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

Improve product development decisions, target unmet market needs, and produce higher prospect-to-client conversion rates.

Industry Report, October 2013
Format: PDF; 158 Pages
 

EXECUTIVE SUMMARY

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. Classified 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 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 to 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.

Your competitors would prefer you didn’t buy this report. But when you do, you’ll be gaining invaluable stem cell market insights to help you control and dominate this market.

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 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 lucrative, 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 Alumni Research Foundation (WARF), which creates significant challenges for companies seeking to develop new products.

Complex Intellectual Property (IP) Environment

Companies interested in developing human embryonic stem cell products have to navigate a risky product environment. Due to the long-standing and controversial patents held by WARF, companies have been largely hindered by the intellectual property environment restricting the development of embryonic stem cell products. However, this means financial rewards are available for the companies that are able to strategically move forward. With the release of this report, companies can now receive clear guidance for navigating the hazards of embryonic stem cell product development.

The report reveals critical alternatives to traditional WARF licensing, including moving research overseas, establishing collaborations with companies that are existing WARF licensees, negotiating alternatives, developing products for non-human species – and other creative strategies. The complex IP landscape requires specialist industry knowledge to help you navigate the legal and commercial challenges you will face. With the simple and expert advice contained in this report you will understand:

  • The background of the hESC patent landscape
  • The licensing of WARF patent rights
  • WARF patent exceptions
  • How to circumvent WARF patents rights through geographic limitations
  • The global embryonic stem cell patent landscape
  • And much more

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.

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)

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