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Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025 - opportunities and challenges in this emerging market with high potentialÜbersetzung: Biosimilars (protein-basierten Nachahmer-Arzneistoff) und biologistische globale Marktaussicht 2010-2025 - Chancen und Herausforderungen in diesem aufstrebenden Markt mit hohem Potenzial
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In 2009, the biological (biologic) drug market generated over $125bn in revenues worldwide. There is great demand for lower-cost biological drugs. Commercial and regulatory developments will make bios.....
In 2009, the biological (biologic) drug market generated over $125bn in revenues worldwide. There is great demand for lower-cost biological drugs. Commercial and regulatory developments will make biosimilars and follow-on biologics seize market share - our new report explains how. Many biologic patents will expire during our forecast period. There is mounting pressure from governments, insurers and patients' groups to reduce drug costs. Biologic drugs - noted as some of the most-expensive medicines - are prime targets. Developments facilitating biosimilars/follow-on biologics are gaining momentum, with commercial opportunities for the taking. The potential revenues are significant. Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025 will provide you with information that you need to understand current trends and future possibilities for those drugs. This report predicts how the biosimilars market will develop from 2010 onwards. We discuss the biosimilar/follow-on drugs and manufacturers most likely to achieve success in coming years. Biologic drug classes covered in this report include: • Monoclonal antibodies • Fusion proteins • Erythropoietin • Growth hormones • Insulin products • Colony stimulating factors and interleukin-2 drugs • Interferons We discuss prospects for each class, with biosimilar/follow-on targets identified and market forecasts to 2025 provided, along with supporting information. Comprehensive analysis of the biosimilars/follow-on biologics sector Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025 examines that sector through a comprehensive review of information sources. We use primary and secondary research. This report provides unique sales forecasts, market share analyses, discussions of R&D pipeline developments and analyses of commercial drivers and restraints, including SWOT analysis. There are over 70 tables and figures included, as well as four interviews with experts. The result is a comprehensive market- and industry-centred study, with detailed analyses and informed opinion to benefit your work. Report Highlights Companies Listed 3SBio Abbott Abraxis BioScience Alexion Pharmaceuticals Amgen Amphastar Pharmaceuticals Apotex AstraZeneca Avesta Biotherapeutics and Research (ABRPL) Avesthagen AxiCorp Barr [acquired by Teva in 2008] Bayer Beijing Shuanglu BIOCEUTICALS Arzneimittel Biocon Biogen Idec BioPartners [acquired by Bioton in 2007] Biotechnology Industry Organization (BIO) [US] Bioton Bristol-Myers Squibb CCL Pharmaceuticals CinnaGen Cipla CJ Corporation CoGenesys [acquired by Teva in 2008] CSL CT Arzneimittel Daiichi Sankyo Dong-A Dr. Reddy’s Laboratories Eden Biodesign Elan Corporation Eli Lilly European Committee for Medicinal Products for Human Use (CHMP) European Medicines Agency (EMEA) Feron Food and Drug Administration (FDA) [US] Fraunhofer Institute [Germany] Genentech Generic Pharmaceutical Association (GPhA) [US] GeneScience Pharmaceutical Getz Pharma GlaxoSmithKline (GSK) GTC Biotherapeutics Halozyme Therapeutics Hexal [acquired by Novartis in 2005] Hospira Hualida Biotech Human Genome Sciences Insmed Intas Biopharmaceuticals Ipsen Pharma Johnson & Johnson Kissei Pharmaceutical Co. Kyowa Hakko Kirin LFB Biotechnologies SASU LG Life Sciences Lonza Biologics McDonnell Boehnen Hulbert & Berghoff LLP Medice Merck & Co. Merck KGaA Merck Serono Mérieux Alliance Ministry of Health, Labour and Welfare (MHLW) [Japan] Mitsubishi Tanabe Pharma Corporation Momenta Pharmaceuticals National Institute for Health and Clinical Excellence (NICE) [UK] Novartis Novo Nordisk Office of Technology Commercialisation [New York, USA] Pfizer PrimaPharm Qilu Ranbaxy Laboratories ratiopharm Roche Sandoz sanofi-aventis Schering-Plough SciGen [subsidiary of Bioton] Shantha Biotechnics Sidus Pharmaceutical Group Siegfried Biologics Stada Pharmaceuticals State Food and Drug Agency [China] Teva Pharmaceutical Industries Wockhardt World Health Organization (WHO) Wyeth Pharmaceuticals [now part of Pfizer] Zenotech [Studien Infos ausblenden] |
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1. Executive Summary 1.1 Biosimilars and Follow-On Biologics: Market Review 1.2 Aims, Methods and Format of the Report 2. Introduction to Biosimilars 2.1 Biotechnology and Biologic Drugs 2.2 Types of Biologic Drugs 2.3 Biosimilars, Biogenerics and 'Follow-On Protein Products' 3. The World Biosimilars Market, 2010-2025 3.1 World Biologic Drug Market 3.1.1 Leading Biologic Drug Types, 2009 3.1.2 The Blockbuster Biologics 3.2 The Biosimilar Market in 2009 3.3 World Biosimilar Market: Sales Forecast, 2010-2025 3.3.1 Biologics Will Continue to Outperform Small-Molecules 3.3.2 Biosimilar Market Comes of Age: World Market Sales Forecast, 2010-2015 3.3.3 World Biosimilar Market: Sales Forecast, 2015-2025 3.4 Monoclonal Antibodies and Anti-Inflammatory Fusion Proteins (AIFPs) 3.4.1 The Monoclonal Antibodies + AIFP Market, 2009 3.4.2 Monoclonal Antibodies + AIFP Market: Further Growth from 2010-2025 3.4.3 Reditux (Dr. Reddy's): The World's First Biosimilar Monoclonal Antibody 3.4.4 Biosimilar Monoclonal Antibodies + AIFPs, 2010-2015 3.4.5 Biosimilar Monoclonal Antibodies Take Off, 2015-2020 3.4.6 Biosimilar Monoclonal Antibodies + AIFPs, 2020-2025 3.5 Insulin 3.5.1 The Branded Insulin Market, 2009 3.5.2 The Biosimilar Insulin Market, 2008 3.5.3 Gensulin/SciLin (Bioton/SciGen) 3.5.4 Insugen (Biocon) 3.5.5 Global Diabetes Increases Will Drive Insulin Market from 2010-2025 3.5.6 Branded Insulin Market: Sales Forecast, 2010-2025 3.5.7 Rapid Biosimilar Insulin Growth, 2010-2015 3.5.8 Biosimilar Insulin Market: Sales Forecast, 2015-2025 3.6 Erythropoietin 3.6.1 The Branded Erythropoietin Market, 2009 3.6.2 The Biosimilar Erythropoietin Market, 2009 3.6.3 Binocrit/Epoetin Alfa Hexal/Abseamed (Sandoz/Medice) 3.6.4 Silapo/Retacrit (Stada/Hospira) 3.6.5 The Erythropoietin Market 2010-2025: Branded Drugs Facing Increasing Biosimilar Competition 3.6.6 Biosimilar Erythropoietin Market: Sales Forecast, 2010-2015 3.6.7 Favourable Long-Term Outlook for Biosimilar Erythropoietin, 2015-2025 3.7 Interferons 3.7.1 The Branded Interferon Market, 2009 3.7.2 The Biosimilar Interferon Market, 2009 3.7.3 Interferon Market Outlook, 2010-2025 3.7.4 Biosimilar Interferon Market: Sales Forecast, 2010-2015 3.7.5 Biosimilar Interferon Market: Sales Forecast, 2015-2025 3.8 Colony Stimulating Factors (CSF) and Interleukin-2 (IL-2) 3.8.1 The Branded CSF and IL-2 Drug Market, 2009 3.8.2 The Biosimilar CSF and IL-2 Drug Market, 2009 3.8.3 The CSF and IL-2 Drug Market, 2010-2025 3.8.4 Biosimilar CSF and IL-2 Drugs Market: Sales Forecast, 2010-2015 3.8.5 Biosimilar CSF and IL-2 Drugs Market: Sales Forecast, 2015-2025 3.9 Growth Hormones 3.9.1 The Branded Growth Hormone Market, 2009 3.9.2 The Biosimilar Growth Hormone Market, 2009 3.9.3 Omnitrope 3.9.4 Eutropin 3.9.5 Growth Hormone Market Outlook, 2010-2025 3.9.6 Branded Growth Hormone Market: Sales Forecast, 2010-2025 3.9.7 Biosimilar Growth Hormone Market: Sales Forecast, 2010-2015 3.9.8 Long Term Prospects for Biosimilar Growth Hormones, 2015-2025 4. Issues Affecting the Biosimilars Industry and Market 4.1 SWOT Analysis for the Biosimilar Industry and Market 4.2 Biological Medicines are Expensive 4.3 Many Biological Drugs have Expired or Soon-to-Expire Patents 4.4 Challenges in Developing Biosimilar Drugs 4.4.1 Biosimilars Not Developed with Ease of Traditional Generics 4.4.2 Biologics are Large, Complex Molecules 4.4.3 Complex Manufacturing Processes 4.4.4 Biologic Drugs are Heterogeneous 4.4.5 Biologic Drugs Difficult to Characterise & Slight Differences Have Important Clinical Consequences 4.4.6 Biologic Drugs Have Potential for Immunogenicity 4.5 Development of Regulations for the Approval of Biosimilars 4.5.1 Key Issues for Development of Biosimilar Regulations 4.5.2 Requirements for Clinical Trials 4.5.3 Debate over Clinical Trial Requirements in the US 4.5.4 Data Exclusivity Period 4.5.5 Biosimilar Substitution 4.5.6 International Non-Proprietary Names (INNs) 4.6 European Biosimilar Guidelines 4.6.1 EMEA Guidelines for Biosimilar Medicines 4.6.2 Testing Requirements 4.6.3 Clinical Testing For Multiple Indications 4.6.4 Data Exclusivity for Biologic Drugs in the EU 4.6.5 Naming of Biosimilars in the EU 4.6.6 Biosimilar Substitution Not Allowed in the EU 4.6.7 Latest Developments in EMEA Biosimilar Guidelines 4.6.8 Future Development of EMEA Guidelines 4.7 Progress Towards Development of 'Follow-On Protein Products' Regulatory Pathway in the US 4.7.1 Lack of Biosimilar Regulatory Pathway in the US Restricted the Market 4.7.2 Issues Affecting 'Follow-on Protein Products' Legislation in the US 4.7.3 Progress in Development and Implementation of a Biosimilar Regulatory Pathway in the US, 2010 4.8 Biosimilar Regulations in Japan 4.8.1 Japanese Guidelines for Biosimilar Approvals, 2009 4.8.2 Guidelines for the Development of a Biosimilar in Japan 4.8.3 Filing a Biosimilar Application in Japan 4.8.4 Naming of Biosimilars in Japan 4.9 Economics of Biosimilar Development and Marketing 4.9.1 Development of Biosimilars More Expensive than for Ordinary Generics 4.9.2 Biosimilars Will Face Competition from Newer Branded Biologic Drugs 4.9.3 Biosimilars Will Not Enjoy the Same Price Discount as Traditional Generics 4.9.4 Opportunities for CROs and CMOs 5. Expert Opinions on the Sector 5.1 Interview with Dr Donald L. Zuhn 5.1.1 Latest Developments in Creating Regulatory Guidelines 5.1.2 Period for Data Exclusivity 5.1.3 When Will We See Biosimilars in the US? 5.2 Interview with Dr Abul-Hassan 5.2.1 Key Developments 5.2.2 Which Biosimilars? 5.2.3 Future Trends 5.2.4 Data Exclusivity 5.3 Interview with Dr Suzanne Sensabaugh 5.3.1 Timescale of 'Follow-On Protein Product' Legislation 5.3.2 The Most Important Factor Delaying 'Follow-on Protein Product' Legislation 5.3.3 Prospects for Asian Biosimilars Manufacturers 5.3.4 Prospects for Biosimilar Monoclonal Antibodies in the US 5.4 Interview with Dr Rustom Mody 5.4.1 Biosimilar Strategy 5.4.2 Biosimilar Pipeline 5.4.3 Biosimilar Monoclonal Antibodies 5.4.4 Prospects for Indian CROs in Biosimilar R&D 6. Regional Biosimilar Markets 6.1 Leading Biologic Drug Country Markets, 2009 6.2 Asia’s Position in the World Biosimilars Market 6.3 Regional Biosimilar Markets: Sales Prospects, 2010-2025 6.4 The EU Biosimilar Market 6.4.1 Regulation of Generic Pharmaceuticals in the EU 6.4.2 Regulation of Biosimilars in the EU 6.4.3 Biosimilar Approvals by the EMEA, 2006-2010 6.4.4 European Biosimilar Market: Sales Forecast, 2010-2025 6.5 The US Biosimilar Market 6.5.1 Regulation of Biopharmaceuticals in the US 6.5.2 No Regulatory Pathway for Biosimilars in the US 6.5.3 FDA Has Already Approved a Number of 'Follow-On Protein Products' 6.5.4 More-Complex 'Follow-On Protein Products' Must Bide Their Time 6.5.5 US Biosimilar Market: Sales Forecast, 2010-2025 6.6 The Japanese Biosimilar Market 7. The Biosimilars R&D Pipeline 7.1 Competitive Landscape of the Biosimilars R&D Pipeline 7.1.1 Leading Players in the Biosimilars Sector, 2010-2025 7.2 Biocon 7.3 Bioton/SciGen/BioPartners 7.3.1 Gensulin/SciLin (Bioton/SciGen) 7.3.2 Eutropin/Valtropin (LG Life Sciences/BioPartners) 7.3.3 Alpheon (BioPartners) 7.4 CinnaGen 7.5 Cipla and Avesthagen 7.6 Dr. Reddy's Laboratories 7.7 GTC Biotherapeutics and LFB Biotechnologies 7.8 Hospira 7.9 Intas and Apotex 7.10 Merck & Co. 7.10.1 Merck BioVentures 7.10.2 Merck & Co.'s Glyco-Engineering Technology 7.10.3 Insmed's Biosimilars Acquired by Merck BioVentures 7.11 Ranbaxy 7.12 Sandoz 7.12.1 Sandoz Pioneered Biosimilars in Europe 7.12.2 Momenta and Sandoz Collaborate to Develop M-Enoxaparin and Other Biosimilars 7.13 Shantha Biotechnics 7.14 Stada 7.15 Teva Pharmaceutical Industries 7.15.1 Teva is a Biosimilar Early-Adopter 7.15.2 Teva's Joint Venture with Lonza 8. Conclusions 8.1 The Biologic Drugs Market - Under-met Need for Lower-Cost Drugs 8.2 Biosimilars are Not Generics 8.3 The World Biosimilars Market in 2009 8.4 Issues Slowing Down Adoption of Biosimilars 8.5 World Biosimilar Market: Sales Forecast, 2010-2025 8.6 Biosimilars and Follow-on Biologics – Summing Up Prospects [Inhaltsverzeichnis ausblenden] |
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Table 2.1 Biologic Drug Types, 2009 Table 3.1 Leading Biologic Drug Types, 2009 Table 3.2 Blockbuster Biologics, 2009 Table 3.3 Leading Biosimilar Drug Types, 2009 Table 3.4 Biosimilar and Branded Biologics: World Market Shares and CAGR, 2009, 2015, 2020 & 2025 Table 3.5 World Biosimilar Market: Sales Forecast, 2010-2017 Table 3.6 World Biosimilar Market: Sales Forecast, 2018-2025 Table 3.7 Biosimilar Drug Types Market: World Sales Forecasts, 2010-2025 Table 3.8 Leading Monoclonal Antibody Brands, 2009 Table 3.9 The World Monoclonal Antibodies and AIFPs Market, 2009 Table 3.10 Biosimilar and Branded Monoclonal Antibodies & AIFPs: World Market Shares and CAGR, 2010, 2015, 2020 & 2025 Table 3.11 Biosimilar Monoclonal Antibodies & AIFPs: World Sales Forecast, 2009-2017 Table 3.12 Biosimilar Monoclonal Antibodies & AIFPs Market: World Sales Forecast, 2018-2025 Table 3.13 Leading Insulin Brands, 2009 Table 3.14 The World Insulin Market, 2009 Table 3.15 Biosimilar and Branded Insulin: World Market Shares and CAGR, 2010, 2015, 2020 & 2025 Table 3.16 Biosimilar Insulin Market: World Sales Forecast, 2009-2017 Table 3.17 Biosimilar Insulin Market: World Sales Forecast, 2018-2025 Table 3.18 The World Erythropoietin Market, 2009 Table 3.19 Biosimilar and Branded Erythropoietin: World Market Shares and CAGR, 2009, 2015, 2020 & 2025 Table 3.20 Biosimilar Erythropoietin Market: World Sales Forecast, 2009-2017 Table 3.21 Biosimilar Erythropoietin Market: World Sales Forecast, 2018-2025 Table 3.22 The World Interferon Market, 2009 Table 3.23 Biosimilar and Branded Interferons: World Market Shares and CAGR, 2009, 2015, 2020 & 2025 Table 3.24 Biosimilar Interferon Market: World Sales Forecast, 2009-2017 Table 3.25 Biosimilar Interferon Market: World Sales Forecast, 2018-2025 Table 3.26 The World CSF and IL-2 Drug Market, 2009 Table 3.27 Biosimilar & Branded CSF & IL-2 Drugs: World Market Shares & CAGR, 2009, 2015, 2020 & 2025 Table 3.28 Biosimilar CSF & IL-2 Drug Market: World Sales Forecast, 2009-2017 Table 3.29 Biosimilar CSF & IL-2 Drug Market: World Sales Forecast, 2018-2025 Table 3.30 The World Growth Hormones Market, 2009 Table 3.31 Biosimilar & Branded Growth Hormones: World Market Shares & CAGR, 2009, 2015, 2020 & 2025 Table 3.32 Biosimilar Growth Hormones Market: World Sales Forecast, 2009-2017 Table 3.33 Biosimilar Growth Hormones Market: World Sales Forecast, 2018-2025 Table 4.1 SWOT Chart for the Biosimilars Sector, 2010-2025 Table 4.2 Expected Patent Expiry Dates for Leading Biologic Drugs, 2010-2020 Table 6.1 Biologic Drugs: Regional Markets, 2009 Table 6.2 Biosimilars: Regional Markets, 2009 Table 6.3 Biosimilar Markets: Regional Sales Forecasts, 2010-2017 Table 6.4 Biosimilar Markets: Regional Sales Forecasts, 2018-2025 Table 6.5 Biosimilar Approvals by the EMEA, 2006-2010 Table 7.1 Pipeline Biosimilar Drugs: Part 1, 2010 Table 7.2 Pipeline Biosimilar Drugs: Part 2, 2010 Figure 3.1 Biologic Drug Types: World Market Shares, 2009 Figure 3.2 Biosimilar Drug Types: World Market Shares, 2009 Figure 3.3 Biosimilar Market: World Sales Forecast, 2010-2025 Figure 3.4 Biosimilar and Branded Biologics: World Market Shares, 2009, 2015, 2020 & 2025 Figure 3.5 Biosimilar Drug Types: World Market Shares, 2015 Figure 3.6 Biosimilar Drug Types: World Market Shares, 2020 Figure 3.7 Biosimilar Drug Types: World Market Shares, 2025 Figure 3.8 Leading Monoclonal Antibodies + AIFP Brands: World Market Shares, 2009 Figure 3.9 Biosimilar and Branded Monoclonal Antibodies & AIFPs: World Market Shares, 2010, 2015, 2020 & 2025 Figure 3.10 Biosimilar Monoclonal Antibodies & AIFP Market: World Sales Forecast, 2010-2025 Figure 3.11 Leading Insulin Brands: World Market Shares, 2009 Figure 3.12 Biosimilar and Branded Insulin: World Market Shares and CAGR, 2009, 2015, 2020 & 2025 Figure 3.13 Biosimilar Insulin Market: World Sales Forecast, 2010-2025 Figure 3.14 Leading Erythropoietin Brands, 2009 Figure 3.15 Biosimilar and Branded Erythropoietin: World Market Shares & CAGR, 2009, 2015, 2020 & 2020 Figure 3.16 Biosimilar Erythropoietin Market: World Sales Forecast, 2010-2025 Figure 3.17 Leading Interferon Brands, 2009 Figure 3.18 Biosimilar and Branded Interferons: World Market Shares & CAGR, 2009, 2015, 2020 & 2020 Figure 3.19 Biosimilar Interferons Market: World Sales Forecast, 2010-2025 Figure 3.20 Leading CSF and IL-2 Brands, 2009 Figure 3.21 Biosimilar & Branded CSF & IL-2 Drugs: World Market Shares, 2009, 2015, 2020 & 2025 Figure 3.22 Biosimilar CSF & IL-2 Drugs Market: World Sales Forecast, 2010-2025 Figure 3.23 Leading Growth Hormone Brands, 2009 Figure 3.24 Biosimilar & Branded Growth Hormones: World Market Shares, 2009, 2015, 2020 & 2025 Figure 3.25 Biosimilar Growth Hormones Market: World Sales Forecast, 2010-2025 Figure 6.1 Biologics Drugs: Regional Markets, 2009 Figure 6.2 Biosimilars: Regional Markets, 2009 Figure 6.3 Regional Biosimilar Market Shares, 2009, 2015, 2020 & 2025 Figure 6.4 European Biosimilar Market: Sales Forecast, 2010-2025 Figure 6.5 US Biosimilar Market: Sales Forecast, 2010-2025 [Tabellenverzeichnis ausblenden] |
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