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Changing evidentiary standards: growth of the IVD market and heightened evidence requirements

This article was originally published in Clinica

Executive Summary

The in vitro diagnostics (IVD) market is currently one of the fastest-growing areas of clinical medicine in the US, with an annual growth of approximately 7% since 2004, and a projected growth rate of 9-13% per year until 2012. Within the IVD market, molecular diagnostics is the fastest-growing sector, constituting a $1-2bn dollar industry with annual growth of 30-50% in recent years. IVD test costs can range from approximately $20 for simple blood tests to thousands of dollars for more complex and novel diagnostics, and prices are quickly rising, particularly in the molecular diagnostics industry. The trend towards value-based pricing for high-end technologies has increased the level of evidence necessary to attain optimal payments from managed care organisations. Payers are now paying close attention to the clinical and economic utility of new products (eg, how the test or diagnostic will impact treatment decisions and the overall impact of the test on a plan's budget) when evaluating them for coverage.

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