PharmaFocus: Biomarkers in Alzheimer’s Disease

                    

Alzheimer’s disease (AD) is a progressive neurodegenerative disease that is characterized by memory loss, cognitive impairment, and functional decline. The disease has emerged as a major global health priority especially because of its rapidly accelerating prevalence worldwide. In order to tackle the AD scourge, there is an urgent need for tools that will allow for the early and accurate diagnosis of AD, as well as the identification of populations at risk. A biomarker is an indicator of biological processes that can be objectively measured and evaluated, and well-validated biomarkers are required to satisfy these needs in AD.

Spanning over 179 pages and 59 tables and 10 figures, “PharmaFocus: Biomarkers in Alzheimer’s Disease” report shows drive revenues by understanding the key trends, innovative products and technologies, and companies likely to impact the AD biomarker market in future. 

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 Findings

• 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. both in the US and in the EU.

Scope

• Overview of Alzheimer's disease, including disease etiology and pathophysiology and how these inform biomarker targets.
• Overview of AD biomarkers, the major classes of biomarkers an the different potential roles of biomarkers in clinical use and drug development.
• Key topics covered include amyloid biomarkers, tau biomarkers, and other molecular biomarkers for AD in development with product profiles for marketed as well as promising pipeline assays. Also discussed are functional and structural imaging biomarkers for AD.
• Analysis of the unmet needs, and opportunities within the AD biomarker arena, as well as drivers and barriers impacting the AD biomarker market.
• Insightful review of the regulatory considerations impacting biomarker development, market access and use in clinical drug development

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