MediPoint: In-Vitro Colorectal Cancer Screening Tests - US 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 US in-vitro CRC screening market to grow at a compound annual growth rate (CAGR) of 51.1% over the next seven years. This growth can be attributed to an aging population (increasing the screening population) and the rapid adoption of emerging 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 US 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 US 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 US 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 the US in-vitro colorectal cancer screening tests market landscape? Identify, understand and capitalize.

Table Of Contents

1 Table of Contents
1 Table of Contents 8


2 Introduction 22
2.1 Catalyst 22
3 Disease Overview 23
3.1 Colorectal Cancer 23
3.2 Anatomy and Physiology 23
3.3 Pathophysiology 25
3.3.1 Histology 25
3.3.2 Genetic Basis 26
3.3.3 Etiology of CRC 27
3.4 Clinical Presentation 29
3.4.1 Symptoms 29
3.4.2 Screening Overview 30
3.4.3 Status of National CRC Screening Programs 31
3.4.4 Diagnosis Overview 33
3.4.5 Staging Colorectal Cancer 39
3.5 Clinical Outcomes 42
3.5.1 Treatment Paradigms 42
3.5.2 Treatment Options Overview 43
3.6 Epidemiology 44
3.6.1 Global and Historical Trends 44
3.6.2 US 45
3.7 Epidemiology Forecast (2010-2019) 45
3.7.1 Total Incident Cases of Colorectal Cancer 45
3.8 Economic Impact 47
3.8.1 Individual Costs 47
4 Competitive Assessment 50
4.1 Overview 50
4.2 Fecal Occult Blood Tests 50
4.2.1 Guaiac Fecal Occult Blood Stool Tests 50
4.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests 54
4.2.3 Readers 62
4.2.4 Immuno-FOB Test ELISA 65
4.2.5 Immuno-FOB Agglutination Tests 68
4.3 CRC DNA Screening Tests 78
4.3.1 Panel DNA Tests 78
4.3.2 Methylated Gene Testing 88
4.4 Other Biomarker Tests 96
4.4.1 Overview 96
4.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test 97
4.4.3 Transferrin Assays 99
5 Unmet Needs 101
5.1 False Negative Results 101
5.2 False Positive Results 103
5.3 Sample Type 105
5.4 Screening Compliance 106
5.5 Alternative to Colonoscopy 109
5.6 Accurate Early Staging of Colorectal Cancer 111
5.7 Screening Test Alternatives 112
5.8 Automation 113
6 Pipeline Products 115
6.1 Overview 115
6.2 Pipeline by Phases in Development 115
6.3 Pipeline Product Profiles 117
6.3.1 BST1 CRC Assay 117
6.3.2 Cologic 118
6.3.3 ColoGuard 120
6.3.4 Colon Cancer BEC Test 124
6.3.5 Colon MarCare Plex 126
6.3.6 Colox 128
6.3.7 CRC Bacterial Signature Assay 131
6.3.8 CRC Breath Test 133
6.3.9 Epi proColon 135
6.3.10 ExiQon MicroRNA Test 141
6.3.11 Gemini CRC Biomarker Assay 144
6.3.12 GenomicTree Methylated DNA Test 145
6.3.13 Measure Fecal Occult Blood Test 147
6.3.14 Metabiomics CRC Test 150
6.3.15 MiR-21 Test 152
6.3.16 Oncolite CR 154
6.3.17 PanC-Dx 156
7 Industry Overview 159
7.1 Colorectal Cancer Screening Test Trends 159
7.2 Market Access 166
7.3 Reimbursement Trends 167
7.4 Regulatory Issues and Recalls 169
7.4.1 Regulatory Issues 169
7.4.2 Recalls 171
7.5 Mergers and Acquisitions 172
8 Current and Future Players 173
8.1 Overview 173
8.2 Trends in Corporate Strategy 174
8.3 Company Profiles 175
8.3.1 Abbott Molecular 175
8.3.2 Alere 176
8.3.3 Beckman Coulter 179
8.3.4 Biomarcare Technologies 180
8.3.5 Companion Dx 182
8.3.6 Eiken Chemical 183
8.3.7 Epigenomics 187
8.3.8 Exact Sciences 191
8.3.9 ExiQon 196
8.3.10 Fujirebio (Miraca Holdings) 198
8.3.11 GeneNews 201
8.3.12 GenomicTree 202
8.3.13 Immunostics 204
8.3.14 Kyowa Medex 207
8.3.15 MDx Health (was OncoMethylome) 209
8.3.16 Merck Millipore 211
8.3.17 Metabiomics 214
8.3.18 Mode Diagnostics 216
8.3.19 Oncocyte (Bio Time) 218
8.3.20 Quest Diagnostics 220
8.3.21 R-Biopharm 223
8.3.22 Randox Laboratories 226
8.3.23 ScheBo Biotech 228
8.3.24 SciMarket Technologies 231
8.3.25 Siemens Healthcare 232
8.3.26 Signature Diagnostics 235
8.3.27 Sysmex 237
8.3.28 Veda Lab 239
9 Market Drivers, Opportunities and Barriers 241
9.1 Market Drivers 241
9.1.1 Uptake of Pipeline Biomarker Tests 241
9.1.2 Increasing Incidence of Colorectal Cancer and Improvements in Treatment 243
9.1.3 Patient Reluctance to Colonoscopies in Opportunistic CRC Screening 244
9.1.4 Increased Pressure on Endoscopy Services 245
9.2 Opportunities 245
9.2.1 Blood Tests 245
9.2.2 Increasing CRC Screening Compliance 245
9.2.3 Integration of CRC Screening Tests with Prognostic Tests and Other Screening Programs 247
9.3 Market Barriers 249
9.3.1 Cultural and Social Resistance to Stool Tests 249
9.3.2 CRC Screening Awareness and Education 249
9.3.3 Reimbursement 250
9.3.4 Local Requirements 251
9.3.5 Test Complexity 253
9.3.6 Patenting Issues 254
10 Country Outlooks and Forecasts 256
10.1 Overview 256
10.2 Market Analysis 260
11 Appendix 263
11.1 Abbreviations 263
11.2 Bibliography 266
11.3 Research Methodology 309
11.3.1 Coverage 309
11.3.2 Secondary Research 310
11.3.3 Forecasting Methodology 310
11.4 Physicians and Specialists Included in this Study 312
11.5 Primary Research 313
11.6 About the Authors 314
11.6.1 Analysts 314
11.6.2 Global Head of Healthcare 315
11.7 About GlobalData 316
11.8 Disclaimer 316

1.1 List of Tables
Table 1: Initial Presenting Symptoms of Colorectal Cancer 29
Table 2: Guideline Organization Recommendations for Non-Invasive Tests 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 42
Table 10: Surgical Options for Colorectal Cancer 43
Table 11: Treatment Alternatives for CRC 44
Table 12: Incident Cases of Colorectal Cancer, Ages ?40 Years, Men and Women, N, 2012-2019 46
Table 13: Costs of CRC Diagnosis, Treatment and Care 47
Table 14: CRC Screening Test Segmentation 50
Table 15: Guaiac Fecal Occult Blood Tests Product Profile 51
Table 16: Guaiac FOB Test SWOT Analysis, 2013 53
Table 17: Immuno-FOB Tests 59
Table 18: Product Profile - Lateral Flow Immunochemical Fecal Occult Blood Tests 61
Table 19: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 62
Table 20: Product Profile - Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) 63
Table 21: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, 2013 64
Table 22: Fecal Occult Blood ELISA Products 65
Table 23: Product Profile - Fecal Occult Blood ELISA 66
Table 24: Immuno-FOB Test ELISA SWOT Analysis, 2013 67
Table 25: Commercially Available Immuno-FOB Agglutination Test Systems 75
Table 26: Product Profile - Immuno-FOB Agglutination Tests 75
Table 27: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 77
Table 28: Key Mutations Associated with CRC 79
Table 29: Key Stages of PCR Gene Test 80
Table 30: Product Profile - PreGen Plus 82
Table 31: PreGen Plus SWOT Analysis, 2013 83
Table 32: Product Profile - K-RAS, B-RAF, PIK3CA Array 84
Table 33: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 85
Table 34: Product Profile - Colonsentry 86
Table 35: Colonsentry SWOT Analysis, 2013 86
Table 36: Product Profile - Detector C 2.0 87
Table 37: Detector C SWOT Analysis, 2013 88
Table 38: Product Profile - ColoSure 91
Table 39: ColoSure SWOT Analysis, 2013 91
Table 40: Product Profile - MS9 93
Table 41: MS9 SWOT Analysis, 2013 94
Table 42: Septin-9 CRC Screening Marketed Laboratory-Developed Tests 94
Table 43: Product Profile - ColoVantage/Septin-9 95
Table 44: ColoVantage/Septin-9 SWOT Analysis, 2013 96
Table 45: Product Profile - Tumor M2-PK Stool Test/2-in-1 Quick Test 98
Table 46: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 98
Table 47: Product Profile - Transferrin Assays 99
Table 48: Transferrin Assays SWOT Analysis, 2013 100
Table 49: Major Reasons for Non-compliance with CRC Screening 107
Table 50: Correlation of Fecal Occult Blood Test with Neoplasia 111
Table 51: CRC Screening Tests Pipeline, 2012 116
Table 52: Product Profile - BST1 CRC Assay 117
Table 53: BST1 CRC Assay SWOT Analysis, 2013 118
Table 54: Product Profile - Cologic 119
Table 55: Cologic SWOT Analysis, 2013 120
Table 56: Product Profile - ColoGuard 122
Table 57: ColoGuard SWOT Analysis, 2013 124
Table 58: Product Profile - Colon Cancer BEC Test 125
Table 59: Colon Cancer BEC Test SWOT Analysis, 2013 125
Table 60: Product Profile - Colon MarCare Plex 127
Table 61: Colon MarCare Plex SWOT Analysis, 2013 128
Table 62: Product Profile - Colox 129
Table 63: Colox SWOT Analysis, 2013 131
Table 64: Product Profile - CRC Bacterial Signature Assay 132
Table 65: CRC Bacterial Signature Assay SWOT Analysis, 2013 132
Table 66: Product Profile - CRC Breath Test 134
Table 67: CRC Breath Test SWOT Analysis, 2013 134
Table 68: Product Profile - Epi proColon 137
Table 69: Epi proColon Clinical Trials 137
Table 70: Epi proColon SWOT Analysis, 2013 141
Table 71: ExiQon MicroRNA Sensitivity and Specificity 142
Table 72: Product Profile - ExiQon microRNA Test 142
Table 73: ExiQon microRNA Test SWOT Analysis, 2013 143
Table 74: Product Profile - Gemini CRC Biomarker Assay 144
Table 75: Gemini CRC Biomarker Assay SWOT Analysis, 2013 145
Table 76: Product Profile - GenomicTree Methylated DNA Test 146
Table 77: GenomicTree Methylated DNA Test SWOT Analysis, 2013 147
Table 78: Product Profile - Measure 149
Table 79: Measure SWOT Analysis, 2013 149
Table 80: Product Profile - Metabiomics CRC Test 151
Table 81: Metabiomics CRC Test SWOT Analysis, 2013 152
Table 82: Product Profile - miR-21 Test 153
Table 83: miR-21 Test SWOT Analysis, 2013 153
Table 84: Product Profile - Oncolite-CR 154
Table 85: Oncolite-CR SWOT Analysis, 2013 155
Table 86: Product Profile - PanC-Dx 158
Table 87: PanC-Dx SWOT Analysis, 2013 158
Table 88: Uptake of Colonoscopy, Sigmoidoscopy and FOB Testing in the US 161
Table 89: Projections for Virtual Colonoscopy use for CRC Screening 164
Table 90: Key Mergers and Acquisitions during 2012-2013 172
Table 91: Company Profile - Abbott Molecular 175
Table 92: Abbott Molecular SWOT Analysis, 2013 176
Table 93: Company Profile - Alere 177
Table 94: Alere SWOT Analysis, 2013 178
Table 95: Company Profile - Beckman Coulter 179
Table 96: Beckman Coulter SWOT Analysis, 2013 180
Table 97: Company Profile - Biomarcare Technologies 181
Table 98: Biomarcare Technologies SWOT Analysis, 2013 181
Table 99: Company Profile - Companion Dx 182
Table 100: Companion Dx SWOT Analysis, 2013 183
Table 101: Company Profile - Eiken Chemical 185
Table 102: Eiken Chemical SWOT Analysis, 2013 186
Table 103: Company Profile - Epigenomics 189
Table 104: Epigenomics SWOT Analysis, 2013 191
Table 105: Company Profile - Exact Sciences 192
Table 106: Exact Sciences SWOT Analysis, 2013 195
Table 107: Company Profile - ExiQon 196
Table 108: ExiQon SWOT Analysis, 2013 197
Table 109: Company Profile - Fujirebio (Miraca Holdings) 198
Table 110: Fujirebio SWOT Analysis, 2013 200
Table 111: Company Profile - GeneNews 201
Table 112: GeneNews SWOT Analysis, 2013 202
Table 113: Company Profile - GenomicTree 203
Table 114: GenomicTree SWOT Analysis, 2013 203
Table 115: Company Profile - Immunostics 204
Table 116: Immunostics SWOT Analysis, 2013 206
Table 117: Company Profile - Kyowa Medex (Kyowa Hakko Kirin Group) 207
Table 118: Kyowa Medex SWOT Analysis, 2013 208
Table 119: Company Profile - MDx Health 209
Table 120: MDx Health SWOT Analysis, 2013 211
Table 121: Company Profile - Merck Millipore 212
Table 122: Merck Millipore SWOT Analysis, 2013 213
Table 123: Company Profile - Metabiomics 214
Table 124: Metabiomics SWOT Analysis, 2013 215
Table 125: Company Profile - Mode Diagnostics 216
Table 126: Mode Diagnostics SWOT Analysis, 2013 217
Table 127: Company Profile - Oncocyte (Bio Time) 218
Table 128: Oncocyte (Bio Time) SWOT Analysis, 2013 219
Table 129: Company Profile - Quest Diagnostics 221
Table 130: Quest Diagnostics SWOT Analysis, 2013 222
Table 131: Company Profile - R-Biopharm 224
Table 132: R-Biopharm SWOT Analysis, 2013 225
Table 133: Company Profile - Randox Laboratories 226
Table 134: Randox Laboratories SWOT Analysis, 2013 227
Table 135: Company Profile - ScheBo Biotech 228
Table 136: Schebo Biotech SWOT Analysis, 2013 230
Table 137: Company Profile - SciMarket Technologies 231
Table 138: SciMarket Technologies SWOT Analysis, 2013 232
Table 139: Company Profile - Siemens Healthcare 233
Table 140: Siemens Healthcare SWOT Analysis, 2013 234
Table 141: Company Profile - Signature Diagnostics 235
Table 142: Signature Diagnostics SWOT Analysis, 2013 236
Table 143: Company Profile - Sysmex 237
Table 144: Sysmex SWOT Analysis, 2013 238
Table 145: Company Profile - Veda Lab 239
Table 146: Veda Lab SWOT Analysis, 2013 240
Table 147: PreGen Plus Compared to Immuno-FOB Test 253
Table 148: Potential Impacts of Restriction of Gene Patents 255
Table 149: Major Events Affecting the Global In-Vitro CRC Screening Test Market 256
Table 150: Sales Forecasts for In-vitro CRC Screening Tests in the US Market, 2010-2019 257
Table 151: Forecasts for Numbers of In-vitro CRC Screening Tests, 2010-2019 258



1.2 List of Figures
Figure 1: Colorectal Cancer Staging 24
Figure 2: US Trends in Colorectal Cancer Incidence, 2010-2019 46
Figure 3: Total Costs of Colorectal Cancer to Society, 2010-2019 49
Figure 4: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen 51
Figure 5: Fecal Occult Blood Test Lateral Flow Device Architecture 55
Figure 6: Biohit Colonview (example of immuno-FOB test) 56
Figure 7: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) 57
Figure 8: Veda Labs Easy Reader Immuno-FOB Test LFD Reader 63
Figure 9: OC-Hemodia Agglutination FOB Test (manually performed) 68
Figure 10: OC-Sensor/Diana FOB Test Sample Cartridge 69
Figure 11: OC-Sensor/Diana FOB Test Instrument 70
Figure 12: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction 71
Figure 13: Sentinel Diagnostic Sentifob Instrument 72
Figure 14: Alere CI5 NS-Plus Instrument 73
Figure 15: Orion Diagnostics Quikread FOB Test and Instrument 74
Figure 16: Basic PCR Process 81
Figure 17: MS9 PCR Response Curve 93
Figure 18: Proposed ColoGuard Patient Stool Sample Collection Kit 121
Figure 19: Exact Sciences Automated Sample Processing WorkStation 122
Figure 20: Colox Kit Contents 129
Figure 21: Measure Fecal Occult Blood Test 148
Figure 22: PanC-Dx Multiplex Detection of CRC-specific Biomarker 157
Figure 23: Uptake of FOB Testing in the US by Income, 2002-2006 163
Figure 24: US Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 257
Figure 25: US Forecast for Numbers of In-vitro CRC Screening Tests, 2010-2019 258
Figure 26: Share of Fecal Occult Blood Tests, by Brand, 2012 260
Figure 27: US Market Segmentation for In-vitro CRC Screening Tests, by Type, 2012 and 2019 261

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