Companion Diagnostics Market Research Reports & Industry Analysis

The companion diagnostics market is one of the fastest growing segments of the IVD and clinical lab services markets. In the United States, over half of all FDA approvals for companion diagnostics have occurred since 2010. The closely associated pharmacodiagnostics IVD market is expected to grow annually by over 20%. The wild success of reference laboratories in the companion diagnostics market even prompted the unprecedented expansion of FDA oversight over laboratory developed tests (LDTs).

Companion diagnostics are increasingly integral to the approval of some new pharmaceuticals, illustrating which individuals are most likely to benefit from the drug. With the approval of CDx-assisted therapies, new high-growth markets are opened for lab tests and IVD products.

Companion diagnostics (CDx) include in vivo or medical imaging procedures and in vitro diagnostic (IVD) lab tests used to determine the efficacy of a particular therapy, most commonly pharmaceutical. Genome research in recent decades has illuminated and detailed the role genetics play in drug metabolism and disease etiology. Drugs can now be paired with IVD and medical imaging tests for prescription decisions and therapeutic monitoring. In vitro companion diagnostics are largely molecular assays, though additional formats include immunohistochemistry (IHC) and immunoassays, and are offered as test kits, analyte specific reagents, and laboratory developed tests (LDTs) or a lab testing service.

The majority of companion diagnostics are pharmacodiagnostic lab tests used to assess an individual’s response to drug therapy. Pharmacodiagnostics represents a major front in a healthcare system-wide push towards personalized medicine. Pharmacodiagnostic tests can be used to determine patient response to clopidogrel anticoagulant drugs, appropriate drug dosage, and the prescription of oncology drugs based on genetic markers.

Stay abreast of fast-paced and promising companion diagnostics markets with’s collection of market research studies. We offer a wide selection of studies treating companion diagnostic regulation, regional and disease-specific market development, product and test pipelines, and companion diagnostic product market tracking.

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Companion Diagnostics Industry Research & Market Reports

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