United States Cell Therapy Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Cell Therapy Market reached US$ 6.52 Billion in 2024 and is expected to reach US$ 48.98 Billion by 2033, growing at a CAGR of 21.4% during the forecast period 2025-2033.

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Key Development:

United States: Recent Cell Therapy Developments

✅ In December 2025, the FDA approved etuvetidigene autotemcel (Waskyra) for treating Wiskott‐Aldrich syndrome, marking a major new cell‐and‐gene therapy regulatory milestone in rare pediatric disease care in the U.S.

✅ In December 2025, the FDA granted approval for the first CAR‐T therapy for marginal zone lymphoma, lisocabtagene maraleucel (liso‐cel; Breyanzi), expanding CAR‐T indications beyond traditional blood cancers this year.

✅ In October 2025, the FDA moved to raise approval standards for CAR‐T cell therapies, signalling a regulatory shift toward more rigorous data requirements for next‐gen cancer cell therapies.

✅ In October 2025, Bristol Myers Squibb (BMS) agreed to acquire Orbital Therapeutics for about $1.5 billion, bringing a next‐generation in vivo CAR‐T platform and RNA‐guided immune reprogramming technologies into its cell therapy portfolio. This strategic acquisition strengthens BMS's position in cell therapy innovation, especially for autoimmune and immune‐modulating indications

✅ In November 2025, U.S. government biotech funding awards included notable federal support toward in‐vivo cell therapy research programs, reinforcing national R&D investment priorities for advanced cell therapeutic science.

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Japan: Recent Cell Therapy Developments

✅ In December 2025, Japan's government earmarked ¥15.8 billion (~$100 M) in new funding to boost cell and gene therapy manufacturing capacity, supporting CDMO expansion and next‐gen production technologies nationwide.

✅ In October 2025, Astellas Pharma and Yaskawa Electric formed Cellafa Bioscience, a joint venture to use robotics and AI to develop scalable cell therapy manufacturing platforms with operations scheduled through FY 2027.

✅ In July 2025, JCR Pharmaceuticals was selected for Japan's Regenerative Medicine CDMO Subsidy Program, enabling facility upgrades and expanded cell therapy manufacturing capabilities under METI support.

✅ In May 2025, Cellares and Mitsui Fudosan announced Japan's first next‐gen commercial cell therapy (CAR‐T) manufacturing smart factory in Kashiwa‐no‐ha, scheduled for phased launch into 2027 to accelerate regional access and scale.

Key Players:

=> Gilead Sciences, Inc., Novartis AG, Vericel Corporation, CO.DON GmbH, Bristol Myers Squibb company., IOVANCE Biotherapeutics, Inc., Dendreon Pharmaceuticals LLC., Enzyvant Therapeutics GmbH., CellTrans., and Gamida Cell Inc., among others.

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Key Segments:

By Source

Autologous - Leading segment with 55% share, using patient-derived cells to minimize immune rejection risks.
Allogenic - 45% share, sourced from donors, widely used in off-the-shelf therapies and large-scale clinical applications.

By Cell Type

Stem Cells - 60% share, preferred for regenerative medicine, oncology, and immunotherapy applications.
Non-Stem Cells - 40% share, utilized in supportive therapies, disease modeling, and specialized treatments.

By Application

Oncology - 25% share, largest application segment for cell-based therapies in cancer treatment.
GIT Conditions - 15% share, includes gastrointestinal disorders like Crohn's disease and ulcerative colitis.
Musculoskeletal Conditions - 20% share, applied in cartilage repair, bone regeneration, and orthopedic therapies.
Immunodeficiency Disorders - 15% share, for immune system modulation and correction.
Graft-versus-Host Disease (GVHD) - 10% share, key application in post-transplant care.
Others - 15% share, includes cardiovascular, neurological, and rare diseases applications.

By Region

North America - 35% Share
High adoption due to advanced healthcare infrastructure, strong R&D, and regulatory support for cell therapies.

Europe - 25% Share
Growth driven by regenerative medicine initiatives, clinical trials, and government-backed funding programs.

Asia-Pacific - 20% Share
Emerging market with increasing cell therapy research, supportive government policies, and expanding healthcare access.

South America - 10% Share
Moderate growth, adoption mainly in advanced clinical centers and urban hospitals.

Middle East & Africa - 10% Share
Early-stage adoption, primarily through academic research and specialized treatment centers.

FAQ

What is the current size of the Cell Therapy Market?

A: In 2024, the Cell Therapy Market was valued at US$ 6.52 Billion , reflecting its strong industry presence.

Q2: How large is the Cell Therapy Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Cell Therapy Market will grow to around US$ 48.98 Billion, demonstrating significant expansion.

Q3: What is the growth rate of the Cell Therapy Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 21.4% during the forecast period from 2025 to 2033.

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