NEW YORK, Oct. 1, 2019 /PRNewswire/ —
INTRODUCTION
CAR-T cell therapies are based on the principle of harnessing the innate potential of the immune system to selectively target and destroy diseased cells. Encouraging clinical results reported across several completed and ongoing trials, coupled to lucrative financing, have inspired many biopharmaceutical developers and academic research groups to focus their efforts on this relatively novel class of cell-based immunotherapies. With two approved products, namely KYMRIAH® (Novartis) and YESCARTA® (Gilead Sciences), CAR-T cell therapies are presently considered among the most promising anticancer therapeutics available, with potential applications in treating other diseases as well. It is worth highlighting that 66% of the pipeline therapies are presently in the clinical stage.
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Over 100 companies and 85 academic / research institutes are actively involved therapy development initiatives in this domain. The ongoing research activity in this domain has led to the discovery of several novel molecular targets, which can be exploited for cell therapy development. Further research and characterization of these targets has significantly strengthened the pipelines of stakeholder entities engaged in this market. Driven by the availability of innovative technology platforms, the CAR-T therapies market is poised for success in the long-run as several therapeutic leads have recently entered mid to late-stage (phase II and above) trials and are anticipated to enter the market over the next 5-10 years.
SCOPE OF THE REPORT
The “CAR-T Therapies Market, 2019-2030 (2nd edition)” report features an extensive study of the current market landscape and the future potential of CAR-T cell therapies. The report highlights the efforts of both industry players and academic organizations working in this domain. Amongst other elements, the report features the following:
• An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, highlighting the yearly trend of tweets, most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers.
• A detailed assessment of the current market landscape of CAR-T cell therapies with respect to type of developer (industry / non-industry), phase of development, target therapeutic indication(s), key target antigen(s), source of T-cells (autologous / allogenic), route of administration, type of therapy (monotherapy / combination therapy) and patient segment (children / adults / seniors).
• Comprehensive profiles of marketed and mid to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan and key clinical trial results.
• An analysis of the CAR constructs of clinical-stage CAR-T therapies based on the generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector and type of co-stimulatory domain used.
• A detailed analysis highlighting several key opinion leaders (KOLs) in this domain. It features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, indicating the geographical locations of eminent scientists / researchers involved in the development of CAR-T cell therapies.
• An analysis of the various CAR-T cell therapy focused clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend of initiation of such studies and distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies, especially in China.
• An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications.
• A detailed discussion on innovative technology platforms that are being used for the development of CAR-T cell therapies, along with profiles of key technology providers. Further, it includes a relative competitiveness analysis of different CAR-T cell therapy-based gene editing platforms, based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology.
• A case study on manufacturing cell therapy products, highlighting the key challenges, and a list of contract service providers and in-house manufacturers that are involved in this space.
• An elaborate discussion on various factors that form the basis for pricing of cell therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a CAR-T cell therapy that is likely to be marketed in the coming years.
• A review of the key promotional strategies that have been adopted by the developers of the marketed CAR-T cell therapies, namely KYMRIAH® and YESCARTA®.
One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for CAR-T cell therapies over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such therapies, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report includes potential sales forecasts of CAR-T cell therapies that are currently marketed or are in late stages of development. Additionally, it provides forecasts for the overall CAR-T cell therapy market, wherein both the current and upcoming opportunity is segmented across [A] target indications (acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, multiple myeloma, chronic lymphocytic leukemia, hepatocellular carcinoma and colorectal cancer), [B] important target antigens (CD19, BCMA, GPC3 and EGFR) and [C] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.
The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):
• Tim Oldham (Chief Executive Officer, Cell Therapies)
• Vincent Brichard (Vice President, Immuno-Oncology, Celyad)
• Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital)
• Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics)
• Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies)
• Adrian Bot (Vice President, Scientific Affairs, Kite Pharma)
• Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys)
• Miguel Forte (Chief Operating Officer, TxCell)
• Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado)
• Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts’ views
While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured during our research. It offers a high-level view on the likely evolution of the CAR-T cell therapy market in the short to mid-term and long term.
Chapter 3 provides a general overview of CAR-T cell therapies. In this section, we have briefly discussed the conventional forms of therapy that are being used for the treatment of various oncological indications. Further, it includes a discussion on the advent and historical evolution of cancer immunotherapy, general manufacturing procedure of CAR-T cell therapies, factors supporting the growing popularity of CAR-T cell therapies and the challenges associated with such therapies.
Chapter 4 provides insights on the popularity of CAR-T cell therapies on the social media platform, Twitter. The section highlights the yearly distribution of tweets posted on the platform in the time period 2012-2019, and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter highlights the most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers.
Chapter 5 provides information on close to 500 CAR-T cell therapies that are currently approved or are in different stages of development (clinical and preclinical / discovery). It features a comprehensive analysis of pipeline molecules with respect to the type of developer(s), phase of development, target therapeutic area(s) and indication(s), key target antigen(s), source of T-cells (autologous / allogenic), route of administration, type of therapy (monotherapy / combination therapy) and patient segment. Further, the chapter features the most active players (in terms of number of pipeline candidates).
Chapter 6 presents a collection of key insights derived from the study. It includes a bubble analysis, highlighting the most popular targets of CAR-T cell therapies in hematological cancer and solid tumor space. To offer due credit to the work of eminent researchers in this domain, we have mapped the presence of key opinion leaders (who are involved in this field of research) across the globe. In addition, we have presented an analysis of the CAR constructs being used in the clinical CAR-T therapies on the basis of generation of CAR-T therapy, type of binding domain, type of vector and type of co-stimulatory domain.
Chapter 7 presents an analysis of the CAR-T clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend and the distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies market in China.
Chapter 8 provides detailed profiles of marketed and mid to late stage CAR-T therapies (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.
Chapter 9 identifies the most commonly targeted therapeutic indications, including hematological cancers and solid tumors and features brief discussions on the CAR-T cell therapies being developed against them. The section also highlights key epidemiological facts and the currently available treatment options for each indication.
Chapter 10 provides a list of technology platforms that are either available in the market or are being designed for the development of CAR-T cell therapies. A detailed discussion on innovative technology platforms that are being used for the development of CAR-T cell therapies, along with profiles of key technology providers. Further, it includes a competitiveness analysis of different CAR-T-based gene editing platforms, based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology.
Chapter 11 provides insights on cell therapy manufacturing, highlighting the current challenges that exist in this domain, and the pre-requisites for owning and maintaining cell therapy manufacturing sites. It includes a list of various cell therapy manufacturers, covering both contract manufacturing organizations and companies with in-house manufacturing capabilities. For the players mentioned in the chapter, we have included details on location of various manufacturing facilities, the products being manufactured, scale of operation and compliance to cGMP standards.
Chapter 12 highlights our views on the various factors that must be taken into consideration while deciding the prices of cell-based therapies. It features discussions on different models / approaches that a pharmaceutical company may choose to follow to decide the price at which their CAR-T cell therapy product can be marketed. Additionally, we have provided a brief overview of the reimbursement consideration for CAR-T cell therapies and a case study on the National Institute for Health and Care Excellence (NICE) appraisal of CAR-T therapy.
Chapter 13 features an elaborate discussion on the future commercial opportunity offered by CAR-T cell therapies. It provides a comprehensive market forecast analysis for molecules that are approved or are in different phases of development (phase I/II and above), taking into consideration the target patient population, existing / future competition, likely adoption rates and the likely price of different therapies. The chapter also presents a detailed market segmentation on the basis of [A] target indications (acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, multiple myeloma, chronic lymphocytic leukemia, hepatocellular carcinoma and colorectal cancer), [B] important target antigens (CD19, BCMA, GPC3 and EGFR) and [C] key geographical regions (North America, Europe and Asia Pacific).
Chapter 14 highlights the key promotional strategies that are being implemented by the developers of the marketed products, KYMRIAH® and YESCARTA®. The promotional aspects covered in the chapter include details that are provided on the product website (covering key messages for patients and healthcare professionals), patient support offerings and informative downloadable content.
Chapter 15 includes brief company profiles of the leading players in the CAR-T cell therapy market. Each company profile includes an overview of the developer and brief description of the product portfolio specific to CAR-T cell therapies, technology portfolio (if available), recent developments related to CAR-T cell therapies and manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.
Chapter 16 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.
Chapter 17 is a collection of transcripts of interviews conducted with key stakeholders in the market. In this chapter, we have presented the details of our conversations with Tim Oldham (Chief Executive Officer, Cell Therapies), Vincent Brichard (Vice President, Immuno-Oncology, Celyad), Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital), Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics), Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies), Adrian Bot (Vice President, Scientific Affairs, Kite Pharma), Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys), Miguel Forte (Chief Operating Officer, TxCell), Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) and Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing).
Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 19 is an appendix, which contains the list of companies and organizations mentioned in the report.
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