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Version 2. Gates Open Res. 2018 Aug 22 [revised 2018 Aug 22];2:23. doi: 10.12688/gatesopenres.12817.2. eCollection 2018.

Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model.

Author information

1
Center for Policy Impact in Global Health, Duke Global Health Institute, Durham, NC, 27710, USA.
2
Policy Cures Research, Sydney, NSW, 2010, Australia.
3
School of Medicine, Duke University, Durham, NC, 27710, USA.
4
Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, 27710, USA.
5
Department of Immunology, Duke University, Durham, NC, 27710, USA.
6
SEEK Developent, Berlin, 10407, Germany.
7
Children's Health and Discovery Institute; Department of Pediatrics, Duke University, Durham, NC, 27710, USA.
8
Foundation for Innovative New Diagnostics, Geneva, Switzerland.
9
Duke Clinical Research Institute, Duke University, Durham, NC, 27715, USA.
10
Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27710, USA.
11
The Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, CH-1211, Switzerland.

Abstract

Background: Funding for neglected disease product development fell from 2009-2015, other than a brief injection of Ebola funding. One impediment to mobilizing resources is a lack of information on product candidates, the estimated costs to move them through the pipeline, and the likelihood of specific launches. This study aimed to help fill these information gaps. Methods: We conducted a pipeline portfolio review to identify current candidates for 35 neglected diseases. Using an adapted version of the Portfolio to Impact financial modelling tool, we estimated the costs to move these candidates through the pipeline over the next decade and the likely launches. Since the current pipeline is unlikely to yield several critical products, we estimated the costs to develop a set of priority "missing" products. Results: We found 685 neglected disease product candidates as of August 31, 2017; 538 candidates met inclusion criteria for input into the model. It would cost about $16.3 billion (range $13.4-19.8B) to move these candidates through the pipeline, with three-quarters of the costs incurred in the first 5 years, resulting in about 128 (89-160) expected product launches.  Based on the current pipeline, there would be few launches of complex new chemical entities; launches of highly efficacious HIV, tuberculosis, or malaria vaccines would be unlikely. Estimated additional costs to launch one of each of 18 key missing products are $13.6B assuming lowest product complexity or $21.8B assuming highest complexity ($8.1B-36.6B). Over the next 5 years, total estimated costs to move current candidates through the pipeline and develop these 18 missing products would be around $4.5B (low complexity missing products) or $5.8B/year (high complexity missing products). Conclusions: Since current annual global spending on product development is about $3B, this study suggests the annual funding gap over the next 5 years is at least $1.5-2.8B.

KEYWORDS:

financing; global health; innovation; neglected diseases; research and development

Conflict of interest statement

Competing interests: SP declares that she is a consultant for Merck, Pfizer, and Moderna vaccines, and has a sponsored program agreement with Merck. The other authors declare no competing interests.

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