The suitability of the published research and development (R&D) cost estimates used to represent the actual R&D costs of the pharmaceutical industry varies. We found a trade-off between transparency and replicability of the analysis and between specificity and reliability of the source data.

Average costs may obscure important differences, such as by therapeutic area, small/large molecules, orphan/non-orphan, original/licensed-in, and firm size; in particular, estimations suggest higher mean costs for oncological drugs.

Moreover, most R&D cost studies do not address current trends in pharmaceutical R&D (e.g., the complexities of drug discovery and clinical trials), nor do they consider regulatory changes over time for a new medicine’s approval.