PharmaFocus: Biomarkers in Alzheimer’s Disease


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Full Paper

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Description: This report provides an analysis of the unmet needs, and opportunities within the AD biomarker arena, as well as drivers and barriers impacting the AD biomarker market.

Research Report Overview

Published Date: 30/06/2013
Category: Drug Discovery & Development

Research Report Decription

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 Alzheimer’s disease (AD) is a progressive neurodegenerative disease that is characterized by memoryloss, cognitive impairment, and functional decline. The disease has emerged as a major global healthpriority especially because of its rapidly accelerating prevalence worldwide. In order to tackle the ADscourge , there is an urgent need for tools that will allow for the early and accurate diagnosis of AD, aswell as the identification of populations at risk. A biomarker is an indicator of biological processes thatcan be objectively measured and evaluated, and well-validated biomarkers are required to satisfy theseneeds in AD. The search for biomarkers that are reflective of the disease process in AD has been and continues to be an active area of research, but has been hampered by a lack of clear understanding of the pathological mechanisms that underlie the disease. Nonetheless, several biomarkers have been developed to date that indicate the presence of AD pathology and AD-associated neuronal injury in vivo. Such biomarkers have the potential for clinical use in etiological determination, predictive prognosis, monitoring disease progression, and in clinical trials of potential disease-modifying therapies for AD.

Key Questions Answered:

  • What are the main biomarkers in AD? What AD biomarkers are commercially available in the market and which are in pipeline development?
  • What are the roles of biomarkers in AD diagnosis and drug discovery?
  • What are the major unmet needs with regards to AD biomarkers?
  • What are the views of KOLs on the present and future landscape of the AD biomarkers market?
  • What is the impact of government regulation on AD biomarker development and market adoption?
  • What governmental and industry changes are likely to influence the use of biomarkers in the near future?

Companies Mentioned:

 Eli Lilly, GE Healthcare, Exonhit, Ctyox, Proteome Biosciences, DiaGenic, Amarantus,

Paper Highlights:

  • Amyloid-based biomarkers, and in particular, amyloid PET ligands, are the furthest developed biomarkers for AD and although they have immense value in diagnosis and drug discovery, there is a remaining need for biomarkers of other pathological processes.
  • There is a great need for simple inexpensive biomarker assays that can be implement as diagnostic screens for AD and there are numerous blood-based biomarker assays in pipeline aiming to target this need.
  • Government regulation will play a major role in biomarker development, clinical market access and use in drug discovery both in the US and in the EU.