Cell therapy market is estimated to be valued at USD 2,583.8 Mn in 2024, exhibiting a CAGR of 9.4% over the forecast period (2024-2031). Technological advancements in cell therapies such as improvements in cell processing techniques and increasing adoption of regenerative medicine procedures are propelling the growth of the market.
Market Dynamics:
The growth of the global cell therapy market is driven by two key factors - technological advancements in cell therapies and growing investment in cell therapy industry. On the technology front, significant improvements have been made in cell processing techniques such as isolation, culture and storage of cells. This has enhanced viability and therapeutic effectiveness of cell therapy products. Furthermore, development of automated cell therapy manufacturing platforms has improved reproducibility and scaled-up production capabilities. On the investments front, both public and private funding towards cell therapy research and development has increased manifold over the past decade. Big pharmaceutical and biotech companies are infusing large capital to develop innovative cell therapy solutions for hard-to-treat medical conditions. This rising influx of investments is facilitating the translation of promising cell therapy candidates from lab to market.
Increasing Number of Regulatory Approvals for Cell Therapy Products
Manufacturers of cell therapy product candidates are engaged in receiving regulatory approvals to enhance their cell therapy process, and this is expected to drive the cell therapy market growth. For instance, in August 2022, Charles River Laboratories International, Inc., a U.S.-based pharmaceutical company, announced that the company had received good manufacturing practice (GMP) certificate from the European Medicines Agency (EMA) for the commercial production of allogeneic cell therapy products for distribution in Europe
Advancements in Cell Therapy Research
Significant investments in cell therapy research by both private and public organizations have boosted the clinical research and development activities. This has led to development of new cell therapy products and refinement of existing processes. For example, CAR T-cell therapy research has revolutionized cancer treatment. Growing clinical evidence for the efficacy and safety of various cell therapies in the treatment of different diseases is boosting their adoption. Advancements in areas such as stem cell biology, regenerative medicine and bioprocessing have provided further impetus to the market growth.
High Cost of Cell Therapy Development and Treatment
Developing an effective and safe cell therapy involves a long and complex research and development process. It requires huge investments at various stages from target identification and cell processing to clinical trials. The associated expenses heavily burden the manufacturers and make the final cell therapy products highly costly. The treatment costs using cell therapies are also substantially high which limits their widespread use. This high cost poses a major challenge to market growth.
Stringent Regulatory Framework
Cell therapy products are strictly regulated by regulatory bodies globally due to serious safety concerns. The approval process for new cell therapies is very long and complex that deters investments in this area. Even approved therapies have to follow stringent post marketing surveillance. Any non-compliance can lead to product recalls or market withdrawals affecting company revenues. The regulatory landscape can act as a restraint for the market.
Expanding Applications of Cell Therapy
Cell therapies are currently used majorly for cancer treatment. However, research is ongoing to explore their potential in a wide range of other diseases such as autoimmune disorders, neurological diseases, cardiovascular diseases, wound healing, and others. Success in these new areas can significantly expand the market size. For instance, stem cell therapy shows promise for conditions like Alzheimer's, Parkinson's and spinal cord injury which does not have effective treatment options.
Increasing Investments by Key Players
Increasing investments by key players for the development of advanced cell therapies is expected to favor growth of the cell therapy market in the near future. For instance, in January 2022, Cellino Biotech, Inc., an autonomous cell therapy manufacturing company, announced the completion of a Series A financing of US$ 80 million, led by the impact investment arm of Bayer AG —Leaps by Bayer— 8VC, and Humboldt Fund. New investors in the round include Felicis Ventures and others, joining existing investors The Engine and Khosla Ventures. The company has raised a total of US$ 96 million in gross proceeds from private financings.
*Link: https://www.coherentmarketinsights.com/market-insight/cell-therapy-market-5413
Key Development
- On February 8, 2024, BioNTech SE, a next-generation immunotherapy company, and Autolus Therapeutics, a biopharmaceutical company, announced a collaboration to advance CAR-T cell therapy programs towards commercialization, pending regulatory authorizations
- In July 2022, INVETECH, a global company offering solutions, systems, and services to cell and gene therapy, announced the launch of new korus technology for autologous cell therapy production
- In March 2022, CARsgen Therapeutics Co., Ltd. announced that CT041, an autologous CAR-T-cell product candidate against the protein Claudin 18.2, had completed the first patient enrollment in the confirmatory phase 2 clinical trial in Beijing Cancer Hospital, China
- In February 2021, Bristol Myers Squibb announced that the company expanded its 89-acre Devens campus, in Massachusetts, U.S. The company will build a new 24,000 sq-foot cell manufacturing facility that will manufacture the company’s lymphoma drug, Breyanzi.
Key Players: Bristol Myers Squibb Company, Amgen Inc., Novartis AG, Gilead Sciences, Inc., Johnson & Johnson Services, Inc., Allogene Therapeutics, Athersys, Inc., Orchard Therapeutics, JW Therapeutics Co., Ltd., Dendreon Pharmaceuticals LLC., Autolus Therapeutics, APAC Biotech, CORESTEM, Inc., BioCardia, Inc., JCR Pharmaceuticals Co., Ltd., Oxford Biomedica, CASI Pharmaceuticals Inc.
