PUBLISHER: BioInformant | PRODUCT CODE: 1609194
PUBLISHER: BioInformant | PRODUCT CODE: 1609194
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 clinical trials employing human iPSC-derived cell types have been undertaken. 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.
Since the discovery of iPSCs approximately 18 years ago, the field has advanced at an unprecedented pace. It took just 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 increasingly used in preclinical studies, physician-led research, and clinical trials worldwide, underscoring their transformative potential.
The discovery of iPSCs has revolutionized several scientific fields, including drug discovery, toxicity testing, and in-a-dish disease modeling, while also having a profound impact on cell and gene therapy. Their ability to multiply indefinitely in vitro and differentiate into specialized cells has made them a highly versatile and ideal source for clinical cell replacement therapies and advanced disease modeling.
The first cellular therapy involving iPSCs began in 2013 at the RIKEN Center in Kobe, Japan. Led by Dr. Masayo Takahashi, this trial investigated the safety of iPSC-derived retinal cell sheets in patients with macular degeneration. In 2016, Cynata Therapeutics achieved a world first by gaining approval for a clinical trial of an allogeneic iPSC-derived cell product, CYP-001, for treating steroid-resistant acute graft-versus-host disease (GvHD). This iPSC-derived mesenchymal stem cell (MSC) product demonstrated positive safety and efficacy results, successfully meeting its clinical endpoints.
Today, iPSCs are at the center of at least 155 ongoing clinical trials targeting a range of conditions. iPSC-derived MSCs are being tested for steroid-resistant acute GvHD, while dopaminergic progenitors derived from iPSCs are being evaluated for Parkinson's disease. In oncology, iPSC-derived natural killer (iNK) cells are being studied as cancer immunotherapies for metastatic solid tumors. Other applications include the use of retinal pigment epithelial cells for age-related macular degeneration (AMD) and insulin-secreting beta cells derived from iPSCs for Type 1 diabetes. These diverse therapeutic programs highlight the vast potential of iPSCs in treating a variety of diseases.
The commercial potential of iPSCs has also expanded significantly. Companies are leveraging iPSC-derived products in drug development, disease modeling, and toxicology testing. FUJIFILM Cellular Dynamics International (FCDI) stands out as one of the largest players in the field. Cellular Dynamics International (CDI), founded in 2004 by Dr. James Thomson at the University of Wisconsin-Madison, became one of the first companies to derive human iPSC lines in 2007. In 2015, FUJIFILM acquired CDI for $307 million, creating FCDI, which is now the world's largest producer of human cells derived from iPSCs for research and regenerative medicine.
ReproCELL, founded in 2009 as a venture from the University of Tokyo and Kyoto University, was the first company to commercialize iPSC products. Its ReproCardio line of iPSC-derived cardiomyocytes paved the way for the industry. In Europe, leading competitors include Evotec and Ncardia. Evotec, based in Hamburg, Germany, has built one of the most advanced iPSC platforms in the world, focusing on industrializing iPSC-based drug screening. Ncardia, formed through the merger of Axiogenesis and Pluriomics in 2017, specializes in cardiac and neural applications of iPSCs. Axiogenesis, one of its predecessors, was the first European company to license iPSC technology in 2010.
Large research supply companies are also playing a major role in the commercialization of iPSC-derived products. These include Lonza, BD Biosciences, Thermo Fisher Scientific, Merck, Takara Bio, and numerous others. Collectively, more than 90 companies are active in the iPSC market, offering a broad range of products, services, and technologies that cater to both research and therapeutic applications.
The global iPSC market continues to grow rapidly. A comprehensive report on the field provides an overview of key players, strategic partnerships, and innovations driving the sector. The report explores the current status of iPSC research, manufacturing technologies, and clinical developments. It highlights the rates of iPSC-related patents, publications, and trials, detailing all known therapeutic programs involving iPSC-derived cells. Additionally, the report covers the funding landscape, examining fundraising efforts, IPOs, and co-development agreements that are shaping the market's trajectory.
The report also delves into the expanding use of iPSCs in drug discovery and the strategic partnerships that are driving growth in this sector. It presents a detailed breakdown of market size by application, technology, cell type, and geography (North America, Europe, Asia-Pacific, and the rest of the world). Total market size figures, along with projected growth rates through 2030, provide insights into the future of the iPSC industry.
With their remarkable versatility, iPSCs are set to redefine medicine and biotechnology. From disease modeling and drug discovery to advanced cell replacement therapies, iPSCs are driving innovation at every level. As companies continue to refine manufacturing technologies and expand therapeutic applications, the future of iPSCs holds immense promise for transforming healthcare and scientific research.