United States Biosimilars Market Report and Forecast 2025-2034
Description
The United States biosimilars market was valued at USD 10.54 Billion in 2024, driven by the increasing number of patent expirations of biologics, which fuels biosimilar development and approvals, as well as the rising demand for cost-effective biologic therapies in chronic disease management in the region. The market is anticipated to grow at a CAGR of 13.90% during the forecast period of 2025-2034, with the values likely to reach USD 38.73 Billion by 2034. Rising FDA approvals and growing demand for affordable biologics support the market. Expansion in oncology and autoimmune therapies, along with improved reimbursement policies, will aid growth in the forecast period.
United States Biosimilars Market Overview
Biosimilars are biologic medical products that are highly like an already approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. They offer cost-effective alternatives and expand access to advanced therapies, particularly in oncology, immunology, and chronic disease treatment. The United States biosimilars market was valued at USD 10.54 Billion in 2024, driven by patent expirations of major biologics, increasing demand for affordable biologic therapies, and supportive regulatory pathways. Rising healthcare costs and the growing prevalence of chronic diseases further accelerate adoption. Continued investments, awareness, and favorable reimbursement policies are expected to boost market growth and competition in the coming years.
United States Biosimilars Market Growth Drivers
Rising Adoption of Biosimilars to Boost Market Value
The growing emphasis on affordable and clinically effective alternatives to original biologics is a major growth driver in the market. Interchangeable biosimilars, which allow for automatic substitution at the pharmacy level, enhance treatment accessibility and help lower healthcare expenditures. A notable example is the June 2025 launch of WYOST® and Jubbonti® by Sandoz, the first FDA-approved interchangeable biosimilars to denosumab. These products offer new, cost-effective options for millions of patients suffering from osteoporosis and cancer-related skeletal complications. Such advancements are set to accelerate adoption and support the sustained growth of the biosimilars market in the United States.
United States Biosimilars Market Trends
The market is experiencing key trends such as FDA approvals boosting the oncology segment and advancements in real-world evidence.
Rising FDA Approvals for Biosimilars to Boost Market Value
A prominent trend in the market is the growing number of FDA approvals for oncology-related biosimilars, which is significantly enhancing treatment accessibility and encouraging healthy market competition. In April 2025, Biocon Biologics announced the U.S. FDA approval of Jobevne™ (bevacizumab-nwgd), a biosimilar to Avastin®, indicated for various cancer types. This approval marks Biocon’s seventh biosimilar entry in the U.S. and further solidifies its presence in the oncology space. The introduction of high-quality, cost-effective biologics is expected to improve patient outcomes and expand therapeutic options, thereby accelerating the growth of the biosimilars market in the United States.
Increasing Integration of Advanced Tools to Facilitate Improved Products Boosting the United States Biosimilars Market Demand
The biosimilars market in the United States is progressively adopting the use of real-world data and sophisticated analytical tools to accelerate the development and approval of biosimilar products. This growing emphasis on generating reliable real-world evidence is helping to address key challenges in biosimilar interchangeability and safety assessments. For instance, in October 2022, the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) was awarded a USD 1.3 million grant by the U.S. Food and Drug Administration (FDA) to support research focused on leveraging real-world data to enhance regulatory decision-making for biosimilars. These advancements in regulatory science and evidence generation are expected to foster innovation, increase market acceptance, and significantly boost the growth trajectory of the U.S. biosimilars market in the coming years.
United States Biosimilars Market Segmentation
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Drug Class
Oncology Biosimilars Expected to Lead the United States Market by Indication
The market, based on indication, is segmented into oncology, inflammatory and autoimmune disorders, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications. Among these, oncology is expected to lead the market owing to the rising incidence of cancer and the growing need for affordable treatment options. According to the American Cancer Society, in 2025, over 2 million new cancer cases with more than 600,000 cancer deaths are estimated to occur in the United States. This high disease burden has increased the demand for biosimilar therapies in oncology, which offer cost-effective alternatives to expensive biologics. Furthermore, patent expirations of blockbuster oncology biologics and a favorable regulatory environment are likely to strengthen the dominance of the oncology segment in the market.
United States Biosimilars Market Analysis by Region
The biosimilars market in the United States covers several key regions, including New England, Mideast, Great Lakes, Plains, Southeast, Southwest, Rocky Mountain, and Far West. Among these, the Mideast and Great Lakes regions are projected to lead the market. This dominance can be attributed to the strong presence of established biopharmaceutical manufacturers, cutting-edge research institutions, extensive healthcare infrastructure, and proactive regulatory frameworks. These regions also benefit from significant investment in biotechnology, a skilled workforce, and growing demand for cost-effective biologic alternatives, all of which contribute to the increased development, approval, and adoption of biosimilars.
Leading Players in the United States Biosimilars Market
The key features of the market report comprise patent analysis, clinical trial analysis, grant analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Pfizer Inc.
Pfizer Inc., established in 1849 and headquartered in New York City, is a prominent leader in the global market. With years of dedicated experience, Pfizer has developed an extensive portfolio of biosimilar products aimed at providing affordable, safe, and effective alternatives to original biologic therapies. The company plays a significant role in the United States biosimilars market by promoting wider adoption to enhance patient access, improve healthcare outcomes, and generate substantial cost savings for the healthcare system.
Eli Lilly and Company
Eli Lilly and Company, established in 1876 and headquartered in Indianapolis, Indiana, is a prominent leader in the biosimilars market. In March 2023, the company introduced Rezvoglar™, a biosimilar basal insulin offered at a substantially reduced price to enhance affordability for patients in the United States. In addition to this, Lilly has implemented aggressive price reductions on its insulin products and expanded patient assistance programs that cap out-of-pocket costs. These initiatives underscore Lilly’s significant commitment to improving access and affordability within the United States biosimilars market, supporting better health outcomes for individuals with diabetes.
Bristol Myers Squibb Company
Founded in 1887, Bristol Myers Squibb is a leading global biopharmaceutical company. It plays a significant role in the biosimilars market. In June 2025, it collaborated with BioNTech to co-develop and co-commercialize BNT327, an innovative next-generation bispecific antibody candidate. This therapy targets multiple solid tumors and aims to transform immuno-oncology treatment by combining two validated mechanisms into one molecule. The partnership leverages both companies’ expertise to accelerate clinical development and expand potential indications, reinforcing Bristol Myers Squibb’s commitment to advancing cutting-edge cancer therapies.
Bioventus LLC
Bioventus LLC, established in 2012 and headquartered in Durham, North Carolina, specializes in active orthopedic healing solutions. The company offers key products such as the EXOGEN ultrasound bone healing system and SUPARTZ hyaluronic acid therapy for knee osteoarthritis, primarily marketed in the United States. Bioventus plays a significant role in the US biosimilars and orthopedic biologics market by providing innovative therapies that support bone healing and pain relief.
Other key players in the market include Sanofi S.A., Assertio Holdings Inc., Pacira Biosciences Inc., and Bayer AG.
Key Questions Answered in the United States Biosimilars Market Report
United States Biosimilars Market Overview
Biosimilars are biologic medical products that are highly like an already approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. They offer cost-effective alternatives and expand access to advanced therapies, particularly in oncology, immunology, and chronic disease treatment. The United States biosimilars market was valued at USD 10.54 Billion in 2024, driven by patent expirations of major biologics, increasing demand for affordable biologic therapies, and supportive regulatory pathways. Rising healthcare costs and the growing prevalence of chronic diseases further accelerate adoption. Continued investments, awareness, and favorable reimbursement policies are expected to boost market growth and competition in the coming years.
United States Biosimilars Market Growth Drivers
Rising Adoption of Biosimilars to Boost Market Value
The growing emphasis on affordable and clinically effective alternatives to original biologics is a major growth driver in the market. Interchangeable biosimilars, which allow for automatic substitution at the pharmacy level, enhance treatment accessibility and help lower healthcare expenditures. A notable example is the June 2025 launch of WYOST® and Jubbonti® by Sandoz, the first FDA-approved interchangeable biosimilars to denosumab. These products offer new, cost-effective options for millions of patients suffering from osteoporosis and cancer-related skeletal complications. Such advancements are set to accelerate adoption and support the sustained growth of the biosimilars market in the United States.
United States Biosimilars Market Trends
The market is experiencing key trends such as FDA approvals boosting the oncology segment and advancements in real-world evidence.
Rising FDA Approvals for Biosimilars to Boost Market Value
A prominent trend in the market is the growing number of FDA approvals for oncology-related biosimilars, which is significantly enhancing treatment accessibility and encouraging healthy market competition. In April 2025, Biocon Biologics announced the U.S. FDA approval of Jobevne™ (bevacizumab-nwgd), a biosimilar to Avastin®, indicated for various cancer types. This approval marks Biocon’s seventh biosimilar entry in the U.S. and further solidifies its presence in the oncology space. The introduction of high-quality, cost-effective biologics is expected to improve patient outcomes and expand therapeutic options, thereby accelerating the growth of the biosimilars market in the United States.
Increasing Integration of Advanced Tools to Facilitate Improved Products Boosting the United States Biosimilars Market Demand
The biosimilars market in the United States is progressively adopting the use of real-world data and sophisticated analytical tools to accelerate the development and approval of biosimilar products. This growing emphasis on generating reliable real-world evidence is helping to address key challenges in biosimilar interchangeability and safety assessments. For instance, in October 2022, the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) was awarded a USD 1.3 million grant by the U.S. Food and Drug Administration (FDA) to support research focused on leveraging real-world data to enhance regulatory decision-making for biosimilars. These advancements in regulatory science and evidence generation are expected to foster innovation, increase market acceptance, and significantly boost the growth trajectory of the U.S. biosimilars market in the coming years.
United States Biosimilars Market Segmentation
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Drug Class
- Monoclonal Antibodies
- Infliximab
- Trastuzumab
- Rituximab
- Adalimumab
- Other monoclonal antibodies
- Insulin
- Granulocyte Colony-Stimulating Factor
- Erythropoietin
- Recombinant Human Growth Hormone
- Etanercept
- Follitropin
- Teriparatide
- Interferons
- Anticoagulants
- Other Drug Class
- Oncology
- Inflammatory & Autoimmune Disorders
- Chronic Diseases
- Blood Disorders
- Growth Hormone Deficiency
- Infectious Diseases
- Other Indications
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
- Others
- New England
- Mideast
- Great Lakes
- Plains
- Southeast
- Southwest
- Rocky Mountain
- Far West
Oncology Biosimilars Expected to Lead the United States Market by Indication
The market, based on indication, is segmented into oncology, inflammatory and autoimmune disorders, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications. Among these, oncology is expected to lead the market owing to the rising incidence of cancer and the growing need for affordable treatment options. According to the American Cancer Society, in 2025, over 2 million new cancer cases with more than 600,000 cancer deaths are estimated to occur in the United States. This high disease burden has increased the demand for biosimilar therapies in oncology, which offer cost-effective alternatives to expensive biologics. Furthermore, patent expirations of blockbuster oncology biologics and a favorable regulatory environment are likely to strengthen the dominance of the oncology segment in the market.
United States Biosimilars Market Analysis by Region
The biosimilars market in the United States covers several key regions, including New England, Mideast, Great Lakes, Plains, Southeast, Southwest, Rocky Mountain, and Far West. Among these, the Mideast and Great Lakes regions are projected to lead the market. This dominance can be attributed to the strong presence of established biopharmaceutical manufacturers, cutting-edge research institutions, extensive healthcare infrastructure, and proactive regulatory frameworks. These regions also benefit from significant investment in biotechnology, a skilled workforce, and growing demand for cost-effective biologic alternatives, all of which contribute to the increased development, approval, and adoption of biosimilars.
Leading Players in the United States Biosimilars Market
The key features of the market report comprise patent analysis, clinical trial analysis, grant analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Pfizer Inc.
Pfizer Inc., established in 1849 and headquartered in New York City, is a prominent leader in the global market. With years of dedicated experience, Pfizer has developed an extensive portfolio of biosimilar products aimed at providing affordable, safe, and effective alternatives to original biologic therapies. The company plays a significant role in the United States biosimilars market by promoting wider adoption to enhance patient access, improve healthcare outcomes, and generate substantial cost savings for the healthcare system.
Eli Lilly and Company
Eli Lilly and Company, established in 1876 and headquartered in Indianapolis, Indiana, is a prominent leader in the biosimilars market. In March 2023, the company introduced Rezvoglar™, a biosimilar basal insulin offered at a substantially reduced price to enhance affordability for patients in the United States. In addition to this, Lilly has implemented aggressive price reductions on its insulin products and expanded patient assistance programs that cap out-of-pocket costs. These initiatives underscore Lilly’s significant commitment to improving access and affordability within the United States biosimilars market, supporting better health outcomes for individuals with diabetes.
Bristol Myers Squibb Company
Founded in 1887, Bristol Myers Squibb is a leading global biopharmaceutical company. It plays a significant role in the biosimilars market. In June 2025, it collaborated with BioNTech to co-develop and co-commercialize BNT327, an innovative next-generation bispecific antibody candidate. This therapy targets multiple solid tumors and aims to transform immuno-oncology treatment by combining two validated mechanisms into one molecule. The partnership leverages both companies’ expertise to accelerate clinical development and expand potential indications, reinforcing Bristol Myers Squibb’s commitment to advancing cutting-edge cancer therapies.
Bioventus LLC
Bioventus LLC, established in 2012 and headquartered in Durham, North Carolina, specializes in active orthopedic healing solutions. The company offers key products such as the EXOGEN ultrasound bone healing system and SUPARTZ hyaluronic acid therapy for knee osteoarthritis, primarily marketed in the United States. Bioventus plays a significant role in the US biosimilars and orthopedic biologics market by providing innovative therapies that support bone healing and pain relief.
Other key players in the market include Sanofi S.A., Assertio Holdings Inc., Pacira Biosciences Inc., and Bayer AG.
Key Questions Answered in the United States Biosimilars Market Report
- What was the United States biosimilars market value in 2024?
- What is the United States biosimilars market forecast outlook for 2025-2034?
- What major factors aid the demand for the United States biosimilars market?
- How has the market performed so far, and how is it anticipated to perform in the coming years?
- What are the market's major drivers, opportunities, and restraints?
- What are the major market trends in the United States biosimilars?
- Which drug class is expected to dominate the market segment?
- Which indication is projected to lead the market segment?
- Which distribution channel is likely to dominate the market segment?
- Who are the key players in the United States biosimilars market?
- What are the current unmet needs and challenges in the market?
- How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?
Table of Contents
250 Pages
- 1 Preface
- 1.1 Objectives of the Study
- 1.2 Key Assumptions
- 1.3 Report Coverage – Key Segmentation and Scope
- 1.4 Research Methodology
- 2 Executive Summary
- 3 Biosimilars Market Overview
- 3.1 North America Biosimilars Market
- 3.1.1 North America Biosimilars Market Historical Value (2018-2024)
- 3.1.2 North America Biosimilars Market Forecast Value (2025-2034)
- 3.2 United States Biosimilars Market
- 3.2.1 United States Biosimilars Market Historical Value (2018-2024)
- 3.2.2 United States Biosimilars Market Forecast Value (2025-2034)
- 4 Vendor Positioning Analysis
- 4.1 Key Vendors
- 4.2 Prospective Leaders
- 4.3 Niche Leaders
- 4.4 Disruptors
- 5 United States Biosimilars Market Landscape
- 5.1 United States Biosimilars Market: Developers Landscape
- 5.1.1 Analysis by Year of Establishment
- 5.1.2 Analysis by Company Size
- 5.1.3 Analysis by Region
- 5.2 United States Biosimilars Market: Product Landscape
- 5.2.1 Analysis By Drug Class
- 5.2.2 Analysis By Indication
- 6 United Biosimilars Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 6.2.1 Strengths
- 6.2.2 Weaknesses
- 6.2.3 Opportunities
- 6.2.4 Threats
- 6.3 PESTEL Analysis
- 6.3.1 Political
- 6.3.2 Economic
- 6.3.3 Social
- 6.3.4 Technological
- 6.3.5 Legal
- 6.3.6 Environment
- 6.4 Porter’s Five Forces Model
- 6.4.1 Bargaining Power of Suppliers
- 6.4.2 Bargaining Power of Buyers
- 6.4.3 Threat of New Entrants
- 6.4.4 Threat of Substitutes
- 6.4.5 Degree of Rivalry
- 6.5 Key Demand Indicators
- 6.6 Key Price Indicators
- 6.7 Industry Events, Initiatives, and Trends
- 6.8 Value Chain Analysis
- 7 United States Biosimilars Market Segmentation (218-2034)
- 7.1 United States Biosimilar Market (2018-2034) by Drug Class
- 7.1.1 Market Overview
- 7.1.2 Monoclonal Antibodies
- 7.1.2.1 Infliximab
- 7.1.2.2 Trastuzumab
- 7.1.2.3 Rituximab
- 7.1.2.4 Adalimumab
- 7.1.2.5 Other monoclonal antibodies
- 7.1.3 Insulin
- 7.1.4 Granulocyte Colony-Stimulating Factor
- 7.1.5 Erythropoietin
- 7.1.6 Recombinant Human Growth Hormone
- 7.1.7 Etanercept
- 7.1.8 Follitropin
- 7.1.9 Teriparatide
- 7.1.10 Interferons
- 7.1.11 Anticoagulants
- 7.1.12 Other Drug Class
- 7.2 United States Biosimilar Market (2018-2034) by Indication
- 7.2.1 Market Overview
- 7.2.2 Oncology
- 7.2.3 Inflammatory & Autoimmune Disorders
- 7.2.4 Chronic Diseases
- 7.2.5 Blood Disorders
- 7.2.6 Growth Hormone Deficiency
- 7.2.7 Infectious Diseases
- 7.2.8 Other Indications
- 7.3 United States Biosimilars Market (2018-2034) by Distribution Channel
- 7.3.1 Market Overview
- 7.3.2 Hospital Pharmacies
- 7.3.3 Retail Pharmacies
- 7.3.4 Online Pharmacies
- 7.3.5 Others
- 7.4 United States Biosimilars Market (2018-2034) by Region
- 7.4.1 Market Overview
- 7.4.2 New England
- 7.4.3 Mideast
- 7.4.4 Great Lakes
- 7.4.5 Plains
- 7.4.6 Southeast
- 7.4.7 Southwest
- 7.4.8 Rocky Mountain
- 7.4.9 Far West
- 8 Regulatory Framework
- 9 Patent Analysis
- 9.1 Analysis by Technology
- 9.2 Analysis by Publication Year
- 9.3 Analysis by Issuing Authority
- 9.4 Analysis by Patent Age
- 9.5 Analysis by CPC Codes
- 9.6 Analysis by Patent Valuation
- 10 Clinical Trials Analysis
- 10.1 Analysis by Trial Registration Year
- 10.2 Analysis by Trial Status
- 10.3 Analysis by Trial Phase
- 10.4 Analysis by Therapeutic Area
- 10.5 Analysis by Geography
- 11 Grants Analysis
- 11.1 Analysis by Year
- 11.2 Analysis by Amount Awarded
- 11.3 Analysis by Issuing Authority
- 11.4 Analysis by Grant Application
- 11.5 Analysis by Funding Institute
- 11.6 Analysis by NIH Departments
- 11.7 Analysis by Recipient Organization
- 12 Funding and Investment Analysis
- 12.1 Analysis by Funding Instances
- 12.2 Analysis by Type of Funding
- 12.3 Analysis by Funding Amount
- 12.4 Analysis by Leading Players
- 12.5 Analysis by Leading Investors
- 12.6 Analysis by Geography
- 13 Strategic Initiatives
- 13.1 Analysis by Partnership Instances
- 13.2 Analysis by Type of Initiatives
- 13.3 Analysis by Leading Players
- 13.4 Analysis by Geography
- 14 Supplier Landscape
- 14.1 Market Share Analysis, By Country (Top 5 Companies)
- 14.2 Sanofi S.A.
- 14.2.1 Financial Analysis
- 14.2.2 Product Portfolio
- 14.2.3 Demographic Reach and Achievements
- 14.2.4 Company News and Developments
- 14.2.5 Certifications
- 14.3 Bayer AG
- 14.3.1 Financial Analysis
- 14.3.2 Product Portfolio
- 14.3.3 Demographic Reach and Achievements
- 14.3.4 Company News and Developments
- 14.3.5 Certifications
- 14.4 Pfizer Inc.
- 14.4.1 Financial Analysis
- 14.4.2 Product Portfolio
- 14.4.3 Demographic Reach and Achievements
- 14.4.4 Company News and Developments
- 14.4.5 Certifications
- 14.5 Eli Lilly and Company
- 14.5.1 Financial Analysis
- 14.5.2 Product Portfolio
- 14.5.3 Demographic Reach and Achievements
- 14.5.4 Company News and Developments
- 14.5.5 Certifications
- 14.6 Bristol Myers Squibb Company
- 14.6.1 Financial Analysis
- 14.6.2 Product Portfolio
- 14.6.3 Demographic Reach and Achievements
- 14.6.4 Company News and Developments
- 14.6.5 Certifications
- 14.7 Assertio Holdings Inc.
- 14.7.1 Financial Analysis
- 14.7.2 Product Portfolio
- 14.7.3 Demographic Reach and Achievements
- 14.7.4 Company News and Developments
- 14.7.5 Certifications
- 14.8 Pacira Biosciences Inc.
- 14.8.1 Financial Analysis
- 14.8.2 Product Portfolio
- 14.8.3 Demographic Reach and Achievements
- 14.8.4 Company News and Developments
- 14.8.5 Certifications
- 14.9 Bioventus LLC
- 14.9.1 Financial Analysis
- 14.9.2 Product Portfolio
- 14.9.3 Demographic Reach and Achievements
- 14.9.4 Company News and Developments
- 14.9.5 Certifications
- 15 Biosimilars Market - Distribution Model (Additional Insight)
- 15.1 Overview
- 15.2 Potential Distributors
- 15.3 Key Parameters for Distribution Partner Assessment
- 16 Key Opinion Leaders (KOL) Insights (Additional Insight)
- 17 Payment Methods (Additional Insight)
- 17.1 Government Funded
- 17.2 Private Insurance
- 17.3 Out-of-Pocket
Pricing
Currency Rates
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