iPSC Market Report
September 2020 | 238 Pages
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Since the discovery of induced pluripotent stem cells (iPSCs) in 2006, a large and thriving research products market has emerged, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment, because methods for commercializing this cell type are expanding and clinical studies investigating iPSCs are swelling in number.
2013 was a landmark year in Japan, because it marked the first transplant of iPSC-derived cells into humans. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), the study 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 world’s first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD.
Today, Cynata Therapeutics is preparing to test its iPSC-derived cell therapeutic, CYP 004, in a historic Phase 3 clinical trial enrolling up to 440 patients. It will be the world’s first clinical trial involving an iPSC-derived cell therapeutic product to enter Phase 3, as well as the largest one ever completed.
Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its “off-the-shelf” iPSC-derived CAR-T cell product candidate. Numerous physician-led studies are also underway in Japan, a leading country for iPSC discoveries and applications.
iPS Cell Market Competitors
Today, FUJIFILM CDI has emerged as one of the largest commercial players within the iPSC sector. FUJIFILM 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 ever. The feat was accomplished simultaneously by Dr. Shinya Yamanaka’s lab in Japan.
In 2009, ReproCELL, a company established as a venture company originating from the University of Tokyo and Kyoto University, made iPSC products commercially available for the first time with the launch of its human iPSC-derived cardiomyocytes, which it called ReproCario.
A European leader within the iPSC market is Ncardia, formed through the merger of Axiogenesis and Pluriomics. Founded in 2001, Axiogenesis initially focused on generating mouse embryonic stem cell-derived cells and assays, but after Yamanaka’s iPSC technology became available, it became the first European company to license it in 2010. Ncardia’s focus is on preclinical drug discovery and drug safety through the development of functional assays using human neuronal and cardiac cells.
In total, at least 68 distinct market competitors now offer various types of iPSC products, services, technologies and therapies.
iPS Cell Commercialization
Methods of commercializing induced pluripotent stem cells (iPSCs) are diverse and continue to expand.
iPSC applications include, but are not limited to:
- Research Products: Market competitors provide iPSC specific tools to scientists worldwide, including human iPSC lines and differentiated cells types, as well as optimized reagents, protocols, differentiation kits and more.
- Drug Development & Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery.
- Cellular Therapy: iPSCs are being explored in a diverse range of cell therapy applications for the purpose of reversing injury or disease.
- Toxicology Screening: 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.
- 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 has added a new dimension to personalized medicine.
- 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.”
- 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.
- Other Applications: Other applications for iPSCs include areas like tissue engineering, 3D bioprinting, clean meat production, wildlife conservation and more.
Since the discovery of iPSC technology nearly 15 years ago, 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.
Thus, the main objectives of this report are to describe the current status of iPSC research, patents, funding events, industry partnerships, biomedical applications, technologies 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 2026.
In addition to conducting months of extensive research, we leveraged 15 years of historical data on the iPSC market to compile this global strategic report. Interviews were conducted with notable iPSC industry leaders, including 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.
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TABLE OF CONTENTS: Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2020
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