Opportunities in Human Embryonic Stem Cell (hESC) Products - Trends and Forecasts to 2017

Published: October 2013
No. of Pages: 158
   

Stem cells are primitive cells found in all multi-cellular organisms that are characterized by self-renewal and the capacity to differentiate into any mature cell type. Categorized by stage of life, several broad categories of stem cells exist, including:

  • Embryonic stem cells, derived from blastocysts
  • Post-natal stem cells, derived from newborn tissues
  • Adult stem cells, found in adult tissues – including hematopoietic stem cells, mesenchymal stem cells, neural stem cells, and more
  • Induced pluripotent stem cells, reprogrammed from adult cells
  • Cancer stem cells, which give rise to clonal populations of cells that form tumors or disperse in the body

Embryonic stem cells are stem cells derived from the inner cell mass of a blastocyst, which is a stage reached four to five days post-fertilization. They are the most pluripotent of all stem cell types and can develop into over 200 different cell types of the human body. Human embryonic stem cells (hESCs) were first derived from mouse embryos in 1981 by Martin Evans and Matthew Kaufman, and independently by Gail R. Martin. In 1995, the first successful culturing of embryonic stem cells from non-human primates occurred at the University of Wisconsin-Madison. Another breakthrough followed at the University of Wisconsin-Madison in November 1998 when a group led by Dr. James Thomson developed a technique to isolate and grow hESCs derived from human blastocysts.

As such, embryonic stem cells are still a relatively new discovery, as the first mouse embryonic stem cells (ESCs) were derived from embryos in 1981, but it was not until 1995 that the first successful culturing of embryonic stem cells from non-human primates occurred and not until November 1998 that a technique was developed to isolate and grow embryonic stem cells from human blastocysts.

Market Segments

To facilitate research resulting from these advances, a large and diverse market has emerged for human embryonic stem cell products, platforms, and technologies. In total, the global sales of these items compose the hESC product marketplace. One thriving component of this marketplace is the segment of companies that sell hESC research products to scientists.

Termed “research supply companies” or “research product vendors,” large companies selling human embryonic stem cell research products include Life Technologies, BD Biosciences, Thermo Fisher Scientific, EMD Millipore, Sigma Aldrich, Lonza, R&D Systems, and STEMCELL Technologies, as well as more than 60 other suppliers that range in size from multinational corporations to small specialty companies. Together, these research supply companies represent a substantial annual percentage of hESC product sales.

As of 2013, the following product categories accounted for more than 85% of all global hESC research product sales:

  • Embryonic stem cell culture products
  • Embryonic stem cell lines
  • Antibodies to embryonic stem cell antigens
  • Bead-based embryonic stem cell separation systems
  • Embryonic stem cell protein purification and analysis tools
  • Tools for DNA and RNA-based characterization of embryonic stem cells
  • Embryonic stem cell specific growth factors and cytokines
  • Tools for embryonic stem cell gene regulation
  • Embryonic stem cell services and mechanisms for in vivo and in vitro stem cell tracking

In addition, pharmaceutical companies also have intense interest in human embryonic stem cell product development. Because of their plasticity and unlimited capacity for self-renewal, hESCs have been proposed for use in a wide range of pharmaceutical applications, including:

  • Drug target validation and testing
  • Toxicology testing
  • Tissue engineering
  • Cellular therapies
  • Personalized medicine
  • And more

For this reason, development of hESC products by the pharmaceutical sector also represents a thriving segment of the global hESC product marketplace. Of particular interest to this community is the potential for use of hESCs to heal tissues that have a naturally limited capacity for renewal, such as the human heart, liver and brain.

Furthermore, within the pharmaceutical sector, development of new drugs is extremely costly and the success rate of bringing new compounds to the market is unpredictable. Therefore, it is crucial that pharmaceutical companies minimize late-stage product failures, such as suboptimal pharmacokinetic properties or unexpected toxicity, that can arise when candidate drugs enter the clinical testing stages.

To achieve this, it would be highly desirable to test candidate drugs using in vitro assays of high human relevance as early as possible. Because hESCs have the potential to differentiate into all of the mature cell types of the human body, they represent an ideal cell type from which to design such drug screening assays.

In summary, the unifying factor within the hESC product marketplace is that all companies involved need to understand market forces, trends, metrics, and financials, in order out-compete the competition and make more profitable decisions. Producing hESC products can involve complicated and confusing decisions, but it doesn't have to. Claim this report to reveal the current and future needs of the hESC marketplace, so you can focus your marketing efforts on the most profitable products, in the most promising research areas, and within the most lucrative domestic and international markets.

Market Characterization

It is also crucial for companies involved in the hESC product marketplace to understand the funding environment which supports hESC research. Within the United States, the federal government is currently an important, although not dominant, source of funding for stem cell research. The reason is that U.S. states are spending almost as much as the federal government on stem cell research and are actually spending more than the federal government on human embryonic stem cell (hESC) research. Private sources also contribute a huge amount of funding to stem cell research, with analysis of recent large gifts summing to over $1.7 billion.

Worldwide, hESC funding also varies widely, with countries varying from “very permissive” to “very limited” in how each elects to fund hESC product and technology development within the federal, private, and not-for-profit sectors.

While there is conclusive evidence that entering the hESC marketplace is financially worthwhile, there are complicating factors for companies that hope to enter the market. Specifically, human embryonic stem cell research is heavily encumbered by patents held by the University of Wisconsin's Wisconsin Alumni Research Foundation (WARF), which creates significant challenges for companies seeking to develop new products.

As such, this market research report explores the complex intellectual property (IP) landscape affecting development of human embryonic stem cell products, providing clear guidance for companies entering or already within the market, from collaborating with WARF to less costly alternatives - such as circumventing the claims, conducting research off-shore, and developing embryonic stem cell products for other species.

Methods and Methodology

As a technology company, BioInformant’s standard techniques derive market data from sources that utilize high-quality primary research inputs. The following constitute the basis for our research and analysis:

  • Preliminary Research - Examination of studies that need further confirmation by the scientific community, using extensive secondary research.
  • Fill-gap Research - Selectively sampled and focused primary research as a fill-gap strategy.
  • Historic Analysis - 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 - Primary market data (historic) is compared with resulting end-user consolidated market data and the variance in percentages between data sets is calculated by year.
  • Variance Determination - A median figure for each year with a tolerance range equal to twice the variance percentage is determined.
  • Projections - End-user markets are projected forward (typically 2013-17) based upon historic growth, technology and market trends, and primary research from the market place.
  • 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 further verified by confirmatory primary research.
  • Confirmatory Primary Research - Resulting data is presented 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 - In addition to the methods described above, electronically based end-user surveys are utilized. Surveys are distributed to a comprehensive panel of academic and industry representatives working within the market segment of interest.

Furthermore, the market intelligence contained in this report was compiled using a broad range of sources, including:

  • Grant Funding Databases (NIH database, DoD database, and more)
  • Patent Databases (USPTO, WIPO)
  • Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
  • Product Launch Announcements (Trade Journals, Company Websites, PR News Feeds)
  • Financial Data (SEC Filings, Investor Relations Packets)
  • International Surveys (Electronically Distributed End-User Surveys)
  • And More

Finally, a rare and valuable feature of this report is an end-user survey of 247 researchers (101 U.S. / 146 International) that identify as having human embryonic stem cell research as their core research focus. These findings reveal hESC researcher needs, technical preferences, key factors influencing buying decisions, and more.

Scientist survey results include:

  • Emerging trends within the hESC research sector
  • Insights into hESC product selection, purchasing decisions, and preferred providers
  • Crucial trends and unmet market needs within the hESC marketplace
  • “Tested Sentences” for selling to hESC scientists
  • Breakdown of the marketing methods used by industry participants
  • And much more

Leverage these insider insights to make effective product development decisions, create targeted marketing messages, and produce higher prospect-to-client conversion rates.
Conclusions

In summary, growth in stem cell research has exploded in the past decade, and so the market to supply hESC products and technologies has grown to meet this huge demand. To profit from this 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 hESC trends. Claim this must-read industry report to optimally position yourself to sell hESC products.

Key Findings Include:

  • Charts, Trends, and Metrics for the hESC Product Market
  • Trends for hESC Grants, Scientific Publications, and Patents
  • 5-Year Market Size Projections (2013-2017)
  • Profitable Opportunities for hESC Product and Technology Development
  • Consumer Behavioral Patterns and Preferred Providers
  • Preferred Species for ESC Research
  • Crucial Trends and Unmet Market Needs
  • Breakdown of the Marketing Methods Used by Industry Participants
  • “Tested Sentences” for Selling to hESC Scientists
  • End-User Survey of hESC Researchers (101 U.S. / 146 International)

Opportunities in Human Embryonic Stem Cell (hESC) Products - Trends and Forecasts to 2017

Table of Contents

I. Strategic Overview

II. Access & Availability of hESC Lines
A. NIH Registry Approved hESC Lines
B. Sources of Additional Published hESC Lines
C. Sources of Additional Unpublished hESC Lines

III. End-User Applications of hESCs
A. Basic Research
B. Cellular Therapies
1. Overview
2. Characterization of Source hESCs for Cellular Therapy
3. Promising Areas of hESC Cellular Therapy Research
a. Heart Regeneration
b. Pancreatic Islet Cell Replacement
c. Neural Regeneration
C. Tissue Engineering
D. Toxicology Testing
1. High-Value Opportunities
2. Optimization & Validation of hESC Toxicology Assays

IV. Patent Environment
A. Landmark hESC Patents: WARF “Composition of Matter” Patents
1. Background
2. Licensing of WARF Patent Rights
3. WARF Patent Exemption: Federal Rights to hESC Research
4. U.S. WARF Patent Challenges
5. Circumventing WARF Patent Rights Using Geographic Limitations
B. Global Stem Cell Patent Landscape
C. U.S. Patents of Importance
1. Geron Corporation Patents
2. Regents of the University of California Patents
3. BresaGen, Inc. Patents
4. Regeneron Pharmaceuticals, Inc.
5. Vanderbuilt University Patents
D. Worldwide Patents of Importance
1. ES Cell International PTE Ltd. Patents (Singapore)
2. DNAVEC Research Inc. Patents (Japan)
3. University of Edinburgh Patents (Scotland)
E. Summary of the hESC Intellectual Property Landscape

V. Market Trend Analysis - Future Growth Projections
A. Scientific Publication Analysis
1. Historical Analysis (Trailing 10 Years)
2. Future Growth Predictions (5-Year Forecasts, 2013-17)
3. Breakdown of ESC Research by Species
B. Grant Analysis
C. Patent Analysis

VI. Market Size
A. Definitions
B. Experimental Approach
C. Annual Market Size - Human Embryonic Stem Cell Products

VII. Market Characterization
A. Key Research Applications
1. Size of Market Segments
2. Trend Data
B.  Geographical Breakdown (Country-by-Country Breakdown)

VIII. hESC Research Supply Competitors
A. Cellartis AB
B. Vitrolife
C. Tataa Biocenter
D. Invitrogen
E. Stem Cell Technologies
F. BD Biosciences
G. Chemicon
H. R&D Systems
I. SA Biosciences
J. Thermo Scientific
K. Australian Stem Cell Centre

IX. Specialty Pharmaceutical Companies Developing hESC Therapies
A. Geron
B. Novocell
C. Cell Cure Neurosciences Ltd
D. Cell Dynamics International
E. Advanced Cell Technology

X. Toxicology Testing Legislation
A. European Union Ban of Animal-Testing for Cosmetic Development (2013)
B. Responses to the European Ban on Animal Testing for Cosmetic Development
1. Overview
2. Skin Irritation
3. Eye Irritation
4. Skin Sensitisation
5. Mutagenicity/Genotoxicity
6. Reproductive Toxicity
C. EU Legislation Regarding Animal-Based Testing for Drug Discovery

XI. Strategic Product & Technology Development
A. Product Categories
B. Product Ideas & Suggestions
1. Areas of Underdeveloped Competition
2. Mouse ESC Products
3. iPS Cells Products
4. Non-animal-derived Culture Reagents for hESCs
5. Strategic Collaborations
6. Products for Generating Pure ESC populations
7. hESC Toxicity Assay Kit

XII. Strategies For Accessing The Marketplace
A. Top Research Institutions Performing hESC Research
1. Academic Labs
2. Private Labs
3. Government Labs
4. International Labs
B. Events of Interest - hESC Conferences & Symposiums

XIII. Scientist Panel: Detailed End-User Survey
A. Survey Overview
B. Characterization of Market Survey Respondents
1. Geographic Distribution of Respondents
2. Respondent Breakdown by Industry Affiliation
3. Breakdown of Respondents by Duration of iPSC Research Activity
C. Survey Findings
1. General Scope
2. Comparison of Providers / Brand Preferences
3. Marketing Assessment
D. Terms Used in Online Product Search

XIV. Conclusions
Appendix

Published By: BioInformant Worldwide, L.L.C.
Product Code: BioInformant Worldwide, L.L.C.1006


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