Delays in drug approvals value pharmaceutical corporations cash. These prices embody each misplaced gross sales in addition to further value if medical trials must span an extended length. 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) gives the reply.
…a single day equals roughly $500,000 in misplaced prescription drug or biologic gross sales, with each day prescription gross sales for infectious, hematologic, cardiovascular, and gastrointestinal ailments among the many highest…The estimated direct each day value 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 very best relative each day direct prices.
About 60% of medication have been first launched within the US. About 37.7% of medication have been “blockbuster” medicine 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 medicine had the very 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 dearer:
… section III medical trials have the very best each day value at $55,716. Section II medical trials value roughly half that quantity at $23,737 per day (consult with Desk 8). Section IV and section I trials have the bottom each 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 Middle for the Research of Drug Improvement (CSDD).