The United States market size of Stem Cell Therapy stood at $150.2 million during 2024 and the market contributed 60.4% to the North American markets
United States Stem Cell Therapy Market Outlook
The U.S. market is characterized by a robust pipeline of clinical trials, regulatory approvals, and a growing number of collaborations between biotech companies, research institutions, and healthcare providers. The US FDA continues to provide a supportive regulatory environment for stem cell therapies, including the Regenerative Medicine Advanced Therapy (RMAT) designation- over 60 regenerative medicine products, including stem cell therapies, have been granted RMAT designation. The market growth is further driven by strong government support for stem cell research. In 2022, the NIH allocated approximately $2 billion toward stem cell research.
The high prevalence of indications treated by stem cell therapies supports the market growth in the country. According to the CDC, approximately 32.5 million U.S. adults are affected by osteoarthritis, which is a leading condition treated with stem cell therapy. Similarly, 38.4 million people (11.6% of the U.S. population) have diabetes. Stem cell therapies are being explored as a treatment for diabetes-related complications, including diabetic foot ulcers and retinopathy. Further, around 20.1 million adults in the U.S. have coronary artery disease, Multiple Sclerosis (1 million), Leukemia, and Lymphoma (60,000 new cases of leukemia and about 85,000 cases of lymphoma annually), with strong prospects for stem cell therapies.
The demand for personalized medicine is also contributing to the market's expansion, as stem cell therapies can be tailored to individual patients, enhancing treatment efficacy and outcomes. In addition, the strong presence of biotech companies and start-ups focused on developing stem cell therapies supports the market, with over 900 clinical trials involving stem cell therapies ongoing as of 2023.
Canada's federal and provincial governments continue to make substantial investments in stem cell research and regenerative medicine through the Canadian Institutes of Health Research (CIHR). The country is home to influential non-profit organizations and advocacy groups, such as the Stem Cell Network and the Canadian Stem Cell Foundation, that promote stem cell research and public awareness. The Stem Cell Network (SCN) announced $19.5 million for 32 stem cell and regenerative medicine research projects and clinical trials.
Most approved therapies use hematopoietic stem cells (HSC) and are used for the treatment of acute lymphoblastic leukemia (ALL), Adult B-cell Lymphoma, and Graft V Host diseases. The high prevalence of conditions drives the market outlook in Canada-
According to the Health Canada, some clinics and health care practitioners are offering unauthorized stem cell therapy and are making unproven health claims to patients. Clinics in Canada are organizing trips to Costa Rica, Bahamas, Panama, Mexico, and other countries. Accordingly, strong prospects for healthcare facilities in these countries are anticipated over the medium to long-term future.
Amidst high costs and strict regulations in countries like the United States, Mexico has become a go-to destination for these treatments, offering competitive prices and fewer regulatory hurdles. A large number of patients from North America travel to Mexico for these therapies, often due to lower costs and the availability of cutting-edge treatments.
According to the travel.state.gov, between 150,000 and 320,000 U.S. citizens travel abroad for medical care each year (Medical tourism includes cosmetic surgery, dentistry, and other surgical procedures).
Mexico is one of the leading destinations for global stem cell tourism, driven by COFEPRIS-certified facilities with long experience, affordable treatment costs, package benefits, convenience, and transportation advantages. Some clinics operate with COFEPRIS certification, which ensures that they meet certain safety and efficacy standards. However, a significant number of clinics operate in a "grey area" without full regulatory oversight, offering experimental or unproven treatments. This regulatory flexibility is both a strength and a challenge, contributing to the market’s growth but also raising concerns about patient safety.
There is a noticeable increase in the number of clinics offering stem cell treatments. These clinics cater to a variety of conditions, including orthopedic injuries, neurodegenerative diseases, and chronic illnesses. The growth is fueled by the demand for alternative therapies that might not be available or affordable in other countries.
Accordingly, a large number of companies are investing in stem cell clinics in the country, to cater to both domestic population and overseas patients. Giostar (Global Institute of Stem Cell Therapy and Research), Stem Cell Institute (Panama and Mexico), Rehealth Regenerative Therapies (Founded by U.S.-trained doctors), and others are among the key US companies with centers in Mexico.
Regenerative medicine clinics in Mexico have a significant online presence using direct-to-consumer advertising to attract stem-cell tourism. Low cost, quick duration, and complete package are widely marketed features by companies to attract a wide patient base. Clinics highlight their certification to build trust, especially among international patients who are concerned about the safety and legitimacy of stem cell treatments abroad. COFEPRIS-certified clinics often promote their use of high-quality, ethically sourced stem cells, including allogeneic cells from donors, which are processed in licensed laboratories.
Tijuana, Mexicali, and Los Algodones are among the leading clusters of stem cell clinics. Factors affecting the cost in Mexico include Type of Stem Cells, Procedure Complexity, Location, and Accreditation. While international patients currently drive much of the demand, the domestic market for stem cell therapies in Mexico expands as awareness and accessibility increase. Educational campaigns and reductions in treatment costs make these therapies more accessible to the Mexican population, leading to broader market growth.
With advancements in stem cell technology, the potential of stem cells in personalized and regenerative medicine becomes increasingly apparent, promising a future where tailored, effective treatments.
Induced pluripotent stem cells (iPSCs) have revolutionized stem cell technology by allowing scientists to reprogram adult cells back into a pluripotent state, where they can differentiate into any cell type. Recent developments in iPSC technology include more efficient reprogramming techniques and the ability to create iPSCs from a wider range of cell types.
The integration of CRISPR-Cas9 gene editing technology with stem cell research is leading to the development of novel therapeutic strategies, including correcting genetic mutations in patient-derived iPSCs.
3D bioprinting has emerged as a critical tool in tissue engineering, where stem cells are used to create complex tissue structures. Advancements in bioprinting technologies have improved the precision and scalability of creating tissues, from simple skin grafts to more complex organs.
Innovations such as microfluidic devices and 3D culture systems mimic the natural cellular environment more closely, promoting better cell growth and differentiation.
Exosomes, small vesicles released by cells, are gaining attention in stem cell research for their potential in regenerative medicine. Stem cell-derived exosomes have shown promise in promoting tissue repair and modulating immune responses. Recent advancements have focused on understanding the mechanisms of exosome biogenesis and optimizing their therapeutic delivery.
The translation of stem cell technology from the lab to clinical applications has seen significant progress in recent years. Stem cell-based therapies are now in various stages of clinical trials for treating conditions such as spinal cord injuries, Parkinson’s disease, and heart failure. Advancements in regulatory frameworks and safety protocols have also accelerated the pace at which these therapies move toward commercialization.
|
Parameter |
Details |
|
Market Size (2024) |
$248.6 Million |
|
Market Size (2032) |
$682.5 Million |
|
Market Growth Rate |
18.33% |
|
Largest Segment- Product |
Allogeneic (54.5% Market Share) |
|
Largest Segment- Cell Source |
Adipose Tissue ($87.7 Million) |
|
Largest Application |
Musculoskeletal ($93.8 Million Sales) |
|
Segments |
Types, Cell Sources, Applications |
|
Study Period |
2018- 2023 and 2024-2032 |
|
Units |
Revenue (USD) |
|
Qualitative Analysis |
Porter’s Five Forces, SWOT Profile, Market Share, Scenario Forecasts, Market Ecosystem, Company Ranking, Market Dynamics, Industry Benchmarking |
|
Companies |
Fate Therapeutics, Inc., Mesoblast Limited, Athersys, Inc., Bluebird Bio, Inc., Vericel Corporation, StemCell Technologies, Inc., Pluristem Therapeutics Inc., Century Therapeutics, Inc., Lineage Cell Therapeutics, Inc., ViaCyte, Inc. |
|
Countries |
United States, Canada, Mexico |
|
States |
California, Texas, New York, Florida, Illinois, Pennsylvania, Ohio, Georgia, New Jersey, North Carolina, Others |
Table of Contents
1. Executive Summary
US Stem Cell Therapy Market Introduction- 2024
Report Scope
Methodology
Market Size Outlook, USD Million, 2021- 2032
2. US Stem Cell Therapy Market Entropy
Competitive Landscape
US Market Share by Company, 2023
Recent Market Developments
Regulatory Scenario
3. US Stem Cell Therapy Market Dynamics
Market Ecosystem- Industry Stakeholders
Porter’s Five Forces Analysis
SWOT Profile
US Industry Trends and Drivers
US Industry Challenges
Inflation, Macroeconomics and Demographics Forecast
4. US Stem Cell Therapy Scenario Analysis
Low Growth
Reference Case
High Growth
5. US Stem Cell Therapy Market Outlook by Type
Allogeneic
Autologous
6. US Stem Cell Therapy Market Outlook by Cell-Source
Adipose Tissue
Bone Marrow
Placement/Umbilical Cord
Others
7. US Stem Cell Therapy Market Outlook by Application
Musculoskeletal
Wounds
Surgeries
Inflammatory
Autoimmune
Cardiovascular
Others
8. North America Stem Cell Therapy Market by Country
Canada
Mexico
United States
9. US Stem Cell Therapy Market by State
California
Texas
New York
Florida
Illinois
Pennsylvania
Ohio
Georgia
New Jersey
North Carolina
Others
10. Company Profiles of Leading US Stem Cell Therapy Companies
Fate Therapeutics, Inc.
Mesoblast Limited
Athersys, Inc.
Bluebird Bio, Inc.
Vericel Corporation
StemCell Technologies, Inc.
Pluristem Therapeutics Inc.
Century Therapeutics, Inc.
Lineage Cell Therapeutics, Inc.
ViaCyte, Inc.
10. Appendix
Data Sources
Methodology and Research Approach
Conclusion