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Biologics and Biosimilars World Markets.

LONDON, Feb. 3, 2014 /PRNewswire/ -- Reportbuyer.com just published a new market research report:

Biologics and Biosimilars World Markets

Biologics are complex molecules manufactured through cell culture recombinant DNA technology. Biologics additionally comprise recombinant insulin, growth hormone and monoclonal antibodies for treating conditions such as cancer and autoimmunity. Also known as follow-on biologics or subsequent entry biologics (SEBs), biosimilars are to biologics what generics are to branded drugs; they lower healthcare expenditures. This TriMark Publications report describes the emergence of biologics and biosimilars and their potential role in shaping the future of the global healthcare industry. The study analyzes the changing dynamics of the pharmaceutical market and provides insight into the regulatory pathways for branded pharmaceuticals and biologics, patent expirations, business strategies, clinical trials and drug applications. Key biologics and biosimilars are covered, including Humira (Adalimumab), Remicade (Infliximab), Lantus (Insulin Glargine), Levemir (Insulin Detemir), Privigen (Immune Globulin Intravenous), Aranesp (Darbepoetin Alfa), Enbrel (Etanercept), Herceptin (Trastuzumab) and Remicade (Infliximab). Moreover, this report examines companies that are actively developing and marketing biologics and biosimilars in the world. Detailed tables and charts with sales forecasts and marketshare data are also included.

TABLE OF CONTENTS

1. Overview 18 1.1 Statement of This Report 18 1.2 About This Report 18 1.3 Scope of the Report 19 1.4 Objectives 20 1.5 Methodology 20 1.6 Executive Summary 21 2. Pharmaceutical Industry: An Overview 23 2.1 Global R&D Spending by Pharma and Biotech Companies 23 2.1.1 Top 20 Companies in R&D Spending 24 2.1.2 Top 20 Most Valuable Pharmaceutical R&D projects 24 2.1.3 Most Valuable R&D Projects Ranked by Net Present Value 25 2.2 FDA New Drug Approvals 26 2.2.1 Top Ten NMEs 27 2.3 Impact of Patent Expirations 27 2.4 Immunity of Pharmaceutical Growth against Drop in GDP Growth 28 2.5 Minimal Annual Growth Rates of Pharmaceuticals in Developed Markets 29 2.6 Falling Operating Profit Rate for Big Pharma 30 2.7 Top Ten Global Pharmaceutical Firms 30 2.6 Top Ten Pharmaceuticals by Sales Revenue 32 2.7 Worldwide Prescription and OTC Sales by Therapy Area in 2018 33 2.8 Top Companies in Oncology Sales 34 2.8.1 Top Five Oncology Products 35 2.9 Top Companies in Anti-Diabetes Market 36 2.9.1 Top Five Anti-Diabetes Products 36 2.10 Top Ten Companies in Anti-Rheumatics Market 37 2.10.1 Top Ten Anti-Rheumatics Products 37 2.11 Top Ten Vaccine Companies and Global Sales 38 2.11.1 Top Five Vaccine Products 38 2.12 Top Ten Anti-Viral Companies 39 2.12.1 Top Five Anti-Viral Products 39 2.13 Top 50 Global Pharmaceutical Brands in 2018 40 2.14 M&A Transactions in 2012 41 2.15 Global Pharmaceutical Market 42 2.15.1 Global Pharmaceutical Sales by Region 42 2.15.2 North American Pharmaceutical Market 43 2.15.2.1 U.S. Prescription Drug Sales by Company 44 2.15.2.2 Top 50 Pharmaceutical Products in the U.S. 45 2.15.2.3 Top 50 Products in the U.S. in 2018 47 2.15.3 Pharmaceutical Market in Europe 48 2.15.3.1 European Prescription Drug Sales by Company 49 2.15.4 Pharmaceutical Market in Asia/Pacific 50 2.15.4.1 Prescription Drug Sales in Japan by Company 51 2.15.5 Pharmaceutical Market in Latin America 52 2.15.6 Pharmaceutical Market in Africa 53 2.15.7 Pharmaceutical Market in the Middle East 54 2.16 Regional Prescription Drug Sales in the U.S., Europe and Japan 55 2.17 Global Prescription Drug Sales 55 3. Brand Name Pharmaceuticals: A Brief Overview 57 3.1 Birth Pangs and Life Span of Branded Drugs 57 3.2 Major Patent Expiries of Branded Drugs 58 3.3 Global Market for Branded Drugs 59 3.4 Increasing R & D Pipeline 59 3.4.1 The 2012 R & D Pipeline by Phase 60 3.4.2 Top Companies by Pipeline Size 61 3.4.3 Total Number of Companies with Active R&D 62 3.4.4 Global Distribution of Companies Active in Pharma R&D 63 3.4.5 Top Therapy Areas in R & D 64 3.4.5.1 Top 25 Individual Diseases in the R & D Pipeline 65 3.4.6 Top 20 Mechanism of Action in R & D Pipeline 66 3.4.7 Top 25 Drug Protein Targets 67 4. Generic Drugs: A Brief Overview 69 4.1 Bioequivalence of Generics 69 4.2 Global Market for Generics 70 4.3 Operating Profit Rate for Generic Companies 71 4.4 Outsourced Manufacture of Generics 72 4.5 Generic Utilization in International Markets 73 4.6 Global Generic Sales by Company 74 5. Biologics 76 5.1 Regulations for Biologics 76 5.2 Complexity of Biologics 76 5.3 Concentration of Global Biopharmaceutical Manufacturing 77 5.4 Number of Biologics Available in the Global Market 78 5.5 Share of Biologics by Country/Region 79 5.6 Rate of Growth for Biologics by Region 80 5.6.1 Growth Rates of APIs and Biologics Compared 80 5.7 Manufacturing Capacity of Biologics 81 5.8 Biologics Market by Segment 82 5.9 Patent Expiry for Biologic Drugs 83 5.9.1 India's Opportunity from Biologic Patent Expirations 84 5.10 Major Players in Biologics 85 5.11 Biopharm Outsourcing 86 5.12 Top 20 Biologics by Sales 87 5.12.1 Roche's Biologics Arsenal 88 5.12.2 Johnson & Johnson's Biologics Arsenal 89 5.12.3 Lonza in Biologics 89 5.13 The Best Selling Biologics by Class 89 5.14 Biologic Drugs: Market Trends in the Past Seven Years 90 5.14.1 Global Market for Biologics 90 5.15 Global and U.S. Sales of Blockbuster Biologics 92 5.15.1 Global Market for Humira 92 5.15.1.1 Humira (adalimumab) Pen's Market by Geography 92 5.15.1.2 U.S. Sales of Humira 93 5.15.1.3 The Leader among Biologics 94 5.15.2 Global Market for Remicade 94 5.15.2.1 Remicade's Market by Geography 95 5.15.2.2 U.S. Sales of Remicade 96 5.15.3 Global Market for Enbrel 97 5.15.3.1 Enbrel's Market by Geography 97 5.15.3.2 U.S. Sales of Enbrel 98 5.15.4 Global Market for Symponi 99 5.15.5 Global Market for Tysarbi 100 5.15.5.1 U.S. Market for Tysarbi 101 5.15.6 Global Market for Lantus 101 5.15.6.1 Lantus' Market by Geography 102 5.15.6.2 U.S. Market for Lantus 103 5.15.7 Global Market for NovoRapid 103 5.15.7.1 Market for Novolog/Novorapid by Geography 104 5.15.7.2 U.S. Market for NovoRapid 105 5.15.8 Global Market for Victoza 105 5.15.9 Global Market for Levemir 107 5.15.9.1 U.S. Market for Levemir 108 5.15.10 Global Market for Humalog 108 5.15.10.1 Market for Humalog by Geography 110 5.15.11 Global Market for Neulasta 110 5.15.11.1 Neulasta's Market by Geography 111 5.15.11.2 U.S. Market for Neulasta 112 5.15.12 Global Market for Privigen 112 5.15.13 Global Market for Perjeta 113 5.15.14 Global Market for Xgeva/Prolia 114 5.15.15 Global Market for Soliris 116 5.15.15.1 U.S. Market for Soliris 117 5.15.16 Global Market for Botox 117 5.15.17 Global Market for Lucentis 119 5.15.17.1 U.S. Market for Lucentis 120 5.15.18 Global Market for Eylea 120 5.15.19 Global Market for Avastin 122 5.15.19.1 U.S. Market for Avastin 123 5.15.20 Global Market for Rituxan 123 5.15.20.1 Rituxan's Market by Geography 124 5.15.20.2 U.S. Market for Rituxan 125 5.15.21 Global Market for Revlimid 125 5.15.22 Global Market for Herceptin 127 5.15.22.1 Herceptin's Market by Geography 127 5.15.21.2 U.S. Market for Herceptin 128 5.15.22 Global Market for Prenvar 13 129 5.15.22.1 U.S. Market for Prenvar 13 130 5.15.23 Global Market for Gardasil 130 5.15.24 Global Market for Fluzone/Varigrip 132 5.15.25 Global Market for Varivax 132 5.15.26 Global Market for Stelara 134 5.15.26.1 U.S. Market for Stelara 135 5.15.27 Global Market for Actemra 135 5.15.28 Global Market for Gammagard Liquid 136 5.16 The U.S. Biotech Landscape 138 5.16.1 Top U.S. Biotech Companies 138 5.16.1.1 Amgen 138 5.16.1.2 Gilead Sciences 139 5.16.1.3 Biogen Idec, Inc. 140 5.16.1.4 Celgene Corporation 141 5.16.1.5 Genzyme (Sanofi) 141 5.16.1.6 Life Technologies Corporation 142 5.16.1.7 Cephalon, Inc/Teva Pharmaceutical Industries Ltd. 142 5.16.1.8 Alexion Pharmaceuticals, Inc. 142 5.16.1.9 Cubist Pharmaceuticals, Inc. 142 5.16.1.10 United Therapeutics Corporation 143 5.16.2 Overall Performance of the U.S. Biotech Companies 143 5.16.3 R & D Spending by Biotech Companies in the U.S. 143 5.16.4 U.S. Market for Biologic Drugs 144 5.16.5 The Leading Biologic Drug Classes in Terms of U.S. Sales 145 5.16.5.1 Top Selling Biologic Drugs in the U.S. 146 5.16.5.2 U.S. Sales of Biologics by Manufacturer 147 5.16.6 U.S. Sales of mAbs 148 5.16.7 U.S. Sales of Recombinant Hormones 149 5.16.8 U.S. Sales of Blood Cell Growth Factors 150 5.16.9 U.S. Market for Cytokines 151 5.16.10 U.S. Sales of Blood Factors 152 5.16.11 U.S. Sales of Therapeutic Enzymes 153 5.16.12 U.S. Sales of Recombinant Vaccines 154 5.16.13 U.S. Sales of Recombinant Anticoagulants 154 5.16.14 Costs of Commonly Used Biologicals in the U.S. 155 5.16.15 Biologics Used for Treating Rheumatoid Arthritis 156 5.16.15.1 Cost Comparison of Arthritis Biologics 157 5.17 Biologics in Europe 157 5.17.1 Uptake of Biologics in Europe by Drug Type 158 5.17.2 European Market for mAbs 159 5.18 Biologics in Hemophilia 160 5.18.1 Marker Leaders in Hemophilia 160 5.18.2 Hemophilia A 161 5.18.3 Hemophilia B 162 5.18.4 Inhibitors 163 6. Biosimilars 164 6.1 Different Names in Different Countries for Biologics 164 6.2 E.U. Approval Pathway for Biosimilars 164 6.3 Contentious Issues in Biosimilars 164 6.4 Biosimilars Opp ortunity 164 6.5 Challenges in Biosimilar Introduction 165 6.6 Production and Market Access of Biosimilars 165 6.7 Country Selection for Biosimilars 165 6.8 High Barriers to the Entry of Biosimilars 165 6.9 Global Competition among Biosimilars 166 6.10 Definitions and Interpretations of Biosimilar Products 167 6.10.1 Regulatory Requirements 167 6.10.1.1 World Health Organization (WHO) 167 6.10.1.2 Key Principles and Basic Concept 168 6.10.2 Reference Biotherapeutic Product 168 6.10.2.1 Quality 168 6.10.2.2 Non-Clinical and Clinical Studies 168 6.10.3 E.U. 169 6.10.3.1 Key Principles and Basic Concept 169 6.10.3.2 Reference Biotherapeutic Product 170 6.10.3.3 Quality 170 6.10.3.4 Non-Clinical and Clinical Evaluation 170 6.10.3.5 Product Class-Specific Guidelines 170 6.10.4 U.S. 171 6.10.5 Canada 172 6.10.6 Japan 172 6.10.7 Korea 172 6.11 FDA Guidelines for Biosimilars 173 6.12 Market Drivers 173 6.12.1 Cost Pressures 173 6.13 Core Therapy Areas for Biosimilars 173 6.14 Competitive Landscape in Biosimilar Sector 174 6.15 Opportunities for Biosimilars in Three Geographies 175 6.15.1 Opportunities for Biosimilars in the U.S. 175 6.15.2 European Opportunities for Biosimilars 176 6.15.3 Opportunities for Biosimilars in Emerging Markets 176 6.16 Biosimilar Experience 177 6.17 Development of Biosimilars 178 6.17.1 Current and Future Trends in Biosimilar Development 178 6.18 Top Players in Biosimilars Market 179 6.18.1 Other Key Players in Biosimilars Market 181 6.19 Number of Biologics Patent Expiries Prior to 2020 182 6.19.1 Biologics Patent Expiries by Region 183 6.20 Monoclonal Antibodies: The Key Focus Area for Biosimilars Development 184 6.20.1 Biosimilar mAbs in Pipeline 184 6.20.2 Disease Indications for Biosimilar mAbs 186 6.21 Global Leaders in Biosimilars 187 6.22 Market Leading Biosimilars 187 6.23 Biosimilar Opportunities: Only for the Heartiest Biotech Firms 188 6.24 Biosimilars Pipeline by Class 189 6.25 Global Biosimilars Market 189 6.25.1 Estimated Value and Growth Rates for Biosimilars by Type 190 6.25.2 Market Leading Biosimilars in 2015 191 6.26 Regulations for Biosimilars in the U.S. 192 6.26.1 BPCIA and Guidance 192 6.26.2 Scientific Considerations 193 6.26.3 Quality Considerations 193 6.26.4 Biosimilar User Fee Act 193 6.26.5 12-Year Exclusivity Period 194 6.26.6 Biosimilars Competitive Landscape in the U.S. 195 6.26.7 Manufacturing Capabilities 195 6.26.8 Clinical Trial Experience 196 6.26.9 Market Experience 197 6.26.10 Likely Early Entrants 197 6.26.11 Recombinant Protein Competition 198 6.26.12 mAbs Competition 198 6.27 U.S. Biosimilars Market 199 6.27.1 HGH Biosimilars in the U.S. Market 200 6.27.2 Cost Benefits from Biosimilars for U.S. Healthcare 201 6.27.3 Development Pipeline and Market Evolution of Biosimilars in the U.S. 202 6.27.3.1 Target Reference Products 203 6.27.3.2 Launchable Dates for Biosimilars in the U.S. 203 6.27.3.3 Number of Biosimilar Products in the Pipeline 205 6.28 Geographic Distribution of Biosimilars Pipeline 206 6.28.1 Developers of Biosimilars 207 6.29 Future of U.S. Biosimilars Market 209 6.29.1 Future Pricing Models 210 6.29.2 Future Price Reduction and the Profit Margin 210 6.30 Biosimilars Market in Europe and Japan 211 6.30.1 The Instant Growth of Biosimilars in Europe 212 6.30.2 Biosimilar mAbs on the Horizon in Europe 213 6.30.3 Biosimilars Approved in the E.U 214 6.30.4 Utilization of G-CSF in Europe 215 6.31 Revenue Forecast for Biosimilar Insulins 216 6.32 Revenue Forecast for Biosimilar HGH 217 6.33 Revenue Forecast for Biosimilar IFN Alpha 218 6.34 Revenue Forecast for Biosimilar IFN Beta Ia 218 6.35 Revenue Forecast for Biosimilar Filgrastim 219 6.36 Revenue Forecast for Biosimilar Epoetin Alpha 220 6.37 Uptake of Biosimilars in Europe 220 6.38 Biosimilars in China 221 6.38.1 Biosimilars Sales in China 222 6.39 Indian Market for Biosimilars 223 6.39.1 Domestic Biosimilar Developers in India 224 6.40 Biosimilar Pipeline of Celtrion in Korea 225 6.41 Deals in Biosimilar Space 226 6.41.1 Technologies 226 6.41.2 Manufacturing Agreements 226 6.41.3 Clinical Development 227 6.41.4 Licensing Agreements 227 6.42 Transactions in Biosimilars Industry 227 6.42.1 Biosimilars Market: Opportunities and Challenges 228 6.42.2 Recent Transactions in Biosimilars Industry 229 6.43 Top Ten Biosimilar Drugs to Watch 230 6.43.1 Aranesp (darbepoetin alfa) 230 6.43.2 Enbrel (etanercept) 231 6.43.3 Epogen/Procrit/Eprex/Erypo (epoetin alfa) 231 6.43.4 Genotropin (somatropin) 231 6.43.5 Herceptin (trastuzumab) 232 6.43.6 Humira (adalimumab) 232 6.43.7 Neulasta (pegfilgrastim) 233 6.43.8 Neupogen (filgrastim) 233 6.43.9 Remicade (infliximab) 234 6.43.10 Rituxan/MabThera (rituximab) 234 7. Company Profiles 236 7.1 3Bio, Inc. 236 7.1.1 EPIAO 236 7.1.2 TPIAO 236 7.1.3 INTEFEN 237 7.1.4 INLEUSIN 237 7.1.5 IV Iron Sucrose 237 7.2 Abbott Laboratories 238 7.3 AbbVie, Inc. 239 7.3.1 Products 239 7.4 Actelion Ltd. 240 7.5 Amgen, Inc. 240 7.5.1 Neulasta (filgrastim) 240 7.5.2 Enbrel (etanercept) 241 7.5.3 Aranesp (darbepoetin alfa) 241 7.5.4 Epogen (epoetin alfa) 241 7.5.5 Sensipar/Mimpara (cinacalcet) 241 7.5.6 Vectibix (panitumumab) 241 7.5.7 Nplate (romiplostim) 242 7.5.8 Prolia/Xgeva (denosumab) 242 7.6 Amoytop Biotech Co., Ltd 242 7.6.1 Molgramostim (rhGM-CSF) 242 7.6.2 Filgrastim (rh G-CSF) 243 7.6.3 Oprelvekin (rhIL-11) 243 7.7 Anhui Anke Biotechnology (Group) Co., Ltd. 243 7.7.1 Alteferon alpha 2b Injection 244 7.7.2 Ansomone 244 7.7.3 Anteferon alpha 2b Cream 244 7.7.4 Anteferon alpha 2b Eyedrop 244 7.8 Apotex, Inc. 244 7.9 Astellas Pharma, Inc. 245 7.10 AstraZeneca 246 7.10.1 AstraZeneca's R&D Portfolio 246 7.10.2 Patent Expiries of AstraZenecas Products 247 7.11 Bayer AG 247 7.12 Beijing Four Rings Biopharmaceuticals 248 7.12.1 Products 248 7.13 Bharat Serums and Vaccines Limited 248 7.14 Biocon Ltd. 249 7.15 Biogen Idec, Inc. 252 7.16 Bioton SA 253 7.17 Boehringer Ingelheim Pharmaceuticals, Inc. 253 7.18 Bristol-Myers Squibb, Co. 254 7.19 Celgene Corporation 255 7.20 Celltrion, Inc. 255 7.20.1 Technology Overview 255 7.20.2 Biosimilars Development 256 7.20.3 Contract Manufacturing 256 7.21 Cipla Ltd. 256 7.21.1 Cipla's Prescription Product Category 256 7.22 Dr. Reddy's Laboratories Ltd. 257 7.23 Elan Corporation, PLC 259 7.23.1 Tysarbi 259 7.24 Eli Lilly & Co. 259 7.25 Gideon Richter 259 7.26 Gilead Sciences, Inc. 260 7.27 GlaxoSmithKline PLC 261 7.28 Hospira, Inc. 263 7.29 Intas Pharmaceuticals Limited 264 7.30 Johnson & Johnson 265 7.31 Merck & Co., Inc. 265 7.32 Mylan, Inc. 267 7.32.1 Mylan's Generics 267 7.32.2 Mylan's Active Pharmaceutical Ingredients 267 7.32.3 Mylan's Specialty 267 7.32.4 Mylan's Anti-Retroviral Franchise 267 7.33 Novartis AG 268 7.34 Pfizer, Inc. 269 7.35 Roche Holdings AG 270 7.36 Sandoz International GmbH 272 7.37 Sanofi 272 7.38 Stada Arzneimittel Aktiengesellschaft 274 7.39 Teva Pharmaceutical Industries Limited 275 7.40 Watson Pharmaceuticals, Inc. 276

APPENDIX

Appendix 1: Biologic Medicines by Development Phase 278 Appendix 2: Declining Medicine Use in the U.S. 302 Appendix 2.1: Changes in Utilization 302 Appendix 2.2: Healthcare Costs and Spending on Medicines 303 Appendix 2.3: Total Spending on Medicines 306 Appendix 2.4: Transformations in Disease Treatment 316 Appendix 2.5: Key Breakthrough Therapies Approved in 2012 319 Appendix 2.5.1: Cystic Fibrosis: ivacaftor (Kalydeco) 319 Appendix 2.5.2: Rheumatoid Arthritis: tofacitinib (Xeljanz) 320 Appendix 2.5.3: Basal-cell carcinoma: vismodegib (Erivedge) 320 Appendix 2.5.4: Irritable bowel syndrome with constipation: linaclotide (Linzess) 320 Appendix 2.5.5: HIV: emtricitabine and tenofovir disoproxil fumarate (Truvada) 320 Appendix 2.5.6: Combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate 320 Appendix 2.6: Spending in Major Therapies 320 Appendix 2.6.1: Oncology Spending (25.9 Billion) by Area, 2012 321 Appendix 2.6.1.1: U.S. Market for Oncology Drugs 322 Appendix 2.6.1.2: U.S. Market for Rituxan 323 Appendix 2.6.1.3: U.S. Market for Avastin 324 Appendix 2.7: Mental Health Spending by Area 324 Appendix 2.7.1: U.S. Market for Mental Health Drugs 325 Appendix 2.7.2: U.S. Market for Cymbalta 326 Appendix 2.7.3: U.S. Market for Abilify 327 Appendix 2.8: Respiratory Spending by Area 328 Appendix 2.8.1: U.S. Market for Respiratory Drugs 329 Appendix 2.8.2: U.S. Market for Adavir 330 Appendix 2.8.3: U.S. Market for Singulair 331 Appendix 2.8.4: U.S. Market for Spiriva 332 Appendix 2.9: Antidiabetes Spending by Area 332 Appendix 2.9.1: U.S. Market for Antidiabetics 333 Appendix 2.9.2: U.S. Market for Januvia 334 Appendix 2.9.3: U.S. Market for Lantus 335 Appendix 2.9.4: U.S. Market for Lantus SoloSTAR 336 Appendix 2.10: Pain Spending by Area 337 Appendix 2.10.1: U.S. Market for Pain Management Drugs 338 Appendix 2.11: U.S. Market for Medicines Used in Nervous System Disorders 339 Appendix 2.11.1: U.S. Market for Oxycontin 340 Appendix 2.11.2: U.S. Market for Lyrica 340 Appendix 2.11.3: U.S. Market for Copaxone 341 Appendix 2.12: U.S. Market for Lipid Regulators 342 Appendix 2.12.1: U.S. Market for Crestor 343 Appendix 2.13: U.S. Market for Autoimmune Drugs 343 Appendix 2.13.1: U.S. Market for Humira 344 Appendix 2.13.2: U.S. Market for Enbrel 345 Appendix 2.13.3: U.S. Market for Remicade 346 Appendix 2.14: U.S. Market for Medicines Used for Multiple Sclerosis 347 Appendix 2.15: U.S. Market for Antiulcerants 348 Appendix 2.15.1: U.S. Market for Nexium 349 Appendix 2.16: U.S. Market for Neulasta 349 Appendix 2.17: U.S. Market for Epogen 350 Appendix 2.18: U.S. Market for Platelet Aggregation Inhibitors 351 Appendix 2.18.1: U.S. Market for Plavix 352 Appendix 2.19: U.S. Market for HIV Antivirals 352 Appendix 2.19.1: U.S. Market for Atripla 353 Appendix 2.19.2: U.S. Market for Truvada 354 Appendix 2.20: U.S. Market for Antibacterials 355 Appendix 2.21: U.S. Market for Antihypertensives 356 Appendix 2.21.1: U.S. Market for Diovan 356 Appendix 2.22: U.S. Market for ADHD 357 Appendix 2.23: U.S. Market for Vaccines (Pure, Comb and Others) 358 Appendix 2.24: U.S. Market for Systemic Hormonal Contraceptives 359 Appendix 2.25: Number of Treated Patients in Selected Therapies in the U.S. 360 Appendix 2.26: Top Therapeutic Classes of Drugs Prescribed in the U.S. 361 Appendix 2.27: Top Medicines Prescribed in the U.S. 362 Appendix 3: Pharma Deals in 2012 364 Appendix 4: Pharma Outsourcing in Asia 367 Appendix 4.1: Cluster One: Pharma Revenue Constraints 367 Appendix 4.2: Cluster Two: Asia Growth Forces 367 Appendix 4.3: Cluster Three: East/West Convergence/Divergence Trends 368 Appendix 4.4: Cluster Four: Technological/Business Model Forces 369 Appendix 4.5: Implications of the Four Clusters for Asia Outsourcing 369 Appendix 4.5.1: Rapid Expansion of Clinical Trials in Asia 370 Appendix 4.5.2: Manufacturing Scales 370 Appendix 4.5.3: Risk and Opportunity Overview 370 Appendix 4.5.4: Cost Ranking of Asian Territories 371 Appendix 4.5.5: Market Opportunity Ranking 372 Appendix 4.6: Outsourcing Hot Spots in Asia 373 Appendix 4.6.1: China 373 Appendix 4.6.2: India 375 Appendix 4.6.3: Singapore 376 Appendix 5: The Changing Payment Landscape for the U.S. Pharmaceutical Industry 378 Appendix 5.1: The Impetus for Defining Value 378 Appendix 5.1.1: Force I 378 Appendix 5.1.2: Force II 379 Appendix 5.1.3: Force III 380 Appendix 5.1.4: Force IV 381 Appendix 5.1.5: Force V 382 Appendix 5.2: The New Arbiters of Value 383 Appendix 5.2.1: Prescribers Looking for Value 383 Appendix 5.2.2: More Investment in Comparative Effectiveness Research 384 Appendix 5.2.3: Unleashing of Imprisoned Value 384 Appendix 5.2.4: Role of Companion Diagnostics 385 Appendix 5.2.5: Outcomes-Dependent Contracts 386 Appendix 5.2.6: Data-Sharing Agreements 388 Appendix 5.2.7: Patient-Reported Outcomes 389 Appendix 5.2.8: Evidence Needed to Secure Formulary Slots 390 Appendix 6: Medical Cost Trend in the U.S., 2013 391 Appendix 6.1: The Components of Medical Cost 391 Appendix 6.2: Leading Factors in Setting Insurance Premiums 392 Appendix 6.3: Factors Affecting 2013 Trend 392 Appendix 6.3.1: Medical Supply and Equipment Cost 392 Appendix 6.3.2: Newer Delivery Methods for Primary Care 393 Appendix 6.4: Uptick in Utilization and Expensive Advances 394 Appendix 6.4.1: Economic Utilization and Economic Growth 394 Appendix 6.4.2: Medical Advances Driving Growth 394 Appendix 6.4.3: The "New Normal" 396 Appendix 6.4.4: Current Practices by Employers 397 Appendix 6.4.4.1: Things to be considered by Employers 397 Appendix 6.5: Current Practices by Providers 397 Appendix 6.5.1: Things to be considered by Providers 398 Appendix 6.6: Current Practices by Hwealth Insurers 398 Appendix 6.6.1: Things to be considered by Health Insurers 398 Appendix 6.7: Current Practices by Pharmaceutical and Life Sciences 399 Appendix 6.7.1: Things to be considered by Pharmaceutical and Life Sciences 399 Appendix 7: Naming of Drug Molecules and Pharmaceutical Brands 400 Appendix 7.1: Names of a Drug 400 Appendix 7.1.1: Chemical Name 400 Appendix 7.1.2: Generic Name 400 Appendix 7.2: Brand Name 401 Appendix 7.2.1: Criteria for Brand Names 402 Appendix 7.3: Stories behind Some Blockbuster Molecules 403

INDEX OF FIGURES

Figure 2.1: Global R&D Spending by Pharma and Biotech Companies, 2005-2018 23 Figure 2.2: Worldwide Sales at Risk by Patent Expiration, 2004-2018 28 Figure 2.3: Immunity of Pharmaceutical Growth against Drop in GDP Growth 29 Figure 2.4: Falling Operating Profit Rate for Big Pharma 30 Figure 2.5: Global Pharmaceutical Market, 2012-2019 42 Figure 2.6: Global Pharmaceutical Sales by Region 43 Figure 2.7: North American Pharmaceutical Market, 2012-2019 44 Figure 2.8: European Pharmaceutical Market, 2012-2019 48 Figure 2.9: Pharmaceutical Market in Asia/Pacific, 2012-2019 51 Figure 2.10: Pharmaceutical Market in Latin America, 2012-2019 53 Figure 2.11: Pharmaceutical Market in Africa, 2012-2019 54 Figure 2.12: Pharmaceutical Market in the Middle East, 2012-2019 55 Figure 2.13: Worldwide Total Prescription Drug Sales, 2004-2018 56 Figure 3.1: The Long-Drawn R & D Process for Branded Drugs 58 Figure 3.2: Global Market for Branded Drugs, 2012-2019 59 Figure 3.3: R & D pipeline, 2001-2012 60 Figure 3.4: R & D Pipeline by Phase, 2007-2012 61 Figure 3.5: Total Number of Companies with Active R & D, 2000-2012 63 Figure 3.6: Global Distribution of Companies Active in Pharma R&D, 2012 64 Figure 4.1: Differences between Originals and Copies (Branded/Generics & Biologics/Biosimilars) 69 Figure 4.2: Global Market for Generics, 2012-2019 71 Figure 4.3: Operating Profit Rate for Top Six Generic Companies, 2006-2012 72 Figure 4.4: Outsourced Manufacturing of Generics by Region/Country 73 Figure 4.5: Generic Drug Use in International Markets 74 Figure 5.1: The Biologic Drug Development Process 76 Figure 5.2: Comparison of Small Molecule Drugs and Biologics 77 Figure 5.3: Concentration of Global Biopharmaceutical Manufacturing as of 2013 78 Figure 5.4: Share of Biologics Sales by Country/Region 79 Figure 5.5: Rate of Growth for Biologics by Region 80 Figure 5.6: Growth Rates (CAGR) of APIs and Biologics Compared 81 Figure 5.7: Global Installed Biopharmaceutical Manufacturing Capacity by Top Ten Companies 82 Figure 5.8: Biologics Market by Segment 83 Figure 5.9: Top Biologics Losing Patent Protection and Market Exclusivity Prior to 2018 84 Figure 5.10: Global Value and Number of Biologic Drugs Losing Patent Protection, 2010-2015 85 Figure 5.11: Top Ten Biopharmaceuticals Manufacturing Companies 85 Figure 5.12: Outsourcing Trends in Biological Production across All Cell-Based Platforms 86 Figure 5.13: The Largest Selling Biologics by Class, 2012 89 Figure 5.14: Global Biologic Drugs Market Trends, 2006-2012 90 Figure 5.15: Global Market for Biologics, 2010-2020 91 Figure 5.16: Global Market for Humira, 2012-2019 92 Figure 5.17: Humira Pen's Market by Geography 93 Figure 5.18: U.S. Market for Humira, 2012-2019 93 Figure 5.19: Global Market for Remicade, 2012-2019 95 Figure 5.20: Remicade's Market by Geography 96 Figure 5.21: U.S. Market for Remicade, 2012-2019 96 Figure 5.22: Global Market for Enbrel, 2012-2019 97 Figure 5.23: Enbrel's Market by Geography 98 Figure 5.24: U.S. Market for Enbrel, 2012-2019 98 Figure 5.25: Global Market for Simponi, 2012-2019 99 Figure 5.26: Global Market for Tysarbi, 2012-2019 100 Figure 5.27: U.S. Market for Tysabri, 2012-2019 101 Figure 5.28: Global Market for Lantus, 2012-2019 102 Figure 5.29: Lantus' Market Share by Geography 102 Figure 5.30: U.S. Market for Lantus, 2012-2019 103 Figure 5.31: Global Market for NovoRapid, 2012-2019 104 Figure 5.32: Market for Novolog/Novorapid by Geography 104 Figure 5.33: U.S. Market for NovoRapid, 2012-2019 105 Figure 5.34: Global Market for Victoza, 2012-2019 106 Figure 5.35: U.S. Market for Victoza, 2012-2019 106 Figure 5.36: Global Market for Levemir, 2012-2019 107 Figure 5.37: U.S. Market for Levemir, 2012-2019 108 Figure 5.38: Global Market for Humalog, 2012-2019 109 Figure 5.39: U.S. Market for Humalog, 2012-2019 109 Figure 5.40: Humalog's Market by Geography 110 Figure 5.41: Global Market for Neulasta, 2012-2019 111 Figure 5.42: Neulasta's Market Share by Geography 111 Figure 5.43: U.S. Market for Neulasta, 2012-2019 112 Figure 5.44: Global Market for Privigen, 2012-2019 113 Figure 5.45: Global Market for Perjeta, 2012-2019 114 Figure 5.46: Global Market for Xgeva/Prolia, 2012-2019 115 Figure 5.47: U.S. Market for Xgeva/Prolia, 2012-2019 115 Figure 5.48: Global Market for Soliris, 2012-2019 116 Figure 5.49: U.S. Market for Soliris, 2012-2019 117 Figure 5.50: Global Market for Botox, 2012-2019 118 Figure 5.51: U.S. Market for Botox, 2012-2019 118 Figure 5.52: Global Market for Lucentis, 2012-2019 119 Figure 5.53: U.S. Market for Lucentis, 2012-2019 120 Figure 5.54: Global Market for Eylea, 2012-2019 121 Figure 5.55: U.S. Market for Eylea, 2012-2019 121 Figure 5.56: Global Market for Avastin, 2012-2019 122 Figure 5.57: U.S. Market for Avastin, 2012-2019 123 Figure 5.58: Global Market for Rituxan, 2012-2019 124 Figure 5.59: Rituxan's Market Share by Geography 124 Figure 5.60: U.S. Market for Rituxan, 2012-2019 125 Figure 5.61: Global Market for Revlimid, 2012-2019 126 Figure 5.62: U.S. Market for Revlimid, 2012-2019 126 Figure 5.63: Global Market for Herceptin, 2012-2019 127 Figure 5.64: Herceptin's Market Share by Geography 128 Figure 5.65: U.S. Market for Herceptin, 2012-2019 128 Figure 5.67: Global Market for Prenvar 13, 2012-2019 129 Figure 5.68: U.S. Market for Prenvar 13, 2012-2019 130 Figure 5.69: Global Market for Gardasil, 2012-2019 131 Figure 5.70: U.S. Market for Gardasil, 2012-2019 131 Figure 5.71: Global Market for Fluzone/Varigrip, 2012-2019 132 Figure 5.72: Global Market for Varivax, 2012-2019 133 Figure 5.73: U.S. Market for Varivax, 2012-2019 133 Figure 5.74: Global Market for Stelara, 2012-2019 134 Figure 5.75: U.S. Market for Stelara, 2012-2019 135 Figure 5.76: Global Market for Actemra, 2012-2019 136 Figure 5.77: Global Market for Gammagard Liquid, 2012-2019 137 Figure 5.78: U.S. Market for Gammagard Liquid, 2012-2019 137 Figure 5.79: U.S. Market for Biologic Drugs, 2007-2012 145 Figure 5.80: The Leading Biologic Drug Classes in Terms of U.S. Sales 146 Figure 5.81: Top Selling Biologic Drugs in the U.S. 147 Figure 5.82: U.S. Sales of Biologics by Manufacturer 148 Figure 5.83: U.S. Sales of mAbs 149 Figure 5.84: U.S. Sales of Recombinant Hormones 150 Figure: 5.85: U.S. Sales of Blood Cell Growth Factors 151 Figure 5.86: U.S. Sales of Cytokines 5.16.10 152 Figure 5.87: U.S. sales of Blood Factors 153 Figure 5.89: U.S. Sales of Therapeutic Enzymes 153 Figure 5.90: U.S. Sales of Recombinant Vaccines 154 Figure 5.91: U.S. Sales of Recombinant Anticoagulants 155 Figure 5.92: Market for Biologics in Europe, 2012-2019 158 Figure 5.93: Uptake of Biologics in Europe by Drug Type 159 Figure 5.94: European Market for mAbs 160 Figure 5.95: Hemophilia Market Share by Company, 2016 161 Figure 6.1: Core Therapy Areas for Biosimilars 174 Figure 6.2: Biosimilars' Market by Geography/Country 175 Figure 6.3: Top Players in Biosimilars Market 180 Figure 6.4: Number of Biologics per Indication to Go Off Patent prior to 2020 183 Figure 6.5: Patent Expiration of leading mAbs 184 Figure 6.6: Biosimilar mAbs in Pipeline 185 Figure 6.7: Disease Indications for Biosimilar mAbs Currently in Clinical Trials 186 Figure 6.8: Global Leaders in Biosimilars, 2012 187 Figure 6.9: Projected Biosimilars Market Split ($10 Billions) in 2015 188 Figure 6.10: The Exploding Global Biosimilars Market, 2012-2020 190 Figure 6.11: Estimated Value and Growth Rates for Biosimilars by Type, 2015 191 Figure 6.12: Global Spending (%) for Biosimilars by Drug Type ($2.5 Billion), 2015 192 Figure 6.13: Biosimilars Market in the U.S., 2011-2019 200 Figure 6.14: HGH Biosimilars in the U.S. Market, June 2009-September 2012 201 Figure 6.15: Projected U.S. Spend on 11 Specific Biologics, 2012-2024 202 Figure 6.16: Biosimilar Launchable Dates in the U.S., 2012-2022 204 Figure 6.17: Cumulative Worldwide Sales of Reference Produc ts, 2012-2022 205 Figure 6.18: Geographic Distribution of Biosimilar Companies as of 2013 207 Figure 6.19: Number of Products by Country as of 2013 208 Figure 6.20: Biosimilars/Biobetters Companies by Size Range (Revenue $ Billions) Worldwide, 2013 209 Figure 6.21: Biosimilars Approved in the E.U., 2012 211 Figure 6.22: Biosimilars Market in Europe and Japan, 2012-2019 212 Figure 6.23: Annual European Sales of Filgrastim Products, 2010-2012 213 Figure 6.24: Number of Scientific Advice from EMA by Biosimilars Firms 214 Figure 6.25: Biosimilars Penetration Rate (%) in Daily G-CSF Class Market, 2012 216 Figure 6.26: Revenue Forecast for Biosimilar Insulin Glargine in Major Seven Markets, 2009-2020 217 Figure 6.27: Revenue Forecast for Biosimilar HGH in the Major Seven Markets, 2009-2020 217 Figure 6.29: Revenue Forecast for Biosimilar IFN Beta Ia in the Major Seven Markets, 2009-2020 219 Figure 6.30: Revenue Forecast for Biosimilar Filgrastim in the Major Seven Markets, 2009-2020 219 Figure 6.31: Revenue Forecast for Biosimilar Epoetin Alpha in the Major Seven Markets, 2009-2020 220 Figure 6.32: Biosimilars Uptake Rates in Europe's Top Five Countries, 2012 221 Figure 6.33: Market for Biosimilars in China, 2012-2019 223 Figure 6.34: Biosimilar Market in India, 2008-2012 224 Figure A.2.1: Percent Change in Hospital Admissions and Office Visits, 2012 303 Figure A.2.2: Percent Population, Prescriptions and Per Capita Change in Prescriptions by Age 304 Figure A.2.3: Therapy Areas for Largest Positive and Negative Contribution to Growth 304 Figure A.2.4: U.S. National Respiratory Illness Estimates, 2010-

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