Driven by high success rates in clinical trials and the potential to confer sustained periods of disease remission, T-cell therapies have received significant financial support, with approved products poised to soon achieve blockbuster status
Having demonstrated the ability to selectively eradicate tumor cells from the body with minimal treatment-related side effects, T-cell therapies have emerged as a promising therapeutic strategy for advanced stage cancers. With three approved therapies, namely KYMRIAH® (Novartis), YESCARTA® (Gilead Sciences) and TECARTUS® (Gilead Sciences), the T-cell immunotherapy pipeline has evolved significantly over the past few years, with several mid to late-stage (phase II and above) candidates anticipated to enter the market over the next 5-10 years.
Key Market Insights
Over 975 T-cell candidate therapies are currently approved / under development
CAR-T cell products continue to dominate the clinical / preclinical pipeline, representing 78% of the total number of molecules, followed by TCR (15%) and TIL (7%) based therapies. Close to 40% of the aforementioned candidates are in preclinical and discovery stages, while more than 10% are being evaluated in late clinical stages (phase II and above). Examples of late-stage clinical candidates include bb2121, JCAR017, GSK3377794, IMCgp100 and lifileucel.
Currently, the focus is on therapies for treating hematological malignancies
More than 95% of the products in the development pipeline are presently being developed to treat various types of cancers, including (in decreasing order of number of pipeline products) acute lymphoblastic leukemia, non-Hodgkin's lymphoma, multiple myeloma and melanoma. Only 2% of pipeline candidates are being evaluated for the treatment of non-oncological indications.
Extensive efforts are underway to improve the CAR constructs
Majority of the CAR-T cell therapies in the clinical development, including the three recently approved products, are based on second generation CARs. Further, lentivirus and retrovirus are presently the preferred type of vectors used for transduction of CAR constructs into T-cells.
China is leading the product development efforts related to CAR-T cell therapies, in terms of number of active trials and supporting hospitals
In the last 10 years, over 410 clinical trials, evaluating various types of CAR-T cell therapies, were registered across different geographies; interestingly, over 50% of these trials are being conducted in China.
Partnership activity within this domain has grown at a CAGR of 42%, between 2005 and 2020
Since 2005, more than 340 agreements were inked related to T-cell therapies, with the maximum activity being reported in 2018. Majority of partnership deals signed within this domain were R&D agreements (25%), technology licensing (18%) and product development and commercialization agreements (11%).
Over USD 17 billion has been invested by both private and public investors, across more than 270 instances
It is important to mention that, between 2013 and 2020, majority of the funding was acquired through venture capital rounds (37%), other equity financing elements (24%), initial public offerings (13%) and grants (13%).
North America and Europe are anticipated to capture over 83% of the market share by 2030
With a promising development pipeline and encouraging clinical results, the market is anticipated to witness an annualized growth rate of over 12.2% during the next decade. The market in China / broader Asia Pacific region is also anticipated to grow at a relatively faster rate.
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Key Questions Answered
• What are the prevalent R&D trends related to T-cell immunotherapies (specifically CAR-Ts, TCRs and TILs)?
• What kind of clinical conditions can be treated using T-cell immunotherapies?
• Who are the leading industry and non-industry players in this market?
• What are the key challenges faced by T-cell therapy developers?
• What kind of partnership models are commonly adopted by industry stakeholders?
• Who are the key investors in T-cell immunotherapies?
• Who are the key opinion leaders / experts from renowned academic and research institutes who can help drive product development efforts?
• What are the key factors that are likely to influence the evolution of the T-cell immunotherapies market?
• How is the current and future market opportunity likely to be distributed across key market segments?
• What are the key promotional strategies used by companies having marketed products?
• Who are the key service providers (CMOs / CDMOs) with capabilities to develop and manufacture T-cell therapies?
The USD 23 billion (by 2030) financial opportunity within the T-cell immunotherapies marketT-cell immunotherapies market has been analyzed across the following segments:
Type of Therapy
• CAR-T cell therapy
• TCR based therapy
• TIL based therapy
Type of target disease Indication
• 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
• Renal cell carcinoma
Type of Target Antigens
• CD19
• BCMA
• CD19/22
• EGFR
• NY-ESO-1
• gp100
• P53
• EBV
• MUC1
• WT-1
• Others
Key Geographies
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and North Africa
• Rest of the World
The report features inputs from eminent industry stakeholders, according to whom T-cell immunotherapies are expected to be the next big step in cancer immunotherapy. The report includes detailed transcripts of discussions held with the following experts:
• Tim Oldham (Chief Executive Officer, Cell Therapies)
• Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics)
• Wei (William) Cao (Co-Founder, Chairman and 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)
The research includes brief profiles, featuring an overview of the company, its financial information (if available), and a description of its product(s), highlighting type of therapy and current development status. Each company profile includes technology portfolio (if available), recent developments related to T-cell immunotherapies and manufacturing capabilities of the companies.
• Adaptimmune Therapeutics
• Autolus
• bluebird bio
• CARsgen Therapeutics
• Celgene
• Cellectis
• Cellular Biomedicine Group
• Cogent Biosciences
• Immunocore
• Innovative Cellular Therapeutics
• Iovance Biotherapeutics
• Kite Pharma
• Kuur Therapeutics
• Lion TCR
• Noile-Immune Biotech
• Novartis
• Shanghai GeneChem
• Sinobioway Cell Therapy
• Takara Bio
• Ziopharm Oncology
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