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Market Research Report

United States Endoscopy Devices Investment Opportunities, Analysis and Forecasts to 2015

Published by Global Markets Direct Contact us : +1-860-674-8796
Published 2009/04 Content info Pages: 131
Product code LABD88990
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Description TOC

Table of Contents

1 Table of Contents 2
1.1 List of Tables 9
1.2 List of Figures 12
2 Introduction 14
2.1 What Is This Report About? 14
3 Definitions of the Markets Covered in the Report 15
3.1 Endoscopy Devices 15
3.2 Capsule Endoscope System 15
3.2.1 Capsule Endoscopy Workstation 15
3.2.2 Capsule Endoscope 15
3.3 Endoscopic Instruments 15
3.4 Endoscopic Reprocessors 15
3.5 Flexible Endoscope 16
3.5.1 Fibroroscopes 16
3.5.2 Videoscopes 16
3.6 Endoscopy Fluid Management System 16
3.7 Rigid Endoscope 17
3.7.1 Hysteroscopes 17
3.7.2 Laparoscopes 17
3.8 Endoscopy Visualization Systems 17
4 Healthcare Sector Review 18
4.1 Healthcare Expenditure 18
4.2 Healthcare Infrastructure 20
4.2.1 Healthcare Personnel Data 22
4.3 United States Healthcare Trade Statistics 24
5 Regulation System 25
5.1 Regulation System 25
5.2 Medical Equipment Approval Process 25
5.2.1 Pre-market Approval Process 26
5.2.2 Intended use and Indications for use 26
5.2.3 Predicate Device 27
5.2.4 Safe and Effective 27
5.2.5 Other Category Devices 29
5.2.6 Post-Market Approval Process 30
5.2.7 Compliance and Enforcement 30
5.2.8 Registration Fee 31
5.2.9 Approval Time 31
6 Pricing and Reimbursement 32
6.1 Government Policies 32
6.2 Private Insurance 33
6.3 Diagnosis Related Groups (DRG) 34
7 Distribution Structure 35
7.1 Distribution Structure 35
8 Endoscopy Devices In United States 36
8.1 Endoscopy Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 36
8.2 Endoscopy Devices, United States, Overall Revenue ($ mn), 2000-2015 37
8.3 Endoscopy Devices, United States, Category Volume (Units), 2000-2015 43
8.4 Endoscopy Devices, United States, Company Share (2006-2007) 46
9 Capsule Endoscope System In United States 47
9.1 Capsule Endoscope System Overall Revenue (2000-2015) 47
9.2 Capsule Endoscope System Overall Volume (2000-2015) 49
9.3 Capsule Endoscope System Average Price (2000-2015) 50
9.4 Capsule Endoscope System Distribution Share (2007-2008) 51
9.5 Capsule Endoscope System, United States, Company Share (2006-2007) 52
10 Endoscopic Instruments In United States 53
10.1 Endoscopic Instruments Overall Revenue (2000-2015) 53
10.2 Endoscopic Instruments Distribution Share (2007-2008) 55
11 Endoscopic Reprocessors In United States 56
11.1 Endoscopic Reprocessors Overall Revenue (2000-2015) 56
11.2 Endoscopic Reprocessors Overall Volume (2000-2015) 58
11.3 Endoscopic Reprocessors Average Price (2000-2015) 60
11.4 Endoscopic Reprocessors Distribution Share (2007-2008) 61
11.5 Endoscopic Reprocessors, United States, Company Share (2006-2007) 62
12 Flexible Endoscope In United States 63
12.1 Flexible Endoscope Overall Revenue (2000-2015) 63
12.1.1 Fibroscope Revenue (2000-2015) 65
12.2 Flexible Endoscope Overall Volume (2000-2015) 67
12.2.1 Fibroscope Volume (2000-2015) 69
12.3 Flexible Endoscope Average Price (2000-2015) 71
12.4 Flexible Endoscope Distribution Share (2007-2008) 72
12.5 Flexible Endoscope, United States, Company Share (2006-2007) 73
13 Endoscopy Fluid Management Systems In United States 74
13.1 Endoscopy Fluid Management Systems Overall Revenue (2000-2015) 74
13.2 Endoscopy Fluid Management Systems Overall Volume (2000-2015) 76
13.3 Endoscopy Fluid Management Systems Average Price (2000-2015) 78
13.4 Endoscopy Fluid Management Systems Distribution Share (2007-2008) 79
14 Rigid Endoscope In United States 80
14.1 Rigid Endoscope Overall Revenue (2000-2015) 80
14.2 Rigid Endoscope Overall Volume (2000-2015) 82
14.3 Rigid Endoscope Average Price (2000-2015) 84
14.4 Rigid Endoscope Distribution Share (2007-2008) 85
14.5 Rigid Endoscope, United States, Company Share (2006-2007) 86
15 Endoscopy Visualization Systems In United States 87
15.1 Endoscopy Visualization Systems Overall Revenue (2000-2015) 87
15.2 Endoscopy Visualization Systems Overall Volume (2000-2015) 89
15.3 Endoscopy Visualization Systems Average Price (2000-2015) 91
15.4 Endoscopy Visualization Systems Distribution Share (2007-2008) 92
16 Overview of Key Companies in United States Endoscopy Devices Market 93
16.1 OLYMPUS CORPORATION 93
16.1.1 Company Overview 93
16.1.2 Value Chain Analysis 94
16.1.3 Olympus Medical Systems Corp. Pipeline Products 95
16.2 PENTAX of America, Inc. 97
16.2.1 Company Overview 97
16.3 Fujinon Corporation 97
16.3.1 Company Overview 97
16.4 KARL STORZ GmbH & Co. KG 98
16.4.1 Company Overview 98
16.5 Given Imaging Ltd. 98
16.5.1 Company Overview 98
16.5.2 Given Imaging Ltd. Pipeline Products 98
16.6 Minntech Corporation 100
16.6.1 Company Overview 100
16.7 Stryker Corporation 100
16.7.1 Company Overview 100
16.7.2 Value Chain Analysis 101
16.8 STERIS Corporation 102
16.8.1 Company Overview 102
16.8.2 Value Chain Analysis 103
16.9 Advanced Sterilization Products 104
16.9.1 Company Overview 104
16.10 A.M. Surgical, Inc. 105
16.10.1 Company Overview 105
16.11 AdivaMed 105
16.11.1 Company Overview 105
16.12 Apollo Endosurgery, Inc. 105
16.12.1 Company Overview 105
16.13 Aragon Surgical, Inc. 105
16.13.1 Company Overview 105
16.13.2 Aragon Surgical, Inc. Pipeline Products 106
16.13.3 Aragon Surgical, Inc. Pipeline Products by Equipment Type 106
16.13.4 Aragon Surgical, Inc. Pipeline Products by Development Stage 106
16.13.5 Aragon Surgical, Inc. Pipeline Products by Therapy Area 106
16.14 Boston Scientific Corporation 106
16.14.1 Company Overview 106
16.14.2 Value Chain Analysis 107
16.15 CONMED Corporation 109
16.15.1 Company Overview 109
16.15.2 Value Chain Analysis 110
16.16 Cook Medical 112
16.16.1 Company Overview 112
16.17 LumeRx, Inc. 112
16.17.1 Company Overview 112
16.17.2 LumeRx, Inc. Pipeline Products 112
16.18 NeoGuide Systems, Inc. 113
16.18.1 Company Overview 113
16.18.2 NeoGuide Systems, Inc. Pipeline Products 113
16.19 Norwood Medical 114
16.19.1 Company Overview 114
16.20 Percutaneous Systems, Inc. 114
16.20.1 Company Overview 114
16.21 Precision Optics Corporation, Inc. 114
16.21.1 Company Overview 114
16.22 Richard Wolf Medical Instruments Corporation 115
16.22.1 Company Overview 115
16.23 RMS Medical 115
16.23.1 Company Overview 115
16.24 SafeStitch Medical, Inc. 115
16.24.1 Company Overview 115
16.24.2 SafeStitch Medical, Inc. Pipeline Products 116
16.25 SOLOS Endoscopy, Inc. 117
16.25.1 Company Overview 117
16.25.2 SOLOS Endoscopy, Inc. Pipeline Products 117
16.26 US Endoscopy 118
16.26.1 Company Overview 118
16.27 USGI Medical, Inc. 118
16.27.1 Company Overview 118
16.28 Vision-Sciences, Inc. 118
16.28.1 Company Overview 118
16.29 Welch Allyn Inc. 118
16.29.1 Company Overview 118
17 Financial Deals Landscape 120
17.1 Partnerships 120
17.1.1 Envisionier Medical Technologies Enters Into An Agreement With Medtronic 120
17.1.2 Visage Imaging Enters Into An Agreement With Viatronix 121
18 Recent Developments 122
18.1 Strategy And Business Planning 122
18.1.1 Dec 12, 2008: Cook Medical Plans To Build New Production Plant 122
18.1.2 Oct 21, 2008: Smith & Nephew To Open New Biologics & Spine Business Unit 122
18.2 Legal and Regulatory 122
18.2.1 Mar 30, 2009: USPTO Rules In Favor Of Smith & Nephew And Confirms Patent Claims Infringed By Arthrex 122
18.2.2 Mar 10, 2009: US District Court Certifies Class Action In Boston Scientific Securities Lawsuit 123
18.3 Government and Public Interest 123
18.3.1 Nov 24, 2008: Study Finds DBE As Cost-Effective Approach For Obscure GI Bleeding 123
18.4 Product Approvals 125
18.4.1 Feb 27, 2009: Cantel Medical Receives FDA 510(k) Clearance For Medivators Advantage Plus Endoscope Reprocessing System 125
18.4.2 Feb 17, 2009: US FDA Grants 510 (k) Clearance For Avantis Medical Systems' Third Eye Retroscope 125
18.4.3 Feb 17, 2009: SafeStitch Medical Receives 510(k) Clearance For SMART Dilator 125
19 Appendix 126
19.1 Global Markets Direct Research Methodology 126
19.2 Coverage 127
19.3 Secondary Research 127
19.4 Primary Research 128
19.5 Models 128
19.6 Forecasts 129
19.7 Expert Panel Validation 129
19.8 Currency Conversion 130
19.9 Contact Us 131
19.10 Disclaimer 131

1.1 List of Tables
Table 1: United States Healthcare Expenditure, 2003-2010 19
Table 2: Total Number of Doctors in the United States, 2003-2010 22
Table 3: Number of Doctors by Specialty in the United States, 2003-2010 23
Table 4: United States Healthcare Trade Statistics, 2001-2006 24
Table 5: Medical Equipment Registration Fee in United States, 2007 31
Table 6: Medical Device Approval Time in United States 31
Table 7: Endoscopy Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 36
Table 8: Endoscopy Devices, United States, Overall Revenue ($ mn), 2000-2015 37
Table 9: Endoscopy Devices, United States, Cross-Category Analysis, 2000-2015 38
Table 10: Endoscopy Devices, United States, Overall Revenue ($ mn), Historic, 2000-2008 40
Table 11: Endoscopy Devices, United States, Overall Revenue ($ mn), Forecast, 2008-2015 42
Table 12: Endoscopy Devices, United States, Category Volume (Units), 2000-2015 43
Table 13: Endoscopy Devices, United States, Category Volume (Units), Historic, 2000-2008 44
Table 14: Endoscopy Devices, United States, Category Volume (Units), Forecast, 2008-2015 45
Table 15: Endoscopy Devices, United States, Company Share by Revenue ($ mn), 2006-2007 46
Table 16: Capsule Endoscope System, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 47
Table 17: Capsule Endoscope System, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 48
Table 18: Capsule Endoscope System, United States, Volume (Units) by Segment, Historic, 2000-2008 49
Table 19: Capsule Endoscope System, United States, Volume (Units) by Segment, Forecast, 2008-2015 49
Table 20: Capsule Endoscope System, United States, Average Price ($), Historic, 2000-2008 50
Table 21: Capsule Endoscope System, United States, Average Price ($), Forecast, 2008-2015 50
Table 22: Capsule Endoscope System, United States, Distribution Share by Revenue ($mn), 2007-2008 51
Table 23: Capsule Endoscope System, United States, Company Share by Revenue ($ mn), 2006-2007 52
Table 24: Endoscopic Instruments, United States, Revenue ($ mn), Historic, 2000-2008 53
Table 25: Endoscopic Instruments, United States, Revenue ($ mn), Forecast, 2008-2015 54
Table 26: Endoscopic Instruments, United States, Distribution Share by Revenue ($mn), 2007-2008 55
Table 27: Endoscopic Reprocessors, United States, Revenue ($ mn), Historic, 2000-2008 56
Table 28: Endoscopic Reprocessors, United States, Revenue ($ mn), Forecast, 2008-2015 57
Table 29: Endoscopic Reprocessors, United States, Volume (Units), Historic, 2000-2008 58
Table 30: Endoscopic Reprocessors, United States, Volume (Units), Forecast, 2008-2015 59
Table 31: Endoscopic Reprocessors, United States, Average Price ($), Historic, 2000-2008 60
Table 32: Endoscopic Reprocessors, United States, Average Price ($), Forecast, 2008-2015 60
Table 33: Endoscopic Reprocessors, United States, Distribution Share by Revenue ($mn), 2007-2008 61
Table 34: Endoscopic Reprocessors, United States, Company Share by Revenue ($ mn), 2006-2007 62
Table 35: Flexible Endoscope, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 63
Table 36: Flexible Endoscope, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 64
Table 37: Fibroscope, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 65
Table 38: Fibroscope, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 66
Table 39: Flexible Endoscope, United States, Volume (Units) by Segment, Historic, 2000-2008 67
Table 40: Flexible Endoscope, United States, Volume (Units) by Segment, Forecast, 2008-2015 68
Table 41: Fibroscope, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 69
Table 42: Fibroscope, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 70
Table 43: Flexible Endoscope, United States, Average Price ($), Historic, 2000-2008 71
Table 44: Flexible Endoscope, United States, Average Price ($), Forecast, 2008-2015 71
Table 45: Flexible Endoscope, United States, Distribution Share by Revenue ($mn), 2007-2008 72
Table 46: Flexible Endoscope, United States, Company Share by Revenue ($ mn), 2006-2007 73
Table 47: Endoscopy Fluid Management Systems, United States, Revenue ($ mn), Historic, 2000-2008 74
Table 48: Endoscopy Fluid Management Systems, United States, Revenue ($ mn), Forecast, 2008-2015 75
Table 49: Endoscopy Fluid Management Systems, United States, Volume (Units), Historic, 2000-2008 76
Table 50: Endoscopy Fluid Management Systems, United States, Volume (Units), Forecast, 2008-2015 77
Table 51: Endoscopy Fluid Management Systems, United States, Average Price ($), Historic, 2000-2008 78
Table 52: Endoscopy Fluid Management Systems, United States, Average Price ($), Forecast, 2008-2015 78
Table 53: Endoscopy Fluid Management Systems, United States, Distribution Share by Revenue ($mn), 2007-2008 79
Table 54: Rigid Endoscope, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 80
Table 55: Rigid Endoscope, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 81
Table 56: Rigid Endoscope, United States, Volume (Units) by Segment, Historic, 2000-2008 82
Table 57: Rigid Endoscope, United States, Volume (Units) by Segment, Forecast, 2008-2015 83
Table 58: Rigid Endoscope, United States, Average Price ($), Historic, 2000-2008 84
Table 59: Rigid Endoscope, United States, Average Price ($), Forecast, 2008-2015 84
Table 60: Rigid Endoscope, United States, Distribution Share by Revenue ($mn), 2007-2008 85
Table 61: Rigid Endoscope, United States, Company Share by Revenue ($ mn), 2006-2007 86
Table 62: Endoscopy Visualization Systems, United States, Revenue ($ mn), Historic, 2000-2008 87
Table 63: Endoscopy Visualization Systems, United States, Revenue ($ mn), Forecast, 2008-2015 88
Table 64: Endoscopy Visualization Systems, United States, Volume (Units), Historic, 2000-2008 89
Table 65: Endoscopy Visualization Systems, United States, Volume (Units), Forecast, 2008-2015 90
Table 66: Endoscopy Visualization Systems, United States, Average Price ($), Historic, 2000-2008 91
Table 67: Endoscopy Visualization Systems, United States, Average Price ($), Forecast, 2008-2015 91
Table 68: Endoscopy Visualization Systems, United States, Distribution Share by Revenue ($mn), 2007-2008 92
Table 69: Olympus Medical Systems Corp. Pipeline Products by Equipment Type 95
Table 70: Olympus Medical Systems Corp. Pipeline Products by Development Stage 96
Table 71: Olympus Medical Systems Corp. Pipeline Products by Therapy Area 96
Table 72: Olympus Medical Systems Corp. Pipeline Products by Clinical Trials 96
Table 73: Olympus Medical Systems Corp. Pipeline Products by News Summary 96
Table 74: Given Imaging Ltd. Pipeline Products by Equipment Type 98
Table 75: Given Imaging Ltd. Pipeline Products by Development Stage 99
Table 76: Given Imaging Ltd. Pipeline Products by Therapy Area 99
Table 77: Given Imaging Ltd. Pipeline Products by Clinical Trials 99
Table 78: Given Imaging Ltd. Pipeline Products by News Summary 99
Table 79: Aragon Surgical, Inc. Pipeline Products by Equipment Type 106
Table 80: Aragon Surgical, Inc. Pipeline Products by Development Stage 106
Table 81: Aragon Surgical, Inc. Pipeline Products by Therapy Area 106
Table 82: LumeRx, Inc. Pipeline Products by Equipment Type 112
Table 83: LumeRx, Inc. Pipeline Products by Development Stage 112
Table 84: LumeRx, Inc. Pipeline Products by Therapy Area 113
Table 85: LumeRx, Inc. Pipeline Products by Clinical Trials 113
Table 86: NeoGuide Systems, Inc. Pipeline Products by Equipment Type 113
Table 87: NeoGuide Systems, Inc. Pipeline Products by Development Stage 113
Table 88: NeoGuide Systems, Inc. Pipeline Products by Therapy Area 114
Table 89: SafeStitch Medical, Inc. Pipeline Products by Equipment Type 116
Table 90: SafeStitch Medical, Inc. Pipeline Products by Development Stage 116
Table 91: SafeStitch Medical, Inc. Pipeline Products by Therapy Area 116
Table 92: SafeStitch Medical, Inc. Pipeline Products by News Summary 117
Table 93: SOLOS Endoscopy, Inc. Pipeline Products by Equipment Type 117
Table 94: SOLOS Endoscopy, Inc. Pipeline Products by Development Stage 117
Table 95: Envisionier Medical Technologies Enters Into An Agreement With Medtronic 120
Table 96: Visage Imaging Enters Into An Agreement With Viatronix 121
Table 97: USD to Local Currency, Average Exchange Rate 2008 130

1.2 List of Figures
Figure 1: United States, Healthcare Expenditure by Source 19
Figure 2: United States, Healthcare Infrastructure, Top Level View, 2007 21
Figure 3: Healthcare Expenses Segmentation by End User 22
Figure 4: Medical Equipment Approval Process in the United States, 2007 26
Figure 5: PMA Approval Process in the United States, 2007 28
Figure 6: The 510(k) Approval Process for Medical Devices in the United States, 2007 29
Figure 7: Reimbursement Structure in the United States, 2007 34
Figure 8: Distribution Structure of Medical Equipment in the United States 35
Figure 9: Endoscopy Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 36
Figure 10: Endoscopy Devices, United States, Overall Revenue ($ mn), 2000-2015 37
Figure 11: Endoscopy Devices, United States, Cross-Category Analysis, 2000-2015 38
Figure 12: Endoscopy Devices, United States, Overall Revenue ($ mn), Historic, 2000-2008 39
Figure 13: Endoscopy Devices, United States, Overall Revenue ($ mn), Forecast, 2008-2015 41
Figure 14: Endoscopy Devices, United States, Category Volume (Units), 2000-2015 43
Figure 15: Endoscopy Devices, United States, Category Volume (Units), Historic, 2000-2008 44
Figure 16: Endoscopy Devices, United States, Category Volume (Units), Forecast, 2008-2015 45
Figure 17: Endoscopy Devices, United States, Company Share (%), 2007 46
Figure 18: Capsule Endoscope System, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 47
Figure 19: Capsule Endoscope System, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 48
Figure 20: Capsule Endoscope System, United States, Company Share (%), 2007 52
Figure 21: Endoscopic Instruments, United States, Revenue ($ mn), Historic, 2000-2008 53
Figure 22: Endoscopic Instruments, United States, Revenue ($ mn), Forecast, 2008-2015 54
Figure 23: Endoscopic Reprocessors, United States, Revenue ($ mn), Historic, 2000-2008 56
Figure 24: Endoscopic Reprocessors, United States, Revenue ($ mn), Forecast, 2008-2015 57
Figure 25: Endoscopic Reprocessors, United States, Volume (Units), Historic, 2000-2008 58
Figure 26: Endoscopic Reprocessors, United States, Volume (Units), Forecast, 2008-2015 59
Figure 27: Endoscopic Reprocessors, United States, Company Share (%), 2007 62
Figure 28: Flexible Endoscope, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 63
Figure 29: Flexible Endoscope, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 64
Figure 30: Fibroscope, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 65
Figure 31: Fibroscope, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 66
Figure 32: Flexible Endoscope, United States, Volume (Units) by Segment, Historic, 2000-2008 67
Figure 33: Flexible Endoscope, United States, Volume (Units) by Segment, Forecast, 2008-2015 68
Figure 34: Fibroscope, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 69
Figure 35: Fibroscope, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 70
Figure 36: Flexible Endoscope, United States, Company Share (%), 2007 73
Figure 37: Endoscopy Fluid Management Systems, United States, Revenue ($ mn), Historic, 2000-2008 74
Figure 38: Endoscopy Fluid Management Systems, United States, Revenue ($ mn), Forecast, 2008-2015 75
Figure 39: Endoscopy Fluid Management Systems, United States, Volume (Units), Historic, 2000-2008 76
Figure 40: Endoscopy Fluid Management Systems, United States, Volume (Units), Forecast, 2008-2015 77
Figure 41: Rigid Endoscope, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 80
Figure 42: Rigid Endoscope, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 81
Figure 43: Rigid Endoscope, United States, Volume (Units) by Segment, Historic, 2000-2008 82
Figure 44: Rigid Endoscope, United States, Volume (Units) by Segment, Forecast, 2008-2015 83
Figure 45: Rigid Endoscope, United States, Company Share (%), 2007 86
Figure 46: Endoscopy Visualization Systems, United States, Revenue ($ mn), Historic, 2000-2008 87
Figure 47: Endoscopy Visualization Systems, United States, Revenue ($ mn), Forecast, 2008-2015 88
Figure 48: Endoscopy Visualization Systems, United States, Volume (Units), Historic, 2000-2008 89
Figure 49: Endoscopy Visualization Systems, United States, Volume (Units), Forecast, 2008-2015 90
Figure 50: Olympus Medical Systems Corp. Value Chain Analysis 94
Figure 51: Stryker Corporation Value Chain Analysis 101
Figure 52: STERIS Corporation Value Chain Analysis 103
Figure 53: Boston Scientific Corporation Value Chain Analysis 107
Figure 54: CONMED Corporation Value Chain Analysis 110
Figure 55: Global Markets Direct Methodology 126

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