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Orphan Drugs’ Share of New Approvals
Share of FDA novel drug approvals designated for rare diseases, %
Plays the chart through its history. Pauses are where the data set a record or moved most.
How much of new drug development now targets rare diseases, and how much comes as biologics. Both have grown as incentives and science have shifted.
What this chart reads
- Orphan Share of FDA Novel Drug Approvalsas “Orphan drugs”latest 2025-12-31
- Biologics Share of FDA Novel Drug Approvalsas “Biologics”latest 2025-12-31
Sources
Orphan Share of FDA Novel Drug Approvals. Source: U.S. Food and Drug Administration: "Compilation of CDER NME and New Biologic Approvals 1985–2025" and the "Novel Drug Approvals" page for each later year. FDA website content is in the public domain.
Biologics Share of FDA Novel Drug Approvals. Source: U.S. Food and Drug Administration: "Compilation of CDER NME and New Biologic Approvals 1985–2025" and the "Novel Drug Approvals" page for each later year. FDA website content is in the public domain.
Charts are drawn from Palanor's signal library and recomputed from source data on every view. Transformations (changes, indexing, year-on-year rates) are Palanor's.