Biomarker Technology Platforms for Cancer Diagnoses and Therapies

Content

• 1. 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 Cancer
    • 2.1.1 The Disease
    • 2.1.2 Metastasis
    • 2.1.3 Demographics And Statistics Of Cancer
  • 2.2 The Drivers Of The Biotech And Diagnostics Industry
    • 2.2.1 Technological Innovation
    • 2.2.2 Government Funding
    • 2.2.3 Pharmaceutical Development
  • 2.3 Outlook For Tumor Markers
• 3. Tumor Markers Market Segment Analysis: Size, Growth And Share
  • 3.1 Market Description
  • 3.2 Clinical Diagnostic Serum Based Cancer Markers
  • 3.3 Psa Testing Market Size
  • 3.4 Dna Markers
  • 3.5 Serum Proteins
  • 3.6 Enzymes
  • 3.7 Occult Blood
  • 3.8 Histology And In Situ Hybridization (Ish)
  • 3.9 Cervical Cytology
  • 3.10 Immunohistochemistry
  • 3.11 In Vivo Detection Cancer Products
  • 3.12 Radionuclides And X-Ray Detection Products
  • 3.13 Human Papillomavirus (Hpv) Testing
  • 3.14 Bladder Cancer Testing
  • 3.15 Tumor Assays For Adjuvant Chemotherapy
• 4. Diagnostic Methods For Cancer Detection
  • 4.1 Organ Specific Tumor Markers
    • 4.1.1 Colon Cancer
    • 4.1.2 Prostate Cancer
    • 4.1.3 Pancreatic Cancer
    • 4.1.4 Breast Cancer
    • 4.1.5 Ovarian Cancer
    • 4.1.6 Cervical Cancer
    • 4.1.7 Lung Cancer
    • 4.1.8 Testicular Cancer
    • 4.1.9 Bladder Cancer
    • 4.1.10 Hepatic Cancer
    • 4.1.11 Stomach Cancer
    • 4.1.12 Malignant Melanoma
    • 4.1.13 Acute Myeloid Leukemia (Aml) And Acute Lymphoblastoid Leukemia (All)
    • 4.1.14 Lymphoma
  • 4.2 Clinical Laboratory Methods For Measuring Tumor Markers
    • 4.2.1 Abbott Diagnostics Axsym
    • 4.2.2 Roche Diagnostics Elecsys
    • 4.2.3 Beckman Coulter Diagnostics Access
    • 4.2.4 Bayer Diagnostics Advia Centaur
    • 4.2.5 Dade Diagnostics Stratus
    • 4.2.6 Diagnostic Products Corporation Immulite
    • 4.2.7 Tosoh Medics A1a
    • 4.2.8 Cis Bio International Kryptor
    • 4.2.9 Ortho-Clinical Diagnostics Vitros Eciq
    • 4.2.10 Fujirebio Diagnostics, Inc.
    • 4.2.11 Biomrieux Vidas
    • 4.2.12 Eisai Picolumi
    • 4.2.13 Tosoh Medics, Inc.
  • 4.3 New Technologies For Cancer Diagnostics
    • 4.3.1 New And Improved Immunoassays
    • 4.3.2 Immunohistochemical Tests
    • 4.3.3 Molecular (Dna And Genomic) Diagnostic Assays
    • 4.3.4 Genomics And Genetic Markers
    • 4.3.5 Proteomics And New Protein Markers
      • 4.3.5.1 Inside The Proteinchip System
      • 4.3.5.2 Rapid Biological Assays On A Chip
      • 4.3.5.3 Proteome Pattern Recognition
    • 4.3.6 New Platform Technologies Including Flow Cytometry
    • 4.3.7 Stem Cell Markers
    • 4.3.8 Monoclonal Antibodies
    • 4.3.9 Proteomics And Cancer Antibodies
    • 4.3.10 Pharmacogenomics And Oncology Diagnostics
    • 4.3.11 Dna Microarrays
    • 4.3.12 In Vitro Diagnostic Multivariate Index Assays (Ivdmia)
    • 4.3.13 Prostate Px Score
    • 4.3.14 Prostate-63
    • 4.3.15 Future Directions
  • 4.4 Clinical Methods For Diagnosis Of Cancer
    • 4.4.1 Screening
    • 4.4.2 Sigmoidoscopy
    • 4.4.3 Imaging
    • 4.4.4 Theranostics
• 5. Implications Of Molecular Biology For New Diagnostic Cancer Tests
• 6. Companies Entering The Cancer Diagnostics Market With Novel Technology Platforms
  • 6.1 Abbott Diagnostics
  • 6.2 Affymetrix, Inc.
  • 6.3 Agendia Bv
  • 6.4 Agensys, Inc.
  • 6.5 Amdl, Inc.
  • 6.6 Arcturus Bioscience, Inc.
  • 6.7 Aureon Biosciences Corporation
  • 6.8 Bard Diagnostics, Inc.
  • 6.9 Bayer Diagnostics
  • 6.10 Beckman Coulter, Inc.
  • 6.11 Biocode S.A.
  • 6.12 Biocurex
  • 6.13 Biomedical Diagnostics
  • 6.14 Biomerica
  • 6.15 Biomrieux
  • 6.16 Biomira
  • 6.17 Biomoda, Inc.
  • 6.18 Bruker Daltonics
  • 6.19 Byk Gulden
  • 6.20 Ciphergen Biosystems, Inc.
  • 6.21 Clarient, Inc.
  • 6.22 Correlogic Systems, Inc.
  • 6.23 Cytogen Corporation
  • 6.24 Cytyc Corporation
  • 6.25 Diadexus, Llc
  • 6.26 Digene Corporation
  • 6.27 Diagnocure, Inc.
  • 6.28 Diagnostic Products Corporation
  • 6.29 Diagnostic Systems Laboratories, Inc.
  • 6.30 Drg International, Inc.
  • 6.31 Eisai Co., Ltd.
  • 6.32 Epigenomics
  • 6.33 Exact Sciences Corporation
  • 6.34 Fujirebio Diagnostics, Inc.
  • 6.35 Gene Logic, Inc.
  • 6.36 Gen-Probe, Inc.
  • 6.37 Genomic Health
  • 6.38 Geron Corporation
  • 6.39 Immunicon Corporation
  • 6.40 Immunomedics, Inc.
  • 6.41 Incyte Pharmaceuticals, Inc.
  • 6.42 Labcorp
  • 6.43 Matritech
  • 6.44 Mitsubishi Kagaku Medical
  • 6.45 Molecular Diagnostics, Inc.
  • 6.46 Myriad Genetics, Inc.
  • 6.47 Neorx Corporation
  • 6.48 Nexell Therapeutics, Inc.
  • 6.49 Northwest Biotherapeutics, Inc.
  • 6.50 Nuvelo
  • 6.51 Oncotech, Inc.
  • 6.52 Polymedco, Inc.
  • 6.53 Princeton Biomeditech Corporation
  • 6.54 Procyon Biopharma, Inc.
  • 6.55 Qiagen
  • 6.56 Sanko Junyaku Co., Ltd.
  • 6.57 Tosoh Medics, Inc.
  • 6.58 Tripath Imaging, Inc.
  • 6.59 Urocor, Inc.
  • 6.60 Ventana Medical Systems, Inc.
  • 6.61 Veridex
  • 6.62 Worldwide Medical Corporation
• 7. Business Trends In The Industry
  • 7.1 Industry Consolidation
  • 7.2 Breath Of Product Offering And Pricing
  • 7.3 Government Regulation Of Medical Devices
  • 7.4 Strategic Business And Marketing Considerations
  • 7.5 Commercial Opportunities In Cancer Markers
  • 7.6 Moderators Of Growth
  • 7.7 Biotechnology Industry Trends
  • 7.8 Pharmaceutical Industry Trends
  • 7.9 Acquisition, License Agreement, Partnerships
  • 7.10 Legal Developments
  • 7.11 Sales And Marketing Strategies For Tumor Marker Tests
    • 7.11.1 North American Market
    • 7.11.2 International Markets
      • 7.11.2.1 Europe
      • 7.11.2.2 Central And South America
      • 7.11.2.3 Asia/Pacific
• 8. Tumor Marker Testing: Important Issues
  • 8.1 Trends In Patient Care And Reimbursement
  • 8.2 Trends In Reimbursement Practice
  • 8.3 Clinical Laboratory Improvement Act (Clia)
  • 8.4 Unmet Needs In Tumor Markers
• 9. Important New Technology Areas
  • 9.1 Proteomics
  • 9.2 Dna Sequencing
  • 9.3 The Human Genome Project
  • 9.4 Liquid Phase Chromatography
  • 9.5 Polymerase Chain Reaction (Pcr)
  • 9.6 Capillary Electrophoresis
  • 9.7 Proteomics
  • 9.8 Use Of Mass Spectroscopy In Sequencing
  • 9.9 High-Throughput Organic Synthesis
• 10. New Cancer Markers In Basic Research
  • 10.1 Genetics Of Cancer
  • 10.2 Telomerase
  • 10.3 Stomach Cancer
  • 10.4 Head And Neck Cancer
  • 10.5 Breast Cancer
  • 10.6 Prostate Cancer: P27 (Kip1) A New Molecular Marker For Prostate Cancer
  • 10.7 Psma
  • 10.8 Cervical Cancer: Nmpi79
  • 10.9 Pancreatic Cancer: Peritoneal Cytology
  • 10.10 Colorectal Cancer: Cea Doubling Time
  • 10.11 Uterine And Kidney Cancer: Mn/Ca9
  • 10.12 Mmsc1 Scaffold Gene
  • 10.13 P16 Tumor Suppressor Gene
  • 10.14 Mts2 And P19 Cell Cycle Genes
  • 10.15 Complement Factor H Related Proteins
  • 10.16 Muc 2, 3, 4
  • 10.17 Cytokeratins
  • 10.18 Colon Cancer: Serum Vegf
  • 10.19 Ras Oncogenes
  • 10.20 Lung Cancer: Ribonucleoprotein A2/B1
  • 10.21 Bcla-4 Matrix Protein
  • 10.22 Rak Antigens
  • 10.23 Serum Urokinase Receptors
  • 10.24 Chips
  • 10.25 Survivin
  • 10.26 Human Endometrial Specific Steroid Binding Factor (Hesf1)
  • 10.27 Reg-4 Protein
  • 10.28 Nox-1
  • 10.29 Psp94 Binding Protein
  • 10.30 Ettan Dige Technology
  • 10.31 Ykl-40
  • 10.32 Afp-L3
  • 10.33 Dna Methylation Technology
  • 10.34 Transthyretin And Apolipoprotein A1
  • 10.35 Adam 12
  • 10.36 Ovarian Cancer: Ciphergen's Seldi-Based Proteinchip
  • 10.37 Lung Cancer: Labeled Porphyrin Binding
  • 10.38 C-Map, A Cervical Cancer Screening System
  • 10.39 Lung Cancer: Pro-Gastrin-Releasing Peptide (Progrp)
  • 10.40 Prostate Cancer: Pca3
  • 10.41 Bladder Cancer: Immunocyt/Ucyt+
• 11. Market Trends And Forecasts
  • 11.1 Ultrasensitive Cancer Tests
  • 11.2 Mergers And Acquisitions Of Diagnostic Companies
  • 11.3 Rt-Pcr
  • 11.4 Genetic Tests Of Hereditary Cancer Risk
  • 11.5 Dna Measurements
  • 11.6 Technical And Practical Issues For Potential New Markers
  • 11.7 Genetic Profiling
  • 11.8 Ploidy
  • 11.9 Advances In Sputum Analysis For Screening And Early Detection Of Lung Cancer
  • 11.10 Pharmacogenetic Tests For Cancer
  • 11.11 Worldwide Healthcare Spending
  • 11.12 R&D Expenditures
  • Appendix 1: Web Links
  • Appendix 2: Cancer Information Resources
  • Appendix 3: Colon Cancer Staging
  • Appendix 4: Reimbursement For Tumor Marker Testing
  • Appendix 5: The Pathology Of Prostate Cancer
  • Appendix 6: Government Regulation Of Tumor Marker Tests
  • Appendix 7: The Clinical Laboratory Improvement Act (Clia)
  • Appendix 8: Marketers Of Occult Blood Diagnostic Test Kits
• List Of Figures
  • Figure 4.1: Model Of Colorectal Cancer Development
  • Figure 4.2: The Bta Stat Test Vs. Cytology
  • Figure 10.1: Estimates For Pca3 Test Volume In U.S., 2005-2008
• List Of Tables
  • Table 2.1: Drug Development By Type Of Cancer
  • Table 2.2: The 402 Organ Specific Medicines In Development For Cancer, 2006
  • Table 2.3: Estimates For The Leading Sites Of New Cancer Cases And Deaths In The U.S. By Sex, 2003
  • Table 2.4: Estimated Worldwide Number Of New Cancer Cases And Deaths By Type Of Cancer
  • Table 2.5: Estimated Number Of New Cancer Cases And Deaths By Region
  • Table 2.6: Cancer Death Rates Per 100,000 Population (And Rank) For All Cancer Sites By Country
  • Table 2.7: Cancer Associated Genes
  • Table 2.8: Carcinogens In The Workplace
  • Table 2.9: Private Funding Levels For The Biotechnology Segment, 1995-2006
  • Table 2.10: Global Pharmaceutical Industry R&D Spending, 1995-2004
  • Table 2.11: U.S. Government Nih Research Budget, 1995-2004
  • Table 2.12: Herceptin Worldwide Sales, 1999-2005
  • Table 2.13: Classes Of Drugs Used To Treat Breast Cancer
  • Table 3.1: In Vitro Cancer Marker Market Segments Worldwide, 2001 And 2007
  • Table 3.2: Tumor Markers Currently In Common Use
  • Table 3.3: Global Ivd Cancer Tumor Marker Testing Market Segments Projected Growth Rates, 2005-2010
  • 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 Psa Sales, 2000-2010
  • Table 3.14: U.S. Psa Sales, 2000-2010
  • Table 3.15: Serum Markers Used Clinically
  • Table 3.16: Drivers Of Ihc Growth
  • Table 3.17: Digene Product Revenues And Assets
  • Table 3.18: Bladder Cancer Testing Efforts In The U.S. And Germany
  • Table 3.19: Worldwide Bladder Cancer Marker Sales, 2001-2010
  • Table 3.20: U.S. Bladder Cancer Marker Sales, 2001-2010
  • Table 3.21: Worldwide Nmp22 Sales, 2001-2010
  • Table 3.22: Current Breast Cancer Product And Product Opportunities
  • Table 3.23: Products In Various Stages Of Development For Cancers Other Than Breast Cancer
  • Table 4.1: Colorectal Cancer Stages
  • Table 4.2: Worldwide Cea Sales, 2001-2010
  • Table 4.3: U.S. Cea Sales, 2001-2010
  • Table 4.4: Population Statistics Of Serum Levels Of Psa In Men Over 50 Years Of Age
  • Table 4.5: Psa Doubling Time And Time To Reach Psa Of 1,000
  • Table 4.6: Psa Doubling Times
  • Table 4.7: Worldwide Ca19-9 Sales, 2001-2010
  • Table 4.8: U.S. Ca19-9 Sales, 2001-2010
  • Table 4.9: Worldwide Ca15-3 Sales, 2001-2010
  • Table 4.10: U.S. Ca15-3 Sales, 2001-2010
  • Table 4.11: Tpa Marker Sensitivity
  • Table 4.12: Worldwide Ca-125 Sales, 2001-2010
  • Table 4.13: U.S. Ca-125 Sales, 2001-2010
  • Table 4.14: Number Of Pap Smears Performed By Country
  • Table 4.15: Lung Cancer Facts
  • Table 4.16: Patient Category Applications
  • Table 4.17: Worldwide Afp Marker Sales, 2001-2010
  • Table 4.18: U.S. Afp Cancer Marker Sales, 2001-2010
  • Table 4.19: Colorectal Cancer Monoclonal Antibody Imaging Kits
  • Table 6.1: Product Sales As A Percent Of Total Product Sales, 2004-2006
  • Table 6.2: Tumor Diagnosis Immunoassay
  • Table 6.3: Tumor Diagnosis Radioimmunoassay
  • Table 6.4: Summary Of Matritech's Product Development Programs
  • Table 6.5: Statements Of Operations Data For Matritech, 2002-2006
  • Table 6.6: Results Of Operations Of Matritech, 2005 And 2006
  • Table 6.7: Pbm Product List
  • Table 7.1: List And Discounted Prices For Abbott Tumor Marker Tests
  • Table 8.1: Cpt Codes For Tumor Markers
  • Table 10.1: Familial Cancer Syndromes And Tumor Suppressor Genes
  • Table 10.2: Oncogenes And Anti-Oncogenes
  • Table A3: Tnm Classification
  • Table A7: Financial Comparison For Moderate And Waived Clia Labs
  • Table A8: List Of Marketers Of Occult Blood Diagnostic Test Kits