TABLE 7 ADVANTAGES AND DISADVANTAGES OF TOXOID VACCINES SUBUNIT VACCINES Applications of Subunit Vaccines TABLE 8 APPLICATIONS OF

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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... 4 DISCLAIMER... 4 CHAPTER TWO: EXECUTIVE SUMMARY... 5 EXECUTIVE SUMMARY... 5 SUMMARY TABLE GLOBAL REVENUE OF HUMAN AND ANIMAL VACCINES, THROUGH 2015 ($ MILLIONS)... 6 SUMMARY FIGURE GLOBAL REVENUE OF HUMAN AND ANIMAL VACCINES, 2008-2015 ($ MILLIONS)... 7 CHAPTER THREE: OVERVIEW... 8 WHAT IS A VACCINE?... 8 HISTORY OF VACCINES... 8 TABLE 1 HISTORY OF VACCINES, 1996-2006... 8 TABLE 1 (CONTINUED)... 9 TYPES OF VACCINES... 9 ATTENUATED (LIVE) VACCINES... 9 Applications of Attenuated (Live) Vaccines... 10 TABLE 2 APPLICATIONS OF ATTENUATED (LIVE) VACCINES... 10 Advantages and Disadvantages of Attenuated (Live) Vaccines... 10 TABLE 3 ADVANTAGES AND DISADVANTAGES OF ATTENUATED (LIVE) VACCINES... 10 TABLE 3 (CONTINUED)... 11 INACTIVATED (KILLED) VACCINES... 11 Applications of Inactivated (Killed) Vaccines... 11 TABLE 4 APPLICATIONS OF INACTIVATED (KILLED) VACCINES... 11 TABLE 4 (CONTINUED)... 12 Advantages and Disadvantages of Inactivated (Killed) Vaccines... 12 TABLE 5 ADVANTAGES AND DISADVANTAGES OF INACTIVED (KILLED) VACCINES... 12 TOXOID VACCINES... 12 Applications of Toxoid Vaccines... 13 TABLE 6 APPLICATIONS OF TOXOID VACCINES... 13 Advantages and Disadvantages of Toxoid Vaccines... 13

TABLE 7 ADVANTAGES AND DISADVANTAGES OF TOXOID VACCINES... 13 SUBUNIT VACCINES... 13 Applications of Subunit Vaccines... 14 TABLE 8 APPLICATIONS OF SUBUNIT VACCINES... 14 Advantages and Disadvantages of Subunit Vaccines... 14 TABLE 9 ADVANTAGES AND DISADVANTAGES OF SUBUNIT VACCINES... 14 CONJUGATE VACCINES... 15 Applications of Conjugate Vaccines... 15 TABLE 10 APPLICATIONS OF CONJUGATE VACCINES... 15 Advantages and Disadvantages of Conjugate Vaccines... 16 TABLE 11 ADVANTAGES AND DISADVANTAGES OF CONJUGATE VACCINES... 16 RECOMBINANT VECTOR VACCINES... 16 Applications of Recombinant Vector Vaccines... 16 TABLE 12 APPLICATIONS OF RECOMBINANT VECTOR VACCINES... 16 Advantages and Disadvantages of Recombinant Vector Vaccines... 17 TABLE 13 ADVANTAGES AND DISADVANTAGES OF RECOMBINANT VECTOR VACCINES... 17 DNA VACCINES... 17 Applications of DNA Vaccines... 18 TABLE 14 APPLICATIONS OF DNA VACCINES... 18 Advantages and Disadvantages of DNA Vaccines... 18 TABLE 15 ADVANTAGES AND DISADVANTAGES OF DNA VACCINES... 18 INFECTIOUS DISEASES PREVENTABLE BY VACCINES... 18 HUMAN DISEASES... 19 Viral Diseases... 19 TABLE 16 VACCINE PREVENTABLE HUMAN VIRAL DISEASES... 19 TABLE 16 (CONTINUED)... 20 TABLE 16 (CONTINUED)... 21 Bacterial Diseases... 21 TABLE 17 VACCINE PREVENTABLE HUMAN BACTERIAL DISEASES... 21 TABLE 17 (CONTINUED)... 22 TABLE 17 (CONTINUED)... 23 ANIMAL DISEASES... 23 TABLE 18 VACCINE PREVENTABLE ANIMAL DISEASES IN COMPANION ANIMALS... 24 TABLE 18 (CONTINUED)... 25 TABLE 19 VACCINE PREVENTABLE ANIMAL DISEASES IN LIVESTOCK ANIMALS... 25 TABLE 19 (CONTINUED)... 26

TABLE 20 LIVESTOCK ANIMAL VACCINES... 26 TABLE 20 (CONTINUED)... 27 TABLE 20 (CONTINUED)... 28 TABLE 20 (CONTINUED)... 29 TABLE 20 (CONTINUED)... 30 TABLE 20 (CONTINUED)... 31 TABLE 20 (CONTINUED)... 32 TABLE 20 (CONTINUED)... 33 TABLE 20 (CONTINUED)... 34 CHAPTER FOUR: PREVALENCE... 35 INCIDENCE AND IMMUNIZATION OF HUMAN DISEASES... 35 REGIONAL DATA... 35 TABLE 21 REPORTED INCIDENCE DATA OF HUMAN DISEASES, BY REGION, 2007-2009... 35 TABLE 21 (CONTINUED)... 36 TABLE 22 IMMUNIZATION COVERAGE DATA OF HUMAN DISEASES, BY REGION, 2007-2009 (%)... 36 TABLE 22 (CONTINUED)... 37 GLOBAL DATA... 37 TABLE 23 REPORTED CASES OF HUMAN DISEASES, 2007 AND 2008... 38 TABLE 24 IMMUNIZATION COVERAGE OF HUMAN DISEASES (%)... 38 GLOBAL IMMUNIZATION UPTAKE DATA... 38 TABLE 25 UPTAKE OF NEW AND UNDERUSED VACCINES, 2008... 39 GLOBAL DEATHS DUE TO VACCINE PREVENTABLE DISEASES... 39 TABLE 26 GLOBAL CHILD DEATHS DUE TO VACCINE PREVENTABLE DISEASES, 2008... 40 CHAPTER FIVE: REGULATORY ASPECTS... 41 TABLE 27 REVISIONS TO EXISTING VACCINES, 2007-2010... 41 TABLE 27 (CONTINUED)... 42 TABLE 27 (CONTINUED)... 43 TABLE 27 (CONTINUED)... 44 TABLE 27 (CONTINUED)... 45 TABLE 27 (CONTINUED)... 46 TABLE 28 NEW VACCINES IN THE GLOBAL MARKET, 2007-2010... 47 TABLE 28 (CONTINUED)... 48 TABLE 28 (CONTINUED)... 49 TABLE 28 (CONTINUED)... 50 TABLE 28 (CONTINUED)... 51 CHAPTER SIX: INDUSTRY STRUCTURE... 52 WHO PREQUALIFIED VACCINE MANUFACTURERS/SUPPLIERS... 52

TABLE 29 WORLD HEALTH ORGANIZATION (WHO) PREQUALIFIED MANUFACTURERS/SUPPLIERS OF HUMAN VACCINES, 2010... 52 TABLE 29 (CONTINUED)... 53 MANUFACTURERS/SUPPLIERS OF HUMAN VACCINES... 53 ATTENUATED (LIVE) VACCINES... 53 TABLE 30 LEADING MANUFACTURERS/SUPPLIERS OF ATTENUATED (LIVE) VACCINES... 53 TABLE 30 (CONTINUED)... 54 INACTIVATED (KILLED) VACCINES... 55 TABLE 31 LEADING MANUFACTURERS/SUPPLIERS OF INACTIVATED (KILLED) VACCINES... 55 CONJUGATE VACCINES... 56 TABLE 32 LEADING MANUFACTURERS/SUPPLIERS OF CONJUGATE VACCINES... 56 RECOMBINANT / RECOMBINANT DNA (RDNA) VACCINES... 56 TABLE 33 LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT/ RECOMBINANT DNA (RDNA) VACCINES... 56 TABLE 33 (CONTINUED)... 57 SUBUNIT VACCINES... 57 TABLE 34 LEADING MANUFACTURERS/SUPPLIERS OF SUBUNIT VACCINES... 57 TOXOID VACCINES... 57 TABLE 35 LEADING MANUFACTURERS/SUPPLIERS OF TOXOID VACCINES... 57 COMBINATION VACCINES... 58 TABLE 36 LEADING MANUFACTURERS/SUPPLIERS OF COMBINATION VACCINES... 58 MARKET SHARES OF INDUSTRY LEADERS OF HUMAN VACCINES... 59 ATTENUATED (LIVE) VACCINES... 59 TABLE 37 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF ATTENUATED (LIVE) VACCINES, 2009 (%)... 59 FIGURE 1 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF ATTENUATED (LIVE) VACCINES, 2009 (%)... 60 INACTIVATED (KILLED) VACCINES... 60 TABLE 38 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF INACTIVATED (KILLED) VACCINES, 2009 (%)... 61 FIGURE 2 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF INACTIVATED (KILLED) VACCINES, 2009 (%)... 61 CONJUGATE VACCINES... 62

TABLE 39 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF CONJUGATE VACCINES, 2009 (%)... 62 FIGURE 3 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF CONJUGATE VACCINES, 2009 (%)... 63 RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES... 63 TABLE 40 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES, 2009 (%)... 64 FIGURE 4 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES, 2009 (%)... 64 SUBUNIT VACCINES... 65 TABLE 41 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SUBUNIT VACCINES, 2009 (%)... 65 FIGURE 5 GLOBAL MARKET SHARES OF MANUFACTURERS/ SUPPLIERS OF SUBUNIT VACCINES, 2009 (%)... 65 TOXOID VACCINES... 66 TABLE 42 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF TOXOID VACCINES, 2009 (%)... 66 FIGURE 6 GLOBAL MARKET SHARES OF MANUFACTURERS/ SUPPLIERS OF TOXOID VACCINES, 2009 (%)... 66 COMBINATION VACCINES... 67 TABLE 43 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF COMBINATION VACCINES, 2009 (%)... 67 FIGURE 7 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF COMBINATION VACCINES, 2009 (%)... 67 CHAPTER SEVEN: NEW DEVELOPMENTS... 68 NEW DEVELOPMENTS... 68 TABLE 44 NEW DEVELOPMENTS IN THE RESEARCH PIPELINE OF HUMAN VACCINES (AS OF AUGUST 2010)... 69 TABLE 44 (CONTINUED)... 70 TABLE 44 (CONTINUED)... 71 TABLE 44 (CONTINUED)... 72 TABLE 44 (CONTINUED)... 73 TABLE 44 (CONTINUED)... 74 CHAPTER EIGHT: MARKET ANALYSIS: HUMAN... 75

TABLE 45 GLOBAL MARKET FOR HUMAN VACCINES BY REGION, THROUGH 2015 ($ MILLIONS)... 75 FIGURE 8 GLOBAL MARKET FOR HUMAN VACCINES BY REGION, 2008-2015 ($ MILLIONS)... 76 ATTENUATED (LIVE) VACCINES... 76 MARKET OVERVIEW... 77 MARKET REVENUE... 78 TABLE 46 GLOBAL MARKET FOR ATTENUATED (LIVE) VACCINES, BY REGION, THROUGH 2015 ($ MILLIONS)... 78 FIGURE 9 GLOBAL MARKET FOR ATTENUATED (LIVE) VACCINES, BY REGION, 2008-2015 ($ MILLIONS)... 79 INACTIVATED (KILLED) VACCINES... 79 MARKET OVERVIEW... 80 MARKET REVENUE... 81 TABLE 47 GLOBAL MARKET FOR INACTIVATED (KILLED) VACCINES, THROUGH 2015 ($ MILLIONS)... 81 FIGURE 10 GLOBAL MARKET FOR INACTIVATED (KILLED) VACCINES, 2008-2015 ($ MILLIONS)... 81 CONJUGATE VACCINES... 82 MARKET OVERVIEW... 82 MARKET REVENUE... 83 TABLE 48 GLOBAL MARKET FOR CONJUGATE VACCINES, THROUGH 2015 ($ MILLIONS)... 83 FIGURE 11 GLOBAL MARKET FOR CONJUGATE VACCINES, 2008-2015 ($ MILLIONS)... 84 RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES... 84 MARKET OVERVIEW... 84 MARKET REVENUE... 85 TABLE 49 GLOBAL MARKET FOR RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES, THROUGH 2015 ($ MILLIONS)... 86 FIGURE 12 GLOBAL MARKET FOR RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES, 2008-2015 ($ MILLIONS)... 86 SUBUNIT VACCINES... 87 MARKET OVERVIEW... 87 MARKET REVENUE... 88 TABLE 50 GLOBAL MARKET FOR SUBUNIT VACCINES, THROUGH 2015 ($ MILLIONS)... 88 FIGURE 13 GLOBAL MARKET FOR SUBUNIT VACCINES, 2008-2015 ($ MILLIONS)... 89 TOXOID VACCINES... 89 MARKET OVERVIEW... 90 MARKET REVENUE... 91 TABLE 51 GLOBAL MARKET FOR TOXOID VACCINES, THROUGH 2015 ($ MILLIONS)... 91

FIGURE 14 GLOBAL MARKET FOR TOXOID VACCINES, 2008-2015 ($ MILLIONS)... 91 COMBINATION VACCINES... 92 MARKET OVERVIEW... 92 MARKET REVENUE... 93 TABLE 52 GLOBAL MARKET FOR COMBINATION VACCINES, BY REGION THROUGH 2015 ($ MILLIONS)... 93 FIGURE 15 GLOBAL MARKET FOR COMBINATION VACCINES, BY REGION, 2008-2015 ($ MILLIONS)... 94 MARKET SHARES OF HUMAN VACCINES, BY REGION... 94 TABLE 53 GLOBAL HUMAN VACCINES MARKET SHARES BY REGION, 2009 (%)... 95 FIGURE 16 GLOBAL HUMAN VACCINES MARKET SHARES BY REGION, 2009 (%)... 95 MARKET SHARES OF HUMAN VACCINES, BY TYPE... 95 TABLE 54 GLOBAL HUMAN VACCINES MARKET SHARES BY VACCINE TYPE, 2009 (%)... 96 FIGURE 17 GLOBAL HUMAN VACCINES MARKET SHARES BY VACCINE TYPE, 2009 (%)... 96 CHAPTER NINE: ANIMAL HEALTH MARKET... 97 INDUSTRY MANUFACTURERS OF ANIMAL HEALTH PRODUCTS... 97 MARKET OVERVIEW... 98 MARKET REVENUE... 99 TABLE 55 GLOBAL ANIMAL HEALTH REVENUES BY MARKET LEADERS, 2008-2010 ($ MILLIONS)... 99 TABLE 56 GLOBAL ANIMAL HEALTH MARKET SHARES BY REVENUE, 2009 (%)... 99 FIGURE 18 GLOBAL ANIMAL HEALTH MARKET SHARES BY REVENUE, 2009 (%)... 100 ANIMAL VACCINES... 100 TABLE 57 GLOBAL MARKET FOR ANIMAL VACCINES, THROUGH 2015 ($ MILLIONS)... 101 FIGURE 19 GLOBAL MARKET FOR ANIMAL VACCINES, 2008-2015 ($ MILLIONS)... 102 CHAPTER TEN: MARKET BY APPLICATIONS HUMANS... 103 TABLE 58 DISEASES AND INFECTIONS WITH DEVELOPED HUMAN VACCINES BASED ON MICROORGANISM... 103 TABLE 59 DISEASES AND INFECTIONS WITH DEVELOPED HUMAN VACCINES BASED ON TREATMENT... 104 MENINGOCOCCAL/PNEUMOCOCCAL DISEASES... 105 MARKET REVENUE... 105

TABLE 60 GLOBAL SALES OF HUMAN VACCINES IN MENINGOCOCCAL/ PNEUMOCOCCAL DISEASES MARKET, THROUGH 2015 ($ MILLIONS)... 106 FIGURE 20 GLOBAL SALES OF HUMAN VACCINES IN MENINGOCOCCAL/ PNEUMOCOCCAL DISEASES MARKET, 2008-2015 ($ MILLIONS)... 106 TABLE 61 TOP SELLING GROUPS OF MENINGOCOCCAL/ PENUMOCOCCAL VACCINES FOR 2009 BY MARKET SHARE (%)... 107 INFLUENZA (SEASONAL AND PANDEMIC) DISEASES... 107 MARKET REVENUE... 108 TABLE 62 GLOBAL SALES OF HUMAN VACCINES IN INFLUENZA DISEASES MARKET, THROUGH 2015 ($ MILLIONS)... 109 FIGURE 21 GLOBAL SALES OF HUMAN VACCINES IN INFLUENZA DISEASES MARKET, 2008-2015 ($ MILLIONS)... 109 TABLE 63 TOP SELLING GROUPS OF INFLUENZA VACCINES BY MARKET SHARE, 2009 (%)... 110 PEDIATRIC/POLIO/PERTUSSIS/HIB DISEASES... 110 MARKET REVENUE... 111 TABLE 64 GLOBAL SALES OF HUMAN VACCINES IN PEDIATRIC/POLIO PERTUSSIS/HIB DISEASES MARKET, THROUGH 2015 ($ MILLIONS)... 112 FIGURE 22 GLOBAL SALES OF HUMAN VACCINES IN PEDIATRIC/ POLIO/PERTUSSIS/HIB DISEASES MARKET, 2008-2015 ($ MILLIONS)... 112 TABLE 65 TOP SELLING GROUPS OF PEDIATRIC/POLIO/PERTUSSIS/HIB VACCINES BY MARKET SHARE, 2009 (%)... 113 ADULT/ADOLESCENT BOOSTER RELATED DISEASES... 113 MARKET REVENUE... 113 TABLE 66 GLOBAL SALES OF HUMAN VACCINES IN ADULT/ADOLESCENT BOOSTER RELATED DISEASES MARKET, THROUGH 2015 ($ MILLIONS)... 114 FIGURE 23 GLOBAL SALES OF HUMAN VACCINES IN ADULT/ADOLESCENT BOOSTER RELATED DISEASES MARKET, 2008-2015 ($ MILLIONS)... 114 TABLE 67 TOP SELLING GROUPS OF ADULT/ADOLESCENT BOOSTER RELATED VACCINES BY MARKET SHARE, 2009 (%)... 115 TRAVEL AND OTHER ENDEMIC DISEASES... 115 MARKET REVENUE... 116 TABLE 68 GLOBAL SALES OF HUMAN VACCINES IN TRAVEL AND OTHER ENDEMIC DISEASES MARKET, THROUGH 2015 ($ MILLIONS)... 117 FIGURE 24 GLOBAL SALES OF HUMAN VACCINES IN TRAVEL AND OTHER ENDEMIC DISEASES MARKET, 2008-2015 ($ MILLIONS)... 117

TABLE 69 TOP SELLING GROUPS OF TRAVEL AND OTHER ENDEMIC VACCINES BY MARKET SHARE, 2009 (%)... 118 HPV DISEASE... 118 MARKET REVENUE... 119 TABLE 70 GLOBAL SALES OF HUMAN VACCINES IN HPV DISEASE MARKET, THROUGH 2015 ($ MILLIONS)... 119 FIGURE 25 GLOBAL SALES OF HUMAN VACCINES IN HPV DISEASE MARKET, 2008-2015 ($ MILLIONS)... 120 TABLE 71 TOP SELLING HPV VACCINES IN THE ORDER OF THEIR SALES, 2009 (%)... 120 ROTAVIRUS DISEASE... 121 MARKET REVENUE... 121 TABLE 72 GLOBAL SALES OF HUMAN VACCINES IN ROTAVIRUS DISEASE MARKET, THROUGH 2015 ($ MILLIONS)... 121 FIGURE 26 GLOBAL SALES OF HUMAN VACCINES IN ROTAVIRUS DISEASE MARKET, 2008-2015 ($ MILLIONS)... 122 TABLE 73 TOP SELLING ROTAVIRUS VACCINES BY MARKET SHARE, 2009 (%)... 122 OTHER DISEASES... 123 MARKET REVENUE... 124 TABLE 74 GLOBAL SALES OF HUMAN VACCINES IN OTHER DISEASES MARKET, THROUGH 2015 ($ MILLIONS)... 124 FIGURE 27 GLOBAL SALES OF HUMAN VACCINES IN OTHER DISEASES MARKET, 2008-2015 ($ MILLIONS)... 125 TABLE 75 TOP SELLING OTHER VACCINES FOR 2009 BY MARKET SHARE (%)... 125 MARKET SHARE OF APPLICATIONS... 126 TABLE 76 SHARE OF VARIOUS CATEGORIES OF VACCINES IN THE HUMAN VACCINES MARKET, 2009 (%)... 126 FIGURE 28 SHARE OF VARIOUS CATEGORIES OF VACCINES IN THE HUMAN VACCINES MARKET, 2009 (%)... 127 CHAPTER ELEVEN: PATENT ANALYSIS... 128 TOTAL NUMBER OF PATENTS... 128 TABLE 77 NUMBER OF SIGNIFICANT PATENTS, 2006 TO SEPTEMBER 2010... 129 FIGURE 29 NUMBER OF SIGNIFICANT PATENTS, 2006 TO SEPTEMBER 2010... 129 FIGURE 30 PERCENT OF SIGNIFICANT PATENTS, 2006 TO SEPTEMBER 2010 (%)... 130 PATENTS BY TYPE AND YEAR... 130 TABLE 78 PATENTS BY TECHNOLOGY, 2006 TO SEPTEMBER 2010... 131 FIGURE 31 PATENTS BY TECHNOLOGY, 2006 TO SEPTEMBER 2010... 131 PATENTS BY COMPANY... 132 INACTIVATED (KILLED) VACCINE TECHNOLOGY... 132

TABLE 79 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING INACTIVATED (KILLED) VACCINE TECHNOLOGY, 2006 TO SPETEMBER 2010... 132 FIGURE 32 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING INACTIVATED (KILLED) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 133 ATTENUATED (LIVE) VACCINE TECHNOLOGY... 133 TABLE 80 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING ATTENUATED (LIVE) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 134 FIGURE 33 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING ATTENUATED (LIVE) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 135 CONJUGATE VACCINE TECHNOLOGY... 135 TABLE 81 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING CONJUGATE VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 136 FIGURE 34 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING CONJUGATE VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 136 TOXOID VACCINE TECHNOLOGY... 137 TABLE 82 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING TOXOID VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 137 FIGURE 35 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING TOXOID VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 137 RECOMBINANT/RDNA VACCINE TECHNOLOGY... 138 TABLE 83 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING RECOMBINANT/RDNA VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 138 TABLE 83 (CONTINUED)... 139 FIGURE 36 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING RECOMBINANT/RDNA VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 139 SUBUNIT VACCINE TECHNOLOGY... 140 TABLE 84 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING SUBUNIT VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 140 FIGURE 37 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING SUBUNIT VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 140 OTHER/COMBINED VACCINE TECHNOLOGY... 141 TABLE 85 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING OTHER/COMBINED VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 141 TABLE 85 (CONTINUED)... 142

FIGURE 38 NUMBER OF U.S. PATENTS BY COMPANY UTILIZING OTHER/ COMBINED VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 143 PATENTS BY COUNTRY... 143 INACTIVATED (KILLED) VACCINE TECHNOLOGY... 143 TABLE 86 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING INACTIVATED (KILLED) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 144 FIGURE 39 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING INACTIVATED (KILLED) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 145 ATTENUATED (LIVE) VACCINE TECHNOLOGY... 145 TABLE 87 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING ATTENUATED (LIVE) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 145 TABLE 87 (CONTINUED)... 146 FIGURE 40 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING ATTENUATED (LIVE) VACCINE TECHNOLOGY, 2006 2010... 146 CONJUGATE VACCINE TECHNOLOGY... 147 TABLE 88 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING CONJUGATE VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 147 FIGURE 41 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING CONJUGATE VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 148 TABLE 89 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING TOXOID VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 148 FIGURE 42 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING TOXOID VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 149 RECOMBINANT/ DNA/ RDNA VACCINE TECHNOLOGY... 149 TABLE 90 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING RECOMBINANT/DNA/RDNA VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 150 FIGURE 43 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING RECOMBINANT/DNA/RDNA VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 151 SUBUNIT VACCINE TECHNOLOGY... 151 TABLE 91 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING SUBUNIT VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 152 FIGURE 44 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING SUBUNIT VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 152 OTHER/COMBINED VACCINE TECHNOLOGY... 152

TABLE 92 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING OTHER/COMBINED VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 153 FIGURE 45 NUMBER OF U.S. PATENTS BY COUNTRY UTILIZING OTHER/COMBINED VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 154 TABLE 93 NUMBER OF U.S. PATENTS BY COUNTRY FOR ALL VACCINE TYPES, 2006 TO SEPTEMBER 2010 (%)... 154 TABLE 93 (CONTINUED)... 155 FIGURE 46 PATENT SHARES BY COUNTRY FOR VACCINES, 2006 TO SEPTEMBER 2010 (%)... 156 PATENTS BY ASSIGNEE... 157 INACTIVATED (KILLED) VACCINE TECHNOLOGY... 157 TABLE 94 PATENTS BY ASSIGNEE UTILIZING INACTIVATED (KILLED) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 157 FIGURE 47 PATENTS BY ASSIGNEE UTILIZING INACTIVATED (KILLED) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 157 ATTENUATED (LIVE) VACCINE TECHNOLOGY... 158 TABLE 95 PATENTS BY ASSIGNEE UTILIZING ATTENUATED (LIVE) VACCINE TECHNOLOGY, 2006 THROUGH SEPTEMBER 2010... 158 FIGURE 48 PATENTS BY ASSIGNEE UTILIZING ATTENUATED (LIVE) VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 158 CONJUGATE VACCINE TECHNOLOGY... 159 TABLE 96 PATENTS BY ASSIGNEE UTILIZING CONJUGATE VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 159 FIGURE 49 PATENTS BY ASSIGNEE UTILIZING CONJUGATE VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 159 TOXOID VACCINE TECHNOLOGY... 160 TABLE 97 PATENTS BY ASSIGNEE UTILIZING TOXOID VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 160 FIGURE 50 PATENTS BY ASSIGNEE UTILIZING TOXOID VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 160 RECOMBINANT/RDNA VACCINE TECHNOLOGY... 161 TABLE 98 PATENTS BY ASSIGNEE UTILIZING RECOMBINANT/RDNA VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 161 FIGURE 51 PATENTS BY ASSIGNEE UTILIZING RECOMBINANT/RDNA VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 161 SUBUNIT VACCINE TECHNOLOGY... 162 TABLE 99 PATENTS BY ASSIGNEE UTILIZING SUBUNIT VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 162

FIGURE 52 PATENTS BY ASSIGNEE UTILIZING SUBUNIT VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 162 OTHER/COMBINED VACCINE TECHNOLOGY... 163 TABLE 100 PATENTS BY ASSIGNEE UTILIZING OTHER/COMBINED VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 163 FIGURE 53 PATENTS BY ASSIGNEE UTILIZING OTHER/COMBINED VACCINE TECHNOLOGY, 2006 TO SEPTEMBER 2010... 163 CHAPTER TWELVE: CURRENT SITUATION OF THE GLOBAL VACCINES MARKET... 164 FACTS ABOUT THE GLOBAL VACCINES MARKET... 164 FACTORS AFFECTING THE SALES OF VACCINES... 165 COMPETITION... 165 COST... 165 TRENDS... 166 IMMUNIZATION FUNDING... 166 GLOBAL IMMUNIZATION VISION AND STRATEGY (GIVS)... 166 TABLE 101 AIMS OF GIVS... 167 TABLE 102 GOALS OF GIVS... 167 TABLE 103 STRATEGIES OF GIVS... 168 CURRENT SITUATION... 168 TABLE 104 GLOBAL FUNDING GAP BY REGION FOR IMMUNIZATION WORK, 2010-2011 ($ MILLIONS)... 169 VACCINE PREVENTABLE DISEASES UPDATE... 169 CURRENT VACCINE PRIORITIZATION... 169 TABLE 105 VACCINE PRIORITIZATION, 2009-2010... 170 CURRENT AND FUTURE (PROPOSED) VACCINE MILESTONES... 171 TABLE 106 VACCINE MILESTONES 2009-2012... 171 INFLUENZA VIRUS VACCINES UPDATE FOR THE 2010 THROUGH 2011 SEASON... 172 TABLE 107 INFLUENZA VACCINES FOR THE 2010 2011 SEASON... 172 CHAPTER THIRTEEN: COMPANY PROFILES... 173 ADVAXIS... 173 BAYER ANIMAL HEALTH... 173 BUL BIO NATIONAL CENTER OF INFECTIOUS AND PARASITIC DISEASES LTD. (BB NCIPD LTD.)... 174 BHARAT BIOTECH... 174 BIO FARMA... 175 BIOLOGICAL E. LIMITED... 176 BIO MANGUINHOS... 176 BIOPROPERTIES... 177

BOEHRINGER INGELHEIM VETMEDICA, INC.... 177 CENTER FOR GENETIC ENGINEERING AND BIOTECHNOLOGY... 178 CEVA SANTE ANIMALE... 179 COLORADO SERUM COMPANY... 179 CRUCELL... 180 CSL LTD.... 180 ELI LILLY & CO.... 181 EMERGENT BIOSOLUTIONS... 182 FATRO... 182 GLAXOSMITHKLINE... 183 GREEN CROSS... 184 HAFFKINE BIO PHARMACEUTICAL CORPORATION LTD.... 184 INDOVAX... 185 INSTITUT PASTEUR DE DAKAR... 185 INTERCELL... 186 JAPAN BCG LABORATORY... 186 KING PHARMACEUTICALS INC.... 187 LOHMANN INTERNATIONAL... 188 MEDIMMUNE... 188 MERCK & CO., INC.... 189 NIPPON BIOLOGICALS, INC.... 190 NOVARTIS AG... 190 PANACEA BIOTEC... 191 PFIZER INC.... 192 ROMVAC... 193 SANOFI AVENTIS (SANOFI PASTEUR)... 193 SERUM INSTITUTE OF INDIA LTD.... 194 STATENS SERUM INSTITUT... 195 THE RESEARCH FOUNDATION FOR MICROBIAL DISEASES OF OSAKA UNIVERSITY... 196 VENTRI BIOLOGICALS... 196 ZYDUS CADILA... 197 APPENDIX I... 198 ABBREVIATIONS... 198 ABBREVIATIONS (CONTINUED)... 199