REFERENCE CODE GDME1013FPR PUBLICATION DATE AUGUST 2013 IN-VITRO COLORECTAL CANCER SCREENING TESTS - CURRENT AND FUTURE PLAYERS

Transcription

1 REFERENCE CODE GDME1013FPR PUBLICATION DATE AUGUST 2013 IN-VITRO COLORECTAL CANCER SCREENING TESTS - CURRENT AND FUTURE PLAYERS

2 List of Tables List of Figures Introduction Catalyst Related Reports Competitive Assessment Overview Fecal Occult Blood Tests Guaiac Fecal Occult Blood Stool Tests Lateral Flow Immuno-Fecal Occult Blood Tests Readers Immuno-FOB Test ELISA Immuno-FOB Agglutination Tests CRC DNA Screening Tests Panel DNA Tests Methylated Gene Testing Other Biomarker Tests Overview Tumor M2-PK Stool Test/2-in-1 Quick Test Transferrin Assays

3 4 Pipeline Products Overview Pipeline by Phases in Development Pipeline Product Profiles BST1 CRC Assay Cologic ColoGuard Colon Cancer BEC Test Colon MarCare Plex Colox CRC Bacterial Signature Assay CRC Breath Test Epi procolon ExiQon MicroRNA Test Gemini CRC Biomarker Assay GenomicTree Methylated DNA Test Measure Fecal Occult Blood Test Metabiomics CRC Test MiR-21 Test Oncolite CR PanC-Dx Current and Future Players Overview

4 5.2 Trends in Corporate Strategy Company Profiles Abbott Molecular Alere Beckman Coulter Biomarcare Technologies Companion Dx Eiken Chemical Epigenomics Exact Sciences ExiQon Fujirebio (Miraca Holdings) GeneNews GenomicTree Immunostics Kyowa Medex MDx Health (was OncoMethylome) Merck Millipore Metabiomics Mode Diagnostics Oncocyte (Bio Time) Quest Diagnostics R-Biopharm

5 Randox Laboratories ScheBo Biotech SciMarket Technologies Siemens Healthcare Signature Diagnostics Sysmex Veda Lab Appendix Abbreviations Bibliography Research Methodology Coverage Secondary Research Physicians and Specialists Included in this Study Primary Research About the Authors Analysts Global Head of Healthcare About GlobalData Disclaimer

6 1.1 List of Tables Table 1: CRC Screening Test Segmentation Table 2: Guaiac Fecal Occult Blood Tests Product Profile Table 3: Guaiac FOB Test SWOT Analysis, Table 4: Immuno-FOB Tests Table 5: Product Profile Lateral Flow Immunochemical Fecal Occult Blood Tests Table 6: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, Table 7: Table 8: Product Profile Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, Table 9: Fecal Occult Blood ELISA Products Table 10: Product Profile Fecal Occult Blood ELISA Table 11: Immuno-FOB Test ELISA SWOT Analysis, Table 12: Commercially Available Immuno-FOB Agglutination Test Systems Table 13: Product Profile Immuno-FOB Agglutination Tests Table 14: Immuno-FOB Agglutination Tests SWOT Analysis, Table 15: Key Mutations Associated with CRC Table 16: Key Stages of PCR Gene Test Table 17: Product Profile PreGen Plus Table 18: PreGen Plus SWOT Analysis, Table 19: Product Profile K-RAS, B-RAF, PIK3CA Array Table 20: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, Table 21: Product Profile Colonsentry Table 22: Colonsentry SWOT Analysis,

7 Table 23: Product Profile Detector C Table 24: Detector C SWOT Analysis, Table 25: Product Profile ColoSure Table 26: ColoSure SWOT Analysis, Table 27: Product Profile MS Table 28: MS9 SWOT Analysis, Table 29: Septin-9 CRC Screening Marketed Laboratory-Developed Tests Table 30: Product Profile ColoVantage/Septin Table 31: ColoVantage/Septin-9 SWOT Analysis, Table 32: Product Profile Tumor M2-PK Stool Test/2-in-1 Quick Test Table 33: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, Table 34: Product Profile Transferrin Assays Table 35: Transferrin Assays SWOT Analysis, Table 36: CRC Screening Tests Pipeline, Table 37: Product Profile BST1 CRC Assay Table 38: BST1 CRC Assay SWOT Analysis, Table 39: Product Profile Cologic Table 40: Cologic SWOT Analysis, Table 41: Product Profile ColoGuard Table 42: ColoGuard SWOT Analysis, Table 43: Product Profile Colon Cancer BEC Test Table 44: Colon Cancer BEC Test SWOT Analysis, Table 45: Product Profile Colon MarCare Plex Table 46: Colon MarCare Plex SWOT Analysis,

8 Table 47: Product Profile Colox Table 48: Colox SWOT Analysis, Table 49: Product Profile CRC Bacterial Signature Assay Table 50: CRC Bacterial Signature Assay SWOT Analysis, Table 51: Product Profile CRC Breath Test Table 52: CRC Breath Test SWOT Analysis, Table 53: Product Profile Epi procolon Table 54: Epi procolon Clinical Trials Table 55: Epi procolon SWOT Analysis, Table 56: ExiQon MicroRNA Sensitivity and Specificity Table 57: Product Profile ExiQon microrna Test Table 58: ExiQon microrna Test SWOT Analysis, Table 59: Product Profile Gemini CRC Biomarker Assay Table 60: Gemini CRC Biomarker Assay SWOT Analysis, Table 61: Product Profile GenomicTree Methylated DNA Test Table 62: GenomicTree Methylated DNA Test SWOT Analysis, Table 63: Product Profile Measure Table 64: Measure SWOT Analysis, Table 65: Product Profile Metabiomics CRC Test Table 66: Metabiomics CRC Test SWOT Analysis, Table 67: Product Profile mir-21 Test Table 68: mir-21 Test SWOT Analysis, Table 69: Product Profile Oncolite-CR Table 70: Oncolite-CR SWOT Analysis,

9 Table 71: Product Profile PanC-Dx Table 72: PanC-Dx SWOT Analysis, Table 73: Company Profile Abbott Molecular Table 74: Abbott Molecular SWOT Analysis, Table 75: Company Profile Alere Table 76: Alere SWOT Analysis, Table 77: Company Profile Beckman Coulter Table 78: Beckman Coulter SWOT Analysis, Table 79: Company Profile Biomarcare Technologies Table 80: Biomarcare Technologies SWOT Analysis, Table 81: Company Profile Companion Dx Table 82: Companion Dx SWOT Analysis, Table 83: Company Profile Eiken Chemical Table 84: Eiken Chemical SWOT Analysis, Table 85: Company Profile Epigenomics Table 86: Epigenomics SWOT Analysis, Table 87: Company Profile Exact Sciences Table 88: Exact Sciences SWOT Analysis, Table 89: Company Profile ExiQon Table 90: ExiQon SWOT Analysis, Table 91: Company Profile Fujirebio (Miraca Holdings) Table 92: Fujirebio SWOT Analysis, Table 93: Company Profile GeneNews Table 94: GeneNews SWOT Analysis,

10 Table 95: Company Profile GenomicTree Table 96: GenomicTree SWOT Analysis, Table 97: Company Profile Immunostics Table 98: Immunostics SWOT Analysis, Table 99: Company Profile Kyowa Medex (Kyowa Hakko Kirin Group) Table 100: Kyowa Medex SWOT Analysis, Table 101: Company Profile MDx Health Table 102: MDx Health SWOT Analysis, Table 103: Company Profile Merck Millipore Table 104: Merck Millipore SWOT Analysis, Table 105: Company Profile Metabiomics Table 106: Metabiomics SWOT Analysis, Table 107: Company Profile Mode Diagnostics Table 108: Mode Diagnostics SWOT Analysis, Table 109: Company Profile Oncocyte (Bio Time) Table 110: Oncocyte (Bio Time) SWOT Analysis, Table 111: Company Profile Quest Diagnostics Table 112: Quest Diagnostics SWOT Analysis, Table 113: Company Profile R-Biopharm Table 114: R-Biopharm SWOT Analysis, Table 115: Company Profile Randox Laboratories Table 116: Randox Laboratories SWOT Analysis, Table 117: Company Profile ScheBo Biotech Table 118: Schebo Biotech SWOT Analysis,

11 Table 119: Company Profile SciMarket Technologies Table 120: SciMarket Technologies SWOT Analysis, Table 121: Company Profile Siemens Healthcare Table 122: Siemens Healthcare SWOT Analysis, Table 123: Company Profile Signature Diagnostics Table 124: Signature Diagnostics SWOT Analysis, Table 125: Company Profile Sysmex Table 126: Sysmex SWOT Analysis, Table 127: Company Profile Veda Lab Table 128: Veda Lab SWOT Analysis,

12 1.2 List of Figures Figure 1: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen Figure 2: Fecal Occult Blood Test Lateral Flow Device Architecture Figure 3: Biohit Colonview (example of immuno-fob test) Figure 4: Beckman Coulter Hemoccult-ICT (example of immuno-fob test) Figure 5: Veda Labs Easy Reader Immuno-FOB Test LFD Reader Figure 6: OC-Hemodia Agglutination FOB Test (manually performed) Figure 7: OC-Sensor/Diana FOB Test Sample Cartridge Figure 8: OC-Sensor/Diana FOB Test Instrument Figure 9: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction Figure 10: Sentinel Diagnostic Sentifob Instrument Figure 11: Alere CI5 NS-Plus Instrument Figure 12: Orion Diagnostics Quikread FOB Test and Instrument Figure 13: Basic PCR Process Figure 14: MS9 PCR Response Curve Figure 15: Proposed ColoGuard Patient Stool Sample Collection Kit Figure 16: Exact Sciences Automated Sample Processing WorkStation Figure 17: Colox Kit Contents Figure 18: Measure Fecal Occult Blood Test Figure 19: PanC-Dx Multiplex Detection of CRC-specific Biomarker

13 Introduction 2 Introduction 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. This report focuses on the in-vitro CRC screening test markets in the US and Europe (France, Germany, Italy, Spain, and the UK), Japan and future markets in China, India and Brazil, and identifies unmet needs in the market, physician attitudes towards current modalities in in-vitro CRC screening, and the future of CRC screening in the face of rapid technological advancement. 2.1 Catalyst Colorectal cancer screening can be carried out using a number of different methods which are either invasive or non-invasive. Typical approaches include endoscopic examination of the bowel or analysis of fecal samples for evidence of disease. Endoscopic procedures pose challenges, in terms of patient access, cost and risk. Fecal sample analysis poses challenges in patient compliance, disease sensitivity and disease specificity. New in-vitro tests promise improved sensitivity and specificity, while at the same time improving patient compliance. Two new CRC screening tests from Exact Sciences and Epigenomics are expected to receive FDA Premarket Approval in late 2013 or early 2014, and these tests may dramatically change the in-vitro CRC screening test landscape. 13

14 Appendix 6.7 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in medical device research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore. 6.8 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisher, GlobalData. 213