IQVIA’s analysis of 34 emerging biopharma launches (2012–2023) shows that clinical differentiation strongly drives commercial success, with only highly differentiated products consistently reaching breakeven. Crysvita, with unique efficacy in rare diseases, achieved profitability by investing in patient identification, KOL engagement, and reimbursement support. Tymlos, despite lower differentiation, gained traction through competitive pricing, copay support, and lean commercial execution. Key lessons: assess clinical positioning early, align commercial size with opportunity, and develop integrated go-to-market strategies. Success requires pairing product profile with tailored investment and access models.

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