Delays in drug approvals price pharmaceutical corporations cash. These prices embody each misplaced gross sales in addition to extra price if medical trials must span an extended length. Whereas these info should not unsure, 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 ailments among the many highest…The estimated direct day by day price to conduct a medical trial is roughly $40,000 per day for section II and III medical trials, with these in respiratory, rheumatology, and dermatology having the best relative day by day direct prices.
About 60% of medication have been first launched within the US. About 37.7% of medication have been “blockbuster” medication with greater than $1m of gross sales per day; 3.1% of medication had >$7m of gross sales per day.
Cardiovascular, hematology, an infection and oncology medication had the best gross sales per day primarily based on median gross sales per day.
The common medical trial price $25 million and took 614.8 days to finish. As anticipated, later stage medical trials are dearer:
… section III medical trials have the best day by day price at $55,716. Section II medical trials price roughly half that quantity at $23,737 per day (check with Desk 8). Section IV and section I trials have the bottom day by day price at $14,091 and $7,829 per day, respectively.
Strategies
rug income knowledge got here from Cortellis database of drug gross sales for all medication and biologics launched in 2000 or after. These knowledge comprise worldwide gross sales figures from firm annual reviews. As drug gross sales knowledge have been extremely right-skewed the authors eliminated (i) COVID-19 medication and vaccines and (ii) any medication 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).
