Non-commercial pharmaceutical R&D: what do neglected diseases suggest about costs and efficiency?

The past two decades have witnessed significant growth in non-commercial research and development (R&D) initiatives, particularly for neglected diseases, but there is limited understanding of the ways in which they compare with commercial R&D. This study analyses costs, timelines, and attrition rates of non-commercial R&D across multiple initiatives and how they compare to commercial R&D. This is a mixed-method, observational, descriptive, and analytic study. We contacted 48 non-commercial R&D initiatives and received either quantitative and/or qualitative data from 13 organizations. We used the Portfolio to Impact (P2I) model's estimates of average costs, timelines, and attrition rates for commercial R&D, while noting that P2I cost estimates are far lower than some previous findings in the literature. The quantitative data suggested that the costs and timelines per candidate per phase (from preclinical through Phase 3) of non-commercial R&D for new chemical entities are largely in line with commercial averages. The quantitative data was insufficient to compare attrition rates. The qualitative data identified more reasons why non-commercial R&D costs would be lower than commercial R&D, timelines would be longer, and attrition rates would be equivalent or higher, though the data does not allow for estimating the magnitude of these effects. The quantitative data suggest that costs and timelines per candidate per phase were largely in line with (lower-end estimates of) commercial averages. We were unable to draw conclusions on overall efficiency, however, due to insufficient data on attrition rates. Given that non-commercial R&D is a nascent area of research with limited data available, this study contributes to the literature by generating hypotheses for further testing against a larger sample of quantitative data. It also offers a range of explanatory factors for further exploration regarding how non-commercial and commercial R&D may differ in costs and efficiency.