MediPoint: In-Vitro Colorectal Cancer Screening Tests - EU Analysis and Market Forecasts

Summary

Colorectal cancer (CRC) is the third most commonly diagnosed cancer, and the second most common cause of mortality amongst cancer patients. Prognosis is directly related to early diagnosis, with survival rates dramatically improved by early diagnosis and treatment. Thanks to the introduction of CRC screening programs, mortality in the developed countries is falling; however incidence continues to rise as a result of diet and increasingly sedentary lifestyles. While historically, colorectal cancer incidence in the developing world is low, in recent years, disease diagnosis rates have dramatically increased, as a result of changing lifestyles, awareness and improved access to medical services. CRC screening can improve survival rates, and reduce the overall cost of patient treatment.

GlobalData has estimated the in-vitro CRC screening market in the EU to grow over the next seven years. This growth can be attributed to an aging population (increasing the screening population); continued adherence to national screening program guidelines and the emergence of new higher-priced gene tests which offer better specificity and sensitivity.

Scope

- An overview of colorectal cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized EU in-vitro colorectal cancer screening tests market revenue and future forecasts from 2010 to 2012, forecast for 7 years to 2019.
- Investigation of current and future market competition for in-vitro colorectal cancer screening tests
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the in-vitro colorectal cancer screening tests sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL)

Reasons to buy

- Understand the trends shaping and driving the EU in-vitro colorectal cancer screening tests Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the EU in-vitro colorectal cancer screening tests market through 2019.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in EU in-vitro colorectal cancer screening tests market landscape? Identify, understand and capitalize.

Table Of Contents

1 Table of Contents
1 Table of Contents 9


2 Introduction 24
2.1 Catalyst 24
3 Disease Overview 25
3.1 Colorectal Cancer 25
3.2 Anatomy and Physiology 25
3.3 Pathophysiology 26
3.3.1 Histology 26
3.3.2 Genetic Basis 27
3.3.3 Etiology of CRC 28
3.4 Clinical Presentation 30
3.4.1 Symptoms 30
3.4.2 Screening Overview 31
3.4.3 Status of National CRC Screening Programs 31
3.4.4 Diagnosis Overview 34
3.4.5 Staging Colorectal Cancer 39
3.5 Clinical Outcomes 42
3.5.1 Treatment Paradigms 42
3.5.2 Treatment Options Overview 44
3.6 Epidemiology 45
3.6.1 Global and Historical Trends 45
3.7 Epidemiology Forecast (2010-2019) 48
3.7.1 Total Incident Cases of Colorectal Cancer 48
3.8 Economic Impact 50
3.8.1 Individual Costs 50
4 Competitive Assessment 53
4.1 Overview 53
4.2 Fecal Occult Blood Tests 53
4.2.1 Guaiac Fecal Occult Blood Stool Tests 53
4.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests 57
4.2.3 Readers 65
4.2.4 Immuno-FOB Test ELISA 68
4.2.5 Immuno-FOB Agglutination Tests 71
4.3 CRC DNA Screening Tests 81
4.3.1 Panel DNA Tests 81
4.3.2 Methylated Gene Testing 91
4.4 Other Biomarker Tests 99
4.4.1 Overview 99
4.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test 100
4.4.3 Transferrin Assays 102
5 Unmet Needs 104
5.1 False Negative Results 104
5.2 False Positive Results 106
5.3 Sample Type 108
5.4 Screening Compliance 109
5.5 Alternative to Colonoscopy 112
5.6 Accurate Early Staging of Colorectal Cancer 114
5.7 Screening Test Alternatives 115
5.8 Automation 116
6 Pipeline Products 118
6.1 Overview 118
6.2 Pipeline by Phases in Development 118
6.3 Pipeline Product Profiles 120
6.3.1 BST1 CRC Assay 120
6.3.2 Cologic 121
6.3.3 ColoGuard 123
6.3.4 Colon Cancer BEC Test 127
6.3.5 Colon MarCare Plex 128
6.3.6 Colox 131
6.3.7 CRC Bacterial Signature Assay 133
6.3.8 CRC Breath Test 134
6.3.9 Epi proColon 137
6.3.10 ExiQon MicroRNA Test 143
6.3.11 Gemini CRC Biomarker Assay 146
6.3.12 GenomicTree Methylated DNA Test 147
6.3.13 Measure Fecal Occult Blood Test 149
6.3.14 Metabiomics CRC Test 152
6.3.15 MiR-21 Test 154
6.3.16 Oncolite CR 156
6.3.17 PanC-Dx 158
7 Industry Overview 161
7.1 Colorectal Cancer Screening Test Trends 161
7.1.1 France 161
7.1.2 Germany 162
7.1.3 Italy 164
7.1.4 Spain 164
7.1.5 UK 165
7.2 Market Access 167
7.3 Reimbursement Trends 169
7.3.1 France 170
7.3.2 Germany 171
7.3.3 Italy 171
7.3.4 Spain 172
7.3.5 UK 172
7.4 Regulatory Issues and Recalls 173
7.4.1 Regulatory Issues 173
7.4.2 Recalls 173
7.5 Mergers and Acquisitions 174
8 Current and Future Players 175
8.1 Overview 175
8.2 Trends in Corporate Strategy 176
8.3 Company Profiles 177
8.3.1 Abbott Molecular 177
8.3.2 Alere 178
8.3.3 Beckman Coulter 181
8.3.4 Biomarcare Technologies 182
8.3.5 Companion Dx 184
8.3.6 Eiken Chemical 185
8.3.7 Epigenomics 189
8.3.8 Exact Sciences 193
8.3.9 ExiQon 198
8.3.10 Fujirebio (Miraca Holdings) 200
8.3.11 GeneNews 203
8.3.12 GenomicTree 204
8.3.13 Immunostics 206
8.3.14 Kyowa Medex 209
8.3.15 MDx Health (was OncoMethylome) 211
8.3.16 Merck Millipore 213
8.3.17 Metabiomics 216
8.3.18 Mode Diagnostics 218
8.3.19 Oncocyte (Bio Time) 220
8.3.20 Quest Diagnostics 222
8.3.21 R-Biopharm 225
8.3.22 Randox Laboratories 228
8.3.23 ScheBo Biotech 230
8.3.24 SciMarket Technologies 233
8.3.25 Siemens Healthcare 234
8.3.26 Signature Diagnostics 237
8.3.27 Sysmex 239
8.3.28 Veda Lab 241
9 Market Drivers, Opportunities and Barriers 243
9.1 Market Drivers 243
9.1.1 Uptake of Pipeline Biomarker Tests 243
9.1.2 Increasing Incidence of Colorectal Cancer and Improvements in Treatment 245
9.1.3 Patient Reluctance to Colonoscopies in Opportunistic CRC Screening 246
9.1.4 Increasing Volume of FOB Tests in Aging Markets 247
9.1.5 Increased Pressure on Endoscopy Services 247
9.2 Opportunities 247
9.2.1 Blood Tests 247
9.2.2 Increasing CRC Screening Compliance 247
9.2.3 Integration of CRC Screening Tests with Prognostic Tests and Other Screening Programs 250
9.3 Market Barriers 251
9.3.1 Cultural and Social Resistance to Stool Tests 251
9.3.2 CRC Screening Awareness and Education 252
9.3.3 Reimbursement 253
9.3.4 Local Requirements 254
9.3.5 Test Complexity 256
9.3.6 Patenting Issues 257
10 Country Outlooks and Forecasts 258
10.1 EU Markets Overview 258
10.2 France 262
10.2.1 France Market Analysis 262
10.3 Germany 264
10.3.1 Germany Market Analysis 264
10.4 Italy 266
10.4.1 Italy Market Analysis 266
10.5 Spain 268
10.5.1 Spain Analysis 268
10.6 UK 270
10.6.1 UK Market Analysis 270
11 Appendix 273
11.1 Abbreviations 273
11.2 Bibliography 275
11.3 Research Methodology 319
11.3.1 Coverage 319
11.3.2 Secondary Research 320
11.3.3 Forecasting Methodology 320
11.4 Physicians and Specialists Included in this Study 323
11.5 Primary Research 324
11.6 About the Authors 325
11.6.1 Analysts 325
11.6.2 Global Head of Healthcare 326
11.7 About GlobalData 327
11.8 Disclaimer 327

1.1 List of Tables
Table 1: Initial Presenting Symptoms of Colorectal Cancer 30
Table 2: Colorectal Screening FOB Test Participation in Italy by Age and Sex, 2008 32
Table 3: TNM Classification System to Stage CRC 39
Table 4: Stage Grouping for CRC 40
Table 5: Stage II CRC Sub-Divisions 40
Table 6: Stage III CRC Sub-Divisions 41
Table 7: Stage IV CRC Sub-Divisions 41
Table 8: Dukes System of CRC Classification 42
Table 9: Treatment Guidelines for Colorectal Cancer 43
Table 10: Surgical Options for Colorectal Cancer 44
Table 11: Treatment Alternatives for CRC 45
Table 12: Incident Cases of Colorectal Cancer, Ages ?40 Years, Men and Women, N, 2012-2019 49
Table 13: Costs of CRC Diagnosis, Treatment and Care 50
Table 14: CRC Screening Test Segmentation 53
Table 15: Guaiac Fecal Occult Blood Tests Product Profile 54
Table 16: Guaiac FOB Test SWOT Analysis, 2013 56
Table 17: Immuno-FOB Tests 62
Table 18: Product Profile - Lateral Flow Immunochemical Fecal Occult Blood Tests 64
Table 19: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 65
Table 20: Product Profile - Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) 66
Table 21: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, 2013 67
Table 22: Fecal Occult Blood ELISA Products 68
Table 23: Product Profile - Fecal Occult Blood ELISA 69
Table 24: Immuno-FOB Test ELISA SWOT Analysis, 2013 70
Table 25: Commercially Available Immuno-FOB Agglutination Test Systems 78
Table 26: Product Profile - Immuno-FOB Agglutination Tests 78
Table 27: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 80
Table 28: Key Mutations Associated with CRC 82
Table 29: Key Stages of PCR Gene Test 83
Table 30: Product Profile - PreGen Plus 85
Table 31: PreGen Plus SWOT Analysis, 2013 86
Table 32: Product Profile - K-RAS, B-RAF, PIK3CA Array 87
Table 33: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 88
Table 34: Product Profile - Colonsentry 89
Table 35: Colonsentry SWOT Analysis, 2013 89
Table 36: Product Profile - Detector C 2.0 90
Table 37: Detector C SWOT Analysis, 2013 91
Table 38: Product Profile - ColoSure 94
Table 39: ColoSure SWOT Analysis, 2013 94
Table 40: Product Profile - MS9 96
Table 41: MS9 SWOT Analysis, 2013 97
Table 42: Septin-9 CRC Screening Marketed Laboratory-Developed Tests 97
Table 43: Product Profile - ColoVantage/Septin-9 98
Table 44: ColoVantage/Septin-9 SWOT Analysis, 2013 99
Table 45: Product Profile - Tumor M2-PK Stool Test/2-in-1 Quick Test 101
Table 46: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 101
Table 47: Product Profile - Transferrin Assays 102
Table 48: Transferrin Assays SWOT Analysis, 2013 103
Table 49: Major Reasons for Non-compliance with CRC Screening 110
Table 50: Correlation of Fecal Occult Blood Test with Neoplasia 114
Table 51: CRC Screening Tests Pipeline, 2012 119
Table 52: Product Profile - BST1 CRC Assay 120
Table 53: BST1 CRC Assay SWOT Analysis, 2013 121
Table 54: Product Profile - Cologic 122
Table 55: Cologic SWOT Analysis, 2013 123
Table 56: Product Profile - ColoGuard 125
Table 57: ColoGuard SWOT Analysis, 2013 127
Table 58: Product Profile - Colon Cancer BEC Test 128
Table 59: Colon Cancer BEC Test SWOT Analysis, 2013 128
Table 60: Product Profile - Colon MarCare Plex 129
Table 61: Colon MarCare Plex SWOT Analysis, 2013 130
Table 62: Product Profile - Colox 132
Table 63: Colox SWOT Analysis, 2013 133
Table 64: Product Profile - CRC Bacterial Signature Assay 134
Table 65: CRC Bacterial Signature Assay SWOT Analysis, 2013 134
Table 66: Product Profile - CRC Breath Test 136
Table 67: CRC Breath Test SWOT Analysis, 2013 136
Table 68: Product Profile - Epi proColon 139
Table 69: Epi proColon Clinical Trials 139
Table 70: Epi proColon SWOT Analysis, 2013 143
Table 71: ExiQon MicroRNA Sensitivity and Specificity 144
Table 72: Product Profile - ExiQon microRNA Test 144
Table 73: ExiQon microRNA Test SWOT Analysis, 2013 145
Table 74: Product Profile - Gemini CRC Biomarker Assay 146
Table 75: Gemini CRC Biomarker Assay SWOT Analysis, 2013 147
Table 76: Product Profile - GenomicTree Methylated DNA Test 148
Table 77: GenomicTree Methylated DNA Test SWOT Analysis, 2013 149
Table 78: Product Profile - Measure 151
Table 79: Measure SWOT Analysis, 2013 151
Table 80: Product Profile - Metabiomics CRC Test 153
Table 81: Metabiomics CRC Test SWOT Analysis, 2013 154
Table 82: Product Profile - miR-21 Test 155
Table 83: miR-21 Test SWOT Analysis, 2013 155
Table 84: Product Profile - Oncolite-CR 156
Table 85: Oncolite-CR SWOT Analysis, 2013 157
Table 86: Product Profile - PanC-Dx 160
Table 87: PanC-Dx SWOT Analysis, 2013 160
Table 88: Key Mergers and Acquisitions during 2012-2013 174
Table 89: Company Profile - Abbott Molecular 177
Table 90: Abbott Molecular SWOT Analysis, 2013 178
Table 91: Company Profile - Alere 179
Table 92: Alere SWOT Analysis, 2013 180
Table 93: Company Profile - Beckman Coulter 181
Table 94: Beckman Coulter SWOT Analysis, 2013 182
Table 95: Company Profile - Biomarcare Technologies 183
Table 96: Biomarcare Technologies SWOT Analysis, 2013 183
Table 97: Company Profile - Companion Dx 184
Table 98: Companion Dx SWOT Analysis, 2013 185
Table 99: Company Profile - Eiken Chemical 187
Table 100: Eiken Chemical SWOT Analysis, 2013 188
Table 101: Company Profile - Epigenomics 191
Table 102: Epigenomics SWOT Analysis, 2013 193
Table 103: Company Profile - Exact Sciences 194
Table 104: Exact Sciences SWOT Analysis, 2013 197
Table 105: Company Profile - ExiQon 198
Table 106: ExiQon SWOT Analysis, 2013 199
Table 107: Company Profile - Fujirebio (Miraca Holdings) 200
Table 108: Fujirebio SWOT Analysis, 2013 202
Table 109: Company Profile - GeneNews 203
Table 110: GeneNews SWOT Analysis, 2013 204
Table 111: Company Profile - GenomicTree 205
Table 112: GenomicTree SWOT Analysis, 2013 205
Table 113: Company Profile - Immunostics 206
Table 114: Immunostics SWOT Analysis, 2013 208
Table 115: Company Profile - Kyowa Medex (Kyowa Hakko Kirin Group) 209
Table 116: Kyowa Medex SWOT Analysis, 2013 210
Table 117: Company Profile - MDx Health 211
Table 118: MDx Health SWOT Analysis, 2013 213
Table 119: Company Profile - Merck Millipore 214
Table 120: Merck Millipore SWOT Analysis, 2013 215
Table 121: Company Profile - Metabiomics 216
Table 122: Metabiomics SWOT Analysis, 2013 217
Table 123: Company Profile - Mode Diagnostics 218
Table 124: Mode Diagnostics SWOT Analysis, 2013 219
Table 125: Company Profile - Oncocyte (Bio Time) 220
Table 126: Oncocyte (Bio Time) SWOT Analysis, 2013 221
Table 127: Company Profile - Quest Diagnostics 223
Table 128: Quest Diagnostics SWOT Analysis, 2013 224
Table 129: Company Profile - R-Biopharm 226
Table 130: R-Biopharm SWOT Analysis, 2013 227
Table 131: Company Profile - Randox Laboratories 228
Table 132: Randox Laboratories SWOT Analysis, 2013 229
Table 133: Company Profile - ScheBo Biotech 230
Table 134: Schebo Biotech SWOT Analysis, 2013 232
Table 135: Company Profile - SciMarket Technologies 233
Table 136: SciMarket Technologies SWOT Analysis, 2013 234
Table 137: Company Profile - Siemens Healthcare 235
Table 138: Siemens Healthcare SWOT Analysis, 2013 236
Table 139: Company Profile - Signature Diagnostics 237
Table 140: Signature Diagnostics SWOT Analysis, 2013 238
Table 141: Company Profile - Sysmex 239
Table 142: Sysmex SWOT Analysis, 2013 240
Table 143: Company Profile - Veda Lab 241
Table 144: Veda Lab SWOT Analysis, 2013 242
Table 145: PreGen Plus Compared to Immuno-FOB Test 255
Table 146: Potential Impacts of Restriction of Gene Patents 257
Table 147: Major Events Affecting the EU In-Vitro CRC Screening Test Market 258
Table 148: Sales Forecasts for In-vitro CRC Screening Tests in the EU Markets, 2010-2019 259
Table 149: Forecasts for Numbers of In-vitro CRC Screening Tests within Europe, 2010-2019 260
Table 150: Sales Forecasts for In-vitro CRC Screening Tests in France, 2010-2019 262
Table 151: Sales Forecasts for In-vitro CRC Screening Tests in Germany, 2010-2019 264
Table 152: Sales Forecasts for In-vitro CRC Screening Tests in Italy, 2010-2019 266
Table 153: Sales Forecasts for In-vitro CRC Screening Tests in Spain, 2010-2019 268
Table 154: Sales Forecasts for In-vitro CRC Screening Tests in the UK, 2010-2019 270



1.2 List of Figures
Figure 1: Colorectal Cancer Staging 26
Figure 2: EU Trends in Colorectal Cancer Incidence, 2010-2019 49
Figure 3: Total Costs of Colorectal Cancer to Society, 2010-2019 52
Figure 4: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen 54
Figure 5: Fecal Occult Blood Test Lateral Flow Device Architecture 58
Figure 6: Biohit Colonview (example of immuno-FOB test) 59
Figure 7: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) 60
Figure 8: Veda Labs Easy Reader Immuno-FOB Test LFD Reader 66
Figure 9: OC-Hemodia Agglutination FOB Test (manually performed) 71
Figure 10: OC-Sensor/Diana FOB Test Sample Cartridge 72
Figure 11: OC-Sensor/Diana FOB Test Instrument 73
Figure 12: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction 74
Figure 13: Sentinel Diagnostic Sentifob Instrument 75
Figure 14: Alere CI5 NS-Plus Instrument 76
Figure 15: Orion Diagnostics Quikread FOB Test and Instrument 77
Figure 16: Basic PCR Process 84
Figure 17: MS9 PCR Response Curve 96
Figure 18: Proposed ColoGuard Patient Stool Sample Collection Kit 124
Figure 19: Exact Sciences Automated Sample Processing WorkStation 125
Figure 20: Colox Kit Contents 131
Figure 21: Measure Fecal Occult Blood Test 150
Figure 22: PanC-Dx Multiplex Detection of CRC-specific Biomarker 159
Figure 23: EU Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 259
Figure 24: Forecast for Numbers of In-vitro CRC Screening Tests within Europe, 2010-2019 260
Figure 25: EU Share of Fecal Occult Blood Tests, by Brand, 2012 261
Figure 26: France Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 262
Figure 27: Germany Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 264
Figure 28: Italy Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 266
Figure 29: Spain Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 268
Figure 30: UK Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 270

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