Leaders in R&D address needs and ensure access for people living in low- and middle-income countries.

Research & Development

Context

Many new health products are urgently needed – particularly for people in low- and middle-income countries. The Access to Medicine Index assesses companies’ efforts to engage in R&D for 51 diseases and conditions that have the greatest burdens in low- and middle- income countries and the greatest need in terms of access to medicine. Within this scope, it also looks at whether companies are developing products that are urgently needed, but offer little commercial incentive to innovate. For this secondary analysis, it refers to the product gaps identified by Policy Cures (G-FINDER). Every company in the Index, regardless of its size or therapeutic focus, for example, can play an important role in addressing the need for new pharmaceuticals.

Main Findings

More projects in the pipeline – 420 in total.
Companies have 420 R&D projects that address specific needs of people in low- and middle-income countries: 93 more than in 2014, with 102 new ones. The pipeline focuses heavily on five diseases: lower respiratory infections, diabetes, malaria, viral hepatitis and HIV/AIDS – diseases that place relatively large burdens on low- and middle-income countries and either have large commercial markets, or tend to be highly prioritised by stakeholders.

Figure 8. Companies have 420 relevant R&D projects.
Companies are developing 420 products that meet the needs of people in low- and middle-income countries. Of these, 36% target a high-priority product gap (they are urgently needed and yet have little commercial potential). 30% have plans in place to ensure successful products are made accessible – the majority of which target a high-priority product gap.
The G-FINDER tool from Policy Cures identifies high-priority product gaps where there is both a need for new products and insufficient commercial market incentives to drive R&D.

Over one third of R&D projects target a high-priority, low-incentive product gap.
G-FINDER identifies high-priority, low-incentive product gaps for 22 of the 51 diseases and conditions in scope: 84 gaps in total. For 18 of these diseases, companies are taking action, addressing 31 product gaps with 151 projects. These mainly target malaria (35 projects), HIV/AIDS (23) and TB (21). The industry is addressing most gaps for medicines, as well as some gaps in vaccines (including for HIV/AIDS, hepatitis C and shigellosis). Companies are less involved in addressing the gaps for other product types, and have no projects targeting Buruli ulcer, trachoma, cysticercosis and syphilis. In some cases, products exist for these diseases but are not optimal, or are unsuitable for use in resource-low settings.

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.

Six companies with distinctive pipelines lead in developing products for the poor.
In product development, six companies lead: GSK is in front, followed by Johnson & Johnson, Novartis, Sanofi, Merck KGaA and then AbbVie. Collectively, they account for over half (55%) the total industry pipeline, and almost three quarters (72%) of products targeting high-priority, low-incentive product gaps. Each has a distinctive pipeline and unique strengths, and all are among the leaders in multiple measures.

Figure 10. Product development: six leaders consistently lead across several key measures.
The leaders in product development account for over 50% of the relevant industry pipeline. They approach R&D in distinct ways, with diverse pipelines varying in size and scope, and targeting a range of therapeutic areas. Nevertheless, the way they conduct R&D has broad similarities.

Companies do not systematically plan ahead to ensure successful R&D projects are rapidly accessible.
Companies rarely have policies for systematically ensuring products developed in partnership (whether partners are public or private) are rapidly made accessible. However, in practice, R&D projects conducted in partnership include access plans more often than for in-house projects. Companies can learn from their experiences of R&D partnerships to ensure all relevant projects have access plans in place as early as possible.

Figure 13. Access provisions are set earlier when projects conducted in partnership
Compared to in-house R&D, a higher proportion of R&D projects conducted in partnership include access provisions – plans for ensuring a successful candidate is made accessible. This relationship is seen at all stages of development. In early stages, 39% of projects carried out in partnerships have access provisions in place, compared to just 9% for in-house projects.

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