Biosimilar Market Research Report Information by Drug Class (Monoclonal Antibodies (Adalimumab, Infliximab, Rituximab, Bevacizumab, Trastuzumab, Ustekinumab, Tocilizumab, Aflibercept, Dupilumab, Denosumab, Others), Insulin, Granulocyte Colony- stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Anticoagulants, Others), by Application (Oncology (Breast Cancer, Lung Cancer, Prostate Cancer, Leukemia, Bladder Cancer, Colorectal Cancer, Others), Autoimmune Diseases, Infectious Diseases, B

Biosimilars Market Summary

As per MRFR Analysis, the Biosimilars Market was valued at 14.14 USD Billion in 2023 and is projected to grow to 40 USD Billion by 2035, reflecting a CAGR of 9.05% from 2025 to 2035. The market is driven by the rising prevalence of chronic diseases, cost-effectiveness of biosimilars, and supportive regulatory frameworks that facilitate quicker approvals and market entry.

Key Market Trends & Highlights

The biosimilars market is witnessing significant growth due to various factors.

• The market is expected to grow from 15.42 USD Billion in 2024 to 40 USD Billion by 2035.
• Monoclonal Antibodies segment valued at 6.62 USD Billion in 2023, projected to reach 17.0 USD Billion by 2035.
• Biosimilars can be priced up to 30% lower than their reference biologics, enhancing patient access.
• North America led the market with a valuation of 6.1 USD Billion in 2024.

Market Size & Forecast

2023 Market Size: USD 14.14 Billion

2024 Market Size: USD 15.42 Billion

2035 Market Size: USD 40 Billion

CAGR (2025-2035): 9.05%

Largest Regional Market Share in 2024: North America.

Major Players

Key players include Pfizer, Generium, Sandoz, Roche, APOTEX, Samsung Bioepis, Boehringer Ingelheim, Eli Lilly, Accord Healthcare, Mylan, Teva Pharmaceuticals, Zydus Cadila, Bristol-Myers Squibb, Celltrion, Amgen.

The growing incidences of cancer and rare disorders and increasing launch of biosimilars and rising healthcare costs are driving the growth of the Biosimilar Market.

As per the Analyst at MRFR, the growing incidences of cancer and rare disorders are playing a pivotal role in boosting the growth of the Biosimilar Market. As the prevalence of these complex and often life-threatening conditions continues to rise, there is an increasing demand for effective and affordable treatment options. Biosimilars, which are highly similar to reference biologic drugs, provide a cost-efficient alternative to expensive therapies, making critical treatments more accessible to patients.

 FIGURE 1: BIOSIMILAR MARKET VALUE (2019-2035) USD BILLION

 Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Biosimilar Market Opportunity

EXPANSION IN EMERGING MARKETS

Expansion in emerging markets is creating significant opportunities for the biosimilars market, driven by the increasing demand for affordable healthcare solutions and the growing burden of chronic diseases in these regions. Countries in Asia, Latin America, the Middle East, and Africa are witnessing rapid population growth, urbanization, and improvements in healthcare infrastructure, which are expanding access to advanced treatments. As these regions face rising prevalence of conditions like cancer, diabetes, and autoimmune disorders, the high cost of originator biologics often limits patient access, creating a strong demand for cost-effective biosimilars. 

Governments and healthcare systems in emerging markets are increasingly adopting supportive regulatory frameworks and policies to encourage biosimilar adoption, further accelerating market growth. Additionally, local manufacturing initiatives and partnerships between global biosimilar developers and regional players are enhancing production capabilities and distribution networks. This expansion not only addresses unmet medical needs but also positions emerging markets as key growth drivers for the global biosimilars industry, offering immense potential for market penetration and improved patient outcomes.

Biosimilar Market Segment Insights

Biosimilar by Drug Class Insights

Based on Drug Class, this segment includes Monoclonal Antibodies (Adalimumab, Infliximab, Rituximab, Bevacizumab, Trastuzumab, Ustekinumab, Tocilizumab, Aflibercept, Dupilumab, Denosumab, Others), Insulin, Granulocyte Colony- stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Anticoagulants, Others. The Monoclonal Antibodies segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period. Monoclonal antibodies offer targeted treatment with improved efficacy and reduced side effects, increasing their adoption among healthcare providers. 

The segment's dominance is also supported by continuous innovations, expanding indications, and favorable reimbursement policies. Looking ahead, it is projected to be the fastest-growing segment due to a strong pipeline of biosimilars, rising healthcare expenditure, and increasing demand for personalized medicine. Additionally, advances in biotechnology and increasing approvals by regulatory agencies are expected to further boost the growth of this segment, solidifying its leadership position in the global drug market over the forecast period.

Biosimilar by Application Insights

Based on Application, this segment includes Oncology (Breast Cancer, Lung Cancer, Prostate Cancer, Leukemia, Bladder Cancer, Colorectal Cancer, Others), Autoimmune Diseases, Infectious Diseases, Blood Disorders, Others. The Oncology segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period. 

Based on Application, this segment includes Oncology (Breast Cancer, Lung Cancer, Prostate Cancer, Leukemia, Bladder Cancer, Colorectal Cancer, Others), Autoimmune Diseases, Infectious Diseases, Blood Disorders, Others. The Oncology segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period.

FIGURE 2: BIOSIMILAR MARKET SHARE BY APPLICATION 2024 AND 2035 (USD BILLION)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Biosimilar by Route of Administration Insights

Based on Route of Administration, this segment includes Subcutaneous and Intravenous. The Intravenous segment dominated the global market in 2024, while the Subcutaneous segment is projected to be the fastest–growing segment during the forecast period. The Intravenous (IV) segment dominated the global market based on route of administration, primarily due to its widespread use in hospitals and clinical settings for delivering biologics such as monoclonal antibodies, insulin, and growth factors. IV administration allows for rapid drug absorption and controlled dosing, making it the preferred method for critical and acute treatments, particularly in oncology and autoimmune diseases.

Biosimilar by Distribution Channel Insights

Based on Distribution Channel, this segment includes Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Specialty Pharmacies. The Hospital Pharmacies segment dominated the global market in 2024, while the Online Pharmacies segment is projected to be the fastest–growing segment during the forecast period. The Hospital Pharmacies segment dominated the global market based on distribution channel, driven by the high volume of biologics administered in clinical settings, particularly for critical conditions such as cancer, autoimmune disorders, and rare diseases. 

Hospital pharmacies play a central role in managing complex therapies that often require professional supervision, including intravenous biologics and specialty medications. Their integration with healthcare providers ensures accurate dosing, patient monitoring, and adherence to treatment protocols, contributing to their market leadership. However, the Online Pharmacies segment is projected to be the fastest growing during the forecast period, fueled by the rising adoption of digital health platforms, increasing internet penetration, and the growing preference for home delivery of prescription drugs.

Biosimilar Regional Insights

Based on the Region, the global Biosimilar are segmented into North America, Europe, Asia-Pacific, Rest of the World. The Europe dominated the global market in 2024, while the Asia-Pacific is projected to be the fastest–growing segment during the forecast period. Major demand factors driving the Europe market are the growing incidences of cancer and rare disorders and increasing launch of biosimilars and rising healthcare costs. The European Medicines Agency (EMA) has been at the forefront of biosimilar approvals, encouraging market penetration and physician confidence. Additionally, the rising healthcare costs across the region have pushed governments and healthcare systems to adopt cost-effective alternatives to branded biologics, further fueling biosimilar uptake. 

The presence of leading pharmaceutical companies and active initiatives to educate healthcare providers and patients have also supported market growth. However, the Asia-Pacific region is projected to be the fastest-growing during the forecast period due to expanding healthcare infrastructure, a large patient population, and increasing investments by domestic and international biopharma companies. Supportive regulatory reforms and growing awareness of affordable treatment options are expected to accelerate biosimilar adoption across emerging markets like India, China, and South Korea.

FIGURE 3: BIOSIMILAR MARKET VALUE BY REGION 2024 AND 2035 (USD BILLION)

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Further, the countries considered in the scope of the Application Tracking System Market are the US, Canada, Mexico, Germany, France, UK, Italy, Spain, China, India, Japan, Australia, South Korea, Middle East and Africa, South America and others.

Global Biosimilar Key Market Players & Competitive Insights

Many global, regional, and local vendors characterize the Biosimilar Market. The market is highly competitive, with all the players competing to gain market share. Intense competition, rapid advances in technology, frequent changes in government policies, and environmental regulations are key factors that confront market growth. The vendors compete based on cost, product quality, reliability, and government regulations. Vendors must provide cost-efficient, high-quality products to survive and succeed in an intensely competitive market.

The major competitors in the market are Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Samsung Bioepis, Amgen Inc., Pfizer Inc., Novartis AG, Biogen, Biocon, Dr. Reddy's Laboratories Ltd., Fresenius Kabi USA, LLC are among others. The Biosimilar Market is a consolidated market due to increasing competition, acquisitions, mergers and other strategic market developments and decisions to improve operational effectiveness.

Key Companies in the Biosimilar Market include

• Eli Lilly and Company


• Teva Pharmaceutical Industries Ltd.


• Samsung Bioepis


• Amgen Inc.


• Pfizer Inc.


• Novartis AG


• Biogen


• Biocon


• Reddy's Laboratories Ltd.


• Fresenius Kabi USA, LLC

Biosimilar Market Industry Developments

February 2025: Dr. Reddy’s Laboratories Ltd. has signed a license agreement with Shanghai Henlius Biotech, Inc. for the development and commercialization of HLX15, Henlius’s investigational daratumumab biosimilar candidate to Darzalex & Darzalex Faspro.

January 2024: Sandoz, a division of Novartis AG, has announced that its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) injection will be available in the United States starting July 1. Hyrimoz HCF (100 mg/mL) is approved to treat all indications for which the regulatory exclusivity of the reference medicine, Humira (adalimumab), has expired as of July 1, 2023. These include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and more.

May 2024: U.S. Food and Drug Administration (FDA) approved Amgen’s Bkemv, the first biosimilar to AstraZeneca’s rare blood disorder treatment, Soliris. Bkemv will be marketed under Amgen’s brand name as a close copy of the complex biological drug. The approval includes a black-box warning highlighting the risk of serious infections caused by the bacteria Neisseria meningitidis.

December 2023: Coya Therapeutics, Inc. and Dr. Reddy’s Laboratories have established an exclusive collaboration to develop and commercialize COYA 302, a combination therapy being investigated for the treatment of amyotrophic lateral sclerosis (ALS).

Biosimilar Market Segmentation

Biosimilar by Drug Class Outlook

• 
  Monoclonal Antibodies
  
  
  
  • Adalimumab
  
  
  • Infliximab
  
  
  • Rituximab
  
  
  • Bevacizumab
  
  
  • Trastuzumab
  
  
  • Ustekinumab
  
  
  • Tocilizumab
  
  
  • Aflibercept
  
  
  • Dupilumab
  
  
  • Denosumab
  
  
  • Others
  
  
  
  


• Insulin


• Granulocyte Colony- stimulating Factor


• Erythropoietin


• Recombinant Human Growth Hormone


• Etanercept


• Follitropin


• Teriparatide


• Anticoagulants


• Others

Biosimilar by Application Outlook

• 
  Oncology
  
  
  
  • Breast Cancer
  
  
  • Lung Cancer
  
  
  • Prostate Cancer
  
  
  • Leukemia
  
  
  • Bladder Cancer
  
  
  • Colorectal Cancer
  
  
  • Others
  
  
  
  


• Autoimmune Diseases


• Infectious Diseases


• Blood Disorders


• Others

Biosimilar by Route of Administration Outlook

• Subcutaneous


• Intravenous

Biosimilar by Distribution Channel Outlook

• Hospital Pharmacies


• Retail Pharmacies


• Online Pharmacies


• Specialty Pharmacies

Biosimilar Regional Outlook

• 
  North America
  
  
  
  • US
  
  
  • Canada
  
  
  • Mexico
  
  
  
  


• 
  Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• 
  Asia-Pacific
  
  
  
  • China
  
  
  • India
  
  
  • Japan
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• 
  Rest of the World
  
  
  
  • Middle East and Africa
  
  
  • South America
  
  
  
  

Report Attribute/Metric	Details
Market Size 2024	USD 32.73 Billion
Market Size 2025	USD 37.76 Billion
Market Size 2035	USD 134.83 Billion
Compound Annual Growth Rate (CAGR)	14.74% (2025-2035)
Base Year	2024
Forecast Period	2025-2035
Historical Data	2019-2023
Forecast Units	Value (USD Billion)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	By Drug Class, By Application, By Route of Administration, By Distribution Channel
Geographies Covered	North America, Europe, Asia Pacific, Rest of the World
Countries Covered	The US, Canada, Mexico, Germany, France, UK, Italy, Spain, China, India, Japan, Australia, South Korea, Middle East and Africa, South America
Key Companies Profiled	Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Samsung Bioepis, Amgen Inc., Pfizer Inc., Novartis AG, Biogen, Biocon, Dr. Reddy's Laboratories Ltd., Fresenius Kabi USA, LLC
Key Market Opportunities	·         Expansion in emerging markets ·         Partnerships and collaborations
Key Market Dynamics	·         Growing incidences of cancer and rare disorders ·         Increasing launch of biosimilars ·         Rising healthcare costs