Biosimilars Market Size, Share, Trends, Growth Outlook | 2025-2034

The Global Biosimilars Market size is estimated at $36.3 Billion in 2025 and is forecast to register an annual growth rate (CAGR) of 12.5% to reach $104.8 Billion by 2034

The Biosimilars Market study analyzes and forecasts the market size across 6 regions and 24 countries for diverse segments- By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins), By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Rheumatoid Arthritis, Chronic & Autoimmune Disorders, Others).

An Introduction to Biosimilars Market in 2025

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing approved reference biologic, also known as the originator or reference product. In 2025, the biosimilar market continues to grow as healthcare systems seek to increase access to affordable biologic therapies while maintaining safety and efficacy standards. Biosimilars offer therapeutic alternatives to expensive biologic drugs, providing cost savings and expanding treatment options for patients with chronic diseases such as cancer, autoimmune disorders, and inflammatory conditions. Moreover, with the expiration of patents for several blockbuster biologics, the biosimilars market is witnessing increased competition and market penetration, driving down prices and improving affordability for patients and healthcare payers. By promoting competition and market access, biosimilars stimulate innovation, drive down healthcare costs, and improve patient access to life-saving treatments, ultimately benefiting patients, healthcare providers, and healthcare systems globally. However, ensuring the safety, efficacy, and interchangeability of biosimilars remains a priority, requiring robust regulatory frameworks, pharmacovigilance programs, and physician education initiatives to build confidence in biosimilar products and promote their acceptance and adoption in clinical practice.

Biosimilars Market Dynamics

Market Trend: Increasing Acceptance and Adoption of Biosimilars

A significant trend in the biosimilars market is the increasing acceptance and adoption of biosimilar products worldwide. Biosimilars are highly similar versions of approved biologic drugs with comparable efficacy, safety, and quality profiles. As healthcare systems face escalating costs and budget constraints, there is growing interest in biosimilars as cost-effective alternatives to originator biologics. Furthermore, regulatory agencies, such as the FDA and EMA, have established rigorous guidelines for biosimilar approval, providing confidence in their safety and efficacy. This trend towards greater acceptance and adoption of biosimilars is driven by their potential to expand patient access to life-saving therapies, reduce healthcare expenditures, and promote competition in the biopharmaceutical market.

Market Driver: Expiration of Patent Protection for Originator Biologic Drugs

The primary driver fueling the growth of the biosimilars market is the expiration of patent protection for originator biologic drugs, allowing for the entry of biosimilar competitors into the market. As patents on biologic drugs expire, biosimilar manufacturers can develop and commercialize biosimilar versions of these drugs, offering comparable therapeutic options at lower prices. The entry of biosimilars into the market introduces competition, driving down prices and increasing accessibility to biologic therapies for patients and healthcare systems globally. Additionally, healthcare payers and providers are incentivized to switch to biosimilar products to capitalize on cost savings opportunities, further accelerating market adoption and driving demand for biosimilars.

Market Opportunity: Expansion into Emerging Markets and Therapeutic Areas

A potential opportunity for the biosimilars market lies in the expansion into emerging markets and therapeutic areas. While biosimilar adoption has been relatively high in developed markets, such as North America and Europe, there is significant untapped potential in emerging markets, including Asia-Pacific, Latin America, and the Middle East. These regions represent large and growing patient populations with increasing healthcare needs and demand for affordable biologic therapies. By expanding their presence in emerging markets, biosimilar manufacturers can capitalize on growing market opportunities and establish a foothold in these regions. Furthermore, there is an opportunity to develop biosimilars for a broader range of therapeutic areas beyond oncology and autoimmune diseases, including infectious diseases, cardiovascular disorders, and rare diseases. By diversifying their biosimilar portfolios and targeting underserved therapeutic areas, manufacturers can address unmet medical needs, expand market share, and drive growth in the biosimilars market.

Biosimilars Market Share Analysis: Oncology Biosimilars is the fastest growing segment over the forecast period to 2034

Among the segments of the Biosimilars Market, the Oncology biosimilars segment is experiencing the fastest growth. This growth can be attributed to several factors. Firstly, the rising prevalence of cancer worldwide has led to an increased demand for more affordable treatment options, driving the adoption of biosimilar products in oncology. Biosimilars offer comparable efficacy and safety to their reference biologic drugs at a lower cost, making them an attractive option for both healthcare providers and patients. Additionally, the expiration of patents for several blockbuster oncology biologics has paved the way for the development and commercialization of biosimilar alternatives, further fueling market growth. Moreover, regulatory initiatives aimed at expediting the approval process for biosimilars in oncology, coupled with increasing investments in research and development by pharmaceutical companies, are contributing to the expansion of the oncology biosimilars market. As a result, the oncology segment within the Biosimilars Market is witnessing rapid growth, driven by the need for cost-effective cancer therapies and the availability of biosimilar alternatives.

Biosimilars Competitive Analysis

The market research study provides in-depth insights into leading companies including the SWOT analyses, product profile, financial details, and recent developments acrossAmega Biotech S.A.S., Amgen Inc, Amneal Pharmaceuticals Inc, Apotex Inc, BIOCAD, Biocon Ltd, Boehringer Ingelheim International GmbH, Celltrion Healthcare Co. Ltd, Coherus BioSciences Inc, Dr. Reddy's Laboratories Ltd, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Fresenius SE & Co. KGaA, Fujifilm Kyowa Kirin Biologics Co. Ltd, Intas Pharmaceuticals Ltd, Kashiv Biosciences LLC, mAbxience S.L., Novartis AG, Pfizer Inc, Probiomed S.A. de C.V., Reliance Life Sciences Pvt. Ltd, Samsung Bioepis Co. Ltd, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd, USV Private Ltd

Biosimilars Market Segmentation

By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others
Geographical Analysis
North America (United States, Canada, Mexico)
Europe (Germany, France, United Kingdom, Spain, Italy, Rest of Europe)
Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific)
South America (Brazil, Argentina, Rest of South America)
Middle East and Africa (Saudi Arabia, UAE, Rest of Middle East, South Africa, Egypt, Rest of Africa)

Biosimilars Market Companies

Amega Biotech S.A.S.
Amgen Inc
Amneal Pharmaceuticals Inc
Apotex Inc
BIOCAD
Biocon Ltd
Boehringer Ingelheim International GmbH
Celltrion Healthcare Co. Ltd
Coherus BioSciences Inc
Dr. Reddy's Laboratories Ltd
Eli Lilly and Company
F. Hoffmann-La Roche Ltd
Fresenius SE & Co. KGaA
Fujifilm Kyowa Kirin Biologics Co. Ltd
Intas Pharmaceuticals Ltd
Kashiv Biosciences LLC
mAbxience S.L.
Novartis AG
Pfizer Inc
Probiomed S.A. de C.V.
Reliance Life Sciences Pvt. Ltd
Samsung Bioepis Co. Ltd
STADA Arzneimittel AG
Teva Pharmaceutical Industries Ltd
USV Private Ltd

* List not Exhaustive

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• Benefit from tailored solutions and expert consultation based on report insights, providing personalized strategies aligned with specific business needs.

TABLE OF CONTENTS

1 Introduction to 2025 Biosimilars Market
1.1 Market Overview
1.2 Quick Facts
1.3 Scope/Objective of the Study
1.4 Market Definition
1.5 Countries and Regions Covered
1.6 Units, Currency, and Conversions
1.7 Industry Value Chain

2 Research Methodology
2.1 Market Size Estimation
2.2 Sources and Research Methodology
2.3 Data Triangulation
2.4 Assumptions and Limitations

3 Executive Summary
3.1 Global Biosimilars Market Size Outlook, $ Million, 2021 to 2034
3.2 Biosimilars Market Outlook by Type, $ Million, 2021 to 2034
3.3 Biosimilars Market Outlook by Product, $ Million, 2021 to 2034
3.4 Biosimilars Market Outlook by Application, $ Million, 2021 to 2034
3.5 Biosimilars Market Outlook by Key Countries, $ Million, 2021 to 2034

4 Market Dynamics
4.1 Key Driving Forces of Biosimilars Industry
4.2 Key Market Trends in Biosimilars Industry
4.3 Potential Opportunities in Biosimilars Industry
4.4 Key Challenges in Biosimilars Industry

5 Market Factor Analysis
5.1 Value Chain Analysis
5.2 Competitive Landscape
5.2.1 Global Biosimilars Market Share by Company (%), 2025
5.2.2 Product Offerings by Company
5.3 Porter’s Five Forces Analysis
5.4 Pricing Analysis and Outlook

6 Growth Outlook Across Scenarios
6.1 Growth Analysis-Case Scenario Definitions
6.2 Low Growth Scenario Forecasts
6.3 Reference Growth Scenario Forecasts
6.4 High Growth Scenario Forecasts

7 Global Biosimilars Market Outlook by Segments
7.1 Biosimilars Market Outlook by Segments, $ Million, 2021- 2034
By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others

8 North America Biosimilars Market Analysis and Outlook To 2034
8.1 Introduction to North America Biosimilars Markets in 2024
8.2 North America Biosimilars Market Size Outlook by Country, 2021-2034
8.2.1 United States
8.2.2 Canada
8.2.3 Mexico
8.3 North America Biosimilars Market size Outlook by Segments, 2021-2034
By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others

9 Europe Biosimilars Market Analysis and Outlook To 2034
9.1 Introduction to Europe Biosimilars Markets in 2024
9.2 Europe Biosimilars Market Size Outlook by Country, 2021-2034
9.2.1 Germany
9.2.2 France
9.2.3 Spain
9.2.4 United Kingdom
9.2.4 Italy
9.2.5 Russia
9.2.6 Norway
9.2.7 Rest of Europe
9.3 Europe Biosimilars Market Size Outlook by Segments, 2021-2034
By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others

10 Asia Pacific Biosimilars Market Analysis and Outlook To 2034
10.1 Introduction to Asia Pacific Biosimilars Markets in 2024
10.2 Asia Pacific Biosimilars Market Size Outlook by Country, 2021-2034
10.2.1 China
10.2.2 India
10.2.3 Japan
10.2.4 South Korea
10.2.5 Indonesia
10.2.6 Malaysia
10.2.7 Australia
10.2.8 Rest of Asia Pacific
10.3 Asia Pacific Biosimilars Market size Outlook by Segments, 2021-2034
By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others

11 South America Biosimilars Market Analysis and Outlook To 2034
11.1 Introduction to South America Biosimilars Markets in 2024
11.2 South America Biosimilars Market Size Outlook by Country, 2021-2034
11.2.1 Brazil
11.2.2 Argentina
11.2.3 Rest of South America
11.3 South America Biosimilars Market size Outlook by Segments, 2021-2034
By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others
12 Middle East and Africa Biosimilars Market Analysis and Outlook To 2034
12.1 Introduction to Middle East and Africa Biosimilars Markets in 2024
12.2 Middle East and Africa Biosimilars Market Size Outlook by Country, 2021-2034
12.2.1 Saudi Arabia
12.2.2 UAE
12.2.3 Oman
12.2.4 Rest of Middle East
12.2.5 Egypt
12.2.6 Nigeria
12.2.7 South Africa
12.2.8 Rest of Africa
12.3 Middle East and Africa Biosimilars Market size Outlook by Segments, 2021-2034
By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others

13 Company Profiles
13.1 Company Snapshot
13.2 SWOT Profiles
13.3 Products and Services
13.4 Recent Developments
13.5 Financial Profile
List of Companies
Amega Biotech S.A.S.
Amgen Inc
Amneal Pharmaceuticals Inc
Apotex Inc
BIOCAD
Biocon Ltd
Boehringer Ingelheim International GmbH
Celltrion Healthcare Co. Ltd
Coherus BioSciences Inc
Dr. Reddy's Laboratories Ltd
Eli Lilly and Company
F. Hoffmann-La Roche Ltd
Fresenius SE & Co. KGaA
Fujifilm Kyowa Kirin Biologics Co. Ltd
Intas Pharmaceuticals Ltd
Kashiv Biosciences LLC
mAbxience S.L.
Novartis AG
Pfizer Inc
Probiomed S.A. de C.V.
Reliance Life Sciences Pvt. Ltd
Samsung Bioepis Co. Ltd
STADA Arzneimittel AG
Teva Pharmaceutical Industries Ltd
USV Private Ltd

14 Appendix
14.1 Customization Offerings
14.2 Subscription Services
14.3 Related Reports
14.4 Publisher Expertise

By Product
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
By Application
Oncology
Blood Disorders
Growth Hormonal Deficiency
Rheumatoid Arthritis
Chronic & Autoimmune Disorders
Others
Countries Analyzed
North America (United States, Canada, Mexico)
Europe (Germany, France, United Kingdom, Spain, Italy, Rest of Europe)
Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific)
South America (Brazil, Argentina, Rest of South America)
Middle East and Africa (Saudi Arabia, UAE, Rest of Middle East, South Africa, Egypt, Rest of Africa)