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 the first clinical trials employing human iPSC-derived cell types have been initiated. 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.
This global strategic report reveals:
- Market size determinations with segmentation and future forecasts
- Clinical trial activity by type, region, phase, and sponsor
- Patent analysis by applicant, type, date and region
- iPSC industry partnerships, alliances, and IPOs
- Emerging trends and future directions
- Competitors composing the global iPSC marketplace
Today, methods of commercializing induced pluripotent stem cells (iPSCs) include:
- Cellular Therapy: iPSCs are being explored in a diverse range of cell therapy applications for the purpose of reversing injury or disease.
- 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”.
- Drug Development and Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery.
- 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 is adding a new dimension to personalized medicine.
- Toxicology Testing: iPSCs can be used for toxicology screening, which is the use of iPSCs or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells.
- Tissue Engineering: iPSCs can be seeded onto scaffolds made from biocompatible materials. These scaffolds mimic the structure and properties of the target tissue and can provide a supportive environment for cell growth and differentiation.
- Organoid Production: iPS cells can be coaxed to self-organize into 3D structures called organoids, which mimic the structure and function of organs. Organoids can be used for studying organ development, modeling diseases, and testing drugs.
- Gene Editing: iPS cells can be genetically modified using techniques like CRISPR-Cas9 to correct disease-causing mutations or introduce specific genetic changes. These edited iPS cells can then be differentiated into the desired cell type for transplantation or disease modeling.
- Research Tools: iPSCs and iPSC-derived cell types are being widely used within a diverse range of basic and applied research applications.
- 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.
- Cultured Meat Production: iPSCs are being utilized in clean meat production by serving as the cellular foundation for the creation of lab-grown meat.
- 3D Bioprinting: iPSCs can be directed to differentiate into cell types of interest, such as skin, heart, or liver cells, which are then incorporated into bioinks.
- Wildlife Conservation and De-extinction Projects: iPSCs are being used in wildlife conservation and de-extinction projects. For example, Colossal Biosciences is using iPSC technology in an effort to achieve woolly mammoth de-extinction.
iPSC Market Dynamics
Since the discovery of iPSCs in 2006, it took only 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 used within a rapidly growing number of preclinical studies, physician-led studies, and clinical trials worldwide.
The discovery of iPSC has not only favorably transformed the field of drug discovery, toxicity testing and in-a-dish disease modeling, but also powerfully impacted the field of cell and gene therapy. The ability of iPSCs to multiply in vitro and then get differentiated into specialized cells makes iPSCs an ideal source of cells of different types for curative clinical cell replacement therapies and disease modeling.
Of course, 2013 was a landmark year because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Dr. Masayo Takahashi, it 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 first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. CYP-001 is an iPSC-derived MSC product. In this historic trial, CYP-001 met its clinical endpoints and produced positive safety and efficacy data for the treatment of steroid-resistant acute GvHD.
Today, at least 155 ongoing clinical trials are using iPSC-derived specialized cells to address various indications. iPSC-derived MSCs are being tested in the treatment of steroid-resistant acute graft versus host disease (GvHD). iPSC-derived dopaminergic progenitors are being evaluated in the treatment of Parkinson’s disease. iNK cell-based cancer immunotherapy is being studied in the treatment of metastatic solid tumors. iPSC-derived retinal pigment epithelial cells have shown positive results in the treatment of age-related macular degeneration (AMD). Furthermore, iPSC derived insulin secreting beta cells are being tested for the treatment of Type 1 diabetes.
Although iPSCs have the potential to be used in both allogeneic and autologous applications, the development of allogeneic therapies using iPSC-derived products is outpacing the development of autologous therapies. Several allogeneic therapies utilizing iPSC-derived cells derived from healthy donors are being used to address diabetes, Parkinson’s disease, and AMD, and these therapies are quickly progressing into early phase clinical trials.
Market competitors are also commercializing iPSC-derived products for use in drug development and discovery, disease modeling, and toxicology testing. Across the broader iPSC sector, FUJIFILM CDI (FCDI) is one of the largest and most dominant players. Cellular Dynamics International (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. The feat was accomplished simultaneously by Dr. Shinya Yamanaka’s lab in Japan. FUJIFILM acquired CDI in April 2015 for $307 million. Today, the combined company (FCDI) is the world’s largest manufacturer of human cells created from iPSCs for use in research, drug discovery and regenerative medicine applications.
Another iPSC specialist is ReproCELL, a company that was established as a venture company originating from the University of Tokyo and Kyoto University in 2009. It became the first company worldwide to make iPSC products commercially available when it launched its ReproCardio product, which are human iPSC-derived cardiomyocytes. Within the European market, the dominant competitors are Evotec, Ncardia, and Axol Bioscience. Headquartered in Hamburg, Germany, Evotec is a drug discovery alliance and development partnership company. It is developing an iPSC platform with the goal to industrialize iPSC-based drug screening as it relates to throughput, reproducibility, and robustness. Today, Evotec’s infrastructure represents one of the largest and most advanced iPSC platforms globally.
Ncardia was formed through the merger of Axiogenesis and Pluriomics in 2017. Its predecessor, Axiogenesis, was founded in 2011 with an initial focus on mouse embryonic stem cell-derived cells and assays. When Yamanaka’s iPSC technology became available, Axiogenesis became the first European company to license it in 2010. Today, the combined company (Ncardia) is a global authority in cardiac and neural applications of human iPSCs. Founded in 2012, Axol Bioscience is a smaller but noteworthy competitor that specializes in iPSC-derived products. Headquartered in Cambridge, UK, it specializes in human cell culture, providing iPSC-derived cells and iPSC-specific cell culture products.
Of course, the world’s largest research supply companies are also commercializing a diverse range of iPSC-derived products and services. Examples of these companies include Lonza, BD Biosciences, Thermo Fisher Scientific, Merck, Takara Bio, and countless others. In total, at least 90 market competitors now offer a diverse range of iPSC products, services, technologies, and therapeutics.
This global strategic report reveals all major market competitors worldwide, including their core technologies, strategic partnerships, and products under development. It covers the current status of iPSC research, biomedical applications, manufacturing technologies, patents, and funding events, as well as all known trials for the development of iPSC-derived cell therapeutics worldwide. Importantly, it profiles leading market competitors worldwide and presents a comprehensive market size breakdown for iPSCs by Application, Technology, Cell Type, and Geography (North America, Europe, Asia/Pacific, and Rest of World). It also presents total market size figures with projected growth rates through 2030.
This 389-page global strategic report will position you to:
- Capitalize on emerging trends
- Improve internal decision-making
- Reduce company risk
- Approach outside partners and investors
- Outcompete your competition
- Implement an informed and advantageous business strategy
Table of Contents
Companies Mentioned
- A*STAR
- 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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