he adoption of biosimilars for cancer and autoimmune conditions, favorable regulatory policies, technological advancements in biomanufacturing, and improved healthcare reach in developing regions are accelerating the global biosimilar market growth trajectory. That market is projected to experience significant growth in the coming years, driven by factors such as patent expirations, more cost-effective therapies, and expanding biologics accessibility. Today, the pharmaceutical industry is at a turning point: the wave of biologic drug patent expirations is creating an unprecedented landscape—a “golden era”—for biosimilars.

What is a Biosimilar?

In the US, a biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved reference product. Biologics, or biological products, are large, complex molecules—often proteins—derived from living organisms like bacteria or mammalian cells.

Key Growth Drivers of the Global Biosimilar Market

Recent analyses indicate that the global biosimilar market size was USD 46.30 billion in 2025, will rise to USD 51.93 billion in 2026, USD 58.25 billion in 2027, and ultimately grow to USD 145.83 billion by 2035. This robust expansion reflects a CAGR forecast of 12.16% from 2026 to 2035, and an even more expansive CAGR of 13.8% from 2026 to 2032.

• Increasing patent expirations of blockbuster biologics are opening the market to biosimilar competition.
• Rising prevalence of chronic and autoimmune diseases is boosting demand for cost-effective biologic alternatives, and the successful use of biosimilars is simultaneously increasing clinician and patient confidence in them.

Global Biosimilar Trends

Key Approved Biosimilars by Drug Class or Modality

FDA has approved 90 biosimilars within the product classes of 1) insulin; 2) granulocyte colony-stimulating factor; 3) monoclonal antibodies; 4) tumor necrosis factor-alpha (TNF-α); and 5) vascular endothelial growth factor (VEGF) inhibitor. Monoclonal antibodies dominated 2025 with a 32.4% biosimilars market share and accounted for the largest revenue share.

EMA has recommended the approval of 144 biosimilars within the product classes of 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis stimulating agent; 4) insulin; 5) follicle-stimulating hormone (FSH); 6) parathyroid hormone; 7) tumor necrosis factor (TNF)-inhibitor; 8) vascular endothelial growth factor (VEGF) inhibitor; and 9) monoclonal antibody. Here, the targeted therapeutic precision of monoclonal antibodies also leads in market share.

Biosimilars Market Growth by Indication

The growth of the biosimilars market is primarily driven by three core therapeutic areas: oncology, immunology, and diabetes, which accounted for more than 70% of the innovative biologic market in 2024. Oncology applications led with 54.30% of 2025 revenue, whereas autoimmune and chronic inflammatory indications grew the quickest from 2024 to 2025 at a 22.10% CAGR.

Biosimilar Market Growth by Region

The Global Biosimilars Market Share, by Country (2025) report explicitly states that North America leads the global biosimilars market with a 42.06% share in 2025, followed by Europe at 33.31% and Asia Pacific (APAC) at 16.48%, while the Middle East & Africa (MEA) and South America account for 5.01% and 3.13%, respectively. Forecasts predict that North America will remain the largest market by value and Europe will see steady growth, whereas APAC is the fastest-growing region, followed by Latin America and MEA.

Patent Cliff Driving Biosimilar Growth, Especially in the US Market

In the world of pharmaceuticals, patents matter. They grant drugmakers exclusive rights to sell a medicine for a defined period, allowing companies to recover massive research and development costs and, in many cases, generate profits to fund future innovation. When patents expire, the competitive landscape shifts dramatically as cheaper generics or biosimilars enter, prices drop, and brand revenues typically fall sharply.

Small-molecule drugs typically lose 90% of their market share within months of patent expiration; due to more complex production and slower adoption, market share for biologics declines by 30% to 70% in that first year.

What is the patent cliff?

Patent cliff refers to a sharp decline in revenue or profitability when a firm’s patents expire, opening these original products up to competition from biosimilars, and opening the door to less costly, more accessible and sustainable treatments for healthcare systems worldwide.

• An IQVIA report found that between 2025 and 2034, 118 biologic medicines will lose patent protection, representing a $232 billion opportunity for biosimilar competition.
• DrugPatentWatch noted: “Industry-wide analyses project that between 2025 and 2030, nearly 70 high-revenue products will face patent expiration, putting a colossal $236 billion in annual revenue at risk.” Unlike the patent cliffs of the early 2010s, which primarily affected primary care small molecules, this cliff targets complex biologics and specialized therapies.

The period between 2025 and 2030, the patent cliff for the biopharma industry, is critical: A massive wave of exclusivity losses for blockbuster biologic drugs, often termed “Patent Cliff 2.0,” as it targets the industry’s most sophisticated biologic assets and specialized therapies. Between 2025 and 2030, $300 billion in pharmaceutical revenue (one-sixth of the industry) will lose patent exclusivity.

Unlike the previous patent cliff in 2008, this period features a higher proportion of biologics, which face slower but substantial erosion from biosimilars. This shift is being accelerated by streamlined regulatory approvals from both the FDA and EMA, creating a more challenging landscape for established pharmaceutical companies.

While this presents substantial revenue challenges for originator companies, it simultaneously heralds a new era of increased patient access and significant cost savings for healthcare systems globally thanks to the introduction of biosimilars.

Blockbuster Biologics Losing Exclusivity: Focus on US Market

Conclusion

The pharmaceutical industry is entering what analysts describe as a “super-cliff.” Between 2026 and 2030, a cluster of mega-blockbuster drugs will lose market exclusivity.

The “patent cliff” for biologics fundamentally shifts the roles and incentives for all healthcare stakeholders by introducing competition through biosimilars. This will redefine the next decade by expanding affordability and access:

• Financial relief to patients: The HHS 2025 fact sheet reports that the typical biosimilar launch price is 50% less than the reference brand biologic’s price; this 2026 study states that biosimilars typically cost 40% less than the reference biologics. Biosimilars generated more than $56 billion in US healthcare savings since their introduction, with continued growth expected as additional biologics lose exclusivity.
• Total Patient Therapy and Expanded Patient Access: “Total Patient Therapy,” often cited as “patient days of therapy,” refers to the cumulative increased volume of treatment days provided to patients, whereas “Expanded Patient Access,” or “incremental patient days,” refers specifically to the increase in the number of patients receiving care, as explained with data in this Association for Accessible Medicines (AAM) report.

In March 2015, FDA issued its landmark decision approving the first biosimilar, to the reference product filgrastim to support white blood cell creation for patients with cancer receiving chemotherapy and radiation.

This biosimilar was approved for all five indications included in the reference product label: patients receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving chemotherapy, patients with cancer undergoing bone marrow transplantation, patients receiving autologous peripheral blood progenitor cell collection and therapy, and patients with neutropenia.

Since this first biosimilar entry, total savings from biosimilars in the US was $12.4 billion in 2023 (AAM 2024 report), increased to $20.2 billion in 2024, and $56.2 billion in total, per the 2025 US Generic & Biosimilar Medicines Savings Report. Since 2015, cumulative “patient days of therapy” has grown to 3.3 billion, with 460 million “incremental days of patent therapy” in the 2025 report.

The growing adoption of biosimilars can be significantly accelerated by the upcoming patent cliff, but realizing this potential will require timely policy action. Policymakers can help unlock broader use of biosimilars by removing unnecessary regulatory barriers and addressing key challenges such as patent thickets and litigation, IRA (Inflation Reduction Act) price controls, and adoption barriers associated with the pharmacy benefit manager (PBM) system. Uptake can be further strengthened by promoting appropriate education and strengthening confidence in biosimilars among patients, providers, and payers.