Abstract

BackgroundRapid diagnostic tests (RDTs) for malaria are a vital part of global malaria control. Over the past decade, RDT prices have declined, and quality has improved. However, the relationship between price and product quality and their larger implications on the market have yet to be characterized. This analysis used purchase data from the Global Fund together with product quality data from the World Health Organization (WHO) and Foundation for Innovative New Diagnostics (FIND) Malaria RDT Product Testing Programme to understand three unanswered questions: (1) Has the market share by quality of RDTs in the Global Fund’s procurement orders changed over time? (2) What is the relationship between unit price and RDT quality? (3) Has the market for RDTs financed by the Global Fund become more concentrated over time?MethodsData from 10,075 procurement transactions in the Global Fund’s database, which includes year, product, volume, and price, was merged with product quality data from all eight rounds of the WHO-FIND programme, which evaluated 227 unique RDT products. To describe trends in market share by quality level of RDT, descriptive statistics were used to analyse trends in market share from 2009 to 2018. A generalized linear regression model was then applied to characterize the relationship between price and panel detection score (PDS), adjusting for order volume, year purchased, product type, and manufacturer. Third, a Herfindahl–Hirschman Index (HHI) score was calculated to characterize the degree of market concentration.ResultsLower-quality RDTs have lost market share between 2009 and 2018, as have the highest-quality RDTs. No statistically significant relationship between price per test and PDS was found when adjusting for order volume, product type, and year of purchase. The HHI was 3,570, indicating a highly concentrated market.ConclusionsAdvancements in RDT affordability, quality, and access over the past decade risk stagnation if health of the RDT market as a whole is neglected. These results suggest that from 2009 to 2018, this market was highly concentrated and that quality was not a distinguishing feature between RDTs. This information adds to previous reports noting concerns about the long-term sustainability of this market. Further research is needed to understand the causes and implications of these trends.

Highlights

  • Rapid diagnostic tests (RDTs) for malaria are a vital part of global malaria control

  • All prices were reported in US dollars (USD) at the time of order, and this analysis adjusts all dollars to 2018 dollars by using World Bank gross domestic product deflator data for the United States as recommended by the World Health Organization (WHO) Guide to Standardization of Economic Evaluations of Immunization Programmes [36, 37]

  • Aim one: trends in RDT panel detection score (PDS) over time For the P. falciparum panel, in 2009 1% of purchased RDTs were below the current WHO minimum quality standard of 75%, while 94% of all purchased RDTs had a PDS > 95%

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Summary

Introduction

Rapid diagnostic tests (RDTs) for malaria are a vital part of global malaria control. The relationship between price and product quality and their larger implications on the market have yet to be characterized This analysis used purchase data from the Global Fund together with product quality data from the World Health Organization (WHO) and Foundation for Innovative New Diagnostics (FIND) Malaria RDT Product Testing Programme to understand three unanswered questions: (1) Has the market share by quality of RDTs in the Global Fund’s procurement orders changed over time? Improving the ability to diagnose malaria quickly and accurately remains a crucial component of the global effort to reduce the burden of malaria on patients and health systems. This has been conducted through diagnosis by expert microscopists. Rapid diagnostic tests (RDTs) have many advantages over microscopy, including removing the need for instrumentation and reliable electricity, as well as the reduced amount of training needed for RDT use compared to microscopy [4]

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