A growing number of drugs, particularly in the cancer field, are designed to treat specific genetic mutations. This means that they won’t work for everyone – but it does also mean that for those patients with the correct mutation, the chances of successful therapy are much higher.
To identify these potential responders, a screening test is required. Unsurprisingly, with the rise in personalised medicines has followed an increase in the number of companion diagnostic tests designed to pinpoint those patients who have the correct genotype or phenotype. Laboratory developed tests do not require FDA approval, as they are run in the US under the auspices of the clinical laboratory improvement amendments, or CLIA, but tests sold as kits for use in labs that do not fall under these requirements have to follow a formal licensing procedure.
Although the companion diagnostics, or CDx, market remains niche, it is growing. A recent report from Research and Markets estimates the current size of the global CDx market at about US$200m, which is dwarfed by the overall size of the diagnostics market at about $50bn. The report predicts that the market size will spiral upwards in the coming years as more CDx products and associated personalised medicines are approved, to an estimated $900m in 2018. That represents a compound annual growth rate of 29% between 2012 and 2018.
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