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Global Stem Cell Therapy Market Size to Surpass 2,612.9 Million by 2033

February 26, 2025 | 
1 min read

The global stem cell therapy market is poised for substantial expansion, with revenue projected to increase from USD 394.5 million in 2024 to USD 2,612.9 million by 2033, achieving a robust CAGR of 23.97%. The market is experiencing rapid expansion, driven by the increasing shift toward personalized medicine and advancements in regenerative treatments. Stem cell-based therapies are emerging as a cornerstone of precision medicine, offering patient-specific solutions for a wide range of conditions. Institutions such as the Wake Forest Institute for Regenerative Medicine are at the forefront of innovation, achieving breakthroughs in lab-grown organs to address donor shortages. Stem cell technologies are also revolutionizing drug discovery by improving the accuracy of preclinical testing. Additionally, researchers explored stem cell therapies for conditions such as COVID-19, with studies demonstrating promising clinical outcomes.

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The rising incidence of cancer further propels market growth, with the International Agency for Research on Cancer (IARC) reporting 20 million new cases in 2022. Stem cell therapies, particularly hematopoietic stem cell transplantation (HSCT), are gaining traction as innovative treatments for cancers like leukemia and lymphoma. Advanced cell therapies, such as Gamida Cell’s Omisirge, approved by the FDA in 2023 for hematologic malignancies, underscores the increasing significance of stem cell-based therapies. With projections estimating cancer cases could rise to 35 million by 2050, the demand for stem cell therapies is expected to accelerate. Increasing investments in research, expanding clinical applications, and continued regulatory approvals are driving the sector’s expansion.

However, challenges such as high development costs and ethical concerns continue to hinder widespread adoption. The financial burden of stem cell therapies, ranging from $5,000 to $50,000 per treatment in the U.S., limits accessibility, especially in regions with limited insurance coverage. Additionally, clinical trials require extensive patient recruitment, monitoring, and data collection, further escalating costs. Ethical complexities surrounding embryonic stem cell research add another layer of challenge. Further, stringent regulations worldwide govern embryonic stem cell use, focusing on embryo destruction and early-stage cell manipulation. While the UK enforces a 14-day research limit, Germany bans embryo creation, whereas China permits research for therapeutic purposes. High costs, regulatory barriers, and ethical concerns collectively slow innovation in the stem cell therapy market.

Despite these challenges, the stem cell therapy market is poised for sustained growth, fueled by rising clinical trials, ongoing R&D investments, and expanding applications across regenerative medicine and drug discovery. Industry stakeholders are actively working to overcome financial and ethical hurdles, paving the way for continued advancements and broader adoption of stem cell-based therapies worldwide.

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Key Findings in Stem Cell Therapy Market

Market Forecast (2033)

US$ 2,612.9 Billion

CAGR

23.97%

Top Drivers

Rising Incidence of Cancer Cases

Increasing R&D investment & Rising healthcare expenditure

Expanding Applications in Drug Discovery and Development

Top Trends 

Increased in Number of Clinical Trials Associated with Stem Cell Therapies

Growing Focus on Developing Personalized Medicine

Recent Advances in Stem Cell Therapy

Top Challenges

 

High Development Costs and Ethical Concerns

Rising Demand of Cell & Gene Therapy

Limited Reimbursement Policies for Stem Cell Treatments

Technological Milestone: Next-Level Innovation Driving Stem Cell Therapy’s Expansion

The rapid evolution of stem cell therapy is reshaping the treatment landscape for complex diseases and accelerating advancements in advanced therapy medicinal products (ATMPs). In 2023, key breakthroughs underscored the regenerative potential of stem cells, recognized for their ability to self-renew and differentiate into multiple tissue types. While stem cell therapies have been in development since 1957, only a few have achieved regulatory approval as ATMPs. However, this is changing swiftly due to continuous technological innovation and evolving regulatory frameworks. A major milestone was the European Medicines Agency’s approval of Holoclar in 2015, which set the stage for accelerated growth in stem cell-based treatments.

One of the most promising advancements involves stem cell therapy for HIV. In March 2023, a research study was published in Cell, highlighting results from a clinical study (NCT02140944). It demonstrated long term remission is possible for HIV patients receiving haplo-cord blood transplant. Unlike previous approaches relying on adult donor cells, this method enhances the accessibility and effectiveness of stem cell-based HIV treatments. Similarly, in February 2023, the Journal of the American College of Cardiology reported findings from the DREAM HF-1 trial, which highlighted the potential of mesenchymal precursor cells (MPCs) in reducing inflammation—a key driver of heart failure. Among patients with severe inflammation, this therapy lowered the risk of heart attack or stroke by up to 75%, reinforcing stem cell therapy’s growing role beyond its traditional applications in oncology.

The expansion of clinical trials further demonstrates the increasing therapeutic potential of stem cell therapies. In neurodegenerative diseases, Phase I trials (NCT01297218/NCT01696591) have confirmed the feasibility of injecting human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSC) into the hippocampus and precuneus for Alzheimer’s disease. Additionally, Phase II trials (NCT02054208/NCT03172117) validated the safety of delivering stem cells into the lateral ventricle using an Ommaya reservoir. In Parkinson’s disease, ongoing trials (NCT03550183) are evaluating hUCB-MSC transplantation, with preliminary results showing neuroprotective benefits and functional improvement. These developments highlight stem cell therapy’s growing role in neurology, fueling further research and commercialization.

The rise of gene-editing technologies, particularly CRISPR-Cas9, is further advancing stem cell therapy by enhancing precision and safety through targeted genetic modifications. CRISPR-Cas9 has been leveraged to facilitate fluorescent screening of stem cell markers, enabling more precise differentiation of cell populations. One notable breakthrough involves the development of a COL2A1-GFP reporter iPSC line, allowing for simultaneous purification of chondrogenic cells. Additionally, CRISPR-based therapies such as CTX001 have shown remarkable success in treating sickle cell anemia and beta-thalassemia, with clinical trials demonstrating restored hemoglobin levels and long-term relief from transfusion dependency. The convergence of these cutting-edge innovations is driving the global expansion of stem cell therapies, positioning them at the forefront of next-generation healthcare solutions.

Global Stem Cell Therapy Boom: Regional Forces Propelling the Future of Regenerative Medicine

The global stem cell therapy market is experiencing rapid expansion, fueled by breakthroughs in regenerative medicine, increasing research investments, and evolving regulatory landscapes. Regional dynamics play a crucial role in shaping market growth, with North America, Europe, and Asia-Pacific emerging as key contributors to innovation, accessibility, and commercialization. North America leads the market, accounting for nearly half of the global share, driven by a well-established healthcare system, strong R&D investments, and major biotechnology and pharmaceutical firms such as Vertex Pharmaceuticals, BlueRock Therapeutics, and Century Therapeutics pioneering regenerative treatments. Favorable regulatory policies, like the FDA’s regenerative medicine advanced therapy (RMAT) designation, are accelerating clinical translation, while AI integration in stem cell research and biomanufacturing is enhancing precision medicine.

Europe follows closely, backed by government-supported research programs, progressive regulations, and early adoption of novel therapies. Countries like Germany, the UK, and France benefit from initiatives such as the European Medicines Agency’s (EMA) Advanced Therapy Medicinal Products (ATMP) framework, which streamlines approvals and fosters innovation. Institutions like the UK Stem Cell Bank and the German Stem Cell Network are driving translational research, while EU funding programs like Horizon Europe continue to support collaborations between academia, biotech firms, and healthcare providers. Meanwhile, the Asia-Pacific region is set to witness the fastest CAGR of 25.03%, fueled by increasing government investments, improved healthcare access, and a rising prevalence of chronic diseases. China and Japan lead this expansion, with China’s National Medical Products Administration (NMPA) simplifying approvals for cell-based therapies and Japan’s Act on the Safety of Regenerative Medicine accelerating commercialization. Further, The Center for iPS Cell Research and Application (CiRA) in Japan is spearheading advancements in induced pluripotent stem cell (iPSC) therapies, while China’s thriving biotech ecosystem is ramping up cost-effective stem cell treatment production. The region’s adoption of AI-driven diagnostics, telemedicine platforms, and public-private partnerships further strengthens its position as a critical driver of market growth.

In contrast, Latin America and the Middle East & Africa are gradually expanding their presence in stem cell therapy but face challenges such as funding constraints, regulatory hurdles, and limited awareness. Brazil and Argentina are making progress through government-backed research initiatives and improved access to cell-based treatments, though infrastructure limitations and affordability remain barriers. Similarly, countries like the UAE and Saudi Arabia are investing in biotechnology hubs and research centers to integrate stem cell therapies into their healthcare systems, yet economic disparities and regulatory inconsistencies hinder widespread adoption. As stem cell therapy continues to revolutionize regenerative medicine, these regional forces will shape the market’s trajectory, influencing innovation, accessibility, and long-term growth on a global scale.

Recent Advancements and Key Players in the Stem Cell Therapy Market

Several prominent players, including Thermo Fisher Scientific, Inc., AlloSource, STEMCELL Technologies, Inc., Merck KGaA, Sartorius AG (CellGenix GmbH), PromoCell GmbH, Takara Holdings, Inc., Lonza, ATCC, AcceGen, Cell Applications, Inc., Bio-Techne, Cellular Engineering Technologies, and Mesoblast Ltd., are driving innovation in the stem cell therapy market. These companies are pioneering advancements in regenerative medicine, cellular therapies, and biomanufacturing to enhance treatment efficacy and accessibility. For instance, in December 2024, the FDA approved Mesoblast Limited’s Ryoncil (remestemcel-L), making it the first mesenchymal stromal cell (MSC) therapy in the U.S. Ryoncil is now the only approved treatment for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children as young as two months. Similarly, in December 2023, Bio-Techne Corporation submitted a Drug Master File (DMF) to FDA for its ExCellerate GMP iPSC Expansion Medium, an animal-free formulation designed to optimize stem cell expansion and standardize manufacturing processes.

Further advancing the field, in November 2024, UBC researchers, Genome BC, and STEMCELL Technologies launched a collaboration focused on using transcription factors to accelerate stem cell differentiation into specific cell types, such as heart, brain, and liver cells. This innovation aims to reduce the time required for developing cell-based therapies. Meanwhile, in October 2024, Aspen Neuroscience, Inc. expanded its San Diego operations with a 22,000-square-foot GMP facility dedicated to manufacturing iPSC-derived therapies. The facility will produce ANPD001, an iPSC-based treatment for Parkinson’s Disease, and includes ISO-certified manufacturing suites, quality control labs, and automation technologies to streamline autologous cell therapy production.

These advancements are reshaping the stem cell therapy landscape, improving patient outcomes, and accelerating the commercialization of regenerative medicine. The ongoing development of cutting-edge therapies and manufacturing innovations from these key players is expected to drive market growth and establish new standards in stem cell-based treatments worldwide.

Future Outlook: Transforming the Stem Cell Therapy Market

The stem cell therapy market is poised for substantial growth, driven by advancements in regenerative medicine, personalized treatments, and improved biomanufacturing technologies. The increasing prevalence of chronic diseases, coupled with a growing demand for cell-based therapies, presents significant opportunities for biotechnology companies, healthcare providers, and investors to reshape the treatment landscape. Industry experts anticipate a surge in the development and approval of innovative stem cell therapies, with a particular focus on mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and gene-edited cell therapies. Companies like Mesoblast Ltd., STEMCELL Technologies, and Bio-Techne are at the forefront, pioneering cutting-edge research and clinical applications aimed at treating conditions ranging from neurodegenerative diseases and cardiovascular disorders to orthopedic injuries and autoimmune diseases.

The rapid integration of automation, artificial intelligence (AI), and 3D bioprinting into stem cell manufacturing is expected to enhance scalability, consistency, and cost-efficiency. Additionally, regulatory advancements and government initiatives supporting regenerative medicine will play a crucial role in accelerating approvals and market adoption. The expansion of Good Manufacturing Practice (GMP) facilities, such as Aspen Neuroscience’s new iPSC manufacturing plant, highlights the industry's commitment to industrializing cell therapy production.

By 2030, stem cell therapies are expected to become more accessible and widely integrated into standard clinical care, revolutionizing treatment paradigms across multiple medical fields. The success of this transformation will depend on regulatory harmonization, cost reduction strategies, and improved reimbursement models to ensure broader patient access. Furthermore, the rise of allogeneic “off-the-shelf” therapies and the continued exploration of CRISPR-based gene editing in stem cell applications could unlock unprecedented therapeutic potential, shaping the future of regenerative medicine.

Key Players in Stem Cell Therapy Market

·         Thermo Fisher Scientific, Inc

·         AlloSource

·         STEMCELL Technologies, Inc.

·         Merck KGaA

·         Sartorius AG (CellGenix GmbH)

·         PromoCell GmbH

·         Takara Holdings, Inc.

·         Lonza

·         ATCC

·         AcceGen

·         Cell Applications, Inc.

·         Bio-Techne

·         Cellular Engineering Technologies

·         Mesoblast Ltd

·         Other Prominent Players

Segments Covered in The Report

  • By Cell Source
    • Adipose tissue-derived MSCs (mesenchymal stem cells)
    • Bone marrow-derived MSCs
    • Placental and umbilical cord-derived MSCs
    • Other Cell Sources
  • By Type
    • Autologous stem cell therapy
    • Allogeneic Stem Cell Therapy
  • By Delivery Method
    • In Vivo
    • Ex Vivo
  • By Therapeutic Use 
    • Oncology
    • Musculoskeletal disorders
    • Wounds and injuries
    • Cardiovascular system diseases
    • Surgery
    • Inflammatory and autoimmune diseases
    • Nervous system disorders
    • Drug Discovery
    • Others
  • By End User
    • Hospitals
    • Ambulatory Surgical Centres
    • Pharmaceutical & Biotechnology Companies
    • Academic & Research Institutes
    • Others