Cancer, CNS & Cardiovascular Biomarkers: Players, products and prospects

Date: August 22, 2008
Pages: 352
Price:
US$ 2,615.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: CC838D4F9A5EN
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Cancer, CNS & Cardiovascular Biomarkers: Players, products and prospects
This new 3-volume report provides a comprehensive analysis of the major therapy areas which are driving growth, along with a critical assessment of the companies involved. Cancer Biomarkers

The cancer biomarker market represents one of the largest segments of biomarkers in terms of revenue. In 2007, the estimated cancer biomarker market accounted for around 55% of biomarker revenues at over US$3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics.

This market is relatively mature due to researchers’ comprehensive understanding of the underlying genetic and proteomic components of the disease. It has been the focus for the majority of the early biomarker research which was aimed at the discovery and identification of biomarkers that guided the development of targeted therapies (companion diagnostics) and has been stimulated by advances in technology platforms for the analysis of biological samples (blood, serum and tissue).

Collaborative working is essential

During the last two years, the leading pharma companies such as Abbott, AstraZeneca, Eisai, Merck & Co, sanofi-aventis, Solvay, Pfizer, Roche and Wyeth have been forming strategic alliances with a variety of companies, including Caprion Proteomics, Celera, Epigenomics, EpiStem, Monogram BioSciences (formerly ViroLogic) and Vermillion which are all actively involved in biomarker discovery and validation.

Many of these agreements have been established in the last 12 months and pursue the identification of multiple oncology biomarkers that complement pharma product pipelines. For example, in March 2008 Abbott established a collaboration with Genentech, Roche and OSI to develop an EGFR FISH based test for NSCLC testing. Similarly, specialty pharma companies such as Amgen, Myriad and OSI Pharmaceuticals have formed collaborations to utilise biomarkers in drug discovery and development programmes.

Increasingly, the industry is establishing relationships with leading academic institutes to clinically validate biomarkers prior to their use in clinical drug development programmes. For example, in the US, the Eastern Virginia Medical School, the Johns Hopkins University, The University of Kentucky, the Mayo Clinic, and the MD Anderson Cancer Center and, in Europe, the Institut Curie in France and the University of Oxford in the UK are all assessing new cancer biomarkers and technology platforms for biomarker discovery and validation.

Questions, Questions
  • What will the global cancer biomarker market be worth in 2015?
  • What developments in proteomic biomarkers are proving fruitful in the cancer sector and which companies are developing them?
  • Why might drug discovery companies be interested in Dutch diagnostic company Agendia BV?
  • How is Beckman Coulter strengthening its presence in the cancer biomarker arena?

Focus on...opportunities

The cancer biomarker sector will be driven by...

Increases in the number of new cases of a range of cancers due to an aging population, e.g. prostate, breast and ovarian cancers. These will continue to drive growth and research interest in cancer therapies and investigation into the underlying mechanisms of the disease.

Improvements in diagnostic tests and technology platforms to direct treatment and surgery which instil confidence and renewed interest in developing PoC diagnostics, e.g. EPCA/PSA tests for prostate cancer and HER-2 for breast cancer.

The development of easy-to-use and rapid PoC diagnostics that may help to increase the number of cancer patients treated with first line therapy.

Companies Analysed

- Abbott Diagnostics
- Affymetrix
- Agendia BV
- AltheaDx
- AVEO Pharmaceuticals
- AviaraDx
- BD Medicine
- Beckman Coulter Inc
- BioCurex Inc
- Biomedical Diagnostics
- Biomerica
- Bruker Daltonics
- Caprion Proteomics
- Celera
- Clinical Data Inc
- Dako Denmark A/S
- DxS Ltd.
- Epigenomics AG
- EpiStem
- Fujirebio Diagnostics
- Gen-Probe Inc
- Genomics Health Inc
- GeneNews
- Genzyme Genetics
- InterGenetics Inc
- Ipsogen Therapeutics
- Laboratory Corporation of America
- Matritech Inc
- Monogram Biosciences Inc
- Orion Genomics Inc
- Oxford Genome Sciences (UK) Ltd
- Power3 Medical Products
- Predictive Biosciences
- Provista Life Sciences
- Quest Diagnostics Inc
- Roche Diagnostics
- SuperArray Bioscience Corporation
- Third Wave Technologies
- Upstream Biosciences Inc
- Veridex
- Vermillion

CNS Biomarkers

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.

Focus on...research approaches

DNA 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.

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
“Biomarkers have the potential to revolutionise the diagnosis of disease and the drug discovery process”

Cardiovascular Biomarkers

In 2007, the cardiovascular biomarker market accounted for an estimated 23% of biomarker revenues to generate over US$1.3 billion with the majority of revenues derived from biomarker discovery and molecular diagnostics. The market has yet to reach the maturity of the oncology biomarker market, but over the coming years the importance of genetic markers and companion diagnostics will grow. By 2015, the estimated market value will be US$6.6 billion, with biomarker discovery being the largest component.

One of the largest markets for cardiovascular biomarkers lies in the diagnosis of acute coronary syndromes in patients presenting with acute signs and symptoms, such as shortness of breath or chest pain.

For example, Troponin is well established as a diagnostic marker of myocardial infarction and has been described as the cornerstone of diagnosis for the condition. However, the marker has a major limitation: troponin levels only rise six to eight hours after a myocardial ischaemia. The search for new diagnostic biomarkers for use in the acute setting has focused on the identification of earlier markers of infarction. These include ischaemia modified albumin (IMA) as well as potential markers, heart fatty acid binding protein and glycogen phosphorylase isoenzyme BB (GPBB). In addition, some of the leading providers are suggesting that panels of cardiac markers are most useful for diagnosis in acute settings. Examples include Biosite’s (now part of Inverness Medical Innovations) CardioProfiler Triage panel. This is a PoC diagnostic that measures a number of markers including Troponin I, CK-MB, myoglobin and BNP. New multi-marker panels are also under development. These include an index score panel for the diagnosis of peripheral artery disease (VASCLIR, Vermillion). The panel evaluates ß-2-microglobulin, cystatin C, hsCRP and glucose to create an index score and is currently in clinical trials.

Screening patients for prediction of future cardiovascular disease is currently the second major market for cardiovascular biomarkers. These markers include lipid biomarkers (e.g. LDL, HDL, triglycerides, LDL particle number and lipoprotein concentrations) or inflammatory biomarkers (e.g. CRP or Lp-PLA2). Lipid profiles are well-established as indicators of future cardiovascular risk that can be reduced through the use of lipid-lowering therapies such as statins.

Questions, Questions
  • What clinical studies are CardioDx currently engaged in?
  • What approach is deCODE Genetics taking in its research?
  • Which pharmaceutical companies are utilising Entelos predictive biostimulation technology?

Focus on...market potential

In 2007, the cardiovascular biomarker market accounted for and estimated 23% of biomarker revenues generating over US$1.3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics. The market has yet to reach the maturity of the oncology biomarker market, but will grow in the short term with the introduction of new, proprietary markers for acute coronary syndromes. Over the coming years, the importance of genetic markers and companion diagnostics will grow.

By 2015, we estimate the global cardiovascular biomarker market will account for around one third of global biomarker sales and will be worth up to US$6.6 billion as it becomes more mature; driven by growth in clinical biomarkers, the development of targeted therapies and associated companion diagnostics, discovery and validation of genetic markers of cardiovascular risk and reimbursement of pharmacogenomic and prognostic tests.

Companies Analysed

- Abbott Diagnostics
- Atherotech
- Affymetrix
- Beckman Coulter
- Berkeley HeartLab
- BG Medicine
- CardioDx
- Celera
- CIS Biotech
- Clinical Data
- Compugen
- Critical Diagnostics
- deCODE Genetics
- diaDexus
- Entelos
- FoxHollow Technologies
- GE Healthcare
- Genomas
- Inverness Medical Innovations
- Jurilab
- Laboratory Corporation of America
- Lipomics Technologies
- LipoScience
- Nanosphere Inc
- Osmetech Molecular Diagnostics
- PrognostiX
- Quest Diagnostics
- Roche Diagnostics
- Siemens Medical Solutions
- Singulex
- SuperArray Bioscience Corporation
- Vermillion
- Zora Biosciences OY
EXECUTIVE SUMMARY

    Figure1: 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

CANCER MARKET & REVENUES

Market revenues - global
    Figure 1: Global cancer drugs sales (2007)
Market revenues – leading brands
    Figure 2: Leading cancer brands (2007)
Market revenues – leading players
    Figure 3: Top 10 oncology players (2007 revenues)
CANCER EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT
Epidemiology
    Table 1: Cancer Statistics for four most common cancers, 2008
Diagnosis
Screening
    Table 2: Cancer screening
Current & future treatment
Future treatment
    Figure 4: Anticancer drugs in clinical development
CANCER BIOMARKERS
Cancer biomarker R&D
    Table 3: Types of biomarker
Known cancer biomarkers
    Table 4: Commercially available known cancer biomarker diagnostics
Probable and possible valid cancer biomarkers
    Table 5: Probable cancer biomarkers diagnostics
    Table 6: Possible cancer biomarkers diagnostics
CANCER BIOMARKER OPPORTUNITIES & CHALLENGES
Opportunities
Challenges
BIOMARKER MARKET
Biomarker market revenues - global
    Figure 8: Global biomarker sales in 2007
Cancer biomarker market revenues - global
    Figure 9: Global cancer biomarker sales in 2007
Future biomarker market revenues – global
    Figure 10: Global biomarker sales in 2015
Future cancer biomarker market revenues - global
    Figure 11: Global cancer biomarker sales in 2015
CANCER BIOMARKER TRENDS
    Table 7: Recent deals in oncology biomarkers
Pharma and specialty pharma deals
Collaborations with service providers
Collaborations with academics and consortia
BIOMARKER ANALYSIS
DNA biomarkers
RNA and microRNA biomarkers
Proteomic biomarkers
KEY BIOMARKER COMPANIES ANALYSED
KEY BIOMARKER EVALUATION CRITERIA

CANCER BIOMARKER- COMPANY ANALYSIS

Abbott Diagnostics
  Biomarker novelty & technology platform
    Figure 12: Abbott’s UroVysion bladder cancer test
  Association studies/clinical data
Pivotal Trial
    Table 7: Comparison of UroVysion vs Cystoscopy/Histology for Detection of Bladder Cancer Recurrence by Stage and Grade*
  Management strategy
  Application & market potential
  Biomarker analysis
Affymetrix
  Biomarker novelty & technology platform
    Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Agendia BV
  Biomarker novelty & technology platform
  Association studies/clinical data
    Figure 14: MammaPrint Profile vs NIH Consensus Criteria
  Management strategy
  Application & market potential
  Biomarker analysis
AltheaDx
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
AVEO Pharmaceuticals
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
AviaraDx
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
    Application & market potential
  Biomarker analysis
BG Medicine
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
    Figure 15: BG Medicines Biomarker Programme
  Application & market potential
  Biomarker analysis
Beckman Coulter
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
BioCurex
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Biomedical Diagnostics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Biomerica
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Bruker Daltonics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Caprion Proteomics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Clinical Data
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Celera
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Dako Denmark A/S
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
DxS Ltd
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Epigenomics AG
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Epistem Plc
  Biomarker novelty & technology platform
    Figure 16: Epistem’s Biomarker Drug Development Programme
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
GeneNews
  Biomarker novelty & technology platform
    Figure 17: GeneNews’ Sentinel Principle
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Fujirebio Diagnostics, Inc
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Genomic Health
  Biomarker novelty & technology platform
    Figure 18: Oncotype Dx test for invasive breast cancer
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Gen-Probe
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Genzyme Genetics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
InterGenetics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Ipsogen Therapeutics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
    Figure 19: Oncotype Dx test for invasive breast cancer
  Application & market potential
  Biomarker analysis
Laboratory Corporation of America
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Matritech
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Monogram Biosciences
  Biomarker novelty & technology platform
    Figure 20: VeraTag Assay
  Association studies/clinical data
    Figure 21: VeraTag Clinical Data: Bordet Cohort
  Management strategy
  Application & market potential
  Biomarker analysis
Orion Genomics
  Biomarker novelty & technology platform
    Figure 22: Orion’s MethylScope
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Oxford Genome Biosciences (UK) Ltd
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Power3 Medical Products
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
    Figure 23: Powder3’s business strategy
  Application & market potential
  Biomarker analysis
Predictive Biosciences
  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
Quest Diagnostics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Roche Diagnostics
  Biomarker novelty & technology platform
    Figure 24: Diagnostic marker candidate to a product
  Association studies/clinical data
    Figure 25: Biomarkers distinguish Leukaemia subclasses
  Management strategy
  Application & market potential
  Biomarker analysis
SuperArray Bioscience Corporation
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Third Wave Technologies
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Upstream Biosciences
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Veridex, LLC
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Vermillion
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis

CANCER BIOMARKER APPENDIX 1

    Table 8: Global biomarker sales 2007-20015E

CANCER BIOMARKER APPENDIX 2

    Table 8: Global cancer biomarker sales 2007-20015E

CANCER BIOMARKER APPENDIX 3

Company Analysis Criteria
Biomarker technology & platforms
Association studies
  Management strategy
Application & potential
    Table 9: Key cancer biomarker companies
    Figure 26: Leading Cancer Biomarker Companies – Service providers, Technology Providers, Biomarker Discovery & Diagnostic Developers

GLOSSARY

ACRONYMS

BIBLIOGRAPHY & end NOTES

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 NeuroSolutions
  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

CARDIOVASCULAR MARKET & REVENUES

Market revenues - global
    Figure 1: Global cardiovascular disease drug sales 2007
Market revenues – leading brands
    Figure 2: Leading Cardiovascular brands (2007)
Market revenues – leading players
    Figure 3: Top 10 cardiovascular players (2007 revenues)
CARDIOVASCULAR EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT
Epidemiology
    Figure 4: Breakdown of deaths from cardiovascular diseases in the US (2004)
Diagnosis
Screening
    Table 1: Screening for cardiovascular disease
Current treatments
    Table 2: Cardiovascular therapeutic drug categories and their indications
Future treatments
    Figure 5: Drugs in clinical development for heart disease
CARDIOVASCULAR BIOMARKERS
Cardiovascular biomarker R&D
    Figure 6: Impact of biomarkers on the drug R&D process
    Table 3: Types of biomarker
Known cardiovascular biomarkers
    Table 4: Commercially available cardiovascular diagnostics
Probable and possible valid cardiovascular biomarkers
    Table 5: Probable cardiovascular biomarkers
    Table 6: Possible cardiovascular biomarkers
CARDIOVASCULAR BIOMARKER OPPORTUNITIES & CHALLENGES
Opportunities
    Figure 7: Cardiovascular biomarker opportunities
Challenges
    Figure 8: Cardiovascular biomarker challenges
BIOMARKER MARKET
Biomarker market revenues – global
    Figure 9: Global biomarker sales in 2007
Cardiovascular biomarker market revenues – global
    Figure 10: Global cardiovascular biomarker sales in 2007
Future biomarker market revenues – global
    Figure 11: Global biomarker sales in 2015
Future cardiovascular biomarker market revenues – global
    Figure 12: Global cardiovascular biomarker sales in 2015
CARDIOVASCULAR BIOMARKER TRENDS
    Table 7: Recent deals in cardiovascular biomarkers
Pharma and specialty pharma deals
Collaborations with service providers
Collaborations with academics and consortia
BIOMARKER ANALYSIS
Assays for circulating biomarkers
DNA and RNA biomarkers
Proteomic, metabolomic biomarkers
Systems biology for biomarker discovery
Imaging biomarkers
KEY BIOMARKER COMPANIES ANALYSED
KEY BIOMARKER EVALUATION CRITERIA

CARDIOVASCULAR BIOMARKERS - COMPANY ANALYSIS

Abbott Diagnostics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Atherotech
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Affymetrix
  Biomarker novelty & technology platform
    Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Beckman Coulter
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Berkeley HeartLab
  Biomarker novelty & technology platform
    Figure 14: Markers of cardiovascular disease measured at Berkeley HeartLab
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
BG Medicine
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
    Figure 15: BG Medicine’s Biomarker Programme
  Application & market potential
  Biomarker analysis
CardioDx
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Competitor Ratio Analysis Score = 9/40
Celera
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
CIS Biotech
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Clinical Data
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Compugen
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Critical Diagnostics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
deCODE Genetics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
    Figure 16: deCODE’s approach to target discovery and development
  Application & market potential
  Biomarker analysis
diaDexus
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Entelos
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
FoxHollow Technologies
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
GE Healthcare
  Biomarker novelty & technology platform
    Figure 17: Cardiology focus at GE Healthcare
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Genomas
  Biomarker novelty & technology platform
    Figure 18: PhysioGenomics Technology from Genomas
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Inverness Medical Innovations
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Jurilab
  Biomarker novelty & technology platform
    Figure 19: Jurilab’s Genetic Discovery Method
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Competitor Ratio Analysis Score = 12/40
Laboratory Corporation of America
  Biomarker novelty & 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
LipoScience
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Competitor Ratio Analysis Score = 15/40
Nanosphere Inc
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Osmetech Molecular Diagnostics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Competitor Ratio Analysis Score = 12/40
PrognostiX
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Quest Diagnostics
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Competitor Ratio Analysis Score = 27/40
Roche Diagnostics
  Biomarker novelty & technology platform
    Figure 20: Roche’s technologies for biomarker discovery and development
  Association studies/clinical data
    Figure 21: Roche’s clinical trial programme for cardiac biomarker NT-proBNP
  Management strategy
  Application & market potential
  Biomarker analysis
Siemens Medical Solutions
  Biomarker novelty & technology platform
    Figure 22: Siemens Integrated in vivo & in vitro diagnostic suites
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Singulex
  Biomarker novelty & technology platform
    Figure 23: Sensitivity of Singulex’s Erenna system compared to ELISA and bead-based fluorescence readout systems
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
SuperArray Bioscience Corporation
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Vermillion
  Biomarker novelty & technology platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis
Zora Biosciences OY
  Biomarker novelty & technology platform
    Table 8: Zora metabolite profiling platform
  Association studies/clinical data
  Management strategy
  Application & market potential
  Biomarker analysis

CARDIOVASCULAR BIOMARKER APPENDIX 1

    Table 9: Global biomarker sales 2007-20015E

CARDIOVASCULAR BIOMARKER APPENDIX 2

    Table 10: Global cardiovascular biomarker sales 2007-20015E

CARDIOVASCULAR BIOMARKER APPENDIX 3

Company Analysis Criteria
Biomarker technology & platforms
Association studies
  Management strategy
Application & potential
    Table 9: Key cardiovascular biomarker companies
    Figure 26: Leading Cardiovascular Biomarker Companies – Service providers, Technology Providers, Biomarker Discovery & Diagnostic Developers

GLOSSARY

ACRONYMS

BIBLIOGRAPHY & end NOTES
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