Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028
Description
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?
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?
Table of Contents
350 Pages
- 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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