Biosimilar Market Analysis by Product (Monoclonal Antibodies, Glucagon, Insulin, Erythropoietin, Interferon, and Calcitonin); Application (Oncology, Growth Hormonal Deficiency, Blood Disorders, Chronic & Autoimmune Disorders, and Others) and by Region: Global Forecast, 2024 - 2033

  • 2022-03-10
  • 271
  • Healthcare & Life Sciences

Market Overview

The Biosimilar market is predicted to develop at a compound annual growth rate (CAGR) of 18.32% from 2024 to 2033, when it is projected to reach USD 125.32 billion, based on an average growth pattern. The market is estimated to reach a value of USD 27.46 billion in 2024.


SOURCE: We Market Research

The biosimilars market is the segment of the pharmaceutical business focused on developing and promoting biosimilar drugs. Affordably priced biologics that closely resemble reference biologics that have already been approved are known as biosimilars. The biologic medication sector has expanded tremendously as a result of the biologic medicine patents expiring, providing businesses with the chance to produce biosimilars. The global biosimilars market is meeting the demand for more affordable versions of complex biologics while also promoting competition, expanding patient access to state-of-the-art therapies, and igniting innovation in the biopharmaceutical sector.

The biosimilars market is being driven by a number of significant reasons. The expiration of biologics originator patents opens the door to the development of biosimilars, boosting market competition and bringing down healthcare costs. The increasing demand for accessible therapeutic options, especially in regions where healthcare expenses are rising, promotes the adoption of biosimilars. Regulatory frameworks that speed up the approval process for biosimilars improve market access. In addition, the growing prevalence of chronic illnesses is driving demand for reasonably priced biologic treatments, which is propelling the biosimilars market. Pharmaceutical companies can increase their market share by strengthening their R&D capabilities through strategic alliances and teamwork. When combined, these elements promote availability to advanced biologic therapies and create a vibrant atmosphere for the development of biosimilar.


Market Scope

Report Attributes


Market Size in 2024

USD 27.46 Billion

Market Forecast in 2033

USD 125.32 Billion

CAGR % 2024-2033


Base Year


Historic Data


Forecast Period


Report USP


Production, Consumption, company share, company heatmap, company production capacity, growth factors and more

Segments Covered

By Product, by Application and By Region

Regional Scope

North America, Europe, APAC, South America and Middle East and Africa

Country Scope

U.S.; Canada; U.K.; Germany; France; Italy; Spain; Benelux; Nordic Countries; Russia; China; India; Japan; South Korea; Australia; Indonesia; Thailand; Mexico; Brazil; Argentina; Saudi Arabia; UAE; Egypt; South Africa; Nigeria


Biosimilar Industry: Dynamics & Restrains

Market Drivers

The increasing prevalence of chronic diseases - A primary driver of the biosimilars market's growth is the increasing number of people suffering from chronic illnesses. Ailments including diabetes, cancer, and autoimmune disorders—which are growing increasingly prevalent as the world's population ages and lifestyles alter—require cutting-edge and reasonably priced treatment alternatives. Biosimilars, or extremely similar versions of biologic medications now on the market, offer a way to achieve therapeutic treatments that are more affordable and efficient. When the patents on several biologics expire, biosimilars become necessary replacements, boosting competition and bringing down healthcare costs. As a result of this market expansion, biosimilars are becoming increasingly important in addressing the growing worldwide burden of chronic diseases. This is in line with the growing desire for sustainable and reasonably priced healthcare solutions.

Biosimilars are generally more affordable than their reference biologics - The cost advantage of biosimilars over their reference biologics is one of the primary drivers of the biosimilars market. Biosimilars give patients access to a wider choice of treatments at a lower cost than those of biologics. The final product will be more cheaply priced because biosimilars are developed with shortened regulatory procedures and lower R&D expenses. Biosimilars are more competitive in the market due to their lower cost, which persuades payers and healthcare providers to accept them as cost-effective alternatives that preserve therapeutic efficacy. The economic attractiveness of biosimilars shapes the dynamics of the biosimilars market and is critical to their wider adoption as healthcare systems seek low-cost solutions to curb growing expenses.

Market restrains

Intellectual Property Issues - Intellectual property issues provide a major barrier to the biosimilars industry. The patents covering reference biologics often create legal barriers that keep competitors developing biosimilars out of the market. Obtaining identical replication is further complicated by complex biologic structures and intricate manufacturing processes. Producers of biosimilars and inventors participate in patent litigation that extends market exclusivity, decreasing competition and hindering timely introduction into the market. Strict IP protection limits the potential cost savings and accessibility benefits that biosimilars may offer by impeding the development of a competitive market. More energy and competition in the biosimilars sector will only come from removing these legal barriers.

We Market Research: Biosimilar Dashboard

Our marketing platform offers a comprehensive dashboard that provides clients with valuable insights into market trends over the years. Included below is a sample image of our dashboard, and specific PDF logins will be furnished to grant access to this insightful tool.


Biosimilar Segmentation

Market- By Product Analysis

By Product, the Biosimilar Market is Categories into Monoclonal Antibodies, Glucagon, Insulin, Erythropoietin, Interferon, and Calcitonin. The Monoclonal Antibodies segment accounts for the largest share of around 49% in 2023.


Many diseases, including multiple sclerosis, rheumatoid arthritis, cancer, and cardiovascular disorders, are treated with monoclonal antibodies. Since monoclonal antibodies specifically target infected cells during treatment, they are widely utilized in the management of cancer, which has caused this category to rise to the top.

The following segments are part of an in-depth analysis of the global Biosimilar market:

Market Segments


By   Application

·         Oncology

·         Growth Hormonal Deficiency

·         Blood Disorders

·         Chronic & Autoimmune Disorders

·         Others


Biosimilar Industry: Regional Analysis

Europe Market Forecast

Europe dominate the Biosimilar Market with the highest revenue generating market with share of more than 46%. Europe is leading the way in the use of biosimilars due to its regulatory environment's support and dedication to providing affordable healthcare. The European Medicines Agency (EMA) has been instrumental in the approval process for biosimilars, providing a strong foundation for their market launch. Many biologics' patents are about to expire, which presents a significant opportunity for producers of biosimilars to enter the market. The region's biosimilars industry is still expanding because to the advanced healthcare systems and significant emphasis on cost containment in European nations.


North America Market Statistics

North America is the second-largest market for Biosimilar. In North America, particularly in the US, a growing emphasis on biosimilars is the result of several significant causes. One crucial element is the regulatory help provided by the Food and Drug Administration (FDA). The FDA has been aggressively working to create a transparent procedure for biosimilar approval, which is intended to incentivize companies to participate in the creation of these less expensive alternatives.

Asia Pacific Market Forecasts

Asia Pacific is expected to be the fastest-growing market for Biosimilar during the forecast period. The Asia-Pacific biosimilars industry is impacted by a number of variables that varies from nation to nation. Growing healthcare infrastructure and rising biosimilar awareness are major drivers of market growth in nations like South Korea and India. Japan's regulatory actions have expedited the biosimilars approval process, increasing their accessibility. The adoption of biosimilars is fueled by the region's growing chronic disease prevalence as well as a focus on affordable treatment choices.


Key Market Players

The Biosimilar Market is dominated by a few large companies, such as

·         Pfizer Inc.

·         Novartis AG

·         Orion Pharma AB

·         Biocon.

·         Coherus BioSciences, Inc.

·         Amgen Inc.

·         Samsung Bioepis.

·         Takeda Pharmaceutical Company Limited.

·         Bristol-Myers Squibb Company

·         Merck KGaA

·         Eli Lilly and Company

·         Teva Pharmaceutical Industries Ltd.

·         Bayer AG

·         Others

Recent Developments:

·         July 2020, The FDA approved Fujifilm Kyowa Kirin Biologics' adalimumab biosimilar Hulio, which is indicated for subcutaneous treatment of psoriatic arthritis, adult Crohn's disease, adult rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis.

·         In May 2020, Fresenius Kabi has been granted approval by the European Medicines Agency and the US Food and Drug Administration (FDA) for its planned pegfilgrastim biosimilar, MSB11455, regulatory submission.

1.      Global Biosimilar Market Introduction and Market Overview

1.1.    Objectives of the Study

1.2.    Global Biosimilar Market Scope and Market Estimation

1.2.1. Global Biosimilar Overall Market Size, Revenue (US$ Mn), Market CAGR (%), Market forecast (2023 - 2033)

1.2.2. Global Biosimilar Market Revenue Share (%) and Growth Rate (Y-o-Y) from 2019 - 2033

1.3.    Market Segmentation

1.3.1. Component of Global Biosimilar Market

1.3.2. Technology of Global Biosimilar Market

1.3.3. Application of Global Biosimilar Market

1.3.4. Region of Global Biosimilar Market

2.      Executive Summary

2.1.    Global Biosimilar Market Industry Trends under COVID-19 Outbreak

2.1.1. Global COVID-19 Status Overview

2.1.2. Influence of COVID-19 Outbreak on Global Biosimilar Market Industry Development

2.2.    Market Dynamics

2.2.1. Drivers

2.2.2. Limitations

2.2.3. Opportunities

2.2.4. Impact Analysis of Drivers and Restraints

2.3.    Pricing Trends Analysis & Average Selling Prices (ASPs)

2.4.    Key Mergers & Acquisitions, Expansions, JVs, Funding / VCs, etc.

2.5.    Porter’s Five Forces Analysis

2.5.1. Bargaining Power of Suppliers

2.5.2. Bargaining Power of Buyers

2.5.3. Threat of Substitutes

2.5.4. Threat of New Entrants

2.5.5. Competitive Rivalry

2.6.    Value Chain / Ecosystem Analysis

2.7.    Russia-Ukraine War Impacts Analysis

2.8.    Economic Downturn Analysis

2.9.      Market Investment Opportunity Analysis (Top Investment Pockets), By Segments & By Region

3.      Global Biosimilar Market Estimates & Historical Trend Analysis (2019 - 2022)

4.      Global Biosimilar Market Estimates & Forecast Trend Analysis, by PRODUCT

4.1.    Global Biosimilar Market Revenue (US$ Mn) Estimates and Forecasts, by PRODUCT, 2019 to 2033

4.1.1. Monoclonal Antibodies

4.1.2. Glucagon

4.1.3. Insulin

4.1.4. Erythropoietin

4.1.5. Interferon

4.1.6. Calcitonin

5.      Global Biosimilar Market Estimates & Forecast Trend Analysis, by Application

5.1.    Global Biosimilar Market Revenue (US$ Mn) Estimates and Forecasts, by Application, 2019 to 2033

5.1.1. Oncology

5.1.2. Growth Hormonal Deficiency

5.1.3. Blood Disorders

5.1.4. Chronic & Autoimmune Disorders

5.1.5. Others

6.      Global Biosimilar Market Estimates & Forecast Trend Analysis, by Region

6.1.    Global Biosimilar Market Revenue (US$ Mn) Estimates and Forecasts, by Region, 2019 to 2033

6.1.1. North America

6.1.2. Europe

6.1.3. Asia Pacific

6.1.4. Middle East & Africa

6.1.5. South America

7.      North America Biosimilar Market: Estimates & Forecast Trend Analysis

7.1.    North America Biosimilar Market Assessments & Key Findings

7.1.1. North America Biosimilar Market Introduction

7.1.2. North America Biosimilar Market Size Estimates and Forecast (US$ Million) (2019 – 2033)   By PRODUCT   By Application   By Country     The U.S.     Canada     Mexico

8.      Europe Biosimilar Market: Estimates & Forecast Trend Analysis

8.1.    Europe Biosimilar Market Assessments & Key Findings

8.1.1. Europe Biosimilar Market Introduction

8.1.2. Europe Biosimilar Market Size Estimates and Forecast (US$ Million) (2019 – 2033)   By PRODUCT   By Application        By Country     Germany     U.K.     France     Italy     Spain     Russia     Rest of Europe

9.      Asia Pacific Biosimilar Market: Estimates & Forecast Trend Analysis

9.1.    Asia Pacific Market Assessments & Key Findings

9.1.1. Asia Pacific Biosimilar Market Introduction

9.1.2. Asia Pacific Biosimilar Market Size Estimates and Forecast (US$ Million) (2019 – 2033)   By PRODUCT   By Application        By Country     China     Japan     India     Australia     South Korea     ASEAN     Rest of Asia Pacific

10.  Middle East & Africa Biosimilar Market: Estimates & Forecast Trend Analysis

10.1.  Middle East & Africa Market Assessments & Key Findings

10.1.1.   Middle East & Africa Biosimilar Market Introduction

10.1.2.   Middle East & Africa Biosimilar Market Size Estimates and Forecast (US$ Million) (2019 – 2033)    By PRODUCT    By Application    By Country U.A.E. Saudi Arabia Egypt South Africa Rest of Middle East & Africa

11.  South America Biosimilar Market: Estimates & Forecast Trend Analysis

11.1.  South America Market Assessments & Key Findings

11.1.1.   South America Biosimilar Market Introduction

11.1.2.   South America Biosimilar Market Size Estimates and Forecast (US$ Million) (2019 – 2033)    By PRODUCT    By Application    By Country Brazil Argentina Colombia Rest of South America

12.  Competition Landscape

12.1.  Global Biosimilar Market Competition Matrix & Benchmarking, by Leading Players / Innovators / Emerging Players / New Entrants

12.2.  Global Biosimilar Market Competition White Space Analysis, By Application

12.3.  Global Biosimilar Market Competition Heat Map Analysis, By Application

12.4.  Global Biosimilar Market Concentration & Company Market Shares (%) Analysis, 2022

13.  Company Profiles

13.1.                     Pfizer Inc.

13.1.1.   Company Overview & Key Stats

13.1.2.   Financial Performance & KPIs

13.1.3.   ProductPortfolio

13.1.4.   Business Strategy & Recent Developments

* Similar details would be provided for all the players mentioned below 

13.2.      Novartis AG

13.3.      Orion Pharma AB

13.4.      Biocon.

13.5.      Coherus BioSciences, Inc.

13.6.      Amgen Inc.

13.7.      Samsung Bioepis.

13.8.      Takeda Pharmaceutical Company Limited.

13.9.      Bristol-Myers Squibb Company

13.10.  Merck KGaA

13.11.  Eli Lilly and Company

13.12.  Teva Pharmaceutical Industries Ltd.

13.13.  Bayer AG

13.14.  Others

14.  Research Methodology

14.1.  External Transportations / Databases

14.2.  Internal Proprietary Database

14.3.  Primary Research

14.4.  Secondary Research

14.5.  Assumptions

14.6.  Limitations

14.7.  Report FAQs

15.  Research Findings & Conclusion

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Frequently Asked Questions

What is the market size of Biosimilar Market in 2024?

Biosimilar Market was valued at USD 27.46 Billion in 2024.

What is the growth rate for the Biosimilar Market?

Biosimilar Market size will increase at approximate CAGR of 18.32% during the forecasted period.

Which are the top companies operating within the market?

Major companies operating within the Biosimilar Market are Pfizer Inc., Novartis AG, Orion Pharma AB, Biocon, Coherus BioSciences, Inc., Amgen Inc., Samsung Bioepis, Takeda Pharmaceutical Company Limited, Bristol-Myers Squibb Company, Merck KGaA, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Bayer AG and Other.

Which region dominates the Biosimilar Market?

Europe dominates the market with an active share of 46%.


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