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.

Over 350 information-packed pages providing Forecasts of biomarker market value and therapy share to 2015 Detailed analysis of the products and potential of - 40 Cancer - 29 CNS - 34 Cardiovascular companies active in each sector Major biomarker approaches include Proteomics RNA & MicroRNA DNA Metabolic Electrophysiology Imaging

By 2015, the biomarker market is forecast to be worth over US$20 billion as the cardiovascular and CNS biomarker market segments begin to mature with the launch of a number of diagnostic tests to guide the treatment of neuropsychiatric and neurodegenerative diseases. 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. Unique analysis and scoring To provide commercial and industry managers with qualified insight to the corporate landscape, the report provides a unique assessment and scoring system for each company covering: Biomarker technology Association/clinical studies Management strategy Application & potential

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