MediPoint: In-Vitro Colorectal Cancer Screening Tests - APAC 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 APAC region in-vitro CRC screening market to grow at a compound annual growth rate (CAGR) of 1.25% over the next seven years. This slow growth can be attributed to an aging population in Japan (increasing the screening population); emerging new higher-priced gene tests which offer better specificity and sensitivity, and slow adoption of organised CRC screening programs in China and India.

Scope

- An overview of colorectal cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized APAC 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 APAC 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 APAC 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 APAC 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 23
2.1 Catalyst 23
3 Disease Overview 24
3.1 Colorectal Cancer 24
3.2 Anatomy and Physiology 24
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 32
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 43
3.6.1 Regional and Historical Trends 43
3.6.2 Japan 43
3.6.3 China 44
3.6.4 India 44
3.7 Epidemiology Forecast (2010-2019) 45
3.7.1 Total Incident Cases of Colorectal Cancer 45
3.8 Economic Impact 46
3.8.1 Individual Costs 46
4 Competitive Assessment 49
4.1 Overview 49
4.2 Fecal Occult Blood Tests 49
4.2.1 Guaiac Fecal Occult Blood Stool Tests 49
4.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests 53
4.2.3 Readers 61
4.2.4 Immuno-FOB Test ELISA 64
4.2.5 Immuno-FOB Agglutination Tests 67
4.3 CRC DNA Screening Tests 77
4.3.1 Panel DNA Tests 77
4.3.2 Methylated Gene Testing 87
4.4 Other Biomarker Tests 95
4.4.1 Overview 95
4.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test 96
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 125
6.3.6 Colox 128
6.3.7 CRC Bacterial Signature Assay 130
6.3.8 CRC Breath Test 131
6.3.9 Epi proColon 134
6.3.10 ExiQon MicroRNA Test 140
6.3.11 Gemini CRC Biomarker Assay 143
6.3.12 GenomicTree Methylated DNA Test 144
6.3.13 Measure Fecal Occult Blood Test 146
6.3.14 Metabiomics CRC Test 149
6.3.15 MiR-21 Test 151
6.3.16 Oncolite CR 153
6.3.17 PanC-Dx 155
7 Industry Overview 158
7.1 Colorectal Cancer Screening Test Trends 158
7.1.1 Japan 158
7.1.2 China 159
7.1.3 India 160
7.2 Market Access 162
7.3 Reimbursement Trends 164
7.3.1 Japan 164
7.3.2 China 164
7.3.3 India 167
7.4 Regulatory Issues and Recalls 168
7.4.1 APAC Region Regulation 168
7.4.2 US 169
7.4.3 5EU 171
7.4.4 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 Increasing Volume of FOB Tests in Emerging Markets 245
9.1.5 Increased Pressure on Endoscopy Services 245
9.2 Opportunities 246
9.2.1 Blood Tests 246
9.2.2 Increasing CRC Screening Compliance 246
9.2.3 Integration of CRC Screening Tests with Prognostic Tests and Other Screening Programs 248
9.2.4 Emerging Markets 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 251
9.3.3 Reimbursement 252
9.3.4 Local Requirements 253
9.3.5 Test Complexity 256
9.3.6 Patenting Issues 257
10 Country Outlooks and Forecasts 258
10.1 APAC Markets Overview 258
10.2 Japan Market Analysis 262
10.3 China Market Analysis 264
10.4 India Market Analysis 265
11 Appendix 268
11.1 Abbreviations 268
11.2 Bibliography 270
11.3 Research Methodology 313
11.3.1 Coverage 313
11.3.2 Secondary Research 314
11.3.3 Forecasting Methodology 314
11.4 Physicians and Specialists Included in this Study 317
11.5 Primary Research 318
11.6 About the Authors 319
11.6.1 Analysts 319
11.6.2 Global Head of Healthcare 320
11.7 About GlobalData 321
11.8 Disclaimer 321

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 41
Table 9: Surgical Options for Colorectal Cancer 41
Table 10: Treatment Alternatives for CRC 43
Table 11: Incident Cases of Colorectal Cancer, Ages ?40 Years, Men and Women, N, 2012-2019 46
Table 12: Costs of CRC Diagnosis, Treatment and Care 46
Table 13: CRC Screening Test Segmentation 49
Table 14: Guaiac Fecal Occult Blood Tests Product Profile 50
Table 15: Guaiac FOB Test SWOT Analysis, 2013 52
Table 16: Immuno-FOB Tests 58
Table 17: Product Profile - Lateral Flow Immunochemical Fecal Occult Blood Tests 60
Table 18: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 61
Table 19: Product Profile - Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) 62
Table 20: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, 2013 63
Table 21: Fecal Occult Blood ELISA Products 64
Table 22: Product Profile - Fecal Occult Blood ELISA 65
Table 23: Immuno-FOB Test ELISA SWOT Analysis, 2013 66
Table 24: Commercially Available Immuno-FOB Agglutination Test Systems 74
Table 25: Product Profile - Immuno-FOB Agglutination Tests 74
Table 26: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 76
Table 27: Key Mutations Associated with CRC 78
Table 28: Key Stages of PCR Gene Test 79
Table 29: Product Profile - PreGen Plus 81
Table 30: PreGen Plus SWOT Analysis, 2013 82
Table 31: Product Profile - K-RAS, B-RAF, PIK3CA Array 83
Table 32: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 84
Table 33: Product Profile - Colonsentry 85
Table 34: Colonsentry SWOT Analysis, 2013 85
Table 35: Product Profile - Detector C 2.0 86
Table 36: Detector C SWOT Analysis, 2013 87
Table 37: Product Profile - ColoSure 90
Table 38: ColoSure SWOT Analysis, 2013 90
Table 39: Product Profile - MS9 92
Table 40: MS9 SWOT Analysis, 2013 93
Table 41: Septin-9 CRC Screening Marketed Laboratory-Developed Tests 93
Table 42: Product Profile - ColoVantage/Septin-9 94
Table 43: ColoVantage/Septin-9 SWOT Analysis, 2013 95
Table 44: Product Profile - Tumor M2-PK Stool Test/2-in-1 Quick Test 97
Table 45: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 98
Table 46: Product Profile - Transferrin Assays 99
Table 47: Transferrin Assays SWOT Analysis, 2013 100
Table 48: Major Reasons for Non-compliance with CRC Screening 107
Table 49: Correlation of Fecal Occult Blood Test with Neoplasia 111
Table 50: CRC Screening Tests Pipeline, 2012 116
Table 51: Product Profile - BST1 CRC Assay 117
Table 52: BST1 CRC Assay SWOT Analysis, 2013 118
Table 53: Product Profile - Cologic 119
Table 54: Cologic SWOT Analysis, 2013 120
Table 55: Product Profile - ColoGuard 122
Table 56: ColoGuard SWOT Analysis, 2013 124
Table 57: Product Profile - Colon Cancer BEC Test 125
Table 58: Colon Cancer BEC Test SWOT Analysis, 2013 125
Table 59: Product Profile - Colon MarCare Plex 126
Table 60: Colon MarCare Plex SWOT Analysis, 2013 127
Table 61: Product Profile - Colox 129
Table 62: Colox SWOT Analysis, 2013 130
Table 63: Product Profile - CRC Bacterial Signature Assay 131
Table 64: CRC Bacterial Signature Assay SWOT Analysis, 2013 131
Table 65: Product Profile - CRC Breath Test 133
Table 66: CRC Breath Test SWOT Analysis, 2013 133
Table 67: Product Profile - Epi proColon 136
Table 68: Epi proColon Clinical Trials 136
Table 69: Epi proColon SWOT Analysis, 2013 140
Table 70: ExiQon MicroRNA Sensitivity and Specificity 141
Table 71: Product Profile - ExiQon microRNA Test 141
Table 72: ExiQon microRNA Test SWOT Analysis, 2013 142
Table 73: Product Profile - Gemini CRC Biomarker Assay 143
Table 74: Gemini CRC Biomarker Assay SWOT Analysis, 2013 144
Table 75: Product Profile - GenomicTree Methylated DNA Test 145
Table 76: GenomicTree Methylated DNA Test SWOT Analysis, 2013 146
Table 77: Product Profile - Measure 148
Table 78: Measure SWOT Analysis, 2013 148
Table 79: Product Profile - Metabiomics CRC Test 150
Table 80: Metabiomics CRC Test SWOT Analysis, 2013 151
Table 81: Product Profile - miR-21 Test 152
Table 82: miR-21 Test SWOT Analysis, 2013 152
Table 83: Product Profile - Oncolite-CR 153
Table 84: Oncolite-CR SWOT Analysis, 2013 154
Table 85: Product Profile - PanC-Dx 157
Table 86: PanC-Dx SWOT Analysis, 2013 157
Table 87: Healthcare Systems in the People’s Republic of China 165
Table 88: Healthcare Principles in the People’s Republic of China 166
Table 89: Key Mergers and Acquisitions during 2012-2013 172
Table 90: Company Profile - Abbott Molecular 175
Table 91: Abbott Molecular SWOT Analysis, 2013 176
Table 92: Company Profile - Alere 177
Table 93: Alere SWOT Analysis, 2013 178
Table 94: Company Profile - Beckman Coulter 179
Table 95: Beckman Coulter SWOT Analysis, 2013 180
Table 96: Company Profile - Biomarcare Technologies 181
Table 97: Biomarcare Technologies SWOT Analysis, 2013 181
Table 98: Company Profile - Companion Dx 182
Table 99: Companion Dx SWOT Analysis, 2013 183
Table 100: Company Profile - Eiken Chemical 185
Table 101: Eiken Chemical SWOT Analysis, 2013 186
Table 102: Company Profile - Epigenomics 189
Table 103: Epigenomics SWOT Analysis, 2013 191
Table 104: Company Profile - Exact Sciences 192
Table 105: Exact Sciences SWOT Analysis, 2013 195
Table 106: Company Profile - ExiQon 196
Table 107: ExiQon SWOT Analysis, 2013 197
Table 108: Company Profile - Fujirebio (Miraca Holdings) 198
Table 109: Fujirebio SWOT Analysis, 2013 200
Table 110: Company Profile - GeneNews 201
Table 111: GeneNews SWOT Analysis, 2013 202
Table 112: Company Profile - GenomicTree 203
Table 113: GenomicTree SWOT Analysis, 2013 203
Table 114: Company Profile - Immunostics 204
Table 115: Immunostics SWOT Analysis, 2013 206
Table 116: Company Profile - Kyowa Medex (Kyowa Hakko Kirin Group) 207
Table 117: Kyowa Medex SWOT Analysis, 2013 208
Table 118: Company Profile - MDx Health 209
Table 119: MDx Health SWOT Analysis, 2013 211
Table 120: Company Profile - Merck Millipore 212
Table 121: Merck Millipore SWOT Analysis, 2013 213
Table 122: Company Profile - Metabiomics 214
Table 123: Metabiomics SWOT Analysis, 2013 215
Table 124: Company Profile - Mode Diagnostics 216
Table 125: Mode Diagnostics SWOT Analysis, 2013 217
Table 126: Company Profile - Oncocyte (Bio Time) 218
Table 127: Oncocyte (Bio Time) SWOT Analysis, 2013 219
Table 128: Company Profile - Quest Diagnostics 221
Table 129: Quest Diagnostics SWOT Analysis, 2013 222
Table 130: Company Profile - R-Biopharm 224
Table 131: R-Biopharm SWOT Analysis, 2013 225
Table 132: Company Profile - Randox Laboratories 226
Table 133: Randox Laboratories SWOT Analysis, 2013 227
Table 134: Company Profile - ScheBo Biotech 228
Table 135: Schebo Biotech SWOT Analysis, 2013 230
Table 136: Company Profile - SciMarket Technologies 231
Table 137: SciMarket Technologies SWOT Analysis, 2013 232
Table 138: Company Profile - Siemens Healthcare 233
Table 139: Siemens Healthcare SWOT Analysis, 2013 234
Table 140: Company Profile - Signature Diagnostics 235
Table 141: Signature Diagnostics SWOT Analysis, 2013 236
Table 142: Company Profile - Sysmex 237
Table 143: Sysmex SWOT Analysis, 2013 238
Table 144: Company Profile - Veda Lab 239
Table 145: Veda Lab SWOT Analysis, 2013 240
Table 146: PreGen Plus Compared to Immuno-FOB Test 255
Table 147: Potential Impacts of Restriction of Gene Patents 257
Table 148: Major Events Affecting the APAC Regionl In-Vitro CRC Screening Test Market 258
Table 149: Sales Forecasts for In-vitro CRC Screening Tests in the APAC Markets, 2010-2019 259
Table 150: Forecasts for Numbers of In-vitro CRC Screening Tests in the APAC Region, 2010-2019 260
Table 151: Sales Forecasts for In-vitro CRC Screening Tests in Japan, 2010-2019 262
Table 152: Sales Forecasts for In-vitro CRC Screening Tests in China, 2010-2019 264
Table 153: Sales Forecasts for In-vitro CRC Screening Tests in India, 2010-2019 266

1.2 List of Figures
Figure 1: Colorectal Cancer Staging 25
Figure 2: APAC Trends in Colorectal Cancer Incidence, 2010-2019 45
Figure 3: Total Costs of Colorectal Cancer to Society in Japan, 2010-2019 48
Figure 4: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen 50
Figure 5: Fecal Occult Blood Test Lateral Flow Device Architecture 54
Figure 6: Biohit Colonview (example of immuno-FOB test) 55
Figure 7: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) 56
Figure 8: Veda Labs Easy Reader Immuno-FOB Test LFD Reader 62
Figure 9: OC-Hemodia Agglutination FOB Test (manually performed) 67
Figure 10: OC-Sensor/Diana FOB Test Sample Cartridge 68
Figure 11: OC-Sensor/Diana FOB Test Instrument 69
Figure 12: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction 70
Figure 13: Sentinel Diagnostic Sentifob Instrument 71
Figure 14: Alere CI5 NS-Plus Instrument 72
Figure 15: Orion Diagnostics Quikread FOB Test and Instrument 73
Figure 16: Basic PCR Process 80
Figure 17: MS9 PCR Response Curve 92
Figure 18: Proposed ColoGuard Patient Stool Sample Collection Kit 121
Figure 19: Exact Sciences Automated Sample Processing WorkStation 122
Figure 20: Colox Kit Contents 128
Figure 21: Measure Fecal Occult Blood Test 147
Figure 22: PanC-Dx Multiplex Detection of CRC-specific Biomarker 156
Figure 23: APAC Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 259
Figure 24: Forecast for Numbers of In-vitro CRC Screening Tests in APAC Region, 2010-2019 260
Figure 25: APACShare of Fecal Occult Blood Tests, by Brand, 2012 261
Figure 26: Japan Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 262
Figure 27: China Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 264
Figure 28: India Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019 266

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