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February 2025
The global stem cell therapy market size is calculated at USD 490 million in 2024, grew to USD 613.7 million in 2025, and is projected to reach around USD 4,777.40 million by 2034. The market is expanding at a CAGR of 25.26% between 2025 and 2034. The rising prevalence of chronic disorders, an increasing number of organ transplantations, and growing research and development activities drive the market.
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Stem cell therapy (SCT) is a type of regenerative medicine used to treat or prevent disease. It uses stem cells that are manipulated to generate any cell type, such as blood, bone, muscle, heart, and nerve cells. The different types of stem cells include embryonic stem cells, induced pluripotent stem cells, and tissue-specific stem cells. However, as of 2024, only hematopoietic stem cells (tissue-specific) are approved by the U.S. Food and Drug Administration (FDA). SCT is used to treat multiple chronic disorders, including leukemia, Hodgkin's disease, non-Hodgkin lymphoma, anemia, immunodeficiencies, and inherited conditions of metabolism.
The rising incidences and prevalence of several chronic disorders and rare genetic disorders increase the demand for SCT. This also leads to an increasing number of organ transplants. SCT eliminates the use of anti-rejection drugs after organ transplants. The increasing investments and favorable government policies support the use of stem cells as therapeutics. New product launches and suitable regulatory frameworks promote the development of novel SCT products. Additionally, the advent of advanced technologies revolutionize SCT.
Artificial intelligence (AI) and machine learning (ML) algorithms have the potential to transform stem cell therapy. AI helps in extracting and storing stem cells from embryos or other sources, preventing their early degradation. It can also facilitate understanding the underlying disease mechanisms and develop customized SCT for their treatment. AI and ML can aid in large-scale production, increasing efficiency and reproducibility. They can streamline the entire research process, resulting in safer and more effective products. They result in lower costs and faster outcomes compared to conventional methods. They enable researchers to analyze vast amounts of data and develop new insights into how cells work, predicting treatment outcomes in patients receiving SCT. AI and ML can aid researchers in characterizing and optimizing stem cells.
Increasing Number of Clinical Trials
The major growth factor of the stem cell therapy market is the increasing number of clinical trials. The rising demand for novel stem cell therapy products due to the increasing prevalence of chronic disorders necessitates their development. Clinical trials are essential to assess the safety and efficacy of SCT. Several regulatory agencies evaluate clinical trial data before approving the product in their countries. Clinical trials are conducted to find extended applications of stem cells. Researchers are investigating the role of SCT in treating type 1 diabetes, Parkinson’s disease, osteoarthritis, heart failure, etc. There are a total of 4,719 clinical trials registered on the clinicaltrial.gov website related to stem cell therapy as of February 2025. The increasing investments and the rising number of contract development and manufacturing organizations (CDMOs) facilitate more clinical trials.
High Treatment Cost
The major challenge of the market is the high treatment cost of stem cell therapy. The average cost of SCT ranges from $5,000 to $50,000. In 2023, the average price for SCT using an expanded cell product was between $15,000 to $30,000. This limits the affordability of numerous people from low- and middle-income countries, restricting market growth.
Advances in Genomics
The future of the stem cell therapy market is promising, driven by recent advances in genomics. Technological advancements drive the latest innovations in genomic techniques to revolutionize the development of SCT. Several gene-editing tools, including CRISPR-Cas9 technique, are continuously evolving to enhance efficiency. This leads to the increased precision and safety of SCT. Apart from this, advancements in next-generation technologies allow for rapid analysis of genomes in stem cells. These technologies enable the modification of specific genes in stem cells, allowing researchers to develop targeted therapeutic interventions and correct genetic disorders at the cellular level. The increasing investments and collaborations potentiate the advancements of genomic techniques. Thus, advancements in genomics present numerous opportunities to develop more effective SCT, illuminating the path of immense potential to revolutionize modern medicine.
By therapy type, the allogeneic stem cell therapies segment held a dominant presence in the stem cell therapy market in 2024. Allogenic stem cell therapies involve the use of stem cells from a donor or other person with healthy cells. They are used in patients who are unable to produce enough healthy cells. This type of therapy is widely used in hematological malignancies and other blood-related disorders. The major benefit of allogeneic stem cells is the graft-versus-tumor effect, in which the donor’s immune cells actively attack and destroy any remaining cancer cells.
By therapy type, the autologous stem cell therapies segment is predicted to witness significant growth in the stem cell therapy market over the forecast period. Autologous stem cell therapies refer to using healthy blood stem cells from the patient’s own body cells. The increasing number of bone marrow transplants boosts the segment’s growth. In 2023, approximately 3,717 bone marrow transplants were performed in Spain, out of which 61% were autologous transplants. Autologous therapies eliminate the risk of immune rejection, resulting in enhanced engraftment and minimal ethical concerns.
By therapeutic application, the oncology segment held the largest share of the stem cell therapy market in 2024. Stem cell therapies are most widely used to treat different types of cancer, such as blood cancer, brain tumors, neuroblastoma, germ cell tumors, and testicular cancer. The rising prevalence of cancer and its complexity augment the segment’s growth. Favorable regulatory frameworks and new product launches also potentiate the segment’s growth. The growing research and development activities lead to the latest innovations, such as genetically modified stem cells, nanoparticle-carrying stem cells, stem cells as carriers for oncolytic viruses, etc., increasing the therapeutic potential for cancer treatment.
By therapeutic application, the musculoskeletal disorders segment is estimated to show lucrative growth in the stem cell therapy market during the forecast period. Stem cells have been found for tissue engineering and regeneration in musculoskeletal disorders. The rising incidences and prevalence of musculoskeletal disorders favor the development of stem cell therapies. Several researchers have investigated the role of stem cells in sports medicine, aiding in muscle recovery, meniscal tears, and ligament injury repair. In 2023, around 3.7 million people were treated in emergency departments due to sports and recreational injuries.
North America led the global stem cell therapy market in 2024. The state-of-the-art research and development facilities, advanced healthcare infrastructure, and technological advancements drive the market. The Food and Drug Administration (FDA) and Health Canada regulate the approval of stem cells in the U.S. and Canada, respectively. The FDA issues guidance on the appropriate use of stem cells in clinical trials and establishes a regulatory framework for developing and testing stem cell products. The increasing investments and favorable government policies also contribute to the market.
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Asia-Pacific is anticipated to grow with a significant CAGR in the stem cell therapy market during the studied years. The rising prevalence of chronic and rare disorders, increasing awareness about stem cell therapy, and growing healthcare expenditure drive the market. As of September 2023, 780,000 rare disease cases have been reported in China. While in India, more than 450 rare diseases are identified, affecting almost 80-100 million people. This necessitates the development of stem cell therapies. Favorable government support and increasing investments support the market. In 2024, China lifted a ban on foreign investments in human stem cell and gene therapies. The availability of suitable manufacturing infrastructure and government emphasis on indigenous manufacturing potentiate the production of stem cells. Asia-Pacific countries like India, Thailand, and China provide the most affordable stem cell therapy globally.
Melissa Little, CEO of the Novo Nordisk Foundation Center for Stem Cell Medicine, commented that researchers have been evaluating the role of iPSCs in the treatment of Parkinson’s disease in human clinical trials. The future involves the generation of gene-edited pluripotent stem cells to address rejection, selecting against tumor formation, or protecting transplanted cells from patient-induced injury.
By Therapy Type
By Therapeutic Application
By Region
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