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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 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.

Table of Contents

1. Overview 7

• 1.1 Statement of Report 7
• 1.2 About this Report 7
• 1.3 Scope of the Report 9
• 1.4 Objectives 9
• 1.5 Methodology 9
• 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 15
  • 2.1.3 Demographics and Statistics of Cancer 15
• 2.2 The Drivers of the Biotech and Diagnostics Industry 19
  • 2.2.1 Technological Innovation 21
  • 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 23
• 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 34
• 3.6 Enzymes 34
• 3.7 Occult Blood 35
• 3.8 Histology and In Situ Hybridization (ISH) 35
• 3.9 Cervical Cytology 36
• 3.10 IHC 38
• 3.11 In Vivo Detection Cancer Products 39
• 3.12 Radionuclides and X-Ray Detection Products 39
• 3.13 HPV Testing 39
• 3.14 Bladder Cancer Testing 43
• 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 68
  • 4.1.3 Pancreatic Cancer 87
  • 4.1.4 Breast Cancer 90
  • 4.1.5 Ovarian Cancer 101
  • 4.1.6 Cervical Cancer 106
  • 4.1.7 Lung Cancer 108
  • 4.1.8 Testicular Cancer 113
  • 4.1.9 Bladder Cancer 114
  • 4.1.10 Hepatic Cancer 120
  • 4.1.11 Stomach Cancer 122
  • 4.1.12 Malignant Melanoma 123
  • 4.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL) 124
  • 4.1.14 Lymphoma 125
• 4.2 Clinical Laboratory Methods for Measuring Tumor Markers 126
  • 4.2.1 Abbott Diagnostics AxSYM 126
  • 4.2.2 Roche Diagnostics Elecsys 126
  • 4.2.3 Beckman Coulter Diagnostics Access 127
  • 4.2.4 Siemens Healthcare Diagnostics ADVIA Centaur 127
  • 4.2.5 Siemens Healthcare Diagnostics Immulite 128
  • 4.2.6 Tosoh Bioscience AIA-2000 128
  • 4.2.7 Thermo Fisher Scientific B.R.A.H.M.S. KRYPTOR 129
  • 4.2.8 Ortho-Clinical Diagnostics Vitros ECiQ 129
  • 4.2.9 Fujirebio Diagnostics, Inc. 129
  • 4.2.10 bioMerieux Vidas 130
  • 4.2.11 Eisai Picolumi 130
• 4.3 New Technologies for Cancer Diagnostics 131
  • 4.3.1 New and Improved Immunoassays 131
  • 4.3.2 IHC Tests 132
  • 4.3.3 Molecular (DNA and Genomic) Diagnostic Assays 133
  • 4.3.4 Genomics and Genetic Markers 134
  • 4.3.5 Proteomics and New Protein Markers 135
    • 4.3.5.1 Inside the ProteinChip System 136
    • 4.3.5.2 Rapid Biological Assays on a Chip 136
    • 4.3.5.3 Proteome Pattern Recognition 136
  • 4.3.6 New Platform Technologies Including Flow Cytometry 137
  • 4.3.7 Stem Cell Markers 140
  • 4.3.8 mAbs 142
  • 4.3.9 Proteomics and Cancer Antibodies 145
  • 4.3.10 Pharmacogenomics and Oncology Diagnostics 146
  • 4.3.11 DNA Microarrays 149
  • 4.3.12 In Vitro Diagnostic Multi-variate Index Assays (IVDMIA) 151
  • 4.3.13 Prostate PX Score 152
  • 4.3.14 Prostate-63 152
  • 4.3.15 Future Directions 152
• 4.4 Clinical Methods for Diagnosis of Cancer 152
  • 4.4.1 Screening 152
  • 4.4.2 Sigmoidoscopy 154
  • 4.4.3 Imaging 155
  • 4.4.4 Theranostics 156

5. Implications of Molecular Biology for New Diagnostic Cancer Tests 158

6. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms 160

• 6.1 Abbott Diagnostics 160
• 6.2 Affymetrix, Inc. 162
• 6.3 Agendia BV 162
• 6.4 Ambrilia Biopharma, Inc. 163
• 6.5 AMDL, Inc. 163
• 6.6 Asuragen, Inc. 163
• 6.7 Aureon Laboratories, Inc. 164
• 6.8 Bard Diagnostics, Inc. 164
• 6.9 Beckman, Dickinson and Company (BD) Diagnostics - TriPath 165
• 6.10 Beckman Coulter, Inc. 166
• 6.11 Biocode S.A. 167
• 6.12 BioCurex 168
• 6.13 Biomedical Diagnostics 168
• 6.14 Biomerica 168
• 6.15 bioMerieux 169
• 6.16 BioModa, Inc. 169
• 6.17 Bruker Daltonics 169
• 6.18 Byk Gulden 170
• 6.19 Cepheid 170
• 6.20 Clarient, Inc. 170
• 6.21 Correlogic Systems, Inc. 172
• 6.22 CytoCore (formerly Molecular Diagnostics, Inc.) 173
• 6.23 Cytogen Corporation (now EUSA Pharma) 173
• 6.24 diaDexus, Inc. 174
• 6.25 DiagnoCure, Inc. 175
• 6.26 Diagnostic Automation / Cortez Diagnostics, Inc. 176
• 6.27 DRG International, Inc. 177
• 6.28 Eisai Co., Ltd. 178
• 6.29 Enigma Diagnostics Ltd. 178
• 6.30 Epigenomics AG 178
• 6.31 Exact Sciences Corporation 178
• 6.32 Exagen Diagnostics, Inc. 180
• 6.33 Fujirebio Diagnostics, Inc. 180
• 6.34 Gene Logic, Inc. 180
• 6.35 Gen-Probe, Inc. 181
• 6.36 Genomic Health 182
• 6.37 Geron Corporation 182
• 6.38 Hologic, Inc. (formerly Cytyc Corporation) 183
• 6.39 Immunicon Corporation (now Veridex, LLC) 184
• 6.40 Immunomedics, Inc. 186
• 6.41 Incyte Pharmaceuticals, Inc. 187
• 6.42 Ipsogen 188
• 6.43 LabCorp 188
• 6.44 Matritech 189
• 6.45 Mitsubishi Kagaku Medical 191
• 6.46 Molecular Devices (formerly Arcturus Bioscience, Inc.) 192
• 6.47 Myriad Genetics, Inc. 192
• 6.48 Nexell Therapeutics, Inc. 197
• 6.49 Northwest Biotherapeutics, Inc. 198
• 6.50 Nuvelo, Inc. 199
• 6.51 Oncotech, Inc. 199
• 6.52 Oncothyreon, Inc. (formerly Biomira) 200
• 6.53 Panacea Pharmaceuticals, Inc. 201
• 6.54 Poniard Pharmaceuticals, Inc. 201
• 6.55 Polymedco, Inc. 203
• 6.56 Princeton BioMeditech Corporation 203
• 6.57 Qiagen 205
• 6.58 Roche (F. Hoffman-La Roche, Ltd.) 206
• 6.59 Sanko Junyaku Co., Ltd. 206
• 6.60 Siemens Heathcare Diagnostics 207
• 6.61 Tosoh Corporation (Bioscience division) 207
• 6.62 Ventana Medical Systems, Inc. 207
• 6.63 Veridex, LLC 208
• 6.64 Vermillion, Inc. 209
• 6.65 Worldwide Medical Corporation 209
• 6.66 Xenomics, Inc. (TrovaGene, Inc.) 210

7. Business Trends in the Industry 211

• 7.1 Industry Consolidation 211
• 7.2 Breadth of Product Offering and Pricing 211
• 7.3 Government Regulation of Medical Devices 212
• 7.4 Commercial Opportunities in Cancer Markers 213
• 7.5 Moderators of Growth 214
• 7.6 Biotechnology Industry Trends 215
• 7.7 Pharmaceutical Industry Trends 216
• 7.8 Sales and Marketing Strategies for Tumor Marker Tests 219
  • 7.8.1 North American Market 220
  • 7.8.2 International Markets 221
    • 7.8.2.1 Europe 221
    • 7.8.2.2 Central and South America 222
    • 7.8.2.3 Asia/Pacific 222

8. Tumor Marker Testing: Important Issues 223

• 8.1 Trends in Patient Care and Reimbursement 223
• 8.2 Trends in Reimbursement Practice 224
• 8.3 Clinical Laboratory Improvement Act (CLIA) 226
• 8.4 Unmet Needs in Tumor Markers 228

9. Important New Technology Areas 229

• 9.1 Proteins 229
• 9.2 DNA Sequencing 230
• 9.3 The Human Genome Project (HGP) 231
• 9.4 Liquid Phase Chromatography 232
• 9.5 Polymerase Chain Reaction (PCR) 233
• 9.6 Capillary Electrophoresis 234
• 9.7 Proteomics 235
• 9.8 Use of MS in Sequencing 236
• 9.9 High-Throughput Organic Synthesis 241

10. New Cancer Markers in Basic Research 242

• 10.1 Genetics of Cancer 242
  • 10.1.1 Activator genes (Oncogenes) 242
  • 10.1.2 Inactivating Genes (Tumor Suppressor Genes) 244
• 10.2 DNA Mismatch Repair Genes (MMRs) 246
• 10.3 Telomeres 247
• 10.4 Diseases 251
  • 10.4.1 t(15;17) in Acute Promyelocytic Leukemia (APL) 251
  • 10.4.2 t(12;21) in Acute Lymphoblastic Leukemia (ALL) 251
  • 10.4.3 Retinoblastoma and Constitutional 13q14 Deletion 251
  • 10.4.4 Stomach Cancer 251
  • 10.4.5 Head and Neck Cancer 252
  • 10.4.6 Breast and Ovarian Cancers 253
  • 10.4.7 Prostate Cancer 254
  • 10.4.8 Cervical Cancer: NMPI79 256
  • 10.4.9 Uterine and Kidney Cancer: MN/CA9 256
  • 10.4.10 Colon Cancer: Serum Vascular Endothelial Growth factor (VEGF) 256
  • 10.4.11 Lung Cancer: Ribonucleoprotein A2/B1 and microRNA Markers 257
• 10.5 Tumor Markers 257
  • 10.5.1 Oncology Biomarker Qualification Initiative 257
  • 10.5.2 CRC: Carcinoembryonic Antigen (CEA) Doubling Time 258
  • 10.5.3 MUC1, 2, 3 and 4 258
  • 10.5.4 Cytokeratins 259
  • 10.5.5 RAK Antigens 259
  • 10.5.6 Serum Urokinase Receptors 259
  • 10.5.7 Survivin 259
  • 10.5.8 Reg-4 Protein 259
  • 10.5.9 NADPH Oxidases 1 and 2 (NOX1 and NOX2) 260
  • 10.5.10 Prostate Secretory Protein 94- (PSP94)-Binding Protein 260
  • 10.5.11 Shc Proteins 260
  • 10.5.12 Anti-Glycan Antibodies 261
  • 10.5.13 YKL-40 261
  • 10.5.14 Alpha-fetoprotein (AFP)-L3 261
  • 10.5.15 Transthyretin and Apolipoprotein A1 (Apo A1) 262
  • 10.5.16 A Disintegrin and Metalloproteinase (ADAM) 262
• 10.6 Technology 262
  • 10.6.1 Chips 262
  • 10.6.2 Ettan DIGE Technology 263
  • 10.6.3 DNA Methylation Technology 263
• 10.7 Disease-specific Technology 263
  • 10.7.1 Ovarian Cancer: Bio-Rad\'s SELDI-based ProteinChip 263
  • 10.7.2 Lung Cancer: Labeled Porphyrin Binding 264
  • 10.7.3 C-MAP, A Cervical Cancer Screening System 264
  • 10.7.4 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP) 264
  • 10.7.5 Prostate Cancer: PCA3 264
  • 10.7.6 Bladder Cancer: ImmunoCyt/uCyt+ 267

11. Market Trends and Forecasts 268

• 11.1 Ultrasensitive Cancer Tests 268
• 11.2 Mergers and Acquisitions (M&As) of Diagnostic Companies 269
• 11.3 Reverse transcriptase-polymerase chain reaction (RT-PCR) 269
• 11.4 Genetic Tests of Hereditary Cancer Risk 270
• 11.5 DNA Measurements 270
• 11.6 Technical and Practical Issues for Potential New Markers 270
• 11.7 Genetic Profiling 271
• 11.8 Ploidy 272
• 11.9 Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer 272
• 11.10 Pharmacogenetic Tests for Cancer 273
• 11.11 Worldwide Healthcare Spending 274

Appendix 1: Web Links 276
Appendix 2: Cancer Information Resources 278
Appendix 3: Colon Cancer Staging 279
Appendix 4: Reimbursement for Tumor Marker Testing 280
Appendix 5: The Pathology of Prostate Cancer 283
Appendix 6: Government Regulation of Tumor Marker Tests 285
Appendix 7: The Clinical Laboratory Improvement Act (CLIA) 288
Appendix 8: Marketers of Occult Blood Diagnostic Test Kits 290


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 97
• Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 98
• Figure 4.5: The BTA stat Test vs. Cytology 119
• Figure 10.1: PCA3 Test Volume in U.S., 2005-2008 267

INDEX OF TABLES

• Table 2.1: Organ-Specific Medicines in Development for Cancer 16
• Table 2.2: Leading Sites of New Cancer Cases and Deaths in 2010 in the U.S. by Sex 17
• Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer 17
• Table 2.4: Number of New Cancer Cases and Deaths by Region 18
• Table 2.5: Cancer-Associated Genes 18
• Table 2.6: Carcinogens in the Workplace 19
• Table 2.7: Private Funding Levels for the Biotechnology Segment, 1995-2010 20
• Table 2.8: Herceptin Worldwide Sales, 2000-2015 22
• Table 2.9: Classes of Drugs Used to Treat Breast Cancer 22
• Table 3.1: Tumor Biomarkers Currently in Common Use 26
• Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates, 2005-2015 27
• Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015 28
• Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015 28
• Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 29
• Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 29
• Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30
• Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30
• Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market 31
• Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Markets 31
• Table 3.11: Worldwide PSA Sales, 2000-2015 33
• Table 3.12: U.S. PSA Sales, 2000-2015 33
• Table 3.13: Serum Markers Used Clinically 34
• Table 3.14: Drivers of IHC Growth 39
• Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany 44
• Table 3.16: Worldwide Bladder Cancer Marker Sales, 2001-2015 45
• Table 3.17: U.S. Bladder Cancer Marker Sales, 2001-2015 46
• Table 3.18: Worldwide NMP22 Sales, 2001-2015 46
• Table 3.19: Current Breast Cancer Products and Product Opportunities 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 75
• 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 89
• Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer 89
• Table 4.9: Worldwide CA 15-3 Sales, 2001-2015 91
• Table 4.10: U.S. CA 15-3 Sales, 2001-2015 91
• Table 4.11: TPA Marker Sensitivity 94
• Table 4.12: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 96
• Table 4.13: Siemens Oncogene Science Biomarker Group Reagents 99
• Table 4.14: Worldwide CA-125 Sales, 2001-2015 102
• Table 4.15: U.S. CA-125 Sales, 2001-2015 102
• Table 4.16: Number of Pap Smears Performed by Country 108
• Table 4.17: Lung Cancer Survival Rates 109
• Table 4.18: American Cancer Society Lung Cancer Facts 110
• Table 4.19: Tests Identifying Molecular Markers in Urine 115
• Table 4.20: Patient Category Applications 116
• Table 4.21: Worldwide AFP Marker Sales, 2001-2015 122
• Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2015 122
• Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management 134
• Table 4.24: Markers Frequently Used to Identify Adult Stem Cells in the Prostate, Breast and Intestine 141
• Table 4.25: CRC mAb Imaging Kits 144
• Table 4.26: MammaPrint: Key Features 150
• Table 6.1: Tumor Marker Tests 177
• Table 6.2: Tumor Diagnosis Immunoassays 177
• Table 6.3: Tumor Diagnosis Radioimmunoassays 178
• Table 6.4: Summary of Matritech\'s Product Development Programs 191
• Table 6.5: PBM Product List 204
• Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests 212
• Table 8.1: CPT Codes for Tumor Markers 225
• Table 10.1: Categories of Oncogenes 243
• Table 10.2: Familial Cancer Syndromes and Tumor Suppressor Genes 246
• Table A3: TNM Classification 279
• Table A7: Financial Comparison for Moderate and Waived CLIA Labs 288
• Table A8: List of Marketers of Occult Blood Diagnostic Test Kits 290

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