Top Biosimilars Companies in 2025

The global biosimilars market is expected to grow from USD 35.04 billion in 2025 to USD 72.29 billion by 2035, registering a compound annual growth rate (CAGR) of 7.5% during the forecast period. This growth is driven by rising adoption rates, supportive regulatory frameworks, and a growing acceptance among healthcare professionals to include biosimilars in treatment regimens.

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Some of the major players in the biosimilars industry with a strong international presence are Sandoz Group AG (Switzerland), Pfizer Inc. (US), Biocon (India), Amgen Inc. (US), Samsung Bioepis (South Korea), Pfizer Inc. (US), and Celltrion, Inc. (South Korea). Companies in the biosimilars sector are leveraging both organic and inorganic growth strategies to enhance their global footprint and fortify their market positions. This approach includes forming strategic partnerships, executing acquisitions, entering licensing agreements, launching new products, and scaling up manufacturing capabilities. As a result of these initiatives, organizations have broadened their biosimilar portfolios and improved market access while establishing a significant presence in both developed and emerging markets. This proactive strategy addresses the rising demand for cost-effective treatment options on a global scale.

In March 2025, Biocon entered into a strategic collaboration with Civica, Inc. to manufacture and market insulin Aspart in the US jointly. As per the agreement, Biocon will provide the drug substance for insulin Aspart, while Civica will handle the downstream processes, including drug development, clinical trials, and the production of the final drug product. This partnership aims to bring biosimilars to the US market, leveraging both companies’ strengths in biopharmaceutical development and commercialization. In February 2025, Dr. Reddy’s collaborated with Shanghai Henlius Biotech (China) to commercialize HLX15 (daratumumab), a biosimilar candidate to Darzalex and Darzalex Faspro, in the US and Europe.

Sandoz Group AG, a prominent player in the biosimilars sector, has strategically concentrated on launching first-to-market products for high-value biologics, exemplified by its offerings Pyzchiva (ustekinumab) and Tyruko (natalizumab). In addition to its commitment to innovative product launches, Sandoz has enhanced its capabilities in manufacturing, technology, and production capacity. A key development in this arena occurred in May 2023, when Sandoz partnered with Just-Evotec Biologics, a CDMO specializing in continuous biomanufacturing; this collaboration develops and manufactures multiple biosimilars, thereby advancing Sandoz’s pipeline to a robust total of 24 assets.

Pfizer, a prominent contender in the biosimilars sector, has strategically concentrated its portfolio on oncology-related biosimilars, capitalizing on its distribution channel expertise. In 2024, the company recorded a 7% growth in its biopharmaceuticals division. Notable recent biosimilar introductions include ZIRABEV (bevacizumab-bvzr), RUXIENCE (rituximab-pVyr), TRAZIMERA (trastuzumab-gyyp), and ABRILADA (adalimumab-afzb), the latter having received an interchangeable designation with Humira. Pfizer has a robust pipeline of biosimilar products, and upcoming launches are anticipated to bolster its competitive stance in the biosimilars market in the years ahead.

Market Ranking

The biosimilars market is characterized by intense competition, with five key players commanding a substantial share of global revenues, estimated to be between 25% and 35% of the total market. These leading companies reinforce their market positions through strategic investments, regulatory advancements, and extensive partnerships. Notably, Sandoz maintains a robust presence, bolstered by its expanding product pipeline and the launch of Afqlir in November 2024. Additionally, Sandoz has allocated USD 90 million to enhance the capabilities of its Biopharma Development Center in Slovenia to improve both R&D and manufacturing. In this competitive landscape, Pfizer has enhanced its portfolio with the FDA approval of Abrilada in late 2023 and a strategic alliance with Samsung Biologics to co-develop a diverse range of biosimilar products. Amgen prioritizes scale and innovation in its manufacturing processes, which are supported by recent acquisitions and the expansion of its facilities in the US to advance its inflammation pipeline. Emerging players such as Biocon Biologics have rapidly carved out an international presence through acquisitions and product launches, emphasizing affordability and accessibility. Similarly, Celltrion has innovated its drug delivery systems, as evidenced by its collaboration with Rani Therapeutics to develop an oral formulation of the ustekinumab biosimilar.

The remainder of the market, comprising approximately 65–75%, is populated by various regional players and emerging biopharmaceutical companies leveraging partnerships and targeting niche indications to secure a foothold. The competitive dynamics are evolving, driven by the patent expirations of significant biologics, shifting regulatory frameworks, and a growing demand for cost-effective biologic alternatives across therapeutic areas such as oncology, immunology, and endocrinology. Companies must focus on innovation, integration, and responsiveness to market demands to thrive in this transforming environment.