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Immunology Biosimilars Global Market Report 2025
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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).

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 from The Business Research Company 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.

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 (2.0%) 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).

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.

Immunology Biosimilars Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on immunology biosimilars market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for immunology biosimilars ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The immunology biosimilars market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Immunology Biosimilars Market Characteristics

3. Immunology Biosimilars Market Trends And Strategies

4. Immunology Biosimilars Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Immunology Biosimilars Growth Analysis And Strategic Analysis Framework

6. Immunology Biosimilars Market Segmentation

7. Immunology Biosimilars Market Regional And Country Analysis

8. Asia-Pacific Immunology Biosimilars Market

9. China Immunology Biosimilars Market

10. India Immunology Biosimilars Market

11. Japan Immunology Biosimilars Market

12. Australia Immunology Biosimilars Market

13. Indonesia Immunology Biosimilars Market

14. South Korea Immunology Biosimilars Market

15. Western Europe Immunology Biosimilars Market

16. UK Immunology Biosimilars Market

17. Germany Immunology Biosimilars Market

18. France Immunology Biosimilars Market

19. Italy Immunology Biosimilars Market

20. Spain Immunology Biosimilars Market

21. Eastern Europe Immunology Biosimilars Market

22. Russia Immunology Biosimilars Market

23. North America Immunology Biosimilars Market

24. USA Immunology Biosimilars Market

25. Canada Immunology Biosimilars Market

26. South America Immunology Biosimilars Market

27. Brazil Immunology Biosimilars Market

28. Middle East Immunology Biosimilars Market

29. Africa Immunology Biosimilars Market

30. Immunology Biosimilars Market Competitive Landscape And Company Profiles

31. Immunology Biosimilars Market Other Major And Innovative Companies

32. Global Immunology Biosimilars Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Immunology Biosimilars Market

34. Recent Developments In The Immunology Biosimilars Market

35. Immunology Biosimilars Market High Potential Countries, Segments and Strategies

36. Appendix

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