May 12, 2008 22:24 ET

Learn about the Cancer Diagnostic Testing World Markets

LONDON, UNITED KINGDOM--(Marketwire - May 12, 2008) - announces that a new market research report related to the Medical devices industry is available in its catalogue.

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 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 Inside the ProteinChip System Rapid Biological Assays on a Chip 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
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 Europe Central and South America 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
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 


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 


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,
Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size,
Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size,
Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size,
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

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