Companies make progress in access planning, but little change in makeup of R&D pipelines

Breakdown of the pipeline

The total number of projects targeting specific disease classifications has remained relatively stable since the 2021 Index, with a slight decrease in the number of R&D projects in the pipeline targeting diseases in scope; 1,060 projects in 2022 compared with 1,073 projects in 2021. A total of 62 products received regulatory approval,* 479 new projects were added to the pipeline and 466 projects were removed during the period of analysis.**

Notably, there has been a decrease in the number of projects targeting neglected tropical diseases (NTDs). Despite 20 new NTD projects being added to the pipeline, the total number of NTD projects fell from 89 in the previous Index to 69 in the 2022 Index. The decrease in the number of active projects is mostly a result of some discovery-phase projects being discontinued and some projects leaving the pipeline after successfully reaching product approval and launch.

Among R&D projects to address priority diseases, a small number of diseases dominate the pipeline                                   

Of the 1,060 projects in the pipeline, one third target a dis- ease identified as a priority R&D treatment gap, as defined by global health organisations (see Appendix VI) – a figure consistent with the findings of the previous Index.

However, although there are 64 priority diseases, over half of these projects (202) focus on four priority diseases: coronaviral diseases, HIV/AIDS, malaria, and tuberculosis. Many diseases with urgent requirements for R&D are not being addressed by research-based pharmaceutical companies.

This figure remains consistent with the 2021 pipeline, where 199 projects targeted these four diseases. This is a long-term trend that was also identified by the Foundation’s 10-year progress report in 2019, which found that, in general, companies’ R&D activities are concentrated on a few diseases.

Companies begin to look ahead but with a narrow lens     

While the ten-year progress report published by the Foundation in 2019 found that the proportion of late- stage R&D projects with access plans had remained largely unchanged over the previous decade, in 2022 the number of late-stage projects with access plans has increased markedly. In the 2021 Index, 40% of late-stage projects analysed had plans for access in place during the R&D stage. This year, 77% of late-stage projects have access plans in place.

This improvement corroborates a Key Finding from the 2021 Index, which identified an industry shift towards systematic access planning during late-stage R&D so that new products quickly reach the people who need them in low- and middle-income countries (LMICs). The significant increase between the 2021 and 2022 Indexes may indicate that companies’ commitments to systematically implementing access planning during R&D are now leading to tangible results.

However, an in-depth analysis of the quality and breadth of these plans concludes that the majority of these plans focus on a select number of countries in scope, thus leaving these important product developments out of reach for most. Furthermore, most of these plans focus solely on registering the product in at least one country in scope of the Index with few provisions for affordability to ensure the product will be accessible for all.

*This includes products that received emergency use authorisation or conditional marketing approval during the period of analysis (1 June 2020 - 31 May 2022).

**Period of analysis (1 June 2022 - 31 May 2022).

The full version of the Special Report is available via our Resource Centre.