Biosimilars Market worth $72.29 billion by 2035
The report "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 2035", is projected to reach USD 72.29 billion by 2035 from USD 35.04 billion in 2025, at a CAGR of 7.5% during the forecast period.
Browse 420 market data Tables and 58 Figures spread through 391 Pages and in-depth TOC on "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 2035"
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Several key factors, including the increasing incidence of chronic diseases and the expiration of patents on numerous high-revenue biologics, primarily drive the expansion of the global biosimilars market. Governments and healthcare systems across various regions are actively facilitating the adoption of biosimilars as cost-effective substitutes for originator biologics, thereby enhancing patient access to advanced therapeutic options. Moreover, advancements in biologics manufacturing processes, the establishment of more streamlined regulatory frameworks, and the growing acceptance among clinicians and patients contribute to a more robust market penetration. For instance, pembrolizumab, originally marketed as Keytruda by Merck & Co., is extensively used in oncology, and its biosimilars are anticipated to enter the market by 2029, potentially capturing 18–20% of the monoclonal antibodies market share by 2035. Key companies developing pembrolizumab biosimilars currently in preclinical or early clinical stages include Celltrion, Samsung Bioepis, Bio-Thera Solutions, and Alteogen.
However, the pervasive pricing pressures among industry stakeholders are anticipated to pose significant challenges to ongoing market development.
The oncology segment accounted for the largest share, by indication, in the biosimilars market in 2024.
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.
The monoclonal antibody segment commanded the largest market share in 2025 and is expected to grow at the highest CAGR from 2025 to 2035.
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.
Europe accounted for the largest regional share in the biosimilars market in 2024.
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.
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).
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