Site icon BioInformant

Global Induced Pluripotent Stem Cell (iPSC) Industry Report – Market Size, Trends, and Forecasts

Cade Hildreth (CEO)
iPSC Market Report; 325 Pages
December 2023

Since the discovery of induced pluripotent stem cell (iPSC) technology 15 years ago, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified, 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 potentially, treat previously incurable diseases. The somatic cells used for reprogramming include skin cells and blood cells, and to a lesser degree, other cell types such hair follicles, cord blood and urine.

iPS Cell Commercialization

Today, methods of commercializing iPSCs include:

Other applications of iPSCs include their use as research products, as well as their integration into 3D bioprinting, tissue engineering, and clean meat production. Technology allowing for the mass-production and differentiation of iPSCs in industrial-scale bioreactors is also advancing at breakneck speed.

The Era of iPSCs

In recent years, iPSC-derived cells have increasingly been used to within preclinical testing and early stage-stage clinical trials. The first clinical trial using iPSCs started in 2008, and today, that number has surpassed 100 worldwide. Most of the current clinical trials do not involve the transplant of iPSCs into humans, but rather, the creation and evaluation of iPSC lines for clinical purposes. Within these trials, iPSC lines are created from specific patient populations to determine if these cell lines could be a good model for a disease of interest. 

The therapeutic applications of induced pluripotent stem cells (iPSCs) have also surged in recent years. 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. From 2013 to present, several clinical trials and physician-led studies employing human iPSC-derived cell types have been initiated.

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 a 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.

Given this early success, Cynata is advancing its iPSC-derived MSCs into Phase 2 trials for the severe complications associated with COVID-19, as well as GvHD and critical limb ischemia (CLI). It is also undertaking an impressive Phase 3 trial that will utilize Cynata’s iPSC-derived MSC product, CYP-004, in 440 patients with osteoarthritis (OA). This trial represents the world’s first Phase 3 clinical trial involving an iPSC-derived cell therapeutic product and the largest one ever completed.

Not surprisingly, the Japanese behemoth FUJIFILM has been involved with the co-development and commercialization of Cynata’s iPSC-derived MSCs through its 9% ownership stake in the company. Headquartered in Tokyo, Fujifilm is one of the largest players in regenerative medicine field. It has pursued a broad base in regenerative medicine across multiple therapeutic areas through its acquisition of Cellular Dynamics International (CDI) and Japan Tissue Engineering Co. Ltd. (J-Tec). The Japanese company Healios K.K. is also preparing, in collaboration with Sumitomo Dainippon Pharma, for a clinical trial using allogeneic iPSC-derived retinal cells to treat age-related macular degeneration (AMD).  

Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. FT819 is the world’s first CAR T therapy derived from a clonal master iPSC line and is engineered with several novel features designed to improve the safety and efficacy of CAR T-cell therapy. Another promising company is iPSirius SAS, who is developing IPVAC 1.0 as a therapeutic cancer vaccine. Leveraging the antigenic overlap between iPSCs and cancer stem cells (CSCs), its goal is prevent relapse and metastatic progression in cancer patients.

Other companies and organizations with iPSC-derived cell therapeutics under development worldwide include:

iPS Cell Market Competitors

In addition to the iPSC cell therapy developers, there are an ever-growing number of competitors who are commercializing iPSC-derived products for use across a diverse range of applications. These applications include drug development and discovery, disease modeling, toxicology testing, and personalized medicine, as well as tissue engineering, 3D bioprinting, and clean meat production.

Across the broader iPSC sector, FUJIFILM CDI 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 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 another noteworthy competitor that specializes in iPSC-derived products. Headquartered in Cambridge, UK, it specializes in iPSC-derived cells and iPSC-specific cell culture products, with a focus on Alzheimer’s, ALS, and other neurodegenerative diseases.

Of course, the world’s largest research supply companies are also commercializing a plethora of iPSC-related products. Examples of these market leaders include Lonza, BD Biosciences, Thermo Fisher Scientific, Merck, Takara Bio, STEMCELL Technologies, and others.

iPSC Report Features

This report reveals all major market competitors worldwide, including their strategic advantages, novel technologies, and products under development. Its main objective is to describe the current status of iPSC research, biomedical applications, manufacturing technologies, patents, funding events, strategic partnerships, and clinical trials for the development of iPSC-based cellular therapeutics.

Importantly, the report presents a comprehensive market size breakdown for iPSCs by Application, Technology, Cell Type and Geography (North America, Europe, Asia/Pacific, and RoW). It also presents market size figures and growth rates through 2030.

This global strategic report reveals:

This 325-page global strategic report will position you to:

Companies and organizations mentioned in the report include:

– Addgene, Inc.
– Aleph Farms
– Allele Biotechnology and Pharmaceuticals, Inc.
– ALSTEM, INC.
– American Type Culture Collection (ATCC)
– AMS Biotechnology Europe, Ltd. (AMSBIO)
– Applied Biological Materials, Inc. (ABM)
– Applied StemCell (ASC), Inc.
– Aruna Bio, Inc.
– Aspen Neuroscience, Inc.
– Avery Therapeutics
– Axol Bioscience, Ltd
– Bayer
– BD Biosciences
– Beckman Coulter Life Sciences
– BioCat GmbH
– BlueRock Therapeutics (acquired by Bayer)
– Bone Therapeutics
– BrainXell
– Brooklyn Immuno Therapeutics
– Cell Biolabs, Inc.
– Cell Signaling Technology
– Cellaria
– CellGenix GmbH
– Cellular Dynamics International, Inc.
– Cellular Engineering Technologies (CET)
– Censo Biotechnologies, Ltd.
– Century Therapeutics, LLC
– CiRA
– Citius Pharmaceuticals
– Corning, Inc.
– Creative Bioarray
– Cynata Therapeutics Ltd.
– Cytovia Therapeutics
– DefiniGEN
– Exacis Biotherapeutics
– Fate Therapeutics, Inc.
– FUJIFILM Cellular Dynamics, Inc.
– GeneCopoeia, Inc.
– GenTarget, Inc.
– Heartseed, Inc.
– Healios K.K.
– Hopstem Biotechnology
– InvivoGen
– I Peace Inc.
– iPSirius
– iPS Portal, Inc.
– iXCells Biotechnologies
– Keio University
– Kyoto University Hospital
– Lindville Bio
– Lonza Group, Ltd.
– Megakaryon Corporation
– Memorial Sloan-Kettering Cancer Center
– Merck/Sigma Aldrich
– Metrion Biosciences, Ltd.
– Miltenyi Biotec B.V. & Co. KG
– Ncardia
– NeuCyte
– Neurophth Biotechnology Ltd.
– Newcells Biotech
– Novo Nordisk
– ONO Pharmaceutical Co., Ltd.
– ORIG3N
– Osaka University
– Oslo University Hospital
– PeproTech
– Phenocell SAS
– Platelet BioGenesis
– Pluricell Biotech
– PromoCell GmbH
– Qiagen
– R&D Systems, Inc.
– ReproCELL
– RheinCell Therapeutics
– RIKEN
– SCG Cell Therapy
– SCM Lifescience
– Semma Therapeutics
– Shoreline Biosciences
– STEMCELL Technologies
– Stemina Biomarker Discovery
– Stemson Therapeutics
– Sumitomo Dainippon Pharma
– Synthego Corp.
– System Biosciences (SBI)
– Takara Bio
– Takeda Pharmaceutical Co., Ltd.
– Tempo Bioscience
– Thermo Fisher Scientific, Inc.
– TreeFrog Therapeutics
– University of California
– U.S. NIH
– Vertex Pharmaceuticals
– VistaGen Therapeutics, Inc.
– Vita Therapeutics
– Waisman Biomanufacturing
– xCell Science, Inc.
– Yashraj Biotechnology, Ltd.

With the competitive nature of this global market, you don’t have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.

About BioInformant

With an online readership of nearly one million viewers per year, BioInformant is a U.S. market research firm with 17+ years of experience. As the first and only market research firm to specialize in the stem cell industry, BioInformant research has been cited by the Wall Street Journal, Xconomy, and Vogue Magazine. Headquartered in Washington, DC, BioInformant is strategically positioned to be near the National Institutes of Health (NIH), the U.S. FDA, the Maryland Biotech Corridor, and policy makers on Capitol Hill. 

To create this report, BioInformant’s  analysts interviewed hundreds of highly regarded iPSC industry leaders, including those those featured here. These KOLs include Kaz Hirao (President & COO of FUJIFILM CDI), Ross Macdonald (CEO of Cynata Therapeutics), Robin Smith (CEO of ORIG3N), Paul Wotton (Board Member of Cynata Therapeutics), and Yutaka Yamaguchi (President of FUJIFILM Irvine Scientific), and others.

The content within this report was compiled using a diverse range of sources, as described in this Research Methodology. You can view License Descriptions here.

TABLE OF CONTENTS: Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report – Market Size, Trends, & Forecasts

Remember, all BioInformant products come with a Greater Than 100% Money Back Guarantee. If the strategies and tools aren’t helpful to you – we’ll cheerfully refund your money, and you can keep the product.

Have questions? Email us at Info@BioInformant.com to get a rapid reply. Checkout below to get immediate access to this report, with printing rights allowed.

4.8/5 - (238 votes)
Exit mobile version