2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Few­er Ap­provals, but Neu­rol­o­gy Ri­vals On­col­o­gy and Sees Ma­jor In­no­va­tions

This re­port, the fourth in our Trin­i­ty Drug In­dex se­ries, out­lines key themes and emerg­ing trends in the in­dus­try as we progress to­wards a new world of tar­get­ed and in­no­v­a­tive prod­ucts. It pro­vides a com­pre­hen­sive eval­u­a­tion of the per­for­mance of nov­el drugs ap­proved by the FDA in 2016, scor­ing each on its com­mer­cial per­for­mance, ther­a­peu­tic val­ue, and R&D in­vest­ment (Table 1: Drug rank­ing – Rat­ings on a 1-5 scale).

Al­though on­ly 26 unique ther­a­peu­tic agents ap­proved by CDER and CBER (Cen­ters for Drug and Bi­o­log­ics Eval­u­a­tion & Re­search) in 2016 were pro­filed in this In­dex, com­pared to the 50+ pro­filed in the Trin­i­ty Drug In­dex re­ports for the two pre­vi­ous years, the ap­provals sig­naled key trends. Of the 26, half were bi­o­log­ic prod­ucts, in­clud­ing nov­el nu­cle­ic acid and cell-based ther­a­pies. In ad­di­tion, neu­rol­o­gy ap­provals rep­re­sent­ed ~20% of the to­tal, while meta­bol­ic and on­col­o­gy each ac­count­ed for 15% of to­tal ap­provals. By com­par­i­son, on­col­o­gy drugs rep­re­sent­ed 30% of ap­provals in 2015, ac­cord­ing to the 2018 Trin­i­ty Drug In­dex.

Key themes and emerg­ing trends across the in­dus­try, in­clud­ing the rel­a­tive in­crease in neu­rol­o­gy prod­ucts as a per­cent­age of to­tal ap­provals, are high­light­ed in the 2019 Trin­i­ty Drug In­dex. To view the full ar­ti­cle, click here