Biosimilars Market

The biosimilars market is projected to reach USD 70.79 billion by 2036 from USD 37.39 billion in 2026 at a CAGR of 6.6% from 2026 to 2036. The growth of this market can be attributed to the increasing approvals of biosimilars products, facilitated by favorable regulatory environments, and an increasing willingness among healthcare providers to integrate biosimilars into treatment protocols.

Key players in the industry include Sandoz Group AG (Switzerland), Pfizer Inc. (US), Amgen Inc. (US), Celltrion Inc. (South Korea), Biocon Limited (India), Dr. Reddy’s Laboratories Ltd. (India), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius Kabi AG (Germany), Stada Arzneimittel AG (Germany), Boehringer Ingelheim International GmbH (Germany), Samsung Bioepis Co., Ltd. (South Korea), Amneal Pharmaceuticals, Inc. (US), Bio-Thera Solutions, Ltd. (China), Aprogen Inc. (South Korea), Shanghai Henlius Biotech, Inc. (China), Alvotech (Iceland), among others. Companies in this market are focusing on product launches and approvals to strengthen their product portfolios and expand their presence in the biosimilars market.

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For instance, in May 2026, Sandoz received European Commission marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, have been developed by Gan & Lee Pharmaceuticals.

In December 2025, Celltrion Healthcare received US FDA approved the 300 mg/2 mL prefilled-syringe presentation of OMLYCLO. OMLYCLO had previously become the first and only FDA-designated interchangeable omalizumab biosimilar.

In May 2025, Amgen reported the launch of WEZLANA in the US in Q1 2025, generating USD 150 million in Q1 sales. It is the first FDA-approved ustekinumab biosimilar for adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Sandoz Group AG (Switzerland)

Sandoz maintains a leading position in the biosimilars market because of its first-mover experience, broad commercial portfolio, extensive geographic reach, and one of the industry's deepest biosimilar pipelines. The company was involved in the launch of the world's first biosimilar, Omnitrope, in 2006, and has subsequently built capabilities across oncology, immunology, ophthalmology, endocrinology, and other biologic categories. In 2025, Sandoz generated USD 3.29 billion in biosimilar sales, up 15% year over year, making approximately 30% of its total sales.

Amgen Inc. (US)

Amgen has established a strong position by combining originator-biologics expertise with substantial manufacturing, regulatory, and commercial capabilities and applying these capabilities to biosimilar development. The company entered the biosimilars domain in 2018 and has since generated USD 13.6 billion in cumulative biosimilar sales; biosimilar sales reached USD 3.0 billion in 2025, increasing 37% year over year.

Celltrion Inc. (South Korea)

Celltrion has secured a leading position in the biosimilars market through an early and highly focused strategy centered on developing, manufacturing, and directly commercializing a broad portfolio of antibody and other biologic biosimilars globally. Its established products include Remsima (infliximab), Truxima (rituximab), Herzuma (trastuzumab), Yuflyma (adalimumab), Vegzelma (bevacizumab), and Steqeyma (ustekinumab), complemented by newer products including Omlyclo and Stoboclo/Osenvelt. Celltrion reported that its legacy biosimilars continued to provide a stable revenue base in 2025, while newer products generated rapid uptake; the newer portfolio accounted for 54% of sales in 2025, highlighting the company's ability to transition from mature products toward higher-growth launches.

Market Ranking

The biosimilars market is highly competitive, with leading pharmaceutical and biotechnology companies competing across high-value therapeutic areas including oncology, immunology, ophthalmology, hematology, endocrinology, and inflammatory diseases. Sandoz, Amgen, and Celltrion are among the leading players, supported by broad commercialized portfolios, extensive biosimilar pipelines, global regulatory capabilities, manufacturing scale, and established market-access infrastructure. Other important participants include Pfizer, Samsung Bioepis, Biocon Biologics, Fresenius Kabi, Viatris, and Teva, which have strengthened competition through launches across major biologic molecules and geographies.

These companies compete primarily through early entry following reference-biologic patent and exclusivity expiry, competitive pricing, manufacturing efficiency, regulatory expertise, interchangeability where applicable, and payer and physician adoption strategies. Leading players continue to expand portfolios targeting high-value biologics such as adalimumab, ustekinumab, denosumab, trastuzumab, rituximab, bevacizumab, and ranibizumab, while investing in additional pipeline assets and global commercialization capabilities. Competitive differentiation increasingly depends on securing favorable formulary positioning and tenders, maintaining reliable supply, accelerating patient switching and treatment-naïve adoption, and managing price erosion as the number of biosimilar competitors increases.

Related Reports:

Biosimilars Market by Drug Class (mAbs [Adalimumab, Infliximab, Rituximab, Trastuzumab], GCSF, Insulin, Anticoagulant, rhGH, Teriparatide, GLP-1), Indication (Oncology, Autoimmune, Diabetes, Obesity), Competitive Landscape, Region - Global Forecast to 2036

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