Delays in drug approvals price pharmaceutical companies cash. These prices embrace each misplaced gross sales in addition to further price if scientific trials must span an extended period. Whereas these information will not be unsure, a key query is how a lot do delays in approval price companies?
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 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 section II and III scientific trials, with these in respiratory, rheumatology, and dermatology having the very 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 very best gross sales per day primarily based 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 dearer:
… section III scientific trials have the very best day by day price at $55,716. Section II scientific trials price roughly half that quantity at $23,737 per day (confer 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 medicine and biologics launched in 2000 or after. These knowledge include worldwide gross sales figures from firm annual studies. 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 commonplace 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 Growth (CSDD).
