Impact of Biomarkers in Alzheimer's Disease - Dx-Rx collaboration paves the way for personalized medicine

Diagnostic and prognostic biomarkers will help to identify patients with early Alzheimer’s disease, while pharmacogenetic biomarkers can inform prescribing decisions and form the basis of personalized medicine. Biomarkers are at the heart of the development of two high-risk pipeline drugs, bapineuzumab and solanezumab, with combined peak-year sales forecasts of $6.6bn in the seven major markets.

The Alzheimer’s disease market is forecast to grow to 2020 at a CAGR of 10.7% from 2011. Catalysts for growth include an aging population, earlier diagnosis, and the introduction of immunotherapies. The absolute impact of biomarkers is predicted to be $6.6bn annually by 2020 with the potential for far greater implications beyond this period.

The last 2 years have seen a spate of collaborations between drug and diagnostic companies. This has allowed drug developers to be at the forefront of diagnostic research; enabling optimized patient recruitment and generating important biomarker data. Furthermore, the potential for allying a new drug to a companion diagnostic is created.

Diagnostic biomarkers to identify MCI due to Alzheimer’s may increase the likelihood that a drug with an anti-amyloid mechanism will show efficacy. Furthermore, pharmacogenetic biomarkers, such as ApoE4 status with bapineuzumab, can identify patients that will be more likely to respond to a treatment with an acceptable safety profile.

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