An Analysis of the
Emerging U.S Stem Cell Industry
Management of Technology - MGMT 620 (EMBA)
Professor – Dr. Gopalakrishnan
Draft Version 3
December 16, 2011
Due to previous government regulations, US companies have not used embryos for stem cell research, and international companies have gained a first mover advantage in commercializing stem cell treatments and therapies.
The use of stem cells has opened up a new field called regenerative medicine or cell therapy, which replaces damaged or diseased cells that are in the body with new ones. Stem cells have the ability to develop into many different cell types within the body during the early life and growth cycle. ...view middle of the document...
The advancement of stem cells in the biological science field has brought new hope for the treatment of Parkinson’s and heart diseases.
Human embryonic stem cells (hESCs) that are derived from the inner cell mass of a blastocyst, 4-5 days after fertilization. They are the most pluripotent of all stem cell types and can develop into over 200 different cell types of the human body, providing tremendous therapeutic potential. The first stem cell (hESC) was first derived from a mouse embryos in 1981.In 1995, the first successful culturing of primate embryonic stem cell occurred, at the University of Wisconsin-Madison. In 1998 another breakthrough occurred with Dr. James Thomson, who developed a technique to isolate and grow human embryonic stem cells.
As a result of these significant accomplishments at the University of Wisconsin, the Wisconsin Alumni Research Foundation (WARF) filed a series of landmark patents that have has affected the intellectual property landscape ever since. The “composition of matter” patents, that they filed concerning embryonic stem cells were so broad in nature, that they covered all human embryonic stem cell lines in the United States, not just the specific stem cell lines that were developed by James Thompson.
Since then, the WARF has been the major “gatekeeper”, determining which research product companies are allowed to conduct research and create commercial products using hESCs. WARF has also controlled what pharmaceutical companies have been allowed to develop hESC therapies. Since obtaining its landmark patents in 1998, WARF has only entered into licensing agreements with only 27 commercial partners for its intellectual portfolio related to isolating and differentiating hESCs. They have also agreed to allow 300 academic laboratories to use the technology without charge.
The low number of licensing agreements suggests that many companies find WARF’s licensing fees to be unwieldy, ranging between $75,000 and $250,000, plus annual payments and royalties. Consequently many other research product companies, have had to explore less costly alternatives to develop stem cells - such as conducting research off-shore, developing embryonic stem cell products for other species, and pursuing strategic collaborations.
Current research indicates that stem cell therapies have immense market potential driven by strong pipeline that caters to high unmet needs. Increasing investment and supportive regulatory environment in key geographies will help the stem cells industry to realize its full potential. Stem cell therapies high market potential is based on their unique ability to offer curative treatment in comparison to the symptomatic treatment offered by conventional treatments.
From a commercial perspective, many diseases arise as a result of irreversible damage to specialized cell types that cannot be served based on conventional pharmaceutical and biotech research. Not serving these diseases has resulted in...