PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933320
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933320
The global cell therapy market is experiencing rapid growth, driven by technological advancements, increasing adoption of advanced cellular therapies, and rising demand for treatments targeting oncology and rare diseases. The market was valued at USD 8.88 billion in 2025, projected to grow to USD 12.34 billion in 2026, and is expected to reach USD 190.36 billion by 2034, reflecting a robust CAGR of 40.78% during the forecast period.
Cell therapy involves the administration of live cells, either autologous or allogeneic, into patients to treat or prevent diseases. These therapies include genetically engineered T-cells, natural killer cells, and induced pluripotent stem cell (iPSC)-derived therapies that restore normal cellular function, eliminate diseased cells, or regenerate damaged tissues. The market is dominated by leading biopharmaceutical players including Novartis AG, Gilead Sciences, Inc., and Bristol Myers Squibb, supported by strong R&D pipelines, wide product availability, and global reach.
Market Dynamics
Market Drivers
High unmet medical needs, particularly in oncology and rare genetic diseases, are a major driver. Many rare diseases, comprising approximately 95% of conditions, lack FDA-approved treatments, creating demand for personalized cell therapies. The increasing number of patients with conditions such as sickle cell disease, estimated at 7.74 million globally in 2021, further fuels the need for targeted therapies. Rapid clinical progress in CAR-T and engineered T-cell therapies, coupled with expanding approvals, is propelling market growth.
Market Restraints
Safety concerns and clinical risks, including tumorigenesis, immune rejection, graft-versus-host disease (GVHD), cytokine release syndrome (CRS), and neurotoxicity, restrict market expansion. These risks necessitate specialized hospital infrastructure and limit adoption to certified centers. For instance, Yescarta (Gilead Sciences, Inc.) recorded grade >=3 neurotoxicity in ~32% of patients with large B-cell lymphoma.
Market Opportunities
The emergence of allogeneic cell therapies offers off-the-shelf solutions, providing scalability, lower costs, and faster treatment initiation. Technological advancements and growing investment in oncology, autoimmune, and neurological applications provide significant growth opportunities. For example, Allogene Therapeutics reported promising Phase 1 data for ALLO-316 in June 2025, targeting advanced renal cell carcinoma.
Market Challenges
The high cost of treatment remains a significant challenge. CAR-T therapies such as Yescarta cost around USD 537,592 per regimen, with additional costs for hospitalization and post-treatment care. This limits accessibility, especially in emerging economies with constrained healthcare budgets.
Market Trends
A notable trend is the expansion of cell therapy applications beyond hematology into solid tumors. Companies are developing dual- and tri-CAR T-cells to overcome antigen escape and improve efficacy in solid cancers. In February 2024, the FDA approved AMTAGVI (lifileucel) by Iovance Biotherapeutics for advanced melanoma, demonstrating regulatory support for innovative therapies in oncology.
By Therapy Type:
By Product:
By Indication:
By End-User:
Competitive Landscape
The market is semi-fragmented, with major players such as Novartis AG, Gilead Sciences, Bristol Myers Squibb, Johnson & Johnson, Iovance Biotherapeutics, Fate Therapeutics, and Adaptimmune. Strategies include R&D, collaborations, licensing, and clinical partnerships to strengthen market presence.
Key Developments:
Conclusion
The global cell therapy market is expected to grow from USD 8.88 billion in 2025 to USD 190.36 billion by 2034, at a CAGR of 40.78%. Growth is driven by the increasing adoption of CAR-T and allogeneic therapies, rising unmet medical needs in oncology and rare diseases, expanding regulatory approvals, and strategic investments by key market players. Despite high treatment costs and safety concerns, cell therapy is poised to revolutionize personalized medicine, offering curative solutions and improving patient outcomes globally.
Segmentation By Therapy Type
By Product
By Indication
By End User
By Geography