The U.S. market for virtual colonoscopy is defined in this report as virtual colonoscopy software installed on workstations and servers for CT and MRI scanners. The value of the total U.S. market for colonoscopy software decreased in 2016. The negative trend is expected throughout the forecast period and will be driven by the drop in the units sales with slightly positive addition from the ASP. The majority of virtual colonoscopy software units are sold as part of the total software package for workstations to hospitals and outpatients facilities alike. Only a small portion of units are sold as a standalone solution. For the purpose of this report the ASP was calculated based on the price of virtual colonoscopy software as part of the software bundle.
Some of the major factors driving units down are an unfavorable reimbursement structure and strong lobbying against using colonography as one of the key colon cancer screening methods. Most of sales have occurred in the period of 2004 and 2009 when colongraphy was gaining traction. However, since 2009 the market started to rapidly decline. As of 2016, colonography is only reimbursable by CMS under certain conditions (such as failed colonoscopy), and could be reimbursed under normal conditions in 21 states. Still, the official status of virtual colonoscopy has not been established within CMS. Many private insurance companies cover colonography. Overall, the market is expected to decline at an annual mid-single digit rate. One positive factor that might help counter unit erosion is a relative affordability of colonography against optical colonoscopy. Given the growing costs of colonoscopy screening in the United States, the market might turn its attention back to colonography.
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TABLE OF CONTENTS I
LIST OF FIGURES VI
LIST OF CHARTS VII
EXECUTIVE SUMMARY 1
U.S. GASTROINTESTINAL ENDOSCOPIC DEVICE MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 3
MARKET TRENDS 6
MARKET DEVELOPMENTS 8
PROCEDURE NUMBERS 9
PROCEDURE CODES INVESTIGATED 10
MARKETS INCLUDED 11
1.1 KEY REPORT UPDATES 15
VERSION HISTORY 15
RESEARCH METHODOLOGY 16
1.1 RESEARCH SCOPE 16
1.2 IDATA’S 9-STEP METHODOLOGY 16
Step 1: Project Initiation & Team Selection 16
Step 2: Prepare Data Systems and Perform Secondary Research 18
Step 3: Preparation for Interviews & Questionnaire Design 19
Step 4: Performing Primary Research 20
Step 5: Research Analysis: Establishing Baseline Estimates 22
Step 6: Market Forecast and Analysis 23
Step 7: Identify Strategic Opportunities 25
Step 8: Final Review and Market Release 26
Step 9: Customer Feedback and Market Monitoring 27
DISEASE OVERVIEW 28
2.1 BASIC ANATOMY 28
2.2 GASTROINTESTINAL DISEASE: TREATMENT AND DIAGNOSTICS 29
2.2.1 Gastro-Esophageal Reflux Disease (GERD) 32
2.2.2 Barrett's Esophagus 33
2.2.3 Digestive Cancer 33
2.2.4 Gastrointestinal bleeding 35
2.2.5 Bile Duct Disorders 36
2.2.6 Crohn’s disease 37
2.2.7 Ulcer 37
2.2.8 Ogilvie Syndrome or Intestinal Pseudo-Obstruction 38
2.3 PATIENT DEMOGRAPHICS 40
2.3.11 Patient Demographics 40
2.3.11.1 All Digestive Diseases 40
2.3.11.2 Abdominal Wall Hernia 42
2.3.11.3 Chronic Constipation 42
2.3.11.4 Diverticular Disease 42
2.3.11.5 Prescriptions 42
2.3.11.6 Gastroesophageal Reflux Disease 43
2.3.11.7 Gastrointestinal Infections 43
2.3.11.8 Hemorrhoids 43
2.3.11.9 Inflammatory Bowel Disease 44
2.3.11.10 Liver Disease 44
2.3.11.11 Pancreatitis 45
2.3.11.12 Peptic Ulcer Diseases 45
2.3.12 Digestive Cancer 46
PRODUCT ASSESSMENT 49
3.1 PRODUCT PORTFOLIOS 49
3.1.1 Virtual Colonoscopy 49
3.1.1.1 Introduction 49
3.1.1.1.1 Product Matrix for Virtual Colonoscopy Market 51
3.2 CLINICAL TRIALS 53
3.2.1 Virtual Colonoscopy 54
3.3 PRODUCT PIPELINES 56
3.3.1 Boston Scientific 56
3.3.1.1 AXIOS™ Stent and Electrocautery Enhanced Delivery System 56
3.3.1.2 Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device 56
3.3.1.3 Safe Enteral Feeding Product 56
3.3.1.4 Rotatable Snare 57
3.3.2 Cook Inc. 57
3.3.2.1 Lehman Manometry Catheter 57
3.3.3 Olympus 57
3.3.3.1 Olympus EZ Shot 3 Plus - a single-use aspiration needle 57
3.3.3.2 Olympus ESG-200 Electrosurgical Generator 57
3.3.3.3 Retooled GI Benchmarking Service 57
3.3.3.4 Big Screen Surgery In 4K: VISERA 4K UHD System 58
3.3.3.5 TJF-Q180V Duodenoscope 58
3.3.3.6 From AR 2015 – new strategy plan for General Surgery Unit 58
3.3.4 Medtronic / Covidien 59
3.3.4.1 Safe Enteral Feeding Product line 2016 59
3.3.4.2 Barrx 360 Express RFA balloon catheter for Barrett's Esophagus 59
3.3.5 Avantis Medical Systems 60
3.3.5.1 Third Eye Panoramic Colonoscopy Device 60
3.3.6 Pentax Medical/ HOYA 60
3.3.6.1 H OPTIVISTA-EPK-i7010 Video Processor for endoscopy 60
3.3.7 Fujifilm 60
3.3.7.1 Sonart SU-1 Endoscopic Ultrasonic Processors 60
3.3.7.2 Double Balloon Endoscope (EN-580T) 60
3.3.8 US Endoscopy 60
3.3.8.1 Moray® micro forceps 60
3.3.9 CONMED Corporation 61
3.3.9.1 ABC D-Flex Probes 61
3.3.10 EndoChoice 61
3.3.10.1 FDA clearance for Orca™ Sterile, Single-Use Air/Water and Suction Valves 61
3.3.10.2 Third generation Fuse® Full Spectrum Endoscopy® System 61
3.3.10.3 RescueNet™ retrieval device 61
3.3.10.4 Lumos™ Adaptive Matrix Imaging System 61
3.3.11 Endogastric Solution 62
3.3.11.1 Next-generation version of EsophyX® Device - EsophyX® Z 62
3.3.12 Mederi Therapeutics 62
3.3.12.1 Stretta RFT3 Technology 62
3.3.13 C2 Therapeutics 63
3.3.13.1 Coldplay III Trial Validating the C2 CryoBalloon™ Focal Ablation System for treating Barret’s Esophagus 63
3.3.14 Medigus 63
3.3.14.1 Next generation MUSE™ System for the long-term treatment of GERD 63
3.3.15 Merit Medical Systems, Inc. 63
3.3.15.1 Corvocet Biopsy System 63
3.3.16 Medivators, Inc. 63
3.3.16.1 AmplifEYE™ endoscopic overtube 63
3.3.17 Fujifilm Medical Systems USA, Inc. 64
3.3.17.1 Fujifilm Diathermic Slitter (flushknife) and Fujifilm Diathermic Slitter (clutchcutter) 64
3.3.17.2 New additions for Double Balloon Endoscopy (DBE) platform and the Advanced Endoscopic Platform including FlushKnife and ClutchCutter 64
3.3.18 Cook Medical 64
3.3.18.1 New study “A Multicenter Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device (ASPRO)” 64
3.3.19 Vital Images, Inc. 65
3.3.19.1 Vitrea CT Colon Analysis 65
VIRTUAL COLONOSCOPY MARKET 66
4.1 MARKET ANALYSIS AND FORECAST 66
4.2 DRIVERS AND LIMITERS 69
4.2.1 Market Drivers 69
4.2.2 Market Limiters 70
4.3 COMPETITIVE MARKET SHARE ANALYSIS 72
ABBREVIATIONS 76
Chart 1 1: Gastrointestinal Endoscopic Device Market by Segment, U.S., 2013 – 2023 2
Chart 1 2: Gastrointestinal Endoscopic Device Market Overview, U.S., 2016 & 2023 2
Chart 2 1: Male Incidence, Digestive Cancer, U.S., 2016 47
Chart 2 2: Male Deaths, Digestive Cancer, U.S., 2016 47
Chart 2 3: Female Incidence, Digestive Cancer, U.S., 2016 48
Chart 2 4: Female Deaths, Digestive Cancer, U.S., 2016 48
Chart 4 1: Virtual Colonoscopy Market, U.S., 2013 – 2023 68
Chart 4 2: Leading Competitors, Virtual Colonoscopy Market, U.S., 2016 75
Figure 1 1: Gastrointestinal Endoscopic Device Market Share Ranking by Segment, U.S., 2016 (1 of 2) 4
Figure 1 2: Gastrointestinal Endoscopic Device Market Share Ranking by Segment, U.S., 2016 (2 of 2) 4
Figure 1 3: Companies Researched in this Report, U.S., 2016 5
Figure 1 4: Factors Impacting the Gastrointestinal Endoscopic Device Market by Segment, U.S. (1 of 2) 6
Figure 1 5: Factors Impacting the Gastrointestinal Endoscopic Device Market by Segment, U.S. (2 of 2) 7
Figure 1 6: Recent Events in the Gastrointestinal Endoscopic Device Market, U.S., 2012 – 2016 8
Figure 1 7: Gastrointestinal Endoscopic Device Markets Covered, U.S., 2016 9
Figure 1 8: Procedure Codes Investigated, U.S., 2016 10
Figure 1 9: Gastrointestinal Endoscopic Device Markets Covered, U.S., 2016 (1 of 4) 11
Figure 1 10: Gastrointestinal Endoscopic Device Markets Covered, U.S., 2016 (2 of 4) 12
Figure 1 11: Gastrointestinal Endoscopic Device Markets Covered, U.S., 2016 (3 of 4) 13
Figure 1 12: Gastrointestinal Endoscopic Device Markets Covered, U.S., 2016 (4 of 4) 14
Figure 1 13: Key Report Updates 15
Figure 1 14: Version History 15
Figure 2 1: Leading Physician Diagnoses for GI Disorders, U.S., 2009 31
Figure 2 2: General Statistic of Digestive Diseases: All Digestive Diseases, U.S., 2004 – 2010 (1 of 2) 40
Figure 2 3: General Statistic of Digestive Diseases: All Digestive Diseases, U.S., 2004 – 2010 (2 of 2) 41
Figure 2 4: Digestive Cancer Statistics by Type and Gender, U.S., 2016 46
Figure 3 1: Core Companies, Virtual Endoscope Market, U.S., 2016 (1 of 2) 51
Figure 3 2: Core Companies, Virtual Endoscope Market, U.S., 2016 (2 of 2) 52
Figure 3 3: Virtual Colonoscopy – Colonoscopy Methods for Screening Colorectal Cancer 54
Figure 3 4: Virtual Colonoscopy – CT-Colonography with Standard CT Scan and Optical Colonoscopy 54
Figure 3 5: Virtual Colonoscopy – Detection Rate of a Colorectal Cancer: CT Colonography vs. Flexible Sigmoidoscopy 55
Figure 4 1: Virtual Colonoscopy Market, U.S., 2013 – 2023 (US$M) 67
Figure 4 2: Virtual Colonoscopy Workstation Penetration Rate, U.S., 2013 – 2023 (US$M) 67
Figure 4 3: Drivers and Limiters, Virtual Colonoscopy Market, U.S., 2016 71
Figure 4 4: Leading Competitors, Virtual Colonoscopy Market, U.S., 2016 74
Boston Scientific
Olympus
Medtronic
Cook Medical
Halyard
Medline
Pentax
ConMed
Fujinon
Moog
C. R. Bard
Endogastric
GE Healthcare
Others include: Alcor Scientific, Applied Medical Technologies, BARD, C2 Therapeutics, Capso Vision, ConMed, CSA Medical, Endochoice, ERBE, Genii, GI Supply, Hobbs Medical, Intromedic, Mederi, Medigus, Medivators, Medline, Merit Endotek, Micro-tech Endoscopy, Mobile Instruments, Moog, Northfield Instruments, Philips, Prezio, MedService International, Rendoscopy, Siemens, Steris, Taewoon Medical, Telemed Systems, TeraREcon, Torax, US Endoscopy, Viatronix, Vital Images, and others.
