The U.S. market for Barret’s esophagus ablation devices is defined in this report as generators and consumables (i.e. probes). While several manufacturers of different modalities exist for this indication, this chapter only includes the specialized three: Medtronic, CSA Medical, and C2 Therapeutics. The largest segment in this market was the consumables. The relatively large size of this segment is mainly due to the growth in the number of procedures performed annually, where a single patient can undergo three procedures in order to complete the treatment.
The value of the total U.S. market for Barret’s ablation devices increased in 2016. Growth is expected to persist throughout the forecasted period and will be driven by increases in unit sales countered by a decrease in the ASP. The growth has started to stabilize after experiencing a hyper stage during the period prior to 2012. The intrinsic pricing of the devices remains relative stable, with the negative trend coming mainly from the market leader expanding its line of products with smaller degree view, which commands lower pricing compared to the 360-degree view option.
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TABLE OF CONTENTS I
LIST OF FIGURES VI
LIST OF CHARTS VIII
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 Barrett’s Esophagus Ablation devices 49
3.1.1.1 Introduction 49
3.1.1.1.1 Product Matrix for Barret’s Esophagus Ablation Device Market 51
3.2 REGULATORY ISSUES AND RECALLS 52
3.2.1 Barrett’s Esophagus Ablation devices 52
3.3 CLINICAL TRIALS 53
3.3.1 Barrett’s Esophagus Ablation devices 54
3.4 PRODUCT PIPELINES 57
3.4.1 Boston Scientific 57
3.4.1.1 AXIOS™ Stent and Electrocautery Enhanced Delivery System 57
3.4.1.2 Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device 57
3.4.1.3 Safe Enteral Feeding Product 57
3.4.1.4 Rotatable Snare 58
3.4.2 Cook Inc. 58
3.4.2.1 Lehman Manometry Catheter 58
3.4.3 Olympus 58
3.4.3.1 Olympus EZ Shot 3 Plus - a single-use aspiration needle 58
3.4.3.2 Olympus ESG-200 Electrosurgical Generator 58
3.4.3.3 Retooled GI Benchmarking Service 58
3.4.3.4 Big Screen Surgery In 4K: VISERA 4K UHD System 59
3.4.3.5 TJF-Q180V Duodenoscope 59
3.4.3.6 From AR 2015 – new strategy plan for General Surgery Unit 59
3.4.4 Medtronic / Covidien 60
3.4.4.1 Safe Enteral Feeding Product line 2016 60
3.4.4.2 Barrx 360 Express RFA balloon catheter for Barrett's Esophagus 60
3.4.5 Avantis Medical Systems 61
3.4.5.1 Third Eye Panoramic Colonoscopy Device 61
3.4.6 Pentax Medical/ HOYA 61
3.4.6.1 H OPTIVISTA-EPK-i7010 Video Processor for endoscopy 61
3.4.7 Fujifilm 61
3.4.7.1 Sonart SU-1 Endoscopic Ultrasonic Processors 61
3.4.7.2 Double Balloon Endoscope (EN-580T) 61
3.4.8 US Endoscopy 61
3.4.8.1 Moray® micro forceps 61
3.4.9 CONMED Corporation 62
3.4.9.1 ABC D-Flex Probes 62
3.4.10 EndoChoice 62
3.4.10.1 FDA clearance for Orca™ Sterile, Single-Use Air/Water and Suction Valves 62
3.4.10.2 Third generation Fuse® Full Spectrum Endoscopy® System 62
3.4.10.3 RescueNet™ retrieval device 62
3.4.10.4 Lumos™ Adaptive Matrix Imaging System 62
3.4.11 Endogastric Solution 63
3.4.11.1 Next-generation version of EsophyX® Device - EsophyX® Z 63
3.4.12 Mederi Therapeutics 63
3.4.12.1 Stretta RFT3 Technology 63
3.4.13 C2 Therapeutics 64
3.4.13.1 Coldplay III Trial Validating the C2 CryoBalloon™ Focal Ablation System for treating Barret’s Esophagus 64
3.4.14 Medigus 64
3.4.14.1 Next generation MUSE™ System for the long-term treatment of GERD 64
3.4.15 Merit Medical Systems, Inc. 64
3.4.15.1 Corvocet Biopsy System 64
3.4.16 Medivators, Inc. 64
3.4.16.1 AmplifEYE™ endoscopic overtube 64
3.4.17 Fujifilm Medical Systems USA, Inc. 65
3.4.17.1 Fujifilm Diathermic Slitter (flushknife) and Fujifilm Diathermic Slitter (clutchcutter) 65
3.4.17.2 New additions for Double Balloon Endoscopy (DBE) platform and the Advanced Endoscopic Platform including FlushKnife and ClutchCutter 65
3.4.18 Cook Medical 65
3.4.18.1 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)” 65
3.4.19 Vital Images, Inc. 66
3.4.19.1 Vitrea CT Colon Analysis 66
BARRET’S ESOPHAGUS ABLATION DEVICE MARKET 67
4.1 MARKET OVERVIEW 67
4.2 MARKET ANALYSIS AND FORECAST 71
4.2.1 Total Barret’s Esophagus Ablation Device Market 71
4.2.2 Capital Equipment Market 72
4.2.3 Disposable Equipment Market 74
4.3 DRIVERS AND LIMITERS 76
4.3.1 Market Drivers 76
4.3.2 Market Limiters 76
4.4 COMPETITIVE MARKET SHARE ANALYSIS 78
ABBREVIATIONS 81
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: Barret’s Esophagus Device Market by Segment, U.S., 2013 – 2023 69
Chart 4 2: Barret’s Esophagus Device Market Breakdown, U.S., 2016 70
Chart 4 3: Barret’s Esophagus Device Market Breakdown, U.S., 2023 70
Chart 4 4: Capital Equipment Market, U.S., 2013 – 2023 73
Chart 4 5: Disposable Equipment Market, U.S., 2013 – 2023 75
Chart 4 6: Leading Competitors, Barrett’s Esophagus Ablation Device Market, U.S., 2016 80
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, Barret’s Esophagus Ablation Device Market, U.S., 2016 51
Figure 3 2: Class 2 Device Recall Covidien HALO Flex Energy Generators 52
Figure 3 3: Barrett’s Esophagus Ablation devices– Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer 54
Figure 3 4: Barrett’s Esophagus Ablation devices– Multi-center Clinical Study to Evaluate the Coldplay Focal Ablation System (ColdPlay3) 54
Figure 3 5: Barrett’s Esophagus Ablation devices– Radiofrequency Ablation for the Treatment of Gastric Dysplasia 55
Figure 3 6: Barrett’s Esophagus Ablation devices– A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy (DOSE) 55
Figure 3 7: Barrett’s Esophagus Ablation devices– Spray Cryotherapy for Esophageal Cancer (ICE-CANCER) 56
Figure 4 1: Barret’s Esophagus Device Market by Segment, U.S., 2013 – 2023 (US$M) 68
Figure 4 2: Capital Equipment Market, U.S., 2013 – 2023 72
Figure 4 3: Disposable Equipment Market, U.S., 2013 – 2023 74
Figure 4 4: Drivers and Limiters, Barrett’s Esophagus Ablation Device Market, U.S., 2016 77
Figure 4 5: Leading Competitors, Barrett’s Esophagus Ablation Device Market, U.S., 2016 79
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.
