Media Citations

Our Reports

A wide portfolio of market research reports in the healthcare industry

latest reports

  • Abuse Deterrent Formulation Technologies Market, 2019-2030

    Abuse Deterrent Formulation Technologies Market, 2019-2030

    July 2019

    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.

    ...read more
  • Vaccine Contract Manufacturing Market (2nd Edition), 2019-2030

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

    July 2019

    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 demand for vaccines (in mL), taking into account the 20 top selling vaccines, based on various parameters, such as target patient population, dosing frequency and dose strength. 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] commonly outsourced vaccine-related operations (cell / virus banking, analytical development / testing, formulation, process development, fill / finish and regulatory filings) [B] types of expression systems (mammalian, microbial and others), [C] size of contract service provider 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. 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.

    ...read more
  • T-Cell Immunotherapies Market (4th Edition), 2019-2030

    T-Cell Immunotherapies Market (4th Edition), 2019-2030

    July 2019

    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 “T-Cell Immunotherapy Market, 2019-2030 (4th 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). 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.

    ...read more

trending reports

press releases

  • Driven by the growing demand for personalized therapies, the companion diagnostics market is anticipated to grow at an annualized rate of ~7.5%, predicts Roots Analysis¬†

    May 2019

    Roots Analysis has announced the addition of “Companion Diagnostics Market (2nd Edition), 2019-2030” report to its list of offerings. Ishita Nanda and Rohan Mukhopadhyay, the principal analysts, stated, “Given the influx of novel technologies and growing demand for personalized medicine, companion diagnostics have gradually become a necessity for modern pharmacological interventions. Tailored therapies are expected to transform healthcare practices, offering improved treatment outcomes, eliminating adverse reactions and, in a way, reducing cost and time barriers associated with drug development and approval. Currently, over 140 companion diagnostics are available / under development for a range of disease indications.”  The report presents opinions on several key aspects of the market. Among other elements, it includes:  A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, availability to patients, corresponding drug(s) / drug class, affiliated biomarkers, 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). It is worth noting that around 87% of the pipeline candidates are being developed for the treatment of oncological indications; of these, more than 35% are being investigated for the treatment of breast and lung cancer. Examples include (in alphabetical order, no specific selection criteria) AmoyDx® EGFR 29 Mutations Detection Kit, FoundationOne CDx™, HER2 FISH pharmDx™ Kit, PathVysion HER-2 DNA Probe Kit, therascreen® EGFR RGQ PCR Kit and VENTANA PD-L1 (SP142) Assay.   Elaborate profiles of developers of companion diagnostics (shortlisted based on strength of product portfolio), featuring an overview of the company, its financial information (if available) and a detailed description of companion diagnostics available / under development. In addition, each profile includes a list of recent collaborations and the likely strategies that may be adopted by these players to support future growth.  An in-depth brand positioning analysis of leading industry players (shortlisted based on 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. It highlights the key strengths / competitive advantages, including our rationale justifying its position as a competitive entity in the market.  An analysis of the partnerships and collaborations pertaining to companion diagnostics for the period 2014-2019, featuring a comprehensive set of analyses based on parameters, such as the type of partnership (R&D collaborations, licensing agreements, acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, and other relevant deals), affiliated biomarkers, therapeutic areas and the most active players. It is worth noting that product development agreement was the most popular type of deal inked in this domain, representing 33% of the total number of collaborations.  A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) that are involved in this domain. The analysis features a qualitative assessment of the current and long-term needs of different stakeholders involved in this domain. It further compares the needs of the drug developers that are involved in development of companion diagnostic tests for their drug molecules, offering a combined perspective on the current and the future scenarios. A discussion on various steps involved in the development of a companion diagnostic test, namely R&D, clinical assessment, manufacturing and assembly, payer negotiation and marketing / sales activities. It also includes and assessment of the cost requirements across each of the aforementioned stages. It is worth mentioning that presently R&D costs are estimated to account for 30-33% of the total expenditure involved in the development of a companion diagnostic. A comprehensive clinical trial analysis of completed, ongoing and planned studies of 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. In the past few years, several organizations, such as (in alphabetic order), AbbVie, Amgen, AstraZeneca, Eli Lilly, Novartis emerged as the leading industry sponsors / collaborators that are engaged in clinical research efforts in this domain.  A comprehensive market forecast analysis based on the primary growth drivers, disease incidence, adoption of companion diagnostic tests and the likely prices, for the period 2019-2030.The report includes information on the likely distribution of the current and forecasted opportunity across the following segments: Type of therapeutic area (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))  Type of techniques used (In situ hybridization, immunohistochemistry, next-generation sequencing, and polymerase chain reaction)  Key geographical regions (North America, Europe and Asia Pacific). Companion diagnostics intended for the treatment of oncological disorders are expected to capture majority of the market share (~80%) by 2030, while those being evaluated for the treatment of neurological disorders are anticipated to grow at a relatively faster rate during the forecast period. Further, North America (primarily the US) and Europe are anticipated to capture the majority share by 2030, in terms of the sales-based revenues.  Mukhopadhyay further remarked, “Despite the increasing demand of personalized medicine, the full potential of companion diagnostics continues to remain untapped owing to an array of concerns associated with their development, regulations and affiliated reimbursement policies. It is worth mentioning that various pharma giants have opted to collaborate or acquire diagnostic developers having broad testing portfolios, in order to meet the growing demand in this domain”.  The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no specific selection criteria): Abbott Agilent Technologies Biocartis bioMérieux  Foundation Medicine Guardant Health Illumina Invivoscribe Myriad Genetics NanoString Technologies QIAGEN  Roche Thermo Fisher Scientific For additional details, please visit https://rootsanalysis.com/reports/view_document/companion-diagnostics-market-2nd-edition-2019-2030/251.html or email sales@rootsanalysis.com  Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com

    ...read more
  • With an investment of over USD 1 billion and an intellectual capital spread across ~3,000 patents, the Encapsulated Cell Therapies and Encapsulation Technologies Market is set to witness a rapid growth, predicts Roots Analysis

    May 2019

    Roots Analysis has announced the addition of “Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030” report to its list of offerings.  Nupur Singh, the principal analyst, stated, “Extensive research on cell encapsulation strategies has enabled the development of a variety of technologies capable of immobilizing / enclosing therapeutic entities within biocompatible matrices / carriers. Such products offer a myriad of advantages, and have demonstrated the capability to address existing challenges related to cell therapies and certain other types of interventions as well. Currently, more than 25 encapsulated therapy products are being evaluated across different stages of development for the treatment of various chronic disorders. Of these, some products are already in mid to late-stage (phase II and above) of development and are likely to enter the market in the next 5-10 years.”  The report presents opinions on several key aspects of the market. Among other elements, it includes: A detailed assessment of the current market landscape of encapsulated cell therapies and affiliated technologies, highlighting various target disease indications, phase of development of various encapsulated therapy candidates, 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 various applications. It is worth noting that around 45% of the pipeline candidates are being developed for the treatment of metabolic disorders; of these, more than 70% are being investigated for the treatment of type 1 diabetes. Examples include (in alphabetical order, no specific selection criteria) ßAir Bio-artificial Pancreas (Beta-O2 Technologies), hPSC (Kadimastem), Neo-Islets (SymbioCellTech), PEC-Encap™ (ViaCyte), Sig-002 (Sigilon Therapeutics / Eli Lilly), SR-01 (Seraxis), and TARGETBCD (Evotec / Sanofi).  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. During our research, we came across more than 3,000 patents that have been filed / granted since 2013. In fact, since 2014, more than 500 patents have been filed / granted each year across the globe; close to 580 patents were filed / granted in 2018 alone. It is worth noting that the R&D activity was observed to be concentrated in the US, which is evident from over 1,600 patents that were filed / granted in this region during the given time period. Other key regions with significant intellectual capital related to encapsulated cell therapies include (in decreasing order of number of patents filed / granted) Australia, Europe, Canada, Japan, China, and Israel. 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, enrolled patient population and regional distribution of trials. In the past few years, several organizations, such as (in decreasing order of number of trials conducted) Stanford University, National Eye Institute, National Institutes of Health Clinical Center, University Hospital Brussels, Lowy Medical Research Institute, and Thomas Jefferson University, have emerged as the leading non-industry sponsors / collaborators that are engaged in clinical research efforts in this domain. It is also worth highlighting that disease-related parameters and safety / efficacy are amongst the most important clinical end points (measured across all trial phases) considered in studies evaluating encapsulated therapy products. An analysis of contemporary development landscape of more than 300 stakeholders that are engaged in the cell therapies domain. The analysis reveals companies that have the necessary expertise to help encapsulated cell therapy developers across various development processes in this field, highlighting the likely strategic partners across different regions. More than 40 cell therapy developers emerged as the most likely potential strategic partners in North America, based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing partnerships and developer strength. Examples of such companies include (in alphabetical order, no specific selection criteria) Gradalis, Innovative Cellular Therapies, Iovance Biotherapeutics, Juno Therapeutics, Kite Pharma, Tmunity Therapeutics, and TVAX Biomedical. A comprehensive market forecast analysis based on the primary growth drivers, the licensing deal structures and agreements that are expected to be signed over the course of next ten years. In addition, the report also includes information on (potential) sales-based revenues generated by encapsulated therapy products 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. It features likely distribution of the current and forecasted opportunity across the following segments: Type of therapeutic area (eye disorders, metabolic disorders, neurological disorders, and oncological disorders) Type of target disease indication (ataxia telangiectasia, breast cancer, diabetes, glaucoma, head and neck cancer, macular telangiectasia, metastatic and non-metastatic pancreatic cancer, Parkinson's disease, and retinitis pigmentosa) Type of encapsulation material used (alginate-based microcapsules, cellulose hydrogels, medical-grade plastics, and red blood cells) Key geographical regions (North America, Europe and Asia Pacific).  Licensing deals are expected to remain the primary source of income for stakeholders in the short-mid term. It is also worth highlighting that encapsulated therapy products intended for the treatment of oncological disorders are expected to capture majority of the market share (~45%) by 2030, while therapy candidates being evaluated for the treatment of metabolic disorders are anticipated to grow at a relatively faster rate during the forecast period. Further, North America (primarily the US) and Europe are anticipated to capture the majority share by 2030, in terms of the sales-based revenues. This can be attributed to the fact that majority of mid-late stage product development programs in this domain, are centered in these regions. In 2030, North America is projected to capture around 50% of the overall market share in this domain. 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. It is worth noting that close to USD 400 million was raised through venture capital financing, representing around 40% of the total capital raised by industry players in the period 2013-2018. Within these instances, we noted that the maximum amount invested was through Series B funding rounds, wherein a sum of over USD 150 million was raised by various companies, from multiple investors. Further, in the last six years, more than 70 grants were awarded to various academic / research institutes in the US alone. Majority of these grants were provided to support research projects (31%) under the R01 mechanism (research grants), followed by grants awarded under R21 mechanism (exploratory / development grants, 14%).   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. It is worth noting that research and product development agreements were the most popular type of deals inked in this domain, each representing 20% of the total number of collaborations. Other popular agreement models adopted by companies in this industry include product / technology licensing agreements, clinical trial agreements, distribution agreements, regulatory service agreements, and product development and commercialization agreements. 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. In addition, each profile 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 foreseen future. The report features inputs from a number of eminent industry stakeholders. Singh remarked, “Most industry experts concur on the opinion that the market is still niche and, in the short-term, technology developers will continue to rely on technology access fees, and other payments from licensing deals related to their proprietary technologies”. The report also features detailed transcripts of discussions held with the following experts: 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) The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no specific selection criteria): ALTuCELL Azellon Cell Therapeutics Beta-Cell Betalin Therapeutics CellProtect Biotechnology Diatranz Otsuka Encellin EryDel Gloriana Therapeutics Living Cell Technologies MaxiVAX Neurotech Pharmaceuticals PharmaCyte Biotech Semma Therapeutics Sernova For additional details, please visit https://rootsanalysis.com/reports/view_document/cell-encapsulation-focus-on-therapeutics-and-technologies-2019-2030/249.html or email sales@rootsanalysis.com  Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com

    ...read more
  • Driven by the growing demand for biologics, the biopharmaceutical contract manufacturing market is expected to grow at an annualized rate of 8.1%, predicts Roots Analysis

    April 2019

    Roots Analysis has announced the addition of “Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030” report to its list of offerings.  Souvik Mohanta, the principal analyst, stated, “Since 2000, more than 115 new CMOs, focused on biopharmaceuticals, have been established. The current biopharmaceutical contract manufacturing landscape features the presence of several established and emerging CMOs, with a diverse set of production capabilities.” The report presents opinions on several key aspects of the market. Among other elements, it includes:  A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring a comprehensive list of over 235 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 strength, 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. It is important to mention that majority of these firms offer services for proteins and peptides (140+), antibodies (125+), and vaccines (80+).  A 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. It is worth mentioning that antibody-based therapies, such as antibody drug conjugates (180+ candidates) and bispecific antibodies (150+ candidates), along with the more complex cell therapies (600+ candidates) and gene therapies (350+ candidates), require specialized infrastructure and handling expertise, thereby, causing innovator companies to rely more on specialty CMOs for their development and manufacturing. CMOs, such as (in alphabetical order, no selection criteria) apceth Biopharma, Brammer Bio, Cell and Gene Therapy Catapult, KBI Biopharma, Waisman Biomanufacturing and WuXi AppTec, claim to specialize in offering services for complex biologics. An informed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders 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)). It is worth mentioning that the current installed contract manufacturing capacity is over 4.5 million litres and is well distributed across various geographies. Currently, more than 50% of the capacity is captured by mammalian expression systems. The remaining share is occupied with microbial and other expression systems.  An analysis of the partnerships and collaborations focused on contract manufacturing of biologics, featuring a comprehensive set of analyses based on various parameters, such as the headquarters of partner companies, year of partnership, type of partnership, therapeutic area, most active players and geographical location. Over the last six years, close to 450 strategic partnerships have been inked between stakeholders in the biopharmaceutical contract manufacturing market. It is worth noting that 50% of these agreements were product-based deals signed for various purposes, including the development, manufacturing and commercialization of biologics. In addition, of the total number of partnership instances, majority were signed for cell therapies (25%) and antibodies (20%).  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. The analysis also depicts the relationship between important deal multiples based on the revenue, number of employees and experience of the acquired companies. Over 50 strategic mergers and acquisitions have recently taken place between different CMOs. It is important to highlight that 23% of the total acquisitions were signed for vaccines, followed by those signed for peptides / proteins (16%) and cell therapies (16%). 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. Over 135 recent expansions were reported between 2013-2018; of these, 75% were focused on the addition of new facilities, or expansion of existing facilities.  An analysis of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products. Currently, the demand of biologics that are being marketed / investigated is primarily driven by patient segments of  oncological disorders and infectious disorders, accounting for ~40% of the total demand. A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs. With over 900 biosimilars under development, the market is highly likely to witness a surge in the demand for contract service providers.   A comprehensive market forecast analysis, based on parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, and direct manufacturing costs, along with 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. The report features likely distribution of the current and forecasted opportunity across the following segments: Commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)) Types of expression systems (mammalian, microbial and others)  Size of the company (small-sized, mid-sized and large / very large) Scale of operation (preclinical, clinical and commercial)  Key geographical regions (North America (the US and Canada), Europe (the UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia)) North America currently holds the larger share (40%) of the market and is anticipated to grow at an annualized growth rate of 7.4%. However, markets in the Asia-Pacific are expected to grow at a significantly higher rate (8.9%), owing to inherent advantages, such as relatively low labor costs and less stringent regulatory constraints. 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. It is worth mentioning that one-third of the responders were at CXO level, 42% formed a part of senior management and 25% responders       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. The report features inputs from several eminent industry stakeholders. Mohanta remarked, “Most industry experts concur that the current bioprocessing challenges can be addressed / mitigated by the integration of emerging technologies, such as single-use technologies, resulting in enhanced productivity levels.” The report also features detailed transcripts of discussions held with the following experts: Astrid Brammer (Senior Manager Business Development, Richter-Helm Biotec) 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) The research covers detailed profiles and assesses service portfolios of several companies (illustrative list below); 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 an informed future outlook. 3P Biopharmaceuticals Abzena Albany Molecular Research Baxter International BioVectra BioXcellence™ (Boehringer Ingelheim) Catalent Celonic CEPiA - Sanofi Charles River Laboratories ChemPartner Cobra Biologics CordenPharma Cytovance Biologics Grand River Aseptic Manufacturing IDT Biologika Kemwell Biopharma LFB Biomanufacturing Lonza Meridian Life Science Patheon Pfizer CentreOne Piramal Pharma Solutions PX'Therapeutics Thermo Fisher Scientific Vetter Pharma International WuXi Biologics For additional details, please visit  https://rootsanalysis.com/reports/view_document/biopharma-contract-manufacturing-market-3rd-edition-2019-2030/250.html  or email sales@rootsanalysis.com  Contact: Gaurav Chaudhary +1 (415) 800 3415 Gaurav.Chaudhary@rootsanalysis.com

    ...read more

The Roots Analysis Edge

200 +

Reports

40 +

Major Pharma Markets

400 +

Clients

50 +

Analytical Frameworks

Consulting

Market insights from across the industry value chain tailored to meet your business needs

  • All
  • Drug Discovery
  • Research & Development
  • Commercialization
  • Affilated services
  • Pipeline Tracking

  • Therapy Area Assessment

  • Clinical Trial Tracking

  • KOL Selection

  • Publication Analysis

  • Investment Analysis

  • Market Assessment

  • Deal Tracking

  • Competitive Profiling

  • Commercial Strategy and Business Development

Why Choose Us?

We are your partners with no equity

We fit in your budget

We love what we do

chance to prove ourselves

Best in class quality of work

Most trusted consulting partner in the industry