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Today, induced pluripotent stem cells (iPSCs) are being exploited for uses in drug discovery and development, toxicology screening, disease modelling, personalized medicine, cell-based therapeutics, and beyond. A fascinatingly diverse range of business models have been developed by market competitors to provide iPSC specific products, services, technologies, and therapies across the life science sector.
iPSC Market Leader by Product Type
Reprogramming kits, reagents, iPS cell lines, and specific culture media are supplied by companies specializing in iPSCs, including FUJIFILM CDI, Ncardia, Axol Bioscience, ReproCELL, and others. Diversified research supply companies such as R&D Systems, Promega, Miltenyi Biotec, STEMCELL Technologies, Takara Bio, Thermo Fisher Scientific, and numerous others also provide iPSC-related research products to the scientific community.
Additionally, iPSC specialists have emerged, such as iXcells Biotechnologies which provides normal and diseased iPS cell lines, iPSC-derived cells, custom iPSC services, and functional bioassay development and execution, among related products and services.
Several of these companies offer contract services as well, such as the development of screening systems for toxicity testing and drug discovery, optimization of reprogramming and culturing conditions, derivation of iPSC and reporter cell lines, and their characterization.
Within the world of industrial scale iPSC manufacturing, FUJIFILM CDI, Treefrog Therapeutics, and Rheincell Therapeutics are three companies who are leading the charge. While most people are familiar with FUJIFILM because it is a stalwart in the field, fewer people know about Treefrog Therapeutics. Founded in 2018, Treefrog Therapeutics has developed C-Stem, a high-throughput cell encapsulation technology allowing for the mass-production and differentiation of iPSCs in industrial bioreactors.
Rheincell is another relatively recent entrant into the iPSC marketplace. Founded in 2017, it focuses on the GMP-compliant generation of human iPSCs derived from HLA-homozygous allogeneic umbilical cord blood. Cynata Therapeutics also has a unique technology for nearly infinite expansion of iPSC-derived MSCs, but currently it is using this capacity for its own iPSC-derived cell therapy product development.
iPSC-Derived Cell Therapeutics
The major firms exploiting iPSC technologies for therapeutic applications include Cynata Therapeutics, iPierian (Bristol-Myers Squibb), Fate Therapeutics, Century Therapeutics, and BlueRock Therapeutics. In addition to these companies, dozens of others have now joined their ranks.
In a world first, Cynata Therapeutics received approval in 2016 to launch the world’s first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. Cynata’s proprietary technology utilizes iPSCs originating from an adult donor as the starting material for generating mesenchymoangioblasts (MCAs). It then differentiates these cells into mesenchymal stem cells (MSCs). Today, Cynata Therapeutics has clinical trials underway for an impressive range of indications, including Graft vs. Host Disease (GvHD), knee osteoarthritis, acute respiratory distress syndrome (ARDS), diabetic foot ulcers, renal transplantation, and critical limb ischemia (CLI).
iPierian and Fate Therapeutics follow the same strategy of reprogramming somatic cells for developing cell-based models to screen small molecules for drug development. iPierian uses cellular reprogramming and differentiation technologies for advancing the understanding of human diseases for which there are poor in vivo and in vitro models and develop cell-based therapeutics for its own pipeline for the treatment of specific diseases. iPerian’s focus is on three neurological disorders, namely Parkinson’s disease, spinal muscular atrophy, and amyotrophic lateral sclerosis.
Fate Therapeutics has developed an intricate understanding of the pathways that can activate and modulate stem cells and iPSC technology for screening stem cell modulators (SCMs), which are capable of impacting cell fate in vivo for repairing and regenerating tissues. Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. Currently, iPSC-derived cell therapeutics have yet to reach the market. Reasons for this include the prohibitively high cost of developing cell-based therapies and the challenging regulatory and scale-up issues associated within living therapeutics.
Other companies operate across multiple iPSC market segments. As an example, Stemgent (a ReproCELL brand) has developed close relationships with several the top academic researchers in the U.S. and China, enabling the company to gain access to their cutting-edge research. Stemgent has signed collaborations with industry heavyweights, Pfizer, and Fate Therapeutics. Stemgent also signed a strategic partnership with Miltenyi Biotec for the co-development and marketing of stem cell research products.
Although iPSC technology originated in Japan in 2006 and the country is still home to major players like FUJIFILM and ReproCELL, the North American region has accelerated its role within the global iPSC market. Within the United States, firms supported by powerful, star-studded advisory boards have emerged, including Fate Therapeutics, Stemgent, iPierian (now a Bristol-Myers Squibb company), FUJIFILM Cellular Dynamics, Century Therapeutics, and BlueRock Therapeutics.
The Future of iPSC Applications
As described above, iPSC technology has developed swiftly since 2006. These cells have already demonstrated their usefulness in drug development and discovery, disease modeling, toxicology testing, cell therapy, gene therapy, disease modelling, personalized medicine, cultured (“clean”) meat production, and beyond. Within recent years, the number of clinical trials involving iPSCs has been steadily increasing, with evidence of life-changing improvements observed within some of these trials.
Put simply, companies are employing an impressive range of business models for exploiting iPSC technology platforms—and the creativity is continuing to expand.
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