Please find here the link to the published HBM New Drug Approval Report covering 2018 (and a comparison to the years before).

While a record number of 59 NMEs (new molecular entities) was approved by FDA in 2018, total peak sales of these new drugs were estimated to reach only $40 billion (down from $50 billion for new drugs approved in 2017). Most new drugs approved in 2018 target orphan or niche indications, and only 13 have “blockbuster” potential (vs. 23 for 2017).

The highest numbers of new drugs were approved in oncology (16, up from 13 in 2017) and in orphan/rare genetic diseases (11, up from 5 in 2017).

Over 80% of approvals were supported by one or more expedited pathways (Priority Review etc.) with close to 60% of new drugs approved having an “Orphan Drug Designation”.

Smaller, innovative biopharma companies are playing an ever-increasing role not only as originators, but also as developers (and owners) of new drugs all the way to approval.

A list of all NMEs approved by FDA since 2003 can be downloaded from HBM Partners’ webpage.

Once again - Link to Report