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Europe: Biosimilars Market - Forecast to 2025

  • ID: 4211563
  • Report
  • March 2017
  • Region: Global, Europe
  • 133 Pages
  • Frost & Sullivan
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A Growing Number of Incentive Policies to Propel Growth in the Next 5-7 Years, with Oncology as the Fastest Adopter


Patent expiration and increased use of traditional generic drugs are leading to a shift of focus in the pharmaceutical industry toward investment in specialty drugs and high growth areas such as biosimilars. Expensive biopharmaceuticals are largely used for life-saving disorders such as cancer and diabetes, the incidence of which is increasing with population aging in Europe. Moreover, patent expiry of key product classes and a growing emphasis on cost effectiveness are making governments switch to affordable alternatives. There is thus a tremendous opportunity for biosimilar manufacturers. However, the development of biosimilar drugs is riddled with complexities, from R&D to manufacturing to marketing, and is one of the most expensive propositions in the pharmaceutical industry.

About 30 companies are actively developing biosimilar medicines and are researching on the biosimilar versions of 16 distinct molecules that will lead to greater competition by 2020, with 8 major biologic medicines expected to lose exclusivity by 2020.

The next five years are going to be an interesting period in the biosimilars market as a number of biologic drugs are going to lose their exclusivity. On the one hand, this will significantly reduce costs for patients and health systems, on the other, it will pose challenges for regulators to confirm the similarity of the biosimilar to the original biologic in terms of efficacy and safety. The experience of European healthcare companies has been encouraging in the 10 years since the endorsement of the first biosimilar in the EU.

Pricing and physician awareness and support from the regulatory agencies are expected to be key factors driving success in the biosimilars market. Europe is expected to remain the largest contributor to biosimilars revenue worldwide for the next 5-7 years.

The study analyzes the supply market dynamics and forecasts future revenues for key biosimilars in the European region. It also identifies the six key issues to determine the strategic imperatives for success and growth in this market. Moreover, it includes an in-depth analysis of the biosimilar value chain and the payer and regulatory environment. By assessing the impact of trends, disruptive technologies, and new business models, the study arrives at key visioning scenarios for the biosimilars market in Europe. These will help market participants make strategic decisions, stay ahead of their competitors, and gain a significant share in the market. The study also sheds light on strategic partnerships among companies in the European biosimilars market.

Highlights of the report include:

  • Growth Opportunities and Challenges
  • Supply Market Dynamics
  • Payer and Regulatory Environment Analysis
  • Strategic Imperatives for Success and Growth-The Six Tactical Issues
  • Visioning Scenarios for the Biosimilars Market
  • Business Model Essentials
  • A Macro Overview of the Biosimilars Market
Note: Product cover images may vary from those shown
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1. Executive Dashboard
  • Pharma/Biotech Market - Emerging Trends
  • Market Snapshot - Biosimilars
  • Revenue Forecast
  • Revenue Forecast by Region
  • Percent Revenue Forecast by Region
  • Biosimilars Ecosystem - Industry Convergence Map
  • Ecosystem Partnerships - An Opportunity
  • Changing Market Scenario - Disruptive Trends
  • Patent Expiries
  • Key Regions
  • Technology Innovation
  • Global Biosimilars Industry - Six Big Market Themes
2. Growth Environment
  • Market Overview
  • Key Challenges in the Biosimilars Market
  • Market Segmentation by Therapeutic Areas
  • Trends in the Global Biosimilars Market
  • Global Biosimilar Patenting Trends
  • Biosimilars Adoption - Key Determinants
  • Physician Adoption of Biosimilars - Major Determinants
3. Drivers and Restraints - Total European Biosimilars Market
  • Drivers and Restraints
  • Impact Mapping of Drivers and Restraints
4. Growth Opportunity and Market Forecast - Total European Biosimilars Market
  • Percent Revenue Forecast by Region
  • Revenue Forecast
  • Revenue Forecast by Molecule Type
  • Snapshot - EU Biosimilars Market
  • Opportunity Heat Map - European Biosimilars Market
5. Growth Opportunity and Market Forecast of Key Biosimilars - Oncology
  • Top-selling Biotech Drugs
  • Growth Opportunities in Oncology
  • Trastuzumab Biosimilars Adoption Rate
  • Trastuzumab Biosimilars Patient Population
  • Trastuzumab Biosimilars - Patient Population Forecast
  • Trastuzumab Biosimilars - Pricing and Discounts
  • Trastuzumab Biosimilars - Revenue Forecast
  • Bevacizumab Biosimilars - Adoption Rate
  • Bevacizumab Biosimilars - Patient Population
  • Bevacizumab Biosimilars - Patient Population Forecast
  • Bevacizumab Biosimilars - Pricing and Discounts
  • Bevacizumab Biosimilars - Revenue Forecast
6. Growth Opportunity and Market Forecast of Key Biosimilars - Diabetes
  • Top-selling Biotech Drugs
  • Growth Opportunities in Diabetes
  • Insulin Glargine Biosimilars - Adoption Rate
  • Insulin Glargine Biosimilars - Patient Population
  • Insulin Glargine Biosimilars - Patient Population Forecast
  • Insulin Glargine Biosimilars - Pricing and Discounts
  • Insulin Glargine Biosimilars - Revenue Forecast
7. Growth Opportunity and Market Forecast of Key Biosimilars - Rheumatoid Arthritis
  • Top-selling Biotech drugs
  • Growth Opportunities in Rheumatoid Arthritis
  • Etanercept Biosimilars - Adoption Rate
  • Etanercept Biosimilars - Patient Population
  • Etanercept Biosimilars - Patient Population Forecast
  • Etanercept Biosimilars - Pricing and Discounts
  • Etanercept Biosimilars - Revenue Forecast
  • Infliximab Biosimilars - Adoption Rate
  • Infliximab Biosimilars - Patient Population
  • Infliximab Biosimilars - Patient Population Forecast
  • Infliximab Biosimilars - Pricing and Discounts
  • Infliximab Biosimilars - Revenue Forecast
  • Adalimumab Biosimilars - Adoption Rate
  • Adalimumab Biosimilars - Patient Population
  • Adalimumab Biosimilars - Patient Population Forecast
  • Adalimumab Biosimilars - Pricing and Discounts
  • Adalimumab Biosimilars - Revenue Forecast
8. Market Challenges - Biosimilars
  • Challenge 1 - Interchangeability
  • Challenge 2 - Innovation in Biologics and Biobetters
9. Supply Market Dynamics - Europe
  • Future of Biosimilars in Europe
  • Competitive Landscape Analysis
  • Market Analysis - Europe
  • Regional Hot Spots - EU5 Perspective
  • Country Attractiveness
  • Biosimilar Uptake in Scandinavia - A Case Study
  • Key Companies to Watch
  • Merger, Acquisition, and Partnership Assessment
  • Biosimilars under Review by EMA
10. Strategic Imperatives and Critical Success Factors for Europe
  • Payer Environment
  • Regulatory Environment
  • Impact of Policies - An EU5 Perspective
  • Development Process and Technical Requirements
  • Business Models to Mitigate Concerns over Cost
  • Strategic Imperatives for Success and Growth
  • Strategies for Innovators - Case Studies
  • Strategies for Foreign Participants in the EU
11. Conclusion
  • Visioning Scenarios for the Biosimilars Market
  • Business Model Essentials
  • 5 Competitive Keys for Success in the Biosimilars Market
  • Legal Disclaimer
12. Appendix
  • Global Regulatory Landscape
  • Impact of Regulations in the Biosimilars Market
13. Introduction to Biosimilars
  • Biosimilars are Not Generics - A Comparison of Generics, Biologics, and Biosimilars
  • Biologics and Biosimilars - Differences in Manufacturing Processes
  • Development Process and Technical Requirements for Biosimilars
  • Timeline for the Development of a Biosimilar Medicine
  • Value Chain Analysis - Development of a Biosimilar
  • Market Evolution of Biosimilars, 2015
  • Comparing the Players - Big Pharma (Innovators), Biotech Firms, and Generic Manufactures
  • List of Biosimilars Approved in Europe
  • List of Biosimilars under Review by EMA
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  • EMA
Note: Product cover images may vary from those shown