U.S. Animal Drug Compounding Market - Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Country: (U.S.)

The animal drug compounding market is witnessing a significant surge in demand, driven by the unavailability of branded drugs with desired active ingredients and the growing trend of pet humanization. Compounding pharmacies, operating with licensed pharmacists or physicians, are stepping up to provide tailored medication solutions for animals, addressing a crucial gap in veterinary care.

Addressing Unavailability of Branded Drugs

Animal drug compounding has become essential for veterinarians, especially when FDA-approved drugs are unavailable. For instance, there is currently no FDA-approved drug for treating megacolon in cats. Cisapride, once the only safe and effective therapy for chronic constipation in cats, was removed from the U.S. market in 2000. Compounded cisapride remains the sole option for effective pro-kinetic drug therapy in these cases.

Similarly, drugs containing bromides, removed from the U.S. market in the 1970s, are still prescribed by compounding pharmacies due to their safety and efficacy in treating idiopathic epilepsy in dogs. This highlights the critical role of animal drug compounding in providing necessary medical therapy where branded drugs are not available.

Meeting Therapeutic Needs with Unapproved FDA Drugs

The spectrum of therapeutic needs in the animal medicine industry is broad, while the availability of FDA-approved drugs for all animal diseases and indications remains limited. Animal drug compounding fills this therapeutic gap, offering customized solutions for various animal species. The demand for compounded animal drugs is significantly higher than for branded prescription drugs, underscoring the importance of this practice in veterinary care.

Flavoring: Enhancing Treatment Compliance

One notable trend in animal drug compounding is the availability of flavored medications. Flavored drugs improve treatment adherence among pets, making it easier for owners to administer necessary medications. For example, metronidazole compounded with sardine or tuna-flavored suspension increases palatability, enhancing compliance. Exotic animals, such as birds and sugar gliders, prefer sweet flavors like strawberry, banana, or tutti frutti. This innovation in flavoring is gaining considerable attention from pet owners and veterinarians alike.

Well-Informed Pet Owners Drive Demand

The increased humanization of pets, rising adoption rates, and the influx of medical information via the internet are propelling the demand for animal drug compounding. According to the American Pet Products Association, U.S. families owned 70-80 million dogs and 74-96 million cats in 2015. Access to ready information makes pet owners more perceptive and demanding, raising the bar for veterinary care and compounding services.

Despite the lack of reimbursement for animal drug compounding, pet owners are willing to bear out-of-pocket expenses. However, issues such as undesired potency levels, dissolution characteristics, and sub-standard dosage can deter the uptake of compounded drugs. Nonetheless, the animal drug compounding industry continues to see a steady increase in revenue generation.

Regulatory Compliance: A Key to Increased Consumer Confidence

Adherence to regulatory requirements and self-nomination for FDA inspections are crucial for the future of animal drug compounding. Compliance with cGMP guidelines enhances drug and brand value, boosting consumer confidence and uptake. Regulatory inspections ensure good manufacturing practices, further increasing the reliability of compounded drugs.

As of 2015, less than 3% of animal drug compounding pharmacies were accredited by the PCAB. Additionally, only 48 facilities in the U.S. are registered and authorized to engage in bulk API manufacturing. If the over 3,500 animal drug compounding pharmacies in the U.S. obtain FDA and PCAB certification, it could significantly impact customer uptake for these customized drugs.

Competitive Analysis

• Hoye's Pharmacy
• Vertisis Custom Pharmacy
• Smith Caldwell Drug Store
• Sixth Avenue Medical Pharmacy
• Dougherty's Pharmacy
• Triangle Compounding Pharmacy Inc.
• Medisca Inc.
• Wedgewood Pharmacy
• Millers Pharmacy

Key Market Segmentation

basis of type*CNS Agents

• Anti-Infective Agents
• Hormones and Substitutes
• Anti-inflammatory Agents
• Others

basis of animal type*Companion Animals

• oDogs
• oCats
• oOthers
• Livestock Animals

basis of formulation*Oral

• Injectable
• Others

Region

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East and Africa (MEA)