Fill out the form below to download your copy.
Companion diagnostics (CDx) is an emerging (+$200M) segment of the ~$50B in vitro diagnostics (IVD) industry, which is growing at double digit rates through 2016. Companion diagnostic tests (also referred to as pharmacogenetic tests) are used to inform patient selection, dosing requirements, or susceptibility to side effects for a particular drug. While many drug labels recommend or provide guidance on pharmacogenetic testing, certain drugs, particularly cancer drugs, require patients to receive a diagnostic test, as the efficacy of these drugs is limited to those with a particular genotype. This report reviews the size, segmentation, growth, competitive, and regulatory landscape of the companion diagnostics manufacturing market, focusing on the drug-test combinations that are considered required by the FDA.