Background: Universal access to antiretroviral therapy (ART) in low- and
middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines
recommending more expensive antiretroviral (ARV) medicines, limited financing, and few fixed-dose combination (FDC)
products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the
impact of global policy interventions.
Methods: We utilize several data sources, including 12,958 donor-funded,
adult first-line ARV purchase transactions, to describe the market from 2002-2008. We examine relationships between market
trends and: World Health Organization (WHO) HIV/AIDS treatment guidelines; WHO Prequalification Programme
(WHO Prequal) and United States (US) Food and Drug Administration (FDA) approvals; and procurement
policies of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), US President's Emergency Plan for AIDS Relief
(PEPFAR) and UNITAID.
Results: WHO recommended 7, 4, 24, and 6 first-line regimens in 2002, 2003,
2006 and 2009 guidelines, respectively. 2009 guidelines replaced a stavudine-based regimen ($88/person/year) with more
expensive zidovudine- ($154-260/ person/year) or tenofovir-based ($244-465/person/year) regimens. Purchase
volumes for ARVs newly-recommended in 2006 (emtricitabine, tenofovir) increased >15-fold from 2006 to 2008.
Twenty-four generic FDCs were quality-approved for older regimens but only four for newer regimens. Generic FDCs were available
to GFATM recipients in 2004 but to PEPFAR recipients only after FDA approval in 2006. Price trends for
single-component generic medicines mirrored generic FDC prices. Two large-scale purchasers, PEPFAR and UNITAID, together
accounted for 53%, 84%, and 77% of market volume for abacavir, emtricitabine, and tenofovir, respectively, in 2008.
PEPFAR and UNITAID purchases were often split across two manufacturers.
Conclusions: Global initiatives facilitated the creation of fairly efficient
markets for older ARVs, but markets for newer ARVs are less competitive and slower to evolve. WHO guidelines shape demand, and
their complexity may help or hinder achievement of economies of scale in pharmaceutical manufacturing.
Certification programs assure ARV quality but can delay uptake of new formulations. Large-scale procurement policies may
decrease the numbers of buyers and sellers, rendering the market less competitive in the longer-term. Global
policies must be developed with consideration for their short- and long-term impact on market dynamics.