MediPoint: In-Vitro Colorectal Cancer Screening Tests – South America 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.

 

The value of the in-vitro CRC screening test market in Brazil was calculated to be worth $6.9m in 2012, and is expected to grow with a CAGR of 3.09% by 2019. The main drivers for the increase in testing are the increase in the population of people likely to benefit from CRC screening. GlobalData expects that as CRC screening DNA tests become more widely known after FDA PMA is issued in late 2013 or early 2014, then more physicians in Brazil will recommend this screening test to patients, as an alternative to FOB testing and screening colonoscopies.

Scope

– An overview of colorectal cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
– Annualized South America 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 South America 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 South America 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 South America in-vitro colorectal cancer screening tests market landscape? Identify, understand and capitalize.

Table of Contents

1 Table of Contents 8
1.1 List of Tables 14
1.2 List of Figures 21
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 31
3.4.5 Staging Colorectal Cancer 37
3.5 Clinical Outcomes 40
3.5.1 Treatment Paradigms 40
3.5.2 Treatment Options Overview 41
3.6 Epidemiology 42
3.6.1 Historical Trends 42
3.7 Epidemiology Forecast (2010-2019) 43
3.7.1 Total Incident Cases of Colorectal Cancer 43
3.8 Economic Impact 45
3.8.1 Individual Costs 45
4 Competitive Assessment 47
4.1 Overview 47
4.2 Fecal Occult Blood Tests 47
4.2.1 Guaiac Fecal Occult Blood Stool Tests 47
4.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests 51
4.2.3 Readers 59
4.2.4 Immuno-FOB Test ELISA 62
4.2.5 Immuno-FOB Agglutination Tests 65
4.3 CRC DNA Screening Tests 75
4.3.1 Panel DNA Tests 75
4.3.2 Methylated Gene Testing 85
4.4 Other Biomarker Tests 93
4.4.1 Overview 93
4.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test 94
4.4.3 Transferrin Assays 97
5 Unmet Needs 99
5.1 False Negative Results 99
5.2 False Positive Results 101
5.3 Sample Type 103
5.4 Screening Compliance 104
5.5 Alternative to Colonoscopy 107
5.6 Accurate Early Staging of Colorectal Cancer 109
5.7 Screening Test Alternatives 110
5.8 Automation 111
6 Pipeline Products 113
6.1 Overview 113
6.2 Pipeline by Phases in Development 113
6.3 Pipeline Product Profiles 115
6.3.1 BST1 CRC Assay 115
6.3.2 Cologic 116
6.3.3 ColoGuard 118
6.3.4 Colon Cancer BEC Test 122
6.3.5 Colon MarCare Plex 123
6.3.6 Colox 126
6.3.7 CRC Bacterial Signature Assay 128
6.3.8 CRC Breath Test 129
6.3.9 Epi proColon 132
6.3.10 ExiQon MicroRNA Test 138
6.3.11 Gemini CRC Biomarker Assay 141
6.3.12 GenomicTree Methylated DNA Test 142
6.3.13 Measure Fecal Occult Blood Test 144
6.3.14 Metabiomics CRC Test 147
6.3.15 MiR-21 Test 149
6.3.16 Oncolite CR 151
6.3.17 PanC-Dx 153
7 Industry Overview 156
7.1 Colorectal Cancer Screening Test Trends 156
7.2 Market Access 157
7.3 Reimbursement Trends 159
7.4 Regulatory Issues and Recalls 160
7.4.1 Recalls 161
7.5 Mergers and Acquisitions 162
8 Current and Future Players 163
8.1 Overview 163
8.2 Trends in Corporate Strategy 164
8.3 Company Profiles 165
8.3.1 Abbott Molecular 165
8.3.2 Alere 166
8.3.3 Beckman Coulter 169
8.3.4 Biomarcare Technologies 170
8.3.5 Companion Dx 172
8.3.6 Eiken Chemical 173
8.3.7 Epigenomics 177
8.3.8 Exact Sciences 181
8.3.9 ExiQon 186
8.3.10 Fujirebio (Miraca Holdings) 188
8.3.11 GeneNews 191
8.3.12 GenomicTree 192
8.3.13 Immunostics 194
8.3.14 Kyowa Medex 197
8.3.15 MDx Health (was OncoMethylome) 199
8.3.16 Merck Millipore 201
8.3.17 Metabiomics 204
8.3.18 Mode Diagnostics 206
8.3.19 Oncocyte (Bio Time) 208
8.3.20 Quest Diagnostics 210
8.3.21 R-Biopharm 213
8.3.22 Randox Laboratories 216
8.3.23 ScheBo Biotech 218
8.3.24 SciMarket Technologies 221
8.3.25 Siemens Healthcare 222
8.3.26 Signature Diagnostics 225
8.3.27 Sysmex 227
8.3.28 Veda Lab 229
9 Market Drivers, Opportunities and Barriers 231
9.1 Market Drivers 231
9.1.1 Uptake of Pipeline Biomarker Tests 231
9.1.2 Increasing Incidence of Colorectal Cancer and Improvements in Treatment 233
9.1.3 Patient Reluctance to Colonoscopies in Opportunistic CRC Screening 234
9.1.4 Increasing Volume of FOB Tests in Emerging Markets 235
9.1.5 Increased Pressure on Endoscopy Services 235
9.2 Opportunities 236
9.2.1 Blood Tests 236
9.2.2 Increasing CRC Screening Compliance 236
9.2.3 Integration of CRC Screening Tests with Prognostic Tests and Other Screening Programs 238
9.2.4 Emerging Markets 240
9.3 Market Barriers 241
9.3.1 Cultural and Social Resistance to Stool Tests 241
9.3.2 CRC Screening Awareness and Education 241
9.3.3 Reimbursement 242
9.3.4 Local Requirements 243
9.3.5 Test Complexity 246
9.3.6 Patenting Issues 247
10 Country Outlooks & Forecasts 248
11 Appendix 251
11.1 Abbreviations 251
11.2 Bibliography 253
11.3 Research Methodology 297
11.3.1 Coverage 297
11.3.2 Secondary Research 298
11.3.3 Forecasting Methodology 298
11.4 Physicians and Specialists Included in this Study 301
11.5 Primary Research 302
11.6 About the Authors 303
11.6.1 Analysts 303
11.6.2 Global Head of Healthcare 304
11.7 About GlobalData 305
11.8 Disclaimer 305

1.1 List of Tables
Table 1: Initial Presenting Symptoms of Colorectal Cancer 29
Table 2: TNM Classification System to Stage CRC 37
Table 3: Stage Grouping for CRC 38
Table 4: Stage II CRC Sub-Divisions 38
Table 5: Stage III CRC Sub-Divisions 39
Table 6: Stage IV CRC Sub-Divisions 39
Table 7: Dukes System of CRC Classification 40
Table 8: Treatment Guidelines for Colorectal Cancer 40
Table 9: Surgical Options for Colorectal Cancer 41
Table 10: Treatment Alternatives for CRC 42
Table 11: Incident Cases of Colorectal Cancer, Ages =40 Years, Men and Women, N, 2012-2019 44
Table 12: Costs of CRC Diagnosis, Treatment and Care 45
Table 13: CRC Screening Test Segmentation 47
Table 14: Guaiac Fecal Occult Blood Tests Product Profile 48
Table 15: Guaiac FOB Test SWOT Analysis, 2013 50
Table 16: Immuno-FOB Tests 56
Table 17: Product Profile - Lateral Flow Immunochemical Fecal Occult Blood Tests 58
Table 18: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 59
Table 19: Product Profile - Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) 60
Table 20: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, 2013 61
Table 21: Fecal Occult Blood ELISA Products 62
Table 22: Product Profile - Fecal Occult Blood ELISA 63
Table 23: Immuno-FOB Test ELISA SWOT Analysis, 2013 64
Table 24: Commercially Available Immuno-FOB Agglutination Test Systems 72
Table 25: Product Profile - Immuno-FOB Agglutination Tests 72
Table 26: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 74
Table 27: Key Mutations Associated with CRC 76
Table 28: Key Stages of PCR Gene Test 77
Table 29: Product Profile - PreGen Plus 79
Table 30: PreGen Plus SWOT Analysis, 2013 80
Table 31: Product Profile - K-RAS, B-RAF, PIK3CA Array 81
Table 32: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 82
Table 33: Product Profile - Colonsentry 83
Table 34: Colonsentry SWOT Analysis, 2013 83
Table 35: Product Profile - Detector C 2.0 84
Table 36: Detector C SWOT Analysis, 2013 85
Table 37: Product Profile - ColoSure 88
Table 38: ColoSure SWOT Analysis, 2013 88
Table 39: Product Profile - MS9 90
Table 40: MS9 SWOT Analysis, 2013 91
Table 41: Septin-9 CRC Screening Marketed Laboratory-Developed Tests 91
Table 42: Product Profile - ColoVantage/Septin-9 92
Table 43: ColoVantage/Septin-9 SWOT Analysis, 2013 93
Table 44: Product Profile - Tumor M2-PK Stool Test/2-in-1 Quick Test 95
Table 45: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 96
Table 46: Product Profile - Transferrin Assays 97
Table 47: Transferrin Assays SWOT Analysis, 2013 98
Table 48: Major Reasons for Non-compliance with CRC Screening 105
Table 49: Correlation of Fecal Occult Blood Test with Neoplasia 109
Table 50: CRC Screening Tests Pipeline, 2012 114
Table 51: Product Profile - BST1 CRC Assay 115
Table 52: BST1 CRC Assay SWOT Analysis, 2013 116
Table 53: Product Profile - Cologic 117
Table 54: Cologic SWOT Analysis, 2013 118
Table 55: Product Profile - ColoGuard 120
Table 56: ColoGuard SWOT Analysis, 2013 122
Table 57: Product Profile - Colon Cancer BEC Test 123
Table 58: Colon Cancer BEC Test SWOT Analysis, 2013 123
Table 59: Product Profile - Colon MarCare Plex 124
Table 60: Colon MarCare Plex SWOT Analysis, 2013 125
Table 61: Product Profile - Colox 127
Table 62: Colox SWOT Analysis, 2013 128
Table 63: Product Profile - CRC Bacterial Signature Assay 129
Table 64: CRC Bacterial Signature Assay SWOT Analysis, 2013 129
Table 65: Product Profile - CRC Breath Test 131
Table 66: CRC Breath Test SWOT Analysis, 2013 131
Table 67: Product Profile - Epi proColon 134
Table 68: Epi proColon Clinical Trials 134
Table 69: Epi proColon SWOT Analysis, 2013 138
Table 70: ExiQon MicroRNA Sensitivity and Specificity 139
Table 71: Product Profile - ExiQon microRNA Test 139
Table 72: ExiQon microRNA Test SWOT Analysis, 2013 140
Table 73: Product Profile - Gemini CRC Biomarker Assay 141
Table 74: Gemini CRC Biomarker Assay SWOT Analysis, 2013 142
Table 75: Product Profile - GenomicTree Methylated DNA Test 143
Table 76: GenomicTree Methylated DNA Test SWOT Analysis, 2013 144
Table 77: Product Profile - Measure 146
Table 78: Measure SWOT Analysis, 2013 146
Table 79: Product Profile - Metabiomics CRC Test 148
Table 80: Metabiomics CRC Test SWOT Analysis, 2013 149
Table 81: Product Profile - miR-21 Test 150
Table 82: miR-21 Test SWOT Analysis, 2013 150
Table 83: Product Profile - Oncolite-CR 151
Table 84: Oncolite-CR SWOT Analysis, 2013 152
Table 85: Product Profile - PanC-Dx 155
Table 86: PanC-Dx SWOT Analysis, 2013 155
Table 87: Key Mergers and Acquisitions during 2012-2013 162
Table 88: Company Profile - Abbott Molecular 165
Table 89: Abbott Molecular SWOT Analysis, 2013 166
Table 90: Company Profile - Alere 167
Table 91: Alere SWOT Analysis, 2013 168
Table 92: Company Profile - Beckman Coulter 169
Table 93: Beckman Coulter SWOT Analysis, 2013 170
Table 94: Company Profile - Biomarcare Technologies 171
Table 95: Biomarcare Technologies SWOT Analysis, 2013 171
Table 96: Company Profile - Companion Dx 172
Table 97: Companion Dx SWOT Analysis, 2013 173
Table 98: Company Profile - Eiken Chemical 175
Table 99: Eiken Chemical SWOT Analysis, 2013 176
Table 100: Company Profile - Epigenomics 179
Table 101: Epigenomics SWOT Analysis, 2013 181
Table 102: Company Profile - Exact Sciences 182
Table 103: Exact Sciences SWOT Analysis, 2013 185
Table 104: Company Profile - ExiQon 186
Table 105: ExiQon SWOT Analysis, 2013 187
Table 106: Company Profile - Fujirebio (Miraca Holdings) 188
Table 107: Fujirebio SWOT Analysis, 2013 190
Table 108: Company Profile - GeneNews 191
Table 109: GeneNews SWOT Analysis, 2013 192
Table 110: Company Profile - GenomicTree 193
Table 111: GenomicTree SWOT Analysis, 2013 193
Table 112: Company Profile - Immunostics 194
Table 113: Immunostics SWOT Analysis, 2013 196
Table 114: Company Profile - Kyowa Medex (Kyowa Hakko Kirin Group) 197
Table 115: Kyowa Medex SWOT Analysis, 2013 198
Table 116: Company Profile - MDx Health 199
Table 117: MDx Health SWOT Analysis, 2013 201
Table 118: Company Profile - Merck Millipore 202
Table 119: Merck Millipore SWOT Analysis, 2013 203
Table 120: Company Profile - Metabiomics 204
Table 121: Metabiomics SWOT Analysis, 2013 205
Table 122: Company Profile - Mode Diagnostics 206
Table 123: Mode Diagnostics SWOT Analysis, 2013 207
Table 124: Company Profile - Oncocyte (Bio Time) 208
Table 125: Oncocyte (Bio Time) SWOT Analysis, 2013 209
Table 126: Company Profile - Quest Diagnostics 211
Table 127: Quest Diagnostics SWOT Analysis, 2013 212
Table 128: Company Profile - R-Biopharm 214
Table 129: R-Biopharm SWOT Analysis, 2013 215
Table 130: Company Profile - Randox Laboratories 216
Table 131: Randox Laboratories SWOT Analysis, 2013 217
Table 132: Company Profile - ScheBo Biotech 218
Table 133: Schebo Biotech SWOT Analysis, 2013 220
Table 134: Company Profile - SciMarket Technologies 221
Table 135: SciMarket Technologies SWOT Analysis, 2013 222
Table 136: Company Profile - Siemens Healthcare 223
Table 137: Siemens Healthcare SWOT Analysis, 2013 224
Table 138: Company Profile - Signature Diagnostics 225
Table 139: Signature Diagnostics SWOT Analysis, 2013 226
Table 140: Company Profile - Sysmex 227
Table 141: Sysmex SWOT Analysis, 2013 228
Table 142: Company Profile - Veda Lab 229
Table 143: Veda Lab SWOT Analysis, 2013 230
Table 144: PreGen Plus Compared to Immuno-FOB Test 245
Table 145: Potential Impacts of Restriction of Gene Patents 247
Table 146: Major Events Affecting the Global In-Vitro CRC Screening Test Market 248
Table 147: Sales Forecasts for In-vitro CRC Screening Tests in Brazil, 2010-2019 249

1.2 List of Figures
Figure 1: Colorectal Cancer Staging 24
Figure 2: Trends in Colorectal Cancer Incidence, 2010-2019 44
Figure 3: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen 48
Figure 4: Fecal Occult Blood Test Lateral Flow Device Architecture 52
Figure 5: Biohit Colonview (example of immuno-FOB test) 53
Figure 6: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) 54
Figure 7: Veda Labs Easy Reader Immuno-FOB Test LFD Reader 60
Figure 8: OC-Hemodia Agglutination FOB Test (manually performed) 65
Figure 9: OC-Sensor/Diana FOB Test Sample Cartridge 66
Figure 10: OC-Sensor/Diana FOB Test Instrument 67
Figure 11: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction 68
Figure 12: Sentinel Diagnostic Sentifob Instrument 69
Figure 13: Alere CI5 NS-Plus Instrument 70
Figure 14: Orion Diagnostics Quikread FOB Test and Instrument 71
Figure 15: Basic PCR Process 78
Figure 16: MS9 PCR Response Curve 90
Figure 17: Proposed ColoGuard Patient Stool Sample Collection Kit 119
Figure 18: Exact Sciences Automated Sample Processing WorkStation 120
Figure 19: Colox Kit Contents 126
Figure 20: Measure Fecal Occult Blood Test 145
Figure 21: PanC-Dx Multiplex Detection of CRC-specific Biomarker 154
Figure 22: Brazil Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 249