Development, launch, and scale-up of health products in low-income and middle-income countries: a retrospective analysis on 59 health products.

BACKGROUND

Low-income and middle-income countries (LMICs) bear a heavy burden from communicable, maternal, and childhood diseases, yet access to health products addressing these burdens is lagging. We aimed to provide empirical evidence about the timelines, and influencing factors, of the end-to-end scale-up pathway of health products in LMICs.

METHODS

We identified products that met our prespecified inclusion criteria. We documented the dates and intervals for five key milestones in the pathway: ideation, proof of concept, regulatory approval, first LMIC country launch, and at least 20% uptake across LMICs. We then explored the association between pace of this pathway and ten characteristics, such as product types, buying environment, and market type. We used robust regression models to test our hypothesis that multiple factors affect a product's pathway to scale-up in LMICs.

FINDINGS

Among 59 included products, the median time to bring a product from ideation to at least 20% uptake in LMICs was 13·5 years (IQR 6·8-41·6). Ideation to proof of concept was the longest interval (median 6·9 years) for most product types, followed by the first country launch to at least 20% uptake in LMICs (median 3·8 years). Infectious disease products tended to need the longest time to launch, whereas maternal and child health products took the longest to scale up. Products with consumer or institutional markets launched and scaled up faster than those with global markets by 6 years and 2 years, respectively (p=0·012 and p<0·0001). Other factors, such as type of developer and buying environment, also had an effect on launch and scale-up timelines.

INTERPRETATION

Stakeholders should make long-term plans to introduce and scale up new products. Better coordination and planning across different stages and among different players could accelerate the process.

FUNDING

Bill & Melinda Gates Foundation.