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

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.

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

“…The study population was selected using the database of pipeline technologies for neglected diseases developed by Duke University and Policy Cures Research 10 . The database does not include all non-commercial R&D initiatives -for example, it excludes biodefense projects that are largely publicly-funded -but it is the most comprehensive database of which we are aware focusing on R&D for neglected diseases, which is by nature largely non-commercial.…”

“…We used parameters from the Portfolio-to-Impact (P2I) tool v2, which was initially developed by TDR 8 and updated by Duke University and Policy Cures Research 10 . The P2I Model is based on assumptions of costs, timeframes and attrition rates.…”

Public Risk-Taking and Rewards During the COVID-19 Pandemic - A Case Study of Remdesivir in the Context of Global Health Equity

“…38 Overall, total biomedical R&D expenditure in 2012 amounted to US$81.8 billion in Europe and US$119.3 billion in the United States, of which the public sector directly contributed US$28.1 billion and US$48.9 billion respectively, equivalent to 30%-35% of biomedical R&D. 39 Finally, the public sector is a main funder of highrisk, early research, 40 making public investments especially important for priority research areas where, despite significant health need, a lack of private sector investment prevails. 41 Which actors ultimately benefit from remdesivir as a biomedical innovation? In our current biopharmaceutical system, the owner of the key patent rights (this may be the owner of a patent or a licensee) has the main control over the extraction of rewards.…”

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 Table 1 shows the trials initiated for Ebola versus TB vaccines in the last 5 years when Ebola vaccine trials entered the clinical 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].…”