Cancer Diagnostic Testing World Markets

Transcription

1 Brochure More information from Cancer Diagnostic Testing World Markets Description: 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 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. 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 The Disease Metastasis Demographics and Statistics of Cancer 2.2 The Drivers of the Biotech and Diagnostics Industry Technological Innovation 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 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

2 4.1 Organ-Specific Tumor Markers Colon Cancer Prostate Cancer Pancreatic Cancer Breast Cancer Ovarian Cancer Cervical Cancer Lung Cancer Testicular Cancer Bladder Cancer Hepatic Cancer Stomach Cancer Malignant Melanoma Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL) Lymphoma 4.2 Clinical Laboratory Methods for Measuring Tumor Markers Abbott Diagnostics AxSYM Roche Diagnostics Elecsys Beckman Coulter Diagnostics Access Systems Siemens Healthcare Diagnostics ADVIA Centaur Siemens Healthcare Diagnostics Immulite Tosoh Bioscience AIA Thermo Fisher Scientific B.R.A.H.M.S. KRYPTOR Ortho-Clinical Diagnostics Vitros ECiQ Fujirebio Diagnostics, Inc biomerieux Vidas 4.3 New Technologies for Cancer Diagnostics New and Improved Immunoassays IHC Tests Molecular (DNA and Genomic) Diagnostic Assays Genomics and Genetic Markers Proteomics and New Protein Markers Inside the ProteinChip System Rapid Biological Assays on a Chip Proteome Pattern Recognition New Platform Technologies Including Flow Cytometry Stem Cell Markers mabs Proteomics and Cancer Antibodies Pharmacogenomics and Oncology Diagnostics DNA Microarrays In Vitro Diagnostic Multi-variate Index Assays (IVDMIA) Prostate PX Score Prostate Future Directions 4.4 Clinical Methods for Diagnosis of Cancer Screening Sigmoidoscopy Imaging 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 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

3 6.10 Beckman Coulter, Inc Biocode S.A BioCurex 6.13 Biomedical Diagnostics 6.14 Biomerica 6.15 biomerieux 6.16 BioModa, Inc Bruker Daltonics 6.18 Byk Gulden 6.19 Cepheid 6.20 Clarient, Inc Correlogic Systems, Inc CytoCore (formerly Molecular Diagnostics, Inc.) 6.23 Cytogen Corporation (now EUSA Pharma) 6.24 diadexus, Inc DiagnoCure, Inc Diagnostic Automation / Cortez Diagnostics, Inc DRG International, Inc Eisai Co., Ltd Enigma Diagnostics Ltd Epigenomics AG 6.31 Exact Sciences Corporation 6.32 Exagen Diagnostics, Inc Fujirebio Diagnostics, Inc Gene Logic, Inc Gen-Probe, Inc Genomic Health 6.37 Geron Corporation 6.38 Hologic, Inc. (formerly Cytyc Corporation) 6.39 Immunicon Corporation (now Veridex, LLC) 6.40 Immunomedics, Inc 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 Northwest Biotherapeutics, Inc ARCA Biopharma 6.49 Oncotech, Inc Oncothyreon, Inc. (formerly Biomira) 6.51 Panacea Pharmaceuticals, Inc Poniard Pharmaceuticals, Inc Polymedco, Inc Princeton BioMeditech Corporation 6.55 Qiagen 6.56 Roche (F. Hoffman-La Roche, Ltd.) 6.57 Sanko Junyaku Co., Ltd Siemens Heathcare Diagnostics 6.59 Tosoh Corporation (Bioscience division) 6.60 Ventana Medical Systems, Inc Veridex, LLC 6.63 Vermillion, Inc 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

4 7.7 Pharmaceutical Industry Trends 7.8 Sales and Marketing Strategies for Tumor Marker Tests North American Market 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 MS in Sequencing 9.9 High-Throughput Organic Synthesis 10. New Cancer Markers in Basic Research 10.1 Genetics of Cancer Activator genes (Oncogenes) Inactivating Genes (Tumor Suppressor Genes) 10.2 DNA Mismatch Repair Genes (MMRs) 10.3 Telomeres 10.4 Diseases t(15;17) in Acute Promyelocytic Leukemia (APL) t(12;21) in Acute Lymphoblastic Leukemia (ALL) Retinoblastoma and Constitutional 13q14 Deletion Stomach Cancer Head and Neck Cancer Breast and Ovarian Cancers Prostate Cancer Cervical Cancer: NMPI Uterine and Kidney Cancer: MN/CA Colon Cancer: Serum Vascular Endothelial Growth factor (VEGF) Lung Cancer: Ribonucleoprotein A2/B1 and microrna Markers 10.5 Tumor Markers Oncology Biomarker Qualification Initiative CRC: Carcinoembryonic Antigen (CEA) Doubling Time MUC1, 2, 3 and Cytokeratins RAK Antigens Serum Urokinase Receptors Survivin Reg-4 Protein NADPH Oxidases 1 and 2 (NOX1 and NOX2) Prostate Secretory Protein 94- (PSP94)-Binding Protein Shc Proteins Anti-Glycan Antibodies YKL Alpha-fetoprotein (AFP)-L Transthyretin and Apolipoprotein A1 (Apo A1) A Disintegrin and Metalloproteinase (ADAM) 10.6 Technology Chips Ettan DIGE Technology

5 DNA Methylation Technology 10.7 Disease-specific technology Ovarian Cancer: Bio-Rad's SELDI-based ProteinChip Lung Cancer: Labeled Porphyrin Binding C-MAP, A Cervical Cancer Screening System Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP) Prostate Cancer: PCA Bladder Cancer: ImmunoCyt/uCyt+ 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 Pharmacogenetic Tests for Cancer 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 63 Figure 4.2: Progression of CRC Development 63 Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 96 Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 97 Figure 4.5: The BTA stat Test vs. Cytology 115 Figure 10.1: PCA3 Test Volume in U.S., INDEX OF TABLES Table 2.1: Organ-Specific Medicines in Development for Cancer 17 Table 2.2: Leading Sites of New Cancer Cases and Deaths in 2010 in the U.S. by Sex 18 Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer 18 Table 2.4: Number of New Cancer Cases and Deaths by Region 19 Table 2.5: Cancer-Associated Genes 19 Table 2.6: Carcinogens in the Workplace 20 Table 2.7: Private Funding Levels for the Biotechnology Segment, Table 2.8: Herceptin Worldwide Sales, Table 2.9: Classes of Drugs Used to Treat Breast Cancer 23 Table 3.1: Tumor Biomarkers Currently in Common Use 27 Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates, Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market 32 Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Markets 32

6 Table 3.11: Worldwide PSA Sales, Table 3.12: U.S. PSA Sales, Table 3.13: Serum Markers Used Clinically 35 Table 3.14: Drivers of IHC Growth 40 Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany 44 Table 3.16: Worldwide Bladder Cancer Marker Sales, Table 3.17: U.S. Bladder Cancer Marker Sales, Table 3.18: Worldwide NMP22 Sales, Table 3.19: Breast Cancer Products and Product Opportunities, Table 3.20: Products in Various Stages of Development for Cancers Other than Breast Cancer 56 Table 4.1: CRC Stages 61 Table 4.2: Worldwide CEA Sales, Table 4.3: U.S. CEA Sales, Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age 74 Table 4.5: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/ml 75 Table 4.6: Worldwide CA 19-9 Sales, Table 4.7: U.S. CA 19-9 Sales, Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer 89 Table 4.9: Worldwide CA 15-3 Sales, Table 4.10: U.S. CA 15-3 Sales, Table 4.11: TPA Marker Sensitivity 93 Table 4.12: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 95 Table 4.13: Oncogene Science Biomarker Group Reagents 98 Table 4.14: Worldwide CA-125 Sales, Table 4.15: U.S. CA-125 Sales, Table 4.16: Number of Pap Smears Performed by Country 105 Table 4.17: Lung Cancer Survival Rates 106 Table 4.18: American Cancer Society Lung Cancer Facts 107 Table 4.19: Tests Identifying Molecular Markers in Urine 112 Table 4.20: Patient Category Applications 113 Table 4.21: Worldwide AFP Marker Sales, Table 4.22: U.S. AFP Cancer Marker Sales, Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management 128 Table 4.24: Markers Frequently Used to Identify Adult Stem Cells in the Prostate, Breast and Intestine 134 Table 4.25: MammaPrint: Key Features 140 Table 6.1: Tumor Marker Tests 162 Table 6.2: Tumor Diagnosis Immunoassays 163 Table 6.3: Tumor Diagnosis Radioimmunoassays 163 Table 6.4: PBM Product List 182 Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests 189 Table 8.1: CPT Codes for Tumor Markers 202 Table 10.1: Categories of Oncogenes 220 Table 10.2: Familial Cancer Syndromes and Tumor Suppressor Genes 223 Table A3: TNM Classification 256 Table A7: Financial Comparison for Moderate and Waived CLIA Labs 265 Table A8: List of Marketers of Occult Blood Diagnostic Test Kits 267 Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.

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