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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