What is the average duration for the development of most new drugs from discovery to marketing approval?

The average duration for the development of most new drugs, from the early stages of discovery through to marketing approval, typically spans a long timeframe, often around 9 years or more. This lengthy process involves several critical phases, including preclinical research, clinical trials (which can take several years), and regulatory review.

In the initial preclinical phase, researchers test the drug in laboratory settings and on animal models to assess its safety and efficacy. If the results are promising, the drug then progresses to clinical trials, which are conducted in phases—each lasting several years—to evaluate the drug's safety, optimal dosages, and effectiveness in human subjects. This meticulous process is necessary to ensure that any new medication is safe for public use and meets regulatory standards set by agencies like the FDA.

Following successful clinical trials, the drug application is submitted for regulatory review, which can also take a considerable amount of time as regulators thoroughly evaluate the submitted evidence. Given these factors, the entire process generally exceeds 9 years, primarily driven by stringent testing and regulatory requirements aimed at ensuring public health and safety.