DNDi views R&D cost transparency as an important matter of accountability for any institution that benefits from public and philanthropic support for the development of health tools for neglected populations.

Data from DNDi’s 20 years of experience can credibly inform a review of drug R&D costs under its virtual, collaborative model. As part of its commitment to cost transparency, DNDi publishes this information periodically, based on its latest historical data set.

How much does it cost DNDi to develop a drug?

DNDi’s historical out-of-pocket expenses for drug development projects have ranged from around €4 million to approximately €60 million, up to and including registration.

DNDi has led diverse R&D projects in the field of anti-infectives, from developing entirely new chemical entities (NCEs) to developing combinations of existing drugs, in loose or fixed-dose combinations, with or without new formulations.

Presented below are DNDi’s direct out-of-pocket expenses per phase of development for eight R&D projects, seven of which are treatments that are already registered, the last of which is in late-stage development. Clear cost differences appear between different types of projects: NCEs require investments all the way from early discovery or, at best, lead optimization to registration, while drug repurposing or combinations can start as late as Phase III. Projects involving new formulations are more costly.

These full, actual costs exclude in-kind contributions from industry partners, which vary significantly according to product, stage of development and partnership terms, but amount to 12.5% of DNDi total expenditures on average.

What about calculating costs with ‘attrition’?

While out-of-pocket costs are a valuable marker of expenditure for any drug development project, they can also vary significantly according to the attrition encountered: the cost of failure that occurs at every stage of the discovery and development cycle.

Adjusting the above figures for average attrition costs per phase of development, we estimate we can develop and register:

• new treatments that combine or repurpose existing drugs for €4-32 million;
• new chemical entities for €60-190 million.

More information on DNDi R&D costs is available:

• Read publication 15 Years of Needs-driven Innovation for Access
• Read additional methodological considerations

Costs of publicly funded clinical trials

Together with other non-profit organizations and individuals – including Doctors Without Borders/Médecins Sans Frontières (MSF) USA, Doctors for America, Knowledge Ecology International, Christopher Morten – DNDi has written a letter to the Biden administration asking that the US government discloses the costs of clinical trials funded by HHS.