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Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024

  • ID: 4752265
  • Report
  • February 2019
  • Region: Europe
  • 140 pages
  • IMARC Group
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  • Accord Healthcare Ltd.
  • Apotex
  • Celltrion
  • Hexal Ag
  • Mylan
  • Pfizer
  • MORE
The biosimilar market in Europe reached a value of US$ 2,934.6 Million in 2018. The market is further projected to reach a value of US$ 11,663.1 Million by 2024, growing at a CAGR of 24.9% during 2019-2024. 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 2018, Italy represented the largest market for biosimilars in Europe.

The report has analysed the market on the basis of molecule. In 2018, 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 2018. 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 2018, in-house manufacturing accounted for a higher share.

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

Samsung Bioepis
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?
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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 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
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  • Novartis
  • Pfizer
  • Teva
  • Ratiopharm
  • Celltrion
  • Merck Sharp & Dohme
  • Samsung Bioepis
  • Eli Lilly
  • Accord Healthcare Ltd.
  • Mylan
  • Boehringer Ingelheim
  • Hexal Ag
  • Apotex
  • Stada Arzneimittel Ag
  • Amgen.
Note: Product cover images may vary from those shown
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