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

OVERVIEW SUMMARY

Recent months have seen the first iPSC clinical trial in humans, creation of the world’s largest iPSC biobank, major funding awards, a historic challenge to the “Yamanaka Patent”, a Supreme Court ruling affecting industry patent rights, announcement of an iPSC cellular therapy clinic scheduled to open in 2019, and much more. Furthermore, iPSC patent dominance continues to cluster in specific geographic regions, while clinical trial and scientific publication trends give clear indicators of what may happen in the industry in 2015 and beyond. Is it worth it to get informed about rapidly-evolving market conditions and identify key industry trends that will give you an advantage over your competition?

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:

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

OVERVIEW

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.
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 iPSC cells. 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.

Over the next few years, iPSC research advances accelerated exponentially. 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 was implanted with retinal tissue generated using iPSCs derived from her own skin cells. Also, Kyoto University Hospital in Kobe, Japan announced in February of 2015 that it will be opening an iPSC therapy center in 2019, for purposes of conducting clinical studies on iPSC therapies.

Landmark Events Create Market Opportunities for iPSCs

In 2009 ReproCELL, a company established as a venture company originating from the University of Tokyo and Kyoto University, was the first to make iPSC product commercially available with the launch of human iPSC-derived cardiomyocytes, which it called “ReproCario.” ReproCELL has since furthered its dominance in the area of iPSC products through a series of strategic acquisitions, including acquisition of Reinnervate, Stemgent, and BioServe Biotechnologies.

Cellular Dynamics International (CDI) is another major market player in the iPSC sector. Similar to ReproCELL, CDI established its “foothold” on the iPSC industry early, being founded in 2004 by Dr. James Thomson at the University of Wisconsin-Madison, who in 2007 subsequently derived iPSC lines from human somatic cells for the first time ever (although the feat was also accomplished simultaneously by Dr. Shinya Yamanaka’s lab in Japan). CDI currently holds more than 800 patents, and the company went public in July 2013 with a public offering that raised $43 million dollars, securing its position as the global leader in producing high-quality human iPSCs and differentiated cells in industrial quantities.

Finally, Cellular Dynamics International (CDI) and the Coriell Institute for Medical Research received multi-million dollar grants ($16 million total) from the California Institute for Regenerative Medicine to create 3,000 iPSC lines from healthy and diseased donors, a result will create the world’s largest human iPSC bank.

In aggregate, there is incredible enthusiasm and investment driving growth of the iPSC sector, with recent years seeing major advances in clinical research applications, production and differentiation technologies, and biobanking of iPSCs. There have been major funding awards, large initial public offerings (IPOs), significant patent challenges, and more. For companies and investors competing within the iPSC marketplace, it is critical to understand these major market events and how they are shifting industry dynamics.

Four Primary Areas of Commercialization

There are currently four major areas of commercialization for induced pluripotent stem cells:

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.

While competition is fierce in each of these areas, with the market leaders for each category are shown below:
  • 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 Researchers

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.

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
In summary, induced pluripotent stem cells represent a promising tool for use in the reversal and repair of many previously incurable diseases. 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:
  • 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 Survey (Electronically Distributed End-User Survey)
  • And More


  • EXECUTIVE SUMMARY
    • Report Overview
    • Key Report Findings
  • PURPOSE
    • To Survey Recent iPSC Advancements
    • To Provide a Snapshot" of the Global iPSC Market
    • To Provide Market Analysis in the Context of Future Applications
    • To Assess Opportunities for Commercialization
    • To Identify Major Market Players and Assess the Competitive Environment
    • To Identify Existing and Emerging Trends
    • To Identify Critical Opportunities and Threats within the iPSC Market
  • TARGET DEMOGRAPHIC
  • SCOPE OF iPSC MARKET
    • Products
    • Services
    • Technologies
    • Therapies
    • Adjunct Products and Services
  • RESEARCH METHODOLOGY
    • Input Sources
    • Research & Analysis Methodologies
    • Criteria for Identiyfing iPSC Market Leaders
  • TECHNICAL OVERVIEW OF iPSCs
    • Definition
    • Discovery of iPSCs
    • Advantages & Disadvantages of iPSCs
  • TIMELINE OF KEY iPSC EVENTS
    • Production of iPSCs (Key Events)
    • 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
    • Gene-Level Repair (Gene Therapy)
      • Table Examples of Gene-Level Repair with iPSCs
    • Cellular-Level Repair: Cell Replacement Therapy
    • iPSC-derived Blood Products
    • Whole Tissue Repair (Organ Replacement Therapy)
  • iPSC INDUSTRY CONDITIONS
    • Origin of the iPSC Market
    • Therapeutic Applications of Induced Pluripotent Stem Cells
    • Landmark Events Create Market Opportunities
    • iPSC Patent Challenges
    • Four Primary Areas of Commercialization
    • Rapidly-Evolving Market Opportunities for iPSCs
    • Market Leaders by Area of Commercialization
    • End-User Perspective of iPSC Scientists
    • Summary of iPSC Industry Findings
  • APPLIED RESEARCH APPLICATIONS
    • Drug Development & Discovery
      • Traditional Drug Development & Discovery
      • Disease Modeling
    • Cell Therapy
    • Toxicology Screening
    • Stem Cell Biobanking
    • Breakdown of iPSC Research, By Applied Research Application
      • Table Percent of iPSC Research, By Applied Research Application
  • CHARACTERIZATION OF iPSC RESEARCH ADVANCES
    • Methods of Making iPSC - Comparison of Methods by Downstream Application
      • Table Methods for Making iPSCs - Comparison of Methods by Downstream Application178
    • Summary of iPSC Derivation Methods, by Cell Type
      • Table Summary of iPSC Derivation Methods, by Cell Type181
    • Diseases in which iPSCs have been Derived from Patients
      • Table Diseases in which iPSCs have Been Derived from Patients
  • COMPANIES SELLING iPSC RESEARCH PRODUCTS
    • List of Companies
      • Table List of Companies Offering iPSC Research Products
    • Rate of Entrants, by Year
      • Table Number of Companies Offering iPSC Research Products, by Year
  • iPSC RESEARCH PRODUCTS MARKET
    • iPSC Research Product Categories
      • Table Induced Pluripotent Stem Cell (iPSC) Product Categories
    • Functionally-Defined Categories
      • Table Functionally-Defined Induced Pluripotent Stem Cell (iPSC) Product Categories
    • iPSC Market Share, by Functional Product Category
      • Table iPSC Market Share Breakdown, by Functional Product Category
  • COMPANIES DEVELOPING iPSC THERAPIES
    • Commercial Entities
      • Cellular Dynamics International, Owned by FujiFilm Holdings (Industrial-Scale Production of iPSCs)
      • ViaCyte
      • Fate Therapeutics
      • iPerian
      • Ocata Therapeutics (Previously "Advanced Cell Technology")
    • Non-Commercial Organizations Developing/Supporting iPSC Therapy Development
      • RIKEN Center
      • Kyoto University
      • 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
    • Life Technologies, Owned by Thermo Fisher Scientific
    • Lonza Group AG
    • EMD Millipore
    • Sigma Aldrich
    • Roslin Cells, Ltd.
    • ArunA Biomedical
    • CeeTox and Cellular Dynamics International (Owned by Fujifilm Holdings)
  • MARKET SIZE DETERMINATIONS & PROJECTIONS
    • Definition: Induced Pluripotent Stem Cell (iPSC) Market
    • Experimental Approach
    • Induced Pluripotent Stem Cell Research Market - Annual Market Size
    • Market Size Determination, by Product Area: iPSC Products, Services, Technologies, Therapies, and Adjunct Products and Services
      • Table iPSC Market Share Breakdown, by Product Area
    • Market Size Projections
      • Product Life Cycle Stage
        • Table Stem Cell Product Life Cycle Chart
      • Five-Year Market Size Projections: iPSC Products, Services, &Technologies Market (2015-2019)
        • Table Induced Pluripotent Stem Cell (iPSC) Market, 5-Year Projections
  • MARKET TREND ANALYSIS
    • Clinical Trial Analysis
      • Clinical Trial Rate, by Year
        • Table Number of iPSC Clinical Trials, by Year
      • Clinical Trial Rate, by Region
        • Table iPSC Clinical Trials, by Region of the World
      • iPSC Clinical Trial Sponsors
        • Table Top iPSC Clinical Trial Sponsors
      • "Pretrial Clinical Research" in Japan (First Cellular Therapy Study)
    • Grant Rate Analysis
      • Table Number of iPSC Grant Rates, by Year (RePORTer Analysis)
    • iPSC Patent Analysis
      • Role of Patent Analysis for Competitive Intelligence
      • Induced Pluripotent Stem Cell (iPSC) Patent Landscape
      • Methodology of Induced Pluripotent Stem Cell (iPSC) Patent Analysis
      • Current iPSC Patents (Including Inventor, Assignee, Assignee Location, and Date)
        • Table iPSC Patents in U.S. Patent and Trademark Office (USPTO) Full-Text and Image Database
      • Breakdown of iPSC Patents, by Inventor
        • Table Breakdown of iPSC Patents, by Inventor
        • Table Full List of iPSC Patent Inventors
      • Breakdown of iPSC Patents, by Assignee
        • Table Breakdown of iPSC Patents, by Assignee
        • Table Full List of iPSC Patent Assignees
      • Breakdown of iPSC Patents, by Assignee Location
        • Table Breakdown of iPSC Patents, by Assignee Location
        • Table Full List of iPSC Patent Assignee Locations
        • Table Breakdown of iPSC Patents, by Country of Assignee
    • Scientific Publication Analysis
      • Table Analysis of iPSC Publications, by Year
      • Table Recent Year-over-Year Growth Rates in iPSC Scientific Publications
  • MARKETING ANALYSI: PRICE-PER-CLICK FOR iPSC-RELATED SEARCH TERMS
    • Purpose of Analysis
    • Exact iPSC Search Terms
      • U.S. Analysis
      • Global Analysis
    • Derivative Search Terms
      • U.S. Analysis
      • Global Analysis
    • Summary of Findings
      • Table Google Adwords Pay-Per-Click Prices for iPSC Related Search Terms
  • SCIENTIST PANEL: DETAILED END-USER SURVEY
    • Survey Overview
    • Characterization of Market Survey Respondents
      • Geographic Distribution of Respondents
      • Respondent Breakdown by Industry Affiliation
      • Breakdown of Respondents by Duration of iPSC Research Activity
    • Survey Findings
      • General Scope
      • Comparison of Providers / Brand Preferences
      • Marketing Assessment
    • Terms Used in Online Product Search
      • Table Write-In Responses, Search Terms Used to Find iPSC Products Online
  • STRATEGIES FOR ACCESSING THE iPSC MARKETPLACE
    • Awards Given to iPSC Researchers
      • Table Awards Given to iPSC Researchers
    • iPSC Industry Influencers
      • Robert J. Palay, CEO of Cellular Dynamics International (a Fujifilm Holdings Company)
      • Masayo Takahashi of the RIKEN Center for Developmental Biology (Kobe, Japan)
      • Prof. Jun Takahashi at CiRA for Developmental Biology (Kobe, Japan)
      • Chikafumi Yokoyam, CEO of ReproCELL, Inc. (Kanagawa, Japan)
      • Dr. Robert Lanza, CSO of Ocata Therapeutics (previously Advanced Cell Therapuetics, "ACT")
    • Events of Interest
      • Table Stem Cell Conferences and Events for 2015-16
    • iPSC Core Facilities
      • Table iPSC Core Facilities
  • CONCLUSIONS
  • APPENDICES
    • Properties and Characteristics of Induced Pluripotent Stem Cells
    • iPSC Patents Held by Cellular Dynamics International (Owned by Fujifilm Holdings Corp.)
    • Current Clinical Trials Involving iPSCs (ClinicalTrials.gov Analysis)
    • Full list of iPSC Clinical Trial Sponsors (ClinicalTrials.gov Analysis)
    • List of Grants that Contain iPSC Search Terms within the Title (2006 to Present; RePORTer Tool)
    • NIH Center for Regenerative Medicine (CRM) iPSC Stem Cell Line - Control, Reporter, &Differentiated Lines393

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