Given the success of approved CAR-T cell therapies, such as KYMRIAH®, YESCARTA®, TECARTUS® and BREYANZI®, this upcoming class of biologics are anticipated to carve out a significant share of the multi-billion dollar cancer immunotherapy market
Roots Analysishas announced the addition of “CAR-T Cell Therapies Market (3rd Edition) by Target Indications (NHL, Multiple Myeloma, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Hepatocellular Carcinoma and Others), Target Antigens (CD19, BCMA, CD19 / CD22, GPC3 and EGFR), Key Players and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World) – Industry Trends and Global Forecasts, 2021-2030” report to its list of offerings.
Given their ability to selectively direct a cell mediated immune response against cancer cells and, thereby, offer prolonged periods of disease remission, several CAR-T cell therapies provide a promising therapeutic strategy for advanced stage cancers and are expected to achieve blockbuster status. With four approved products and many candidate therapies under evaluation for the treatment of multiple disease indications, the CAR-T cell therapy market is characterized by a healthy and growing pipeline. Further, with lucrative financial support and notable increase in partnerships, the CAR-T-cell therapies market is abuzz with activity.
Over 755 CAR-T cell therapies are currently approved / under development
Close to 40% of the aforementioned candidates are in preclinical and discovery stages, while more than 25% are being evaluated in clinical stages (phase I/II and above). Examples of late-stage clinical candidates include bb2121, CD123/CLL1 CAR-T CD19 CAR-T and LCAR-B38M CAR-T / JNJ-68284528.
Currently, the focus is on developing product candidates to treat various types of cancers
Over 95% of the products in the development pipeline are being evaluated for the treatment of hematological malignancies, including (in decreasing order of number of pipeline products) acute lymphoblastic leukemia, non-Hodgkin's lymphoma, multiple myeloma, and acute myeloid leukemia. Only 2% of current pipeline candidates are being developed for the treatment of non-oncological indications.
Extensive efforts are underway to improve CAR constructs
Majority of the product candidates in the clinical pipeline, including the four approved drug products, are based on second generation CARs. Further, a number of novel therapies armed with fourth generation CAR constructs, CAR-based products containing humanized scFv and bispecific CARs (CD19+CD20 or CD19+CD22 or CD19+CD30) are being evaluated worldwide.
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 half of the 410 clinical trials evaluating various types of CAR-T cell therapies, were registered in China.In addition, owning to a favorable clinical research environment, China is presently considered to be among the leading regions in the CAR-T cell therapy space, with close to 40 industry players and more than 100 non-industry players, including hospitals and universities, contributing to this field.
Partnership activity within this domain has grown at a CAGR of 26%, between 2011 and 2020
More than 220 agreements were inked related to CAR-T cell therapies, with the maximum activity being reported in 2018. Majority of partnership deals signed within this domain were R&D agreements (21%), technology licensing (20%) and product development and commercialization agreements (11%).
Over USD 13 billion has been invested by both private and public investors, across more than 205 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%), grants (12%) and secondary offerings (12%).
The market is anticipated to grow at a CAGR of over 28%, during the period 2021-2030
Growth in this domain is anticipated to be primarily driven by encouraging clinical trial results and the recent success of the four approved CAR-T cell therapies. North America (primarily the US) and Europe are expected to capture over 75% of the market share by 2030, in terms of the sales-based revenues.
The USD 14 billion (by 2030) financial opportunity within the CAR-T cell therapy market has been analyzed across the following segments:
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