Companion Diagnostics - Thematic Research
Summary
Companion diagnostics (CDx) are molecular assays that measure levels of proteins, genes, or specific mutations to reveal a specific, efficacious therapy for an individual’s condition. CDx are a form of personalized, stratified, and precision medicine, and they herald a new era of treatment in which a patient’s treatment will become increasingly individualized.
CDx are developed in parallel to the drug using the drug-diagnostic co-development model. The field has expanded from a handful of oncology drugs with corresponding diagnostics to include multiple therapeutic areas, and the number of combinations has grown significantly over the years. However, oncology remains the largest segment for FDA-defined marketed drugs with CDx. The FDA has cleared or approved more than 40 CDx in the field of oncology. GlobalData expects that oncology will likely remain the therapeutic area at the forefront of CDx in the future. Although precision medicine encompasses many areas, oncology is the area that is expected to exhibit high growth.
This report looks at the CDx medical devices market and some of the oncology biomarkers, indications, and diagnostic technologies being utilized. The market for biomarker testing continues to increase due to increases in disease, awareness, improved accessibility to personalized medicine, and technological advancements.
Scope
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