Delays in drug approval value pharmaceutical firms cash. These prices embody each misplaced gross sales and extra prices if medical trials must cowl an extended period. Whereas there isn’t any doubt about these info, an necessary query is: how a lot do approval delays value firms?

An article by Smith, DiMasi and Getz (2024) offers the reply.

…a single day equates to roughly $500,000 in misplaced drug or biologic gross sales, with day by day prescription gross sales for infectious, hematologic, cardiovascular, and gastrointestinal ailments among the many highest…The estimated direct day by day prices of conducting a medical trial quantities to roughly $40,000 per day for the part II and III medical trials, with these in respiratory, rheumatology, and dermatology having the best relative day by day direct prices.

About 60% of the medicine had been first launched within the US. About 37.7% of the medicine had been “blockbuster” medicine with gross sales exceeding $1 million per day; 3.1% of medicine had gross sales of greater than $7 million per day.

Medicines for cardiovascular ailments, hematology, infections and oncology had the best gross sales per day based mostly on common gross sales per day.

The typical medical trial value $25 million and lasted 614.8 days. As anticipated, later-stage medical trials are dearer:

… part III medical trials have the best day by day prices: $55,716. Section II medical trials value about half that quantity, at $23,737 per day (see Desk 8). Section IV and Section I trials have the bottom day by day prices at $14,091 and $7,829 per day, respectively.

Strategies

Carpet income information got here from the Cortellis drug gross sales database for all medicine and biologics launched in 2000 or after. This information consists of world gross sales figures from firms' annual reviews. As a result of the drug gross sales information had been extremely right-skewed, the authors eliminated (i) COVID-19 medicine and vaccines and (ii) all medicine with gross sales >2 normal deviations from the imply.

Drug growth prices per day had been estimated from a proprietary information set developed and maintained by the Middle for the Research of Drug Growth (CSDD) at Tufts College.