Veterinary medicine is a multi-billion dollar market. In the United States, there are an estimated 150 million dogs and cats. In recent years, an increasing number of biomedical companies (biotech, pharmaceutical, bio pharmaceutical, medical device, and diagnostic) have initiated efforts to advance their technologies and/or services into the animal health market. This serves two primary purposes, being to generate revenue and often obtain valuable data capture.

Misconceptions:

The process is simple. The process to get a veterinary product approved is not simple, and often requires years of work to obtain the necessary data to obtain an approval and support the product in the market.

The process is cheap. The costs do develop veterinary drugs or biologists is not cheap, and can range from several hundred thousand dollars to tens of millions, depending on the species, disease, etc.

The Food and Drug Administration (FDA) regulates all animal products: The FDA-Center for Veterinary Medicine regulates drugs. However, the United States Department of Agriculture (USDA) – Center for Veterinary Biologic regulates diagnostics, vaccines, immune based products (immune modulators and immune stimulants), and immunoglobulin products. In addition, the Environmental Protection Agency (EPA) regulates topical parasitical products like topical flea and tick control.

How to Develop and Animal Health Product:

We advise seeking an expert in the field. Far too often, someone tries to develop a product for veterinary medicine only to find out they did not have the expertise or understanding (regulatory, market, etc.) to effectively develop the product. There are several consulting groups that can advise on how to develop veterinary products or those for the pet market. Some consultants may limit their services to regulatory affairs, while others may focus more on clinical trials or marketing. Finding a group which satisfies your needs is important.

What are the Biggest Markets:

This is often hard to define. Companion animals (dogs, cats, horses) often represent the largest spending per species per visit. Livestock (cattle, swine, poultry) represent the largest volume but the economic pressures are often far greater per animal. Minor species (ferrets, rabbits, etc) is a growing market, and the FDA has recently enacted the Minor Use Minor Species Act (MUMS Act) to facilitate the develop of drugs for these species.

How to get Started:

Define the regulatory path: The first step is to understand which regulatory agency will oversee the development of the technology or service. Once this is defined, it will set the foundation for the necessary clinical trials, manufacturing, labeling, promotional materials, and other aspects that will define the product or service. If you are not certain of which group will have oversight of the regulations, you should consult with an expert to help define your regulatory strategy. Define the clinical path: Next, determining which trials (GLP, GCP) in target species will be required to support label claims and the approval. Don’t assume that previous lab animal work or unapproved studies will support your approval process. Define the market strategy and economics: After the regulatory path, clinical path, and timeline are estimated, it is very important to understand the economics of the market you are proposing to go into. The concept that pet owners will spend anything on their pets is a huge mistake. There is a limit, as with any market, on the cost of treatment. Constructing the financial justification will help avoid financial mistakes and raise the confidence that the project will meet financial metrics (ROI, NPV, etc.).