Cancer Diagnostic Testing World Markets

Table of Contents:

1. Overview 8
1.1 Statement of Report 8
1.2 About This Report 8
1.3 Scope of the Report 9
1.4 Objectives 10
1.5 Methodology 10
1.6 Executive Summary 11
2. Introduction to Cancer Biology and the Diagnostic Industry 14
2.1 Cancer 14
2.1.1 The Disease 14
2.1.2 Metastasis 14
2.1.3 Demographics and Statistics of Cancer 14
2.2 The Drivers of the Biotech and Diagnostics Industry 19
2.2.1 Technological Innovation 20
2.2.2 Government Funding 21
2.3 Outlook for Tumor Markers 21
3. Tumor Markers Market Segment Analysis: Size, Growth and Share 23
3.1 Market Description 24
3.2 Clinical Diagnostic Serum Based Cancer Markers 31
3.3 PSA Testing Market Size 32
3.4 DNA Markers 33
3.5 Serum Proteins 33
3.6 Enzymes 34
3.7 Occult Blood 34
3.8 Histology and In Situ Hybridization (ISH) 35
3.9 Cervical Cytology 36
3.10 Immunohistochemistry 38
3.11 In Vivo Detection Cancer Products 39
3.12 Radionuclides and X-Ray Detection Products 39
3.13 Human Papillomavirus (HPV) Testing 39
3.14 Bladder Cancer Testing 42
3.15 Tumor Assays for Adjuvant Chemotherapy 46
4. Diagnostic Methods for Cancer Detection 60
4.1 Organ Specific Tumor Markers 60
4.1.1 Colon Cancer 60
4.1.2 Prostate Cancer 67
4.1.3 Pancreatic Cancer 84
4.1.4 Breast Cancer 87
4.1.5 Ovarian Cancer 96
4.1.6 Cervical Cancer 101
4.1.7 Lung Cancer 104
4.1.8 Testicular Cancer 107
4.1.9 Bladder Cancer 108
4.1.10 Hepatic Cancer 114
4.1.11 Stomach Cancer 115
4.1.12 Malignant Melanoma 116
4.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL) 117
4.1.14 Lymphoma 118
4.2 Clinical Laboratory Methods for Measuring Tumor Markers 118
4.2.1 Abbott Diagnostics AxSYM 118
4.2.2 Roche Diagnostics Elecsys 119
4.2.3 Beckman Coulter Diagnostics Access 119
4.2.4 Bayer Diagnostics ADVIA Centaur 120
4.2.5 Dade Diagnostics Stratus 120
4.2.6 Diagnostic Products Corporation Immulite 120
4.2.7 Tosoh Medics A1A 120
4.2.8 CIS bio International Kryptor 121
4.2.9 Ortho-Clinical Diagnostics Vitros ECiQ 122
4.2.10 Fujirebio Diagnostics, Inc. 122
4.2.11 bioMérieux Vidas 123
4.2.12 Eisai Picolumi 123
4.2.13 Tosoh Medics, Inc. 123
4.3 New Technologies for Cancer Diagnostics 123
4.3.1 New and Improved Immunoassays 124
4.3.2 Immunohistochemical Tests 125
4.3.3 Molecular (DNA and Genomic) Diagnostic Assays 126
4.3.4 Genomics and Genetic Markers 126
4.3.5 Proteomics and New Protein Markers 127
4.3.5.1 Inside the ProteinChip System 128
4.3.5.2 Rapid Biological Assays on a Chip 128
4.3.5.3 Proteome Pattern Recognition 128
4.3.6 New Platform Technologies Including Flow Cytometry 129
4.3.7 Stem Cell Markers 132
4.3.8 Monoclonal Antibodies 132
4.3.9 Proteomics and Cancer Antibodies 135
4.3.10 Pharmacogenomics and Oncology Diagnostics 136
4.3.11 DNA Microarrays 139
4.3.12 In Vitro Diagnostic Multivariate Index Assays (IVDMIA) 141
4.3.13 Prostate PX Score 141
4.3.14 Prostate-63 141
4.3.15 Future Directions 141
4.4 Clinical Methods for Diagnosis of Cancer 142
4.4.1 Screening 142
4.4.2 Sigmoidoscopy 144
4.4.3 Imaging 144
4.4.4 Theranostics 146
5. Implications of Molecular Biology for New Diagnostic Cancer Tests 147
6. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms 148
6.1 Abbott Diagnostics 148
6.2 Affymetrix, Inc. 149
6.3 Agendia BV 150
6.4 Agensys, Inc. 150
6.5 AMDL, Inc. 151
6.6 Arcturus Bioscience, Inc. 152
6.7 Asuragen, Inc. 153
6.8 Aureon Biosciences Corporation 153
6.9 Bard Diagnostics, Inc. 153
6.10 Bayer Diagnostics 154
6.11 Beckman Coulter, Inc. 154
6.12 Biocode S.A. 156
6.13 BioCurex 156
6.14 Biomedical Diagnostics 156
6.15 Biomerica 157
6.16 bioMérieux 157
6.17 Biomira 157
6.18 BioModa, Inc. 158
6.19 Bruker Daltonics 158
6.20 Byk Gulden 158
6.21 Cepheid 158
6.22 Ciphergen Biosystems, Inc. 159
6.23 Clarient, Inc. 160
6.24 Correlogic Systems, Inc. 162
6.25 Cytogen Corporation 162
6.26 Cytyc Corporation 165
6.27 DiaDexus, LLC 165
6.28 DiagnoCure, Inc. 166
6.29 Diagnostic Products Corporation 168
6.30 Diagnostic Systems Laboratories, Inc. 168
6.31 DRG International, Inc. 168
6.32 Eisai Co., Ltd. 169
6.33 Enigma Diagnostics Ltd. 169
6.34 Epigenomics 169
6.35 Exact Sciences Corporation 170
6.36 Exagen Diagnostics, Inc. 170
6.37 Fujirebio Diagnostics, Inc. 171
6.38 Gene Logic, Inc. 171
6.39 Gen-Probe, Inc. 172
6.40 Genomic Health 172
6.41 Geron Corporation 172
6.42 Immunicon Corporation 173
6.43 Immunomedics, Inc. 177
6.44 Incyte Pharmaceuticals, Inc. 178
6.45 Ipsogen 178
6.46 LabCorp 178
6.47 Matritech 179
6.48 Mitsubishi Kagaku Medical 183
6.49 Molecular Diagnostics, Inc. 183
6.50 Myriad Genetics, Inc. 184
6.51 Poniard Corporation 188
6.52 Nexell Therapeutics, Inc. 189
6.53 Northwest Biotherapeutics, Inc. 190
6.54 Nuvelo 190
6.55 Panacea Pharmaceuticals, Inc. 191
6.56 Oncotech, Inc. 191
6.57 Polymedco, Inc. 192
6.58 Princeton BioMeditech Corporation 193
6.59 Ambrilla Biopharma, Inc. 194
6.60 Qiagen 195
6.61 Sanko Junyaku Co., Ltd. 196
6.62 Tosoh Medics, Inc. 196
6.63 TriPath Imaging, Inc. 196
6.64 UroCor, Inc. 198
6.65 Ventana Medical Systems, Inc. 202
6.66 Veridex 203
6.67 Worldwide Medical Corporation 204
6.68 Xenomics, Inc. 204
7. Business Trends in the Industry 205
7.1 Industry Consolidation 205
7.2 Breath of Product Offering and Pricing 205
7.3 Government Regulation of Medical Devices 206
7.4 Strategic Business and Marketing Considerations 207
7.5 Commercial Opportunities in Cancer Markers 208
7.6 Moderators of Growth 209
7.7 Biotechnology Industry Trends 209
7.8 Pharmaceutical Industry Trends 210
7.9 Acquisition, License Agreement, Partnerships 212
7.10 Legal Developments 214
7.11 Sales and Marketing Strategies for Tumor Marker Tests 215
7.11.1 North American Market 216
7.11.2 International Markets 217
7.11.2.1 Europe 217
7.11.2.2 Central and South America 218
7.11.2.3 Asia/Pacific 218
8. Tumor Marker Testing: Important Issues 219
8.1 Trends in Patient Care and Reimbursement 219
8.2 Trends in Reimbursement Practice 220
8.3 Clinical Laboratory Improvement Act (CLIA) 222
8.4 Unmet Needs in Tumor Markers 223
9. Important New Technology Areas 224
9.1 Proteomics 224
9.2 DNA Sequencing 225
9.3 The Human Genome Project 226
9.4 Liquid Phase Chromatography 227
9.5 Polymerase Chain Reaction (PCR) 227
9.6 Capillary Electrophoresis 228
9.7 Proteomics 229
9.8 Use of Mass Spectroscopy in Sequencing 230
9.9 High-Throughput Organic Synthesis 234
10. New Cancer Markers in Basic Research 236
10.1 Genetics of Cancer 236
10.2 Telomerase 239
10.3 Stomach Cancer 241
10.4 Head and Neck Cancer 242
10.5 Breast Cancer 243
10.6 Prostate Cancer: p27 (Kip1) A New Molecular Marker for Prostate Cancer 244
10.7 PSMA 245
10.8 Cervical Cancer: NMPI79 246
10.9 Pancreatic Cancer: Peritoneal Cytology 246
10.10 Colorectal Cancer: CEA Doubling Time 246
10.11 Uterine and Kidney Cancer: MN/CA9 246
10.12 MMSC1 Scaffold Gene 246
10.13 p16 Tumor Suppressor Gene 247
10.14 MTS2 and p19 Cell Cycle Genes 247
10.15 Complement Factor H Related Proteins 247
10.16 MUC 2, 3, 4 247
10.17 Cytokeratins 248
10.18 Colon Cancer: Serum VEGF 248
10.19 Ras Oncogenes 248
10.20 Lung Cancer: Ribonucleoprotein A2/B1 249
10.21 BCLA-4 Matrix Protein 249
10.22 RAK Antigens 249
10.23 Serum Urokinase Receptors 249
10.24 Chips 250
10.25 Survivin 250
10.26 Human Endometrial Specific Steroid Binding Factor (hESF1) 250
10.27 Reg-4 Protein 251
10.28 Nox-1 251
10.29 PSP94 Binding Protein 251
10.30 Ettan DIGE Technology 251
10.31 YKL-40 252
10.32 AFP-L3 252
10.33 DNA Methylation Technology 252
10.34 Transthyretin and Apolipoprotein A1 252
10.35 ADAM 12 253
10.36 Ovarian Cancer: Ciphergen's SELDI-based ProteinChip 253
10.37 Lung Cancer: Labeled Porphyrin Binding 253
10.38 C-MAP, A Cervical Cancer Screening System 253
10.39 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP) 253
10.40 Prostate Cancer: PCA3 253
10.41 Bladder Cancer: ImmunoCyt™/uCyt+™ 256
10.42 Shc Proteins 256
10.43 Oncology Biomarker Qualification Initiative 256
10.44 Anti-Glycan Antibodies 257
11. Market Trends and Forecasts 258
11.1 Ultrasensitive Cancer Tests 258
11.2 Mergers and Acquisitions of Diagnostic Companies 259
11.3 RT-PCR 259
11.4 Genetic Tests of Hereditary Cancer Risk 260
11.5 DNA Measurements 260
11.6 Technical and Practical Issues for Potential New Markers 260
11.7 Genetic Profiling 261
11.8 Ploidy 262
11.9 Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer 262
11.10 Pharmacogenetic Tests for Cancer 263
11.11 Worldwide Healthcare Spending 264
11.12 R&D Expenditures 264
Appendix 1: Web Links 265
Appendix 2: Cancer Information Resources 267
Appendix 3: Colon Cancer Staging 268
Appendix 4: Reimbursement for Tumor Marker Testing 269
Appendix 5: The Pathology of Prostate Cancer 271
Appendix 6: Government Regulation of Tumor Marker Tests 273
Appendix 7: The Clinical Laboratory Improvement Act (CLIA) 275
Appendix 8: Marketers of Occult Blood Diagnostic Test Kits 277
INDEX OF FIGURES
Figure 4.1: Model of Colorectal Cancer Development 62
Figure 4.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 92
Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 93
Figure 4.4: The BTA stat Test vs. Cytology 112
Figure 6.1: Qiagen Global Sales 196
Figure 10.1: Estimates for PCA3 Test Volume in U.S., 2005-2008 255
INDEX OF TABLES
Table 2.1: Organ-Specific Medicines in Development for Cancer, 2007 15
Table 2.2: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex 16
Table 2.3: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer 16
Table 2.4: Estimated Number of New Cancer Cases and Deaths by Region 17
Table 2.5: Cancer Death Rates per 100,000 Population (and Rank) for all Cancer Sites by Country 18
Table 2.6: Cancer Associated Genes 18
Table 2.7: Carcinogens in the Workplace 19
Table 2.8: Private Funding Levels for the Biotechnology Segment, 1995-2006 20
Table 2.9: Herceptin Worldwide Sales, 2000-2006 21
Table 2.10: Classes of Drugs Used to Treat Breast Cancer 22
Table 3.1: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007 24
Table 3.2: Tumor Markers Currently in Common Use 26
Table 3.3: Global IVD Cancer Tumor Marker Testing Market Segments Projected Growth Rates, 2005-2010 28
Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 28
Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 28
Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 29
Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 29
Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 30
Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 30
Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 2005 30
Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market 31
Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets 31
Table 3.13: Worldwide PSA Sales, 2000-2010 32
Table 3.14: U.S. PSA Sales, 2000-2010 33
Table 3.15: Serum Markers Used Clinically 33
Table 3.16: Drivers of IHC Growth 38
Table 3.17: Bladder Cancer Testing Efforts in the U.S. and Germany 43
Table 3.18: Worldwide Bladder Cancer Marker Sales, 2001-2010 44
Table 3.19: U.S. Bladder Cancer Marker Sales, 2001-2010 45
Table 3.20: Worldwide NMP22 Sales, 2001-2010 46
Table 3.21: Current Breast Cancer Product and Product Opportunities 54
Table 3.22: Products in Various Stages of Development for Cancers Other than Breast Cancer 56
Table 4.1: Colorectal Cancer Stages 61
Table 4.2: Worldwide CEA Sales, 2001-2010 63
Table 4.3: U.S. CEA Sales, 2001-2010 63
Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age 73
Table 4.5: PSA Doubling Time and Time to Reach PSA of 1,000 73
Table 4.6: PSA Doubling Times 74
Table 4.7: Worldwide CA19-9 Sales, 2001-2010 85
Table 4.8: U.S. CA19-9 Sales, 2001-2010 85
Table 4.9: CA19-9 Levels in Management of Pancreatic Cancer 86
Table 4.10: Worldwide CA15-3 Sales, 2001-2010 87
Table 4.11: U.S. CA15-3 Sales, 2001-2010 88
Table 4.12: TPA Marker Sensitivity 90
Table 4.13: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 91
Table 4.14: Siemens Oncogene Science Biomarker Group Reagents 94
Table 4.15: Worldwide CA-125 Sales, 2001-2010 97
Table 4.16: U.S. CA-125 Sales, 2001-2010 98
Table 4.17: Number of Pap Smears Performed by Country 103
Table 4.18: Lung Cancer Facts 105
Table 4.19: Patient Category Applications 110
Table 4.20: Worldwide AFP Marker Sales, 2001-2010 115
Table 4.21: U.S. AFP Cancer Marker Sales, 2001-2010 115
Table 4.22: Potential Uses of Molecular Diagnostics in Cancer Management 126
Table 4.23: Colorectal Cancer Monoclonal Antibody Imaging Kits 134
Table 6.1: Product Sales as a Percent of Total Product Sales, 2004-2006 156
Table 6.2: Tumor Diagnosis Immunoassay 168
Table 6.3: Tumor Diagnosis Radioimmunoassay 169
Table 6.4: Summary of Matritech's Product Development Programs 181
Table 6.5: Statements of Operations Data for Matritech, 2002-2006 182
Table 6.6: Results of Operations of Matritech, 2005 and 2006 183
Table 6.7: PBM Product List 193
Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests 206
Table 8.1: CPT Codes for Tumor Markers 221
Table 10.1: Familial Cancer Syndromes and Tumor Suppressor Genes 237
Table 10.2: Oncogenes and Anti-oncogenes 237
Table A3: TNM Classification 268
Table A7: Financial Comparison for Moderate and Waived CLIA Labs 275
Table A8: List of Marketers of Occult Blood Diagnostic Test Kits 277