ReportsnReports – Cancer Diagnostic Testing World Markets


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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.

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ReportsnReports – Cancer Diagnostic Testing World Markets

  1. 1. Cancer Diagnostic Testing World MarketsCancer testing is one of the most important growth opportunities for the next three to fiveyears in the diagnostics segment. The National Cancer Institute estimates that about tenmillion 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 newmedicines for cancer, some of which are in development for more than one type of thedisease, for a total of more than 500 ongoing R&D projects.Buy Now: Cancer Diagnostic Testing World MarketsBrowse All: Latest Market Research ReportsThe goal of this TriMark Publications report is to review the market for tumor marker testingequipment and supplies using screening reagents and instruments for analysis of individualcomponents in blood, serum or plasma. It defines the dollar volume of sales, bothworldwide and in the U.S., and analyzes the factors that influence the size and the growthof 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 influencepurchases are discussed. The report surveys almost all of the companies known to bemarketing, 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 thecompany’s market position.TABLE OF CONTENTS1. Overview 81.1 Statement of Report 81.2 About this Report 81.3 Scope of the Report 101.4 Objectives 101.5 Methodology 101.6 Executive Summary 122. Introduction to Cancer Biology and the Diagnostic Industry 152.1 Cancer 152.1.1 The Disease 152.1.2 Metastasis 162.1.3 Demographics and Statistics of Cancer 162.2 The Drivers of the Biotech and Diagnostics Industry 202.2.1 Technological Innovation 222.2.2 Government Funding 222.3 Outlook for Tumor Markers 223. Tumor Markers Market Segment Analysis: Size, Growth and Share 243.1 Market Description 24
  2. 2. 3.2 Clinical Diagnostic Serum-Based Cancer Markers 323.3 PSA Testing Market Size 333.4 DNA Markers 343.5 Serum Proteins 353.6 Enzymes 353.7 Occult Blood 363.8 Histology and In Situ Hybridization (ISH) 363.9 Cervical Cytology 373.10 IHC 393.11 In Vivo Detection Cancer Products 403.12 Radionuclides and X-Ray Detection Products 403.13 HPV Testing 403.14 Bladder Cancer Testing 443.15 Tumor Assays for Adjuvant Chemotherapy 474. Diagnostic Methods for Cancer Detection 604.1 Organ-Specific Tumor Markers 604.1.1 Colon Cancer 604.1.2 Prostate Cancer 674.1.3 Pancreatic Cancer 874.1.4 Breast Cancer 894.1.5 Ovarian Cancer 994.1.6 Cervical Cancer 1034.1.7 Lung Cancer 1064.1.8 Testicular Cancer 1104.1.9 Bladder Cancer 1114.1.10 Hepatic Cancer 1174.1.11 Stomach Cancer 1194.1.12 Malignant Melanoma 1194.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL) 1204.1.14 Lymphoma 1214.2 Clinical Laboratory Methods for Measuring Tumor Markers 1214.2.1 Abbott Diagnostics AxSYM 1214.2.2 Roche Diagnostics Elecsys 1224.2.3 Beckman Coulter Diagnostics Access Systems 1224.2.4 Siemens Healthcare Diagnostics ADVIA Centaur 1234.2.5 Siemens Healthcare Diagnostics Immulite 1234.2.6 Tosoh Bioscience AIA-2000 1234.2.7 Thermo Fisher Scientific B.R.A.H.M.S. KRYPTOR 1244.2.8 Ortho-Clinical Diagnostics Vitros ECiQ 1254.2.9 Fujirebio Diagnostics, Inc. 1254.2.10 bioMerieux Vidas 1264.3 New Technologies for Cancer Diagnostics 1264.3.1 New and Improved Immunoassays 1274.3.2 IHC Tests 1284.3.3 Molecular (DNA and Genomic) Diagnostic Assays 1284.3.4 Genomics and Genetic Markers 1294.3.5 Proteomics and New Protein Markers 1304.3.5.1 Inside the ProteinChip System 130
  3. 3. Rapid Biological Assays on a Chip 1304.3.5.3 Proteome Pattern Recognition 1314.3.6 New Platform Technologies Including Flow Cytometry 1314.3.7 Stem Cell Markers 1344.3.8 mAbs 1354.3.9 Proteomics and Cancer Antibodies 1364.3.10 Pharmacogenomics and Oncology Diagnostics 1364.3.11 DNA Microarrays 1394.3.12 In Vitro Diagnostic Multi-variate Index Assays (IVDMIA) 1414.3.13 Prostate PX Score 1414.3.14 Prostate-63 1424.3.15 Future Directions 1424.4 Clinical Methods for Diagnosis of Cancer 1424.4.1 Screening 1424.4.2 Sigmoidoscopy 1444.4.3 Imaging 1454.4.4 Theranostics 1465. Implications of Molecular Biology for New Diagnostic Cancer Tests 1476. Companies Entering the Cancer Diagnostics Market with Novel TechnologyPlatforms 1496.1 Abbott Diagnostics 1496.2 Affymetrix, Inc. 1496.3 Agendia BV 1506.4 Ambrilia Biopharma, Inc. 1516.5 Radient Pharmaceuticals 1516.6 Asuragen, Inc. 1526.7 Aureon Biosciences, Inc. 1526.8 C. R. Bard 1526.9 Beckman, Dickinson and Company (BD) Diagnostics – TriPath 1536.10 Beckman Coulter, Inc. 1546.11 Biocode S.A. 1566.12 BioCurex 1566.13 Biomedical Diagnostics 1566.14 Biomerica 1566.15 bioMerieux 1576.16 BioModa, Inc. 1576.17 Bruker Daltonics 1576.18 Byk Gulden 1586.19 Cepheid 1586.20 Clarient, Inc. 1596.21 Correlogic Systems, Inc. 1596.22 CytoCore (formerly Molecular Diagnostics, Inc.) 1596.23 Cytogen Corporation (now EUSA Pharma) 1596.24 diaDexus, Inc. 1606.25 DiagnoCure, Inc. 1616.26 Diagnostic Automation / Cortez Diagnostics, Inc. 1626.27 DRG International, Inc. 162
  4. 4. 6.28 Eisai Co., Ltd. 1636.29 Enigma Diagnostics Ltd. 1636.30 Epigenomics AG 1646.31 Exact Sciences Corporation 1646.32 Exagen Diagnostics, Inc. 1656.33 Fujirebio Diagnostics, Inc. 1656.34 Gene Logic, Inc. 1666.35 Gen-Probe, Inc. 1666.36 Genomic Health 1666.37 Geron Corporation 1676.38 Hologic, Inc. (formerly Cytyc Corporation) 1686.39 Immunicon Corporation (now Veridex, LLC) 1686.40 Immunomedics, Inc. 1696.41 Incyte Corporation 1696.42 Ipsogen 1696.43 LabCorp 1706.44 Mitsubishi Kagaku Medical 1716.45 Molecular Devices (formerly Arcturus Bioscience, Inc.) 1716.46 Myriad Genetics, Inc. 1716.47 Northwest Biotherapeutics, Inc. 1776.48 ARCA Biopharma 1786.49 Oncotech, Inc. 1786.50 Oncothyreon, Inc. (formerly Biomira) 1786.51 Panacea Pharmaceuticals, Inc. 1796.52 Poniard Pharmaceuticals, Inc. 1796.53 Polymedco, Inc. 1806.54 Princeton BioMeditech Corporation 1816.55 Qiagen 1836.56 Roche (F. Hoffman-La Roche, Ltd.) 1846.57 Sanko Junyaku Co., Ltd. 1846.58 Siemens Heathcare Diagnostics 1856.59 Tosoh Corporation (Bioscience division) 1856.60 Ventana Medical Systems, Inc. 1856.62 Veridex, LLC 1856.63 Vermillion, Inc. 1866.63 Worldwide Medical Corporation 1866.64 Xenomics, Inc. (TrovaGene, Inc.) 1867. Business Trends in the Industry 1887.1 Industry Consolidation 1887.2 Breadth of Product Offering and Pricing 1887.3 Government Regulation of Medical Devices 1897.4 Commercial Opportunities in Cancer Markers 1907.5 Moderators of Growth 1917.6 Biotechnology Industry Trends 1927.7 Pharmaceutical Industry Trends 1937.8 Sales and Marketing Strategies for Tumor Marker Tests 1967.8.1 North American Market 1977.8.2 International Markets 198
  5. 5. Europe 1987.8.2.2 Central and South America 1997.8.2.3 Asia/Pacific 1998. Tumor Marker Testing: Important Issues 2008.1 Trends in Patient Care and Reimbursement 2008.2 Trends in Reimbursement Practice 2018.3 Clinical Laboratory Improvement Act (CLIA) 2038.4 Unmet Needs in Tumor Markers 2059. Important New Technology Areas 2069.1 Proteins 2069.2 DNA Sequencing 2079.3 The Human Genome Project (HGP) 2089.4 Liquid Phase Chromatography 2099.5 Polymerase Chain Reaction (PCR) 2109.6 Capillary Electrophoresis 2119.7 Proteomics 2129.8 Use of MS in Sequencing 2139.9 High-Throughput Organic Synthesis 21810. New Cancer Markers in Basic Research 21910.1 Genetics of Cancer 21910.1.1 Activator genes (Oncogenes) 21910.1.2 Inactivating Genes (Tumor Suppressor Genes) 22110.2 DNA Mismatch Repair Genes (MMRs) 22410.3 Telomeres 22510.4 Diseases 22810.4.1 t(15;17) in Acute Promyelocytic Leukemia (APL) 22810.4.2 t(12;21) in Acute Lymphoblastic Leukemia (ALL) 22810.4.3 Retinoblastoma and Constitutional 13q14 Deletion 22810.4.4 Stomach Cancer 22810.4.5 Head and Neck Cancer 22910.4.6 Breast and Ovarian Cancers 23010.4.7 Prostate Cancer 23110.4.8 Cervical Cancer: NMPI79 23310.4.9 Uterine and Kidney Cancer: MN/CA9 23310.4.10 Colon Cancer: Serum Vascular Endothelial Growth factor (VEGF) 23410.4.11 Lung Cancer: Ribonucleoprotein A2/B1 and microRNA Markers 23410.5 Tumor Markers 23410.5.1 Oncology Biomarker Qualification Initiative 23410.5.2 CRC: Carcinoembryonic Antigen (CEA) Doubling Time 23510.5.3 MUC1, 2, 3 and 4 23510.5.4 Cytokeratins 23610.5.5 RAK Antigens 23610.5.6 Serum Urokinase Receptors 23610.5.7 Survivin 23610.5.8 Reg-4 Protein 236
  6. 6. 10.5.9 NADPH Oxidases 1 and 2 (NOX1 and NOX2) 23710.5.10 Prostate Secretory Protein 94- (PSP94)-Binding Protein 23710.5.11 Shc Proteins 23710.5.12 Anti-Glycan Antibodies 23810.5.13 YKL-40 23810.5.14 Alpha-fetoprotein (AFP)-L3 23810.5.15 Transthyretin and Apolipoprotein A1 (Apo A1) 23910.5.16 A Disintegrin and Metalloproteinase (ADAM) 23910.6 Technology 23910.6.1 Chips 23910.6.2 Ettan DIGE Technology 24010.6.3 DNA Methylation Technology 24010.7 Disease-specific technology 24010.7.1 Ovarian Cancer: Bio-Rad’s SELDI-based ProteinChip 24010.7.2 Lung Cancer: Labeled Porphyrin Binding 24110.7.3 C-MAP, A Cervical Cancer Screening System 24110.7.4 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP) 24110.7.5 Prostate Cancer: PCA3 24110.7.6 Bladder Cancer: ImmunoCyt/uCyt+ 24411. Market Trends and Forecasts 24511.1 Ultrasensitive Cancer Tests 24511.2 Mergers and Acquisitions (M&As) of Diagnostic Companies 24611.3 Reverse transcriptase-polymerase chain reaction (RT-PCR) 24611.4 Genetic Tests of Hereditary Cancer Risk 24711.5 DNA Measurements 24711.6 Technical and Practical Issues for Potential New Markers 24711.7 Genetic Profiling 24811.8 Ploidy 24911.9 Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer 24911.10 Pharmacogenetic Tests for Cancer 25011.11 Worldwide Healthcare Spending 251Appendix 1: Web Links 253Appendix 2: Cancer Information Resources 255Appendix 3: Colon Cancer Staging 256Appendix 4: Reimbursement for Tumor Marker Testing 257Appendix 5: The Pathology of Prostate Cancer 260Appendix 6: Government Regulation of Tumor Marker Tests 262Appendix 7: The Clinical Laboratory Improvement Act (CLIA) 265Appendix 8: Marketers of Occult Blood Diagnostic Test Kits 267LIST OF FIGURESFigure 4.1: Model of CRC Development 63Figure 4.2: Progression of CRC Development 63Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results withIHC 96Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 97
  7. 7. Figure 4.5: The BTA stat Test vs. Cytology 115Figure 10.1: PCA3 Test Volume in U.S., 2005-2008 244LIST OF TABLESTable 2.1: Organ-Specific Medicines in Development for Cancer 17Table 2.2: Leading Sites of New Cancer Cases and Deaths in 2010 in the U.S. by Sex 18Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer 18Table 2.4: Number of New Cancer Cases and Deaths by Region 19Table 2.5: Cancer-Associated Genes 19Table 2.6: Carcinogens in the Workplace 20Table 2.7: Private Funding Levels for the Biotechnology Segment, 1995-2010 21Table 2.8: Herceptin Worldwide Sales, 2000-2015 23Table 2.9: Classes of Drugs Used to Treat Breast Cancer 23Table 3.1: Tumor Biomarkers Currently in Common Use 27Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates, 2005-2015 28Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays ProductMarket, 2001-2015 29Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market,2001-2015 29Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 31Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 31Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker DiagnosticsMarket 32Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Markets 32Table 3.11: Worldwide PSA Sales, 2000-2015 34Table 3.12: U.S. PSA Sales, 2000-2015 34Table 3.13: Serum Markers Used Clinically 35Table 3.14: Drivers of IHC Growth 40Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany 44Table 3.16: Worldwide Bladder Cancer Marker Sales, 2001-2015 46Table 3.17: U.S. Bladder Cancer Marker Sales, 2001-2015 46Table 3.18: Worldwide NMP22 Sales, 2001-2015 47Table 3.19: Breast Cancer Products and Product Opportunities, 2006 55Table 3.20: Products in Various Stages of Development for Cancers Other than BreastCancer 56Table 4.1: CRC Stages 61Table 4.2: Worldwide CEA Sales, 2001-2015 64Table 4.3: U.S. CEA Sales, 2001-2015 64Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age 74Table 4.5: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/mL 75Table 4.6: Worldwide CA 19-9 Sales, 2001-2015 88Table 4.7: U.S. CA 19-9 Sales, 2001-2015 88Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer 89Table 4.9: Worldwide CA 15-3 Sales, 2001-2015 90Table 4.10: U.S. CA 15-3 Sales, 2001-2015 90Table 4.11: TPA Marker Sensitivity 93
  8. 8. Table 4.12: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret TestResults 95Table 4.13: Oncogene Science Biomarker Group Reagents 98Table 4.14: Worldwide CA-125 Sales, 2001-2015 100Table 4.15: U.S. CA-125 Sales, 2001-2015 100Table 4.16: Number of Pap Smears Performed by Country 105Table 4.17: Lung Cancer Survival Rates 106Table 4.18: American Cancer Society Lung Cancer Facts 107Table 4.19: Tests Identifying Molecular Markers in Urine 112Table 4.20: Patient Category Applications 113Table 4.21: Worldwide AFP Marker Sales, 2001-2015 118Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2015 118Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management 128Table 4.24: Markers Frequently Used to Identify Adult Stem Cells in the Prostate, Breast andIntestine 134Table 4.25: MammaPrint: Key Features 140Table 6.1: Tumor Marker Tests 162Table 6.2: Tumor Diagnosis Immunoassays 163Table 6.3: Tumor Diagnosis Radioimmunoassays 163Table 6.4: PBM Product List 182Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests 189Table 8.1: CPT Codes for Tumor Markers 202Table 10.1: Categories of Oncogenes 220Table 10.2: Familial Cancer Syndromes and Tumor Suppressor Genes 223Table A3: TNM Classification 256Table A7: Financial Comparison for Moderate and Waived CLIA Labs 265Table A8: List of Marketers of Occult Blood Diagnostic Test Kits 267Latest Market Research Reports:Cancer Diagnostic Testing World MarketsCompanion Diagnostics in Personalized Medicine and Cancer TherapyChina – Telecoms, Mobile, Broadband and ForecastsMolecular Diagnostics in Infectious Disease TestingMolecular Diagnostics in Cancer TestingMolecular Diagnostics MarketsAbout Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: Facebook Page:
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