Pipeline Tracking
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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.
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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.
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June 2019
Natural killer (NK) cells, or killer (K) cells, represent an important subset of cellular mediators of the innate immune system. These cells are known to be instrumental in containing viral infections and regulating tumor development, while the adaptive immune system generates an antigen-specific response. Technically, they are classified as group I innate lymphocytes. Although they share a common progenitor, NK cells are very different from B-lymphocytes and T-lymphocytes, and do not require specific antigen-based activation in order to function. The cytotoxic effects of these cells are mediated using perforin and granzymes, which is somewhat similar to the mode of action of cytotoxic T cells. Additionally, studies have demonstrated that NK cells can also secrete certain cytokines and chemokines, such as IFNγ and TNFα, through which they can recruit other immune components to augment and sustain an immune response. For instance, IFNγ secreted by NK cells has been shown to be involved in T-helper (TH1) cell based immune response, and the activation of certain antigen-presenting cells and macrophages. Alternatively, NK cells have been shown to respond to certain types of interferons and macrophage-derived cytokines. Several studies have demonstrated the various benefits of NK cells as a therapeutic tool. Currently, these cells are being evaluated across multiple clinical trials to treat various types of cancer and infectious diseases. Further, the genetic modification of NK cells has demonstrated additional benefits, and many companies are also working on developing allogenic product candidates that can be used as off-the-shelf therapies. Scope of the Report The “Natural Killer Cell Therapies: Pipeline Review” report features an extensive study of the current market landscape and clinical research scenario related to all NK cell-based products / product candidates. The information in this report has been presented in the form of interactive dashboards, aiming to provide a comprehensive overview of the ongoing activity in this domain, and offering insights on a number of important parameters, including: An analysis of the contemporary developer landscape, providing information on key innovator companies and their respective NK cell therapies, current (highest) phase of development, source of NK cells (autologous and allogenic), target disease indication (hematological malignancies, solid tumors and others), type of therapy (monotherapy and combination therapy), route of administration and other relevant details (if available). Analysis of both completed and active clinical trials, initiated from January 2009, featuring details on (primary) developer company (year of establishment, location of headquarters, and company size), type of developer (industry and non-industry), name of therapy, source of NK cells (autologous and allogenic), and other trial related details (collaborating sponsors, trial title, study objectives, location of trial, current status, availability of results, target therapeutic indication, study type, current / anticipated enrolment, study start / end date and key outcomes / results). Analysis of terminated clinical trials, highlighting the developer company, type of developer (industry and non-industry), name of therapy, source of NK cells (autologous and allogenic), other trial related details (collaborating sponsors, trial title, study objectives, target therapeutic indication and study type) and reason for termination. All information has been sourced and analyzed from company websites, press releases, reliable clinical trial data repositories (such as clinicaltrials.gov), and other publicly available information platforms.
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February 2019
Clinical trials represent an arduous step in the drug development process and are crucial to understanding the safety and efficacy profiles of novel therapeutic interventions. As these trials are prone to delays, and can even fail altogether, they impose an immense financial pressure on sponsors. Amongst several known challenges, patient recruitment is considered to be one of the rate limiting steps when it comes to getting drugs to the market. It is estimated that 80% of clinical trials do not meet their designated patient enrolment deadlines. In fact, around 37% of research sites fail to meet their subject accrual goals, while more than 10% don’t even enroll a single patient. In addition, retaining patients is also a matter of concern, considering that the approximate dropout rate across clinical studies is around 30%. Delays in product launch, due to inability of the sponsors to recruit / retain patients, are highly common and are estimated to result in an average loss of USD 8 million per day in opportunity costs, for a blockbuster drug. The abovementioned challenges have led several players in the pharmaceutical industry to outsource their patient recruitment-related needs to capable, specialty service providers. Employing contract service providers has been shown to expedite the patient recruitment process. Such service providers employ a variety of outreach methods, such as social media, mobile technologies, electronic health records (EHRs) and real-world evidence (RWE), and, over time, have attained a vital role in the successful conduct of clinical research. Although some big pharma players carry out patient recruitment in-house, the growing complexity of clinical trials and demand for niche patient populations for studies evaluating orphan drugs / personalized medicines is likely to prompt more developer companies to outsource various aspects of their clinical research-related operations in the foreseen future. In fact, the market has recently witnessed the establishment of several partnerships, which include agreements between study sponsors and patient recruitment firms (outsourcing deals) and partnerships between stakeholders aimed to combine their respective services portfolios related to patient recruitment and retention (service alliances). This niche services industry has also witnessed some consolidation as multiple smaller players have been acquired by more established entities, in an effort to expand geographical reach. Scope of the Report The ‘Patient Recruitment and Retention Services, 2019-2030’ report offers a comprehensive study of the current scenario and future potential of the players providing patient enrollment and retention services. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape of companies offering patient recruitment and retention services, including information on over 10 types of patient outreach methods employed, types of services offered ([A] patient recruitment (including pre-screening and Institutional Review Board (IRB) / Ethics Committee (EC) submission), [B] patient retention (considering various strategies, such as the use of study-branded gifts, study-branded reminders, providing education and support materials, reimbursement programs, transportation programs, patient engagement web site, patient reconnect programs, mobile applications to track patient engagement and others) and [C] other associated services (including site identification and selection,study feasibility / protocol development, project management, clinical trial monitoring and other services), year of establishment, geographical location, and size of company. The chapter also covers an analysis of the geographical reach and therapeutic expertise of service providers, along with details on the payment model, patient recruitment platforms / technologies used, and the various certifications / accreditations awarded by regulatory bodies. An analysis of the most active regions (in terms of patient recruitment activity), based on the locations of headquarters of companies engaged in this domain, featuring schematic world map representations that highlight key hubs across the globe. An insightful 2X2 representation of the results of a competitiveness analysis of various service providers (segregated into three peer groups based on their employee count (small-sized (1-50 employees), mid-sized (50-200 employees) and large (>200 employees)), highlighting capable players in this domain, based on their respective capabilities. Comprehensive profiles of patient recruitment and retention service providers, featuring information on the location of their headquarters, year of establishment, patient recruitment services / platforms portfolio, recent developments and a comprehensive future outlook. An analysis of the partnerships that have been established in the recent past, covering outsourcing agreements, service alliances, acquisitions, joint ventures, mergers, technology licensing and development agreements, and other forms of partnerships. A review of emerging trends in the industry, including the use of social media, mobile technologies, EHRs and RWE, to overcome the challenges associated with patient recruitment and retention. One of the key objectives of the report was to estimate the existing market size and review the potential growth opportunities for patient recruitment service providers over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2019-2030. In addition, we have segmented the future opportunity across [A] therapeutic area (oncology, infectious diseases, cardiovascular diseases, CNS disorders, respiratory disorders, metabolic disorders, and others), [B] steps in patient recruitment process (pre-screening and screening), [C] phases of development (phase I, phase II, phase III and phase IV), and [D] different global regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Simon Klaasen (Co-founder and Managing Director, Link2Trials) Hagit Nof (Chief Operation Officer and Business Development, nRollmed) Paul Ivsin (Managing Director, Seeker Health) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
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April 2018
Cancer is known to be one of the leading causes of death worldwide, accounting for 0.6 million deaths in 2017 in the US alone. The World Health Organization states that the number of new cancer cases globally is expected to rise by 70% in the coming 20 years. Although cancer therapeutics continue to be one of the most active areas in terms of drug development, there is still a significant unmet need in this domain. Conventional cancer treatments, such as chemotherapy, surgery and radiation therapy, have demonstrated very limited efficacy in late-stage cancers. Specifically, chemotherapy and radiation therapy are also associated with several side effects. Their non-specific nature has severe detrimental effects on the patients’ quality of life. Amidst the current initiatives to develop more targeted anti-cancer therapies, immunotherapy has emerged as a highly potent option to eradicate tumor cells with minimal side effects. It is based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. It encompasses several treatment approaches, such as monoclonal antibodies, immune checkpoint inhibitors, therapeutic vaccines, cytokine therapies and cell-based therapies. In recent years, adoptive T-cell therapy (ACT) has emerged as a potent and viable therapeutic intervention. There are certain key characteristics that render T-cells suitable for use as effective therapeutic tools; these include target specificity, adaptability and the capability to retain immunologic memory. Close to 120 academic and research institutes across the globe have made significant contributions to this field, mostly by convening the initial research on potential product candidates. These efforts have built the intellectual framework for the establishment of several start-ups; in fact, during the last five years, over USD 8 billion has been invested by VC firms / other strategic investors. It is also worth highlighting that there have been more than 200 instances of collaborations between industry / academic stakeholders. The ongoing innovation has also led to the discovery of several novel molecular targets, strengthening the research pipelines of various companies engaged in this domain. Encouraged by the recent approval of two CAR-T therapies, namely Kymriah® (Novartis) and Yescarta® (Gilead Sciences), and a robust development pipeline, the T-cell immunotherapy market offers considerable promise to a number of industry stakeholders. Scope of the Report The “T-Cell Immunotherapy Market, 2018-2030 (3rd edition)” report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies (focusing particularly on CAR-T therapies, TCR therapies and TIL therapies). One of the key objectives of the study was to review and quantify the future opportunities associated with the ongoing development programs of both small and big pharmaceutical firms. Amongst other elements, the report features the following: An analysis depicting prevalent and emerging trends related to T-cell immunotherapies as observed on the social media platform, Twitter. In addition to the yearly chatter trends, the analysis highlights the most frequently talked about product candidates. A detailed assessment of the current market landscape of T-cell immunotherapies with respect to type of therapies, type of developer (industry / non-industry), phase of development, target therapeutic indications, key target antigens, source of T-cells (autologous and allogenic), and route of administration. In addition, we have provided an overview of the competitive landscape, key challenges and anticipated future trends associated with T-cell based therapies. Comprehensive profiles of marketed and mid to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results. An analysis of the CAR constructs of clinical CAR-T therapies based on generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector and type of co-stimulatory domain used. An analysis of the global CAR-T clinical trials registered between 2009 and 2018, highlighting the year wise trend and the distribution across different geographies. An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications. A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers. An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements and others. An analysis of the investments that have been made into companies that have proprietary products / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants and debt financing. A case study on other T-cell based therapies, apart from CAR-Ts, TCRs and TILs. It presents a detailed analysis of the approved / pipeline products in this domain, including information on the current phase of development, target therapeutic areas, type of T-cells used, and source of T-cells. A case study on manufacturing cell therapy products, highlighting the key challenges, and a list of contract service providers and in-house manufacturers that are involved in this space. An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a T-cell based immunotherapy that is likely to be marketed in the coming years. A review of the key promotional strategies that have been adopted by the developers of the marketed T-cell therapies, namely Kymriah and Yescarta. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. The report includes potential sales of T-cell immunotherapies that are currently marketed or are in late stages of development. Additionally, the chapter presents a detailed market segmentation on the basis of type of therapy (CAR-T, TCR and TIL), geography (North America, Europe and Asia Pacific) and target indications (acute lymphoblastic leukemia, acute myeloid leukemia, bladder cancer, cervical carcinoma, chronic lymphocytic leukemia, esophageal cancer, head and neck cancer, multiple myeloma, hepatocellular carcinoma, melanoma, non-Hodgkin’s lymphoma, non-small cell lung cancer, ovarian cancer and synovial sarcoma). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals: Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) Miguel Forte (Chief Operating Officer, TxCell) Peter Ho (Director, Process Development, Iovance Biotherapeutics) Tim Oldham (Chief Executive Officer, Cell Therapies) Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) Vincent Brichard (Vice President, Immuno-Oncology, Celyad) Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
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February 2018
The concept of gene transfer into mammalian cells can be traced back to the 1920s. However, the first gene therapy, Gendicine® , was only approved in 2003 in China; since then, the domain has evolved significantly. The year 2017 was particularly eventful; despite the withdrawal of Glybera from the European market in early 2017, the latter half of the year witnessed the approval of two gene therapies, namely Invossa™ and Luxturna™. In fact, Luxturna™ became the first gene therapy to gain approval in the US. Further, promising clinical results were reported for several gene therapies that are currently in late phases of development. The growing popularity and potential of gene therapies can be correlated with an exponential increase in the number of patents that have been filed; the cumulative number has increased from 7,300 patents in 2013 to 42,300 patents till the third quarter of 2017. Further, over the past five years, capital worth more than USD 9.8 billion has been invested by venture capital (VC) firms and government bodies to fund research activities in this domain. The overall market is expected to witness significant growth in opportunities for a variety of stakeholders in the coming decade. It is important to highlight that several technology providers, aiming to develop and / or support the development of gene therapies, with improved efficacy and safety, have designed and already introduced advanced platforms for the engineering of vectors. Innovation in this domain has also led to the discovery of novel molecular targets and strengthened the research pipelines of companies focused in this space. The capability to target diverse therapeutic areas is considered to be amongst the most prominent growth drivers of this market. Scope of Report The ‘Gene Therapy Market (2nd Edition), 2018-2030’ report provides an extensive study on the current market landscape of gene therapies, with a prime focus on gene augmentation based therapies and oncolytic viral therapies, featuring an elaborate discussion on the future potential of this evolving market. Amongst other elements, the report features: A detailed assessment of the current market landscape of gene therapies, providing information on various drug / therapy developers, phase of development (clinical, preclinical or discovery stage) of product candidates, key therapeutic areas and indication(s), information on gene type, vector type, type of therapy (ex vivo, in vivo) and type of modification (gene augmentation, oncolytic viral therapy and others). A discussion on the various types of viral and non-viral vectors, highlighting information on design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vectors. A world map representation, depicting the most active geographies in terms of the presence of companies developing gene therapies, and a bull’s eye analysis highlighting the distribution of clinical pipeline candidates in terms of phase of development, type of vector and type of therapy (ex vivo / in vivo). Comprehensive profiles of marketed drugs, highlighting their history of development, current developmental status, mechanism of action, affiliated technology, patent portfolio, dosage and manufacturing, and information on the developer. Comprehensive profiles of clinical stage (phase II/III and above) drug candidates, highlighting their current status of development, mechanism of action, affiliated technology, patent portfolio, clinical trial information and recent developments. A section on emerging technologies and platforms that are aiding the development of gene therapies, featuring detailed profiles of technologies that are presently being used in the development of four or more products / product candidates. An overview of the most commonly targeted therapeutic indications and details on the gene therapies that are being developed against them. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. A detailed analysis of the recently filed patents (since 2013); the study highlights the emerging trends in innovation and identifies the key players involved. In addition, it presents a high-level view on the valuation of these patents as well. A case study on the prevalent and emerging trends in vector manufacturing, with information on companies offering contract services for manufacturing vectors. The study includes a detailed discussion on the manufacturing processes of various types of vectors as well. An analysis on the various factors that may form the basis for the pricing of gene therapies, featuring different models / approaches that may be adopted in order to decide the price of a product that is likely to be marketed in the coming years. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2018-2030. To account for the uncertainties associated with the development of gene therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Adam Rogers (CEO, Hemera Biosciences), Al Hawkins (CEO, Milo Biotechnology), Cedric Szpirer (Executive & Scientific Director, Delphi Genetics), Christopher Reinhard (CEO and Chairman, Cardium Therapeutics), Jeffrey Hung (CCO, Vigene Biosciences), Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory) and Michael Triplett (CEO, Myonexus Therapeutics). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
...read moreMay 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 moreMay 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 moreApril 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
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