Collaborative research models appear effective in engaging the industry in developing urgently needed products with low commercial potential

Research & Development

The top 20 pharmaceutical companies are developing 420 products for the 51 most burdensome diseases and conditions in low- and middle-income countries. This includes more than 100 products that have entered the pipeline since the previous Index and 151 with low commercial potential but which are urgently needed, mainly by the poor.

The Index examines 22 diseases and conditions for which the G-FINDER tool from Policy Cures has identified a need for new products with limited commercial incentive. Companies are addressing 18 of these diseases, with most activity focusing on malaria, HIV/AIDS and tuberculosis, followed by viral hepatitis.

Activity in this area is concentrated among a handful of companies. A core group of six account for nearly three-quarters of the 151 high-priority, low-incentive products in development. GSK is developing the most, with 32 projects in the pipeline, followed by AbbVie, with 19 projects, and Johnson & Johnson with 17. Meanwhile, four of these companies devote more than 50% of their relevant pipelines to high-priority, low-incentive product gaps.

Figure 2. Six companies account for majority of projects targeting high-priority, low-incentive gaps
There are 151 high-priority, low-incentive R&D projects in company pipelines. Nearly three quarters are being developed by just six companies. For four of these companies, this accounts for more than 50% of their pipelines for high-burden diseases: GSK, AbbVie, Sanofi and Merck KGaA.

Product gaps unaddressed

G-FINDER has identified 84 high-priority product gaps for the 22 diseases in the scope of the Index. Companies are directly addressing 31 of these gaps. The industry is addressing most gaps for medicines, as well as some of the gaps in vaccines, including for HIV/AIDS, hepatitis C, shigellosis and typhoid and paratyphoid fever. However, companies are less involved in addressing the gaps for other product types. Other stakeholders are paying attention to these, for example to develop diagnostics and vector control products.

Some diseases that urgently need products, such as soil-transmitted helminthiasis, have very few R&D projects targeting them, while others, such as Buruli ulcer, trachoma, cysticercosis and syphilis, have none. Some diarrhoeal diseases are being addressed, but not cholera, giardiasis or particular intestinal E. coli infections even though they have all been identified as needing attention.

Figure 3. Pharma companies are addressing over one third (37%) of product gaps with low commercial incentive.
Companies are developing products for 31 out of 84 (37%) high-priority product gaps with low commercial incentive. Most of these target malaria (35 projects), followed by HIV/AIDS (23), TB (21) and then viral hepatitis (13). Projects that target multiple diseases, or are being developed by multiple companies, are counted more than once.

*Specific product gap identified, e.g., for a new administration route to be developed, or serotypes to be targeted.

R&D in partnership

The majority (67%) of the R&D projects for high-priority, low-incentive products are being conducted in partnership, signalling that collaborative models are effective at engaging companies in R&D aimed at addressing priority product gaps. This proportion is significantly higher than for other R&D in scope, where 14% of projects involve partners. Three quarters of partnerships for high-priority, low-incentive products involve companies partnering with public, non-governmental and/or non-profit organisations. Another 14% of them involve collaboration between companies, and these partnerships focus mainly on products for HIV/AIDS and hepatitis C. The remaining ones involve wider partnership that entails collaboration among several companies and public-sector actors.

Access plans in place for most high-priority pipeline products

Overall, 56% of 151 high-priority, low-incentive products in R&D have access plans in place. As expected, there are more products with access plans toward the end of the pipeline; there is a marked increase as projects move into clinical development, and then again between clinical phases II and III. The majority (72%) of late-stage projects have access plans in place.

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