The U.S. market for gastrointestinal (GI) endoscopes defined in this report as colonoscopes, sigmoidoscopies, duodenoscopes, enteroscopes, ultrasound endoscopes, double-balloon endoscopes, gastroscopes, and third-party resale. The largest segment in the total GI endoscope market was the colonoscope segment. The relatively large size of this segment is mainly due to the device being used in the most prevalent GI procedure, colonoscopy. On average, scopes are used 2.5 times per day with product life expectancy ranging from five to seven years depending on the usage rate and reprocessing routine. The market units are expected to continue growing in line with the macro trends such as aging population and growing popularity of screening programs. The prices, however, are trending down, fueled by negative reimbursement changes. Overall, the GI endoscope market is expected to grow steadily at a single-digit rate over the forecast period.
The value of the total U.S. market for GI endoscopes increased in 2016. Growth is expected to persist throughout the forecasted period and will be driven by increases in unit sales countered by a decline in the ASP. The majority of total GI endoscopes unit sales consisted of colonoscopes used in the hospital setting, either at a designated endoscopy room or general surgery suite, with the balance being used in the outpatient centers.
One major factor driving ASPs down is the on-going consolidation on the demand end of the market with hospitals and outpatients centers combining resources into Group Purchasing Organizations (GPOs), thus negotiating lower purchase prices. This trend affects the majority of units and will have continuing effect on the ASP downtrend.
As a rule of thumb, Olympus, the market leader by a large margin, on average has the highest pricing overall, followed by Pentax and Fujifilm relatively close to each other.
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TABLE OF CONTENTS I
LIST OF FIGURES VI
LIST OF CHARTS IX
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 Gastrointestinal Endoscopes 49
3.1.1.1 Introduction 49
3.1.1.1.1 Product Matrix for GI Endoscope Market 52
3.2 REGULATORY ISSUES AND RECALLS 55
3.2.1 Gastrointestinal endoscopes 55
3.2.2 Refurbishment endoscopes 59
3.3 CLINICAL TRIALS 60
3.3.1 Gastrointestinal Endoscopes 61
3.4 PRODUCT PIPELINES 69
3.4.1 Boston Scientific 69
3.4.1.1 AXIOS™ Stent and Electrocautery Enhanced Delivery System 69
3.4.1.2 Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device 69
3.4.1.3 Safe Enteral Feeding Product 69
3.4.1.4 Rotatable Snare 70
3.4.2 Cook Inc. 70
3.4.2.1 Lehman Manometry Catheter 70
3.4.3 Olympus 70
3.4.3.1 Olympus EZ Shot 3 Plus - a single-use aspiration needle 70
3.4.3.2 Olympus ESG-200 Electrosurgical Generator 70
3.4.3.3 Retooled GI Benchmarking Service 70
3.4.3.4 Big Screen Surgery In 4K: VISERA 4K UHD System 71
3.4.3.5 TJF-Q180V Duodenoscope 71
3.4.3.6 From AR 2015 – new strategy plan for General Surgery Unit 71
3.4.4 Medtronic / Covidien 72
3.4.4.1 Safe Enteral Feeding Product line 2016 72
3.4.4.2 Barrx 360 Express RFA balloon catheter for Barrett's Esophagus 72
3.4.5 Avantis Medical Systems 73
3.4.5.1 Third Eye Panoramic Colonoscopy Device 73
3.4.6 Pentax Medical/ HOYA 73
3.4.6.1 H OPTIVISTA-EPK-i7010 Video Processor for endoscopy 73
3.4.7 Fujifilm 73
3.4.7.1 Sonart SU-1 Endoscopic Ultrasonic Processors 73
3.4.7.2 Double Balloon Endoscope (EN-580T) 73
3.4.8 US Endoscopy 73
3.4.8.1 Moray® micro forceps 73
3.4.9 CONMED Corporation 74
3.4.9.1 ABC D-Flex Probes 74
3.4.10 EndoChoice 74
3.4.10.1 FDA clearance for Orca™ Sterile, Single-Use Air/Water and Suction Valves 74
3.4.10.2 Third generation Fuse® Full Spectrum Endoscopy® System 74
3.4.10.3 RescueNet™ retrieval device 74
3.4.10.4 Lumos™ Adaptive Matrix Imaging System 74
3.4.11 Endogastric Solution 75
3.4.11.1 Next-generation version of EsophyX® Device - EsophyX® Z 75
3.4.12 Mederi Therapeutics 75
3.4.12.1 Stretta RFT3 Technology 75
3.4.13 C2 Therapeutics 76
3.4.13.1 Coldplay III Trial Validating the C2 CryoBalloon™ Focal Ablation System for treating Barret’s Esophagus 76
3.4.14 Medigus 76
3.4.14.1 Next generation MUSE™ System for the long-term treatment of GERD 76
3.4.15 Merit Medical Systems, Inc. 76
3.4.15.1 Corvocet Biopsy System 76
3.4.16 Medivators, Inc. 76
3.4.16.1 AmplifEYE™ endoscopic overtube 76
3.4.17 Fujifilm Medical Systems USA, Inc. 77
3.4.17.1 Fujifilm Diathermic Slitter (flushknife) and Fujifilm Diathermic Slitter (clutchcutter) 77
3.4.17.2 New additions for Double Balloon Endoscopy (DBE) platform and the Advanced Endoscopic Platform including FlushKnife and ClutchCutter 77
3.4.18 Cook Medical 77
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)” 77
3.4.19 Vital Images, Inc. 78
3.4.19.1 Vitrea CT Colon Analysis 78
GASTROINTESTINAL ENDOSCOPE MARKET 79
4.1 MARKET OVERVIEW 79
4.2 MARKET ANALYSIS AND FORECAST 83
4.2.1 Total Gastrointestinal Endoscope Market. 83
4.2.2 Colonoscope Market 85
4.2.3 Sigmoidoscope Market 87
4.2.4 Duodenoscope Market 89
4.2.5 Enteroscope Market 91
4.2.6 Ultrasound Endoscope Market 93
4.2.7 Double-Balloon Endoscope Market 95
4.2.8 Gastroscope Market 97
4.2.9 Third Party Endoscope Resale Market 99
4.3 DRIVERS AND LIMITERS 101
4.3.1 Market Drivers 101
4.3.2 Market Limiters 102
4.4 COMPETITIVE MARKET SHARE ANALYSIS 104
4.4.1 Gastrointestinal Endoscope 104
4.4.2 Third Party Endoscope Resale and Repair Market 108
ABBREVIATIONS 111
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: Gastrointestinal Endoscope Market by Segment, U.S., 2013 – 2023 81
Chart 4 2: Gastrointestinal Endoscope Market Breakdown, U.S., 2016 82
Chart 4 3: Gastrointestinal Endoscope Market Breakdown, U.S., 2023 82
Chart 4 4: Total Gastrointestinal Endoscope Market, U.S., 2013 – 2023 84
Chart 4 5: Colonoscope Market, U.S., 2013 – 2023 86
Chart 4 6: Sigmoidoscope Market, U.S., 2013 – 2023 88
Chart 4 7: Duodenoscope Market, U.S., 2013 – 2023 90
Chart 4 8: Enteroscope Market, U.S., 2013 – 2023 92
Chart 4 9: Ultrasound Endoscope Market, U.S., 2013 – 2023 94
Chart 4 10: Double-Balloon Endoscope Market, U.S., 2013 – 2023 96
Chart 4 11: Gastroscope Market, U.S., 2013 – 2023 98
Chart 4 12: Third Party Endoscope Refurbishment Market, U.S., 2013 – 2023 100
Chart 4 13: Leading Competitors, Gastrointestinal Endoscope Market, U.S., 2016 107
Chart 4 14: Leading Competitors, Third Party Endoscope Refurbishment and Repair Market, U.S., 2016 110
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, GI Endoscope Market, U.S., 2016 (1 of 3) 52
Figure 3 2: Core Companies, GI Endoscope Market, U.S., 2016 (2 of 3) 53
Figure 3 3: Core Companies, GI Endoscope Market, U.S., 2016 (3 of 3) 54
Figure 3 4: Class 2 Device Recall Olympus Duodenoscope 55
Figure 3 5: Class 2 Device Recall Olympus Gastroscope 55
Figure 3 6: Class 2 Device Recall Fujifilm Duodenoscope 56
Figure 3 7: Class 2 Device Recall Fujifilm Image processor for Endoscopy 56
Figure 3 8: Class 2 Device Recall Fujifilm Duodenoscopes 56
Figure 3 9: Class 2 Device Recall Fujifilm Ultrasound Endoscope 56
Figure 3 10: Class 2 Device Recall EndoChoice Colonoscope 57
Figure 3 11: Class 2 Device Recall Pentax Ultrasound Video Gastroscopes 57
Figure 3 12: Class 2 Device Recall Pentax 58
Figure 3 13: Class2 Device Recall Integrated Medical Systems Inc., Olympus refurbishment flexible endoscopes 59
Figure 3 14: GI Endoscopes –Exploratory Study of Upper and Lower Endoscopic Fuse System 61
Figure 3 15: GI Endoscopes – Infrared Endoscope for diagnosis gastric cancer 61
Figure 3 16: GI Endoscopes – Assessing Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods 62
Figure 3 17: GI Endoscopes – A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy 63
Figure 3 18: GI Endoscopes – Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy 64
Figure 3 19: GI Endoscopes – Transnasal Endoscopy 64
Figure 3 20: GI Endoscopes – Post-marketing Study of SC20 Colonoscope (SC20 Scope) 64
Figure 3 21: GI Endoscopes – ENdocuff Optimisation of Mucosal Abnormalities 65
Figure 3 22: GI Endoscopes – Cap-assisted Endoscopy 65
Figure 3 23: GI Endoscopes – Visualization Balloon for Colonoscopy 65
Figure 3 24: GI Endoscopes – Third Eye Panoramic Device 66
Figure 3 25: GI Endoscopes – Disposable Sheathed Gastroscopic System 66
Figure 3 26: GI Endoscopes – Motus GI CleanUp System for Colonoscopy 66
Figure 3 27: GI Endoscopes – The Peerscope System™ for Polyp Detection 67
Figure 3 28: GI Endoscopes – Double-balloon Colonoscopy 67
Figure 3 29: GI Endoscopes – Magnetic Endoscope Imaging (MEI) in Single-balloon Enteroscopy 67
Figure 3 30: GI Endoscopes – ColoAssist vs. Magnetic Endoscope Imaging 68
Figure 3 31: GI Endoscopes – Visualization Technique in Colonoscopy 68
Figure 3 32: GI Endoscopes – Imaging Techniques 68
Figure 4 1: Gastrointestinal Endoscope Market by Segment, U.S., 2013 – 2023 (US$M) (1 of 2) 80
Figure 4 2: Gastrointestinal Endoscope Market by Segment, U.S., 2013 – 2023 (US$M) (2 of 2) 80
Figure 4 3: Total Gastrointestinal Endoscope Market, U.S., 2013 – 2023 83
Figure 4 4: Colonoscope Market, U.S., 2013 – 2023 85
Figure 4 5: Sigmoidoscope Market, U.S., 2013 – 2023 87
Figure 4 6: Duodenoscope Market, U.S., 2013 – 2023 89
Figure 4 7: Enteroscope Market, U.S., 2013 – 2023 91
Figure 4 8: Ultrasound Endoscope Market, U.S., 2013 – 2023 93
Figure 4 9: Double-Balloon Endoscope Market, U.S., 2013 – 2023 95
Figure 4 10: Gastroscope Market, U.S., 2013 – 2023 97
Figure 4 11: Third Party Endoscope Resale Market, U.S., 2013 – 2023 99
Figure 4 12: Drivers and Limiters, Gastrointestinal Endoscope Market, U.S., 2016 103
Figure 4 13: Leading Competitors, Gastrointestinal Endoscope Market, U.S., 2016 (1 of 2) 106
Figure 4 14: Leading Competitors, Gastrointestinal Endoscope Market, U.S., 2016 (2 of 2) 106
Figure 4 15: Leading Competitors, Third Party Endoscope Resale and Repair Market, U.S., 2016 109
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.
