Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model [version 1; referees: 1 approved, 2 approved with reservations]

• Main Authors: Ruth Young, Tewodros Bekele, Alexander Gunn, Nick Chapman, Vipul Chowdhary, Kelsey Corrigan, Lindsay Dahora, Sebastián Martinez, Sallie Permar, Johan Persson, Bill Rodriguez, Marco Schäferhoff, Kevin Schulman, Tulika Singh, Robert F Terry, Gavin Yamey
• Format: Article
• Language: English
• Published: F1000 Research Ltd 2018-04-01
• Series: Gates Open Research
• Online Access: https://gatesopenresearch.org/articles/2-23/v1

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.