Tuberculosis diagnostics in 2015: landscape, priorities, needs, and prospects

Abstract

In 2015, tuberculosis remains a major global health problem, and drug-resistant tuberculosis is a growing threat. Although tuberculosis diagnosis in many countries is still reliant on older tools, new diagnostics are changing the landscape. Stimulated, in part, by the success and roll out of Xpert MTB/RIF, there is now considerable interest in new technologies. The landscape looks promising, with a robust pipeline of new tools, particularly molecular diagnostics, and well over 50 companies actively engaged in product development. However, new diagnostics are yet to reach scale, and there needs to be greater convergence between diagnostics development and development of shorter-duration tuberculosis drug regimens. Another concern is the relative absence of non-sputum-based diagnostics in the pipeline for children and of biomarker tests for triage, cure, and progression of latent Mycobacterium tuberculosis infection. Several initiatives, described in this supplement, have been launched to further stimulate product development and policy, including assessment of needs and priorities, development of target product profiles, compilation of data on resistance-associated mutations, and assessment of market size and potential for new diagnostics. Advocacy is needed to increase funding for tuberculosis research and development, and governments in high-burden countries must invest more in tuberculosis control to meet post-2015 targets for care, control, and prevention.

Keywords: diagnostics; market potential; pipeline; tuberculosis; unmet needs.

Figure 1.

Status of the tuberculosis problem in 2014. The graphic is reproduced with permission from the World Health Organization (http://www.who.int/tb/features_archive/globaltb_report2014/en/).

Figure 2.

Current tuberculosis diagnostics pipeline listing the development phases and the types of technologies in development or evaluation. Complexity categorization was based on criteria that are used for similar diagnostics by the US Food and Drug Administration. Early development refers to prototype development after the proof-of-concept stage. Late-stage development refers to turning the prototype into a design-locked, manufacturable product. The graphic is reproduced with permission from the Foundation for Innovative New Diagnostics.

Figure 3.

Pipeline of molecular diagnostics for tuberculosis, by level of deployment (ie, reference, intermediate, and peripheral microscopy laboratories). The graphic is reproduced with permission from the UNITAID (http://unitaid.org/images/marketdynamics/publications/UNITAID_TB_Diagnostics_Landscape_3rd-edition.pdf).