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PharmaFocus: Biomarkers in Alzheimer’s Disease

Global AD biomarkers market: Eli Lilly has a monopoly on molecular biomarkers of AD

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2014-02-12 09:19:03 - PharmaFocus: Biomarkers in Alzheimer’s Disease - a new market research report on

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. However, these imaging tests can be administered in AD patients, at least at the basic level, without the need for AD-specific products or modifications. These tools don´t provide as many opportunities for further development in AD compared with other biomarkers and thus there aren´t many companies that have been involved in the development and commercialization of structural and functional imaging biomarker products for




Molecular biomarkers of AD, on the other hand, present more viable opportunities for the development of novel assays with commercial potential. At the time of this writing, Amyvid ([18F] Florbetapir), an amyloid positron emission tomography (PET) imaging ligand marketed by Eli Lilly, is the only diagnostic assay approved by the Food and Drug Administration (FDA) for AD.

Despite Lilly´s market monopoly at present, there are several similar amyloid PET imaging ligands in the pipeline, with GE Healthcare´s [18F] Flutemetamol and Piramal´s [18F] Florbetaben currently undergoing regulatory review in the US and the European Union (EU), and these are likely to provide active competition.

There are also several companies actively developing fluid-based biomarker panel assays for AD, including Innogenetics, which has produced assay kits for amyloid and tau proteins that are widely used in academic research and in clinical drug development. Some of these Innogenetics AD biomarker kits have received CE (Conformité Européenne) marking in the EU, but to date, none are FDA approved for clinical diagnostic use in the US.

Blood-based assays for AD biomarkers hold great promise as screening tests that can be widely applied in a cost-effective manner and are a major unmet need for AD. Several companies, such as Exonhit, Ctyox, Proteome Biosciences, DiaGenic, and Amarantus, have products in development that, if validated, may satisfy this need.

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. However, there have been challenges in producing widely reproducible assays, as described below.

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Mike King
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