Biosimilars Market Size - Industry Report on Share, Growth Trends & Forecasts Analysis (2025 - 2030)

The Global Biosimilars Market is Segmented by Product Class (Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-Inflammatory Agents, and Other Product Classes), Applications (Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, Oncology, and Other Applications), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The Report Offers the Value (in USD Million) for the Above Segments.

Biosimilars Market Size - Industry Report on Share, Growth Trends & Forecasts Analysis (2025 - 2030)

Biosimilars Market Size

Biosimilars Market Summary
Study Period 2019 - 2030
Base Year For Estimation 2024
Market Size (2025) USD 41.97 Billion
Market Size (2030) USD 97.32 Billion
CAGR (2025 - 2030) 18.32 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Biosimilars Market Major Players

*Disclaimer: Major Players sorted in no particular order

Compare market size and growth of Global Biosimilars Market with other markets in Healthcare Industry

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Biosimilars Market Analysis

The Global Biosimilars Market size is estimated at USD 41.97 billion in 2025, and is expected to reach USD 97.32 billion by 2030, at a CAGR of 18.32% during the forecast period (2025-2030).

The impact of COVID-19 on the biosimilars market may be significant, and it has imposed a great challenge on the pharmaceutical companies focused on biosimilar development. The reduction in the approval by regulatory bodies of non-COVID therapeutics during the current pandemic is expected to delay the process of product approvals and launches, hindering the biosimilars market growth. Additionally, as per the research article titled "Impact of Covid-19 on Cancer Care: A Global Collaborative Study" published in September 2020, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including preventive measures, lack of personal protective equipment, and staff shortages due to COVID-19. As biosimilars are injections that need experts to be administered and as the supply chain was greatly impaired in the early pandemic phase, it has significantly impacted the market growth. Therefore, COVID-19 impacted the growth of the biosimilars industry in its initial phase, however, the resumption of supply chain activities and clinical trials for drug development globally will boost the biosimilars market growth rate over the coming years. 

Moreover, several blockbuster biologic drugs of major pharmaceutical companies, such as Truvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs, lost United States exclusivity in 2020. In the coming decade, there will be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, and Orencia, which would provide an opportunity for many biosimilar companies as well as generic manufacturers to offer services specially tailored toward biosimilars. Factors such as the cost-effective nature of biosimilars, rising acceptance and adoption by various stakeholders, the need for diversification in technology and business models, and the growing prevalence of chronic diseases are expected to drive the global biosimilar market. 

Furthermore, the growing burden of cancer and increasing deaths due to it create the need for affordable treatment and thus boost the growth of the biosimilars in the market. For instance, according to GLOBOCAN 2020, in the United States, there were 2,281,658 estimated new cases of cancer and nearly 612,390 deaths in 2020. Additionally, the largest biosimilar companies anticipated market growth over the forecast period through various strategic activities, such as product launches, mergers, and acquisitions. For instance, in July 2021, the Food and Drug Administration (FDA) approved Viatris Inc.'s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine). 

On the other hand, factors such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, discourage many companies from investing in this market, thereby impeding the growth of the biosimilars market. 

Biosimilars Industry Overview

The market is highly competitive, with many of the largest biosimilar companies dominating the market. The major players in the studied market comprise Novartis AG, Pfizer Inc., Amgen Inc., Coherus Biosciences Inc., Mylan NV (Viatris Inc.), and Samsung Bioepis Co., Ltd., among others. Most top biosimilar companies are adopting various growth strategies, such as acquisitions, partnerships, and new product launches, to secure their position in the global market.

Biosimilars Market Leaders

  1. Pfizer Inc

  2. Novartis AG

  3. Samsung Bioepies Co., Ltd

  4. Coherus Biosciences, Inc.

  5. Amgen Inc

  6. *Disclaimer: Major Players sorted in no particular order
Biosimilars Market Concentration
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Biosimilars Market News

  • In May 2022, Amneal Pharmaceuticals, Inc. received United States Food and Drug Administration ("FDA") approval for a Biologics License Application ("BLA") for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.
  • In September 2021, Samsung Bioepis and Biogen announced that the Food and Drug Administration (FDA) had approved BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ was the first ophthalmology biosimilar approved in the United States.

Biosimilars Market Report - Table of Contents

1. INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Several Blockbuster Biopharmaceuticals Going Off-patent over the Next Five to Ten Years
    • 4.2.2 Growing Burden of Chronic Diseases and Increasing R&D Investments
    • 4.2.3 Increasing Demand for Biosimilar Drugs Due to Their Cost Effectiveness
  • 4.3 Market Restraints
    • 4.3.1 Concerns Regarding Substitutability and Interchangeability
    • 4.3.2 Regulatory Uncertainty and Growing Competition from Biobetters
    • 4.3.3 High Cost Involvement and Complexities in Manufacturing
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value - USD million)

  • 5.1 By Product Class
    • 5.1.1 Monoclonal Antibodies
    • 5.1.2 Recombinant Hormones
    • 5.1.3 Immunomodulators
    • 5.1.4 Anti-Inflammatory Agents
    • 5.1.5 Other Product Classes
  • 5.2 By Application
    • 5.2.1 Blood Disorders
    • 5.2.2 Growth Hormonal Deficiency
    • 5.2.3 Chronic and Autoimmune Disorders
    • 5.2.4 Oncology
    • 5.2.5 Other Applications
  • 5.3 Geography
    • 5.3.1 North America
    • 5.3.1.1 United States
    • 5.3.1.2 Canada
    • 5.3.1.3 Mexico
    • 5.3.2 Europe
    • 5.3.2.1 Germany
    • 5.3.2.2 United Kingdom
    • 5.3.2.3 France
    • 5.3.2.4 Italy
    • 5.3.2.5 Spain
    • 5.3.2.6 Rest of Europe
    • 5.3.3 Asia-Pacific
    • 5.3.3.1 China
    • 5.3.3.2 Japan
    • 5.3.3.3 India
    • 5.3.3.4 Australia
    • 5.3.3.5 South Korea
    • 5.3.3.6 Rest of Asia-Pacific
    • 5.3.4 Middle East and Africa
    • 5.3.4.1 GCC
    • 5.3.4.2 South Africa
    • 5.3.4.3 Rest of Middle East and Africa
    • 5.3.5 South America
    • 5.3.5.1 Brazil
    • 5.3.5.2 Argentina
    • 5.3.5.3 Rest of South America

6. COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Pfizer Inc.
    • 6.1.2 Eli Lilly and Company
    • 6.1.3 Celltrion Healthcare
    • 6.1.4 Viatris Inc. (Mylan)
    • 6.1.5 Novartis AG
    • 6.1.6 Samsung Bioepis Co. Ltd
    • 6.1.7 Stada Arzneimittel AG
    • 6.1.8 Teva Pharmaceutical Industries Ltd
    • 6.1.9 Intas Pharmaceutical Ltd
    • 6.1.10 LG Life Sciences (LG Chem)
    • 6.1.11 Biocon Limited
    • 6.1.12 Amgen Inc.
    • 6.1.13 Dr. Reddy's Laboratories
    • 6.1.14 Coherus Biosciences Inc.
    • 6.1.15 Biocad
  • *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments
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Biosimilars Industry Segmentation

As per the scope of the report, a biosimilar is a biologic that is "similar" to another biologic medicine (known as a reference product) that is already licensed by the US Food and Drug Administration (FDA). Biosimilars are highly similar to the reference product in terms of safety, purity, and potency but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity, or potency in one or more uses for which the reference product is licensed, and the biosimilar seeks licensure. The biosimilars market is segmented by product class (monoclonal antibodies, recombinant hormones, immunomodulators, anti-inflammatory agents, and other product classes), application (blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, oncology, and other applications), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated global biosimilar market sizes and trends for 17 countries across various regions. The report offers the value (USD million) for the above-mentioned segments. 

By Product Class Monoclonal Antibodies
Recombinant Hormones
Immunomodulators
Anti-Inflammatory Agents
Other Product Classes
By Application Blood Disorders
Growth Hormonal Deficiency
Chronic and Autoimmune Disorders
Oncology
Other Applications
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
South America Brazil
Argentina
Rest of South America
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Biosimilars Market Research FAQs

How big is the Global Biosimilars Market?

The Global Biosimilars Market size is expected to reach USD 41.97 billion in 2025 and grow at a CAGR of 18.32% to reach USD 97.32 billion by 2030.

What is the current Global Biosimilars Market size?

In 2025, the Global Biosimilars Market size is expected to reach USD 41.97 billion.

Who are the key players in Global Biosimilars Market?

Pfizer Inc, Novartis AG, Samsung Bioepies Co., Ltd, Coherus Biosciences, Inc. and Amgen Inc are the major companies operating in the Global Biosimilars Market.

Which is the fastest growing region in Global Biosimilars Market?

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).

Which region has the biggest share in Global Biosimilars Market?

In 2025, the North America accounts for the largest market share in Global Biosimilars Market.

What years does this Global Biosimilars Market cover, and what was the market size in 2024?

In 2024, the Global Biosimilars Market size was estimated at USD 34.28 billion. The report covers the Global Biosimilars Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Biosimilars Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.

Biosimilars Industry Report

The Global Biosimilars Market is segmented by product class, including monoclonal antibodies, recombinant hormones, immunomodulators, anti-inflammatory agents, and other product classes. Applications cover blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, oncology, and other applications. Geographically, the market spans North America, Europe, Asia-Pacific, Middle East and Africa, and South America.

The market size and market growth are key focal points in the market report. Market research highlights trends and market share, providing a comprehensive market overview. This market analysis offers a detailed market forecast and market outlook, essential for understanding the industry's trajectory.

The industry outlook and industry trends are critical for stakeholders to grasp the market's direction. Market leaders and market predictions play significant roles in shaping market strategies. The report also delves into market segmentation, providing valuable market data and market value insights.

Industry reports and industry analysis are vital for in-depth industry research. The industry size and industry statistics offer a granular view of market dynamics. Market review and market overview sections present a holistic view of the biosimilars market.

Growth rate and market segmentation are crucial for identifying emerging opportunities. The report example and report pdf provide accessible formats for stakeholders. Research companies utilize this data for strategic planning and market positioning.

Overall, the report provides a thorough examination of the biosimilars market, integrating market trends, market outlook, and market value to deliver actionable insights.