Biosimilars Market Assessment, By Product Class [Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-Inflammatory Agents, Others], By Indication [Oncology, Growth Hormone Deficiency, Blood Disorders, Chronic and Autoimmune Disorders, Infec

Global biosimilars market is projected to witness a CAGR of 16.73% during the forecast period 2025-2032, growing from USD 32.03 billion in 2024 to USD 110.44 billion in 2032. The biosimilars market is being driven by the rising demand for affordable biologic therapies, rapid patent expirations of blockbuster biologics, and favorable regulatory reforms supporting biosimilar approvals. Technological innovations in biomanufacturing are also improving production efficiency and scalability. Additionally, the growing acceptance among physicians and patients is fueling broader market penetration.

For instance, in January 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued favorable opinions recommending the approval of marketing authorizations for three biosimilar products: Amgen’s PAVBLU and SKOJOY, as well as DYRUPEG from CuraTeQ Biologics. Amgen’s PAVBLU and SKOJOY, both biosimilars that reference EYLEA (aflibercept), are approved for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment resulting from macular edema due to retinal vein occlusion (branch RVO or central RVO), and visual impairment caused by myopic choroidal neovascularization (myopic CNV).

Rising Global Demand for Cost-Effective Therapies

The global biosimilars market is experiencing significant expansion driven by the increasing need for affordable therapeutic alternatives to branded biologics. As the prevalence of chronic illnesses such as cancer, diabetes, and autoimmune diseases rises, healthcare systems face mounting pressure to offer cost-effective treatment options. Biosimilars provide considerable cost reductions while ensuring efficacy and safety, which is propelling their adoption in both developed and emerging markets. Additionally, the expiration of patents for key biologics has created opportunities for biosimilar producers. Governments and insurance companies are actively promoting the use of biosimilars to lower healthcare costs. This escalating demand for accessible treatment options is fostering the global adoption of biosimilars. For instance, the introduction of Wezlana (ustekinumab-auub) as the first ustekinumab biosimilar in January 2025, three additional products entered the market, thereby enhancing the availability of more ‘low-cost’ alternatives to the widely used Stelara (ustekinumab). Samsung Bioepis/Sandoz, Biocon Biologics, and Teva/Alvotech subsequently launched their ustekinumab formulations: Pyzchiva (ustekinumab-ttwe), Yesintek (ustekinumab-kfce), and Selarsdi (ustekinumab-aekn).

Technological Advancements in Manufacturing and Development

Recent advancements in biologics manufacturing technologies are greatly improving the development, scalability, and quality of biosimilars. Innovations such as single-use bioreactors, enhanced cell line development, and AI-driven analytics are facilitating quicker and more efficient production. These improvements also contribute to cost reduction and enhance batch-to-batch consistency, thereby increasing the competitiveness of biosimilar production. Regulatory bodies in various regions are also expediting approval processes for biosimilars through accelerated pathways and standardized guidelines. As manufacturers adopt contemporary bioprocessing methods, biosimilars are becoming increasingly accessible and dependable. This technological progress fosters wider market penetration and acceptance among healthcare professionals and patients. For instance, in March 2024, Biocon Biologics Limited announced a patent settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals Inc., which paves the way for the launch of a biosimilar product in Canada. This agreement permits the introduction of Yesafili, a proposed biosimilar to Eeylea (aflibercept) injection, into the Canadian market, as indicated by Biocon Biologics in a regulatory filing. Under the terms of the agreement, Biocon Biologics has set a launch date for the product no later than July 1, 2025. Yesafili, an ophthalmology product, is intended for the treatment of neovascular (wet AMD) and age-related macular degeneration, among other conditions.

Oncology Segment Dominating the Market

Among all indications, oncology remains the dominant segment in the biosimilars market, driven by the high cost of cancer biologics and increasing global cancer burden. Biosimilars for oncology biologics such as bevacizumab, rituximab, and trastuzumab offer a cost-effective alternative without compromising treatment efficacy. The growing incidence of cancers and rising adoption of biosimilars in cancer care centers and hospitals are further propelling segmental growth. As oncologists gain confidence in the real-world effectiveness and safety profiles of biosimilars, their prescription rates continue to rise. Biosimilars in oncology are also supported by regulatory advantages and expedited market approvals to meet critical therapeutic demands. For example, in October 2024, Teva Pharmaceutical Industries Ltd. and Mabxience Holding S.L. revealed an enhanced collaboration agreement aimed at developing an anti-PD1 oncology biosimilar candidate.

Europe Leading Global Biosimilars Adoption

Europe continues to dominate the global biosimilars market due to its early regulatory framework, proactive policies, and widespread acceptance among physicians and payers. The region’s healthcare systems emphasize cost-containment, making biosimilars a critical strategy in managing drug expenditures. Countries such as Germany, the UK, and France have implemented supportive pricing, substitution policies, and physician incentives to encourage biosimilar adoption. Moreover, the European Medicines Agency (EMA) maintains a robust and transparent approval process, fostering trust in biosimilar efficacy and safety. These favorable dynamics have enabled Europe to achieve one of the highest biosimilar penetration rates globally, setting a benchmark for other regions. In October 2023, Sandoz Group AG (a division of Novartis AG) launched Hyrimoz (adalimumab) high-concentration biosimilar in Germany, further reinforcing Europe’s leadership in biosimilar uptake.

Future Market Scenario (2025-2032F)

The global biosimilars market is poised for substantial growth over the coming years, driven by the increasing expiration of biologic drug patents, rising healthcare costs, and growing prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes. As regulatory pathways mature and streamline, biosimilars are becoming more accepted among healthcare providers, patients, and payers. With advancements in bio-manufacturing technologies, companies are now able to produce high-quality biosimilars more efficiently and cost-effectively. Emerging economies, particularly in Asia-Pacific and Latin America, are expected to witness accelerated adoption due to supportive government policies and growing demand for affordable biologics. Moreover, the expanding application of biosimilars across diverse therapeutic areas will further bolster market expansion globally.

Key Players Landscape and Outlook

The key players in the market are significantly investing in the development of biosimilars and are utilizing strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing large-cap industry players to increase their presence and, therefore, find new opportunities in this market.

For example, in February 2025, Teva Pharmaceutical Industries Ltd. and Alvotech hf1 officially announced the launch of Selarsdi (ustekinumab-aekn) injection in the United States, which is a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). This medication is approved for treating Crohn’s disease, pediatric plaque psoriasis, pediatric psoriatic arthritis, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. This represents the second biosimilar introduced in the country because of the strategic partnership between the two companies.