Global Monoclonal Antibodies Market Share Grows at a Staggering CAGR of 15.2%

Introduction

Monoclonal antibodies are the laboratory-engineered proteins developed to target specific antigens and stimulate the immune system. These drugs are exact copies of one antibody; therefore, they are named monoclonal antibodies. Based on the source, the monoclonal antibodies are classified into human, humanized, murine, and chimeric. Oncology, inflammatory and autoimmune disorders, infections, and nervous system disorders are treated with monoclonal antibodies. After the approval of the first monoclonal antibody, there is a year-on-year growth was observed in the approvals of monoclonal antibody drugs. Patients can access these medications from hospitals, specialty clinics, and other healthcare facilities.

Market Dynamics

Rising prevalence of chronic diseases necessitates the demand for monoclonal antibodies

Increasing global incidence of chronic diseases such as cancer, neurological diseases, and autoimmune diseases is one of the drivers propelling the growth of the monoclonal antibodies market. This rise is mainly due to the geriatric population and lack of timely disease diagnosis, fuelling the demand for monoclonal antibody drugs.

• For instance, in 2022, as per the report of World Cancer Research Fund, a total of 420,368 cases of endometrial cancer were witnessed across the globe, in which UK landed in the list of top 10 countries of endometrial cancer cases, which signifies the need for monoclonal antibodies for the treatment of such conditions.
• For instance, in 2022, as per the data in the Global Cancer Observatory, 7452 cases of breast cancer were witnessed among the population across the country, signifying the need for monoclonal antibodies.

This highlighted rise in chronic conditions drives the need for effective medication, which, in turn, supports the market growth.

Surge in the development of advanced monoclonal antibodies: Key market opportunity

Expanding product pipelines and funding for developing novel monoclonal antibodies present numerous opportunities for the monoclonal antibodies market growth during the forecast period.

• In September 2024, the University of Texas Medical Branch was awarded an amount of USD 15 million per year from National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop vaccines and monoclonal antibodies.
• In November 2022, Torgny Stigbrand invested in Lipum for financing the recently initiated phase I study with SOL-116, which is a humanized monoclonal antibody that blocks Bile Salt-Stimulated Lipase (BSSL), which is a previously overlooked target molecule in the immune system.

Furthermore, as the healthcare systems shift toward personalized medicine, demand for monoclonal antibodies is expected to increase during the forecast period.

Regional Analysis

North America is the most significant global monoclonal antibodies market shareholder accounting for 47.09% share in 2024, owing to high prevalence of cancer and autoimmune diseases, availability and accessibility of monoclonal antibodies across the region, and presence of major key players such as Johnson & Johnson, Biogen Inc., and others that offers novel monoclonal antibodies. Additionally, the favourable reimbursement policies, continuous investment in R&D for developing novel targeted monoclonal antibodies further highlight the dominance of North America in the biologics industry.

The Asia-Pacific region is expected to register the fastest CAGR during the forecast period. This growth is attributed to rising awareness of disease management and the use of monoclonal antibodies in chronic care. Furthermore, regional companies such as Takeda Pharmaceuticals are actively engaged in developing new monoclonal antibodies, emerging as a competitive player in the region. Furthermore, the increasing geriatric population that is more prone to chronic diseases such as cancer and gastrointestinal diseases, exacerbates the demand for monoclonal antibodies. Moreover, countries such as China, India, and Japan are witnessing high demand for novel monoclonal antibodies due to a surge in cancer cases. osteoarthritis and other chronic diseases. The shift of foreign manufacturers towards Asia Pacific also makes it the fastest-growing region in the global market.

Key Highlights

• The global monoclonal antibodies market size was valued at USD 2,54,219.64 million in 2024 and is projected to grow at USD 9,16,719.19 million by 2033, exhibiting a CAGR of 15.2% during the forecast period (2025-2033).
• Based on type, the market is segmented into human, humanized, murine, and chimeric. The human segment accounted for a major monoclonal antibodies market share of owing to its high effectiveness in treating cancer and autoimmune diseases, wide availability of approved human monoclonal antibodies in developed countries, strong product pipeline, and rising product approvals for human monoclonal antibodies, making it a dominating segment in the monoclonal antibodies market.
• Based on application, the market is segmented into oncology, autoimmune diseases, hematologic diseases, neurological diseases, infectious diseases, dermatology, and others. The oncology segment dominated the monoclonal antibodies industry and is expected to register the fastest CAGR during the forecast period. This growth is attributed to growing prevalence of various cancers such as breast cancer, lung cancer, and others. Furthermore, monoclonal antibodies are increasingly used in cancer treatment as it offer effective disease management.
• Based on distribution channel, the market is segmented into hospital pharmacies, drug stores & retail pharmacies, and others. The hospitals' pharmacies segment accounted for the largest share in the monoclonal antibodies market, owing to requirements of cold storage, infusion administration, and close patient monitoring. All these requirements are easily fulfilled by hospital settings. Furthermore, drugs used in the treatment of cancer and autoimmune diseases are primarily treated in hospital settings, thereby driving the demand for monoclonal antibodies from hospital pharmacies.

Competitive Players

F. Hoffmann-La Roche Ltd., Johnson & Johnson Services, Inc., Merck Co., Inc., AbbVie Inc., Regeneron Pharmaceuticals Inc., Sanofi, Amgen Inc., AstraZeneca, Novartis AG, Biogen Inc., Eli Lilly and Company, Genmab A/S, Regeneron Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited

Recent Developments

• August 2024: Johnson and Johnson received approval for Nipocalimab, designed for antibody-positive generalized myasthenia gravis.
• August 2024: Incyte and Syndax announced U.S. FDA approval of Niktimvo (axatilimab-csfr) for Chronic Graft-Versus-Host Disease (GVHD).
• June 2023: Merck completed the acquisition of Prometheus Biosciences, Inc., delivering industry-leading research capability and strengthening the pipeline with a novel candidate.
• February 2024- Almirall announced its partnership with Novo Nordisk for developing and commercialising the IL-21 blocking monoclonal antibody NN-8828 for dermatological diseases.

Segmentation

1. By Type
   1. Human
   2. Humanized
   3. Chimeric
   4. Murine
2. By Application
   1. Oncology
   2. Autoimmune Diseases
   3. Hematologic diseases
   4. Neurological Diseases
   5. Infectious Diseases
   6. Dermatology
   7. Others
3. By Distribution Channel
   1. Hospital Pharmacies
   2. Drug Stores & Retail Pharmacies
   3. Others
4. By Region
   1. North America
   2. Europe
   3. Asia-Pacific
   4. Middle East & Africa
   5. Latin America