Cell Therapy Market Growth Accelerates with CAR-T Dominance and New Research Milestones
The cell therapy manufacturing market is projected to reach $14.01 billion by 2035, with CAR-T therapies dominating at 65% market share. Recent FDA approvals for new CAR-T indications and Japanese regulatory acceleration highlight growing clinical adoption, while research advances include new anti-aging protein platforms and CRISPR-based treatments.
The global cell therapy market is experiencing significant growth, with CAR-T cell therapies holding the largest market share and new research advancing anti-aging protein platforms. The cell therapy manufacturing market is estimated to grow from $7.17 billion in the current year to $14.01 billion by 2035, at a compound annual growth rate of 7.7% during the forecast period.
The broader cell and gene therapy sector is forecast to surge from $10.4 billion to more than $45 billion by 2035, with more than 40 FDA-approved products now on the market. The global cell therapy market has surpassed $8.2 billion in 2026. Researchers are exploring over 1,000 cell and gene therapy candidates targeting a wide range of disease indications, with approximately 45 cell-based therapies having already received approval from various global regulatory agencies.
In the present year, the CAR-T cell therapies segment holds the largest market share (approximately 65%), attributed to the shorter treatment regimen that requires fewer infusions. The Global CAR-T Cell Therapy Market size reached $4.8 billion in 2024 and is expected to reach $20.4 billion by 2033, growing at a CAGR of 16.3% during the forecast period 2025-2033. The segment of other cell therapies, which includes natural killer cell therapies and gene-modified cell therapies, is anticipated to experience a higher compound annual growth rate of 16.15% throughout the forecast period.
Recent regulatory developments include the FDA approving Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR-T therapy, for adults with relapsed/refractory marginal zone lymphoma after at least two prior therapies in December 2025. This marks the first CAR-T approval for this lymphoma subtype. FDA leaders also published guidance favoring randomized clinical trials with survival endpoints for initial CAR-T approvals in oncology, aiming to strengthen evidence over single-arm studies.
Japanese authorities fast-tracked approvals and insurance reimbursements for imported and domestic CD19-targeted CAR-T therapies targeting lymphoma and leukemia in January 2026, supporting broader access amid rising hematologic cancer cases. Adoption grew in Japan's university hospitals and cancer centers due to higher diagnosis rates and infrastructure for advanced hematologic treatments.
On the research front, Avaí Bio recently announced a critical early-stage milestone alongside joint venture partner Austrianova: beginning the creation of a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein. An MCB is the process of taking a single genetically engineered cell and cloning it into tens of millions of identical copies, creating a standardized, GMP-compliant bank of cellular starting material. The cells banked in the MCB will be used in conjunction with Austrianova's proprietary Cell-in-a-Box® encapsulation technology, which protects therapeutic cells inside a biocompatible shell to allow continuous protein secretion without triggering immune rejection.
Vertex Pharmaceuticals demonstrated what that looks like at scale. The company's gene-edited cell therapy Casgevy — developed with CRISPR Therapeutics — became the world's first approved CRISPR-based treatment, now available for sickle cell disease and transfusion-dependent beta-thalassemia. Vertex expects to file regulatory submissions for the 5–11 age group in the first half of 2026. CRISPR Therapeutics reported Phase 1 data showing its in vivo gene-editing therapy CTX310 achieved mean reductions of 73% in ANGPTL3, 55% in triglycerides, and 49% in LDL cholesterol after a single intravenous infusion.
The manufacturing of cell and gene therapies is a complex process that occurs in a meticulously controlled, contamination-free environment and involves multiple critical stages, such as isolating, modifying, and expanding immune cells, including T-cells and stem cells. Companies are focused on enhancing cell handling and processing equipment, improving ancillary materials and cell counting techniques, and addressing current logistical challenges. Despite strong demand, the cell therapy manufacturing sector faces multiple challenges including a shortage of skilled workers, regulatory compliance issues, and insufficient advanced facilities and infrastructure.