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2014 UNITAID TB Diagnostics Landscape

Tuberculosis (TB), despite being a curable disease, continues to be a major public health threat: the World Health Organization (WHO) estimated that 1.3 million people died of the disease in 2012. Rapid, accurate diagnosis is critical for timely initiation of treatment and, ultimately, control of the disease. But of the 8.6 million people who developed TB in 2012, over one third were not diagnosed - an estimated 3 million missed cases. Lack of access to appropriate diagnostic tools is caused, in part, by shortcomings in TB diagnostics markets. For example, currently available diagnostics are often ill-adapted to resource-limited settings or specific patient needs, or may be priced out of reach.
Although TB diagnosis often still relies on basic tools, such as smear microscopy and culture, new diagnostics are changing the TB diagnostics landscape. Several technologies have been endorsed by WHO and incorporated into country policies since 2007. Further change can be expected, with a robust technology pipeline promising new products and continued development to address persisting unmet needs.


This report reviews current and potential future technologies, as well as critical market issues, to identify market-based approaches to alleviate market shortcomings and, ultimately, access issues related to TB diagnostics. For example, potential opportunities may include efforts to accelerate market entry for inno- vative TB diagnostics that address unmet needs, and to engage private-sector care providers to increase access to appropriate diagnostic tools. 


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