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

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

    November 2019

    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 (infectious diseases, autoimmune disorders, oncology disorders, neurological disorders, ophthalmic diseases, metabolic disorders 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

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

    November 2019

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

    November 2019

    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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  • The non-invasive cancer diagnostics market is projected to grow at annualized rate of nearly 20%, between 2019 and 2030, claims Roots Analysis

    November 2019

    Given the invasive and cost-intensive nature of tissue biopsies, there is a significant unmet need for safer and more patient-friendly cancer diagnostics that are capable of offering highly accurate, and actionable insights related to the disease  Roots Analysis has announced the addition of “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 to its list of offerings.  Advances in the field of biotechnology have enabled the development of several non-invasive approaches for cancer diagnosis with applications ranging from early diagnosis to patient and recurrence monitoring. Leveraging an array of versatile genomic tools, liquid biopsies have emerged as a powerful diagnostic solution, especially in cases where conventional diagnostic tests are inconclusive or the clinical condition is related to an organ that is not amenable to biopsy access. To order this 350+ page report, which features 150+ figures and 200+ tables, please visit this link  Key Market Insights  Close to 300 liquid biopsy-based diagnostics are currently available / under development Nearly 60% such solutions are available for commercial use, while the rest are either available for research purposes only or under development. Presently, majority of these tests are being developed for the isolation and analysis of cell-free DNA (cfDNA); other popular tumor markers analyzed via this method include circulating tumor DNA (ctDNA), circulating tumor cells (CTCs) and exosomes. North America is currently a hub of diagnostics development activity; over 50% of developers are based in this region Recent reports indicate that there are 70 small-sized companies / start-ups, 39 mid-sized players and 6 large and very large business entities based in this part of the world.  USD 3+ billion was invested by both private and public investors, between 2015 and 2019 More than USD 2 billion was raised through venture capital financing alone, representing nearly 80% of the total capital raised. It is worth highlighting that GRAIL raised a total of USD 900 million in its series B financing round. Partnership activity in this domain has increased at an annualized rate of 74% In fact, around 80% of the deals reported in the study were established post 2016; the maximum partnership activity was observed in 2018. Majority of these agreements (80+) were observed to be either distribution & supply agreements and R&D agreements. Several mergers and acquisitions inked between 2016 and 2019 Recent examples include (in reverse chronological order) the acquisition of Bellwether Bio by Guardant Health (2019), MolecularMD by ICON (2019) and Exosome Diagnostics by Bio-Techne (2018). Currently, tests intended for patient monitoring have captured more than 60% of the overall market share Given the challenges related to repeatedly performing invasive biopsies, liquid biopsy is expected to be widely adopted for patient monitoring purposes. However, ongoing efforts to address the high unmet need for early cancer detection are likely to result in an increase in the share of early diagnosis-focused tests, in the foreseen future. Tests for prostate, breast, lung and colorectal cancer are anticipated to capture nearly 70% of the current market share  By 2030, the market is expected to expand significantly as liquid biopsies for other indications, such as bladder cancer, gastric cancer, melanoma, ovarian cancer and pancreatic cancer will likely get introduced. To request a sample copy / brochure of this report, please visit this link Key Questions Answered What are the key applications of liquid biopsy? Apart from liquid biopsy, what are the other novel non-invasive cancer diagnostics? What is the role of big pharma players in the non-invasive cancer diagnostics domain? Who are the key service providers for liquid biopsy products? What are the prevalent financing and investment trends within the liquid biopsy market? What are the most popular cancer indications for which non-invasive diagnostics are being developed? How is the current and future market opportunity likely to be distributed across key market segments? The financial opportunity within the liquid biopsy and other non-invasive cancer diagnostics market has been analyzed across the following segments: Type of Tumor Marker ctDNA cfDNA CTCs Exosomes Others  Application Diagnosis / Early Diagnosis Patient Monitoring Recurrence Monitoring  Target Cancer Indication Breast Cancer Lung Cancer Colorectal Cancer Prostate Cancer Bladder Cancer Melanoma Gastric Cancer Pancreatic Cancer Ovarian Cancer Others End Users Hospitals Research Institutes Others Key Geographical Regions  North America Europe Asia-Pacific Rest of the World The report features inputs from eminent industry stakeholders, according to whom liquid biopsy has the potential to diagnose cancer at a very early stage by analyzing rare circulating tumour markers, thereby, facilitating appropriate / timely treatment decisions. The report includes detailed transcripts of discussions held with the following industry experts: Shibichakravarthy Kannan (Founder and CEO, Theranosis Life Sciences) Abizar Lakdawalla (Founder, ProXeom) Philippe Nore (CEO and Co-founder, MiNDERA) Frank Szczepanski (President and CEO, IVDiagnostics) Mark Li (CEO, Resolution Bioscience) Anton 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) The research includes detailed profiles of key players (listed below), featuring an overview of the companies, their financial information (if available), a description of product(s) offered and an informed future outlook. Amoy Diagnostics DiaCarta HaploX Biotechnology NeoGenomics QIAGEN Swift Biosciences Sysmex Inostics Thermo Fisher Scientific For additional details, please visit  https://www.rootsanalysis.com/reports/view_document/liquid-biopsy-and-nicd-market/279.html or email sales@rootsanalysis.com You may also be interested in the following titles:  Companion Diagnostics Market (2nd Edition), 2019-2030 Novel Technologies for Delivery of Proteins, Antibodies and Nucleic Acids, 2019-2030 Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030 Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com

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  • The Needle-free injection systems and microneedle devices markets are projected to grow at annualized rates of nearly 15% and 20%, respectively, claims Roots Analysis

    October 2019

    Over the years, there has been a rise in preference for self-administration of drugs / therapies, resulting in an increasing demand for user-friendly drug delivery solutions that are not only safe and efficient, but also promote therapy adherence Roots Analysis has announced the addition of “Microneedles and Needle-Free Injection Systems / Jet Injectors (Devices based on Spring, Gas and Other Mechanisms) Market, 2019-2030” report to its list of offerings.  The widespread prevalence of a diverse range of chronic clinical conditions has compelled the pharmaceutical industry to develop better, more advanced, healthcare solutions. Needle-free injection systems and microneedle-based drug delivery devices have been designed to facilitate pain-free dosing experience and also enable the administration of therapeutic formulations that are difficult to deliver via conventional means.  To order this 300+ page report, which features 90+ figures and 115+ tables, please visit this link Key Market Insights  Close to 60 needle-free injection systems are presently available / under development Around 65% of needle-free injection systems are powered with spring actuators, followed by 28% devices which use compressed gas-based actuation mechanisms. It is worth highlighting that there are devices that use electromagnetic / Lorentz force-based actuators as well. Nearly 50 microneedle devices are either already available in the market, or under development Around 38% of such devices use dissolving microneedles, while 30% are based on hollow microneedles. With respect to the length of the needle, 41% of these devices have a needle length of 500-1,000 µ, while 29% claim to use 1,000 µ needles.  More than 70 biologics / small molecule drugs have been identified as likely products to be developed in combination with needle-free injection systems and microneedle devices The report provides insights on over 600+ marketed drugs / therapies and pipeline candidates, assessing the likelihood of whether they may be developed in combination with needle-free injection systems and microneedle devices. The analysis takes into consideration stage of development, dosage, dose concentration, route of administration, type of dose and information on drug sales (for marketed drugs). Outsourcing has emerged as a popular strategy for manufacturing important device components The development of needle-free injection systems and microneedle devices is complex, characterized by the need for multiple components and multidisciplinary technical experience. It is worth highlighting that close to 30% of the total number of CMOs providing services for such injectors, have an employed workforce of more than 1,000 individuals.  North America and Europe are anticipated to capture over 60% of the overall market share by 2030 Growth in this market is anticipated to be primarily driven by reduced instances of needlestick injuries, consequently leading to improved patient compliance. Although developed markets are expected to capture the majority share, in terms of the sales-based revenues, by 2030, the market in Asia-Pacific is anticipated to exhibit a significantly higher annualized growth rate. Chronic disorders and infectious diseases are expected to capture over 65% of the current market share Given the minimally invasive nature of needle-free injection systems and microneedle devices, these products are likely to be preferred by patients suffering from chronic clinical conditions and for the delivery of vaccines, especially to infants.  To request a sample copy / brochure of this report, please visit this link  Key Questions Answered Who are the leading needle-free injection system and microneedle device developers?  What are the prevalent trends within competitive landscape of needle-free injections systems and microneedle devices? What are the types of drug candidates that are suited for delivery via needle-free injections systems and microneedle devices? Who are the key contract service providers involved in this domain?  How is the current and future market opportunity likely to be distributed across key market segments? The financial opportunity within the needle-free injection systems and microneedle devices market has been analyzed across the following segments: Actuation Mechanism (Needle-Free Injection Systems only) Spring-based Gas powered Others  Product Usability (Needle-Free Injection Systems only) Disposable Re-usable  Route of Administration (Needle-Free Injection Systems only) Subcutaneous Intramuscular Intradermal Types of Microneedle Devices (Microneedle Devices only) Hollow Solid Dissolving  Type of Intervention (Microneedle Devices only) Vaccine Therapeutic Agent Others Target Disease Indication Infectious Diseases Osteoarthritis Pain Disorders Cancer Others Key geographical regions  North America Europe Asia Rest of the World The report features inputs from eminent industry stakeholders, according to whom such systems are capable of addressing many of the limitations of conventional parenteral drug delivery, such as the administration of high viscosity formulations and dealing with patients suffering from trypanophobia. The report includes detailed transcripts of discussions held with the following experts: Michael Schrader (Chief Executive Officer and Founder, Vaxess Technologies) Patrick Anquetil (Chief Executive Officer, Portal Instruments) Henry King (Market Intelligence and Business Development Manager, Innoture) The research includes detailed profiles of key players (listed below), featuring an overview of the companies, their financial information (if available), a description of product(s) offered, details of recent developments related to needle-free injection systems and microneedle devices and an informed future outlook. 3M  D'Antonio Consultants International Enesi Pharma Inolife Sciences Inovio Pharmaceuticals Medical International Technology Micropoint Technologies NanoPass Technologies  Nemaura Pharma PharmaJet Valeritas For additional details, please visit  https://www.rootsanalysis.com/reports/view_document/microneedles-and-needle-free-injection-systems--jet-injectors-devices-based-on-spring-gas-and-other-mechanisms-market-2019-2030/276.html or email sales@rootsanalysis.com You may also be interested in the following titles:  Large Volume Wearable Injectors Market (4th Edition), 2018-2030 Novel Technologies for Delivery of Proteins, Antibodies and Nucleic Acids, 2019-2030 Medical Device Contract Manufacturing Market, 2019-2030 Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com

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  • The viral and non-viral vector manufacturing market is anticipated to grow at an annualized rate of over 20%, claims Roots Analysis

    October 2019

    The recent surge in interest in genetically-modified therapies has resulted in a steep rise in demand for different vectors for fundamental and pharmacological research, opening up opportunities for companies with expertise in targeted gene delivery Roots Analysis has announced the addition of “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 to its list of offerings.  Currently, biopharmaceutical developers are plagued by high development costs, complex production protocols and the need for specialized equipment, in order to ensure the safety and quality of complex biological interventions, such as cell and gene therapies. Consequently, a number of innovator companies have demonstrated a preference for outsourcing vector manufacturing, a key aspect of advanced, genetically-modified product development, to contract service providers. To order this 430+ page report, which features 140+ figures and 180+ tables, please visit this link Key Market Insights  The market is fragmented, with over 180 industry players and non-industry players Over 50% of industry players are large or mid-sized firms. In recent years, the growing demand for vectors has spurred the establishment of several start-ups, as well. Further, more than 80 non-industry players, including universities, research institutes and hospitals, are also currently involved in producing viral vectors or plasmid DNA for use in genetically modified therapies  The demand for vectors for research / clinical use is presently more than that for commercial applications Approximately 80% of industry stakeholders presently claim to manufacture vectors at the laboratory and / or clinical scale. However, some firms (around 40, as per our research) have developed / are developing commercial scale capacity for the production of viral vectors or plasmid DNA.  The US and EU have emerged as major vector manufacturing hubs High volume of active clinical studies, requiring vectors, being conducted in these regions makes the US and EU the major vector manufacturing hubs. Approximately 50% of the vector manufacturing facilities are located in North America. This is followed by the EU, where approximately 45% of the world’s vector manufacturing facilities are located. The current installed vector manufacturing capacity in the world is estimated to be over 60,000 L  The major share (70%) of the global vector manufacturing capacity belongs to companies that are manufacturing vectors at both clinical and commercial scales. Across the major global regions, 50% of the total installed vector manufacturing capacity is in the US. This can be attributed to the large number of small-sized and mid-sized companies that are presently situated in this region. Around 140 partnerships were inked during the last three years The maximum number of deals (37) were reported in 2016, followed by 27 partnerships established in 2018. Around 30% of the deals were related to the manufacturing of vectors across different scales of operation; this was followed by technology licensing agreements (23%). 90% of the market share is captured by viral vectors intended for use in oncological disorders  Driven by the rapidly evolving pipeline of genetically modified therapies, including T-cell therapies and vector-based vaccines, and the increasing adoption of advanced production technologies, the vector manufacturing market is projected to grow at an accelerated pace. Specifically, revenues generated from the sales of lentiviral vectors currently represent the largest share of the market, followed by retroviral vectors.  To request a sample copy / brochure of this report, please visit this link Key Questions Answered What are the various types of vectors being used for the production of cell and gene therapies? Who are the leading industry and non-industry players in this market? What is the trend of outsourcing in the vector manufacturing domain? What are the key technical advances / innovations in vector manufacturing? What are the trends in partnership and licensing activity in this domain? What is the installed vector manufacturing capacity across key global geographies? What is the current and future demand for viral and non-viral vectors? How is the current and future market opportunity likely to be distributed across key market segments? Close to USD 2 billion (by 2030) financial opportunity within the vector manufacturing market has been analyzed across the following segments: Type of Vector AAV Adenoviral Lentiviral Retroviral Plasmid DNA Other Vectors Application Gene Therapy T-Cell Therapy Vaccines Therapeutic Area Oncological Disorders Inflammation & Immunological Disorders Neurological Disorders Ophthalmological Disorders Muscle Disorders Metabolic Disorders Cardiovascular Disorders Others  Scale of Operation Preclinical Clinical Commercial Key geographical regions  North America Europe Asia Pacific Rest of the World The report features inputs from eminent industry stakeholders, according to whom there is an evident need for industry stakeholders to modify operational models and expand manufacturing capabilities in order to ensure uninterrupted growth within the market. The report includes detailed transcripts of discussions held with the following experts: 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, (President / Co-Founder, 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) The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), vector manufacturing technology, manufacturing facilities, vector manufacturing experience and an informed future outlook of the company. Aldevron BioReliance (a part of SAFC Commercial) Biovian bluebird bio Brammer Bio Cell and Gene Therapy Catapult Cobra Biologics FinVector FUJIFILM Diosynth Biotechnologies Kaneka Eurogentec Lonza MassBiologics MolMed Novasep Oxford BioMedica Richter-Helm Sanofi (CEPiA, Sanofi Pasteur, Genzyme) Spark Therapeutics uniQure Vigene Biosciences VIVEbiotech WuXi AppTec For additional details, please visit  https://www.rootsanalysis.com/reports/view_document/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/274.html or email sales@rootsanalysis.com  You may also be interested in the following titles:  Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (4th Edition), 2019 – 2030 Gene Therapy Market (3rd Edition), 2019 – 2030 Biopharma Contract Manufacturing Market (3rd Edition), 2019 – 2030 Vaccine Contract Manufacturing Market (2nd Edition), 2019-2030 Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com

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