Cancer Diagnostic Testing World Markets

Table of Contents

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
• 2.3 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 bioMérieux 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 Ambrilla Biopharma, Inc.
• 6.6 AMDL, Inc.
• 6.7 Asuragen, Inc.
• 6.8 Aureon Biosciences Corporation
• 6.9 Bard Diagnostics, Inc.
• 6.10 Bayer Diagnostics
• 6.11 Beckman Coulter, Inc.
• 6.12 Biocode S.A.
• 6.13 BioCurex
• 6.14 Biomedical Diagnostics
• 6.15 Biomerica
• 6.16 bioMérieux
• 6.17 Biomira
• 6.18 BioModa, Inc.
• 6.19 Bruker Daltonics
• 6.20 Byk Gulden
• 6.21 Cepheid
• 6.22 Clarient, Inc.
• 6.23 CytoCore (Formerly known as Molecular Diagnostics, Inc.)
• 6.24 Correlogic Systems, Inc.
• 6.25 Cytogen Corporation
• 6.26 diaDexus, LLC
• 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 Enigma Diagnostics Ltd.
• 6.33 Epigenomics
• 6.34 Exact Sciences Corporation
• 6.35 Exagen Diagnostics, Inc.
• 6.37 Gene Logic, Inc.
• 6.38 Gen-Probe, Inc.
• 6.39 Genomic Health
• 6.40 Geron Corporation
• 6.42 Immunicon Corporation
• 6.43 Immunomedics, Inc.
• 6.44 Incyte Pharmaceuticals, Inc.
• 6.45 Ipsogen
• 6.46 LabCorp
• 6.47 Matritech
• 6.48 Mitsubishi Kagaku Medical
• 6.49 Molecular Devices (Formerly known as Arcturus Bioscience, Inc.)
• 6.50 Myriad Genetics, Inc.
• 6.51 Poniard Corporation
• 6.52 Nexell Therapeutics, Inc.
• 6.53 Northwest Biotherapeutics, Inc.
• 6.54 Nuvelo, Inc.
• 6.55 Panacea Pharmaceuticals, Inc.
• 6.56 Oncotech, Inc.
• 6.57 Polymedco, Inc.
• 6.58 Princeton BioMeditech Corporation
• 6.59 Qiagen
• 6.60 Sanko Junyaku Co., Ltd.
• 6.61 Tosoh Medics, Inc.
• 6.62 TriPath Imaging, Inc.
• 6.63 UroCor, Inc.
• 6.64 Ventana Medical Systems, Inc.
• 6.65 Veridex
• 6.66 Vermillion, Inc. (Formerly known as Ciphergen)
• 6.67 Worldwide Medical Corporation
• 6.68 Xenomics, Inc.

7. Business Trends in the Industry

• 7.1 Industry Consolidation
• 7.2 Breadth 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 Proteins
• 9.2 DNA Sequencing
• 9.3 The Human Genome Project (HGP)
• 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: Vermillion' 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+™
• 10.42 Shc Proteins
• 10.43 Oncology Biomarker Qualification Initiative
• 10.44 Anti-Glycan Antibodies

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

INDEX OF FIGURES

• Figure 4.1: Model of Colorectal Cancer Development
• Figure 4.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
• Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
• Figure 4.4: The BTA stat Test vs. Cytology
• Figure 6.1: Qiagen Global Sales
• Figure 10.1: Estimates for PCA3 Test Volume in U.S., 2005-2008

INDEX OF TABLES

• Table 2.1: Organ-Specific Medicines in Development for Cancer, 2007
• Table 2.2: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex
• Table 2.3: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer
• Table 2.4: Estimated Number of New Cancer Cases and Deaths by Region
• Table 2.5: Cancer Death Rates per 100,000 Population (and Rank) for all Cancer Sites by Country
• Table 2.6: Cancer Associated Genes
• Table 2.7: Carcinogens in the Workplace
• Table 2.8: Private Funding Levels for the Biotechnology Segment, 1995-2006
• Table 2.9: Herceptin Worldwide Sales, 2000-2007
• Table 2.10: 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: ASCO-CAP Guidelines for HER-2 Testing in Breast Cancer
• Table 3.17: Drivers of IHC Growth
• 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 CA-19-9 Sales, 2001-2010
• Table 4.8: U.S. CA-19-9 Sales, 2001-2010
• Table 4.9: CA-19-9 Levels in Management of Pancreatic Cancer
• Table 4.10: Worldwide CA-15-3 Sales, 2001-2010
• Table 4.11: U.S. CA-15-3 Sales, 2001-2010
• Table 4.12: TPA Marker Sensitivity
• Table 4.13: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results
• Table 4.14: Siemens Oncogene Science Biomarker Group Reagents
• Table 4.15: Worldwide CA-125 Sales, 2001-2010
• Table 4.16: U.S. CA-125 Sales, 2001-2010
• Table 4.17: Number of Pap Smears Performed by Country
• Table 4.18: Lung Cancer Survival Rates
• Table 4.19: Lung Cancer Facts
• Table 4.20: Patient Category Applications
• Table 4.21: Worldwide AFP Marker Sales, 2001-2010
• Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2010
• Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management
• Table 4.24: 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