APPLICATIONS OF CELL CULTURE MODEL SYSTEM CANCER RESEARCH VIROLOGY TABLE 5 CULTURE MEDIA USED FOR THE PRODUCTION OF

Similar documents
Transcription:

CHAPTER ONE: INTRODUCTION... 1 STUDY OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 2 SCOPE OF THE STUDY... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 3 RELATED BCC RESEARCH REPORTS... 3 BCC ONLINE SERVICES... 3 DISCLAIMER... 4 CHAPTER TWO: EXECUTIVE SUMMARY... 5 EXECUTIVE SUMMARY... 5 SUMMARY TABLE GLOBAL REVENUES FROM MEDIA, SERA AND REAGENTS USED IN THE BIOTECHNOLOGY MARKET, THROUGH 2016 ($ MILLIONS)... 6 SUMMARY FIGURE GLOBAL REVENUES FROM MEDIA, SERA AND REAGENTS USED IN THE BIOTECHNOLOGY MARKET, 2009-2016 ($ MILLIONS)... 6 EXECUTIVE SUMMARY (CONTINUED)... 7 CHAPTER THREE: OVERVIEW... 8 DEFINITIONS... 8 HISTORY... 8 TABLE 1 HISTORICAL EVENTS IN CELL CULTURE DEVELOPMENT... 9 TABLE 1 (CONTINUED)... 10 TYPES OF CELL CULTURES... 10 PRIMARY CULTURES... 10 TABLE 2 ADVANTAGES AND DISADVANTAGES OF PRIMARY CELL CULTURE... 11 SECONDARY CELL CULTURE... 11 CONTINUOUS CELL CULTURE... 11 TABLE 3 ADVANTAGES AND DISADVANTAGES OF CONTINUOUS CELL CULTURE... 12 MORPHOLOGY OF CELLS IN CULTURE... 12 FIBROBLASTIC CELLS... 12 EPITHELIAL-LIKE CELLS... 12 LYMPHOBLAST-LIKE CELLS... 12 BASIC SYSTEMS FOR CELL CULTURE... 12 TABLE 4 ADHERENT CULTURE VS. SUSPENSION CULTURE... 13 CELL LINE, CELL STRAIN AND TRANSFORMED CELL LINES... 13 CHARACTERISTICS OF IMMORTALIZED CELL LINES... 14 FACTORS AFFECTING CELL CULTURE... 14

APPLICATIONS OF CELL CULTURE... 15 MODEL SYSTEM... 15 CANCER RESEARCH... 15 VIROLOGY... 15 TABLE 5 CULTURE MEDIA USED FOR THE PRODUCTION OF VACCINES... 16 TABLE 5 (CONTINUED)... 17 GENETICALLY ENGINEERED PROTEINS... 17 TABLE 6 POTENTIAL SOURCES OF CELL CULTURE ADDITIVES... 18 Recombinant Thrombolytic Agents... 19 TABLE 7 RECOMBINANT THROMBOLYTIC AGENTS... 19 Recombinant Coagulation Factor... 19 TABLE 8 RECOMBINANT COAGULATION FACTOR... 20 Cytokines... 20 Hematopoietic Growth Factors... 21 Human Growth Hormones... 22 Monoclonal Antibodies... 22 TISSUE AND ORGAN REPLACEMENT... 22 GENETIC COUNSELING... 23 GENE THERAPY... 23 PROBLEMS DURING CELL CULTURE... 23 TOXICITY... 23 MICROBIAL CONTAMINATION... 23 Cross-Contamination... 24 BASIC REQUIREMENTS OF CELL CULTURE... 24 CELL CULTURE MEDIA... 24 Basic Constituents of Media... 24 Inorganic Salts... 24 TABLE 9 THE ROLES OF DIFFERENT INORGANIC NUTRIENTS... 25 Buffering Systems... 25 Energy Source... 26 Amino Acids... 26 Vitamins... 26 Proteins and Peptides... 27 Fatty Acids and Lipids... 27 Trace Elements... 27 Antibiotics... 28 TABLE 10 COMMONLY USED ANTIBIOTICS IN CELL CULTURES... 28 Serum... 29 Types of Cell Culture Media... 29 Serum-Containing Media... 29 TABLE 11 ADVANTAGES AND DISADVANTAGES OF SERUM- CONTAINING MEDIA... 30 Serum-free Media... 30

TABLE 12 ADVANTAGES AND DISADVANTAGES OF SERUM-FREE MEDIA... 31 Chemically Defined Media... 31 Amino Acids... 31 Carbohydrates... 32 Inorganic Salts... 32 Vitamins... 32 Protein-Free Media... 32 Selection of Cell Culture Media... 33 Serum-Free Media: Reasons for Preference... 33 Supplements for Serum-Free Media... 33 Hormones... 34 Transferrin... 34 Lipids... 34 Hydrolysates... 35 SERUM... 35 Role of Serum in Cell Culture... 35 Serum Components... 36 Growth Factors... 36 Albumin... 36 Protease Inhibitors... 36 TABLE 13 NORMAL RANGE OF CONCENTRATION OF SERUM CONSTITUENTS... 36 TABLE 13 (CONTINUED)... 37 Sources of Serum... 37 Fetal Bovine Serum... 37 Calf Serum... 37 Calf Serum, Donor (Bovine)... 37 Calf Serum, Newborn (Bovine)... 37 Other Animal Sera... 38 Chicken Serum... 38 Dog Serum... 38 Donor Donkey Serum... 38 Donor Goat Serum... 38 Donor Rat Serum... 38 Rat Serum... 38 Feline Serum... 38 Guinea Pig Serum... 39 Monkey Serum... 39 Mouse Serum... 39 Porcine Serum... 39 Rabbit Serum... 39 Sheep Serum... 39 Horse Serum... 39

Potential Problems with Serum... 40 Serum Selection... 40 CELL CULTURE REAGENTS... 41 Amino Acids and Vitamins... 41 Antibiotics and Antimycotics... 41 Buffers... 41 Cell Dissociation Agents... 42 Growth Supplements... 42 REGULATORY ASPECTS... 42 APPROVALS OF BIOLOGICAL LICENSE APPLICATIONS... 43 TABLE 14 APPROVALS OF BIOLOGICAL LICENSE APPLICATIONS, 2010 TO AUG. 2011... 43 TABLE 14 (CONTINUED)... 44 ADMINISTRATIVE ACTIONS: BIOLOGICS... 44 TABLE 15 ADMINISTRATIVE ACTIONS: BIOLOGICS, 2007 TO AUG. 2011... 44 TABLE 15 (CONTINUED)... 45 TABLE 16 PRODUCT RECALLS, 2007 TO AUG. 2011... 46 TABLE 16 (CONTINUED)... 47 TABLE 16 (CONTINUED)... 48 LEADING MANUFACTURERS OF MEDIA... 48 TABLE 17 LEADING MANUFACTURERS OF MEDIA... 48 TABLE 17 (CONTINUED)... 49 TABLE 17 (CONTINUED)... 50 TABLE 17 (CONTINUED)... 51 TABLE 17 (CONTINUED)... 52 TABLE 17 (CONTINUED)... 53 TABLE 17 (CONTINUED)... 54 TABLE 18 LEADING MANUFACTURERS OF SERA... 54 TABLE 18 (CONTINUED)... 55 TABLE 18 (CONTINUED)... 56 TABLE 19 LEADING MANUFACTURERS OF BIOLOGIC RESPONSE MODIFIERS... 57 TABLE 19 (CONTINUED)... 58 TABLE 19 (CONTINUED)... 59 TABLE 19 (CONTINUED)... 60 TABLE 20 LEADING MANUFACTURERS OF CELL DISSOCIATION REAGENTS... 60 TABLE 20 (CONTINUED)... 61 TABLE 21 LEADING MANUFACTURERS OF ANTIBIOTICS AND ANTIMYCOTICS USED IN CELL CULTURE... 62 TABLE 21 (CONTINUED)... 63 TABLE 22 LEADING MANUFACTURERS OF OTHER REAGENTS... 63 TABLE 22 (CONTINUED)... 64

TABLE 22 (CONTINUED)... 65 NEW DEVELOPMENTS... 66 TABLE 23 NEW DEVELOPMENTS IN THE CELL CULTURE INDUSTRY SINCE 2008... 67 TABLE 23 (CONTINUED)... 68 NEW DEVELOPMENTS IN APPLICATIONS... 68 NEW DEVELOPMENTS IN APPLICATIONS (CONTINUED)... 69 TABLE 24 NEW DEVELOPMENTS IN APPLICATION OF CELL CULTURE... 70 TABLE 24 (CONTINUED)... 71 CHAPTER FOUR: GLOBAL MARKETS... 72 GLOBAL MARKETS... 72 GLOBAL MARKETS (CONTINUED)... 73 TABLE 25 GLOBAL MARKET FOR CELL CULTURE PRODUCTS, THROUGH 2016 ($ MILLIONS)... 74 FIGURE 1 GLOBAL MARKET FOR CELL CULTURE PRODUCTS, 2009-2016 ($ MILLIONS)... 74 MEDIA... 75 MARKET REVENUE... 76 TABLE 26 GLOBAL MARKET FOR MEDIA USED IN BIOTECHNOLOGY BY REGION, THROUGH 2016 ($ MILLIONS)... 76 FIGURE 2 GLOBAL MARKET FOR MEDIA USED IN BIOTECHNOLOGY BY REGION, 2009-2016 ($ MILLIONS)... 77 MARKET SHARES... 77 TABLE 27 GLOBAL BIOTECHNOLOGY MEDIA MARKET SHARES BY REGION, 2010 (%)... 77 FIGURE 3 GLOBAL BIOTECHNOLOGY MEDIA MARKET SHARES BY REGION, 2010 (%)... 78 SERUM-FREE MEDIA AND SERUM-REQUIRING MEDIA... 78 Serum-Free Media Market Revenue... 79 TABLE 28 GLOBAL MARKET FOR SERUM-FREE MEDIA BY REGION, THROUGH 2016 ($ MILLIONS)... 79 FIGURE 4 GLOBAL MARKET FOR SERUM-FREE MEDIA BY REGION, 2009-2016 ($ MILLIONS)... 79 Serum-Requiring Media Market Revenue... 80 TABLE 29 GLOBAL MARKET FOR SERUM-REQUIRING MEDIA BY REGION, THROUGH 2016 ($ MILLIONS)... 80 FIGURE 5 GLOBAL MARKET FOR SERUM-REQUIRING MEDIA BY REGION, 2009-2016 ($ MILLIONS)... 81 POWDERED MEDIA AND LIQUID MEDIA... 81 Powdered Media Market Revenue... 82 TABLE 30 GLOBAL MARKET FOR POWDERED MEDIA, THROUGH 2016 ($ MILLIONS)... 82

FIGURE 6 GLOBAL MARKET FOR POWDERED MEDIA, 2009-2016 ($ MILLIONS)... 82 Liquid Media Market Revenue... 83 TABLE 31 GLOBAL MARKET FOR LIQUID MEDIA BY REGION, THROUGH 2016 ($ MILLIONS)... 83 FIGURE 7 GLOBAL MARKET FOR LIQUID MEDIA BY REGION, 2009-2016 ($ MILLIONS)... 83 CLASSICAL AND SPECIALTY MEDIA... 84 Classical Media Market Revenue... 84 TABLE 32 GLOBAL MARKET FOR CLASSICAL MEDIA BY REGION, THROUGH 2016 ($ MILLIONS)... 85 FIGURE 8 GLOBAL MARKET FOR CLASSICAL MEDIA BY REGION, 2009 2016 ($ MILLIONS)... 85 Specialty Media Market Revenue... 86 TABLE 33 GLOBAL MARKET FOR SPECIALTY MEDIA BY REGION, THROUGH 2016 ($ MILLIONS)... 86 FIGURE 9 GLOBAL MARKET FOR SPECIALTY MEDIA BY REGION, 2009-2016 ($ MILLIONS)... 86 SERA... 87 MARKET REVENUE... 88 TABLE 34 GLOBAL MARKET FOR SERA BY REGION, THROUGH 2016 ($ MILLIONS)... 88 FIGURE 10 GLOBAL MARKET FOR SERA BY REGION, 2009 2016 ($ MILLIONS)... 88 MARKET SHARES... 89 TABLE 35 GLOBAL SERA MARKET SHARES BY REGION, 2010 (%)... 89 FIGURE 11 GLOBAL SERA MARKET SHARES BY REGION, 2010 (%)... 89 BOVINE SERA OR FETAL BOVINE SERA... 90 TABLE 36 GLOBAL MARKET FOR BOVINE SERA BY REGION, THROUGH 2016 ($ MILLIONS)... 90 FIGURE 12 GLOBAL MARKET FOR BOVINE SERA BY REGION, 2009 2016 ($ MILLIONS)... 91 OTHER SERA... 91 TABLE 37 GLOBAL MARKET FOR OTHER SERA BY REGION, THROUGH 2016 ($ MILLIONS)... 92 FIGURE 13 GLOBAL MARKET FOR OTHER SERA BY REGION, 2009-2016 ($ MILLIONS)... 92 REAGENTS... 93 MARKET OVERVIEW... 94 MARKET REVENUE... 95 TABLE 38 GLOBAL MARKET FOR CELL CULTURE REAGENTS BY REGION, THROUGH 2016 ($ MILLIONS)... 95 FIGURE 14 GLOBAL MARKET FOR CELL CULTURE REAGENTS BY REGION, 2009-2016 ($ MILLIONS)... 96

MARKET SHARES... 96 TABLE 39 GLOBAL CELL CULTURE REAGENT MARKET SHARES BY REGION, 2010 (%)... 96 FIGURE 15 GLOBAL CELL CULTURE REAGENT MARKET SHARES BY REGION, 2010 (%)... 97 BIOLOGICAL RESPONSE MODIFIERS... 97 TABLE 40 GLOBAL MARKET FOR BIOLOGICAL RESPONSE MODIFIERS BY REGION, THROUGH 2016 ($ MILLIONS)... 97 FIGURE 16 GLOBAL MARKET FOR BIOLOGICAL RESPONSE MODIFIERS BY REGION, 2009-2016 ($ MILLIONS)... 98 Growth Factors... 98 TABLE 41 GLOBAL MARKET FOR GROWTH FACTORS BY REGION, THROUGH 2016 ($ MILLIONS)... 99 FIGURE 17 GLOBAL MARKET FOR GROWTH FACTORS BY REGION, 2009-2016 ($ MILLIONS)... 99 Cytokines... 99 TABLE 42 GLOBAL MARKET FOR CYTOKINES BY REGION, THROUGH 2016 ($ MILLIONS)... 100 FIGURE 18 GLOBAL MARKET FOR CYTOKINES BY REGION, 2009-2016 ($ MILLIONS)... 100 Other Biological Response Modifiers... 100 TABLE 43 GLOBAL MARKET FOR OTHER BIOLOGICAL RESPONSE MODIFIERS BY REGION, THROUGH 2016 ($ MILLIONS)... 101 FIGURE 19 GLOBAL MARKET FOR OTHER BIOLOGICAL RESPONSE MODIFIERS BY REGION, 2009-2016 ($ MILLIONS)... 101 CELL DISSOCIATION REAGENTS... 102 TABLE 44 GLOBAL MARKET FOR CELL DISSOCIATION REAGENTS BY REGION, THROUGH 2016 ($ MILLIONS)... 102 FIGURE 20 GLOBAL MARKET FOR CELL DISSOCIATION REAGENTS BY REGION, 2009-2016 ($ MILLIONS)... 102 OTHERS... 103 TABLE 45 GLOBAL MARKET FOR OTHERS BY REGION, THROUGH 2016 ($ MILLIONS)... 103 FIGURE 21 GLOBAL MARKET FOR OTHERS BY REGION, 2009-2016 ($ MILLIONS)... 104 CHAPTER FIVE: U.S. MARKET... 105 TABLE 46 U.S. MARKET FOR CELL CULTURE PRODUCTS, THROUGH 2016 ($ MILLIONS)... 105 FIGURE 22 U.S. MARKET FOR CELL CULTURE PRODUCTS, 2009-2016 ($ MILLIONS)... 106 MEDIA... 106 MARKET OVERVIEW... 106 Market Overview (Continued)... 107 MARKET REVENUE... 108

TABLE 47 U.S. MARKET FOR CELL CULTURE MEDIA, THROUGH 2016 ($ MILLIONS)... 108 FIGURE 23 U.S. MARKET FOR CELL CULTURE MEDIA, 2009-2016 ($ MILLIONS)... 109 SERUM-REQUIRING AND SERUM-FREE MEDIA... 109 Market Revenue... 110 TABLE 48 U.S. MARKET FOR SERUM-REQUIRING AND SERUM- FREE MEDIA, THROUGH 2016 ($ MILLIONS)... 111 FIGURE 24 U.S. MARKET FOR SERUM-REQUIRING AND SERUM- FREE MEDIA, 2009-2016 ($ MILLIONS)... 111 POWDERED AND LIQUID MEDIA... 111 Market Revenue... 112 TABLE 49 U.S. MARKET FOR POWDERED AND LIQUID MEDIA, THROUGH 2016 ($ MILLIONS)... 112 FIGURE 25 U.S. MARKET FOR POWDERED AND LIQUID MEDIA, 2009-2016 ($ MILLIONS)... 113 CLASSICAL AND SPECIALTY MEDIA... 113 Market Revenue... 114 TABLE 50 U.S. MARKET FOR CLASSICAL AND SPECIALTY MEDIA, THROUGH 2016 ($ MILLIONS)... 114 FIGURE 26 U.S. MARKET FOR CLASSICAL AND SPECIALTY MEDIA, 2009-2016 ($ MILLIONS)... 114 SERA... 115 MARKET OVERVIEW... 115 MARKET REVENUE... 116 TABLE 51 U.S. MARKET FOR BOVINE AND OTHER SERA, THROUGH 2016 ($ MILLIONS)... 116 FIGURE 27 U.S. MARKET FOR BOVINE AND OTHER SERA, THROUGH 2016 ($ MILLIONS)... 117 REAGENTS... 117 MARKET OVERVIEW... 118 Market Overview (Continued)... 119 MARKET REVENUE... 120 TABLE 52 U.S. MARKET FOR CELL CULTURE REAGENTS, THROUGH 2016 ($ MILLIONS)... 120 FIGURE 28 U.S. MARKET FOR CELL CULTURE REAGENTS, 2009-2016 ($ MILLIONS)... 120 BIOLOGICAL RESPONSE MODIFIERS... 121 TABLE 53 U.S. MARKET FOR BIOLOGICAL RESPONSE MODIFIERS, THROUGH 2016 ($ MILLIONS)... 122 FIGURE 29 U.S. MARKET FOR BIOLOGICAL RESPONSE MODIFIERS, 2009-2016 ($ MILLIONS)... 122 U.S. MARKET LEADERS... 123 MEDIA... 123

Serum-Free Media... 123 TABLE 54 U.S. MARKET SHARES OF SERUM-FREE MEDIA, 2010 (%)... 123 FIGURE 30 U.S. MARKET SHARES OF SERUM-FREE MEDIA, 2010 (%)... 124 Serum-Requiring/Containing Media... 124 TABLE 55 U.S. MARKET SHARES OF SERUM-CONTAINING MEDIA, 2010 (%)... 124 FIGURE 31 U.S. MARKET SHARES OF SERUM-CONTAINING MEDIA, 2010 (%)... 125 Powdered Media... 125 TABLE 56 U.S. MARKET SHARES OF POWDERED MEDIA, 2010 (%)... 125 FIGURE 32 U.S. MARKET SHARES OF POWDERED MEDIA, 2010 (%)... 126 Liquid Media... 126 TABLE 57 U.S. MARKET SHARES OF LIQUID MEDIA, 2010 (%)... 126 FIGURE 33 U.S. MARKET SHARES OF LIQUID MEDIA, 2010 (%)... 127 Classical Media... 127 TABLE 58 U.S. MARKET SHARES OF CLASSICAL MEDIA, 2010 (%)... 127 FIGURE 34 U.S. MARKET SHARES OF CLASSICAL MEDIA, 2010 (%)... 128 Specialty Media... 128 TABLE 59 U.S. MARKET SHARES OF SPECIALTY MEDIA, 2010 (%)... 128 FIGURE 35 U.S. MARKET SHARES OF SPECIALTY MEDIA, 2010 (%)... 129 SERA... 129 Bovine Sera... 129 TABLE 60 U.S. MARKET SHARES OF BOVINE SERA, 2010 (%)... 129 FIGURE 36 U.S. MARKET SHARES OF BOVINE SERA, 2010 (%)... 130 Other Sera... 130 TABLE 61 U.S. MARKET SHARES OF OTHER SERA, 2010 (%)... 130 FIGURE 37 U.S. MARKET SHARES OF OTHER SERA, 2010 (%)... 131 REAGENTS... 131 Biological Response Modifiers... 131 TABLE 62 U.S. MARKET SHARES OF BIOLOGICAL RESPONSE MODIFIERS, 2010 (%)... 132 FIGURE 38 U.S. MARKET SHARES OF BIOLOGICAL RESPONSE MODIFIERS, 2010 (%)... 132 Cell Dissociation Reagents... 132 TABLE 63 U.S. MARKET SHARES OF CELL DISSOCIATION REAGENTS, 2010 (%)... 133 FIGURE 39 U.S. MARKET SHARES OF CELL DISSOCIATION REAGENTS, 2010 (%)... 133 Other Reagents... 133 TABLE 64 U.S. MARKET SHARES OF OTHER REAGENTS, 2010 (%)... 134 FIGURE 40 U.S. MARKET SHARES OF OTHER REAGENTS, 2010 (%)... 134 CHAPTER SIX: END USERS... 135 MARKET SHARE OF APPLICATIONS... 135

TABLE 65 GLOBAL MEDIA, SERA AND REAGENT MARKET SHARES BY END USER, 2010 (%)... 136 FIGURE 41 GLOBAL MEDIA, SERA AND REAGENT MARKET SHARES BY END USER, 2010 (%)... 136 RESEARCH SEGMENT... 136 RESEARCH SEGMENT (CONTINUED)... 137 RESEARCH SEGMENT (CONTINUED)... 138 MARKET REVENUE... 139 TABLE 66 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE RESEARCH SEGMENT, THROUGH 2016 ($ MILLIONS)... 139 FIGURE 42 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE RESEARCH SEGMENT, 2009-2016 ($ MILLIONS)... 140 PRODUCTION SEGMENT... 140 PRODUCTION SEGMENT (CONTINUED)... 141 MARKET REVENUE... 142 TABLE 67 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE PRODUCTION SEGMENT, THROUGH 2016 ($ MILLIONS)... 142 FIGURE 43 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE PRODUCTION SEGMENT, 2009-2016 ($ MILLIONS)... 143 CONTRACT SEGMENT... 143 CONTRACT SEGMENT (CONTINUED)... 144 MARKET REVENUE... 145 TABLE 68 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE CONTRACT SEGMENT, THROUGH 2016 ($ MILLIONS)... 146 FIGURE 44 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE CONTRACT SEGMENT, 2009-2016 ($ MILLIONS)... 146 OTHERS SEGMENT... 146 MARKET REVENUE... 147 TABLE 69 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE OTHERS SEGMENT, THROUGH 2016 ($ MILLIONS)... 148 FIGURE 45 GLOBAL SALES OF MEDIA, SERA AND REAGENTS IN THE OTHERS SEGMENT, 2009-2016 ($ MILLIONS)... 148 CHAPTER SEVEN: PATENT ANALYSIS... 149 PATENTS BY YEAR... 149 TABLE 70 NUMBER OF U.S. PATENTS ISSUED BY YEAR, 2007 TO OCT. 2011... 150 FIGURE 46 U.S. PATENTS ISSUED BY YEAR, 2007 TO OCT. 2011 (%)... 150 PATENTS BY TYPE... 150 TABLE 71 PATENTS BY TYPE FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY, 2007 2011... 151 FIGURE 47 PATENTS BY TYPE FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY, 2007 2011 (NO. OF PATENTS)... 151 PATENTS BY COMPANY... 151

TABLE 72 U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS IN BIOTECHNOLOGY BY COMPANY, 2007 TO OCT. 2011 (NO.)... 152 PATENTS BY COUNTRY... 153 TABLE 73 U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY BY COUNTRY, 2007 TO OCT. 2011 (NO.)... 153 TABLE 74 SHARES OF U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY BY COUNTRY, 2007 OCT. 2011 (%)... 154 PATENTS BY ASSIGNEE... 154 TABLE 75 U.S. PATENTS ISSUED FOR MEDIA, SERA AND REAGENTS USED IN BIOTECHNOLOGY BY TYPE OF END USER, 2007 TO OCT. 2011 (NO.)... 154 CHAPTER EIGHT: THE CURRENT SITUATION... 155 REGIONAL MARKETS... 155 UNITED STATES... 155 EUROPE... 156 ASIA... 156 EMERGING MARKETS... 157 TRENDS AND ISSUES IN THE CELL CULTURE MARKET... 157 GLOBAL ECONOMY... 157 INCREASED RESEARCH AND DEVELOPMENT BUDGET... 157 TABLE 76 R&D BUDGETS OF TOP 10 COMPANIES IN 2009 AND 2010 ($ BILLIONS)... 158 GROWING DEMAND AND RICH PIPELINE OF BIOTHERAPEUTICS... 158 RESEARCH ON THERAPEUTIC VACCINES... 159 BIOMEDICAL RESEARCH... 160 STEM CELL RESEARCH... 160 GOVERNMENT POLICIES ON RESEARCH... 160 INNOVATIONS... 161 ETHICAL AND ANIMAL WELFARE ISSUES... 161 REGULATORY ISSUES... 162 USE OF HUMAN BLOOD ALTERNATIVES... 162 MERGERS, ACQUISITIONS AND ALLIANCES... 163 SHIFT TOWARD CONTRACT MANUFACTURING... 163 CHAPTER NINE: COMPANY PROFILES... 164 ADVANCED BIOTECHNOLOGIES INC.... 164 AFFYMETRIX... 164 AMRESCO LLC... 165 ATHENA ENVIRONMENTAL SCIENCES INC.... 165 ATLANTA BIOLOGICALS INC.... 166

BD BIOSCIENCES... 167 BIORECLAMATION INC.... 167 BOVOGEN BIOLOGICALS PTY. LTD.... 168 CELL APPLICATIONS INC.... 168 CELL CULTURE TECHNOLOGIES GMBH... 169 CLONTECH LABORATORIES INC.... 170 EQUITECH-BIO INC.... 170 GEMINI BIO-PRODUCTS... 171 GENEX INDIA BIOSCIENCES PVT. LTD.... 171 HIMEDIA LABORATORIES... 172 INVITROGEN CORP.... 172 IRVINE SCIENTIFIC... 173 J R SCIENTIFIC INC.... 174 LONZA... 174 MEDIATECH INC.... 175 MEDOX BIOTECH INDIA PVT. LTD.... 175 MILLIPORE CORP.... 176 MP BIOMEDICALS... 177 PAA LABORATORIES... 178 PEPROTECH INC.... 178 PROMOCELL GMBH... 179 QUALITY BIOLOGICAL INC.... 179 R&D SYSTEMS... 180 ROCHE APPLIED SCIENCES... 181 SERA LABORATORIES INTERNATIONAL LTD... 181 SERACARE LIFE SCIENCES INC.... 182 SIGMA-ALDRICH... 182 STEMCELL TECHNOLOGIES... 183 STEMCELLS INC.... 183 THERMO FISHER SCIENTIFIC INC.... 184 TICO EUROPE... 185 VALLEY BIOMEDICAL PRODUCTS AND SERVICES INC.... 186 APPENDIX: ABBREVIATIONS... 187 ABBREVIATIONS... 187 ABBREVIATIONS (CONTINUED)... 188 ABBREVIATIONS (CONTINUED)... 189