DUBLIN–(BUSINESS WIRE)–The “Global Induced Pluripotent Stem Cell (iPSC) Industry Report – Market Size, Trends, and Forecasts, 2023” report has been added to ResearchAndMarkets.com’s offering.
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 enables precise, directed the 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 stem cells or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells.
- Research Tools: iPSCs and iPSC-derived cell types are being widely used within basic and applied research applications.
- Other Applications: Other applications of iPSCs include their integration into 3D bioprinting, tissue engineering, and clean meat production.
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. There are also over 100 clinical trials underway that donotinvolve the transplant of iPSCs into humans, but rather, the creation and evaluation of iPSC lines for clinical purposes. Within these trials, iPSC lines are created from specific patient populations to determine if these cell lines could be a good model for a disease of interest.
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 a 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.
Given this early success, Cynata is has advanced its iPSC-derived MSCs into Phase 2 trials for the severe complications associated with COVID-19, as well as GvHD and critical limb ischemia (CLI). It is also undertaking an impressive Phase 3 trial that will utilize Cynata’s iPSC-derived MSC product, CYP-004, in 440 patients with osteoarthritis (OA). This trial represents the world’s first Phase 3 clinical trial involving an iPSC-derived cell therapeutic product and the largest one ever completed. Not surprisingly, the Japanese behemoth FUJIFILM has been involved with the co-development and commercialization of Cynata’s iPSC-derived MSCs through its 9% ownership stake in the company.
Many 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 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 80 market competitors now offer a diverse range of iPSC products, services, technologies, and therapeutics.
Key Topics Covered:
1. Report Overview
2. Introduction
3. Current Status of iPSC Industry
4. History of Induced Pluripotent Stem Cells (iPSCs)
5. Research Publications on iPSCs
6. iPSC: Patent Landscape Analysis
7. iPSC: Clinical Trial Landscape
8. Research Funding for iPSCs
9. M&A, Collaborations & Funding Activities in iPSC Sector
10. Generation of Induced Pluripotent Stem Cells: An Overview
11. Human iPSC Banking
12. Biomedical Applications of iPSCs
13. Market Overview
14. Company Profiles
Selection of Companies Mentioned
- ALSTEM, Inc.
- AMS Biotechnology Ltd. (AMSBIO)
- Accellta
- AddGene, Inc.
- Allele Biotechnology, Inc.
- Altos Labs
- Aspen Neuroscience, Inc.
- Astellas Pharma, Inc.
- Avery Therapeutics
- Axol Bioscience Ltd.
- Bit.bio
- BlueRock Therapeutics
- BrainXell
- Brooklyn Immuno Therapeutics
- CellGenix, GmbH
- Cellaria
- Cellino Biotech
- Cellular Engineering Technologies (CET)
- Celogics, Inc.
- Censo Biotechnologies, Ltd.
- Century Therapeutics, Inc.
- Citius Pharmaceuticals, Inc.
- Curi Bio
- Cymerus Platform
- Cynata Therapeutics Ltd.
- Cytovia Therapeutics
- DefiniGEN
- ElevateBio
- Elixirgen Scientific, Inc.
- Evia Bio
- Evotec A.G.
- Exacis Biotherapeutics
- Eyestem
- FUJIFILM Cellular Dynamics, Inc. (FCDI)
- Heartseed, Inc.
- HebeCell
- Helios K.K.
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Hera BioLabs
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