Delays in drug approvals price pharmaceutical companies cash. These prices embrace each misplaced gross sales in addition to extra price if scientific trials have to span an extended period. Whereas these information usually are not doubtful, a key query is how a lot do delays in approval price companies?
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 each day prescription gross sales for infectious, hematologic, cardiovascular, and gastrointestinal illnesses among the many highest…The estimated direct each day price to conduct a scientific trial is roughly $40,000 per day for section II and III scientific trials, with these in respiratory, rheumatology, and dermatology having the very best relative each day direct prices.
About 60% of medicine have been first launched within the US. About 37.7% of medicine have 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 very best gross sales per day primarily based on median gross sales per day.
The common scientific trial price $25 million and took 614.8 days to finish. As anticipated, later stage scientific trials are dearer:
… section III scientific trials have the very best each day price at $55,716. Section II scientific trials price roughly half that quantity at $23,737 per day (seek advice from Desk 8). Section IV and section I trials have the bottom each 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 include worldwide gross sales figures from firm annual stories. 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 customary 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 Research of Drug Improvement (CSDD).
