Delays in drug approvals price pharmaceutical corporations cash. These prices embody each misplaced gross sales in addition to extra price if scientific trials have to span an extended length. Whereas these details are usually not doubtful, a key query is how a lot do delays in approval price corporations?
A paper by Smith, DiMasi and Getz (2024) supplies 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 price to conduct a scientific trial is roughly $40,000 per day for part II and III scientific trials, with these in respiratory, rheumatology, and dermatology having the best relative day by day direct prices.
About 60% of medicine had been first launched within the US. About 37.7% of medicine had been “blockbuster” medication 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 medication had the best gross sales per day based mostly on median gross sales per day.
The typical scientific trial price $25 million and took 614.8 days to finish. As anticipated, later stage scientific trials are costlier:
… part III scientific trials have the best day by day price at $55,716. Section II scientific trials price roughly half that quantity at $23,737 per day (discuss with Desk 8). Section IV and part I trials have the bottom day by day price at $14,091 and $7,829 per day, respectively.
Strategies
rug income information got here from Cortellis database of drug gross sales for all medication and biologics launched in 2000 or after. These information comprise worldwide gross sales figures from firm annual experiences. As drug gross sales information had been extremely right-skewed the authors eliminated (i) COVID-19 medication and vaccines and (ii) any medication with gross sales >2 customary deviations from the imply
Drug growth prices per day had been estimated from a proprietary dataset developed and maintained by Tufts College’s Middle for the Research of Drug Improvement (CSDD).
