Biosimilar Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028
Global Biosimilar Market Outlook 2023-2028
The global biosimilar market size reached US$ 16.8 Billion in 2022. 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 reach US$ 77.1 Billion by 2028, exhibiting a growth rate (CAGR) of 25.9% during 2023-2028.
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 Industry 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 biosimilars market growth. This includes negative perception from physicians, patent extensions, lower price differential compared to small-molecule generics, etc.
Key Market Segmentation:
IMARC Group provides an analysis of the key trends in each sub-segment of the global biosimilar market report, along with forecasts at the global and regional level from 2023-2028. Our report has categorized the market based on molecule, indication and manufacturing type.
Molecule insights:
Infliximab
Insulin Glargine
Epoetin Alfa
Etanercept
Filgrastim
Somatropin
Rituximab
Follitropin Alfa
Adalimumab
Pegfilgrastim
Trastuzumab
Bevacizumab
Others
On the basis of the molecule, the market has been segmented as Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, Adalimumab, Pegfilgrastim, Trastuzumab, Bevacizumab, and Others.
Indication Insights:
Auto-Immune Diseases
Blood Disorder
Diabetes
Oncology
Growth Deficiency
Female Infertility
Others
On the basis of the indication, the market has been segmented as Auto-Immune Diseases, Blood Disorders, Diabetes, Oncology, Growth Deficiency, Female Infertility, and Others.
Manufacturing Type Insights:
In-house Manufacturing
Contract Manufacturing
Based on the type of manufacturing, the market is segregated into in-house manufacturing and contract manufacturing. Amongst these, in-house manufacturing accounts for the majority of the market share.
Regional Insights:
Europe
Germany
France
Italy
Spain
United Kingdom
Rest of Europe
United States
Japan
India
South Korea
Others
Region-wise, the market has been segmented into Europe (Germany, France, Italy, Spain, the United Kingdom and Rest of Europe), the United States, Japan, India, South Korea and Others.
Competitive Landscape:
The competitive landscape of the global biosimilar market has also been analysed. Some of the leading players operating in the market are:
Sandoz International GmbH
Pfizer Inc.
Teva Pharmaceutical Industries Limited
Celltrion Inc.
Biocon Limited
Samsung Biologics
Amgen, Inc.
Dr. Reddy's Laboratories Limited
Stada Arzneimittel Ag
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 Questions Answered in This Report
1. What was the size of the global biosimilar market in 2022?
2. What is the expected growth rate of the global biosimilar market during 2023-2028?
3. What are the key factors driving the global biosimilar market?
4. What has been the impact of COVID-19 on the global biosimilar market?
5. What is the breakup of the global biosimilar market based on the molecule?
6. What is the breakup of the global biosimilar market based on the indication?
7. What is the breakup of the global biosimilar market based on the manufacturing type?
8. What are the key regions in the global biosimilar market?
9. Who are the key companies/players in the global biosimilar market?
- 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 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 Global 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 Manufacturing 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
- 7.11.2.1 Characterization of Biosimilars
- 7.11.2.2 Developing a Unique Cell Line
- 7.11.3 Product Development
- 7.11.3.1 Pre-Testing
- 7.11.3.2 Intermediary Clinical Testing (PK/PD)
- 7.11.3.3 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
- 8 Market Breakup by Molecule
- 8.1 Infliximab
- 8.2 Insulin Glargine
- 8.3 Epoetin Alfa
- 8.4 Etanercept
- 8.5 Filgrastim
- 8.6 Somatropin
- 8.7 Rituximab
- 8.8 Follitropin Alfa
- 8.9 Adalimumab
- 8.10 Pegfilgrastim
- 8.11 Trastuzumab
- 8.12 Bevacizumab
- 8.13 Others
- 9 Market Breakup by Manufacturing Type
- 9.1 In-house Manufacturing
- 9.1.1 Market Trends
- 9.1.2 Market Forecast
- 9.2 Contract Manufacturing
- 9.2.1 Market Trends
- 9.2.2 Market Forecast
- 10 Market Breakup by Indication
- 10.1 Auto-Immune Diseases
- 10.1.1 Market Trends
- 10.1.2 Market Forecast
- 10.2 Blood Disorder
- 10.2.1 Market Trends
- 10.2.2 Market Forecast
- 10.3 Diabetes
- 10.3.1 Market Trends
- 10.3.2 Market Forecast
- 10.4 Oncology
- 10.4.1 Market Trends
- 10.4.2 Market Forecast
- 10.5 Growth Deficiency
- 10.5.1 Market Trends
- 10.5.2 Market Forecast
- 10.6 Female Infertility
- 10.6.1 Market Trends
- 10.6.2 Market Forecast
- 10.7 Others
- 10.7.1 Market Trends
- 10.7.2 Market Forecast
- 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
- 11.1.5.1 Market Performance
- 11.1.5.2 Key Players and Biosimilars
- 11.1.5.3 Market Forecast
- 11.1.6 Germany
- 11.1.6.1 Market Performance
- 11.1.6.2 Key Players and Biosimilars
- 11.1.6.3 Market Forecast
- 11.1.7 France
- 11.1.7.1 Market Performance
- 11.1.7.2 Key Players and Biosimilars
- 11.1.7.3 Market Forecast
- 11.1.8 United Kingdom
- 11.1.8.1 Market Performance
- 11.1.8.2 Key Players and Biosimilars
- 11.1.8.3 Market Forecast
- 11.1.9 Spain
- 11.1.9.1 Market Performance
- 11.1.9.2 Key Players and Biosimilars
- 11.1.9.3 Market Forecast
- 11.1.10 Rest of Europe
- 11.1.10.1 Market Performance
- 11.1.10.2 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
- 13 Competitive Landscape
- 13.1 Market Structure
- 13.2 Key Players
- 13.3 Profiles of Key Players
- 13.3.1 Sandoz International GmbH
- 13.3.2 Pfizer Inc.
- 13.3.3 Teva Pharmaceutical Industries Limited
- 13.3.4 Celltrion Inc.
- 13.3.5 Biocon Limited
- 13.3.6 Samsung Biologics
- 13.3.7 Amgen, Inc.
- 13.3.8 Dr. Reddy's Laboratories Limited
- 13.3.9 Stada Arzneimittel Ag
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