Evaluate’s 2026 Orphan Drugs Report projects global orphan drug sales will reach roughly $409 billion by 2032, up from about 15% of prescription sales in 2022 to more than 21% a decade later. The forecast attributes growth to existing high‑earning orphan franchises, expanding indications, and new gene and cell therapies. The analysis highlights winners such as J&J’s daratumumab and Vertex’s cystic fibrosis combinations, while warning that regulatory scrutiny, pricing pressure, and competition from mainstream blockbuster classes (notably obesity drugs) could temper growth. Evaluate also notes policy shifts like IRA exceptions and pediatric voucher reauthorizations that influence market dynamics. What happened: Evaluate released a market forecast projecting substantial orphan drug revenue growth through 2032. Why it matters: the projection underpins investor and BD strategy, signaling sustained commercial opportunity in rare disease even as regulatory and pricing headwinds complicate development and launch planning.