Immunology Biosimilars Industry to See Robust Expansion, Valued at $13.57 Billion by 2029

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What Is the Projected CAGR for the Immunology Biosimilars Market from 2024 to 2025?
The market size for immunology biosimilars has seen a fast-paced growth in the past years. The expansion will see it grow from $7.38 billion in 2024 to $8.35 billion in 2025 with a compound annual growth rate (CAGR) of 13.1%. Factors that contributed to this growth during the historical period include the heightened acceptance of biosimilars, increased demand for reasonably priced biologics, growing occurrences of autoimmune diseases, enhanced patient knowledge regarding biosimilar therapies, and the rise in regulatory backing for biosimilar approval.

What are the Expected Market Size and CAGR for Immunology Biosimilars by 2029?
In the upcoming years, the immunology biosimilars market is anticipated to experience swift expansion, with its size projected to hit $13.57 billion by 2029, growing at a compound annual growth rate (CAGR) of 12.9%. The surge during the prediction period is attributed to the heightened focus on minimizing healthcare costs, an increasing number of chronic inflammatory conditions, growing penetration in new markets, escalating support for biosimilar interchangeability, and increasing investments by pharmaceutical companies. The forecast period will also see significant trends such as advancements in biologics manufacturing technology, collaborations in research and development, the emergence of next-generation biosimilars, innovations in delivery mechanisms, and the application of artificial intelligence in biosimilar development.

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Which Factors Are Driving the Global Immunology Biosimilars Market Expansion?
The growth of the immunology biosimilars market is anticipated to be fueled by the rising incidence of chronic immunological diseases. These are enduring conditions where the immune system does not function correctly, either attacking the body's tissues or inadequately safeguarding it. This increase is associated with the escalating number of people afflicted by long-duration immune system disorders that necessitate continuous therapy, active disease control, and sustained healthcare assistance. In managing these chronic immunological conditions, Immunology biosimilars give cost-effective and successful treatment options, encouraging long-term disease control, and boosting patient access to vital treatments to regulate immune system poor functioning. For example, the Australian Institute of Health and Welfare, in June 2024, stated that rheumatoid arthritis, a systemic autoimmune disease, affected an estimated 514,000 individuals (2.0%) in 2022, with 2.5% of females and 1.6% of males living with this condition. Consequently, the mounting occurrence of chronic immunological diseases is steering the immunology biosimilars market's growth.

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Which Segment Currently Holds the Largest Share of the Immunology Biosimilars Market?
The immunology biosimilars market covered in this report is segmented -

1) By Drug Type: Monoclonal Antibodies, Fusion Proteins, Recombinant Proteins, Interferons, Other Biosimilar Immunomodulators
2) By Disease: Inflammatory Bowel Disease, Arthritis, Other Diseases
3) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Other Distribution Channels
4) By End User: Hospitals, Clinics, Homecare Settings, Ambulatory Surgical Centers (ASCs)

Subsegments:
1) By Monoclonal Antibodies: Anti-Tumor Necrosis Factor Agents, Anti-Interleukin-6 Agents, Anti-Cluster of Differentiation 20 Agents, Anti-Interleukin-12/23 Agents, Other Monoclonal Antibodies
2) By Fusion Proteins: Etanercept Biosimilars, Other Fusion Protein Biosimilars
3) By Recombinant Proteins: Recombinant Human Insulin, Recombinant Human Growth Hormone, Recombinant Human Erythropoietin, Other Recombinant Protein Biosimilars
4) By Interferons: Interferon Alpha, Interferon Beta, Interferon Gamma
5) By Other Biosimilar Immunomodulators: Interleukin Inhibitors, Janus Kinase Inhibitors, Other Immunomodulatory Biosimilars

Which Major Trends Are Shaping the Future of the Immunology Biosimilars Industry?
Leading businesses in the immunology biosimilars market are concentrating on creating next-generation biosimilar advancements, like expected interchangeability designation, enhanced stable formulations, and innovative delivery mechanisms. These developments aim to offer more effective and convenient treatment alternatives for patients. Expected interchangeability designation implies that the biosimilar meets the regulatory standards and can replace the reference biologic at the pharmacy without the necessity for prescriber's intervention. An example of this is Sandoz Group AG, a pharmaceutical company based in Switzerland, which in February 2025, rolled out Pyzchiva (ustekinumab-ttwe), a Stelara biosimilar. The drug was developed for the treatment of chronic autoimmune diseases. These include plaque psoriasis, psoriatic arthritis, Crohn's Disease, and ulcerative colitis. The launch was facilitated by a cooperation with Samsung Bioepis Co. Ltd., a biopharmaceutical company based in South Korea. This partnership underlines Sandoz's dedication to improving access to immunology biosimilars by offering a treatment that's adaptable in dosage, stable for an extended period, economical, patient-focused, and uniquely capable of being re-refrigerated after the initial chilling phase.

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Which Key Players Dominate the Immunology Biosimilars Industry Globally?
Major companies operating 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, Mabion S.A.

What Are the Fastest-Growing Regions in the Immunology Biosimilars Market?
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 the immunology biosimilars market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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