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Cancer Diagnostic Testing World Markets

TriMark Publications
July 1, 2011
201 Pages - SKU: TRI6444089

Abstract Table of Contents Related Reports

Countries covered: Global

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.

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; 2.2 The Drivers of the Biotech and Diagnostics Industry; 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 IHC; 3.11 In Vivo Detection Cancer Products; 3.12 Radionuclides and X-Ray Detection Products; 3.13 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; 4.2 Clinical Laboratory Methods for Measuring Tumor Markers; 4.3 New Technologies for Cancer Diagnostics; 4.4 Clinical Methods for Diagnosis of Cancer
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 Ambrilia Biopharma, Inc.; 6.5 Radient Pharmaceuticals; 6.6 Asuragen, Inc.; 6.7 Aureon Biosciences, Inc.; 6.8 C. R. Bard; 6.9 Beckman, Dickinson and Company (BD) Diagnostics - TriPath; 6.10 Beckman Coulter, Inc.; 6.11 Biocode S.A.; 6.12 BioCurex; 6.13 Biomedical Diagnostics; 6.14 Biomerica; 6.15 bioMerieux; 6.16 BioModa, Inc.; 6.17 Bruker Daltonics; 6.18 Byk Gulden; 6.19 Cepheid; 6.20 Clarient, Inc.; 6.21 Correlogic Systems, Inc.; 6.22 CytoCore (formerly Molecular Diagnostics, Inc.); 6.23 Cytogen Corporation (now EUSA Pharma); 6.24 diaDexus, Inc.; 6.25 DiagnoCure, Inc.; 6.26 Diagnostic Automation / Cortez Diagnostics, Inc.; 6.27 DRG International, Inc.; 6.28 Eisai Co., Ltd.; 6.29 Enigma Diagnostics Ltd.; 6.30 Epigenomics AG; 6.31 Exact Sciences Corporation; 6.32 Exagen Diagnostics, Inc.; 6.33 Fujirebio Diagnostics, Inc.; 6.34 Gene Logic, Inc.; 6.35 Gen-Probe, Inc.; 6.36 Genomic Health; 6.37 Geron Corporation; 6.38 Hologic, Inc. (formerly Cytyc Corporation); 6.39 Immunicon Corporation (now Veridex, LLC); 6.40 Immunomedics, Inc.; 6.41 Incyte Corporation; 6.42 Ipsogen; 6.43 LabCorp; 6.44 Mitsubishi Kagaku Medical; 6.45 Molecular Devices (formerly Arcturus Bioscience, Inc.); 6.46 Myriad Genetics, Inc.; 6.47 Northwest Biotherapeutics, Inc.; 6.48 ARCA Biopharma; 6.49 Oncotech, Inc.; 6.50 Oncothyreon, Inc. (formerly Biomira); 6.51 Panacea Pharmaceuticals, Inc.; 6.52 Poniard Pharmaceuticals, Inc.; 6.53 Polymedco, Inc.; 6.54 Princeton BioMeditech Corporation; 6.55 Qiagen; 6.56 Roche (F. Hoffman-La Roche, Ltd.); 6.57 Sanko Junyaku Co., Ltd.; 6.58 Siemens Heathcare Diagnostics; 6.59 Tosoh Corporation (Bioscience division); 6.60 Ventana Medical Systems, Inc.; 6.62 Veridex, LLC; 6.63 Vermillion, Inc.; 6.63 Worldwide Medical Corporation; 6.64 Xenomics, Inc. (TrovaGene, 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 Commercial Opportunities in Cancer Markers; 7.5 Moderators of Growth; 7.6 Biotechnology Industry Trends; 7.7 Pharmaceutical Industry Trends; 7.8 Sales and Marketing Strategies for Tumor Marker Tests
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 MS in Sequencing; 9.9 High-Throughput Organic Synthesis
10. New Cancer Markers in Basic Research: 10.1 Genetics of Cancer; 10.2 DNA Mismatch Repair Genes (MMRs); 10.3 Telomeres; 10.4 Diseases; 10.5 Tumor Markers; 10.6 Technology; 10.7 Disease-specific technology
11. Market Trends and Forecasts: 11.1 Ultrasensitive Cancer Tests; 11.2 Mergers and Acquisitions (M&As) of Diagnostic Companies; 11.3 Reverse transcriptase-polymerase chain reaction (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; 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 CRC Development; Figure 4.2: Progression of CRC Development; Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC; Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH; Figure 4.5: The BTA stat Test vs. Cytology
INDEX OF TABLES: Table 2.1: Organ-Specific Medicines in Development for Cancer; Table 2.2: Leading Sites of New Cancer Cases and Deaths in 2010 in the U.S. by Sex; Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer; Table 2.4: Number of New Cancer Cases and Deaths by Region; Table 2.5: Cancer-Associated Genes; Table 2.6: Carcinogens in the Workplace; Table 2.7: Private Funding Levels for the Biotechnology Segment, 1995-2010; Table 2.8: Herceptin Worldwide Sales, 2000-2015; Table 2.9: Classes of Drugs Used to Treat Breast Cancer; Table 3.1: Tumor Biomarkers Currently in Common Use; Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates, 2005-2015; Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015; Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015; Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size,2001-2015; Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015; Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015; Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015; Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market; Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Markets; Table 3.11: Worldwide PSA Sales, 2000-2015; Table 3.12: U.S. PSA Sales, 2000-2015; Table 3.13: Serum Markers Used Clinically; Table 3.14: Drivers of IHC Growth; Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany; Table 3.16: Worldwide Bladder Cancer Marker Sales, 2001-2015; Table 3.17: U.S. Bladder Cancer Marker Sales, 2001-2015; Table 3.18: Worldwide NMP22 Sales, 2001-2015; Table 3.19: Breast Cancer Products and Product Opportunities, 2006; Table 3.20: Products in Various Stages of Development for Cancers Other than Breast Cancer; Table 4.1: CRC Stages; Table 4.2: Worldwide CEA Sales, 2001-2015; Table 4.3: U.S. CEA Sales, 2001-2015; Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age; Table 4.5: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/mL; Table 4.6: Worldwide CA 19-9 Sales, 2001-2015; Table 4.7: U.S. CA 19-9 Sales, 2001-2015; Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer; Table 4.9: Worldwide CA 15-3 Sales, 2001-2015; Table 4.10: U.S. CA 15-3 Sales, 2001-2015; Table 4.11: TPA Marker Sensitivity; Table 4.12: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results; Table 4.13: Oncogene Science Biomarker Group Reagents; Table 4.14: Worldwide CA-125 Sales, 2001-2015; Table 4.15: U.S. CA-125 Sales, 2001-2015; Table 4.16: Number of Pap Smears Performed by Country; Table 4.17: Lung Cancer Survival Rates; Table 4.18: American Cancer Society Lung Cancer Facts; Table 4.19: Tests Identifying Molecular Markers in Urine; Table 4.20: Patient Category Applications; Table 4.21: Worldwide AFP Marker Sales, 2001-2015; Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2015; Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management; Table 4.24: Markers Frequently Used to Identify Adult Stem Cells in the Prostate, Breast and Intestine; Table 4.25: MammaPrint: Key Features; Table 6.1: Tumor Marker Tests; Table 6.2: Tumor Diagnosis Immunoassays; Table 6.3: Tumor Diagnosis Radioimmunoassays; Table 6.4: 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: Categories of Oncogenes; Table 10.2: Familial Cancer Syndromes and Tumor Suppressor Genes; 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

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