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Emerging Diagnostic Markers in Alzheimer's Disease
Decision Resources, Inc, June 2005, Pages: 19
Currently, Alzheimers disease (AD) is diagnosed based on patient clinical history and exclusion of other neurological disorders. Because early signs of AD are hard to distinguish from normal signs of aging, most patients are not diagnosed until neuronal damage is extensive. A diagnostic marker would enable physicians to diagnose more AD patients earlier and begin drug treatment when it could be most effective. The AD therapeutics market would also benefit: early diagnosis and treatment translates to more therapy sales over longer treatment periods.
In this report, we review AD diagnostic markers currently in use and in development, the main players in the AD diagnostics arena, and the impact that these markers will have on the U.S. AD market over the next ten years.
Business Implications
- Currently, the most promising diagnostic agent for Alzheimer’s disease (AD) is Pittsburgh Compound B, an Aß-amyloid imaging agent in development by GE Healthcare. We expect this agent to reach the market by 2011 and to increase the number of diagnosed and drug-treated patients by 2013.
- Several drugs are in development for treatment of AD; we expect two of these to reach the market by 2008. To be most effective, these treatments must be initiated in patients as soon as possible.
- Besides elucidating the progression of AD, a biomarker for AD would increase drug-treatment rates and therefore increase revenues for drug companies with marketed AD therapies. The increase in drug-treatment rates would result from earlier diagnosis of more patients and, consequently, longer durations of disease treatment. However, if no biomarker becomes available during our study period, we estimate that AD drugs will not attain their full market potential.
- The potential for sales of an AD diagnostic agent could be significant, due to the increasing prevalence of the disease and the potential for a diagnostic agent to command better pricing than a traditional diagnostic, given the large unmet need.
- A diagnostic agent approved by the FDA as an efficacy end point could dramatically grow the market potential for a disease-modifying drug by increasing diagnosis rates, drug-treatment rates, and duration of therapy. A therapeutic agent that demonstrated disease modification based on a biomarker could command a significant premium.
- An AD biomarker will greatly reduce costs associated with drug development by enabling selection of a more homogeneous patient population for smaller, more cost-effective clinical trials. A biomarker will also accelerate drug development by facilitating decisions as to whether to pursue or abandon agents in the early stages of clinical development.
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