The biosimilar market reached a value of US$ 7.7 Billion in 2020. This market is currently being driven by a number of factors such as patent expires of blockbuster biological drugs, lower prices, rising prevalence of chronic diseases, and cost-saving initiatives from governments and third-party payers. Catalyzed by these factors, the market is expected to witness strong growth during the next five years.
Biosimilars, also known as follow-on biologics, refers to a biotherapeutic product which is highly similar to a reference biologic drug. It is produced using living organisms or cells and has a complex molecular structure. When the patent of a biologic drug expires, manufacturers resort to the approval from the regulatory authorities so as to start the production of biosimilars. For being labelled as a biosimilar, a biological drug should be proved similar in terms of quality, safety and efficacy. In comparison with generic drugs, biosimilars are expensive as their production process is more complex and requires higher investment in research and development.
Global Biosimilar Market Drivers/Constraints:
Over the years, the patents of several blockbuster biologic drugs have expired and a number of blockbuster drugs are further expected to lose patent protection in the coming years. This is expected to provide tremendous opportunities for biosimilar manufacturers in the near future.
Cost-saving initiatives undertaken by governments and third-party payers have encouraged the use of biosimilars over branded biologics, thereby propelling the demand of biosimilars.
Some of the other factors bolstering the demand for biosimilars include cost-effectiveness, rising prevalence of chronic diseases (such as autoimmune diseases and cancer) and growing geriatric population.
There are some factors hampering the growth of the biosimilars market. This includes negative perception from physicians, patent extensions, lower price differential compared to small-molecule generics, etc.
The competitive landscape of the global biosimilar market has also been analysed. Some of the leading players operating in the market are:
Merck & Co
Dr. Reddy's Laboratories
This report provides a deep insight into the global 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 biosimilars market in any manner.
Key Topics Covered:
2 Scope and Methodology
3 Executive Summary
4 Biosimilar Market - Introduction 4.1 Overview 4.2 WHO and FDA Terminology on Biosimilars 4.3 Biosimilars and Generics 4.4 Biosimilars and Branded Biological Products
5 Why are Biosimilars So Lucrative? 5.1 Patent Expiry of Blockbuster Biological Drugs 5.2 Significant Price Differential between Biosimilars and Innovator Drugs 5.3 Savings for the Government and Third Party Payers 5.4 Rising Prevalence of Lifestyle Diseases 5.5 Incentives for Prescribers, Pharmacists and Patients 5.6 Emergence of New Players in Europe and Emerging Markets 5.7 Increasing Product Differentiation as Manufacturers Tie-Up with Drug Delivery Device Companies
6 Biosimilar Research, Development and Manufacturing 6.1 Research and Development: Biosimilars vs. Innovator Drugs 6.2 Manufacturing: Biosimilars vs. Innovator Drugs
7 Biosimilar Market 7.1 Market Overview 7.2 Historical Performance 7.3 Impact of COVID-19 7.4 Market Breakup by Segment 7.5 Market Breakup by Manufacturer Type 7.6 Market Breakup by Indication 7.7 Market Breakup by Region 7.8 Market Forecast 7.9 Biosimilar Patent Landscape 7.9.1 Patent Landscape in the US 7.9.2 Patent Landscape in Europe 7.9.3 Patent Landscape in Japan 7.10 SWOT Analysis 7.10.1 Overview 7.10.2 Strengths 7.10.3 Weaknesses 7.10.4 Opportunities 7.10.5 Threats 7.11 Value Chain Analysis 7.11.1 Characterizing the Existing Innovator Drug 7.11.2 Research and Development 184.108.40.206 Characterization of Biosimilars 220.127.116.11 Developing a Unique Cell Line 7.11.3 Product Development 18.104.22.168 Pre-Testing 22.214.171.124 Intermediary Clinical Testing (PK/PD) 126.96.36.199 Confirmatory Clinical Phase-III 7.11.4 Final Product Formulation 7.11.5 Marketing and Distribution 7.12 Porter's Five Forces Analysis 7.12.1 Overview 7.12.2 Bargaining Power of Buyers 7.12.3 Bargaining Power of Suppliers 7.12.4 Degree of Competition 7.12.5 Threat of New Entrants 7.12.6 Threat of Substitutes 7.13 Price Analysis 7.13.1 Key Price Indicators 7.13.2 Price Trends 7.13.3 Margin Analysis
11 Market Breakup by Region 11.1 Europe 11.1.1 Market Performance 11.1.2 Key Players and Biosimilars 11.1.3 Market Breakup by Country 11.1.4 Market Forecast 11.1.5 Italy 188.8.131.52 Market Performance 184.108.40.206 Key Players and Biosimilars 220.127.116.11 Market Forecast 11.1.6 Germany 18.104.22.168 Market Performance 22.214.171.124 Key Players and Biosimilars 126.96.36.199 Market Forecast 11.1.7 France 188.8.131.52 Market Performance 184.108.40.206 Key Players and Biosimilars 220.127.116.11 Market Forecast 11.1.8 United Kingdom 18.104.22.168 Market Performance 22.214.171.124 Key Players and Biosimilars 126.96.36.199 Market Forecast 11.1.9 Spain 188.8.131.52 Market Performance 184.108.40.206 Key Players and Biosimilars 220.127.116.11 Market Forecast 11.1.10 Rest of Europe 18.104.22.168 Market Performance 22.214.171.124 Market Forecast 11.2 United States 11.2.1 Current Market Trends 11.2.2 Key Players and Biosimilars 11.2.3 Market Forecast 11.3 Japan 11.3.1 Market Performance 11.3.2 Key Players and Biosimilars 11.3.3 Market Forecast 11.4 India 11.4.1 Current Market Trends 11.4.2 Key Players and Biosimilars 11.4.3 Market Forecast 11.5 South Korea 11.5.1 Current Market Trends 11.5.2 Key Players and Biosimilars 11.5.3 Market Forecast 11.6 Rest of the World 11.6.1 Current Market Trends 11.6.2 Market Forecast
12 Requirements for Setting Up a Biosimilar Manufacturing Plant 12.1 Manufacturing Process 12.2 Raw Material Requirements 12.3 Raw Material Pictures 12.4 Land and Construction Requirements 12.5 Machinery and Infrastructure Requirements 12.6 Machinery Pictures 12.7 Plant Layout 12.8 Packaging Requirements 12.9 Utility Requirements 12.10 Manpower Requirements