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 8
1.1 Statement of Report 8
1.2 About this Report 8
1.3 Scope of the Report 10
1.4 Objectives 10
1.5 Methodology 10
1.6 Executive Summary 12

2. Introduction to Cancer Biology and the Diagnostic Industry 15
2.1 Cancer 15
2.1.1 The Disease 15
2.1.2 Metastasis 16
2.1.3 Demographics and Statistics of Cancer 16
2.2 The Drivers of the Biotech and Diagnostics Industry 20
2.2.1 Technological Innovation 22
2.2.2 Government Funding 22
2.3 Outlook for Tumor Markers 22

3. Tumor Markers Market Segment Analysis: Size, Growth and Share 24
3.1 Market Description 24
3.2 Clinical Diagnostic Serum-Based Cancer Markers 32
3.3 PSA Testing Market Size 33
3.4 DNA Markers 34
3.5 Serum Proteins 35
3.6 Enzymes 35
3.7 Occult Blood 36
3.8 Histology and In Situ Hybridization (ISH) 36
3.9 Cervical Cytology 37
3.10 IHC 39
3.11 In Vivo Detection Cancer Products 40
3.12 Radionuclides and X-Ray Detection Products 40
3.13 HPV Testing 40
3.14 Bladder Cancer Testing 44
3.15 Tumor Assays for Adjuvant Chemotherapy 47

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 87
4.1.4 Breast Cancer 89
4.1.5 Ovarian Cancer 99
4.1.6 Cervical Cancer 103
4.1.7 Lung Cancer 106
4.1.8 Testicular Cancer 110
4.1.9 Bladder Cancer 111
4.1.10 Hepatic Cancer 117
4.1.11 Stomach Cancer 119
4.1.12 Malignant Melanoma 119
4.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL) 120
4.1.14 Lymphoma 121
4.2 Clinical Laboratory Methods for Measuring Tumor Markers 121
4.2.1 Abbott Diagnostics AxSYM 121
4.2.2 Roche Diagnostics Elecsys 122
4.2.3 Beckman Coulter Diagnostics Access Systems 122
4.2.4 Siemens Healthcare Diagnostics ADVIA Centaur 123
4.2.5 Siemens Healthcare Diagnostics Immulite 123
4.2.6 Tosoh Bioscience AIA-2000 123
4.2.7 Thermo Fisher Scientific B.R.A.H.M.S. KRYPTOR 124
4.2.8 Ortho-Clinical Diagnostics Vitros ECiQ 125
4.2.9 Fujirebio Diagnostics, Inc. 125
4.2.10 bioMerieux Vidas 126
4.3 New Technologies for Cancer Diagnostics 126
4.3.1 New and Improved Immunoassays 127
4.3.2 IHC Tests 128
4.3.3 Molecular (DNA and Genomic) Diagnostic Assays 128
4.3.4 Genomics and Genetic Markers 129
4.3.5 Proteomics and New Protein Markers 130
4.3.5.1 Inside the ProteinChip System 130
4.3.5.2 Rapid Biological Assays on a Chip 130
4.3.5.3 Proteome Pattern Recognition 131
4.3.6 New Platform Technologies Including Flow Cytometry 131
4.3.7 Stem Cell Markers 134
4.3.8 mAbs 135
4.3.9 Proteomics and Cancer Antibodies 136
4.3.10 Pharmacogenomics and Oncology Diagnostics 136
4.3.11 DNA Microarrays 139
4.3.12 In Vitro Diagnostic Multi-variate Index Assays (IVDMIA) 141
4.3.13 Prostate PX Score 141
4.3.14 Prostate-63 142
4.3.15 Future Directions 142
4.4 Clinical Methods for Diagnosis of Cancer 142
4.4.1 Screening 142
4.4.2 Sigmoidoscopy 144
4.4.3 Imaging 145
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 149
6.1 Abbott Diagnostics 149
6.2 Affymetrix, Inc. 149
6.3 Agendia BV 150
6.4 Ambrilia Biopharma, Inc. 151
6.5 Radient Pharmaceuticals 151
6.6 Asuragen, Inc. 152
6.7 Aureon Biosciences, Inc. 152
6.8 C. R. Bard 152
6.9 Beckman, Dickinson and Company (BD) Diagnostics - TriPath 153
6.10 Beckman Coulter, Inc. 154
6.11 Biocode S.A. 156
6.12 BioCurex 156
6.13 Biomedical Diagnostics 156
6.14 Biomerica 156
6.15 bioMerieux 157
6.16 BioModa, Inc. 157
6.17 Bruker Daltonics 157
6.18 Byk Gulden 158
6.19 Cepheid 158
6.20 Clarient, Inc. 159
6.21 Correlogic Systems, Inc. 159
6.22 CytoCore (formerly Molecular Diagnostics, Inc.) 159
6.23 Cytogen Corporation (now EUSA Pharma) 159
6.24 diaDexus, Inc. 160
6.25 DiagnoCure, Inc. 161
6.26 Diagnostic Automation / Cortez Diagnostics, Inc. 162
6.27 DRG International, Inc. 162
6.28 Eisai Co., Ltd. 163
6.29 Enigma Diagnostics Ltd. 163
6.30 Epigenomics AG 164
6.31 Exact Sciences Corporation 164
6.32 Exagen Diagnostics, Inc. 165
6.33 Fujirebio Diagnostics, Inc. 165
6.34 Gene Logic, Inc. 166
6.35 Gen-Probe, Inc. 166
6.36 Genomic Health 166
6.37 Geron Corporation 167
6.38 Hologic, Inc. (formerly Cytyc Corporation) 168
6.39 Immunicon Corporation (now Veridex, LLC) 168
6.40 Immunomedics, Inc. 169
6.41 Incyte Corporation 169
6.42 Ipsogen 169
6.43 LabCorp 170
6.44 Mitsubishi Kagaku Medical 171
6.45 Molecular Devices (formerly Arcturus Bioscience, Inc.) 171
6.46 Myriad Genetics, Inc. 171
6.47 Northwest Biotherapeutics, Inc. 177
6.48 ARCA Biopharma 178
6.49 Oncotech, Inc. 178
6.50 Oncothyreon, Inc. (formerly Biomira) 178
6.51 Panacea Pharmaceuticals, Inc. 179
6.52 Poniard Pharmaceuticals, Inc. 179
6.53 Polymedco, Inc. 180
6.54 Princeton BioMeditech Corporation 181
6.55 Qiagen 183
6.56 Roche (F. Hoffman-La Roche, Ltd.) 184
6.57 Sanko Junyaku Co., Ltd. 184
6.58 Siemens Heathcare Diagnostics 185
6.59 Tosoh Corporation (Bioscience division) 185
6.60 Ventana Medical Systems, Inc. 185
6.62 Veridex, LLC 185
6.63 Vermillion, Inc. 186
6.63 Worldwide Medical Corporation 186
6.64 Xenomics, Inc. (TrovaGene, Inc.) 186

7. Business Trends in the Industry 188
7.1 Industry Consolidation 188
7.2 Breadth of Product Offering and Pricing 188
7.3 Government Regulation of Medical Devices 189
7.4 Commercial Opportunities in Cancer Markers 190
7.5 Moderators of Growth 191
7.6 Biotechnology Industry Trends 192
7.7 Pharmaceutical Industry Trends 193
7.8 Sales and Marketing Strategies for Tumor Marker Tests 196
7.8.1 North American Market 197
7.8.2 International Markets 198
7.8.2.1 Europe 198
7.8.2.2 Central and South America 199
7.8.2.3 Asia/Pacific 199

8. Tumor Marker Testing: Important Issues 200
8.1 Trends in Patient Care and Reimbursement 200
8.2 Trends in Reimbursement Practice 201
8.3 Clinical Laboratory Improvement Act (CLIA) 203
8.4 Unmet Needs in Tumor Markers 205

9. Important New Technology Areas 206
9.1 Proteins 206
9.2 DNA Sequencing 207
9.3 The Human Genome Project (HGP) 208
9.4 Liquid Phase Chromatography 209
9.5 Polymerase Chain Reaction (PCR) 210
9.6 Capillary Electrophoresis 211
9.7 Proteomics 212
9.8 Use of MS in Sequencing 213
9.9 High-Throughput Organic Synthesis 218

10. New Cancer Markers in Basic Research 219
10.1 Genetics of Cancer 219
10.1.1 Activator genes (Oncogenes) 219
10.1.2 Inactivating Genes (Tumor Suppressor Genes) 221
10.2 DNA Mismatch Repair Genes (MMRs) 224
10.3 Telomeres 225
10.4 Diseases 228
10.4.1 t(15;17) in Acute Promyelocytic Leukemia (APL) 228
10.4.2 t(12;21) in Acute Lymphoblastic Leukemia (ALL) 228
10.4.3 Retinoblastoma and Constitutional 13q14 Deletion 228
10.4.4 Stomach Cancer 228
10.4.5 Head and Neck Cancer 229
10.4.6 Breast and Ovarian Cancers 230
10.4.7 Prostate Cancer 231
10.4.8 Cervical Cancer: NMPI79 233
10.4.9 Uterine and Kidney Cancer: MN/CA9 233
10.4.10 Colon Cancer: Serum Vascular Endothelial Growth factor (VEGF) 234
10.4.11 Lung Cancer: Ribonucleoprotein A2/B1 and microRNA Markers 234
10.5 Tumor Markers 234
10.5.1 Oncology Biomarker Qualification Initiative 234
10.5.2 CRC: Carcinoembryonic Antigen (CEA) Doubling Time 235
10.5.3 MUC1, 2, 3 and 4 235
10.5.4 Cytokeratins 236
10.5.5 RAK Antigens 236
10.5.6 Serum Urokinase Receptors 236
10.5.7 Survivin 236
10.5.8 Reg-4 Protein 236
10.5.9 NADPH Oxidases 1 and 2 (NOX1 and NOX2) 237
10.5.10 Prostate Secretory Protein 94- (PSP94)-Binding Protein 237
10.5.11 Shc Proteins 237
10.5.12 Anti-Glycan Antibodies 238
10.5.13 YKL-40 238
10.5.14 Alpha-fetoprotein (AFP)-L3 238
10.5.15 Transthyretin and Apolipoprotein A1 (Apo A1) 239
10.5.16 A Disintegrin and Metalloproteinase (ADAM) 239
10.6 Technology 239
10.6.1 Chips 239
10.6.2 Ettan DIGE Technology 240
10.6.3 DNA Methylation Technology 240
10.7 Disease-specific technology 240
10.7.1 Ovarian Cancer: Bio-Rad's SELDI-based ProteinChip 240
10.7.2 Lung Cancer: Labeled Porphyrin Binding 241
10.7.3 C-MAP, A Cervical Cancer Screening System 241
10.7.4 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP) 241
10.7.5 Prostate Cancer: PCA3 241
10.7.6 Bladder Cancer: ImmunoCyt/uCyt+ 244

11. Market Trends and Forecasts 245
11.1 Ultrasensitive Cancer Tests 245
11.2 Mergers and Acquisitions (M&As) of Diagnostic Companies 246
11.3 Reverse transcriptase-polymerase chain reaction (RT-PCR) 246
11.4 Genetic Tests of Hereditary Cancer Risk 247
11.5 DNA Measurements 247
11.6 Technical and Practical Issues for Potential New Markers 247
11.7 Genetic Profiling 248
11.8 Ploidy 249
11.9 Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer 249
11.10 Pharmacogenetic Tests for Cancer 250
11.11 Worldwide Healthcare Spending 251

Appendix 1: Web Links 253
Appendix 2: Cancer Information Resources 255
Appendix 3: Colon Cancer Staging 256
Appendix 4: Reimbursement for Tumor Marker Testing 257
Appendix 5: The Pathology of Prostate Cancer 260
Appendix 6: Government Regulation of Tumor Marker Tests 262
Appendix 7: The Clinical Laboratory Improvement Act (CLIA) 265
Appendix 8: Marketers of Occult Blood Diagnostic Test Kits 267
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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., 2005-2008 244


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, 1995-2010 21
Table 2.8: Herceptin Worldwide Sales, 2000-2015 23
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, 2005-2015 28
Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015 29
Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015 29
Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30
Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30
Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 31
Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 31
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
Table 3.11: Worldwide PSA Sales, 2000-2015 34
Table 3.12: U.S. PSA Sales, 2000-2015 34
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, 2001-2015 46
Table 3.17: U.S. Bladder Cancer Marker Sales, 2001-2015 46
Table 3.18: Worldwide NMP22 Sales, 2001-2015 47
Table 3.19: Breast Cancer Products and Product Opportunities, 2006 55
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, 2001-2015 64
Table 4.3: U.S. CEA Sales, 2001-2015 64
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, 2001-2015 88
Table 4.7: U.S. CA 19-9 Sales, 2001-2015 88
Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer 89
Table 4.9: Worldwide CA 15-3 Sales, 2001-2015 90
Table 4.10: U.S. CA 15-3 Sales, 2001-2015 90
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, 2001-2015 100
Table 4.15: U.S. CA-125 Sales, 2001-2015 100
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, 2001-2015 118
Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2015 118
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
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