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Cancer Diagnostic Testing World Markets
http://www.reportlinker.com/p089470/Cancer-Diagnostic-Testing-World-Markets.html
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 bioMerieux 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 bioMerieux 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(TM)/uCyt+(TM) 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 Cancer11.11 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
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Cancer Diagnostic Testing World Markets
http://www.reportlinker.com/p089470/Cancer-Diagnostic-Testing-World-Markets.html
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