Size and usage patterns of private TB drug markets in the high burden countries

Abstract

Background: Tuberculosis (TB) control is considered primarily a public health concern, and private sector TB treatment has attracted less attention. Thus, the size and characteristics of private sector TB drug sales remain largely unknown.

Methodology/principal findings: We used IMS Health data to analyze private TB drug consumption in 10 high burden countries (HBCs), after first mapping how well IMS data coverage overlapped with private markets. We defined private markets as any channels not used or influenced by national TB programs. Private markets in four countries--Pakistan, the Philippines, Indonesia and India--had the largest relative sales volumes; annually, they sold enough first line TB drugs to provide 65-117% of the respective countries' estimated annual incident cases with a standard 6-8 month regimen. First line drug volumes in five countries were predominantly fixed dose combinations (FDCs), but predominantly loose drugs in the other five. Across 10 countries, these drugs were available in 37 (loose drug) plus 74 (FDCs) distinct strengths. There were 54 distinct, significant first line manufacturers (range 2-11 per country), and most companies sold TB drugs in only a single study country. FDC markets were, however, more concentrated, with 4 companies capturing 69% of FDC volume across the ten countries. Among second line drugs, fluoroquinolones were widely available, with significant volumes used for TB in India, Pakistan and Indonesia. However, certain WHO-recommended drugs were not available and in general there were insufficient drug volumes to cover the majority of the expected burden of multidrug-resistant TB (MDR-TB).

Conclusions/significance: Private TB drug markets in several HBCs are substantial, stable, and complicated. This calls for appropriate policy and market responses, including expansion of Public-Private Mix (PPM) programs, greater reach, flexibility and appeal of public programs, regulatory and quality enforcement, and expansion of public MDR-TB treatment programs.

Figure 1. First line TB drug volumes broken down by strength, compared to GDF/NTP standards.

First line drugs were classified as having strengths identical to those purchased by the Global Drug Facility (GDF) or recommended by the relevant National TB Program (NTP), or integer multiples of such strengths (e.g., twice as much or half as much). The remaining strengths (“other”; purple bars at top) constituted 35% of total volume. (Note: only products with known strengths were used in the calculation.)

Figure 2. Strength variation for each first line drug.

For each country and each active pharmaceutical ingredient (API), average strengths (weighted according to volume) were calculated and compared to those purchased by GDF.

Figure 3. Prices of loose drug- and FDC-based 6 month regimens.

Average prices per mg (for loose drugs) and for 4- and 2-drug FDCs (for FDCs) were used to calculate the average cost of a daily, 6 month 2HRZE/4HR regimen.

Figure 4. Number of manufacturers with first line FDC or loose drug market share greater than 3% (by volume, 2008–2009).

Compared to countries with predominantly FDCs, countries with predominantly loose drugs have more manufacturers with >3% first line market share of either loose drugs (40 vs 17) or all first line drugs (40 vs 16). Numbers in figure legend are not a simple summation of numbers in figure as some companies are present in multiple countries.