Biosimilars Market to Reach USD 73.24 Billion by 2036 at 6.9% CAGR as Patent Expiries and Faster Approval Pathways Reshape Biologics Pricing

A new wave of biologic patent expiries, combined with regulators cutting the cost of biosimilar development, is setting up the next decade of growth for lower-cost biologics. According to a new report from Polaris Market Research, the global biosimilars market was valued at USD 35.22 billion in 2025. It is estimated at USD 37.54 billion in 2026 and is projected to reach USD 73.24 billion by 2036, growing at a CAGR of 6.9% from 2026 to 2036.

What Are the Key Findings of the Biosimilars Market Report?

• Market size in 2025: USD 35.22 billion
• Projected value by 2036: USD 73.24 billion
• CAGR from 2026 to 2036: 6.9%
• Largest region: North America, with a 34.68% share in 2025
• Fastest-growing region: Asia Pacific, at an 8.47% CAGR
• Leading drug class: monoclonal antibodies, with a 46.18% share
• Leading therapeutic area: oncology, with a 38.64% share and an 8.36% CAGR

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What Are Biosimilars?

Biosimilars are biologic medicines shown to be highly similar to an approved reference biologic, with no clinically meaningful differences in safety, purity or potency. In the United States, they are approved under the 351(k) pathway of the Biologics Price Competition and Innovation Act (BPCIA). Because they compete with some of the most expensive drugs on the market, biosimilars have become one of the main tools health systems use to control biologics spending.

Why Is the Biosimilars Market Growing?

The biggest driver is a fresh round of patent expiries on high-revenue biologics. The pipeline is now moving beyond adalimumab and older oncology drugs toward blockbusters such as pembrolizumab, nivolumab, omalizumab, ocrelizumab and high-dose aflibercept. Keytruda alone made up 49% of Merck's 2025 sales, and Merck expects biosimilar competition as early as December 2028. PD-1 inhibitors have become the center of development activity, with Samsung Bioepis, Formycon and Amgen all advancing pembrolizumab candidates.

Interchangeability is the second driver. A product designated as interchangeable can be substituted at the pharmacy without a new prescription, where state law allows. As of January 2026, 25 of 90 FDA-approved biosimilars held that designation, and most marketed adalimumab biosimilars now carry it.

Price gaps are making the case to payers. Boehringer Ingelheim's adalimumab-adbm, for example, is listed at USD 550 per two-pack, about 92% below the list price of the reference product, Humira.

How Are Regulators Making Biosimilar Development Faster and Cheaper?

Regulators in the US and Europe have moved in the same direction over the past year: less duplicate clinical testing, more reliance on analytical and pharmacokinetic evidence.

The FDA issued draft guidance in October 2025 that proposed reducing the need for comparative efficacy studies, one of the costliest steps in biosimilar development. In March 2026, it followed up with a revised draft Q&A that would let developers skip three-way pharmacokinetic studies in some cases, when a non-US comparator can be shown to represent the US-licensed reference product. The FDA estimates this alone could save about USD 20 million per biosimilar program.

The European Medicines Agency finalized its reflection paper on a tailored clinical approach in March 2026. It allows comparative efficacy studies to be waived for well-characterized products, provided developers supply strong analytical comparability and pharmacokinetic data.

Formycon has already replaced a planned Phase 3 trial for its pembrolizumab candidate with a streamlined FDA strategy built on pharmacokinetic bioequivalence.

What Challenges Could Restrain Biosimilar Adoption?

Manufacturing biologics remains complex and expensive, and capacity is now as important as clinical data in deciding who reaches the market first. Rebate agreements between originator companies and payers can wipe out a biosimilar's list-price advantage on formularies. Patent litigation is another barrier. In September 2026, Bristol Myers Squibb and Ono filed a BPCIA suit against Amgen over its nivolumab candidate, asserting seven patents, and further litigation is expected around Keytruda patents that run to 2029.

Which Segments Lead the Biosimilars Market?

➢ By Drug Class
Monoclonal antibodies led with a 46.18% share in 2025, followed by TNF-alpha inhibitors at 14.72%, insulins at 11.36% and G-CSF agents at 9.84%. VEGF inhibitors are the fastest-growing drug class at an 8.12% CAGR, supported by new aflibercept launches in ophthalmology.

➢ By Therapeutic Area
Oncology held 38.64% of the market and is growing at 8.36% a year. Autoimmune and inflammatory disorders followed closely at 35.27%, with ophthalmology at 9.83% and diabetes at 7.62%.

➢ By Interchangeability Status
Non-interchangeable products made up 71.36% of the market in 2025. Interchangeable products are expanding at an 8.92% CAGR, and adalimumab accounts for 61.35% of that segment.

➢ By Distribution Channel
Hospital pharmacies held 58.37% of sales. Online and cash-pay platforms are the fastest-growing channel at a 9.26% CAGR, as discount pharmacy programs make lower biosimilar prices visible to patients.

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Which Region Leads the Biosimilars Market?

North America held the largest share at 34.68% in 2025, driven by US approvals, interchangeable designations and pharmacy-level substitution. Europe followed at 31.54%, supported by long-standing tender systems and the region's early adoption of biosimilars. Asia Pacific is the fastest-growing region at an 8.47% CAGR, led by manufacturers in South Korea, China and India that increasingly license products to global partners. The Middle East and Africa is projected to grow at 7.56%, and Latin America held a 4.11% share.

Who Are the Key Players in the Biosimilars Market?

• Accord BioPharma Inc.
• Alvotech S.A.
• Amgen Inc.
• Amneal Pharmaceuticals, Inc.
• Biocon Biologics Ltd.
• Bio-Thera Solutions, Ltd.
• Boehringer Ingelheim International GmbH
• Celltrion, Inc.
• Dr. Reddy's Laboratories Ltd.
• EirGenix, Inc.
• Formycon AG
• Fresenius Kabi AG
• mAbxience Holdings S.L.
• Organon & Co.
• Pfizer Inc.
• Samsung Bioepis Co., Ltd.
• Sandoz Group AG
• Shanghai Henlius Biotech, Inc.
• Teva Pharmaceutical Industries Ltd.
• Zydus Lifesciences Limited

What Are the Latest Regulatory Developments in the Biosimilars Market?

• May 2026: The FDA approved Accord's ENNUMO, the eighth pegfilgrastim biosimilar in the US.

• March 2026: The EMA finalized its reflection paper allowing comparative efficacy studies to be waived for well-characterized biosimilars.

• March 2026: The FDA issued revised draft Q&As on biosimilar development, allowing three-way pharmacokinetic studies to be waived in some cases.

• March 2026: The FDA and EMA accepted Teva's omalizumab biosimilar applications, with an FDA decision expected in Q1 2027.

• October 2025: The FDA issued draft guidance proposing to reduce the need for comparative efficacy studies.

What Are the Latest Industry Developments in the Biosimilars Market?

• September 2026: Shilpa Biologicals signed an exclusive MENA license with SPIMACO Bio for PD-1 inhibitor biosimilars.

• August 2026: Henlius granted Sandoz rights outside China to up to 10 monoclonal antibody and ADC biosimilars, worth up to USD 322 million.

• June 2026: Samsung Bioepis reported positive preliminary data for SB27, its pembrolizumab candidate.

• May 2026: Teva began launching AHZANTIVE, its aflibercept biosimilar, in France, Germany, Spain and the Netherlands.

What Do Analysts Say About the Biosimilars Market Outlook?

"Biosimilars are entering their most important decade since adalimumab," said Apurva Agarwal, Research Analyst at Polaris Market Research. "Regulators are removing expensive trials that added little new evidence, and the next patents to expire belong to some of the largest drugs in oncology. Companies with manufacturing capacity and strong partnerships will be best placed to win as those exclusivity periods end."

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