Market assessment of tuberculosis diagnostics in South Africa, 2012-2013.

OBJECTIVE To assess the current served available market of tuberculosis (TB) diagnostics in South Africa in the public and private sectors. DESIGN Public and private sector test volumes and unit costs were collected for tuberculin skin tests, interferon-gamma release assays, smear microscopy, culture, speciation, Xpert MTB/RIF, other nucleic acid amplification tests, drug susceptibility testing and adenosine deaminase tests. RESULTS In 2012, during Xpert scale-up, the public and private sectors performed a total of 9.2 million TB diagnostic tests, at an estimated total value of US$98 million. The public sector accounted for 93% of the overall test volume and value. There were no major differences in the types of tests performed in both sectors, with microscopy and culture accounting for the majority of tests performed (72%). In 2013, the public sector market value increased to US$101 million (a 10% increase over 2012): Xpert volumes increased by 166%, while total TB test volumes decreased by 12% compared to 2012. CONCLUSION South Africa has a substantial TB diagnostic market in terms of both volume and value. The roll-out of Xpert provides insights into how markets change in volume and value with the introduction of new tools.