The global pediatric antiretroviral market: analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children

Abstract

BackgroundImportant 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.MethodsWe 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.ResultsFewer 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.ConclusionPediatric 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.

Promoting Drug Development and Access: The Role of International Networks and Organizations

“…The commitment from UNITAID to fund this market was the main driving force for the entry of generic manufacturers. In an analysis of the global paediatric ARV market, UNITAID was the largest donor for paediatric ARV products with 97-100 % market volume in 2008-2009 [ 21 ].…”

Advance market commitment for pneumococcal vaccines: putting theory into practice

“…A prominent exception is the dominant role that UNITAID plays in purchasing a high proportion of paediatric antiretrovirals. 21 This AMC pilot also shows the importance of predictability, particularly of sufficient funding commitments from donors and/or beneficiary countries to pay the long-term purchasing price of vaccines in addition to the AMC envelope. Ongoing monitoring and evaluations scheduled for the coming years will provide further information about the value of this AMC and its applicability to other interventions.…”

Improving treatment outcome for children with HIV

“…Currently only four quality-assured triple-drug fi xed-dose combinations are available in solid and dispersible forms from manu facturers of generic drugs, and less desirable dose formulations continue to dominate this small and fragmented market. 10 …”