Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

The biosimilar market in Europe size reached US$ 9,841 Million in 2022. Looking forward, IMARC Group expects the market to reach US$ 35,993 Million by 2028, exhibiting a growth rate (CAGR) of 20.41% during 2023-2028.

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 report, along with forecasts at the regional and country level from 2023-2028. 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 analyzed the market on the basis of indication, covering oncology, autoimmune diseases, blood disorders, growth deficiency, diabetes, and female infertility.

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 Questions Answered in This Report

1. What was the size of the biosimilar market in Europe in 2022?
2. What is the expected growth rate of the biosimilar market in Europe during 2023-2028?
3. What are the key factors driving the biosimilar market in Europe?
4. What has been the impact of COVID-19 on the biosimilar market in Europe?
5. What is the breakup of biosimilar market in Europe breakup based on the molecule?
6. What is the breakup of biosimilar market in Europe based on the indication?
7. What is the breakup of biosimilar market in Europe based on the manufacturing type?
8. What are the key regions in the biosimilar market in Europe?
9. Who are the key players/companies in the biosimilar market in Europe?


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

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