GLOBAL INDUCED PLURIPOTENT STEM CELLS MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

The global induced pluripotent stem cells market was valued at US$ 1,595.4 Mn in 2023 and is expected to reach US$ 3,707 Mn by 2031, growing at a compound annual growth rate (CAGR) of 11.1% from 2024 to 2031.  

Induced pluripotent stem cells (iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The discovery of iPSCs introduced a breakthrough in the stem cell research as it overcomes many of the ethical issues that are associated with embryonic stem cells. iPSCs are generated through the expression of genes and factors that can ‘reprogram’ a normal adult differentiated somatic cell into an embryonic stem cell-like pluripotent state. This process allows scientists to generate patient and disease-specific stem cells without the destruction of human embryos.

There are two main types of iPSCs - virus-based and non-virus-based iPSCs. Virus-based iPSCs make use of integrating viruses like retroviruses and lentiviruses to deliver reprogramming genes into adult cells. This method has a high reprogramming efficiency but risks genomic modification and tumor formation. Non-virus methods utilize molecules like proteins, and chemicals to generate iPSCs without altering the host genome. These reprogramming methods have a lower efficiency but higher safety. In summary, while both cell types hold promise for disease modeling, drug screening and personalized regenerative medicine, non-integrating iPSCs are considered safer for potential clinical applications due to less risk of tumor formation.

Global Induced Pluripotent Stem Cells Market Regional Insights

• North America is expected to be the largest market for induced pluripotent stem cells over the forecast period and it accounted for over 36.3% of the market share in 2024. The growth of the market in North America is due to the presence of leading medical device companies, established healthcare infrastructure, and high healthcare expenditure, have driven market growth over the years.
• Europe is expected to be the second-largest market for induced pluripotent stem cells, which accounted for over 30.4% of the market share in 2024. The growth of the market is due to the presence of several ongoing research initiatives at universities and hospitals across major European countries like Germany, U.K., and France have established standardized protocols for efficiently reprogramming blood cells into iPSCs.
• Asia Pacific is expected to be the fastest-growing market for induced pluripotent stem cells, which is expected to grow at a CAGR of over 12.3% during the forecast period. The growth of the market in Asia Pacific is due to the rapidly developing economies such as China and India, which are expected to showcase high investment opportunities due to increasing healthcare expenditures and expanding healthcare infrastructure. Improving regulatory guidelines and reimbursement policies is positively impacting market dynamics.

Figure 1. Global Induced Pluripotent Stem Cells Market Share (%), By Region, 2024

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Analyst’s Views:

Global induced pluripotent stem cells market is expected to grow significantly over the next decade driven by increasing stem cell research activities and investments. The ability of iPSCs to generate patient-specific cells provides opportunities for developing safer and more effective regenerative medicines. Furthermore, iPSCs can be used as a valuable research tool for drug discovery and toxicity screening applications. Asia Pacific is expected to dominate the market due to supporting government policies and rising number of clinics offering stem cell therapies in countries like China, Japan, and South Korea. North America will continue its strong position in the market supported by ongoing clinical trials and availability of advanced healthcare facilities.

However, high costs that are associated with iPSC development and commercialization remain a major challenge to widespread adoption. Standardization of differentiation protocols is another bottleneck that needs to be addressed. Limited understanding of epigenetic changes during reprogramming is also a concern from efficacy and safety point of view. Market players should focus on refining techniques to generate clinical-grade iPSCs easily and cost-effectively. Industry-academia collaborations would help enhance applications of iPSC platforms. While regulations differ across regions, favorable regulations and guidelines would provide an impetus to the market. Ongoing stem-cell banking initiatives could help facilitate accessibilities to iPSC lines for research purposes.

Global Induced Pluripotent Stem Cells Market Drivers:

• Increasing research funding: Government and private funding for stem cell research has increased substantially in recent years, fueling innovations with induced pluripotent stem cells (iPSCs) that are expanding their applications and driving more research. Countries like Japan, China, and several nations in Europe have significantly boosted budgets for stem cell science, with a particular emphasis on iPSC technology's potential role in developing personalized regenerative medicines. For example, in 2022, according to a statement provided by the U.K. Stem Cell Foundation indicated government grants for iPSC projects had doubled since 2020. Private donations to stem cell nonprofit organizations have also grown, with the California Institute for Regenerative Medicine announced in late 2021 of the private contributions which exceeded US$ 300 Mn that year.
• Growing prevalence of neurodegenerative diseases: Induced pluripotent stem cell technology has emerged as a promising avenue for developing novel treatments targeting the underlying causes of these incurable diseases. iPSCs offer a potential alternative to human embryonic stem cells for achieving personalized cell therapies and developing disease models for drug discovery efforts. According to the article published by World Health Organization (WHO) in 2022, over 55 Mn people globally lived with dementia, with nearly 10 Mn new cases emerging every year. Alzheimer's disease alone is estimated to affect over 30 Mn people worldwide. As the aging population increases across many countries, especially in developed nations, the burden of such neurodegenerative conditions is projected to escalate substantially over the coming decades.
• Surging demand for personalized medicine: Many pharmaceutical companies are investing heavily in iPSC research to develop biomarkers for disease diagnosis and monitoring treatment response. They are using iPSC-derived cells from disease-specific donors to validate drug targets and toxicity. For example, Astellas Pharma, a Japan based multinational pharmaceutical company, established disease modeling and drug discovery platforms by using iPSCs from amyotrophic lateral sclerosis and duchenne muscular dystrophy patients. Several clinical trials are ongoing to evaluate the safety and efficacy of iPSC-derived cells for retinal dystrophy, spinal cord injury, heart disease, and cartilage damage. The success of these studies will demonstrate the potential of iPSCs to transform regenerative medicine from a research concept to an established clinical solution.
• Rising numbers of clinical trials: More research institutes and pharmaceutical companies are conducting clinical trials to evaluate the therapeutic potential of iPSCs. For instance, according to the World Health Organization (WHO), over 300 iPSC clinical trials were registered between 2020-2022 worldwide targeting a variety of conditions like macular degeneration, Parkinson's disease, heart disease and diabetes. Countries with most registered iPSC clinical trials during this period included Japan, USA, China, and U.K. These trials are investigating the efficacy and safety of using iPSC-derived cells for transplantation, drug testing, and disease modeling. Successful trial outcomes could validate their use in the clinic in the near future.

Global Induced Pluripotent Stem Cells Market Opportunities:

• Increasing collaborations and partnerships between research institutes and pharma companies: The field of regenerative medicine has experienced significant advancements in recent years due to growing stem cell research. More research institutes and pharmaceutical companies are conducting clinical trials to evaluate the therapeutic potential of iPSCs. For instance, according to the article published by World Health Organization (WHO) in 2023, over 300 iPSC clinical trials were registered between 2020-2022 worldwide targeting a variety of conditions like macular degeneration, Parkinson's disease, heart disease, and diabetes. Countries with most registered iPSC clinical trials during this period included Japan, U.S., China and U.K. These trials are investigating the efficacy and safety of using iPSC-derived cells for transplantation, drug testing, and disease modeling. Successful trial outcomes could validate their use in the clinic in the near future.
• Growing application areas in regenerative medicine: Regenerative medicine has the potential to revolutionize treatment for various degenerative diseases and injuries. The ability of induced pluripotent stem cells (iPSCs) to differentiate into any cell type in the body makes them incredibly useful for regenerative therapies. This could be a major growth opportunity for the global iPSC market. Some key therapeutic areas that are actively researching iPSC applications include musculoskeletal disorders, neurodegenerative diseases, cardiovascular diseases, diabetes, and ocular diseases. For example, iPSC-derived retinal epithelial cells are being tested in clinical trials to treat age-related macular degeneration, one of the leading causes of blindness worldwide. Ipsaga, a biotech company, has also had success by using iPSC-derived chondrocytes to regenerate cartilage in animal models of osteoarthritis. As the science progresses, additional clinical applications are sure to emerge for regenerative treatments of cartilage, bone, heart, pancreatic islets, and various neurological tissues.
• Scope for development of advanced therapies using iPSCs: The capabilities of iPSCs to turn into any cell type of the body have attracted significant investments from pharmaceutical and biotechnology companies. They are working towards developing iPSC based therapies and products across different therapeutic categories like neurodegenerative disorders, blood disorders, and diabetes. Successful clinical trials and approvals will demonstrate the real-world applicability of this technology. Commercialization of first few iPSC products will prove to be a landmark achievement and significantly boost the future research pipelines. Government agencies like the National Institutes of Health, U.S. and National Institute for Health Research, U.K. are supporting large number of iPSC projects through funding. For instance, in 2023, National Institute for Health (NIH) invested US$ 79 Mn in iPSC research in 2021 according to its annual report.

Global Induced Pluripotent Stem Cells Market Trends:

• Increasing focus on development of xeno-free culture media: Many researchers and industry players are investing resources to engineer xeno-free solutions for stem cell maintenance and differentiation. Several bio-tech startups as well as large corporations like Thermo Fisher Scientific, a biotechnology and laboratory equipment company introduced human extracellular matrix-based culture plates that facilitate the growth of iPSCs in nutrient solutions devoid of animal feeders, serum and other xenogenic materials. For example, in 2022, STEMCELL Technologies, develops cell culture media, cell separation systems, instruments and other reagents for use in life sciences research, launched mTeSR XF, a xeno-free culture medium that is designed for expansion and maintenance of pluripotent stem cells under completely defined and animal product-free conditions.
• Rising adoption of 3D cell culture technology: Rising adoption of 3D cell culture technology is having a significant impact on the global induced pluripotent stem cells (iPSCs) market. 3D cell culture allows for the growth of living cells in all three dimensions, which better mimics the natural cellular environment in the human body as compared to traditional two-dimensional cell cultures. This opens up new possibilities for disease modeling and drug development by using iPSCs. Many researchers and pharmaceutical companies are utilizing 3D cell culture techniques to develop more physiologically relevant in vitro disease and toxicity models by using iPSC-derived cells. This is helping yield results that translate better to in vivo human conditions. For instance, in 2021, according to a study published by the Nature Communications, a 3D lung tissue was developed by using iPSC-derived epithelial and endothelial cells that showed response to respiratory viruses similar to lung tissues. Such accurate disease modeling was not possible earlier by using conventional 2D cell culture methods.
• Growing preference for customer specific iPSC lines: Rising demand is encouraging more players to invest in developing advanced capabilities for generating large numbers of gene-edited and disease-relevant iPSC lines on a customer-specific basis. This is enabling outsourcing of certain research activities to specialized firms, thus reducing time and costs for academic institutes and pharmaceutical developers. According to the article published by the National Institutes of Health, in 2022, funding for stem cell research in the U.S. grew from US$ 476 Mn in 2010 to US$ 1.45 billion in 2021, reflecting increasing support for such approaches in drug discovery and regenerative medicine. Growing preference for patient-specific iPSC lines is expected to significantly influence research trends and market dynamics in the near future.

Global Induced Pluripotent Stem Cells Market Restraints:

• High cost involved: One of the major factors holding back the growth of the global induced pluripotent stem cells market is the extremely high costs associated with research and development in this area. Producing clinical-grade iPS cells and differentiated cells involves complex culturing, transfection, and cellular reprogramming processes that require specialized equipment, materials, and facilities. Maintaining sterile laboratory environments suitable for human cell culture work is also an expensive undertaking that increases costs substantially. Considering that iPS cell therapy is still an emerging field and the technologies involved are rapidly evolving, there are significant research expenses that are associated with advancing of the science, validating techniques, and moving new therapies through clinical trials.
• Lack of skilled professionals: The lack of skilled professionals is one of the major challenges restraining the growth of the global induced pluripotent stem cells market. For example, according to a survey conducted by the U.K. Stem Cell Foundation in 2022, over 85% of university stem cell labs in U.K. faced manpower shortages, especially for specialized iPSC roles. More than 60% of respondents said lack of trained personnel was a key limitation for expanding their iPSC experimental work. Similarly, a study published in 2021 by the International Society for Stem Cell Research reported talent crunch as a major roadblock for commercialization of iPSC-based therapies, with over 70% of biotech firms finding it hard to hire suitable iPSC-focused candidates. Unless dedicated efforts are made by academic, government and industry stakeholders to enhance workforce preparedness, this skills gap will persist as a restraint on the potential market growth of iPSC-based products.
• Counterbalance: To counterbalance this restraint, dedicated efforts needs to be under taken by the government of the said region, academic and industry stakeholders to upgrade workforce preparedness.
• Ethical issues related to embryonic stem cells research: Ethical issues have boosted interest in alternatives like induced pluripotent stem cells which do not require the use and destruction of human embryos. iPSCs offer a way to generate personalized stem cells for research and potential therapies without crossing any ethical boundaries. Several studies have also shown that iPSCs are as pluripotent and versatile as embryonic stem cells for modeling diseases. The lack of ethical baggage gives iPSCs an advantage over embryonic stem cells in attracting private funding from companies and investors. For instance, according to a recent study by the Pew Research Center, funding for iPSC research grew by over 25% each year between 2010-2020, while funding for embryonic stem cell research stagnated due to ethical issues.

Recent Developments

Facility Expansion

• In 2022, Century Therapeutics, a pharmaceutical company and Bristol Myers Squibb, a global biopharmaceutical company entered into a research collaboration and license agreement in order to develop and commercialize up to four induced pluripotent stem cell derived, engineered natural killer cell and / or T cell programs for hematologic malignancies and solid tumors. The first two programs include a program in acute myeloid leukemia and a program in multiple myeloma, which could incorporate either the iNK or a gamma delta iT platform. Bristol Myers Squibb has the option to add two additional programs which can be nominated subject to certain conditions agreed with Century Therapeutics in the agreement.
• In 2022, Promega Corporation, one of the leaders in providing innovative solutions and technical support to the life sciences industry, and FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cell (iPSC) technologies, entered into a strategic collaboration in order to advance novel assay development for drug discovery. Under a multi-year licensing agreement, FUJIFILM Cellular Dynamics will offer a wide range of custom differentiated iPSCs integrated with Promega Corporation biosensor and intracellular bioluminescent reporter capabilities for researchers and scientists to use as part of novel assay development in the drug discovery process.

Figure 2. Global Induced Pluripotent Stem Cells Market Share (%), By Cell Source, 2024

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Top Companies in the Global Induced Pluripotent Stem Cells Market

• Takara Bio Inc.
• Thermo Fisher Scientific
• Fujifilm Holdings Corporation
• Astellas Pharma
• Fate Therapeutics
• Ncardia
• ViaCyte
• Cellular Dynamics International
• Lonza
• Blueprint Medicines
• Other Prominent Players

Definition: Induced pluripotent stem cells (iPSC) are derived from skin or blood cells that have been reprogrammed back into an embryonic-like pluripotent state that enables the development of an unlimited source of any type of human cell needed for therapeutic purposes. For example, iPSC can be prodded into becoming beta islet cells to treat diabetes, blood cells to create new blood free of cancer cells for a leukemia patient, or neurons to treat neurological disorders.