Blockbuster drugs and forecast accuracy: How sponsor type is associated with commercial success of FDA-approved medicines.

We evaluated the commercial performance of 490 FDA-approved new molecular entities (NMEs) and biologic products approved from 2016 through 2025 against analyst forecasts, testing the hypothesis that only a small proportion of approved drugs have the potential to generate substantial returns for their sponsors. We demonstrate that analyst forecasts are subject to considerable limitations, with systematic overestimation of sales particularly prevalent for drugs with biotech sponsors. We further identify a strong association with large, established pharmaceutical companies and their ability to select or develop commercially successful products relative to smaller competitors and emerging companies. Large pharma achieved blockbuster (BB) or super-blockbuster (SBB) status for approximately 34% of their approved portfolio, compared to approximately 9% for medium pharma and approximately 2% for biotech sponsors.