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:
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. 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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Market by Molecule
Market by Manufacturing Type
Market by Indication
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