Since the discovery of induced pluripotent stem cells (iPSCs) in 2006, a large and diverse market for iPSC research tools has emerged. Included below is a ten-year history of iPSC grants (source: RePORT.NIH.gov), clinical trials (source: ClinicalTrials.gov), and scientific publications (source: PubMed.gov).
Both graphs below reveal the iPSC market is expanding.
Next, view this ten-year history of iPSC clinical trials (source: ClinicalTrials.gov):
Finally, view this ten-year history of iPSC scientific publications (source: PubMed.gov):
Characterizing the Induced Pluripotent Stem Cell (iPSC) Market
Bases on growth rates for iPSC clinical trials, grants, and scientific publications, it is important to characterize the market for iPSC research products in greater detail.
Currently, there are more than 40 companies offering iPSC research products.
In 2009, ReproCELL, a company established as a venture company originating from the University of Tokyo and Kyoto University, was the first company to launch a commercial iPSC product.
It released a human iPSC-derived cardiomyocyte product, called “ReproCario.”1 Other stem cell derived cardiomyocytes are now available commercially from Cellular Dynamics International, GE Healthcare, Cellectis, and others.
ReproCELL’s innovation in the area of iPSC commercialization has been driven in part by joint research relationships it established in 2003 with Tokyo University and in 2004 with Kyoto University, the eventual site of iPSC discovery in 2006.2 Since 2009, ReproCELL has expanded its line of iPSC reagents and iPSC-derived cell lines to include heart, liver, and nerve cells. The company primarily sells these products as research tools, although they also have the potential for use for toxicology and drug discovery applications.
Currently, ReproCELL offers the following iPSC products:3
• Research reagents optimized for human iPSC culture
• Human iPSC-derived cardiomyocytes, which launched in April of 2009 (the first iPSC product to be sold commercially)
• Human iPSC-derived neurons, launched in October 2010
• Human iPSC-derived hepatocytes, launched in May 2012
• Disease model cell generation using human iPSC technologies
To date, ReproCELL has furthered its dominance in the area of iPSC products through a series of strategic acquisitions, including acquisition of Reinnervate, Stemgent, and BioServe Biotechnologies, all occurring in 2014.4
Cellular Dynamics International (CDI), acquired by FUJIFILM Holdings Corporation in March 2015 for $307 million, is another major market player in the iPSC sector.
In contrast to ReproCELL, CDI has largely pursued pharmaceutical clients, although it does offer iPSC products to researchers as well. Similar to ReproCELL, CDI established its “foothold” on the iPSC industry early, being founded in 2004 by Dr. James Thomson at the University of Wisconsin-Madison, who, in 2007, subsequently derived iPSC lines from human somatic cells for the first time, although the feat was also accomplished simultaneously by Dr. Shinya Yamanaka’s lab in Japan.5
CDI currently holds more than 800 patents, which gives it a strong competitive position within the stem cell marketplace.
CDI has been promoting adoption of iPSC technology by adapting its methods to fit into standard clinical practice through the creation of individual stem cell lines from a standard blood draw.6 In a landmark event, the company went public in July 2013 with a public offering that raised $43 million, securing its position as the global leader in producing high-quality human iPSCs and differentiated cells in industrial quantities.
Then, in March 2013, Cellular Dynamics International (CDI) and the Coriell Institute for Medical Research announced receipt of multi-million dollar grants from the California Institute for Regenerative Medicine (CIRM) for the creation of iPSC lines from 3,000 healthy and diseased donors. CIRM awarded CDI $16 million to create three iPSC lines for each of the 3,000 healthy and diseased donors, and awarded the Coriell Institute $10 million to set up and biobank the iPSC lines. This grant is creating the world’s largest human iPSC bank, an incredible feat.
Not surprisingly, Cellular Dynamics International has continued its innovation, announcing in February of 2015 that it would be manufacturing cGMP HLA “Superdonor” stem cell lines that will support cellular therapy applications through genetic matching.7 Currently, CDI has two HLA superdonor cell lines that provide a partial HLA match to approximately 19% of the population within the U.S., and it aims to expand its master stem cell bank by collecting more donor cell lines that will cover 95% of the U.S. population.8 The HLA superdonor cell lines were manufactured using blood samples that were processed to produce pluripotent iPSC lines, giving the cells the capacity to differentiate into nearly any cell within the human body.
CDI also leads the iPSC market in terms of supporting drug development and discovery. For example, CDI’s “MyCell” products are created using custom iPSC reprogramming and differentiation methods, thereby providing biologically relevant human cells from patients with unique disease-associated genotypes and phenotypes.9 The company’s iCell and MyCell cells can also be adapted to screening platforms and are matched to function with common readout technologies.10 CDI’s products are also used for high-throughput screening,11 and have been used as supporting data for Investigational New Drug (IND) applications submitted to the Federal Drug Administration (FDA).12
While there are other companies participating in this area, including ReproCELL, Cellectis, ArunA Biomedical, and others, competitors are limited, and CDI currently leads the way.
More recently, other specialty providers of iPSC products have also entered the marketplace, such as Axol Bioscience, headquartered in Cambridge, UK.
Founded in 2012, Axol Bioscience specializes in human cell culture, providing iPSC-derived cells and iPSC-specific cell culture products. Over the past four years, Axol Bioscience has risen to become a well-known name among iPSC researchers worldwide.
Of course, all of the “big name” players providing a diversified portfolio of research products to scientists have diversified into iPSC products as well, including Thermo Fisher Scientific, R&D Systems, STEMCELL Technologies, Sigma-Aldrich, Miltenyi Biotec, and many more. However, these companies do not specialize in iPSC products, as do companies like ReproCELL, Cellular Dynamics International, and Axol Bioscience.
1 WIRE, BUSINESS. ‘Reprocell Acquires The IPS Cell Business Unit Of Stemgent, Inc. | Business Wire’. Businesswire.com. N.p., 2014. Web. 7 Mar. 2015.
2 Kazutoshi Takahashi and Shinya Yamanaka. Induction of Pluripotent Stem Cells from Mouse Embryonic and Adult Fibrolast Cultures by Defined Factors. Cell. 2006 Aug 25;126(4):663-76.
3 Reprocell.com,. ‘History｜Reprocell – World Leading Stem Cell Technologies From Japan’. N.p., 2015. Web. 7 Mar. 2015.
4 WIRE, BUSINESS. ‘Reprocell Acquires The Ips Cell Business Unit Of Stemgent, Inc. | Business Wire’. Businesswire.com. N.p., 2014. Web. 7 Mar. 2015.
5 Yu J, Vodyanik MA, Smuga-Otto K, Antosiewicz-Bourget J, Frane JL, Tian S, Nie J, Jonsdottir GA, Ruotti V, Stewart R, Slukvin II, Thomson JA. Induced pluripotent stem cell lines derived from human somatic cells. Science. 2007 Dec 21;318(5858):1917-20.
6 Cellulardynamics.com,. ‘About CDI’. N.p., 2015. Web. 7 Mar. 2015.
7 Investors.cellulardynamics.com,. ‘Cellular Dynamics Manufactures Cgmp HLA “Superdonor” Stem Cell Lines To Enable Cell Therapy With Genetic Matching (NASDAQ:ICEL)’. N.p., 2015. Web. 7 Mar. 2015.
9 Cellulardynamics.com,. ‘Cellular Dynamics | Mycell Products’. N.p., 2015. Web. 7 April 2015.
10 Sirenko, O. et al. ‘Multiparameter In Vitro Assessment Of Compound Effects On Cardiomyocyte Physiology Using Ipsc Cells’.Journal of Biomolecular Screening 18.1 (2012): 39-53. Web. 7 Mar. 201
11 Sciencedirect.com,. ‘Prevention Of Β-Amyloid Induced Toxicity In Human Ips Cell-Derived Neurons By Inhibition Of Cyclin-Dependent Kinases And Associated Cell Cycle Events’. N.p., 2015. Web. 7 April 2015.
12 Sciencedirect.com,. ‘HER2-Targeted Liposomal Doxorubicin Displays Enhanced Anti-Tumorigenic Effects Without Associated Cardiotoxicity’. N.p., 2015. Web. 7 Mar. 2015.