Biosimilar Market

Global Biosimilar Market Outlook - 2026

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.

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 for growth at the global, regional and country-level from 2021-2026. Our report has categorized the market based on region, molecule insights, indication insights, and manufacturing insights.

Molecule insights:    

On the basis of molecule, the market has been segmented as Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, etc. Currently, Infliximab dominates the market, holding the largest share.

Indication Insights:

Based on the indication, autoimmune diseases account for the majority of the total market share. Other major indications include oncology, diabetes, blood disorder, growth deficiency, female infertility, etc.

Manufacturing Insights:

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:

Region-wise, the market has been segmented into the United States, Germany, France, Italy, Spain, United Kingdom, 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:

• Novartis 
• Pfizer
• Teva
• Celltrion
• Merck & Co
• Samsung Bioepis 
• Eli Lilly
• Biocon
• Dr. Reddy's Laboratories
• Amgen
• Boehringer Ingelheim

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   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   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
            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
9   Market Breakup by Type of Manufacturing
    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
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    Novartis 
        13.3.2    Pfizer
        13.3.3    Teva 
        13.3.4    Celltrion 
        13.3.5    Merck & Co
        13.3.6    Samsung Bioepis 
        13.3.7    Eli Lilly
        13.3.8    Biocon 
        13.3.9    Amgen
        13.3.10    Dr. Reddy's Laboratories 
        13.3.11    Boehringer Ingelheim

List of Figure

Figure 1: Global: Biosimilar Market: Sales Value (in Billion US$), 2015-2020
Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2020
Figure 3: Global: Biosimilar Market: Breakup by Manufacturer (in %), 2020
Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2020
Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2020
Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion US$), 2021-2026
Figure 7: Global Biosimilars Industry: SWOT Analysis
Figure 8: Global: Biosimilar Industry: Value Chain Analysis
Figure 9: Global: Biosimilars Industry: Porter’s Five Forces Analysis
Figure 10: Global: Biosimilar Market: Average Price Trends of Inflectra
Figure 11: Global: Biosimilar Market: Average Price Trends of Zarxio
Figure 12: Biosimilars Industry: Breakup of Profit Margins at Various Level of the Value Chain
Figure 13: Rituximab: Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 14: Infliximab: Biosimilar Market: Sales Value (in Million US$), 2015 - 2017
Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 16: Epoetin Alfa: Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 17 Filgrastim: Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 18: Somatropin: Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 20: Follitropin Alfa: Biosimilar Market: Sales Value (in Million US$), 2015 – 2017
Figure 21: In-House Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 22: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 23: Contract Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 24: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 25: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2015 & 2020
Figure 26: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2021-2026
Figure 27: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2015 & 2020
Figure 28: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2021-2026
Figure 29: Global: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2015 & 2020
Figure 30: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2021-2026
Figure 31: Global: Biosimilar Market (Oncology): Sales Value (in Million US$), 2015 & 2020
Figure 32: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2021-2026
Figure 33: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2015 & 2020
Figure 34: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2021-2026
Figure 35: Global: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2015 & 2020
Figure 36: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2021-2026
Figure 37: Europe: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 38: Europe: Biosimilar Market: Breakup by Country (in %), 2020
Figure 39: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 40: Italy: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 41: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 42: Germany: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 43: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 44: France: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 45: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 46: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 47: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 48: Spain: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 49: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 50: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 51: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 52: United States: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 53: United States: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 54: Japan: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 55: Japan: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 56: India: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 57: India: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 58: South Korea: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 59: South Korea: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 60: Others: Biosimilar Market: Sales Value (in Million US$), 2015-2020
Figure 61: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 62: Biosimilar Manufacturing: Detailed Process Flow
Figure 63: Biosimilar Manufacturing Plant: Raw Materials Requirement
Figure 64: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
Figure 65: Biosimilar Manufacturing Plant: Machinery Costs (in US$)
Figure 66: Biosimilar Manufacturing Plant: Primary Packaging
Figure 67: Biosimilar Manufacturing Plant: Secondary Packaging
Figure 68: Biosimilar Manufacturing Plant: Tertiary Packaging

List of Table

Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$), 2017
Table 2: Global: Biosimilar Market: Biosimilars Vs Innovators Drug Development
Table 3: Global: Biosimilar Market: Biosimilars Vs Biologics Manufacturing
Table 4: Global: Biosimilar Market: Key Industry Highlights, 2020 and 2026
Table 5: US: Biosimilar Market: Patent Landscape
Table 6: Europe: Biosimilar Market: Patent Landscape
Table 7: Japan: Biosimilar Market: Patent Landscape
Table 8: Global: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
Table 9: Global: Biosimilar Market: Breakup by Molecule (in Million US$), 2012-2017
Table 10: Global: Rituximab: Brand & Biosimilar Market Overview
Table 11: Global: Infliximab: Brand & Biosimilar Market Overview
Table 12: Global: Insulin Glargine: Brand & Biosimilar Market Overview
Table 13: Global: Epoetin Alfa: Brand & Biosimilar Market Overview
Table 14: Global: Filgrastim: Brand & Biosimilar Market Overview
Table 15: Global: Somatropin: Brand & Biosimilar Market Overview
Table 16: Global: Etanercept: Brand & Biosimilar Market Overview
Table 17: Global: Follitropin Alfa: Brand & Biosimilar Market Overview
Table 18: Global: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million US$), 2021-2026
Table 19: Global: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2021-2026
Table 20: Global: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2021-2026
Table 21: Europe: Biosimilar Market: Key Players and Biosimilars
Table 22: Italy: Biosimilar Market: Key Players and Biosimilars
Table 23: Germany: Biosimilar Market: Key Players and Biosimilars
Table 24: France: Biosimilar Market: Key Players and Biosimilars
Table 25: United Kingdom: Biosimilar Market: Key Players and Biosimilars
Table 26: Spain: Biosimilar Market: Key Players and Biosimilars
Table 27: United States: Biosimilar Market: Key Players and Biosimilar
Table 28: United States: Biosimilar Market: Launch of Expected Biosimilar
Table 29: Japan: Biosimilar Market: Key Players and Biosimilars
Table 30: India: Biosimilar Market: Key Players and Biosimilars
Table 31: South Korea: Biosimilar Market: Key Players and Biosimilar
Table 32: Biosimilar Manufacturing Plant: Manpower Requirements
Table 33: Biosimilar Market: Competitive Structure
Table 34: Global: Biosimilar Market: Key Players