Biosimilars and Follow-On Biologics Report: The Global Outlook 2009-2024

Table of Contents

1. Executive Summary

2. Introduction to Biosimilars

• 2.1 Biotechnology and Biologic Drugs
• 2.2 Type of Biologic Drug
• 2.3 Biosimilars, Biogenerics and ‘Follow-On Protein Products'

3. The World Biosimilar Market, 2009-2024

• 3.1 World Biologic Drug Market
  • 3.1.1 Leading Biologic Drug Types
  • 3.1.2 Blockbuster Biologics
• 3.2 The Biosimilar Market in 2008
• 3.3 World Biosimilar Market Forecast, 2009-2024
  • 3.3.1 Biologics Will Continue to Outperform ‘Small-Molecules'
  • 3.3.2 Biosimilar Market Takes Off: World Market Forecast, 2009-2014
  • 3.3.3 World Biosimilar Market Forecast, 2014-2024
• 3.4 Growth Hormones
  • 3.4.1 The Branded Growth Hormone Market, 2008
  • 3.4.2 The Biosimilar Growth Hormone Market, 2008
  • 3.4.3 Omnitrope (Sandoz)
  • 3.4.4 Eutropin/Valtropin (LG Life Sciences/BioPartners)
  • 3.4.5 Growth Hormone Market Outlook, 2009-2024
  • 3.4.6 Branded Growth Hormone Market Forecast, 2009-2024
  • 3.4.7 Biosimilar Growth Hormone Market Forecast, 2009-2014
  • 3.4.8 What are the Prospects for Biosimilar Growth Hormones from 2014-2024?
• 3.5 Insulin
  • 3.5.1 The Branded Insulin Market, 2008
  • 3.5.2 The Biosimilar Insulin Market, 2008
  • 3.5.3 Gensulin/SciLin (Bioton/SciGen)
  • 3.5.4 Insugen (Biocon)
  • 3.5.5 Rising Diabetes Prevalence Will Drive Insulin Market from 2009-2024
  • 3.5.6 Branded Insulin Market Forecast, 2009-2024
  • 3.5.7 Rapid Biosimilar Insulin Growth, 2009-2014
  • 3.5.8 Biosimilar Insulin Market Forecast, 2014-2024
• 3.6 Erythropoietin
  • 3.6.1 The Branded Erythropoietin Market, 2008
  • 3.6.2 The Biosimilar Erythropoietin Market, 2008
  • 3.6.3 Binocrit/Epoetin Alfa Hexal/Abseamed (Sandoz/Medice)
  • 3.6.4 Epiao (3SBio)
  • 3.6.5 Silapo/Retacrit (Stada/Hospira)
  • 3.6.6 The Erythropoietin Market 2009-2024: Branded Drugs Facing Increasing Biosimilar Competition
  • 3.6.7 Biosimilar Erythropoietin Market Forecast, 2009-2014
  • 3.6.8 A Favourable Outlook for Biosimilar Erythropoietin from 2014-2024
• 3.7 Colony Stimulating Factors (CSF) and Interleukin-2 (IL-2)
  • 3.7.1 The Branded CSF and IL-2 Drug Market, 2008
  • 3.7.2 The Biosimilar CSF and IL-2 Drug Market, 2008
  • 3.7.3 The CSF and IL-2 Drug Market, 2009-2024: Prospects for Biosimilar Entry
  • 3.7.4 Biosimilar CSF and IL-2 Drugs Market Forecast, 2009-2014
  • 3.7.5 Biosimilar CSF and IL-2 Drugs Market Forecast, 2014-2024
• 3.8 Interferons
  • 3.8.1 The Branded Interferon Market, 2008
  • 3.8.2 The Biosimilar Interferon Market, 2008
  • 3.8.3 Interferon Market Outlook, 2009-2024
  • 3.8.4 Biosimilar Interferon Market Forecast, 2009-2014
  • 3.8.5 Biosimilar Interferon Market Forecast, 2014-2024
• 3.9 Monoclonal Antibodies and Anti-Inflammatory Fusion Proteins (AIFPs)
  • 3.9.1 The Monoclonal Antibodies + AIFP Market, 2008
  • 3.9.2 Reditux (Dr. Reddy' s): The World' s First Biosimilar Monoclonal Antibody
  • 3.9.3 Monoclonal Antibodies + AIFP Market: Further Growth during 2009-2024
  • 3.9.4 Biosimilar Monoclonal Antibodies + AIFPs, 2009-2014
  • 3.9.5 Biosimilar Monoclonal Antibodies Come into Play
  • 3.9.6 Biosimilar Monoclonal Antibodies + AIFPs, 2019-2024

4. Issues Affecting the Biosimilars Industry

• 4.1 SWOT Analysis for the Biosimilar Industry
• 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 Process
  • 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 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 Restricts Market
  • 4.7.2 Major Issues Affecting ‘Follow-on Protein Products' Legislation in the US
  • 4.7.3 When Will a Biosimilar Pathway be Created in the US?
• 4.8 Expert Opinion from Dr Suzanne Sensabaugh: Progress on Follow-On Protein Product Legislation in the US
  • 4.8.1 Timescale of ‘Follow-On Protein Product' Legislation
  • 4.8.2 The Most Important Factor Delaying Follow-on Protein Product Legislation
  • 4.8.3 Prospects for Asian Biosimilars Manufacturers
  • 4.8.4 Prospects for Biosimilar Monoclonal Antibodies in the US
• 4.9 Economics of Biosimilar Development and Marketing
  • 4.9.1 Development of Biosimilars More Expensive than Ordinary Generics
  • 4.9.2 Biosimilars Will Face Competition from Newer Branded Biologic Drugs
  • 4.9.3 Biosimilars Will Not Enjoy the Same Price Discounts as Traditional Generics
  • 4.9.4 Opportunities for CROs and CMOs

5. Regional Biosimilar Markets

• 5.1 Leading Biologic Drug Country Markets, 2008
• 5.2 Asia Dominates the World Biosimilar Market
• 5.3 Regional Biosimilar Market Forecast, 2009-2024
• 5.4 The EU Biosimilar Market
  • 5.4.1 Regulation of Generic Pharmaceuticals in the EU
  • 5.4.2 Regulation of Biosimilars in the EU
  • 5.4.3 Biosimilar Approvals by the EMEA, 2006-2009
  • 5.4.4 European Biosimilar Market Forecast, 2009-2024
• 5.5 The US Biosimilar Market
  • 5.5.1 Regulation of Biopharmaceuticals in the US
  • 5.5.2 No Regulatory Pathway for Biosimilars in the US
  • 5.5.3 FDA Has Already Approved a Number of ‘Follow-On Protein Products'
  • 5.5.4 More-Complex Follow-On Protein Products Must Bide Their Time
  • 5.5.5 US Biosimilar Market Forecast, 2009-2024
• 5.6 The Japanese Biosimilar Market

6. The Biosimilars Pipeline

• 6.1 The Competitive Landscape of the Biosimilar Pipeline
  • 6.1.1 Who Will Become Major Biosimilar Players?
  • 6.1.2 Prospects for Biosimilar Monoclonal Antibodies
• 6.2 Biocon
• 6.3 Bioton/SciGen/BioPartners
  • 6.3.1 Gensulin/SciLin (Bioton/SciGen)
  • 6.3.2 Eutropin/Valtropin (LG Life Sciences/BioPartners)
  • 6.3.3 Alpheon (BioPartners)
  • 6.3.4 Biferonex (BioPartners)
• 6.4 CinnaGen
• 6.5 Cipla and Avesthagen
• 6.6 Dr. Reddy' s Laboratories
• 6.7 GTC Biotherapeutics and LFB Biotechnologies
• 6.8 Hospira
• 6.9 Intas and Apotex
• 6.10 Merck & Co.
  • 6.10.1 Merck BioVentures
  • 6.10.2 Merck & Co.' s Glyco-Engineering Technology
  • 6.10.3 Insmed' s Biosimilars Acquired by Merck BioVentures
• 6.11 Ranbaxy/Zenotech
• 6.12 Sandoz
  • 6.12.1 Sandoz Has Pioneered Biosimilars in Europe
  • 6.12.2 Momenta and Sandoz Collaboration to Develop M-Enoxaparin and Other Biosimilars
• 6.13 Shantha Biotechnics
• 6.14 Stada
• 6.15 Teva
  • 6.15.1 Teva is a Biosimilar Early-Adopter
  • 6.15.2 Teva' s Joint Venture with Lonza
  • 6.15.3 Teva' s Recent Acquisitions
• 6.16 Wockhardt
• 6.17 Interview with Dr. Rustom Mody, Director (Strategic Research & Quality), Intas Biopharmaceuticals: The Intas Biosimilars Pipeline and Prospects for Indian Companies in the Biosimilar Market
  • 6.17.1 Intas' Biosimilar Strategy
  • 6.17.2 Intas' Biosimilar Pipeline
  • 6.17.3 Intas and Biosimilar Monoclonal Antibodies
  • 6.17.4 Prospects for Indian CROs in Biosimilar R&D

7. Conclusions

• 7.1 Unmet Need for Cheaper Biologic Drugs
• 7.2 Biosimilars Are Not Generics
• 7.3 The World Biosimilar Market in 2008
• 7.4 Issues Slowing Down Adoption of Biosimilars
• 7.5 World Biosimilar Market Forecast, 2009-2024
• 7.6 Who Will Become Major Biosimilar Players?

List of Tables

• Table 2.1 Biologic Drug Types
• Table 3.1 Leading Biologic Drug Types, 2008
• Table 3.2 Blockbuster Biologics
• Table 3.3 Leading Biosimilar Drug Types, 2008
• Table 3.4 Biosimilar and Branded Biologics: Market Shares and CAGR, 2009-2024
• Table 3.5 World Biosimilar Market Forecast, 2009-2014
• Table 3.6 World Biosimilar Market Forecast, 2015-2024
• Table 3.7 Biosimilar Drug Type Market Forecast, 2009-2024
• Table 3.8 The Growth Hormone Market, 2008
• Table 3.9 Biosimilar & Branded Growth Hormones: Market Shares & CAGR, 2009-2024
• Table 3.10 Biosimilar Growth Hormones Forecast, 2009-2014
• Table 3.11 Biosimilar Growth Hormones Forecast, 2015-2024
• Table 3.12 Leading Insulin Brands, 2008
• Table 3.13 The Insulin Market, 2008
• Table 3.14 Biosimilar and Branded Insulin: Market Shares and CAGR, 2009-2024
• Table 3.15 Biosimilar Insulin Forecast, 2009-2014
• Table 3.16 Biosimilar Insulin Forecast, 2015-2024
• Table 3.17 The Erythropoietin Market, 2008
• Table 3.18 Biosimilar and Branded Erythropoietin: Market Shares and CAGR, 2009-2024
• Table 3.19 Biosimilar Erythropoietin Forecast, 2009-2014
• Table 3.20 Biosimilar Erythropoietin Forecast, 2015-2024
• Table 3.21 The CSF and IL-2 Drug Market, 2008
• Table 3.22 Biosimilar & Branded CSF & IL-2 Drugs: Market Shares & CAGR, 2009-2024
• Table 3.23 Biosimilar CSF and IL-2 Drugs Forecast, 2009-2014
• Table 3.24 Biosimilar CSF and IL-2 Drugs Forecast, 2015-2024
• Table 3.25 The Interferon Market, 2008
• Table 3.26 Biosimilar and Branded Interferons: Market Shares and CAGR, 2009-2024
• Table 3.27 Biosimilar Interferons Forecast, 2009-2014
• Table 3.28 Biosimilar Interferons Forecast, 2015-2024
• Table 3.29 The Monoclonal Antibodies + AIFP Market, 2008
• Table 3.30 Leading Monoclonal Antibody Brands
• Table 3.31 The Monoclonal Antibodies Market, 2008
• Table 3.32 The Anti-Inflammatory Fusion Protein (AIFP) Market, 2008
• Table 3.33 Biosimilar and Branded Monoclonal Antibodies + AIFPs: Market Shares and CAGR, 2009-2024
• Table 3.34 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2009-2014
• Table 3.35 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2015-2024
• Table 4.1 SWOT Chart for the Biosimilar Market, 2009-2024
• Table 4.2 Expected Key-Patent Expiry Dates for Leading Biologic Drugs, 2009-2019
• Table 5.1 Leading Biologic Drug Country Markets, 2008
• Table 5.2 Biosimilar Regional Markets, 2008
• Table 5.3 Regional Biosimilar Market Forecasts, 2009-2014
• Table 5.4 Regional Biosimilar Market Forecast, 2015-2024
• Table 5.5 Biosimilar Approvals by the EMEA, 2006-2009
• Table 6.1 Example Pipeline Biosimilar Drugs 1
• Table 6.2 Example Pipeline Biosimilar Drugs 2

List of Figures

• Figure 3.1 Biologic Drug Type Market Share, 2008
• Figure 3.2 Biosimilar Drug Type Market Share, 2008
• Figure 3.3 Biosimilar and Branded Biologics: Market Shares and CAGR, 2009-2024
• Figure 3.4 World Biosimilar Market Forecast, 2009-2024
• Figure 3.5 Biosimilar Drug Type Market Share, 2014
• Figure 3.6 Biosimilar Drug Type Market Share, 2019
• Figure 3.7 Biosimilar Drug Type Market Share, 2024
• Figure 3.8 Leading Growth Hormone Brands, 2008
• Figure 3.9 Biosimilar and Branded Growth Hormones: Forecasts and Market Shares, 2009-2024
• Figure 3.10 Biosimilar Growth Hormones Forecast, 2009-2024
• Figure 3.11 Leading Insulin Brands, 2008
• Figure 3.12 Biosimilar and Branded Insulin: Market Shares and CAGR, 2009-2024
• Figure 3.13 Biosimilar Insulin Forecast, 2009-2024
• Figure 3.14 Leading Erythropoietin Brands, 2008
• Figure 3.15 Biosimilar and Branded Erythropoietin: Market Shares & CAGR, 2009-2024
• Figure 3.16 Biosimilar Erythropoietin Forecast, 2009-2024
• Figure 3.17 Leading CSF and IL-2 Brands, 2008
• Figure 3.18 Biosimilar & Branded CSF & IL-2 Drugs: Market Shares & CAGR, 2009-2024
• Figure 3.19 Biosimilar CSF and IL-2 Drugs Forecast, 2009-2024
• Figure 3.20 Leading Interferon Brands, 2008
• Figure 3.21 Biosimilar and Branded Interferons: Market Shares and CAGR, 2009-2024
• Figure 3.22 Biosimilar Interferons Forecast, 2009-2024
• Figure 3.23 Leading Monoclonal Antibodies + AIFP Brands, 2008
• Figure 3.24 Biosimilar and Branded Monoclonal Antibodies + AIFPs: Market Shares and CAGR, 2009-2024
• Figure 3.25 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2009-2024
• Figure 5.1 Leading Biologic Drug Country Markets, 2008
• Figure 5.2 Biosimilar Regional Markets, 2008
• Figure 5.3 Regional Biosimilar Market Forecast, 2009-2024
• Figure 5.4 European Biosimilar Market Forecast, 2009-2024
• Figure 5.5 US Biosimilar Market Forecast, 2009-2024
• Figure 7.1 World Biosimilar Market Forecast, 2009-2024

Companies Listed

• 3SBio
• Abbott
• Abraxis BioScience
• Alexion
• Amgen
• Amphastar
• Apotex
• AstraZeneca
• Avesthagen
• AxiCorp
• Barr
• Bayer
• Beijing Shuanglu
• Biocon
• Biogen Idec
• BioPartners
• Biotechnology Industry Organization (BIO)
• Bioton
• Bristol-Myers Squibb
• CCL Pharmaceuticals
• CinnaGen
• Cipla
• CJ Corporation
• CoGenesys
• CSL
• CT Arzneimittel
• Daiichi Sankyo
• Dong-A
• Dr. Reddy' s
• Eden Biodesign
• Elan
• Eli Lilly
• European Medicines Agency (EMEA)
• Feron
• Food and Drug Administration (FDA) [US]
• Fraunhofer Institute
• Genentech
• Generic Pharmaceutical Association (GPhA)
• GeneScience
• Getz Pharma
• GlaxoSmithKline (GSK)
• GlycoFi
• GTC Biotherapeutics
• Halozyme Therapeutics
• Hexal
• Hospira
• Hualida Biotech
• Human Genome Sciences
• Insmed
• Intas
• Ipsen
• Johnson & Johnson
• Kissei
• Kyowa Hakko Kirin
• LFB Biotechnologies
• LG Life Sciences
• Lonza
• Medice
• Merck & Co.
• Merck KGaA
• Merieux Alliance
• Ministry of Health, Labour and Welfare (MHLW) [Japan]
• Mitsubishi Tanabe
• Momenta
• National Institute for Health and Clinical Excellence (NICE)
• Novartis
• Novo Nordisk
• Pfizer
• PrimaPharm
• Qilu
• Ranbaxy
• Ratiopharm
• Roche
• Sandoz
• Sanofi-Aventis
• Schering-Plough
• SciGen
• Shantha Biotechnics
• Siegfried Biologics
• Stada
• Teva
• Therapeutic Goods Administration (TGA) [Australia]
• Tonghua Dongbao
• Upsher-Smith
• Wockhardt
• World Health Organization (WHO)
• Wyeth
• Zenotech