Biosimilars – Forecast – Endocrinology
In 2024, sales of branded biologics for endocrinology indications (insulins and antiresorptive analogues) exceeded $22 billion in the major pharmaceutical markets under study (United States, EU5, and Japan). Throughout our 2024-2034 forecast period, we expect biosimilar launches to erode both brand share and prices. By 2034, we forecast major-market insulins to reach sales of $21 billion, with $11 billion from biosimilars, authorized generics, and follow-on insulins—primarily in the United States. For antiresorptive analogues we forecast sales of $6.5 billion for 2034, with $4 billion from biosimilars and authorized generics. Although U.S. regulatory alignment under the BLA 351(k) pathway simplified classification, development remains capital-intensive due to manufacturing scale, device requirements, and commercial complexity.
