Veterinary Monoclonal Antibodies Market Size, Growth, Share & Trends Analysis

The expansion of the companion animal population and a rise in pet ownership worldwide are the primary drivers of the veterinary monoclonal antibodies market. In developed regions, such as North America and Europe, and emerging economies, including India and China, more individuals are keeping pets, which is increasing the demand for veterinary healthcare treatments and services. The American Pet Products Association (APPA) reported that 86.9 million US households (66%) had a pet during the 2023–2024 period, and the American Veterinary Medical Association (AVMA) indicated an increase in households owning dogs, from 31.3 million in 1996 to 59.8 million in 2024. Additionally, according to the European Pet Food Industry Federation (FEDIAF), the number of dogs increased from 104.34 million in 2022 to 106.36 million in 2023. With more companion animals in need of dermatological treatments and pain management, the growth of the veterinary monoclonal antibodies market is significantly driven.

Regulatory barriers and extended timelines for product approval remain a key limitation to growth in monoclonal antibodies for animal health. In the US, regulatory influence is bifurcated: immunomodulatory monoclonal antibodies are regulated by the USDA's Center for Veterinary Biologics (CVB), while other products fall under the control of the FDA's Center for Veterinary Medicine (CVM). The two-way path creates complexity of classification and lengthens submission periods. In both the US and Europe, veterinary monoclonal antibodies are required to follow stringent standards comparable to those for human biologics. These involve strict standards for safety, efficacy, and manufacturing consistency. Moreover, regulators are increasingly harmonizing veterinary monoclonal antibody standards with those of human biologics, thereby extending timelines further. For instance, Elanco's Canine Parvovirus Monoclonal Antibody (CPMA) received conditional approval from the USDA in 2023. Although demonstrating enhanced survival rates in puppies, CPMA still requires post-approval studies. This conditional route, although helpful in cases of immediate necessity, does not decrease the regulatory burden overall. Extended approval durations add expense and fiscal risk for manufacturers. These barriers hinder innovation, slowing the introduction of viable therapies to the market and thereby limiting the overall growth potential of veterinary monoclonal antibodies.

Traditionally, veterinary monoclonal antibodies are injected subcutaneously (SC) or intravenously (IV), which increases visits to veterinarians and compliance hurdles for chronic treatments. Researchers are exploring new routes, such as oral and intranasal delivery, to overcome these factors. For instance, Animab's Nanoprotec, intended for piglets, will be administered orally through drinking water to provide passive immunity against enterotoxigenic E. coli (ETEC) F4. The disease causes havoc-inducing diarrhea in piglets, and Animab's technology provides tight, antibiotic-free regulation via a gut-delivered mAb, streamlining administration in livestock environments and eliminating the need for injections. The product is positioned to be filed with the European Medicines Agency (EMA) in 2025 and will be marketed in Europe by late 2026. Although currently directed toward swine, this oral delivery method presents opportunities for analogous uses in companion animals, such as gastrointestinal disease oral formulations or intranasal monoclonal antibodies against respiratory viruses. These non-parenteral routes have the potential to enhance pet owner compliance, decrease stress in animals, and expand biologic utilization into home care, particularly in regions with limited veterinary coverage.

A growing concern regarding the use of monoclonal antibodies in veterinary medicine is the emergence of adverse events associated with their administration, particularly with respect to Zoetis' Librela (bedinvetmab) for the treatment of osteoarthritis in dogs. Since the US licensing in May 2023, the FDA's Center for Veterinary Medicine (CVM) has begun collecting an overwhelming number of adverse event reports, which were highlighted by the American Veterinary Medical Association (AVMA) in April 2024. Reported side effects were lethargy, vomiting, anorexia, diarrhea, pain at the injection site, and, in the most severe instances, neurological events such as seizures, ataxia, and death. It is essential to note that although several cases involved dogs with health issues that may have contributed to the events or were taking other concomitant medications, the frequency of these events prompted the FDA to conduct a formal assessment, stating the need for limitless scrutiny regarding adverse events. Moreover, there is also concern about the long-term safety of chronic administration of mAbs in veterinary medicine, such as Librela and Cytopoint, which involve monthly repeat dosing or long-term administration as needed for care. Due to the lack of strong longitudinal studies, the cumulative effects of chronic immune-modulation therapies, such as Librela, remain uncertain.