Delays in drug approvals value pharmaceutical corporations cash. These prices embrace each misplaced gross sales in addition to extra value if medical trials have to span an extended period. Whereas these details will not be doubtful, a key query is how a lot do delays in approval value corporations?
A paper by Smith, DiMasi and Getz (2024) offers the reply.
…a single day equals roughly $500,000 in misplaced prescription drug or biologic gross sales, with day by day prescription gross sales for infectious, hematologic, cardiovascular, and gastrointestinal illnesses among the many highest…The estimated direct day by day value to conduct a medical trial is roughly $40,000 per day for 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 medicine have been first launched within the US. About 37.7% of medicine have been “blockbuster” medicine with greater than $1m of gross sales per day; 3.1% of medicine had >$7m of gross sales per day.
Cardiovascular, hematology, an infection and oncology medicine had the best gross sales per day based mostly on median gross sales per day.
The common medical trial value $25 million and took 614.8 days to finish. As anticipated, later stage medical trials are costlier:
… part III medical trials have the best day by day value at $55,716. Section II medical trials value roughly half that quantity at $23,737 per day (check with Desk 8). Section IV and part I trials have the bottom day by day value at $14,091 and $7,829 per day, respectively.
Strategies
rug income knowledge got here from Cortellis database of drug gross sales for all medicine and biologics launched in 2000 or after. These knowledge include worldwide gross sales figures from firm annual reviews. As drug gross sales knowledge have been extremely right-skewed the authors eliminated (i) COVID-19 medicine and vaccines and (ii) any medicine with gross sales >2 normal deviations from the imply
Drug growth prices per day have been estimated from a proprietary dataset developed and maintained by Tufts College’s Heart for the Examine of Drug Growth (CSDD).