Oct 31, 2015
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Biosimilars and Follow-On Biologics: World Market 2013-2023
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Contents
1.1 Biosimilar Drugs: World Market Overview 2013-2023
1.2 Report Contents
1.3 Research and Analysis Methods
1.4 Terminology Used in this Report
2.1 Biological and Biosimilar Drugs
2.1.1 What Is a Biosimilar Drug?
2.2 Key Classes of Biologics and Biosimilars
2.2.1 Monoclonal Antibodies
2.2.2 Insulin for Diabetes
2.2.3 Interferons Are Used for Multiple Sclerosis and Hepatitis
2.2.4 Erythropoietin (EPO)
2.2.5 Granulocyte Colony Stimulating Factor (G-CSF)
2.2.6 Human Growth Hormone
2.2.7 Fertility Hormones
2.3 Why Is There Demand for Biosimilars?
2.4 Considerations for the Development of Biosimilars
3.1 The World Biologics Market 2012
3.1.1 Strong Growth for the Biologics Market 2013-2023
3.2 Biosimilars Account for a Small Proportion of Biologics Revenues
3.2.1 The Biosimilars Market: Overall Revenue Forecast 2013-2023
3.2.2 How Will Biosimilar Submarket Shares Change 2013-2023?
1. Executive Summary
2. An Introduction to Biosimilars
3. The World Biosimilar Drugs Market 2013-2023
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Contents 3.3 What Will Drive Growth in the Biosimilars Market 2013-2023?
3.4 Biosimilar Market Restraints 2013-2023
4.1 Which Were the Leading National Markets for Biosimilar Sales in 2012?
4.2 Which National Markets Will Grow Fastest to 2023?
4.2.1 National Market Shares 2013-2023
4.3 The Outlook for Biosimilars in the US 2013-2023
4.3.1 Final FDA Biosimilar Guidelines Expected in 2013
4.3.2 Legal Challenges for Biosimilars in the US
4.3.3 State Regulation of Biosimilar Substitution
4.3.4 US Biosimilars Submarket Forecast 2013-2023
4.4 Biosimilars Market Outlook in the EU 2013-2023
4.4.1 The EU Led the World in Biosimilar Regulation
4.4.2 The EMA Continues to Update Biosimilar Guidelines
4.4.3 EMA Simplifies Biosimilar Development in the EU
4.4.4 Two New Biosimilar Classes to Launch in the EU in 2013-2014
4.4.5 The EU Biosimilars Submarket by Country 2012
4.4.6 The EU Biosimilars Submarket Forecast 2013-2023
4.4.7 Germany: The Largest National Market for Biosimilars in the EU
4.4.8 France: Biosimilars Submarket 2013-2023
4.4.9 Biosimilar Uptake is High in the UK
4.4.10 Spain Has the Highest Biosimilar Discounting in Western Europe
4.4.11 Biosimilar Uptake Will Rise in Italy 2013-2023
4.5 The Outlook for Biosimilars in Japan 2013-2023
4.5.1 Regulatory Processes for Biosimilars in Japan
4.5.1.1 Regulations for Naming Biosimilars
4.5.2 Two New Biosimilars Will Be Launched in Japan in 2013
4. Commercial and Regulatory Outlook for Biosimilars in Leading National Markets 2013-2023
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Contents 4.5.3 Japanese Biosimilar Submarket Forecast 2013-2023
4.6 The Chinese Biosimilar Submarket 2013-2023
4.6.1 China to Release Formal Biosimilar Development Guidelines
4.6.2 Strong Growth for the Chinese Biosimilars Market 2013-2023
4.7 India: The Second Largest Biosimilars National Market 2013
4.7.1 India Releases New Biosimilar Development Guidelines
4.7.2 Indian Biosimilars Submarket Forecast 2013-2023
4.8 Brazil: Biosimilars Submarket Outlook 2013-2023
4.8.1 ANVISAs Biosimilar Regulations Are Similar to the EMAs
4.8.2 Brazilian Biosimilars Submarket Forecast 2013-2023
4.9 Russia
4.9.1 No Specific Biosimilar Legislation Exists in Russia 2013
4.9.2 Russian Biosimilars Submarket Forecast 2013-2023
4.10 South Korea
4.10.1 KFDA Introduced Biosimilar Guidelines in 2009
4.10.2 There Has Been Significant Investment in Biosimilars in South Korea
4.10.3 South Korean Biosimilars Submarket Forecast 2013-2023
5.1 The World Monoclonal Antibodies (MAbs) Submarket 2012
5.1.1 Outlook for the MAbs Submarket 2013-2023
5.2 The Biosimilar MAbs Submarket 2013-2023
5.2.1 Biosimilar MAbs Submarket Forecast 2013-2023
5.2.2 Large Market Potential to Drive Growth to 2023
5.2.3 What Will Restrain Growth for the Biosimilar MAbs Submarket 2013-2023?
5.2.3.1 There Have Been Delays in Biosimilar Antibody Development
5.2.3.2 There Are Challenges in Developing Biosimilar MAbs
5.3 How Has the Industry Reacted to New EMA Development Guidelines?
5.4 Collaboration in Biosimilar MAb Development
5. Biosimilar Monoclonal Antibodies Submarket 2013-2023
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Contents 5.5 Rituximab: The Most Popular Biosimilar MAb Target?
5.5.1 Increasing Incidence of Non-Hodgkins Lymphoma 2013-2023
5.5.2 The Outlook for Roches Rituxan 2013-2023
5.5.3 Reditux: Indias First Biosimilar MAb
5.5.4 Kikuzubam: Probiomeds Biosimilar Rituximab
5.5.5 Biosimilar Rituximab Development for Developed Markets
5.5.6 Biosimilar Rituximab Development in Emerging Markets
5.5.7 Biosimilar Rituximab: Revenue Forecast 2013-2023
5.6 Infliximab Will Be the First Developed Market Biosimilar MAb
5.6.1 How Will Rheumatoid Arthritis Prevalence Change in this Decade?
5.6.2 Biosimilars Must Compete With Novel Therapies
5.6.3 Remsima: The Worlds First Biosimilar Infliximab
5.6.4 Epirus Biopharmaceuticals: Developing Biosimilar Infliximab for the US Market
5.6.5 Reliance Life Sciences: Biosimilar Infliximab in India
5.6.6 Biosimilar Infliximab: Revenue Forecast 2013-2023
5.7 Biosimilar Trastuzumab
5.7.1 Roche Has Developed a Next Generation Breast Cancer Therapy
5.7.2 Biosimilar Pipeline for Trastuzumab 2013
5.7.2.1 Celltrion Is Leading Biosimilar Development in Emerging Markets
5.7.2.2 Biosimilars in Developed Markets
5.7.3 Biosimilar Trastuzumab: Revenue Forecast 2013-2023
5.8 Other Biosimilar MAbs in Development
5.8.1 Humira is the Worlds Bestselling Drug
5.8.1.1 AbbVie Seeks to Protect its Bestselling Drug
5.8.1.2 Biosimilar Adalimumab Pipeline 2013
5.8.2 Biosimilar Etanercept Development Has Been Delayed
5.8.2.1 Biosimilar Etanercept in Emerging Markets
5.8.3 ReoPro: Limited Biosimilar Potential
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Contents
6.1 The Insulin Therapy Submarket 2013-2023
6.1.1 Outlook for the Insulin Therapy Submarket 2013-2023
6.1.2 The Rising Incidence of Diabetes Worldwide 2013-2023
6.1.2.1 Obesity and Ageing Will Drive Rising Incidence
6.1.3 What Potential Is There for Oral Insulin?
6.1.4 The Cost of Insulin Therapy as a Driver for Biosimilar Uptake
6.2 The Biosimilar Insulin Submarket 2013-2023
6.2.1 Biosimilar Insulin Submarket Forecast 2013-2023
6.2.2 Collaborative Agreements in Biosimilar Insulin
6.2.3 EMA Publishes Draft Guidelines for Biosimilar Insulin
6.3 The Biosimilar Human Insulin Submarket 2013-2023
6.3.1 Human Insulin Biosimilars Are Popular in Emerging Markets
6.3.2 Approval Application Withdrawals in the EU 2007-2012
6.3.3 Biosimilar Human Insulin Uptake in China
6.3.4 Biosimilar Human Insulin in India
6.3.5 Biosimilar Human Insulin Revenue Forecast 2013-2023
6.4 Biosimilar Fast-Acting Insulin Analogues 2013-2023
6.4.1 Few Insulin Lispro Biosimilars Are Approved in Emerging Markets
6.4.2 Biosimilar Fast-Acting Insulin Analogues Submarket Forecast 2013-2023
6.5 Biosimilar Long-Acting Insulin Analogues 2013-2023
6.5.1 Two Insulin Glargine Biosimilars Are Marketed in India
6.5.2 Development of Ultra-Long Acting Insulin Analogues
6.5.3 Biosimilar Long-Acting Insulin Analogues Submarket Forecast 2013-2023
6. Biosimilar Insulin Submarket 2013-2023
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Contents
7.1 The Interferon Therapy Submarket 2013-2023
7.1.1 The Threat of Oral Therapies in Hepatitis C and MS
7.2 Biosimilar Interferons in the EU
7.2.1 Failed Development Attempts
7.2.2 New EMA Development Guidelines Released 2013
7.2.3 What Challenges Exist in Developing Interferon Biosimilars?
7.3 Biosimilar Interferon Alpha Submarket 2013-2023
7.3.1 Limited Demand for Interferon Alpha Therapy in Hepatitis C to 2023
7.3.2 Many Companies Already Market Biosimilar Interferon Alpha
7.3.3 Biosimilar Peginterferon Alpha Development
7.3.4 The Prevalence of Hepatitis C Will Rise 2013-2023
7.3.5 Biosimilar Interferon Alpha Submarket Forecast 2013-2023
7.4 Biosimilar Interferon Beta Submarket 2013-2023
7.4.1 Interferon Beta in Emerging Markets 2013
7.4.2 Biosimilar Interferon Beta Submarket Forecast 2013-2023
8.1 The Biosimilar Erythropoietin (EPO) Submarket 2013-2023
8.1.1 Branded EPO Submarket 2012
8.1.2 Branded EPO Submarket Outlook 2013-2023: Revenues Will Continue to Decline
8.1.3 Erythropoietins Come With Safety Concerns
8.1.4 The Rising Risk of Chronic Kidney Disease 2013-2023
8.1.5 The Biosimilar EPO Submarket in Europe 2013
8.1.5.1 Companies Are Preparing to Launch in the US
8.1.5.2 JCR Pharmaceuticals and Kissei Market Biosimilar EPO in Japan
8.1.6 Many Companies Offer Biosimilar EPO in India
7. Biosimilar Interferon Submarket Outlook 2013-2023
8. Outlook for Other Leading Biosimilar Submarkets 2013-2023
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Contents 8.1.7 Developing Second Generation EPO Biosimilars
8.1.8 Biosimilar EPO Submarket Forecast 2013-2023
8.2 The Biosimilar Filgrastim Submarket 2013-2023
8.2.1 Filgrastim Submarket Outlook 2013-2023
8.2.2 The Biosimilar Filgrastim Submarket 2012
8.2.3 What Trends Are There in Biosimilar Cost and Uptake in Europe?
8.2.4 Biosimilar Pegfilgrastim in India: An Increasingly Fragmented Market Driving Down
Prices
8.2.5 Pegfilgrastim Is a More Lucrative Target in the US
8.2.6 Biosimilar Filgrastim Submarket Forecast 2013-2023
8.3 The Biosimilar Somatropin Submarket 2013-2023
8.3.1 A Competitive Branded Submarket 2013-2023
8.3.2 Product Lifecycle Management to Maintain Market Share
8.3.3 Limited Uptake for Biosimilar Somatropin in the US and EU
8.3.4 Biosimilar Somatropin in Emerging Markets
8.3.5 Biosimilar Somatropin Submarket Forecast 2013-2023
8.4 The Biosimilar Follicle Stimulating Hormone (FSH) Market 2013-2023
8.4.1 Patents Expiries Affecting Leading Therapies 2009-2015
8.4.2 EMA Releases Biosimilar FSH Guidelines 2013
8.4.3 Infertility Is a Common Problem Worldwide
8.4.4 Biosimilar FSH Will Be Launched in the EU in 2013
8.4.5 Biosimilars FSH Submarket Forecast 2013-2023
9.1 What Are the Strengths and Weaknesses of the Biosimilars Market in 2013?
9.2 Opportunities and Threats for Biosimilars Developers 2013-2023
9.3 Biosimilars Market: STEP Analysis 2013-2023
9.3.1 Social Factors
9.3.2 Technological Developments Will Simplify Biosimilar Production
9. Biosimilars and Follow-On Biologics: Industry Trends 2013-2023
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Contents 9.3.3 Economic Pressures Driving Biosimilar Demand
9.3.4 Political Issues: Patent Challenges, Data Exclusivity and Regulatory Pathways
9.3.4.1 Regularly Updated Guidelines Will Benefit Developers
9.3.4.2 International Cooperation Is Required
9.4 Opportunities and Challenges in Biosimilar Development
9.4.1 Biologics and Biosimilars Are Large, Complex Molecules
9.4.2 Clinical Trials Are Required for Biosimilars
9.4.3 How Big a Concern Is Immunogenicity?
9.4.4 Outsourcing to Gain Biological Expertise
9.4.5 Biosimilars Are Expensive to Develop
9.5 Considerations for Commercialising Biosimilars
9.5.1 Biosimilars Need Branding
9.5.1.1 Marketing Strategy and Doctors Response to Biosimilars
9.5.2 Biosimilars Can Offer Cost Savings
9.5.2.1 Pricing Strategies for Biosimilars
9.5.3 The Importance of Naming Biosimilars
9.5.3.1 There Is Not Yet Automatic Substitution for Biosimilars
9.5.4 Protecting Important Biological Assets
9.5.4.1 Intellectual Property Challenges
9.5.4.2 Data Exclusivity for New Biologics
9.5.4.3 Biobetters as a Threat to Biosimilars
9.6 Key Players in the Biosimilars Market 2013-2023
9.6.1 Big Pharma Will Play an Increasing Role in the Biosimilars Market
9.6.2 Collaborative Agreements to Bring Biosimilars to New Markets
10.1 Dr Terence Ryan, SVP, iBio
10.1.1 iBio and its Biosimilar Pipeline, 2013
10.1.2 The Benefits of the iBioLaunch Platform
10. Research Interviews
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Contents 10.1.3 Differences Between Developing Biosimilar and Biologics
10.1.4 Product Differentiation in the Biosimilar Market
10.1.5 Biosimilars and Immunogenicity
10.1.6 Challenges in Developing Biosimilars for the US Market
10.2 Anjan Selz, CEO, Finox
10.2.1 Finox
10.2.2 Challenges in Biosimilar Development
10.2.3 Differences Between Europe and the US
10.2.4 Product Differentiation
10.2.5 Opportunities Existing in the Biosimilars Market
11.1 The World Biosimilars Market in 2012
11.1.1 Growth for the Market 2013-2023
11.1.2 Which National Markets Will Dominate in 2023?
11.2 The Biosimilars Pipeline Is Long
11.3 Opportunities for Companies Looking to Enter the Market
11. Conclusions from Our Study
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Contents
Table 1.1 Currency Exchange Rates, 2012
Table 2.1 Comparison of Major Biological Drug Classes by Size
Table 2.2 Monoclonal Antibody Classification
Table 2.3 Insulin Peak Action Times
Table 3.1 Top Ten Prescription Drugs by Revenue, 2012
Table 3.2 Biologics Market by Sector, 2012
Table 3.3 Next Generation Development for Biologics, 2013
Table 3.4 Biosimilars Market by Sector, 2012
Table 3.5 Biosimilars Market: Overall Market and Revenue Forecasts by Sector, 2012-2023
Table 3.6 Biosimilars Market: Submarket Shares, 2013-2023
Table 3.7 Biosimilars Market: Drivers and Restraints, 2013-2023
Table 4.1 Biosimilars Market by Country: Revenues and Market Shares, 2012
Table 4.2 Biosimilars Market: Revenue Forecasts by Country, 2012-2023
Table 4.3 Biosimilar Market: National Submarket Shares, 2012-2023
Table 4.4 US Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.5 European Approved Biosimilars, 2013
Table 4.6 EU Biosimilars Submarket by Country, 2012
Table 4.7 EU Biosimilars Submarket: Revenue Forecasts by Country, 2012-2023
Table 4.8 German Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.10 UK Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.11 Spanish Biosimilars Submarket: Revenue Forecast, 2012-2023
List of Tables
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Contents Table 4.12 Italian Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.13 Japanese Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.14 Selected Chinese Biosimilar Manufacturers and their Activities, 2013
Table 4.15 Chinese Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.16 Indian Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.17 Brazilian Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.18 Russian Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 4.19 South Korean Biosimilars Submarket: Revenue Forecast, 2012-2023
Table 5.1 Monoclonal Antibody (MAb) Submarket by Drug: Revenues, 2011-2012
Table 5.2 Blockbuster MAbs: US and EU Patent Expiries, 2013-2022
Table 5.3 Biosimilar MAbs Submarket and Leading Drugs: Revenue Forecasts, 2012-2023
Table 5.4 Biosimilar MAbs Submarket: Drivers and Restraints, 2013-2023
Table 5.5 EMA Biosimilar Mab Development Guidelines: Key Points, 2013
Table 5.6 Selected Collaborations for Biosimilar MAb Development, 2009-2013
Table 5.7 Rituxan: Revenue by Company, 2011-2012
Table 5.8 Reditux: Revenue, 2008-2012
Table 5.9 Biosimilar Rituximab: Selected Pipeline, 2013
Table 5.10 Biosimilar Rituximab: Revenue Forecast, 2012-2023
Table 5.11 Remicade: Revenue by Company, 2011-2012
Table 5.12 Rheumatoid Arthritis: Prevalence, 2013
Table 5.13 Biosimilar Infliximab: Selected Pipeline, 2013
Table 5.14 Biosimilar Infliximab: Revenue Forecast, 2012-2023
Table 5.15 Herceptin: Revenue, 2010-2012
Table 5.16 Biosimilar Trastuzumab: Selected Pipeline, 2013
Table 5.17 Biosimilar Trastuzumab: Revenue Forecast, 2012-2023
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Contents Table 5.18 Biosimilar Adalimumab: Selected Pipeline, 2013
Table 5.19 Biosimilar Etanercept: Selected Pipeline, 2013
Table 6.1 Insulin Therapy Submarket by Sector, 2012
Table 6.2 Diabetes: Global Prevalence by Country, 2013
Table 6.3 Population Ageing in Developed and Emerging Markets, 2010 and 2050
Table 6.4 Biosimilar Insulin Submarket: Drivers and Restraints, 2013-2023
Table 6.5 Biosimilar Insulin Submarket and Leading Sectors: Revenue Forecasts, 2012-2023
Table 6.6 Human Insulin Submarket by Company: Revenues, 2011-2012
Table 6.7 Chinese Insulin Market by Company: Shares, 2011
Table 6.8 Biosulin: Revenue, 2009-2011
Table 6.9 Biosimilar Human Insulin Submarket: Revenue Forecast, 2012-2023
Table 6.10 Fast-Acting Insulin Analogue Submarket by Drug: Revenues, 2011-2012
Table 6.11 Biosimilar Fast-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023
Table 6.12 Long-Acting Insulin Analogue Submarket by Drug: Revenues, 2011-2012
Table 6.13 Biosimilar Long-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023
Table 7.1 Interferon Submarket by Sector, 2011-2012
Table 7.2 Leading Phase III Oral Hepatitis C Therapies, 2013
Table 7.3 Marketed Oral MS Therapies, 2013
Table 7.4 Interferon Alpha Submarket by Drug: Revenues, 2011-2012
Table 7.5 Pegasys: Revenue, 2008-2012
Table 7.6 Interferon Alpha and Beta: US and EU Patent Expiries
Table 7.7 Selected Interferon Alpha Biosimilars Available in Emerging Markets, 2013
Table 7.8 Selected Peginterferon Alpha Biosimilars Available and in Development in Emerging
Markets, 2013
Table 7.9 Hepatitis C: Global Prevalence by Region, 2013
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Contents Table 7.10 Biosimilar Interferon Alpha Submarket: Revenue Forecast, 2012-2023
Table 7.11 Interferon Beta Submarket by Drug: Revenues, 2011-2012
Table 7.12 Selected Interferon Beta Biosimilars Available in Emerging Markets, 2013
Table 7.13 Biosimilar Interferon Beta Submarket: Revenue Forecast, 2012-2023
Table 8.1 Erythropoietin (EPO) Market by Drug: Revenues, 2011-2012
Table 8.2 EPO Biosimilars Available in Developed Markets, 2013
Table 8.3 Binocrit and Silapo: Revenue, 2009-2011
Table 8.4 EPO: US and EU Patent Expiries
Table 8.5 Retacrit: US Phase III Trials, 2013
Table 8.6 Selected Biosimilar Erythropoietins Available in Emerging Markets, 2013
Table 8.7 EPIAO: Revenue, 2009-2012
Table 8.8 Espogen: Revenue, 2006-2012
Table 8.9 Biosimilar EPO Submarket: Drivers and Restraints, 2013-2023
Table 8.10 Biosimilar Erythropoietins Submarket: Revenue Forecast, 2012-2023
Table 8.11 Filgrastim Submarket by Drug: Revenues, 2011-2012
Table 8.12 Biosimilar Filgrastim Products Marketed in the EU, 2013
Table 8.13 Selected Biosimilar Filgrastim Products Marketed in Emerging Markets, 2013
Table 8.14 Biosimilar Pegfilgrastim Products Marketed in India, 2013
Table 8.15 Filgrastim and Pegfilgrastim: US and EU Patent Expiries
Table 8.16 Biosimilar Filgrastim Submarket: Revenue Forecast, 2012-2023
Table 8.17 Biosimilar Filgrastim Submarket: Drivers and Restraints, 2013-2023
Table 8.18 Somatropin Submarket by Drug: Revenues, 2011-2012
Table 8.19 Omnitrope: National Market Launches, 2004-2011
Table 8.20 Selected Biosimilar Somatropin Products Available in Emerging Markets, 2013
Table 8.21 Growtropin: Revenue, 2009-2012
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Contents Table 8.22 Biosimilar Somatropin Submarket: Drivers and Restraints, 2013-2023
Table 8.23 Biosimilar Somatropin Submarket: Revenue Forecast, 2012-2023
Table 8.24 Follicle Stimulating Hormone (FSH) Submarket by Drug: Revenues, 2011-2012
Table 8.25 FSH: US and EU Patent Expiries
Table 8.26 Biosimilar FSH Submarket: Drivers and Restraints, 2013-2023
Table 8.27 Biosimilar FSH Submarket: Revenue Forecast, 2012-2023
Table 9.1 Biosimilars Market: Strengths and Weaknesses, 2012-2013
Table 9.2 Biosimilars Market: Opportunities and Threats, 2013-2023
Table 9.3 Biosimilars Market: STEP Analysis, 2013-2023
Table 9.4 Outsourcing Deals in the Biosimilars Industry, 2011-2012
Table 9.5 Selected Biosimilars Marketed in Pen Injectors, 2013
Table 9.6 Websites for EU and US Marketed Biosimilars, 2013
Table 9.7 Biosimilar Market Leaders by Revenue, 2012
Table 9.8 Big Pharmas Role in the Biosimilars Market, 2013
Table 9.9 Selected Biosimilar Industry Partnerships, 2009-2013
Table 11.1 Biosimilars Market by Sector, 2012, 2017 and 2023
Table 11.2 Biosimilars Market by Country, 2012, 2017 and 2023
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Contents
Figure 3.1 Biologics Market by Sector: Shares, 2012
Figure 3.2 Biologics Market Forecast, 2012, 2017 and 2023
Figure 3.3 Biosimilars Market by Sector: Shares, 2012
Figure 3.4 Biosimilars Market Forecast, 2012-2023
Figure 3.5 Biosimilars Market by Sector: Shares, 2017
Figure 3.6 Biosimilars Market by Sector: Shares, 2023
Figure 4.1 Biosimilars Market by Country: Shares, 2012
Figure 4.2 Biosimilars Market by Country: Shares, 2017
Figure 4.3 Biosimilars Market by Country: Shares, 2023
Figure 4.4 FDA Biosimilar Guidelines 2012: Key Points
Figure 4.5 US Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.6 EU Biosimilars Submarket by Country: Shares, 2012
Figure 4.7 EU Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.8 German Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.10 UK Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.11 Spanish Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.12 Italian Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.13 Japanese Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.14 Chinese Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.15 Indian Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.16 Brazilian Biosimilars Submarket: Revenue Forecast, 2012-2023
List of Figures
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Contents Figure 4.17 Russian Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 4.18 South Korean Biosimilars Submarket: Revenue Forecast, 2012-2023
Figure 5.1 Monoclonal Antibody (MAb) Submarket by Drug: Shares, 2012
Figure 5.2 Biosimilar MAbs Submarket: Revenue Forecast, 2012-2023
Figure 5.3 Rituxan: Revenue by Company, 2011-2012
Figure 5.4 Reditux: Revenue, 2008-2012
Figure 5.5 Biosimilar Rituximab: Revenue Forecast, 2012-2023
Figure 5.6 Remicade: Revenue by Company, 2011-2012
Figure 5.7 Biosimilar Infliximab: Revenue Forecast, 2012-2023
Figure 5.8 Herceptin: Revenue, 2010-2012
Figure 5.9 Biosimilar Trastuzumab: Revenue Forecast, 2012-2023
Figure 6.1 Insulin Therapy Submarket by Sector: Shares, 2012
Figure 6.2 Diabetes: Global Prevalence by Country, 2013
Figure 6.3 Biosimilar Insulin Submarket: Revenue Forecast, 2012-2023
Figure 6.4 Human Insulin Submarket by Company, 2012
Figure 6.5 Chinese Insulin Market by Company: Shares, 2011
Figure 6.6 Biosulin: Revenue, 2009-2011
Figure 6.7 Biosimilar Human Insulin Submarket: Revenue Forecast, 2012-2023
Figure 6.8 Fast-Acting Insulin Analogue Submarket by Drug: Shares, 2012
Figure 6.9 Biosimilar Fast-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023
Figure 6.10 Long-Acting Insulin Analogue Submarket by Drug: Shares, 2012
Figure 6.11 Biosimilar Long-Acting Insulin Analogues Submarket: Revenue Forecast, 2012-2023
Figure 7.1 Interferon Submarket by Sector: Shares, 2012
Figure 7.2 Interferon Alpha Submarket by Drug: Shares, 2012
Figure 7.3 Hepatitis C: Global Prevalence by Region, 2013
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Contents Figure 7.4 Biosimilar Interferon Alpha Submarket: Revenue Forecast, 2012-2023
Figure 7.5 Interferon Beta Submarket by Drug: Shares, 2012
Figure 7.6 Biosimilar Interferon Beta Submarket: Revenue Forecast, 2012-2023
Figure 8.1 Erythropoietin (EPO) Submarket by Drug: Shares, 2012
Figure 8.2 Binocrit and Silapo: Revenue, 2009-2011
Figure 8.3 EPIAO: Revenue, 2009-2012
Figure 8.4 Espogen: Revenue 2006-2012
Figure 8.5 Biosimilar Erythropoietins Submarket: Revenue Forecast, 2012-2023
Figure 8.6 Filgrastim Submarket by Drug, 2012
Figure 8.7 Biosimilar Filgrastim Submarket: Revenue Forecast, 2012-2023
Figure 8.8 Somatropin Submarket by Drug: Shares, 2012
Figure 8.9 Growtropin: Revenue, 2009-2012
Figure 8.10 Biosimilar Somatropin Submarket: Revenue Forecast, 2012-2023
Figure 8.11 Follicle Stimulating Hormone (FSH) Submarket by Drug: Shares, 2012
Figure 8.12 Biosimilar FSH Submarket: Revenue Forecast, 2012-2023
Figure 9.1 Biosimilar Start-Up and Development Cost Estimates, 2013
Figure 9.2 Biosimilar Market Leaders by Revenue: Shares, 2012
Figure 11.1 Biosimilars Market, 2012, 2017 and 2023
Figure 11.2 Biosimilars Market by Region, 2012, 2017 and 2023
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Contents
3SBio
AbbVie
Ach
Actavis (formerly Watson Pharmaceuticals)
AET BioTech
Agila Biotech
Allozyne
Amega Biotech
Amgen
Antares Pharma
Apotex
Aprogen
AstraZeneca
Avesthagen
Baxter International
Bayer
Beijing Four Rings Biopharmaceutical
Beijing SL Pharmaceutical
Biocad
Bioceuticals Arzneimittel (part of Stada)
Biocon
Biogen Idec
BioGeneriX (part of Teva)
BioGenomics
Bionovis
Biopartners (part of Bioton)
Biosidus
Companies Mentioned in This Report
www.visiongain.com
Contents Bioton
BioXpress Therapeutics
Boehringer Ingelheim
Bristol-Myers Squibb
CCL Pharmaceuticals
Celltrion
Centocor Ortho Biotech (now Janssen Biotech part of J&J)
Chiron (part of Novartis)
Chugai Pharmaceutical (part of Roche)
CinnaGen
Cipla
CJ Corporation
Coherus BioSciences
Compass Biotechnologies
CT Arzneimittel (part of Teva)
Daiichi Sankyo
Dong-A Pharmaceutical
Dr. Reddy's Laboratories
Egis Pharmaceuticals
Eli Lilly
Emcure Pharmaceuticals
EMS
Epirus Biopharmaceuticals
EvaluatePharma (now Evaluate)
Finox
Fresenius Kabi
Fuji Pharma
Fujifilm
Fujifilm Kyowa Kirin Biologics
Gan & Lee Pharmaceutical
www.visiongain.com
Contents Gedeon Richter
Genentech (part of Roche)
GeneScience Pharmaceuticals (GenSci)
Genexine
Gennova Biopharmaceuticals (part of Emcure Pharmaceuticals)
Genzyme (part of Sanofi)
Getz Pharmaceuticals
Gilead Sciences
GSK
Hangzhou Jiuyuan Gene Engineering
Hanwha Chemical
Haselmeier
Hexal (part of Novartis)
Hikma Pharmaceuticals
Hospira
Hualida Biotech
Hypermarcas
iBio
ImmunoGen
IMS Health
Incepta Pharmaceuticals
Insmed
Intas Biopharmaceuticals
InterMune
Isu Abxis
J&J
JCR Pharmaceuticals
Kissei Pharmaceutical
Kyowa Hakko Kirin
Laboratrios Biosinttica (part of Ach)
www.visiongain.com
Contents Landsteiner Scientific
LG Life Sciences
Lonza
Mabion
Marvel Life Sciences
Medice
MedImmune
Medipolis
Medivir
Merck & Co.
Merck Serono
Minapharm Pharmaceuticals
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Momenta Pharmaceuticals
Mycenax Biotech
Mylan
Nichi-Iko Pharmaceutical
Nippon Kayaku
Novartis
Novo Nordisk
Nuron Biotech
Octoplus
Oncobiologics
Oramed Pharmaceuticals
Owen Mumford
Parexel International
Pfenex
Pfizer
Pharmapark (part of Pharmstandard)
www.visiongain.com
Contents PharmaPraxis
Pharmstandard
PlantForm
Pliva (part of Teva)
Polfa Tarchomin
PRA International
Probiomed
Prolor Biotech
Protalix Biotherapeutics
Qilu Pharmaceutical
Quintiles
Ranbaxy Laboratories
ratiopharm (part of Teva)
Reliance GeneMedix (pat of Reliance Life Sciences)
Reliance Life Sciences
Rentschler Biotechnologie
Roche
Samsung
Samsung Bioepis
Samsung BioLogics
Sandoz (part of Novartis)
Sanofi
Schnell Biopharmaceuticals
SciGen (part of Bioton)
Shandong Kexing Bioproducts
Shanghai Celgen Bio-Pharmaceutical
Shanghai CP Guojian Pharmaceutical
Shanghai Fosun Pharmaceutical
Shantha Biotechnics (part of Sanofi)
Sicor Biotech (part of Teva)
www.visiongain.com
Contents Sothema Laboratories
Spectrum Pharmaceuticals
Square Pharmaceuticals
Stada Arzneimittel
Sundiro Pharma
Synthon
Teva Pharmaceutical Industries
Tibotec Pharmaceuticals (part of J&J)
Tonghua Dongbao
UCB
Unio Qumica
United Laboratories
USV Biologics
Viropro
Wanbang Biopharmaceuticals (part of Shanghai Fosun Pharmaceutical)
Wockhardt
Wolters Kluwer
Xiamen Amoytop Biotech
Ypsomed
Zenotech Laboratories
Zenyaku Kogyo
Zuventus Healthcare (part of Emcure Pharmaceuticals)
Zydus Cadila
www.visiongain.com
Contents
Agence nationale de scurit du mdicament et des produits de sant (ANSM) [France]
Agncia Nacional de Vigilncia Sanitria (ANVISA) [Brazil]
American Cancer Society
American Diabetes Association
Biopharmaceuticals and Herbal Medicines Bureau [South Korea]
Biotechnology Industry Organization (BIO)
Cambridge University
Cardiovascular and Renal Drugs Advisory Committee [US]
Centers for Disease Control and Prevention (CDC) [US]
Central Drugs Standard Control Organisation (CDSCO) [India]
Centers of Medicare and Medicaid Services (CMS) [US]
Comisin Federal para la Proteccin contra Riesgos Sanitarios (Cofepris) [Mexico]
Congressional Budget Office [US]
Department of Biotechnology (DBT) [India]
Drug Controller General of India (DCGI)
EMA Committee for Medicinal Products for Human Use (CHMP) [EU]
European Medicines Agency (EMA)
Food and Drug Administration (FDA) [US]
Fraunhofer Institute [Germany]
Fundao Ezequiel Dias (Funed) [Brazil]
Health Canada
Instituto Vital Brazil
Intellectual Property Appellate Board (IPAB) [India]
Korea Food and Drug Administration (KFDA)
Medicines and Healthcare Products Regulatory Agency (MHRA) [UK]
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Government Agencies and Other Organisations Mentioned in This Report
www.visiongain.com
Contents Ministry of Health [Brazil]
National Health Service (NHS) [UK]
National Institute for Health and Care Excellence (NICE) [UK]
National Institute for the Control of Pharmaceutical and Biological Products [China]
Pharmaceutical Research and Manufacturers of America (PhRMA)
Pro Generika [Germany]
State Food and Drug Administration (SFDA) [China]
State's Employees Social Security and Social Services Institute (ISSSTE) [Mexico]
Therapeutic Goods Administration (TGA) [Australia]
University of California, Los Angeles (UCLA)
University of Michigan
US Patent and Trademark Office
Walter and Eliza Hall Institute of Medical Research
Washington Legal Foundation
World Economic Forum
World Health Organization (WHO)
Page 67
www.visiongain.com
Biosimilars and Follow-On Biologics: World Market 2013-2023
4.4.8 France: Biosimilars Submarket 2013-2023 Compared with other leading Western European nations, pharmaceutical spending, per capita, is
high in France, while generic drug use is low. In France, low uptake of generics is a result of
comparatively low prices for branded drugs, as well as many patents for leading products being
extended in the country. Low uptake of generics is matched there by low uptake of biosimilars,
when compared other leading nations such as the UK and Germany. In France, biosimilars
account for only around 15% of prescriptions in the EPO, filgrastim and somatropin markets. For
EPO, the level of biosimilar uptake is estimated to be just 5%. In that submarket, as well as for
growth hormones, low uptake is the result of mandatory price reductions for the reference biologics
and biosimilars. These price reductions mean that there is little difference between the cost of the
reference biologic and the biosimilar. Generally speaking, though, biosimilars are launched at a
discount of 20% over the reference biologics in France.
Reports suggest that doctors in France have not yet gained confidence in prescribing biosimilars,
giving another possible explanation as to why uptake remains low. The reason given is that
biosimilars are relatively new to the market - confidence in these drugs will grow in the coming 10
years, visiongain predicts. This growing confidence will drive revenues to $321m in 2017, up from
$61m in 2012 (Table 4.9 and Figure 4.9). Growth in the second half of the forecast period will be
driven by the launch of biosimilar mAbs. By 2023, the French biosimilars submarket will be worth
$1,146m, having grown since 2012 with a CAGR of 30.6%. Visiongain predicts that France will fall
further behind Germany, in terms of market size, although its European market share will increase
relative to that country.
2012 2013 2014 2015 2016 2017
Submarket ($m) 61 75 119 170 236 321
Annual Growth (%) 23 58 44 39 36
CAGR (%) 39.4
2018 2019 2020 2021 2022 2023
Submarket ($m) 423 547 682 832 977 1,146
Annual Growth (%) 32 29 25 22 18 17
CAGR (%) 23.7
Source: visiongain 2013
Table 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023
Page 68
www.visiongain.com
Biosimilars and Follow-On Biologics: World Market 2013-2023
4.4.9 Biosimilar Uptake is High in the UK In 2012, biosimilar revenues in the UK totalled $40m, accounting for 12.5% of the EU biosimilars
submarket. Uptake for biosimilars in the UK is higher than for France, with around two thirds of
NHS filgrastim prescriptions being filled with biosimilars. Price and cost effectiveness are two
important features of the UK pharmaceutical market, visiongain notes. However, upon launch
discounts for biosimilars are not as high as has been seen in other countries. For example, In July
2009, Sandoz Zarzio was launched on the UK market with a 10% discount over Neupogen,
although this may be the result of a low price for the reference biologic. Pricing is a key element of
entering the UK market, with only drugs found to be cost-effective - as determined by the criteria of
the National Institute for Health and Care Excellence (NICE) - available through the NHS. While
generic drugs are exempt from pricing regulation schemes in the UK, biosimilars are covered.
As with other leading European markets, biosimilar substitution is not possible in the EU. The UK
Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a number of
safeguards to prevent against accidental substitution. In 2008, for example, it advised that doctors
should always prescribe biological drugs by brand name to avoid confusion for the pharmacist. In
addition, packaging for biosimilars in the UK must be printed with a black triangle to identify the
product as a follow-on biologic. The UK was among the first countries to introduce such a
regulation, although similar EU-wide rules are set to take effect in 2013.
0
200
400
600
800
1,000
1,200
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
Mar
ket
Size
($m
)
Year
Figure 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023
Source: visiongain 2013
Biosimilars and Follow-On Biologics World Market 2013-2023 CoverBiosimilars and Follow-On Biologics World Market 2013-2023 ToC1. Executive Summary2. An Introduction to Biosimilars3. The World Biosimilar Drugs Market 2013-20234. Commercial and Regulatory Outlook for Biosimilars in Leading National Markets 2013-20235. Biosimilar Monoclonal Antibodies Submarket 2013-20236. Biosimilar Insulin Submarket 2013-20237. Biosimilar Interferon Submarket Outlook 2013-20238. Outlook for Other Leading Biosimilar Submarkets 2013-20239. Biosimilars and Follow-On Biologics: Industry Trends 2013-202310. Research Interviews11. Conclusions from Our StudyList of TablesList of FiguresCompanies Mentioned in This ReportGovernment Agencies and Other Organisations Mentioned in This Report
Sample pages from Biosimilars and Follow-On Biologics World Market 2013-2023