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


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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

Table of Content

 

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