A total of 667 innovative biopharmaceuticals launched in the U.S. over the past 20 years, 1996-2015, bringing new treatment options to patients. After a low point of only 19 NAS launches in 2008, the number has steadily increased and reached 47 in 2015. The characteristics of biopharmaceutical innovation have also evolved over the past two decades, with increases in the share of cancer treatment launches from 11% to 28%, orphan indications from 21% to 42% and biologic launches.
The time between when a medicine is discovered and when the originator ceases to receive significant revenues can be considered its lifetime. The average time from initial patent filing until launch for all molecules studied is 12.8 years,
while the time from a product’s launch until the expiration of its patent or other form of exclusivity is just over 13.5 years and has been steadily declining. The combination of these factors are contributing to a decline in economic returns from investment in research and development, although these remain positive.
The majority of drug launches achieve modest levels of average annual sales in their first five years on the market, although a relatively small number of outlier products garner significantly higher sales. A growing percentage of products are taking longer than five years to reach their peak sales, which may reflect slower progress to reach the patients who will benefit from the new medicines. (Más)