Abstract
“Biomarkers have the potential to revolutionise the diagnosis of disease
and the drug discovery process”
Part of Espicom' s new 3-volume report on Cancer, CNS and Cardiovascular
Biomarkers, this volume provides a comprehensive analysis of the CNS biomarker
sector, along with a critical assessment of the companies involved.
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.
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.
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.
Companies Analysed
- Affymetrix
- Applied NeuroSolutions Inc
- Banyan Biomarkers
- BG Medicine
- BioSite Inc
- Biospective
- Celera
- Clinical Data Inc
- Curidium Medica Plc
- DigiLabs Peptidomics
- EnVivo Pharmaceuticals
- Innogenetics NV
- KineMed Inc
- Lipomics Technologies
- Luminex Corporation
- Memory Pharmaceuticals Corporation
- Metabolon Inc
- Nanogen Inc
- Nanosphere Inc
- Nymox Pharmaceutical Corporation
- Osta Biotechnologies
- PDD Inc
- Phenomenome Discoveries Inc
- Power3 Medical Products
- Provista Life Sciences
- Psynova Neurotech Ltd
- Satoris Inc
- Siemens Medical Solutions
- SuperArray Bioscience Corporation
Table of Contents
EXECUTIVE SUMMARY
- Figure 1: Growth in biomarker market 2007-2015
- What are biomarkers?
- Why are they important?
- Figure 2: Potential impact of biomarkers on disease pathways
- What technologies are involved?
- What impact will biomarkers have on R&D?
- Figure 3: Potential impact of biomarkers on R&D
- Who are the major biomarker players and in what research area?
- Cancer biomarker companies
- Cardiovascular biomarker companies
- CNS biomarkers companies
- Company Analysis Criteria
- Biomarker technology & platforms
- Association/clinical studies
- Management strategy
- Application & potential
CNS MARKET & REVENUES
- Market revenues - global
- Figure 1: Global CNS drugs sales (2007)
- Market revenues - leading brands
- Figure 2: Leading CNS brands (2007)
- Market revenues - leading players
- Figure 3: Top 10 CNS players (2007 revenues)
- CNS EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT
- Epidemiology
- Table 1: CNS statistics for the most common CNS disorders, 2008
- Diagnosis
- Table 2: Indication for CT and MRI in the CNS
- Screening
- Current & future treatment
- Table 3: Classes of CNS drugs approved for acute and chronic conditions
- Future treatment
- Figure 4: CNS drugs in clinical development
- CNS BIOMARKERS
- CNS biomarker R&D
- Figure 5: Imaging biomarkers as surrogate endpoints
- Table 4: Types of biomarker
- Known CNS biomarkers
- Table 5: Commercially available known CNS biomarker diagnostics
- Probable and possible valid CNS biomarkers
- Table 6: Probable CNS biomarkers diagnostics
- Table 7: Possible CNS biomarkers diagnostics
CNS BIOMARKER OPPORTUNITIES & CHALLENGES
- Opportunities
- Figure 7: CNS biomarker opportunities
- Challenges
- Figure 8: CNS biomarker challenges
- BIOMARKER MARKET
- Biomarker market revenues - global
- Figure 9: Global biomarker sales in 2007
- CNS biomarker market revenues - global
- Figure 10: Global CNS biomarker sales in 2007
- Future biomarker market revenues - global
- Figure 11: Global biomarker sales in 2015
- Future CNS biomarker market revenues - global
- Figure 12: Global CNS biomarker sales in 2015
- CNS BIOMARKER TRENDS
- Table 8: Recent deals in the oncology biomarkers
- Pharma deals
- Collaborations with CNS discovery companies
- Collaborations with academics and consortia
- BIOMARKER ANALYSIS
- DNA biomarkers
- Proteomic biomarkers
- Metabolomic biomarkers
- Electrophysiology biomarkers
- Imaging biomarkers
- KEY BIOMARKER COMPANIES ANALYSED
- KEY BIOMARKER EVALUATION CRITERIA
CNS BIOMARKER- COMPANY ANALYSIS
- Affymetrix
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Applied Neuro Solutions
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Banyan Biomarkers
- Biomarker novelty & technology platform
- Figure 14: Source Of Banyans TNI biomarkers
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- BG Medicine
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Biosite, Inc.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Biospective
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Celera, Inc.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Clinical Data Inc.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Curidium Medica
- Biomarker novelty & technology platform
- Association studies/clinical data
- Figure 17: Curidium' s PsychINDx test for schizophrenia/bipolar disorder
- Management strategy
- Application & market potential
- Digilab Peptidomics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- EnVivo Pharmaceuticals
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Innogenetics NV
- Biomarker novelty & technology platform
- Figure 18: Innogenetic multiparameter analysis
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- KineMed, Inc
- Biomarker novelty & technology platform
- Figure 19: KineMarker technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Lipomics Technologies
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Luminex Corporation
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Figure 20: Luminex is capturing end-user market share
- Application & market potential
- Biomarker analysis
- Memory Pharmaceuticals Corporation
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Metabolon, Inc.
- Biomarker novelty & technology platform
- Figure 21: Metabolon integrated analytic platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Nanogen, Inc.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Nanosphere, Inc.
- Biomarker novelty & technology platform
- Figure 22. Nanosphere' s gold nanoparticle technology
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Nymox Pharmaceutical
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Competitor Ratio Analysis Score = 12/40
- Osta Biotechnologies
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Phenomenome Discoveries, Inc.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- PPD, Inc.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Competitor Ratio Analysis Score = 16/40
- Power3 Medical Products
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Provista Life Sciences
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Psynova Neurotech Ltd.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Figure 23: Two proteins identified in CSF are also biomarkers in serum
- Management strategy
- Application & market potential
- Biomarker analysis
- Satoris, Inc.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Figure 24: Early identification of Alzheimer' s disease in at-risk MCI
patients
- Management strategy
- Application & market potential
- Biomarker analysis
- Siemens Medical Solutions
- Biomarker novelty & technology platform
- Figure 25: Siemens Integrated in vivo & in vitro diagnostic suites
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Competitor Ratio Analysis Score = 20/40
- SuperArray Bioscience Corporation
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
CNS BIOMARKER APPENDIX 1
- Table 9: Global biomarker sales 2007-20015E
CNS BIOMARKER APPENDIX 2
- Table 10: Global CNS biomarker sales 2007-20015E
CNS BIOMARKER APPENDIX 3
- Company Analysis Criteria
- Biomarker technology & platforms
- Association studies
- Management strategy
- Application & potential
- Table 9: Key CNS Biomarker Companies
- Figure 26: Leading CNS Biomarker Companies - Service Providers,
Technology Providers, Biomarker Discovery & Diagnostic Developers
GLOSSARY
ACRONYMS
BIBLIOGRAPHY
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