Human vs Animal Drug Approval Process Comparison – Part II
The Market and Regulatory Process Timelines
The animal health market is around 5% of the human pharmaceutical market size. The global pharmaceuticals market was worth $934.8 billion in 2017 and will reach $1170 billion in 2021, growing at 5.8% meaning the global animal health market size is large in its own right [Business Research Company] Animal health was valued at $44.74 billion in 2018 and is expected to witness a CAGR of 5% through to 2026. [GVR-1-68038-763-6]
The drug industries for both humans and animals are fuelled by a constant, very long pipeline of innovative new medicines that must be approved by regulatory agencies before they can be sold on the market. This process takes decades and is very costly. In the complete 2018 cohort of FDA approved drugs, regulatory approval took a median of 14 years from the time of first patent filing to commercial launch. According to the pharmaceutical giant Roche "it takes, on average, 7,000,874 hours of work, 6,587 experiments and 423 researchers to get a single drug from molecule discovery to market." The average cost of bringing a single drug for people to market has been estimated to be over $2.6 billion. [DiMasi]
The approval process for animal drugs is comparatively faster and more cost-efficient. According to the Animal Health Institute on average, it can take between 7-9 years to bring an animal drug to market. Toxicology studies constitute a significant component and take 2-5 years to complete. [Hunter] In 2015 it took on average 6.5 years and $22.5 million to bring a new pet pharmaceutical to market. [Animal Health Institute]
