportunity analysis, estimating the existing market size and potential growth opportunities across different applications (early stage research, clinical development, regulatory approval, pricing / reimbursement, and post-approval studies) of real world evidence. Based on multiple parameters, such as number of pre- or post-approval studies conducted annually, investment associated with these studies, and the likely cost and time saving opportunities, we have provided an informed estimate on the likely evolution of the market over the period 2018-2030. The opinions presented in this study were influenced by inputs (through a comprehensive survey) of several key players in this domain. In addition, the report features detailed transcripts of interviews held with the following individuals: Jane Reed (Head of Life Science Strategy, Linguamatics) Jonathan Moshinsky (Head of Market Strategy, uMotif) Anonymous (Vice President, Big Pharmaceutical Company) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Medical Device CROs Market

According to the World Bank, more than 50,000 different types of medical devices are currently being used every day in health care facilities worldwide.In 2018, the global medical devices market is estimated to reach a net worth of approximately USD 450 billion. Further, another study estimated that the number of medical device related trials increased by 63% in the period between 2012 and 2016.However, a relatively larger proportion of device developers lack the required internal resources and technical expertise to conduct in-house clinical trials. Moreover, the costs associated with acquiring the necessary infrastructure / capabilities for such elaborate research initiatives are high; therefore, it is difficult for companies with limited finances to initiate and manage clinical studies by themselves. In addition, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments. The aforementioned challenges have led several players in the industry to outsource a significant part of their clinical stage research efforts to capable contract research organizations (CROs). In the foreseen future, the growing complexity of clinical trials and demand for reliable evidence on therapeutic benefits offered by various medical devices are likely to prompt more developer companies to outsource various aspects of their operations. The evolving practices have led a number of new players to enter the contract services domain. Moreover, in order to cope up with emerging technologies and the latest research trends, several legacy CROs are also re-evaluating their operational models and business strategies. In addition, the demand for integrated data platforms to manage and analyze vast amount of data, coupled with challenges associated with unstructured datasets and data privacy, has resulted in several collaboration and acquisition agreements between CROs and data management solutions providers. It is also worth highlighting that the industry has witnessed some consolidation in the last five years as smaller players have been acquired in an effort to widen the parent company’s geographical reach.   Scope of the report The ‘Medical Device CROs Market, 2018-2030’ report features a comprehensive study on the current landscape of contract research service providers focused on medical devices. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe. Amongst other elements, the report includes: An overview of the current market landscape, featuring a comprehensive list of CROs, and detailed analysis of the research service providers based on a number of parameters, such as geographical location, year of establishment, company size, scale of operation (clinical and preclinical), types of services provided by [A] clinical service providers  (biostatistics, consulting, clinical operations, post marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement, resourcing and training), [B] preclinical service providers (consulting, biocompatibility testing, materials characterization and analytical testing, preclinical trials support, sterility testing and microbiology testing, and training) and [C] stand-alone service providers (biostatistics, consulting, data management, pharmacovigilance, quality assurance, and regulatory affairs management), and popular therapeutic areas. An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe. Comprehensive profiles of popular players that specialize in providing services for both clinical and preclinical stage medical device development. Each profile features an overview of the company, its financial performance (if available), service portfolio details, and a future outlook. A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry. A comprehensive geographical clinical trial analysis of ongoing and planned studies related to medical devices. It provides details related to medical devices being investigated across various geographies, based on the number of registered trials, current status of trials, therapeutic area(s) and disease indication(s), and number of patients enrolled. A detailed analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2012-2018, along with the geographical distribution of this activity. The analysis also features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain. A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CRO services to medical device developers. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical device CRO industry. An elaborate discussion on the future opportunities / trends for the medical device outsourcing market that are likely to influence the growth of this domain over the coming years. One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device CROs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the opportunity across different [A] therapeutic areas (bone disorders, cardiological disorders, dental disorders, metabolic disorders, neurological disorders, ophthalmic disorders, respiratory disorders, wound management and others), [B] geographical regions (covering North America, Europe, Asia-Pacific and rest of the world), [C] type of device (class I, class II and class III), [D] phase of development (clinical and preclinical) and [E] type of services offered (clinical trial management, data management, regulatory affairs management, consulting and others). To account for the uncertainties associated with the growth of the medical device CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary sources. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Pre-Sterilized / Ready-to-Use Primary Packaging: Focus on Cartridges, Syringes and Vials, 2018-2030

Pharmaceutical packaging plays a key role in ensuring the sterility and quality of a drug product, while providing information related to its identity and, in certain cases, dosing instructions as well. Primary packaging, owing to the fact that it is in direct contact with the drug / therapy, is considered to be critical to the preservation of the product’s stability, efficacy and safety. Further, given the growing complexity of modern pharmacological interventions, especially biologics, it has become imperative for drug / therapy packaging considerations to be reevaluated, taking into consideration the evident shift from large batches of one remedy for everyone to smaller batches of more personalized treatment options. In addition to optimizing drug-packaging compatibility, stakeholders in the pharmaceutical packaging industry have adopted a number of other flexible solutions to reduce overall cost and expedite time to market. The use of ready-to-use (RTU), or pre-sterilized / pre-treated, container-closure systems have emerged as a promising alternative to conventional primary packaging, adding significant value to streamline pharmaceutical fill / finish operations. These packaging components eliminate multiple steps in the overall fill / finish process (mainly washing, sterilizing and preparing containers), thereby, helping improve operational efficiencies in compliance to existing regulatory standards. Owing to several other benefits, RTU container-closure systems have gradually gained popularity in the pharmaceutical industry. Moreover, many drug product manufacturers and fill / finish service providers have also adopted such systems to better serve their clients. In the future, as drug developers continue to strive to achieve greater flexibility in their operational protocols, RTU containers and closure systems are expected to play a key role.   Scope of the Report The ‘Pre-Sterilized / Ready-to-Use Primary Packaging Systems: Focus on Cartridges, Syringes and Vials, 2018-2030’ report offers a comprehensive study of the current scenario and future potential of the RTU primary packaging components market. The study features an in-depth analysis, highlighting the various types of containers that are available in the aforementioned format, including cartridges, syringes and vials, and their respective closure systems (such as stoppers, needle shields and plungers). In addition to other elements, the study includes: A detailed assessment of the current market landscape of containers and closures that are available in the RTU format, featuring information on the companies that manufacture such products, their respective scale(s) of production, material(s) used for fabricating such components, packaging formats and affiliated fill volumes. Elaborate profiles of key players in this domain; each profile features an overview of the company, its financial details, recent developments and a comprehensive future outlook. An analysis of the partnerships that have been established in this domain in the recent past, covering acquisitions, supply agreements, product development agreements, licensing agreements and other relevant deals established in the period between 2011 and 2018. An elaborate discussion on upcoming trends in the pharmaceutical industry that are likely to have an impact on the adoption of RTU container-closure systems. A case study on the use of robots / robotics-based technologies in pharmaceutical manufacturing and fill / finishoperations, along with profiles of industry players offering such equipment for handling RTU systems. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on various parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the financial evolution of the market in the short and long terms, for the period 2018-2030. To account for the uncertainties associated with the adoption of RTU components and to add robustness to our predictions, we have provided three scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of insights gathered both from secondary and primary sources.  All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cold Chain Logistics Market for Healthcare: Focus on Cell Therapies, Vaccines, and Human Organs, 2018-2030

The origins of the cold chain for transportation of temperature sensitive products can be traced back to 1797, when British fishermen first used natural ice to preserve their fish stock.Presently, a wide variety of pharmaceutical products, such as biologics, vaccines, human organs for transplantation and certain conventional pharmacological interventions as well, are temperature sensitive and require freezing / cryogenic holding temperatures for transport. In fact, over 95% of all approved biologics and 90% of all vaccines are cold chain dependent.Other healthcare products which are required to be shipped / stored under specific temperature conditions include aerosols, blood plasma samples, certain types of diagnostics kits, fertility samples, and laboratory specimens. For some products, even the slightest variations in temperature / storage conditions can adversely alter their integrity and / or viability. Over the years, the growing demand for such products has necessitated the need for well-defined infrastructure and protocols to support cold chain dependent logistics operations. Further, stakeholders in this segment of the industry have designed and established a variety of innovative solutions to serve the evolving demands of the healthcare sector. Moreover, connected cold chain solutions have been observed to offer a variety of advantages over conventional methodologies, such as automation of most of the steps and elimination of human handling errors that are associated with human intervention. In addition, the industry has witnessed several facility / capability expansions and acquisitions owing to an increasing demand for cold chain logistics services, which is indicative of the growing interest of stakeholders in this particular type of supply chain. Given the recent technical breakthroughs and advances, and the steadily rising demand for biopharmaceuticals, the reliance on cold chain is expected to increase substantially, causing logistics service providers to contemplate, devise and implement flexible business strategies and operational models to cope up with the future needs.   Scope of the Report The ‘Cold Chain Logistics Market for Healthcare: Focus on Cell Therapies, Vaccines, and Human Organs, 2018-2030’ report features an extensive study of the current landscape and future outlook of the growing cold chain logistics services market. The study features an in-depth analysis, highlighting the capabilities of the various service providers engaged in this domain. Amongst other elements, the report features: An analysis comparing the logistical complexities associated with cell therapies, vaccines and human organs, based on several parameters, such as holding temperatures, delivery time restrictions, handling / transportation requirements, and storage related needs. A detailed assessment of the overall market landscape, featuring a comprehensive list of over 80 players that offer cold chain logistics services for cell therapies, vaccines and human organs, and detailed analyses based on a number of parameters, such as the location of headquarters, size of employee base, type of products (cell therapies, vaccines, human organs, pharmaceutical products, and others), type of services offered (storage, packaging, and transportation), mode of transportation (ground, air, and ocean), holding temperature range (ambient, refrigerated, frozen, and deep frozen / cryogenic), type of packaging methods (dry ice, liquid nitrogen, and gel packs), type of container (active and passive containers), type of end-users (industry players and non-industry players), geographical activity and location of cold chain facilities. An insightful 2X2 representation of the results of a competitiveness analysis of various logistics service providers (segregated into three peer groups based on their employee count (small-sized (1-200 employees), mid-sized (>201-1,000 employees) and large (>1,000 employees)), highlighting capable players in this domain, based on their cold chain logistics capabilities (such as type(s) of container, type(s) of service(s) offered, holding temperature range, modes of transportation employed, geographical activity and type(s) of cold chain product(s)) and supplier power. Elaborate profiles of leading cold chain logistics service providers (shortlisted on the basis of the company competitiveness analysis), featuring an overview of the company, its financial information (if available), funding information (if available), information on cold chain logistics service(s) / product(s), recent partnerships, and a comprehensive future outlook. An analysis of the partnerships that have been established in the recent past, covering service alliances, logistics service agreements, merger / acquisitions, equipment development / manufacturing agreements, R&D agreements, and joint ventures. A detailed discussion on the various regulatory guidelines that have been laid down by major regulatory bodies (such as European Medicines Agency (EMA), United States Food and Drug Administration (USFDA), Health Canada (HC), International Air Transport Association (IATA), International Council for Harmonisation (ICH), International Safe Transit Association (ISTA), Parenteral Drug Association (PDA), United States Pharmacopeia (USP), and World Health Organization (WHO)), specific to cold chain management. In addition, it features an insightful analysis, comparing regulatory authorities based on the guidelines issued by them for different stages of the cold chain. A case study on the cold chain management strategies used for over 190 drugs (both biologics and small molecules)that were approved in the last five years, highlighting year-wise trend of cold chain adoption. In addition, it analyzes the cold chain temperature requirements of these drugs, based on several parameters, including type of molecule(s), dosage form and route of administration. A detailed estimation of the likely demand for logistics services for [A] cell therapies (including stem cell therapies, T-cell therapies, dendritic cell therapies, natural killer cell therapies and tumor therapies), considering the contributions of clinical and commercial stage products over the period 2018-2030; [B] vaccines (including over 15 types of mandatory and optional vaccines), considering the contributions of both clinical and commercially available products for both infants and adults, over the period 2018-2030; and [C] human organs (including heart, intestine, kidney, liver, lung, and pancreas) for transplants, over the period 2018-2030. A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry’s evolution, under a comprehensive SWOT framework. It also includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall cold chain logistics market. A discussion on the upcoming tools / technologies (such as integration of automation and robotics, cloud computing, blockchain technology, artificial intelligence and other such advanced technical solutions) in the field of cold chain logistics and their likely impact on the future evolution of this market. One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for cold chain logistics over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the future opportunity based on [A] regional evolution of the market covering key geographies, such as North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Germany, Spain and Italy), Asia-Pacific and Rest of the World (Australia, China, India, and Japan), [B] type of products (cell therapies, vaccines, and human organs), [C] holding temperature ranges (refrigerated, frozen, and cryogenic), [D] type of containers (active and passive containers), and [E] type of end-users (industry players and non-industry players). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were also influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: Elena Boykova (Marketing Communications Manager, AirBridgeCargo Airlines) Jacqueline Barry (Chief Clinical Officer, Catapult Cell and Gene Therapy) Michelle Arnot-Kruger (Health Specialist, Cold Chain Logistics, UNICEF) Shehdeh Abusnineh (Supply Chain Manager, Tabuk Pharmaceuticals). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Extractables and Leachables Testing Services Market, 2018-2028

Harmful chemicals / contaminants from primary packaging have often been shown to migrate into pharmaceutical products, threatening the safety of several patients who use these products. For instance, in 2010, McNeil Consumer Healthcare was compelled to recall more than 500 lots of Tylenol, Motrin, Benadryl and Zyrtec upon being made aware of the presence of an antifungal chemical, called 2, 4, 6-tribromoanisole (which is used to chemically treat shipping pallets), in the aforementioned product formulations. In this particular case, the chemical, which is a potential carcinogen, had leached from the pallet, through the outer packaging into the drug containers. It is worth highlighting that this incident caused the manufacturer to suffer a loss of approximately USD 900 million. In fact, in 2014, data by the FDA demonstrated that in the previous two years, there have been over 2,000 drug and device recalls. In the year 2014 alone, FDA has recalled over 800 drugs. In addition, in 2015, Allergan voluntarily recalled certain batches of its eye ointment due to contamination reported by customers. Considering the aforementioned cases, it can be inferred that, during drug product manufacturing and fill / finish, it is important to consider not only the impurity profiles of the drugs, but also identify potential sources of contamination in the containers / packaging material used. Extractables is the term used to refer to compounds that are extracted from the material used to fabricate closed container systems, in the presence of a particular solvent. On the other hand, leachables are substances that passively migrate into drug formulations from the container closure system used, upon direct contact with the product. Further, due to high variability in the type of impurities (organic (volatile, non-volatile or semi- volatile compounds) or inorganic (metals or salts) elements) that are usually extracted / leached out of various manufacturing components and container closures, it is not possible to identify, characterize and quantify all extractables, using a single analytical technique. Nowadays, a variety of testing solutions / assays are available to assess the risk associated with the migration of mobile chemical species from either the components used during manufacturing, or storage containers. Moreover, regulatory bodies have implemented stringent guidelines, making it mandatory for drug developers and packaging service providers to closely monitor the levels of extractables and leachables in pharmaceutical products, drug delivery systems and biomedical devices. Presently, a number of companies offer services for extractables and leachables testing, and such offerings have grown to become an important segment of the overall pharmaceutical industry.   Scope of the Report The ‘Extractables and Leachables Testing Services Market, 2018-2028’ report provides an extensive study on the current market landscape and future outlook of the players offering such services. The study features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. Amongst various elements, the report includes:  A detailed assessment of the current market landscape of companies offering extractables and leachables testing services, including information on their respective geographical location, company size, types of pharmaceutical products tested (parenteral, ophthalmic, topical, nasal and others), types of container closures and devices tested (container closure components, single use systems, medical devices and combination products, electronic nicotine delivery systems and others), types of techniques used (spectroscopic techniques, chromatographic techniques and others) and different regulatory guidelines that they comply with. A competitiveness analysis of contemporary service providers, presented in the form of a 2X2 matrix, highlighting the most important companies within North America, Europe and Asia Pacific, based on the number of products tested, number of techniques used, extent of regulatory compliance and the company’s experience. Comprehensive profiles of service providers, featuringbrief overview of the company, details on its extractables and leachables testing services portfolio,information on the location of their headquarters, year of establishment, recent developments and a detailed future outlook. In addition, each profile features a peer group-based benchmark comparison matrix, wherein the companies that have been profiled were compared on the basis of several different parameters, such as the number of products tested, number of techniques used, extent of regulatory compliance and the company’s experience. A detailed analysis of the acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired from 2013-2018, along with the geographical distribution of this activity. The analysis features an ownership change matrix and presents a detailed financial evaluation of the aforementioned deals (in terms of company revenues and deal multiples). An elaborate discussion of the various guidelines laid down by major regulatory bodies across different countries and the risk-based approach to extractables and leachables testing. The section also highlights the various regulatory considerations for specific products, such as single use systems, biopharmaceuticals, parenteral and ophthalmic drug products (PODPs) and electronic nicotine delivery systems. An analysis on packaging trends for drugs approved in the last five years (beginning 2014). In this section, we have analyzed the various container closure systems used based on parameters such as year of approval of the drug, type of molecule, dosage forms and the packaging material(s) used. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on a proprietary forecast model, we have provided insights on the likely evolution of the market in different regions, including North America, Europe, Asia-Pacific and the rest of the world. In addition, we have provided the likely distribution of the opportunity across the type of service provider companies (small-sized, mid-sized and large companies) and types of products being tested (pharmaceutical products, container closure systems, medical devices and combination products). The opinions and insights presented in this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following industry stakeholders: Cheryl Johnson (Commercial Development Manager of Biotechnology, Alcami) Mike Ludlow (Technical Study Manager Drug Development Services, LGC) Mourad Rahi (Director of Analytical Services, American Preclinical Services) Roger Pearson (President of Analytical Services, Aspen Research) All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

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ADC Contract Manufacturing Market (3rd Edition), 2018-2030

Antibody drug conjugates (ADCs) are one of the most popular classes of targeted therapeutic agents and have captured the attention of both large and small pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of an antibody and the cytotoxic potential of a chemotherapy drug; such conjugates are believed to be more efficient and effective in specifically identifying and eliminating cells / pathogens that are associated with disease(s). Since the approval of first ADC (MYLOTARG™) in 2000and its subsequent withdrawal in the year 2010, the ADC market has evolved considerably. Presently, there are four approved ADCs in the market: BESPONSA (2017), MYLOTARG™ (2017, reapproval), KADCYLA (2013) and ADCETRIS (2011). In fact, in the last 4-5 years, the market has witnessed an increasing interest from drug developers and healthcare investors alike. This is justified by the fact that currently there are close to 200 unique ADC product candidates in the clinical / preclinical phase of development. Owing to the fact that these novel conjugates are highly potent toxic molecules, their manufacturing requires elaborate technical capabilities, along with the required expertise and manufacturing acumen related to both biologics and highly potent chemical substances. Specifically, the development of an antibody requires experience in protein engineering, cell line development, bioprocess development and related scale-up techniques. The production of the cytotoxic payloads that are used in ADCs requires specialized manufacturing facilities and equipment, highly contained production environments and experts in advanced synthetic chemistry and purification techniques. In addition, ADC developers require access to state-of-art linker technologies and must possess the ability to carry out the bioconjugation of the antibody to the cytotoxic drug. Due to the aforementioned challenges, stakeholders generally don’t opt for manufacturing ADCs in-house. In fact, some of the leading players in this domain are dependent on contract manufacturers for the supply of one or more components of their ADC product candidates. Although some big pharma companies carry out in-house manufacturing of their ADC products, the trend of outsourcing such operations is likely to flourish in the coming years. This trend is expected to be driven by the several small companies and start-ups that are presently involved in development of ADCs.   Scope of the Report The “ADC Contract Manufacturing Market (3rd edition), 2018-2030” report offers a comprehensive study of the current scenario and future potential of the contract manufacturing market for ADCs. The study features an in-depth analysis, highlighting the capabilities of contract services providers engaged in this domain. In addition to other elements, the study includes: An overview of the current status of the market with respect to the players involved in the manufacturing of ADCs. It features information on headquarters, size of the company, the types of services offered (antibody manufacturing / HPAPI or cytotoxic manufacturing / linker manufacturing / conjugation / fill-finish), location of manufacturing facilities, year of establishment of company / organization, scale of operations, and additional development services offered for ADCs (proof-of-concept studies / process development and scale-up / anaytical development). Elaborate profiles of the contract service providers that are either one-stop-shops (offering services from antibody manufacturing to fill/ finish operations) or offer conjugation services at the commercial scale. Each profile provides a brief overview of the company, its financial information, details on ADC manufacturing capabilities, location of facilities, recent developments, and a comprehensive future outlook. A comparative analysis of the key contract manufacturers based onvarious parameters, including company size, year of establishment, number of ADC manufacturing services offered, annual revenues, scale of operation, number of ADC development services offered and number of facilities for conjugation services. An analysis of the recent investments (since 2012) made in this domain, the proceeds of which were intended to be used for the expansion or establishment of new facilities dedicated to offering ADC related services. An analysis of the recent collaborations (since 2012) focused on manufacturing of ADCs on the basis of year in which the agreement was signed, type of agreement, key players and the geographical distribution of this activity. An estimate of the overall ADC manufacturing / bioconjugation capacity (in grams / batch) of contract service providers based on information provided on their respective websites (wherever available) and additional data collated via secondary and primary research. The analysis highlights the distribution of global capacity by size of the company / organization (small-sized, mid-sized and large-sized) and geography (North America, Europe and Asia Pacific). An overview of the ADCs that are already approved and those that are under development (clinical and preclinical), featuring information related to their current phase of development (wherever applicable), key target indications, developer company / organization, affiliated technology provider(s) and the type(s) of cytotoxin(s) and linker(s) used. A review of the evolution of ADC conjugation technologies, highlighting the various types pf approaches that have been adopted in the past, and the different generations of linkers. It also highlights the competition between contemporary technology platforms. A comprehensive geographical clinical trial analysis of completed, ongoing and planned studies of various ADCs (approved / under development). It provides details related to the different types of payloads and linkers investigated / being investigated across various geographies, based on the number of trials registered, current trial status, phase of development, number of patients enrolled and duration of the (recently initiated) trials (2015 onwards). An informed estimate of the annual demand for ADC products (in grams), taking into account commercial, as well as clinical scale requirements, based on parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates. A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall ADC contract manufacturing market. One of the key objectives of this report was to evaluate the current opportunity and the future potential of the ADC contract manufacturing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on scale of operation (commercial, phase III, phase II and phase I), component / process type (antibody manufacturing, HPAPI / cytotoxic production, conjugation / linker and fill / finish), target indications (solid tumors and hematological malignancies), type of payload used (auristatin, calicheamicin (ozogamicin), duocarmycin, DXd (exatecan derivative), maytansinoid, pyrrolobenzodiazepines (talirine, tesirine) and others), type of linker used (succinimidyl 4-(n-maleimidomethyl) cyclohexane-1-carboxylate, valine-citrulline, hydrazone, valine-alanine, n-succinimidyl-4-(2-pyridyldithio) butanoate and others) and geography (North America, Europe, Asia Pacific and rest of the world). The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with following stakeholders: Aldo Braca (Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Manager, BSP Pharmaceuticals) Anthony DeBoer (Director, Business Development, Synaffix) Christian Bailly (Director of CDMO, Pierre Fabre) Christian Rohlff (Chief Executive Officer & Founder, Oxford BioTherapeutics) Jennifer L. Mitcham (Director,  Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions) John Burt (Chief Executive Officer, Abzena) Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza) Mark Wright (Site Head, Piramal Healthcare) Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia) Anonymous (Director, Business Development, Leading CMO) Anonymous (Chief Executive Officer, Leading CMO) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Neurostimulation Devices Market (2nd Edition), 2018-2030

The National Academy of Medicine indicates that as many as 100 million people in the US suffer from some form of pain, which has been shown to be associated with a socioeconomic burden of around USD 600 billion per year, in treatment costs and lost productivity. Further, it has been estimated that nearly 1 million people in America suffer from Parkinson’s disease, with approximately 60,000 new patients being diagnosed every year.Over the past few decades, the prevalence of such chronic disorders has grown at an alarming rate. In fact, a recent World Health Organization’s Global Burden of Disease study recognized these chronic conditions as one of the leading causes of deteriorating public health in the world. Such clinical conditions have often been shown to result in serious physical, cognitive and psychosocial consequences in patients.This indicates an urgent need for novel and effective treatment methods as the drawbacks of existing treatment options (such as high risk of addiction / abuse associated with long-term use of oral opioids, and complications due to complex surgical procedures) are substantial. Extensive research in the field of neurostimulation has demonstrated the potential of this technique in providing therapeutic relief to a number of patients, who have developed resistance to conventional medication. Since the introduction of the first neurostimulation therapy in 1960s, their numerous observed benefits, such as reversible and minimally invasive nature of the procedures (to administer such treatments), targeted approach to therapeutic relief that can be modulated as well, provisions for integrating various safety mechanisms, and negligible use of opioids / other medications, have captured the interest of several stakeholders in the industry. In fact, since 2010, over 4,000 patents have been published in this domain, indicating the rapid pace at which research is being carried out. It is anticipated that such efforts are likely to boost the overall growth of this market in the coming years. Scope of the Report The ‘Neurostimulation Devices Market (2nd Edition), 2018-2030’ report features an extensive study of the current landscape and future outlook of the growing market for neurostimulation devices. The focus of this study is on invasive neurostimulation devices, such as devices for spinal cord stimulation (SCS), deep brain stimulation (DBS), spinal nerve stimulation (SNS), vagus nerve stimulation (VNS), other cranial nerve stimulation (Other CNS) and other variants of neurostimulation devices. Amongst other elements, the report features: A detailed assessment of the overall landscape of neurostimulation devices market, featuring the contributions of various companies engaged in this domain and highlighting key device specifications (size, weight, battery type, battery life, number of electrodes, type of programming, and MRI compatibility), along with information on different types of neurostimulation devices, target therapeutic areas, and regulatory approvals received across various geographies. A comprehensive product competitiveness analysis, taking into consideration the supplier power and specific device-related parameters, such as number of target indications, target nerves, regulatory approvals, and key device specifications. Comprehensive profiles of developers of leading neurostimulation devices (shortlisted on the basis of the product competitiveness analysis), featuring an overview of the company, its financial information (if available), and a detailed description of the device(s). Each profile also includes a list of recent developments, highlighting the achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. An elaborate discussion on the regulatory landscape related to medical devices across various geographies, namely North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific (Australia, China and Japan). The information covers details on the payer mix, and the reimbursement processes of various public / private organizations across these geographies. A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands across different device types, taking into consideration several aspects, such as strength / diversity of product portfolio, extent of patent portfolio, recent collaborations, number of target indications and regulatory approvals, and the overall market positioning of the players. An in-depth analysis of the patents that have been published since 2013. The analysis also highlights the key trends associated with these patents, including patent type, regional applicability, CPC classification, IP litigations, emerging areas, leading industry players (in terms of number of patents filed / granted), and patent benchmarking and valuation. A comprehensive clinical trial analysis of completed, ongoing and planned studies of various neurostimulation devices. For the purpose of this analysis, we looked at the clinical studies that have been last updated in 2013, and analyzed them on the basis of various parameters, such as current trial status, regional distribution, leading industry and non-industry players, key indications, and enrolled patient population across different geographies. An analysis of the partnerships that have been established in the recent past, covering product development / commercialization agreements, R&D collaborations, technology licensing deals, distribution agreements, mergers / acquisitions, and others. An analysis of investments made at various stages of product development / commercialization; these include seed financing, venture capital financing, debt financing and grants / awards received by the companies that are operating in this domain. A comprehensive list of non-invasive neurostimulation devices, along with information on their developers, various types of non-invasive technologies used, target therapeutic areas, and development / approval status of the devices. An elaborate discussion on the upcoming opportunities / trends in the field of neurostimulation devices that are likely to impact the evolution of this market over the coming years. One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for neurostimulation devices. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market over the period 2018-2030. The report provides sales forecasts for the overall neurostimulation devices market with detailed market segmentation on the basis of type neurostimulation devices (SCS, DBS, VNS, and other types), indication (chronic pain, dystonia, epilepsy, essential tremor, heart failure, major depressive disorder, Parkinson’s disease, obsessive compulsive disorder, overactive bladder, sleep apnea), MRI compatibility (MRI compatible and MRI non-compatible), and the geographical distribution of the market (US, Canada, UK, Germany, France, Spain, Italy, Australia, China, and Japan). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were also influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: Dave Rosa (President and Chief Executive Officer, NeuroOne Medical Technologies) Deborah Schmalz (Vice President, Regulatory Affairs, Clinical Research and Compliance, ReShape Lifesciences) and Diane Utzman-O’Neill (Vice President, Marketing, ReShape Lifesciences) Jan Pieter Heemels (Vice President, Commercial Operations, Mainstay Medical) Laura Tyler Perryman (Chief Executive Officer, Stimwave) Luca Ravagnan (Chief Executive Officer, WISE) Steve Goedeke (President and Chief Executive Officer, Cardionomic) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Antibody Discovery: Services and Platforms Market (2nd Edition), 2018-2028

Given the increasing focus on personalized medicine, biologics have established a strong foothold in the pharmaceutical industry. Owing to several beneficial features, such as high specificity, and a favorable safety profile, antibody based pharmacological interventions presently represent the largest class of biologics, with 79 molecules approved till date and over 200 molecules in the preclinical / discovery stages. It is worth mentioning that the research and development efforts associated with antibody-based therapeutics have significantly paced up in 2017; this momentum is projected to continue over the coming several years. In fact, in 2017, more than 10 monoclonal antibodies were approved by the FDA and EMA. Additionally, close to 20 monoclonal antibodies are currently being evaluated in late stages of clinical development.In addition to monoclonal antibodies, other novel antibody-based therapeutics, such as bispecific antibodies, antibody drug conjugates (ADCs) and antibody fragments, are steadily gaining traction. The discovery of antibodies is a long, arduous and cost intensive process. As a result, many biopharmaceutical developers are opting to outsource such operations. Modern contract research organizations (CROs), offering antibody discovery services, claim to have novel and advanced technologies to support players developing antibody-based products in their early stage research requirements. Additionally, there are a number of companies that have developed proprietary antibody discovery platforms and have made them available to drug developers. In-licensing the technology of such players for use in drug discovery operations is considered a viable business strategy, offering both time and cost related benefits to drug / therapy developers. As the demand for such therapeutic / diagnostic products increases, the opportunity for contract service provides and technology developers is also anticipated to grow in the foreseen future.   Scope of the Report The ‘Antibody Discovery: Services and Platforms (2nd Edition), 2018-2028’ report provides an extensive studyon the current market landscape and future outlook of companies offering antibody discovery services and platforms. Amongst various elements, the report includes: A detailed assessment of the current market landscape of companies offering antibody drug discovery services, including information on their geographical location, types of services offered (antigen designing, hit generation, lead selection, and lead optimization / and lead characterization), antibody generation methods (hybridoma based, library based, single cell based, transgenic animal based, wild type animal based and others), purpose of antibody discovery (therapeutic and diagnostic) and animal models used (rabbits, rats, mouse, llamas, chicken and others). An in-depth analysis of antibody platform providers, featuring information on their geographical location, antibody generation methods (hybridoma based, library based, single cell based, transgenic animal based, wild type animal based and others), type of antibodies discovered (ADCs, antibody fragments, bispecific antibodies, monoclonal antibodies and others), and animal models used (transgenic mice, rabbits, llamas and others). A comprehensive benchmark analysis, highlighting the key focus areas of small, mid-sized and large sized companies, comparing their existing capabilities within and beyond their respective peer groups, and providing a means for stakeholders to identify ways to gain a competitive edge in the industry. A comparative landscape of service providers, highlighting the most important companies within North America, Europe and Asia Pacific, based on number of discovery services offered, number of discovery methods available, number of subject specific agreements signed, the company’s experience and size of employee base. An insightful 2X2 competitiveness analysis of various antibody discovery platforms (segregated into three peer groups, namely library based method, transgenic mice, single cell based method), highlighting popular products based on the library size of the platform, types of antibody discovered, need for humanization, platform-specific collaborations established per year, therapeutic areas addressed and supplier power (in terms of experience of the company). Comprehensive profiles of antibody discovery service and platform providers, featuring information on the location of their headquarters, year of establishment, antibody discovery service / platform portfolio, recent developments and a comprehensive future outlook. A case study on antibody humanization and affinity maturation, including an exemplary list of players that are presently offering such services and platforms, a publication analysis highlighting the research trends related to this field and a detailed discussion on other affiliated trends, key drivers and challenges, under a comprehensive SWOT framework. An analysis of the partnerships that have been established in the recent past, covering research collaborations, licensing agreements (related to both technology platforms and service providers), product development, service agreements, merger / acquisitions and othersforms of collaborations. An analysis of investments received by the service and platform providers, featuring details of capital raised via seed financing, venture capital financing, IPOs, debt financing and grants / awards, by companies that are operating within this domain. A discussion on the upcoming opportunities (such as novel antibody therapeutics, innovative technologies and other future opportunities) in the field of drug discovery that are likely to impact the future evolution of this market over the coming years. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. We have provided insights on the likely evolution of the market in different regions, including North America, Europe, China and the rest of the world. In addition, we have provided the likely distribution of the opportunity across the various steps involved in antibody discovery (antigen designing, hit generation, lead selection, lead optimization and lead characterization), antibody discovery methods (hybridoma based, library based, single cell based, transgenic animal based, wild type animal based and others), and the nature of antibody generated (chimeric, humanized and fully human). In addition, we have estimated the future opportunity for platform providers in term of the likely licensing deal structures and the agreements that are expected to be signed in the foreseen future.The opinions and insights presented in this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following industry stakeholders: Aaron Sato (Chief Scientific Officer, LakePharma) Christel Iffland (Vice President, Ligand Pharmaceuticals) Chun-Nan Chen (Chief Executive Officer and Chief Scientific Officer, Single Cell Technology) Debra Valsamis (Business Development Associate, Antibody Solutions) Garren Hilow (Co-Founder and Chief Executive Officer, Abveris) Giles Day (Co-Founder and Chief Executive Officer, Distributed Bio) Ignacio Pino (President and Chief Executive Officer, CDI Laboratories) Jeng Her (Chief Executive Officer, AP Biosciences) Kevin Heyries (Co-Founder and Lead of Business Development Strategy, AbCellera) Nalini Ghag- Motwani (President and Founding Chief Scientist, BioSavita) Sanjiban K Banerjee (Director, AbGenics Life Sciences) Thomas Schirrmann (Chief Executive Officer and General Manager, YUMAB) All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Non-Opioid Drugs for Chronic Pain and Pain Management Devices Market, 2018-2025

Chronic pain refers to the psychophysiological response to an underlying clinical condition, which is observed to persist for a duration greater than six months and is generally unresponsive to multiple treatment regimens. It is estimated that more than 1.5 billion individuals across the world suffer from this type of pain. Some of the most common physiological conditions that are characterized by a chronic sensation of pain include migraine, lower back pain, pain associated with cancer, arthritis-related pain and neurogenic pain. Owing to the rapid onset of their medicinal effect, which offers immediate relief with high efficacy, opioids are still considered to be one of the most widely used pharmacological interventions for the management of moderate to severe forms of pain. However, these drugs are known to induce a euphoric state upon intake, often causing patients to abuse them; increased recreational use of opioids has also been shown to lead to drug addiction. The over-prescription of such medicinal products, which promotes their misuse, is considered as one of the root causes of the opioid crisis. In a recent article, published in 2017, 11.5 million individuals were reported to have been caught misusing prescription opioids, while over 42,000 died from opioid overdose, in the US alone. Moreover, opioid abuse was estimated to have been responsible for over USD 500 billion worth of economic deficit (in the US) due to loss of productivity and healthcare costs. The opioid crisis has prompted drug manufacturers to develop non-addictive, non-narcotic-based therapeutics / analgesics for the management of pain. Unlike opioids, non-opioid drugs do not affect receptors present in the brain and, thus, are not addictive. These drugs work directly on injured / diseased body tissues and generally block the production of prostaglandins by inhibiting the cyclooxygenase (COX) enzyme at the site of injury / infection, thereby, decreasing the generation of pain mediators within the peripheral nervous system. Additionally, there are various pain management devices that have been reported to significantly reduce or eliminate the need for pharmacological interventions. Such devices are increasingly being used to treat a variety of clinical conditions that are characterized by chronic pain and offer the convenience of being used in the homecare setting as well. However, it is imperative for patients to consult qualified healthcare professionals, who have the required understanding of such therapeutic options, prior to using such devices.   Scope of the Report The “Non-Opioid Drugs for Chronic Pain and Pain Management Devices Market, 2018-2025” report provides an extensive study on the marketed, clinical and preclinical products / product candidates for management of chronic pain. The report also features a detailed overview of the devices that are used for the treatment / management of pain associated with chronic clinical conditions. Amongst other elements, the report includes: A detailed assessment of the current market landscape of drugs being developed for the treatment of chronic pain, providing information on their respective developer(s), phase of development (clinical, and preclinical / discovery), type of molecule (small molecule and biologic), indication (nociceptive and neuropathic), mechanism of action (channel blockers, receptor antagonists, protein pathway modulators and others) and route of administration (intra-articular, intravenous, intranasal,  intranasal, intrathecal, oral, subcutaneous, topical and transdermal). An in-depth analysis of the product pipeline and developer companies, featuring [A] a mirror analysis highlighting the relative popularity of different disease indications based on the number of molecules available / under development for each indication and the number of companies involved, [B] a logo landscape of the various industry players involved in this domain, distributed on the basis of location of headquarters and company size (small-sized, mid-sized and large), [C] a heptagon representation highlighting the distribution of marketed and pipeline molecules based on their respective mechanisms of action, and [D] a funnel analysis highlighting the distribution of molecules on the basis of stage of development, route of administration and treatment type. An analysis highlighting the key unmet needs across chronic pain, featuring insights generated from data sourced from patient blogs, recent scientific publications, social media posts and the views of key opinion leaders expressed on various online platforms. An elaborate discussion on lifecycle management strategies, describing how different companies are using various methods to prolong patent age and, thereby, expand marketing exclusivity in order to exploit the revenue generation potential of their proprietary products. The section also includes detailed case studies elaborating on diverse lifecycle management strategies of marketed drugs that are nearing patent expiry. Comprehensive profiles of drugs that are in phase III of clinical development, with information on developer companies (including location of headquarters and year of establishment), type of molecule, mechanism of action, current status of development, route of administration, information on clinical trials and key developments (if available). A detailed assessment of the current market landscape of various devices that are being developed for chronic pain management, highlighting information on developer (size of company and location of headquarters), mechanism of action (electrical stimulation, electromagnetic pulse, heat therapy, light therapy, radiofrequency stimulation and others), site of application on the body (head, arm, knees and other areas), modality of the device (invasive and non-invasive), and treatment requirements (at home and at hospitals / outpatient clinics), and type of device (wearable, hand-held and implants). An insightful 2X2 competitive analysis for the various devices, highlighting the most important products based on the modality of device, treatment requirement, type of device, and supplier power (based on size of employee base of the company). The chapter also includes profiles of devices that emerged as relatively superior (based on the analysis); each profile features details on the developer (location of headquarters and year of establishment), approval year, mechanism of action, key features and key developments. An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, licensing agreements (related to both technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements and others An analysis of investments made at various stages of product development; these include seed financing, venture capital financing, debt financing and grants / awards, received by companies that are operating in this domain. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term, for the period 2018-2025. The report includes a detailed market segmentation on the basisof indication (chronic back pain, lumbar radiculopathy, migraine, osteoarthritis and neuropathic pain), type of molecule (small  molecule and biologic), mechanism of action (CGRP inhibitors, COX/ NGF inhibitors, TRPV1 receptor antagonists, channel blockers and others) and geography (North America, Europe, Asia Pacific and rest of the World). In addition, the report features an opportunity analysis for the chronic pain management devices market. The opinions and insights presented in this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Ryan Jeffcoat (Director of Clinical Affairs & New Markets, AVACEN Medical), Lisa Robin (Chief Advocacy Officer, Federation of State Medical Boards), Nelson Hendler (Chief Executive Officer, Mensana Clinic Diagnostics) and Mark Wiederhold (Chief Executive Officer, Virtual Reality Medical Center). All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

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CAR-T Therapies Market, 2018-2030

Amidst the current initiatives to develop more targeted anti-cancer therapies, chimeric antigen receptor T-cell (CAR-T) therapy has emerged as a potent and viable therapeutic intervention to eradicate tumor cells, with minimal side effects. It is based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. There are certain key characteristics that render CAR-T cells suitable for use as effective therapeutic tools; these include target specificity, adaptability and the capability to retain immunologic memory. Close to 70 academic and research institutes across the globe have made significant contributions to this field, mostly by convening the initial research on potential product candidates. These efforts have built the intellectual framework for the establishment of several start-ups. The ongoing innovation has also led to the discovery of several novel molecular targets, strengthening the research pipelines of various companies engaged in this domain. Given the recent approval of two CAR-T therapies, namely Kymriah® (Novartis) and Yescarta® (Gilead Sciences), and a robust development pipeline, the CAR-T therapy market also offers considerable promise to a number of industry stakeholders.   Scope of the Report The “CAR-T Therapies Market, 2018-2030” report features an extensive study of the current market landscape and the future potential of CAR-T therapies. One of the key objectives of the study was to review and quantify the future opportunities associated with the ongoing development programs of both small and big pharmaceutical firms. Amongst other elements, the report features the following: An analysis depicting prevalent and emerging trends related to CAR-T therapies as observed on the social media platform, Twitter. In addition to the yearly chatter trends, the analysis highlights the most frequently talked about product candidates as well. A detailed assessment of the current market landscape of CAR-T therapies with respect to type of developer (industry and non-industry), phase of development, target therapeutic indications, key target antigens, source of T-cells (autologous and allogenic), and route of administration (intravenous infusion and regional route). Comprehensive profiles of marketed and mid to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, history of development, current development status, key clinical trial results, details on administered dose, price and manufacturing process of the therapy (wherever available). An analysis of the CAR constructs of clinical stage therapies based on generation of CAR-T product (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector (lentivirus, retrovirus, mRNA electroporation, sleeping beauty and other vectors) and type of co-stimulatory domain used. An analysis of the CAR-T clinical trials registered across the world in the period between 2009 and 2018, highlighting the year wise trend and the geographical distribution. A detailed analysis highlighting the key opinion leaders (KOLs) in this domain. It features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, indicating the geographical locations of eminent scientists / researchers involved in the development of CAR-T therapies. An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications. A detailed discussion on innovative technology platforms that are being used for the development of CAR-T therapies, along with profiles of key technology providers. A case study on manufacturing cell therapy products, highlighting the key challenges, and a list of contract service providers and in-house manufacturers that are involved in this space. An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies, featuring different models / approaches that a pharmaceutical company may choose to adopt to decide the price of its proprietary products that are likely to be marketed in the coming years. A review of the key promotional strategies that have been adopted by the developers of the marketed CAR-T therapies, Kymriah® and Yescarta®. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. The report includes information on (potential) sales-based revenues of CAR-T therapies that are currently marketed or are in late stages of development. Additionally, it presents detailed segmentation of the overall opportunity on the basis of geography (North America, Europe and Asia Pacific) and target indications (acute lymphoblastic leukemia, chronic lymphocytic leukemia, multiple myeloma, hepatocellular carcinoma and non-Hodgkin’s lymphoma). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals: Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) Miguel Forte (Chief Operating Officer, TxCell) Vincent Brichard (Vice President, Immuno-Oncology, Celyad) Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell Therapy Manufacturing Market (2nd Edition), 2018-2030

Cell-based therapies have gained significant attention in the overall biopharmaceutical industry. The personalized nature of these treatment options render them highly specific and, according to a number of clinical studies, safe and efficacious. Such therapies are considered to possess the potential to address various unmet medical needs associated with the treatment of several types of physiological disorders and clinical conditions. A number of pharmaceutical companies and investors have already invested significant capital towards the development and commercialization of such products. Around 20 such therapies have been approved; recent approvals include Alofisel® (2018), YESCARTA® (2017) and Kymriah® (2017). It is also worth highlighting that over 500 cell-based therapy candidates are in different stages of clinical development, and are being evaluated in more than 1,000 active clinical studies across various regions of the globe. The growing number of cell therapy candidates, coupled to their rapid progression through various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these complex therapies. There is a wide array of industry players, including well-established companies, mid-sized firms and start-ups, as well as academic institutes that are significantly contributing to the production of GMP grade cell therapies. In addition, several players offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. Most of these players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for the production of cell-based therapies. Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums, to accelerate the transition of these therapies from laboratories to clinics. Looking at the evolutionary trend so far, we believe that the cell therapy manufacturing market is poised to steadily grow, driven by a robust pipeline of therapy candidates and technological advances aimed at mitigating challenges posed by the conventional methods of production.   Scope of the Report The “Cell Therapy Manufacturing Market (2nd Edition), 2018-2030” report provides an extensive study of the rapidly growing market of cell therapy manufacturing, focusing on contract manufacturers, as well as cell therapy developers with in-house manufacturing facilities. The study presents an in-depth analysis of various organizations that are engaged in this domain across different regions of the globe. Amongst other elements, the report includes: A review of the current status of the market with respect to key players, along with information on the location of their manufacturing facilities, scale of production, type of cells manufactured (immune cells (such as T cells, dendritic cells, NK cells), stem cells (such as adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), purpose of production (fulfilling in-house requirements / as a contract service provider), type of organization (industry / non-industry), source of cell-based therapies (autologous / allogeneic), cGMP regulatory compliance, and availability of fill / finish services for cell-based therapies. A discussion on roadmaps published by different agencies across the globe to provide strategies to advance cell therapy manufacturing. Elaborate profiles of key players (industry and non-industry) that offer contract manufacturing services for cell-based therapies; each profile presents an overview of the company, information on its manufacturing facilities, and recent collaborations. A discussion on the role of non-profit organizations that have aided in the advancement of cell-based therapies, as well as manufacturing processes. Detailed information on the role of automation technologies in improving current manufacturing methods, along with a qualitive comparative analysis of cost differences between manual and automated processes. An analysis of the recent collaborations (signed since 2014) focused on the manufacturing of cell-based therapies; the analysis is based on various parameters, such as the year in which the agreement was signed, type of agreement, and scale of operation (clinical and / or commercial). An estimate of the overall installed capacity for manufacturing cell-based therapies of various organizations, based on information reported by industry stakeholders in the public domain (wherever available) and affiliated data collated via both secondary and primary research. The analysis highlights the distribution of the global capacity of industry and non-industry players on the basis of scale of operation (clinical and commercial), regions (North America, EU and Asia Pacific) and size of the organization (small-sized, mid-sized and large-sized organizations). An analysis of the various factors that are likely to influence the pricing of cell-based therapies, featuring different models / approaches that may be adopted by manufacturers to decide the prices of these therapies. An in-depth analysis of the cell-based therapy manufacturers, featuring three schematic representations; these include [A] a three dimensional grid analysis, representing the distribution of cell-based therapy manufacturers on the basis of the type of cells manufactured, scale of operation and purpose of production (in-house operations / contract manufacturing services), [B] a logo landscapes of cell therapy manufacturers based on the type of cells manufactured, geographical location (North America, EU and Asia Pacific) and the type / size of organization (non-industry players, and small-sized, mid-sized and large companies), and [C] a schematic world map representation, highlighting the geographical locations of cell therapy manufacturing facilities of industry and non-industry stakeholders. A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry’s evolution, under a comprehensive SWOT framework. It also includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall market. A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in development and / or manufacturing of cell-based therapies. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as increase in number of clinical studies, target patient population, anticipated adoption of cell-based therapies and expected variation in manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2018-2030. In addition, to account for the uncertainties associated with the manufacturing of cell-based therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy) Tim Oldham (Chief Executive Officer, Cell Therapies) Gerard MJ Bos (Chief Executive Officer, CiMaas) Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified

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Digital Health Market: Focus on Digital Therapeutic, Monitoring and Diagnostic Solutions, 2018-2030

Chronic disorders, such as diabetes, heart disease, obesity, mental health problems and insomnia, are considered to be the leading causes of death and disability across the world. These are largely considered to be the consequence of unhealthy lifestyle choices and exposure to harmful disease stimulants. According to a 2018 report published by the Center for Managing Chronic Disease at the University of Michigan, more than 50% of the global population currently lives with some form of chronic disease. Projections indicate that the global prevalence of diabetes (considered to be one of the fastest-growing chronic disease indications), is around 451 million, and is expected to reach 693 million by 2025. In addition, the World Health Organization (WHO) estimates that, at present, 450 million people worldwide are suffering from some form of mental health problem and / or neurological disorder. The increasing prevalence of such clinical conditions has imposed a significant burden on the modern healthcare system. In the US, the cost burden related to such long-term clinical conditions has been estimated to be approximately 86% of the USD 3.2 trillion that is spent by the country on healthcare, each year. Digital healthcare, a relatively new concept that emerged only a few years ago, is believed to possess the potential to address the rising concerns related to the growing socio-economic burden. Driven by the demand for self-management approaches, personalized healthcare solutions and customized treatment regimens made available in the home-care setting, digital health companies are presently engaged in developing several innovative solutions for therapeutic, surveillance and diagnostic use. Various digital therapeutics, through behavioral and psychological interventions, have been designed to have a direct impact on the chronic clinical conditions by providing motivational support and encouraging patients to make better lifestyle choices. Such therapeutics are available in a variety of gaming solutions, standalone software applications or combinations of the aforementioned solutions with personal coaching support, artificial intelligence (AI) support and medical device(s). A number of digital therapeutics have already been marketed and a significant proportion of such candidate therapies are in R&D phase. In order to introduce such unconventional products into the market, companies have followed multiple approaches, which include both B2B and B2C variants. It is also worth highlighting that certain companies are even attempting to offer reimbursements for their proprietary products by conducting clinical trials in order to establish therapeutic credibility and convince insurance providers and payers. Significant advancements have also been made towards the development of novel solutions for remote monitoring and diagnosis of chronic disorders. Such solutions have been developed to provide healthcare assistance in real-time through smartphone applications and connected devices. These solutions vary significantly in complexity and range from simple solutions capable of tracking weight loss, blood pressure, body temperature and heart rate to more sophisticated solutions that are equipped to independently conduct blood tests to confirm the presence of a bacterial / viral infection.   Scope of the Report The ‘Digital Health Market: Focus on Digital Therapeutic, Monitoring & Diagnostic Solutions, 2018-2030’ report features an extensive study of the current landscape and future outlook of the growing market for digital therapeutics, monitoring and diagnostic solutions that are either commercialized or under development within the healthcare industry. This burgeoning field presently offers a lot of opportunities to innovation focused start-ups and investors. Amongst other elements, the report features: A discussion on the current market landscape of digital therapeutics, monitoring and diagnostic solutions, featuring information on the various developers of digital solutions, along with information on their type of solution offered, primary disease area, mechanism of action, purpose of solution, status of development (discovery, research / development, approved and marketed), launch year (if applicable) and business channels being used by stakeholders in this domain. Detailed profiles of some of the emerging players in the industry, highlighting their current focus area(s), information on digital solutions offered and clinical research results (wherever available). Each profile also includes a section on recent developments and a comprehensive future outlook, highlighting the achievements, partnerships / collaborations, and the likely strategies that may be adopted by these players for future growth. A comprehensive product competitiveness analysis of digital therapeutics for the most popular therapeutic areas taking into consideration the product portfolio (based on the total number of digital therapeutics being developed in that disease area) and key specifications of the solution, such as disease management support, user motivation features, tracking of health data and others. A case study highlighting the focus area and results of clinical trials that have been conducted for the evaluation of various digital therapeutics. An analysis of funding and investments made into companies involved in this segment of the overall healthcare industry; the analysis covers information on seed financing, venture capital financing, debt financing, other equity financing and grants / awards received by these companies. An analysis of the partnerships that have been forged between companies in this domain in the recent past, covering clinical trial collaborations, product development and commercialization agreements, pilot product offerings, product integration and other relevant agreements. A detailed case study highlighting the various business models and go-to-market strategies adopted by companies involved in this space. It provides details on various channels being adopted by stakeholders in the industry to increase awareness and offer access to their proprietary products. A SWOT analysis capturing the key parameters and trends that are likely to influence the future of digital therapeutics market. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on multiple parameters, such as prices of digital solutions, indication / region specific adoption trends, distribution channels and competitive landscape, we have provided an informed estimate on the likely evolution of digital therapeutics and digital monitoring / diagnostic solutions till 2030. We have segmented the market by therapeutic areas (such as metabolic disorders, mental health disorders, cardiovascular disorders, substance use disorders, neurological disorders, chronic pain disorders, sleep disorders and respiratory disorders), distribution channels (B2C (patients) and B2B (healthcare providers, payers, employers and pharmaceutical companies)), purpose of solution (therapeutic or preventive), focus of solution (medication replacement or medication augmentation), type of solution (standalone software applications and software application + device or AI or personal coach) and key regions across the globe (North America (the US and Canada), Europe (Germany, France, Italy, the UK, Russia, and Spain), Asia-Pacific (China, Japan, India, Australia and South Korea) and rest of the world. In order to account for the uncertainties associated with the development of digital therapeutics and novel diagnostic / monitoring solutions and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Adam Kaufman (Canary Health), Amelie Janson (Voluntis), Prayat Shah (Co-founder, Vice President, Partnerships, Wellthy Therapeutics) and Reshma Nayak (Vice President, Marketing and Communications, Wellthy Therapeutics), Stephanie Tilenius (Vida Health) and Vijay Ravindran (Floreo). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Computer-Aided Drug Discovery Services Market, 2018-2030

The early stages of research related to drug discovery, including the identification of a relevant biological target and a viable lead compound, play a crucial role in the overall success of a drug candidate in preclinical and clinical studies. It is also worth noting that the process of drug discovery is extremely demanding, both in terms of capital requirements and time. Moreover, there is always a high risk of failure associated with R&D programs and, considering the increasing regulatory stringency, the approval of new drugs has become significantly more difficult. Given the increase in complexity of the drug discovery process, the overall R&D spending in the pharmaceutical / biotechnology sector has grown from around USD 128 billion in 2008 to USD 158 billion in 2017. As a result, the industry is currently under tremendous pressure not only to meet the expectations of a growing patient population, but also to identify ways to mitigate the risks associated with novel drug discovery programs to avoid failure. Over the years, various computational tools and services have emerged, enabling the selection, modeling, analysis and optimization of potential lead candidates. The predictive power of computer-aided drug discovery (CADD) has proven to be extremely advantageous, allowing researchers to bypass the random screening of billions of molecules across hundreds of biological targets. As a result, players offering novel in silico drug discovery services, such as CADD, have now become an integral part of the pharmaceutical industry. According to industry experts, almost 30% of the total cost and time invested in developing a new drug can be saved by utilizing such services. Owing to the significant cost benefits offered by such approaches, the adoption of CADD is anticipated to increase in the coming years. Furthermore, the growing number of drug discovery projects, coupled to their rapid progression through various stages of drug discovery, is expected to continue to create an increasing demand for computational services. Scope of the Report The ‘Computer-Aided Drug Discovery Services Market, 2018-2030’ report features an extensive study on the current landscape and the likely future potential of the players providing CADD services for drug discovery. The study provides an in-depth analysis, highlighting the capabilities of a diverse set of companies that offer such services across different stages of drug discovery, such as target identification, target validation, hit generation, hit-to-lead and lead optimization. Amongst other elements, the report features: An overview of the current market landscape, featuring a comprehensive list of over 120 players that offer CADD services, and detailed analysis based on a number of parameters, such as the location of headquarters, employee count, type of business model used (contract service providers, software / technology providers and consulting service providers), number of drug discovery step(s) for which the company offers CADD services (target identification, target validation, hit generation, hit-to-lead and lead optimization), type of molecule(s) (biologics and small molecules), type of clientele (pharmaceutical / biotechnology companies and academic / research institutes), CADD approach adopted (structure-based drug design,  ligand-based drug design and fragment-based drug design) and type of CADD service(s) offered (docking, molecular modeling and virtual screening etc.). In addition, the report features a year-wise analysis of the number of players that have been established over the past three decades. An analysis of the most active regions based on the presence of CADD service providers; the report contains a schematic world map representation indicating the geographical location of key hubs with respect to outsourcing activity within this domain. A logo landscape of the industry players engaged in this domain, distributed on the basis of the location of their respective headquarters and company size (very small-sized (50 employees) and large (>200 employees)). Elaborate profiles of established players that offer a comprehensive range of CADD services and have received funding in the past two decades. Each profile provides an overview of the company, its financial performance (if available), funding information (if available), information on its CADD specific service(s) portfolio, and a comprehensive future outlook. In addition, each profile features a peer group-based benchmark comparison matrix for the players based on several parameters, such as the number of CADD service(s) offered, number of drug discovery step(s), type of molecule(s), type of clientele and experience of the company. Tabulated profiles of emerging players (mid-sized companies or start-ups, established after 2012), featuring details on company headquarters, year of establishment, number of employees, key executives, funding information (if available), CADD serviceportfolio, CADD technology(if any), key developments related to CADD (if any) and business strategy. An analysis of investments made in this domain; these include seed financing, venture capital financing, debt financing, equity crowdfunding and grants / awards received by the companies that are operating in this area. An elaborate valuation analysis of companies involved in providing CADD services to the pharmaceutical / biotechnology industry. For this purpose, we have focused only on companies that have received funding in the past two decades, and built a multi-variable dependent model to estimate the current valuation of the aforementioned players. A detailed analysis of the cost saving potential in the drug discovery process that can be brought about by the adoption of CADD. A discussion on the upcoming computational approaches (such as artificial intelligence and cloud computing) that are being adopted for drug discovery and are likely to impact early stage research over the coming years. One of the key objectives of this report was to evaluate the current opportunity and the future potential of the CADD market over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the future opportunity based on [A] regional evolution of the market covering key geographies, such as North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), and Asia-Pacific (China, India and Japan), along with the rest of the world, [B] key step(s) of drug discovery (target identification, target validation, hit generation, hit-to-lead and lead optimization), [C] type of molecule(s) (biologics and small molecules), [D] type of sponsor (pharmaceutical / biotechnology companies and academic / research institutes) and [E] therapeutic areas. Considering the uncertainties associated with the growth of CADD market, and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Edelmiro Moman (Scientific Consultant and Teacher, ProSciens), John L Kulp (Chief Executive Officerand Chief Technical Officer, Conifer Point Pharmaceuticals), Mark Whittaker(Senior Vice President, Evotec), and Sven Benson (Founder, candidum). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Subcutaneous Biologics, Technologies and Drug Delivery Systems (2nd Edition), 2018-2030

Biologics constitute a majority of the top selling drugs of today and also represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, the share of biologics in the overall pharmaceutical market has increased from 16% in 2006 to over 25% in 2017.Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.Despite their clinical and commercial success, biopharmaceutical products are associated with high development costs, which are evidently reflected in their prices. Moreover, such therapies are usually designed for intravenous administration, which require a clinical setting (hospitals / infusion centers) for dosing; this further adds to the overall treatment cost. Of late, the subcutaneous route of administration has emerged as a promising and viable approach for the parenteral delivery of biologic drugs. Owing to several compelling advantages, such as patient convenience, potential for self-administration, better therapy adherence and reduced healthcare costs, the concept is steadily gaining traction within the healthcare industry. Given the robust pipeline of biologics, which include monoclonal antibodies, vaccines and other protein-based therapeutic products, subcutaneous delivery options are being investigated for various clinical candidates across different phases of development. In fact, several approved therapeutic products that are currently delivered intravenously are also being reformulated and evaluated for subcutaneous administration in order to improve their adoption, and for life cycle management of drugs nearing patent expiry. In addition, several drug delivery devices that can be used for self-administration have been developed, and many others are under development. Some of the most popular self-administration enabling devices include large volume wearable injectors, autoinjectors, pen injectors, needle free injectors and prefilled syringes. In fact, these innovative drug-device combination products have witnessed high adoption rates over the past few years and have brought about marked improvements in adherence to prescribed therapeutic regimens. Further, to overcome the limitations and challenges associated with the delivery of subcutaneous formulations, several novel technology platforms have been developed to enable the delivery of (highly) viscous formulations. The rising incidence of chronic clinical conditions (which are characterized by the need for frequent medications) and continuous efforts of therapy / device developers in this field are anticipated to drive the overall growth of this market in the coming years.   Scope of the Reoprt The ‘Subcutaneous Biologics, Technologies and Drug Delivery Systems (2nd Edition), 2018-2030’ report provides a comprehensive study on the current market landscape and future potential of biologics designed for subcutaneous administration. In addition, the study provides an in-depth analysis of the formulation technologies and drug delivery systems (focusing on large volume wearable injectors, autoinjectors, pen injectors, needle free injectors, prefilled syringes, drug reconstitution systems and implants) that enable subcutaneous delivery of the aforementioned drugs. Amongst other elements, the report features the following: A detailed assessment of the current market landscape of commercially available biologics that are designed for delivery via the subcutaneous route, along with information on the developer(s), type of molecule, target indication / therapeutic area, approval year, dose strength, treatment regimen and available dosage forms. The study also includes comprehensive case studies on leading subcutaneous biologics, featuring details on annual sales, mechanisms of action, development histories, technology platforms (if available), and a comparison of their intravenous and subcutaneous formulations (if applicable). An in-depth analysis of the various subcutaneous biologics that are currently under clinical development, with information on the developer(s), phase of development, type of molecule, and target therapeutic area. A review of various innovative technology platforms that are used for the formulation of drugs for subcutaneous delivery, highlighting their key features and providing information on their developers, mechanisms of action and advantages. The study also includes an insightful three-dimensional analysis of the technology platforms that are presently engaged in developing drug formulations for subcutaneous delivery, comparing them based on pipeline strength (in terms of marketed / under development drugs based on the technology), supplier power (in terms of year of establishment and size of employee base) of the developer and number of collaborations established related to the technology. A detailed benchmark analysis of technology providers that are based in North America and Europe, highlighting the advantage(s) of their proprietary technology platforms, applicability to other types of molecules, and other possible modes of drug delivery. Elaborate profiles of key technology providers, featuring overview of the companies, a review of their proprietary technologies, mechanisms of action, key advantages, list of product candidates developed using the technology, recent developments related to the technology (funding and collaborations) and a comprehensive future outlook. An in-depth review of the most advanced and popular subcutaneous drug delivery systems, focused on large volume wearable injectors, autoinjectors, pen injectors, needle free injectors, prefilled syringes, drug reconstitution systems and implants, providing information on their developer(s) and device specifications / features. Details of specific parameters captured for different device categories are mentioned as follows: Large volume wearable injectors: Type of device (infusion pump and patch pump), type of dose delivered (continuous and bolus), volume of drug container / storage capacity (in mL), usability (disposable and reusable) and stage of development (commercialized and under development). Autoinjectors: Type of drug container (syringe, cartridge and others), usability (disposable and reusable), mechanism of action (automatic, semi-automatic and manual), volume of the drug container (in mL) and dosage type (fixed dose and variable dose). Pen injectors: Usability (disposable and reusable), volume of the drug container (in mL) and dosage type (fixed dose and variable dose). Needle free injection systems: Type of technology (jet, spring and gas), usability (disposable and reusable) and drug volume delivered (in mL). Prefilled syringes: Type of syringe (glass and plastic). Drug reconstitution systems: Type of device (dual chambered systems and other novel systems), type of container (cartridge and others) and usability (disposable and reusable). Implants: Type of material (silicone, titanium, polymers and others), target therapeutic indication, type of implant (biodegradable and non-biodegradable), treatment duration, type of drug delivered, dose strength and stage of development. A comprehensive product competitiveness analysis of large volume wearable injectors and subcutaneous autoinjectors taking into consideration the supplier power (based on size of employee base) and product specifications. A discussion on affiliated trends, key drivers and challenges, under a SWOT framework. The analysis features a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall subcutaneous products market. One of the key objectives of this study was to understand the primary growth drivers and estimate the future potential of the market. Based on historical trends and sales related information for subcutaneous biologic drugs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have segmented the market based on [A] therapeutic areas (autoimmune disorders, metabolic disorders, blood disorders, bone disorders, oncological disorders, genetic disorders, neurological disorders, respiratory disorders and others) and [B] molecule type (proteins, peptides (recombinant), monoclonal antibodies, other antibody based products, cell / gene therapies and vaccines). In addition to the market forecast for subcutaneous biologic drugs, we have also provided an 8-year forecast for subcutaneous delivery systems, covering large volume wearable injectors, autoinjectors, prefilled syringes and drug reconstitution systems. Further, we have also forecasted the revenues that subcutaneous formulation technology developers are likely to generate through licensing agreements; for this, we have provided a view on the likely upfront payments and milestone payments that will be involved in the deals signed or planned with an aim to develop subcutaneous formulation of biologics. To account for the uncertainties associated with the growth of the subcutaneous formulation technologies market, we have provided three forecast scenarios, portraying conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. This enabled us to solicit inputs on upcoming opportunities and challenges that were considered to develop estimates for a more inclusive growth. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals: David Daily (Chief Executive Officer & Co-Founder, DALI Medical Devices) Deborah Bitterfield (Chief Executive Officer and Founder, Lindy Biosciences) Frederic Ors (Chief Executive Officer, Immunovaccine Technologies) Matthew Young (Founder & Chief Technology Officer, Oval Medical Technologies) Menachem Zucker (Vice President & Chief Scientist, Elcam Medical) Michael Reilly (Chief Executive Officer & Co-Founder, Excelse Bio) Michael Hooven (Chief Executive Officer, Enable Injections) Poonam R Velagaleti (Co-Founder, i-novion) Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services) and Graham Reynolds (Vice President & General Manager, Global Biologics, West Pharmaceutical Services) David Heuzé (Communication Leader, MedinCell) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Parkinson's Disease Market: Pipeline Review, Developer Landscape and Competitive Insights

Parkinson’s disease is a chronic disorder that gradually leads to progressive deterioration of motor functions due to loss of dopamine-producing brain cells. It is presently the second most common neurodegenerative disease (after Alzheimer’s disease) and is characterized by symptoms such as shaking, rigidity, difficulty in walking / movement, and several other cognitive and behavioral problems. Parkinson’s disease is known to affect 1-2 per 1,000 individuals and has been shown to impact approximately 1% of the population aged above 60 years. It is also worth highlighting that, every year, nearly 60,000 Americans are diagnosed with Parkinson’s. The disease has been estimated to incur combined direct and indirect costs of close to USD 25 billion in the US annually. With increasing disease prevalence and the corresponding growth in socioeconomic burden, the field faces a pressing need for accurate diagnostic (predictive) tests, and efficient treatment options for slowing the progression of the disease. Despite the availability of several types of dopamine agonists, there still are a myriad of motor and non-motor symptoms that currently available therapies are unable to treat. The unavailability of neuroprotective therapies remains one of the prime unmet needs in this domain. The disease is highly complex and is known to render any single therapeutic approach inadequate to deal with its multifaceted etiopathogenesis. Currently, several stakeholders in the pharmaceutical industry are engaged in efforts to advance the development of various types of disease modifying pharmacological interventions, therapies to offer symptomatic relief and drugs to try to cure the disease as well. In fact, there are multiple initiatives established by start-ups that are being backed by venture capital funding to expedite the development of potential therapeutic options for better disease management.   Scope of the Report The “Parkinson’s Disease Market: Pipeline Review, Developer Landscape and Competitive Insights"  report provides an extensive study on the marketed, clinical and preclinical molecules being investigated for the treatment of Parkinson’s disease. Figure 1 summarizes the scope of the report and the specific modules that have been covered in extensive detail. Figure 1 Parkinson’s Disease: Scope and Competitive Insights Amongst other elements, the report includes: A detailed assessment of the current market landscape of drugs being developed for the treatment of Parkinson’s disease, providing information on drug developer(s), phase of development (clinical, preclinical / discovery stage) of product candidates, type of molecule (small molecule, biologic or gene / cell therapy), treatment type (disease modifying agent, drugs offering symptomatic relief or drugs for curing the disease), mechanism of action, and route of administration. An in-depth analysis of the product pipeline and developer companies, featuring four schematic representations; these include [A] a heptagon representation highlighting the distribution of the marketed and development stage molecules based on their mechanisms of action, [B] a 2X2 grid analysis, representing the distribution of drug candidates across various molecule types and stages of development, [C] a funnel analysis highlighting the distribution of molecules (segregated by stage of development) based on route of administration and treatment type, and [D] a logo landscape of the various industry players involved in the development of drugs, distributed on the basis of location of headquarters and company size (small-sized, mid-sized and large). An analysis highlighting the key unmet needs across Parkinson’s disease, featuring insights generated from real-time data on unmet needs as identified from social media posts, recent publications, patient blogs and the views of key opinion leaders expressed on online platforms. Comprehensive profiles of drugs in phase III of clinical development, with information on the developer, specific target patient population, mechanism of action, clinical trials, current status of development, and recent developments (if available). An insightful competitive analysis, highlighting the key players in the domain on the basis of the strength of their development portfolio. For all companies that emerged as important players in this field, we have presented a five-dimensional spider web analysis,  taking into account the company’s size, activity on Google Trends, stage of development of lead molecule, strength of the Parkinson’s disease pipeline and the (present) number of clinical trials being conducted by the player. A detailed analysis of the mergers and acquisitions that have taken place in this space, highlighting the trend in the number of companies acquired in the last few years, along with the geographical distribution of this activity. The analysis features an ownership change matrix and presents a financial evaluation of these deals (revenues and respective deal multiples) as well. A detailed analysis identifying the key opinion leaders (KOLs), featuring a 2X2 analysis to assess the relative experience of certain KOLs who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers involved in the development of molecules in this domain. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in development of anti-Parkinson’s therapeutics. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered from both secondary and primary sources. The opinions and insights presented in this study were influenced by inputs (through a comprehensive survey) of several key players in this domain. All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Global Autoinjectors Market (2nd Edition), 2018-2030

Over the years, the self-injection devices market has grown into a promising segment of the pharmaceutical industry. The domain is presently characterized by the presence of advanced technology platforms and innovative devices, offering a variety of user-friendly drug delivery solutions. One of the major driving forces behind the growth in this field is the rising incidence of chronic clinical conditions, such as rheumatoid arthritis, multiple sclerosis and diabetes. Although various pharmacological interventions are available for the treatment of these conditions, they require parenteral administration, frequent hospital visits, and are associated with multiple concerns, such as dosing and medication errors, risk of microbial contamination and needlestick injuries. However, therapies developed in combination with self-administration enabling devices have witnessed high adoption rates and have actually resulted in marked improvements in adherence to prescribed therapeutic regimens. In addition, such devices have been widely utilized in the treatment of emergency conditions such as anaphylaxis and other allergic disorders. Since the introduction of the first autoinjector device in 1980s, their numerous benefits, such as ease-of-use, reduced chances of dosing errors, integrated safety mechanisms, and almost negligible risk of needlestick injuries, have been widely recognized among consumers and healthcare service providers. Autoinjectors are also considered to be potential life cycle management tool. Drugs nearing patent expiry can be developed for delivery using an autoinjector and retain market exclusivity as a combination product. Lyophilized Enbrel® is a well-known example; it was reformulated for delivery as a liquid formulation in the Sureclick™ autoinjector, extending its patent age by almost 11 years. It is worth highlighting that such devices have captured the interest of several stakeholders in the industry. Various initiatives are underway to further improve safety, add better features (such as controlled-release capabilities) and make these devices more patient-friendly. In fact, between January 2013 and December 2017, close to 3,800 patents were filed in this domain, indicating the rapid pace at which research is being carried out. We believe that such efforts are likely to boost the overall growth of this market in the coming years.   Scope of the Report The ‘Global Autoinjectors Market (2nd Edition), 2018-2030’ report provides a comprehensive analysis of the current state of the autoinjectors market and the likely future evolution of these devices over the next decade. The study presents an in-depth analysis of a diverse set of companies that are engaged in this domain across different regions of the globe. Amongst other elements, the report includes: A review of the overall landscape of the autoinjectors market, highlighting the contributions of industry players and the key device specifications, including the primary drug container used, its volume, usability of the device, route of administration, indication and targeted drugs. An in-depth patent analysis to provide an overview on how the industry has evolved from the R&D perspective. For this analysis, we looked at the patents that have been published since 2013. The analysis also highlights key information associated with these patents, such as patent type, regional distribution, CPC classification, IP litigations, emerging areas and leading industry players. A comprehensive product competitiveness analysis of disposable and reusable autoinjectors taking into consideration the supplier power (based on size of employee base) and product specifications, such as route of administration, primary drug container used, mechanism of operation, dosage type and user friendliness. Comprehensive profiles of autoinjector manufacturers that have more than three devices in their respective product portfolios; each profile features an overview of the company, its financial information (if available), information on its product portfolio, autoinjector device specifications, collaborations, recent developments and a comprehensive future outlook. Additionally, the report includes brief profiles of emerging players that have been established in the past decade. Detailed case studies on the most commonly targeted indications, covering history of development and detailed description of the approved autoinjector products, along with their respective mechanisms of action and historical sales records. In addition, we have listed all the drugs that are currently being delivered through autoinjectors. A list of marketed and pipeline candidates that are likely to be developed in combination with autoinjectors in the near future; the candidate drugs / therapies were selected based on various parameters, such as their current route of administration, target therapeutic indication and dosage. For the purpose of this analysis, we collated a list of over 100 top-selling marketed drugs, which were initially screened on the basis of route of administration (subcutaneous / intramuscular). Additionally, we reviewed over 900 clinical trials and compiled a list of pipeline molecules that are being investigated for delivery via the aforementioned routes. The likelihood of delivery via autoinjector device in the future was estimated by assigning a specific score (weight) to each parameter. A SWOT analysis capturing the key parameters and trends that are likely to influence the future of autoinjectors market. One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for autoinjector devices. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market over the period 2018-2030. The report provides sales forecasts for the overall autoinjectors market with detailed market segmentation on the basis of indication (anaphylaxis / multiple sclerosis / rheumatoid arthritis / migraine / diabetes / other indications), route of administration (subcutaneous / intramuscular), usability (disposable / reusable) and the geographical distribution of the market (North America / Europe / Asia Pacific / rest of the World). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent three different tracks of the industry’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with David Daily (CEO and Co-founder, DALI Medical Devices), Tsachi Shaked (Senior Marketing and BD Director, Injectable Drug Delivery Devices, Elcam Medical) and Douglas Marenzi (Managing Director, PHC). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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New Frontiers in Cancer Therapies: Focus on Transcription Factors, GTPases, Phosphatases and GPCRs, 2018-2030

Cancer therapeutics continues to be one of the most active segments, in terms of drug development efforts, within the pharmaceutical industry. In fact, in the past five years, USFDA has approved more than 70 drugs for the treatment of different types of cancer. However, there is still a pressing need to develop more specific and potent therapeutics to combat this complex, life threatening clinical condition. According to the National Institutes of Health, the economic burden of cancer care in the US was estimated to be over USD 147 billion in 2017. As the global population continues to increase, the number of cancer patients is likely to rise as well; by 2030, it is estimated that about 21.6 million people are likely to be newly diagnosed with the disease. Thereby, the overall global economic burden related to the disease is anticipated to increase significantly in the foreseen future. Conventional cancer treatments, such as chemotherapy and radiation therapy are associated with several side effects. Their non-specific nature has been shown to have severe detrimental effects on patients’ quality of life. Current drug development initiatives are focused on targeted therapies against specific oncogenic mutations that are responsible for disease development and / or progression. Over the years, several targeted drugs have been designed against specific proteins, such as human epidermal growth factor (HER2), BCR-ABL protein kinase and vascular endothelial growth factor (VEGF). However, certain biological targets have long eluded drug development efforts and, for a considerable period of time, have been reported to be undruggable. One such target is Ras family, which has been identified to a play critical role in oncogenesis. Scientific literature suggests that the RAS gene is mutated across about 30% of cancer types; the mutation is known to be present in about 90% of pancreatic cancers, over 50% of colorectal cancers and 35% of lung cancers. Likewise, there are several other targets that have not yet been successfully drugged and researchers are making significant efforts to identify novel approaches to target them. Advances in drug discovery and development technologies / platforms have increased the likelihood of targeting a number of the abovementioned types of biological targets. As a result, novel product development opportunities have emerged and are likely to benefit both drug developers and investors alike. Ongoing R&D is focused on the development of treatment modalities that can also combat complications, such as off target toxicities and disease relapse, which are associated with the current standard of care therapies. As various clinical stage candidates progress towards advanced stages of development, we expect the market to witness aggressive growth over the coming years.   Scope of the Report The ‘New Frontiers in Cancer Therapies: Focus on Transcription Factors, GTPases, Phosphatases and GPCRs, 2018-2030’ report provides a comprehensive study on the current market and therapeutic potential of the various pharmacological interventions designed against difficult-to-modulate cancer targets. It features an elaborate discussion on the future potential of this evolving domain, focusing on phosphatases, transcription factors, small GTPases (specifically Ras family) and undruggable G-protein coupled receptors (GPCRs). One of the key objectives of the study was to review and quantify the future opportunity for the ongoing product development programs of both small and big pharmaceutical firms. Amongst other elements, the report features: A detailed assessment of the current market landscape of drugs being developed against various undruggable cancer targets, featuring information on the developer, phase of development (clinical, preclinical or discovery stage) of product candidate(s), information on type of molecule(s), biological target(s), mechanism of action, route of administration, and key therapeutic indication(s). Elaborate profiles of key companies (selected based on pipeline strength); each profile features an overview of the company, details on it product portfolio, technology overview (wherever applicable), detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical trial information and recent developments) and a comprehensive future outlook. A section on emerging technologies and platforms that are aiding the development of therapies capable of targeting biological molecules which were previously considered as undruggable. A detailed publication analysis on more than 70 research articles that have been published between January 2014 and March 2018, highlighting the key focus areas (biological targets and indications) of the ongoing research activity in this field. An analysis of the partnerships that have been established in this domain in the recent past, covering R&D agreements, license agreements, clinical trial collaborations, mergers and acquisitions, and other relevant agreements. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. A compilation of key insights derived based on various parameters; these include [A] a bull’s eye analysis highlighting the distribution of pipeline candidates in terms of phase of development, type of target family and type of molecule [B]a three-dimensional and five-dimensional spider web analyses of candidate therapeutics based on different parameters, namely number of publications, grants awarded to promote development, active clinical trials, current phase of development and the number of companies developing drugs against various undruggable targets, and [C] a world map representation, depicting the most active geographies in terms of the presence of companies developing drug candidates against difficult-to-modulate cancer targets. One of the key objective of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to long-term, for the period 2018 to 2030. To account for the uncertainties associated with the development of cancer therapeutics and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Amotz Shemi (CEO, Silenseed), Brian Frenzel (President and CEO, Tosk), Miguel Vega (CEO, Allinky Biopharma) and Stephen Franklin (CEO, Evgen Pharma). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Bioavailability Enhancement Technologies and Services Market, 2018-2030

Low bioavailability is one of the primary concerns associated with marketed drugs; in fact, various studies indicate that around 40% of available drugs are poorly bioavailable / soluble. As the drug developers shift their focus towards development of lipophilic drug compounds, the issue with aqueous solubility / bioavailability of the drugs is likely to increase further. It is estimated that around 90% of NCEs belong to BCS class II and IV, which are known to be associated with low solubility / permeability. Given that a large number of drugs fail to reach the market due to poor bioavailability, the industry is looking for various tools / methods to mitigate this challenge. Moreover, as many companies seek to re-formulate existing product candidates that exhibit poor bioavailability (via the 505(b)(2) pathway), the demand for novel bioavailability enhancement methods has grown significantly. To cater to this increasing demand, several contract manufacturers and technology providers have emerged in this domain. With more than 150 companies offering technologies / services for bioavailability enhancement, the market is highly fragmented; having said that, several mergers / acquisitions have also taken place as stakeholders strive to broaden their respective service portfolios. A number of players have developed novel, state-of-the art technologies to maintain a competitive edge in this rapidly emerging market. As drug developers continue to evaluate novel drug targets and classes, the bioavailability enhancement domain is expected to grow at a steady pace. In fact, since 2010, more than 4,000 articles, evaluating various bioavailability enhancement technologies have been published across several reputed journals. In addition, more than 6,000 patents have been filed post 2010, providing a significant scientific push to the development of novel approaches.   Scope of the Report The ‘Bioavailability Enhancement Technologies and Services Market, 2018-2030’ report provides a comprehensive study on the current scenario of technologies and contract services related to bioavailability enhancement. The study features an elaborate discussion on the novel approaches adopted by different players offering solutions for altering the bioavailability of various drugs. Amongst other elements, the report features: An overview of the current market landscape, featuring a comprehensive list of over 150 active contract services / technology providers, and a detailed analysis based on a number of parameters, such as geographical location of the company, approach adopted for bioavailability enhancement (size reduction, solid dispersion, lipid based methods and other novel approaches), type of dosage forms (solid, liquid, semi-solid, others), route of drug administration (oral, injectable, inhalation and topical). Elaborate profiles of key players (identified on the basis of the breadth of their respective service portfolios) that are offering bioavailability enhancement services. Each profile features an overview of the company, its financial performance (if available), services portfolio, recent collaborations and the future outlook of the company. An analysis of ongoing clinical studies evaluating the bioavailability of various drug compounds. The chapter features a comprehensive view on the focus areas of these clinical studies, highlighting the key players involved. A review of the published scientific literature on bioavailability enhancement technologies, highlighting the heightened research activity and the focus areas of research groups across different types of bioavailability enhancement technologies. A detailed analysis of over 6,000 patents that have been filed related to bioavailability enhancement technologies. The study presents a high-level view on the valuation of these patents and also highlights the emerging trends related to the innovation in this domain. An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements, mergers and acquisitions, co-service agreements, manufacturing and service agreements, and other relevant types of deals. A comprehensive benchmark analysis, highlighting the key focus areas of small, mid-sized and large sized companies; the benchmark analysis provides a means to compare the existing capabilities within respective peer groups and help industry stakeholders identify ways to achieve a competitive edge over contemporary players. A detailed estimation of the likely demand for bioavailability enhancement technologies / services. It provides a comprehensive view, in terms, of the annual number of projects, that are likely to require bioavailability enhancement over the period 2018-2030. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as likely number of candidates in BCS II and IV, likely adoption rates of bioavailability enhancement approaches, expected trend in outsourcing and likely pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. To account for the uncertainties associated with the expected future demand and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Next-Generation Batteries Market: Focus on Lithium Polymer, Printed, Solid-state, Thin Film and Ultra-thin Batteries, 2018-2030

Batteries are considered amongst the most remarkable man-made inventions in history and have been the focus of intense investigation by both scientists and engineers across the globe. Evolving from the primitive Voltaic Pile (the first electrical battery created in 1799), which used zinc and copper electrodes and brine-soaked paper as an electrolyte, a wide range of batteries are now available in the market. Amongst these, lithium-ion (Li-ion) batteries have long been considered a breakthrough in the battery landscape, resulting in revolutionary growth in the chargeable consumer electronics industry. It is estimated that, at present, more than one billion rechargeable Li-ion cells are produced each year to cater to the demands of the portable electronics market alone. However, despite thier successful market deployment, excellent energy density and cost-effectiveness, certain limitations, such as concerns related to the use of liquid electrolytes (risk of leakage and flammability), have also been associated with Li-ion batteries. A case-in-point being Samsung’s massive global recall of its Galaxy Note 7 series of mobile phones in September 2016, due to the safety issues associated with the Li-ion batteries used in them. It is also worth highlighting that a wide variety of niche and disparate application areas, such as miniature medical devices, smart wearables, wireless sensors / IoT devices, radio frequency identification (RFID) tags, powered smart cards, cosmetic patches, smart labels / packaging, electric / hybrid vehicles, and energy storage systems have surfaced in the past few years. Most of these advanced technology-enabled applications require new form factors and designs that conventional Li-ion batteries are unable to provide, pertaining to their size and safety limitations. These drawbacks have opened the door to immense innovation opportunities and added a new dimension to the competition amongst global battery developers, resulting in the establishment of next-generation battery technologies. In contrast to the conventional Li-ion batteries, next-generation product chemistries, which include lithium polymer, printed, solid-state, thin film and ultra-thin films batteries, have been proven to be safe under abusive conditions, demonstrated significant improvements in terms of overall performance, and are environmental-friendly. Moreover, owing to their flexible form factor, it is believed that these batteries can offer virtually limitless flexibility in term of design, materials and construction. At about 1/10th of the thickness of the thinnest prismatic liquid Li-ion cells, next-generation batteries have demonstrated significant potential to serve various upcoming markets. As a result, these batteries have captured the interest of several stakeholders in this industry; in fact, since 2010, over 7,000 patents have been published on next-generation battery technologies. It is anticipated that as the market becomes more mature, it is likely to benefit from economies of scale, resulting in further performance improvements and cost reductions.   Scope of the Report The ‘Next-Generation Batteries Market, 2018-2030’ report features an extensive study of the current landscape and future outlook of the growing opportunities for next-generation batteries (beyond Li-ion). The focus of this study is on advanced battery chemistries that are currently being developed / have already been developed, such as lithium polymer (LiPo) batteries, solid-state batteries, thin film batteries, printed batteries and other advanced variation of Li-ion batteries, and the likely evolution of these novel concepts in the mid to long term. Backed by funding from several venture capital firms and strategic investors, this evolving market has its hopes pinned on the efforts of a significant number of start-ups, small-and mid-sized companies. Amongst other elements, the report features: A detailed assessment of the current market landscape, providing information on various types of next-generation batteries, their respective specifications (such as thickness, capacity, voltage, operating temperature, cycle life / shelf life and chargeability), and targeted application areas. Elaborate profiles of some of the leading players in the industry, highlighting the current focus of various companies, financial information, proprietary battery technologies and specific products. Each profile also has a section on recent developments, highlighting the achievements, partnerships / collaborations, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. An in-depth patent analysis to provide an overview of how the industry is evolving from the R&D perspective. For this analysis, we looked at the patents that have been published by various industry players since 2010, across different types of next generation batteries. The analysis also highlights the key trends associated with these patents, including patent type, regional distribution, CPC classification, IP litigations, emerging areas and leading industry players. A comprehensive benchmark analysis, highlighting the key focus areas of small, mid- and large-sized companies; primarily, it provides a means to compare the existing capabilities of companies within and beyond their peer groups, and help them identify ways to achieve a competitive edge over contemporary players. An analysis of investments made at various stages of product development; these include seed financing, venture capital financing, debt financing and grants / awards received by the companies that are operating in this area. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. We have provided an informed estimate on the likely evolution of the market for the period of 2018-2030 across several potential application areas of next-generation batteries, such as consumer electronics, electric vehicles, medical devices, powered smart cards / smart labels, RFID tags, smart wearables and wireless sensors / IoT devices. In addition, on the basis of the likely usability of different next-generation battery types across aforementioned applications, we have provided the distribution of the market across various types of batteries, such as lithium polymer, printed, solid-state, thin film, ultra-thin and other types of advanced Li-ion batteries. The forecast also includes distribution of the market opportunity across major regions of the globe, namely North America, Europe and Asia-Pacific. Considering the uncertainties related to investments and large-scale production of next generation batteries across different geographies, and to add robustness to our model, we have provided three forecast scenarios, representing the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: David A. Ainsworth (CEO, OXIS Energy) Graeme Purdy (CEO, Ilika) Jeff Sather (VP, Technology and Customer Solutions, Cymbet) Lisa Hsu (Spokesperson and Deputy Marketing Manager, ProLogium Technology) Pritesh Hiralal (CEO, Zinergy UK) Xiachang Zhang (Chairman, Enfucell) Yuan Yang (Assistant Professor, Columbia University, New York) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Pharmaceutical Spray Drying Market (2nd Edition), 2018-2028

The origins of spray drying can be traced back to 1872, when the first patent related to the technique was registered in the US. The first commercial use of this form of drying was reported in the 1920s when powdered milk was introduced into the market. Spray drying, which is already established in the food and chemical sector, is also considered to be a rapid, cost-effective, and scalable process for the production of dry powder formulations of pharmacological material. Owing to characteristics, such as reproducibility and its continuous mode of operation, the technique has become very popular in the pharmaceutical and biotechnology industry. It offers several advantages over alternate drying technologies, such as lyophilization (characterized by high dependence on cold chain for storage and logistics, which is prone to failure due to human error) and vacuum foam drying (characterized by volumetric restrictions due to the properties of foam, which limits the quantity of sample that can be dried in a single run) that are currently deployed in the pharmaceutical industry. Amongst other merits, spray drying is known to be suitable for drying heat-sensitive products such as biologics. Moreover, this method imparts improved properties to the formulations that can be administered through more efficient and less invasive modes of delivery, such as oral, and inhalation routes. The technology also aids in improving the compression properties of drugs, allowing developers to design concentrated dose variants of medications and reduce tablet size. Such alterations have the potential to improve patient compliance. Given the flexibility offered in terms of drug development and formulation, the economics of the technique, the introduction of aseptic methods, and the recent approval of the first spray dried biologic, Raplixa ®, the adoption of spray drying is anticipated to increase steadily in the pharmaceutical industry.   Scope of the Report The ‘Pharmaceutical Spray Drying Market (2nd Edition), 2018-2028’ report provides an extensive study on the use of spray drying in the pharmaceutical sector. The key focus of the report is primarily to estimate the future potential of spray drying in the manufacturing of APIs, inhalables, injectables, biologics and other pharmaceutical products. The study presents an in-depth analysis of a diverse set of companies that provide spray drying equipment and services across different regions of the globe.Amongst other elements, the report includes: A detailed discussion the applications of spray drying in the pharmaceutical industry; these include enhancement of solubility and bioavailability, formulation of inhalables, taste masking, development of controlled release formulations, and aseptic production of biopharmaceuticals. An assessment of the various players that are engaged in the manufacturing of spray dryers used in the pharmaceutical industry, including a detailed analysis of their products based on inlet temperature, type of nozzle (fluid, pressure, rotary disc, centrifugal and others), size of the dryer (lab, clinical and commercial) and atomizing gas (air, nitrogen and inert gases). An overview of the current market landscape of spray drying service providers, featuring an analysis based on the location of their operating facilities, type of spray dryers used, scale of operation (lab, clinical and commercial), information on cGMP status of their facilitiesand availability of fill / finish services. An insightful 2X2 analysis of different spray drying service providers. This analysis is based on the spray drying capabilities (represented in terms of number of manufacturing sites, scale of operation and the types of spray dryers used) and the company size. In addition, similar analysis has been done to compare the spray dryer manufacturers. This assessment is based on the company’s spray drying portfolio (number of spray dryers offered and availability of spray drying services), company’s year of establishment and the geographical coverage of its client base. Tabulated profiles of the players offering spray drying services, featuring company overview, service portfolio, spray dryers used, and key developments related to its spray drying capabilities. Detailed profiles of spray dryer manufacturers, featuring an overview of the company, its financial information (if available), types of spray dryers in their respective product portfolios, recent developments and a comprehensive future outlook. A case study on the lyophilization of biologics, highlighting the underlying process, its applications, and merits and demerits. It features a detailed list of companies offering lyophilization services with information on location of facilities, types of drug candidates lyophilized, scale of operation and the containment systems utilized for such operations. A detailed analysis of the mergers and acquisitions that have taken place in this space, highlighting the trend in the number of companies acquired in the last few years, along with the geographical distribution of this activity. The analysis highlights the ownership change matrix and presents financial evaluation of these deals (revenues and respective deal multiples). A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as trends in the pharmaceutical contract manufacturing industry, operation costs associated with spray drying and the challenges and opportunities presented by this technique, we have provided an informed estimate of the likely evolution of the market in the long term, for the period 2018-2028. In addition, we have provided insights on the likely regional evolution of the market in North America, Europe, Asia Pacific and the rest of the world. It also includes estimates regarding the likely distribution of the market based on type of industry (pharmaceuticals and biologics) and type of nozzles used in spray dryers (fluid nozzle, pressure nozzle, rotary disc atomizer, centrifugal nozzle, and others). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following key opinion leaders: Sam de Costa (Stabilization Projects Manager, Nova Laboratories) Manuel Leal (Business Development Director, Idifarma) Anonymous (Founder, India based Manufacturer) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Viral Vectors and Plasmid DNA Manufacturing Market (2nd Edition), 2018-2030

Genetically modified therapies have emerged as a promising treatment option for various diseases (primarily ones that currently have no cure), including cancers, inherited disorders and certain viral infections. These therapies have demonstrated the potential to treat chronic indications, such as Alzheimer’s disease, Parkinson’s disease and rheumatoid arthritis, as well. Gene therapies, and other therapies that require genetic modification, involve the introduction of therapeutic DNA / gene of interest into a patient’s body / cells. This process is accomplished by the use of vectors. Over the last few decades, various viral and non-viral vectors have been developed, optimized and standardized for this purpose. Currently, the most popular viral vectors, on the basis of their use in active clinical trials, are those based on AAV, adenovirus, lentivirus and retrovirus. On the other hand, among non-viral gene delivery tools, plasmid DNA has emerged as the preferred option. Plasmid DNA is also used in the development and production of viral vectors and DNA vaccines. Recent advances have led to the emergence of several other innovative viral / non-viral gene delivery approaches that are being utilized for development of various therapies that require gene modification.   Overall, eleven genetically modified therapies have been approved so far; these are (in the order of approval, most recent first) LUXTURNA™, YESCARTA™, Kymriah™, INVOSSA™, Zalmoxis™, Strimvelis™, Imlygic™, Neovasculagen™, Rexin-G®, Oncorine®, and Gendicine® . Amongst these, YESCARTA™ and Kymriah™ are T-cell based gene therapies that were recently approved by the FDA, in October 2017 and August 2017, respectively. In addition, over 430 gene therapy candidates are presently in different stages of clinical development, for which over 500 clinical studies are currently underway in various regions across the globe. The growing number of gene therapy candidates, coupled with their rapid progression through various phases of clinical development, is expected to continue to create an increasing demand for vectors.   Scope of the Report The “Viral Vectors and Plasmid DNA Manufacturing Market (2nd Edition), 2018-2030” report offers a comprehensive study of the current scenario of manufacturing of viral and non-viral vectors that are primarily used for the development of gene therapies and T-cell therapies. The study features an in-depth analysis, highlighting the capabilities of a diverse set of players, covering both contract manufacturers and companies with in-house capabilities. In addition to other elements, the study includes: An overview of the current status of the market with respect to the players involved in manufacturing viral vectors, non-viral vectors and other / novel vectors. It features information on the location of their manufacturing facilities, year of establishment, scale of production, type of vectors manufactured and purpose of production (fulfilling in-house requirement / contract service provider) and the type of organization (industry / non-industry). Elaborate profiles of key players that are currently carrying out, or are planning to conduct, commercial scale production of viral vectors / plasmid DNA; each profile provides an overview of the organization, its financial performance (if available), information on its manufacturing facilities, vector manufacturing technology, recent investments, expansions and collaborations, and a comprehensive future outlook. A discussion on the factors driving the market and the various challenges associated with the vector production process. An estimate of the overall installed vector manufacturing capacity of industry players based on their reported capacities (wherever available) and additional data collated via both secondary and primary research. The analysis highlights the distribution of the global capacity by vector type (viral vector and plasmid DNA), scale of operation (clinical and commercial), regions (North America, EU, Asia Pacific and the rest of the world) and size of the organization (small-sized, mid-sized and large-sized organizations).  An analysis of the various factors that are likely to influence the pricing of vectors, featuring different models / approaches that may be adopted by manufacturers to decide the prices of proprietary vectors. An in-depth analysis of the viral vector and plasmid DNA manufacturers, featuring three schematic representations; these include [A] a three dimensional grid analysis, representing the distribution of vector manufacturers (on the basis of the type of vector) across various scales of operation and purpose of production (in-house operations / contract manufacturing services), [B] a logo landscape of viral vector and plasmid DNA manufacturers based on the type (industry / non-industry) and the size of the industry player (small-sized, mid-sized and large companies), and [C] a schematic world map representation, highlighting the geographical locations of vector manufacturing hubs. An analysis of the recent collaborations (signed since 2015) focused on manufacturing of vectors on the basis of year in which the agreement was signed, type of agreement, type of vector, and scale of operation (laboratory, clinical and commercial).  An overview of other viral / non-viral gene delivery approaches that are currently being researched for the development of therapies involving genetic modification. One of the key objectives of this report was to evaluate the current opportunity and the future potential of the vector manufacturing market over the coming decade. Based on various parameters, such as the likely increase in the number of clinical studies, increase in the patient population, existing price variations among different vector types, and the anticipated success of commercial gene therapy products, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on type of vectors (AAV vector, adenoviral vector, lentiviral vector, retroviral vector, plasmid DNA and others), applications (gene therapy and T-cell therapy), therapeutic area (oncology, inflammation & immunology, neurological, ophthalmology, muscular, metabolic disorder, cardiovascular disorder and others), scale of operation (clinical, commercial and both) and geography (North America, EU, Asia Pacific and rest of the world). The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. For the purpose of the study, we invited over 150 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with following stakeholders: Joost van den Berg (Director, Amsterdam BioTherapeutics Unit) Semyon Rubinchik (Scientific Director, ACGT) Nicole Faust (Chief Scientific Officer, CEVEC Pharmaceuticals) Xavier Leclerc (Head of Gene Therapy, Clean Cells) Colin Lee Novick (Managing Director, CJ Partners) Cedric Szpirer (Executive & Scientific Director, Delphi Genetics) Nicolas Grandchamp (R&D Leader, GEG Tech) Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital) Alain Lamproye (President of Biopharma Business Unit, Novasep) Astrid Brammer (Senior Manager Business Development, Richter-Helm) Marco Schmeer (Project Manager, Plasmid Factory) and Tatjana Buchholz (Marketing Manager, Plasmid Factory) Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences) Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing)

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T-Cell Immunotherapy Market (3rd Edition), 2018-2030

  Cancer is known to be one of the leading causes of death worldwide, accounting for 0.6 million deaths in 2017 in the US alone. The World Health Organization states that the number of new cancer cases globally is expected to rise by 70% in the coming 20 years. Although cancer therapeutics continue to be one of the most active areas in terms of drug development, there is still a significant unmet need in this domain. Conventional cancer treatments, such as chemotherapy, surgery and radiation therapy, have demonstrated very limited efficacy in late-stage cancers. Specifically, chemotherapy and radiation therapy are also associated with several side effects. Their non-specific nature has severe detrimental effects on the patients’ quality of life. Amidst the current initiatives to develop more targeted anti-cancer therapies, immunotherapy has emerged as a highly potent option to eradicate tumor cells with minimal side effects. It is based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. It encompasses several treatment approaches, such as monoclonal antibodies, immune checkpoint inhibitors, therapeutic vaccines, cytokine therapies and cell-based therapies. In recent years, adoptive T-cell therapy (ACT) has emerged as a potent and viable therapeutic intervention. There are certain key characteristics that render T-cells suitable for use as effective therapeutic tools; these include target specificity, adaptability and the capability to retain immunologic memory. Close to 120 academic and research institutes across the globe have made significant contributions to this field, mostly by convening the initial research on potential product candidates. These efforts have built the intellectual framework for the establishment of several start-ups; in fact, during the last five years, over USD 8 billion has been invested by VC firms / other strategic investors. It is also worth highlighting that there have been more than 200 instances of collaborations between industry / academic stakeholders. The ongoing innovation has also led to the discovery of several novel molecular targets, strengthening the research pipelines of various companies engaged in this domain. Encouraged by the recent approval of two CAR-T therapies, namely Kymriah®  (Novartis) and Yescarta®  (Gilead Sciences), and a robust development pipeline, the T-cell immunotherapy market offers considerable promise to a number of industry stakeholders.   Scope of the Report The “T-Cell Immunotherapy Market, 2018-2030 (3rd edition)” report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies (focusing particularly on CAR-T therapies, TCR therapies and TIL therapies). One of the key objectives of the study was to review and quantify the future opportunities associated with the ongoing development programs of both small and big pharmaceutical firms. Amongst other elements, the report features the following: An analysis depicting prevalent and emerging trends related to T-cell immunotherapies as observed on the social media platform, Twitter. In addition to the yearly chatter trends, the analysis highlights the most frequently talked about product candidates. A detailed assessment of the current market landscape of T-cell immunotherapies with respect to type of therapies, type of developer (industry / non-industry), phase of development, target therapeutic indications, key target antigens, source of T-cells (autologous and allogenic), and route of administration. In addition, we have provided an overview of the competitive landscape, key challenges and anticipated future trends associated with T-cell based therapies. Comprehensive profiles of marketed and mid to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results. An analysis of the CAR constructs of clinical CAR-T therapies based on generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector and type of co-stimulatory domain used. An analysis of the global CAR-T clinical trials registered between 2009 and 2018, highlighting the year wise trend and the distribution across different geographies. An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications. A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers. An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements and others. An analysis of the investments that have been made into companies that have proprietary products / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants and debt financing. A case study on other T-cell based therapies, apart from CAR-Ts, TCRs and TILs. It presents a detailed analysis of the approved / pipeline products in this domain, including information on the current phase of development, target therapeutic areas, type of T-cells used, and source of T-cells. A case study on manufacturing cell therapy products, highlighting the key challenges, and a list of contract service providers and in-house manufacturers that are involved in this space. An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a T-cell based immunotherapy that is likely to be marketed in the coming years. A review of the key promotional strategies that have been adopted by the developers of the marketed T-cell therapies, namely Kymriah and Yescarta. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. The report includes potential sales of T-cell immunotherapies that are currently marketed or are in late stages of development. Additionally, the chapter presents a detailed market segmentation on the basis of type of therapy (CAR-T, TCR and TIL), geography (North America, Europe and Asia Pacific) and target indications (acute lymphoblastic leukemia, acute myeloid leukemia, bladder cancer, cervical carcinoma, chronic lymphocytic leukemia, esophageal cancer, head and neck cancer, multiple myeloma, hepatocellular carcinoma, melanoma, non-Hodgkin’s lymphoma, non-small cell lung cancer, ovarian cancer and synovial sarcoma). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals: Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) Miguel Forte (Chief Operating Officer, TxCell) Peter Ho (Director, Process Development, Iovance Biotherapeutics) Tim Oldham (Chief Executive Officer, Cell Therapies) Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) Vincent Brichard (Vice President, Immuno-Oncology, Celyad) Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Oral Proteins and Peptides Market (3rd Edition), 2018-2030

Protein and peptide-based therapeutics have been in use for more than three decades since the approval of recombinant human insulin, the first protein therapy, in 1982. Earlier, most biologic drugs were delivered through the subcutaneous route. However, over time, advances in delivery formulations have enabled the development of orally administrable versions of therapeutic proteins / peptides. Owing to numerous compelling reasons, the concept of oral delivery has gained significant traction. The first oral protein / peptide-based product candidate, Linzess ®, was launched in 2012 in the US and EU. Recently, Trulance ®, another orally administrable product was approved in the US (January 2017) for the treatment of chronic idiopathic constipation (CIC). In fact, in January 2018, Trulance® was approved for another indication, namely irritable bowel syndrome with constipation (IBS-C). The growing popularity of this upcoming class of therapeutics has led to the development of several oral protein / peptide-based product candidates for the treatment of a myriad of diseases. In addition, the need for efficient and patient-friendly treatment options for chronic disorders, such as diabetes, is estimated to boost the demand for oral proteins and peptides in the coming years. Despite their clinical and commercial success, oral formulations of protein / peptide-based drugs have been associated with multiple drawbacks, such as concerns related to unwanted enzymatic degradation, inherent structural complexities, high manufacturing costs and low bioavailability. The aforementioned issues tend to have an impact on the overall efficacy of such products, thereby, limiting their therapeutic potential. This has prompted researchers to develop better technologies in order to improve product stability and therapeutic efficiency. The ongoing innovation has led to the discovery of novel biological targets, strengthening the research pipelines of various companies focused in this domain. Increasing research and development activities, and rising demand for effective drugs with better therapy adherence profiles are anticipated to encourage growth of the global oral proteins and peptides market in the coming years. Scope of the Report The ‘Oral Proteins and Peptides Market (3rd Edition), 2018-2030’ report provides an extensive study on the current market landscape of orally administrable protein / peptide-based therapeutics, featuring a comprehensive discussion on the future potential of this evolving market. The field has captured the interest of several drug developers, including both small to mid-sized players and large companies. While more than half of these pipeline candidates are in the discovery / preclinical stages, around 28% of drug candidates are presently in advanced stages of evaluation (phase II and above). Amongst other elements, the report features: A detailed assessment of the current market landscape of oral proteins / peptides, providing information on various drug developers, phase of development (clinical, preclinical or discovery stage) of product candidates, type of molecule (protein or peptide), biological target, mechanism of action, affiliated technology platform, key therapeutic area(s) and indication(s), and dosage. An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a four dimensional grid analysis, representing the distribution of oral proteins / peptides (on the basis of the type of molecule) across various target therapeutic areas and stages of development, [B] a logo landscape of the various industry and non-industry players involved in the development of oral protein / peptide-based drugs, distributed on the basis of phase of development of pipeline candidates and size of developer companies (small-sized, mid-sized and large companies), and [C] a schematic world map representation, highlighting the most active geographies, in terms of the presence of various industry players that are involved in the development of oral proteins / peptides. Details of recently held / upcomingconferences focused solely / partially on various aspects related to the oral delivery of proteins / peptides. A detailed analysis identifying the key opinion leaders (KOLs) in the field of oral proteins / peptides. This features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers involved in the development of already marketed molecules in this domain. Identification of the most commonly targeted therapeutic indications, and details of the oral proteins / peptides being developed against them. The study presents information on epidemiology, available diagnostic tests, and details of current treatment options and their side effects. Comprehensive profiles of marketed and phase III drugs, highlighting their history of development, mechanism of action, dosage information (if available), manufacturing information (if available), current status of development, clinical trial information, key clinical trial results, historical sales (if marketed) and information on the developer. A case study, featuring profiles of three of the most popular orally administrable protein / peptide-based drugs belonging to other drug classes, namely cyclic peptides and pancreatic enzyme replacement therapies (PERTs), which are either commercialized or under development. Each profile provides an overview of the drug, history of development, chemical structure and mechanism of action, dosage information (if marketed), clinical trial information (if the product is currently under development), patent portfolio (if available), and information on the other commercially available treatment options. A review of the various oral drug delivery technology platforms that are being used for the development of product candidates in this domain, highlighting their key features and providing information on their developers. Specifically, for each technology platform, we have captured information on the various components of the technology, approach / system being used, type of formulation and type of molecules(s) that can be delivered using the technology. Elaborate profiles of the technologies that are presently being used in the development of three or more products / product candidates (in both preclinical and clinical stages of development) with at least one candidate in the clinical stages of development, along with technologies for which the drugs are in advanced clinical stages of development (phase III and above). Each profile features an overview of the developer and technology, mechanism of action, key advantages, pipeline molecules developed using the technology and recent developments specific to the technology (acquisitions / mergers, collaborations and expansions).  An insightful 2X2 analysis of the different oral delivery technology platforms that are presently being utilized for the generation of oral proteins / peptides. The analysis is based on the supplier power (represented in terms of venture funding activity and company size) and product competitiveness (represented in terms of development activity (number of drugs in both preclinical / clinical stages of development), indication coverage, partnerships activity). An analysis of the partnerships that have been established in the recent past, covering product development / commercialization agreements, R&D collaborations, technology licensing deals, manufacturing agreements, merger / acquisitions, product licensing deals, clinical trial collaborations and others. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. A publication analysis, featuring inputs from close to 90 articles that have been published in 2017, highlighting the key focus areas of the ongoing research activity in this field. An analysis depicting the prevalent and emerging trends related to this domain as represented on the social media platform, Twitter. In addition to providing information on quarterly trends related to the volume of tweets in 2017, the analysis highlights the most talked about biological targets, drug candidates, active players, technology platforms, disease indications, and therapeutic areas. A detailed case study on protein / peptide contract manufacturing, featuring a list of over 140 CMOs that are currently offering contract manufacturing services for such products / product candidates. A discussion on affiliated trends, key drivers and challenges, under a SWOT framework. The analysis features a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall oral proteins / peptides market. One of the key objectives of this study was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on [A] therapeutic areas (autoimmune disorders, bone disorders, digestive and gastrointestinal disorders, hormonal disorders, infectious diseases, metabolic disorders, urogenital disorders and others), [B] molecule type (protein and peptide), [C] technology platforms, [D] key players, and [E] geography (North America (the US, Canada and Mexico), Europe (EU5 countries), Asia-Pacific and RoW). To account for the uncertainties associated with the growth of the oral proteins / peptides market and to add robustness to our model, we have provided three forecast scenarios, portraying conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. This enabled us to solicit inputs on upcoming opportunities and challenges that were considered to develop estimates for a more inclusive growth. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Dinesh Srinivasan (Director, Anthera Pharmaceuticals), Stig K Hansen (Co-founder and CEO, Carmot Therapeutics), Terry Dyck (CEO, IGY Life Sciences and Technology) and Richard Franklin (Director and CEO, Tarix Orphan). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028

The present pipeline of pharmaceutical products is increasingly complex and requires specialized facilities, equipment and operational expertise. Small molecule drugs account for nearly 90% of the therapeutics in the pharmaceutical market. In fact, in 2017, FDA’s Center for Drug Evaluation and Research approved 34 small molecule drugs; this represents an annual growth of nearly 56%, signifying the growing importance of contract manufacturing in the overall pharmaceutical industry. The costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. The aforementioned constraints have led many of the smaller players in the industry and, at times, certain pharma giants as well, to outsource a significant part of their business operations to contract service providers. Third-party service providers are known to offer significant cost-benefits, access to larger production capacities and reductions in time-to-market. Over the years, the contract manufacturing market has grown into a prominent and promising segment of the overall pharmaceutical industry. Since 2000, close to 150 new CMOs have been established, offering cost-efficient solutions to several stakeholders in the industry. The current global CMO market is highly fragmented but characterized by multiple acquisitions and mergers as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to start offering end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings. Despite the fact that the pharmaceutical sector is amongst the most highly regulated industries, we expect the demand for core competencies to continue to drive sponsor companies to outsource various parts of their manufacturing operations. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor and will grant a competitive edge to certain CMOs over other stakeholders in the industry. However, given the ongoing innovation in production technologies and the steadily evolving pipeline of small molecules, the pressure on the contract manufacturing industry is expected to increase in the coming years. This is likely to require CMOs to devise and implement different business strategies and models in order to cope with the evolving demand.   Scope of Report The ‘Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028’ report provides a comprehensive study on the current scenario of contract manufacturing services related to pharmaceutical products. The study features an in-depth analysis, highlighting the capabilities of a diverse set of pharmaceutical CMOs. Amongst other elements, the report features: An overview of the current market landscape, featuring a comprehensive list of over 500 active CMOs, and detailed analysis of manufacturing service providers based on a number of parameters, such as geographical location of CMOs, type of business segments (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), type of FDFs manufactured (solids, liquids / semi-solids and injectables), scale of operation (pilot, clinical, and commercial), type of service(s) offered, specific location of manufacturing facilities (country-wise) and  types of primary packaging forms being manufactured (tablet / capsule / blister packing, ointment /  gel / tube, vial, ampoule, sachet / pouch / bag, glass / plastic bottle and pre-filled syringe). In addition, the report features a year-wise analysis of the number of CMOs that have been established over the past five decades, based on the year in which they were founded. An analysis of the most active regions, based on the presence of contract manufacturers; the report contains schematic world map representations indicating the geographical location of key hubs with respect to contract manufacturing activity across the globe. A detailed discussion of various guidelines laid down by major regulatory bodies in different countries. The report also includes a comprehensive assessment of over 500 CMOs, including details of operational approvals and certifications received by each firm. In addition, the report highlights the relative popularity of the key regulatory bodies across the globe based on the number of companies which comply to the guidelines laid down by each of these authorities. The report also features an insightful multi-dimensional bubble analysis, featuring a comparison of the current regulatory scenario in key geographies across the globe. Elaborate profiles of key players that offer end-to-end services ranging from product design and discovery to final packaging. Each profile provides an overview of the company, its financial performance (if available), information on its service(s) portfolio, manufacturing facilities and capabilities, recent developments (acquisitions / mergers, collaborations and expansions) and a comprehensive future outlook. A case study comparing the key characteristics of large molecule and small molecule drugs, along with the steps involved in their respective manufacturing processes. In addition, it provides an overview of the current biopharmaceutical contract manufacturing landscape, featuring a list of over 200 CMOs that are currently offering contract manufacturing services for large molecules. A comprehensive set of analyses on pharmaceutical contract manufacturing service providers featuring three schematic representations, which include [A] a heat map analysis featuring the distribution of integrated contract service providers (companies offering manufacturing services for both small and large molecules), on the basis of  location of headquarters, year of establishment and number of employees, [B] a geographical landscape analysis,highlighting those CMOs that have a significantly wide geographical reach, on the basis of their presence (manufacturing facilities) across various regions, and [C] a grid representation, highlighting the global and regional trend of API and FDF outsourcing services, based on the location of headquarters of the company, number of employees and the type of business operation. A detailed capacity analysis, based on global, market wide research on the individual development and manufacturing capacities of various stakeholders in the industry. The analysis takes into consideration the actual capacities of small-sized, mid-sized, large and very large CMOs, and is based on robust data collection done via both secondary and primary research. The study highlights the distribution of global capacity by scale of operation (clinical, commercial, both), regions (North America, Europe, Asia-Pacific, rest of the world) and specific countries within North America (the US, Canada and Mexico), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia-Pacific (China, India, Japan, Australia and rest of Asia) and rest of the world. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution. It also offers a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry. A review of emerging trends, including the increase in outsourcing activity in emerging markets, shift towards an integrated business model through expansions and consolidation, introduction of innovative technologies / continuous processing systems, use of big data and advanced analytics to improve the manufacturing process and adoption of cybersecurity solutions to protect confidential customer data. It also includes a detailed discussion on the various growth drivers, such as increasing demand for biologics, biosimilars, and highly potent and cytotoxic drugs. One of the key objectives of this report was to evaluate the current opportunity and the future potential of the pharmaceutical contract manufacturing market over the coming decade. Based on various parameters, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2028. In addition, we have provided the likely distribution of the market based on [A] type of business segment (API and FDF), [B] regional evolution of the market covering North America (the US, Canada and Mexico), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia-Pacific (China, India, Japan, Australia and rest of Asia) and rest of the world, [C] type of API product (branded and generic) within the aforementioned regions, [D] type of FDFs manufactured (solids, liquids / semi-solids and injectables), [E] type of packaging forms (tablet / capsule / blister packing, ointment / gel / tube, vial, ampoule, sachet / pouch / bag, glass / plastic bottle and pre-filled syringe), [F] scale of API manufacturing (clinical, commercial, and both) and [G] size of manufacturers (small sized, mid-sized, large and very large companies). To account for the uncertainties associated with the growth of pharmaceutical contract manufacturing market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. This enabled us to solicit inputs on upcoming opportunities and challenges that were considered to develop estimates for a more inclusive growth. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following stakeholders: Scott Goldstein (Associate Director, Drug Product Manufacturing, Ajinomoto Althea) Thomas Früh (CEO, Bachem) Piyush Desai (Director, Operations, Sovereign Pharma) Claire Otjes (Assistant Manager, Marketing, Batavia Biosciences) Dietmar Katinger (CEO, Polymun Scientific) Birgit Schwab (Senior Manager, Strategic Marketing, Rentschler Biopharma) Sebastian Schuck (Head, Business Development, WACKER Biotech) Bhaskar Venepalli (President and CEO, CiVentiChem) Roberto Margarita (Director, Business Development, CordenPharma) Allison Vavala (Senior Manager, Business Development, Helsinn Group) Kevin Daley (Director, Pharmaceuticals Marketing, Novasep) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Gene Therapy Market (2nd Edition), 2018-2030

The concept of gene transfer into mammalian cells can be traced back to the 1920s. However, the first gene therapy, Gendicine® , was only approved in 2003 in China; since then, the domain has evolved significantly. The year 2017 was particularly eventful; despite the withdrawal of Glybera from the European market in early 2017, the latter half of the year witnessed the approval of two gene therapies, namely Invossa™ and Luxturna™. In fact, Luxturna™ became the first gene therapy to gain approval in the US. Further, promising clinical results were reported for several gene therapies that are currently in late phases of development. The growing popularity and potential of gene therapies can be correlated with an exponential increase in the number of patents that have been filed; the cumulative number has increased from 7,300 patents in 2013 to 42,300 patents till the third quarter of 2017. Further, over the past five years, capital worth more than USD 9.8 billion has been invested by venture capital (VC) firms and government bodies to fund research activities in this domain. The overall market is expected to witness significant growth in opportunities for a variety of stakeholders in the coming decade. It is important to highlight that several technology providers, aiming to develop and / or support the development of gene therapies, with improved efficacy and safety, have designed and already introduced advanced platforms for the engineering of vectors. Innovation in this domain has also led to the discovery of novel molecular targets and strengthened the research pipelines of companies focused in this space. The capability to target diverse therapeutic areas is considered to be amongst the most prominent growth drivers of this market.   Scope of Report The ‘Gene Therapy Market (2nd Edition), 2018-2030’ report provides an extensive study on the current market landscape of gene therapies, with a prime focus on gene augmentation based therapies and oncolytic viral therapies, featuring an elaborate discussion on the future potential of this evolving market. Amongst other elements, the report features: A detailed assessment of the current market landscape of gene therapies, providing information on various drug / therapy developers, phase of development (clinical, preclinical or discovery stage) of product candidates, key therapeutic areas and indication(s), information on gene type, vector type, type of therapy (ex vivo, in vivo) and type of modification (gene augmentation, oncolytic viral therapy and others). A discussion on the various types of viral and non-viral vectors, highlighting information on design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vectors. A world map representation, depicting the most active geographies in terms of the presence of companies developing gene therapies, and a bull’s eye analysis highlighting the distribution of clinical pipeline candidates in terms of phase of development, type of vector and type of therapy (ex vivo / in vivo). Comprehensive profiles of marketed drugs, highlighting their history of development, current developmental status, mechanism of action, affiliated technology, patent portfolio, dosage and manufacturing, and information on the developer. Comprehensive profiles of clinical stage (phase II/III and above) drug candidates, highlighting their current status of development, mechanism of action, affiliated technology, patent portfolio, clinical trial information and recent developments. A section on emerging technologies and platforms that are aiding the development of gene therapies, featuring detailed profiles of technologies that are presently being used in the development of four or more products / product candidates. An overview of the most commonly targeted therapeutic indications and details on the gene therapies that are being developed against them. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. A detailed analysis of the recently filed patents (since 2013); the study highlights the emerging trends in innovation and identifies the key players involved. In addition, it presents a high-level view on the valuation of these patents as well. A case study on the prevalent and emerging trends in vector manufacturing, with information on companies offering contract services for manufacturing vectors. The study includes a detailed discussion on the manufacturing processes of various types of vectors as well. An analysis on the various factors that may form the basis for the pricing of gene therapies, featuring different models / approaches that may be adopted in order to decide the price of a product that is likely to be marketed in the coming years. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2018-2030. To account for the uncertainties associated with the development of gene therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Adam Rogers (CEO, Hemera Biosciences), Al Hawkins (CEO, Milo Biotechnology), Cedric Szpirer (Executive & Scientific Director, Delphi Genetics), Christopher Reinhard (CEO and Chairman, Cardium Therapeutics), Jeffrey Hung (CCO, Vigene Biosciences), Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory) and Michael Triplett (CEO, Myonexus Therapeutics). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Smart Grids Infrastructure Market, 2018-2030

With growing electricity consumption, the peak electricity demand is expected to increase manifold by 2050. It is believed that, owing to their intelligence features, smart grids have the potential to reduce the projected peak demand increases by up to 24% across some of the major regions of the world. This is because sensors in smart grids can detect peak load in advance and divert surplus supply from low demand areas to meet the peak requirements in a particular region.Moreover, with countries having ambitious renewable energy targets, it is important to ensure that a compatible infrastructure is put in place in parallel. Several geographies across the world have already recognized the need of upgrading to smart grids and have taken initiatives to encourage this transition. The US, for instance, allocated USD 4.5 billion initially towards grid modernization; the investment increased over the years under the American Recovery Reinvestment Act of 2009. In Europe, the European Technology Platform (ETP) SmartGrids was formalized in 2005 to create a vision for the European networks till 2020 and beyond. A recent 2017 report by Joint Research Centre (JRC) included 950 smart grid projects (R&D and demonstration) across Europe; across these, a total of EUR 5 billion has been invested. Emerging economies are also planning to upgrade existing systems to smart grids. The ambitious renewable energy targets of countries such as China and India are expected to drive the smart grids market in the future. In China, the government announced an investment of USD 96 billion between 2010 and 2020 to accelerate smart grids deployment. Similarly, in India, several pilot stage smart grid projects are underway. Smart Grids are expected to play a pivotal role in clean energy initiatives. Specifically, smart meters are amongst the most focused infrastructures across several countries. In the US, more than 75 million smart meters had been installed by 2017.In addition, the EU has set a target of replacing at least 80% (~ 245 million) of the conventional electricity meters with smart meters by 2020. In fact, it is reported that Sweden, Finland, Italy and Luxembourg have already reached full deployment.The EU Smart Grids Task Force believes that the planned rollout of smart meters and smart grids has the potential to reduce carbon emissions in the EU by 9%.   Scope of The Report The ‘Smart Grids Infrastructure Market, 2018 - 2030’ report features an extensive study of the current landscape and future outlook of the growing market for smart grids. The focus of this study is on the smart grids infrastructure, equipment, modules / components / systems offered by different players. The field is backed by grants / investments from various government agencies and is characterized by the presence of several well-established companies. Amongst other elements, the report features: A detailed assessment of the current market landscape, providing information on various infrastructure components offered by companies for deploying smart grids in an existing network; these include transmission and distribution equipment, substation automation modules / components and supported communication channels. Detailed profiles of some of the leading players in the industry, highlighting the current focus of the companies with details on their specific smart grid infrastructure equipment / module / component / systems and services. The profiles also include a section on recent developments, highlighting the achievements, partnerships / collaborations and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. A comprehensive benchmark analysis, highlighting key focus areas of small, mid-sized and large sized companies; the benchmark analysis provides a means to compare the existing capabilities within respective peer groups and help industry stakeholders identify ways to achieve a competitive edge over contemporary players. A detailed market attractiveness analysis elucidating the attractiveness of major markets across the globe based on parameters that are likely to determine the future growth opportunities in specific regions. A case study highlighting the regulatory initiatives across various geographies and the regulatory standards / norms designed for a uniform and standardized smart grid deployments. An overview of some of the recent smart grid deployment projects across the EU, North America and rest of the world (Australia, China, India, Japan and South Korea). Specifically, we have highlighted the current focus area across the regions defined by the type of projects that have been undertaken (AMI, distribution network or transmission network). One of the key objectives of the study was to understand the primary growth drivers and estimate the future size of the market. We looked at the likely future investments to be made in the key geographies (the US, the EU, China, Japan, South Korea, Australia, Canada, Russia, Singapore, India and UAE). Based on this, we have provided an informed estimate on the likely evolution of the market in the long term, for the period of 2018 - 2030. Considering the uncertainties related to the investments and political influence across the geographies, and to add robustness to our model, we have provided three forecast scenarios, representing the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights highlighted in this report were influenced by discussions held with senior stakeholders in the industry. These include Emmanuel Albert (CEO, Trispectra Innovation), Fulvio Ferrari (Founding Partner, Wemworld) and Jenny Erwin (Business Development Manager, Smart Wires). All the actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless specified otherwise.

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Novel Drugs and Smart Devices for Respiratory Disorders, 2018 - 2030

According to the Forum of International Respiratory Societies, around 4 million individuals die each year due to chronic respiratory diseases. The World Health Organization (WHO) estimates the global prevalence of two of the most common chronic respiratory diseases, namely asthma and chronic obstructive pulmonary disease (COPD), to be around 335 million and 400 million patients respectively. Specifically, COPD is currently known to be the fourth leading cause of death worldwide. According to the data provided by the WHO, more than 3 million people die annually from COPD; this represents a total of 6% of the global annual deaths. Around 90% of these deaths occur in low and middle-income countries. Asthma, on the other hand, is more common in pediatric population. Asthma alone results in more than 30% of pediatric hospitalizations. Moreover, it is responsible for around 180,000 annual deaths worldwide. In addition to asthma and COPD, other chronic respiratory disorders are also associated with high unmet needs. Specifically, the patients suffering from cystic fibrosis, which is known to have a global prevalence of 70,000, have reported median lifespan of less than 30 years. In addition, the patients suffering from cystic fibrosis are at a relatively higher risk of acquiring life threatening lung infections. The high prevalence, high rate of hospitalization and high cost of treatment for these disorders places a huge burden on the society in terms of direct healthcare costs and the loss of productivity associated with disability and premature mortality of the patients. Although these diseases cannot be cured, government agencies and big pharma companies have made significant investments in R&D to improve disease management and address the unmet needs. These investments and development initiatives have led to the approval of several therapies, such as LAMA / LABA fixed dose combinations, ICS / LAMA / LABA fixed combinations, CFTR modulators, and novel biologics and antibiotics, which have helped improve the quality of life of patients. The industry is gradually transitioning towards the development of more targeted therapies. This shift is facilitating a scenario, wherein therapeutic strategies are changing from broad spectrum remedies to those that target individual patient segments.   Scope of the Report The ‘Novel Drugs and Smart Devices for Respiratory Disorders, 2018-2030’ report provides a comprehensive study on the current landscape of novel therapies and smart devices being evaluated for the treatment of asthma, COPD and cystic fibrosis. The field has captured the interest of several drug developers, both small and large companies. With several novel drug candidates in development, we anticipate the market to witness continued growth over the next 5-10 years. Amongst other elements, the report features: A discussion on the novel therapies under development for the treatment of asthma, COPD and cystic fibrosis. The report provides information on the developers, phase of development of candidate drugs / therapies, mechanism of action, route of administration, type of molecule, type of formulation and the dose frequency of the various therapies. An analysis highlighting the key unmet needs across asthma, COPD and cystic fibrosis. The study presents insights generated from real-time data on unmet needs identified from social media posts, recent publications, patient blogs and discussions of key opinion leaders. An extensive review of the development portfolio and key initiatives undertaken by established players (players with approved / late-stage drug candidates). This section also provides an overview of the companies, their financial performance, recent collaborations and a comprehensive future outlook. Elaborate profiles of marketed and phase III drugs; each profile features an overview of the drug, its mechanism of action, dosage information, details on the cost and sales (wherever available), clinical development plan, and key clinical trial results. An assessment of the key players involved in the development of smart inhalers. It provides information on the development status of the inhalers, type of inhalers and the key collaborators. In addition, the report provides a comparative assessment of the various smart inhalers on the basis of several parameters, such as availability of Bluetooth, USB connection, reminder function and rechargeable options. A discussion on the regulatory landscape for the approval of combination products (drugs and inhalers), as well as smart inhalers in different countries. Detailed analysis of the key trends (for instance, relative start-up activity) in the development of novel therapies across asthma, COPD and cystic fibrosis. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. The research, analysis and insights presented in this report include potential sales of novel therapies, as well as smart inhalers that are currently marketed or are in the late stages of development. To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.                                     The opinions and insights presented in the report were influenced by discussions with senior stakeholders in the industry. These include Antonio Anzueto (Pulmonologist, University of Texas Health Science Center), Richard Moss (Pediatric Pulmonologist, Lucile Packard Children’s Hospital, Stanford University), Alex Stenzler (Founder and President, Novoteris), Dinesh Srinivasan (Director, Anthera Pharmaceuticals) and Dinu Sen (CEO, CURx Pharmaceuticals). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cybersecurity in Healthcare, 2018-2030

The digital revolution has transformed the way businesses operate across the globe. However, digitally stored information is prone to hacking and manipulation by cyber criminals. The concern is validated by the fact that more than 5.1 million records are compromised due to data breaches every day. In 2016, close to 1,800 incidents of data breaches were reported across all the industries; in total, almost 1.4 billion data records were lost or stolen. The year 2017 also witnessed several cyberattacks; notable examples include WannaCry and NotPetya ransomware attacks, Equifax data breach, MongoDB databases leak, Elasticsearch server hack, Cloudbleed security bug, Zomato hack, HBO hack / Game of Thrones leaks, Uber data breach, and Ethereum hack. The healthcare industry has been amongst the prime targets for hackers over the last several years. The Ponemon Institute’s Fifth Annual Study reported that cyberattacks in healthcare have increased by a factor of 125% since 2010. In the first half of 2017, the healthcare industry had been compromised a number of times, having experienced a total of 228 data breaches, representing 25% of the total number of breaches worldwide. Across these instances, around 31 million records were compromised, stolen or lost, representing an increase of 423% as compared to the first six months of 2016. In addition, according to a report published in May 2016, it is estimated that, with each electronic health record (EHR) costing around USD 355 in the black market, healthcare data breaches have resulted in losses worth USD 6.2 billion per year to the US healthcare industry. Examples of organizations that have recently been the victims of cyberattacks / security incidents include (in alphabetical order) Abbott / St. Jude Medical, Anthem BlueCross BlueShield, Bayer, Bupa Global Health Insurance, Bronx Lebanon Hospital Center, HealthNow Networks, Johnson & Johnson, Med Center Health, Merck, National Health System (NHS), Pacific Alliance Medical Center, Patient Home Monitoring, and Smiths Medical. In order to overcome these challenges, various cybersecurity solution providers have started to specifically focus on healthcare. Along with the presence of big companies, the entry of several start-ups is driving the innovation in this domain. Contrary to the expectation, capital spending on cybersecurity in the healthcare industry is far less compared to some other industries. In addition, the scarcity of skilled cybersecurity professionals capable of catering to the complex regulatory demands in the healthcare industry is making it even more difficult for the successful implementation of cybersecurity policies across this field.   Scope of the Report The ‘Cybersecurity in Healthcare Market, 2018-2030’ report features an extensive study of the current landscape and future outlook of the growing market of cybersecurity within the healthcare industry. The focus of this study is on the cybersecurity products / solutions and services that are currently available for protecting internet connected devices against cybercriminals, and the likely evolution of novel technologies / platforms in the mid to long term. Backed by funding from several venture capital firms and strategic investors, this evolving market has its hopes pinned on the efforts of multiple start-ups. Amongst other elements, the report features: A detailed assessment of the current market landscape of cybersecurity within the healthcare domain, providing information on cybersecurity core products / solutions, threat intelligence solutions, information on different threat types, security elements and modes of deployment. Detailed profiles of some of the emerging players in the industry, highlighting the current focus of the companies, capital raised, and details on their specific cybersecurity products / solutions and services. The profiles also have a section on recent developments, highlighting the achievements, partnerships / collaborations, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. A comprehensive benchmark analysis, highlighting key focus areas of mid to large sized companies, thereby, providing a means to compare the existing capabilities within respective peer groups and help industry stakeholders identify ways to achieve a competitive edge over contemporary players. In addition, we have provided detailed profiles of some of the established players within each peer group. An analysis of investments made at various stages of product development; these include seed financing, venture capital financing, debt financing and grants / awards received by the companies that are focused in this area. An elaborate valuation analysis of companies that are involved in providing cybersecurity products / solutions / services to the healthcare industry; for the purpose of this analysis, we focused on companies that have been established over the last 5-6 years. An overview of how artificial intelligence (AI), machine learning and deep learning techniques can augment cybersecurity, once integrated. In addition, we have outlined a detailed assessment of the current market landscape of AI-based cybersecurity, and provided high-level insights on the market competitiveness within this domain. A case study on cybersecurity use cases within the healthcare industry, highlighting some of the notable healthcare data breaches and security incidents that have happened in 2017. In addition, we have briefly outlined some of the recently reported medical device hacks / security vulnerabilities that led to the recalling of these devices. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on various parameters, such as number of healthcare data breaches, number of records compromised, expected pricing of the stolen medical records and spending trends on cybersecurity in the healthcare industry, we have provided an informed estimate on the likely evolution of the market in the long term, for the period 2018-2030. To account for the uncertainties associated with the number of data breaches, and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. These include Garrett Silver (CEO, Critical Informatics), John Gomez (CEO, Sensato), Matan Kubovsky (VP, R&D, illusive networks), Mike Kijewski (CEO, MedCrypt), Mike Meikle (CEO, secureHIM), Robert Dobson (Director, Device Authority) and Rosa Lenders (Marketing Executive, Device Authority), Rod Schultz (CPO, Rubicon Labs) and Julia Cline (Senior Director, Product and Marketing, Rubicon Labs), Saïd Kenj (Account Executive, Cyberlytic) and Rebecca Bourke (Marketing Manager, Cyberlytic), Steve Leatherman (IT Consultant, BlackRidge Technology), and Yoni Shohet (CEO, SCADAfence). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Back of the Eye Disorders: Novel Drugs and Delivery Technologies, 2017-2030

According to the World Health Organization, close to 250 million individuals, including 36 million blind people, presently suffer from some form of vision impairment. Further, a recent study published in September 2017 estimates that the number of blind people is likely to increase to 38.5 million, by 2020, and to 115 million, by 2050. Current projections also indicate that, in the US alone, the total economic burden related to vision loss is expected to reach approximately USD 715 billion by 2050. In fact, chronic eye diseases are considered to be one of the main causes of vision loss globally, and an estimated 90% cases of visual impairment are reported to be caused due to such conditions. It is worth highlighting that a significant portion of these chronic ophthalmological disorders are clinical conditions related to the back of the eye. The current treatment landscape for back of the eye disorders is characterized by the presence of blockbuster drugs, such as Lucentis® and Eylea® , and various other therapeutic options. Despite the success of these therapies, their invasive mode of administration, high dosage frequency and other drug related side effects, are some of the drawbacks that have an adverse impact on their therapeutic potential and adoption. Further, there are no treatment approaches available for a number of ophthalmological indications, such as dry age related macular degeneration (dry AMD), retinitis pigmentosa (RP) and leber congenital amaurosis. In order to overcome these challenges, various stakeholders are engaged in the development of novel therapeutic approaches. With the entry of several start-ups that are driving the innovation in this domain, the pipeline has several novel product candidates in various stages of development. Companies are steadily collaborating to develop and commercialize their products globally, in-license intellectual property to design new treatment modalities and advance research initiatives in this domain.   Scope of Report The ‘Back of the Eye Disorders: Novel Drugs and Delivery Technologies, 2017-2030’ report features an extensive study of the market for novel drugs, drug-device combinations and technologies for the treatment of back of the eye disorders. The focus of this study is on the applications and the likely evolution of novel treatment options (excluding steroids and corticosteroids) in the mid to long term. The evolving market has its hopes pinned on the efforts of multiple start-ups, small and large-sized companies. Amongst other elements, the report features: A detailed assessment of the current market landscape of novel drugs, providing information on various drug / therapy developers, phase of development (clinical, preclinical or discovery stage) of product candidates, information on drug class, molecular target, type of therapy, mechanism of action, route of administration, and key therapeutic indication(s). In addition, we have provided a list of drug device combinations that target the back of the eye. A world map representation, depicting the most active geographies in terms of the presence of companies developing drugs to treat back of the eye disorders. A bull’s eye analysis highlighting distribution of pipeline candidates in terms of phase of development, type of target and drug class. A grid analysis based on type of drug class developed / being developed across different indications and stages of development. An elaborate discussion on lifecycle management strategies, depicting how companies are using various methods to expand patent exclusivity in order to exploit the revenue generation potential of their proprietary products. Comprehensive profiles of clinical stage (phase II/III and above) drug candidates specifically targeting back of the eye disorders, highlighting their current status of development, mechanism of action, technology, patent portfolio, clinical trial information and recent developments. A review of currently available technologies and delivery systems that are being used to administer therapeutics to the back of the eye, featuring brief profiles of the various technical advances, key benefits offered and information on the product candidates pipeline that are based on these technologies. A discussion on various visual prosthesis that are available, highlighting their mechanism of action. In addition, we have provided a comparative 2X2 analysis of the different types visual prosthesis based on supplier power and product competitiveness. An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements, mergers and acquisitions, manufacturing and services agreements, and other relevant agreements. A discussion on the key promotional strategies that have been adopted for marketing approved drugs, namely (based on the approval year) Macugen®, Lucentis®, Eylea® and Jetrea®, that are presently prescribed to treat back of the eye disorders. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on various parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2017-2030. To account for the uncertainties associated with the development of novel drugs and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. These include Elise Brownell (Senior Vice President of Operations and Project Management, Amarantus Bioscience), Quinton Oswald (President and CEO, Neurotech Pharmaceuticals) and Samantha Cobb (CEO, AdAlta). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cancer Stem Cell Therapies Market, 2017-2030

Cancer stem cells (CSCs) are known to be rare, immortal cells within a tumor that can both self-renew and differentiate into several cell types that form the tumor mass. Over time, the development of CSCs has been shown to be associated with several signaling pathways, which regulate the survival and proliferation of these cells. Presently, a number of initiatives are underway to explore specific targets that can be used to selectively eliminate cancer stem cells and, thereby, confer therapeutic benefits to patients suffering from various forms of cancers. The presence of CSCs has been established in various cancers, including oesophageal cancer, gastric cancer, intestinal cancer, colon cancer, hepatic cancer and pancreatic cancer. However, it is postulated that these self-renewing CSCs represent only a small fraction of the cell population (approximately 1%) within the bulk tumor mass. The frequent failure in trying to treat advanced cancers using the current standard of care therapies has been attributed to the presence of CSCs as these cells actively resist all methods of treatment, including chemotherapy and radiotherapy. The objective of the ongoing R&D is to develop novel CSC directed treatments that can combat complications, such as off target toxicities and disease relapse, associated with the current standard of care treatments. In fact, between January 2008 and December 2016, the number of publications in this domain grew at an annualized rate of 10.4%; overall, there are over 9000 publications available on PubMed, indicating the extensive research activity unfolding in this domain.   Scope of the Report The ‘Cancer Stem Cell Therapies Market, 2017-2030’ report examines the current landscape and the future outlook of the growing pipeline of products targeting CSCs. We identified over 150 molecules that are currently being investigated as therapeutic interventions for the elimination of CSCs. Over the past few years, this burgeoning field of research has captured the interest of several players in the pharmaceutical industry. Amongst other elements, the report features: An elaborate discussion on the origin, properties and methods for identification of CSCs. It covers the key therapeutic strategies that are being investigated for eliminating CSCs; these include targeting signaling pathways, targeting cancer stemness factors and related surface markers, inhibiting ATP-binding cassette transporters, targeting the tumor microenvironment, and the induction of apoptosis in CSCs. A review of the overall landscape of the CSC therapy market with respect to the phase of development, key therapeutic targets, oncological indications, mode of administration, type of molecule (small molecule, monoclonal antibody, peptides, bispecific antibody, gene therapy, fusion proteins and other biologics), geographical distribution of R&D efforts and the key players in this domain. A detailed publication analysis on more than 340 articles that have been published between September 2016 and October 2017, highlighting the key focus areas of the ongoing research activity in this field. Comprehensive profiles of phase III and marketed drugs featuring a brief company overview and financial details, product description, mechanism of action, current status of development, active clinical trials, key clinical trial results, manufacturing information, dosage and sales information, collaborations established related to the product, and a comprehensive future outlook of the developer. Additionally, the report also includes profiles of drugs that are in phase II of clinical development. Insightful representations of the distribution of CSC targeting molecules across various parameters, such as target molecular pathway, therapeutic area, type of molecule and highest phase of development. The report features a bull’s eye analysis to specifically highlight the most popular targets from a clinical standpoint. In addition, we have provided a comprehensive overview (in the form of a 2 X 2 matrix) of the competitive landscape of developers, highlighting each developer’s product portfolio, company size and location of headquarters. An analysis depicting the prevalent and emerging trends related to CSC therapies as observed on the social media platform, Twitter. In addition to the yearly trend, the analysis highlights the most talked about therapeutic targets for CSC therapies and the popular cancer indications. One of the key objectives of the report was to estimate the future size of the CSC therapy market, specifically in the US and EU. We adopted a bottom-up approach to evaluate the likely success and growth of marketed drugs and those that are in phase II and phase III of clinical development, over the next 10-15 years. The insights generated on the future opportunity are segmented on the basis of key indications, important target strategies and key products. In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios for the period 2017-2030, namely the conservative, base and optimistic scenarios, which represent three different tracks of the industry’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The report presents details of conversations with (in alphabetical order of company name) Stephen Franklin (CEO, Evgen Pharma), Steven Swanson (Senior Vice President, ImmunoCellular Therapeutics) and Jaffer Ajani (Researcher at MD Anderson Cancer Center).

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3D Bioprinting: Technologies, Products and Key Application Areas, (2nd Edition), 2018-2035

3D printing has garnered significant attention within the healthcare industry. The concept of 3D bioprinting was conceived in the late 1990s; since then, various industry stakeholders and academicians have undertaken several initiatives in order to further develop / improve this technology for a variety of applications. Organovo was the first company to enter the 3D bioprinting space by printing functional blood vessels in 2010. The company now offers 3D printed kidney and liver tissue models. There have been a number of other notable attempts to create fully functional 3D bioprinted tissues. For instance, in 2015, 3D Bioprinting Solutions became the first company to print and transplant a thyroid gland in a mouse. Subsequently, in the same year, Aspect Biosystems developed and commercialized 3D printed human respiratory tissue for clinical testing. In addition to these, other companies with commercialized tissue products include MEDPRIN, Poietis, and Nano3D Biosciences. The current applications of 3D bioprinted products cater to various requirements within the pharmaceutical industry for clinical testing of therapeutic drugs. Owing to the evident interspecies differences, drug candidates that are shown to be efficacious in animal models often fail in humans. For such purposes, 3D bioprinting can be used to develop more accurate, human specific disease models. Further, there is a severe unmet need when it comes to organ transplants. Therefore, the ability to synthetically create organs for transplantation purposes is expected to generate a lot of interest amongst pharmaceutical / biotechnology players in the coming years. The current market landscape of 3D bioprinting is characterized by the presence of nearly equal number of industry and non-industry players, featuring a number of startups and university spin-offs. Although there are several 3D bioprinting technologies already available, active efforts are being made to add to the intellectual property portfolio. The field has witnessed growing partnering activity and has also managed to capture the interest of both public and private sector investors.Despite certain challenges, several technical advancements and high unmet need of current patients waiting for organ transplants is anticipated to significantly drive future growth.   Scope of Report The ‘3D Bioprinting: Technologies, Products and Key Application Areas, (2nd Edition), 2018-2035’ report providesa comprehensive study on the current market landscape of the 3D bioprinting industry, featuring an elaborate discussion on the future potential of this evolving market. The field has seen the emergence of many new players in the past few years; in fact, several well-known players of the 3D printing industry have broadened their focus to launch new initiatives specific to 3D bioprinting. Amongst other things, the report features: A detailed overview of the current market landscape of 3D bioprinters and 3D bioprinted products, highlighting the contributions of industry and non-industry players, including information on the various technological aspects and key specifications of such technologies / products. Profiles of developers of bioprinting devices / technologies and bioprinted products. Each profile includes an overview of the company, information on their financials (wherever available), details on their respective product portfolios, 3D bioprinting specific collaborations, and an informed future outlook. A comprehensive product competitiveness analysis of existing 3D bioprinters, based on supplier power and product specific features such as type of technology and range of applications. An analysis of the partnerships that have been established in the recent past, covering research agreements, distribution agreements, product development agreements and other relevant deals, along with information on the collaborators / partners. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are focused in this area. An analysis depicting the prevalent and emerging trends in 3D bioprinting as observed on the social media platform, Twitter. The report also includes a detailed case study on the upcoming trends, such as use of stem cells as bioinks, emergence of the concept of 4D bioprinting and commercialization of low-cost bioprinters, based on inputs from primary and secondary research. An analysis of intellectual property portfolio related to 3D bioprinting. The study presents a high-level view on the granted patents and submitted patent applications related to these technologies, highlighting the prevalent trends in this domain. In addition, the analysis highlights the most active geographies and the key players driving innovation in this field. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on various parameters, such as target consumer segments, expected adoption rates and pricing, we have provided an informed estimate of the likely evolution of the opportunity within the market in the short to mid-term and long term, for the period 2018-2035. To account for the uncertainties associated with the development of 3D bioprinted products and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Douglas Chrisey (Professor, Tulane University), Lisa Oliver (Doctor, University of Nantes) and Fanny Geraldo (Engineer, University of Nantes), Glauco R. Souza (President and Chief Scientific Officer, n3D Biosciences), Igor Zlatkin (Application Scientist, Digilab), Kenneth Church (President and Chief Executive Officer, nScrypt) and Xudong Chen (Executive Vice President Business Development & Sales, nScrypt), Laura Bosworth (Chief Executive Officer and Co-founder, TeVido BioDevices), Lauralyn McDaniel (Industry Manager, SME), Marc Thurner (Chief Executive Officer, regenHU), Roger Narayan (Professor, North Carolina State University) and Simon Fried (Chief Business Officer, Nano Dimension). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Non-Antibody Protein Scaffolds: Drugs and Diagnostics Market, 2017-2030

Monoclonal antibodies have been in use for more than two decades. The first product candidate was launched in 1986; since then, they have been used for the treatment of a myriad of diseases, including cancer, inflammatory diseases and infectious diseases. However, despite their clinical and commercial successes, these therapies are known to have certain drawbacks that have had an impact on their overall efficacy, thereby, limiting their therapeutic potential. These drawbacks are related to their inherent structural complexities, high manufacturing costs, difficulties in formulation and insufficient understanding of their precise in vivo mechanisms of action. The above-mentioned limitations have prompted researchers to identify alternative protein scaffold based therapeutic strategies. Amongst other novel formats, non-antibody protein scaffolds have emerged as viable alternatives, having the capability to address the existing challenges associated with classical antibody based therapies. Although the concept of non-antibody protein scaffolds was conceived more than a decade ago, this field has gained popularity in recent years. Presently, there is one approved product (Kalbitor®), and several non-antibody protein scaffold based product candidates that are being developed across various clinical and preclinical stages.Monoclonal antibodies have been in use for more than two decades. The first product candidate was launched in 1986; since then, they have been used for the treatment of a myriad of diseases, including cancer, inflammatory diseases and infectious diseases. However, despite their clinical and commercial successes, these therapies are known to have certain drawbacks that have had an impact on their overall efficacy, thereby, limiting their therapeutic potential. These drawbacks are related to their inherent structural complexities, high manufacturing costs, difficulties in formulation and insufficient understanding of their precise in vivo mechanisms of action.   Scope of the Report The ‘Non-Antibody Protein Scaffolds: Drugs and Diagnostics Market, 2017-2030’ report provides a comprehensive study of the current market landscape of non-antibody protein scaffolds, and related drugs and diagnostics, featuring an elaborate discussion on the likely future potential of this upcoming market. Over the past few years, this burgeoning field of research has captured the interest of several players in the pharmaceutical industry. Amongst other elements, the report features: An overview of the current market landscape, featuring comprehensive list of active industry / non industry players, and detailed analysis of non-antibody protein scaffold based product candidates, based on phase of development (clinical and preclinical / discovery), target therapeutic area(s), end-use (therapeutic agents, diagnostic imaging agents and diagnostic tests), type of scaffold format, route of administration (intravenous, subcutaneous, and intravitreal) and non-antibody protein scaffold technology used. A review of the various non-antibody protein scaffolds that are presently available for the development of therapeutics / diagnostics, highlighting information on their developers, and structural and pharmacokinetic features. Specifically, for each scaffold type, we have captured information on size, origin of parent protein, structure, mode of randomization of scaffolds and number of disulfide bonds, type of production system used, method of selection, in vitro half-life and melting temperature. A detailed comparative analysis of various non-antibody protein scaffolds, featuring two schematic representations, including [A] an insightful 2 X 2 analysis, to assess the technical strength of the non-antibody protein scaffolds, based on product competitiveness and pipeline strength, and [B] a spider-web analysis, highlighting the popularity of non-antibody protein scaffolds (those that have products in phase I and higher stages of clinical). The analysis was based on various parameters, such as the pipeline strength (number of drugs in both preclinical / clinical stages of development), end-use, number of related publications, target indications and technical strength. Comprehensive profiles of marketed and clinical stage (phase I/II and above) non-antibody protein scaffold based drugs / diagnostics, highlighting details of the product, a brief history of development, mechanism of action, non-antibody protein scaffold technology used, manufacturing details, current status of development, information on clinical studies (including key clinical trial results) and target patient population. Each profile also features information on the developer, including an overview of the company, information on its finances and funding (if available), and an informed future outlook. An analysis of the partnerships that have been inked between stakeholders in the industry in the recent past, covering R&D collaborations, product / technology licensing agreements, product development / commercialization agreements, mergers / acquisitions, clinical trial collaborations, manufacturing agreements and service agreements. An in-depth analysis of the product pipeline, featuring an elaborate funnel analysis, highlighting the most popular targets being considered for therapeutic, as well as diagnostic purposes, along with the formats used and highest phase of development. It includes a grid analysis, representing the distribution of non-antibody protein scaffold based products (on the basis of their end-use) across various target therapeutic areas and different stages of development. A detailed analysis of the developer companies, featuring three schematic representations; these include [A] a logo landscape of the various industry and non-industry players involved in the development of non-antibody protein scaffold based products, distributed on the basis of the phase of development of pipeline candidates and size of the companies (small, mid-sized and large companies), [B] a schematic world map representation, highlighting the geographical locations of various industry players, and [C] a bubble analysis comparing the leading players engaged in the generation of drugs / diagnostics, on the basis of parameters such as clinical activity (based on the number of drug candidates developed by a particular company, across different phases of development), number of partnerships established (between 2012 and 2017) and the size of the developer company. One of the key objectives of this report was to evaluate the current opportunity and the future potential of the non-antibody protein scaffolds market. Based on various parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2017-2030. In addition, we have provided the likely distribution of the market based on end-use (therapeutic agents and diagnostic agents), key therapeutic areas (genetic disorders, eye disorders, autoimmune disorders, oncology and others), and non-antibody protein scaffold technologies. To account for the uncertainties associated with the development of non-antibody protein scaffold based drugs / diagnostics and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions with senior stakeholders in the industry. These include Alastair Smith (CEO, Avacta), Kyu-Tae-Kim (Director, AbClon), Ratmir Derda (Assistant Professor, University of Alberta) and Aditya Pandey (Postdoctoral Fellow, University of Toronto). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Antibody Drug Conjugates Market (4th Edition), 2017-2030

Since the first approval of MYLOTARG™ in 2000 and its subsequent withdrawal in the year 2010, the ADC market has evolved considerably. In the last seven years, the market has witnessed an increasing interest from drug developers and healthcare investors alike. Post the commercialization of ADCETRIS® in 2011 and KADCYLA® in 2013, there was a temporary, but evident, decline in the popularity of ADCs. This was attributed to the fact that no new ADC candidates were approved after 2013 and the focus had shifted to other novel therapies, such as immune checkpoint inhibitors and T-cell therapies. However, the recent approval of BESPONSA® and re-approval of MYLOTARG™ has renewed the interest of stakeholders in the domain. This growing popularity and potential of ADCs can also be correlated with an exponential increase in the number of patents that have been filed; the cumulative number has increased from 1,395 patents in 2009 to 10,208 patents in the first half of 2017. While there are close to 200 ADCs in clinical / preclinical stages of development, the field is currently going through a gradual transition. The industry is shifting from relying on conventional technologies to newer approaches for generating ADCs. This transition has paved way for several well-funded start-ups, which offer novel conjugation approaches, more potent warheads and modified linker technologies. In addition, the ADCs are now being evaluated in combination with several other novel therapies, such as immune checkpoint inhibitors, epigenetic modulators and monoclonal antibodies.   Scope of the Report The ‘Antibody Drug Conjugates Market (4th Edition), 2017-2030’ report provides a comprehensive study on the current landscape of ADCs, featuring an elaborate discussion on the future potential of this evolving market. The field has captured the interest of several drug developers, both small and large companies. While more than half of these pipeline candidates are in the discovery / preclinical stages, around 10% of candidate therapies are presently in advanced stages (phase II and above); we anticipate the market to witness continued growth in the next 5-10 years. Amongst other elements, the report features: A discussion on the pipeline of ADCs along with information on the developers / technology providers, phase of development of candidate therapies, drug targets, therapeutic indications, and the types of linkers and payloads / warheads used. Identification of the most commonly targeted therapeutic indications and details of the ADCs being developed against them. The study highlights the key epidemiological facts about the diseases and also lists the currently available treatment options. Extensive review on the key opinion leaders (KOLs) in the field of ADCs; the report contains a detailed 2X2 analysis to assess the relative experience of certain KOLs. It also contains schematic representations of world maps highlighting the geographical locations of these eminent scientists / researchers. An assessment of the various therapies that are being evaluated in combination with ADCs; the study also presents the likely evolution of these therapies across different therapeutic indications. Elaborate profiles of clinical stage companies and their respective product portfolios; each profile features an overview of the company, its financial performance, product portfolio, and detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical development plan and clinical trial results). An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements, mergers and acquisitions, manufacturing and service agreements, and other relevant agreements. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are focused in this area. Moreover, the report features a detailed study on the various grants that have been awarded to research institutes in this field. A review of the evolution of ADC conjugation technologies, highlighting the various approaches that have been adopted across different generations. This section also highlights the competition between contemporary technology platforms. An overview of the studies conducted to better analyze non-clinical data and support first-in-human (FIH) dose selection in ADCs. The study presents findings from various ADC studies in different animal models. The report presents an analysis of the different methods used in estimating FIH doses. In addition, it presents possible FIH starting doses and the estimated dose escalations required to reach human maximum tolerated dose (MTD). A detailed analysis of the patents that have recently been filed related to ADCs. The study also highlights the emerging trends in innovation and identifies the key players involved. In addition, it presents a high-level view on the valuation of these patents. A detailed case study on ADC contract manufacturers, highlighting the prevalent and emerging trends in ADC manufacturing. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2017-2030. The research, analysis and insights presented in this report include potential sales of ADCs that are currently marketed or are in the late stages of development. To account for the uncertainties associated with the development of novel ADCs and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.                                      The opinions and insights presented in the report were influenced by discussions with senior stakeholders in the industry. These include Alan Burnett (Professor, School of Medicine, James Cardiff University), Aldo Braca, (Chief Executive Officer, BSP Pharmaceuticals), Anthony DeBoer (Director, Business Development, Synaffix), Anonymous (Chief Executive Officer, Leading CMO), Christian Bailly (Head of CDMO, Pierre Fabre), Christian Rohlff, (Founder and CEO, Oxford BioTherapeutics), Anonymous (Director, Business Development, Leading CMO), John Burt (Chief Executive Officer, Abzena), Laurent Ducry (ADC R&D, Lonza), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Sasha Koniev (Chief Executive Officer, Syndivia), Stacy McDonald (Group Product Manager) and Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell Line Characterization Services Market, 2017-2027

Cross contamination and cell line misidentification are some of the major concerns associated with the use of cell lines. According to published literature, cell lines used for scientific experiments are either misidentified or contaminated in approximately 15-25% cases. The use of such cell lines yields unreliable and irreproducible results, and leads to significant delays in research time lines and financial losses. The detrimental impact of using incorrect / misidentified cell lines poses a significant burden on the global healthcare budget. It has been estimated that a net loss of USD 28 billion is incurred every year on research that cannot be replicated due to the involvement of misidentified or contaminated cell lines in the US. Therefore, it is crucial to properly identify and authenticate cell lines used for research, both at the start of a project, as well as during the course of the study. To carry out cell line characterization, factors such as source of cell lines, their development history and the biological properties of cells determine the analytical tests required for characterization. It is also worth highlighting that several regulatory authorities and scientific communities have undertaken different initiatives to spread awareness on the importance of cell line characterization. Various rules and standards have also been formulated, making it mandatory to characterize cell lines while submitting applications for marketing authorization, for receipt of grants / funds, or for publishing cell-based research in leading journals.   Scope of the Report The ‘Cell Line Characterization Services Market, 2017-2027’ report features a comprehensive view on the current market landscape and future outlook of testing and / or authentication services for the characterization of cell lines. The report provides information on organizations that offer contract services for the characterization of cell lines. In addition to other elements, the report includes: A discussion on the current market landscape of cell line characterization service providers (industry and non-industry players), along with information on their headquarters, type of cell lines characterized (mammalian, microbial, insect-derived, avian, marine and reptilian) and the testing services offered. An analysis of the requirements established by various regulatory authorities, across different global regions, related to the characterization of cell lines. In addition, it provides insights from the various guideline documents that have been issued by these bodies on protocols that need to be followed and general tips for the testing of cell lines. A comprehensive study on cell line authentication services, highlighting the need for such services. It features a brief historical overview, discussion on the contributions of key institutes / organizations involved in this domain, a list of awareness surveys conducted by various research groups, and a schematic world map representation depicting the most active geographies, in terms of the presence of cell line authentication service providers. Profiles of biorepositories that offer testing services for characterization of cell lines; each profile features an overview of the repository and a brief description of its overall operations and cell line characterization services offered. Profiles of key industry players that offer cell line characterization services. Each profile features an overview of the company, its financial performance, overall services portfolio, cell line characterization services, and an informed future outlook. A detailed analysis of the database, featuring three schematic representations; these include a world map depicting the most active geographies (in terms of the presence of companies / organizations providing services for cell line characterization), a heat map featuring the distribution of companies on the basis of their location, number of employees and the source of cell lines and a spin wheel analysis of companies / organizations based on the number and type of tests offered, and location. One of the key objectives of the report was to understand the existing market size and potential future growth opportunities within this domain. Based on parameters, such as number of projects involving the use of cell lines, source of cell lines, and cost of characterizing different types of cell lines, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2017-2027. To account for the uncertainties associated with the with the characterization of cell lines and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Fan Chen (Vice President Bioprocessing, LakePharma), Michael Pointek (Managing Director, ARTES Biotechnology), Nienke Smits (Business Development, ModiQuest) and Oscar Hoogteijling (Business Development Manager, Bioceros). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Modular Facilities in Pharmaceutical / Biotechnology Industry, 2017-2030

The business strategies and operational processes in the pharmaceutical industry have regularly evolved over time. Over the past few years, there has been an increased pressure on drug manufacturers to optimize drug development costs and speed up the drug development process. Specifically, with the rise of personalized therapies and orphan drugs, manufacturers are now expected to produce significantly low volumes of a wide range of drugs owing to the patient specific nature of such therapies. In addition, with the increasing number of biosimilars in the pipeline, companies are aiming to reduce the time to market in order to ensure faster patient access. In general, the current market scenario demands the existing operational modes to be altered in such a way that the focus shifts to faster processes, lower manufacturing costs and smaller batch sizes. Modular facilities have demonstrated tremendous potential in several fields; specifically, the shorter time taken to establish such facilities has a significant impact on expediting various operational processes. Over the years, the interest in such facilities has also gradually risen amongst drug manufacturers within the pharmaceutical and biopharmaceutical industries. In fact, various companies have already transitioned from establishing conventional manufacturing facilities (focused on the large-scale production of a single product) to using small, flexible and modular facilities that can handle multiple products, simultaneously. It has been reported that the time required for the construction of modular facilities, starting from design to approval, could be reduced to half the time required for the construction of conventional facilities. This is primarily due to the fact that modular buildings (modules) are typically constructed offsite, transported to the site and then assembled into fully functional entities. As a consequence of the approach used, facility construction, site preparation and regulatory documentation can proceed in parallel. This is very different from the traditional approach where the aforementioned activities have to be performed sequentially.   Scope of the Report The ‘Modular Facilities in the Pharmaceutical / Biotechnology Industry, 2017-2030’ report provides an extensive studyon the current market landscape and future outlook of modular facility manufacturers that cater to the demands of pharmaceutical and biopharmaceutical companies. The study presents an in-depth analysis of a diverse set of companies that provide complete modular facilities and / or modular cleanrooms to drug researchers / developers. In addition to other elements, the report features: A review of the competitive market landscape of modular facility / modular cleanroom manufacturers with information on their geographical location (North America, Europe, Asia Pacific and rest of the world), establishment year, size (small-sized, mid-sized or large-sized) and type of industries served (pharmaceutical, biotechnology or others). It also includes information on regulatory certifications and recent projects undertaken by these companies. Elaborate profiles of established players that offer a wide range of modular manufacturing solutions to pharmaceutical and biotechnology industries; each profile includes a brief overview of the company, information on its financial status, comprehensive modular services portfolio, recent collaborations, information on capability / facility expansionsand an informed future outlook. An analysis of the most active regions based on the locations of modular manufacturing solution providers; the report contains schematic representations of world maps that clearly indicate the modular facility / cleanroom manufacturing hubs. A review of emerging trends, including the combination of single use technologies / continuous processing technologies with modular facilities, the shift to using smaller, multi-purpose and multi-product modular facilities. A discussion on key points that should be considered to facilitate the shift from using conventional facilities to modular facilities. We have provided a case study on JHL Biotech’s KUBio biomanufacturing facility, which was constructed by GE Healthcare Life Sciences in China. A detailed discussion on the various growth drivers, such as the development of personalized medicines, biosimilars, orphan drugs, and the anticipated increase in adoption of modular solutions in emerging markets and by pharmaceutical / biopharmaceutical CMOs. A detailed analysis of the collaborations and agreements, covering facility construction agreements, service alliances and acquisitions, which have been established amongst various stakeholders in the past few years. The study features a detailed analysis on the likely evolution of the pharmaceutical / biotechnology modular manufacturing market over the time period 2017 to 2030. We have provided insights on the expected growth of the market in different regions, including North America, Europe, Asia Pacific and rest of the world. In addition, we have segmented the likely evolution of the market on the basis of type of construction component(process equipment, base building, mechanical, electrical, process utilities, process piping and others), size of the facility (small-sized, mid-sized and large-sized), type of product (small molecules, biologics and others), purpose of facility (manufacturing facility, R&D facility and others) and type of facility (new facility and expansions). In order to account for the uncertainties associated with some of the parameters used and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. The opinions and insights presented in the report were also influenced by discussions with senior stakeholders in the industry. The report presents detailed transcripts of discussions held with Maik Jornitz (CEO, G-CON Manufacturing), Pär Almhem (President, ModWave), Sulogna Roy (Sales Manager / Project Manager, Zeton) and Vernon Solomon (President, Environmental Systems Corporation).

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3D Cell Cultures: Products, Technologies and Key Application Areas (2nd Edition), 2017-2030

A number of research efforts in drug discovery are being directed towards the introduction of in vitro testing models that replicate the in vivo microenvironment and provide physiologically relevant insights. Cell culture monolayers or 2D cell cultures are known to harbor differences in morphology, growth rate, function, viability and the overall behavior, as compared to those in natural environment. However, it has been realized that 3D cell cultures facilitate cell interaction with the surrounding media in all the possible dimensions. Cells cultivated using 3D techniques provide an appropriate ecosystem for cells to grow and proliferate and, consequently generate more accurate results of the experiments conducted on them. The 3D cell culture industry is currently characterized by presence of several scaffold-based and scaffold-free products and services, widely being used for the purpose of research across a variety of application areas. Examples of scaffold-based 3D culture products include solid scaffolds, hydrogels, ECM-coated plates and microcarriers. Products, such as hanging drop plates, ultra-low attachment surfaces, micropatterned plates and suspension culture systems (such as 3D bioreactors), are some of the important scaffold-free 3D technologies that are currently available. It is worth highlighting that despite the advantages that they offer, the adoption of 3D cell cultures is hindered by certain challenges. These cell culture systems are currently limited to small scale production of cells, thereby, restricting their use to research applications only. Moreover, 3D culture techniques still need to be optimized in order to ensure consistency of results generated across different scales of operation. Due to the aforementioned challenges, 2D cultures continue to be preferred over 3D culture systems; however, with increasing awareness of the advantages of 3D cultures, a significant proportion of researchers are anticipated to gradually transition towards 3D culture systems.   Scope of the Report It is well-known that, of the several drug / therapy candidates undergoing clinical evaluation, very few make it to advanced stages and an even lesser number receive regulatory approval. One of the key reasons for the failure of therapeutic candidates in clinical trials is the use of conventional 2D cell culture systems in early research studies. It is important to reiterate that these 2D systems are severely limited in a number of aspects. For instance, only 50% of the cell surface is exposed to the culture media; as a result, the actual responses of cells to specific modulators / stimulants cannot be accurately understood. It is also worth noting that attrition rates of close to 95% have been reported for anti-cancer drug candidates as a result of inaccurate in vitro drug efficacy results and unforeseen toxicity issues that were not properly assessed due to the limitation of 2D culture models. The use of advanced 3D cell culture techniques in in vitro studies is seen to have the capability to overcome several such challenges, currently associated with 2D systems. The ‘3D Cell Cultures: Products, Technologies and Key Application Areas (2nd Edition), 2017-2030’ report features an extensive study on the various scaffold-based and scaffold-free 3D culture systems. We identified over 80 hydrogel / ECM based products, 70 inserts / plates / other cultureware and 50 3D bioreactors that are widely being used for a variety of research applications across the globe. In addition, several kits, assays and tools are also available to carry out cytotoxicity assessments, transfections and cell viability testing. Amongst other elements, the report features: An elaborate discussion on the methods used for fabrication of 3D scaffolds and matrices, highlighting the materials used, the process of fabrication, merits and demerits, and the applications of all of the methods. An in-depth classification of 3D culture systems, which are categorized under scaffold-based systems (such as hydrogels / ECMs, solid scaffolds, micropatterned surfaces and microcarriers) and scaffold-free (such as hanging drop plates, suspension culture systems and organ-on-chips) 3D culture systems. A review of the overall landscape of the 3D cell culture market with respect to scaffold-format (scaffold-based / scaffold-free), product type (Hydrogels / ECMs, 3D cultureware, 3D bioreactors), product sub-type (hydrogels / ECMs are further classified on the basis of source and 3D cultureware on the basis of solid scaffolds, suspension culture systems, microfluidic systems, ECM-coated plates, attachment resistant cell culture plates, micropatterned surfaces) and product availability across different regions of the world. Comprehensive profiles of the key developers (with two or more unique bioreactors in their portfolio) of 3D bioreactors, featuring a brief company overview, description of the product, advantages, applications, collaborations related to the product, and a comprehensive future outlook. Additionally, the report includes profiles of companies with more than five unique 3D culture products (inserts or plates or hydrogels) in their portfolio and those that specialize in the field of organ-on-chips. A social media analysis depicting the prevalent and emerging trends, and the popularity of 3D cell cultures on the social media platform, Twitter. The analysis was carried out using tweets posted on the platform from 2008 to 2017. An insightful analysis, highlighting the applications of each of the 3D culture products mentioned in the market landscape. The applications have been categorized under [A] Cancer research, [B] Drug discovery and toxicity screening, [C] Stem cell research, [D] Tissue engineering / regenerative medicine. Additionally, the section represents the distribution of each of the product segments across the aforementioned applications, highlighting the relevance of different types of products in biomedical research. One of the key objectives of the report was to estimate the future size of the global 3D cell culture market. We adopted a top-down approach to evaluate the likely success and the growth of the market over the next 10-15 years. The insights generated on the future opportunity are segmented on the basis of applications areas, key geographies (the US, EU, Asia and the rest of the world), product type, scaffold format (scaffold-based versus scaffold-free) and the end use (research versus therapeutics). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios for the period 2017-2030, namely conservative, base and optimistic scenarios, which represent three different tracks of the industry’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The report presents details of the conversations with (in alphabetical order of company name) Scott Brush (VP Sales and Marketing, BRTI Life Sciences), Jens Kelm (CSO, InSphero), Darlene Thieken (Project Manager, Nanofiber Solutions), Colin Sanctuary (Co-Founder and CEO, QGel), Bill Anderson (President / CEO, Synthecon), Anonymous (President and CEO, US based start-up), Anonymous (VP Technical, Business Operations & Co-Founder, US based company).

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Bispecific Antibody Therapeutics Market (3rd Edition), 2017-2030

A number of monoclonal antibodies (more than 70) have already been approved for use in humans. These therapeutic products, which target a particular epitope on an antigen, have become a popular and robust treatment option for various diseases. However, despite the success of antibody therapeutics, there are several limitations associated with the use of mono-specific antibodies. It has been reported that certain patients treated using these therapeutic modalities have failed to respond, or have developed resistance to the therapy. Moreover, since the development and progression of several diseases, such as cancer, are dependent on the cross-talk between multiple signaling pathways, molecules directed against a single target may not elicit the desired therapeutic effect. Bispecific antibodies have demonstrated the capability to address the existing challenges associated with monoclonal antibodies, such as high manufacturing costs, limited applicability in assays and the general lack of understanding of precise in vivo mechanisms of action. Although the concept of bispecific antibodies was conceived more than five decades ago, this field has gained significant popularity in recent years. These molecules have the potential to be used across a broad range of application areas; for example, they can be used to redirect effector cells, simultaneously modulate more than one signaling pathway, and deliver toxic payloads to target sites in a more specific manner. It is also important to highlight that advances in molecular cloning technologies, coupled with a better understanding of antibody engineering techniques, have led to the discovery and development of a number of different bispecific antibody formats, setting them up for use across novel application areas as well.   Scope of the Report The ‘Bispecific Antibody Therapeutics Market (3rd Edition), 2017-2030’ report provides a comprehensive study of the current landscape of bispecific antibodies, featuring an elaborate discussion on the future potential of this upcoming market. The field has captured the interest of several drug developers, including both small and large companies. As indicated before, the applicability of these engineered biomolecules is vast. Presently, only one bispecific antibody, BLINCYTO® (2014), is available for therapeutic use. However, the development pipeline of bispecific antibody based drugs has several promising candidates that are likely to result in commercial success stories in the foreseen future. The overall pipeline comprises of over 200 molecules that are under development for the treatment of various disease indications across different therapeutic areas, including oncology, autoimmune disorders and infectious diseases. Of these, more than 60 molecules are currently under clinical evaluation, while over 140 product candidates are in the discovery / preclinical stages.  The evolving market has its hopes pinned on multiple start-ups, small and large-sized companies, which are engaged in this domain. Amongst other elements, the report features: A review of the current market landscape, featuring a detailed analysis based on target disease indications / patient segments, phases of development of product candidates (clinical and preclinical / discovery), bispecific antibody formats (fragment based bispecific antibodies, asymmetric bispecific antibodies and symmetric bispecific antibodies), routes of administration (intravenous, subcutaneous, and intravitreal) and mechanisms of action (dual targeting, T-cell engagement, NK-cell engagement, half-life extension and bispecific antibody drug conjugate). Comprehensive profiles of marketed and clinical stage (phase II and above) bispecific antibody therapeutics, highlighting their current status of development, clinical trial information and trial results, and a brief overview, financial performance (if available), and an informed future outlook of the developer. An analysis of the partnerships that have been inked between stakeholders in the industry in the recent past, covering research collaborations, licensing agreements, product development / commercialization agreements, manufacturing agreements, mergers / acquisitions, product development agreements, clinical trial collaboration and other deals. A grid analysis, representing the distribution of the pipeline of bispecific antibodies (on the basis of mechanisms of action of product candidates and antibody formats) across different therapeutic areas and stages of development. A bubble analysis comparing the available technology platforms on the basis of important parameters, such as clinical activity (based on the number of drug candidates developed using a particular technology), number of partnerships established and the size of the developer company. A spider-web analysis highlighting the popularity of different mechanisms of action of bispecific antibody candidates. The analysis takes into consideration various parameters, such as number of bispecific antibodies, number of ongoing clinical trials, target therapeutic indications, number of publications and the companies that are developing these molecules. An elaborate discussion on a lifecycle management strategy, depicting how companies are using indication expansion as a tool to expand their foothold in the field of bispecific antibody therapeutics. A case study on the key promotional strategies adopted for marketing the approved bispecific antibody, BLINCYTO®, and other competitive molecules that have been recently approved for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2017-2030. The research, analysis and insights presented in this report include potential sales of bispecific antibody therapeutics that are currently marketed or are in the late stages of development. To account for the uncertainties associated with the development of novel bispecific antibody therapeutics and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Jane Dancer (CBO, F-star), Siobhan Pomeroy (Senior Director, Business Development, CytomX Therapeutics), Ludge Große-Hovest (Founder and CSO, Synimmune) and Yinjue Wang (Associate Director, Process Development, Innovent Biologics). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Antibody Humanization and Affinity Maturation: Services and Platforms, 2017 - 2030

First discovered in 1975, monoclonal antibodies are considered to be one of the fastest growing therapy segments in the biopharmaceutical industry. In the year 2016, Humira, a monoclonal antibody, generated revenues worth more than USD 16 billion to become the highest selling drug. With a strong development pipeline and high clinical success rate, the market continues to witness increasing adoption of antibody based therapies and products. The growing industry has faced / continues to face several challenges. One of the biggest hurdles to the growth of antibody based products has been the lack of technical know-how across different stages of drug discovery. This situation is particularly true for the more traditional pharmaceutical companies that have recently ventured into the targeted therapies domain. Some of these companies have mitigated this issue by making specific acquisitions and / or hiring trained personnel to cater to the requirements. However, several others have preferred to out-source these steps to contract services providers. In fact, over the years, a number of services providers offering antibody discovery have been established, and have grown to become an indispensable part of the biopharmaceutical market. Certain steps of the antibody drug discovery process require advanced expertise, and companies offering these specialized services have attracted significant attention of drug / therapy developers. Two such specific services are to reduce antibody immunogenicity (humanization) and enhance its affinity (affinity maturation). Immunogenicity has continued to be one of the most limiting factors of the clinical success of antibodies. Antibody humanization has emerged as an extensively studied method for reducing antibody immunogenicity. There are several contract services providers that are providing novel technologies beyond the traditional methods to facilitate antibody humanization as well as to enhance antibody affinity. These contract services providers have enabled the drug developers to develop therapeutic antibodies with low immunogenicity and high affinity.   Scope of Report The “Antibody Humanization and Affinity Maturation: Services and Platforms, 2017-2030” report provides a comprehensive view on the current landscape and the future outlook of the antibody humanization and affinity maturation contract research services and platforms market. The study presents an in-depth analysis of a diverse set of companies that provide such services across different regions worldwide. In addition to other elements, the report covers the following: The current state of the market with respect to key players along with information on location of these companies, their expertise across antibody humanization and / or affinity maturation, the methodology adopted for providing these services and the revenue / business models used. Elaborate profiles of established / emerging players that have expertise in providing antibody humanization and / or affinity maturation services, highlighting the methodologies adopted by these companies and their recent partnerships and collaborations in the antibody humanization and affinity maturation domain. The profiles also have a detailed future outlook section, detailing the likely strategies that may be adopted by these players to fuel growth in the foreseen future. An analysis of the most active regions in terms of humanization and affinity maturation services for biologics, featuring schematic representations on world maps clearly indicating the location of active services hubs. A benchmark analysis to provide a means to compare existing capabilities within respective peer groups and help stakeholders in the industry to identify ways to achieve a competitive edge over contemporary players. A publication analysis representing recent trends in research on antibody humanization across various academic institutes, highlighting the ongoing innovation in this domain. A SWOT analysis, which elaborates on the strengths, weaknesses, opportunities and threats related to players engaged in this domain. A go-to-guide for outsourcing, representing different models that can be used to facilitate the decision whether companies should out-source a particular activity / operation, or not. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as number of projects being out-sourced, number of projects undertaken per year and expected pricing, we have provided an informed estimate of the likely evolution of the opportunity for antibody humanization and affinity maturation services providers for the period 2017-2030. The base year for the report is 2017. To account for the uncertainties associated with these services and to add robustness to our model, we have provided three forecast scenarios portraying conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. These included contributions from Aaron Sato (CSO of LakePharma), Andrew C.R. Martin (Reader in Bioinformatics and Computational Biology at University College London) and Thomas Schirrmann (General Manager of YuMab).

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Microbiome Therapeutics and Diagnostics Market (2nd Edition), 2017-2030

Microbiome therapeutics represent a new frontier in the field of medicine. The human microbiome is characterized by more than 100 trillion commensal, symbiotic and pathogenic microorganisms that colonize the gut, mouth, skin and various other parts of the body. Majority of these microorganisms benefit humans by supplementing them with traits that they do not otherwise possess; these include the capability to metabolize complex carbohydrates and prevention of growth of pathogens. However, some of these microorganisms are pathogenic in nature or have the capability to transform into disease-causing agents. In fact, an imbalance in the human microbiome, or dysbiosis, has been shown to be associated with various diseases, such as Clostridium difficile infections (CDIs), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), diabetes and other chronic conditions. In addition to the existing treatment plans for the above mentioned health conditions, approaches related to modifying the natural microbiome of an individual, either by adding / removing individual microbes or entire microbial communities, have been shown to demonstrate significant health benefits. Such therapies offer unique advantages over traditional small molecules or biologics based treatment regimens. In fact, one of the driving forces for developing microbiome therapeutics is to avoid the harmful side-effects of antibiotic therapies; some of these side-effects include disruption of protective / beneficial microbiota and the generation of antibiotic-resistant pathogenic strains. Currently, there are many probiotics, prebiotics, and medical foods and supplements that are commercially available as over the counter (OTC) products. Such products claim to be capable of preventing a number of diseases by restoring the human microbiome to its natural (normal) state; however, these products cannot be used as a replacement for medication or as a treatment option. At the same time, several drug / therapy candidates that claim to be capable of modifying / manipulating the microbiome in order to provide therapeutic benefits are being developed as prescription drugs. With a rich development pipeline, microbiome therapeutics has managed to capture the interest of several strategic investors and venture capital firms. We believe, if approved, these therapeutics are likely to change the treatment modalities for several indications across GI disorders, metabolic disorders, dermatological indications and inflammatory diseases.   Scope of the Report The ‘Microbiome Therapeutics and Diagnostics Market (2nd Edition), 2017-2030’ report provides a comprehensive study on the current landscape and the future outlook of the growing pipeline of products (therapeutics and diagnostics) in this area. The rising popularity and potential within this domain can be correlated with the exponential increase in the number of citations of the term microbiome on PubMed, the popular scientific literature resource; the number increased from 959 citations in 2003 to 33,809 citations in the first half of 2017. While the field has captured the interest of several companies and investors alike, no approved microbiome drugs are yet available in the market; FMT is currently the only commercially available microbiome based therapy. In addition, a few microbiome diagnostic tests are commercially available for the detection of gastrointestinal (GI) disorders and inflammatory diseases. Having said that, the development pipeline of microbiome therapeutics has several promising candidates that are likely to result in commercial success stories in the foreseen future. The report is primarily focused on prescription drugs, probiotic drugs and prebiotic drugs, which are being developed in this domain. In addition, we have captured FMT products and screening / diagnostic tests that are already available / under development. During the course of our study, we identified over 170 microbiome therapeutics and close to 25 microbiome diagnostics across various stages of development; majority of the therapeutic products are currently in early phases of development. Amongst other elements, the report features: A review of the current status of the market with respect to the microbiome therapeutics pipeline, providing information on the developers, phase of development (clinical, preclinical or discovery stage) of various product candidates, product type, target indication(s) and therapeutic areas. In addition, the report highlights the growing pipeline of microbiome based diagnostics and FMTs. An assessment of the emerging role of big data in microbiome therapeutics, highlighting the development and implementation of various algorithms / tools to analyze data generated from research, in order to understand the relationship between the microbiome and the host. A discussion on potential target disease indications across popular therapeutic areas includingmetabolic disorders, GI disorders, oncological diseases, dermatological diseases, inflammatory disorders, and women disorders. It includes detailed disease descriptions, epidemiology, current treatment plans, side effects of current treatment options and upcoming microbiome therapies. Elaborate profiles of clinical stage companies (selected based on the number of pipeline products and year of establishment); each profile features an overview of the company, its financial performance, product portfolio, detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical development plan and clinical trial results) and a comprehensive future outlook. A detailed analysis of the database presented as three schematic representations; a world map depicting the most active geographies in terms of the presence of companies developing microbiome therapeutics, a heat map featuring the distribution of companies on the basis of their location, number of employees and phase of development of pipeline products, and a grid analysis of the microbiome therapeutics pipeline, wherein individual product candidates have been compared according to their respective target therapeutic areas and phases of development. A social media analysis on the emerging trends and popularity of microbiome therapeutics on the social media platform, Twitter. An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements, mergers and acquisitions, manufacturing and services agreements, and other relevant agreements. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, and capital raised from IPOs and subsequent offerings, received by companies that are focused in this area. A detailed discussion on the various steps involved in the development and manufacturing of microbiome therapeutics, featuring information on various players that offer contract manufacturing services, or have in-house manufacturing capabilities, and those that offer other contract services, such as screening, sequencing and characterization of the microbiome, related to microbiome therapeutics. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2017-2030. The research, analysis and insights presented in this report include potential sales of FMT therapies, drugs in late stages of development and diagnostics that are already approved, and those that are likely to receive approval in the near future. The base year for the report is 2017. To account for the uncertainties associated with the development of novel therapeutic classes and to add robustness to our model, we have provided three forecast scenarios portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were influenced by discussions with senior stakeholders in the industry. These include James Burges (Executive Director, OpenBiome), Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic), Nikole E Kimes (Co-founder and Vice President, Siolta Therapeutics), Lee Jones (President and Chief Executive Officer, Rebiotix) and Colleen Cutcliffe (Co-founder and Chief Executive Officer, Whole Biome), JP Benya (Vice President, Business Development, Assembly Biosciences), Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra), Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)and  Dr. Mark Heiman (Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell Line Development Services Market, 2017-2027

The growing pipeline of biological drugs has resulted in a continuous increase in the demand for different types of cell lines. More than 650 biologics have been approved till date, and over 1,500 are under clinical development. Additionally, the loss of patent exclusivity of several biologics in the coming years is likely to be followed by the entry of numerous biosimilars as many companies compete to grab a share of already established drug markets. The importance of cell lines in other areas, such as drug screening, gene functional studies, cell-based assay development, diagnostics and tissue engineering, has resulted in further increase in the demand for different types of cell lines. The rapid progression of biological drug candidates through various phases of development, coupled with the growing demand of cell lines for other applications, presents significant opportunities to cell line development service providers. The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players are contributing to the production of GMP and non-GMP grade cell lines that are obtained from mammalian, microbial, insect-derived, avian, marine, reptilian and other sources. Stakeholders have entered into multiple partnerships / collaborations in order to improve and scale-up production processes, and expand their capabilities. Considering the heightened activity in this domain, we believe the market is likely to evolve at a steady pace in the mid to long term, driven primarily by the increasing demand for cell lines, and advances in technology platforms and production methodologies.   Scope of the Report The ‘Cell Line Development Services Market, 2017 - 2027’ report provides an extensive study of the rapidly growing market of cell lines. Cells obtained from mammalian and microbial sources are widely used for the development and manufacturing of biotherapeutic products, such as recombinant proteins, antibodies and vaccines. Mammalian cell lines, owing to their inherent high productivity and ability to produce complex biopharmaceuticals, are relatively more preferred. At the same time, microbial cell lines are also widely used due to their less complex nature, low cost and high versatility. As mentioned earlier, in addition to the large number of biologics that are already available in market, many are under various stages of development. In fact, close to 50% of product candidates in the current development pipeline are in the preclinical stage. Moreover, a number of important biologics, such as Aransep®, Avastin®, Herceptin®, HUMIRA®, Neulasta® and REMICADE®, are approaching patent expiration, and several companies are already engaged in the development of biosimilars and biobetters. As of May 2017, five biosimilars in the US and 28 in Europe have been approved. In addition to the US and EU, several companies based in Asia are also focused on the development of biosimilars. These developments have led to an upward surge in the demand for highly-productive and stable cell lines. High yielding cell lines, capable of producing top quality biopharmaceuticals, help in significantly reducing development and manufacturing costs. Hence, several companies have designed and developed innovative systems / technologies / proprietary manufacturing processes in order to optimize manufacturing costs and production timelines of the overall cell line development process. In addition to development-related services, several cell line manufacturers provide other services related to cell lines as a part of their respective services portfolios; examples of these services include cell line characterization, cell banking, cell bank characterization, process development and commercialization of reagents / equipment. It is also important to highlight that some of these companies offer cGMP production of biologics and fill / finish of end products as well. This study presents an in-depth analysis of companies that are actively involved in providing cell line development services. In addition to other elements, the study features: A discussion on the database of cell line development service providers along with information on the location of their manufacturing facilities, distribution of cell lines based on the source from which they are obtained (mammalian, microbial, insect-derived, avian, marine and reptilian), type of cell lines (recombinant, hybridoma and primary cell lines), technology used for the production of cell lines, purpose of production (R&D, diagnostics, biomanufacturing and tissue engineering), and other associated services (cell line characterization, cell banking, cell bank characterization, process development, cGMP manufacturing of biologics, fill / finish of end products and commercialization of reagents / equipment). A detailed analysis of the database presented as three schematic representations; a world map depicting the most active geographies in terms of the presence of cell line development facilities, a heat map representing the distribution of database companies on the basis of their location (continent-wise distribution), year of establishment and cell line development capabilities, and a logo landscape signifying the distribution of companies based on the number of employees and the source from which cell lines are obtained. Elaborate profiles of key industry players that have proprietary technologies for the development of cell lines and offer cell line characterization, cell banking and cGMP production of biologics as part of their services portfolios; each profile features an overview of the company, its financial performance, information on cell line development services and proprietary technology, manufacturing facilities, expansions and collaborations, and a comprehensive future outlook. Profiles of non-industry players (cell line repositories) that play an active role in the development of cell lines and offer affiliated services; each profile features an overview of the repository and a brief description about its cell line development services. Potential future growth opportunities in the cell line development market, segmented by regions, source and grade of cell lines. For the purposes of this analysis, we took into consideration several parameters, such as the number of companies involved, price of cell lines depending upon whether they are characterized or uncharacterized, source of cell lines, and average annual cell line development projects undertaken by companies. We have provided informed estimates of the size of the market in the short to mid-term and long term for the period 2017-2027. To account for the uncertainties associated with the development of cell lines and to add robustness to our model, we have provided three forecast scenarios portraying conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. The insights presented in this study were also influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Fan Chen (Vice President Bioprocessing, LakePharma), Michael Pointek(Managing Director, Artes Biotechnology), Nienke Smits (Business Development, Modiquest) and Oscar Hoogteijling (Business Development Manager, Bioceros).

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Thin Film Photovoltaics Market, 2017 - 2030

The renewable energy industry has witnessed an unprecedented growth in the last few years, owing to the increasing energy demand and concerted efforts to prevent environmental damage. Factors, such as increasing population, advances in technology, rapid industrialization in emerging markets (such as China and India), rising standard of living, and globalization are driving the global demand. In fact, the global economy is predicted to grow three folds between now and 2050; this is anticipated to create a significant increase in demand for energy around the world. It is well known that, owing to the detrimental effects of non-renewable sources on the environment, the focus has shifted towards renewable energy sources. Amongst the available energy sources, non-renewables (including fossil fuels and nuclear energy) have a share of about 76.3% and renewables have a share of about 23.7%, in global electricity production. The Paris Agreement at the 21st Conference of Parties (COP), the first ever legally binding global climate deal, was signed by 195 countries in 2015, where it was decided to limit the global average temperature rise to 1.5C till the year 2100, by reducing carbon emissions. Even though quite recently, the US has decided to pull out of the agreement, other countries, such as China and India, are still optimistic about the success of the agreement. As a result of the aforementioned developments, there has been a rapid surge in installation of solar photovoltaics. In 2017 alone, about 74 GW of solar photovoltaics (PV) were installed across the globe, taking the cumulative installed solar PV capacity to over 300 GW. More growth is predicted in the future; the International Renewable Energy Agency (IRENA) has estimated that the global photovoltaic installations will reach between 1,760 GW and 2,500 GW by 2030. Historically, crystalline silicon (c-Si) photovoltaic cells have dominated the solar PV market, occupying a share of about 90%. However, it is believed that the cost reduction potential, as well as efficiency increase potential in case of silicon based photovoltaic modules are limited. Therefore, the industry’s focus is gradually shifting towards the use of thin film photovoltaic technologies. The growth of these technologies is also being driven by newer applications of solar panels, such as for building integrated photovoltaics (BIPV), rooftops / facades and applications that demand more flexibility, as well as low angle installations. As the demand for solar PV continues to rise at a steady pace, we are optimistic about the future of the thin film PV industry.   Scope of the Report The Thin Film Photovoltaics Market, 2017-2030 report provides a comprehensive analysis of the current market landscape and a detailed future outlook of the thin film photovoltaics (PV) industry. As the global economy aims for energy security, renewable energy sources, such as solar power, are expected to play a pivotal role. In 2015, the solar energy sector attracted 56% of the total new investments (USD 286 billion) that were made in the renewable power and fuels industry. As a result of heavy funding and significant government support (in the form of subsidies), the prices of solar energy have plummeted by over 60% in the last 10 years. Our study encompasses the various thin film photovoltaic technologies that are currently available in the market, such as cadmium telluride (CdTe), copper indium selenide / gallium selenide (CIS / CIGS) and amorphous silicon (a-Si). We expect that, as this generation of thin film photovoltaic technologies matures, they are likely to benefit from economies of scale, resulting in further cost reductions. Subsequently, these technologies are likely to become one of the primary drivers behind the growth of the solar PV industry. In addition to aforementioned technologies, next generation thin film photovoltaic technologies, such as dye sensitized solar cells (DSCs), organic PV, and perovskite PV, are already being developed. These next generation thin film photovoltaic technologies are anticipated to gain more importance in the long term as they are believed to be superior in terms of energy generation capacity as well as flexibility. The study provides a deep dive into the developments that are impacting the current solar energy generation industry and are likely to drive significant changes in the long term. We were able to identify over 80 industry stakeholders, distributed across the three major thin film photovoltaic technologies. In addition to other elements, the study elaborates on the following: The current status of the market with respect to key players / technologies along with information on a company’s business model (whether it is focused on products or services or technology licensing or a combination of these), scale of operation (small, medium or large), substrate used, deposition process involved, cell / module capacity, conversion efficiency achieved, and geographical location of the companies. Comprehensive profiles of some of the key players across each type of thin film photovoltaic technologies, covering the current focus of the companies, details on their specific thin film PV technology, products and services, and associated recent developments & future outlooks. The impact of venture capital funding in this area. We believe that investments from private investors is a key enabler that is likely to drive significant developments in this industry in the long term. Investments from external sources generally enable stakeholders in the industry to scale-up their operations and develop / acquire the necessary technologies to carry out production at larger scales. This usually results in significant reductions in cost per unit. Next generation thin film PV technologies, such as dye-sensitized solar cells (DSCs), organic PV, and perovskite PV, with details on the key technologies involved, industry players focused in the area, current trends in the market, as well as future prospects. A high level patent analysis to provide an overview of how the industry is evolving from the R&D perspective. For this analysis, we looked at the patents that have been granted to various players in the last five years, across the current and next generation thin film PV technologies. Potential future growth in the thin film PV industry (both in terms of installed capacity and expected revenue generation) across the currently available technologies (CdTe, CIGS and a-Si). We have taken into account the overall installation cost of thin film PV modules to estimate future revenues. The report provides a comprehensive market forecast (till 2030) for the global, as well as the current top 10 regional solar PV markets, which includes the US, EU5 and Asia Pacific (Australia, China, India, and Japan), in terms of installed capacity. It also includes a segmentation by applications, distributed by small scale (such as consumer electronics), medium scale (such as residential rooftops and building facades) and large scale (such as solar parks, farms, plants), in terms of installed capacity and the potential revenues. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Andreas Zimmerman (Owner, Sunplugged), Dieter Manz (Founder and CEO, Manz), Rombout Swanborn (Chairman, HyET Solar), Edward Hamers (CTO, HyET Solar) and Robin Quax (Production Engineer, HyET Solar).

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Oncology Drug Discovery Services Market, 2017-2030

The early stages of research related to drug discovery, including the identification of a relevant target and a viable lead compound, play a crucial role in the overall success of a drug in preclinical and / or clinical studies. The process of drug discovery is extremely demanding, both in terms of capital expenses and time. Moreover, there is always a high risk of failure associated with R&D programs and, given the increasing regulatory stringency, the approval of new drugs has become significantly complex as well. Over the years, outsourcing has emerged as a popular trend in the pharmaceutical and biotechnology industry, and has demonstrated the potential to effectively cater to the growing demands associated with drug discovery as well. Contract Research Organizations (CROs), with dedicated teams of experts and innovative solutions across the various stages of the drug discovery and development process, are now located in all major global markets. Employing the services of these CROs offers a number of benefits to drug developers, including access to better technologies, latest R&D tools, cost and time savings and the potential to minimize risks associated with the drug discovery process. Specifically, the oncology market, with an estimated global prevalence of 32 million, imposes a heavy burden on the healthcare system. There exists a significantly high unmet need for novel therapeutic options in this domain, translating into a growing demand for drug discovery initiatives. Therefore, CROs have now emerged as important stakeholders in the oncology market. The increasing trend towards outsourcing has triggered the establishment of several strategic collaborations between drug / therapy developers and CROs. In fact, several CROs have acquired other small / mid-sized CROs or collaborated with them for upgrading their own drug discovery capabilities in an effort to provide integrated services to its clients. Opportunities arising from the growth of personalized medicines, the vast unmet need for therapies for orphan indications, and the adoption of novel technology solutions, such as deep learning solutions, cloud-based technology platforms and 3D cell culture systems, are likely to act as some of the primary drivers of growth within this sector.   Scope of the Report The “Oncology Drug Discovery Services Market, 2017-2030” report features an extensive study of the current market landscape and the future potential of CROs providing drug discovery services in oncology. Cancer, one of the leading causes of death worldwide, is an extremely complex disease and medical science is still struggling to figure out the various factors associated with the disease’s origin, propagation, spread (metastasis) and relapse. In fact, in 2017, a total of 1.7 million new cancer cases are estimated to be diagnosed in the US alone; during the same time period, close to 0.6 million patients are estimated to die due to cancer. With the increasing complexity of drug discovery and development process, the overall spending on R&D in the pharmaceutical / biotechnology sector has increased over the past few years. According to one particular source, this spending has increased from USD 108 billion in 2006 to USD 145 billion in 2016. Heavy investments are being made towards the discovery of novel approaches for the treatment of various types of cancers. The industry is currently under tremendous pressure not only to meet the expectations of a growing patient population but also to identify ways to address the risks associated with novel drug discovery programs. Over the years, CROs offering drug discovery services have contributed significantly and have now grown to become an integral and indispensable part of the pharmaceutical and biotechnology industry. This study presents an in-depth analysis of a diverse set of companies that offer services across the different steps, such as target identification, target validation, hit generation, hit-to-lead and lead optimization, of the drug discovery process. In addition to other elements, the report features: A discussion on the current state of the market with respect to key players, along with information on the location of headquarters, drug discovery services provided (target identification, target validation, hit generation, hit-to-lead, lead optimization), depth of service portfolio (discovery / preclinical / clinical / commercial manufacturing) and product type (biologics / small molecules). Elaborate profiles of established / emerging players. Each profile features a company overview, financial information, drug discovery service portfolio, recent developments and a view on its future outlook and strategy. An overview of the most active regions in terms of drug discovery services for oncology. The report contains schematic representations of world maps that clearly indicate the location of drug discovery hubs across the world. A comprehensive benchmark analysis, comparing the existing capabilities of various stakeholders within their respective peer groups, to identify ways to become more competitive in the industry. The analysis is based on key parameters such as the depth of service portfolio, the type of molecules researched and the nature of services offered by different companies. An analysis of the agreements that have been established in the recent past, covering drug discovery agreements / research collaborations, license agreements, acquisitions, service alliances and joint venture agreements. A competitive landscape review, featuring a multivariate bubble analysis, based on parameters such as the geographical location, founding year, number of drug discovery services offered and the level of partnering activity in recent years. A discussion on the potential growth areas such as personalized medicines, orphan drugs and complex biopharmaceuticals, and innovative technologies including deep learning solutions and 3D cell culture systems, that are likely to present opportunities or act as growth drivers during the coming years. In addition, the study features a detailed analysis of the existing market size and the future growth potential of the oncology drug discovery services market for the period 2017-2030. We have provided insights on the likely regional evolution of the market, across North America, Europe, China and the rest of the world. Additionally, we have provided informed estimates of the likely market evolution on the basis of type of product (small molecule, biologics) and key steps of drug discovery (target identification, target validation, hit generation, hit-to-lead and lead optimization). In order to account for the uncertainties associated with some of the key parameters, and to add robustness to our model, we have presented three different forecast scenarios, depicting the conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of this study, we invited over 100 stakeholders to participate in a survey, in order to solicit their opinions on upcoming opportunities, challenges and likely future trends. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. 

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Antibody Discovery: Services and Platforms, 2017-2027

The rising demand of personalized medicines to provide targeted treatment options has encouraged pharmaceutical companies to shift their focus from small molecules to discovery and development of biologics, particularly antibody based therapeutics. Antibodies, because of several advantages such as high specificity and targeted approach, are increasingly becoming crucial for the treatment of a number of diseases. In fact, since 2015, more than 20 antibodies have been approved by the USFDA. The growing popularity of antibody based therapeutics is also reflected from the dominance of these biologics in the portfolios of major biopharmaceutical companies. At present, the focus of majority of biopharmaceutical companies is on discovering therapeutic antibodies against novel targets. However, discovery of antibodies is a long, arduous and costly process; as a result, there is a growing preference to outsource such operations. Drug developers are partnering with contract research organizations (CROs) that provide antibody discovery services using novel and advanced technologies. Outsourcing enables biopharmaceutical companies / academic institutes accelerate their drug discovery process by leveraging the technical capabilities and expertise of CROs. Additionally, a number of drug developers and academic institutes have obtained rights to access novel antibody discovery platforms from technology providers. As the demand of novel therapeutic antibodies for various disease areas is expected to rise steadily, we are optimistic about the future of the contract research firms that are driving innovation in the drug discovery process.   Scope of the Report The ‘Antibody Discovery: Services and Platforms, 2017-2027’ report provides an extensive study on the current market landscape and future outlook of the antibody discovery service and platform providers. The study presents an in-depth analysis of a diverse set of companies that provide antibody discovery services and / or provide access to their platforms to drug developers. In addition to other elements, the report provides information on the following: The competitive market landscape and industry analysis with respect to key players along with information on their geographical location, type of business operation, methods used for antibody generation and the purpose of antibody discovery (therapeutic and / or diagnostic). Elaborate profiles of established / emerging players that offer a wide range of services in the overall antibody discovery process; each profile includes a brief overview of the company, information on its financial and funding details (if available), antibody discovery service portfolio and novel antibody discovery technology / platforms,and a view on its future outlook and strategy. Most active regions in terms of antibody discovery services and platforms; the report contains schematic representations of world maps that clearly indicate the location of antibody discovery service hubs. Platform competitiveness and supplier power (in the form of 2 X 2 matrices) across the growing landscape of antibody discovery platforms that are available for licensing. A case study covering detailed information on the historical background of drug discovery process of some of the blockbuster therapeutic monoclonal antibodies such as Humira®, Remicade®, Herceptin®, Lucentis®and Simponi®. Partnerships that have taken place in the recent past covering research collaborations, service agreements, license agreements, mergers / acquisitions and other deals signed between industry / non-industry stakeholders. The study features a detailed analysis of the existing size and potential future growth opportunities (2017-2027) in the antibody discovery services market. We have provided insights on the likely evolution of the market in different regions including North America, Europe, China and rest of the world. In addition, we have provided the likely evolution on the basis of the steps involved in antibody discovery (antigen designing, hit generation, lead selection, lead optimization and lead characterization), antibody discovery methods (phage display, hybridoma, transgenic animal based, yeast display, single cell based and others), and the nature of antibody generated (chimeric, humanized and fully human). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 60 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities, challenges and likely future trends. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. These include contributions from Aaron Sato (Chief Scientific Officer, LakePharma), Debra Valsamis (Business Development Associate, Antibody Solutions), Christel Iffland (Vice President, Ligand Pharmaceuticals), Ignacio Pino (President and CEO, CDI Laboratories), Jeng Her (CEO, AP Biosciences) and Thomas Schirrmann (CEO and General Manager, YUMAB).

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Global Non-Invasive Prenatal Testing and Newborn Screening Market, 2017-2027

It has been estimated that close to 131 million babies are born each year across the globe. Of these, approximately 7.9 million are born with birth defects. In fact, more than 7,000 genetic disorders have been identified so far and the number is rising.Genetic testing solutions that enable early detection of genetic abnormalities in fetuses and newborns are important to ensure that the person does not face complications later in life. With the emergence of innovative diagnostic and screening techniques, several methods of genetic testing have become popular. These include carrier testing, preimplantation genetic diagnosis / screening (PGD / PGS), prenatal testing, paternity testing and newborn screening. Amongst these, prenatal testing (primarily Non-invasive prenatal testing (NIPT)) and newborn screening have gained relatively more traction in prenatal and neonatal care. Specifically, NIPT has emerged as an efficient screening method in prenatal care that can analyze the cell-free DNA (cfDNA) extracted from maternal blood sample during pregnancy. NIPTs offer several advantages over conventional prenatal testing procedures; in addition to being non-invasive, these tests offer shorter turnaround times and high accuracy. It has been reported that the increasing popularity of NIPTs has led to a 50% decline in the use of invasive prenatal testing procedures (such as amniocentesis and chorionic villus sampling (CVS)). With the changing mindset of people belonging to different cultural and socio-economic background, the uptake of NIPTs is likely to increase further. Moreover, with the rising awareness and availability of NIPTs designed for a wide array of disease indications, and development of innovative and versatile technologies, we expect that the interest will continue to grow. Within neonatal care, the emergence of advanced technologies in this domain has reflected a gradual rise in the overall development of advanced newborn screening tests in the last few years. In fact, public service bodies in more than 70 countries across the globe have facilitated the establishment of newborn screening programs in their respective countries. With an already established platform, we expect the overall newborn screening market to continue its gradual rise driven by higher adoption, competitive prices and availability of these tests in various geographies across the globe.   Scope of the Report The “Global Non-Invasive Prenatal Testing and Newborn Screening Market, 2017-2027” report features an extensive study on the current market landscape of non-invasive prenatal testing (NIPT) and newborn screening diagnostics that are commercially available or are under development. NIPT and newborn screening tests are designed for the detection of different types of genetic abnormalities in fetuses and newborns. Detection of genetic disorders in prenatal and neonatal stages is critical tolower the child mortality rates. Moreover, early detection, treatment and management of these genetic disorders is important to avoid serious health problems at later stages in life. The study offers a comprehensive discussion on the future potential of these tests in prenatal and neonatal care. Ever since the launch and subsequent success of the first NIPT, the NIFTY® test (launched by BGI in August 2011), several firms have taken initiatives to develop and commercialize NIPTs. Currently, a number of NIPTs that are designed to screen for conditions such as chromosomal abnormalities, sex chromosomal abnormalities and microdeletion syndromes are available in the market.In addition, many companies have entered into collaborations to distribute these tests across various geographies in order to expand the availability to a wider population. Examples of popular NIPT tests include Harmony® test(Ariosa Diagnostics, acquired by Roche), PraenaTest® / PrenaTest® (LifeCodexx, a subsidiary of GATC Biotech), Panorama® (Natera®), NIFTY® (BGI), Verifi® (Verinata Health, acquired by Illumina®), VisibiliTTM (SequenomTM, acquired by LabCorp®) and IONA® test / Safe NIPT (Premaitha Health). The advent of routine newborn screening in the 1960s for the detection of phenylketonuria (PKU) established the role and importance of newborn screening in mitigating disorders in newborns. The field is continuously evolving as the awareness related to benefits of newborn screening increases. Moreover, introduction of advanced technologies such as next-generation sequencing (NGS) and tandem mass spectroscopy has notably accelerated the development in this domain. Newborn screening diagnostics are primarily available for conditions such as metabolic disorders, endocrine disorders, hemoglobin disorders, congenital heart disorders and hearing disorders. Both prenatal testing and newborn screening offer several benefits in terms of disease management in neonatal care and has gathered interest from a wide range of companies worldwide. In total, we have identified 76 NIPT tests and 38 advanced newborn screening tests. In addition, there are several companies that are engaged in the development of basic tests, devices, systems and technology platforms for both prenatal testing and newborn screening. One of the key objectives of this report was to understand the current activity and the future potential of the NIPT and newborn screening markets. Amongst other elements, the report covers the following: NIPT: The overall landscape of NIPT tests with respect to the stage of development, sample type, technology platforms, type of indications, stage of pregnancy and result turnaround time. In addition, the report provides a detailed discussion and analysis on the various innovative technology platforms available for the development of NIPTs and the indications screened. Comprehensive profiles of the leading players in the field of NIPT and their products, highlighting details of the company, financial and funding information (if available), product portfolio and a comprehensive future outlook. Likewise, the product profiles provide information on the product and their development history, technology platforms, test procedure, specifications, advantages and clinical information (if available). An elaborate geographical coverage analysis of the NIPT tests available / under development across the globe, a comparative heat map analysis of NIPTs (on the basis of sensitivity, specificity, result turnaround time and stage of pregnancy when the test can be performed), harvey ball analysis highlighting the panel strength of each test based on the number of indications being screened, and the geographical distribution of the companies involved in the development of NIPTs. Newborn Screening: The overall landscape of newborn screening tests with respect to the stage of development, screening type, technology platform, type of indication, period of sample collection after birth and result turnaround time. Detailed profiles of the players involved in the field of newborn screening and their products highlighting details on the company, financial and funding information (if available), product portfolio and a comprehensive future outlook. Likewise, the product profiles provide information on the product specifications and test methodology. In addition, the report includes a comprehensive list of the core and secondary disorders / deficiencies recommended for newborn screening. An illustrative grid representation of the newborn screening tests based on screening type (basic newborn screening, expanded newborn screening, comprehensive newborn screening and advanced newborn screening) and technology platform, and an overview of the landscape of industry developers (start-ups, mid-sized and large-sized players). Additionally, the report includes: A detailed discussion of the existing regulatory landscape in the field of NIPT and the current status of the government mandated newborn screening programs established in various countries across the globe to provide proper medical care to newborns. Partnerships that have been recently been inked amongst different stakeholders, covering product distribution / marketingagreements, development / commercialization agreements and mergers / acquisitions. A detailed survey analysis primarily focused on gaining additional insights on the company’s tests or services, highlighting the focus area of the company, type of the products, purpose and commercial availability of the lead product(s). The study features a detailed analysis on the existing size and future growth opportunities (2017-2027) in the NIPT and newborn screening markets. We have provided insights on the likely regional evolution of the NIPT market across patients in three risk group segments (high risk, average risk and low risk) covering North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe) Asia (Japan, China and India) and rest of the world. In addition, we have provided the likely distribution by type of indications, stage of pregnancy when the test can be conducted and the share of individual NIPTs. The forecast takes into account the impending price variations that are likely to emerge in the mid-long term as a result of growing adoption and increased competition. In order to account for uncertainties associated with some of the key parameters and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data and primary research discussions. For the purpose of the study, we invited over 150 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities, challenges and likely future trends. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. These include contributions from Jim Patterson (Vice President, Sales and Marketing North America, EvolveGene®), Osama Fikry (Metabolic and Diagnostic Head, NewBridge Pharmaceuticals) and Silke Arndt (Medical Scientist and NGS Manager, Inqaba Biotec).All financial figures mentioned in this report are in USD, unless otherwise specified.

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Biopharmaceutical Contract Manufacturing Market (2nd Edition), 2017 - 2027

Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Characterized by a number of blockbuster therapies (HUMIRA, RITUXAN, Lantus, Avastin, Herceptin and REMICADE) and a robust pipeline of product / therapy candidates, the market is poised for significant growth in the coming years. It is worth mentioning that much of the anticipated success of the biopharmaceutical market is dependent on new biologics, which are currently under development, and biosimilars, which are generic versions of these biologics. The field continues to witness significant growth in terms of innovation; this activity is clearly indicative of the growing demand for biologics to cater to existing unmet needs in the industry. It is necessary to highlight the fact that the development and manufacturing processes for biologics are complex, and usually require advanced capabilities and specialized expertise. In addition, the costs associated with acquiring capabilities in this field are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. These complications have led many stakeholders in the biopharmaceutical industry to outsource significant parts of their business operations to contract service providers. As a result of the above mentioned industry dynamics, the contract manufacturing industry landscape is steadily evolving. CMOs aiming to consolidate their presence in the market are rapidly expanding their service portfolios to provide end-to-end services to their clients and sponsors. Scope of the Report The ‘Biopharmaceutical Contract Manufacturing Market (2nd edition), 2017 - 2027’ report provides an extensive study of the contract manufacturing market for biopharmaceuticals. As the biotechnology industry continues to strive to maximize profits, outsourcing has emerged as a promising trend. The study features in-depth analysis, highlighting capabilities of a diverse set of biopharmaceutical CMOs. In addition to other elements, it provides information on the following: The competitive market landscape and industry analysis based on a number of parameters, such as geographical location, scale of operation, type of biologics manufactured, expression systems used, type of bioreactors used, mode of operation of bioreactors and bioprocessing capacity. Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing and packaging of biologics. Each profile provides an overview of the company, its financial performance, information on its manufacturing service and facilities, partnerships and recent developments. A detailed discussion on the key enablers, including certain niche sub-segments, such as ADCs, bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market. A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical contract service providers. A detailed capacity analysis, based on global, market wide research on the individual development and manufacturing capacities of various stakeholders in the market. The analysis takes into consideration the average capacities of small, mid-sized, large and very large CMOs, and is based on robust data collection done via both secondary and primary research. Information on other aspects of biopharmaceutical outsourcing, which include the growing number of collaborations, partnerships and investments in facility expansions. Affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution. One of the key focus areas of the study was to estimate size of the future opportunity for biopharmaceutical CMOs over the coming decade. In order to provide a detailed future outlook, our projections have been segmented on the basis of commonly outsourced business operations (Active Pharmaceutical Ingredients (APIs) and Finished Dosage Formulations (FDFs)), types of expression systems and key geographical regions. The base year for the report is 2017, and it provides a detailed market forecast for the period between 2017 and 2027. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. For the purpose of the study, we invited more than 200 senior stakeholders in the industry to participate in a survey. This enabled us to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. In addition, the opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie), Claire Otjes (Assistant Marketing Manager, Batavia Biosciences), David C Cunningham (Director Corporate Development, Goodwin Biotechnology), Dietmar Katinger (CEO, Polymun Scientific), Kevin Daley (Director Pharmaceuticals, Novasep Synthesis), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Raquel Fortunato (CEO, GenIbet Biopharmaceuticals), Sebastian Schuck (Head of Business Development, Wacker Biotech), Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies) and Tim Oldham (CEO, Cell Therapies). It is worth highlighting that the biopharmaceutical market is characterized by a huge unmet need for adequate manufacturing facilities and expertise. Given the inherent complexities associated with the development of biologics, the aforementioned need is likely to translate into promising business opportunities for CMOs.

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Non-Invasive Cancer Diagnostics Market (2nd Edition), 2017 - 2030

Cancer is an extremely complex disease and medical science is still struggling to figure out the reasons and factors that influence the disease origin, propagation, spread (metastasis) and relapse. In 2017, a total of 1.7 million new cancer cases are estimated to be diagnosed in the US alone; during the same time period, close to 0.6 million patients are estimated to die due to cancer. The high cancer mortality rate is primarily due to delay in detection of the disease. Therefore, in addition to satisfying the unmet market need for advanced and efficient treatment interventions, early cancer diagnosis and screening form an important component of disease prevention and cure. Early diagnosis increases the survival rate that is unlikely to happen if the disease is identified at an advanced stage. Invasive cancer diagnostic methods such as tissue biopsies have been the gold standard to determine the clinico-pathological characteristics of cancer tissues for many years. The procedure is not only cost-intensive but is also a traumatic experience for the patients. Additionally, endoscopies such as colonoscopy, gastroscopy and laparoscopy are also employed for cancer diagnosis. However, biopsies and endoscopies only offer insights of the disease state at a single point of time. They are unable to measure the disease progression or monitor the effects of the administered therapy over the treatment period. Therefore, the current cancer diagnostics market faces a pressing need for more accurate non-invasive methods of diagnosis to ensure better patient care. There are several advanced approaches that are not only non-invasive / minimally invasive but also outweigh the limitations posed by invasive diagnostic procedures. Liquid biopsy has emerged as a promising non-invasive cancer diagnostic tool that analyzes biofluids (blood, urine or plasma) to detect rare cells and biomarkers such as circulating tumor cells (CTCs), circulating tumor DNA / RNA (ctNAs) or exosomes. Moreover, liquid biopsies are capable of not only analyzing the tumor state at the time of sample extraction but can also monitor and track changes in tumor genetics over the course of treatment. In addition to liquid biopsy, the market is gradually witnessing the emergence of several other non-invasive diagnostic technologies that exploit skin lesions, bronchial fluid and exhaled breath as samples to trace signatures of cancer. These tests use gene expression profiles, biomarker analysis, volatile organic compound detection and other advanced techniques of molecular genetics to identify a particular cancer indication. These non-invasive diagnostic techniques, backed by patient success stories, awareness and the availability of successful clinical validation data for several cancer indications, hold a significant promise and are anticipated to replace the existing invasive diagnostic tools in the coming few years. In fact, social media platforms, such as Twitter, have witnessed an increasing volume of tweets over the years. Between 2010 and 2016, we were able to identify over 7,000 tweets; this clearly indicates an upsurge in the popularity of these non-invasive tests in the given time period. With liquid biopsy on the forefront, the overall non-invasive cancer diagnostics market is likely to receive a significant boost in the near future.   Scope of the Report The ‘Non-Invasive Cancer Diagnostics Market (2nd Edition), 2017-2030’ report provides an extensive study on liquid biopsy kits / assays that are either commercialized or are under development for diagnosis and / or monitoring of different types of cancer. The market is characterized by the presence of several companies that have proprietary technologies / platforms for either isolation / enrichment / enumeration of CTCs or for molecular characterization / sequencing of the genetic material extracted from the CTCs / exosomes. Based on these platforms, a number of liquid biopsy kits and systems are being developed for non-invasive diagnosis, prognosis, and patient and recurrence monitoring of different cancer indications. Such kits are likely to transform the cancer diagnostics market with many commercial success stories in the near future. The market is primarily led by start-ups / small companies, such as (in alphabetical order) CellMax Life, Celsee Diagnostics, Datar Genetics, DiaDx, EONE-DIAGNOSTICS Genome Center, Exosome Sciences,  iCellate Medical, Inivata, IVDiagnostics, LCM Genect and MDNA Life Sciences. It also has presence of mid to large-sized pharma players; notable examples include (in alphabetical order) Biocartis, Counsyl, Foundation Medicine, Genomic Health and NeoGenomics Laboratories. In addition to the aforementioned players, a number of pharma giants are also developing assets in this field. Prominent players under this category include (in alphabetical order) Affymetrix, Menarini Silicon Biosystems, Myriad Genetics, QIAGEN, Roche, Siemens Healthineers and Thermo Fisher Scientific. As companies continue to initiate and expand their research programs and platforms in this area, one of the key objectives of this report was to understand the future potential of the market. Amongst other elements, the report provides information on: The overall landscape of liquid biopsies and other novel non-invasive diagnostic tests with respect to the stage of development, type of markers (CTCs / ctNA / exosomes), test sample source (blood / urine / others), indications and type of application (early diagnosis / recurrence monitoring / patient monitoring). Additionally, the market overview highlights the geographical distribution and coverage of the tests across the globe, depicting the activity of this domain in different regions of the world. Comprehensive profiles of the popular tests and systems highlighting details on development status, specifications and advantages, clinical information, and related collaborations. Additionally, we have provided detailed profiles of the key players involved in the domain. The impact of venture capital funding in this area. It is important to mention that since the industry has witnessed the emergence of several start-ups, funding is a key enabler that is likely to drive both innovation and product development in the coming years. An elaborate valuation analysis of start-ups and small players that are involved in the liquid biopsy domain. We built a multi-variable dependent valuation model to estimate the current valuation of a number of companies focused in this domain. The emerging trends and the popularity of liquid biopsy on social media platforms, such as Twitter, over the last few years. The volume of tweets has witnessed an increasing trend in the last six years, influenced by the approval and launch of several liquid biopsy tests in the market. The competitive landscape of the players involved in the space. This is represented as an illustrative bubble analysis, which is based on parameters such as the liquid biopsy portfolio of a company, its number of employees and geographical coverage of the tests. Contribution of the other non-invasive cancer diagnostics market, taking into account the number of tests and the sales registered by the marketed tests. In addition, we have provided a comprehensive market estimation to determine the global evolution of the liquid biopsy market. This has been done by evaluating the likely success of key applications of early diagnosis, recurrence monitoring and patient monitoring. We have included insights on the likely regional evolution of the market covering US, EU5 and rest of the world. In addition, we have estimated the likely contribution of different target patient populations to the global market; this covered key indications including (in alphabetical order) bladder cancer, breast cancer, colorectal cancer, gastric cancer, lung cancer, melanoma, ovarian cancer, pancreatic cancer and prostate cancer. Further, we segmented the market by the type of markers (CTCs, ctNAs, exosomes) and the sample source (blood, urine, saliva) used in different liquid biopsies. In order to account for uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios for the time period 2017-2030. The conservative, base and optimistic scenarios represent three different tracks of the industry’s evolution. The research, analysis and insights presented in this report are backed by the deep understanding of key insights gathered from both secondary and primary research. Our opinions and insights presented in this study were influenced by discussions that we conducted with several experts in this area. These included contributions from (in alphabetical order of companies) Burkhard Jansen (Chief Medical Officer, DermTech), Christer Ericsson (Chief Scientific Officer, iCellate Medical), Frank Szczepanski (President and CEO, IVDiagnostics), Riccardo Razzini (Sales and Marketing Manager, LCM Genect), Philippe Nore (CEO and Co-founder, MiNDERA Corporation), Nathalie Bernard (Marketing Director, OncoDNA), Abizar Lakdawalla (Founder, ProXeom), Mark Li (CEO, Resolution Bioscience) and Jake Micallef (Chief Scientific Officer, VolitionRx). All actual figures have been sourced and analyzed from publicly available information and discussions with industry experts. The figures mentioned in this report are in USD, unless otherwise specified.

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Grid Scale Energy Storage Technologies Market, 2017 - 2030

It is predicted that the global economy will increase by three-folds between now and 2050. This, in turn, is likely to result in increased energy demands.According to Enerdata Energy Statistical Yearbook 2016, electricity demand has more than doubled between 1990 and 2015 to reach 20,568 TWh. This demand is projected to grow even further; in fact, by 2035, the growth is expected to be in the range of 69% to 81%. As the global economy aims for energy security, renewable energy sources such as solar and wind are expected to hold a key position in the future. However, a major constraint with such renewable sources is that energy is generated with a highly variable output in an intermittent manner. Therefore, the surplus energy is required to be stored so that it can be supplied during non-optimal generation periods such as at night time or when the wind is not blowing. Storage at a large scale has remained a major challenge; however, several developments have taken place in this domain and efforts are being made towards their feasible commercial deployments. A variety of grid scale energy storage technologies are known to the industry and can be broadly categorized based on the type of energy being stored. Pumped hydro energy storage (PHES) is a well-established energy storage technique; however, because of known challenges, various other energy storage techniques, backed by public and private lending, have surfaced over the last decade. For a market such as energy storage, which is linked to the economy of a country, initiatives related to policy decisions and mass awareness play a key role in the growth. Some countries have introduced reforms / amendments in the policies to encourage the market for energy storage, while others are still debating on it. The White House Summit 2016 is a recent example of such initiatives. At the summit, a range of utility, industry and government storage commitments were highlighted to signify the importance of this subject. Post this, the Federal Energy Regulatory Commission (FERC) started working on re-evaluating some of the policies to encourage energy storage in the US. At the time of release of this study, policies favoring renewable energy over other sources were in place in about 50 countries. The common theme across these policies is priority dispatch of electricity from renewable sources, special feed-in tariffs, quota obligations for renewable energy and energy tax exemptions. In addition, legal bindings / agreements, such as COP21, to tackle climate change are encouraging the use of renewable energy, which, in turn, is likely to drive the energy storage industry.   Scope of the Report The Grid Scale Energy Storage Technologies Market, 2017-2030 report provides a comprehensive analysis of the current market landscape and a detailed future outlook of the large scale energy storage technologies. The study highlights various energy storage technologies that are currently commercially available or are under development. These technologies can be classified as mechanical energy storage, chemical energy storage, electrochemical energy storage, thermal energy storage or electromagnetic energy storage technologies. The industry has long revolved around pumped hydro energy storage, which currently contributes close to 95% of the global energy storage capacity. However, several geographical and environmental constraints associated with it are likely to limit its growth in the long term. As a result, stakeholders have developed / are developing novel energy storage technologies to overcome the limitations of conventional systems. The primary focus of this study is on these novel / upcoming energy storage technologies, including different types of battery storage, compressed air energy storage, concentrated solar power / molten salt energy storage, flywheel energy storage and power-to-gas energy storage. The study provides a holistic coverage of the developments that are impacting the current energy storage setup and are likely to drive significant changes in energy management approaches in the long term. We were able to identify close to 170 energy storage technologies (excluding PHES) segmented across aforementioned categories. In addition to other elements, the study elaborates on the following: The current status of the market with respect to key players / technologies along with information on rated power, energy, duration / discharge time of the technologies and geographical location of the companies. Comprehensive profiles of some of the upcoming players under each energy storage category, covering details on the current focus of the companies, their specific energy storage technologies and associated recent developments / initiatives. Various investments and grants received by companies focused in this area to support their R&D activities, a key enabler that will continue to drive developments in the long term. In addition, respective governments have taken encouraging policy decisions, which have provided positive outlook to the energy storage industry. A case study on pumped hydro energy storage, where we have provided information on the plants that are currently operational as well as the ones expected to be operational in the near future. In addition, we have highlighted the historical trends that are likely to govern the future evolution. Key drivers and restraints for the growth of the grid scale energy storage market. Factors such as rising adoption of renewable energy sources, limitations of conventional energy storage systems and high electricity charges are likely to fuel the demand of energy storage systems. Potential future growth of the grid scale energy storage market (both in terms of installed capacity and expected revenue generation) across different technologies (CSP / molten salt energy storage, compressed air energy storage, lithium-ion batteries, lead acid batteries, flow batteries, flywheel energy storage, power-to-gas energy storage and other upcoming technologies). We have taken into account the levelized cost of energy storage to determine revenues for different energy storage technologies. The report covers forecast (till 2030) for the global as well as specific regional markets (North America, Europe, Asia and Rest of World) in terms of installed capacity. It also includes individual forecasts  on the installed capacity in specific countries, including the US, France, Germany, Italy, Spain, the UK, Ireland, China, India, Japan, South Africa, South Korea, Chile and Morocco, that are poised to witness healthy growth in the short-midterm and long term. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Anoop Mathur (CTO and Founder, Terrafore Technologies), Camilo Lopez Tobar (Business Development Manager, Electrochaea), Dr. Markus Ostermeier (Product Development Manager, Electrochaea), Eric Murray (President and CEO, Temporal Power), Itai Karelic (Vice President Business Development, EnStorage), John McCleod (Vice President Engineering, ZincNyx Energy Solutions) and Suresh Singh (President and CEO, ZincNyx Energy Solutions), Nicolas Velasco (Commercial Director, Albufera Energy Storage), Rainer Grumann (Vice President Sales, Heliocentris), Sonya Davidson (President and CEO, H2 Energy Now), and Tom Stepien (CEO and Co-founder, Primus Power).

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Cancer Metabolism Based Therapeutics, 2017-2030

Cancer metabolism is based on the principle that cancer cells, as compared to normal cells, have different metabolic activities in order to support their enhanced energy and anabolic requirements. The pioneering discovery by Otto Warburg in the middle of the 20th century led to the observation that metabolic activity in tumor tissues leads to a ten-fold increase in production of lactate (from glucose) under aerobic conditions. This revelation generated a significant interest and led industry stakeholders to target metabolic pathways in an effort to find the treatment of cancer. In addition, several academic players have also initiated studies to explore the functional consequences of alterations in various metabolic pathways. The idea behind therapeutic strategies that target cancer metabolism is to limit / modulate the supply of crucial nutrients in cancer cells in order to induce cell death. Over the years, experimental and conceptual advances in this field have resulted in a better understanding of the role of metabolic pathways for the treatment of cancer. Owing to the complex nature of these pathways, innovation in this domain has been gradual. However, the knowledge that metabolic adaptations in cancer cells promote their malignant properties has led to the development of novel therapeutic approaches for cancer treatment; selective inhibition of altered metabolic pathways in cancer cells is believed to be a highly promising approach. Currently, there are several molecules that are under preclinical and clinical evaluation. Extensive research is currently being carried out to explore the potential of certain enzymes of metabolic pathways to act as targets for the treatment of cancer. The alterations in metabolic pathways in cancer cells are often mediated by mutations in oncogenes and cell signaling pathways. However, with the recognition of specific enzymes within each metabolic pathway, it is anticipated that drugs targeting these enzymes are likely to have high efficacy in treating cancer with minimal side-effects. Despite the fact that the field of cancer metabolism therapeutics is still in early stages, there are many active players in this area. A larger proportion of players (on the basis of number of molecules) are small-sized and start-up companies. In fact, well-known big pharma companies have come together with smaller players to support discovery and development of such therapies. Our research indicates that there are several players with mid / late-stage clinical candidates that are likely to enter the market in the coming decade; examples include Agios Pharmaceuticals, Celgene, Polaris Group, Bio-Cancer Treatment International, BERG Health, Cornerstone Pharmaceuticals, Taiho Pharmaceutical, Novartis and 3-V Biosciences. A number of strategic and research collaborations have been inked between companies to progress research activities in this area. As clinical stage candidates progress towards advanced stages of development and companies continue to receive monetary support from different stakeholders, we expect an aggressive growth to unfold over the coming years.   Scope of the Report The “Cancer Metabolism Based Therapeutics Market, 2017-2030” report provides an extensive study on the current landscape of the emerging pipeline of novel drugs that target metabolic pathways in cancer cells and offers a comprehensive discussion on the likely future potential. The primary focus is on drugs that lead to metabolic reprogramming in cancer cells by altering / inhibiting the activity of key enzymes / transporters that are a part of glucose metabolism, amino acid metabolism, TCA cycle, lipid metabolism, nucleotide metabolism and pentose phosphate pathway. The scope includes novel products that are being specifically developed to target altered metabolic pathways and key enzymes / amino acids involved in the metabolism of cancer cells. Examples of such enzymes / amino acids include isocitrate dehydrogenase 1 mutant (IDH 1), arginine, glutamine, MTH1, L-type amino acid transporter 1 (LAT1), 6-phosphofructo-2-kinase/fructose-2,6-biphosphatase (PFKFB3), choline kinase (ChoK), glucose transporter-1 (Glut-1) and hexokinase II. Specifically, certain drugs based on amino acid metabolism are being developed under the class of immuno-oncology drugs; these have been excluded from the scope of this document. The overall pipeline comprises of 48 molecules that are under development for the treatment of a variety of oncological indications. Of these, 20 molecules are undergoing clinical evaluation while others (28) are in discovery / preclinical stages. This unexploited and promising market has its hopes pinned on multiple start-ups and small-sized companies, which have received significant financial support from strategic investors and venture capital firms in the recent past. Amongst other elements, the report provides information on: The current state of the market with respect to key players, phase of development of pipeline products (both clinical and preclinical / discovery), target enzymes / metabolic pathways and the key disease indications. Comprehensive profiles of the clinical stage (phase III, phase II/III, phase II, phase II (planned)) molecules highlighting details on development of the drug, clinical trials, clinical trial endpoints, key preclinical / clinical findings, developer details including their financial performance (if available) and future market opportunity. Various investments and grants received by companies focused in this area in order to accelerate and support their R&D activities. Partnerships that have taken place in the recent past covering product development / commercialization agreements, research collaborations, clinical trial collaborations, license agreements, mergers / acquisitions and other such deals signed between stakeholders in the industry or with non-industrial players. Distribution of the pipeline through a schematic funnel analysis, an overview of the landscape of industry developers (small, mid-sized and large players) and the geographical distribution of the companies involved in the development of cancer metabolism therapeutics. Key targets, shortlisted based on dot-plot analysis, three-dimensional bubble analysis and five-dimensional spider-web analysis. Relevant parameters such as number of publications, grant programs, number of clinical trials, phase of development, and number of companies developing drugs for specific targets were considered for these analyses. One of the key objectives of this report was to understand the current activity and the future potential of the market. The study provides a detailed market forecast and opportunity analysis from 2017 to 2030. The research, analysis and insights presented in this report are backed by a detailed understanding of the therapies targeting cancer metabolism and other targets closely associated with them. To account for uncertaintiesassociated with the development of novel therapeutics and add robustness to our model, we have provided three scenarios for our market forecast, namely the conservative, base and optimistic scenarios. All actual figures have been sourced and analyzed from publicly available information forums and from primary research. All financial figures mentioned in this report are in USD, unless otherwise specified.

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Lyophilization Services for Biopharmaceuticals, 2017-2027

The number of biopharmaceuticals being developed and manufactured has increased significantly in recent years. This is evident from the fact that over 10 novel biologics have been approved annually by FDA over the last three years; this represents around 30% of the total novel drugs approved during this time period. Currently, more than 50% of the drugs in clinical pipeline comprise of biologics. It is worth highlighting that most of these products are not stable as aqueous formulations, making it difficult to preserve them for longer durations. In order to achieve longer and commercially viable shelf lives, lyophilization has emerged as the preferred choice for making dry biopharmaceutical formulations. The method proves to be beneficial for biologics with stability issues or when providing exact dosage is challenging (for instance, very small and highly concentrated doses). In addition, it is suitable for biologics that are sensitive to heat, oxygen and / or humidity. The lyophilization process requires specialized equipment, expertise and care. Contract manufacturing organizations (CMOs) that provide such services have specialized facilities and dedicated lines for lyophilization operations. A number of biopharmaceutical companies are outsourcing their lyophilization operations to CMOs to leverage their expertise and capabilities. It is well-known that setting up in-house lyophilization capabilities and operations is an expensive and time-consuming process. In order to decrease the overall cost of the product and yield cost savings, we expect that drug developers will continue to outsource such operations to CMOs. Key drivers, both in the short-mid term and long term, not only include the increasing demand for biological therapies but also the expected entry of a number of biosimilars and the technological advancements that are steadily resulting in improved productivity for clients. Scope of the Report The ‘Lyophilization Services for Biopharmaceuticals, 2017-2027’ report provides an extensive study on the current market landscape of lyophilization services for biopharmaceuticals. The study presents an in-depth analysis of a diverse set of companies that provide such services across different regions worldwide. In fact, we identified close to 90 companies that are actively involved in providing lyophilization services for biopharmaceuticals. In addition to other elements, the report covers the following: The current state of the market with respect to key players along with information on location of facilities, the type of biopharmaceuticals lyophilized (antibodies, proteins, peptides, vaccines, nucleic acids and ADCs), scale of operation (lab, clinical and commercial) and the containment systems (vials, bulk containers, syringes, ampoules and cartridges) utilized for lyophilization operations. Elaborate profiles of established / emerging players that primarily have expertise in providing broader lyophilization services and / or are focused on providing lyophilization services for emerging containment systems such as syringes; each profile provides a company overview, financial information, details on lyophilization capabilities and facilities, recent developments and an informed future outlook. Most active regions in terms of lyophilization services for biologics; the report contains schematic representations of world maps that clearly indicate the location of active lyophilization service hubs. Benchmark analysis allowing companies to compare their existing capabilities within respective peer groups and identify ways to become more competitive in the industry. Competitive landscape of companies providing lyophilization cycle development and / or optimization services for biopharmaceuticals. A case study on alternative approaches to lyophilization such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying. The study features a detailed analysis of the existing size and potential future growth opportunities (2017-2027) in the lyophilization services market for biopharmaceuticals. We have provided insights on the likely regional evolution of the market covering North America, Europe (UK, France, Italy, Spain, Germany and rest of Europe), Asia Pacific (Japan, China, India and South Korea) and rest of the world. In addition, we have provided the likely evolution and a market attractiveness analysis on the basis of the type of containment system (bulk containers, vials, syringes, ampoules and cartridges). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 80 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities, challenges and likely future trends. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. These included contributions from Steven Nail (Principal Scientist, Baxter BioPharma Solutions), Adam Viverette (Lyophilization Manager, Patheon), Patrick DePalma (Director, CMO Business Development, BioDefense Division, Emergent BioSolutions) and John Shaw (Head of Business Development and Marketing, Vibalogics).

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BCMA Targeted Therapies, 2017-2030

B-cell maturation antigen (BCMA), an important biomarker of the B-cells, has emerged as a promising therapeutic target for the treatment of multiple myeloma and other hematological malignancies. The antigen is universally expressed on the surface of multiple myeloma cells. The research focus shifted towards BCMA targeted therapies in 2004, when the role of BCMA was first indicated in the progression of multiple myeloma. It is the second most common type (13%) of all hematological malignancies. The disease proves to be fatal due to serious complications associated with it and the frequent events of re-occurrence of illness. The widespread presence of multiple myeloma and other related B-cell malignancies demands confident diagnosis and treatments. Hence, there is an immediate need for effective therapies for proper medical care. Currently, researchers are actively involved in developing three major types of immunotherapies (classified by product class) targeting BCMA; these are chimeric antigen receptor T-cells (CAR-T cells), bispecific antibodies and antibody drug conjugates (ADCs). Several biopharmaceutical companies have been active in this area since last few years while others have recently stepped in. A number of strategic partnerships have also been inked between various stakeholders to advance R&D activities in this domain. Results of preclinical and clinical studies have demonstrated the potential benefits of this class of therapies; the major highlight being their attractive safety profile. As more molecules undergo clinical validation and eventually get commercialized, we believe the overall interest will continue to rise. In fact, our promising outlook is backed by a strong belief that this novel class of therapies is likely to cater to the current unmet need where the existing treatment modalities are not efficient. The upside could be higher; however, it depends on a favorable market environment, reimbursement practices and regulatory regimes.   Scope of the Report The “BCMA Targeted Therapies, 2017-2030” report features an extensive study on the current market landscape of B-cell maturation antigen (BCMA) targeted therapies and offers a comprehensive discussion on the future potential of this market. With no commercial products, the market is still in its infancy.However, industry experts have pinned significant hopes on the novel technologies being developed by start-ups / small companies and the research being conducted at academic institutes. The prime target indication of these novel molecules is B-cell malignancies, specifically multiple myeloma. BCMA-specific therapies are anticipated to emerge as viable treatment options for such indications. Post initial research on such therapies, many players have entered into collaborations with other stakeholders to fund the clinical and commercial development of their products. Some clinical stage products that have emerged out of such collaborations include bb2121 (bluebird bio / Celgene) and BCMA-CART (Novartis / Abramson Cancer Center of the University of Pennsylvania). The pipeline currently comprises of 23 molecules that are under development for the treatment of a variety of B-cell malignancies. One of the key objectives of this report was to understand the evolution of the current market and to quantify the opportunities laid down by the innovative BCMA targeted programs of both small and big pharma companies. Among other elements, the report provides information on the following: The current state of the market with respect to key players, phase of development of pipeline products (both clinical and preclinical / discovery) and the type of molecules. Comprehensive profiles highlighting clinical trial details such as dosage regimens, key preclinical / clinical findings, and future market opportunity for the clinical stage BCMA targeted therapies. Comparative analysis of the design of clinical trials being conducted for therapies in clinical stages of development. Various investments and grants received by companies focused in this area supporting their R&D activities. Partnerships that recently been inked amongst different stakeholders, covering product development / commercialization agreements, research collaborations, license agreements and acquisitions. The study provides a detailed market forecast and opportunity analysis for the period between 2017 and 2030. The research, analysis and insights presented in this report are backed by deep understanding of key insights gathered from a variety of sources. To account for future uncertainties and add robustness to our model, we have provided three scenarios of our market forecast, namely the conservative, base and optimistic scenarios. All actual figures have been sourced and analyzed from publicly available information forums. All financial figures mentioned in this report are in USD, unless otherwise specified.

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Cell Therapy Manufacturing Market, 2017-2027

The use of live cells for therapeutic purposes can be traced back to 1968, when patients were first successfully treated with allogeneic human hematopoietic stem cell transplants. This practice has now become an integral part of clinical procedures in the space of bone marrow regeneration and organ transplantation. Cell-based therapies are an emerging segment of the overall biopharmaceutical industry. Post the approval of first cell-based therapy, Carticel, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. Given the personalized nature of these treatment options, they are highly specific and hold the potential to address unmet medical needs associated with the treatment of several disorders. The promising therapeutic potential has led many pharmaceutical companies and investors to put in a significant amount of capital towards the development and commercialization of these therapies. Popular examples of approved cell-based therapies include (in order of their year of approval) Carticel, CreaVax-RCC, JACE, ReliNethra, PROVENGE and Prochymal. In addition, over 500 cell-based therapy candidates are currently in different stages of clinical development; these are being evaluated in over 1,000 active clinical studies in various regions across the globe. The growing number of cell therapy candidates, coupled with their rapid progression through the various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these therapies. The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players as well as academic institutes are significantly contributing to the production of GMP grade cell types. In addition, the market has witnessed the entry of several players that offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. We have observed that such players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for production of cell-based therapies. Looking at the evolutionary trends, we believe that the cell therapy manufacturing market will continue to be steadily driven in the mid to long term by expansion of existing manufacturing facilities and establishment of new dedicated facilities. Technological advancements to mitigate challenges posed by conventional methods of production will act as a key enabler to this growth.   Scope of the Report The “Cell Therapy Manufacturing Market, 2017-2027” report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy developers with in-house manufacturing facilities. These therapies are anticipated to emerge as viable alternatives to conventional treatment options. The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand. Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.  During the course of our study, we identified over 110 organizations that are actively involved in the manufacturing of cell therapies. In addition to other elements, the study provides information on: The current status of the market with respect to key players along with information on the location of their manufacturing facilities, scale of production, type of cells manufactured, purpose of production (fulfilling in-house requirements / as a contract service provider) and the type of organization (industry / non-industry). Most active regions in terms of cell therapy manufacturing with schematic representations of world maps that clearly highlight the global cell therapy manufacturing hubs. Roadmaps published by different agencies across the globe to provide strategies to advance cell therapy manufacturing. Elaborate profiles of key players that offer contract manufacturing services (industry and non-industry) or manufacture cell therapies in-house; each profile covers an overview of the company, information on its manufacturing facilities, and recent collaborations. Partnerships that have taken place in the recent past covering manufacturing and services agreements, agreements specific to technology / instruments / process developments, and mergers and acquisitions. A discussion on the key enablers of the market and challenges associated with the cell therapy manufacturing process. Potential future growth of the cell therapy manufacturing market segmented by the type of cell therapy, source of cells (autologous and allogeneic) and purpose of manufacturing (in-house and contract services). For the purposes of our analysis, we took into consideration several parameters that are likely to impact the growth of this market over the next decade; these include the likely increase in number of clinical studies, patient population, anticipated adoption of commercial cell-therapies and expected variation in manufacturing costs. We have provided an estimate of the size of the market in the short to mid-term and long term for the period 2017 to 2027. The base year for the report is 2016. To account for the uncertainties associated with the development of novel therapeutics and to add robustness to our model, we have provided three forecast scenarios portraying the conservative, base, and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Tim Oldham (CEO, Cell Therapies), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) and Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi), Dr. Gerard J Bos (CEO, CiMaas).

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Deep Learning in Drug Discovery and Diagnostics, 2017 - 2035

Deep learning is a novel machine learning technique that can be used to generate relevant insights from large volumes of data. The term Deep Learning was coined in 2006 by Geoffrey Hinton to refer to algorithms that enable computers to analyze objects and text in videos and images. Fundamentally, deep learning algorithms are designed to analyze and use large volumes of data to improve the capabilities of machines. Companies, such as Google, Amazon, Facebook, LinkedIn, IBM and Netflix, are already using deep learning algorithms to analyze users activities and make customized suggestions and recommendations based on individual preferences. Today, in many ways, deep learning algorithms have enabled computers to see, read and write. In light of recent advances, the error rate associated with machines being able to analyze and interpret medical images has come down to 6%, which, some research groups claim, is even better than humans. The applications of the technology are being explored across a variety of areas. Specifically in healthcare, the American Recovery and Reinvestment Act of 2009 and the Precision Medicine Initiative of 2015 have widely endorsed the value of medical data in healthcare. Owing to several such initiatives, medical big data is expected to grow approximately 50-fold to reach 25,000 petabytes by 2020. Since 80% of this is unstructured, it is difficult to generate valuable / meaningful insights using conventional data mining techniques. In such cases, deep learning has emerged as a novel solution. Lead identification and optimization in drug discovery, support in patient recruitment for clinical trials, medical image analysis, biomarker identification, drug efficacy analysis, drug adherence evaluation, sequencing data analysis, virtual screening, molecule profiling, metabolomic data analysis, EMR analysis and medical device data evaluation are examples of applications where deep learning based solutions are being explored. The likely benefits associated with the use of deep learning based solutions in the above mentioned areas is estimated to be worth multi billion dollars. There are well-known references where deep learning models have accelerated the drug discovery process and provided solutions to precision medicine. With potential applications in drug repurposing and preclinical research, deep learning in drug discovery is likely to have great opportunity. In diagnostics, an increase in the speed of diagnosis is likely to have a profound impact in regions with large patient to physician ratios. The implementation of such solutions is anticipated to increase the efficiency of physicians providing a certain amount of relief to the overly-burdened global healthcare system.   Scope of the Report The “Deep Learning: Drug Discovery and Diagnostics Market, 2017-2035” report examines the current landscape and future outlook of the growing market of deep learning solutions within the healthcare domain. Primarily driven by the big data revolution, deep learning algorithms have emerged as a novel solution to generate relevant insights from medical data. This continuing shift towards digitalization of healthcare system has been backed by a number of initiatives taken by the government, and has also sparked the interest of several industry / non-industry players. The involvement of global technology companies and their increasing collaborations with research institutes and hospitals are indicative of the research intensity in this field. At the same time, the pharma giants have been highly active in adopting the digital models. Companies such as AstraZeneca, Pfizer and Novartis continue to evaluate the digital health initiatives across drug discovery, clinical trial management and medical diagnosis. Some notable examples of such digital health initiatives include GSK and Pfizer’s collaboration with Apple for the use of the latter’s research kit in clinical trials, Biogen’s partnership with Fitbit for using smart wearables in clinical trial management, and Teva Pharmaceuticals’ partnership with American Well to use Smart Inhalers for patients with asthma and COPD. Backed by funding from several Venture Capital firms and strategic investors, deep learning has emerged as one of the most widely explored initiatives within digital healthcare. The current generation of deep learning models are flexible and have the ability to evolve and become more efficient over time. Despite being a relatively novel field of research, these models have already demonstrated significant potential in the healthcare industry. One of the key objectives of this study was to identify the various deep learning solutions that are currently available / being developed to cater to unmet medical needs, and also evaluate the future prospects of deep learning within the healthcare industry. These solutions are anticipated to open up significant opportunities in the field of drug discovery and diagnostics as the healthcare industry gradually shifts towards digital solutions. In addition to other elements, the study covers the following: The current status of the market with respect to key players, specific applications and the therapeutic areas in which these solutions can be applied. The various initiatives that are being undertaken by technology giants, such as IBM, Google, Facebook, Microsoft, NVIDIA and Samsung. The presence of these stakeholders signifies the opportunity and the impact that these solutions are likely to have in the near future. Specifically, we have presented a comparative analysis of the deep learning solutions developed by IBM and Google. Detailed profiles of some of the established, as well as emerging players in the industry, highlighting key technology features, primary applications and other relevant information. The impact of venture capital funding in this area. It is important to mention that since the industry has witnessed the emergence of several start-ups, funding is a key enabler that is likely to drive both innovation and product development in the coming years. An elaborate valuation analysis of companies that are involved in applying deep learning in drug discovery and diagnostics. We built a multi-variable dependent valuation model to estimate the current valuation of a number of companies focused in this domain. Future growth opportunities and likely impact of deep learning in the drug discovery and diagnostics domains. The forecast model, backed by robust secondary research and credible inputs from primary research, was primarily based on the likely time-saving and its associated cost-saving opportunity to the healthcare system. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Mausumi Acharya (CEO, Advenio Technosys), Carla Leibowitz (Head of Strategy and Marketing, Arterys) and Deekshith Marla (CTO, Arya.ai).

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Large Volume Wearable Injectors Market (3rd Edition), 2017-2027

Drug delivery systems optimized to provide flexibility in dosing regimen, reduce the number of hospital visits, decrease dependence on healthcare professionals and enhance adherence to the therapeutic regimen have become the preferred choice of drug administration. The large scale adoption of prefilled syringes, the first ready-to-use injection device to be marketed, demonstrated the growing interest in the concept of such convenient drug delivery systems. In addition, several pen-injectors and autoinjectors have witnessed an impressive growth in the recent past. However, these hand-held devices are only capable of administering drugs with dosing volume close to 1 ml. With over 900 biologics being developed (most of these are highly viscous and are required to be delivered in volumes greater than 1 ml), there is a growing demand for self-administration devices than can overcome this unmet need. Large volume wearable injectors, an advanced version of the existing self-injection devices, are expected to gather interest from a wide customer base. In fact, there are a number of such injectors commercially available for delivery of insulin. OmniPod, from Insulet Corporation, is a very well-known device that has generated significant year-on-year revenue growth. However, it is worth highlighting that till date only a few large volume wearable injectors (for instance, Amgen . Insulet Corporation's OnProTM and West Pharmaceutical's SmartDose Electronic Wearable Injector) have been approved for the administration of a non-insulin biologic. Despite the uncertainties related to the device development and approval, many companies are investing their time, money and resources to develop these novel devices. In addition to the publically known programs, pharma companies have many undisclosed programs that are likely to provide the necessary growth impetus in the long term. It is worth noting that the VC community has demonstrated significant interest in funding projects related to such wearable injectors. These investments are expected to drive further innovation and lead to the introduction of novel device candidates in the industry. Quite recently, in January 2017, scPharmaceuticals closed a series B investment round worth USD 45.6 million. The company intends to use the funding to bring Furoscix and the sc2Wear Infusor to the market in the US. Earlier, in July 2016, SteadyMed Therapeutics raised USD 32 million in a private placement round financed by Deerfield Capital Management, Federated Investors and OrbiMed. In September 2015, CeQur completed a USD 100 million Venture (Series C) financing round, which was led by Woodford Investment Management, Arthurian Life Sciences, Endeavour Vision, VI Partners and Schroders. Several partnerships have also been inked in this domain in the last few years. Most of these are focused on the development / commercialization of a variety of wearable injectors. Such partnerships are important for technological integration, supply of devices and also facilitate the conduct of clinical trials related to drug-device combination products. We believe that the device developers will continue to strive to introduce unique and user-friendly features into their proprietary range of devices. The upgradation of existing devices to more competent / next generation devices will serve as a key driver of immediate near-term growth.   Scope of the Report The “Large Volume Wearable Injectors Market (3rd Edition), 2017-2027” report features an extensive study of the current landscape and the likely future evolution of this category of drug delivery devices over the next ten years. With the increasing incidence of chronic and lifestyle-related diseases across the globe, the demand for efficient drug delivery systems is growing at a rapid pace. In order to simplify the process of drug delivery, eliminate costs and reduce the incidence of needlestick injuries, the pharmaceutical industry has shifted its focus towards the development of self-injection devices for parenteral drugs / therapies. This report specifically lays emphasis on the emergence of such patient-centric, convenient, cost-effective and user-friendly wearable injectors that are capable of administering large volumes of a drug subcutaneously in a home-care setting. It is worth noting that the concept behind such injectors is being widely employed for the delivery of insulin. Over 15 such unique series of injectors (excluding variants) have already entered the market. On the other hand, there is only one large volume wearable injector (mentioned above) approved for the administration of a non-insulin biologic in the US. However, with a variety of biologics under investigation, we believe that device developers have a significant opportunity waiting to be tapped. The field is likely to pick up momentum in the next few years. In fact, an increase in the partnerships and investment activities demonstrate that the market is geared towards significant growth in the mid to long term. One of the key objectives outlined for the study was to evaluate the future potential of the ongoing development programs of both big and small firms. Amongst other elements, the report elaborates on the following areas: An overview of the current market landscape in terms of the key players involved, development status of pipeline products (marketed / under development), type of dose (bolus / continuous / both), usability (disposable / reusable) and key indications. Detailed profiles of large volume wearable devices that are being developed for the delivery of biologics (including insulin), highlighting their key features, current status of development, recent developments and associated collaborations. An exhaustive review of over 300 biologics, which are potential candidates for delivery using large volume wearable injectors. The molecules / therapies have been categorized into most-likely, likely and less-likely candidates for administration using large volume wearable injectors. This categorization is based on various parameters including recommended volume, route of administration, frequency of the dose, standard / weight based dose and the chronicity of target indication. Comprehensive case studies on drugs that are being evaluated for delivery via large volume wearable injectors, highlighting their specifications, mechanisms of action, current status of development, sales, respective dosages and any other recent developments. An illustrative grid representation of the devices based on the category of device (insulin / non-insulin biologic), type of dose and type of device (infusion pump / patch pump). In addition, the report includes an insightful 2 X 2 matrix analysis, highlighting the positioning of the devices based on product competitiveness and supplier power. A discussion on the key drivers and challenges, in terms of the strengths, weaknesses, opportunities and threats (SWOT), which are likely to impact the future growth of this upcoming area. The study provides a detailed market forecast and opportunity analysis for the period between 2017 and 2027. The research, analysis and insights presented in this report include potential sales of the drug-device combinations that are being evaluated and are anticipated to enter the market in the next few years. To add robustness to our model, we have provided three market forecast scenarios, namely the conservative, base and optimistic scenarios. It is worth noting that, although the market of insulin delivery devices is relatively more mature, we have included a high-level opportunity analysis on the large volume wearable injectors being developed for delivery of insulin as well. Our opinions and insights presented in this study were influenced by discussions conducted with several experts in this area. Specifically, we solicited the opinions of senior representatives including Menachem Zucker (VP and Chief Scientist, Elcam Medical), Michael Hooven (CEO, Enable Injections), Ben Moga (President, Ratio Drug Delivery), Pieter Muntendam (President and CEO, scPharmaceuticals), Graham Reynolds, (VP and GM, Biologics, West Pharmaceutical Services) and Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. The financial figures mentioned in this report are in USD, unless otherwise specified.

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Lupus: Clinical Trial Tracker

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissue. The different types of the disease covered in the tracker include systemic lupus erythematosus (SLE), discoid lupus erythematosus (DLE), cutaneous lupus erythematosus (CLE), lupus nephritis and lupus vulgaris. Several drugs, including anti-inflammatory drugs (aspiri