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Complete 2015-16 Induced Pluripotent Stem Cell (iPSC) Industry Report

  • ID: 3163771
  • April 2015
  • Region: Global
  • 175 Pages
  • BioInformant

FEATURED COMPANIES

  • ArunA Biomedical
  • EMD Millipore
  • Fate Therapeutic
  • iPerian
  • Kyoto University
  • Lonza Group AG
  • MORE

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, READ MORE >

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • ArunA Biomedical
  • EMD Millipore
  • Fate Therapeutic
  • iPerian
  • Kyoto University
  • Lonza Group AG
  • MORE

1. EXECUTIVE SUMMARY
1.1. Report Overview
1.2. Key Report Findings

2. PURPOSE OF REPORT
2.1. To Survey Recent iPSC Advancements
2.2. To Provide a Snapshot” of the Global iPSC Market
2.3. To Provide Market Analysis in the Context of Future Applications
2.4. To Assess Opportunities for Commercialization
2.5. To Identify Major Market Players and Assess the Competitive Environment
2.6. To Identify Existing and Emerging Trends
2.7. To Identify Critical Opportunities and Threats within the iPSC Market

3. TARGET DEMOGRAPHIC

4. SCOPE OF iPSC MARKET
4.1. Products
4.2. Services
4.3. Technologies
4.4. Therapies
4.5. Adjunct Products and Services

5. RESEARCH METHODOLOGY
5.1. Input Sources
5.2. Research & Analysis Methodologies
5.3. Criteria for Identifying iPSC Market Leaders
5.3.1. Size of Company
5.3.2. Type of Product/Services
5.3.3. Degree of Specialization
5.3.4. Patent Positions
5.3.5. Business Reputation
5.3.6. Financial Strength
5.3.7. Partnerships
5.3.8. Certifications

6. TECHNICAL OVERVIEW OF iPSCs
6.1. Definition
6.2. Discovery of iPSCs
6.3. Advantages & Disadvantages of iPSCs

7. TIMELINE OF KEY iPSC EVENTS
7.1. Production of iPSCs (Key Events)
- (TIMELINE) Production of Induced Pluripotent Stem Cells
7.2. Full Timeline of Events
- (TABLE) Key Events in the Discovery and Evolution of iPSC Products

8. LEVELS OF REPAIR INDUCIBLE WITH iPSCs
- (TABLE) Four Levels of Repair Inducible with iPSCs
8.1. Gene-Level Repair (Gene Therapy)
- (TABLE) Examples of Gene-Level Repair with iPSCs
8.2. Cellular-Level Repair (Cell Replacement Therapy)
8.3. iPSC-derived Blood Products
8.4. Whole Tissue Repair (Organ Replacement Therapy)

9. iPSC INDUSTRY CONDITIONS
9.1. Origin of the iPSC Market
9.2. Therapeutic Applications of Induced Pluripotent Stem Cells
9.3. Landmark Events Create Market Opportunities
9.4. iPSC Patent Challenges
9.5. Four Primary Areas of Commercialization
- (IMAGE) Four Primary Areas of Commercialization for iPSCs
9.6. Rapidly-Evolving Market Opportunities for iPSCs
9.7. Market Leaders by Area of Commercialization
9.8. End-User Perspective of iPSC Scientists
9.9. Summary of iPSC Industry Findings

10. RESEARCH APPLICATIONS FOR iPSCs
10.1. Drug Development & Discovery
10.1.1. Traditional Drug Development & Discovery
10.1.2. Disease Modeling
- (IMAGE) Disease Modeling with Induced Pluripotent Stem Cells
10.2. Cell Therapy
10.3. Toxicology Screening
10.4. Stem Cell Biobanking
10.5. Breakdown of iPSC Research, By Applied Research Application
- (TABLE) Percent of iPSC Research, By Applied Research Application

11. CHARACTERIZATION OF iPSC RESEARCH ADVANCES
11.1. Methods of Making iPSCs – Comparison of Methods by Downstream Application
- (TABLE) Methods for Making iPSCs - Comparison of Methods by Downstream Application
11.2. Summary of iPSC Derivation Methods, by Cell Type
- (TABLE) Summary of iPSC Derivation Methods, by Cell Type
11.3. Diseases in Which iPSCs Have Been Derived from Patients
- (TABLE) Diseases in which iPSCs have Been Derived from Patients

12. COMPANIES SELLING iPSC RESEARCH PRODUCTS
12.1. List of Companies
- (TABLE) List of Companies Offering iPSC Research Products
12.2. 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

13. iPSC RESEARCH PRODUCTS MARKET
13.1. iPSC Research Product Categories
- (TABLE) Induced Pluripotent Stem Cell (iPSC) Product Categories
13.2. Functionally-Defined Categories
- (TABLE) Functionally-Defined Induced Pluripotent Stem Cell (iPSC) Product Categories
13.3. 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

14. COMPANIES DEVELOPING iPSC THERAPIES
14.1. Commercial Entities
14.1.1. Cellular Dynamics International, Owned by FujiFilm Holdings (Industrial-Scale Production of iPSCs)
14.1.2. ViaCyte
14.1.3. Fate Therapeutic
14.1.4. iPerian
14.1.5. Ocata Therapeutics (Previously “Advanced Cell Technology”)
14.2. Non-Commercial Organizations Developing/Supporting iPSC Therapy Development
14.2.1. RIKEN Center
14.2.2. Kyoto University
14.2.3. California Institute for Regenerative Medicine (CIRM)
- (TABLE) Amount of Grant Funding by CIRM for iPSC Production and Biobanking

15. STRATEGIC COLLABORATIONS FOR DEVELOPMENT OF iPSC PRODUCTS
15.1. Life Technologies, Owned by Thermo Fisher Scientific
15.2. Lonza Group AG
15.3. EMD Millipore
15.4. Sigma Aldrich
15.5. Roslin Cells, Ltd.
15.6. ArunA Biomedical
15.7. CeeTox and Cellular Dynamics International (Owned by Fujifilm Holdings)

16. MARKET SIZE DETERMINATIONS & PROJECTIONS
16.1. Definition: Induced Pluripotent Stem Cell (iPSC) Market
16.2. Experimental Approach
16.3. Induced Pluripotent Stem Cell Market – Annual Market Size
16.4. 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
16.5. Market Size Projections
16.5.1. Product Life Cycle Stage
- (TABLE) Stem Cell Product Life Cycle Chart
16.5.2. Five-Year Market Size Projections: iPSC Products, Services, & Technologies Market (2015-2019)
- (TABLE) Induced Pluripotent Stem Cell (iPSC) Market, 5-Year Projections
- (CHART) Induced Pluripotent Stem Cell (iPSC) Market, 5-Year Projections

17. MARKET TREND ANALYSIS
17.1. Clinical Trial Rate Analysis
17.1.1. Clinical Trial Rate, by Year
- (TABLE) Number of iPSC Clinical Trials, by Year
- (GRAPH) Number of iPSC Clinical Trials, by Year
17.1.2. Clinical Trial Rate, by Region
- (TABLE) iPSC Clinical Trial, by Region of the World
- (IMAGE) iPSC Clinical Trials, by Region of the World
17.1.3. iPSC Clinical Trial Sponsors
- (TABLE) Top iPSC Clinical Trial Sponsors
17.1.4. “Pretrial Clinical Research” in Japan (First Celular Therapy Study)
17.2. Grant Rate Analysis
- (TABLE) Number of iPSC Grant Rates, by Year (REPORTer Analysis)
- (IMAGE) Number of iPSC Grant Rates, by Year
17.3. iPSC Patent Rate Analysis
17.3.1. Role of Patent Analysis for Competitive Intelligence
17.3.2. Induced Pluripotent Stem Cell (iPSC) Patent Landscape
17.3.3. Methodology of Induced Pluripotent Stem Cell (iPSC) Patent Analysis
17.3.4. Current iPSC Patents (Including Inventor, Assignee, Assignee Location, and Date)
- (TABLE) iPSC Patents in U.S. Patent and Trademark Office (USPTO) Full-Text & Image Database
17.3.5. 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
17.3.6. 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 Assignees
17.3.7. 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
17.4. 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

18. MARKETING ANALYSIS: PRICE-PER-CLICK FOR iPSC-RELATED SEARCH TERMS
18.1. Purpose of Analysis
18.2. Exact iPSC Search Terms
18.2.1. U.S. Analysis
- (IMAGE) Google Adwords Price-Per-Click iPSC Terms (Geography: USA Only)
18.2.2. Global Analysis
- (IMAGE) Google Adwords Price-Per-Click iPSC Terms (Geography: Worldwide)
18.3. Derivative Search Terms
18.3.1. U.S. Analysis
- (IMAGE) Search Terms Containing iPSC Search Phrases (Geography: USA Only)
18.3.2. Global Analysis
- (IMAGE) Search Terms Containing iPSC Search Phrases (Geography: Worldwide)
18.4. Summary of Findings
- (TABLE) Google Adwords Pay-Per-Click Prices for iPSC Related Search Terms

19. SCIENTIST PANEL: DETAILED END-USER SURVEY
19.1. Survey Overview
19.2. Characterization of Market Survey Respondents
19.2.1. Geographic Distribution of Respondents
- (GRAPH) Geographic Distribution of Respondents
19.2.2. Respondent Breakdown by Industry Affiliation
- (GRAPH) Respondent Breakdown by Industry Affiliation
19.2.3. Breakdown of Respondents by Duration of iPSC Research Activity
- (GRAPH) Analysis of Time Duration for iPSC Research
19.3. Survey Findings
19.3.1. 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?
19.3.2. 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?
19.3.3. 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?
19.4. Terms Used in Online Product Search
- (TABLE) Write-In Responses, Search Terms Used to Find iPSC Products Online

20. STRATEGIES FOR ACCESSING THE iPSC MARKETPLACE
20.1. Awards Given to iPSC Researchers
- (TABLE) Awards Given to iPSC Researchers
20.2. iPSC Industry Influencers
20.2.1. Robert J. Palay, CEO of Cellular Dynamics International (Owned by Fujifilm Holdings Corp.)
20.2.2. Masayo Takahashi of the RIKEN Center for Developmental Biology (Kobe, Japan)
20.2.3. Prof. Jun Takahashi at CiRA for Developmental Biology (Kobe, Japan)
20.2.4. Chikafumi Yokoyam, CEO of ReproCELL, Inc. (Kanagawa, Japan)
20.2.5. Dr. Robert Lanza, CSO of Ocata Therapeutics (previously “Advanced Cell Therapeutics)
20.3. Events of Interest
- (TABLE) Stem Cell Conferences and Events for 2015-16
20.4. iPSC Core Facilities
- (TABLE) iPSC Core Facilities

21. CONCLUSIONS

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 (ClinicalTrials.gov Analysis)
APPENDIX D – Full List of iPSC Clinical Trial Sponsors (ClinicalTrials.gov 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, & Differentiated Lines

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • ArunA Biomedical
  • EMD Millipore
  • Fate Therapeutic
  • iPerian
  • Kyoto University
  • Lonza Group AG
  • MORE

Four Primary Areas of Commercialization

There are currently four major areas of commercialization for induced pluripotent stem cells, as described below:

1) 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.

2) Cellular Therapy: iPSCs can be used for cellular therapy applications, including autologous transplantation and potentially gene therapy. The purpose of cellular therapy is to reverse injury or disease.

3) 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.

4) Stem Cell Biobanking: The goal of stem cell biobanking is to create a repository of stem cell specimens, including source tissue from which iPSCs can be derived, differentiated cell types produced from iPSCs, and disease tissues produced from iPSCs. Large-scale stem cell repositories provide researchers with the opportunity to investigate a diverse range of conditions using iPSC derived cells produced from both healthy and diseased donors. Importantly, these repositories can also greatly expand the capacity for global research and collaboration.

Each of these areas will be vital to the future commercialization of iPSCs. At this time, Cellular Dynamics International (CDI) is best positioned to excel in all areas, largely due to its participation in creating the world’s largest ever iPSC bank (funded through a CIRM grant and in partnership with Coriell Institute for Medical Research), and its ability to produce clinical grade iPSCs in industrial quantities. However, there are other industry competitors that could be well-positioned to control one of these market areas, such as ReproCELL’s strong positioning in the iPSC reagent space. Therefore, smaller industry players may choose to specialize and compete in one of these market areas, with the potential for later expansion into other areas.
Rapidly-Evolving Market Opportunities for iPSCs

Since the discovery of iPSCs a large and thriving research product market has grown into existence, largely because the cells are completely non-controversial and can be generated directly from adult cells. Today, the number of iPSC products sold worldwide is increasing with double-digit growth. In addition, 22% of all stem cell researchers now self-report having used iPSCs within a research project. It is clear that iPSCs represent a lucrative product market, but methods for commercializing this cell type are still being explored, as clinical studies investigating iPSCs continue to increase in number.

Currently, nearly all clinical studies involving iPSCs are for the creation and evaluation of iPSC lines from specific patient populations in order to determine if these cell lines could be a good model for a disease of interest in that patient population. (See ClinicalTrials.gov for a current list of these trials or view the “Clinical Trial Trend Analysis” section of this report for a full discussion of findings.) However, the first clinical study involving transplant of iPSCs into humans was initiated in August 2013.

Market Leaders Have Begun to Emerge in All Areas of iPSC Development

Finally, market leaders have begun to emerge in all areas of iPSC development, including:
- Drug Development and Discovery: Cellular Dynamics International (CDI) in Madison, Wisconsin
- Cellular Therapy (Therapeutic Applications of iPSCs): RIKEN Center, in Kobe, Japan, and Kyoto University in Kyoto, Japan
- Stem Cell Biobanking: Cellular Dynamics International (CDI) in Madison, Wisconsin
- iPSC Research Products: ReproCELL in Kanagawa, Japan; Thermo Fisher Scientific in Rockville, MD; STEMCELL Technologies in Vancouver, Canada; and BD Biosciences in San Jose, California

End-User Survey of iPSC Scientists

A distinctive feature of this report is an end-user survey of 273 researchers (131 U.S. / 143 International) that identify as having induced pluripotent stem cells as a research focus. These survey findings reveal iPSC researcher needs, technical preferences, key factors influencing buying decisions, and more. The findings can be used to make effective product development decisions, create targeted marketing messages, and produce higher prospect-to-client conversion rates.
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
- And Much More

Summary of Findings

Induced pluripotent stem cells represent a promising tool for use in the reversal and repair of many previously incurable diseases. The cell type represents one of the most promising advances discovered within the field of stem cell research during the past decade, making this a valuable industry report for both companies and investors to claim in order 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.

Input Sources

The content and statistics contained in this report were compiled using a broad range of sources. These sources include:
- Stem Cell Grant Funding Database (NIH database)
- Stem Cell Patent Database (USPTO)
- Stem Cell Clinical Trial Database (ClinicalTrials.gov)
- Stem Cell Scientific Publication Database (PubMed)
- Stem Cell Product Launch Announcements (Trade Journals, Google News)
- Stem Cell Industry Events (Google News, Google Alerts)
- Stem Cell Company News (SEC Filings, Investor Publications)
- International Surveys (Electronically Distributed End-User Surveys)
- And More

Methodologies

This report employs varied techniques for deriving market research. The following constitute the basis for our Research & Analysis:
- Preliminary Research:Extensive secondary research based on preliminary market evaluations
- Fill-Gap Research:Selectively sampled and focused primary research as a fill-gap strategy
- Historic Analysis – Primary Products:Comprehensive analysis of all data for each primary product market
- Historic Analysis – End-user Markets:Historic analysis of all end-user industries/markets, requiring technology and market evaluations, growth projections, and market size estimation of end-user markets
- Historic Supply Chain/Raw Materials Analysis:Comprehensive analysis of data for each primary market segment
- Data Consolidation:Merging historic end-user market data to yield consolidated primary market data
- Cross Linking:Comparing primary market data (historic) with resulting end-user consolidated market data and calculating the variance in percentages between data sets by year
- Variance Determination:Placing a median figure for each year with a tolerance range equal to twice the variance percentage and recording the resulting numbers
- Projections:Projecting forward end-user markets based upon historic metrics, technology and market trends, and primary research from the marketplace
- Variance Factorization:Consolidation of projected end-user market data to yield derived primary market data. The data is adjusted to the historic variance determinations, as above. The resulting data is verified by confirmatory primary research
- Confirmatory Primary Research:Presenting resulting data from companies or individuals participating as research partners. Variations from derived data are adjusted to reflect primary research based consensus
- Electronically Based End-User Surveys:Distribution of electronically based end-user surveys to a panel of industry representatives working within market segment(s) of interest. Statistical filtering and analysis is performed on collected user-response data

Note: Product cover images may vary from those shown

- ArunA Biomedical
- California Institute for Regenerative Medicine (CIRM)
- CeeTox and Cellular Dynamics International (Owned by Fujifilm Holdings)
- Cellular Dynamics International, Owned by FujiFilm Holdings (Industrial-Scale Production of iPSCs)
- EMD Millipore
- Fate Therapeutic
- Kyoto University
- Life Technologies, Owned by Thermo Fisher Scientific
- Lonza Group AG
- Ocata Therapeutics (Previously “Advanced Cell Technology”)
- RIKEN Center
- Roslin Cells, Ltd.
- Sigma Aldrich
- ViaCyte
- iPerian

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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