United States Stem Cell Therapy Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Stem Cell Therapy Market reached US$ 16.44 billion in 2024 and is expected to reach US$ 45.69 billion by 2033, growing at a CAGR of 12.7 % during the forecast period 2025-2033.

Key Development:

United States: Recent Industry Developments

✅ In July 2025, Longeveron Inc. received FDA approval of an IND application to commence a Phase 2 pivotal clinical trial of their stem cell therapy laromestrocel for treating pediatric dilated cardiomyopathy. The trial aims to advance regenerative treatments for severe heart conditions in children.

✅ In February 2025, BioRestorative Therapies, Inc. announced FDA clearance of its IND for BRTX‐100, a stem cell‐based therapeutic for chronic cervical discogenic pain, marking the first such product in this indication. The program supports innovative regenerative medicine for spinal conditions.

✅ In February 2025, the U.S. Food & Drug Administration held a public workshop on "Cell Therapies and Tissue‐based Products" to address best practices and evidence generation in stem cell and regenerative medicine product development. The initiative guides safe and effective commercialization of new therapies.

✅ In January 2025, ADIA Nutrition Inc. opened its flagship clinic in Winter Park, Florida, offering umbilical‐cord stem cell therapies for MS, orthopedic injuries, and joint pain, providing regulated access to advanced regenerative treatments.

Japan: Recent Industry Developments

✅ In October 2025, Stempeutics Research signed a licensing deal with Tokyo‐listed Medinet Co., Ltd. to commercialize its stem cell therapy Stempeucel in Japan for chronic limb‐threatening ischemia (CLTI), pending regulatory clearance. The collaboration expands access to advanced regenerative therapies in Japan.

✅ In September 2025, Japan's Sumitomo Pharma Co., Ltd. filed for manufacturing and marketing authorization for a stem cell transplant therapy derived from iPS cells to treat advanced Parkinson's disease, supporting Japan's leadership in cell-based neurotherapies.

✅ In August 2025, Biostar Stem Cell Technology Research Institute received approval in Japan to offer autologous fat‐derived mesenchymal stem cell therapy for autism spectrum disorder (ASD) patients aged four or older at its Osaka clinic. The move pioneers regenerative treatments for neurodevelopmental disorders.

✅ In June 2025, Tokyo‐based ADR Therapeutics signed a letter of intent with Saudi Arabia's King Abdullah International Medical Research Center to conduct a joint clinical trial of its "90‐minute complete stem cell therapy" system, enabling same‐day autologous tissue-derived cell treatment.

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Key Players:

=> Mesoblast Ltd, Lineage Cell Therapeutics, Inc., BlueRock Therapeutics LP, Orchard Therapeutics plc., Vericel Corporation., CRISPR Therapeutics AG, Fate Therapeutics, Inc., Novartis AG, Bristol Myers Squibb (Juno Therapeutics, Inc.), Bluebird bio, Inc., MEDIPOST Co., Ltd., ANTEROGEN.CO., LTD., CORESTEMCHEMON Inc., PHARMICELL Co., Ltd, and JCR Pharmaceuticals Co., Ltd. among others.

Recent Mergers and Acquisitions:

United States: Recent M&A / Strategic Deals in Stem‐Cell & Cell Therapy

✅ In August 2025, US WorldMeds completed the acquisition of Adaptimmune Therapeutics plc's cell‐therapy portfolio including TECELRA®, lete‐cel, and uza‐cel for USD 55 million in cash plus up to USD 30 million in milestone payments. The deal strengthens US WorldMeds' regenerative medicine pipeline.

✅ In March 2025, Bristol Myers Squibb agreed to acquire 2seventy bio for approximately USD 286 million, gaining full manufacturing and commercialization rights for the CAR‐T therapy Abecma® outside the U.S. The acquisition expands BMS's global cell therapy footprint.

✅ In March 2025, AstraZeneca announced the acquisition of EsoBiotec a company focused on in‐vivo engineered cell therapies for up to USD 1 billion (USD 425 million upfront plus USD 575 million in milestones). The deal accelerates AZ's regenerative medicine capabilities.

Japan: Recent M&A / Strategic Deals in Stem‐Cell & Cell Therapy

✅ In October 2025, MEDINET Co., Ltd. (Tokyo) inked an option‐licensing agreement with India's Stempeutics Research Pvt Ltd. for the Japanese commercialization of Stempeucel® (allogeneic MSC therapy for CLTI), with upfront, milestone, and royalty payments. The agreement brings advanced stem cell therapy to Japan.

✅ In October 2025, Takeda Pharmaceutical Company Limited announced it would exit its cell‐therapy programmes and seek partners to advance existing assets, recognizing an impairment of ~¥58 billion (~USD 395 million) tied to its gamma‐delta T‐cell platform. The move refocuses Takeda's strategic pipeline in regenerative medicine.

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Key Segments:

> By Therapy Type
Autologous stem cell therapy involves harvesting a patient's own cells for treatment, offering reduced risk of immune rejection and faster recovery. Allogeneic stem cell therapy uses donor-derived cells, enabling treatment of a broader patient population but requiring immune compatibility management. Other emerging therapies explore hybrid approaches and specialized cell modifications to enhance efficacy.

> By Cell Source
Adipose tissue-derived mesenchymal stem cells are increasingly preferred due to easy harvesting and regenerative potential. Bone marrow-derived cells remain widely used, especially in musculoskeletal and hematologic applications. Cord blood and embryonic stem cells offer high pluripotency, making them attractive for complex regenerative therapies.

> By Therapeutic Application
Musculoskeletal disorders are the leading segment, driven by orthopedic and sports medicine needs. Neurological, autoimmune, and cardiovascular disorders are witnessing growing adoption of stem cell therapies. Wounds, surgeries, inflammatory conditions, and other niche applications represent emerging growth opportunities.

> By Region

North America dominates the market with advanced infrastructure, strong R&D, and government support for stem cell therapies.

Europe shows steady growth with regulatory frameworks supporting both autologous and allogeneic treatments.

Asia-Pacific is rapidly expanding, particularly in China, India, and Japan, due to increasing healthcare investment and clinical trial activity.

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