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 period. Whereas these info aren’t doubtful, a key query is how a lot do delays in approval price corporations?
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 every day prescription gross sales for infectious, hematologic, cardiovascular, and gastrointestinal illnesses among the many highest…The estimated direct every day price to conduct a medical trial is roughly $40,000 per day for part II and III medical trials, with these in respiratory, rheumatology, and dermatology having the very best relative every 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 price $25 million and took 614.8 days to finish. As anticipated, later stage medical trials are costlier:
… part III medical trials have the very best every day price at $55,716. Part II medical trials price roughly half that quantity at $23,737 per day (consult with Desk 8). Part IV and part I trials have the bottom every 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 stories. 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).