Market Research Report
Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report, 2021
|Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report, 2021|
Published: August 17, 2021
BIOINFORMANT WORLDWIDE, LLC
Content info: 257 Pages
Delivery time: 1-2 business days
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:
Other applications of iPSCs include their use as research products, as well as their integration into 3D bioprinting, tissue engineering, and clean meat production. Technology allowing for the mass-production and differentiation of iPSCs in industrial-scale bioreactors is also advancing at breakneck speed.
The first clinical trial using iPSCs started in 2008, and today, that number has surpassed 100 worldwide. Most of the current clinical trials do not involve 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.
The therapeutic applications of induced pluripotent stem cells (iPSCs) have also surged in recent years. 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 formal clinical trials worldwide.
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 advancing 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 of Cynata's iPSC-derived MSCs through its 9% ownership stake in the company. Headquartered in Tokyo, Fujifilm is one of the largest players in regenerative medicine field. It has pursued a broad base in regenerative medicine across multiple therapeutic areas through its acquisition of Cellular Dynamics International (CDI) and Japan Tissue Engineering Co. Ltd. (J-Tec). The Japanese company Healios K.K. is also preparing, in collaboration with Sumitomo Dainippon Pharma, for a clinical trial using allogeneic iPSC-derived retinal cells to treat age-related macular degeneration (AMD).
Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. FT819 is the world's first CAR T therapy derived from a clonal master iPSC line and is engineered with several novel features designed to improve the safety and efficacy of CAR T-cell therapy. Notably, the use of a clonal master iPSC line as the starting cell source could enable CAR-T cells to be mass produced and delivered off-the-shelf at an industrial scale.
Other companies and organizations with iPSC-derived cell therapeutics under development worldwide include:
In addition to the iPSC cell therapy developers, there are an ever-growing number of competitors who are commercializing iPSC-derived products for use in drug development and discovery, disease modeling, toxicology testing, and personalized medicine, as well as tissue engineering, 3D bioprinting, and clean meat production.
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 70 market competitors now offer various types of iPSC products, services, manufacturing technologies, and therapeutics.
This report reveals all major market competitors worldwide, including their advantages, core technologies, and products under development. Its main objective is to describe the current status of iPSC research, biomedical applications, manufacturing technologies, patents, funding events, strategic partnerships, and clinical trials for the development of iPSC-based therapeutics. Importantly, the report presents a comprehensive market size breakdown for iPSCs by Application, Technology, Cell Type and Geography (North America, Europe, Asia/Pacific, and RoW). It also presents total market size figures and growth rates through 2027.
Claim this global strategic report to become immediately informed about the iPSC market, without sacrificing weeks of unnecessary research or being at risk of missing critical market opportunities.