Global Induced Pluripotent Stem Cell (iPSC) Industry Report – Market Size, Trends, & Forecasts, 2024

Global Induced Pluripotent Stem Cell (iPSC) Industry Report - Market Size, Trends, and Forecasts, 2024

EXECUTIVE SUMMARY:

Global Induced Pluripotent Stem Cell (iPSC) Industry Report – Market Size, Trends, and Forecasts, 2024

Since the discovery of induced pluripotent stem cell (iPSC) technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. iPSCs can be used to explore the causes of disease onset and progression, create and test new drugs and therapies, and treat previously incurable diseases.

Today, methods of commercializing induced pluripotent stem cells (iPSCs) include:

Cellular Therapy: iPSCs are being explored in a diverse range of cell therapy applications for the purpose of reversing injury or disease.

Disease Modelling: By generating iPSCs from patients with disorders of interest and differentiating them into disease-specific cells, iPSCs can effectively create disease models “in a dish”.

Drug Development and Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery.

Personalized Medicine: The use of techniques such as CRISPR enable precise, directed creation of knock-outs and knock-ins (including single base changes) in many cell types. Pairing iPSCs with genome editing technologies is adding a new dimension to personalized medicine.

Toxicology Testing: iPSCs can be used for toxicology screening, which is the use of iPSCs or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells.

Tissue Engineering: iPSCs can be seeded onto scaffolds made from biocompatible materials. These scaffolds mimic the structure and properties of the target tissue and can provide a supportive environment for cell growth and differentiation.

Organoid Production: iPS cells can be coaxed to self-organize into 3D structures called organoids, which mimic the structure and function of organs. Organoids can be used for studying organ development, modeling diseases, and testing drugs.

Gene Editing: iPS cells can be genetically modified using techniques like CRISPR-Cas9 to correct disease-causing mutations or introduce specific genetic changes. These edited iPS cells can then be differentiated into the desired cell type for transplantation or disease modeling.

Research Tools: iPSCs and iPSC-derived cell types are being widely used within a diverse range of basic and applied research applications.
Stem Cell Banking: iPSC repositories provide researchers with the opportunity to investigate a diverse range of conditions using iPSC-derived cell types produced from both healthy and diseased donors.

Cultured Meat Production: iPSCs are being utilized in clean meat production by serving as the cellular foundation for the creation of lab-grown meat.

3D Bioprinting: iPSCs can be directed to differentiate into cell types of interest, such as skin, heart, or liver cells, which are then incorporated into bioinks.

Wildlife Conservation and De-extinction Projects: iPSCs are being used in wildlife conservation and de-extinction projects. For example, Colossal Biosciences is using iPSC technology in an effort to achieve woolly mammoth de-extinction.

iPSC Market Dynamics

Since the discovery of iPSCs in 2006, it took only seven years for the first iPSC-derived cell product to be transplanted into a human patient in 2013. Since then, iPSC-derived cells have been used within a rapidly growing number of preclinical studies, physician-led studies, and clinical trials worldwide.

The discovery of iPSC has not only favorably transformed the field of drug discovery, toxicity testing and in-a-dish disease modeling, but also powerfully impacted the field of cell and gene therapy. The ability of iPSCs to multiply in vitro and then get differentiated into specialized cells makes iPSCs an ideal source of cells of different types for curative clinical cell replacement therapies and disease modeling.

Of course, 2013 was a landmark year because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Dr. Masayo Takahashi, it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration. In another world first, Cynata Therapeutics received approval in 2016 to launch the first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. CYP-001 is an iPSC-derived MSC product. In this historic trial, CYP-001 met its clinical endpoints and produced positive safety and efficacy data for the treatment of steroid-resistant acute GvHD.

Today, at least 155 ongoing clinical trials are using iPSC-derived specialized cells to address various indications. iPSC-derived MSCs are being tested in the treatment of steroid-resistant acute graft versus host disease (GvHD). iPSC-derived dopaminergic progenitors are being evaluated in the treatment of Parkinson’s disease. iNK cell-based cancer immunotherapy is being studied in the treatment of metastatic solid tumors. iPSC-derived retinal pigment epithelial cells have shown positive results in the treatment of age-related macular degeneration (AMD). Furthermore, iPSC derived insulin secreting beta cells are being tested for the treatment of Type 1 diabetes.

Although iPSCs have the potential to be used in both allogeneic and autologous applications, the development of allogeneic therapies using iPSC-derived products is outpacing the development of autologous therapies. Several allogeneic therapies utilizing iPSC-derived cells derived from healthy donors are being used to address diabetes, Parkinson’s disease, and AMD, and these therapies are quickly progressing into early phase clinical trials.

Market competitors are also commercializing iPSC-derived products for use in drug development and discovery, disease modeling, and toxicology testing. Across the broader iPSC sector, FUJIFILM CDI (FCDI) is one of the largest and most dominant players. Cellular Dynamics International (CDI) was founded in 2004 by Dr. James Thomson at the University of Wisconsin-Madison, who in 2007 derived iPSC lines from human somatic cells for the first time. The feat was accomplished simultaneously by Dr. Shinya Yamanaka’s lab in Japan. FUJIFILM acquired CDI in April 2015 for $307 million. Today, the combined company (FCDI) is the world’s largest manufacturer of human cells created from iPSCs for use in research, drug discovery and regenerative medicine applications.

Another iPSC specialist is ReproCELL, a company that was established as a venture company originating from the University of Tokyo and Kyoto University in 2009. It became the first company worldwide to make iPSC products commercially available when it launched its ReproCardio product, which are human iPSC-derived cardiomyocytes. Within the European market, the dominant competitors are Evotec, Ncardia, and Axol Bioscience. Headquartered in Hamburg, Germany, Evotec is a drug discovery alliance and development partnership company. It is developing an iPSC platform with the goal to industrialize iPSC-based drug screening as it relates to throughput, reproducibility, and robustness. Today, Evotec’s infrastructure represents one of the largest and most advanced iPSC platforms globally.

Ncardia was formed through the merger of Axiogenesis and Pluriomics in 2017. Its predecessor, Axiogenesis, was founded in 2011 with an initial focus on mouse embryonic stem cell-derived cells and assays. When Yamanaka’s iPSC technology became available, Axiogenesis became the first European company to license it in 2010. Today, the combined company (Ncardia) is a global authority in cardiac and neural applications of human iPSCs. Founded in 2012, Axol Bioscience is a smaller but noteworthy competitor that specializes in iPSC-derived products. Headquartered in Cambridge, UK, it specializes in human cell culture, providing iPSC-derived cells and iPSC-specific cell culture products.

Of course, the world’s largest research supply companies are also commercializing a diverse range of iPSC-derived products and services. Examples of these companies include Lonza, BD Biosciences, Thermo Fisher Scientific, Merck, Takara Bio, and countless others. In total, at least 90 market competitors now offer a diverse range of iPSC products, services, technologies, and therapeutics.

This global strategic report reveals all major market competitors worldwide, including their core technologies, strategic partnerships, and products under development. It covers the current status of iPSC research, biomedical applications, manufacturing technologies, patents, and funding events, as well as all known trials for the development of iPSC-derived cell therapeutics worldwide. Importantly, it profiles leading market competitors worldwide and presents a comprehensive market size breakdown for iPSCs by Application, Technology, Cell Type, and Geography (North America, Europe, Asia/Pacific, and Rest of World). It also presents total market size figures with projected growth rates through 2030.

About the Publisher

Founded in 2006, BioInformant is a U.S. market research firm that attracts an online readership of nearly one million readers per year. As the first and only market research firm to specialize in the stem cell industry, BioInformant’s research has been cited by the Wall Street Journal, Xconomy, and Vogue Magazine. Headquartered near Washington, DC, BioInformant is strategically positioned to be near the National Institutes of Health (NIH), U.S. FDA, Maryland Biotech Corridor, and policy makers on Capitol Hill. Serving all-star clients that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in cell therapy industry data.