Monoclonal Antibody Therapeutics Market Size to Reach USD 619.60 Billion by 2031, Driven by Production of mAB-Based Drugs to Treat Several Diseases and Innovative Product Launches Propels | The Insight Partners

According to a new comprehensive report from The Insight Partners, the global monoclonal antibody therapeutics market is witnessing substantial growth with the production of mAB-based drugs to treat several diseases and innovative product launches.

/EIN News/ -- US & Canada, May 30, 2025 (GLOBE NEWSWIRE) -- The report carries an in-depth analysis of market trends, key players, and future opportunities. The monoclonal antibody therapeutics market study focuses on an array of products and technologies that are expected to fuel the demand in the coming years.

The monoclonal antibody therapeutics market is booming with advancements in technology, the increase in chronic diseases, and the demand for personalized medicine. Recombinant DNA and hybridoma technology have enabled monoclonal antibody therapies to be more effective and specific. These therapies have been put to use in treating cancer, autoimmune diseases, and infectious diseases. North America is the leading investing region and will benefit more than Europe and the United Kingdom, mainly due to high healthcare spending and more advanced healthcare infrastructure.

Asia Pacific is also likely to be the space with the fastest growth potential as healthcare infrastructure improves, healthcare awareness and spending accelerate, and investment in biopharmaceuticals and related research grows. The increased adoption of biosimilars and strategic alliances among pharmaceutical companies is set to give the FDA more tools, tactics, and plans for correcting declines that limit the accessibility and affordability of monoclonal antibody therapies. In summary, the monoclonal antibody therapeutics market will experience explosive growth as technology advances, rates of diseases increase, and personalized medicine adoption continues to expand.

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Overview of Report Findings

1. Market Growth: The monoclonal antibody therapeutics market is expected to reach US$ 619.60 billion by 2031 from US$ 249.14 billion in 2024; it is anticipated to record a CAGR of 13.9% during the forecast period. Monoclonal antibody therapeutics are artificially manufactured antibodies that can imitate, restore, or enhance the immune system's response to harmful agents. These biologics are characterized by their high specificity as they are made to bind to identifiable antigens on cancer cells, viruses, and other disease-causing agents. Monoclonal antibodies are administered for treating various diseases and conditions (including oncology, autoimmune diseases, and infectious diseases). Monoclonal antibody therapeutics allow for specificity and reduced adverse effects, unlike traditional therapies. The therapeutic market for monoclonal antibodies continues to grow significantly due to the increased incidence of chronic diseases, breakthroughs in biotechnology, and the growth of personalized medicines. The success of monoclonal antibodies as a treatment for COVID-19 opened the door to investing in monetizing their therapeutic potential, leading to significant research and investment. Trends also suggest that the market for monoclonal antibodies will remain on a growth trajectory due to supportive regulatory policies, an increase in approval rates for novel monoclonal antibody products, and strong acceptance in emerging economies. Projections for the monoclonal antibody market continue to indicate it will reach considerable market figures in the coming years, indicating that monoclonal antibody therapeutics should be a priority in the biopharmaceutical sector.
   
2. Increasing Incidence of Chronic and Autoimmune Diseases: The increasing incidence of both chronic and autoimmune diseases is a considerable force propelling the growth of the monoclonal antibody (mAb) therapeutics market. Although mAb therapeutics remain a small segment of the overall therapeutics market, they treat a number of chronic and autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, Crohn’s Disease, and various types of cancers. Unlike traditional therapies, mAb therapeutics are highly specific in targeting disease-associated antigens and provide better responses with higher efficacy and fewer side effects. As awareness grows among healthcare providers and patients regarding biologic treatments, the demand for mAb therapeutics propels. Along with recognized demand, biotechnology and genetic engineering have made significant progress to allow developments in creating and producing better, lower-cost monoclonal antibodies, creating considerable excitement in the healthcare market. Pharmaceuticals are responding with enormous investments in research and development, accelerating their (new mAb therapeutics) product pipelines, ending with more mAb therapeutics on the market.
   
3. Next-Generation Antibody Technologies: Next-generation antibody technologies are transforming the mAb therapeutics market with better efficacy, safety, and specificity. Novel approaches, including bispecific antibodies, antibody-drug conjugates (ADCs), and engineered Fc regions, are allowing for more precise classes of therapeutics for difficult-to-treat diseases such as cancers, autoimmune diseases, and infectious diseases. These novel approaches allow for better pharmacokinetics and the capability to engage multiple antigens or immune pathways simultaneously. In addition, antibody humanization and fully human antibody libraries minimize potential immunogenicity risks in patients, improving overall outcomes. Artificial intelligence and high-throughput screening are also speeding up the mAb discovery and optimizing processes, allowing pharmaceutical companies to shorten timeframes for development. The monoclonal antibody business will begin to skyrocket as biopharmaceutical companies embrace novel antibody technologies and change the monoclonal antibody landscape toward demand for more efficient, effective, and tailored therapeutics. As a result, next-generation antibody platforms represent a major opportunity for transformation and development of the future of targeted therapeutics.
   
4. Geographical Insights: In 2024, North America led the monoclonal antibody therapeutics market with a substantial revenue share, followed by Europe and Asia Pacific. Further, Asia Pacific is expected to register the highest CAGR during the forecast period.
   
   

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Market Segmentation

• Based on product, the market is segmented into recombinant mABs, antibody-drug conjugates, bispecific and multispecific mABs, biosimilars, and others. The recombinant mABs segment held the largest share of the market in 2024.
• By application, the market is categorized into cancer, autoimmune diseases, rheumatoid arthritis, psoriasis, ulcerative colitis, and others. The autoimmune diseases segment accounted for the largest share of the market in 2024.
• In terms of distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and others. The hospital pharmacies segment dominated the market in 2024.
• The monoclonal antibody therapeutics market is segmented into five major regions: North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

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Competitive Strategy and Development

• Key Players: GlaxoSmithKline, F.Hoffmann-La-Roche, Bayer AG, Amgen, Novartis, AbbVie, Bristol-Myers Squibb, Janssen Pharmaceutical, Merck KgaA, and AstraZeneca are among the major companies operating in the market.
• Trending Topics: Radiolabeled monoclonal antibodies (radioimmunotherapy), AI-engineered antibody design & in silico screening, sustainable manufacturing of mAbs, and microbiome-modulating monoclonal antibodies.

Global Headlines on Monoclonal Antibody Therapeutics

• Salipro Biotech and Icosagen launch antibody discovery collaboration.
• Antibody therapeutics approved or in regulatory review in the EU or US.
• LifeArc and Cleveland Clinic join forces to develop new monoclonal antibody therapeutics for patients with high unmet medical needs.
• AbbVie and OSE Immunotherapeutics announce a partnership to develop a novel monoclonal antibody for the treatment of chronic inflammation.

Conclusion

The report from The Insight Partners lists several stakeholders—including pharmaceutical companies, biotechnology firms, contract research organizations (CROs), and healthcare providers—along with valuable insights to navigate this evolving market landscape and unlock new opportunities successfully.

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