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Home > Market Research > Biotechnology > Stem Cell Technology: Current Applications and Future Directions
This Report: The U.S. market for stem cells in regenerative medicine is expected to increase from $112.0 million in 2007 to an estimated $423.1 million by the end of 2012, a compound annual growth rate (CAGR) of 30.5%. Stem cell banking was valued at $58.9 million in 2005 and $65.9 million in 2007. This is expected to rise to $155.7 million in 2012, for a CAGR of 18.8%. Human adult stem cells for cell-based therapeutics were worth $21.4 million in 2006. This increased to $28.1 in 2007 and should increase to $173.8 in 2012 at a CAGR of 44.0%.
INTRODUCTION STUDY GOALS AND OBJECTIVES BCC’s goal in conducting this study was to determine the current status of stem cell technology and its applications and assess its growth potential over a 5-year period from 2007 to 2012. We are particularly interested in the position of adult stem cell technology and applications as compared to the development and applications of embryonic stem cells. Additionally, we are interested in the market potential of emerging breakthroughs in stem cell research such as induced pluripotent stem cells (iPS). Our key objective is to present a comprehensive analysis of the current state of stem cell research and development (R&D) as well as the current stem cell market and its future direction. REASONS FOR DOING THE STUDY Stem cell technology has been described as the next revolution in medicine. Therapeutic stem cell applications have been proposed to address a wide range of health care needs. We are interested in determining the current state of stem cell technology, where stem cells are currently being applied, and evaluating the potential growth for stem-cell-based applications. In particular, we are interested in discerning the current technological state and potential growth of adult stem-cell-based applications as compared to embryonic-stem-cell-based applications. Additionally, we are interested in looking forward to emerging advancements in stem cell technology and evaluating the potential impact these advancements could have on the development of stem-cell-based products. SCOPE OF REPORT This report encompasses the two major classes of stem cells: adult and embryonic. BCC examined the current state of stem cell technology, focusing on these two major classes as well as emerging breakthroughs in stem cell research and development. Further, BCC evaluated the current stem cell market in the United States (U.S.) and examined the future impact of stem-cell-based technology, presenting forecasts of growth over the next 5 years. Technological issues covering current and emerging stem-cell-based therapeutic applications are also reviewed. Further issues considering stem-cell-based therapeutic research and development and its applications are additionally discussed. Given the major role that the U.S. plays in the world health care market (both as provider and consumer), this analysis is focused predominantly on the current state of stem cell technology and its applications in the U.S., with some discussion regarding worldwide stem cell technology impact. In addition to technological considerations as well as market issues, we examine governmental (legal and political) as well as social issues regarding the research and development of stem-cell-based therapeutic applications. The present and projected status of stem-cell-based technology is compared for high value applications of cellular therapeutics, engineered tissue for transplantation, and therapeutic stem cell banking. Further, the present and projected status of stem-cell-based therapeutic research applications are projected for high value applications such as cell-based assays, diagnostic tools, and necessary support reagents and materials. INTENDED AUDIENCE Given the broad application potential of stem-cell-based technology, the present study will be of interest to the life science industry, in particular, to individuals in the biotechnology, pharmaceutical, and medical device markets. Further, it will be of interest to manufacturers of reagents and tools that support the research and development of stem-cell-based products and services. Further, this report will of be of interest to professionals presently focused in areas of stem cell research, development, and commercialization as well as those surveying potential stem-cell-based opportunities for investment. Additionally, this report will be of particular interest to health care professionals surveying the potential therapeutic application of stem-cell-based technology and its growth.
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INTRODUCTION STUDY GOALS AND OBJECTIVES REASONS FOR DOING THE STUDY SCOPE OF REPORT INTENDED AUDIENCE INFORMATION SOURCES ANALYST CREDENTIALS RELATED REPORTS BCC ONLINE SERVICES DISCLAIMER SUMMARY SUMMARY TABLE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, THROUGH 2012 ($ MILLIONS) SUMMARY FIGURE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, 2005-2012 ($ MILLIONS) OVERVIEW HISTORICAL REVIEW OF STEM CELL BIOLOGY HISTORY OF STEM CELL BIOLOGY EARLY OBSERVATION AND CLASSIFICATIONS STEM CELL CLASSIFICATION Derivation of Human Tissue Types during Development from Embryonic Stem Cells TABLE 1 DERIVATION OF HUMAN TISSUE TYPES DURING DEVELOPMENT FIGURE 1 FLOW DIAGRAM OF HUMAN DEVELOPMENT PROCESS Derivation of Human Tissue Following Maturation from Adult Stem Cells STEM CELL CONCEPTS IN HEALTH CARE INITIAL STEM CELL ISOLATION AND CHARACTERIZATION Initial Stem Cell Isolation ?(Continued) EARLY CELL-BASED THERAPEUTICS Xeno Transplants Blood Transfusions and Bone Marrow Transplantation AREAS OF HEALTH CARE NEED AND STEM CELLS DISEASE- AND DEGENERATION-RELATED HEALTH CARE NEED Disease- and Degeneration-?(Continued) ORGAN TRANSPLANTATION-RELATED HEALTH CARE NEED CANCER- AND GENETIC DISORDER-RELATED HEALTH CARE NEED INFECTIOUS DISEASE-RELATED HEALTH CARE NEED HEALTH CARE NEED AND COSTS Health Care Need and Costs (Continued) CURRENT STATE OF REGENERATIVE MEDICINE STEM CELL CLASSIFICATION BASED ON SOURCE Embryonic Stem Cells Adult (and Progenitor) Stem Cells Adult (and Progenitor) ?(Continued) STEM CELL CLASSIFICATION BASED ON DIFFERENTIATION POTENTIAL Pluripotent Stem Cell Differentiation Potential Multipotent Stem Cell Differentiation Potential Unipotent Stem Cell Differentiation Potential TABLE 2 STEM CELL CLASSIFICATION BASED ON DIFFERENTIATION POTENTIAL DYNAMICALLY EVOLVING AREAS IN STEM CELL BIOLOGY CLONAL STEM CELLS LINES IN NONHUMAN PRIMATES EMBRYONIC STEM CELL LINES DERIVED FROM INNER CELL MASS OF VIABLE EMBRYOS STEM CELLS FROM NEONATAL FLUID ADULT STEM SOURCING/NICHES Adult Stem Sourcing/Niches (Continued) TABLE 3 ADULT STEM CELL TYPES AND POTENTIAL TISSUE SOURCES DISEASE-SPECIFIC EMBRYONIC STEM CELL LINES ADULT STEM CELL REPROGRAMMING PERSONALIZED HEALTH CARE CELL-BASED THERAPEUTICS Using Embryonic-derived Stem Cells Using Adult/Progenitor-derived Stem Cells ENGINEERED TISSUE FOR TRANSPLANTATION Using Embryonic-derived Stem Cells Using Adult Stem Cells (and Progenitor Cells) THERAPEUTIC STEM CELL BANKING STEM-CELL-BASED BIOMEDICAL RESEARCH MARKETS FOR STEM-CELL-BASED CELLULAR THERAPEUTICS HEALTH CARE NEED AND THE APPLICATION OF STEM CELLS Cardiovascular System-related Clinical Stem Cell Applications Nervous System-related Clinical Stem Cell Applications Skeletal/Muscular System-related Clinical Stem Cell Applications Whole Organ (Tissue) System-related Clinical Stem Cell Applications Stem-cell-related Cancer and Clinical Applications Infectious Disease/Cancer (General) and Clinical Applications GOVERNMENT REGULATIONS AND THE USE OF STEM CELLS IN RESEARCH AND THERAPEUTIC APPLICATIONS GOVERNMENT REGULATION OF THE APPLICATION OF STEM-CELL-BASED THERAPEUTICS Government Regulation of?(Continued) GOVERNMENT REGULATION OF THE APPLICATION OF STEM-CELL-BASED RESEARCH TABLE 4 THE NATIONAL INSTITUTES OF HEALTH STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS) TABLE 4 (CONTINUED) FIGURE 2 THE NATIONAL INSTITUTES OF HEALTH HUMAN STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS) TABLE 5 THE NATIONAL INSTITUTES OF HEALTH HUMAN EMBRYONIC STEM CELL REGISTRY TABLE 5 (CONTINUED) TABLE 6 STATES FUNDING STEM-CELL-RELATED RESEARCH FUTURE IMPACT OF STEM CELLS ON UNMET HEALTH CARE NEED FUTURE IMPACT OF STEM ?(CONTINUED) STEM CELL TECHNOLOGY IN THE REGENERATIVE MEDICINE MARKET TABLE 7 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, THROUGH 2012 ($ MILLIONS) FIGURE 3 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, 2005-2012 ($ MILLIONS) INTRODUCTION TO STEM CELLS TECHNOLOGY IN REGENERATIVE MEDICINE MARKET STEM CELLS IN CELLULAR THERAPEUTICS Stem Cells in Cellular Therapeutics (Continued) Stem Cells in Cellular Therapeutics (Continued) FIGURE 4 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN CELLULAR THERAPEUTICS Stem Cells in Cellular Therapeutics (Continued) TABLE 8 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, THROUGH 2012 ($ MILLIONS) FIGURE 5 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, 2005-2012 ($ MILLIONS) Stem Cells in Cellular Therapeutics towards Engineering Tissue in Vitro for Transplantation Stem Cells in Cellular Therapeutics ?(Continued) Stem Cells in Cellular Therapeutics ?(Continued) FIGURE 6 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN ENGINEERING TISSUE FOR TRANSPLANTATION THERAPEUTIC STEM CELL BANKING FIGURE 7 FLOW DIAGRAM FOR PROCESS OF THERAPEUTIC BANKING OF STEM CELLS Therapeutic Stem Cell Banking (Continued) TABLE 9 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, THROUGH 2012 ($ MILLIONS) FIGURE 8 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, 2005-2012 ($ MILLIONS) INTRODUCTION TO STEM CELLS TECHNOLOGY IN THERAPEUTIC-RELATED RESEARCH STEM CELL TECHNOLOGY IN CELL-BASED ASSAYS AND DIAGNOSTIC RESEARCH APPLICATIONS TABLE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH ($ MILLIONS) FIGURE 9 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH, 2005-2012 ($ MILLIONS) THERAPEUTIC STEM-CELL-RELATED RESEARCH SUPPORT TABLE 11 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, THROUGH 2012 ($ MILLIONS) FIGURE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, 2005-2012 ($ MILLIONS) FACTORS DRIVING AND INHIBITING APPLICATION OF STEM CELL TECHNOLOGY Factors Driving and Inhibiting ?(Continued) Factors Driving and Inhibiting ?(Continued) Factors Driving and Inhibiting ?(Continued) TABLE 12 FACTORS DRIVING AND INHIBITING THE APPLICATION OF STEM-CELL-BASED THERAPEUTICS MARKETS BY TYPES OF APPLICATIONS INTRODUCTION TO STEM-CELL-THERAPEUTIC-BASED APPLICATIONS STEM CELL APPLICATIONS: REGENERATIVE MEDICINE Stem Cell Applications Specifically by Tissue Type Stem Cell Applications Specifically by Organ System Type Stem Cell Applications in Infectious Disease, Genetic Disorders, and Cancer-related TABLE 13 STEM CELL TECHNOLOGY APPLICATIONS IN REGENERATIVE MEDICINE STEM CELL APPLICATIONS IN RESEARCH AND DEVELOPMENT Stem Cell Applications in Academic Research Stem Cell Applications in Biotechnology and Medical Device Research Stem Cells in Pharmaceutical Research TABLE 14 STEM CELL TECHNOLOGY AREAS OF APPLICATION WITHIN THE LIFE SCIENCES STEM CELL TECHNOLOGY AND DEVELOPMENT STEM CELL PRODUCTION STEM CELL ACQUISITION CHARACTERIZATION AND EXPANSION MAINTENANCE AND STORAGE FIGURE 11 FLOW DIAGRAM FOR PROCESS OF STEM CELL PRODUCTION STEM CELL PRODUCTION ECONOMICS STEM CELL PRODUCTION ECONOMICS (CONTINUED) NOVEL STEM CELL PRODUCTION DEVELOPMENTS ISOLATION AND ENGINEERING NOVEL DEVELOPMENTS IN THE PRODUCTION OF ADULT STEM CELLS NOVEL DEVELOPMENTS IN THE PRODUCTION OF EMBRYONIC STEM CELLS Novel Developments in the Production ?(Continued) LEADERS IN STEM CELL RESEARCH DEVELOPMENT ACADEMIC RESEARCH AND DEVELOPMENT LEADERS Academic Stem Cell Research and Development Scientists George Q. Daley, MD, Ph.D Kevin Eggan, Ph.D Doug Melton, Ph.D Amy Wagers, Ph.D Robert Langer, Sc.D Irving Weissman, MD Stuart Orkin, MD Joseph Vacanti, MD Kenneth Chien, MD, Ph.D Rudolf Jaenisch, MD Daniel Tenen, MD Konrad Hochedlinger, Ph.D. Paul Matsudaira, Ph.D Anthony Atala, MD Elaine Fuchs, Ph.D. David J. Mooney, Ph.D. James A. Thomson, Ph.D Shinya Yamanaka, MD, Ph.D. Kacey G. Marra, Ph.D Gordon Keller, Ph.D Johnny Huard, Ph.D Hans Keirstead, Ph.D. Shoukhrat Mitalipov, Ph.D. Gordon Keller, Ph.D TABLE 15 HIGHLIGHTED STEM CELL RESEARCH PUBLICATIONS, 2005-2008 TABLE 15 (CONTINUED) TABLE 15 (CONTINUED) INDUSTRY RESEARCH AND DEVELOPMENT LEADERS TECHNOLOGY PATENT ANALYSIS GENERAL TRENDS TABLE 16 STEM CELL PATENT TRENDS, 2000-2008 FIGURE 12 STEM CELL PATENT TRENDS, 2000-2008 TRENDS BY COUNTRY TABLE 17 STEM CELL PATENT COUNTRY CODES, 2000-2008 TABLE 18 STEM CELL PATENT TRENDS BY COUNTRY, 2000-2008 TABLE 19 STEM CELL PATENT TRENDS BY COUNTRY OF PATENTS, 2000-2008 (%) FIGURE 13 STEM CELL PATENT TRENDS BY COUNTRY % OF PATENTS, 2000-2008 (%) TRENDS BY COMPANIES TABLE 20 STEM CELL PATENT TRENDS BY COMPANIES ASSIGNED TWO OR MORE PATENTS, 2000-2008 STEM CELL INDUSTRY STRUCTURE DRIVING FORCES IN STEM-CELL-BASED INDUSTRIES DRIVING FORCES IN THE HEALTH CARE MARKET BIOTECHNOLOGY PHARMACEUTICAL COMPETITIVE ADVANTAGES IN STEM-CELL-BASED INDUSTRIES TECHNOLOGY DEVELOPMENT AND UTILIZATION COST OF NEW PRODUCT DEVELOPMENT, MANUFACTURING, AND LAUNCH Cost of New Product Development, ? (Continued) MARKET POSITIONING AND CAPTURE Market Positioning and Capture (Continued) Market Positioning and Capture (Continued) IMPORTANT SHIFTS IN INDUSTRY CONTINUOUSLY EVOLVING TECHNOLOGICAL BASE Continuously Evolving Technological Base (Continued) EFFECTS OF FLUCTUATIONS IN FEDERAL GOVERNMENT AND FOOD AND DRUG ADMINISTRATION REGULATORY FACTORS TABLE 21 RESTRICTIONS ON STEM CELL RESEARCH BY STATE TABLE 21 (CONTINUED) TABLE 21 (CONTINUED) TABLE 21 (CONTINUED) TABLE 21 (CONTINUED) TABLE 21 (CONTINUED) TABLE 21 (CONTINUED) Food and Drug Administration Approval Requirements for Implementation of Stem-cell-based Therapeutics STAGE OF STEM CELL LIFE CYCLE TABLE 22 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008 FIGURE 14 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008 TABLE 23 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008 FIGURE 15 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008 TABLE 24 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%) FIGURE 16 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%) IMPACT ON EXISTING HEALTH CARE MARKET MAY BE SIGNIFICANT MAJOR STEM CELL COMPANIES MAJOR STEM CELL MARKETS Stem Cell Market Segmentation Stem Cell Market Forces Stem Cell Market Forces (Continued) GENERAL STEM CELL TECHNOLOGY ISSUES STEM CELL TECHNOLOGY ISSUES BY TECHNOLOGY TYPE Embryonic Stem Cells Adult Stem Cells STEM CELL COMPANIES PERCENT MARKET SHARE Stem Cell Companies Percent Market Share (Continued) TABLE 25 MARKET SHARE OF STEM CELL THERAPEUTICS (AND BANKING) COMPANIES, 2005-2007 (%) COMPANY PROFILES AASTROM BIOSCIENCES, INC TABLE 26 AASTROM BIOSCIENCES, INC. STEM CELL CLINICAL TRIALS TABLE 26 (CONTINUED) TABLE 27 AASTROM BIOSCIENCES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED ALDAGEN, INC TABLE 28 ALDAGEN, INC. STEM CELL CLINICAL TRIALS TABLE 29 ALDAGEN, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED ADVANCED CELL TECHNOLOGY, INC TABLE 30 ADVANCED CELL TECHNOLOGY, INC. STEM CELL CLINICAL TRIALS TABLE 31 ADVANCED CELL TECHNOLOGY, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 31 (CONTINUED) ARTERIOCYTE, INC. TABLE 32 ARTERIOCYTE, INC. STEM CELL CLINICAL TRIALS ATHERSYS, INC. BD BIOSCIENCES BIO-MATRIX SCIENTIFIC GROUP, INC. BIOE TABLE 33 BIOE STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED BIOHEART, INC TABLE 34 BIOHEART, INC. STEM CELL CLINICAL TRIALS TABLE 35 BIOHEART, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED CELGENE CORP CELLERANT THERAPEUTICS, INC TABLE 36 CELLERANT THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 37 CELLERANT THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED CELLULAR DYNAMICS INTERNATIONAL, INC COGNATE BIOSERVICES, INC. TABLE 38 COGNATE BIOSERVICES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED CRYO-CELL INTERNATIONAL, INC. CYTOMATRIX, LLC TABLE 39 CYTOMATRIX, LLC STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED CYTORI THERAPEUTICS, INC TABLE 40 CYTORI THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 41 CYTORI THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 41 (CONTINUED) ENDGENITOR TECHNOLOGIES, INC. FORTICELL BIOSCIENCE, INC. TABLE 42 FORTICELL BIOSCIENCE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED GERON CORP TABLE 43 GERON CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED HEALTHEUNIVERSE, INC. TABLE 44 HEALTHEUNIVERSE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED INTERNATIONAL STEM CELL CORPORATION INVITROGEN CORPORATION MATTEK CORPORATION TABLE 45 MATTEK CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED MEDISTEM LABORATORIES, INC. TABLE 46 MEDISTEM LABORATORIES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED MEDRA, INC MILLIPORE MORPHOGENESIS, INC TABLE 47 MORPHOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED MG BIOTHERAPEUTICS, LLC MORAGA BIOTECHNOLOGY CORPORATION NEOSTEM, INC TABLE 48 NEOSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED NEURALSTEM, INC TABLE 49 NEURALSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED NEUROGENERATION NEURONYX, INC TABLE 50 NEURONYX, INC. STEM CELL CLINICAL TRIALS TABLE 51 NEURONYX, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED NUTECH MEDICAL, INC. NOVOCELL, INC. TABLE 52 NOVOCELL, INC STEM CELL CLINICAL TRIALS TABLE 53 NOVOCELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED OPEXA THERAPEUTICS, INC. TABLE 54 OPEXA THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS ORGANOGENESIS, INC. TABLE 55 ORGANOGENESIS, INC. STEM CELL CLINICAL TRIALS TABLE 56 ORGANOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED OSIRIS THERAPEUTICS, INC. TABLE 57 OSIRIS THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 57 (CONTINUED) TABLE 58 OSIRIS THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED PHARMASTEM THERAPEUTICS, INC TABLE 59 PHARMASTEM THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED PRIMEGEN BIOTECH, LLC PROGENITOR CELL THERAPY, LLC REGENETECH, INC TABLE 60 REGENETECH, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED SANERON CCEL THERAPEUTICS, INC. STEM CELL INNOVATIONS TABLE 61 STEM CELL INNOVATIONS STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED STEM CELLS, INC TABLE 62 STEM CELLS, INC. STEM CELL CLINICAL TRIALS TABLE 63 STEM CELLS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED STEM CELL THERAPY INTERNATIONAL CORP STEMCELL PHARMA, INC. STEMCYTE, INC STEMEDICA CELL TECHNOLOGIES, INC TENGION, INC TABLE 64 TENGION, INC. STEM CELL CLINICAL TRIALS THERADIGM, INC TABLE 65 THERADIGM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED THERMOGENESIS CORP VESTA THERAPEUTICS, INC. TABLE 66 VESTA THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED VIACELL, INC TABLE 67 VIACELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED VIACORD VISTAGEN THERAPEUTICS, INC. TABLE 68 VISTAGEN THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 69 VISTAGEN THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED VITRO DIAGNOSTICS, INC. VITRO DIAGNOSTICS, INC. (CONTINUED) INTERNATIONAL ASPECTS OF REGENERATIVE MEDICINE/STEM CELL MARKET INTERNATIONAL ASPECTS OF? TABLE 70 LEADING GLOBAL REGENERATIVE MEDICINE/STEM CELL COMPANIES REFERENCES REFERENCES REFERENCES (CONTINUED) REFERENCES (CONTINUED) REFERENCES (CONTINUED) REFERENCES (CONTINUED) REFERENCES (CONTINUED) REFERENCES (CONTINUED) REFERENCES (CONTINUED) REFERENCES (CONTINUED) REFERENCES (CONTINUED) APPENDIX A ? ABBREVIATIONS APPENDIX B ? GLOSSARY APPENDIX B ? GLOSSARY APPENDIX B ? GLOSSARY (CONTINUED) APPENDIX B ? GLOSSARY (CONTINUED) APPENDIX C - STEM CELL PATENTS, 2000-2008 TABLE 71 STEM CELL PATENTS BETWEEN THE YEARS 2000 AND 2008 TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) TABLE 71 (CONTINUED) LIST OF TABLES SUMMARY TABLE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, THROUGH 2012 ($ MILLIONS) TABLE 1 DERIVATION OF HUMAN TISSUE TYPES DURING DEVELOPMENT TABLE 2 STEM CELL CLASSIFICATION BASED ON DIFFERENTIATION POTENTIAL TABLE 3 ADULT STEM CELL TYPES AND POTENTIAL TISSUE SOURCES TABLE 4 THE NATIONAL INSTITUTES OF HEALTH STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS) TABLE 5 THE NATIONAL INSTITUTES OF HEALTH HUMAN EMBRYONIC STEM CELL REGISTRY TABLE 6 STATES FUNDING STEM-CELL-RELATED RESEARCH TABLE 7 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, THROUGH 2012 ($ MILLIONS) TABLE 8 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, THROUGH 2012 ($ MILLIONS) TABLE 9 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, THROUGH 2012 ($ MILLIONS) TABLE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH ($ MILLIONS) TABLE 11 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, THROUGH 2012 ($ MILLIONS) TABLE 12 FACTORS DRIVING AND INHIBITING THE APPLICATION OF STEM-CELL-BASED THERAPEUTICS TABLE 14 STEM CELL TECHNOLOGY AREAS OF APPLICATION WITHIN THE LIFE SCIENCES TABLE 15 HIGHLIGHTED STEM CELL RESEARCH PUBLICATIONS, 2005-2008 TABLE 16 STEM CELL PATENT TRENDS, 2000-2008 TABLE 17 STEM CELL PATENT COUNTRY CODES, 2000-2008 TABLE 18 STEM CELL PATENT TRENDS BY COUNTRY, 2000-2008 TABLE 19 STEM CELL PATENT TRENDS BY COUNTRY OF PATENTS, 2000-2008 (%) TABLE 20 STEM CELL PATENT TRENDS BY COMPANIES ASSIGNED TWO OR MORE PATENTS, 2000-2008 TABLE 21 RESTRICTIONS ON STEM CELL RESEARCH BY STATE TABLE 22 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008 TABLE 23 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008 TABLE 24 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%) TABLE 25 MARKET SHARE OF STEM CELL THERAPEUTICS (AND BANKING) COMPANIES, 2005-2007 (%) TABLE 26 AASTROM BIOSCIENCES, INC. STEM CELL CLINICAL TRIALS TABLE 27 AASTROM BIOSCIENCES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 28 ALDAGEN, INC. STEM CELL CLINICAL TRIALS TABLE 29 ALDAGEN, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 30 ADVANCED CELL TECHNOLOGY, INC. STEM CELL CLINICAL TRIALS TABLE 31 ADVANCED CELL TECHNOLOGY, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 32 ARTERIOCYTE, INC. STEM CELL CLINICAL TRIALS TABLE 33 BIOE STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 34 BIOHEART, INC. STEM CELL CLINICAL TRIALS TABLE 35 BIOHEART, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 36 CELLERANT THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 37 CELLERANT THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 38 COGNATE BIOSERVICES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 39 CYTOMATRIX, LLC STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 40 CYTORI THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 41 CYTORI THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 42 FORTICELL BIOSCIENCE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 43 GERON CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 44 HEALTHEUNIVERSE, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 45 MATTEK CORP STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 46 MEDISTEM LABORATORIES, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 47 MORPHOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 48 NEOSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 49 NEURALSTEM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 50 NEURONYX, INC. STEM CELL CLINICAL TRIALS TABLE 51 NEURONYX, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 52 NOVOCELL, INC STEM CELL CLINICAL TRIALS TABLE 53 NOVOCELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 54 OPEXA THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 55 ORGANOGENESIS, INC. STEM CELL CLINICAL TRIALS TABLE 56 ORGANOGENESIS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 57 OSIRIS THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 58 OSIRIS THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 59 PHARMASTEM THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 60 REGENETECH, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 61 STEM CELL INNOVATIONS STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 62 STEM CELLS, INC. STEM CELL CLINICAL TRIALS TABLE 63 STEM CELLS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 64 TENGION, INC. STEM CELL CLINICAL TRIALS TABLE 65 THERADIGM, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 66 VESTA THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 67 VIACELL, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 68 VISTAGEN THERAPEUTICS, INC. STEM CELL CLINICAL TRIALS TABLE 69 VISTAGEN THERAPEUTICS, INC. STEM CELL PATENTS ISSUED OR EXCLUSIVELY LICENSED TABLE 70 LEADING GLOBAL REGENERATIVE MEDICINE/STEM CELL COMPANIES TABLE 71 STEM CELL PATENTS BETWEEN THE YEARS 2000 AND 2008 LIST OF FIGURES SUMMARY FIGURE U.S. MARKET FOR STEM CELLS IN REGENERATIVE MEDICINE REVENUE, 2005-2012 ($ MILLIONS) FIGURE 1 FLOW DIAGRAM OF HUMAN DEVELOPMENT PROCESS FIGURE 2 THE NATIONAL INSTITUTES OF HEALTH HUMAN STEM CELL RESEARCH FUNDING, 2004-2009 ($ MILLIONS) FIGURE 3 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN REGENERATIVE MEDICINE, 2005-2012 ($ MILLIONS) FIGURE 4 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN CELLULAR THERAPEUTICS FIGURE 5 PROJECTED U.S. GROWTH TREND FOR STEM CELLS IN CELL-BASED THERAPEUTICS FOR HUMAN ADULT AND EMBRYONIC STEM CELLS, 2005-2012 ($ MILLIONS) FIGURE 6 FLOW DIAGRAM OF PROCESS USING STEM CELLS IN ENGINEERING TISSUE FOR TRANSPLANTATION FIGURE 7 FLOW DIAGRAM FOR PROCESS OF THERAPEUTIC BANKING OF STEM CELLS FIGURE 8 PROJECTED U.S. GROWTH TREND FOR THERAPEUTIC STEM CELL BANKING, 2005-2012 ($ MILLIONS) FIGURE 9 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED THERAPEUTIC RESEARCH, 2005-2012 ($ MILLIONS) FIGURE 10 PROJECTED U.S. GROWTH TREND FOR STEM-CELLRELATED CELL-BASED ASSAYS/DIAGNOSTICS THERAPEUTIC RESEARCH BY SEGMENT, 2005-2012 ($ MILLIONS) FIGURE 11 FLOW DIAGRAM FOR PROCESS OF STEM CELL PRODUCTION FIGURE 12 STEM CELL PATENT TRENDS, 2000-2008 FIGURE 14 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS, 2000-2008 FIGURE 15 TOTAL NUMBER OF STEM CELL CLINICAL TRIALS FUNDED BY INDUSTRY, 2000-2008 FIGURE 16 STEM CELL CLINICAL TRIALS RELATED TO CANCER (PERIPHERAL BLOOD/BONE MARROW TRANSPLANTATION), 2000-2008 (%)
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