Background: Important advances in the development and production of
quality-certified pediatric antiretroviral (ARV) formulations have recently been made despite significant market
disincentives for manufacturers. This progress resulted from lobbying and innovative interventions from HIV/AIDS
activists, civil society organizations, and international organizations. Research on uptake and dispersion of these
improved products across countries and international organizations has not been conducted but is needed to inform
next steps towards improving child health.
Methods: We used information from the World Health Organization
Prequalification Programme and the United States Food and Drug Administration to describe trends in quality-certification
of pediatric formulations and used 7,989 donor-funded, pediatric ARV purchase transactions from 2002-2009 to
measure uptake and dispersion of new pediatric ARV formulations across countries and programs. Prices for new
pediatric ARV formulations were compared to alternative dosage forms.
Results: Fewer ARV options exist for HIV/AIDS treatment in children than
adults. Before 2005, most pediatric ARVs were produced by innovator companies in single-component solid and liquid forms.
Five 2-in1 and four 3-in-1 generic pediatric fixed-dose combinations (FDCs) in solid and dispersible forms
have been quality-certified since 2005. Most (67%) of these were produced by one quality-certified manufacturer.
Uptake of new pediatric FDCs outside of UNITAID is low. UNITAID accounted for 97-100% of 2008-2009 market
volume. In total, 33 and 34 countries reported solid or dispersible FDC purchases in 2008 and 2009,
respectively, but most purchases were made through UNITAID. Only three Global Fund country recipients reported
purchase of these FDCs in 2008. Prices for pediatric FDCs were considerably lower than liquids but typically higher
than half of an adult FDC.
Conclusion: Pediatric ARV markets are more fragile than adult markets.
Ensuring a long-term supply of quality, well-adapted ARVs for children requires ongoing monitoring and improved
understanding of global pediatric markets, including country-based research to explain and address low uptake of
new, improved formulations. Continued innovation in pediatric ARV development may be threatened by outdated
procurement practices failing to connect clinicians making prescribing decisions, supply chain staff dealing
with logistics, donors, international organizations, and pharmaceutical manufacturers. Perceptions of global demand
must be better informed by accurate estimates of actual country-level demand.