The U.S. market for specimen and foreign-body removal devices is defined in this report as polyp retrieval traps, specimen retrieval nets, foreign-body removal nets, foreign-body removal graspers, and foreign-body removal snares. The largest segment in this market was the specimen retrieval segment. This segment represented approximately 78.4% of the total market in 2016. The relatively large size of this segment is mainly due to these devices being involved in most of the high-volume polyp removal procedures with the snare technique, where a separate device to remove the polyp is required. Most of the devices discussed in this chapter are single-use and therefore correspond one-to-one with the underlying procedure. Only a small number of graspers and snare units were reusable.
The value of the total U.S. market for specimen and foreign body removal 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 vast majority of units in this market are sold to hospitals, with only relatively few units used in the outpatient centers.
The two segments have different growth profiles with the specimen retrieval segment experiencing a low growth, while the foreign-body removal segment is on the decline. The major contributor to the unit growth in this market is the polyp retrieval trap segment due to high volume coupled with the low-single digit growth rate.
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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 Foreign Body Retrieval and Specimen Removal devices 49
3.1.1.1 Introduction 49
3.1.1.1.1 Product matrix for Specimen Retrieval and Foreign Body Removal Devices 51
3.2 REGULATORY ISSUES AND RECALLS 53
3.2.1 Foreign Body Retrieval and Specimen Removal devices 53
3.3 CLINICAL TRIALS 54
3.3.1 Foreign Body and Specimen Removal devices 55
3.4 PRODUCT PIPELINES 56
3.4.1 Boston Scientific 56
3.4.1.1 AXIOS™ Stent and Electrocautery Enhanced Delivery System 56
3.4.1.2 Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device 56
3.4.1.3 Safe Enteral Feeding Product 56
3.4.1.4 Rotatable Snare 57
3.4.2 Cook Inc. 57
3.4.2.1 Lehman Manometry Catheter 57
3.4.3 Olympus 57
3.4.3.1 Olympus EZ Shot 3 Plus - a single-use aspiration needle 57
3.4.3.2 Olympus ESG-200 Electrosurgical Generator 57
3.4.3.3 Retooled GI Benchmarking Service 57
3.4.3.4 Big Screen Surgery In 4K: VISERA 4K UHD System 58
3.4.3.5 TJF-Q180V Duodenoscope 58
3.4.3.6 From AR 2015 – new strategy plan for General Surgery Unit 58
3.4.4 Medtronic / Covidien 59
3.4.4.1 Safe Enteral Feeding Product line 2016 59
3.4.4.2 Barrx 360 Express RFA balloon catheter for Barrett's Esophagus 59
3.4.5 Avantis Medical Systems 60
3.4.5.1 Third Eye Panoramic Colonoscopy Device 60
3.4.6 Pentax Medical/ HOYA 60
3.4.6.1 H OPTIVISTA-EPK-i7010 Video Processor for endoscopy 60
3.4.7 Fujifilm 60
3.4.7.1 Sonart SU-1 Endoscopic Ultrasonic Processors 60
3.4.7.2 Double Balloon Endoscope (EN-580T) 60
3.4.8 US Endoscopy 60
3.4.8.1 Moray® micro forceps 60
3.4.9 CONMED Corporation 61
3.4.9.1 ABC D-Flex Probes 61
3.4.10 EndoChoice 61
3.4.10.1 FDA clearance for Orca™ Sterile, Single-Use Air/Water and Suction Valves 61
3.4.10.2 Third generation Fuse® Full Spectrum Endoscopy® System 61
3.4.10.3 RescueNet™ retrieval device 61
3.4.10.4 Lumos™ Adaptive Matrix Imaging System 61
3.4.11 Endogastric Solution 62
3.4.11.1 Next-generation version of EsophyX® Device - EsophyX® Z 62
3.4.12 Mederi Therapeutics 62
3.4.12.1 Stretta RFT3 Technology 62
3.4.13 C2 Therapeutics 63
3.4.13.1 Coldplay III Trial Validating the C2 CryoBalloon™ Focal Ablation System for treating Barret’s Esophagus 63
3.4.14 Medigus 63
3.4.14.1 Next generation MUSE™ System for the long-term treatment of GERD 63
3.4.15 Merit Medical Systems, Inc. 63
3.4.15.1 Corvocet Biopsy System 63
3.4.16 Medivators, Inc. 63
3.4.16.1 AmplifEYE™ endoscopic overtube 63
3.4.17 Fujifilm Medical Systems USA, Inc. 64
3.4.17.1 Fujifilm Diathermic Slitter (flushknife) and Fujifilm Diathermic Slitter (clutchcutter) 64
3.4.17.2 New additions for Double Balloon Endoscopy (DBE) platform and the Advanced Endoscopic Platform including FlushKnife and ClutchCutter 64
3.4.18 Cook Medical 64
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)” 64
3.4.19 Vital Images, Inc. 65
3.4.19.1 Vitrea CT Colon Analysis 65
SPECIMEN AND FOREIGN-BODY REMOVAL DEVICE MARKET 66
4.1 MARKET OVERVIEW 66
4.2 MARKET ANALYSIS AND FORECAST 70
4.2.1 Total Specimen and Foreign Body Removal Device Market 70
4.2.2 Total Specimen Retrieval Device Market 72
4.2.2.1 Polyp Retrieval Trap Market 74
4.2.2.2 Specimen Retrieval Net Market 76
4.2.3 Total Foreign-Body Removal Device Market 78
4.2.3.1 Foreign-Body Removal Net Market 80
4.2.3.2 Foreign-Body Removal Grasper Market 82
4.2.3.3 Foreign-Body Removal Snare Market 84
4.3 DRIVERS AND LIMITERS 86
4.3.1 Market Drivers 86
4.3.2 Market Limiters 87
4.4 COMPETITIVE MARKET SHARE ANALYSIS 88
ABBREVIATIONS 91
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: Specimen and Foreign Body Removal Device Market by Segment, U.S., 2013 – 2023 68
Chart 4 2: Specimen and Foreign Body Removal Device Market Breakdown, U.S., 2016 69
Chart 4 3: Specimen and Foreign Body Removal Device Market Breakdown, U.S., 2023 69
Chart 4 4: Total Specimen and Foreign Body Removal Device Market, U.S., 2013 – 2023 71
Chart 4 5: Total Specimen Retrieval Device Market, U.S., 2013 – 2023 73
Chart 4 6: Polyp Retrieval Trap Market, U.S., 2013 – 2023 75
Chart 4 7: Specimen Retrieval Net Market, U.S., 2013 – 2023 77
Chart 4 8: Total Foreign-Body Removal Device Market, U.S., 2013 – 2023 79
Chart 4 9: Foreign-Body Removal Net Market, U.S., 2013 – 2023 81
Chart 4 10: Foreign-Body Removal Grasper Market, U.S., 2013 – 2023 83
Chart 4 11: Foreign-Body Removal Snare Market, U.S., 2013 – 2023 85
Chart 4 12: Leading Competitors, Specimen and Foreign-Body Removal Device Market, U.S., 2016 90
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, Retrieval and Foreign Body Removal Device Market, U.S., 2016 (1 of 2) 51
Figure 3 2: Core Companies, Retrieval and Foreign Body Removal Device Market, U.S., 2016 (2 of 2) 52
Figure 3 3: Class 2 Device Recall Boston Scientific TWISTER PLUS Rotatable Retrieval Device 53
Figure 3 4: Class 2 Device Recall US Endoscopy Group Talon Grasping Device 53
Figure 3 5: Class 2 Device Recall US Endoscopy Group Raptor grasping device 53
Figure 3 6: Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM 55
Figure 4 1: Specimen and Foreign Body Removal Device Market by Segment, U.S., 2013 – 2023 (US$M) 67
Figure 4 2: Total Specimen and Foreign Body Removal Device Market, U.S., 2013 – 2023 70
Figure 4 3: Total Specimen Retrieval Device Market, U.S., 2013 – 2023 72
Figure 4 4: Polyp Retrieval Trap Market, U.S., 2013 – 2023 74
Figure 4 5: Specimen Retrieval Net Market, U.S., 2013 – 2023 76
Figure 4 6: Total Foreign-Body Removal Device Market, U.S., 2013 – 2023 78
Figure 4 7: Foreign-Body Removal Net Market, U.S., 2013 – 2023 80
Figure 4 8: Foreign-Body Removal Grasper Market, U.S., 2013 – 2023 82
Figure 4 9: Foreign-Body Removal Snare Market, U.S., 2013 – 2023 84
Figure 4 10: Drivers and Limiters, Specimen and Foreign-Body Removal Device Market, U.S., 2016 87
Figure 4 11: Leading Competitors, Specimen and Foreign-Body Removal Device Market, U.S., 2016 89
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.
