Revolutionizing Medicine: The Transformative Power and Commercial Potential of Induced Pluripotent Stem Cells (iPSCs)
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.
Today, methods of commercializing induced pluripotent stem cells (iPSCs) include:
- Cellular Therapy: iPSCs are being investigated for use in a wide range of cell therapy applications aimed at reversing injuries or curing diseases by replacing damaged or lost cells.
- Disease Modeling: iPSCs derived from patients with specific disorders can be differentiated into disease-specific cell types, enabling the creation of accurate, functional disease models "in a dish" for research and therapeutic development.
- Drug Development and Discovery: iPSCs provide physiologically relevant cells for drug discovery processes, including compound identification, target validation, compound screening, and tool development, significantly improving the efficiency and relevance of these efforts.
- Personalized Medicine: By combining iPSCs with genome-editing technologies like CRISPR, scientists can introduce precise genetic modifications, such as knock-outs, knock-ins, or single base changes, paving the way for customized treatments tailored to individual genetic profiles.
- Toxicology Testing: iPSCs or their derivatives (tissue-specific cells) are used for toxicology screening to assess the safety and efficacy of compounds or drugs in living cells, reducing reliance on animal testing.
- Tissue Engineering: iPSCs can be cultured on biocompatible scaffolds that mimic the structure and properties of target tissues, providing a supportive environment for cell growth and differentiation and aiding the development of engineered tissues for transplantation.
- Organoid Production: iPSCs can self-organize into 3D structures called organoids, which closely resemble the structure and function of human organs. Organoids are valuable for studying organ development, modeling diseases, and testing drug candidates.
- Gene Editing: iPSCs can be modified using techniques like CRISPR-Cas9 to correct disease-causing mutations or introduce specific genetic alterations. These edited iPSCs can then be differentiated into functional cells for transplantation or advanced disease studies.
- Research Tools: iPSCs and their derivatives are extensively used in both basic and applied research to study cellular processes, understand diseases, and test experimental therapies.
- Stem Cell Banking: iPSC repositories store and provide access to diverse iPSC-derived cell types, offering researchers valuable resources to investigate conditions using cells from both healthy and affected donors.
- Cultured Meat Production: iPSCs are utilized in lab-grown meat production, serving as a cellular foundation for creating clean, sustainable meat products without the need for traditional animal farming.
- 3D Bioprinting: iPSCs can be differentiated into specific cell types, such as skin, heart, or liver cells, and incorporated into bioinks for use in 3D bioprinting applications, enabling the creation of complex tissue structures.
iPSC Market Dynamics
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.
Table of Contents
Companies Mentioned
- AcceGen
- Acellta, Ltd.
- AddGene, Inc.
- Allele Biotechnology, Inc.
- Almiral
- ALSTEM, Inc.
- Altos Labs
- AMS Biotechnology, Ltd. (AMSBIO)
- Applied Stem Cell (ASC)
- Asgard Therapeutics
- Aspen Neurosciences, Inc.
- Astellas Pharma, Inc.
- Atara Biotherapeutics
- Axiogenesis
- Axol Biosciences, Ltd.
- Bayer AG
- BioBridge Global
- Biocentriq
- Bioqube Ventures
- bit.bio
- BlueRock Therapeutics LP
- Boehringer Ingelheim
- Bone Therapeutics
- BrainXell
- Bristol Myers Squibb
- Cartherics Pty, Ltd.
- Catalent Biologics
- CCRM
- Cellatoz
- Cellectis
- Cellino Biotech, Inc.
- Cellistic
- CellOrigin Biotech (Hangzhou) Co. Ltd.
- Cellular Engineering Technologies (CET)
- Cellusion, Inc.
- Celogics, Inc.
- Censo Biotechnologies
- Century Therapeutics, Inc.
- Charles River Laboratories
- CIRM
- Citius Pharmaceuticals, Inc.
- Clade Therapeutics
- Creative Bioarray
- Curi Bio
- Cynata Therapeutics, Ltd.
- CytoLynx
- Cytomed
- Cytovia Therapeutics
- DefiniGEN
- Edigene
- Editas Medicine
- Editco Bio. Inc.
- ElevateBio
- Elixirgen Scientific, Inc.
- Eterna Therapeutics
- Evotec
- Evotech
- Exacis Biotherapeutics
- Eyestem
- Fate Therapeutics
- FUJIFILM Cellular Dynamics, Inc.
- Fujifilm Corporation
- Gameto
- GeneCure
- Greenstone Biosciences
- Heartseed, Inc.
- Heartworks, Inc.
- Hebecell Corporation
- Helios K.K.
- Hera BioLabs
- Hopstem Biotechnology
- I Peace, Inc.
- Implant Therapeutics, Inc.
- IN8bio
- IPS HEART
- iPS Portal, Inc.
- iPSirius
- iXCells Biotechnologies
- Jacobio
- Kenai Therapeutics, Inc.
- Khloris Biosciences, Inc.
- KIF1A.ORG
- Kite
- Kytopen
- Laverock Therapeutics
- Lindville Bio, Ltd.
- Lonza Group, Ltd.
- Matricelf
- MDimmune
- Medical Center Hamburg-Eppdorf (UKE)
- Megakaryon Corporation
- Metrion Biosciences, Ltd.
- Mogrify Ltd.
- MRC Laboratory of Molecular Biology
- National Cancer Institute
- National Eye Institute
- National Resilience, Inc.
- Ncardia Services B.V.
- NeuCyte
- Neukio Biotherapeutics
- Neuropath Therapeutics
- Newcells Biotech
- NEXEL, Co. Ltd.
- Notch Therapeutics
- OmniaBio, Inc.
- Opsis Therapeutics
- Orizuru Therapeutics, Inc.
- Panasonic
- Pancella
- Pheno Vista Biosciences
- Phenocell SAS
- Pluriomix
- Pluristyx, Inc.
- Qihan Biotech
- Quell Therapeutics
- Ramot
- ReNeuron
- Repairon GmbH
- REPROCELL, Inc.
- Res Nova Bio, Inc.
- Resolution Therapeutics
- RheinCell Therapeutics
- Rigenerand
- Ryne Biotech
- Sana Biotechnology
- Sartorius CellGenix GmbH
- SCG Cell Therapy Pte
- Seaver Autism Center for Research and Treatment
- Sernova
- Shinobi Therapeutics
- Shoreline Biosciences
- Stemina Biomarker Discovery
- StemSight
- Stemson Therapeutics
- Synthego
- Takeda
- Tempo Bioscience, Inc.
- TEXCELL
- Thyas, Co. Ltd
- TreeFrog Therapeutics
- Uncommon (Higher Steaks)
- Undisclosed Biotech
- Universal Cells
- University of Texas
- VCCT, Inc.
- ViaCyte, Inc.
- Vita Therapeutics
- XCell Science
- Yashraj Biotechnology, Ltd.
- YiPSCELL
Methodology
The content and statistics contained within the publisher's reports are compiled using a broad range of sources, as described below.
Input Sources
- Clinical Trial Databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, European Union Clinical Trials Register, Chinese Clinical Trial Registry, Others)
- Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
- Patent Databases (United States Patent and Trade Office, World Intellectual Property Organization, Google Patent Search)
- Grant Funding Databases (RePORT Database, CIRM, MRC, Wellcome Trust - UK, Others)
- Product Launch Announcements (Trade Journals, Google News)
- Industry Events (Google News, Google Alerts, Press Releases)
- Company News (SEC Filings, Investor Publications, Historical Performance)
- Social Analytics (Google Adwords, Google Trends, Twitter, Topsy.com, Hashtagify.me, BuzzSumo.com)
- Interviews with Stem Cell Industry Leaders
Research & Analysis Methodologies
The publisher employs the following techniques for deriving its market research:
- Historical Databases: As the first and only market research firm to specialize in the stem cell industry, the publisher has 13+ years of historical data on each segment of the stem cell the industry. This provides an extremely rare and robust database for establishing market size determinations, as well as making future market predictions.
- Prolific Interviews with Industry Leaders: As the global leader in stem cell industry data, the publisher has interviewed hundreds of leaders from across the stem cell industry, including the CEO of FUJIFILM CDI, FUJIFILM Irvine Scientific, Pluristem Therapies, Celularity, and many others.
- Industry Relationships: The research team and its President/Founder, Cade Hildreth, Chair and present at a wide range of stem cell industry events, including Phacilitate's Advanced Therapies Week, World Stem Cell Summit (WSCS), Perinatal Stem Cell Society Congress, AABB's International Cord Blood Symposium (ICBS), and other events hosted within the U.S. and worldwide.
- Global Integrated Feedback: Because the publisher maintains the world's largest stem cell industry news site that is read by nearly a million unique readers per year and the company has large social media audiences (25.7K+ followers on Linked, 21.2K+ followers on Twitter, and 4.3K+ followers on Facebook), the publisher is able to publish content relevant to the industry and receive immediate feedback/input from a global community of readers. In short, the publisher's data is crowd-sourced from market participants worldwide, including those in diverse geographic regions.
- Preliminary Research: In addition to the interviews described above, the publisher conducts market surveys, executes social media polls, and aggregates market data from stem cell industry announcements, press releases, and corporate filings/presentations.
- Secondary Research: The publisher summarizes, collects and synthesizes existing market research that is relevant to the market area of interest.
- Future Projections: Using the resources described above, the publisher is uniquely positioned to make future projections about market size, market growth by segment, market trends, technology evolution, funding activities (financing rounds, M&A, and IPOs), and importantly, market leadership (market share by company).
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