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Complete 2015-16 Induced Pluripotent Stem Cell Industry Report

  • April 2015
  • -
  • BioInformant Worldwide, L.L.C.
  • -
  • 175 pages

Report Applications

This global strategic report is produced for:

Management of Stem Cell Product Companies
Management of Stem Cell Therapy Companies
Stem Cell Industry Investors
It is designed to increase your efficiency and effectiveness in:

Commercializing iPSC products, technologies, and therapies
Making intelligent investment decisions
Launching high-demand products
Selling effectively to your client base
Increasing revenue
Taking market share from your competition

Executive Summary

Stem cell research and experimentation have been in process for well over five decades, as stem cells have the unique ability to divide and replicate repeatedly In addition, their “unspecialized” nature allows them to differentiate into a wide variety of specialized cell types The possibilities arising from these characteristics have resulted in great commercial interest, with potential applications ranging from the use of stem cells in reversal and treatment of disease, to targeted cell therapy, tissue regeneration, pharmacological testing on cell-specific tissues, and more Conditions such as Huntington’s disease, Parkinson’s disease, and spinal cord injuries are examples of clinical applications in which stem cells could offer benefits in halting or even reversing damage

Traditionally, scientists have worked with both embryonic and adult stem cells for research tools, as well as for cellular therapy While the appeal of embryonic cells has been their ability to differentiate into any type of cell, there has been significant ethical, moral, and spiritual controversy surrounding their use Although some adult stem cells do have differentiation capacity, it is often limited in nature, which results in fewer options for use Thus, induced pluripotent stem cells represent a promising combination of adult and embryonic stem cell characteristics

Discovery of Induced Pluripotent Stem Cells

Groundbreaking experimentation in 2006 led to the introduction of induced pluripotent stem cells (iPSCs) These are adult cells which are isolated and then transformed into embryonic-like stem cells through the manipulation of gene expression, as well as other methods Research and experimentation using mouse cells by Shinya Yamanaka’s lab at Kyoto University in Japan was the first instance in which there was successful generation of iPSCs In 2007, a series of follow-up experiments was done at Kyoto University in which human adult cells were transformed into iPSCs Nearly simultaneously, a research group led by James Thomson at the University of Wisconsin-Madison accomplished the same feat of deriving iPSC lines from human somatic cells

Continued research and experimentation have resulted in numerous advances over the last few years For example, several independent research groups have announced that they have derived human cardiomyocytes from iPSCs These cells could be used in a laboratory context to test drugs that treat arrhythmia and other cardiac conditions, and in a clinical context they could potentially be implanted into patients with heart disorders

Similar advances will continue to be perfected for use of reprogrammed adult cells in the treatment of other diseases and disorders Original techniques for iPSC production, such as viral induced transcription processes, are being replaced with newer technologies as private industry joined with the scientific community to develop safer and more efficient methods of iPSC production As innovation around methods of iPSC production continues, clinical grade production of industrial quantities of iPSCs is now becoming possible due to sustained research and experimentation

Therapeutic Applications of Induced Pluripotent Stem Cells

While there has been continued excitement at the prospect of what such artificially re-manufactured cells could contribute to medical advances, there have also been setbacks along the way By 2010, there were a number of private companies that were ready to capitalize on the breakthrough technology that iPSCs represent One such company, Advanced Cell Technology (ACT) in Marlborough, Massachusetts, discovered several problematic issues while conducting experiments for the purpose of applying for US Food and Drug Administration approval to use iPSCs in therapeutic applications Concerns such as premature cell death, mutation into cancer cells, and low proliferation rates were some of the problems that surfaced

As a result, ACT (now named “Ocata Therapeutics”) has shifted its induced pluripotent stem cell approach to producing iPSC derived human platelets One of the benefits of a platelet-based product is that platelets do not contain nuclei, and therefore, cannot divide or carry genetic information While nothing is completely safe, iPSC derived platelets are likely to be substantially safer than other currently available iPSC therapies, in which uncontrolled proliferation may be a concern It also shifted to using embryonic stem cells for clinical trial purposes, despite the ethical concerns surrounding this cell type

Over the next few years, iPSC research advances accelerated exponentially, with perhaps the most momentous milestone being the launch of the first clinical research trial ever involving the transplant of autologous iPSCs into humans (“autologous” meaning the cells are both derived and implanted into the same patient) Previously, all clinical trials using iPSCs involved only the creation of iPSC lines from specific patient populations and subsequent evaluation of these lines for determining whether they could represent a good “model” for a disease of interest within that population

Therefore, 2013 was the first time in which clinical research involving transplant of iPSCs into humans was initiated, led by Masayo Takahashi of the RIKEN Center for Developmental Biology in Kobe, Japan Dr Takahashi and her team are investigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration While the trial was initiated in 2013 and production of iPSCs from patients began at that time, it was not until August of 2014 that the first patient, a Japanese woman, was implanted with retinal tissue generated using iPSCs derived from her own skin cells A team of three eye specialists, led by Yasuo Kurimoto of the Kobe City Medical Center General Hospital, implanted a 13 by 30mm sheet of iPSC-derived retinal pigment epithelium cells into the patient’s retina Preliminary results are indicating positive results for the participants in this iPSC clinical trial

Key Report Findings


Induced pluripotent stem cells represent one of the most promising research advances within the past decade, making this a valuable report for both executives and investors to use to optimally position themselves to sell iPSC products To profit from this lucrative and rapidly expanding market, you need to understand your key strengths relative to the competition, intelligently position your products to fill gaps in the market place, and take advantage of crucial iPSC trends

Key report findings include:

Metrics, Timelines, Tables, and Graphs for the iPSC Industry
Trend Rate Data for iPSC Grants, Clinical Trials, and Scientific Publications
Analysis of iPSC Patent Environment, including Key Patents and Patent Trends
Market Segmentation
5-Year Market Size Projections (2015-2019)
Market Size Estimations, by Market Segment
Updates on Crucial iPSC Industry and Technology Trends
Analysis of iPSC Market Leaders, by Market Segment
Geographical Assessment of iPSC Innovation
SWOT Analysis for the iPSC Sector (Strengths, Weaknesses, Opportunities, Threats)
Preferred Species for iPSC Research
Influential Language for Selling to iPSC Scientists
Breakdown of the Marketing Methods, including Exposure and Response Rates

Table Of Contents

Complete 2015-16 Induced Pluripotent Stem Cell Industry Report
EXECUTIVE SUMMARY
11 Report Overview
12 Key Report Findings
PURPOSE OF REPORT
21 To Survey Recent iPSC Advancements
22 To Provide a Snapshot” of the Global iPSC Market
23 To Provide Market Analysis in Context of Future Applications 24 To Assess Opportunities for Commercialization
25 To Identify Major Market Players and Assess Competitive Environment
26 To Identify Existing and Emerging Trends
27 To Identify Critical Opportunities and Threats within the iPSC Market
TARGET DEMOGRAPHIC
SCOPE OF iPSC MARKET
41 Products
42 Services
43 Technologies
44 Therapies
45 Adjunct Products and Services
RESEARCH METHODOLOGY
51 Input Sources
52 Research and Analysis Methodologies
53 Criteria for Identifying iPSC Market Leaders
531 Size of Company
532 Type of Product/Services
533 Degree of Specialization
534 Patent Positions
535 Business Reputation
536 Financial Strength
537 Partnerships
538 Certifications
TECHNICAL OVERVIEW OF iPSCs
61 Definition
62 Discovery of iPSCs
63 Advantages and Disadvantages of iPSCs
TIMELINE OF KEY iPSC EVENTS
71 Production of iPSCs (Key Events)
- (TIMELINE) Production of Induced Pluripotent Stem Cells
72 Full Timeline of Events
- (TABLE) Key Events in the Discovery and Evolution of iPSC Products
LEVELS OF REPAIR INDUCIBLE WITH iPSCs
- (TABLE) Four Levels of Repair Inducible with iPSCs
81 Gene-Level Repair (Gene Therapy)
- (TABLE) Examples of Gene-Level Repair with iPSCs
82 Cellular-Level Repair (Cell Replacement Therapy)
83 iPSC-derived Blood Products
84 Whole Tissue Repair (Organ Replacement Therapy)
iPSC INDUSTRY CONDITIONS
91 Origin of the iPSC Market
92 Therapeutic Applications of Induced Pluripotent Stem Cells
93 Landmark Events Create Market Opportunities
94 iPSC Patent Challenges
95 Four Primary Areas of Commercialization
- (IMAGE) Four Primary Areas of Commercialization for iPSCs
96 Rapidly-Evolving Market Opportunities for iPSCs
97 Market Leaders by Area of Commercialization
98 End-User Perspective of iPSC Scientists
99 Summary of iPSC Industry Findings
RESEARCH APPLICATIONS FOR iPSCs
101 Drug Development and Discovery
1011 Traditional Drug Development and Discovery
1012 Disease Modeling
- (IMAGE) Disease Modeling with Induced Pluripotent Stem Cells
102 Cell Therapy
103 Toxicology Screening
104 Stem Cell Biobanking
105 Breakdown of iPSC Research, By Applied Research Application
- (TABLE) Percent of iPSC Research, By Applied Research Application
CHARACTERIZATION OF iPSC RESEARCH ADVANCES
111 Methods of Making iPSCs - Comparison of Methods by Downstream Application
- (TABLE) Methods for Making iPSCs - Comparison of Methods by Downstream Application
112 Summary of iPSC Derivation Methods, by Cell Type
- (TABLE) Summary of iPSC Derivation Methods, by Cell Type
113 Diseases in Which iPSCs Have Been Derived from Patients
- (TABLE) Diseases in which iPSCs have Been Derived from Patients
COMPANIES SELLING iPSC RESEARCH PRODUCTS
121 List of Companies
- (TABLE) List of Companies Offering iPSC Research Products
122 Rate of Entrants, by Year
- (TABLE) Number of Companies Offering iPSC Research Products, by Year
- (GRAPH) Number of Companies Offering iPSC Research Products, by Year
iPSC RESEARCH PRODUCTS MARKET
131 iPSC Research Product Categories
- (TABLE) Induced Pluripotent Stem Cell (iPSC) Product Categories
132 Functionally-Defined Categories
- (TABLE) Functionally-Defined Induced Pluripotent Stem Cell (iPSC) Product Categories
133 iPSC Market Share, by Functional Product Category
- (TABLE) iPSC Market Share Breakdown, by Functional Product Category
- (CHART) iPSC Market Share Breakdown, by Functional Product Category
COMPANIES DEVELOPING iPSC THERAPIES
141 Commercial Entities
1411 Cellular Dynamics International, Owned by FujiFilm Holdings (Industrial-Scale Production of iPSCs)
1412 ViaCyte
1413 Fate Therapeutic
1414 iPerian
1415 Ocata Therapeutics (Previously “Advanced Cell Technology”)
142 Non-Commercial Organizations Developing/Supporting iPSC Therapy Development
1421 RIKEN Center
1422 Kyoto University
1423 California Institute for Regenerative Medicine (CIRM)
- (TABLE) Amount of Grant Funding by CIRM for iPSC Production and Biobanking
STRATEGIC COLLABORATIONS FOR DEVELOPMENT OF iPSC PRODUCTS
151 Life Technologies, Owned by Thermo Fisher Scientific
152 Lonza Group AG
153 EMD Millipore
154 Sigma Aldrich
155 Roslin Cells, Ltd
156 ArunA Biomedical
157 CeeTox and Cellular Dynamics International (Owned by Fujifilm Holdings)
MARKET SIZE DETERMINATIONS and PROJECTIONS
161 Definition: Induced Pluripotent Stem Cell (iPSC) Market
162 Experimental Approach
163 Induced Pluripotent Stem Cell Market - Annual Market Size
164 Market Size Determination, by Product Area: iPSC Products, Services, Technologies, Therapies, and Adjunct Products and Services
- (TABLE) iPSC Market Share Breakdown, by Product Area
- (GRAPH) iPSC Market Share Breakdown, by Product Area
165 Market Size Projections
1651 Product Life Cycle Stage
- (TABLE) Stem Cell Product Life Cycle Chart
1652 Five-Year Market Size Projections: iPSC Products, Services, and Technologies Market (2015-2019)
- (TABLE) Induced Pluripotent Stem Cell (iPSC) Market, 5-Year Projections
- (CHART) Induced Pluripotent Stem Cell (iPSC) Market, 5-Year Projections
MARKET TREND ANALYSIS
171 Clinical Trial Rate Analysis
1711 Clinical Trial Rate, by Year
- (TABLE) Number of iPSC Clinical Trials, by Year
- (GRAPH) Number of iPSC Clinical Trials, by Year
1712 Clinical Trial Rate, by Region
- (TABLE) iPSC Clinical Trial, by Region of the World
- (IMAGE) iPSC Clinical Trials, by Region of the World
1713 iPSC Clinical Trial Sponsors
- (TABLE) Top iPSC Clinical Trial Sponsors
1714 “Pretrial Clinical Research” in Japan (First Cellular Therapy Study)
172 Grant Rate Analysis
- (TABLE) Number of iPSC Grant Rates, by Year (REPORTer Analysis)
- (IMAGE) Number of iPSC Grant Rates, by Year
173 iPSC Patent Rate Analysis
1731 Role of Patent Analysis for Competitive Intelligence
1732 Induced Pluripotent Stem Cell (iPSC) Patent Landscape
1733 Methodology of Induced Pluripotent Stem Cell (iPSC) Patent Analysis
1734 Current iPSC Patents (Including Inventor, Assignee, Assignee Location, and Date)
- (TABLE) iPSC Patents in US Patent and Trademark Office (USPTO) Full-Text and Image Database
1735 Breakdown of iPSC Patents, by Inventor
- (TABLE) Breakdown of iPSC Patents, by Inventor
-(GRAPH) Breakdown of iPSC Patents, by Inventor
- (TABLE) Full List of iPSC Patent Inventors
1736 Breakdown of iPSC Patents, by Assignee
- (TABLE) Breakdown of iPSC Patents, by Assignee
- (GRAPH) Breakdown of iPSC Patents, by Assignee
-(TABLE) Full List of iPSC Patent
1737 Breakdown of iPSC Patents, by Assignee Location
- (TABLE) Breakdown of iPSC Patents, by Assignee Location
- (GRAPH) Breakdown of iPSC Patents, by Assignee Location
- (TABLE) Full List of iPSC Patent Assignee Locations
- (TABLE) Breakdown of iPSC Patents, by Country of Assignee
- (GRAPH) Breakdown of iPSC Patents, by Country of Assignee
174 Scientific Publication Rate Analysis
- (TABLE) Analysis of iPSC Publications, by Year
- (GRAPH) Analysis of iPSC Publications, by Year
- (TABLE) Recent Year-over-Year Growth Rates in iPSC Scientific Publications
MARKETING ANALYSIS: PRICE-PER-CLICK FOR iPSC-RELATED SEARCH TERMS
181 Purpose of Analysis
182 Exact iPSC Search Terms
1821 US Analysis
- (IMAGE) Google Adwords Price-Per-Click iPSC Terms (Geography: USA Only)
1822 Global Analysis
- (IMAGE) Google Adwords Price-Per-Click iPSC Terms (Geography: Worldwide)
183 Derivative Search Terms
1831 US Analysis
- (IMAGE) Search Terms Containing iPSC Search Phrases (Geography: USA Only)
1832 Global Analysis
- (IMAGE) Search Terms Containing iPSC Search Phrases (Geography: Worldwide)
184 Summary of Findings
- (TABLE) Google Adwords Pay-Per-Click Prices for iPSC Related Search Terms
SCIENTIST PANEL: DETAILED END-USER SURVEY
191 Survey Overview
192 Characterization of Market Survey Respondents
1921 Geographic Distribution of Respondent
- (GRAPH) Geographic Distribution of Respondents
1922 Respondent Breakdown by Industry Affiliation
- (GRAPH) Respondent Breakdown by Industry Affiliation
1923 Breakdown of Respondents by Duration of iPSC Research Activity
- (GRAPH) Analysis of Time Duration for iPSC Research
193 Survey Findings
1931 General Scope
Question 1 - Do you perform basic or applied research?
Question 2 - What is your preferred species source for iPSCs utilized in your research?
Question 3 - What kind of culture do you use for your iPSC research (feeder-dependent vs feeder-free culture)?
Question 4 - How often do you purchase iPSC products? Question 5 - How much do you spend annually on iPSC products?
Question 6 - How important is price on your iPSC purchasing decisions?
Question 7 - What is the primary source of your iPSC research funding?
1932 Comparison of Providers / Brand Preferences
Question 1 - What is most influential in your choice to purchase from a specific provider of iPSC products?
Question 2 - What is your primary method for making iPSC product purchasing decisions?
Question 3 - What is the number of different suppliers from whom you have bought iPSC products?
1933 Marketing Assessment
Question 1 - What is your preferred provider for purchasing iPSC products?
Question 2 - To what types of iPSC advertising have you been exposed?
Question 3 - When purchasing iPSC products, have you ever responded to the following?
Question 4 - Which of the following phrases would be “most influential” to cause you to buy?
194 Terms Used in Online Product Search
- (TABLE) Write-In Responses, Search Terms Used to Find iPSC Products Online
STRATEGIES FOR ACCESSING THE iPSC MARKETPLACE
201 Awards Given to iPSC Researchers
- (TABLE) Awards Given to iPSC Researchers
202 iPSC Industry Influencers
2021 Robert J Palay, CEO of Cellular Dynamics International (Owned by Fujifilm Holdings Corp)
2022 Masayo Takahashi of the RIKEN Center for Developmental Biology (Kobe, Japan)
2023 Prof Jun Takahashi at CiRA for Developmental Biology (Kobe, Japan)
2024 Chikafumi Yokoyam, CEO of ReproCELL, Inc (Kanagawa, Japan)
2025 Dr Robert Lanza, CSO of Ocata Therapeutics (previously “Advanced Cell Therapeutics)
203 Events of Interest
- (TABLE) Stem Cell Conferences and Events for 2015-16
204 iPSC Core Facilities
- (TABLE) iPSC Core Facilities
CONCLUSION
APPENDICES

APPENDIX A - Properties and Characteristics of Induced Pluripotent Stem Cells
APPENDIX B - iPSC Patents Held by Cellular Dyamics International (Owned by Fujifilm Holdings)
APPENDIX C - Current Clinical Trials Involving iPSCs (ClinicalTrialsgov Analysis)
APPENDIX D - Full List of iPSC Clinical Trial Sponsors (ClinicalTrialsgov Analysis)
APPENDIX E - List of Grants that Contain iPSC Search Terms within the Title
(2006 to Present; RePORTer Tool)
APPENDIX F - NIH Center for Regenerative Medicine (CRM) iPSC Stem Cell Line - Control, Reporter, and Differentiated Lines

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