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


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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.

Questions Answered in this Report
  • Colorectal cancer can be caused by somatic mutations as well as inherited mutations. These mutations lead to changes in the colon, that can be detected by detection of bleeding. But many of these mutations can be also be detected by genetic and other tests. How quickly will new gene tests be adopted by the CRC screening market??
  • What are the key differences in CRC screening carried out in different countries, and how will these differences affect adoption of new screening tests?
  • Existing CRC screening is based on inexpensive, but inaccurate stool analysis tests, or expensive but accurate endoscopies. The first DNA screening tests are expected to come to market in 2014, from Exact Sciences and EpiGenomics. Which new DNA-based screening test will win out ?
  • In-vitro CRC screening is a fast evolving technological area. How will change in technology affect sales of existing CRC screening tests? Who are the new players in CRC screening? How will patient attitudes affect the In-vitro CRC screening test market?
Table of Contents

1 Table of Contents 
1.1 List of Tables 
1.2 List of Figures

2 Introduction 
2.1 Catalyst 
2.2 Related Reports

3 Disease Overview 
3.1 Colorectal Cancer 
3.2 Anatomy and Physiology 
3.3 Pathophysiology 
3.3.1 Histology 
3.3.2 Genetic Basis 
3.3.3 Etiology of CRC 
3.4 Clinical Presentation 
3.4.1 Symptoms 
3.4.2 Screening Overview 
3.4.3 Status of National CRC Screening Programs 
3.4.4 Diagnosis Overview 
3.4.5 Staging Colorectal Cancer 
3.5 Clinical Outcomes 
3.5.1 Treatment Paradigms 
3.5.2 Treatment Options Overview 
3.6 Epidemiology 
3.6.1 Global and Historical Trends 
3.7 Epidemiology Forecast (2012–2018) 
3.7.1 Total Incident Cases of Colorectal Cancer 
3.8 Economic Impact 
3.8.1 Individual Costs

4 Competitive Assessment 
4.1 Overview 
4.2 Fecal Occult Blood Tests 
4.2.1 Guaiac Fecal Occult Blood Stool Tests 
4.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests 
4.2.3 Readers 
4.2.4 Immuno-FOB Test ELISA 
4.2.5 Immuno-FOB Agglutination Tests 
4.3 CRC DNA Screening Tests 
4.3.1 Panel DNA Tests 
4.3.2 Methylated Gene Testing 
4.4 Other Biomarker Tests 
4.4.1 Overview 
4.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test 
4.4.3 Transferrin Assays

5 Unmet Needs 
5.1 False Negative Results 
5.2 False Positive Results 
5.3 Sample Type 
5.4 Screening Compliance 
5.5 Alternative to Colonoscopy 
5.6 Accurate Early Staging of Colorectal Cancer 
5.7 Screening Test Alternatives 
5.8 Automation

6 Pipeline Products 
6.1 Overview 
6.2 Pipeline by Phases in Development 
6.3 Pipeline Product Profiles 
6.3.1 BST1 CRC Assay 
6.3.2 Cologic 
6.3.3 ColoGuard 
6.3.4 Colon Cancer BEC Test 
6.3.5 Colon MarCare Plex 
6.3.6 Colox 
6.3.7 CRC Bacterial Signature Assay 
6.3.8 CRC Breath Test 
6.3.9 Epi proColon 
6.3.10 ExiQon MicroRNA Test 
6.3.11 Gemini CRC Biomarker Assay 
6.3.12 GenomicTree Methylated DNA Test 
6.3.13 Measure Fecal Occult Blood Test 
6.3.14 Metabiomics CRC Test 
6.3.15 MiR-21 Test 
6.3.16 Oncolite CR 
6.3.17 PanC-Dx

7 Industry Overview 
7.1 Colorectal Cancer Screening Test Trends 
7.1.1 US 
7.1.2 5EU 
7.1.3 APAC 
7.1.4 South America (Brazil) 
7.2 Market Access 
7.3 Reimbursement Trends 
7.3.1 US 
7.3.2 5EU 
7.3.3 APAC 
7.3.4 South America (Brazil) 
7.4 Regulatory Issues and Recalls 
7.4.1 US 
7.4.2 5EU 
7.4.3 Recalls 
7.5 Mergers and Acquisitions

8 Current and Future Players 
8.1 Overview 
8.2 Trends in Corporate Strategy 
8.3 Company Profiles 
8.3.1 Abbott Molecular 
8.3.2 Alere 
8.3.3 Beckman Coulter 
8.3.4 Biomarcare Technologies 
8.3.5 Companion Dx 
8.3.6 Eiken Chemical 
8.3.7 Epigenomics 
8.3.8 Exact Sciences 
8.3.9 ExiQon 
8.3.10 Fujirebio (Miraca Holdings) 
8.3.11 GeneNews 
8.3.12 GenomicTree 
8.3.13 Immunostics 
8.3.14 Kyowa Medex 
8.3.15 MDx Health (was OncoMethylome) 
8.3.16 Merck Millipore 
8.3.17 Metabiomics 
8.3.18 Mode Diagnostics 
8.3.19 Oncocyte (Bio Time) 
8.3.20 Quest Diagnostics 
8.3.21 R-Biopharm 
8.3.22 Randox Laboratories 
8.3.23 Schebo Biotech 
8.3.24 SciMarket Technologies 
8.3.25 Siemens Healthcare 
8.3.26 Signature Diagnostics 
8.3.27 Sysmex 
8.3.28 Veda Lab

9 Market Drivers, Opportunities and Barriers 
9.1 Market Drivers 
9.1.1 Uptake of Pipeline Biomarker Tests 
9.1.2 Increasing Incidence of Colorectal Cancer and Improvements in Treatment 
9.1.3 Patient Reluctance to Colonoscopies in Opportunistic CRC Screening 
9.1.4 Increasing Volume of FOB Tests in Emerging Markets 
9.1.5 Increased Pressure on Endoscopy Services 
9.2 Opportunities 
9.2.1 Blood Tests 
9.2.2 Increasing CRC Screening Compliance 
9.2.3 Integration of CRC Screening Tests with Prognostic Tests and Other Screening Programs 
9.2.4 Emerging Markets 
9.3 Market Barriers 
9.3.1 Cultural and Social Resistance to Stool Tests 
9.3.2 CRC Screening Awareness and Education 
9.3.3 Reimbursement 
9.3.4 Local Requirements 
9.3.5 Test Complexity 
9.3.6 Patenting Issues

10 Country Outlooks & Forecasts 
10.1 10 Major Markets Overview 
10.2 US 
10.2.1 US Market Analysis 
10.3 France 
10.3.1 France Market Analysis 
10.4 Germany 
10.4.1 Germany Market Analysis 
10.5 Italy 
10.5.1 Italy Market Analysis 
10.6 Spain 
10.6.1 Spain Analysis 
10.7 UK 
10.7.1 UK Market Analysis 
10.8 Rest of World 
10.8.1 Japan Market Analysis 
10.8.2 Brazil Market Analysis 
10.8.3 China Market Analysis 
10.8.4 India Market Analysis

11 Appendix 
11.1 Abbreviations 
11.2 Bibliography 
11.3 Research Methodology 
11.3.1 Coverage 
11.3.2 Secondary Research 
11.3.3 Forecasting Methodology 
11.4 Physicians and Specialists Included in this Study 
11.5 Primary Research 
11.6 About the Authors 
11.6.1 Analysts 
11.6.2 Global Head of Healthcare 
11.7 About GlobalData 
11.8 Disclaimer

Table 1: Initial Presenting Symptoms of Colorectal Cancer 
Table 2: Guideline Organization Recommendations for Non-Invasive Tests 
Table 3: Colorectal Screening FOB Test Participation in Italy by Age and Sex, 2008 
Table 4: TNM Classification System to Stage CRC 
Table 5: Stage Grouping for CRC 
Table 6: Stage II CRC Sub-Divisions 
Table 7: Stage III CRC Sub-Divisions 
Table 8: Stage IV CRC Sub-Divisions 
Table 9: Dukes System of CRC Classification 
Table 10: Treatment Guidelines for Colorectal Cancer 
Table 11: Surgical Options for Colorectal Cancer 
Table 12: Treatment Alternatives for CRC 
Table 13: Incident Cases of Colorectal Cancer, Ages =40 Years, Men and Women, N, 2012–2019 
Table 14: Costs of CRC Diagnosis, Treatment and Care 
Table 15: CRC Screening Test Segmentation 
Table 16: Guaiac Fecal Occult Blood Tests Product Profile 
Table 17: Guaiac FOB Test SWOT Analysis, 2013 
Table 18: Immuno-FOB Tests 
Table 19: Product Profile – Lateral Flow Immunochemical Fecal Occult Blood Tests 
Table 20: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 
Table 21: Product Profile – Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers)
Table 22: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, 2013 
Table 23: Fecal Occult Blood ELISA Products 
Table 24: Product Profile – Fecal Occult Blood ELISA 
Table 25: Immuno-FOB Test ELISA SWOT Analysis, 2013 
Table 26: Commercially Available Immuno-FOB Agglutination Test Systems 
Table 27: Product Profile – Immuno-FOB Agglutination Tests 
Table 28: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 
Table 29: Key Mutations Associated with CRC 
Table 30: Key Stages of PCR Gene Test 
Table 31: Product Profile – PreGen Plus 
Table 32: PreGen Plus SWOT Analysis, 2013 
Table 33: Product Profile – K-RAS, B-RAF, PIK3CA Array 
Table 34: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 
Table 35: Product Profile – Colonsentry 
Table 36: Colonsentry SWOT Analysis, 2013 
Table 37: Product Profile – Detector C 2.0 
Table 38: Detector C SWOT Analysis, 2013 
Table 39: Product Profile – ColoSure 
Table 40: ColoSure SWOT Analysis, 2013 
Table 41: Product Profile – MS9 
Table 42: MS9 SWOT Analysis, 2013 
Table 43: Septin-9 CRC Screening Marketed Laboratory-Developed Tests 
Table 44: Product Profile – ColoVantage/Septin-9 
Table 45: ColoVantage/Septin-9 SWOT Analysis, 2013 
Table 46: Product Profile – Tumor M2-PK Stool Test/2-in-1 Quick Test 
Table 47: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 
Table 48: Product Profile – Transferrin Assays 
Table 49: Transferrin Assays SWOT Analysis, 2013 
Table 50: Major Reasons for Non-compliance with CRC Screening 
Table 51: Correlation of Fecal Occult Blood Test with Neoplasia 
Table 52: CRC Screening Tests Pipeline, 2012 
Table 53: Product Profile – BST1 CRC Assay 
Table 54: BST1 CRC Assay SWOT Analysis, 2013 
Table 55: Product Profile – Cologic 
Table 56: Cologic SWOT Analysis, 2013 
Table 57: Product Profile – ColoGuard 
Table 58: ColoGuard SWOT Analysis, 2013 
Table 59: Product Profile – Colon Cancer BEC Test 
Table 60: Colon Cancer BEC Test SWOT Analysis, 2013 
Table 61: Product Profile – Colon MarCare Plex 
Table 62: Colon MarCare Plex SWOT Analysis, 2013 
Table 63: Product Profile – Colox 
Table 64: Colox SWOT Analysis, 2013 
Table 65: Product Profile – CRC Bacterial Signature Assay 
Table 66: CRC Bacterial Signature Assay SWOT Analysis, 2013 
Table 67: Product Profile – CRC Breath Test 
Table 68: CRC Breath Test SWOT Analysis, 2013 
Table 69: Product Profile – Epi proColon 
Table 70: Epi proColon Clinical Trials 
Table 71: Epi proColon SWOT Analysis, 2013 
Table 72: ExiQon MicroRNA Sensitivity and Specificity 
Table 73: Product Profile – ExiQon microRNA Test 
Table 74: ExiQon microRNA Test SWOT Analysis, 2013 
Table 75: Product Profile – Gemini CRC Biomarker Assay 
Table 76: Gemini CRC Biomarker Assay SWOT Analysis, 2013 
Table 77: Product Profile – GenomicTree Methylated DNA Test 
Table 78: GenomicTree Methylated DNA Test SWOT Analysis, 2013 
Table 79: Product Profile – Measure 
Table 80: Measure SWOT Analysis, 2013 
Table 81: Product Profile – Metabiomics CRC Test 
Table 82: Metabiomics CRC Test SWOT Analysis, 2013 
Table 83: Product Profile – miR-21 Test 
Table 84: miR-21 Test SWOT Analysis, 2013 
Table 85: Product Profile – Oncolite-CR 
Table 86: Oncolite-CR SWOT Analysis, 2013 
Table 87: Product Profile – PanC-Dx 
Table 88: PanC-Dx SWOT Analysis, 2013 
Table 89: Uptake of Colonoscopy, Sigmoidoscopy and FOB Testing in the US 
Table 90: Projections for Virtual Colonoscopy use for CRC Screening 
Table 91: Healthcare Systems in the People’s Republic of China 
Table 92: Healthcare Principles in the People’s Republic of China 
Table 93: Key Mergers and Acquisitions during 2012–2013 
Table 94: Company Profile – Abbott Molecular 
Table 95: Abbott Molecular SWOT Analysis, 2013 
Table 96: Company Profile – Alere 
Table 97: Alere SWOT Analysis, 2013 
Table 98: Company Profile – Beckman Coulter 
Table 99: Beckman Coulter SWOT Analysis, 2013 
Table 100: Company Profile – Biomarcare Technologies 
Table 101: Biomarcare Technologies SWOT Analysis, 2013 
Table 102: Company Profile – Companion Dx 
Table 103: Companion Dx SWOT Analysis, 2013 
Table 104: Company Profile – Eiken Chemical 
Table 105: Eiken Chemical SWOT Analysis, 2013 
Table 106: Company Profile – Epigenomics 
Table 107: Epigenomics SWOT Analysis, 2013 
Table 108: Company Profile – Exact Sciences 
Table 109: Exact Sciences SWOT Analysis, 2013 
Table 110: Company Profile – ExiQon 
Table 111: ExiQon SWOT Analysis, 2013 
Table 112: Company Profile – Fujirebio (Miraca Holdings) 
Table 113: Fujirebio SWOT Analysis, 2013 
Table 114: Company Profile – GeneNews 
Table 115: GeneNews SWOT Analysis, 2013 
Table 116: Company Profile – GenomicTree 
Table 117: GenomicTree SWOT Analysis, 2013 
Table 118: Company Profile – Immunostics 
Table 119: Immunostics SWOT Analysis, 2013 
Table 120: Company Profile – Kyowa Medex (Kyowa Hakko Kirin Group) 
Table 121: Kyowa Medex SWOT Analysis, 2013 
Table 122: Company Profile – MDx Health 
Table 123: MDx Health SWOT Analysis, 2013 
Table 124: Company Profile – Merck Millipore 
Table 125: Merck Millipore SWOT Analysis, 2013 
Table 126: Company Profile – Metabiomics 
Table 127: Metabiomics SWOT Analysis, 2013 
Table 128: Company Profile – Mode Diagnostics 
Table 129: Mode Diagnostics SWOT Analysis, 2013 
Table 130: Company Profile – Oncocyte (Bio Time) 
Table 131: Oncocyte (Bio Time) SWOT Analysis, 2013 
Table 132: Company Profile – Quest Diagnostics 
Table 133: Quest Diagnostics SWOT Analysis, 2013 
Table 134: Company Profile – R-Biopharm 
Table 135: R-Biopharm SWOT Analysis, 2013 
Table 136: Company Profile – Randox Laboratories 
Table 137: Randox Laboratories SWOT Analysis, 2013 
Table 138: Company Profile – Schebo Biotech 
Table 139: Schebo Biotech SWOT Analysis, 2013 
Table 140: Company Profile – SciMarket Technologies 
Table 141: SciMarket Technologies SWOT Analysis, 2013 
Table 142: Company Profile – Siemens Healthcare 
Table 143: Siemens Healthcare SWOT Analysis, 2013 
Table 144: Company Profile – Signature Diagnostics 
Table 145: Signature Diagnostics SWOT Analysis, 2013 
Table 146: Company Profile – Sysmex 
Table 147: Sysmex SWOT Analysis, 2013 
Table 148: Company Profile – Veda Lab 
Table 149: Veda Lab SWOT Analysis, 2013 
Table 150: PreGen Plus Compared to Immuno-FOB Test 
Table 151: Potential Impacts of Restriction of Gene Patents 
Table 152: Major Events Affecting the Global In-Vitro CRC Screening Test Market 
Table 153: Sales Forecasts for In-vitro CRC Screening Tests in the 10 Major Markets, 2010–2019 
Table 154: Forecasts for Numbers of In-vitro CRC Screening Tests, 2010–2019 
Table 155: Sales Forecasts for In-vitro CRC Screening Tests in the US, 2010–2019 
Table 156: Sales Forecasts for In-vitro CRC Screening Tests in France, 2010–2019 
Table 157: Sales Forecasts for In-vitro CRC Screening Tests in Germany, 2010–2019 
Table 158: Sales Forecasts for In-vitro CRC Screening Tests in Italy, 2010–2019 
Table 159: Sales Forecasts for In-vitro CRC Screening Tests in Spain, 2010–2019 
Table 160: Sales Forecasts for In-vitro CRC Screening Tests in the UK, 2010–2019 
Table 161: Sales Forecasts for In-vitro CRC Screening Tests in Japan, 2010–2019 
Table 162: Sales Forecasts for In-vitro CRC Screening Tests in Brazil, 2010–2019 
Table 163: Sales Forecasts for In-vitro CRC Screening Tests in China, 2010–2019 
Table 164: Sales Forecasts for In-vitro CRC Screening Tests in India, 2010–2019

Figure 1: Colorectal Cancer Staging 
Figure 2: Global Trends in Colorectal Cancer Incidence, 2010–2019 
Figure 3: Total Costs of Colorectal Cancer to Society, 2010–2019 
Figure 4: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen 
Figure 5: Fecal Occult Blood Test Lateral Flow Device Architecture 
Figure 6: Biohit Colonview (example of immuno-FOB test) 
Figure 7: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) 
Figure 8: Veda Labs Easy Reader Immuno-FOB Test LFD Reader 
Figure 9: OC-Hemodia Agglutination FOB Test (manually performed) 
Figure 10: OC-Sensor/Diana FOB Test Sample Cartridge 
Figure 11: OC-Sensor/Diana FOB Test Instrument 
Figure 12: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction 
Figure 13: Sentinel Diagnostic Sentifob Instrument 
Figure 14: Alere CI5 NS-Plus Instrument 
Figure 15: Orion Diagnostics Quikread FOB Test and Instrument 
Figure 16: Basic PCR Process 
Figure 17: MS9 PCR Response Curve 
Figure 18: Proposed ColoGuard Patient Stool Sample Collection Kit 
Figure 19: Exact Sciences Automated Sample Processing WorkStation 
Figure 20: Colox Kit Contents 
Figure 21: Measure Fecal Occult Blood Test 
Figure 22: PanC-Dx Multiplex Detection of CRC-specific Biomarker 
Figure 23: Uptake of FOB Testing in the US by Income, 2002-2006 
Figure 24: Global Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 25: Global Forecast for Numbers of In-vitro CRC Screening Tests, 2010–2019 
Figure 26: Global Share of Fecal Occult Blood Tests, by Brand, 2012 
Figure 27: US Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 28: US Market Segmentation for In-vitro CRC Screening Tests, by Type, 2012 and 2019 
Figure 29: France Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 30: Germany Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 31: Italy Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 32: Spain Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 33: UK Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 34: Japan Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 35: Brazil Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 36: China Sales Forecast for In-vitro CRC Screening Tests ($m), 2010–2019 
Figure 37: India Sales Forecast for In-vitro CRC Screening Tests ($m), 2010-2019