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Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2021

  • ID: 5024881
  • Report
  • August 2021
  • Region: Global
  • 257 Pages
  • BioInformant

FEATURED COMPANIES

  • Addgene, Inc.
  • BioCat GmbH
  • Corning, Inc.
  • Healios KK
  • Merck/Sigma Aldrich
  • PromoCell GmbH

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.


Today, methods of commercializing induced pluripotent stem cells (iPSCs) include:

  • Cell 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 stem cells or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells.

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.


iPSC Derived 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. Since then, iPSC-derived cells have been used within a rapidly growing number of preclinical studies, physician-led studies, and formal clinical trials worldwide.


Therapeutic Advances with iPSCs:


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 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. Notably, the use of a clonal master iPSC line as the starting cell source could enable CAR-T cells to be mass produced and delivered off-the-shelf at an industrial scale.


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


  • Aspen Neuroscience is combining stem cell biology and genomics to provide the world’s first autologous induced pluripotent stem cell (iPSC)-derived neuron replacement therapy for Parkinson disease.
  • Avery Therapeutics and I Peace, Inc., are collaborating to advance an iPSC-derived cell therapeutic for heart failure. I Peace is generating and supplying GMP-grade iPSCs, while Avery Therapeutics is using them to manufacture its MyCardia™
  • Bayer acquired iPSC cell therapy company BlueRock Therapeutics in August 2019. Since May 2021, BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics have had an R&D alliance to develop allogeneic iPSC-derived cell therapies for ocular diseases.
  • BlueRock Therapeutics, a subsidiary of Bayer since August 2019, develops iPSC-derived cell therapies to target Parkinson’s disease, heart failure, and ocular diseases.
  • Century Therapeutics was created in July 2019 by Versant Ventures and Fujifilm to develop iPSC-derived adaptive and innate immune effector cell therapies.
  • Citius Pharmaceuticals uses iPSCs from a single-donor dermal fibroblast to create iPSC-derived MSCs (i-MSCs). It has completed the development of an i-MSC Accession Cell Bank (ACB) and is testing and expanding these cells to create an allogeneic cGMP i-MSC Master Cell Bank.
  • Cynata Therapeutics manufacturers iPSC-derived MSCs using its proprietary Cymerus™ technology. In partnership with FUJIFILM Corporation, it is clinically testing these cells for the treatment of graft-versus-host disease (GvHD). It is also conducting trials for the treatment of critical limb ischemia (CLI), osteoarthritis (OA), and respiratory failure/distress, including ARDS. 
  • Fate Therapeutics is developing iPSC-derived NK and CAR-T cells for the treatment of cancer and immune disorders.
  • FUJIFILM Cellular Dynamics, Inc. (FCDI) is investing in a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products.
  • Heartseed Inc. is a Japanese biotech company that is developing iPSC-derived cardiomyocytes (HS-001) for the treatment of heart failure. The company is positioned to initiate a phase 1/2 study of this investigational cell therapy in Japan in the second half of 2021.
  • Healios K.K., in collaboration with Sumitomo Dainippon Pharma, is undertaking a clinical trial using allogeneic iPSC-derived retinal cells to treat age-related macular degeneration.
  • Hopstem Biotechnology is one of the first iPSC cell therapy companies in China and a market leader in iPSC-derived clinical-grade cell products. In June 2021, it partnered with Neurophth Biotechnology to co-develop aniPSC-derived cell therapy for the treatment of ocular diseases. Hopstem has a proprietary neural differentiation platform, as well as a patented iPSC reprogramming method and GMP manufactory and quality systems.
  • I Peace Inc. and Avery Therapeutics are collaborating to advance an iPSC-derived cell therapeutic for heart failure. I Peace is generating GMP-grade iPSCs, while Avery Therapeutics is using them to manufacture its MyCardia™ I Peace is able to mass production clinical-grade iPSC lines simultaneously in a single room using a miniaturized plate and robotic technology, and its facility is equipped with a fully-closed automated iPSC manufacturing system that meets the safety standards of the U.S. FDA and Japanese PMDA.
  • Keio University won approval from the the Japanese government in February 2018 for an iPSC trial that involves the treatment of patients with spinal cord injuries (led by Professor Hideyuki Okano).
  • Kyoto University Hospital, in partnership with the Center for iPS Cell Research and Application (CiRA), is performing a physician-led study of iPSC-derived dopaminergic progenitors in patients with Parkinson’s disease.
  • Neurophth Biotechnology Ltd. is a gene therapy company specializing in AAV-mediated gene therapies for the treatment of ocular diseases. In June 2021, it partnered with Hopstem Biotechnology to develop an iPSC-derived candidate cell product for an agreed upon retinal degenerative disorder.
  • Novo Nordisk signed a co-development agreement with Heartseed in mid-2021 that grants it exclusive rights to develop, manufacture, and commercialize HS-001 globally, excluding Japan where Heartseed retained exclusive rights to develop HS-001. HS-001 is an investigational therapy comprised of purified iPSC-derived ventricular cardiomyocytes for the treatment of heart failure.
  • Osaka Universitygrafted a sheet of iPS-derived corneal cells into the cornea of a patient with limbal stem cell deficiency, a condition in which corneal stem cells are lost.
  • RIKEN administered the world’s first iPSC-derived cell therapeutic into a human patient in 2014 when it transplanted an autologous iPSC-RPE cell sheet into a patient with AMD.
  • RheinCell Therapeutics GmbH is a developer and manufacturer of GMP-compliant human iPSCs derived from HLA-homozygous, allogeneic umbilical cord blood. In January 2021, the company received GMP certification and Manufacturing Authorization within the EU.
  • Semma Therapeutics, which was acquired by Vertex Pharmaceuticals for $950 million in late 2019, is developing a treatment for Type 1 diabetes. This treatment consists of cells derived from iPSCs that behave like pancreatic cells.
  • Shoreline Biosciences is a biotech company that is developing allogeneic “off-the-shelf” natural killer (NK) and macrophage cellular immunotherapies derived from iPSCs for cancer and other serious diseases.
  • Stemson Therapeutics has been developing a therapy for hair loss involving generation of de novo hair follicles.
  • TreeFrog Therapeutics has developed C-Stem™, a high-throughput cell encapsulation technology allowing for the mass-production and differentiation of iPSCs in industrial bioreactors. This C-Stem™ technology platform could provide a scalable solution to improve the quality of iPSC-derived therapeutics and slash treatment costs.
  • The S. NIH is undertaking the first U.S. clinical trial of an iPSC-derived therapeutic. Its Phase I/IIa clinical trial will involve 12 patients with advanced-stage geographic atrophy of the eye.

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 in 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 (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 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 70 market competitors now offer various types of iPSC products, services, manufacturing technologies, and therapeutics.


iPSC Report Details


This report reveals all major market competitors worldwide, including their advantages, core 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 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 total market size figures and growth rates through 2027.


Claim this global strategic report to become immediately informed about the iPSC market, without sacrificing weeks of unnecessary research or being at risk of missing critical market opportunities.


Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Addgene, Inc.
  • BioCat GmbH
  • Corning, Inc.
  • Healios KK
  • Merck/Sigma Aldrich
  • PromoCell GmbH

1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary


2. INTRODUCTION 
2.1 Discovery of iPSCs
2.2 Barriers in iPSC Application
2.3 Timeline and Cost of iPSC Development
2.4 Current Status of iPSCs Industry
2.4.1 Share of iPSC-based Research within the Overall Stem Cell Industry
2.4.2 Major Focuses of iPSC Companies
2.4.3 Commercially Available iPSC-Derived Cell Types
2.4.4 Relative Use of iPSC-Derived Cell Types in Toxicology Testing Assays
2.4.5 Toxicology/Safety Testing Assays using iPSC-Derived Cell Types
2.5 Currently Available iPSC Technologies
2.6 Advantages and Limitations of iPSCs Technology


3. HISTORY OF INDUCED PLURIPOTENT STEM CELLS (iPSCs)
3.1 First iPSC generation from Mouse Fibroblasts, 2006
3.2 First Human iPSC Generation, 2007
3.3 Creation of CiRA, 2010
3.4 First High-Throughput Screening Using iPSCs, 2012
3.5 First iPSC Clinical Trial Approved in Japan, 2013
3.6 The First iPSC-RPE Cell Sheet Transplantation for AMD, 2014
3.7 EBiSC Founded, 2014
3.8 First Clinical Trial using Allogeneic iPSCs for AMD, 2017
3.9 Clinical Trials for Parkinson’s disease using Allogeneic iPSCs, 2018
3.10 Commercial iPSC Plant SMaRT Established, 2018
3.11 First iPSC Therapy Center in Japan, 2019
3.12 The First U.S.-based NIH Sponsored Clinical Trial using iPSCs, 2019
3.13 Cynata Therapeutics’ Worlds Largest Phase III Clinical Trial, 2020


4. RESEARCH PUBLICATIONS ON iPSCs
4.1 Categories of Research Publications
4.2 Percent Share of Published Articles by Disease Type
4.3 Number of Articles by Country


5. iPSCs: PATENT LANDSCAPE
5.1 Timeline and Status of Patents
5.2 Patent Filing Destinations
5.2.1 Patent Applicant’s Origin
5.2.2 Top Ten Global Patent Applicants
5.2.3 Collaborating Applicants of Patents
5.3 Patent Application Trends iPSC Preparation Technologies
5.4 Patent Application Trends in iPSC Differentiation Technologies
5.5 Patent Application Trends in Disease-Specific Cell Technologies


6. CLINICAL TRIALS INVOLVING iPSCs
6.1 Current Clinical Trials Landscape
6.1.1 Clinical Trials Involving iPSCs by Major Diseases
6.1.2 Clinical Trials Involving iPSCs by Country


7. FUNDING FOR iPSCs
7.1 Value of NIH Funding for iPSCs
7.1.1 NIH’s Intended Funding Through its Component Organizations in 2020
7.1.2 NIH Funding for Select Universities for iPSC Studies
7.2 CIRM Funding for iPSCs


8. GENERATION OF INDUCED PLURIPOTENT STEM CELLS: AN OVERVIEW
8.1 Reprogramming Factors
8.1.1 Pluripotency-Associated Transcription Factors
8.1.2 Different Cell Sources and Different Combinations of Factors
8.1.3 Delivery of Reprogramming Factors
8.1.4 Integrative Delivery Systems
8.1.4.1 Integrative Viral Vectors
8.1.4.2 Integrative Non-Viral Vectors
8.1.5 Non-Integrative Delivery Systems
8.1.5.1 Non-Integrative Viral Vectors
8.1.5.2 Non-Integrative Non-Viral Delivery
8.2 Overview of Four Key Methods of Gene Delivery
8.3 Comparative Effectiveness of Different Vector Types
8.4 Genome Editing Technologies in iPSCs Generation


9. HUMAN iPSC BANKING
9.1 Cell Sources for iPSCs Banking
9.2 Reprogramming methods used in iPSC Banking
9.2.1 Factors used in reprogramming by Different Banks
9.3 Workflow in iPSC Banks
9.4 Existing iPSC Banks
9.4.1 California Institute for Regenerative Medicine (CIRM)
9.4.1.1 CIRM iPSC Repository
9.4.1.2 Key Partnerships Supporting CIRM’s iPSC Repository
9.4.2 Regenerative Medicine Program (RMP)
9.4.2.1 Research Grade iPSC Lines for Orphan and Rare Diseases from RMP
9.4.2.2 RMP’s Stem Cell Translation Laboratory (SCTL)
9.4.3 Center for iPS Cell Research and Application (CiRA)
9.4.3.1 FiT: Facility for iPS Cell Therapy
9.4.4 European Bank for Induced Pluripotent Stem Cells (EBiPC)
9.4.5 Korean Society for Cell Biology (KSCB)
9.4.6 Human Induced Pluripotent Stem Cell Intitiative (HipSci)
9.4.7 RIKEN - BioResource Research Center (BRC)
9.4.8 Taiwan Human Disease iPSC Consortium
9.4.9 WiCell


10. BIOMEDICAL APPLICATIONS OF iPSCs
10.1 iPSCs in Basic Research
10.1.1 Understanding Cell Fate Control
10.1.2 Cell Rejuvenation
10.1.3 Studying Pluripotency
10.1.4 Tissue and Organ Development and Physiology
10.1.5 Generation of Human Gametes from iPSCs
10.1.6 Providers of iPSC-Related Services for Researchers
10.2 iPSCs in Drug Discovery
10.2.1 Drug Discovery for Cardiovascular Disease using iPSCs
10.2.2 Drug Discovery for Neurological and Neuropsychiatric Diseases
10.2.3 Drug Discovery for Rare Diseases using iPSCs
10.3 iPSCs in Toxicology Studies
10.3.1 Relative Use of iPSC-Derived Cell Types within Toxicity Testing
10.4 iPSCs in Disease Modeling
10.4.1 Cardiovascular Diseases Modeled with iPSCs
10.4.2 Percent Share Utilization of iPSCs for Cardiovascular Disease Modeling
10.4.3 Proportion of iPSC Sources in Cardiac Studies
10.4.4 Proportion of Vector Types used in Reprogramming
10.4.5 Proportion of Differentiated Cardiomyocytes used in Disease Modeling
10.4.6 iPSC-Derived Organoids for Modeling Development and Disease
10.4.7 Modeling Liver Diseases using iPSC-derived Hepatocytes
10.4.8 iPSCs in Neurodegenerative Disease Modeling
10.4.9 Cancer-Derived iPSCs
10.5 iPSCs within Cell-Based Therapies
10.5.1 iPSC-Derived Therapeutics under Development Worldwide
10.5.1.1 Clinical Trials for AMD
10.5.1.2 Autologous iPSC-RPE for AMD
10.5.1.3 Allogeneic iPSC-RPE for AMD
10.5.1.4 iPSC-Derived Dopaminergic Neurons for Parkinson’s disease
10.5.1.5 iPSC-Derived NK Cells for Solid Cancers
10.5.1.6 iPSC-derived Cells for GvHD
10.5.1.7 iPSC-derived Cells for Spinal Cord Injury
10.5.1.8 iPSC-derived Cardiomyocytes for Ischemic Cardiomyopathy
10.5.1.9 Cynata’s CYP-001 for Acute Respiratory Distress Syndrome (ARDS)
10.5.1.10 Cynata’s CYP-004 for Osteoarthritis
10.5.1.11 Cynata’s CYP-002 for Critical Limb Ischemia (CLI)
10.5.1.12 iPSC-Derived RPE Cells for Age-Related Macular Degeneration
10.5.1.13 Stem Cell Treatment for Aplastic Anemia
10.5.1 All Known Companies Developing iPSC-Derived Cell Therapeutics Worldwide
10.5.2 U.S. Clinical Trials Involving iPSCs


11. OTHER NOVEL APPLICATIONS OF iPSCs
11.1 iPSCs in Tissue Engineering
11.1.1 3D Bioprinting Techniques
11.1.2 Biomaterials
11.1.3 3D Bioprinting Strategies
11.1.4 Bioprinting Undifferentiated iPSCs
11.1.5 Bioprinting iPSC-Differentiated Cells
11.2 iPSCs in Animal Conservation
11.2.1 iPSC Lines for the Preservation of Endangered Species of Animals
11.2.2 iPSCs in Wildlife Conservation
11.3 iPSCs and Cultured Meat
11.3.1 Funding Raised by Cultured Meat Companies
11.3.4 Global Market for Cultured Meat


12. DEAL-MAKING WITHIN THE iPSC SECTOR
12.1 Novo Nordisk’s Deal with Heartseed
12.2 Partnership between Neuropath Biotechnology Ltd. and Hopstem Biotechnology
12.3 License Agreement between FUJIFILM Cellular Dynamics and Sana Biotechnology
12.4 Century Therapeutics Closes $160 Million Series C Financing
12.5 Bluerock Gains Access to Ncardia’s iPSCs-derived Cardiomyocytes
12.6 Fate Therapeutics’ deal with Janssen Biotech
12.7 Century Therapeutics Acquires Empirica Therapeutics
12.8 $250 million Raised by Century Therapeutics
12.9 BlueRock Therapeutics Launched with $225 Million
12.10 Collaboration between Allogene Therapeutics and Notch Therapeutics
12.11 Acquisition of Semma Therapeutics by Vertex Therapeutics
12.12 Evotec’s Extended Collaboration with BMS
12.13 Licensing Agreement between Allele Biotechnology and Astellas Pharma
12.14 Codevelopment Agreement between Allele & SCM Lifesciences
12.15 Fate Therapeutics Signs $100 Million Deal with Janssen
12.16 Allele’s Deal with Alpine Biotherapeutics
12.17 Editas and BlueRock’s Development Agreement
12.18 Avery Therapeutics and I Peace, Inc. Sign Service Agreement
12.19 Evotec SE Signed a Licensing and Investment Agreement with panCELLa, Inc.


13. MARKET OVERVIEW
13.1 Global Market for iPSCs by Geography
13.2 Global Market for iPSCs by Technology
13.3 Global Market for iPSCs by Biomedical Application
13.4 Global Market for iPSCs by Cell Types
3.5 Market Drivers
13.6 Market Restraints
13.6.1 Economic Issues
13.6.2 Genomic Instability
13.6.3 Immunogenicity
13.6.4 Biobanking of iPSCs


14. COMPANY PROFILES
14.1 Addgene, Inc.
14.1.1 Viral Plasmids
14.2 Aleph Farms
14.3 Allele Biotechnology and Pharmaceuticals, Inc.
14.3.1 iPSC Reprogramming and Differentiation
14.4 AMS Biotechnology Europe, Ltd. (AMSBIO)
14.4.1 Services
14.4.2 Products
14.4.3 Corneal Epithelial Cells Cultured in StemFit in Clinical Trials
14.5 ALSTEM, INC.
14.5.1 Products
14.5.2 Services
14.6 Applied Biological Materials, Inc. (ABM)
14.6.1 Gene Expression Vectors and Viruses
14.7 Applied StemCell, Inc.
14.7.1 Services & Products
14.8 American Type Culture Collection (ATCC)
14.8.1 Product
14.9 Applied StemCell (ASC), Inc.
14.9.1 Products
14.10 Aruna Bio, Inc.
14.10.1 Program in Stroke
14.10.2 Exosomes as Therapeurics
14.11 Aspen Neuroscience, Inc.
14.11.1 Technology
14.12 Avery Therapeutics
14.12.1 MyCardia
14.13 Axol Bioscience, Ltd.
14.13.1 iPSC-derived Cells
14.13.2 Disease Models
14.13.3 Primary Cells
14.13.4 Media & Reagents
14.13.5 Services
14.14 Beckman Coulter Life Sciences
14.14.1 Cell Counters, Sizers and Media Analyzers
14.15 BD Biosciences
14.15.1 Products
14.16 BioCat GmbH
14.16.1 Products & Services
14.17 BlueRock Therapeutics
14.17.1 CELL + GENE Platform
14.18 BrainXell
14.18.1 Products
14.19 Cellaria
14.19.1 Product
14.20 Cell Biolabs, Inc.
14.20.1 Products
14.21 CellGenix GmbH
14.21.1 Products
14.22 Cell Signaling Technology
14.22.1 Products
14.23 Cellular Engineering Technologies (CET)
14.23.1 iPS Cell Lines
14.24 Cellular Dynamics International, Inc.
14.24.1 Products
14.25 Censo Biotechnologies, Ltd.
14.25.1 Human iPSC Reprogramming Services
14.25.2 iPSC Gene Editing Services
14.25.3 iPSC Target Validation and Assay Services
14.26 Century Therapeutics, LLC
14.26.1 Allogeneic Immune Cell Therapy
14.27 CiRA
14.27.1 Collaborations
14.28 Corning, Inc.
14.28.1 Products
14.29 Creative Bioarray
14.29.1 Products
14.30 Cynata Therapeutics Ltd.
14.30.1 Cymerus MSCs
14.30.2 Cynata’s Lead in iPSC-based Clinical Trials
14.30.2.1 CYP-001
14.30.2.2 CYP-002
14.30.2.3 CYP-004
14.30.2.4 MEND Clinical Trial
14.31 Cytovia Therapeutics
14.31.1 iPSC CAR NK Cells
14.32 DefiniGEN
14.32.1 OptiDIFF iPSC Platform
14.32.2 Service
14.32.3 Patient-Derived Custom Cell Lines
14.32.4 Hepatocytes WT
14.32.5 Hepatocyte A1ATD
14.32.6 Hepatocyte GSD1a
14.32.7 Hepatocyte NAFLD
14.32.8 Hepatocyte FH
14.32.9 Pancreatic WT
14.32.10 Pancreatic MODY3
14.33 Evotec A.G.
14.33.1 iPSC-Based Drug Discovery Platform
14.34 Fate Therapeutics, Inc.
14.34.1 iPSC Platform
14.34.2 Collaboration with ONO Pharmaceutical Co., Ltd.
14.34.3 Collaboration with Memorial Sloan-Kettering Cancer Center
14.34.4 Collaboration with University of California, San Diego
14.34.5 Collaboration with Oslo University Hospital
14.35 FUJIFILM Cellular Dynamics, Inc.
14.35.1 iCell Products
14.35.2 MyCell Products
14.35.3 FCDI’s Partners & Providers
14.35.4 Groundbreaking Cellular Therapy Applications
14.35.5 New Paradigm for Drug Discovery
14.35.6 FCDI & Stem Cell Banking
14.36 GeneCopoeia, Inc.
14.36.1 Products & Services
14.37 GenTarget, Inc.
14.37.1 Products
14.37.2 Services
14.38 Healios KK
14.38.1 Healios’ iPSCs for Regenerative Medicine
14.39 Heartseed, Inc.
14.39.1 Technology
14.40 Hopstem Biotechnology LLC
14.40.1 Products & Services
14.41 InvivoGen
14.41.1 Products
14.42 iPS Portal, Inc.
14.42.1 Services
14.43 I Peace, Inc.
14.43.1 Mass Production of iPSCs
14.44 iXCells Biotechnologies
14.44.1 Products
14.45 Lonza Group, Ltd.
14.45.1 Nucleofector Technology
14.46 Merck/Sigma Aldrich
14.46.1 Products
14.47 Megakaryon Corporation
14.47.1 Technology
14.48 Metrion Biosciences, Ltd.
14.48.1 Cardiac Translational Assays
14.49 Miltenyi Biotec B.V. & Co. KG
14.49.1 Cell Manufacturing Platform
14.50 Rue Adrienne Bolland
14.50.1 iPSC Solutions for Cell Therapy
14.50.2 Drug Safety and Toxicity Services
14.51 NeuCyte
14.51.1 Technology
14.52 Newcells Biotech
14.52.1 Expertise
14.52.2 iPSC Reprogramming Services
14.52.3 Assay Products and Services
14.52.4 Assay Development
14.53 Novo Nordisk A/S
14.53.1 Partnership with HeartSeed
14.54 PeproTech
14.54.1 Products
14.55 Phenocell SAS
14.55.1 Human iPSCs
14.56 Platelet BioGenesis
14.56.1 Technology
14.57 Pluricell Biotech
14.57.1 Pluricell’s Projects
14.58 PromoCell GmbH
14.58.1 Products
14.59 Qiagen
14.59.1 Single Cell Analysis
14.60 R&D Systems, Inc.
14.60.1 Products
14.61 ReproCELL
14.61.1 Services
14.61.2 Products
14.62 RHEINCELL Therapeutics GmbH
14.62.1 GMP-Grade iPSC Products
14.62.2 Services
14.63 Stemson Therapeutics
14.63.1 Hair Follicle Biology
14.64 TEMCELL Technologies
14.64.1 Products
14.65 Stemina Biomarker Discovery
14.65.1 Cardio quickPredict
14.65.2 devTOX quickPredict
14.66 Synthego Corp.
14.66.1 CRISPR-Edited iPSCs
14.67 System Biosciences (SBI)
14.67.1 Products
14.68 Takara Bio
14.68.1 Stem Cell Research Products
14.69 Takeda Pharmaceutical Co., Ltd.
14.69.1 Collaboration between CiRA and Takeda
14.69.2 FUJIFILM’s Collaboration with Takeda
14.70 Tempo Bioscience
14.70.1 Human Cell Models
14.71 Thermo Fisher Scientific, Inc.
14.71.1 Products for Stem Cell Culture
14.71.2 Products for Stem Cell Characterization
14.71.3 Products for Stem Cell Engineering
14.72 TreeFrog Therapeutics
14.72.1 C-Stem Technology
14.73 VistaGen Therapeutics, Inc.
14.73.1 CardioSafe 3D
14.74 Waisman Biomanufacturing
14.74.1 GMP iPSCs
14.75 xCell Science, Inc.
14.75.1 Control Lines
14.75.2 Products
14.75.3 Services
14.76 Yashraj Biotechnology, Ltd.
14.76.1 Products and Services for Drug Discovery


List of Figures
Figure 2.1: The Share of iPSC-related Research Compared with other Stem Cell Types
Figure 2.2: Major Focuses of iPSC Companies
Figure 2.3: Commercially Available iPSC-Derived Cell Types
Figure 2.4: Relative Use of iPSC-Derived Cell Types in Toxicology/Safety Testing Assays
Figure 2.5: Toxicology/Safety Testing Assays using iPSC-Derived Cell Types
Figure 3.1: CiRA’s Budget of ¥6.37 Billion
Figure 4.1: Number of Research Publications on iPSCs in PubMed.gov, 2006-2020
Figure 4.2: Percent Share of Published Articles by Research Themes
Figure 4.3: Percent Share of Published Articles by Disease Type
Figure 4.4: Percent Share of iPSC Research Publications by Country
Figure 5.1: Number of Patents Granted, Being Sought, and “Dead”
Figure 5.2: Patent Families by Filing Jurisdiction
Figure 5.3: Patent Families by Applicant Origin
Figure 5.4: Top Ten Global Applicants
Figure 5.5: Top Ten Global Collaborators on PSC/iPSC Patents
Figure 5.6: Share of Patents on iPSC Preparation Technologies by Geography
Figure 5.7: Percent Share of iPSC Preparation Methods in the U.S., Japan and Europe
Figure 5.8: Percent Share of Patents Related to Cell Types Differentiated from iPSCs
Figure 5.9: Percent Share of Patent Applications for Disease-Specific Cell Technologies
Figure 5.10: Percent Share of Patents Representing Different Disorders
Figure 6.1: Number of Clinical Trials Involving iPSCs by Year, 2006-2020
Figure 6.2: Clinical Trials Involving iPSCs by Major Diseases
Figure 6.3: Clinical Trials Involving iPSCs by Country
Figure 7.1: Number of NIH Funding for iPSC Projects, 2010-2020
Figure 7.2: Value of NIH Funding for iPSCs by Year, 2010-2020
Figure 8.1: Overview of iPSC Technology
Figure 8.2: Generation of iPSCs from MEF Cultures through 24 Factors by Yamanaka
Figure 8.3: The Roles of OSKM Factors in the Induction of iPSCs
Figure 8.4: Schematic Representation of Delivery Methods for iPSCs Induction
Figure 8.5: Overview of Four Key Methods of Gene Delivery
Figure 9.1: Workflow in iPSC Banks
Figure 10.1: Biomedical Applications of iPSCs
Figure 10.2: Relative Use of iPSC-Derived Cell Types in Toxicity Testing
Figure 10.3: A Schematic for iPSC-Based Disease Modeling
Figure 10.4: Proportion of iPS Cell Lines Generated by Disease Type
Figure 10.5: Proportion of iPSC Sources in Cardiac Studies
Figure 10.6: Proportion of Vector Types used in Reprogramming
Figure 10.7: The Proportion of Differentiated Cardiomyocyte Types
Figure 10.8: Schematic for iPSC-Based Cell Therapy
Figure 11.1: Schematic Representation of Printing Techniques used for iPSC Bioprinting
Figure 11.2: Schematic Showing the use of iPSCs in Protecting Endangered Species
Figure 11.3: Funding raised by Cultured Meat Companies, 2016-2019
Figure 11.4: Estimated Global Market for Cultured Meat, 2023-2030
Figure 13.1: Estimated Global Market for iPSCs by Geography through 2026
Figure 13.2: Estimated Global Market for iPSCs by Technology through 2026
Figure 13.3: Estimated Global Market for iPSCs by Biomedical Application through 2026
Figure 13.4: Estimated Global Market Share for Differentiated Cell Types, 2020
Figure 14.1: Comparison of Conventional Meat Production and Cultured Meat Production


List of Tables
Table 2.1: Companies Offering Commercially Available iPSC Technologies
Table 2.2: Advantages and Limitations of iPSC Technology
Table 3.1: Timeline of the Most Important Milestones in iPSC Research, 2006-2019
Table 4.1: Number of Research Publications on iPSCs in PubMed.gov, 2006-2021
Table 5.1: Patent Families by Filing Jurisdiction
Table 5.2: Patents Granted and Patents Pending in the Global Patent Landscape
Table 6.1: Select Clinical Trials involving iPSCs as of May 2021
Table 7.1: NIH Funding for iPSC Projects in 2020
Table 7.1: NIH’s Intended Funding Through its Component Organizations in 2020
Table 7.2: NIH Funding for Select Universities/Organizations for iPSC Studies
Table 7.3: CIRM Funding for Clinical Trials Involving iPSCs
Table 8.1: Characterization of iPSCs
Table 8.2: Reprogramming Factors used in the Generation of iPSCs
Table 8.3: Different Cell Sources and Different Combinations of Reprogramming Factors
Table 8.1: Comparative Effectiveness of Different Vector Types
Table 8.2: iPSC Disease Models using Isogenic Control Lines Generated by CRISPR/Cas9
Table 9.1: Cell Sources and Reprogramming Agents used in iPSCs Banks
Table 9.2: Diseased iPSC Lines Available in CIRM Repository
Table 9.3: CIRMS’ iPSC Initiative Awards
Table 9.4: Research Grade iPSCs Available with RMP
Table 9.5: Research Grade iPSC Lines for Orphan and Rare Diseases Available with RMP
Table 9.6: SCTL’s Collaborations
Table 9.7: A Partial List of iPSC Lines Available with EBiPC
Table 9.8: List of Disease-Specific iPSCs Available with RIKEN
Table 9.9: An Overview of iPSC Banks Worldwide
Table 10.1: Providers of iPS Cell Lines and Parts Thereof for Research
Table 10.2: Comparison of hiPSC-Based & Animal-Based Drug Discovery
Table 10.3: Drug Discovery for Cardiovascular Diseases using iPSCs
Table 10.4: Drug Discovery for Neurological and Neuropsychiatric Diseases using iPSCs
Table 10.5: Drug Discovery for Rare Diseases using iPSCs
Table 10.6: Examples of Drug Testing in iPSC-Derived Disease Models
Table 10.7: Published Human iPSC Disease Models
Table 10.8: Partial List of Cardiovascular and Related Diseases Modeled with iPSCs
Table 10.9: iPSC-Derived Organoids for Modeling Development and Disease
Table 10.10: Liver Diseases and Therapeutic Interventions Modeled using iPSCs
Table 10.11: Examples of iPSC-Based Neurodegenerative Disease Modeling
Table 10.12: Cancer-Derived iPSCs
Table 10.13: iPSC-Derived Cell Thearpeutics Being Tested within Clinical Trials Worldwide
Table 10.14: U.S. Clinical Trials Involving iPSCs
Table 11.1: Features of Different Bioprinting Techniques
Table 11.2: Bioprinting of iPSC-Derived Tissues
Table 11.3: Timeline of Achievements Made using iPSCs for Conservation of Animals
Table 11.4: Companies Working on Meat Production based on Cellular Agriculture
Table 13.1: Estimated Global Market for iPSCs by Geography, 2020-2027
Table 13.2: Estimated Global Market for iPSCs by Technology, 2020-2027
Table 13.3: Estimated Global Market for iPSCs by Biomedical Application, 2020-2027
Table 13.4: Estimated Global Market for iPSCs by Differentiated Cell Types, 2020-2027


Note: Product cover images may vary from those shown

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  • 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.
  • Applied StemCell, Inc.
  • Aruna Bio, Inc.
  • Aspen Neuroscience, Inc.
  • Avery Therapeutics
  • Axol Bioscience, Ltd.
  • BD Biosciences
  • Beckman Coulter Life Sciences
  • BioCat GmbH
  • BlueRock Therapeutics
  • BrainXell
  • Cell Biolabs, Inc.
  • Cell Signaling Technology
  • Cellaria
  • CellGenix GmbH
  • Cellular Dynamics International, Inc.
  • Cellular Engineering Technologies (CET)
  • Censo Biotechnologies, Ltd.
  • Century Therapeutics, LLC
  • CiRA
  • Corning, Inc.
  • Creative Bioarray
  • Cynata Therapeutics Ltd.
  • Cytovia Therapeutics
  • DefiniGEN
  • Evotec A.G.
  • Fate Therapeutics, Inc.
  • FUJIFILM Cellular Dynamics, Inc.
  • GeneCopoeia, Inc.
  • GenTarget, Inc.
  • Healios KK
  • Heartseed, Inc.
  • Hopstem Biotechnology LLC
  • I Peace, Inc.
  • InvivoGen
  • iPS Portal, Inc.
  • iXCells Biotechnologies
  • Lonza Group, Ltd.
  • Megakaryon Corporation
  • Merck/Sigma Aldrich
  • Metrion Biosciences, Ltd.
  • Miltenyi Biotec B.V. & Co. KG
  • NeuCyte
  • Newcells Biotech
  • Novo Nordisk A/S
  • PeproTech
  • Phenocell SAS
  • Platelet BioGenesis
  • Pluricell Biotech
  • PromoCell GmbH
  • Qiagen
  • R&D Systems, Inc.
  • ReproCELL
  • RHEINCELL Therapeutics GmbH
  • Rue Adrienne Bolland
  • Stemina Biomarker Discovery
  • Stemson Therapeutics
  • Synthego Corp.
  • System Biosciences (SBI)
  • Takara Bio
  • Takeda Pharmaceutical Co., Ltd.
  • TEMCELL Technologies
  • Tempo Bioscience
  • Thermo Fisher Scientific, Inc.
  • TreeFrog Therapeutics
  • VistaGen Therapeutics, Inc.
  • Waisman Biomanufacturing
  • xCell Science, Inc.
  • Yashraj Biotechnology, Ltd.
Note: Product cover images may vary from those shown

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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