Biologics and Biosimilars World Markets

Publisher Name :
Date:1-Aug-2013
No. of pages: 403

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.

Biologics and Biosimilars World Markets

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 Opportunity 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

List of Tables

Table 2.1: R&D Spending by Top 20 Companies, 2012-2018 24
Table 2.2: Top 20 Most Valuable Pharmaceutical R&D projects, 2018 25
Table 2.3: Most Valuable R&D Projects (Ranked by NPV), May 2012 and Current 26
Table 2.4: FDA Approval Count (NMEs & Biologics) vs. Fifth Year after Launch U.S. Product Sales 26
Table 2.5: Top Ten NMEs of 2012 Ranked by U.S. Consensus Sales in 2017 27
Table 2.6: Increasing Demand for Pharmaceuticals in Emerging Markets 29
Table 2.7: Top Ten Global Pharmaceutical Firms, 2011-2012 32
Table 2.8: Top Ten Pharmaceuticals by Sales in 2012 33
Table 2.9: Worldwide Prescription and OTC Sales by Therapy Area in 2018 34
Table 2.10: Top Ten Companies in Global Oncology Sales, 2012-2018 35
Table 2.11: Top Five Oncology Product Sales, 2018 35
Table 2.12: Top Ten Companies and Global Antidiabetic Sales, 2012-2018 36
Table 2.13: Top Five Anti-Diabetic Products, 2018 36
Table 2.14: Top Ten Companies and Global Anti-Rheumatic Sales, 2012-2018 37
Table 2.15: Top Five Anti-Rheumatic Products, 2012-2018 37
Table 2.16: Top Ten Companies and Total Global Vaccine Sales, 2012-2018 38
Table 2.17: Top Five Vaccine Products, 2018 38
Table 2.18: Top Ten Companies and Total Global Anti-Viral Sales, 2012-2018 39
Table 2.19: Top Five Anti-Viral Products, 2018 39
Table 2.20: Top 50 Global Pharmaceutical Brands in 2018 40
Table 2.21: M&A Transactions in 2012 41
Table 2.22: U.S. Prescription Drug Sales by Top 20 Companies, 2010-2012 45
Table 2.23: Top 50 Pharmaceutical Products in the U.S., 2012 45
Table 2.24: Top 50 Pharmaceutical Brands in the U.S. in 2018 47
Table 2.25: Prescription Drug Sales in Europe by Top 20 Companies, 2010-2012 50
Table 2.26: Prescription Drug Sales in Japan by the Top 20 Companies, 2010-2012 52
Table 2.27: Regional Prescription Drug Sales in the U.S., Europe and Japan (Top 20 Companies), 2012 55
Table 3.1: Patent Expiries by Country and Year, 2011-2015 58
Table 3.2: Top 25 Companies by R & D Pipeline Size, 2012 62
Table 3.3: Top 25 Therapeutic Categories in R & D, 2011-2012 65
Table 3.4: Top 25 Individual Diseases in the R & D Pipeline, 2012 66
Table 3.5: Top 20 Mechanism of Action in 2012 R&D Pipeline 67
Table 3.6: Top 25 Drug Protein Targets in 2012 R&D Pipeline 68
Table 4.1: Top 20 Companies in Global Generics Sales, 2012 75
Table 5.1: Number of Biologics Available in the Global Market 79
Table 5.2: Global Sales of Top 12 Biologics ($67 Billion), 2012 88
Table 5.3: Patent Protection for Roche’s Biologics 88
Table 5.4: Humira’s Revenues, Growth Rate and Market Share, 2010-2015 94
Table 5.6: Humira’s Revenues, Growth Rate and Market Share, 2016-2022 94
Table 5.7: Top U.S. Biotech Companies Ranked by Revenue, 2011-2012 138
Table 5.8: Sales if Neulasta/Neupogen, 2010-2012 139
Table 5.9: U.S. Biotechnology at a Glance, 2011-2012 143
Table 5.10: R & D Investment by the Top Ten Biotech Companies in the U.S., 2010-2012 144
Table 5.11: Cost of Commonly Used Biologics in the U.S. 155
Table 5.12: Biologics Used for Treating Rheumatoid Arthritis 156
Table 5.13: Biologics and Their Mode of Administration for Arthritis Patients 156
Table 5.14: Cost Comparison of Arthritis Biologics 157
Table 5.15: Total Hemophilia Market, 2011-2016 160
Table 5.16: Hemophilia A (Factor VIII) and von Willebrand Disease, Sales from Marketed Products and Late-Stage Pipeline, 2012-2016 162
Table 5.17: Hemophilia B, Marketed Products and Late Stage Pipeline, 2012-2016 163
Table 5.18: The Inhibitor Market: Products and Pipeline 163
Table 6.1: Definitions of Biosimilar Products 167
Table 6.2: Biosimilar Pipeline in the U.S. 178
Table 6.3: Other Key Players in Biosimilars Space 182
Table 6.4: Patent Expiration for Major Biologics 183
Table 6.5: Development Status of mAbs Biosimilars 186
Table 6.6: Generic Companies Active in Biosimilar Space 189
Table 6.7: Biosimilars Pipeline by Class, 2012 189
Table 6.8: Market Exclusivity Period for Specific Biologics in the U.S. 195
Table 6.9: Selected Biosimilars and Biobetters Currently in Development as of 2013 206
Table 6.10: Companies with the Largest Biosimilar Portfolios as of 2013 208
Table 6.11: Biosimilars Approved by the E.U. 215
Table 6.12: Native mAbs Developers in China 223
Table 6.13: Domestic Biosimilar Developers in India 225
Table 6.14: Celtrion’s Biosimilar Pipeline 225
Table 6.15: Summary of Publicly Announced Biosimilar Product Transactions Through 2012 229
Table 7.1: Selected Generics from Apotex 245
Table 7.2: AstraZeneca’s Development Projects 247
Table 7.3: Patent Expiries of AstraZeneca’s Key Marketed Products 247
Table 7.4: Plasma Derivatives from Bharat Serums and Vaccines Limited 249
Table 7.5: Biogen Idec’s Product Pipeline 252
Table 7.6: Bristol’s Key Products 255
Table 7.7: Reddy’s Product List 258
Table 7.8: New Products Launched by Richter in Hungary 260
Table 7.9: New Products Launched by Richter in Central and Eastern Europe 260
Table 7.10: GSK’s Prescription Medicines 261
Table 7.11: Key Products from Intas 264
Table 7.12: Merck’s Key Pharmaceutical Products 265
Table 7.13: Pfizer’s Major Biopharmaceutical Products 269
Table A.1.1: Biologic Medicines by Development Phase, 2013 278
Table A.2.1: List of NMEs Launched in 2012 318
Table A.2.2: Other NMEs Launched in 2012 319
Table A.2.3: Top Therapeutic Classes by Prescriptions, 2008-2012 361
Table A.2.4: Top Medicines by Prescriptions in the U.S., 2008-2012 362
Table A.3.1: Pharmaceutical Deals in 2012 364

List 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 Products, 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, 2010-2013 305
Figure A.2.5: Per Capita Spending Growth, 2002-2017 306
Figure A.2.6: Percent of Health Plan Members Ranked by Healthcare Spending ($) 307
Figure A.2.7: Percent of Health Plan Members Healthcare Spending ($) 308
Figure A.2.8: Components of Change in Total Spending ($ Billion), 2011-2012 309
Figure A.2.9: Protected Brand Price Spending Growth, 2008-2012 310
Figure A.2.10: New Brand Spending ($ Billions) 311
Figure A.2.11: Percent Share of Prescriptions, 2003-2012 311
Figure A.2.12: Comparison of Medicine Spending by Segment, 2012 312
Figure A.2.13: Significant Increase in Consumer-Driven Health Plans Enrollment, 2008-2012 312
Figure A.2.14: Average Patient Out-of-Pocket Costs by Plan Type, 2008-2012 313
Figure A.2.15: Average Annual Out-of-Pocket Costs for Deductibles, Co-Pay and Co-Insurance Spend 314
Figure A.2.16: Percent of Retail Dispensed Prescriptions by Out-of-Pocket Costs ($), 2012 315
Figure A.2.17: Percent of Retail Dispensed Prescriptions by Out-of-Pocket Costs ($) 315
Figure A.2.18: New Molecular Entities (NMEs) Launched in the U.S., 2003-2012 316
Figure A.2.19: New Oncology NME Launches in the U.S., 2003-2012 317
Figure A.2.20: Spending in Leading Therapy Areas 321
Figure A.2.21: Oncology Spending by Area 322
Figure A.2.22: U.S. Market for Oncologics, 2008-2012 323
Figure A.2.23: U.S. Market for Rituxan, 2008-2012 323
Figure A.2.24: U.S. Market for Avastin, 2008-2012 324
Figure A.2.25: Mental Health Spending by Area, 2012 325
Figure A.2.26: U.S. Market for Mental Health Medicines, 2008-2012 326
Figure A.2.27: U.S. Market for Cymbalta, 2008-2012 327
Figure A.2.28: U.S. Market for Abilify, 2008-2012 328
Figure A.2.29: Respiratory Spending by Area, 2012 329
Figure A.2.30: U.S. Market for Respiratory Agents, 2008-2012 330
Figure A.2.31: U.S. Market for Adavair Diskus, 2008-2012 331
Figure A.2.32: U.S. Market for Sigulair, 2008-2012 331
Figure A.2.33: Spiriva Handihaler, 2008-2012 332
Figure A.2.34: Antidiabetes Spending by Area, 2008-2012 333
Figure A.2.35: U.S. Market for Antidiabetics, 2008-2012 334
Figure A.2.36: U.S. Market for Januvia, 2008-2012 335
Figure A.2.37: U.S. Market for Lantus, 2008-2012 336
Figure A.2.38: U.S. Market for Lantus SoloSTAR, 2008-2012 337
Figure A.2.39: Pain Spending by Area, 2008-2012 337
Figure A.2.40: Pain Spending by Area, 2008-2012 338
Figure A.2.41: U.S. Market for Pain Management Drugs, 2008-2012 339
Figure A.2.42: U.S. Market for Medicines Used in Nervous System Disorders, 2008-2012 339
Figure A.2.43: U.S. Market for Oxycontin, 2008-2012 340
Figure A.2.44: U.S. Market for Lyrica, 2008-2012 341
Figure A.2.45: U.S. Market for Copaxone, 2008-2012 342
Figure A.2.46: U.S. Market for Lipid Regulators, 2008-2012 342
Figure A.2.47: U.S. Market for Crestor, 2008-2012 343
Figure A.2.48: U.S. Market for Autoimmune Drugs, 2008-2012 344
Figure A.2.49: U.S. Market for Humira, 2008-2012 345
Figure A.2.50: U.S. Market for Enbrel, 2008-2012 346
Figure A.2.51: U.S. Market for Remicade, 2008-2012 347
Figure A.2.52: U.S. Market for Medicines Used for Multiple Sclerosis, 2008-2012 348
Figure A.2.53: U.S. Market for Antiulcerants, 2008-2012 348
Figure A.2.54: U.S. Market for Nexium, 2008-2012 349
Figure A.2.55: U.S. Market for Neulasta, 2008-2012 350
Figure A.2.56: U.S. Market for Epogen, 2008-2012 351
Figure A.2.57: U.S. Market for Platelet Aggregation Inhibitors, 2008-2012 351
Figure A.2.58: U.S. Market for Plavix, 2008-2012 352
Figure A.2.59: U.S. Market for HIV Antivirals, 2008-2012 353
Figure A.2.60: U.S. Market for Atripla, 2008-2012 354
Figure A.2.61: U.S. Market for Truvada, 2008-2012 355
Figure A.2.62: U.S. Market for Antibacterials, 2008-2012 355
Figure A.2.63: U.S. Market for Antihypertensives, Plain & Combo, 2008-2012 356
Figure A.2.64: U.S. Market for Diovan, 2008-2012 357
Figure A.2.65: U.S. Market for ADHD, 2008-2012 358
Figure A.2.66: U.S. Market for Vaccines (Pure, Comb and Others), 2008-2012 359
Figure A.2.67: U.S. Market for Systemic Hormonal Contraceptives, 2008-2012 359
Figure A.2.68: Treated Patients in Selected Therapies in the U.S., 2012 360
Figure A.4.1: Ranking of Asian Territories across All Factors 371
Figure A.4.2: Cost Ranking of Asian Territories 372
Figure A.4.3: Market Opportunity Ranking of Asian Territories 373
Figure A.5.1: Steady Increase of Biologics as a Share of Total FDA Approval 379
Figure A.5.2: Proportion of Health Insurers with Plans for Implementing Novel Contracting Models 380
Figure A.5.3: Insurer Expectations of Clinical and Cost Evidence from the Pharma for Formulary Placement 381
Figure A.5.4: Data on Total U.S. Prescription Drug Spending 382
Figure A.5.5: Need for Aligned Efforts of Providers, Payers and Patients for Better Patient Outcomes 385
Figure A.5.6: Number of Companion Diagnostics Partnerships with Pharma 386
Figure A.5.7: Payer’s Perceived Barriers to Novel Contracting Practices 387
Figure A.5.8: Current and Future State of Data Conversions and Analysis 389
Figure A.5.9: Sources of Influence for Formulary Coverage and Decision Making 390
Figure A.6.1: Medical Cost Trend, 2010-2013 391
Figure A.6.2: Private Health Insurance Benefits by Spending Category 392
Figure A.6.3: Percent of U.S. Patients Seeking Treatment in Retail Clinics 393
Figure A.6.4: Surgical Cosmetic Procedures in the U.S. 394
Figure A.6.5: Increase in High-Cost Insurance Claims 395
Figure A.6.6: Percentage of Individuals with Employer-Sponsored Coverage in a High-Deductible Plan with a Savings Option 396
Figure A.6.7: Percentage of Consumers Delaying Care Because of Cost 396

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  • The World Market for Biosimilars (EPO, G-CSF, HGH, Insulin, Interferon Alpha, Monoclonal Antibodies, Other), 4th Edition
    Published: 22-Sep-2013        Price: US $2995 Onwards        Pages: 195
    This study, The World Market for Biosimilars, 4th Edition (EPO, G-CSF, HGH, Insulin, Interferon alpha, mAbs, Others), is designed to provide a comprehensive look at the various strategies being used by select worldwide generic companies in exploring the emerging area of biosimilars, the issues and trends that are shaping the marketplace, and the potential feasibility of providing biosimilars within the United States regulatory environment.Generic drugs continue to represent one of the greate......
  • Biological and Biosimilars Drug Market in Poland 2013
    Published: 31-Aug-2013        Price: US $2660 Onwards        Pages: 120
    Examine the future of biologics in the Polish pharma market.Report surveys biologic and biosimilar drugs, epidemiology and growth potential 2013- 2015.In Poland, as in many parts of the world, a growing number of patients are being treated using biological or biosimilar drugs. The list of illnesses for which these drugs are prescribed includes psoriasis, Crohn's disease, colitis, psoriatic and rheumatoid arthritis, ankylosing spondylitis and others. Consequently, the market has expanded ......
  • Biosimilar Opportunities in an Evolving Market
    Published: 1-Aug-2013        Price: US $1495 Onwards        Pages: 113
    Biosimilars: another milestone passedAt the end of June 2013, the European Medicines Agency's Committee for Medical Products for Human Use issued a positive opinion for the first biosimilar version of Johnson & Johnson's infliximab for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. For the two successful applicants, Celltrion and Hospira, this development passes a significant milestone for the whole biosimilar sector as the products are the first ......
  • PharmaSphere: Global Biosimilars Strategy – Regulatory Landscape, Key Drivers, Markets and Trends in 2013
    Published: 27-May-2013        Price: US $2995 Onwards        Pages: 152
    SummaryGlobalData’s "PharmaSphere: Global Biosimilars Strategy - Regulatory Landscape, Key Drivers, Markets and Trends in 2013", provides strategic analysis of the global biosimilars industry. It discusses key market trends, regulatory requirements in various markets, recent deals activity and trends, as well as describes the operations strategy of these companies. Furthermore, it includes a geographical segmentation of various markets including the EU and US, as well as emerging markets s......
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