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PHARMA REPORT

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Biosimilars And Follow-On Biologics: World Market 2013-2023

Biosimilars And Follow-On Biologics: World Market 2013-2023

  • Publication date: 30/04/2013
  • Number of Pages: 235
  1. Report Details
  2. Table of Contents
  3. Companies Listed

Report Details

Biosimilar drugs - discover trends and areas with highest revenue potential

Do you want to find the sales potential of biosimilars? Visiongain's updated report gives you revenue predictions for those biological drugs from 2013, helping you stay ahead. There you find financial data, R&D trends, opportunities and discussions of prospects.

In that work you see forecasted sales to 2023 at overall world market, submarket, molecule and national level. You also assess emerging trends, technologies and expected products.

You see what shapes that industry and find its revenue prospects

Discover, then, what the future holds for biosimilars (follow-on biologics, follow-on protein products). Read on to scan features of that industry and see what its future market could be worth.

Forecasts and other analyses show you the best commercial areas

In our study you find revenue forecasting to 2023, historical data, growth rates and market shares. There you assess quantitative and qualitative analysis, business news, outlooks and developments (R&D). You also gain 113 tables, 66 charts and two research interviews.

Many opportunities exist for those competitors of original biological drugs (biologics). You discover areas most likely to prosper. Finding data you need has just got easier.

The following sections show how you benefit from the new analysis.

Discover sales predictions for the world market and submarkets

Along with revenue prediction for the overall world market for biosimilars and related agents, our work shows forecasts from 2013 to 2023 for its individual submarkets:
• Monoclonal antibodies (mAbs)
• Insulins - with sub forecasts for human insulin, fast-acting and long-acting analogues
• Interferons - with sub forecasts for alpha and beta interferon
• Erythropoietin (EPO)
• Filgrastim
• Somatropin
• Follicle stimulating hormone (FSH).

The new report shows you revenue potentials of those biopharmaceuticals, helping you find opportunities to develop your business.

Also our investigation discusses what stimulates and restrains sales of those subsequent entry biologics. There you explore that industry, seeing what products can achieve the most success.

Discover sales forecasts for prominent therapeutic molecules

Our study forecasts revenues of prominent biosimilar agents at molecular level:
• Rituximab
• Infliximab
• Trastuzumab.

There you discover how high sales can go, to 2023, with individual forecasts. You see what's happening, understanding trends, competition, challenges and opportunities.

Our study also divides its overall world forecast into those for geographical regions.

Leading national markets - where will highest revenue growth occur?

Developments worldwide will influence that follow-on biologics market, especially rising demand in emerging countries - e.g. China, India and South Korea. See how and where.

Our analyses show you individual revenue forecasts to 2023 for twelve national markets and one regional block:
• The US
• Japan
• The EU and its leading countries - Germany, France, the UK, Italy and Spain
• The BRIC countries - Brazil, Russia, India and China
• South Korea.

There you discover progress and outlooks. You assess the biosimilar industry's future - hear about developments and find their significance. Our work explains, exploring crucial issues.

What affects that biopharma industry and market?

The new report discusses issues and events affecting that industry and market from 2013, including these developments:
• Considerations for developing biosimilars
• Guidelines from the FDA expected in 2013
• Other regulations - including EMA and MHLW - with their effects on producers
• Challenges in developing biosimilar mAbs
• Collaborations for follow-on drug development.

That study also discusses other aspects of the field, including these:
• Developments in technology to aid biosimilar production
• Incidence and prevalence of diseases affecting demand for the treatments
• Economics stimulating demand for substitute biological medicines
• Biobetters as rivals of biosimilars
• Patent challenges and data exclusivity
• Outsourcing to gain expertise in pharma biotechnology.

That way you explore technological, economic, social and political (STEP) questions, assessing outlooks for that area of business. You also analyse that industry's strengths, weaknesses, opportunities and threats (SWOT). Discover, then, what the future holds.

Leading companies and 2017 market value

From 2013, product launches there hold great potential for investment, uptake and revenues. Our study predicts the world market for biosimilars and follow-on biologics will reach $8.8bn in 2017, and multiply in size to 2023. See how high its revenues can go.

You assess what biosimilar technologies, products types and companies hold most potential. Our analyses cover these and many other developers and producers:
• Sandoz
• Hospira
• Mylan
• Pfizer
• Merck & Co.
• Boehringer Ingelheim
• Dr. Reddy's Laboratories
• Teva Pharmaceutical Industries.

In our report you find 210 organisations mentioned. Also, you read two interviews with authorities in the industry. See what shapes it, discovering what participants do and say.

Anyhow, from this decade onwards there will arise many opportunities. Prospects for those rivals of established biologics are strong. Our work shows you technological and commercial possibilities for those substitutes, helping you stay ahead.

Nine ways Biosimilars and Follow-On Biologics: World Market 2013-2023 helps you

In particular, then, our investigation gives you the following knowledge on the topic:
• Revenue to 2023 for the world biosimilars market - discover that industry's overall sales prospects
• Revenues to 2023 for world-level submarkets - investigate the potential of its components, finding the most promising areas for investments and revenues
• Prospects to 2023 for leading biomolecules - find biosimilar revenue forecasts for top therapies
• Forecasts to 2023 for leading national markets in the Americas, Europe and Asia - discover the best regions and countries for revenues and potential growth
• Activities of leading companies - hear about participants' strategies, capabilities and outlooks
• Discussions of R&D - investigate progress in the industry, finding technological, medical and commercial possibilities
• Interviews with authorities in the industry - discover thoughts to help you stay ahead
• Competition and opportunities - see what affects that market, learning what shapes its future, esp. prospects for developing business
• Analysis of what stimulates and restrains that pharma segment - assess challenges and strengths, helping you compete and gain advantages.

You gain information found nowhere else

That work gives independent analysis. There you receive business intelligence found only in our report, seeing where prospects are most rewarding.

With our new study you are less likely to fall behind in knowledge or miss opportunity. See there how you could benefit your research, analyses and decisions, also saving time.

Discover potential now in the biosimilars market and find what you can gain.

See commercial prospects from 2013 by ordering now

Our investigation is for everyone needing to assess the future of biological drugs. There you find data, trends, opportunities and predictions. Please order that report now.

Visiongain is a trading partner with the US Federal Government
CCR Ref number: KD4R6

To view free sample pages of this report please click here

Table of Contents

1. Executive Summary
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. An Introduction to Biosimilars
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. The World Biosimilar Drugs Market 2013-2023
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?
3.3 What Will Drive Growth in the Biosimilars Market 2013-2023?
3.4 Biosimilar Market Restraints 2013-2023

4. Commercial and Regulatory Outlook for Biosimilars in Leading National Markets 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
4.5.3 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 ANVISA's Biosimilar Regulations Are Similar to the EMA's
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. Biosimilar Monoclonal Antibodies Submarket 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
5.5 Rituximab: The Most Popular Biosimilar MAb Target?
5.5.1 Increasing Incidence of Non-Hodgkin's Lymphoma 2013-2023
5.5.2 The Outlook for Roche's Rituxan 2013-2023
5.5.3 Reditux: India's First Biosimilar MAb
5.5.4 Kikuzubam: Probiomed's 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 World's 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 World's 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

6. Biosimilar Insulin Submarket 2013-2023
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

7. Biosimilar Interferon Submarket Outlook 2013-2023
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. Outlook for Other Leading Biosimilar Submarkets 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
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. Biosimilars and Follow-On Biologics: Industry Trends 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
9.3.3 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. Research Interviews
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
10.1.3 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. Conclusions from Our Study
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

List of Tables
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
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
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
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
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 Pharma's 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

List of Figures
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
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
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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Companies Listed

3SBio
AbbVie
Aché
Actavis (formerly Watson Pharmaceuticals)
AET BioTech
Agence nationale de sécurité du médicament et des produits de santé (ANSM) [France]
Agência Nacional de Vigilância Sanitária (ANVISA) [Brazil]
Agila Biotech
Allozyne
Amega Biotech
American Cancer Society
American Diabetes Association
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)
Biopharmaceuticals and Herbal Medicines Bureau [South Korea]
Biosidus
Biotechnology Industry Organization (BIO)
Bioton
BioXpress Therapeutics
Boehringer Ingelheim
Bristol-Myers Squibb
Cambridge University
Cardiovascular and Renal Drugs Advisory Committee [US]
CCL Pharmaceuticals
Celltrion
Centers for Disease Control and Prevention (CDC) [US]
Centers of Medicare and Medicaid Services (CMS) [US]
Centocor Ortho Biotech (now Janssen Biotech part of J&J)
Central Drugs Standard Control Organisation (CDSCO) [India]
Chiron (part of Novartis)
Chugai Pharmaceutical (part of Roche)
CinnaGen
Cipla
CJ Corporation
Coherus BioSciences
Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) [Mexico]
Compass Biotechnologies
Congressional Budget Office [US]
CT Arzneimittel (part of Teva)
Daiichi Sankyo
Department of Biotechnology (DBT) [India]
Dong-A Pharmaceutical
Dr. Reddy's Laboratories
Drug Controller General of India (DCGI)
Egis Pharmaceuticals
Eli Lilly
EMA Committee for Medicinal Products for Human Use (CHMP) [EU]
Emcure Pharmaceuticals
EMS
Epirus Biopharmaceuticals
European Medicines Agency (EMA)
EvaluatePharma (now Evaluate)
Finox
Food and Drug Administration (FDA) [US]
Fraunhofer Institute [Germany]
Fresenius Kabi
Fuji Pharma
Fujifilm
Fujifilm Kyowa Kirin Biologics
Fundação Ezequiel Dias (Funed) [Brazil]
Gan & Lee Pharmaceutical
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
Health Canada
Hexal (part of Novartis)
Hikma Pharmaceuticals
Hospira
Hualida Biotech
Hypermarcas
iBio
ImmunoGen
IMS Health
Incepta Pharmaceuticals
Insmed
Instituto Vital Brazil
Intas Biopharmaceuticals
Intellectual Property Appellate Board (IPAB) [India]
InterMune
Isu Abxis
J&J
JCR Pharmaceuticals
Kissei Pharmaceutical
Korea Food and Drug Administration (KFDA)
Kyowa Hakko Kirin
Laboratórios Biosintética (part of Aché)
Landsteiner Scientific
LG Life Sciences
Lonza
Mabion
Marvel Life Sciences
Medice
Medicines and Healthcare Products Regulatory Agency (MHRA) [UK]
MedImmune
Medipolis
Medivir
Merck & Co.
Merck Serono
Minapharm Pharmaceuticals
Ministry of Health [Brazil]
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Momenta Pharmaceuticals
Mycenax Biotech
Mylan
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]
Nichi-Iko Pharmaceutical
Nippon Kayaku
Novartis
Novo Nordisk
Nuron Biotech
Octoplus
Oncobiologics
Oramed Pharmaceuticals
Owen Mumford
Parexel International
Pfenex
Pfizer
Pharmaceutical Research and Manufacturers of America (PhRMA)
Pharmapark (part of Pharmstandard)
PharmaPraxis
Pharmstandard
PlantForm
Pliva (part of Teva)
Polfa Tarchomin
PRA International
Pro Generika [Germany]
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)
Sothema Laboratories
Spectrum Pharmaceuticals
Square Pharmaceuticals
Stada Arzneimittel
State Food and Drug Administration (SFDA) [China]
State's Employees´ Social Security and Social Services Institute (ISSSTE) [Mexico]
Sundiro Pharma
Synthon
Teva Pharmaceutical Industries
Therapeutic Goods Administration (TGA) [Australia]
Tibotec Pharmaceuticals (part of J&J)
Tonghua Dongbao
UCB
União Química
United Laboratories
University of California, Los Angeles (UCLA)
University of Michigan
US Patent and Trademark Office
USV Biologics
Viropro
Walter and Eliza Hall Institute of Medical Research
Wanbang Biopharmaceuticals (part of Shanghai Fosun Pharmaceutical)
Washington Legal Foundation
Wockhardt
Wolters Kluwer
World Economic Forum
World Health Organization (WHO)
Xiamen Amoytop Biotech
Ypsomed
Zenotech Laboratories
Zenyaku Kogyo
Zuventus Healthcare (part of Emcure Pharmaceuticals)
Zydus Cadila

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