Abstract
Tuberculosis (TB) is a curable disease yet remains a global health problem with 9 million cases, including an estimated 550 000 in children, occurring in 2013. It is the second most common cause of death in adults from an infectious disease. An estimated 480 000 people developed drug-resistant TB. China, India and South Africa have the highest number of TB cases globally and, together with Brazil, account for 46% of all new cases. The majority of TB cases in high-burden countries are diagnosed by smear microscopy on a sputum specimen at peripheral microscopy centres. However, smear microscopy has low sensitivity and cannot detect extrapulmonary TB or drug-resistant TB. Thus there is a need for simpler, more rapid and more effective diagnostics that are designed for use in peripheral settings. In addition, universal drug susceptibility testing (DST) – now included in the End TB Strategy – requires countries to scale-up DST capacity. New TB drugs are now on the market, and shorter, novel drug regimens are expected to be introduced by 2018. These regimens will require the use of diagnostics specifically designed for new regimens.
Test developers and manufacturers interested in entering the TB diagnostic market need data on current market size, both global and country-specific, on prioritized unmet diagnostic needs, and on estimated market opportunity associated with these needs. This report focuses on current and future markets in four high-burden, emerging economies – Brazil, China, India and South Africa. These four countries offer tremendous opportunities for new TB diagnostics, in part due to their national commitment to TB control in the face of high TB burdens, increased investments in new technologies, and growing economies. This report builds on a previous global market assessment by FIND and the World Health Organization (WHO) Special Programme for Research and Training in Tropical Diseases (TDR), published in 2006, and provides an updated snapshot of the TB testing landscape that has rapidly evolved in the past decade. WHO endorsed seven new TB diagnostic tools from 2007 to 2013, and there are several novel assays in the development pipeline. Thus, an updated analysis is warranted.
