Global Strategic Report
January 2019; 145 pages
Stem cell research and experimentation have been in process for well over five decades, as stem cells have the unique ability to divide and replicate repeatedly. In addition, their “unspecialized” nature allows them to differentiate into a wide variety of specialized cell types. The possibilities arising from these characteristics have resulted in great commercial interest, with potential applications including basic research, cell therapeutics, tissue regeneration, pharmacological testing on cell-specific tissues, personalized medicine and more.
Traditionally, scientists have worked with both embryonic and adult stem cells. While the appeal of embryonic stem cells is their ability to differentiate into any type of cell, there is significant ethical, moral, and spiritual controversy surrounding their use. Although adult stem cells do have differentiation capacity, it is often limited in nature, which results in fewer options for use.
Groundbreaking experimentation in 2006 led to the introduction of induced pluripotent stem cells (iPSCs). These are adult cells which are isolated and then transformed into embryonic-like stem cells through the manipulation of gene expression or other methods. Research and experimentation using mouse cells by Shinya Yamanaka’s lab at Kyoto University in Japan was the first instance in which there was successful generation of iPSCs. In 2007, a series of follow-up experiments was done at Kyoto University in which human cells were transformed into iPSCs. Nearly simultaneously, a research group led by James Thomson at the University of Wisconsin-Madison accomplished the same feat of deriving iPSC lines from human somatic cells.
Since the discovery of iPSCs a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells.
Market for iPSCs
The market for iPS cell therapies is rapidly expanding, with Cynata Therapeutics recently completing the world’s first Phase I trial with an iPSC-derived therapeutic product (CYP-001). In January 2017, FUJIFILM took a strategic equity stake in Cynata Therapeutics of 9%, for which it paid A$3.97 million. Under the agreement, the parties are collaborating on the development and commercialisation CYP-001 for graft-versus-host disease (GvHD).
Additionally, Fate Therapeutics is positioned to launch the world’s first trial with an iPSC-derived therapeutic product within the United States, following the FDA’s November 2018 approval of its IND Application for FT500. FT500 is a universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line.
There are also numerous physician-led studies underway in Japan exploring the use of iPSC-derived therapies for the treatment of macular degeneration, Parkinson’s disease, heart disease, and the production of human platelets.
In addition to these therapeutic advances, recent years have seen advances in drug development and discovery, as iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery. iPSCs are also valuable 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. Finally, growing numbers of iPSC banks are providing researchers with iPSC-derived cell types from both healthy and diseased donors.
iPSC Market Breakdown
As shown in the image below, the iPSC market can be segmented into three primary categories (Product Category, Commercial Application, and Geography), as well as sub-segmented into a total of 15 different market categories.
This global strategic report presents market size estimations for each of these 15 segments, accompanied by 5-year projections. It also presents an aggregated value for the global iPSC marketplace.
The dominant company within the iPSC market is FUJIFILM Cellular Dynamics, Inc. (FCDI). Headquartered in Madison, Wisconsin, Cellular Dynamics International (CDI) was founded by Dr. James Thomson, who derived iPSC lines from human somatic cells in 2007. Now owned by Fujifilm, CDI is the world’s largest manufacturer of human iPSCs. Another early market competitor was ReproCELL, a company established in 2009 as a venture company originating from the University of Tokyo and Kyoto University.
A European leader within the iPSC market is Ncardia, formed through the merger of Axiogenesis and Pluriomics in 2017. After Yamanaka’s groundbreaking iPSC technology became available, Axiogenesis was the first European company to license it in 2010. Today, Ncardia’s focus is on preclinical drug discovery and drug safety through the development of functional assays using human neuronal and cardiac cells, although it is expanding into new areas. Its flagship offering is its Cor.4U human cardiomyocyte product family, including cardiac fibroblasts.
Based in the UK, Axol Bioscience also specializes in iPSC-derived cells, disease models, human primary cells and culture media optimized for pluripotent stem cell growth. Dozens of other market competitors also offer innovative iPSC products and services.
Key report findings include:
- Market Size Determination for the Global iPSC Market
- Market Segmentation by Product Category, Application, and Geography
- Five-Year Market Size Projecitons
- Trend Analysis for iPSC Grants, Trials, and Scientific Publications
- Analysis of iPSC Patent Environment, including Key Patents and Assignees
- SWOT Analysis for the iPSC Market (Strengths, Weaknesses, Opportunities, Threats)
- Review of Clinical Progress with iPSCs
- Competitive Analysis of iPSC Market Leaders
- Review of iPSC Product and Service Offerings
- And Much More
iPSC Report Inputs
In addition to extensive secondary research performed by BioInformant’s team of analysts, telephone interviews were conducted with key industry leaders, including Kaz Hirao (President and COO of Fujifilm Cellular Dynamics), Robin Smith (CEO of ORIG3N), Dr. Ross Macdonald (CEO of Cynata Therapeutics), Dr. Paul Wotton (Board Member of Cynata Therapeutics), and others.
In summary, iPSCs represent a promising tool for use in the reversal and repair of many previously incurable diseases. To profit from this lucrative and rapidly expanding market, you need to understand your key strengths relative to the competition, intelligently position your products to fill gaps in the market place, and take advantage of crucial iPSC trends.
TABLE OF CONTENTS: Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2019
Founded in 2006 in Washington, DC, BioInformant is the first and only market research firm to specialize in the stem cell industry. With research cited by the Wall Street Journal, Xconomy, and Vogue Magazine, BioInformant serves Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs. With more than a decade of historical data on the stem cell market, BioInformant is your global leader in stem cell industry data.
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