Monoclonal Antibodies Market Size, Share & Trends Analysis Report By Source (Murine, Chimeric, Humanized, Human), By Indication (Cancer, Autoimmune Diseases, Inflammatory Diseases, Infectious Diseases, Microbial Diseases, Others), By End-User (Hospitals, Research Institutes, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Monoclonal Antibodies Market Size

The global monoclonal antibodies market size was valued at USD 232.72 million in 2024 and is projected to grow from USD 261.44 million in 2025 to reach USD 707.81 million by 2033, exhibiting a CAGR of 13.3% during the forecast period (2025-2033). 

Monoclonal antibodies are laboratory-engineered molecules designed to bind specifically to antigens, such as those found on the surface of pathogens or cancer cells. These antibodies are produced by creating identical immune cells cloned from a unique parent cell, allowing for precise targeting of harmful cells while minimizing damage to healthy ones.

Monoclonal antibodies mimic the immune system's natural defense mechanisms and are widely used in treating various diseases, including cancers, autoimmune disorders, and infectious diseases. The rising prevalence of chronic diseases, the increasing use of monoclonal antibodies in oncology, and the growing approval of new monoclonal antibody therapies are significant contributors.

Moreover, the development of bispecific and multi-specific antibodies is advancing the field. Collaborations and partnerships between biotechnology companies and government research institutes further fuel market growth, solidifying the dominance of monoclonal antibodies in the healthcare sector.

Below graph represents the global incidence of cancer in 2022

Source: World Cancer Research Fund and Straits Research

Monoclonal Antibodies Market Trends

Growing development of bispecific & multi-specific antibodies

The trend of bispecific and multi-specific antibodies, including tri-specific and tetra-specific variations, is significantly driving market growth. These advanced antibodies represent a breakthrough in therapeutic applications by providing multiple antigen-binding sites, which enable targeting two or more different epitopes simultaneously.

The FDA has approved numerous bispecific antibodies, and over 100 multi-specific antibodies are currently undergoing clinical trials. This multi-targeting capability enhances specificity and effectiveness in treatment.

For example, in October 2023, EpimAb Biotherapeutics and Almirall entered a bispecific antibody license agreement targeting three undisclosed pairs, highlighting the growing industry focus on such innovative therapies.

These advancements in antibody technology are propelling market growth by offering enhanced therapeutic efficiency.

Rising adoption of monoclonal antibodies as personalized medicine

Monoclonal antibodies are increasingly adopted as personalized medicines due to their potential to tailor treatment for various diseases, offering a significant alternative to standard therapies. Their specificity in targeting diseases like cancer, autoimmune disorders, and infectious diseases underscores their role in personalized medicine.

• In December 2024, researchers from the University of Connecticut's Department of Pharmaceutical Sciences highlighted the monoclonal antibody 3E10, which targets the RAD51 protein. This study showcased the antibody's promise in advancing personalized medicine by effectively penetrating cells and enhancing targeted treatment.

The growing adoption of monoclonal antibodies for personalized medicine is a major driver of market growth, emphasizing their targeted efficiency and potential to transform therapeutic approaches.

Monoclonal Antibodies Market Growth Factors

Increasing approval of new mAb therapies

The rising number of approvals for new monoclonal antibodies is a significant driver of market growth. Monoclonal antibodies have proven highly effective in treating diseases such as cancer and other chronic conditions, making them increasingly valuable for disease-specific and personalized treatment approaches. This growing efficacy has spurred extensive research and development, leading to more regulatory approvals.

• For instance, in August 2023, the FDA approved elranatamab-bcmm for multiple myeloma, a bispecific B-cell maturation antigen-directed CD3 T-cell engager designed for adults with relapsed or refractory multiple myeloma. Likewise, the same month, the FDA approved talquetamab-tgvs, a first-in-class bispecific therapy for heavily pretreated multiple myeloma patients.

These approvals highlight the expanding role of monoclonal antibodies in modern therapeutics, driving market growth.

Increasing use of mAB in oncology

The adoption of monoclonal antibodies in cancer treatment is another key market driver. Cancer, a notoriously challenging disease to treat, demands highly targeted and effective therapies. Monoclonal antibodies provide a strong, targeted approach that significantly enhances cancer treatment outcomes.

• In April 2024, the FDA approved Pfizer's TIVDAK, an antibody-drug conjugate combining Genmab’s human monoclonal antibody with monomethyl auristatin E, for treating recurrent or metastatic cervical cancer. Similarly, fam-trastuzumab deruxtecan-nxki received FDA approval in April 2024 for treating unresectable or metastatic HER2-positive solid tumors.

These developments underscore the growing reliance on monoclonal antibodies in oncology, further propelling market expansion.

Market Restraining Factor

Patent expirations present challenges

Patent expirations pose significant challenges to the growth of the monoclonal antibodies market in several ways. When the patent for a monoclonal antibody expires, it opens the market to biosimilar manufacturers, increasing competition and potentially reducing the market share of the original product. This competition can lead to lower prices, thereby affecting the revenue of original manufacturers.

For example, Stelara, an IgG1 kappa human monoclonal antibody approved in 2016 for treating Crohn’s disease, had its patent protection expire in the U.S. in 2023 and is set to expire in Europe in 2024. The expiration of such patents invites biosimilar competition, challenging market dynamics and growth.

Thus, patent expirations restrain market growth by introducing challenges from biosimilar manufacturers and impacting investment strategies.

Market Opportunities

Expanding pipeline with emerging applications

The expanding pipeline of monoclonal antibodies, driven by their emerging applications across various diseases, presents significant market opportunities. Monoclonal antibodies are proving highly effective in treating different types of cancers and chronic diseases, and their role in personalized medicine is growing rapidly.

This efficiency and disease specificity are encouraging key players to invest heavily in research and development, leading to a robust pipeline of monoclonal antibodies in clinical trials. As these trials progress and new therapies gain approval, the market stands to benefit from innovative treatments tailored to specific medical needs.

Below table represents the number of monoclonal antibody products in the pipeline of various market players

Source: Company Websites & Straits Research

Thus, the presence of multiple products in the pipeline provides the scope for opportunities for overall market growth.

Regional Insights

North America: Dominant region with 47.43% market share

North America holds the largest revenue share in the monoclonal antibodies industry, driven by a robust healthcare infrastructure, substantial R&D investments, and a high prevalence of cancer. The presence of major industry players such as AbbVie Inc., Alexion Pharmaceuticals, Inc., and Amgen Inc. further reinforces the region’s leadership. Moreover, favorable regulatory support from agencies like the FDA accelerates the approval and adoption of monoclonal antibody therapies. These factors collectively ensure North America’s continued dominance in the global market, fostering innovation and growth.

Asia-Pacific: Rapid growth in China, Japan, and India

Asia Pacific is expected to experience the fastest CAGR in the global market, driven by the rising incidence of cancer and increasing awareness of advanced cancer treatments. The region's rapid market expansion is also supported by growing investments in healthcare infrastructure and government initiatives to improve access to immuno-oncology therapies.

In October 2024, the Indian government launched the Biotechnology Research Innovation and Entrepreneurship Development (bio-RIDE) scheme to advance the country’s biotechnology sector, boosting the regional market’s growth prospects.

Countries Insights

• U.S. –The U.S. leads the global market due to its robust healthcare system and substantial investments in R&D. Administrative bodies are committed to advancing monoclonal antibody development, as seen in October 2022 when the ASPR awarded a $109.8 million contract to Mapp Biopharmaceutical Inc. for developing treatments for Sudan ebolavirus (SUDV). Such initiatives ensure the continuous launch of innovative therapeutic products to address various diseases, reinforcing the U.S.'s market dominance.
• Canada –Canada's global market is growing, bolstered by government support and funding to expand manufacturing capacities. In February 2024, Eurofins CDMO Alphora, with substantial backing from the Federal Government of Canada, opened a new pilot-scale biologics development facility for monoclonal antibodies. These strategic investments are driving the market's growth, enabling biotechnology companies to scale production and meet increasing demand.
• Germany–Germany's well-established healthcare system and dedication to medical innovation fuel the market for monoclonal antibodies, especially with the rising cancer prevalence. In 2022, the World Cancer Research Fund reported 605,805 cancer cases in Germany, highlighting the growing need for effective treatments. This demand drives the development and adoption of monoclonal antibodies, solidifying Germany's position in the market.
• UK –The UK’s monoclonal antibodies industry benefits from strong government and regulatory support, ensuring the availability of various treatments. In August 2024, the UK became the first European country to authorize Leqembi (lecanemab) for early Alzheimer's disease. Such proactive measures by the government promote market growth by addressing life-threatening conditions with innovative therapies.
• France –France's market is expanding, driven by major players increasing their manufacturing capacity. In May 2024, Sanofi invested an additional $1.03 billion, doubling its monoclonal antibody production. These significant investments enhance the availability of multiple therapies, supporting the market's growth and readiness to tackle diverse diseases effectively.
• China -China’s market thrives on partnerships between key players, fostering innovation. In December 2024, Porton Pharma Solutions and Dragon Sail Pharmaceutical formed a strategic alliance, combining their expertise in biological drugs to develop novel monoclonal antibodies. Such collaborations drive market expansion by introducing advanced therapeutic options.
• Australia–Australia's market is booming, driven by growing R&D investments and increasing cancer prevalence. The Australian Institute of Health and Welfare estimates around 169,500 cancer cases will be diagnosed in 2024, emphasizing the need for effective treatments. These factors collectively contribute to the market’s rapid expansion and the development of advanced therapies.

Segmentation Analysis

The global monoclonal antibodies market is segmented into type, application, and distribution channels.

By Type

Human segment dominates the market with the largest market revenue

The human segment dominates the monoclonal antibodies market due to its superior efficacy, safety, and preventive value. Human monoclonal antibodies are developed quickly, aiding in the rapid response to health crises. Their ability to mitigate significant health and economic disruptions further bolsters their market leadership.

• For instance, in September 2023, Biocytogen launched the RenMice series, featuring fully human antibody mice and TCR mice, highlighting their innovative capabilities in developing novel biologics.

This innovation underscores the human segment’s dominance, driven by its ability to provide effective and timely solutions.

By Application

Oncology segment dominates the market with the largest market revenue

The oncology segment leads the global market due to the rising global prevalence of cancer and the increased focus of market players on developing targeted cancer therapies. This has resulted in a robust pipeline of monoclonal antibodies for oncology. According to the American Cancer Society, 20 million new cancer cases were reported globally in 2022, with projections reaching 35 million by 2050. The escalating need for effective cancer treatments ensures the oncology segment remains the dominant application, driving continued investment and innovation in monoclonal antibody therapies.

By Distribution Channel

Hospital pharmacies segment dominates the market with the largest market revenue

Hospital pharmacies dominate the market due to their essential role in the integrated care and treatment of critical conditions like cancer and autoimmune diseases. Monoclonal antibodies often require specialized administration in hospital settings, where hospital pharmacies provide superior support compared to other channels. Their direct connection with hospitals ensures patient-centric care, which is crucial for life-threatening conditions. This critical function makes hospital pharmacies the leading distribution channel, as they cater effectively to the specialized needs of patients requiring monoclonal antibody treatments.

Company Market Share

Key players in the global market are actively pursuing strategic collaborations, acquisitions, and partnerships to enhance their product offerings and broaden their market reach. These strategies enable companies to leverage complementary strengths, access new technologies, and enter emerging markets.

Fortis Life Sciences: An emerging provider in the global Monoclonal Antibodies Market

Fortis Life Sciences is an emerging player recognized for its innovative antibodies and antisera products, antigen proteins, assays, and kits, positioning the company as a key player in advancing biologics. The company’s commitment to research and development has led to the creation of high-quality, customizable solutions catering to diverse therapeutic needs.

Recent Development:

In May 2023, Fortis Life Sciences announced a strategic partnership with Lunaphore and Bethyl Laboratories to leverage its extensive library of primary antibodies on the COMET platform, aimed at expanding spatial biology services. This collaboration enhances Fortis's capability to offer advanced spatial biology solutions, facilitating precise and comprehensive analysis of tissue samples.

Recent Developments

• September 2024 -Harbour BioMed presented promising clinical data on HBM1020, a first-in-class, fully human anti-B7H7/HHLA2 monoclonal antibody, at the ESMO Congress 2024. This Phase I trial (NCT05824663) involved patients with advanced solid tumors and demonstrated that HBM1020 was well-tolerated across all tested doses, with no dose-limiting toxicities observed.

Analyst Opinion

As per our analyst, the global market is experiencing rapid expansion, driven by a variety of key factors. The rising prevalence of life-threatening diseases, such as cancer, autoimmune disorders, and infectious diseases, coupled with the increasing need for monoclonal antibodies as effective treatment options, is propelling market demand.

Moreover, advancements in biotechnology, the growing focus on personalized medicine, and the expanding pipeline of monoclonal antibody-based therapies are contributing to the market's robust growth. However, challenges like the high cost of monoclonal antibody therapies remain a significant barrier, limiting access to treatment for patients, especially in emerging markets.

The complexity of manufacturing monoclonal antibodies, along with regulatory hurdles and intellectual property concerns, poses risks to market expansion. Despite these challenges, the continued advancements in research and the increasing acceptance of monoclonal antibodies in clinical settings are expected to fuel future growth.