+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Biosimilar Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

  • PDF Icon

    Report

  • 148 Pages
  • May 2023
  • Region: Global
  • IMARC Group
  • ID: 5820766
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:

The publisher 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?

Table of Contents

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
List of Figures
Figure 1: Global: Biosimilar Market: Sales Value (in Billion US$), 2017-2022
Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2022
Figure 3: Global: Biosimilar Market: Breakup by Manufacturing Type (in %), 2022
Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2022
Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2022
Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion US$), 2023-2028
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: Infliximab: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 14: Infliximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 16: Insulin Glargine: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 17: Epoetin Alfa: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 18: Epoetin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 20: Etanercept: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 21: Filgrastim: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 22: Filgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 23: Somatropin: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 24: Somatropin: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 25: Rituximab: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 26: Rituximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 27: Follitropin Alfa: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 28: Follitropin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 29: Adalimumab: Biosimilar Market: Sales Value (in Million US$), 2018-2022
Figure 30: Adalimumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 31: Pegfilgrastim: Biosimilar Market: Sales Value (in Million US$), 2019-2022
Figure 32: Pegfilgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 33: Trastuzumab: Biosimilar Market: Sales Value (in Million US$), 2018-2022
Figure 34: Trastuzumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 35: Bevacizumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 36: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 37: In-House Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 38: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 39: Contract Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 40: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 41: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2017 & 2022
Figure 42: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2023-2028
Figure 43: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2017 & 2022
Figure 44: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2023-2028
Figure 45: Global: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2017 & 2022
Figure 46: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2023-2028
Figure 47: Global: Biosimilar Market (Oncology): Sales Value (in Million US$), 2017 & 2022
Figure 48: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2023-2028
Figure 49: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2017 & 2022
Figure 50: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2023-2028
Figure 51: Global: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2017 & 2022
Figure 52: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2023-2028
Figure 53: Global: Biosimilar Market (Others): Sales Value (in Million US$), 2017 & 2022
Figure 54: Global: Biosimilar Market Forecast (Others): Sales Value (in Million US$), 2023-2028
Figure 55: Europe: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 56: Europe: Biosimilar Market: Breakup by Country (in %), 2022
Figure 57: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 58: Italy: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 59: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 60: Germany: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 61: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 62: France: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 63: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 64: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 65: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 66: Spain: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 67: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 68: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 69: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 70: United States: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 71: United States: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 72: Japan: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 73: Japan: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 74: India: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 75: India: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 76: South Korea: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 77: South Korea: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 78: Others: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 79: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 80: Biosimilar Manufacturing: Detailed Process Flow
Figure 81: Biosimilar Manufacturing Plant: Raw Materials Requirement
Figure 82: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
Figure 83: Biosimilar Manufacturing Plant: Machinery Costs (in US$)
Figure 84: Biosimilar Manufacturing Plant: Primary Packaging
Figure 85: Biosimilar Manufacturing Plant: Secondary Packaging
Figure 86: Biosimilar Manufacturing Plant: Tertiary Packaging
List of Tables
Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$), 2022
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, 2022 and 2028
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$), 2023-2028
Table 10: Global: Infliximab: Brand & Biosimilar Market Overview
Table 11: Global: Insulin Glargine: Brand & Biosimilar Market Overview
Table 12: Global: Epoetin Alfa: Brand & Biosimilar Market Overview
Table 13: Global: Etanercept: Brand & Biosimilar Market Overview
Table 14: Global: Filgrastim: Brand & Biosimilar Market Overview
Table 15: Global: Somatropin: Brand & Biosimilar Market Overview
Table 16: Global: Rituximab: Brand & Biosimilar Market Overview
Table 17: Global: Follitropin Alfa: Brand & Biosimilar Market Overview
Table 18: Global: Adalimumab: Brand & Biosimilar Market Overview
Table 19: Global: Pegfilgrastim: Brand & Biosimilar Market Overview
Table 20: Global: Trastuzumab: Brand & Biosimilar Market Overview
Table 21: Global: Bevacizumab: Brand & Biosimilar Market Overview
Table 22: Global: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million US$), 2023-2028
Table 23: Global: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2023-2028
Table 24: Global: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2023-2028
Table 25: Europe: Biosimilar Market: Key Players and Biosimilars
Table 26: Italy: Biosimilar Market: Key Players and Biosimilars
Table 27: Germany: Biosimilar Market: Key Players and Biosimilars
Table 28: France: Biosimilar Market: Key Players and Biosimilars
Table 29: United Kingdom: Biosimilar Market: Key Players and Biosimilars
Table 30: Spain: Biosimilar Market: Key Players and Biosimilars
Table 31: United States: Biosimilar Market: Key Players and Biosimilar
Table 32: United States: Biosimilar Market: Launch of Expected Biosimilar
Table 33: Japan: Biosimilar Market: Key Players and Biosimilars
Table 34: India: Biosimilar Market: Key Players and Biosimilars
Table 35: South Korea: Biosimilar Market: Key Players and Biosimilar
Table 36: Biosimilar Manufacturing Plant: Manpower Requirements
Table 37: Biosimilar Market: Competitive Structure
Table 38: Global: Biosimilar Market: Key Players

Companies Mentioned

  • Sandoz International GmbH
  • Pfizer Inc.
  • Teva Pharmaceutical Industries Limited
  • Celltrion Inc.
  • Biocon Limited
  • Samsung Biologics
  • Amgen Inc.
  • Dr. Reddy's Laboratories Limited and Stada Arzneimittel Ag

Methodology

Loading
LOADING...

Table Information