신약의 최고매출액과 최고매출소요기간: 2001~2009년 미국 시판 신약의 매출 곡선 분석

Peak Sales and Time to Peak Sales of New Drugs: Sales Curve Analysis of New Drugs Launched in the U.S. from 2001 to 2009

Size of peak sales and time to peak sales, which are key indicators of the commercial performance of new drugs launch, vary depending on factors such as the therapeutic area, FDA review type, drug modality, company size, and orphan drug status. Therefore, analyzing the current status and related factors of peak sales and time to peak becomes a crucial element in establishing successful commercialization strategies for new drugs. This study analyzed peak sales and time to peak sales of FDA approved drugs launched in the U.S. from 2001 to 2009. One-hundred and twenty nine drugs’ sales data are gathered from the Evaluate Pharma database and analyzed by therapeutic area, FDA review type, drug modality, company size, and orphan drug status. As a result of the analysis, the median time to peak sales for all analyzed drugs was 7 years and the median peak sales was $258 million. There was a difference in time to peak sales for each therapeutic area, but no difference was seen in other categories. Median value of peak sales was higher for ‘standard review drugs’ than ‘priority review drugs’, for ‘big pharma drugs’ than for ‘non-big pharma drugs’, and for ‘non-orphan drugs’ than ‘orphan drugs’. In particular, there was a large difference in peak sales by therapeutic area. Additionally, the sales curve is similar to the S-shaped diffusion curve proposed by Rogers (1983), confirming that the ‘Diffusion of innovations’ theory can also be applied to the pharmaceutical industry. This study is the latest research using actual sales data that standardizes the peak sales and time to peak sales of FDA approved new drugs.