Published Date: 28/08/2008
Category: Emerging Technologies & Scientific Research
The CNS biomarker market represents one of the smallest segments of biomarkers in terms of revenue as relatively few CNS biomarkers are commercially available. In 2007, we estimate the CNS biomarker market accounted for less than 5% of biomarker revenues, with the majority coming from biomarker discovery in schizophrenia and neurodegenerative disorders. Collaboration between the industry and academia is critical if the potential of CNS biomarkers is to be realised. During the last ten years several public-private partnerships have been established to discover biomarkers and their uses in the diagnosis of CNS disorders. According to PhRMA, around US$44 .5 billion was spent on R&D. However, there is still only an 8% chance that a drug entering clinical trials will reach the market. Reliable read-outs are essential if the industry is to improve its track record on drug attrition and continue to attract investment.By 2015, we estimate the global CNS biomarker market will account for around 15% of global biomarker sales to be worth over US$3.4 billion as the market matures; driven by growth in clinical biomarkers for neurodegenerative diseases, the development of biomarkers for neuropsychiatric diseases (e.g. schizophrenia and depression) for clinical trial guidance and the commercialisation of the first molecular tests to predict AD and MCI and to differentiate MS patients. 57% of the market will be taken by the biomarker discovery sector.
Affymetrix, Applied NeuroSolutions, Banyan Biomarkers, BG Medicine, BioSite, Biospective, Celera, Clinical Data, Curidium Medica, DigiLabs, Peptidomics, EnVivo Pharmaceuticals, Innogenetics NV, KineMed, Lipomics Technologies, Luminex Corporation, Memory Pharmaceuticals Corporation, Metabolon, Nanogen, Nanosphere, Nymox Pharmaceutical Corporation, Osta Biotechnologies, PDD, Phenomenome Discoveries, Power3 Medical Products, Provista Life Sciences, Psynova Neurotech, Satoris, Siemens Medical Solutions, SuperArray Bioscience Corporation
The majority of the CNS biomarker research at the present time is aimed at the discovery and identification of biomarker signatures through the application of gene expression profiling, protein profiling and/or metabolomics, as well as the use of imaging and electrophysiological surrogate biomarkers. Many “probable” biomarker signatures are now under evaluation, particularly in AD, MS and schizophrenia.
This market is immature as CNS disorders are often ill-defined and their underlying aetiology poorly understood. However, in certain areas such as neurodegenerative diseases, a clear genetic component has been established and significant strides have been made in discovering and identifying novel biomarkers to guide drug development programmes and/or as diagnostic aids.
Focus on...research approachesDNA biomarkers
Companies have utilised gene expression profiling using microarray based technologies to discover and identify novel genetic biomarkers for development. One approach is to identify single genes associated with a disease state (e.g. schizophrenia susceptibility genes) or treatment response (pharmacometabolomic biomarkers). Conversely, companies are increasingly applying panels of biomarkers or biosignatures to develop prognostic diagnostics.
Proteomic biomarkers
In addition, companies may evaluate single proteins or quantitative proteomic profiling of blood plasma, serum, urine or CSF using chromatography and mass spectrometry based technologies (BG Medicine) to discover and identify novel biomarkers. This approach has been widely adopted by Applied NeuroSolutions, BioSite, Nymox Pharmaceuticals, PPD, Power3 Medical Products, Provista Life Sciences and Satoris
Electrophysiology biomarkers
Some companies have adopted alternative surrogate biomarkers that measure electrophysiological changes in neural pathways. For example, EnVivo Pharmaceuticals and Memory Pharmaceuticals monitor P50 auditory evoked response and mismatch negativity as a read-out where abnormalities in sensory gating are associated with schizophrenia.