Monoclonal Antibodies Market Size, Growth & Forecast To 2033

Monoclonal antibodies (mAbs) are laboratory-produced molecules engineered to act as substitute antibodies that restore, enhance, or mimic the immune system's attack on harmful cells, such as cancer cells, bacteria, or viruses. These antibodies are designed to bind to one particular target, a protein found on the surface of a pathogen or diseased cell. There are various types of mAbs, such as murine, chimeric, humanized, and human, which are applicable for treating various types of diseases such as cancer, autoimmune diseases, infectious diseases, neurological diseases, and some other diseases.

Increasing approval of new mAb therapies drives the global market

The increasing approval of new monoclonal antibody (mAb) therapies is a key factor driving the market's expansion. Monoclonal antibodies have demonstrated exceptional effectiveness in treating diseases like cancer and chronic conditions, making them crucial for both disease-specific and personalized treatment strategies. This success has led to greater research investments and a growing number of regulatory approvals.

For example, in August 2023, the FDA granted approval to elranatamab-bcmm for multiple myeloma, a bispecific B-cell maturation antigen-directed CD3 T-cell engager designed for patients with relapsed or refractory multiple myeloma.
These regulatory milestones underscore the increasing importance of monoclonal antibodies in modern medicine, further accelerating market growth.

Growing development of bispecific & multi-specific antibodies creates tremendous opportunities

The growing focus on bispecific and multi-specific antibodies, including tri-specific and tetra-specific variations, presents significant opportunities in the monoclonal antibodies market. These advanced antibodies represent a breakthrough in therapeutic applications, as they feature multiple antigen-binding sites that allow for targeting two or more different epitopes simultaneously. This multi-targeting ability enhances both specificity and therapeutic efficacy.

For instance, in October 2023, EpimAb Biotherapeutics and Almirall entered into a bispecific antibody license agreement targeting three undisclosed pairs. This collaboration underscores the increasing industry shift toward innovative, multi-targeted therapies. Such advancements in antibody technology are opening new doors for more effective treatments, driving future market growth, and offering opportunities for companies.

North America dominates the global market, capturing the largest revenue share. This dominance is driven by several factors, including a well-established healthcare infrastructure, significant investments in research and development, and a high prevalence of chronic diseases, particularly cancer. The region also benefits from a favorable regulatory environment that accelerates approval processes and the introduction of innovative therapies. The presence of leading pharmaceutical companies such as AbbVie Inc., Alexion Pharmaceuticals, Inc., and Amgen Inc. further strengthens the market.

• 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).
• By type, the global monoclonal antibodies market is segmented into murine, chimeric, humanized, and human. The human segment leads the market, accounting for a significant share.
• By application, the global monoclonal antibodies market is segmented into oncology, autoimmune diseases, infectious diseases, neurological diseases, and others. The oncology segment owns the highest market share.
• By distribution channel, the global market is segmented into hospital pharmacies, drug stores & retail pharmacies, and others. The hospital pharmacies segment dominates the market, accounting for a significant share.
• North America is the most significant global monoclonal antibodies market shareholder.

The key players in the global market are AbbVie Inc., Alexion Pharmaceuticals, Inc., Amgen Inc., AstraZeneca plc, Bayer AG, Biogen Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Genmab A/S, GlaxoSmithKline plc, Novartis AG, Pfizer Inc., Regeneron Pharmaceuticals, Inc., Roche Holding AG, Sanofi S.A., Takeda Pharmaceutical Company Limited, UCB S.A., Fortis Life Sciences, and others.

• In 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.