Market Research Report
Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2021
|Published by||BIOINFORMANT WORLDWIDE, LLC||Product code||998611|
|Published||Content info||240 Pages
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|Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2021|
|Published: April 1, 2021||Content info: 240 Pages||
Since the discovery of induced pluripotent stem cell (iPSC) technology 15 years ago, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified, 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 potentially, treat previously incurable diseases. The somatic cells used for reprogramming include skin cells and blood cells, and to a lesser degree, other cell types such hair follicles, cord blood and urine.
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.
In recent years, iPSC-derived cells have increasingly been used to within preclinical testing and early stage-stage clinical trials. The first clinical trial using iPSCs started in 2008, and by 2020, that number rose to 53. 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.
Intriguingly, 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. From 2013 to present, multiple clinical trials and physician-led studies employing human iPSC-derived cell types have been initiated.
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 the next breakthrough, 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. Thus, Cynata is advancing CYP-001 into later stage trials and new indications.
Specifically, Cynata plans to advance 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. 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 Inc 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.
TreeFrog Therapeutics, headquartered in Pessac, France, has developed C-Stem™, a high-throughput cell encapsulation technology allowing for the mass-production and differentiation of iPSCs in industrial bioreactors. This C-Stem™ technology platform could provide a scalable solution to improve the quality of iPSC-derived therapeutics and slash treatment costs.
Companies with earlier-stage iPSC derived cell therapeutics under development include:
In addition to the iPSC cell therapy developers, there is are ever-growing number of competitors who are commercializing iPSC-derived products for use across a diverse range of applications, including research, drug development, disease modelling, toxicology screening, personalized medicine, and industrial-scale manufacturing, as well as less common applications that include tissue engineering, 3D bioprinting, and clean meat production.
Across the broader iPSC sector, FUJIFILM CDI 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.
Currently, the U.S. is the largest target market for pluripotent stem cell (PSC) technology, with more than 2,800 patent families filed. This accounts for more than 50% of the total patent families filed from 2006 to present. Europe is the second largest target market with over 1,800 patent families. China is the third largest market, with over 1,600 patent families filed, followed closely by Japan, Korea and Canada, respectively.
Since 2006 when Kyoto University filed its first patent application for iPSCs, iPSC patents have expanded dramatically. While there are regional differences, common areas of focus including genetically engineered cells, drug screening technologies, and disease-specific cell technologies.
There have also been major lawsuits pursued within the induced pluripotent stem cell (iPSC) sector. Of particular note is the patent lawsuit between Cellular Dynamics International, Inc. and Lonza Walkersville, Inc. This lawsuit assessed whether CDI (a FUJIFILM Company) and WARF had sufficiently proven that Lonza infringed on their iPSC patent claims. Lonza is a multinational biotech company headquartered in Switzerland.
Founded in 2006, BioInformant's exclusive focus on the stem cell industry allows us to acquire specialized knowledge and access. Since its inception, BioInformant has collected 15 years of historical data on the global iPSC market. Meaning, we have tracked this sector since the Japanese scientist Shinya Yamanaka first demonstrated that an ordinary cell can be turned into a pluripotent cell by genetic modification in 2006.
In contrast, other market analysis companies are "generalists" who publish superficial reports about a wide range of topics that they know little about, such as stem cells, as well as oil, beverages, and electronics. This unique expertise also provides us with critical access to key opinion leaders (KOL's), most of whom are clients and partners of BioInformant.
In addition to conducting extensive secondary research, BioInformant's experienced analysts interviewed hundreds of highly regarded iPSC industry leaders, including those those featured here. These KOLs include Kaz Hirao (President and COO of FUJIFILM CDI), Ross Macdonald (CEO of Cynata Therapeutics), Robin Smith (CEO of ORIG3N), Paul Wotton (Board Member of Cynata Therapeutics), and Yutaka Yamaguchi (President of FUJIFILM Irvine Scientific - FISI), among many others.
Clearly, iPSC-derived cells represent a promising new technology. As their manufacture, administration, and safety profile improve, these cells will usher in a new era of medicine.
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.
With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.