Monoclonal Antibody Therapeutics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Source Type (Murine, Chimeric, Humanized, and Human) By Application (Oncology, Autoimmune Diseases, Infectious Diseases, Neurological Diseases, and Others), By End User (Hospitals, Specialty Centers, and Others) and Region Forecast 2020-2031

Monoclonal Antibody Therapeutics Market size was valued at US$ 254.88 billion in 2024 and is expected to reach US$ 657.61 billion by 2031, growing at a significant CAGR of 14.5% from 2025-2031. The monoclonal antibody therapeutics industry seeks to develop and sell monoclonal antibodies (mAbs) as therapeutic agents against diseases, including cancer, autoimmune disorders, and infectious diseases. The market is driven by technological advancements in biotechnology, increasing incidence of chronic diseases, and drug development investments, enabling highly targeted treatments with greater efficacy. Restrictions to market expansion are high development expenses, rigorous regulatory approval, and biosimilar competition for established products. Though these limitations cause the market to retreat, developments in manufacturing technologies and expanding usage of personalized medicine will result in further growth in the market.

Facts & Figures:

• Oncology is still the largest area of application, where monoclonal antibodies are applied widely to treat cancer, e.g., checkpoint inhibitors against PD-1 and PD-L1.
• The U.S. FDA has approved more than 100 monoclonal antibody products, with existing breakthroughs in antibody fragments and bispecific antibodies.
• Expansion of biosimilars is transforming the monoclonal antibody market, with biosimilar adoption to increase at a CAGR of over 15%, increasing competition as well as the affordability of prices.
• The aging population is contributing towards market growth, with over 24% of the American population expected to be 65 years or older by 2060.
• In 2020, cancer alone accounted for an estimated 10 million deaths worldwide.

Key Developments:

• In January 2024, UCB Inc. received FDA approval for RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG).
• In November 2023, Almirall S.A.'s EBGLYSS (lebrikizumab) received an approval from the European Commission (EC). The medication is utilized in the therapy of moderate-to-severe atopic dermatitis (AD).
• In August 2023, Regeneron Pharmaceuticals, Inc. was approved by the FDA for Veopoz (pozelimab-bbfg) for CHAPLE disease.
• In March 2023, BioNTech SE and OncoC4, Inc. formed a strategic collaboration for co-development of monoclonal antibody candidate.

Monoclonal Antibody Therapeutics Market Segmentation:

Based on the source type:

• Murine
• Chimeric
• Humanized
• Human

The human source type dominated the largest proportion. Human mAbs provide effective modulation in effector functions and are less immunogenic than chimeric or humanized mAbs. These kinds of antibodies may be generated by application of phage display and hybridoma technologies to transgenic mice. Consequently, owing to recent technological advancements in genetic engineering, the manufacture of fully human mAbs is expected to gain momentum in the near future.

Based on the application:

• Oncology
• Autoimmune Diseases
• Infectious Diseases
• Neurological Diseases
• Others

Oncology segment accounted for the highest share in the applications market for mAbs. This is due to the fact that a high rate of regulatory approvals for the treatment of cancer using mAbs has occurred. Cancer prevalence is one of the major drivers that are expected to drive mAbs therapeutics growth since they may have zero or minimal side effects as compared to other drugs and chemotherapy. Some of the mAb therapies used now are non-small cell lung, brain tumor, ovarian, breast, gastric, melanoma, colorectal, Hodgkin's lymphoma, etc.

Based on the end user:

• Hospitals
• Specialty Centers
• Others

The hospitals segment accounted for the maximum market share because of the rising use of mAbs in cancer treatment at hospitals. Increased healthcare spending worldwide, patient awareness levels rising, and ready availability of sophisticated hospital infrastructure in developed nations are the drivers set to lead the segment to hold dominance in the forecast period.