Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets

Abstract

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.

Figure 1

Description of analytic data set.

Figure 2

Trends in numbers of 1^st line ARV regimens in WHO treatment guidelines.

Figure 3

Consumption trends of WHO-recommended first-line ARVs (2002-2008).

Figure 4

Timeline of WHO Prequalification Programme and US FDA approvals of first-line fixed-dose combination ARVs.

Figure 5

Price trends for three-in-one FDCs and their component medicines. 5a. Price trends for 3TC, NVP, and d4T30. 5b. Price trends for 3TC, NVP, and ZDV.

Figure 6

Market dynamics for three-in-one FDCs*. * # of manufacturers refers to the number of manufacturers who sold ARVs to donor recipients in a given year, as reported to either GFATM or WHO; this is NOT the total # of manufacturers in the market. 6a. Market dynamics for lamivudine/nevirapine/stavudine 30 FDC. 6b. Market dynamics for lamivudine/nevirapine/zidovudine 30 FDC.

Figure 7

FDC Annal market trends by purchaser and manufacturer. 7a. Market trends for 3TC/NVP/d4T30 by purchaser and manufacturer. 7b. Market trends for 3TC/NVP/ZDV by purchaser and manufacturer.

Figure 8

2008 Market share across purchasers. 8a. 2008 Market share by value across purchasers. 8b. 2008 Market share by volume across purchasers.