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Biomarker Technology Platforms for Cancer Diagnoses and TherapiesPublished by: Trimark Publications Published: Apr. 1, 2008 - 355 Pages Table of Contents1. Overview 1.1 Statement of Report 1.2 About This Report 1.3 Scope of the Report 1.4 Objectives 1.5 Methodology 1.6 Executive Summary 2. Introduction to Cancer Biology and the Diagnostic Industry 2.1 Biomarkers 2.1.1 The Biomarker Market Drivers 2.1.1.1 The Sector 2.1.1.2 The Critical Path Opportunities 2.1.1.3 The Capital Markets 2.2 Cancer Detection and Treatment with Biomarkers 2.2.1 The Problem 2.3 Cancer: The Disease 2.3.1 Metastasis 2.3.2 Demographics and Statistics of Cancer 2.4 Drivers of the Biotech and Diagnostics Industry 2.4.1 Venture Funding of Biotech Sector 2.4.2 Technological Innovation 2.4.3 Government Funding 2.4.4 Pharmaceutical Development and Bioanalytical Services 2.4.5 The War on Cancer 2.4.6 Current Oncology Drug Development 2.5 Outlook for Tumor Markers 2.6 Focus on Proteomics 2.6.1 Scientific Background 2.6.2 The Relationship between Proteins and Diseases 2.6.3 Limitations of Existing Diagnostic Approaches 2.6.4 Addressing the Heterogeneity of Cancer 2.6.5 Validation of Biomarkers Through Proper Study Design 2.6.6 Exploiting the Power of Mass Spectrometry to Improve Assay Specificity 2.6.7 Creating and Maintaining a Multi-Disease Product Pipeline 2.6.8 Partnerships for Developing Proteomic Biomarkers 2.7 Epigenic Markers for Cancer 2.8 Molecular Diagnostics Testing for Cancer 2.9 Market Opportunities 2.9.1 Industry Overview 2.9.2 Medical Indications and Medically Useful Information 2.9.3 Research Market 2.9.4 Competition 2.9.5 Diagnostic Services 2.9.6 Clinical Image Analysis 2.9.7 Research Imaging Market 2.9.8 Genomic Disease Management and In Vitro Diagnostic Multivariate Index Assays (IVDMIA) 2.9.9 Predictive Expression Profiles 3. Market Analysis of the Cancer Biomarkers Space 3.1 Scope of this Chapter 3.2 The Overall Market Opportunity and Segmentation of the Total Cancer Biomarkers Marketplace 3.3 Potential Cancer Biomarker Commercial Applications 3.3.1 Market for Routine Tumor Markers 3.3.2 Market for Genomic Cancer Biomarkers 3.3.3 Market Size and Forecasts for Companion Diagnostic Tests for Cancer Therapeutics 3.3.4 SWOT Analysis of the Major Cancer Biomarker Market Segments 3.3.4.1 Traditional Serum Cancer Biomarkers 3.3.4.2 Proteomic Cancer Biomarkers 3.3.4.3 Companion Diagnostic Cancer Biomarkers 3.4 Cancer Biomarker Market Estimates by Tissue of Origin 3.4.1 Colorectal 3.4.2 Prostate 3.4.3 Lung 3.4.4 Breast 3.4.5 Ovarian 3.5 Challenges Facing Cancer Biomarker Developers 3.6 Unmet Product Needs in the Cancer Biomarkers Space 3.7 Competitive Landscape of the Cancer Biomarkers Marketplace 4. Major Clinical Applications of Cancer Biomarkers 4.1 Launched Products and Pipeline 4.2 CYP2C9 Pharmacogenetics and Role in Personalized Medicine 4.3 Personalized Breast Cancer Therapy 4.4 Personalized NSCLC Therapy 4.5 AmpliChip®-based Personalized Medicine 5. Breast Cancer 5.1 Overview of Breast Cancer Disease 5.2 BRCA1 and BRCA2 Genes 5.2.1 Types of Genetic Testing Available for Breast Cancer 5.2.1.1 DNA Sequencing 5.2.1.2 Multi-Site Analysis 5.2.1.3 Single-Site Analysis 5.2.2 BRCA Test Results 5.2.2.1 What Does a Positive BRCA1 or BRCA2 Test Result Mean? 5.2.2.2 What Does a Negative BRCA1 or BRCA2 Test Result Mean? 5.2.2.3 What Does an Ambiguous BRCA1 or BRCA2 Test Result Mean? 5.2.2.4 What are the Options for a Person Who Tests Positive? 5.2.3 What are Some of the Benefits of Genetic Testing for Breast Cancer Risk? 5.2.4 What Are Some of the Risks of Genetic Testing for Breast and Ovarian Cancer Risk? 5.3 Estrogen Receptors and Breast Cancer 5.3.1 Expression and Prognostic Value of ER 5.3.2 Progesterone Receptors and Breast Cancer 5.3.3 ER and PR Predict Response to Endocrine Therapy 5.4 HER2 Gene and Protein 5.4.1 HER2 Tests 5.4.1.1 IHC Test 5.4.1.2 FISH Test 5.4.1.3 Questions About Testing 5.4.1.4 HER2 Tumor Status 5.5 Herceptin® Treatment 5.6 Tumor Assays for Adjuvant Chemotherapy 5.7 Use of Genomics to Understand Breast Cancer 5.8 Genetic Analysis Solution 5.8.1 The Use of Proteomics in Breast Cancer 5.8.2 Tissue Microarrays 5.8.3 Protein Microarrays 5.9 Gene Expression Microarrays and Recurrence Prediction 5.9.1 Oncotype DX 5.9.2 Oncotype DX for Breast Cancer 5.9.3 Risk Assessment 5.9.4 Use of Chemotherapy 5.9.5 Utility of the Oncotype Test 5.9.6 Clinical Development and Validation of Oncotype DX 5.9.6.1 Clinical Development of the Oncotype DX Recurrence Score 5.9.6.2 Clinical Validation of Prediction of Recurrence and Survival in N−, ER+ Patients Treated with Tamoxifen 5.9.6.3 Oncotype DX Predicts the Likelihood of Recurrence 5.9.6.4 Oncotype DX Predicts the Likelihood of Breast Cancer Survival in a Community Hospital Setting 5.9.6.5 Oncotype DX Predicts both Prognosis and Tamoxifen Benefit 5.10 Economic Benefits of Oncotype DX 5.11 Increased Clinical Utility of Oncotype DX 5.12 Second Generation Oncotype DX 5.12.1 Recurrence and Benefit Test for N−, ER− Breast Cancer 5.12.2 Taxane Benefit Test 5.13 MammaPrint 5.14 Rotterdam Signature 76-Panel 5.15 Summary of Microarray Technologies 5.16 Mass Spectrometry-based Approaches 5.16.1 Gel-based Approaches 5.16.2 Non-Gel-based Approaches 5.16.2.1 SELDI-TOF MS 5.16.2.2 SELDI and Prognosis 5.16.2.3 SELDI and Treatment Monitoring 5.16.3 Limitations of Mass Spectroscopy 5.17 Outlook 5.18 Future Perspectives 5.19 Breast Cancer Program (NMP66) 5.20 Myriad Genetics 5.21 Veridex GeneSearch™ Breast Lymph Node 5.22 OncoVue Cancer Risk Test 5.23 Research Biomarkers for Breast Cancer 5.24 Protein Biomarkers for Breast Cancer Prevention 5.25 Biomarker Prognosis of Breast Cancer Treated with Doxorubicin 6. Ovarian Cancer 6.1 Serum Markers 6.2 Biomarkers 6.2.1 Strategies for Discovering New Cancer Biomarkers 6.3 Serum Protein Biomarkers for Ovarian Cancer 6.3.1 Clinical Proteomics 6.4 Ovarian Cancer Triage Testing 6.4.1 Vermillion’s Ovarian Cancer Triage Diagnostic Program 7. Prostate Cancer 7.1 Overview 7.1.1 Prevalence 7.1.2 Prostate Cancer Progression and Recurrence Test 7.1.3 Current Market Size 7.2 Genes Involved in Prostate Cancer 7.3 Androgen Independence 7.4 Gene Markers in Prostate Cancer 7.5 Microarray Gene Identification of Prostate Biomarkers 7.6 GEArray DNA Microarrays 7.7 Vermillion’s Cancer Diagnostic Program 7.8 Hepsin 7.9 Matritech’s Prostate Cancer Program (NMP48) 7.10 Gen-Probe’s PCA3 Assay 7.11 Early Prostate Cancer Antigen-2 (EPCA-2) 7.12 Mass Spectrometry 7.13 Summary 8. Bladder Cancer 8.1 Overview 8.1.1 Prevalence 8.1.2 Progression and Recurrence 8.1.3 Bladder Cancer Risk Factors 8.1.4 Bladder Cancer Symptoms 8.2 Bladder Cancer Tests 8.3 UroVysion Bladder Cancer Kit 8.4 Ikoniscope® Robotic Digital Microscopy Platform 8.4.1 The CellOptics Platform 8.4.2 Cell Staining and Genetic Characterization 8.4.3 Ikoniscope/IkoniLAN Automated Microscopy 8.5 Nuclear Matrix Protein Markers 8.6 ImmunoCyt™/uCyt+™ 8.7 Cangen Microsatellite DNA 8.8 Bladder Cancer Market 8.8.1 Urologist Market 8.8.2 Clinical Lab Market 8.8.3 Primary Care Market 8.8.4 Private and Public Sector Markets 8.8.5 POC Market 8.8.6 Market Distribution 8.8.7 Reimbursement 9. Colorectal Cancer 9.1 Overview 9.1.1 Prevalence 9.1.2 Progression and Recurrence 9.2 Screening for CRC 9.2.1 Stool-based DNA (sDNA) Screening 9.3 Almac Diagnostics DSA 9.4 Colon Cancer Program (NMP35) 9.5 Myriad Genetics Colaris AP Risk Assessment 9.6 Summary 10. Genetic Diagnostics Set to Revolutionize Cancer Diagnostic Testing 10.1 Overview 10.1.1 Clinicians Need for More Information with Regard to Therapeutic Treatment Drives Demand for Pharmacogenomic Testing 10.1.2 Predictive Medicine Shows Potential for Genetic Diagnostics 10.1.3 Different Rates of Growth 10.1.4 Effective Competitive Strategies 10.1.5 Improvements in Marketing Effectiveness 10.1.6 Emerging Technologies Imply Start of a New Era and Offer Tremendous Growth Opportunities 10.1.7 Increased Market Share 10.1.8 Technologies Used in Genetic Testing 10.2 AMAS Test 10.3 Corixa Antibodies as Tumor Markers 10.4 Cytovision 10.5 Ariol System 10.6 Mammaglobin Protein Expression 10.7 L523S or KOC RNA Binding Protein 10.8 CA1-18 from EDP Biotech 11. Leukemia Biomarkers 11.1 Overview 11.1.1 Prevalence 11.1.1.1 Progression and Recurrence 12. Lung Cancer 13. Enabling Technologies for Oncology Biomarker Discovery 13.1 Automated Cellular Imaging System (ACIS®) 13.1.1 ACIS for HER2 Protein Expression Testing 13.1.2 ACIS for ER Protein Expression Testing 13.1.3 ACIS for PR Protein Expression Testing 13.1.4 ACIS for Cell Proliferation Expression 13.1.5 ACIS for Protein Expression 13.1.6 ACIS for Protein Micrometastases in Bone Marrow 13.1.7 ACIS for Protein Micrometastases in Tissue 13.1.8 ACIS for Tissue Microarray 13.1.9 ACIS for DNA Ploidy 13.1.10 ACIS for HPV 13.2 DNA Methylation 13.2.1 Differential Methylation Hybridization (DMH) 13.2.2 MIRA-Assisted Microarrays for DNA Methylation Analysis and Cancer Diagnosis 13.3 Proteomics 13.3.1 Proteomics Technologies for Cancer Marker Discovery 13.3.2 Validation of Candidate Biomarkers 13.3.3 Requirements Bringing a New Marker into the Market 13.3.4 Value Chain in the Development of New Cancer Biomarkers 13.4 Secreted Proteins as Cancer Biomarkers 13.4.1 Markers of Known Tissue Origin 13.4.2 Secreted Proteins as Low Abundance Markers 13.4.3 Secreted Proteins in Tissue and Blood 13.5 Noncodings RNA as Potential Tumor Markers 13.5.1 miRNA Meets Microarray 13.5.2 Mimetics and Inhibitors 13.5.3 Clinical Patterns in Cancer 13.6 Architect TIMP-1 (Tissue Inhibitor of Metalloproteinases-1) Immunoassay for Colorectal Cancer Detection 13.7 Companies Developing Automated Microscope-based Analysis Systems 13.8 Companies Developing Research Products for Tumor Cell Isolation 13.9 Companies Supplying Fluorescently Labeled Antibodies to Characterize Tumor Cells 13.10 PerkinElmer High Throughput Platforms: AlphaScreen®, AequoScreen®, DELFIA® and LANCE® Technologies 14. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 14.1 Sector Overview 14.2 Companion Diagnostics 14.3 EGFR for Colorectal Cancer and Camptostar (Irinotecan) 14.4 EGFR Express and Erbitux (Cetuximab) 14.5 HER2 and Heceptin 14.6 Myriad’s TheraGuide 5-FU 14.7 TheraScreen: EGFR29 14.8 Drivers and Barriers to Companion Diagnostics 14.9 Partnerships with Pharma Companies to Identify Therapeutic Targets 14.10 Future Developments for Companion Diagnostics 15. Companion Diagnostics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends 15.1 Scope of this Chapter 15.2 Introduction to Companion Diagnostics and Personalized Medicine 15.3 The Compelling Case for Personalized Medicine 15.4 Drug Metabolism and Implications for Companion Diagnostics and Personalized Medicine 15.5 Examples of Personalized Medicine 15.6 Personalized Medicine and Companion Diagnostics Testing Product Pipeline 15.7 The Personalized Medicine Coalition 15.8 Regulatory Trends and Guidelines in the Personalized Medicine Space 15.8.1 The Changing Regulatory Landscape for Personalized Medicine 15.9 Patenting Personalized Medicine 15.10 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine and Companion Diagnostics is Appropriate and Being Deployed 15.10.1 EGFR Assay 15.10.2 Individualized Warfarin Therapy 15.10.3 UGT1A1 Molecular Assay for Camptosar 15.10.4 Response to Gleevec in Gastrointestinal Stromal Tumors 15.10.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 15.10.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Companion Diagnostics 15.11 Companion Diagnostics and Personalized Medicine: Qualitative and Quantitative Market Analysis 15.11.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics and Personalized Medicine 15.11.2 Diagnostics vs. Pharmaceuticals 15.11.3 Molecular Diagnostic Market 15.11.4 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine 15.12 Snapshot of Companion Diagnostics Industry Structure 15.13 The Case for Theranostics (Therapeutic/Companion Diagnostic) 15.14 Personalized Medicine Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 15.15 How the Market Segregates Today 15.16 Timeline for Impact of Various Segments in Personalized Medicine 15.17 Challenges for Personalized Therapeutics and Companion Diagnostics Development 15.18 Macro Trends in Personalized Medicine 15.19 Personalized Medicine and Companion Diagnostics: Industry SWOT Analysis 16. Cancer Biomarker Testing Sector and Company Analysis 16.1 Abbott Molecular, Inc. (Formerly Vysis, Inc.) 16.2 Agendia 16.3 AMDL, Inc. 16.4 Aureon Laboratories, Inc. 16.5 BioCurex 16.6 Biomarker Technologies 16.7 Biomedical Diagnostics LLC 16.8 Biomerica 16.9 Biomira, Inc. 16.10 Biomoda 16.11 Byk Gulden 16.12 Clarient 16.13 Correlogic Systems, Inc. 16.14 Cytogen Corporation 16.15 Dako (Formerly Dako Cytomation) 16.16 diaDexus 16.17 Diagnocure, Inc. (ImmunoCyt™/uCyt+™) 16.18 DxS Ltd. 16.19 Epigenomics 16.20 Exagen Diagnostics, Inc. 16.21 Genesis Genomics 16.22 Health Discovery Corporation 16.23 Immunicon 16.24 Ipsogen 16.25 InterGenetics 16.26 Miraculins, Inc. 16.27 Molecular Devices Inc. (Formerly Arcturus Bioscience, Inc.) 16.28 Myriad Genetics, Inc. 16.29 Orion Genomics 16.30 Power3 Medical Products 16.31 Qiagen N.V. 16.32 SuperArray Bioscience Corporation 16.33 Upstream Biosciences, Inc. 16.34 Ventana Medical Systems, Inc. 16.35 Veridex 16.36 Vermillion 17. Business Trends in the Industry 17.1 Industry Consolidation 17.2 Breadth of Product Offering and Pricing 17.3 Government Regulation of Medical Devices 17.3.1 FDA Guidance on Drug Test Co-development 17.4 Strategic Business and Marketing Considerations 17.5 Commercial Opportunities in Cancer Markers 17.5.1 Licensing and Intellectual Property (IP) Constraints and how they will Impact New Product Development 17.6 Moderators of Growth 17.6.1 Roadblocks to Integrating Cancer Biomarkers into Clinical Practice 17.7 Biotechnology Industry Trends 17.8 Pharmaceutical Industry Trends 17.9 Acquisition, License Agreement, Partnerships 17.10 Legal Developments 17.11 Sales and Marketing Strategies for Tumor Marker Tests 17.11.1 North American Market 17.11.2 International Markets 17.11.2.1 Europe 17.11.2.2 Central and South America 17.11.2.3 Asia/Pacific 17.12 Product Commercialization 17.13 Reimbursement 17.14 Self Referral Rules 17.15 Health Insurance Portability and Accountability Act 17.16 Clinical Laboratory Improvement Amendments (CLIA) 17.17 In-Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 17.18 FDA’s Quality System Regulation (QSR) 17.19 FDA’s OIVD on IVDMIAs 17.20 FDA’s Qualification of Cancer Biomarkers 17.20.1 Regulatory Perspectives of Biomarker Validation 17.21 Genetic Tests and Medical Records 17.21.1 Laws against Genetic Discrimination 17.22 Medicare Reimbursement 17.22.1 Medicare Part B Spending Trends 17.23 Global Drivers of Clinical Laboratory Testing 17.24 Global Outlook for Cancer Biomarkers 17.24.1 Which Companies are Utilizing Cutting-Edge Technologies to Develop, Validate and Implement Cancer Biomarkers for Clinical Use? 17.24.2 What Impediments Still Exist to Incorporating Promising Research into Clinical Practice? 17.24.3 Which Biomarkers Show the Most Promise for Approval? 17.24.4 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 17.24.5 Which Alliances Show the Greatest Synergy in Bringing Valid Biomarkers to Market? 17.24.6 Which Shared Technologies are Driving the Most Encouraging Development? 17.24.7 How Strategic Alliances and Interdisciplinary Involvement Drive Development and Implementation of Emerging Biomarker Technologies 17.25 Oncology Biomarker Qualification Initiative 17.26 FDA Critical Path 17.27 FDA Criteria for a Valid Biomarker 18. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms 18.1 Abbott Diagnostics 18.2 Affymetrix, Inc. 18.3 Agendia BV 18.4 Agensys, Inc. 18.5 Almac Group 18.6 AMDL, Inc. 18.7 Aureon Laboratories, Inc. 18.8 Bayer Diagnostics Corporation 18.9 Beckman Coulter, Inc. 18.10 Biocode S.A. 18.11 BioCurex, Inc. 18.12 Biomarker Technologies LLC 18.13 Biomedical Diagnostics LLC 18.14 Biomerica 18.15 bioMérieux 18.16 Biomira, Inc. 18.17 Biomoda, Inc. 18.18 Bruker Daltonics, Inc. 18.19 Byk Gulden 18.20 Cangen Biotechnologies, Inc. 18.21 Caprion Proteomics 18.22 Celera Diagnostics 18.23 Cepheid 18.24 Clarient, Inc. 18.25 Claros Diagnostics, Inc. 18.26 Clinical Data, Inc.: PGxHealth and Cogenics 18.27 Correlogic Systems, Inc. 18.28 CytoCore (Formerly Molecular Diagnostics, Inc.) 18.29 Cytogen Corporation 18.30 Dako (Formerly Dako Cytomation) 18.31 diaDexus LLC 18.32 DiagnoCure, Inc. 18.33 Diagnostic Products Corporation 18.34 Diagnostic Systems Laboratories, Inc. 18.35 Digene Corporation 18.36 DRG International, Inc. 18.37 DxS Ltd. 18.38 EDP Biotech Corporation 18.39 Eisai Co., Ltd. 18.40 Epigenomics 18.41 Exact Sciences Corporation 18.42 Exagen Diagnostics, Inc. 18.43 Gene Logic, Inc. 18.44 Genesis Genomics, Inc. 18.45 Genomic Health, Inc. 18.46 Gen-Probe, Inc. 18.47 Health Discovery Corporation 18.48 Hologic, Inc. (Formerly Cytyc Corporation) 18.49 Ikonisys, Inc. 18.50 Immunicon Corporation 18.51 Immunomedics, Inc. 18.52 Incyte Pharmaceuticals, Inc. 18.53 InterGenetics® 18.54 Ipsogen 18.55 LabCorp® 18.56 Matritech, Inc. 18.57 Miraculins, Inc. 18.58 Mitsubishi Kagaku Medical 18.59 Molecular Devices (Formerly Arcturus Biosciences, Inc.) 18.60 Myriad Genetics, Inc. 18.61 NimbleGen Systems, Inc. 18.62 Northwest Biotherapeutics, Inc. 18.63 Oncotech, Inc. 18.64 Orion Genomics 18.65 Oxford Genome Sciences 18.66 Panacea Pharmaceuticals, Inc. 18.67 Phenomenone Discoveries 18.68 Polymedco, Inc. 18.69 Power3 Medical Products 18.70 Proteome Systems Ltd. 18.71 Qiagen N.V. 18.72 Sanko Junyaku Co., Ltd. 18.73 SensiGen LLC 18.74 SuperArray Bioscience Corporation 18.75 Third Wave Technologies, Inc. 18.76 Tosoh Medics, Inc. 18.77 TriPath Imaging, Inc. 18.78 Upstream Biosciences, Inc. 18.79 Ventana Medical Systems, Inc. 18.80 Veridex LLC 18.81 Vermillion, Inc. (Formerly Ciphergen) Appendix 1: Cancer Biomarker Centers of Research Appendix 2: Myriad Patents on Genes BRAC1 and BRAC2 Appendix 3: Common Laboratory Tests for Cancer Appendix 4: Questions/Issues in the Cancer Biomarkers Space Appendix 5: Cancer Markers Currently in Common Clinical Use Appendix 6: International Federation of Gynecology and Obstetrics (FIGO) Staging System for Primary Carcinoma of the Ovary Appendix 7: FDA Guidance for Industry: Pharmacogenomic Data Submission A7.1 Introduction A7.2 Background A7.3 Submission Policy A7.3.1 General Principles A7.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling A7.3.3 Benefits of Voluntary Submissions to Sponsors and FDA A7.4 Submission of Pharmacogenomic Data A7.4.1 Submission of Pharmacogenomic Data During the IND Phase A7.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement A7.4.3 Submission to a Previously Approved NDA or BLA A7.4.4 Compliance with 21 CFR Part 58 A7.4.5 Submission of Voluntary Genomic Data from Application-Independent Research A7.5 Format and Content of a VGDS A7.6 Process for Submitting Pharmacogenomic Data A7.7 Agency Review of VGDSs Glossary INDEX OF FIGURES Figure 3.1: Potential Market for Cancer Biomarkers, 2006 Figure 3.2: Segmentation of the Cancer biomarkers Marketplace Based Upon Commercial Offerings—Products and Services Figure 3.3: Geographical Distribution of Cancer Tumor Diagnostic Testing Figure 3.4: Cancer Biomarkers Research Market, 2006-2011 Figure 3.5: Breast Cancer Biomarker Market Potential, 2005 Figure 3.6: Challenges in the Study or Utilization of Proteomic Cancer Biomarkers Figure 3.7: Challenges in the Study or Utilization of Companion Diagnostic Cancer Biomarkers Figure 3.8: Challenges in the Study or Utilization of Serum Cancer Markers Figure 3.9: Top Unmet Needs in Commercial Products in the Cancer Biomarkers Space Figure 5.1: Hybridization Process Figure 5.2: FISH Test Procedure Figure 5.3: Gene Expression Profiling Figure 15.1: Phase I and II Processes of Drug Metabolism Figure 15.2: Human Phase I Enzymes Figure 15.3: Human Phase II Enzymes Figure 15.4: Hepatic Distribution of Human CYP450 Figure 15.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism Figure 15.6: Genetic Components Determine Drug Metabolism Figure 15.7: From Genetic Content to Personalized Medicine Figure 15.8: Remuneration for Diagnostics Figure 15.9: Breakout of the Molecular Diagnostics Marketplace Figure 15.10: Molecular Diagnostics Market Segmentation Figure 15.11: Molecular Diagnostics Market Segmentation by Technology Figure 15.12: Market Survey Respondent Demographics Figure 15.13: Breakout of the Respondent Pool by Affiliation Figure 15.14: Segmentation of the Personalized Medicine Market Figure 15.15: Personalized Medicine Market Drivers Figure 15.16: Challenges in the Personalized Medicine Space Figure 16.1: Epigenomics Product Development Pipeline Figure 17.1: Medicare Part B Spending on Clinical Laboratory Services, 1991-2005 INDEX OF TABLES Table 2.1: Cancer Biomarkers at the Nexus Point Table 2.2: Drug Development by Type of Cancer Table 2.3: Organ Specific Medicines in Development for Cancer, 2006 Table 2.4: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex, 2007 Table 2.5: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer Table 2.6: Estimated Number of New Cancer Cases and Deaths by Region Table 2.7: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country Table 2.8: Cancer Associated Genes Table 2.9: Carcinogens in the Workplace Table 2.10: Cancer Biomarker Markets Table 2.11: Private Funding Levels for the Biotechnology Segment, 1995-2006 Table 2.12: Global Pharmaceutical Industry R&D Spending, 1995-2006 Table 2.13: U.S. Government NIH Research Budget, 1995-2007 Table 2.14: Tumor Markers Currently in Common Use Table 2.15: Herceptin Worldwide Sales, 1999-2007 Table 2.16: Classes of Drugs Used to Treat Breast Cancer Table 2.17: Solutions to Biomarker Developments Table 2.18: Vermillion Collaborations Table 2.19: Uses of Molecular Diagnostics in Detection and Management of Cancer Table 2.20: U.S. Cancer Diagnostic Testing Market Size, 2005-2012 Table 2.21: Market Opportunities for Cancer Biomarker Technology Platforms Table 3.1: Characteristics of Different Cancer Biomarker Types and Associated Market Opportunities Table 3.2: Segmentation of the Cancer Biomarker Market by Type/Lineage of Cancer Biomarkers and Market Size Table 3.3: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007 Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 2005 Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets Table 3.13: Worldwide CEA Sales, 2001-2010 Table 3.14: U.S. CEA Sales, 2001-2010 Table 3.15: Cancer Genomic Biomarker Markets, 2002-2012 Table 3.16: Cancer Biomarkers Research Market Forecast, 2006-2011 Table 3.17: Cancer Biomarker Market Estimates by Tissue of Origin Table 3.18: Companies Developing New Proteomic Cancer Biomarker Technology Platforms Table 4.1: Cancer Biomarkers Used to Maximize Likelihood of Response Table 4.2: Biomarkers for Monitoring Therapeutic Effectiveness and Resistance Table 4.3: Biomarkers for Dose Response of Therapy Table 4.4: Decision on Optimal Duration of Therapy Table 5.1: U.S. Breast Cancer Rate Decline, 2002-2006 Table 5.2: BRCA Development Model Table 5.3: BRCA Test Development and Commercialization Table 5.4: BRAC Analysis Table 5.5: Revenue for BRACAnalysis® Risk Assessment Test, 2002-2006 Table 5.6: GEArray DNA Microarrays and RT2 Profiler PCR Arrays Table 5.7: Product Development Opportunities in Breast Cancer Table 5.8: Concentration of Some Abundant Proteins, New Cancer Biomarkers Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum Table 5.9: Questions Related to Diagnostic SELDI-TOF Technology Table 6.1: Worldwide CA-125 Sales, 2001-2010 Table 6.2: U.S. CA-125 Sales, 2001-2010 Table 6.3: Some Clinically Established Cancer Serum Markers Currently in Use for Cancer Table 6.4: Pathophysiology of Ovarian Cancer and Characterization of Ovarian Epithelial Tumors Table 7.1: Worldwide PSA Sales, 2000-2010 Table 7.2: U.S. PSA Sales, 2000-2010 Table 7.3: Molecular Gene Markers for Prostate Cancer Table 8.1: Worldwide Bladder Cancer Marker Sales, 2001-2010 Table 8.2: U.S. Bladder Cancer Marker Sales, 2001-2010 Table 8.3: Worldwide NMP22 Sales, 2001-2010 Table 8.4: Summary of Matritech’s Product Development Programs Table 8.5: Opportunities for Bladder Cancer Biomarkers Table 9.1: TNM Staging for Colorectal Cancer Table 10.1: Genetic Diagnostics Market, 2004-2012 Table 13.1: Genomic and Proteomic Technologies Table 14.1: Potential Benefits of Biomarkers as Companion Diagnostics Table 14.2: Utility of Biomarker as Companion Diagnostics to Drug Development Table 14.3: Device Submission Elements for the FDA Table 14.4: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics Table 14.5: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests Table 15.1: Percentage of Non-Responders in Various Drug Classes Table 15.2: High Profile Drug Withdrawals from the Marketplace Table 15.3: Drug Metabolism Drives Drug Efficacy/Toxicity Table 15.4: Population Frequency of the Various Cytochromes Table 15.5: Selected List of Personalized Medicine Tests Table 15.6: Personalized Medicine and Companion Diagnostics Product Pipeline Table 15.7: Marketed Personalized Therapies, 2006 Table 15.8: Various Molecular Diagnostics Technologies: Timeline for Impact Table 15.9: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine Table 15.10: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine Table 15.11: Classification of Diagnostics by Risk Table 15.12: Areas in Personalized Medicine—Timeline of Impact Table 15.13: Impact of Personalized Medicine on Various Therapeutic Areas Table 15.14: Hurdles in Personalized Medicine and Companion Diagnostics Development in Various Therapeutic Areas Table 15.15: Market Opportunities in Personalized Medicine Table 15.16: Challenges for Market Adoption of the Various Personalized Medicine Tests Table 15.17: Personalized Medicine Industry SWOT Table 16.2: Clarient Revenue, 2002-2006 Table 16.3: Clarient Percentage of Revenue, 2004-2006 Table 16.4: Opportunities for Biomarkers in Cancer Diagnosis and Treatment Table 16.5: Myriad Biomarker Revenue, 2002-2006 Table 17.1: List and Discounted Prices for Abbott Tumor Marker Tests Table 17.2: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005 Table 17.3: Medicare Spending on Clinical Lab Services, 1991-2005 Table 17.4: Medicare Part B Spending Per Medicare Enrollee, 1998-2005 Table 18.1: Tumor Diagnosis Immunoassay Table 18.2: Tumor Diagnosis Radioimmunoassay Table 18.3: Summary of Matritech’s Product Development Programs Table A1: Team Descriptions Table A5: Cancer Markers in Use AbstractThe global market for glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the glucose testing segment of the in vitro diagnostics (IVD) industry is mature, certain segments of the market such as home testing devices for diabetes management will exhibit strong growth, with some—such as non-invasive testing—representing major new areas of application for IVD testing. Direct access testing, or over-the-counter, which allows consumers to order tests themselves without visiting a doctor, has emerged as a strong force in the glucose-testing segment. Moreover, an increasing range of test devices is now available to consumers for use in self-testing. The purpose of this TriMark Publications report is to describe the specific market segments for blood glucose testing and diabetes management. This study reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum or plasma or whole-blood glucose concentrations. Moreover, it examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor's offices and at-home care locations. Please note: Trimark uses a digital rights management tool to distribute their reports. The client will need to download SealedMedia viewer before the client will be able to access the secured PDF files. Upon ordering an electronic version, the Publisher will provide a link to download the software and the purchased report. Get Full Details About This Report >> |
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