Immunology Biosimilars Market Report 2025

The immunology biosimilars market size has grown rapidly in recent years. It will grow from $7.38 billion in 2024 to $8.35 billion in 2025 at a compound annual growth rate (CAGR) of 13.1%. The growth during the historic period can be attributed to the rising adoption of biosimilars, growing demand for affordable biologic treatments, increasing prevalence of autoimmune diseases, expanding patient awareness of biosimilar therapies, and enhanced regulatory support for biosimilar approvals.

The immunology biosimilars market size is expected to see rapid growth in the next few years. It will grow to $13.57 billion in 2029 at a compound annual growth rate (CAGR) of 12.9%. The projected growth in the forecast period can be attributed to an increasing emphasis on lowering healthcare costs, rising prevalence of chronic inflammatory diseases, expanding market penetration in emerging economies, growing regulatory support for biosimilar interchangeability, and heightened investments from pharmaceutical companies. Key trends expected during this time include advancements in biologics manufacturing technologies, strengthened research and development collaborations, the emergence of next-generation biosimilars, innovations in drug delivery systems, and the incorporation of artificial intelligence in biosimilar development.

The rising prevalence of chronic immunological conditions is expected to drive growth in the immunology biosimilars market in the coming years. Chronic immunological conditions are persistent disorders where the immune system either attacks the body’s own tissues or fails to defend it properly. This increase is linked to a growing number of people living with long-term immune system disorders that require ongoing treatment, proactive management, and continuous healthcare support. Immunology biosimilars offer affordable and effective treatment alternatives, aiding long-term disease management and improving patient access to essential therapies that regulate immune system dysfunction. For example, in June 2024, the Australian Institute of Health and Welfare, a government agency in Australia, reported that rheumatoid arthritis - a systemic autoimmune disease, affected approximately 514,000 people (2%) in 2022, with prevalence rates of 2.5% among females and 1.6% among males. Hence, the rising incidence of chronic immunological diseases is fueling growth in the immunology biosimilars market.

Leading companies in the immunology biosimilars market are concentrating on next-generation biosimilar developments such as expected interchangeability designations, improved formulations with greater stability, and innovative delivery systems to offer patients more accessible and effective treatment choices. The anticipated interchangeability designation indicates that a biosimilar meets regulatory requirements to be substituted for the reference biologic at the pharmacy level without prescriber approval. For instance, in February 2025, Sandoz Group AG, a pharmaceutical company based in Switzerland, launched Pyzchiva (ustekinumab-ttwe), a biosimilar to Stelara, intended to treat chronic autoimmune diseases including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. This launch, in collaboration with Samsung Bioepis Co. Ltd., a biopharmaceutical firm from South Korea, underscores Sandoz’s dedication to broadening access to immunology biosimilars by providing a cost-effective, patient-friendly therapy featuring multiple dosing options, extended stability, and the distinctive ability to be re-refrigerated after initial refrigeration.

In November 2022, Biocon Biologics Ltd., an India-based biosimilars company, acquired the global biosimilars business of Viatris Inc. for an undisclosed sum. Through this acquisition, Biocon Biologics aims to become a fully integrated global leader in biosimilars by securing direct commercial access to both advanced and emerging markets, expanding its portfolio with critical immunology assets, and strengthening its capacity to offer affordable biologic medicines to patients worldwide. Viatris Inc. is a US-based healthcare company engaged in developing and commercializing immunology biosimilars.

Major players in the immunology biosimilars market are Pfizer Inc., Novartis AG, LG Chem Ltd., Amgen Inc., Teva Pharmaceutical Industries Ltd., Astellas Pharma Inc., Sandoz Group AG, Fresenius Kabi AG, Intas Pharmaceuticals Ltd., Stada Arzneimittel AG, Cipla Ltd., Kyowa Kirin Co. Ltd., Dr. Reddy's Laboratories Ltd., Samsung Bioepis Co. Ltd., Gedeon Richter Plc, Celltrion Inc., Biocon Ltd., Innovent Biologics Inc., Biocad, and Mabion S.A.

North America was the largest region in the immunology biosimilars market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in immunology biosimilars report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the immunology biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The immunology biosimilars market consists of sales of tumor necrosis factor inhibitors, recombinant cytokines, t-cell co-stimulation modulators, and monoclonal antibodies. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

The immunology biosimilars medicine market research report is one of a series of new reports that provides immunology biosimilars medicine market statistics, including the immunology biosimilars medicine industry global market size, regional shares, competitors with the immunology biosimilars medicine market share, detailed immunology biosimilars medicine market segments, market trends, and opportunities, and any further data you may need to thrive in the immunology biosimilars medicine industry. This immunology biosimilars medicine market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

Immunology biosimilars are biologic drugs that closely resemble already approved original biologics used to treat immune-related conditions, with no meaningful differences in safety, purity, or effectiveness. They offer more cost-effective treatment options for patients with diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, thereby improving access to vital therapies.

The main categories of immunology biosimilars include monoclonal antibodies, fusion proteins, recombinant proteins, interferons, and others. Monoclonal antibodies are lab-engineered molecules that replicate the immune system’s ability to combat harmful agents like viruses and bacteria. These biosimilars are used to treat diseases including inflammatory bowel disease, arthritis, and more. Distribution channels consist of hospital pharmacies, retail pharmacies, online pharmacies, among others. The key end users include hospitals, clinics, homecare providers, and ambulatory surgical centers (ASCs).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

This product will be delivered within 1-3 business days.