Cancer Diagnostic Testing World Markets

Cancer Diagnostic Testing World Markets

Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer. Overall costs of the disease are $126 billion annually. Pharmaceutical companies are developing more than 300 new medicines for cancer, some of which are in development for more than one type of the disease, for a total of more than 500 ongoing R&D projects.

The goal of this TriMark Publications report is to review the market for tumor marker testing equipment and supplies using screening reagents and instruments for analysis of individual components in blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including: the physician office labs, hospital labs and commercial laboratories. Additionally, the numbers of institutions using this type of testing and the factors that influence purchases are discussed. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the clinical point-of-care market in the U.S. Each company is discussed in depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position.

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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