PharmaFocus: Biomarkers in Alzheimer’s Disease

From a commercial standpoint, the AD biomarkers market is still relatively young. Biomarkers for AD can be classified in terms of pathological mechanism and also in terms of the assay technology used to detect and assess the biomarker. Magnetic resonance imaging (MRI) and fluorodeoxyglucose-positron emission tomography (FDG-PET) are valuable biomarker tools for assessing brain structure and function.

The AD biomarker field is rife with unmet needs, both environmental and clinical. Environmental unmet needs include limited physician knowledge of the appropriate application of existing biomarker tools, as well as limited public awareness of the disease, which prevents people from seeking a clinical diagnosis. Often, Alzheimer’s symptoms are ascribed to normal aging. Cost and accessibility are currently limiting the widespread use of the available biomarker tools, since most of these are imaging-based technologies (MRI, PET) that can be quite expensive and require access to specialized imaging facilities.

There are also several unmet needs intrinsic to the biomarkers themselves. There is a lack of biomarkers that adequately assess the multiple pathological processes that are thought to contribute to AD; although tools to assess amyloid as a biomarker for AD have been actively developed, molecular measures of neurodegeneration, inflammation, and oxidative stress remain limited. Consequently, there remains plenty of room in the market for products that can satisfy these needs, provided that their accuracy and validity can be demonstrated.


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