2013 Tuberculosis Diagnostics Technology and Market Landscape: 2nd Edition
Author: David Boyle and Madhukar Pai
Organization: UNITAID
Year: 2013
Document Type: Report
Abstract/Summary: Although most cases of tuberculosis (TB) are curable, there were 1.4 million deaths from TB in 2011. Effective and rapid diagnosis is critical for timely initiation of appropriate treatment, but many patients – roughly one-third of new cases – do not have access to appropriate TB diagnostics. Multidrug-resistant (MDR) TB, in particular, presents diagnostic-related challenges. The World Health Organization (WHO) reports that of an estimated 8.7 million cases in 2011, only 6.2 million cases were diagnosed and notified to national TB programmes. Lack of access to TB diagnostics can be traced, in part, to market shortcomings, including unavailability of appropriate diagnostic tools, high prices, and tools that are ill-adapted to resource-limited settings. Basic tools such as smear microscopy and culture still often form the mainstay of TB diagnosis, especially in resource-limited settings. However, these tools have notable shortcomings (e.g., long time to results for culture, intensive labour requirements, and low sensitivity of smears), and recently have seen only incremental improvements. In contrast, more rapid change and innovation are evident in the area of nucleic acid amplification technologies (NAAT). Developments have been particularly pronounced since 2010,when WHO endorsed Xpert® MTB/RIF. While a major advance, Xpert MTB/RIF is still relatively expensive, and tools adapted for use at the point of patient care in resource-limited settings are still needed. Improved market function is needed to increase TB case finding and, subsequently, access to appropriate TB care—especially for MDR and paediatric TB. Review of the landscape of TB diagnostics – considering current and expected future technologies, as well as critical market issues – highlights potential market-based approaches to address shortcomings and improve market function. For example, opportunities for TB diagnostics market interventions may include efforts to accelerate market entry for innovative TB diagnostics to be used at the point of patient care, and innovative means of engaging with the private sector to increase uptake of existing WHO-endorsed tests.
Disease/Therapeutic Area: Tuberculosis
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Global Health Market Dynamics 