Evaluate’s 2026 Orphan Drugs Report forecasts global annual orphan drug sales reaching roughly $409 billion by 2032, up from an estimated 15% share of prescription medicines in 2022 to more than 21% by 2032. The report highlights blockbuster orphan franchises—led by Johnson & Johnson’s Darzalex and Vertex’s Alyftrek—as primary contributors to the projection. Evaluate cautions that the trajectory faces regulatory and pricing headwinds, noting a more scrutinizing FDA and potential reimbursement pressures. The analysis also underscores policy changes that helped—such as IRA exceptions and pediatric voucher reauthorization—while flagging sustainability and access challenges for the rare‑disease market.