Biologics and Biosimilars World Markets

NEW YORK, Aug.存倉 19, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:Biologics and Biosimilars World Markets.reportlinker.com/p01597712/Biologics-and-Biosimilars-World-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=BiopharmaceuticalBiologics 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.1. Overview 181.1 Statement of This Report 181.2 About This Report 181.3 Scope of the Report 191.4 Objectives 201.5 Methodology 201.6 Executive Summary 212. Pharmaceutical Industry: An Overview 232.1 Global R&D Spending by Pharma and Biotech Companies 232.1.1 Top 20 Companies in R&D Spending 242.1.2 Top 20 Most Valuable Pharmaceutical R&D projects 242.1.3 Most Valuable R&D Projects Ranked by Net Present Value 252.2 FDA New Drug Approvals 262.2.1 Top Ten NMEs 272.3 Impact of Patent Expirations 272.4 Immunity of Pharmaceutical Growth against Drop in GDP Growth 282.5 Minimal Annual Growth Rates of Pharmaceuticals in Developed Markets 292.6 Falling Operating Profit Rate for Big Pharma 302.7 Top Ten Global Pharmaceutical Firms 302.6 Top Ten Pharmaceuticals by Sales Revenue 322.7 Worldwide Prescription and OTC Sales by Therapy Area in 2018 332.8 Top Companies in Oncology Sales 342.8.1 Top Five Oncology Products 352.9 Top Companies in Anti-Diabetes Market 362.9.1 Top Five Anti-Diabetes Products 362.10 Top Ten Companies in Anti-Rheumatics Market 372.10.1 Top Ten Anti-Rheumatics Products 372.11 Top Ten Vaccine Companies and Global Sales 382.11.1 Top Five Vaccine Products 382.12 Top Ten Anti-Viral Companies 392.12.1 Top Five Anti-Viral Products 392.13 Top 50 Global Pharmaceutical Brands in 2018 402.14 M&A Transactions in 2012 412.15 Global Pharmaceutical Market 422.15.1 Global Pharmaceutical Sales by Region 422.15.2 North American Pharmaceutical Market 432.15.2.1 U.S. Prescription Drug Sales by Company 442.15.2.2 Top 50 Pharmaceutical Products in the U.S. 452.15.2.3 Top 50 Products in the U.S. in 2018 472.15.3 Pharmaceutical Market in Europe 482.15.3.1 European Prescription Drug Sales by Company 492.15.4 Pharmaceutical Market in Asia/Pacific 502.15.4.1 Prescription Drug Sales in Japan by Company 512.15.5 Pharmaceutical Market in Latin America 522.15.6 Pharmaceutical Market in Africa 532.15.7 Pharmaceutical Market in the Middle East 542.16 Regional Prescription Drug Sales in the U.S., Europe and Japan 552.17 Global Prescription Drug Sales 553. Brand Name Pharmaceuticals: A Brief Overview 573.1 Birth Pangs and Life Span of Branded Drugs 573.2 Major Patent Expiries of Branded Drugs 583.3 Global Market for Branded Drugs 593.4 Increasing R & D Pipeline 593.4.1 The 2012 R & D Pipeline by Phase 603.4.2 Top Companies by Pipeline Size 613.4.3 Total Number of Companies with Active R&D 623.4.4 Global Distribution of Companies Active in Pharma R&D 633.4.5 Top Therapy Areas in R & D 643.4.5.1 Top 25 Individual Diseases in the R & D Pipeline 653.4.6 Top 20 Mechanism of Action in R & D Pipeline 663.4.7 Top 25 Drug Protein Targets 674. Generic Drugs: A Brief Overview 694.1 Bioequivalence of Generics 694.2 Global Market for Generics 704.3 Operating Profit Rate for Generic Companies 714.4 Outsourced Manufacture of Generics 724.5 Generic Utilization in International Markets 734.6 Global Generic Sales by Company 745. Biologics 765.1 Regulations for Biologics 765.2 Complexity of Biologics 765.3 Concentration of Global Biopharmaceutical Manufacturing 775.4 Number of Biologics Available in the Global Market 785.5 Share of Biologics by Country/Region 795.6 Rate of Growth for Biologics by Region 805.6.1 Growth Rates of APIs and Biologics Compared 805.7 Manufacturing Capacity of Biologics 815.8 Biologics Market by Segment 825.9 Patent Expiry for Biologic Drugs 835.9.1 India's Opportunity from Biologic Patent Expirations 845.10 Major Players in Biologics 855.11 Biopharm Outsourcing 865.12 Top 20 Biologics by Sales 875.12.1 Roche's Biologics Arsenal 885.12.2 Johnson & Johnson's Biologics Arsenal 895.12.3 Lonza in Biologics 895.13 The Best Selling Biologics by Class 895.14 Biologic Drugs: Market Trends in the Past Seven Years 905.14.1 Global Market for Biologics 905.15 Global and U.S. Sales of Blockbuster Biologics 925.15.1 Global Market for Humira 925.15.1.1 Humira (adalimumab) Pen's Market by Geography 925.15.1.2 U.S. Sales of Humira 935.15.1.3 The Leader among Biologics 945.15.2 Global Market for Remicade 945.15.2.1 Remicade's Market by Geography 955.15.2.2 U.S. Sales of Remicade 965.15.3 Global Market for Enbrel 975.15.3.1 Enbrel's Market by Geography 975.15.3.2 U.S. Sales of Enbrel 985.15.4 Global Market for Symponi 995.15.5 Global Market for Tysarbi 1005.15.5.1 U.S. Market for Tysarbi 1015.15.6 Global Market for Lantus 1015.15.6.1 Lantus' Market by Geography 1025.15.6.2 U.S. Market for Lantus 1035.15.7 Global Market for NovoRapid 1035.15.7.1 Market for Novolog/Novorapid by Geography 1045.15.7.2 U.S. Market for NovoRapid 1055.15.8 Global Market for Victoza 1055.15.9 Global Market for Levemir 1075.15.9.1 U.S. Market for Levemir 1085.15.10 Global Market for Humalog 1085.15.10.1 Market for Humalog by Geography 1105.15.11 Global Market for Neulasta 1105.15.11.1 Neulasta's Market by Geography 1115.15.11.2 U.S. Market for Neulasta 1125.15.12 Global Market for Privigen 1125.15.13 Global Market for Perjeta 1135.15.14 Global Market for Xgeva/Prolia 1145.15.15 Global Market for Soliris 1165.15.15.1 U.S. Market for Soliris 1175.15.16 Global Market for Botox 1175.15.17 Global Market for Lucentis 1195.15.17.1 U.S. Market for Lucentis 1205.15.18 Global Market for Eylea 1205.15.19 Global Market for Avastin 1225.15.19.1 U.S. Market for Avastin 1235.15.20 Global Market for Rituxan 1235.15.20.1 Rituxan's Market by Geography 1245.15.20.2 U.S. Market for Rituxan 1255.15.21 Global Market for Revlimid 1255.15.22 Global Market for Herceptin 1275.15.22.1 Herceptin's Market by Geography 1275.15.21.2 U.S. Market for Herceptin 1285.15.22 Global Market for Prenvar 13 1295.15.22.1 U.S. Market for Prenvar 13 1305.15.23 Global Market for Gardasil 1305.15.24 Global Market for Fluzone/Varigrip 1325.15.25 Global Market for Varivax 1325.15.26 Global Market for Stelara 1345.15.26.1 U.S. Market for Stelara 1355.15.27 Global Market for Actemra 1355.15.28 Global Market for Gammagard Liquid 1365.16 The U.S. Biotech Landscape 1385.16.1 Top U.S. Biotech Companies 1385.16.1.1 Amgen 1385.16.1.2 Gilead Sciences 1395.16.1.3 Biogen Idec, Inc. 1405.16.1.4 Celgene Corporation 1415.16.1.5 Genzyme (Sanofi) 1415.16.1.6 Life Technologies Corporation 1425.16.1.7 Cephalon, Inc/Teva Pharmaceutical Industries Ltd. 1425.16.1.8 Alexion Pharmaceuticals, Inc. 1425.16.1.9 Cubist Pharmaceuticals, Inc. 1425.16.1.10 United Therapeutics Corporation 1435.16.2 Overall Performance of the U.S. Biotech Companies 1435.16.3 R & D Spending by Biotech Companies in the U.S. 1435.16.4 U.S. Market for Biologic Drugs 1445.16.5 The Leading Biologic Drug Classes in Terms of U.S. Sales 1455.16.5.1 Top Selling Biologic Drugs in the U.S. 1465.16.5.2 U.S. Sales of Biologics by Manufacturer 1475.16.6 U.S. Sales of mAbs 1485.16.7 U.S. Sales of Recombinant Hormones 1495.16.8 U.S. Sales of Blood Cell Growth Factors 1505.16.9 U.S. Market for Cytokines 1515.16.10 U.S. Sales of Blood Factors 1525.16.11 U.S. Sales of Therapeutic Enzymes 1535.16.12 U.S. Sales of Recombinant Vaccines 1545.16.13 U.S. Sales of Recombinant Anticoagulants 1545.16.14 Costs of Commonly Used Biologicals in the U.S. 1555.16.15 Biologics Used for Treating Rheumatoid Arthritis 1565.16.15.1 Cost Comparison of Arthritis Biologics 1575.17 Biologics in Europe 1575.17.1 Uptake of Biologics in Europe by Drug Type 1585.17.2 European Market for mAbs 1595.18 Biologics in Hemophilia 1605.18.1 Marker Leaders in Hemophilia 1605.18.2 Hemophilia A 1615.18.3 Hemophilia B 1625.18.4 Inhibitors 1636. Biosimilars 1646.1 Different Names in Different Countries for Biologics 1646.2 E.U. Approval Pathway for Biosimilars 1646.3 Contentious Issues in Biosimilars 1646.4 Biosimilars Opportunity 1646.5 Challenges in Biosimilar Introduction 1656.6 Production and Market Access of Biosimilars 1656.7 Country Selection for Biosimilars 1656.8 High Barriers to the Entry of Biosimilars 1656.9 Global Competition among Biosimilars 1666.10 Definitions and Interpretations of Biosimilar Products 1676.10.1 Regulatory Requirements 1676.10.1.1 World Health Organization (WHO) 1676.10.1.2 Key Principles and Basic Concept 1686.10.2 Reference Biotherapeutic Product 1686.10.2.1 Quality 1686.10.2.2 Non-Clinical and Clinical Studies 1686.10.3 E.U. 1696.10.3.1 Key Principles and Basic Concept 1696.10.3.2 Reference Biotherapeutic Product 1706.10.3.3 Quality 1706.10.3.4 Non-Clinical and Clinical Evaluation 1706.10.3.5 Product Class-Specific Guidelines 1706.10.4 U.S. 1716.10.5 Canada 1726.10.6 Japan 1726.10.7 Korea 1726.11 FDA Guidelines for Biosimilars 1736.12 Market Drivers 1736.12.1 Cost Pressures 1736.13 Core Therapy Areas for Biosimilars 1736.14 Competitive Landscape in Biosimilar Sector 1746.15 Opportunities for Biosimilars in Three Geographies 1756.15.1 Opportunities for Biosimilars in the U.S. 1756.15.2 European Opportunities for Biosimilars 1766.15.3 Opportunities for Biosimilars in Emerging Markets 1766.16 Biosimilar Experience 1776.17 Development of Biosimilars 1786.17.1 Current and Future Trends in Biosimilar Development 1786.18 Top Players in Biosimilars Market 1796.18.1 Other Key Players in Biosimilars Market 1816.19 Number of Biologics Patent Expiries Prior to 2020 1826.19.1 Biologics Patent Expiries by Region 1836.20 Monoclonal Antibodies: The Key Focus Area for Biosimilars Development 1846.20.1 Biosimilar mAbs in Pipeline 1846.20.2 Disease Indications for Biosimilar mAbs 1866.21 Global Leaders in Biosimilars 1876.22 Market Leading Biosimilars 1876.23 Biosimilar Opportunities: Only for the Heartiest Biotech Firms 1886.24 Biosimilars Pipeline by Class 1896.25 Global Biosimilars Market 1896.25.1 Estimated Value and Growth Rates for Biosimilars by Type 1906.25.2 Market Leading Biosimilars in 2015 1916.26 Regulations for Biosimilars in the U.S. 1926.26.1 BPCIA and Guidance 1926.26.2 Scientific Considerations 1936.26.3 Quality Considerations 1936.26.4 Biosimilar User Fee Act 1936.26.5 12-Year Exclusivity Period 1946.26.6 Biosimilars Competitive Landscape in the U.S. 1956.26.7 Manufacturing Capabilities 1956.26.8 Clinical Trial Experience 1966.26.9 Market Experience 1976.26.10 Likely Early Entrants 1976.26.11 Recombinant Protein Competition 1986.26.12 mAbs Competition 1986.27 U.S. Biosimilars Market 1996.27.1 HGH Biosimilars in the U.S. Market 2006.27.2 Cost Benefits from Biosimilars for U.S. Healthcare 2016.27.3 Development Pipeline and Market Evolution of Biosimilars in the U.S. 2026.27.3.1 Target Reference Products 2036.27.3.2 Launchable Dates for Biosimilars in the U.S. 2036.27.3.3 Number of Biosimilar Products in the Pipeline 2056.28 Geographic Distribution of Biosimilars Pipeline 2066.28.1 Developers of Biosimilars 2076.29 Future of U.S. Biosimilars Market 2096.29.1 Future Pricing Models 2106.29.2 Future Price Reduction and the Profit Margin 2106.30 Biosimilars Market in Europe and Japan 2116.30.1 The Instant Growth of Biosimilars in Europe 2126.30.2 Biosimilar mAbs on the Horizon in Europe 2136.30.3 Biosimilars Approved in the E.U 2146.30.4 Utilization of G-CSF in Europe 2156.31 Revenue Forecast for Biosimilar Insulins 2166.32 Revenue Forecast for Biosimilar HGH 2176.33 Revenue Forecast for Biosimilar IFN Alpha 2186.34 Revenue Forecast for Biosimilar IFN Beta Ia 2186.35 Revenue Forecast for Biosimilar Filgrastim 2196.36 Revenue Forecast for Biosimilar Epoetin Alpha 2206.37 Uptake of Biosimilars in Europe 2206.38 Biosimilars in China 2216.38.1 Biosimilars Sales in China 2226.39 Indian Market for Biosimilars 2236.39.1 Domestic Biosimilar Developers in India 2246.40 Biosimilar Pipeline of Celtrion in Korea 2256.41 Deals in Biosimilar Space 2266.41.1 Technologies 2266.41.2 Manufacturing Agreements 2266.41.3 Clinical Development 2276.41.4 Licensing Agreements 2276.42 Transactions in Biosimilars Industry 2276.42.1 Biosimilars Market: Opportunities and Challenges 2286.42.2 Recent Transactions in Biosimilars Industry 2296.43 Top Ten Biosimilar Drugs to Watch 2306.43.1 Aranesp (darbepoetin alfa) 2306.43.2 Enbrel (etanercept) 2316.43.3 Epogen/Procrit/Eprex/Erypo (epoetin alfa) 2316.43.4 Genotropin (somatropin) 2316.43.5 Herceptin (trastuzumab) 2326.43.6 Humira (adalimumab) 2326.43.7 Neulasta (pegfilgrastim) 2336.43.8 Neupogen (filgrastim) 2336.43.9 Remicade (infliximab) 2346.43.10 Rituxan/MabThera (rituximab) 2347. Company Profiles 2367.1 3Bio, Inc. 2367.1.1 EPIAO 2367.1.2 TPIAO 2367.1.3 INTEFEN 2377.1.4 INLEUSIN 2377.1.5 IV Iron Sucrose 2377.2 Abbott Laboratories 2387.3 AbbVie, Inc. 2397.3.1 Products 2397.4 Actelion Ltd. 2407.5 Amgen, Inc. 2407.5.1 Neulasta (filgrastim) 2407.5.2 Enbrel (etanercept) 2417.5.3 Aranesp (darbepoetin alfa) 2417.5.4 Epogen (epoetin alfa) 2417.5.5 Sensipar/Mimpara (cinacalcet) 2417.5.6 Vectibix (panitumumab) 2417.5.7 Nplate (romiplostim) 2427.5.8 Prolia/Xgeva (denosumab) 2427.6 Amoytop Biotech Co., Ltd 2427.6.1 Molgramostim (rhGM-CSF) 2427.6.2 Filgrastim (rh G-CSF) 2437.6.3 Oprelvekin (rhIL-11) 2437.7 Anhui Anke Biotechnology (Group) Co., Ltd. 2437.7.1 Alteferon alpha 2b Injection 2447.7.2 Ansomone 2447.7.3 Anteferon alpha 2b Cream 2447.7.4 Anteferon alpha 2b Eyedrop 2447.8 Apotex, Inc. 2447.9 Astellas Pharma, Inc. 2457.10 AstraZeneca 2467.10.1 AstraZeneca's R&D Portfolio 2467.10.2 Patent Expiries of AstraZenecas Products 2477.11 Bayer AG 2477.12 Beijing Four Rings Biopharmaceuticals 2487.12.1 Products 2487.13 Bharat Serums and Vaccines Limited 2487.14 Biocon Ltd. 2497.15 Biogen Idec, Inc. 2527.16 Bioton SA 2537.17 Boehringer Ingelheim Pharmaceuticals, Inc. 2537.18 Bristol-Myers Squibb, Co. 2547.19 Celgene Corporation 2557.20 Celltrion, Inc. 2557.20.1 Technology Overview 2557.20.2 Biosimilars Development 2567.20.3 Contract Manufacturing 2567.21 Cipla Ltd. 2567.21.1 Cipla's Prescription Product Category 2567.22 Dr. Reddy's Laboratories Ltd. 2577.23 Elan Corporation, PLC 2597.23.1 Tysarbi 2597.24 Eli Lilly & Co. 2597.25 Gideon Richter 2597.26 Gilead Sciences, Inc. 2607.27 GlaxoSmithKline PLC 2617.28 Hospira, Inc. 2637.29 Intas Pharmaceuticals Limited 2647.30 Johnson & Johnson 2657.31 Merck & Co., Inc. 2657.32 Mylan, Inc. 2677.32.1 Mylan's Generics 2677.32.2 Mylan's Active Pharmaceutical Ingredients 2677.32.3 Mylan's Specialty 2677.32.4 Mylan's Anti-Retroviral Franchise 2677.33 Novartis AG 2687.34 Pfizer, Inc. 2697.35 Roche Holdings AG 2707.36 Sandoz International GmbH 2727.37 Sanofi 2727.38 Stada Arzneimittel Aktiengesellschaft 2747.39 Teva Pharmaceutical Industries Limited 2757.40 Watson Pharmaceuticals, Inc. 276APPENDIXAppendix 1: Biologic Medicines by Development Phase 278Appendix 2: Declining Medicine Use in the U.S. 302Appendix 2.1: Changes in Utilization 302Appendix 2.2: Healthcare Costs and Spending on Medicines 303Appendix 2.3: Total Spending on Medicines 306Appendix 2.4: Transformations in Disease Treatment 316Appendix 2.5: Key Breakthrough Therapies Approved in 2012 319Appendix 2.5.1: Cystic Fibrosis: ivacaftor (Kalydeco) 319Appendix 2.5.2: Rheumatoid Arthritis: tofacitinib (Xeljanz) 320Appendix 2.5.3: Basal-cell carcinoma: vismodegib (Erivedge) 320Appendix 2.5.4: Irritable bowel syndrome with constipation: linaclotide (Linzess) 320Appendix 2.5.5: HIV: emtricitabine and tenofovir disoproxil fumarate (Truvada) 320Appendix 2.5.6: Combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate 320Appendix 2.6: Spendi自存倉g in Major Therapies 320Appendix 2.6.1: Oncology Spending (25.9 Billion) by Area, 2012 321Appendix 2.6.1.1: U.S. Market for Oncology Drugs 322Appendix 2.6.1.2: U.S. Market for Rituxan 323Appendix 2.6.1.3: U.S. Market for Avastin 324Appendix 2.7: Mental Health Spending by Area 324Appendix 2.7.1: U.S. Market for Mental Health Drugs 325Appendix 2.7.2: U.S. Market for Cymbalta 326Appendix 2.7.3: U.S. Market for Abilify 327Appendix 2.8: Respiratory Spending by Area 328Appendix 2.8.1: U.S. Market for Respiratory Drugs 329Appendix 2.8.2: U.S. Market for Adavir 330Appendix 2.8.3: U.S. Market for Singulair 331Appendix 2.8.4: U.S. Market for Spiriva 332Appendix 2.9: Antidiabetes Spending by Area 332Appendix 2.9.1: U.S. Market for Antidiabetics 333Appendix 2.9.2: U.S. Market for Januvia 334Appendix 2.9.3: U.S. Market for Lantus 335Appendix 2.9.4: U.S. Market for Lantus SoloSTAR 336Appendix 2.10: Pain Spending by Area 337Appendix 2.10.1: U.S. Market for Pain Management Drugs 338Appendix 2.11: U.S. Market for Medicines Used in Nervous System Disorders 339Appendix 2.11.1: U.S. Market for Oxycontin 340Appendix 2.11.2: U.S. Market for Lyrica 340Appendix 2.11.3: U.S. Market for Copaxone 341Appendix 2.12: U.S. Market for Lipid Regulators 342Appendix 2.12.1: U.S. Market for Crestor 343Appendix 2.13: U.S. Market for Autoimmune Drugs 343Appendix 2.13.1: U.S. Market for Humira 344Appendix 2.13.2: U.S. Market for Enbrel 345Appendix 2.13.3: U.S. Market for Remicade 346Appendix 2.14: U.S. Market for Medicines Used for Multiple Sclerosis 347Appendix 2.15: U.S. Market for Antiulcerants 348Appendix 2.15.1: U.S. Market for Nexium 349Appendix 2.16: U.S. Market for Neulasta 349Appendix 2.17: U.S. Market for Epogen 350Appendix 2.18: U.S. Market for Platelet Aggregation Inhibitors 351Appendix 2.18.1: U.S. Market for Plavix 352Appendix 2.19: U.S. Market for HIV Antivirals 352Appendix 2.19.1: U.S. Market for Atripla 353Appendix 2.19.2: U.S. Market for Truvada 354Appendix 2.20: U.S. Market for Antibacterials 355Appendix 2.21: U.S. Market for Antihypertensives 356Appendix 2.21.1: U.S. Market for Diovan 356Appendix 2.22: U.S. Market for ADHD 357Appendix 2.23: U.S. Market for Vaccines (Pure, Comb and Others) 358Appendix 2.24: U.S. Market for Systemic Hormonal Contraceptives 359Appendix 2.25: Number of Treated Patients in Selected Therapies in the U.S. 360Appendix 2.26: Top Therapeutic Classes of Drugs Prescribed in the U.S. 361Appendix 2.27: Top Medicines Prescribed in the U.S. 362Appendix 3: Pharma Deals in 2012 364Appendix 4: Pharma Outsourcing in Asia 367Appendix 4.1: Cluster One: Pharma Revenue Constraints 367Appendix 4.2: Cluster Two: Asia Growth Forces 367Appendix 4.3: Cluster Three: East/West Convergence/Divergence Trends 368Appendix 4.4: Cluster Four: Technological/Business Model Forces 369Appendix 4.5: Implications of the Four Clusters for Asia Outsourcing 369Appendix 4.5.1: Rapid Expansion of Clinical Trials in Asia 370Appendix 4.5.2: Manufacturing Scales 370Appendix 4.5.3: Risk and Opportunity Overview 370Appendix 4.5.4: Cost Ranking of Asian Territories 371Appendix 4.5.5: Market Opportunity Ranking 372Appendix 4.6: Outsourcing Hot Spots in Asia 373Appendix 4.6.1: China 373Appendix 4.6.2: India 375Appendix 4.6.3: Singapore 376Appendix 5: The Changing Payment Landscape for the U.S. Pharmaceutical Industry 378Appendix 5.1: The Impetus for Defining Value 378Appendix 5.1.1: Force I 378Appendix 5.1.2: Force II 379Appendix 5.1.3: Force III 380Appendix 5.1.4: Force IV 381Appendix 5.1.5: Force V 382Appendix 5.2: The New Arbiters of Value 383Appendix 5.2.1: Prescribers Looking for Value 383Appendix 5.2.2: More Investment in Comparative Effectiveness Research 384Appendix 5.2.3: Unleashing of Imprisoned Value 384Appendix 5.2.4: Role of Companion Diagnostics 385Appendix 5.2.5: Outcomes-Dependent Contracts 386Appendix 5.2.6: Data-Sharing Agreements 388Appendix 5.2.7: Patient-Reported Outcomes 389Appendix 5.2.8: Evidence Needed to Secure Formulary Slots 390Appendix 6: Medical Cost Trend in the U.S., 2013 391Appendix 6.1: The Components of Medical Cost 391Appendix 6.2: Leading Factors in Setting Insurance Premiums 392Appendix 6.3: Factors Affecting 2013 Trend 392Appendix 6.3.1: Medical Supply and Equipment Cost 392Appendix 6.3.2: Newer Delivery Methods for Primary Care 393Appendix 6.4: Uptick in Utilization and Expensive Advances 394Appendix 6.4.1: Economic Utilization and Economic Growth 394Appendix 6.4.2: Medical Advances Driving Growth 394Appendix 6.4.3: The "New Normal" 396Appendix 6.4.4: Current Practices by Employers 397Appendix 6.4.4.1: Things to be considered by Employers 397Appendix 6.5: Current Practices by Providers 397Appendix 6.5.1: Things to be considered by Providers 398Appendix 6.6: Current Practices by Hwealth Insurers 398Appendix 6.6.1: Things to be considered by Health Insurers 398Appendix 6.7: Current Practices by Pharmaceutical and Life Sciences 399Appendix 6.7.1: Things to be considered by Pharmaceutical and Life Sciences 399Appendix 7: Naming of Drug Molecules and Pharmaceutical Brands 400Appendix 7.1: Names of a Drug 400Appendix 7.1.1: Chemical Name 400Appendix 7.1.2: Generic Name 400Appendix 7.2: Brand Name 401Appendix 7.2.1: Criteria for Brand Names 402Appendix 7.3: Stories behind Some Blockbuster Molecules 403INDEX OF FIGURESFigure 2.1: Global R&D Spending by Pharma and Biotech Companies, 2005-2018 23Figure 2.2: Worldwide Sales at Risk by Patent Expiration, 2004-2018 24Figure 2.3: Immunity of Pharmaceutical Growth against Drop in GDP Growth 29Figure 2.4: Falling Operating Profit Rate for Big Pharma 30Figure 2.5: Global Pharmaceutical Market, 2012-2019 42Figure 2.6: Global Pharmaceutical Sales by Region 43Figure 2.7: North American Pharmaceutical Market, 2012-2019 44Figure 2.8: European Pharmaceutical Market, 2012-2019 48Figure 2.9: Pharmaceutical Market in Asia/Pacific, 2012-2019 51Figure 2.10: Pharmaceutical Market in Latin America, 2012-2019 53Figure 2.11: Pharmaceutical Market in Africa, 2012-2019 54Figure 2.12: Pharmaceutical Market in the Middle East, 2012-2019 55Figure 2.13: Worldwide Total Prescription Drug Sales, 2004-2018 56Figure 3.1: The Long-Drawn R & D Process for Branded Drugs 58Figure 3.2: Global Market for Branded Drugs, 2012-2019 59Figure 3.3: R & D pipeline, 2001-2012 60Figure 3.4: R & D Pipeline by Phase, 2007-2012 61Figure 3.5: Total Number of Companies with Active R & D, 2000-2012 63Figure 3.6: Global Distribution of Companies Active in Pharma R&D, 2012 64Figure 4.1: Differences between Originals and Copies (Branded/Generics & Biologics/Biosimilars) 69Figure 4.2: Global Market for Generics, 2012-2019 71Figure 4.3: Operating Profit Rate for Top Six Generic Companies, 2006-2012 72Figure 4.4: Outsourced Manufacturing of Generics by Region/Country 73Figure 4.5: Generic Drug Use in International Markets 74Figure 5.1: The Biologic Drug Development Process 76Figure 5.2: Comparison of Small Molecule Drugs and Biologics 77Figure 5.3: Concentration of Global Biopharmaceutical Manufacturing as of 2013 78Figure 5.4: Share of Biologics Sales by Country/Region 79Figure 5.5: Rate of Growth for Biologics by Region 80Figure 5.6: Growth Rates (CAGR) of APIs and Biologics Compared 81Figure 5.7: Global Installed Biopharmaceutical Manufacturing Capacity by Top Ten Companies 82Figure 5.8: Biologics Market by Segment 83Figure 5.9: Top Biologics Losing Patent Protection and Market Exclusivity Prior to 2018 84Figure 5.10: Global Value and Number of Biologic Drugs Losing Patent Protection, 2010-2015 85Figure 5.11: Top Ten Biopharmaceuticals Manufacturing Companies 85Figure 5.12: Outsourcing Trends in Biological Production across All Cell-Based Platforms 86Figure 5.13: The Largest Selling Biologics by Class, 2012 89Figure 5.14: Global Biologic Drugs Market Trends, 2006-2012 90Figure 5.15: Global Market for Biologics, 2010-2020 91Figure 5.16: Global Market for Humira, 2012-2019 92Figure 5.17: Humira Pen's Market by Geography 93Figure 5.18: U.S. Market for Humira, 2012-2019 93Figure 5.19: Global Market for Remicade, 2012-2019 95Figure 5.20: Remicade's Market by Geography 96Figure 5.21: U.S. Market for Remicade, 2012-2019 96Figure 5.22: Global Market for Enbrel, 2012-2019 97Figure 5.23: Enbrel's Market by Geography 98Figure 5.24: U.S. Market for Enbrel, 2012-2019 98Figure 5.25: Global Market for Simponi, 2012-2019 99Figure 5.26: Global Market for Tysarbi, 2012-2019 100Figure 5.27: U.S. Market for Tysabri, 2012-2019 101Figure 5.28: Global Market for Lantus, 2012-2019 102Figure 5.29: Lantus' Market Share by Geography 102Figure 5.30: U.S. Market for Lantus, 2012-2019 103Figure 5.31: Global Market for NovoRapid, 2012-2019 104Figure 5.32: Market for Novolog/Novorapid by Geography 104Figure 5.33: U.S. Market for NovoRapid, 2012-2019 105Figure 5.34: Global Market for Victoza, 2012-2019 106Figure 5.35: U.S. Market for Victoza, 2012-2019 106Figure 5.36: Global Market for Levemir, 2012-2019 107Figure 5.37: U.S. Market for Levemir, 2012-2019 108Figure 5.38: Global Market for Humalog, 2012-2019 109Figure 5.39: U.S. Market for Humalog, 2012-2019 109Figure 5.40: Humalog's Market by Geography 110Figure 5.41: Global Market for Neulasta, 2012-2019 111Figure 5.42: Neulasta's Market Share by Geography 111Figure 5.43: U.S. Market for Neulasta, 2012-2019 112Figure 5.44: Global Market for Privigen, 2012-2019 113Figure 5.45: Global Market for Perjeta, 2012-2019 114Figure 5.46: Global Market for Xgeva/Prolia, 2012-2019 115Figure 5.47: U.S. Market for Xgeva/Prolia, 2012-2019 115Figure 5.48: Global Market for Soliris, 2012-2019 116Figure 5.49: U.S. Market for Soliris, 2012-2019 117Figure 5.50: Global Market for Botox, 2012-2019 118Figure 5.51: U.S. Market for Botox, 2012-2019 118Figure 5.52: Global Market for Lucentis, 2012-2019 119Figure 5.53: U.S. Market for Lucentis, 2012-2019 120Figure 5.54: Global Market for Eylea, 2012-2019 121Figure 5.55: U.S. Market for Eylea, 2012-2019 121Figure 5.56: Global Market for Avastin, 2012-2019 122Figure 5.57: U.S. Market for Avastin, 2012-2019 123Figure 5.58: Global Market for Rituxan, 2012-2019 124Figure 5.59: Rituxan's Market Share by Geography 124Figure 5.60: U.S. Market for Rituxan, 2012-2019 125Figure 5.61: Global Market for Revlimid, 2012-2019 126Figure 5.62: U.S. Market for Revlimid, 2012-2019 126Figure 5.63: Global Market for Herceptin, 2012-2019 127Figure 5.64: Herceptin's Market Share by Geography 128Figure 5.65: U.S. Market for Herceptin, 2012-2019 128Figure 5.67: Global Market for Prenvar 13, 2012-2019 129Figure 5.68: U.S. Market for Prenvar 13, 2012-2019 130Figure 5.69: Global Market for Gardasil, 2012-2019 131Figure 5.70: U.S. Market for Gardasil, 2012-2019 131Figure 5.71: Global Market for Fluzone/Varigrip, 2012-2019 132Figure 5.72: Global Market for Varivax, 2012-2019 133Figure 5.73: U.S. Market for Varivax, 2012-2019 133Figure 5.74: Global Market for Stelara, 2012-2019 134Figure 5.75: U.S. Market for Stelara, 2012-2019 135Figure 5.76: Global Market for Actemra, 2012-2019 136Figure 5.77: Global Market for Gammagard Liquid, 2012-2019 137Figure 5.78: U.S. Market for Gammagard Liquid, 2012-2019 137Figure 5.79: U.S. Market for Biologic Drugs, 2007-2012 145Figure 5.80: The Leading Biologic Drug Classes in Terms of U.S. Sales 146Figure 5.81: Top Selling Biologic Drugs in the U.S. 147Figure 5.82: U.S. Sales of Biologics by Manufacturer 148Figure 5.83: U.S. Sales of mAbs 149Figure 5.84: U.S. Sales of Recombinant Hormones 150Figure: 5.85: U.S. Sales of Blood Cell Growth Factors 151Figure 5.86: U.S. Sales of Cytokines 5.16.10 152Figure 5.87: U.S. sales of Blood Factors 153Figure 5.89: U.S. Sales of Therapeutic Enzymes 153Figure 5.90: U.S. Sales of Recombinant Vaccines 154Figure 5.91: U.S. Sales of Recombinant Anticoagulants 155Figure 5.92: Market for Biologics in Europe, 2012-2019 158Figure 5.93: Uptake of Biologics in Europe by Drug Type 159Figure 5.94: European Market for mAbs 160Figure 5.95: Hemophilia Market Share by Company, 2016 161Figure 6.1: Core Therapy Areas for Biosimilars 174Figure 6.2: Biosimilars' Market by Geography/Country 175Figure 6.3: Top Players in Biosimilars Market 180Figure 6.4: Number of Biologics per Indication to Go Off Patent prior to 2020 183Figure 6.5: Patent Expiration of leading mAbs 184Figure 6.6: Biosimilar mAbs in Pipeline 185Figure 6.7: Disease Indications for Biosimilar mAbs Currently in Clinical Trials 186Figure 6.8: Global Leaders in Biosimilars, 2012 187Figure 6.9: Projected Biosimilars Market Split ($10 Billions) in 2015 188Figure 6.10: The Exploding Global Biosimilars Market, 2012-2020 190Figure 6.11: Estimated Value and Growth Rates for Biosimilars by Type, 2015 191Figure 6.12: Global Spending (%) for Biosimilars by Drug Type ($2.5 Billion), 2015 192Figure 6.13: Biosimilars Market in the U.S., 2011-2019 200Figure 6.14: HGH Biosimilars in the U.S. Market, June 2009-September 2012 201Figure 6.15: Projected U.S. Spend on 11 Specific Biologics, 2012-2024 202Figure 6.16: Biosimilar Launchable Dates in the U.S., 2012-2022 204Figure 6.17: Cumulative Worldwide Sales of Reference Products, 2012-2022 205Figure 6.18: Geographic Distribution of Biosimilar Companies as of 2013 207Figure 6.19: Number of Products by Country as of 2013 208Figure 6.20: Biosimilars/Biobetters Companies by Size Range (Revenue $ Billions) Worldwide, 2013 209Figure 6.21: Biosimilars Approved in the E.U., 2012 211Figure 6.22: Biosimilars Market in Europe and Japan, 2012-2019 212Figure 6.23: Annual European Sales of Filgrastim Products, 2010-2012 213Figure 6.24: Number of Scientific Advice from EMA by Biosimilars Firms 214Figure 6.25: Biosimilars Penetration Rate (%) in Daily G-CSF Class Market, 2012 216Figure 6.26: Revenue Forecast for Biosimilar Insulin Glargine in Major Seven Markets, 2009-2020 217Figure 6.27: Revenue Forecast for Biosimilar HGH in the Major Seven Markets, 2009-2020 217Figure 6.29: Revenue Forecast for Biosimilar IFN Beta Ia in the Major Seven Markets, 2009-2020 219Figure 6.30: Revenue Forecast for Biosimilar Filgrastim in the Major Seven Markets, 2009-2020 219Figure 6.31: Revenue Forecast for Biosimilar Epoetin Alpha in the Major Seven Markets, 2009-2020 220Figure 6.32: Biosimilars Uptake Rates in Europe's Top Five Countries, 2012 221Figure 6.33: Market for Biosimilars in China, 2012-2019 223Figure 6.34: Biosimilar Market in India, 2008-2012 224Figure A.2.1: Percent Change in Hospital Admissions and Office Visits, 2012 303Figure A.2.2: Percent Population, Prescriptions and Per Capita Change in Prescriptions by Age 304Figure A.2.3: Therapy Areas for Largest Positive and Negative Contribution to Growth 304Figure A.2.4: U.S. National Respiratory Illness Estimates, 2010-2013 305Figure A.2.5: Per Capita Spending Growth, 2002-2017 306Figure A.2.6: Percent of Health Plan Members Ranked by Healthcare Spending ($) 307Figure A.2.7: Percent of Health Plan Members Healthcare Spending ($) 308Figure A.2.8: Components of Change in Total Spending ($ Billion), 2011-2012 309Figure A.2.9: Protected Brand Price Spending Growth, 2008-2012 310Figure A.2.10: New Brand Spending ($ Billions) 311Figure A.2.11: Percent Share of Prescriptions, 2003-2012 311Figure A.2.12: Comparison of Medicine Spending by Segment, 2012 312Figure A.2.13: Significant Increase in Consumer-Driven Health Plans Enrollment, 2008-2012 312Figure A.2.14: Average Patient Out-of-Pocket Costs by Plan Type, 2008-2012 313Figure A.2.15: Average Annual Out-of-Pocket Costs for Deductibles, Co-Pay and Co-Insurance Spend 314Figure A.2.16: Percent of Retail Dispensed Prescriptions by Out-of-Pocket Costs ($), 2012 315Figure A.2.17: Percent of Retail Dispensed Prescriptions by Out-of-Pocket Costs ($) 315Figure A.2.18: New Molecular Entities (NMEs) Launched in the U.S., 2003-2012 316Figure A.2.19: New Oncology NME Launches in the U.S., 2003-2012 317Figure A.2.20: Spending in Leading Therapy Areas 321Figure A.2.21: Oncology Spending by Area 322Figure A.2.22: U.S. Market for Oncologics, 2008-2012 323Figure A.2.23: U.S. Market for Rituxan, 2008-2012 323Figure A.2.24: U.S. Market for Avastin, 2008-2012 324Figure A.2.25: Mental Health Spending by Area, 2012 325Figure A.2.26: U.S. Market for Mental Health Medicines, 2008-2012 326Figure A.2.27: U.S. Market for Cymbalta, 2008-2012 327Figure A.2.28: U.S. Market for Abilify, 2008-2012 328Figure A.2.29: Respiratory Spending by Area, 2012 329Figure A.2.30: U.S. Market for Respiratory Agents, 2008-2012 330Figure A.2.31: U.S. Market for Adavair Diskus, 2008-2012 331Figure A.2.32: U.S. Market for Sigulair, 2008-2012 331Figure A.2.33: Spiriva Handihaler, 2008-2012 332Figure A.2.34: Antidiabetes Spending by Area, 2008-2012 333Figure A.2.35: U.S. Market for Antidiabetics, 2008-2012 334Figure A.2.36: U.S.To order this report:Biopharmaceutical Industry: Biologics and Biosimilars World MarketsContact Clare: clare@reportlinker.comUS:(339) 368 6001Intl:+1 339 368 6001ReportlinkerWeb site: .reportlinker.com/迷你倉新蒲崗