PUBLISHER: The Business Research Company | PRODUCT CODE: 1949803
PUBLISHER: The Business Research Company | PRODUCT CODE: 1949803
Autoimmune monoclonal antibodies are laboratory-engineered proteins designed to target specific components of the immune system involved in autoimmune diseases. They work by regulating or blocking abnormal immune responses that mistakenly attack the body's tissues. Their primary purpose is to reduce inflammation and prevent immune-mediated tissue damage, helping maintain normal physiological function.
The main types of autoimmune monoclonal antibodies include Immunoglobulin G (IgG) monoclonal antibodies, Immunoglobulin M (IgM) monoclonal antibodies, chimeric monoclonal antibodies, and fully human monoclonal antibodies. IgG monoclonal antibodies are lab-engineered proteins that specifically target molecules in the body, modulating immune responses to provide precise and long-lasting therapeutic effects in autoimmune treatments. These antibodies can be administered subcutaneously, intravenously, or intramuscularly. They are used to treat conditions such as rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, psoriasis, and inflammatory bowel disease. Distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies, with primary end users being hospitals, outpatient clinics, homecare settings, and research institutions.
Tariffs have affected the autoimmune monoclonal antibody market by increasing the cost of imported biologic active pharmaceutical ingredients, cell culture media, and injectable formulation components. These impacts have been most pronounced in rheumatoid arthritis and multiple sclerosis segments, particularly in north america and europe where biologic sourcing is globally diversified. Asia-pacific manufacturers have faced production cost pressures. However, tariffs have supported domestic biologics manufacturing and biosimilar development.
The autoimmune monoclonal antibody market research report is one of a series of new reports from The Business Research Company that provides autoimmune monoclonal antibody market statistics, including autoimmune monoclonal antibody industry global market size, regional shares, competitors with a autoimmune monoclonal antibody market share, detailed autoimmune monoclonal antibody market segments, market trends and opportunities, and any further data you may need to thrive in the autoimmune monoclonal antibody industry. This autoimmune monoclonal antibody market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The autoimmune monoclonal antibody market size has grown strongly in recent years. It will grow from $70.86 billion in 2025 to $76.6 billion in 2026 at a compound annual growth rate (CAGR) of 8.1%. The growth in the historic period can be attributed to autoimmune disease prevalence, biologic drug approvals, hospital infusion center growth, chronic inflammation management, specialty clinic expansion.
The autoimmune monoclonal antibody market size is expected to see strong growth in the next few years. It will grow to $104.57 billion in 2030 at a compound annual growth rate (CAGR) of 8.1%. The growth in the forecast period can be attributed to precision immunology advancement, biosimilar penetration, long-acting antibody development, outpatient biologic administration, personalized autoimmune therapy. Major trends in the forecast period include increased adoption of targeted biologic therapies, expansion of fully human antibody development, rising use in chronic autoimmune conditions, growth in subcutaneous administration preference, focus on long-term disease control.
The growing demand for biologics is expected to drive the expansion of the autoimmune monoclonal antibody market in the coming years. Biologics are medical products derived from living organisms or their components, used for the treatment, prevention, or diagnosis of diseases. This rising demand is primarily fueled by their effectiveness in managing complex conditions such as cancer, autoimmune disorders, and genetic diseases, where traditional therapies may be less effective. Autoimmune monoclonal antibodies enhance biologic treatments by providing targeted immune modulation, enabling precise management of overactive immune responses. They reduce reliance on broad immunosuppressants, improving patient outcomes while minimizing side effects. For example, in June 2024, Cardinal Health Inc., a US-based healthcare company, reported that 40 biosimilar products had been approved by the U.S. Food and Drug Administration (FDA) in 2023, with 25 commercially available in the US market, up from 33 biosimilar products in 2022. Consequently, the increasing demand for biologics is driving growth in the autoimmune monoclonal antibody market.
Leading companies in the autoimmune monoclonal antibody market are focusing on developing innovative solutions, such as biosimilars, to improve safety, efficacy, and quality. Biosimilar development involves creating biological products that are highly similar to existing approved biologics, using advanced biotechnology, thorough analytical testing, and clinical studies to demonstrate comparable quality, effectiveness, and safety for regulatory approval. For example, in February 2025, Biocon Biologics Limited, an India-based biopharmaceutical company, launched YESINTEK, a biosimilar for treating autoimmune diseases such as Crohn's disease, ulcerative colitis, and psoriasis. YESINTEK targets and inhibits interleukin-12 and interleukin-23 to reduce inflammation and modulate the immune response. By mimicking the reference product Stelara, YESINTEK supports long-term disease management while improving patient access to biologic therapies.
In June 2023, Merck & Co., a US-based pharmaceutical company, acquired Prometheus Biosciences, Inc. for approximately $10.8 billion. Through this acquisition, Merck aims to accelerate the development of precision medicine in immunology by leveraging Prometheus' technology, data analytics, and its TL1A-targeting candidate PRA023 to address unmet needs in immune-mediated diseases. Prometheus Biosciences, Inc., based in the US, specializes in developing autoimmune monoclonal antibody therapies.
Major companies operating in the autoimmune monoclonal antibody market are Johnson & Johnson, F. Hoffmann-La Roche Ltd, Pfizer Inc., Merck & Co. Inc., AbbVie Inc., Novartis AG, Sanofi S.A., Bristol-Myers Squibb Company, AstraZeneca PLC, Eli Lilly and Company, Amgen Inc., Teva Pharmaceutical Industries Ltd., Regeneron Pharmaceuticals Inc., UCB S.A., Genmab A/S, Zymeworks Inc., Xencor Inc., Immutep Limited, Cue Biopharma Inc., Santa Ana Bio Inc.
North America was the largest region in the autoimmune monoclonal antibody market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the autoimmune monoclonal antibody market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the autoimmune monoclonal antibody market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The autoimmune monoclonal antibody market consists of sales of adalimumab (humira), etanercept (enbrel), infliximab (remicade), rituximab (rituxan), tocilizumab (actemra), belimumab (benlysta), and secukinumab (cosentyx). 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 that 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.
Autoimmune Monoclonal Antibody Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses autoimmune monoclonal antibody 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.
Where is the largest and fastest growing market for autoimmune monoclonal antibody ? 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 autoimmune monoclonal antibody 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, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
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