Published: February 2023
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
Roots Analysis has announced the addition of “Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (6th Edition), 2022-2035” report to its list of offerings.
Having demonstrated the ability to selectively eradicate tumor cells from the body with minimal treatment-related side effects, a number of chimeric antigen receptor T-cell (CAR-T) therapies have so far been evaluated and approved for several hematological malignancies, including KYMRIAH® (Novartis), YESCARTA® (Gilead Sciences), TECARTUS™ (Gilead Sciences), Breyanzi® (Bristol Myers Squibb), Abecma™ (Bristol Myers Squibb) and CARVYKTI™ (Janssen Biotech / Legend Biotech). It is worth mentioning that, recently, KIMMTRAK® (Immunocore) became the first T-cell receptor (TCR) therapy to receive approval from the USFDA. Driven by the availability of innovative technology platforms, lucrative funding and encouraging clinical trial results, the T-cell immunotherapies market is anticipated to grow in the long-run, as multiple product candidates are expected to receive marketing approval in the coming decade.
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Over 1,200 T-cell candidate therapies are currently approved / under development
CAR-T cell products continue to dominate the clinical / preclinical pipeline, representing 77% of the total number of molecules, followed by TCR (15%) and TIL (8%) based therapies. Over 30% of the aforementioned candidates are in preclinical and discovery stages, while close to 10% are being evaluated in late clinical stages (phase II and above).
Currently, the industry is focused on T-cell therapies targeting hematological malignancies
More than 90% 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. On the other hand, only 3% of the pipeline candidates are being evaluated for the treatment of non-oncological indications.
Extensive efforts are underway to improve CAR constructs
Majority of the CAR-T cell therapies in clinical development, along with the six 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.
More than 49,470 patients have been enrolled in close to 960 clinical trials, worldwide
Clinical research activity, in terms of number of trials registered, is reported to have increased over the last five years. Of the total number of trials, more than 85% are active and still recruiting patients, while close 15% have already been completed.
Partnership activity within this domain has grown at a CAGR of 25%, between 2015 and 2022
Since pre-2015, more than 430 agreements were inked related to T-cell therapies, with the maximum activity being reported in 2021. Majority of partnership deals signed within this domain were licensing agreements (26%), R&D agreements (24%), and product development and commercialization agreements (12%).
~ USD 30 billion has been invested by both private and public investors, across 330+ instances
It is important to mention that, between pre-2018 and 2022, majority of the funding was acquired through venture capital rounds (42%), other equity financing elements (20%), secondary offerings (12%) and grants (12%).
6,820+ patents related to T-cell immunotherapies have been granted / filed between pre-2017- 2022
R&D activity related to T-cell immunotherapies is largely concentrated on development of CAR-T cell therapies, considering the fact that 96% of the total number of patents were filed for the aforementioned type of therapy. In addition, most of these patents are applications (84%), followed by granted patents (13%).
North America and Europe are anticipated to capture close to 75% of the market share by 2035
In addition, the market in China / broader Asia Pacific region is anticipated to grow at a relatively faster pace in the foreseen future. With a promising development pipeline and encouraging clinical results, CAR-T cell therapies is expected to capture the majority share (~73%) of the total market in 2035.
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The financial opportunity within the T-cell immunotherapies market has been analyzed across the following segments:
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:
The research includes brief profiles of key players (listed below); each profile features an overview of the company, details related to its financial information (if available), T-cell based product(s), such as information on type of therapy and current development status, as technology portfolio (if available), recent developments related to T-cell immunotherapies and manufacturing capabilities of the players.
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