U.S. Monoclonal Antibodies Market Report Highlights
• By source, the human source type held the largest share and accounted for 34.3% of the market value in 2024.
• By source, Humanized mAbs are expected to grow at the fastest CAGR of 11.7% over the forecast period.
• By production type, the In Vitro segment registered its dominance over the U.S. market share of 56.9% in 2024.
• By production type, the In Vivo segment is predicted to witness significant growth in the market over the forecast period.
• By application, the Oncology segment dominated the applications market for mAbs and accounted for 38.2% of the market value in 2024.
• By application, the autoimmune diseases segment will gain a significant share of the market over the studied period of 2025 to 2034.
• By end use, the hospitals segment dominated the market share of 30.7%.in 2024.
• By end use, the specialty centers segment is projected to expand rapidly in the market in the coming years.
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The market Growing demand for biosimilars is estimated to drive the growth of the U.S. monoclonal antibodies market. The expiration of patents for blockbuster mAbs (e.g., Humira) has led to a rise in biosimilars, making mAb therapies more affordable. Companies like Amgen, Sandoz, and Biocon are investing heavily in biosimilar development. The key players operating in the market are focused on adopting inorganic growth strategies like partnership or collaboration to develop monoclonal antibodies, which has been estimated to drive the growth of the U.S. monoclonal antibodies market.
The rising prevalence of chronic and autoimmune diseases has been estimated to drive the growth of the U.S. monoclonal anti-bodies market in the near future. mAbs are widely used in cancer treatment, autoimmune diseases (e.g., rheumatoid arthritis, multiple sclerosis), and inflammatory disorders. Increasing cases of cancer, diabetes, and neurological diseases drive demand for targeted mAb therapies. For instance, in January 2025, according to the data published by the World Health Organization, it was estimated that Approximately 8% of people in the US suffer from an autoimmune disease, and women make up almost 80% of those affected. New features to increase accuracy, usability, and interoperability are part of the ICD-11 update for 2025. By 2033, the market for autoimmune disease diagnostics is anticipated to grow to US$10.63 billion.
Advancements in biotechnology and genetic engineering are estimated to drive the growth of the U.S. monoclonal antibodies market in the near future. Improved recombinant DNA technology and hybridoma technology have enhanced the development of mAbs. Innovations like bispecific antibodies and antibody-drug conjugates (ADCs) improve treatment efficacy. For instance, in October 2024, City Therapeutics, Inc., a leading next-generation RNAi therapeutics company, declared its intention to spearhead the development of RNA interference (RNA1)-based therapeutics in the future. By using next-generation engineering of tiny interfering RNAS (siRNAs), the "trigger" molecules that drive RNAi, City Therapeutics TM hopes to develop a strong and long-lasting product engine and increase the therapeutic reach of RNAi-based medications. The company has completed a US$135 million Series A financing led by ARCH Venture Partners, with participation from other top life sciences investors such as Fidelity Management & Research Company, Invus, Slate Path Capital, Rock Springs Capital, Regeneron Ventures, AN Ventures, and others. The financing was led by executive chair John Maraganore, Ph.D., the founding CEO of Alnylam Pharmaceuticals, Inc.
Expanding applications beyond oncology has been estimated to drive the U.S. monoclonal anti bodies market in the near future. mAbs are now widely used in infectious diseases, cardiovascular diseases, and neurological disorders. COVID-19 treatment: Emergency use of mAbs like bamlanivimab and casirivimab/imdevimab. Increasing investments in R&D and biopharmaceutical manufacturing are estimated to drive the growth of the U.S. monoclonal anti bodies market in the near future. Pharmaceutical giants (e.g., Roche, AbbVie, Pfizer) and biotech startups are investing in next-generation mAb research. Improved production techniques, such as cell culture engineering, have made large-scale mAb manufacturing more efficient.
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Monoclonal Antibodies Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2026 |
USD 106.41 billion |
|
Revenue forecast in 2034 |
USD 284.90 billion |
|
Growth rate |
CAGR of 13.1% from 2025 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2019 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD billion and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Source type, production type, application, end-use, region |
|
Key companies profiled |
Novartis AG; Pfizer Inc; GlaxoSmithKline plc; Amgen Inc.; Merck & Co., Inc.; Daiichi Sankyo Company, Limited; Abbott Laboratories; AstraZeneca plc; Eli Lilly And Company; Johnson & Johnson Services, Inc.; Bayer AG; Bristol Myers Squibb; F. Hoffman-La Roche Ltd.; Viatris Inc.; Biogen Inc.; Thermo Fisher Scientific, Inc.; Novo Nordisk A/S; Sanofi S.A.; Merck KGaA |
Risks / Benefits
What are the advantages of using monoclonal antibodies?
One key advantage of using monoclonal antibodies is they’ve been used to make drugs that have been more successful at treating certain diseases, such as some cancers.
Another advantage of using monoclonal antibodies as a treatment is that they’re more precise than other treatments. This improves the effectiveness and can reduce some side effects.
Monoclonal antibody quality is standard for all production batches, which is important for use as therapy, as well as for diagnostics.
It’s now possible to make monoclonal antibodies in large quantities.
What are the risks or complications of using monoclonal antibodies?
Infusion reactions are common, and occur during or shortly after monoclonal antibody treatment. These occur when your body has a strong immune response to the monoclonal antibody treatment. Common signs of infusion reaction are rash, fever, rigors/chills, shortness of breath, sweating, changes in blood pressure and increased heart rate. Slowing down the infusion or decreasing the dose can help limit such reactions.
There’re more serious but less common risks linked to unwanted immune system reactions, such as acute anaphylaxis, cytokine release syndrome (CRS) and serum sickness.
Acute anaphylaxis is a massive allergic reaction that can be life-threatening. Serum sickness happens when your body’s immune system attacks the antiserum, or a blood product containing the proteins that your healthcare team is using to try to help you. CRS is also called cytokine storm and can lead to organ damage.
Some of the risks related to monoclonal antibody therapy are specific to the type of condition being treated. For instance, tumor lysis syndrome is a condition that’s usually caused by cancer treatment that can result in kidney failure.
Artificial Intelligencerole in U.S. Monoclonal Antibodies Market
AI integration is revolutionizing the monoclonal antibodies (mAbs) industry by improving drug discovery, development, manufacturing, and personalization. AI-powered algorithms analyze vast biological and chemical datasets to identify potential mAb targets faster. Machine learning (ML) models predict antibody-antigen interactions, reducing the need for extensive laboratory experiments. AI-driven platforms like DeepMind’s AlphaFold help design optimized antibody structures.
AI helps modify antibody structures to improve binding affinity, stability, and specificity. AI-based de novo antibody design enables the creation of novel mAbs that were previously impossible to develop. Companies like Insilico Medicine and BenevolentAI use AI to generate next-generation antibody therapeutics. AI analyzes patient genomics and real-world clinical data to identify biomarkers for mAb therapies. The AI integration helps in patient selection for clinical trials, increasing trial success rates. AI-assisted companion diagnostics predict which patients will respond best to mAb treatments. AI-driven automation in bioreactors optimizes cell culture conditions, improving antibody yield and purity. AI detects contaminants and production errors in real time, ensuring consistent manufacturing standards. AI-powered predictive maintenance reduces downtime in mAb production plants.
AI analyzes genomic and proteomic data to tailor mAb therapies for individual patients. Supports the development of bispecific and multi-target antibodies for complex diseases. AI reduces R&D timelines by predicting antibody behavior before expensive lab testing. Automated AI platforms lower production costs, making mAb therapies more affordable. AI identifies new disease indications for existing mAbs, expanding their market potential. AI found that certain cancer-targeting mAbs may be effective in treating autoimmune diseases. AI integration is transforming the mAbs industry by reducing development time, lowering costs, and improving drug efficacy. With AI-powered innovation, next-generation monoclonal antibodies will reach patients faster, making personalized and precision treatments more accessible.
Market Trends
• Expansion into Oncology: Biopharmaceutical companies are increasingly focusing on developing mAbs for cancer treatment. For instance, Vir Biotechnology, initially known for its infectious disease treatments, has pivoted towards oncology. In mid-2023, Vir reported positive early-stage trial results for its cancer drugs VIR-5818 and VIR-5500, showing encouraging clinical responses in patients with solid tumors.
• Diversification of Therapeutic Applications: Beyond oncology, mAbs are being developed for a range of therapeutic areas, including autoimmune diseases, infectious diseases, and cardiovascular conditions. This diversification is expanding the market and providing new treatment options for various medical conditions.
• Technological Advancements: Innovations in biotechnology and genetic engineering are enhancing the development and production of mAbs. Techniques such as recombinant DNA technology and hybridoma technology are improving the efficacy and safety profiles of mAb therapies.
• Increased Investment in Research and Development: There is a notable increase in public-private investments in R&D within the U.S., contributing to the growth of the research antibodies market.
U.S. Monoclonal Antibodies Market Segment Insights
Source type Insights
The human mAb segment held a dominant presence in the U.S. monoclonal anti bodies market in 2024. Compared to chimeric or humanized mAbs, human mAbs are less immunogenic and provide effective regulation of effector activities. Transgenic mice can be used to manufacture these antibodies using phage display and hybridoma technologies. The creation of fully human mAbs is, therefore, expected to gain pace soon because of recent advancements in genetic engineering technology.
The humanized mAbs segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034. Since they are widely used to combat a variety of target antigens, including cancer cells, immunosuppressive and immunomodulatory substances, and more, their decreased immunogenicity in comparison to chimeric mAbs further supports the need for such antibodies. However, compared to human mAbs, these antibodies are more immunogenic, which could limit market expansion.
Production Methods Insights
In Vitro production type segment led the U.S. monoclonal anti bodies market as it is less likely to become contaminated with foreign antigens and is economically viable in large production runs. Serum-free culture media and semi-permeable membrane-based systems have also made biomanufacturing processes more feasible and are anticipated to spur market expansion. Nevertheless, the production type is constrained by differences in hybridoma properties, which may cause antibodies to become denatured or inactivated and limit the growth of the segment.
In vivo production type segment is anticipated to grow with the highest CAGR in the market during the studied years. Since it can create a high concentration of mAbs and is far more affordable to produce than in vitro methods, these mAbs are employed in the diagnostic sector, where optimizing in vivo processes to boost mAb secretion is possible and economic considerations are crucial.
Application Insights
By indication, the oncology segment dominated the market in 2024. This is explained by the large number of regulatory approvals for monoclonal antibodies intended to treat cancer. Since mAbs medicines can have fewer side effects than other medications and chemotherapy treatments, the rise in cancer incidence is one of the main factors expected to propel their expansion. Non-small cell lung, brain tumor, ovarian, breast, gastric, melanoma, colorectal, Hodgkin's lymphoma, and other conditions are among the current range of mAb therapies that are accessible.
The autoimmune disease segment is projected to expand rapidly in the U.S. monoclonal antibodies market in the coming years as a result of autoimmune diseases like rheumatoid arthritis becoming more common. Furthermore, it is expected that the use of mAbs in this field will increase as more cytokine proteins linked to inflammatory pathways are discovered and can be targeted to reduce disease.
By Distribution Channel Insights
The hospitals segment led the market in 2024. Since hospitals are increasingly using mAbs to treat cancer. The category is anticipated to dominate over the projected period due to factors such as rising healthcare expenditures worldwide, rising patient awareness, and the availability of sophisticated hospital infrastructure in developed nations.
The retail pharmacy segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034, as of the government's growing assistance in recent years. For instance, the Cancer Centers Program of the National Cancer Institute is creating guidelines for transdisciplinary cancer centers that specialize in the detection, diagnosis, and treatment of different kinds of cancer. It is anticipated that such activities will have a positive impact on the growth of the segment.
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Recent Developments:
• In December 2024, The U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for clesrovimab (MK-1654), Merck's investigational prophylactic long-acting monoclonal antibody intended to shield newborns from respiratory syncytial virus (RSV) illness during their first RSV season. Merck is known as MSD outside of the United States and Canada. June 10, 2025, is the date of the FDA's Prescription Drug User Fee Act (PDUFA) target action.
• In February 2025, The 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress, which will take place in San Diego, California, from February 28 to March 3, 2025, will feature new data presented by IgGenix, Inc., a clinical-stage biotechnology company that is leading the way in developing revolutionary treatments for immune-mediated diseases. The information advances our knowledge of Alpha-gal Syndrome (AGS), commonly referred to as red meat allergy, by demonstrating the identification of alpha-gal-specific monoclonal antibodies (mAbs) from red meat-allergic patients.
U.S. Monoclonal Antibodies Market Top Key Companies:
• Novartis AG
• Pfizer Inc
• GlaxoSmithKline plc
• Amgen Inc.
• Merck & Co., Inc.
• Daiichi Sankyo Company, Limited
• Abbott Laboratories
• AstraZeneca plc
• Eli Lilly And Company
• Johnson & Johnson Services, Inc.
• Bayer AG
• Bristol Myers Squibb
• F. Hoffman-La Roche Ltd.
• Viatris Inc.
• Biogen Inc.
• Thermo Fisher Scientific, Inc.
• Novo Nordisk A/S
• Sanofi S.A.
• Merck KGaA
U.S. Monoclonal Antibodies Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. Monoclonal Antibodies Market
By Source type
• Murine
• Chimeric
• Humanized
• Human
By Production Type
• In Vivo
• In Vitro
By Application
• Oncology
• Autoimmune Diseases
• Infectious Diseases
• Neurological Diseases
• Others
By End-use
• Hospitals
• Specialty Centers
• Others
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Browse More Research Reports ;
U.S. Biosimilar Monoclonal Antibody Market : The U.S. biosimilar monoclonal antibody market size accounted for USD 3,210 million in 2024 and is expected to exceed around USD 26,500 million by 2034, growing at a CAGR of 23.5% from 2025 to 2034.
U.S. Biosimilars Market : The U.S. biosimilars market size is calculated at USD 22.59 billion in 2025 and is predicted to reach around USD 93.52 billion by 2034, expanding at a CAGR of 17.1% from 2025 to 2034.
U.S. Antibody Drug Conjugates Market : The U.S. antibody drug conjugates market size was estimated at USD 4,020 million in 2024 and is projected to be worth around USD 12,050 million by 2034, growing at a CAGR of 11.6% from 2024 to 2034.
Antibody Discovery Market ; The global antibody discovery market size is calculated at USD 8,700 million in 2024 and is predicted to reach around USD 22,570 million by 2034, expanding at a CAGR of 10% from 2024 to 2034.
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