Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2
Introduction 11
2.1 What Is This Report About? 11
3 Definitions of the
Markets Covered in the Report 12
3.1 Endoscopy Devices 12
3.2 Capsule
Endoscope System 12
3.2.1 Capsule Endoscopy Workstation 12
3.2.2
Capsule Endoscope 12
3.3 Endoscopic Instruments 12
3.4 Endoscopic
Reprocessors 12
3.5 Flexible Endoscope 12
3.5.1 Fibroroscopes 13
3.5.2 Videoscopes 13
3.6 Endoscopy Fluid Management System 13
3.7
Rigid Endoscope 13
3.7.1 Hysteroscopes 14
3.7.2 Laparoscopes 14
3.8 Endoscopy Visualization Systems 14
4 Healthcare Sector Review 15
4.1 Healthcare Sector Review 15
4.2 Healthcare Expenditure 15
4.3
Healthcare Infrastructure 18
4.4 Healthcare Policy 20
5 Regulation
System 22
5.1 Medical Equipment Approval Process 22
5.1.1
Classification of Medical Devices 22
5.1.2 Conformity Assessment Process
31
5.2 Classificazione Nazionale Dispositivi (CND) - New Medical Device
Classification 34
5.3 Post Market Surveillance 35
6 Pricing and
Reimbursement 36
6.1 Market Pricing 36
6.2 Government Policies for
Reimbursement 36
7 Distribution Structure 37
8 Endoscopy Devices In
Italy 38
8.1 Endoscopy Devices Cross Country Comparison, Revenue ($ mn),
2000-2015 38
8.2 Endoscopy Devices, Italy, Overall Revenue ($ mn),
2000-2015 39
8.3 Endoscopy Devices, Italy, Category Volume (Units),
2000-2015 45
8.4 Endoscopy Devices, Italy, Company Share (2006-2007)
48
9 Capsule Endoscope System In Italy 49
9.1 Capsule Endoscope System
Overall Revenue (2000-2015) 49
9.2 Capsule Endoscope System Overall Volume
(2000-2015) 51
9.3 Capsule Endoscope System Average Price (2000-2015)
52
9.4 Capsule Endoscope System Distribution Share (2007-2008) 53
9.5
Capsule Endoscope System, Italy, Company Share (2006-2007) 54
10
Endoscopic Instruments In Italy 55
10.1 Endoscopic Instruments Overall
Revenue (2000-2015) 55
10.2 Endoscopic Instruments Distribution Share
(2007-2008) 57
11 Endoscopic Reprocessors In Italy 58
11.1 Endoscopic
Reprocessors Overall Revenue (2000-2015) 58
11.2 Endoscopic Reprocessors
Overall Volume (2000-2015) 60
11.3 Endoscopic Reprocessors Average Price
(2000-2015) 62
11.4 Endoscopic Reprocessors Distribution Share (2007-2008)
63
11.5 Endoscopic Reprocessors, Italy, Company Share (2006-2007) 64
12 Endoscopy Fluid Management Systems In Italy 65
12.1 Endoscopy Fluid
Management Systems Overall Revenue (2000-2015) 65
12.2 Endoscopy Fluid
Management Systems Overall Volume (2000-2015) 67
12.3 Endoscopy Fluid
Management Systems Average Price (2000-2015) 69
12.4 Endoscopy Fluid
Management Systems Distribution Share (2007-2008) 70
13 Endoscopy
Visualization Systems In Italy 71
13.1 Endoscopy Visualization Systems
Overall Revenue (2000-2015) 71
13.2 Endoscopy Visualization Systems
Overall Volume (2000-2015) 73
13.3 Endoscopy Visualization Systems Average
Price (2000-2015) 75
13.4 Endoscopy Visualization Systems Distribution
Share (2007-2008) 76
14 Flexible Endoscope In Italy 77
14.1 Flexible
Endoscope Overall Revenue (2000-2015) 77
14.1.1 Fibroscope Revenue
(2000-2015) 79
14.2 Flexible Endoscope Overall Volume (2000-2015) 81
14.2.1 Fibroscope Volume (2000-2015) 83
14.3 Flexible Endoscope Average
Price (2000-2015) 85
14.4 Flexible Endoscope Distribution Share
(2007-2008) 86
14.5 Flexible Endoscope, Italy, Company Share (2006-2007)
87
15 Rigid Endoscope In Italy 88
15.1 Rigid Endoscope Overall Revenue
(2000-2015) 88
15.2 Rigid Endoscope Overall Volume (2000-2015) 90
15.3
Rigid Endoscope Average Price (2000-2015) 92
15.4 Rigid Endoscope
Distribution Share (2007-2008) 93
15.5 Rigid Endoscope, Italy, Company
Share (2006-2007) 94
16 Overview of Key Companies in Italy Endoscopy
Devices Market 95
16.1 OLYMPUS CORPORATION 95
16.1.1 Company Overview
95
16.1.2 Value Chain Analysis 95
16.1.3 Olympus Medical Systems Corp.
Pipeline Products 97
16.2 PENTAX of America, Inc. 98
16.2.1 Company
Overview 98
16.3 Fujinon Corporation 98
16.3.1 Company Overview 98
16.4 Richard Wolf Medical Instruments Corporation 98
16.4.1 Company
Overview 98
16.5 ARL STORZ GmbH & Co. KG 99
16.5.1 Company Overview
99
16.6 Minntech Corporation 99
16.6.1 Company Overview 99
16.7
Advanced Sterilization Products 99
16.7.1 Company Overview 99
16.8
Custom Ultrasonics Incorporated 99
16.8.1 Company Overview 99
16.9
Given Imaging Ltd. 100
16.9.1 Company Overview 100
16.9.2 Given
Imaging Ltd. Pipeline Products 100
16.10 Stryker Corporation 101
16.10.1 Company Overview 101
16.10.2 Value Chain Analysis 102
16.11
DEKA M.E.L.A. s.r.l. 103
16.11.1 Company Overview 103
17 Appendix
104
17.1 Global Markets Direct Research Methodology 104
17.2 Coverage
105
17.3 Secondary Research 105
17.4 Primary Research 106
17.5
Models 106
17.6 Forecasts 107
17.7 Expert Panel Validation 107
17.8 Currency Conversion 108
17.9 Contact Us 109
17.10 Disclaimer
109
1.1 List of Tables
Table 1: Number of Doctors by Specialty in
Italy, 2003-2007 19
Table 2: Number of Hospital Wards by Specialty in
Italy, 2003-2007 20
Table 3: Endoscopy Devices Cross Country
Comparison, Revenue ($ mn), 2000-2015 38
Table 4: Endoscopy Devices,
Italy, Overall Revenue ($ mn), 2000-2015 39
Table 5: Endoscopy
Devices, Italy, Cross-Category Analysis, 2000-2015 40
Table 6:
Endoscopy Devices, Italy, Overall Revenue ($ mn), Historic, 2000-2008 42
Table 7: Endoscopy Devices, Italy, Overall Revenue ($ mn), Forecast,
2008-2015 44
Table 8: Endoscopy Devices, Italy, Category Volume
(Units), 2000-2015 45
Table 9: Endoscopy Devices, Italy, Category
Volume (Units), Historic, 2000-2008 46
Table 10: Endoscopy Devices,
Italy, Category Volume (Units), Forecast, 2008-2015 47
Table 11:
Endoscopy Devices, Italy, Company Share by Revenue ($ mn), 2006-2007 48
Table 12: Capsule Endoscope System, Italy, Revenue ($ mn) by Segment,
Historic, 2000-2008 49
Table 13: Capsule Endoscope System, Italy,
Revenue ($ mn) by Segment, Forecast, 2008-2015 50
Table 14: Capsule
Endoscope System, Italy, Volume (Units) by Segment, Historic, 2000-2008 51
Table 15: Capsule Endoscope System, Italy, Volume (Units) by Segment,
Forecast, 2008-2015 51
Table 16: Capsule Endoscope System, Italy,
Average Price ($), Historic, 2000-2008 52
Table 17: Capsule Endoscope
System, Italy, Average Price ($), Forecast, 2008-2015 52
Table 18:
Capsule Endoscope System, Italy, Distribution Share by Revenue ($mn),
2007-2008 53
Table 19: Capsule Endoscope System, Italy, Company Share
by Revenue ($ mn), 2006-2007 54
Table 20: Endoscopic Instruments,
Italy, Revenue ($ mn), Historic, 2000-2008 55
Table 21: Endoscopic
Instruments, Italy, Revenue ($ mn), Forecast, 2008-2015 56
Table 22:
Endoscopic Instruments, Italy, Distribution Share by Revenue ($mn), 2007-2008
57
Table 23: Endoscopic Reprocessors, Italy, Revenue ($ mn),
Historic, 2000-2008 58
Table 24: Endoscopic Reprocessors, Italy,
Revenue ($ mn), Forecast, 2008-2015 59
Table 25: Endoscopic
Reprocessors, Italy, Volume (Units), Historic, 2000-2008 60
Table 26:
Endoscopic Reprocessors, Italy, Volume (Units), Forecast, 2008-2015 61
Table 27: Endoscopic Reprocessors, Italy, Average Price ($), Historic,
2000-2008 62
Table 28: Endoscopic Reprocessors, Italy, Average Price
($), Forecast, 2008-2015 62
Table 29: Endoscopic Reprocessors, Italy,
Distribution Share by Revenue ($mn), 2007-2008 63
Table 30:
Endoscopic Reprocessors, Italy, Company Share by Revenue ($ mn), 2006-2007
64
Table 31: Endoscopy Fluid Management Systems, Italy, Revenue ($
mn), Historic, 2000-2008 65
Table 32: Endoscopy Fluid Management
Systems, Italy, Revenue ($ mn), Forecast, 2008-2015 66
Table 33:
Endoscopy Fluid Management Systems, Italy, Volume (Units), Historic, 2000-2008
67
Table 34: Endoscopy Fluid Management Systems, Italy, Volume
(Units), Forecast, 2008-2015 68
Table 35: Endoscopy Fluid Management
Systems, Italy, Average Price ($), Historic, 2000-2008 69
Table 36:
Endoscopy Fluid Management Systems, Italy, Average Price ($), Forecast,
2008-2015 69
Table 37: Endoscopy Fluid Management Systems, Italy,
Distribution Share by Revenue ($mn), 2007-2008 70
Table 38: Endoscopy
Visualization Systems, Italy, Revenue ($ mn), Historic, 2000-2008 71
Table
39: Endoscopy Visualization Systems, Italy, Revenue ($ mn), Forecast,
2008-2015 72
Table 40: Endoscopy Visualization Systems, Italy, Volume
(Units), Historic, 2000-2008 73
Table 41: Endoscopy Visualization
Systems, Italy, Volume (Units), Forecast, 2008-2015 74
Table 42:
Endoscopy Visualization Systems, Italy, Average Price ($), Historic, 2000-2008
75
Table 43: Endoscopy Visualization Systems, Italy, Average Price
($), Forecast, 2008-2015 75
Table 44: Endoscopy Visualization
Systems, Italy, Distribution Share by Revenue ($mn), 2007-2008 76
Table
45: Flexible Endoscope, Italy, Revenue ($ mn) by Segment, Historic,
2000-2008 77
Table 46: Flexible Endoscope, Italy, Revenue ($ mn) by
Segment, Forecast, 2008-2015 78
Table 47: Fibroscope, Italy, Revenue
($ mn) by Sub-Segment, Historic, 2000-2008 79
Table 48: Fibroscope,
Italy, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 80
Table 49:
Flexible Endoscope, Italy, Volume (Units) by Segment, Historic, 2000-2008
81
Table 50: Flexible Endoscope, Italy, Volume (Units) by Segment,
Forecast, 2008-2015 82
Table 51: Fibroscope, Italy, Volume (Units) by
Sub-Segment, Historic, 2000-2008 83
Table 52: Fibroscope, Italy,
Volume (Units) by Sub-Segment, Forecast, 2008-2015 84
Table 53:
Flexible Endoscope, Italy, Average Price ($), Historic, 2000-2008 85
Table
54: Flexible Endoscope, Italy, Average Price ($), Forecast, 2008-2015
85
Table 55: Flexible Endoscope, Italy, Distribution Sheare by
Revenue ($mn), 2007-2008 86
Table 56: Flexible Endoscope, Italy,
Company Share by Revenue ($ mn), 2006-2007 87
Table 57: Rigid
Endoscope, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 88
Table
58: Rigid Endoscope, Italy, Revenue ($ mn) by Segment, Forecast,
2008-2015 89
Table 59: Rigid Endoscope, Italy, Volume (Units) by
Segment, Historic, 2000-2008 90
Table 60: Rigid Endoscope, Italy,
Volume (Units) by Segment, Forecast, 2008-2015 91
Table 61: Rigid
Endoscope, Italy, Average Price ($), Historic, 2000-2008 92
Table 62:
Rigid Endoscope, Italy, Average Price ($), Forecast, 2008-2015 92
Table
63: Rigid Endoscope, Italy, Distribution Share by Revenue ($mn),
2007-2008 93
Table 64: Rigid Endoscope, Italy, Company Share by
Revenue ($ mn), 2006-2007 94
Table 65: Olympus Medical Systems Corp.
Pipeline Products by Equipment Type 97
Table 66: Olympus Medical
Systems Corp. Pipeline Products by Development Stage 97
Table 67:
Olympus Medical Systems Corp. Pipeline Products by Therapy Area 97
Table
68: Olympus Medical Systems Corp. Pipeline Products by Clinical Trials
97
Table 69: Olympus Medical Systems Corp. Pipeline Products by News
Summary 97
Table 70: Given Imaging Ltd. Pipeline Products by
Equipment Type 100
Table 71: Given Imaging Ltd. Pipeline Products by
Development Stage 100
Table 72: Given Imaging Ltd. Pipeline Products
by Therapy Area 100
Table 73: Given Imaging Ltd. Pipeline Products by
Clinical Trials 101
Table 74: Given Imaging Ltd. Pipeline Products by
News Summary 101
Table 75: USD to Local Currency, Average Exchange Rate
2008 108
1.2 List of Figures
Figure 1: Total Healthcare
Expenditure in Italy, 2000 - 2006 16
Figure 2: Healthcare Financing
Framework in Italy, 2007 17
Figure 3: Flowchart for Classification of
Non-invasive Devices in Italy, 2007 23
Figure 4: Flowchart for
Classification of Invasive Devices in Italy, 2007 24
Figure 5: Flowchart
for Classification of Invasive Devices in Italy, 2007 25
Figure 6:
Flowchart for Classification of Invasive Devices in Italy, 2007 26
Figure
7: Flowchart for Classification of Invasive Devices in Italy, 2007 27
Figure 8: Flowchart for Classification of Active Devices in Italy, 2007 28
Figure 9: Flowchart for Classification of Active Devices in Italy, 2007 29
Figure 10: Flowchart for Classification of Devices except Non-invasive,
Invasive and Active Devices in Italy, 2007 30
Figure 11: Conformity
Assessment of Class-I Medical Devices in Italy, 2007 31
Figure 12:
Conformity Assessment of Class-IIa Medical Devices in Italy, 2007 32
Figure 13: Conformity Assessment of Class-IIb Medical Devices in Italy, 2007
33
Figure 14: Conformity Assessment of Class-III Medical Devices in Italy,
2007 34
Figure 15: Endoscopy Devices Cross Country Comparison,
Revenue ($ mn), 2000-2015 38
Figure 16: Endoscopy Devices, Italy,
Overall Revenue ($ mn), 2000-2015 39
Figure 17: Endoscopy Devices, Italy,
Cross-Category Analysis, 2000-2015 40
Figure 18: Endoscopy Devices,
Italy, Overall Revenue ($ mn), Historic, 2000-2008 41
Figure 19:
Endoscopy Devices, Italy, Overall Revenue ($ mn), Forecast, 2008-2015 43
Figure 20: Endoscopy Devices, Italy, Category Volume (Units), 2000-2015
45
Figure 21: Endoscopy Devices, Italy, Category Volume (Units),
Historic, 2000-2008 46
Figure 22: Endoscopy Devices, Italy, Category
Volume (Units), Forecast, 2008-2015 47
Figure 23: Endoscopy Devices,
Italy, Company Share (%), 2007 48
Figure 24: Capsule Endoscope
System, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 49
Figure
25: Capsule Endoscope System, Italy, Revenue ($ mn) by Segment, Forecast,
2008-2015 50
Figure 26: Capsule Endoscope System, Italy, Company
Share (%), 2007 54
Figure 27: Endoscopic Instruments, Italy, Revenue
($ mn), Historic, 2000-2008 55
Figure 28: Endoscopic Instruments,
Italy, Revenue ($ mn), Forecast, 2008-2015 56
Figure 29: Endoscopic
Reprocessors, Italy, Revenue ($ mn), Historic, 2000-2008 58
Figure 30:
Endoscopic Reprocessors, Italy, Revenue ($ mn), Forecast, 2008-2015 59
Figure 31: Endoscopic Reprocessors, Italy, Volume (Units), Historic,
2000-2008 60
Figure 32: Endoscopic Reprocessors, Italy, Volume
(Units), Forecast, 2008-2015 61
Figure 33: Endoscopic Reprocessors,
Italy, Company Share (%), 2007 64
Figure 34: Endoscopy Fluid
Management Systems, Italy, Revenue ($ mn), Historic, 2000-2008 65
Figure
35: Endoscopy Fluid Management Systems, Italy, Revenue ($ mn), Forecast,
2008-2015 66
Figure 36: Endoscopy Fluid Management Systems, Italy,
Volume (Units), Historic, 2000-2008 67
Figure 37: Endoscopy Fluid
Management Systems, Italy, Volume (Units), Forecast, 2008-2015 68
Figure
38: Endoscopy Visualization Systems, Italy, Revenue ($ mn), Historic,
2000-2008 71
Figure 39: Endoscopy Visualization Systems, Italy,
Revenue ($ mn), Forecast, 2008-2015 72
Figure 40: Endoscopy
Visualization Systems, Italy, Volume (Units), Historic, 2000-2008 73
Figure 41: Endoscopy Visualization Systems, Italy, Volume (Units),
Forecast, 2008-2015 74
Figure 42: Flexible Endoscope, Italy, Revenue
($ mn) by Segment, Historic, 2000-2008 77
Figure 43: Flexible
Endoscope, Italy, Revenue ($ mn) by Segment, Forecast, 2008-2015 78
Figure
44: Fibroscope, Italy, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
79
Figure 45: Fibroscope, Italy, Revenue ($ mn) by Sub-Segment,
Forecast, 2008-2015 80
Figure 46: Flexible Endoscope, Italy, Volume
(Units) by Segment, Historic, 2000-2008 81
Figure 47: Flexible
Endoscope, Italy, Volume (Units) by Segment, Forecast, 2008-2015 82
Figure
48: Fibroscope, Italy, Volume (Units) by Sub-Segment, Historic, 2000-2008
83
Figure 49: Fibroscope, Italy, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 84
Figure 50: Flexible Endoscope, Italy, Company
Share (%), 2007 87
Figure 51: Rigid Endoscope, Italy, Revenue ($ mn)
by Segment, Historic, 2000-2008 88
Figure 52: Rigid Endoscope, Italy,
Revenue ($ mn) by Segment, Forecast, 2008-2015 89
Figure 53: Rigid
Endoscope, Italy, Volume (Units) by Segment, Historic, 2000-2008 90
Figure
54: Rigid Endoscope, Italy, Volume (Units) by Segment, Forecast,
2008-2015 91
Figure 55: Rigid Endoscope, Italy, Company Share (%),
2007 94
Figure 56: Olympus Medical Systems Corp. Value Chain Analysis
95
Figure 57: Stryker Corporation Value Chain Analysis 102
Figure
58: Global Markets Direct Methodology 104
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