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

April 2013 | 235 pages | ID: B2779D29512EN
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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
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

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 biologicsand 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 increaserelative to that country.

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. Inaddition, 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. 



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