Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2021: Methods of Commercializing iPSCs are Diverse and Continue to Expand

Dublin, IRELAND


Dublin, April 13, 2021 (GLOBE NEWSWIRE) -- The "Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2021" report has been added to ResearchAndMarkets.com's offering.

The main objectives of this report are to describe the current status of iPSC research, patents, funding events, industry partnerships, biomedical applications, technologies, and clinical trials for the development of iPSC-based therapeutics.

Since the discovery of induced pluripotent stem cells (iPSCs) a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number.

Therapeutic applications of iPSCs have surged in recent years. 2013 was a landmark year in Japan because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), 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 world's first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD.

Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its "off-the-shelf" iPSC-derived CAR-T cell product candidate. Numerous physician-led studies using iPSCs are also underway in Japan, a leading country for basic and applied iPSC applications.

iPS Cell Market Competitors

Today, FUJIFILM CDI has emerged as one of the largest commercial players within the iPSC sector. FUJIFILM 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 ever. The feat was accomplished simultaneously by Dr. Shinya Yamanaka's lab in Japan.

In 2009, ReproCELL, a company established as a venture company originating from the University of Tokyo and Kyoto University, made iPSC products commercially available for the first time with the launch of its human iPSC-derived cardiomyocytes, which it called ReproCario.

A European leader within the iPSC market is Ncardia, formed through the merger of Axiogenesis and Pluriomics. Founded in 2001, Axiogenesis initially focused on generating mouse embryonic stem cell-derived cells and assays, but after Yamanaka's iPSC technology became available, it became the first European company to license it in 2010. Ncardia's focus is on preclinical drug discovery and drug safety through the development of functional assays using human neuronal and cardiac cells.

In total, at least 68 distinct market competitors now offer various types of iPSC products, services, technologies and therapies.

iPS Cell Commercialization

Methods of commercializing induced pluripotent stem cells (iPSCs) are diverse and continue to expand. iPSC cell applications include, but are not limited to:

  • Research Products: Market competitors provide iPSC specific tools to scientists worldwide, including human iPSC lines and differentiated cell types, as well as optimized reagents, protocols, differentiation kits, and more.
  • Drug Development & Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery.
  • Cellular Therapy: iPSCs are being explored in a diverse range of cell therapy applications for the purpose of reversing injury or disease.
  • Toxicology Screening: 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.
  • Personalized Medicine: The use of techniques such as CRISPR enables precise, directed the creation of knock-outs and knock-ins (including single-base changes) in many cell types. Pairing iPSCs with genome editing technologies has added a new dimension to personalized medicine.
  • 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."
  • Stem Cell Banking: iPSC repositories provide researchers with the opportunity to investigate a diverse range of conditions using iPSC-derived cell types produced from both healthy and diseased donors.
  • Other Applications: Other applications for iPSCs include areas like tissue engineering, 3D bioprinting, clean meat production, wildlife conservation, and more.

Since the discovery of 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.

Key Topics Covered:

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 iPSCs 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

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 NHI'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
8.2 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
9.3 Workflow in iPSC Banks
9.4 Existing iPSC Banks

10. BIOMEDICAL APPLICATIONS OF iPSCS
10.1 iPSCs in Basic Research
10.2 iPSCs in Drug Discovery
10.3 iPSCs in Toxicology Studies
10.4 iPSCs in Disease Modeling
10.5 iPSCs within Cell-Based Therapies

11. OTHER NOVEL APPLICATIONS OF iPSCS
11.1 iPSCs in Tissue Engineering
11.2 iPSCs in Animal Conservation
11.3 iPSCs and Cultured Meat

12. DEAL-MAKING WITHIN THE iPSC SECTOR
12.1 License Agreement between FUJIFILM Cellular Dynamics and Sana
12.2 Century Therapeutics Closes $160 Million Series C Financing
12.3 Bluerock Gains Access to Ncardia's iPSCs-derived Cardiomyocytes
12.4 Fate Therapeutics' Deal with Janssen Biotech
12.5 Century Therapeutics Acquires Empirica Therapeutics
12.6 $250 Million Raised by Century Theraputics
12.7 BlueRock Therapeutics Launched with $225 Million
12.8 Collaboration between Allogene Therapeutics and Notch Therapeutics
12.9 Acquisition of Semma Therapeutics by Vertex Therapeutics
12.10 Evotec's Extended Collaboration with BMS
12.11 Licensing Agreement between Allele Biotechnology and Astellas
12.12 Codevelopment Agreement between Allele & SCM Lifesciences
12.13 Fate Therapeutics Signs $100 Million Deal with Janssen
12.14 Allele's Deal with Alpine Biotherapeutics
12.15 Editas and BlueRock's Development Agreement

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

14. COMPANY PROFILES

  • 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.
  • 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 SE
  • Fate Therapeutics, Inc.
  • FUJIFILM Cellular Dynamics, Inc.
  • GeneCopoeia, Inc.
  • GenTarget, Inc.
  • Heartseed, Inc.
  • InvivoGen
  • iPS Portal, Inc.
  • iXCells Biotechnologies
  • Lonza Group, Ltd.
  • Megakaryon Corporation
  • Merck/Sigma Aldrich
  • Metrion Biosciences, Ltd.
  • Miltenyi Biotec B.V. & Co. KG
  • Ncardia
  • NeuCyte
  • Newcells Biotech
  • Pancreatic MODY3
  • PeproTech
  • Phenocell SAS
  • Platelet BioGenesis
  • Pluricell Biotech
  • PromoCell GmbH
  • Qiagen
  • R&D Systems, Inc.
  • ReproCELL
  • RHEINCELL Therapeutics GmbH
  • Stemina Biomarker Discovery
  • 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.

For more information about this report visit https://www.researchandmarkets.com/r/d2jcbt

 

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