Delays in drug approvals value pharmaceutical companies cash. These prices embrace each misplaced gross sales in addition to extra value if medical trials must span an extended length. Whereas these details aren’t unsure, a key query is how a lot do delays in approval value companies?
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 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 best relative each day direct prices.
About 60% of medicine had been first launched within the US. About 37.7% of medicine had 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 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 best each day value at $55,716. Section II medical trials value 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 value at $14,091 and $7,829 per day, respectively.
Strategies
rug income information got here from Cortellis database of drug gross sales for all medicine and biologics launched in 2000 or after. These information include worldwide gross sales figures from firm annual stories. As drug gross sales information had 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 had been estimated from a proprietary dataset developed and maintained by Tufts College’s Middle for the Examine of Drug Improvement (CSDD).
