The U.S. market for hemostasis devices is defined in this report as hemostasis probes, ligation devices, sclerotherapy needles and electrosurgical generators. The largest segment in this market was ligation devices. This segment represented approximately 66.1% of the total market in 2016. The relatively large size of this segment is mainly due to these devices being used as both a stand-alone and combination therapy with other devices to address gastrointestinal (GI) bleeding. Also, several units of clips are often used during one procedure. The smallest segment in this market was electro surgical generators (ESUs) due to the longevity of this capital equipment that extends beyond ten years, only one unit required per room, and 100% penetration, all resulting in a lower annual sale volume. Most of the devices discussed in this chapter are single-use, except for reusable heat probes and capital equipment, electro surgical generators including argon modules.
The value of the total U.S. market for hemostasis 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 four segments have different growth profiles with ligation devices exhibiting low-single digit rate cannibalizing into other segment, and thus resulting in a negative trend within the hemostasis probe segment. The ESU segment remains relatively flat, as this is mainly the replacement market as of 2016. The needle segment is growing at 1% annually as physicians use it as part of the combination therapy. The major contributor to the unit growth in this market is ligation device 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 Hemostasis Devices 49
3.1.1.1 Introduction 49
3.1.1.1.1 Product Matrix for Hemostasis Devices 51
3.2 REGULATORY ISSUES AND RECALLS 54
3.2.1 Hemostasis devices 54
3.3 CLINICAL TRIALS 55
3.3.1 Hemostasis devices 56
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
HEMOSTASIS DEVICE MARKET 67
4.1 MARKET OVERVIEW 67
4.2 MARKET ANALYSIS AND FORECAST 71
4.2.1 Total Hemostasis Device Market 71
4.2.2 Total Hemostasis Probe Market 73
4.2.2.1 Total Electrosurgical Probe Market 75
4.2.2.1.1 Conventional Electrosurgical Probe Market 76
4.2.2.1.2 Injection-Needle Probe Market 78
4.2.2.2 Heat Probe Market 80
4.2.2.3 Argon Plasma Coagulation Probe Market 82
4.2.3 Ligation Device Market 84
4.2.3.1 Ligation Band Market 86
4.2.3.2 Ligation Clip Market 88
4.2.4 Sclerotherapy Needle Market 90
4.2.5 Electrosurgical Generator Market 92
4.2.6.1 Electrosurgical Unit Market 93
4.2.7.1 Argon Module Market 94
4.3 DRIVERS AND LIMITERS 96
4.3.1 Market Drivers 96
4.3.2 Market Limiters 96
4.4 COMPETITIVE MARKET SHARE ANALYSIS 98
ABBREVIATIONS 102
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: Hemostasis Device Market by Segment, U.S., 2013 – 2023 69
Chart 4 2: Hemostasis Device Market Breakdown, U.S., 2016 70
Chart 4 3: Hemostasis Device Market Breakdown, U.S., 2023 70
Chart 4 4: Total Hemostasis Device Market, U.S., 2013 – 2023 72
Chart 4 5: Total Hemostasis Probe Market, U.S., 2013 – 2023 74
Chart 4 6: Total Electrosurgical Probe Market, U.S., 2013 – 2023 75
Chart 4 7: Conventional Electrosurgical Probe Market, U.S., 2013 – 2023 77
Chart 4 8: Injection-Needle Probe Market, U.S., 2013 – 2023 79
Chart 4 9: Heat Probe Market, U.S., 2013 – 2023 81
Chart 4 10: Argon Plasma Coagulation Probe Market, U.S., 2013 – 2023 83
Chart 4 11: Total Ligation Device Market, U.S., 2013 – 2023 85
Chart 4 12: Ligation Band Market, U.S., 2013 – 2023 87
Chart 4 13: Ligation Clip Market, U.S., 2013 – 2023 89
Chart 4 14: Sclerotherapy Needle Market, U.S., 2013 – 2023 91
Chart 4 15: Electrosurgical Generator Market, U.S., 2013 – 2023 95
Chart 4 16: Leading Competitors, Hemostasis Device Market, U.S., 2016 101
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, Hemostasis Device Market, U.S., 2016 (2 of 3) 51
Figure 3 2: Core Companies, Hemostasis Device Market, U.S., 2016 (2 of 3) 52
Figure 3 3: Core Companies, Hemostasis Device Market, U.S., 2016 (3 of 3) 53
Figure 3 4: Class 2 Device Olympus Electrosurgical Unit. 54
Figure 3 5: Hemostasis device– Effectiveness Study of the BioVac Direct Suction Device in Upper GI Bleeding 56
Figure 3 6: Hemostasis device– Argon Plasma Coagulation for Bleeding Peptic Ulcers 56
Figure 4 1: Hemostasis Device by Segment, U.S., 2013 – 2023 (US$M) 68
Figure 4 2: Total Hemostasis Device Market, U.S., 2013 – 2023 71
Figure 4 3: Total Hemostasis Probe Market, U.S., 2013 – 2023 73
Figure 4 4: Total Electrosurgical Probe Market, U.S., 2013 – 2023 75
Figure 4 5: Conventional Electrosurgical Probe Market, U.S., 2013 – 2023 76
Figure 4 6: Injection-Needle Probe Market, U.S., 2013 – 2023 78
Figure 4 7: Heat Probe Market, U.S., 2013 – 2023 80
Figure 4 8: Argon Plasma Coagulation Probe Market, U.S., 2013 – 2023 82
Figure 4 9: Total Ligation Device Market, U.S., 2013 – 2023 84
Figure 4 10: Ligation Band Market, U.S., 2013 – 2023 86
Figure 4 11: Ligation Clip Market, U.S., 2013 – 2023 88
Figure 4 12: Sclerotherapy Needle Market, U.S., 2013 – 2023 90
Figure 4 13: Electrosurgical Generator Market, U.S., 2013 – 2023 92
Figure 4 14: Electrosurgical Unit Market, U.S., 2013 – 2023 93
Figure 4 15: Argon Module Market, U.S., 2013 – 2023 94
Figure 4 16: Drivers and Limiters, Hemostasis Device Market, U.S., 2016 97
Figure 4 17: Leading Competitors, Hemostasis Device Market, U.S., 2016 100
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.
