Product Code: SR1018G64_Report
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.
- 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?
Table of Contents
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