The United States biosimilars market was valued at USD 12.01 Billion in 2025, 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 2026-2035, with the values likely to reach USD 44.13 Billion by 2035. 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.
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An estimated 38.4 million people in the United States had diabetes in 2021, significantly increasing the demand for affordable treatments. This growing diabetic population is driving biosimilar adoption, thereby fueling market growth.
In May 2025, the FDA granted full interchangeable biosimilars to HADLIMA™ (adalimumab-bwwd), enabling pharmacy-level substitution for Humira. This is expected to boost biosimilar adoption and significantly drive market growth through enhanced access and cost savings.
The FDA’s approval of new biosimilars like Starjemza and Hadlima, is expanding affordable treatment options in the United States, driving the United States biosimilars market growth.
Compound Annual Growth Rate
13.9%
Value in USD Billion
2026-2035
*this image is indicative*
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 12.01 Billion in 2025, 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.
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.
The market is experiencing key trends such as FDA approvals boosting the oncology segment and advancements in real-world evidence.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Drug Class
Market Breakup by Indication
Market Breakup by Distribution Channel
Market Breakup by Region
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.
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.
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., 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, 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.
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, 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.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include Sanofi S.A., Assertio Holdings Inc., Pacira Biosciences Inc., and Bayer AG.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Drug Class |
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| Breakup by Indication |
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| Breakup by Distribution Channel |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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