April 2025
The global induced pluripotent stem cells market size accounted for USD 1.93 billion in 2024 and is predicted to increase from USD 2.13 billion in 2025 to approximately USD 5.12 billion by 2034, expanding at a CAGR of 10.25% from 2025 to 2034. The market growth is attributed to the increasing demand for patient-specific cell therapies and disease models driven by advancements in reprogramming technologies and regenerative medicine.
Artificial intelligence (AI) is a game-changer in the induced pluripotent stem cell (iPSC) market as it improves research productivity, scalability, and accuracy in therapeutic development. The algorithms of AI guide the reprogramming of adult cells into iPSCs to optimize, reduce errors, and enhance the reproducibility in companies and research institutions. Furthermore, the further advance of AI opens the prospects of clinical application scaling opportunities and promotes the worldwide expansion of iPSC-based technologies.
The U.S. induced pluripotent stem cells market size was exhibited at USD 625.32 million in 2024 and is projected to be worth around USD 1,691.26 million by 2034, growing at a CAGR of 10.46% from 2025 to 2034.
Why Did North America Emerge as the Leading Region in the Induced Pluripotent Stem Cells Market in 2024?
North America led the induced pluripotent stem cells market, capturing the largest revenue share in 2024, accounting for an estimated 45% market share, due to the presence of well-developed infrastructure, a high amount of research funding by both the government and the private sectors. Funding The California Institute for Regenerative Medicine (CIRM) and the NIH Stem Cell Program have provided funds for large numbers of focused grants to spur translational iPSC research as well as policymaking regulations. The main centers of academic excellence, such as Harvard Stem Cell Institute, Gladstone Institutes, and Johns Hopkins Institute of Cell Engineering, were innovation-driven by collaborations with biopharmaceutical firms.
It is expected that regulatory clarity on the United States Food and Drug Administration, especially with non-integrating reprogramming technologies and autologous cell therapies, will maintain regional leadership in the short run. The Mayo Clinic Center for Regenerative Medicine initiated a new iPSC-derived chondrocytes clinical program to treat Osteoarthritis as the transition to the broad phenomenon of large-scale therapy. Furthermore, the launch of new solutions by large organizations in this region further facilitates the market in the coming years.
In January 2025, Pluristyx, a leading provider of Good Manufacturing Practices (GMP), cutting-edge, induced pluripotent stem cell (iPSC) technologies, announced the immediate availability of the PSXi013 iPSC line made under GMP. This off-the-shelf, readily available cell line will revolutionize the cell and gene therapy landscape, breaking the mold of how cells are supplied and offering an unprecedented solution for researchers and developers seeking to accelerate clinical translation of their iPSC-based therapies.
(Source: https://pluristyx.com)
Asia Pacific is anticipated to grow at the fastest rate in the market during the forecast period, owing to the superior government investments growth in the prevalence of chronic diseases that iPSC-based therapies treat. China the National Stem Cell Resource Center developed region-specific iPSC banks to support precision medicine projects in the country. There have also been partnerships, based on the knowledge platform, to scale iPSC reprogramming and differentiation services to enable local clinical trials.
A new and improved regulation framework was proposed in 2024 by the regional governments in South Korea, Australia, and Singapore. They improved the timeline of getting stem cell-based therapy approved, which boosted investment and start-up biotechnology companies. Furthermore, the improvement in enrollment in regional iPSC clinical trials, notably cardiology and neurodegenerative disease trials in Japan, China, and India, is thus expected to lead to momentum in the market.
The induced pluripotent stem cells market comprises products and services related to stem cells that are genetically reprogrammed from adult somatic cells to an embryonic-like pluripotent state. These cells can differentiate into any cell type, making them a powerful tool in regenerative medicine, drug discovery, disease modeling, toxicology screening, and cell-based therapies. Unlike embryonic stem cells, iPSCs avoid ethical concerns and can be patient-specific, enabling personalized medicine and immune-compatible therapies. Market growth is fueled by advances in cell engineering, automation, CRISPR technology, and increasing R&D investment in cell-based therapeutics.(Source: https://www.eurogct.org)
Despite existing innovations, the increased incidence of chronic illnesses and genetic problems is contributing to an increasing global need for advanced regenerative therapies. Induced pluripotent stem cell (iPSC) technology is becoming one of the most vital focuses of biomedical research and innovation, as they are cells derived from an already present adult somatic cell and reprogrammed into a pluripotent form. The National Institutes of Health (NIH) reported that in 2024, there were more than 100 active clinical trials using iPSC-derived products, including Parkinson's treatment, macular degeneration, and cardiac repair. The California Institute of Regenerative Medicine (CIRM) is a government-sponsored program that, along with other initiatives, has statistics devoted to scores of iPSC-related projects aiming at taking laboratory breakthroughs to the clinic. Furthermore, with personalized medicine being the latest trend in health care, further investments in iPSC systems will drive the market in the coming years. (Source: https://www.nih.gov)
Report Coverage | Details |
Market Size by 2034 | USD 5.12 Billion |
Market Size in 2025 | USD 2.13 Billion |
Market Size in 2024 | USD 1.93 Billion |
Market Growth Rate from 2025 to 2034 | CAGR of 10.25% |
Dominating Region | North America |
Fastest Growing Region | Asia Pacific |
Base Year | 2024 |
Forecast Period | 2025 to 2034 |
Segments Covered | Application, Cell Type / Lineage, Product & Service, End User, Technology and Region |
Regions Covered | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
How Is the Increasing Prevalence of Chronic and Genetic Disorders Accelerating Demand in the Induced Pluripotent Stem Cells Market?
The increasing presence of endocrine disruptors, obesity, and related co-morbidities, and an increasing number of carcinogens in the environment are damaging DNA structures, leading to a rise in both genetic and chronic conditions. These factors have driven the induced pluripotent stem cells market in the last few years. The rise in incidences of these diseases is likely to fuel the market demand involving superior cell-based models and custom-made therapies. According to the CDC's 2024 report, approximately 60% of Americans live with at least one chronic disease, while 40% are affected by two or more chronic conditions. Increasing instances of diseases, such as Parkinson's, Alzheimer's, diabetes, and several rare genetic diseases, have induced investigators and drug companies to examine patient-derived iPSC lines to execute precise modeling and regenerative efforts. (Source: https://web.brc.riken.jp)
These cells are an ethically acceptable, genetically matched source of cells to study the disease progression and also to assess response to drugs by increasing the preclinical success rates. The use of iPSC platforms is a topic that is gaining traction in hospitals and research centers so that they can conduct clinical tests that seek to provide long-term solutions rather than symptomatic ones. In 2024, the RIKEN Center for Biosystems Dynamics Research in Japan went further to develop its iPSC platform by adding CRISPR-Cas9 gene editing to its platform to study inherited retinal diseases to further strengthen the use of iPSCs in the personalized development of therapy. Furthermore, such a change in order to disease-modifying solutions is further reinforcing the research and development base of the induced pluripotent stem cells market and further fuelling its growth.(Source: https://www.cdc.gov)
How has Regulatory Complexity Slowed Therapeutic Approval in Clinical-Grade iPSC Applications?
High costs associated with iPSC development and manufacturing are anticipated to hinder the market. The specialized infrastructure, specialized personnel, and high degree of quality control involved in establishing the iPSC lines under GMP conditions introduce barriers to entry. Such expenses limit entry to well-capitalized academic hubs and giant biotech companies, with the minor stakeholders left with reduced choices of licensing or joint ventures. Furthermore, the regulatory complexity surrounding clinical-grade iPSC applications is expected to limit the pace of therapeutic approvals, thus further hampering the induced pluripotent stem cells market.
Why Is The High Investment In Stem Cell Research And Regenerative Medicine Reshaping The Technological Roadmap Of The Induced Pluripotent Stem Cells Market?
Growing investment in stem cell research and regenerative medicine is anticipated to create immense opportunities for the market. Governments, universities, and private corporations have increased funding efforts on a great scale to hasten the discovery and commercialization of iPSCs. Nations, such as the U.S., Japan, and the UK, offer large grants to work on translational studies, and the biotech companies join hands with universities to scale up the protocols, started in laboratories, to clinical grades.
In Canada, the Centre for Commercialization of Regenerative Medicine (CCRM) opened a new venture lab in 2024 to assist early-stage ventures in doing work on iPSC production and clinical development. Furthermore, the increase in financial and infrastructural grants by the government and private organizations to facilitate innovation in these technologies further fuels the induced pluripotent stem cells market in the coming years. (Source: https://www.ccrm.ca)
On February 23, 2024, the California Institute for Regenerative Medicine (CIRM)—the world’s largest organization focused on regenerative medicine—allocated $56 million to advance clinical research targeting Parkinson’s disease, autoimmune disorders, and various cancers. The funding supports seven projects under CIRM’s clinical program, which facilitates the progression of stem cell and gene therapy-based therapies through every phase of clinical trial development.
(Source: https://www.cirm.ca.gov)
Why Do Drug Development and Toxicity Testing Lead the Application Landscape in the Induced Pluripotent Stem Cells Market?
The drug discovery and toxicology testing segment dominated the induced pluripotent stem cells market in 2024, accounting for an estimated 36% market share, due to the increased need for valid, relevant, and predictive in vitro models to determine the efficacy and safety of drugs before clinical trials. Furthermore, this enhanced the company as the value of the iPSCs as patient-specific, scalable cell sources that gave them the edge in the induced pluripotent stem cells market.
The disease modeling segment is expected to grow at the fastest rate/fastest CAGR in the coming years, owing to the need for patient-specific models of complex and rare diseases. Such a segment acquires impetus through the fact that iPSCs have the potential to recapitulate the disease phenotype in a cellular model, which allows the accurate study of disease processes and pathogenesis.
Biotechnology companies and research centers are putting huge investments in iPSC-based frameworks to investigate neurodegenerative disorders, cardiovascular abnormalities, and genetic disorders. To aid iPSC-based disease modeling, NIH and other research organizations around the world have also raised their funding on the subject, particularly on disease conditions that are unlikely to be resolved using effective treatments. In 2024, the Harvard Stem Cell Institute partnered with Vertex Pharmaceuticals to model cystic fibrosis with iPSC-derived lung epithelial cells to generate data published in Nature Medicine. Furthermore, the emergence of the souped-up, personalized medicine market and the development of CRISPR genome editing further facilitate the segment. (Source: https://investors.vrtx.com)
What Drives the Dominance of Cardiomyocytes in the Induced Pluripotent Stem Cells Market by Cell Lineage?
Hematopoietic cells segment held the largest revenue share in the induced pluripotent stem cells market in 2024, due to the widespread application of using them in regenerative medicine, immunotherapy, and modelling of haematological disease. The iPSC-derived cells find wide application in the study of blood-related diseases, such as leukaemia, anaemia, and immunodeficiencies, as they recapitulate the stages of the native haematopoiesis.
Hematopoietic cells are of interest to researchers and biopharmaceutical developers due to their applicability in the generation of a number of different immune cells, such as T cells and natural killer (NK) cells. They are more frequently being studied in off-the-shelf cell therapies. In 2024, the NIH and the California Institute for Regenerative Medicine (CIRM) invested more heavily in the study of iPSC-derived blood cell products. Furthermore, the new directions in differentiation procedures, the large-scale production of hematopoietic cells using GMP processing, likely continue to fuel the hematopoietic cells segment.
(Source: https://pmc.ncbi.nlm.nih.gov)
Hepatocytes segment is expected to grow at the fastest rate/fastest CAGR in the coming years, owing to the increasing need for liver disease modeling, toxicity testing, and accurate drug screening. Such liver cells, differentiated by iPSCs, are being used more to investigate nonalcoholic steatohepatitis (NASH), viral hepatitis, and inherited metabolic disorders since they are able to recapitulate important hepatic functions. Moreover, the hepatocytes offer scalability, reproduction, and greater metabolic fidelity, further propelling the growth of this segment.
What Makes iPSC-Derived Cells the Dominant Offering in the Induced Pluripotent Stem Cells Market?
iPSC-derived cells segment dominated the induced pluripotent stem cells market in 2024, accounting for 41% market share, due to their prominent use in drug research, disease modeling, regenerative medicine, and toxicity screening, creating massive demand in both research and clinical scenarios. It is the ability to produce different lineages of tissues that are considered useful, as the chances of generating functional relevance of models of complex tissue in humans. Furthermore, the superior predictive validity of iPSC-derived hepatocytes compared to traditional models in drug-induced liver injury (DILI) modelling further boosts the segment in the coming years.
The stem cell banking services segment is expected to grow at the fastest CAGR in the coming years, owing to the increased awareness of customized regenerative medicine and the lifelong benefit of an autologous iPSC repository. Institutions increase their banking facilities to meet rising demands regarding safe and GMP-compliant storage of patient-specific iPSC lines. These services provide access to genetically stable cell lines that have been quality-controlled and can be used in future therapeutic applications of neurology, oncology, and rare diseases. Moreover, the California Institute of Regenerative Medicine (CIRM) also invested in a statewide infrastructure to facilitate the use of iPSC biorepositories, further facilitating the segment.
How Are Pharmaceutical & Biotechnology Companies Driving the Induced Pluripotent Stem Cells Market Forward?
Pharmaceutical & biotechnology companies segment held the largest revenue share in the induced pluripotent stem cells market in 2024, accounting for 44% of the market share, due to the vast use of iPSCs in their drug discovery pipeline, drug toxicity assessment, and regenerative therapies pipeline. To increase target identification and to enhance predictive toxicology, more companies are embracing the use of iPSC-derived cellular models to reduce loss during major clinical trials that have a high failure rate. Additionally, the current evolution towards human-relevant preclinical models is expected to fuel the segment.
The CROs & CDMOs segment is expected to grow at the fastest rate in the coming years, as they play a central role in the upscaling of iPSC applications into commercial and translational applications. The growing outsourcing by drug and biotech companies to cut R&D expenses and improve time-to-market is compelling the pharmaceutical industry towards CROs and CDMOs that provide specialized iPSC services.
Lonza and Pluristyx extended their iPSC manufacturing capabilities, such as the GMP-grade cell lines development and cryopreservation services for personalized regenerative therapy in 2024. The rest of these organizations are expected to increase their momentum further since they assist in early clinical initiatives, genome editing services, and custom differentiation procedures. In 2025, the Mayo Clinic Center for Regenerative Medicine and a U.S.-based CDMO will contract to produce iPSC-derived dopaminergic neurons to a clinical grade. Furthermore, the new guidelines regarding the commercialization-grade iPSC production further facilitated the segment in the coming years.(Source: https://www.cira-foundation.or.jp)
What Positions Non-Integrating Methods as the Preferred Reprogramming Technology in the Induced Pluripotent Stem Cells Market?
Non-integrating methods segment dominated the global induced pluripotent stem cells market in 2024 and is expected to sustain the growth in the coming years, as it eliminates insertional mutagenesis and preserves genomic fitness. The most popular of them are episomal vectors, Sendai virus-based reprogramming, and mRNA transfection, implemented widely in the research and clinical pipeline. This strategy should work to enhance the rate of clinical translation, especially in the area of cell therapy and regenerative medicine, with safety and reproducibility that fits the regulatory requirements of the genome. (Source: https://www.cirm.ca.gov)
In 2024, scientists in the Stanford Institute for Stem Cell Biology and Regenerative Medicine reported increased success rates with synthetic modified mRNA-based reprogramming, with reports of increased consistency in the quality of iPSC across neurological and cardiovascular disease models. NIH Stem Cell Program in its 2024 iPSC roadmap, identified an increasing interest in adopting xeno-free, feeder-free, and integration-free methods of reprogramming that simplify downstream differentiation and potential therapeutic uses. Furthermore, regulators such as the European Medicines Agency (EMA) are marshaling to harmonize frameworks of GMP to promote integration-free, clinically validated iPSC production protocols, thus further fuelling the segment. (Source: https://www.asgct.org)
(Source: https://pubmed.ncbi.nlm.nih.gov)
Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc.
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