A situation analysis of the state of supply of in vitro diagnostics in Low-Income Countries.

Stevenson, Michael

In vitro diagnostics (IVDs) are medical devices and accessories used to test bodily samples for causative agents of disease. IVDs play a central role in the diagnosis of individuals, in the rationale use of medicines, in burden of disease estimates, as well as in public health surveillance; especially for detection of emerging epidemics, the identification and monitoring of antimicrobial resistance, and the documentation of infection rates in populations. This article examines how the state of (a) product quality, (b) pricing, and (c) development country manufacturing capacity, are affecting the supply of IVDs in Low-Income Countries (LICs). Data informing this work is derived from interviews with representatives of leading stakeholder organisations working in this space, and analysis of secondary literature. The findings of this analysis are that the supply of IVDs in LICs is undermined by (i) significant variation in product quality; (ii) inconsistent market demand from governments; (iii) limited opportunities for pooled procurement; (iv) a lack of transparency and consistency in product pricing; and (v) insufficient competition among producers capable of innovating for populations with limited purchasing power and low-resource settings. The article then examines four strategies for how these challenges can be overcome.