Stem Cell Research - Market Trends, Investment Trends and Pipeline Analysis by GBIResearch

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									   Stem Cell Research - Market Trends, Investment Trends and
                        Pipeline Analysis
 Reference Code: GBIHC009MR                                                                             Publication Date: February 2010

  Stem cell therapies have          Stem Cell Research and Development - Executive Summary
  immense market potential,
  driven by a strong pipeline       GBI Research analysis suggests that stem cell therapies have immense market potential, driven by
  that caters to high unmet         a strong pipeline that caters to high unmet needs. Increasing investment and a supportive
  needs. Increasing                 regulatory environment in key geographies will help the stem cells industry to realize the potential.
  investment and a                  Stem cell therapies high market potential is based on their unique ability to offer curative treatment
  supportive regulatory             in comparison to the symptomatic treatment offered by conventional treatments. From a
  environment in key                commercial perspective, many diseases that arise as a result of irreversible damage of terminally
  geographies will help the         differentiated cells, currently have large unmet needs that cannot be served based on conventional
  stem cells industry to            pharmaceutical and biotech research. Not serving these unmet needs results in lost growth
  realize the potential.            opportunities for the pharmaceutical industry. Stem cell research has the potential to serve these
                                    unmet needs by providing alternatives to conventional pharmaceutical and biotech research which
                                    target the symptoms more than the cause.
                                    High Unmet Needs Associated with Chronic Diseases Boosts Stem Cell Research and
                                    Development
                                    Stem cell therapies are expected to serve the unmet needs that are associated with the treatment
                                    of certain chronic diseases. In spite of advancements in medical technologies, there are very few
                                    treatment options available in the market to cure certain cardiovascular disorders, cancers,
                                    autoimmune and inflammatory disorders, spinal cord injury and others. Also, most of these
                                    therapies treat the symptoms without curing the disease. Stem cell therapies will fill this gap of
                                    unmet need through its novel therapeutic approach that has the ability to cure the diseases.
                                    High Market Potential for Stem Cell Therapies has resulted in Establishing Strategic
                                    Partnerships between Large Pharmaceutical Companies and Stem Cell Research Based
                                    Companies
                                    Strategic partnerships between Pharmaceutical companies and Stem cell research companies
                                    have given a boost to stem cell research and development. Almost 90% of the drugs in clinical
                                    trials fail due to factors such as lack of effectiveness and adverse side effects of the drug. Usually
                                    animal or tumor cells are being used and this leads to jury-rigged tests. Hence, all major
                                    pharmaceutical companies look forward to new technologies that increase the possibility to launch
                                    new therapies in the market place. At present, there has been a spur in investments from
                                    pharmaceutical companies into stem cell research through strategic partnerships with stem cell
                                    research companies. Major pharmaceutical companies have planned and aligned their objectives
                                    to enter the stem cell market in the next five years. Pharmaceutical companies are also keen to
                                    explore various methods where stem cells could be utilized in the drug discovery process that
                                    would accelerate the discovery of novel drug molecules.
                                    Promising Pipeline in Phase II and Phase III has Increased the Hopes of Commercialization
                                    of Stem Cell Therapies
                                    The total number of stem cell clinical trials has increased tremendously over the last few years. The
                                    number of Phase II clinical trials has witnessed more than a 40% jump between 2005 and 2008.
                                    With more than five ongoing Phase III trials, the market is keenly awaiting the launch of these
                                    therapies within the next five years. The Preclinical research and Phase I trials have also increased
                                    at a phenomenal rate. This increase demonstrates the emerging interests in stem cell research
                                    across the globe.
                                    Supportive Regulatory Environment Coupled with Increase in Investments have Bolstered
                                    the Growth of Stem Cell Research
                                    In the United States, President Barack Obama has lifted the federal funding restrictions on
                                    embryonic stem cell research. With the removal of this barrier, the authority of the department of
                                    health and human services, including National Institutes of Health (NIH) will provide support for
                                    human embryonic stem cell research. This will enable new therapies and new discoveries and will
                                    potentially lead to dramatic advances in the understanding and treatment of conditions such as


Stem Cell Research - Market Trends, Investment Trends and                                                 GBIHC009MR /Published FEB 2010
Pipeline Analysis
                                                                                                                                      Page 1
                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                    diabetes, heart diseases and Alzheimer’s. The federal funding and VC funding for stem cell
                                    research is also expected to increase with this amendment from the US government.

                                      Political Environment – Impact Analysis (2009-2015)
                                                                                               1-2 years         3-4 years     5-6 years

                                                                        High Impact
                                        Supporting political
                                        environment on embryonic
                                        stem cell research will         Medium Impact
                                        advance the stem cell
                                        industry to prosper in the US
                                                                          Low Impact



                                                                            The federal funding restrictions on stem cell research has been
                                            1-7 Years – High Impact         removed and would support research and development in US for
                                                                            the next 7 years. Government spending as well as philanthropic
                                                                            donations on stem cell research is set to increase throughout the
                                                                            forecast period.

                                      Source: GBI Research



                                    Key Geographies are Attracting Investments by Promoting Stem Cell Tourism
                                    Countries that are advanced in providing stem cell therapies are taking advantage to attract
                                    investments from other countries by promoting stem cell tourism. The lack of stem cell therapy in a
                                    country forces its citizens suffering from debilitating conditions to travel to other countries where
                                    stem cell treatment is available. There has been an increase in the number of patients traveling
                                    from developed nations to countries like China, Thailand, Germany, Dominican Republic, Costa
                                    Rica, Israel and Argentina. Most of these countries promote stem cell tourism. This has the
                                    potential to provide excellent revenue generation for these countries.

                                      Preferred Countries for Stem Cell Tourism
                                      Disease Conditions                                        Countries
                                      Parkinson Disease                                         Germany
                                      Optic Nerve Disorders                                     China
                                      Diabetes                                                  Argentina
                                      Cancer & Leukemia                                         Israel
                                      Congestive Heart Failure                                  Thailand
                                      Multiple Sclerosis                                        China & Israel
                                      Kidney related Disease                                    Dominican Republic
                                      Source: GBI Research



                                    The role of stem cell research as an integral part of therapeutics as well as its commercial potential
                                    is now being recognized by most major countries of the world. Stem cell based therapies have
                                    immense market potential, driven by a strong pipeline that caters to high unmet needs. Stem cell
                                    research is now firmly on the path to being developed and commercialized fully. Currently, the
                                    technology is in its early stages of development which implies that barriers to entry in this market
                                    are relatively low. Meeting the vast unmet need that stem cell research will eventually target, along
                                    with a strong pipeline of therapeutic candidates, suggests that it is a fast growing market that will
                                    offer attractive opportunities for investment in the near future.




Stem Cell Research - Market Trends, Investment Trends and                                                        GBIHC009MR /Published FEB 2010
Pipeline Analysis
                                                                                                                                           Page 2
                                                                         © GBI Research. This is a licensed product and is not to be photocopied
                                    1 Table of Contents
                                    1      Table of Contents .................................................................................................................... 3
                                        1.1      List of Tables.................................................................................................................. 5
                                        1.2      List of Figures................................................................................................................. 6
                                    2      Introduction .............................................................................................................................. 7
                                        2.1      GBI Research Report Guidance..................................................................................... 7
                                    3      Market Overview...................................................................................................................... 9
                                        3.1      Stem Cell Research – An Introduction ........................................................................... 9
                                        3.2      Types of Stem Cell Research......................................................................................... 9
                                        3.3      Unmet Needs ............................................................................................................... 10
                                        3.4      Applications of Stem Cell Research ............................................................................. 14
                                    4      Market Characterization......................................................................................................... 16
                                        4.1      Stem Cell Market – An Introduction.............................................................................. 16
                                        4.2      Market Sizing ............................................................................................................... 16
                                        4.3      Therapy cost ................................................................................................................ 18
                                        4.4      Technology Adoption Framework................................................................................. 19
                                        4.5      Types of Business Models ........................................................................................... 19
                                        4.6      Market Drivers.............................................................................................................. 21
                                           4.6.1      Supporting Political Environment on Embryonic Stem Cell Research will Advance
                                                      the Stem Cell Industry to Prosper in the United States............................................ 21
                                           4.6.2      Limited Availability of Treatments to Treat Certain Disease Conditions Increases
                                                      Market Opportunity for Stem Cell Research ............................................................ 22
                                        4.7      Market Barriers & Challenges ...................................................................................... 23
                                           4.7.1      Stem Cell Research and Development is an expensive process which requires
                                                      considerable funding to be operational.................................................................... 23
                                           4.7.2      Availability of Adequate Reimbursements are Unclear and leads to a conundrum . 23
                                           4.7.3      Ethical, legal and social issues persists and acts as a challenge ............................ 24
                                           4.7.4      Identifying, recruiting and retaining the best scientific talents is an intractable
                                                      process for stem cell research based companies.................................................... 25
                                        4.8      Stem Cell Research and Development - Market Trends .............................................. 25
                                           4.8.1      Booming Stem Cell Tourism is a Potential Opportunity for Countries to Attract
                                                      Investments. ............................................................................................................ 25
                                           4.8.2      ASLAP Analysis of Stem Cell Tourism .................................................................... 26
                                           4.8.3      Federal Funding Support Improves the Stem Cell Research Environment ............. 27
                                           4.8.4      Increasing Entry of Pharmaceutical Companies Boosts Stem Cell Research &
                                                      Development ........................................................................................................... 28
                                           4.8.5      PESTLE Analysis .................................................................................................... 30
                                           4.8.6      SWOT Analysis of Stem Cell Research & Development ......................................... 31
                                        4.9      Industry Analysis .......................................................................................................... 33
                                    5      Stem Cell Research and Development - Pipeline Analysis.................................................... 35
                                        5.1      Pipeline by Various Phases.......................................................................................... 35
                                        5.2      Phase III Pipeline Analysis ........................................................................................... 35
                                        5.3      Phase II Pipeline Analysis ............................................................................................ 37
                                        5.4      Preclinical and Phase 1 Pipeline .................................................................................. 39
                                    6      Stem Cell Research and Development - Investment Trends ................................................. 40
                                        6.1      Investor’s Perspective on Stem Cell Research ............................................................ 40
                                        6.2      NIH spending in Stem Cell Research and Development is Increasing and is Supportive
                                                  ..................................................................................................................................... 42
                                           6.2.1      NIH Spending by Stem Cell Research Type............................................................ 43
                                           6.2.2      High Budget Projects Funded by NIH...................................................................... 44
                                        6.3      States Funding on Stem Cell Research in the US is in Reconsideration. .................... 45
                                        6.4      R&D Spending by Stem Cell Research Companies..................................................... 46
                                    7      Stem Cell Research and Development - Geographical Trends ............................................. 47
                                        7.1      Stem Cell Companies by Geographic Regions ............................................................ 47
                                        7.2      The United States ........................................................................................................ 48


Stem Cell Research - Market Trends, Investment Trends and                                                                               GBIHC009MR /Published FEB 2010
Pipeline Analysis
                                                                                                                                                                                Page 3
                                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                       7.3      United Kingdom............................................................................................................ 49
                                       7.4      China............................................................................................................................ 50
                                       7.5      Netherlands.................................................................................................................. 51
                                       7.6      Singapore..................................................................................................................... 52
                                       7.7      South Korea ................................................................................................................. 53
                                       7.8      Japan ........................................................................................................................... 54
                                       7.9      India ............................................................................................................................. 55
                                       7.10     Sweden ........................................................................................................................ 56
                                       7.11     Denmark....................................................................................................................... 57
                                       7.12     France .......................................................................................................................... 58
                                       7.13     Germany ...................................................................................................................... 59
                                       7.14     Israel ............................................................................................................................ 60
                                       7.15     Australia ....................................................................................................................... 61
                                       7.16     Canada......................................................................................................................... 62
                                       7.17     Czech Republic ............................................................................................................ 63
                                    8     Stem Cell Research and Development - Mergers and Acquisitions....................................... 64
                                    9     Stem Cell Research and Development - Competitive Structure ............................................ 65
                                       9.1      Stem Cell Companies by Therapy Areas ..................................................................... 65
                                       9.2      Stem Cell Companies by Stem Cell Types................................................................... 66
                                    10    Stem Cell Research and Development - Company Profiles................................................... 67
                                       10.1     Aastrom Biosciences.................................................................................................... 67
                                       10.2     Osiris Therapeutics ...................................................................................................... 67
                                       10.3     Bioheart........................................................................................................................ 68
                                       10.4     Aldagen ........................................................................................................................ 68
                                       10.5     Mesoblast..................................................................................................................... 69
                                       10.6     Geron ........................................................................................................................... 69
                                       10.7     Advanced Cell Technology........................................................................................... 70
                                       10.8     Cytori Therapeutics ...................................................................................................... 70
                                       10.9     Pluristem Therapeutics................................................................................................. 71
                                       10.10 Medistem...................................................................................................................... 71
                                       10.11 Neostem....................................................................................................................... 72
                                    11    Stem Cell Research and Development - Conclusion ............................................................. 73
                                    12    Appendix................................................................................................................................ 74
                                       12.1     Market Definitions ........................................................................................................ 74
                                       12.2     Key Support Data......................................................................................................... 74
                                       12.3     Abbreviations ............................................................................................................... 74
                                       12.4     Methodology................................................................................................................. 74
                                          12.4.1       Coverage ............................................................................................................ 75
                                          12.4.2       Secondary Research .......................................................................................... 75
                                          12.4.3       Primary Research ............................................................................................... 76
                                          12.4.4       Expert Panels ..................................................................................................... 76
                                       12.5     Contact Us ................................................................................................................... 76
                                       12.6     Disclaimer .................................................................................................................... 76




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