United States Biosimilars Market: Size, Future, Growth, Trends - PriyaMND/marketsresearch GitHub Wiki
United States biosimilars market is projected to witness a CAGR of 15% during the forecast period 2025–2032, growing from USD 9.52 billion in 2024 to USD 29.12 billion in 2032. The U.S. biosimilars market is being propelled by rising healthcare costs and demand for affordable treatment options, especially in oncology and chronic conditions. Regulatory reforms such as interchangeability designations and automatic substitution laws are accelerating biosimilar uptake. Simultaneously, expanding product pipelines and strategic initiatives by key players strengthen market presence and patient access.
Report Attributes
Details
Base Year
2024
Forecast Period
2025–2032F
Historical Period
2018–2023
Projected Growth Rate
CAGR of 15% between 2025 and 2032
Revenue Forecast in 2032
USD 29.12 billion
Increasing Healthcare Cost Burden Driving Demand for Cost-Effective Biosimilars The increasing expenses associated with biologic therapies in the United States have heightened the need for more cost-effective biosimilars. As the healthcare system faces challenges from the prevalence of chronic diseases, an aging population, and inflationary pressures, biosimilars present a viable alternative that maintains efficacy while being more affordable. Typically, biosimilars are introduced to the market at prices 15–35% lower than their reference biologics, which significantly alleviates treatment costs for both patients and healthcare providers. Their adoption is especially prominent in high-cost therapeutic fields such as oncology and autoimmune diseases. Additionally, the growing emphasis on value-based care by payers and the strategic placement of biosimilars in formularies are further promoting their use. Government initiatives, including the Biologics Price Competition and Innovation Act (BPCIA), continue to facilitate quicker approvals and enhance market competition. In December 2023, Pfizer reported a 43% year-over-year growth in its biosimilars portfolio in the U.S., largely driven by oncology biosimilars like ZIRABEV and NYVEPRIA. This momentum underscores how healthcare systems and providers are embracing biosimilars to enhance access, reduce drug expenditure, and improve long-term sustainability.
Expanding Oncology Indications Accelerating Market Penetration
Biosimilars are rapidly gaining popularity in oncology, a crucial sector of the U.S. pharmaceutical industry. The expiration of patents for several leading monoclonal antibodies (mAbs), including trastuzumab, rituximab, and bevacizumab, has created significant opportunities for biosimilar producers. Given that oncology treatment regimens are generally long-term and costly, they represent an ideal candidate for biosimilar replacement. The acceptance of biosimilars in clinical settings has grown as oncologists become more assured of their safety and efficacy, supported by real-world data and endorsements from the FDA. Furthermore, healthcare systems and cancer treatment centers are promoting the use of biosimilars by incorporating them into their formularies and treatment guidelines. For instance, in October 2024, Teva Pharmaceuticals and mAbxience announced an expanded collaboration agreement for the development of an anti-PD1 oncology biosimilar candidate. These advancements highlight the strategic importance of oncology in shaping biosimilar growth. The continuous pipeline of new biosimilars targeting oncologic indications is expected to further strengthen this trend, creating a ripple effect across other specialty therapeutic areas.
Supportive Regulatory Reforms and Regional Initiatives Boosting Market Expansion The U.S. FDA has optimized the biosimilar approval process through the BPCIA, creating a more advantageous regulatory landscape for biosimilar developers. These modifications have led to shorter approval periods, enhanced interchangeability designations, and heightened trust among prescribers. On a regional level, states are enacting automatic substitution laws that permit pharmacists to replace interchangeable biosimilars without needing physician consent, thereby further promoting adoption. Additionally, the FDA’s educational initiatives, including the ‘Biosimilars Action Plan,’ are significantly contributing to the enhancement of awareness among providers and patients. On April 14, 2025, Celltrion declared that the FDA has granted its adalimumab-aaty (marketed as YUFLYMA) an interchangeable designation. This biosimilar is based on adalimumab (known as Humira). The FDA has approved adalimumab-aaty as a high-concentration (100mg/mL) and citrate-free formulation of the reference biologic adalimumab for the treatment of various inflammatory conditions. Regional expansion is notably apparent in states with significant Medicaid participation, where biosimilars are regarded as a cost-effective alternative. With increasing regulatory backing, it is anticipated that biosimilar manufacturers will gain enhanced market access, higher adoption rates, and diminished resistance to pricing.
Future Market Scenario (2025–2032F)
The U.S. biosimilars market is set for substantial expansion in the coming decade, fueled by the expiration of patents for major biologics, rising demands to lower healthcare expenses, and supportive regulatory changes that facilitate biosimilar approvals and their interchangeability. The growing range of therapeutic uses for biosimilars in fields such as oncology, autoimmune disorders, and endocrinology will further enhance demand. As healthcare providers and payers gain greater confidence in the safety and effectiveness of biosimilars, a wider acceptance in various healthcare environments, including hospitals, cancer treatment centers, and specialized clinics — is anticipated. Moreover, increased investments from leading pharmaceutical firms and greater patient awareness will enhance market penetration. By the year 2030, the biosimilars market is expected to play a pivotal role in transforming specialty drug pricing and improving access to essential therapies for patients in the United States.
Report Scope
“Biosimilars Market Assessment, Opportunities and Forecast, 2018–2032F”, is a comprehensive report by Markets and Data, providing in-depth analysis and qualitative and quantitative assessment of the current state of United States biosimilars market, industry dynamics, and challenges. The report includes market size, segmental shares, growth trends, opportunities, and forecast between 2025 and 2032. Additionally, the report profiles the leading players in the industry, mentioning their respective market share, business models, competitive intelligence, etc.
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