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Biosimilar Market in Europe Driven by Ongoing Awareness Initiatives


Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2018-2023

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The biosimilar market in Europe reached US$ 2,013 Million in 2017. The market is further projected to exceed US$ 9,173 Million by 2023, at a CAGR of 29% during 2017-2023. The European biosimilar market represents the most mature in the world and continues to rally momentum. This market is expected to grow robustly in the next five years, as a number blockbuster biologics are scheduled to lose patent protection in Europe.

Biosimilars are biotherapeutic products which are similar to already licensed reference biologics, in terms of quality, safety and efficiency. Biosimilar manufacturers wait till the patent of the reference product expires and then seek approval from the regulatory authorities in order to produce their biosimilar versions. These manufacturers use the state-of-the-art technology for comparing the characteristics, such as purity, chemical identity and bioactivity, of the proposed biosimilar to its reference product. In 2005, a science-based regulatory framework was established in the European Union (EU) for ensuring the production of high-quality biosimilars. Later in 2006, the European Medicines Agency (EMA) approved the first biosimilar medicine, Omnitrope. Since then, a number of biosimilars belonging to various therapeutic classes have been approved in Europe.

Biosimilars Market in Europe: Drivers

  • Biosimilars are less expensive than their branded counterparts as they do not require extensive research and testing which saves both money and time; thereby lowering the costs. Moreover, they also have short marketing times as launching a biosimilar does not require extensive marketing as the safety and efficacy profile of their branded counterparts have already been established.
  • Several blockbuster biologics are expected to lose their patent protection over the next 5 to 10 years. This expiration of patents and other intellectual property rights is expected to create huge opportunities for biosimilar manufacturers.
  • The European population is ageing with around one fifth of the total EU population above 65 years of age. There has resulted in a significant increase in the burden of lifestyle diseases in the region. The prevalence of diseases such as diabetes, autoimmune diseases, oncology, etc. has been increasing rapidly in Europe. This is also expected to propel the market growth during the next few years.
  • As a result of rising healthcare costs, governments across a number of European countries have formulated policies incentivising physicians, pharmacists and patients in favour of biosimilars over branded biologics.


Market Summary:

  • Country-wise, the market has been segmented into Italy, Germany, United Kingdom, France, Spain, and Others. In 2017, Italy represented the largest market for biosimilars in Europe.
  • The report has analysed the market on the basis of molecule.  In 2017, Infliximab dominated the market, accounting for the highest sales. Other major molecules include Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, etc.
  • The report has also analysed the market on the basis of indication.  Autoimmune diseases represented the biggest indication for biosimilars in 2017. Other major indications include oncology, autoimmune diseases, blood disorders, growth deficiency, diabetes, etc.
  • On the basis of manufacturing type, the report has segmented the market into in-house manufacturing and contract manufacturing. In 2017, in-house manufacturing accounted for a higher share.


Some of the leading players operating in the European biosimilars market include:

  • Novartis
  • Pfizer
  • Teva 
  • Celltrion 
  • Samsung Bioepis 
  • Amgen
  • Apotex 
  • Ratiopharm
  • Mylan
  • Merck Sharp & Dohme
  • Eli Lilly
  • Accord Healthcare Ltd
  • Boehringer Ingelheim
  • Hexal Ag 
  • Stada Arzneimittel Ag


This report provides a deep insight into the European biosimilars market covering all its essential aspects. This ranges from macro overview of the market to micro details of the industry performance, recent trends, key market drivers and challenges, SWOT analysis, Porter’s five forces analysis, value chain analysis, etc. This report is a must-read for entrepreneurs, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the European biosimilars market in any manner.

Key Questions Answered in This Report:

  • How has the European biosimilars market performed so far and how will it perform in the coming years?
  • What are the key regional markets in the European biosimilars industry?
  • What are the major molecule types in the European biosimilars industry?
  • What is the share of in-house manufacturing vs. contract manufacturing in the European biosimilars industry?
  • What are the various indications in the European biosimilars industry?
  • What are the price trends of biosimilars?
  • What are the various stages in the value chain of the European biosimilars industry?
  • What are the key driving factors and challenges in the European biosimilars industry?
  • What is the structure of the European biosimilars industry and who are the key players?
  • What is the degree of competition in the European biosimilars industry?
  • What are the key requirements for setting up a biosimilar manufacturing plant?
  • How are biosimilars manufactured?
  • What are the machinery requirements for setting up a biosimilar manufacturing plant?
  • What is the capital cost for setting up a biosimilar manufacturing plant?

1    Preface
2    Scope and Methodology
    2.1    Objectives of the Study
    2.2    Stakeholders
    2.3    Data Sources
      2.3.1    Primary Sources
      2.3.2    Secondary Sources
    2.4    Market Estimation
      2.4.1    Bottom-Up Approach
      2.4.2    Top-Down Approach
    2.5    Forecasting Methodology
3    Executive Summary
4    Europe Biosimilars Market – Introduction
    4.1    Overview
    4.2    WHO and EMA Terminology on Biosimilars
    4.3    Biosimilars and Generics
    4.4    Biosimilars and Branded Biological Products
5    Europe Biosimilars Market 
    5.1    Market Overview
    5.2    Historical and Current Market Trends
    5.3    Market Breakup by Country
    5.4    Market Breakup by Molecule
    5.5    Market Breakup by Indication
    5.6    Market Breakup by Manufacturing Type
    5.7    Patent Landscape
    5.8    Market Forecast    
 6    Market Breakup by Country 
    6.1    Italy
      6.1.1     Market Performance
      6.1.2     Key Players and Biosimilars
      6.1.3     Market Forecast
    6.2    Germany
      6.2.1     Market Performance
      6.2.2     Key Players and Biosimilars
      6.2.3     Market Forecast
    6.3    France
      6.3.1     Market Performance
      6.3.2     Key Players and Biosimilars
      6.3.3     Market Forecast
    6.4    United Kingdom
      6.4.1     Market Performance
      6.4.2     Key Players and Biosimilars
      6.4.3     Market Forecast
    6.5    Spain
      6.5.1     Market Performance
      6.5.2     Key Players and Biosimilars
      6.5.3     Market Forecast
    6.6    Rest of Europe
      6.6.1     Market Performance
      6.6.2     Market Forecast
7    Market Breakup by Molecule
    7.1    Infliximab
    7.2    Insulin Glargine
    7.3    Epoetin Alfa
    7.4    Etanercept
    7.5    Filgrastim
    7.6    Somatropin
    7.7    Rituximab
    7.8    Follitropin Alfa
8    Market Breakup by Type of Manufacturing
    8.1    In-house Manufacturing
    8.2    Contract Manufacturing
9   Market Breakup by Indication
    9.1   Auto-Immune Diseases
    9.2   Blood Disorder
    9.3   Diabetes
    9.4   Oncology
    9.5   Growth Deficiency
    9.6    Female Infertility
10 European Biosimilar Market: SWOT Analysis
    10.1   Strengths
    10.2   Weaknesses
    10.3   Opportunities
    10.4   Threats
11  European Biosimilar Market: Value Chain Analysis
    11.1   Characterizing the Existing Innovator Drug
    11.2   Research and Development
        11.2.1   Characterization of Biosimilars
        11.2.2    Developing a Unique Cell Line
    11.3   Product Development
        11.3.1    Pre-Testing
        11.3.2    Intermediary Clinical Testing (PK/PD)
        11.3.3    Confirmatory Clinical Phase-III
    11.4   Final Product Formulation
    11.5   Marketing and Distribution
12   Porter’s Five Forces Analysis
    12.1   Overview
    12.2   Bargaining Power of Buyers
    12.3   Bargaining Power of Suppliers
    12.4   Degree of Competition
    12.5   Threat of New Entrants
    12.6   Threat of Substitutes
13    Price Analysis
    13.1   Price Indicators
    13.2   Price Trends
    13.3   Margin Analysis
14   Requirements for Setting Up a Generic Drug Manufacturing Plant
    14.1    Manufacturing Process
    14.2    Raw Material Requirements
    14.3    Raw Material Pictures
    14.4    Land and Construction Requirements
    14.5    Machinery and Infrastructure Requirements
    14.6    Machinery Pictures
    14.7    Plant Layout
    14.8    Packaging Requirements
    14.9    Utility Requirements
    14.10    Manpower Requirements
15    Competitive Landscape
    15.1    Market Structure
    15.2    Key Players
    15.3    Profiles of Key Players
        15.3.1    Novartis 
        15.3.2    Pfizer
        15.3.3    Teva 
        15.3.4    Celltrion 
        15.3.5    Merck Sharp & Dohme
        15.3.6    Samsung Bioepis 
        15.3.7    Eli Lilly
        15.3.8    Accord Healthcare Ltd.
        15.3.9    Amgen
        15.3.10   Boehringer Ingelheim
        15.3.11   Hexal Ag 
        15.3.12   Apotex 
        15.3.13   Stada Arzneimittel Ag
        15.3.14   Ratiopharm
        15.3.15   Mylan
 

List of Figures

Figure 1: Europe: Biosimilar Market: Sales Value (in Million US$), 2012-2017
Figure 2: Europe: Biosimilar Market: Breakup by Molecule (in %), 2017
Figure 3: Europe: Biosimilar Market: Breakup by Manufacturer (in %), 2017
Figure 4: Europe: Biosimilar Market: Breakup by Indication (in %), 2017
Figure 5: Europe: Biosimilar Market: Breakup by Country (in %), 2017
Figure 6: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 7: Europe: Biosimilar Market: Sales Value (in Million US$), 2010-2017
Figure 8: Europe: Biosimilar Market: Breakup by Country (in %), 2017
Figure 9: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 10: Italy: Biosimilar Market: Sales Value (in Million US$), 2010-2017
Figure 11: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 12: Germany: Biosimilar Market: Sales Value (in Million US$), 2010-2017
Figure 13: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 14: France: Biosimilar Market: Sales Value (in Million US$), 2010-2017
Figure 15: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 16: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2010-2017
Figure 17: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 18: Spain: Biosimilar Market: Sales Value (in Million US$), 2010-2017
Figure 19: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 20: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2010-2017
Figure 21: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 22: Europe: Rituximab Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 23: Europe: Infliximab Biosimilar Market: Sales Value (in Million US$), 2015 - 2017
Figure 24: Europe: Insulin Glargine Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 25: Europe: Epoetin Alfa Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 26: Europe: Filgrastim Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 27: Europe: Somatropin Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 28: Europe: Etanercept Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 29: Europe: Follitropin Alfa Biosimilar Market: Sales Value (in Million US$), 2015 – 2017
Figure 30: Europe: Biosimilar Market: In-House Manufacturing: Sales Value (in Million US$), 2012-2017
Figure 31: : Europe: Biosimilar Market Forecast: In-House Manufacturing: Sales Value (in Million US$), 2018-2023
Figure 32: Europe: Biosimilar Market: Contract Manufacturing: Sales Value (in Million US$), 2012-2017
Figure 33: Europe: Biosimilar Market Forecast: Contract Manufacturing: Sales Value (in Million US$), 2018-2023
Figure 34: Europe: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2017-2023
Figure 35: Europe: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2017-2023
Figure 36: Europe: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2017-2023
Figure 37: Europe: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2017-2023
Figure 38: Europe: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2017-2023
Figure 39: Europe: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2017-2023
Figure 40: Europe: Biosimilar Industry: SWOT Analysis
Figure 41: Europe: Biosimilar Market: Value Chain Analysis
Figure 42: Europe: Biosimilar Industry: Porter’s Five Forces Analysis
Figure 43: Europe: Biosimilar Industry: Breakup of Profit Margins at Various Levels of the Value Chain
Figure 44: Biosimilar Manufacturing: Detailed Process Flow
Figure 45: Biosimilar Manufacturing Plant: Raw Material Requirement
Figure 46: Biosimilar Manufacturing Plant: Machinery Costs (in US$)


List of Tables

Table 1: Europe: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$)
Table 2: Biosimilar vs. Innovators Drug Development
Table 3: Biosimilar vs. Biologics Manufacturing
Table 4: Europe: Biosimilar Market: Key Industry Highlights, 2017 and 2023
Table 5: Europe: Biosimilar Market: Patent Landscape
Table 6: Europe: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
Table 7: Europe: Biosimilar Market: Breakup by Molecule (in Million US$), 2012-2017
Table 8: Europe: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2017-2023
Table 9: Europe: Biosimilar Market: Key Players and Biosimilars
Table 10: Italy: Biosimilar Market: Key Players and Biosimilars
Table 11: Germany: Biosimilar Market: Key Players and Biosimilars
Table 12: France: Biosimilar Market: Key Players and Biosimilars
Table 13: United Kingdom: Biosimilar Market: Key Players and Biosimilars
Table 14: Spain: Biosimilar Market: Key Players and Biosimilars
Table 15: Europe: Rituximab: Brand & Biosimilar Market Overview
Table 16: Europe: Infliximab: Brand & Biosimilar Market Overview
Table 17: Europe: Insulin Glargine: Brand & Biosimilar Market Overview
Table 18: Europe: Epoetin Alfa: Brand & Biosimilar Market Overview
Table 19: Europe: Filgrastim: Brand & Biosimilar Market Overview
Table 20: Europe: Somatropin: Brand & Biosimilar Market Overview
Table 21: Europe: Etanercept: Brand & Biosimilar Market Overview
Table 22: Europe: Follitropin Alfa: Brand & Biosimilar Market Overview
Table 23: Europe: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million US$), 2017-2023
Table 24: Europe: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2017-2023
Table 25: Biosimilar Manufacturing Plant: Manpower Requirements
Table 26: Biosimilar Market: Competitive Structure
Table 27: Europe: Biosimilar Market: Key Players


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