SPI Infoamtion

Table of Contents

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

List of Tables
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

List of Figures
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