Biosimilars Market worth US$72.29 billion by 2035 with 7.5% CAGR | MarketsandMarkets™

The European Medicines Agency (EMA) has approved 132 biosimilars across various therapeutic classes, enhancing patient access, lowering treatment costs, and expediting market entry.

The global Biosimilars Market, valued at US$32.75 billion in 2024 stood at US$35.04 billion in 2025 and is projected to advance at a resilient CAGR of 7.5% from 2025 to 2035, culminating in a forecasted valuation of US$72.29 billion by the end of the period. This growth is driven by several key factors, including a rising number of regulatory approvals and product launches, the patent expiries of major biologics, and the increasing prevalence of chronic diseases that require effective and affordable treatment options. Furthermore, cost containment pressures in global healthcare systems and a surge in R&D collaborations among biopharma companies have significantly accelerated biosimilar development and commercialization. Notably, the first biosimilar version of the blockbuster GLP-1 agonist Semaglutide is projected to launch in China by 2026, and it is anticipated to contribute to approximately 25% of the global biosimilars market share by 2035, underscoring its transformative impact on the market landscape. However, the intricacies involved in the manufacturing processes of biosimilars may present challenges that could impede market expansion throughout the forecast period.

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By indication, the escalating global burden of cancer, coupled with the high costs associated with biologic therapies, has positioned oncology as the leading segment in the biosimilars market. These biologic medications offer a cost-effective alternative to reference products, thereby improving patient access to crucial treatments. The heightened investment in R&D within oncology has established biosimilars as a strategic option for healthcare systems aiming to enhance treatment affordability. The primary biosimilars utilized for oncological treatments include trastuzumab, bevacizumab, rituximab, filgrastim, epoetin alfa, and denosumab. Ongoing regulatory approvals continue to expand this market segment, while sustained research initiatives and collaborative endeavors are poised to augment market development further.

By Drug Class, Infliximab, rituximab, adalimumab, trastuzumab, pembrolizumab, dupilumab, ustekinumab, risankizumab, and other monoclonal antibodies are biologic therapeutics for managing autoimmune diseases, malignancies, chronic conditions, and infectious diseases. These agents are engineered through recombinant DNA (rDNA) technology, enabling them to selectively target specific antigens or cellular receptors, which enhances their therapeutic efficacy and specificity. The introduction of biosimilars for these established mAbs has the potential to significantly reduce healthcare expenditures while improving patient access to vital therapies. Moreover, with the patent expirations of several prominent mAbs, the subsequent surge in market competition is expected to drive down prices and generate increased pharmaceutical interest in mAb development. Given their affordability and versatility across oncology and autoimmune therapy, mAb biosimilars are poised to play a pivotal role in shaping the future landscape of therapeutic options.

By geography, the European market has emerged as the leading contributor to the biosimilar sector, driven by pro-biosimilar governmental policies, heightened investments in research and development, and an increasing disease burden. Key suppliers in this arena include France, Italy, Spain, Germany, and the UK. The European Medicines Agency (EMA) has approved 132 biosimilars across various therapeutic classes, enhancing patient access, lowering treatment costs, and expediting market entry. This approval encompasses a range of biologics, including insulin, TNF inhibitors, VEGF inhibitors, and monoclonal antibodies. Notably, in February 2025, the European Commission approved YESINTEK, Biocon Biologics’ biosimilar of ustekinumab, underscoring Europe’s commitment to improving access to biologic therapies and reinforcing its leadership position in the global biosimilars landscape.

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Key players in the biosimilars market include Sandoz Group AG (Switzerland), Pfizer Inc. (US), Amgen Inc. (US), Celltrion, Inc. (South Korea), Biocon (India), Dr. Reddy’s Laboratories Ltd. (India), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius Kabi AG (Germany), and STADA Arzneimittel AG (Germany).

Biocon (India):

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 (Switzerland)

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.

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