CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THE STUDY... 1 SCOPE OF REPORT... 2 MARKET ANALYSES AND FORECASTS... 2 METHODOLOGY... 2 INTENDED AUDIENCE... 3 INFORMATION SOURCES... 3 ANALYST CREDENTIALS... 3 RELATED REPORTS... 3 BCC ONLINE SERVICES... 4 DISCLAIMER... 4 CHAPTER TWO: SUMMARY... 5 SUMMARY... 5 MARKET SIZE AND EVOLUTION... 6 SUMMARY TABLE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 7 SUMMARY FIGURE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 7 CHAPTER THREE: OVERVIEW... 8 OVERVIEW... 8 OVERVIEW (CONTINUED)... 9 TABLE 1 GLOBAL PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 10 RECENT HISTORY OF THE GENERICS SECTOR... 11 ROCHE-BOLAR... 11 Roche-Bolar (Continued)... 12 GENERICS LOBBY... 13 ICH... 14 CHAPTER FOUR: THE NEW GENERICS ERA... 15 THE PATENT CLIFF... 16 TABLE 2 FIRST PATENT EXPIRIES, 2012 2023... 17 TYPES OF GENERICS... 17 SIMPLE GENERICS... 17 Factors Influencing the Success or Failure of Generics... 18 Adequate Market Size... 18 Patent-Expired Therapies... 18 Older Products Still Used... 19 Long-Term Use... 19 Straightforward Production Technology... 19 Drugs Used in Primary Care... 20
SUPERGENERICS... 20 BIOSIMILARS... 21 Biosimilars (Continued)... 22 TABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001 2006... 23 Special Challenges... 24 Special Challenges (Continued)... 25 The Biosimilar Market... 26 Some Biosimilar Developments and Introductions... 26 EPO... 26 G-CSF... 26 Interferons... 26 HGH... 27 Monoclonal Antibodies... 27 Monoclonal (Continued)... 28 MAJOR GENERIC ISSUES... 29 REGULATORY ENVIRONMENT... 29 U.S.... 29 TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS... 30 U.S. (Continued)... 31 European Union... 32 EU Marketing Authorization Systems... 32 The Centralized Procedure... 33 Decentralized and Mutual Recognition Procedures... 34 Mutual-Recognition Procedure... 34 Types of Applications... 35 Applications Under Article 10 (Generic Products)... 35 Japan... 36 Approval (Shonin) of Pharmaceuticals... 37 REGULATION OF BIOSIMILARS... 37 EU Provisions... 38 Evolving Situation in the U.S.... 39 Hatch-Waxman and Bolar... 39 Defensive Strategies by Big Pharma... 40 AUTHORIZED GENERICS... 41 User Fees... 42 A Mood Swing Toward Generics... 43 The Situation in Europe... 44 PATENTS AND IP... 45 SUPPLEMENTARY PROTECTION CERTIFICATES... 46 Supplementary Protection Certificates (Continued)... 47
CHAPTER FIVE: THE GLOBAL PHARMACEUTICAL AND GENERICS MARKET... 48 GLOBAL GENERICS MARKET... 48 MAIN NATIONAL GENERICS MARKETS... 49 TABLE 5 WORLD PHARMA AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 49 TABLE 6 CURRENT AND FORECAST NATIONAL GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 50 MARKET OPPORTUNITIES BY PRODUCT CLASS... 50 LEADING GENERIC MOLECULES... 50 TABLE 7 WIDELY PRESCRIBED GENERIC MOLECULES IN THE U.S. AND EUROPE... 50 TABLE 7 (CONTINUED)... 51 Anti-infectives... 51 Anti-infectives (Continued)... 52 TABLE 8 LEADING ANTI-INFECTIVE PRODUCTS SALES ESTIMATES WITH YEAR OF PATENT EXPIRY, 2010 ($ BILLIONS)... 53 CNS Therapies... 54 TABLE 9 CNS MARKET BY MAJOR INDICATIONS, 2010 ($ BILLIONS)... 54 FIGURE 1 CNS MARKET SHARES BY MAJOR INDICATIONS, 2010 (%)... 55 Antidepressants... 55 Antipsychotics... 56 TABLE 10 LEADING CNS PRODUCT SALES ESTIMATES, 2010 ($ BILLIONS)... 57 Anxiolytics... 57 Sleep Disorders... 58 Epilepsy... 58 Parkinson s Disease... 59 Migraine... 59 Cardiovascular Products... 60 TABLE 11 LEADING CARDIOVASCULAR PRODUCT SALES, 2009 ($ BILLIONS)... 61 Anti-arthritis Products... 62 Steroids... 62 NSAIDs... 63 COX- II Inhibitors... 63 DMARDs... 64 TABLE 12 LEADING ANTI-ARTHRITIS PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS)... 65 Respiratory Products... 66 Asthma... 66 COPD... 66
Allergic Rhinitis... 67 Allergic (Continued)... 68 TABLE 13 LEADING RESPIRATORY PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS)... 69 Drugs Used to Treat Asthma and COPD... 69 Bronchodilators... 69 Inhaled Bronchodilators... 69 Anticholinergics... 70 Oral Bronchodilators... 70 Leukotriene Antagonists... 70 Steroids... 71 FIGURE 2 USAGE OF MAIN PRODUCT CATEGORIES BASED REVENUES (%)... 71 FIGURE 2 (CONTINUED)... 72 Anticancer Products... 72 Cytotoxic Drugs... 72 Hormonal Therapy... 72 Biologic Response Modifiers... 73 Antiangiogenesis Drugs... 73 Monoclonal Antibodies... 73 TABLE 14 LEADING ANTICANCER PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS)... 74 Monoclonal Antibodies (Continued)... 75 CHAPTER SIX: THE AMERICAN MARKET... 76 THE U.S. MARKET... 76 VITAL STATISTICS... 76 HEALTH AND HEALTHCARE... 76 Health and Healthcare (Continued)... 77 THE U.S. PHARMACEUTICAL MARKET... 78 THE GENERICS MARKET: SIZE AND GROWTH... 78 Biosimilars... 79 Generic Prices... 79 Carve-Outs... 80 Generics Industry... 80 FIGURE 3 U.S. PHARMACEUTICAL MARKET SHARES BASED ON DOLLAR SALES AND PERCENTAGE SHARE OF PRESCRIPTIONS BY TYPE, 2010 (%)... 81 FIGURE 3 (CONTINUED)... 82 The Future... 83 TABLE 15 U.S. PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 84 CANADA... 84 VITAL STATISTICS... 84 HEALTH AND HEALTHCARE... 85
THE PHARMACEUTICAL MARKET... 86 GENERICS... 86 Generic Prices... 87 Future Market Growth... 88 How Generics are Supplied... 88 TABLE 16 GENERICS MARKET IN CANADA, THROUGH 2016 ($ BILLIONS)... 89 LATIN AMERICA... 89 BRAZIL... 90 Vital Statistics... 90 Health and Healthcare... 90 Pharmaceutical Market... 91 Generics Market... 92 M&A Activity... 92 Background... 93 Background (Continued)... 94 PróGenéricos... 95 TABLE 17 PHARMACEUTICAL AND GENERICS MARKET IN BRAZIL, THROUGH 2016 ($ BILLIONS)... 95 MEXICO... 95 Vital Statistics... 95 Health and Healthcare... 96 Pharmaceutical Market... 96 Market Resistors... 97 Generic Sector... 97 Generic Industry... 98 Regulatory Issues... 99 AMEGI... 100 Forecasts... 100 TABLE 18 PHARMACEUTICAL AND GENERICS MARKET IN MEXICO, THROUGH 2016 ($ BILLIONS)... 101 CHAPTER SEVEN: THE EUROPEAN MARKET... 102 TABLE 19 PHARMACEUTICAL PRICES IN EUROPE AND U.S., 2000-2008 ($)... 102 FRANCE... 103 VITAL STATISTICS... 103 HEALTH AND HEALTHCARE... 104 Healthcare Provision... 104 FIGURE 4 TOTAL EXPENDITURES ON HEALTH IN MAJOR EUROPEAN MARKETS AND THE U.S. AS A PERCENTAGE OF GDP, 2007 (%)... 105 PHARMACEUTICAL MARKET... 106 GENERIC SECTOR... 106
TABLE 20 PHARMACEUTICAL AND GENERICS MARKET IN FRANCE, THROUGH 2016 ($ BILLIONS)... 107 GERMANY... 108 VITAL STATISTICS... 108 HEALTH AND HEALTHCARE... 108 Provision of Healthcare... 108 PHARMACEUTICAL MARKET... 109 Price Controls... 109 GENERICS SECTOR... 110 TABLE 21 PHARMACEUTICAL AND GENERICS MARKET IN GERMANY, THROUGH 2016 ($ BILLIONS)... 111 ITALY... 111 VITAL STATISTICS... 111 HEALTH AND HEALTHCARE... 112 Healthcare System... 112 PHARMACEUTICAL MARKET... 113 Implications for Research... 114 TABLE 22 SELECTED PRIORITY AREAS IN ITALY S NATIONAL HEALTH PLAN... 115 GENERICS SECTOR... 115 Generics Sector (Continued)... 116 TABLE 23 PHARMACEUTICAL AND GENERICS MARKET IN ITALY, THROUGH 2016 ($ BILLIONS)... 117 SPAIN... 117 VITAL STATISTICS... 117 HEALTH AND HEALTHCARE... 117 Healthcare Provision... 118 Pharmaceutical Services... 119 PHARMACEUTICAL MARKET... 119 GENERICS SECTOR... 120 Generics Industry... 121 TABLE 24 LEADING GENERICS COMPANIES IN SPAIN, 2010 ($ MILLIONS)... 121 TABLE 25 PHARMACEUTICAL AND GENERICS MARKET IN SPAIN, THROUGH 2016 ($ BILLIONS)... 122 UNITED KINGDOM... 122 VITAL STATISTICS... 122 HEALTH AND HEALTHCARE... 122 Healthcare Provision... 123 Private Sector Involvement... 123 Pharmaceuticals... 124 THE PHARMACEUTICAL MARKET... 124 GENERICS SECTOR... 125
TABLE 26 PHARMACEUTICAL AND GENERICS MARKET IN THE UNITED KINGDOM, THROUGH 2016 ($ BILLIONS)... 126 RUSSIA... 126 VITAL STATISTICS... 126 HEALTH AND HEALTHCARE... 127 Healthcare Delivery... 127 PHARMACEUTICAL MARKET... 127 Pharma 2020... 128 GENERICS SECTOR... 128 TABLE 27 PHARMACEUTICAL AND GENERICS MARKET IN RUSSIA, THROUGH 2016 ($ BILLIONS)... 129 CHAPTER EIGHT: THE ASIAN REGION... 130 JAPAN... 130 VITAL STATISTICS... 130 HEALTH AND HEALTHCARE... 130 PHARMACEUTICAL MARKET... 131 TABLE 28 TOP 5 JAPANESE PHARMA COMPANIES, 2008 (%)... 132 GENERICS SECTOR... 133 Foreign Presence... 134 Market Resistance... 135 Generics Industry... 136 TABLE 29 JAPANESE PHARMACEUTICAL AND GENERICS MARKET, 2011 2016 ($ BILLIONS)... 137 INDIA... 137 VITAL STATISTICS... 137 HEALTH AND HEALTHCARE... 137 Growing Affluence Changing Medical Needs... 138 Regulatory Changes... 138 PHARMACEUTICAL MARKET... 138 Demographic Factors... 139 Pharma Industry... 139 Patent Reform... 140 GENERICS INDUSTRY... 141 TABLE 30 LEADING PHARMA COMPANIES IN INDIA, 2010 ($ MILLIONS)... 141 TABLE 31 PHARMACEUTICAL AND GENERICS MARKET IN INDIA, THROUGH 2016 ($ BILLIONS)... 142 CHINA... 142 VITAL STATISTICS... 142 HEALTH AND HEALTHCARE... 142 Health and Healthcare (Continued)... 143 PHARMACEUTICAL MARKET... 144 Domestic Industry... 145 Foreign Company Involvement... 146
Importance of R&D... 147 Challenges... 148 Market Trends... 148 Regulatory Changes... 149 Generic Exports... 149 Domestic Generics Market... 150 Local Dominance... 151 FIGURE 5 GENERICS MARKET THERAPEUTIC CATEGORIES 2008 (%)... 152 TABLE 32 PHARMACEUTICAL AND GENERICS MARKET, CHINA, THROUGH 2016 ($ BILLIONS)... 153 CHAPTER NINE: PROFILES OF THE TOP TEN GENERICS COMPANIES... 154 TABLE 33 LEADING GENERICS MANUFACTURERS, 2010 ($ BILLIONS/%)... 154 TRENDS... 154 STRUCTURE OF THE GENERICS INDUSTRY... 155 PROFILES OF TOP 10 GENERICS COMPANIES... 156 ACTAVIS... 156 Actavis (Continued)... 157 APOTEX INC... 158 DR. REDDY S LABORATORIES, LTD.... 159 Acquisitions... 160 Financials... 161 HOSPIRA, INC.... 161 Biogenerics... 162 Financials... 163 MYLAN INC.... 163 Mylan Inc. (Continued)... 164 Financials... 165 Looking Ahead... 165 PAR PHARMACEUTICAL, INC.... 165 Generics... 166 Financials... 166 RANBAXY LABORATORIES, LTD.... 167 History... 167 Acquisition by Daiichi Sankyo... 168 Financials... 169 Looking Ahead... 169 SANDOZ INTERNATIONAL GMBH... 170 Products... 170 TEVA PHARMACEUTICAL INDUSTRIES, LTD.... 171 Teva Pharmaceutical Industries, Ltd. (Continued)... 172 Financials... 173 WATSON PHARMACEUTICALS, INC.... 174
Products... 174 Financials... 174 Looking Ahead... 175 CHAPTER TEN: PROFILES OF OTHER INTERNATIONAL GENERICS COMPANIES... 176 PROFILES... 176 ALAPIS GROUP... 176 AMNEAL PHARMACEUTICALS, LLC... 177 Amneal Pharmaceuticals Co. India Pvt., Ltd.... 177 ASPEN PHARMACARE HOLDINGS, LTD.... 178 Financial Results... 179 AUROBINDO PHARMA, LTD.... 180 Products... 180 Financials... 181 Looking Ahead... 181 BERLIN-CHEMIE AG... 181 BIOCON... 182 Biocon U.S.... 182 Biocon U.S. (Continued)... 183 Biocon U.S. (Continued)... 184 BIOGARAN FRANCE... 185 CIPLA, LTD.... 186 COBALT... 187 EGIS PHARMACEUTICALS, PLC... 188 APIs... 189 Pharmaceutical R&D... 189 GEDEON RICHTER, PLC... 190 GENEPHARM GROUP... 191 KRKA, D.D., NOVO MESTO... 192 Products... 193 Financials... 194 Looking Ahead... 194 KV PHARMACEUTICAL CO.... 194 LUPIN, LTD.... 194 Lupin, Ltd. (Continued)... 195 MITSUBISHI TANABE PHARMA CORP.... 196 Tanabe Seiyaku Hanbai Co., Ltd.... 196 NICHI-IKO PHARMACEUTICAL CO., LTD.... 197 Products... 197 Financials... 198 Looking Ahead... 198 NIPPON CHEMIPHAR CO., LTD... 198 Financials... 199 Looking Ahead... 199
NOVARTIS INTERNATIONAL AG... 199 Looking Ahead... 200 ORION CORP.... 200 Products... 200 Generics... 201 Financials... 201 Looking Ahead... 201 PFIZER INC.... 201 U.S. Basic Patent Expiry... 202 TABLE 34 PFIZER S U.S. PATENT EXPIRIES, THROUGH 2021... 202 Financials... 203 PLIVA D.D.... 203 ROXANE LABORATORIES, INC.... 204 SANOFI-AVENTIS... 205 Looking Ahead... 206 SAWAI PHARMACEUTICAL... 206 Products... 207 Financials... 207 Looking Ahead... 207 STADA ARZNEIMITTEL... 208 Generics... 208 Biosimilars... 209 Financials... 209 Looking Ahead... 209 STRIDES ARCOLAB, LTD.... 210 Product Range... 211 Looking Ahead... 211 WOCKHARDT, LTD.... 212 Financials... 213 Looking Ahead... 213 ZYDUS CADILA... 214 Zydus U.S. Corporate Office... 214 Zydus U.S. (Continued)... 215