Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2
List of Figures 10
2 Introduction 12
2.1 What Is This Report About?
12
3 Definitions of the Markets Covered in the Report 13
3.1 Patient
Monitoring 13
3.2 Micro-Electromechanical Systems 13
3.3
Multiparameter Patient Monitoring 13
3.3.1 Critical Care Monitors 13
3.3.2 Perioperative Care Monitors 13
3.4 Non-Invasive Blood Pressure
Monitors 13
3.4.1 Aneroid Sphygmomanometer 13
3.4.2 Automatic
Sphygmomanometer 14
3.4.3 Mercury Sphygmomanometer 14
3.5 Remote
Patient Monitoring 14
3.6 Wireless and Ambulatory Monitoring 14
3.6.1
Cardiac Rehabilitation Ambulatory 14
3.6.2 Hospital Ambulatory 14
4
Healthcare Sector Review 15
4.1 Healthcare Sector Review 15
4.2
Healthcare Expenditure 15
4.3 Healthcare Infrastructure 19
4.4
Healthcare Policy 21
5 Regulation System 23
5.1 Medical Equipment
Approval Process 23
5.1.1 Classification of Medical Devices 23
5.1.2
Conformity Assessment Process 32
5.1.2.1 Class I devices 32
5.1.2.2
Class IIa devices 33
5.1.2.3 Class IIb devices 34
5.1.2.4 Class III
devices 35
5.2 Classificazione Nazionale Dispositivi (CND) - New Medical
Device Classification 35
5.3 Post Market Surveillance 36
6 Pricing and
Reimbursement 37
6.1 Market Pricing 37
6.2 Government Policies for
Reimbursement 37
7 Distribution Structure 38
8 Patient Monitoring In
Italy 39
8.1 Patient Monitoring, Cross Country Comparison, Revenue ($ mn),
2000-2015 39
8.2 Patient Monitoring, Italy, Overall Revenue ($ mn),
2000-2015 41
8.3 Patient Monitoring, Italy, Category Volume (Units),
2000-2015 47
8.4 Patient Monitoring, Italy, Company Share (2007-2008)
49
9 Micro-Electromechanical Systems In Italy 50
9.1
Micro-Electromechanical Systems Overall Revenue (2000-2015) 50
9.2
Micro-Electromechanical Systems Overall Volume (2000-2015) 52
9.3
Micro-Electromechanical Systems Average Price (2000-2015) 54
9.4
Micro-Electromechanical Systems Distribution Share (2007-2008) 55
9.5
Micro-Electromechanical Systems, Italy, Company Share (2007-2008) 56
10
Multiparameter Patient Monitoring In Italy 57
10.1 Multiparameter Patient
Monitoring Overall Revenue (2000-2015) 57
10.2 Multiparameter Patient
Monitoring Overall Volume (2000-2015) 59
10.3 Multiparameter Patient
Monitoring Average Price (2000-2015) 61
10.4 Multiparameter Patient
Monitoring Distribution Share (2007-2008) 62
10.5 Multiparameter Patient
Monitoring, Italy, Company Share (2007-2008) 63
11 Non-Invasive Blood
Pressure Monitors In Italy 64
11.1 Non-Invasive Blood Pressure Monitors
Overall Revenue (2000-2015) 64
11.2 Non-Invasive Blood Pressure Monitors
Overall Volume (2000-2015) 65
11.3 Non-Invasive Blood Pressure Monitors
Average Price (2000-2015) 67
11.4 Non-Invasive Blood Pressure Monitors
Distribution Share (2007-2008) 68
11.5 Non-Invasive Blood Pressure
Monitors, Italy, Company Share (2007-2008) 69
12 Remote Patient Monitoring
In Italy 70
12.1 Remote Patient Monitoring Overall Revenue (2000-2015)
70
12.2 Remote Patient Monitoring Overall Volume (2000-2015) 72
12.3
Remote Patient Monitoring Average Price (2000-2015) 74
12.4 Remote Patient
Monitoring Distribution Share (2007-2008) 75
12.5 Remote Patient
Monitoring, Italy, Company Share (2007-2008) 76
13 Wireless and Ambulatory
Monitoring In Italy 77
13.1 Wireless and Ambulatory Monitoring Overall
Revenue (2000-2015) 77
13.2 Wireless and Ambulatory Monitoring Overall
Volume (2000-2015) 79
13.3 Wireless and Ambulatory Monitoring Average
Price (2000-2015) 81
13.4 Wireless and Ambulatory Monitoring Distribution
Share (2007-2008) 82
13.5 Wireless and Ambulatory Monitoring, Italy,
Company Share (2007-2008) 83
14 Overview of Key Companies in Italy Patient
Monitoring Market 85
14.1 Welch Allyn Inc. 85
14.1.1 Company Overview
85
14.2 Terumo Corporation 85
14.2.1 Company Overview 85
14.3 St.
Jude Medical, Inc. 86
14.3.1 Company Overview 86
14.4 Siemens
Healthcare 86
14.4.1 Company Overview 86
14.5 Schiller AG 87
14.5.1 Company Overview 87
14.6 Philips Healthcare 87
14.6.1 Company
Overview 87
14.7 OSI Systems, Inc. 88
14.7.1 Company Overview 88
14.8 OMRON HEALTHCARE Co., Ltd. 89
14.8.1 Company Overview 89
14.8.2
OMRON HEALTHCARE Co., Ltd. Pipeline Products 89
14.8.2.1 OMRON HEALTHCARE
Co., Ltd. Pipeline Products By Equipment Type 89
14.8.2.2 OMRON HEALTHCARE
Co., Ltd. Pipeline Products By Development Stage 89
14.8.2.3 OMRON
HEALTHCARE Co., Ltd. Pipeline Products By Therapy Area 89
14.8.2.4 OMRON
HEALTHCARE Co., Ltd. Pipeline Products By News Summary 90
14.9 Nihon
Kohden Corporation 91
14.9.1 Company Overview 91
14.10 Mindray Medical
International Limited 91
14.10.1 Company Overview 91
14.11 Microlife
Corporation 92
14.11.1 Company Overview 92
14.12 Medtronic, Inc.
92
14.12.1 Company Overview 92
14.13 HARTMANN GROUP 93
14.13.1
Company Overview 93
14.14 GE Sensing & Inspection Technologies 93
14.14.1 Company Overview 93
14.15 GE Healthcare 94
14.15.1 Company
Overview 94
14.15.2 GE Healthcare Pipeline Products 94
14.15.2.1 GE
Healthcare Pipeline Products By Equipment Type 94
14.15.2.2 GE Healthcare
Pipeline Products By Development Stage 95
14.15.2.3 GE Healthcare Pipeline
Products By Therapy Area 95
14.15.2.4 GE Healthcare Pipeline Products By
Clinical Trials 95
14.15.2.5 GE Healthcare Pipeline Products By News
Summary 95
14.16 Edwards Lifesciences Corporation 96
14.16.1 Company
Overview 96
14.17 Draegerwerk AG & Co. KGaA 96
14.17.1 Company
Overview 96
14.17.2 Drager Medical AG & Co. KG Pipeline Products 97
14.17.2.1 Drager Medical AG & Co. KG Pipeline Products By Equipment Type
97
14.17.2.2 Drager Medical AG & Co. KG Pipeline Products By Development
Stage 97
14.17.2.3 Drager Medical AG & Co. KG Pipeline Products By Therapy
Area 97
14.18 Datascope Corporation 98
14.18.1 Company Overview 98
14.19 Boston Scientific Corporation 98
14.19.1 Company Overview 98
14.20 BIOTRONIK GmbH & Co. KG 99
14.20.1 Company Overview 99
14.21 A&D
Medical / LifeSource 99
14.21.1 Company Overview 99
15 Recent
Developments 100
15.1 Strategy and Business Planning 100
15.1.1 Dec
15, 2008: Royal Philips Acquires Aerosol Therapy Business Of Medel In Italy
100
15.1.2 Sep 24, 2008: Philips Strikes Healthcare Research Alliance With
Urbino For Development Of Long Retention-Time Contrast Agents 100
16
Appendix 102
16.1 Global Markets Direct Research Methodology 102
16.2
Secondary Research 103
16.3 Primary Research 103
16.4 Models 104
16.5 Forecasts 104
16.6 Expert Panel Validation 104
16.7 Currency
Conversion 105
16.8 Contact Us 106
16.9 Disclaimer 106
1.1
List of Tables
Table 1: Healthcare Expenditure in Italy, 2000 - 2007
16
Table 2: Number of Doctors by Specialty in Italy, 2003-2007 20
Table 3: Number of Hospital Wards by Specialty in Italy, 2003-2007 21
Table 4: Patient Monitoring, Cross Country Comparison, Revenue ($ mn),
2000-2015 40
Table 5: Patient Monitoring, Italy, Overall Revenue ($
mn), 2000-2015 41
Table 6: Patient Monitoring, Italy, Cross-Category
Analysis, 2000-2015 42
Table 7: Patient Monitoring, Italy, Overall
Revenue ($ mn), Historic, 2000-2008 44
Table 8: Patient Monitoring,
Italy, Overall Revenue ($ mn), Forecast, 2008-2015 46
Table 9:
Patient Monitoring, Italy, Category Volume (Units), 2000-2015 47
Table 10:
Patient Monitoring, Italy, Category Volume (Units), Historic, 2000-2008
47
Table 11: Patient Monitoring, Italy, Category Volume (Units),
Forecast, 2008-2015 48
Table 12: Patient Monitoring, Italy, Company
Share by Revenue ($ mn), 2007-2008 49
Table 13:
Micro-Electromechanical Systems, Italy, Revenue ($ mn), Historic, 2000-2008
50
Table 14: Micro-Electromechanical Systems, Italy, Revenue ($ mn),
Forecast, 2008-2015 51
Table 15: Micro-Electromechanical Systems,
Italy, Volume (Units), Historic, 2000-2008 52
Table 16:
Micro-Electromechanical Systems, Italy, Volume (Units), Forecast, 2008-2015
53
Table 17: Micro-Electromechanical Systems, Italy, Average Price
($), Historic, 2000-2008 54
Table 18: Micro-Electromechanical
Systems, Italy, Average Price ($), Forecast, 2008-2015 54
Table 19:
Micro-Electromechanical Systems, Italy, Distribution Share by Revenue ($mn),
2007-2008 55
Table 20: Micro-Electromechanical Systems, Italy,
Company Share by Revenue ($ mn), 2007-2008 56
Table 21:
Multiparameter Patient Monitoring, Italy, Revenue ($ mn) by Segment, Historic,
2000-2008 57
Table 22: Multiparameter Patient Monitoring, Italy,
Revenue ($ mn) by Segment, Forecast, 2008-2015 58
Table 23:
Multiparameter Patient Monitoring, Italy, Volume (Units) by Segment, Historic,
2000-2008 59
Table 24: Multiparameter Patient Monitoring, Italy,
Volume (Units) by Segment, Forecast, 2008-2015 60
Table 25:
Multiparameter Patient Monitoring, Italy, Average Price ($), Historic,
2000-2008 61
Table 26: Multiparameter Patient Monitoring, Italy,
Average Price ($), Forecast, 2008-2015 61
Table 27: Multiparameter
Patient Monitoring, Italy, Distribution Share by Revenue ($mn), 2007-2008
62
Table 28: Multiparameter Patient Monitoring, Italy, Company Share
by Revenue ($ mn), 2007-2008 63
Table 29: Non-Invasive Blood Pressure
Monitors, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 64
Table
30: Non-Invasive Blood Pressure Monitors, Italy, Revenue ($ mn) by
Segment, Forecast, 2008-2015 64
Table 31: Non-Invasive Blood Pressure
Monitors, Italy, Volume (Units) by Segment, Historic, 2000-2008 65
Table
32: Non-Invasive Blood Pressure Monitors, Italy, Volume (Units) by
Segment, Forecast, 2008-2015 66
Table 33: Non-Invasive Blood Pressure
Monitors, Italy, Average Price ($), Historic, 2000-2008 67
Table 34:
Non-Invasive Blood Pressure Monitors, Italy, Average Price ($), Forecast,
2008-2015 67
Table 35: Non-Invasive Blood Pressure Monitors, Italy,
Distribution Share by Revenue ($mn), 2007-2008 68
Table 36:
Non-Invasive Blood Pressure Monitors, Italy, Company Share by Revenue ($ mn),
2007-2008 69
Table 37: Remote Patient Monitoring, Italy, Revenue ($
mn), Historic, 2000-2008 70
Table 38: Remote Patient Monitoring,
Italy, Revenue ($ mn), Forecast, 2008-2015 71
Table 39: Remote
Patient Monitoring, Italy, Volume (Units), Historic, 2000-2008 72
Table
40: Remote Patient Monitoring, Italy, Volume (Units), Forecast, 2008-2015
73
Table 41: Remote Patient Monitoring, Italy, Average Price ($),
Historic, 2000-2008 74
Table 42: Remote Patient Monitoring, Italy,
Average Price ($), Forecast, 2008-2015 74
Table 43: Remote Patient
Monitoring, Italy, Distribution Share by Revenue ($mn), 2007-2008 75
Table
44: Remote Patient Monitoring, Italy, Company Share by Revenue ($ mn),
2007-2008 76
Table 45: Wireless and Ambulatory Monitoring, Italy,
Revenue ($ mn) by Segment, Historic, 2000-2008 77
Table 46: Wireless
and Ambulatory Monitoring, Italy, Revenue ($ mn) by Segment, Forecast,
2008-2015 78
Table 47: Wireless and Ambulatory Monitoring, Italy,
Volume (Units) by Segment, Historic, 2000-2008 79
Table 48: Wireless
and Ambulatory Monitoring, Italy, Volume (Units) by Segment, Forecast,
2008-2015 80
Table 49: Wireless and Ambulatory Monitoring, Italy,
Average Price ($), Historic, 2000-2008 81
Table 50: Wireless and
Ambulatory Monitoring, Italy, Average Price ($), Forecast, 2008-2015 81
Table 51: Wireless and Ambulatory Monitoring, Italy, Distribution Share
by Revenue ($mn), 2007-2008 82
Table 52: Wireless and Ambulatory
Monitoring, Italy, Company Share by Revenue ($ mn), 2007-2008 84
Table 53:
OMRON HEALTHCARE Co., Ltd. Pipeline Products by Equipment Type 89
Table 54: OMRON HEALTHCARE Co., Ltd. Pipeline Products By Development
Stage 89
Table 55: OMRON HEALTHCARE Co., Ltd. Pipeline Products By
Therapy Area 89
Table 56: OMRON HEALTHCARE Co., Ltd. Pipeline
Products By News Summary 90
Table 57: GE Healthcare Pipeline Products
by Equipment Type 94
Table 58: GE Healthcare Pipeline Products By
Development Stage 95
Table 59: GE Healthcare Pipeline Products By
Therapy Area 95
Table 60: GE Healthcare Pipeline Products By Clinical
Trials 95
Table 61: GE Healthcare Pipeline Products By News Summary
95
Table 62: Drager Medical AG & Co. KG Pipeline Products by
Equipment Type 97
Table 63: Drager Medical AG & Co. KG Pipeline
Products By Development Stage 97
Table 64: Drager Medical AG & Co. KG
Pipeline Products By Therapy Area 97
Table 65: USD to Local Currency,
Average Exchange Rate 2008 105
1.2 List of Figures
Figure 1:
Total Healthcare Expenditure in Italy, 2000 - 2007 16
Figure 2: Government
and Private Healthcare Expenditure in Italy, 2007 17
Figure 3: Healthcare
Financing Framework in Italy, 2007 18
Figure 4: Flowchart for
Classification of Non-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 Invasive Devices in Italy,
2007 28
Figure 9: Flowchart for Classification of Active Devices in Italy,
2007 29
Figure 10: Flowchart for Classification of Active Devices in
Italy, 2007 30
Figure 11: Flowchart for Classification of Devices except
Non-invasive, Invasive and Active Devices in Italy, 2007 31
Figure 12:
Conformity Assessment of Class-I Medical Devices in Italy, 2007 32
Figure
13: Conformity Assessment of Class-IIa Medical Devices in Italy, 2007 33
Figure 14: Conformity Assessment of Class-IIb Medical Devices in Italy, 2007
34
Figure 15: Conformity Assessment of Class-III Medical Devices in Italy,
2007 35
Figure 16: Patient Monitoring, Cross Country Comparison,
Revenue ($ mn), 2000-2015 39
Figure 17: Patient Monitoring, Italy,
Overall Revenue ($ mn), 2000-2015 41
Figure 18: Patient Monitoring,
Italy, Cross-Category Analysis, 2000-2015 42
Figure 19: Patient
Monitoring, Italy, Overall Revenue ($ mn), Historic, 2000-2008 43
Figure
20: Patient Monitoring, Italy, Overall Revenue ($ mn), Forecast,
2008-2015 45
Figure 21: Patient Monitoring, Italy, Company Share (%),
2008 49
Figure 22: Micro-Electromechanical Systems, Italy, Revenue ($
mn), Historic, 2000-2008 50
Figure 23: Micro-Electromechanical
Systems, Italy, Revenue ($ mn), Forecast, 2008-2015 51
Figure 24:
Micro-Electromechanical Systems, Italy, Volume (Units), Historic, 2000-2008
52
Figure 25: Micro-Electromechanical Systems, Italy, Volume (Units),
Forecast, 2008-2015 53
Figure 26: Micro-Electromechanical Systems,
Italy, Company Share (%), 2008 56
Figure 27: Multiparameter Patient
Monitoring, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 57
Figure 28: Multiparameter Patient Monitoring, Italy, Revenue ($ mn) by
Segment, Forecast, 2008-2015 58
Figure 29: Multiparameter Patient
Monitoring, Italy, Volume (Units) by Segment, Historic, 2000-2008 59
Figure 30: Multiparameter Patient Monitoring, Italy, Volume (Units) by
Segment, Forecast, 2008-2015 60
Figure 31: Multiparameter Patient
Monitoring, Italy, Company Share (%), 2008 63
Figure 32: Non-Invasive
Blood Pressure Monitors, Italy, Volume (Units) by Segment, Historic, 2000-2008
65
Figure 33: Non-Invasive Blood Pressure Monitors, Italy, Volume
(Units) by Segment, Forecast, 2008-2015 66
Figure 34: Non-Invasive
Blood Pressure Monitors, Italy, Company Share (%), 2008 69
Figure 35:
Remote Patient Monitoring, Italy, Revenue ($ mn), Historic, 2000-2008 70
Figure 36: Remote Patient Monitoring, Italy, Revenue ($ mn), Forecast,
2008-2015 71
Figure 37: Remote Patient Monitoring, Italy, Volume
(Units), Historic, 2000-2008 72
Figure 38: Remote Patient Monitoring,
Italy, Volume (Units), Forecast, 2008-2015 73
Figure 39: Remote
Patient Monitoring, Italy, Company Share (%), 2008 76
Figure 40:
Wireless and Ambulatory Monitoring, Italy, Revenue ($ mn) by Segment,
Historic, 2000-2008 77
Figure 41: Wireless and Ambulatory Monitoring,
Italy, Revenue ($ mn) by Segment, Forecast, 2008-2015 78
Figure 42:
Wireless and Ambulatory Monitoring, Italy, Volume (Units) by Segment,
Historic, 2000-2008 79
Figure 43: Wireless and Ambulatory Monitoring,
Italy, Volume (Units) by Segment, Forecast, 2008-2015 80
Figure 44:
Wireless and Ambulatory Monitoring, Italy, Company Share (%), 2008 83
Figure 45: Global Markets Direct Methodology 102
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