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

Published: | BIOINFORMANT WORLDWIDE, LLC | 257 Pages | Delivery time: 1-2 business days

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Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report, 2021
Published: August 17, 2021
BIOINFORMANT WORLDWIDE, LLC
Content info: 257 Pages
Delivery time: 1-2 business days
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  • Description
  • Table of Contents
Description

Executive Summary

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™ product.
  • 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 an iPSC-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™ product. 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 University grafted 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 U.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.

Table of Contents

TABLE OF CONTENTS

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
      • Tempo-iSenso: Human iPSC-derived Sensory Neurons
  • 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

INDEX 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

INDEX 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 6.1: (CONTINUED)
  • TABLE 6.1: (CONTINUED)
  • TABLE 6.1: (CONTINUED)
  • TABLE 6.1: (CONTINUED)
  • TABLE 6.1: (CONTINUED)
  • TABLE 6.1: (CONTINUED)
  • TABLE 7.1: NIH Funding for iPSC Projects in 2020
  • TABLE 7.1: (CONTINUED)
  • TABLE 7.1: (CONTINUED)
  • 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 7.2: (CONTINUED)
  • TABLE 7.3: CIRM Funding for Clinical Trials Involving iPSCs
  • TABLE 7.3: (CONTINUED)
  • 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 8.2: (CONTINUED)
  • 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 9.8: (CONTINUED)
  • TABLE 9.8: (CONTINUED)
  • 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 10.3: (CONTINUED)
  • TABLE 10.4: Drug Discovery for Neurological and Neuropsychiatric Diseases using iPSCs
  • TABLE 10.4: (CONTINUED)
  • TABLE 10.5: Drug Discovery for Rare Diseases using iPSCs
  • TABLE 10.5: (CONTINUED)
  • TABLE 10.6: Examples of Drug Testing in iPSC-Derived Disease Models
  • TABLE 10.6: (CONTINUED)
  • TABLE 10.7: Published Human iPSC Disease Models
  • TABLE 10.7: (CONTINUED)
  • TABLE 10.7: (CONTINUED)
  • TABLE 10.7: (CONTINUED)
  • TABLE 10.7: (CONTINUED)
  • 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 10.10: (CONTINUED)
  • TABLE 10.11: Examples of iPSC-Based Neurodegenerative Disease Modeling
  • TABLE 10.11: (CONTINUED)
  • TABLE 10.11: (CONTINUED)
  • TABLE 10.11: (CONTINUED)
  • TABLE 10.12: Cancer-Derived iPSCs
  • TABLE 10.13: iPSC-Derived Cell Thearpeutics Being Tested within Clinical Trials Worldwide
  • TABLE 10.13: (CONTINUED)
  • TABLE 10.13: (CONTINUED)
  • TABLE 10.14: U.S. Clinical Trials Involving iPSCs
  • TABLE 10.14: (CONTINUED)
  • 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