The WHO and the IUATLD have recommended fixed dose combination (FDC) tablets containing Rifampicin for TB treatment. However, due to variation in bioavailability of the Rifampicin and quality of Rifampicin in FDCs have prevented their large scale use resulting in lower production and higher prices beyond affordability in developing countries. In this paper, the authors estimate the potential size of the market for Rifampicin containing FDCs assuming that all the currently marketed Rifampicin will be sold in FDCs. The quantity of Rifampicin is estimated by the following equations : the quality of Rifampicin per treatment regimen multiplied by the number of TB cases treated in public and private sector. The future size of the market for FDCs will be influenced by trends in numbers of cases, the ratio of cases treated in the public v/s the private sector and the ratio of cases not treated at all. The future trends of the TB epidemic may be influenced by several factors such as implementation of control strategy, commitment of government for TB control and the impact of the HIV epidemic. Hence, the authors have decided to provide an estimate of the present market.

WHO collected the information on the use of FDCs in public sector through a questionnaire; 85 countries representing about 90% of the world’s TB cases responded to the WHO questionnaire. About 50% of the 85 countries use Rifampicin as FDCs in the public sector, however most of these are small countries. In the public sector, an estimated 23.8% of the total number of notified TB cases are treated with two or three drug FDCs. In the public sector it is estimated that the global amount of Rifampicin used yearly to treat 3.57 million TB cases is 123.7 metric tons, representing 78.9% million tablets of 150 mg Rifampicin or 34 g per TB case. In the private sector, it is estimated that 2.54 million TB cases are treated using 99.9 metric tons, representing 666.3 million tablets of 150 mg Rifampicin or 39 g per case. Thus, the potential global market for the four drug FDC tablet (R-150 mg, H-75 mg, PZA-400 mg and Emb-75 mg) is 305 million tablets per year, 105 and 200 million of which would be distributed in the public and private sectors respectively. The uncertainty of the estimate remains considerable, as shown by the 90% confidence intervals. In conclusion, the study demonstrated a large potential global market for FDCs that should encourage pharmaceutical manufacturers to produce WHO recommended dosages of FDCs at affordable prices. Current use of Rifampicin in the FDCs is only 25% of the total Rifampicin used in the world.