Cancer accounts for nearly 1 in 6 deaths worldwide, accounting for nearly 10 million deaths annually, as per World Health Organization statistics. However, early detection and effective treatment of cancers could help reduce the mortality rate. The ground-breaking and game-changing CAR T-cell therapy, a kind of immunotherapy, is evolving as a promising treatment for cancer patients who have not responded to standard treatment. CAR T-cell therapy is designed to genetically alter a patient’s immune cells to prepare them for attacking the cancer cells. The treatment involves collecting lymphocytes (also known as T-cells), sending them to the lab for genetic modification, and then infusing them into the same patient. Since the advent of the treatment, CAR T-cell therapy has amassed a lot of popularity among patients and the medical fraternity. Different kinds of CAR T-cell therapies have entered mainstream cancer treatment and become a quintessential part of modern medicine after approval from Food & Drug Administration.  

Faster approval of CAR T-cell therapy from regulatory bodies, an increase in the number of cell therapy clinical studies and flourishing pharmaceutical research expenditure by both government and private sectors are boosting the growth of the global CAR T-cell therapy market. In April 2022, Gilead Lifesciences’s Yescarta received US FDA approval as the first CAR T-cell therapy for the initial treatment of relapsed or refractory large B-cell Lymphoma among adults. Currently, Yescarta accounts for 45.64% of the global CAR T-cell market. However, Tecartus is expected to register the fastest growth during the forecast period. 

Huge Investments in CAR T-cell Therapy to Drive Market Growth 

Biotech and pharmaceutical organizations are investing in R&D initiatives to advance the technology and enhance the cost-effectiveness of the treatment to make it accessible and affordable. In December 2021, Novartis announced T-Charge, the company’s next-generation CAR-T platform that will serve as a foundation for various experimental CAR T-cell therapies. The experiments will help attain a better understanding of the new products that have the potential to offer patients better and long-term outcomes. In Feb 2022, CARsgen Therapeutics, a company focused on innovative CAR T-cell therapies, announced the commencement of operations at the state-of-the-art RTP Manufacturing Facility. The facility will support the company’s clinical studies and commercial launches in North America and Europe. 

Expedited Regulatory Approvals for CAR T-cell Therapies 

CAR T-cell therapies are designed for potentially fatal diseases and address unmet medical needs. Hence, the Food & Drug Administration has put forth expedited programs enabling accelerated treatment development for life-threatening conditions. Accelerated approval allows for shortening review lifetime based on a surrogate endpoint, a predictive measure of clinical benefit rather than a measurable direct clinic benefit. Besides FDA, other regulatory bodies such as the European Commission are building regulations to support the accelerated assessment of medicines, which is expected to fuel the growth of the global CAR T-cell therapy market. 

The manufacturing complexity of CAR T-cells remains a major reason for the exorbitant cost of the treatment and its limited availability. However, Biotechnology Industry Research Assistance Council (BIRAC) is taking initiatives to support the greater accessibility and affordability of the CAR T-cell treatment. 

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