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

Abstract

Background: Funding for product development for neglected diseases fell from 2009-2015, other than a short-term 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 (P2I) 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 product candidates for neglected diseases 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 very few launches of complex new chemical entities; launches of highly efficacious vaccines for HIV, tuberculosis, or malaria would be unlikely. Estimated additional costs to launch one of each of 18 key missing products range from $13.6B-$21.8B, depending on product complexity. Over the next 5 years, total estimated costs to move current candidates through the pipeline and develop these 18 missing products would be around $4.5-5.8B/year. 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, which is probably an underestimate. The current portfolio is not balanced across health needs.

International Funding for Global Common Goods for Health: An Analysis Using the Creditor Reporting System and G-FINDER Databases

“…For example, a recent modeling study by Young et al estimated that about $6 billion annually would be needed to (a) advance the current pipeline of products under development, and (b) develop key "missing" products that the current pipeline is unlikely to yield (e.g., highly effective vaccines for HIV, TB, malaria, and hepatitis C and a combined vaccine for multiple causes of diarrhea). 26 The need for additional funding is particularly acute for late stage (phases IIb and III) clinical trials.…”

Funding global health product R&D: the Portfolio-To-Impact Model (P2I), a new tool for modelling the impact of different research portfolios

“…An example of this adaptation is described in an accompanying paper. In that paper Young et al describe how they adapted the modelling tool to create a new version, P2I V.2, in order to undertake a whole portfolio analysis of the current pipeline for those neglected diseases included in the annual G-FINDER survey of R&D financing 16 . The model estimates it would cost about $16.3 billion to move the 538 applicable products through the pipeline, resulting in about 128 (89–160) expected product launches.…”

Development of a TB vaccine trial site in Africa and lessons from the Ebola experience

“…As of September 2019, there were only eight preclinical vaccine candidates for TB (www.tbvi.eu/what-wedo/pipeline-of-vaccines) accessed 30 September 2019. A main reason for this, other than minimal public interest in accelerating a new TB vaccine, is funding restrictions [24]. As a result, stage-gate criteria have been developed to constrict the movement of candidates from one phase to the next, with the idea of advancing only the most promising candidates, defined largely by available immunogenicity, efficacy, and safety data [21,22].…”