Credit from Access To Medicine Foundation
Most priority R&D projects (63%) are being conducted by 5 companies: GSK, Johnson & Johnson, Merck KGaA, Novartis and Sanofi. The global health community has identified specific medicines, vaccines, diagnostic tests or other products that are needed as a priority by people living in low- and middle-income countries. The Index terms R&D into these needs as ‘priority R&D’. The need for priority R&D has been identified for 45 diseases, conditions and pathogens, with different sets of gaps per disease.
Priority R&D represents one quarter of the total R&D pipeline analysed by the Index (298 out of 1,314 projects). The industry’s engagement in priority R&D is overwhelmingly focused on five diseases: 144 of the projects in the priority R&D pipeline target malaria, HIV/AIDS, tuberculosis, Chagas disease and leishmaniasis. These diseases include the leading causes of death in low- and middle-income countries. All five of these diseases have global health donors or product development partnerships behind them. Overall, almost two-thirds of priority R&D projects are being developed in collaboration with other organisations.
Many priority product gaps go unaddressed
A total of 91 of the 139 identified gaps are unaddressed, and 16 prioritised diseases have no projects at all. The average number of projects across the 45 diseases is only two. Diseases with the least attention here include several haemorrhagic fevers, several parasitic worm diseases, syphilis, Buruli ulcer, cholera and diarrhoea caused by E. coli. Some of these are rarer diseases, while others have weaker global health community push and donor support.
For malaria, there is at least one project for each gap identified. For both tuberculosis and HIV/AIDS, there is one gap left unaddressed by the 20 companies. Coverage of product gaps for leishmaniasis and Chagas disease is more patchy, with four out of nine product gaps being addressed.
Specific product gaps have not been established to address antibiotic resistance. The industry has 40 such projects in the pipeline, including 13 new antibiotics, 22 vaccines (mostly for pneumonia) and a new diagnostic test for the superbug MRSA.
The pipelines for HIV/AIDS, malaria, tuberculosis, leishmaniasis and Chagas disease show that the combination of (1) prioritising gaps, (2) donor funding and (3) research collaboration can be successful in engaging pharmaceutical companies in priority R&D. However, the model is currently being applied to only a handful of diseases. The next challenge for donors, research organisations and the pharmaceutical industry is to extend this model to other prioritised diseases.
The global health community can also address the current lack of a list of R&D priorities for non-communicable diseases, such as cancer, heart disease and diabetes to ensure that products moving through the pipeline are adequately tailored to any particular needs of low- and middle-income countries. Getting more companies involved in priority R&D would not only increase the numbers of products being developed, but would also reduce the negative impact of individual companies deciding to halt their engagement in such R&D.