Chart Insights
Personalized Health 2.0
Recent advances in diagnostics, therapies, and data availability have resulted in personalized health moving from an emerging theme to a core driver of health care.
Targeted therapies represented ~36% of new FDA therapeutic approvals in 2025, marking the sixth consecutive year in which targeted therapies accounted for more than one-third of new drug approvals.
Diagnostics are becoming core clinical infrastructure. Companion diagnostic non-invasive screening helps match patients with the right therapies.
The theme has broadened beyond liquid biopsy. Opportunities include new therapies, recurrence monitoring, companion diagnostics, AI-enabled tools, and continuous patient monitoring.
Liquid biopsy is moving closer to routine screening. Liquid biopsy is expanding from tumor profiling toward earlier cancer detection, with the FDA approval Shield underscoring the shift.
Personalized Health’s Growing Share of Approvals
Note: Personalized health has remained a durable share of new drug innovation for more than a decade, accounting for at least one-quarter of new drug approvals in each year since 2015 and more than one-third in most recent years.
Source: Personalized Medicine at FDA: The Scope & Significance of Progress in 2025. Companion Diagnostics | FDA. Shield -P230009 | FDA.
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