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1053286

Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027

Published: | IMARC Services Private Limited | 142 Pages | Delivery time: 2-3 business days

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Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027
Published: January 10, 2022
IMARC Services Private Limited
Content info: 142 Pages
Delivery time: 2-3 business days
  • Description
  • Table of Contents
  • List of Tables

The biosimilar market in Europe reached a value of US$ 6,735 Million in 2021. Looking forward, IMARC Group expects the market to reach US$ 25,446 Million by 2027, exhibiting a CAGR of 22.8% during 2022-2027. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic. These insights are included in the report as a major market contributor.

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.

Key Market Segmentation:

  • IMARC Group provides an analysis of the key trends in each sub-segment of the biosimilar market in Europe, along with forecasts at the regional and country level from 2022-2027. Our report has categorized the market based on molecule, indication and manufacturing type.

Breakup by Country:

  • Italy
  • Germany
  • United Kingdom
  • France
  • Spain
  • Rest of Europe
  • Country-wise, the market has been segmented into Italy, Germany, United Kingdom, France, Spain and Rest of Europe.

Breakup by Molecule:

  • Infliximab
  • Insulin Glargine
  • Epoetin Alfa
  • Etanercept
  • Filgrastim
  • Somatropin
  • Rituximab
  • Follitropin Alfa
  • Adalimumab
  • The report has analysed the market on the basis of molecule. The market has been segmented into Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, Adalimumab, etc.

Breakup by Indication:

  • Auto-Immune Diseases
  • Blood Disorder
  • Diabetes
  • Oncology
  • Growth Deficiency
  • Female Infertility
  • The report has also analysed the market on the basis of indication. Other major indications include oncology, autoimmune diseases, blood disorders, growth deficiency, diabetes, female infertility etc.

Breakup by Manufacturing Type:

  • In-house Manufacturing
  • Contract Manufacturing
  • On the basis of manufacturing type, the report has segmented the market into in-house manufacturing and contract manufacturing.

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 Question Answered in this Report
  • 1. What is the market size for the Europe biosimilar market?
  • 2. What is the Europe biosimilar market growth?
  • 3. What are the Europe biosimilar market drivers?
  • 4. What are the key industry trends in the Europe biosimilar market?
  • 5. What is the impact of COVID-19 on the Europe biosimilar market?
  • 6. What is the Europe biosimilar market breakup by molecule?
  • 7. What is the Europe biosimilar market breakup by indication?
  • 8. What is the Europe biosimilar market breakup by manufacturing type?
  • 9. What are the major regions in the Europe biosimilar market?
  • 10. Who are the key companies/players in the Europe biosimilar market?
Product Code: SR0122A33_Report

Table of Contents

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 Impact of COVID-19
  • 5.4 Market Breakup by Country
  • 5.5 Market Breakup by Molecule
  • 5.6 Market Breakup by Indication
  • 5.7 Market Breakup by Manufacturing Type
  • 5.8 Patent Landscape
  • 5.9 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
  • 7.9 Adalimumab

8 Market Breakup by Manufacturing Type

  • 8.1 In-house Manufacturing
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Contract Manufacturing
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast

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 Overview
  • 10.2 Strengths
  • 10.3 Weaknesses
  • 10.4 Opportunities
  • 10.5 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 Key Price Indicators
  • 13.2 Price Trends

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$), 2016-2021
  • Figure 2: Europe: Biosimilar Market: Breakup by Molecule (in %)
  • Figure 3: Europe: Biosimilar Market: Breakup by Manufacturer (in %), 2021
  • Figure 4: Europe: Biosimilar Market: Breakup by Indication (in %), 2021
  • Figure 5: Europe: Biosimilar Market: Breakup by Country (in %), 2021
  • Figure 6: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2022-2027
  • Figure 7: Italy: Biosimilar Market: Sales Value (in Million US$), 2016-2021
  • Figure 8: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2022-2027
  • Figure 9: Germany: Biosimilar Market: Sales Value (in Million US$), 2016-2021
  • Figure 10: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2022-2027
  • Figure 11: France: Biosimilar Market: Sales Value (in Million US$), 2016-2021
  • Figure 12: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2022-2027
  • Figure 13: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2016-2021
  • Figure 14: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2022-2027
  • Figure 15: Spain: Biosimilar Market: Sales Value (in Million US$), 2016-2021
  • Figure 16: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2022-2027
  • Figure 17: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2016-2021
  • Figure 18: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2022-2027
  • Figure 19: Europe: Rituximab Biosimilar Market: Sales Value (in Million US$), 2017
  • Figure 20: Europe: Infliximab Biosimilar Market: Sales Value (in Million US$), 2015 - 2017
  • Figure 21: Europe: Insulin Glargine Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
  • Figure 22: Europe: Epoetin Alfa Biosimilar Market: Sales Value (in Million US$), 2014 - 2017
  • Figure 23: Europe: Filgrastim Biosimilar Market: Sales Value (in Million US$), 2014 - 2017
  • Figure 24: Europe: Somatropin Biosimilar Market: Sales Value (in Million US$), 2014 - 2017
  • Figure 25: Europe: Etanercept Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
  • Figure 26: Europe: Follitropin Alfa Biosimilar Market: Sales Value (in Million US$), 2015 - 2017
  • Figure 27: Europe: Adalimumab Biosimilar Market: Sales Value (in Million US$), 2018
  • Figure 28: Europe: Biosimilar Market (In-House Manufacturing): Sales Value (in Million US$), 2016-2021
  • Figure 29: Europe: Biosimilar Market Forecast (In-House Manufacturing): Sales Value (in Million US$), 2022-2027
  • Figure 30: Europe: Biosimilar Market (Contract Manufacturing): Sales Value (in Million US$), 2016 & 2021
  • Figure 31: Europe: Biosimilar Market Forecast (Contract Manufacturing): Sales Value (in Million US$), 2022-2027
  • Figure 32: Europe: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2016 & 2021
  • Figure 33: Europe: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2022-2027
  • Figure 34: Europe: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2016 & 2021
  • Figure 35: Europe: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2022-2027
  • Figure 36: Europe: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2016 & 2021
  • Figure 37: Europe: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2022-2027
  • Figure 38: Europe: Biosimilar Market (Oncology): Sales Value (in Million US$), 2016 & 2021
  • Figure 39: Europe: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2022-2027
  • Figure 40: Europe: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2016 & 2021
  • Figure 41: Europe: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2022-2027
  • Figure 42: Europe: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2016 & 2021
  • Figure 43: Europe: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2022-2027
  • Figure 44: Europe: Biosimilar Industry: SWOT Analysis
  • Figure 45: Europe: Biosimilar Industry: Value Chain Analysis
  • Figure 46: Europe: Biosimilar Industry: Porter's Five Forces Analysis
  • Figure 47: Biosimilar Manufacturing: Detailed Process Flow

List of Tables

  • Table 1: Europe: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$)
  • Table 2: Biosimilar vs. Innovators Drug Development
  • Table 3: Biosimilar vs. Biologics Manufacturing
  • Table 4: Europe: Biosimilar Market: Key Industry Highlights, 2021 and 2027
  • Table 5: Europe: Biosimilar Market: Patent Landscape
  • Table 6: Europe: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
  • Table 7: Europe: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2022-2027
  • Table 8: Europe: Biosimilar Market: Key Players and Biosimilars
  • Table 9: Italy: Biosimilar Market: Key Players and Biosimilars
  • Table 10: Germany: Biosimilar Market: Key Players and Biosimilars
  • Table 11: France: Biosimilar Market: Key Players and Biosimilars
  • Table 12: United Kingdom: Biosimilar Market: Key Players and Biosimilars
  • Table 13: Spain: Biosimilar Market: Key Players and Biosimilars
  • Table 14: Europe: Rituximab: Brand & Biosimilar Market Overview
  • Table 15: Europe: Infliximab: Brand & Biosimilar Market Overview
  • Table 16: Europe: Insulin Glargine: Brand & Biosimilar Market Overview
  • Table 17: Europe: Epoetin Alfa: Brand & Biosimilar Market Overview
  • Table 18: Europe: Filgrastim: Brand & Biosimilar Market Overview
  • Table 19: Europe: Somatropin: Brand & Biosimilar Market Overview
  • Table 20: Europe: Etanercept: Brand & Biosimilar Market Overview
  • Table 21: Europe: Follitropin Alfa: Brand & Biosimilar Market Overview
  • Table 22: Europe: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million US$), 2022-2027
  • Table 23: Europe: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2022-2027
  • Table 24: Biosimilar Manufacturing Plant: Raw Material Requirements
  • Table 25: Biosimilar Manufacturing Plant: Land and Construction Requirements
  • Table 26: Biosimilar Manufacturing Plant: Machinery Requirements
  • Table 27: Biosimilar Manufacturing Plant: Manpower Requirements
  • Table 28: Europe: Biosimilar Market: Competitive Structure
  • Table 29: Europe: Biosimilar Market: Key Players