Personalized medicine

Grader A: hit

Personalized medicines were 39% of FDA new molecular entities in 2020 and over a third in three of four years; biomarker-selected therapy is routine in oncology. Well above 5% by 2020.

Test: D37 health: share of relevant patients, providers or procedures using it by 2022 (hit >=5%; partial <5% real use by 2022 or 5% in 2023-2025; miss no real use by 2025); relevant: new therapies and patients in oncology

• Personalized Medicines Top One-Third of All New Drug Approvals in 2020 (2021-02): 39% of 2020 FDA new drug approvals personalized; <10% a decade earlier

Grader B: hit

Personalized medicines made up 34% of FDA new molecular entity approvals in 2022 and at least 25% for eight years running; biomarker-guided oncology treatment and companion diagnostics are routine. Well above 5% by 2022.

Test: D37 health: >=5% of relevant treatments or new therapies are biomarker-guided by 2022 = hit.

• Personalized Medicines Topped 25 Percent of New Drug Approvals for Eighth Year in a Row in 2022 (2023-02): 12 personalized medicines, 34% of 2022 NMEs; >=25% each year 2015-2022.