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Cancer Diagnostic Testing World Markets

  • January 2016
  • -
  • TriMark Publications
  • -
  • 264 pages

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. 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.

Table Of Contents

Cancer Diagnostic Testing World Markets










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 17

2.1 Cancer 17

2.1.1 The Disease 17

2.1.2 Metastasis 18

2.1.3 Demographics and Statistics of Cancer 18

2.2 The Drivers of the Biotech and Diagnostics Industry 23

2.2.1 Technological Innovation 25

2.2.2 Government Funding 25

2.3 Outlook for Tumor Markers 25



3. Tumor Markers Market Segment Analysis: Size, Growth and Share 28

3.1 Market Description 29

3.2 Clinical Diagnostic Serum-based Cancer Markers 36

3.3 PSA Testing Market Size 36

3.4 DNA Markers 38

3.5 Serum Proteins 38

3.6 Enzymes 39

3.7 Occult Blood 39

3.8 Histology and In Situ Hybridization (ISH) 39

3.9 Cervical Cytology 40

3.10 Immunohistochemistry (IHC) 42

3.11 In Vivo Detection Cancer Products 43

3.12 Radionuclides and X-Ray Detection Products 43

3.13 HPV Testing 43

3.14 Bladder Cancer Testing 46

3.15 Tumor Assays for Adjuvant Chemotherapy 49



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 70

4.1.3 Pancreatic Cancer 104

4.1.4 Breast Cancer 108

4.1.5 Ovarian Cancer 121

4.1.6 Cervical Cancer 127

4.1.7 Lung Cancer 132

4.1.8 Testicular Cancer 144

4.1.9 Bladder Cancer 145

4.1.10 Hepatic Cancer 153

4.1.11 Stomach Cancer 156

4.1.12 Malignant Melanoma 157

4.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL) 158

4.1.14 Lymphoma 159

4.2 Clinical Laboratory Methods for Measuring Tumor Markers 159

4.2.1 Abbott Diagnostics 159

4.2.2 Roche Diagnostics Systems 160

4.2.3 Beckman Coulter Diagnostics Immunoassay Systems 160

4.2.4 Siemens Healthcare Diagnostics ADVIA Centaur CP Immunoassay System, the
ADVIA Centaur XP Immunoassay System and ADVIA Centuar XPT Immunoassay System 161

4.2.5 Tosoh Bioscience AIA-2000 162

4.2.6 Thermo Fisher Scientific B.R.A.H.M.S. KRYPTOR 162

4.2.7 Ortho-Clinical Diagnostics Vitros ECiQ (Johnson and Johnson) 163

4.2.8 Fujirebio Diagnostics, Inc. 163

4.2.9 bioMerieux Vidas 164

4.3 New Technologies for Cancer Diagnostics 165

4.3.1 New and Improved Immunoassays 165

4.3.2 IHC Tests 166

4.3.3 Molecular (DNA and Genomic) Diagnostic Assays 167

4.3.4 Genomics and Genetic Markers 167

4.3.5 Proteomics and New Protein Markers 169

4.3.5.1 Inside the ProteinChip System 169

4.3.5.2 Rapid Biological Assays on a Chip 170

4.3.5.3 Proteome Pattern Recognition 170

4.3.6 New Platform Technologies Including Flow Cytometry 170

4.3.7 Stem Cell Markers 173

4.3.8 mAbs 174

4.3.9 Pharmacogenomics and Oncology Diagnostics 175

4.3.10 DNA Microarrays 177

4.3.11 In Vitro Diagnostic Multivariate Index Assays (IVDMIA) 180

4.3.12 Prostate-63 180

4.3.13 Future Directions 180



5. Companies Entering the Cancer Diagnostics Market with Novel Technology
Platforms 181

5.1 Abbott Diagnostics 181

5.2 Agendia BV 184

5.3 bioMerieux 185

5.4 DRG International, Inc. 185

5.5 Eisai Co., Ltd. 186

5.6 Exact Sciences Corporation 187

5.7 Fujirebio Diagnostics, Inc. 187

5.8 Genomic Health, Inc. 188

5.9 Hologic, Inc. 189

5.10 LabCorp 192

5.11 Myriad Genetics, Inc. 193

5.12 Neogenomics 195

5.13 Roche 195

5.14 Siemens 197

5.15 Tosoh Corporation (Bioscience Division) 198



6. Business Trends in the Industry 199

6.1 Industry Consolidation 199

6.2 Breadth of Product Offering and Pricing 201

6.3 Government Regulation of Medical Devices 202

6.4 Commercial Opportunities in Cancer Markers 203

6.5 Moderators of Growth 204

6.6 Biotechnology Industry Trends 205

6.7 Pharmaceutical Industry Trends 206

6.8 Sales and Marketing Strategies for Tumor Marker Tests 208

6.8.1 North American Market 209

6.8.2 International Markets 210

6.8.2.1 Europe 210

6.8.2.2 Central and South America 210

6.8.2.3 Asia-Pacific 211

6.9 Mergers and Acquisitions (Mandamp;As) of Diagnostic Companies 211



7. New Cancer Markers in Basic Research 214

7.1 Genetics of Cancer 214

7.1.1 Activator Genes (Oncogenes) 214

7.1.2 Inactivating Genes (Tumor Suppressor Genes) 217

7.2 DNA Mismatch Repair Genes (MMRs) 219

7.3 Telomeres 220

7.4 Diseases 223

7.4.1 t(15;17) in Acute Promyelocytic Leukemia (APL) 223

7.4.2 t(12;21) in Acute Lymphoblastic Leukemia (ALL) 223

7.4.3 Retinoblastoma and Constitutional 13q14 Deletion 224

7.4.4 Stomach Cancer 224

7.4.5 Head and Neck Cancer 225

7.4.6 Breast and Ovarian Cancers 226

7.4.7 Prostate Cancer 227

7.4.8 Cervical Cancer: NMPI79 229

7.4.9 Uterine and Kidney Cancer: Transmembrane Protein Carbonic Anhydrase IX (CA
IX) 229

7.4.10 Colon Cancer: Serum Vascular Endothelial Growth factor (VEGF) 230

7.4.11 Lung Cancer: Ribonucleoprotein A2/B1 and microRNA Markers 230

7.5 Tumor Markers 231

7.5.1 Oncology Biomarker Qualification Initiative 231

7.5.2 CRC: Carcinoembryonic Antigen (CEA) Doubling Time 231

7.5.3 MUC1, 2, 3 and 4 232

7.5.4 Cytokeratins 233

7.5.5 RAK Antigens 233

7.5.6 Serum Amyloid A (SAA) 233

7.5.7 Survivin 234

7.5.8 Reg-4 Protein 234

7.5.9 NADPH Oxidases 1 and 2 (NOX1 and NOX2) 234

7.5.10 Prostate Secretory Protein 94- (PSP94)-Binding Protein 234

7.5.11 Shc Proteins 235

7.5.12 Anti-Glycan Antibodies 235

7.5.13 YKL-40 235

7.5.14 Alpha-Fetoprotein (AFP)-L3 236

7.5.15 Transthyretin and Apo Lipoprotein A1 (Apo A1) 236

7.5.16 A Disintegrin and Metalloproteinase (ADAM) 236

7.6 Technology 236

7.6.1 Chips 236

7.6.2 Ettan DIGE Technology 237

7.6.3 DNA Methylation Technology 237

7.7 Disease-Specific Technology 238

7.7.1 Ovarian Cancer: Bio-Rad's SELDI-Based ProteinChip 238

7.7.2 Lung Cancer: Labeled Porphyrin Binding 238

7.7.3 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP) 238

7.7.4 Prostate Cancer: PCA3 238

7.7.5 Bladder Cancer: ImmunoCyt/uCyt+ 241

7.8 Ultrasensitive Cancer Tests 242

7.9 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) 243

7.10 Genetic Tests of Hereditary Cancer Risk 243

7.11 Technical and Practical Issues for Potential New Markers 244

7.12 Genetic Profiling 245

7.13 Ploidy 246

7.14 Worldwide Healthcare Spending 246



Appendix 1: Web Links 247

Appendix 2: Cancer Information Resources 250

Appendix 3: Colon Cancer Staging 251

Appendix 4: Reimbursement for Tumor Marker Testing 254

Appendix 5: The Pathology of Prostate Cancer 257

Appendix 6: Government Regulation of Tumor Marker Tests 259

Appendix 7: The Clinical Laboratory Improvement Act (CLIA) 262

Appendix 8: Marketers of Occult Blood Diagnostic Test Kits 265





INDEX OF FIGURES



Figure 1.1: Medicines in Development in Cancer 13

Figure 4.1: Bowel Cancer including Anal Cancer: Estimates: World
Age-Standardized Incidence Rates per 100,000 Population, World Regions 61

Figure 4.2: Percentage of Adults Aged 50-75 Years Who Reported Being Up-to-Date
with Colorectal Test Screening, by State Behavioral Risk Factor Surveillance
System in the U.S., 2010 64

Figure 4.3: Progression of CRC Development 65

Figure 4.4: Prostate Cancer (C61): Estimates: World Age-Standardized Incidence
Rates per 100,000 Population, Males, World Regions 73

Figure 4.5: Prostate Cancer (C61): Estimated Incidence 74

Figure 4.6: Estimates for PCA3 Test Volume in U.S., 2005-2012 95

Figure 4.7: Pancreatic Cancer: Estimates: World Age-Standardized Incidence Rates
per 100,000 Population, Male and Females, World Regions 105

Figure 4.8: Breast Cancer: Estimates: World Age-Standardized Incidence Rates per
100,000 Population, Females, World Regions 109

Figure 4.9: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer, 2013 118

Figure 4.10: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer, 2013 119

Figure 4.11: Ovarian Cancer: Estimates: European Age-Standardized Incidence
Rates per 100,000 Population, Females, World Regions 122

Figure 4.12: Cervical Cancer: Estimates: World Age-Standardized Incidence Rates
per 100,000 Population, Females, World Regions 127

Figure 4.13: Lung Cancer: Estimates: World Age-Standardized Incidence Rates per
100,000 Population, World Regions 133

Figure 4.14: The BTA stat Test vs. Cytology 151





INDEX OF TABLES



Table 2.1: Organ-Specific Medicines in Development for Cancer 19

Table 2.2: Estimates for the Leading Sites of New Cancer Cases in the U.S. by
Gender, 2015 20

Table 2.3: Estimates for the Leading Sites of Cancer Deaths in the U.S. by
Gender, 2015 20

Table 2.4: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer
(Men) 20

Table 2.5: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer
(Women) 21

Table 2.6: Estimated Incidence, Mortality and Prevalence Worldwide in 2012 22

Table 2.7: Cancer-Associated Genes 22

Table 2.8: Carcinogens in the Workplace 23

Table 2.9: Private Funding Levels for the Biotechnology Segment, 1995-2014 24

Table 2.10: Herceptin Worldwide Sales, 2000-2017 26

Table 2.11: Classes of Drugs Used to Treat Breast Cancer 27

Table 3.1: Tumor Biomarkers Currently in Common Use 31

Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates,
2011-2021 33

Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays
Product Market,

2011-2021 33

Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product
Market, 2011-2021 33

Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size,
2011-2021 34

Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2011-2021
34

Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size,
2011-2021 35

Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size,
2011-2021 35

Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker
Diagnostics Market 35

Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Market 36

Table 3.11: Worldwide PSA Sales, 2011-2021 37

Table 3.12: U.S. PSA Sales, 2011-2021 37

Table 3.13: Serum Markers Used Clinically 38

Table 3.14: Drivers of IHC Growth 43

Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany 47

Table 3.16: Worldwide Bladder Cancer Marker Sales, 2011-2021 48

Table 3.17: U.S. Bladder Cancer Marker Sales, 2011-2021 48

Table 3.18: Worldwide NMP22 Sales, 2011-2021 49

Table 3.19: 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 62

Table 4.2: Colon Cancer Facts 63

Table 4.3: Number of Procedures Based on Patients Aged =50 Years who Reported
Receiving a Fecal Occult Blood Test within One Year or a Lower Endoscopy within
Ten Years, by Age and Sex in the U.S. 64

Table 4.4: Worldwide CEA Sales, 2011-2021 65

Table 4.5: U.S. CEA Sales, 2011-2021 66

Table 4.6: Japan CEA Sales, 2011-2021 66

Table 4.7: Europe CEA Sales, 2011-2021 66

Table 4.8: Rest of the World CEA Sales, 2011-2021 67

Table 4.9: Worldwide PSA Sales, 2011-2021 71

Table 4.10: U.S. PSA Sales, 2011-2021 71

Table 4.11: Japan PSA Sales, 2011-2021 72

Table 4.12: Europe PSA Sales, 2011-2021 72

Table 4.13: Rest of the World PSA Sales, 2011-2021 73

Table 4.14: Population Statistics of Serum Levels of PSA in Men Over 50 Years of
Age 80

Table 4.15: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/mL 81

Table 4.16: Human tissue Kallikreins as Cancer Markers 84

Table 4.17: New Diagnostic Tests for Prostate Cancer 90

Table 4.18: Gen-Probe Genetic Testing Product Line 96

Table 4.19: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers
Ranked in

Order of Impact 102

Table 4.20: Prostate Cancer Molecular Diagnostic Testing Market: Market
Restraints Ranked in

Order of Impact 102

Table 4.21: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Prostate Cancer Molecular Diagnostic Market 103

Table 4.22: Worldwide CA 19-9 Sales, 2011-2021 106

Table 4.23: U.S. CA 19-9 Sales, 2011-2021 106

Table 4.24: Japan CA 19-9 Sales, 2011-2021 106

Table 4.25: Europe CA 19-9 Sales, 2011-2021 107

Table 4.26: Rest of the World CA 19-9 Sales, 2011-2021 107

Table 4.27: CA 19-9 Levels in Management of Pancreatic Cancer 108

Table 4.28: Worldwide CA 15-3 Sales, 2011-2021 111

Table 4.29: U.S. CA 15-3 Sales, 2011-2021 111

Table 4.30: Japan CA 15-3 Sales, 2011-2021 111

Table 4.31: Europe CA 15-3 Sales, 2011-2021 112

Table 4.32: Rest of the World CA 15-3 Sales, 2011-2021 112

Table 4.33: TPA Marker Sensitivity 115

Table 4.34: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to
Interpret Test Results 117

Table 4.35: Worldwide CA-125 Sales, 2011-2021 123

Table 4.36: U.S. CA-125 Sales, 2011-2021 123

Table 4.37: Japan CA-125 Sales, 2011-2021 124

Table 4.38: Europe CA-125 Sales, 2011-2021 124

Table 4.39: Rest of the World CA-125 Sales, 2011-2021 124

Table 4.40: Worldwide HVP Sales, 2011-2021 128

Table 4.41: U.S. HPV Sales, 2011-2021 129

Table 4.42: Japan HVP Sales, 2011-2021 129

Table 4.43: Europe HVP Sales, 2011-2021 129

Table 4.44: Rest of the World HVP Sales, 2011-2021 130

Table 4.45: HCPCS Codes for Screening Pap Tests 131

Table 4.46: HCPCS Codes for Screening Pap Tests Rate 131

Table 4.47: Number of Pap Smears Performed by Country 132

Table 4.48: Lung Cancer Survival Rates 134

Table 4.49: American Cancer Society Lung Cancer Facts 135

Table 4.50: Predictive and Prognostic Rates 140

Table 4.51: Tests Identifying Molecular Markers in Urine 146

Table 4.52: Worldwide NMP22/BTA Sales, 2011-2021 147

Table 4.53: U.S. NMP22/BTA Sales, 2011-2021 147

Table 4.54: Japan NMP22/BTA Sales, 2011-2021 148

Table 4.55: Europe NMP22/BTA Sales, 2011-2021 148

Table 4.56: Rest of the World NMP22/BTA Sales, 2011-2021 148

Table 4.57: Patient Category Applications 149

Table 4.58: Worldwide Alpha-Fetal Protein (AFP) Sales, 2011-2021 154

Table 4.59: U.S. Alpha-Fetal Protein (AFP) Sales, 2011-2021 155

Table 4.60: Japan Alpha-Fetal Protein (AFP) Sales, 2011-2021 155

Table 4.61: Europe Alpha-Fetal Protein (AFP) Sales, 2011-2021 155

Table 4.62: Rest of the World Alpha-Fetal Protein (AFP) Sales, 2011-2021 156

Table 4.63: Key Oncology Diagnostic Tests, Roche, 2015 160

Table 4.64: Potential Uses of Molecular Diagnostics in Cancer Management 167

Table 4.65: Markers Frequently Used to Identify Adult Stem Cells in the
Prostate, Breast and Intestine 173

Table 4.66: MammaPrint: Key Features 179

Table 5.1: Tumor Diagnosis Immunoassays 186

Table 5.2: Tumor Diagnosis Radioimmunoassays 186

Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 202

Table 7.1: Categories of Oncogenes 215

Table 7.2: Familial Cancer Syndromes and Tumor Suppressor Genes 219

Table A7.1: Financial Comparison for Moderate and Waived CLIA Labs 262

Table A8.1: List of Marketers of Fecal Occult Blood Diagnostic Test Kits 265






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