United States Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Autologous Stem Cell and Non-Stem Cell-Based Therapies Market reached USD 6.8 billion in 2022 and is projected to witness lucrative growth by reaching up to USD 18.4 billion by 2031. The Global Autologous Stem Cell and Non-Stem Cell-Based Therapies Market is expected to exhibit a CAGR of 13.7% from 2024 to 2031.

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Key Development:

United States: Recent Autologous & Non‐Stem Cell Therapy Developments

✅ In December 2025, the U.S. Food and Drug Administration (FDA) approved Waskyra (etuvetidigene autotemcel), the first autologous hematopoietic stem cell‐based gene therapy for Wiskott‐Aldrich syndrome, expanding options for rare immune disorder patients.

✅ In November 2025, BioRestorative Therapies secured a Type B meeting with the FDA to discuss an accelerated Biologics License Application (BLA) pathway for BRTX‐100, its autologous mesenchymal stem cell therapy candidate targeting chronic lumbar disc disease, underscoring progress toward clinical launch.

✅ In October 2025, multiple iPSC‐based therapies received IND clearance from the FDA for conditions including Parkinson's disease, ALS and spinal cord injury, reflecting momentum in autologous and engineered cell therapy pipelines.

✅ In September 2025, Cellino launched a scalable autologous iPSC biomanufacturing platform (Nebula) at Massachusetts General Hospital, enabling decentralized production of patient‐derived therapeutic cells and addressing key manufacturing challenges.

✅ In August 2025, US WorldMeds completed the acquisition of Adaptimmune's cell‐therapy portfolio (including TECELRA® and related engineered T‐cell assets), securing rights to advanced autologous T‐cell therapeutic programs and strengthening its immunotherapy pipeline.

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Japan: Recent Autologous & Non‐Stem Cell Therapy Developments

✅ In November 2025, FUJIFILM Toyama Chemical applied for marketing approval in Japan for FF‐31501, an autologous synovial MSC‐based therapy to improve healing in patients with meniscus injuries, advancing regenerative orthopedic care.

✅ In October 2025, Astellas Pharma and Yaskawa Electric established a joint venture ("Cellafa Bioscience") to industrialize iPS cell and other regenerative therapies using robotics and AI, aimed at overcoming manufacturing bottlenecks.

✅ In September 2025, Takeda Pharmaceutical introduced a new autologous stem cell cartilage regeneration therapy and committed significant funding to scale domestic cell processing infrastructure, pushing Japan's regenerative strategy forward.

✅ In July 2025, A‐SEEDS Co., Ltd. closed ¥2.38 billion (~USD 15 million) Series A financing to accelerate clinical development of its non‐viral gene‐modified CAR‐T cell therapies and prepare for Australian trials, strengthening Japan's immunotherapy ecosystem.

Key Players:

=> Novartis AG, BrainStorm Cell Limited, Caladrius, Cytori Therapeutics Inc., Gilead Sciences Inc., Regeneus Ltd, U.S. Stem Cell, Vericel Corporation, MEDIPOST, Castle Creek Biosciences, Inc., among others.

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Key Segments:

By Type

Autologous stem cells lead with 52% share, driven by strong adoption in regenerative therapies, cancer treatment, and orthopedic applications due to their high therapeutic potential and reduced risk of immune rejection. Autologous non-stem cells account for 34%, supported by increasing clinical applications in personalized medicine, wound healing, and cardiovascular therapies. Other cell types hold 14%, including allogeneic and specialized cell-based therapies used in niche research and treatment areas.

By Application

Cancer applications dominate with 28% share, fueled by rising prevalence, clinical trials, and growing use of autologous stem cell therapies in oncology. Neurodegenerative disorders represent 22%, driven by research and treatment of Alzheimer's, Parkinson's, and related conditions. Cardiovascular disease holds 20%, supported by regenerative therapies for heart failure, myocardial infarction, and vascular repair. Orthopedic diseases account for 18%, fueled by bone, cartilage, and joint repair applications. Other applications make up 12%, including autoimmune disorders, wound healing, and emerging therapeutic areas.

By End-User

Hospitals dominate with 45% share, driven by high adoption of stem cell therapies, clinical infrastructure, and patient access to advanced treatments. Ambulatory surgical centers hold 25%, supported by outpatient procedures and specialized regenerative therapy clinics. Research facilities account for 20%, fueled by ongoing R&D, clinical trials, and translational studies in stem cell therapies. Other end-users represent 10%, including specialty clinics, biopharma companies, and experimental treatment centers.

By Region

North America - 38% Share
North America leads with 38%, driven by advanced healthcare infrastructure, strong clinical trial activity, high adoption of stem cell therapies, and favorable regulatory frameworks in the U.S. and Canada.

Europe - 26% Share
Europe holds 26%, supported by well-established hospitals, research facilities, and increasing investment in regenerative medicine across Germany, the U.K., France, Italy, and Spain.

Asia Pacific - 24% Share
Asia Pacific accounts for 24%, fueled by rising healthcare infrastructure, growing regenerative medicine research, and increasing patient access in China, India, Japan, and Southeast Asia.

Latin America - 7% Share
Latin America holds 7%, driven by gradual adoption of stem cell therapies, expanding hospital networks, and rising research initiatives in Brazil, Mexico, and Argentina.

Middle East & Africa - 5% Share
Middle East & Africa represent 5%, supported by emerging healthcare infrastructure, government initiatives, and growing interest in regenerative therapies in GCC countries, South Africa, and North Africa.

FAQ

What is the current size of the Autologous Stem Cell and Non-Stem Cell-Based Therapies Market?

A: In 2022, the Autologous Stem Cell and Non-Stem Cell-Based Therapies Market was valued at USD 6.8 billion, reflecting its strong industry presence.

Q2: How large is the Autologous Stem Cell and Non-Stem Cell-Based Therapies Market expected to be by 2031?

A: By 2031, industry forecasts suggest the Autologous Stem Cell and Non-Stem Cell-Based Therapies Market will grow to around USD 18.4 billion , demonstrating significant expansion.

Q3: What is the growth rate of the Autologous Stem Cell and Non-Stem Cell-Based Therapies Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 13.7% during the forecast period from 2024 to 2031.

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