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
Wireless Ambulatory Telemetry Monitoring 13
3.2.1 Hospital Ambulatory
13
3.2.2 Cardiac Rehabilitation 13
3.3 Multiparameter Patient
Monitoring 13
3.3.1 Critical Care Monitors 13
3.3.2 Perioperative Care
Monitors 13
3.4 Remote Patient Monitoring 13
3.5 Non-Invasive Blood
Pressure Monitors 14
3.5.1 Mercury Sphygmomanometer 14
3.5.2 Aneroid
Sphygmomanometer 14
3.5.3 Automatic Sphygmomanometer 14
3.6 Micro-
Electromechanical Systems (MEMS) 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 21
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
5.1.2.1 Class I devices 31
5.1.2.2 Class IIa devices 32
5.1.2.3
Class IIb devices 33
5.1.2.4 Class III devices 34
5.2 Classificazione
Nazionale Dispositivi (CND) - New Medical Device Classification 35
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 Patient Monitoring In Italy 38
8.1 Patient Monitoring,
Italy, Overall Revenue 38
8.2 Patient Monitoring, Italy, Overall Volume
41
8.3 Patient Monitoring in Italy, Cross Category Analysis 43
8.4
Patient Monitoring in Italy, Competitive Landscape 45
8.5 Patient
Monitoring Market Dynamics 46
8.5.1 Market Drivers 46
8.5.2 Market
Restraints 46
9 Micro-Electromechanical Systems In Italy 47
9.1
Micro-Electromechanical Systems, Overall Revenue 47
9.2
Micro-Electromechanical Systems, Overall Volume 49
9.3
Micro-Electromechanical Systems, Average Price 51
9.4
Micro-Electromechanical Systems, Distribution Share 51
9.5
Micro-Electromechanical Systems in Italy, Competitive Landscape 52
10
Multiparameter Patient Monitoring In Italy 53
10.1 Multiparameter Patient
Monitoring, Overall Revenue 53
10.2 Multiparameter Patient Monitoring,
Overall Volume 56
10.3 Multiparameter Patient Monitoring, Average Price
58
10.4 Multiparameter Patient Monitoring, Distribution Share 59
10.5
Multiparameter Patient Monitoring, Italy, Competitive Landscape 60
11
Non-Invasive Blood Pressure Monitors In Italy 61
11.1 Non-Invasive Blood
Pressure Monitors, Overall Revenue 61
11.2 Non-Invasive Blood Pressure
Monitors, Overall Volume 63
11.3 Non-Invasive Blood Pressure Monitors,
Average Price 64
11.4 Non-Invasive Blood Pressure Monitors, Distribution
Share 65
11.5 Non-Invasive Blood Pressure Monitors in Italy, Competitive
Landscape 66
12 Remote Patient Monitoring In Italy 67
12.1 Remote
Patient Monitoring, Overall Revenue 67
12.2 Remote Patient Monitoring,
Overall Volume 69
12.3 Remote Patient Monitoring, Average Price 71
12.4 Remote Patient Monitoring, Distribution Share 71
12.5 Remote Patient
Monitoring in Italy, Competitive Landscape 72
13 Wireless and Ambulatory
Monitoring In Italy 73
13.1 Wireless and Ambulatory Monitoring, Overall
Revenue 73
13.2 Wireless and Ambulatory Monitoring, Overall Volume 75
13.3 Wireless and Ambulatory Monitoring, Average Price 77
13.4 Wireless
and Ambulatory Monitoring, Distribution Share 78
13.5 Wireless and
Ambulatory Monitoring in Italy, Competitive Landscape 79
14 GE Healthcare
Company Profile 80
14.1 Company Overview 80
14.1.1 Location - Italy
80
15 OMRON HEALTHCARE Co., Ltd. Company Profile 81
15.1 Company
Overview 81
15.2 OMRON HEALTHCARE Co., Ltd 81
15.2.1 OMRON HEALTHCARE
Co., Ltd. Pipeline Products By Equipment Type 81
15.2.2 OMRON HEALTHCARE
Co., Ltd. Pipeline Products by Development Stage 81
15.2.3 OMRON
HEALTHCARE Co., Ltd. Pipeline Products By Therapy Area 82
15.2.4 OMRON
HEALTHCARE Co., Ltd. Pipeline Products by News Summary 82
16 Philips
Healthcare Company Profile 83
16.1 Company Overview 83
16.2 Value
Chain Analysis 83
16.2.1 Manufacturing 84
16.2.1.1 In House
Manufacturing 84
16.2.1.2 Outsourcing 84
16.2.2 Product Development
84
16.2.2.1 Regulatory Approvals 84
16.2.2.2 Clinical Trials 84
16.2.2.3 Research and Development 85
16.2.3 Sales and Marketing 85
16.2.3.1 Partnerships and Alliances 85
16.2.3.2 Licensing Agreements
85
16.2.3.3 E-distribution 85
17 Draegerwerk Aktiengesellschaft
Company Profile 86
17.1 Company Overview 86
17.1.1 Location - Italy
86
17.2 Value Chain Analysis 87
17.2.1 Manufacturing 87
17.2.1.1
Outsourcing 87
17.2.1.2 In House Manufacturing 87
17.2.2 Product
Development 88
17.2.2.1 Regulatory Approvals 88
17.2.2.2 Research and
Development 88
17.2.3 Sales and Marketing 88
17.2.3.1 Licensing
Agreements 88
17.2.3.2 Partnerships and Alliances 88
17.3 Drager
Medical AG & Co. KG Pipeline Products 88
17.3.1 Drager Medical AG & Co. KG
Pipeline Products By Equipment Type 88
18 HARTMANN GROUP Company Profile
89
18.1 Company Overview 89
18.1.1 Location - Italy 89
18.2 Value
Chain Analysis 90
18.2.1 Manufacturing 90
18.2.1.1 Outsourcing 90
18.2.1.2 In House Manufacturing 90
18.2.2 Product Development 90
18.2.2.1 Regulatory Approvals 90
18.2.2.2 Research and Development 91
18.2.3 Sales and Marketing 91
18.2.3.1 Partnerships and Alliances 91
19 Abbott Laboratories Company Profile 92
19.1 Company Overview 92
19.2 Value Chain Analysis 92
19.2.1 Manufacturing 93
19.2.1.1 In House
Manufacturing 93
19.2.2 Product Development 93
19.2.2.1 Regulatory
Approvals 93
19.2.2.2 Research and Development 93
19.2.2.3 Clinical
Trials 93
19.2.3 Sales and Marketing 94
19.2.3.1 Partnerships and
Alliances 94
20 Appendix 95
20.1 GlobalData Research Methodology
95
20.2 Coverage 96
20.3 Secondary Research 97
20.4 Primary
Research 97
20.5 Models 98
20.6 Forecasts 98
20.7 Expert Panel
Validation 98
20.8 Currency Conversion 100
20.9 Contact Us 101
20.10 Disclaimer 101
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: Patient
Monitoring, Italy, Overall Revenue ($ mn), Historic, 2000-2008 38
Table 4:
Patient Monitoring, Italy, Overall Revenue ($ mn), Forecast, 2008-2015
40
Table 5: Patient Monitoring, Italy, Overall Volume (Units),
Historic, 2000-2008 41
Table 6: Patient Monitoring, Italy, Overall
Volume (Units), Forecast, 2008-2015 42
Table 7: Patient Monitoring, Italy,
Portfolio Analysis, 2000-2015 43
Table 8: Patient Monitoring, Italy,
Company Share by Revenue ($ mn), 2006-2007 45
Table 9:
Micro-Electromechanical Systems, Italy, Revenue ($ mn), Historic, 2000-2008
47
Table 10: Micro-Electromechanical Systems, Italy, Revenue ($ mn),
Forecast, 2008-2015 48
Table 11: Micro-Electromechanical Systems,
Italy, Volume (Units), Historic, 2000-2008 49
Table 12:
Micro-Electromechanical Systems, Italy, Volume (Units), Forecast, 2008-2015
50
Table 13: Micro-Electromechanical Systems, Italy, Average Price
($), Historic, 2000-2008 51
Table 14: Micro-Electromechanical
Systems, Italy, Average Price ($), Forecast, 2008-2015 51
Table 15:
Micro-Electromechanical Systems, Italy, Distribution Share by Revenue ($mn),
2007-2008 51
Table 16: Micro-Electromechanical Systems, Italy,
Company Share by Revenue ($ mn), 2006-2007 52
Table 17:
Multiparameter Patient Monitoring, Italy, Overall Revenue ($ mn) by Segment,
Historic, 2000-2008 53
Table 18: Multiparameter Patient Monitoring,
Italy, Overall Revenue ($ mn) by Segment, Forecast, 2008-2015 55
Table 19:
Multiparameter Patient Monitoring, Italy, Overall Volume (Units) by
Segment, Historic, 2000-2008 56
Table 20: Multiparameter Patient
Monitoring, Italy, Overall Volume (Units) by Segment, Forecast, 2008-2015
57
Table 21: Multiparameter Patient Monitoring, Italy, Average Price
($), Historic, 2000-2008 58
Table 22: Multiparameter Patient
Monitoring, Italy, Average Price ($), Forecast, 2008-2015 58
Table 23:
Multiparameter Patient Monitoring, Italy, Distribution Share by Revenue
($mn), 2007-2008 59
Table 24: Multiparameter Patient Monitoring,
Italy, Company Share by Revenue ($ mn), 2006-2007 60
Table 25:
Non-Invasive Blood Pressure Monitors, Italy, Overall Revenue ($ mn) by
Segment, Historic, 2000-2008 61
Table 26: Non-Invasive Blood Pressure
Monitors, Italy, Overall Revenue ($ mn) by Segment, Forecast, 2008-2015 62
Table 27: Non-Invasive Blood Pressure Monitors, Italy, Overall Volume
(Units) by Segment, Historic, 2000-2008 63
Table 28: Non-Invasive
Blood Pressure Monitors, Italy, Overall Volume (Units) by Segment, Forecast,
2008-2015 63
Table 29: Non-Invasive Blood Pressure Monitors, Italy,
Average Price ($), Historic, 2000-2008 64
Table 30: Non-Invasive
Blood Pressure Monitors, Italy, Average Price ($), Forecast, 2008-2015 64
Table 31: Non-Invasive Blood Pressure Monitors, Italy, Distribution Share
by Revenue ($mn), 2007-2008 65
Table 32: Non-Invasive Blood Pressure
Monitors, Italy, Company Share by Revenue ($ mn), 2006-2007 66
Table 33:
Remote Patient Monitoring, Italy, Revenue ($ mn), Historic, 2000-2008
67
Table 34: Remote Patient Monitoring, Italy, Revenue ($ mn),
Forecast, 2008-2015 68
Table 35: Remote Patient Monitoring, Italy,
Volume (Units), Historic, 2000-2008 69
Table 36: Remote Patient
Monitoring, Italy, Volume (Units), Forecast, 2008-2015 70
Table 37:
Remote Patient Monitoring, Italy, Average Price ($), Historic, 2000-2008
71
Table 38: Remote Patient Monitoring, Italy, Average Price ($),
Forecast, 2008-2015 71
Table 39: Remote Patient Monitoring, Italy,
Distribution Share by Revenue ($mn), 2007-2008 71
Table 40: Remote
Patient Monitoring, Italy, Company Share by Revenue ($ mn), 2006-2007 72
Table 41: Wireless and Ambulatory Monitoring, Italy, Overall Revenue ($
mn) by Segment, Historic, 2000-2008 73
Table 42: Wireless and
Ambulatory Monitoring, Italy, Overall Revenue ($ mn) by Segment, Forecast,
2008-2015 74
Table 43: Wireless and Ambulatory Monitoring, Italy,
Overall Volume (Units) by Segment, Historic, 2000-2008 75
Table 44:
Wireless and Ambulatory Monitoring, Italy, Overall Volume (Units) by Segment,
Forecast, 2008-2015 76
Table 45: Wireless and Ambulatory Monitoring,
Italy, Average Price ($), Historic, 2000-2008 77
Table 46: Wireless
and Ambulatory Monitoring, Italy, Average Price ($), Forecast, 2008-2015
77
Table 47: Wireless and Ambulatory Monitoring, Italy, Distribution
Share by Revenue ($mn), 2007-2008 78
Table 48: Wireless and
Ambulatory Monitoring, Italy, Company Share by Revenue ($ mn), 2006-2007
79
Table 49: OMRON HEALTHCARE Co., Ltd. Pipeline Products by
Equipment Type 81
Table 50: OMRON HEALTHCARE Co., Ltd. Pipeline
Products By Development Stage 81
Table 51: OMRON HEALTHCARE Co., Ltd.
Pipeline Products By Therapy Area 82
Table 52: OMRON HEALTHCARE Co.,
Ltd. Pipeline Products By News Summaries 82
Table 53: Drager Medical
AG & Co. KG Pipeline Products by Equipment Type 88
Table 54: USD to
Local Currency, Average Exchange Rate 2008 100
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: Patient Monitoring, Italy, Overall Revenue
($ mn), Historic, 2000-2008 38
Figure 16: Patient Monitoring, Italy,
Overall Revenue ($ mn), Forecast, 2008-2015 39
Figure 17: Patient
Monitoring, Italy, Portfolio Analysis, 2000-2015 43
Figure 18:
Patient Monitoring, Italy, Company Share (%), 2007 45
Figure 19:
Micro-Electromechanical Systems, Italy, Revenue ($ mn), Historic, 2000-2008
47
Figure 20: Micro-Electromechanical Systems, Italy, Revenue ($ mn),
Forecast, 2008-2015 48
Figure 21: Micro-Electromechanical Systems,
Italy, Volume (Units), Historic, 2000-2008 49
Figure 22:
Micro-Electromechanical Systems, Italy, Volume (Units), Forecast, 2008-2015
50
Figure 23: Micro-Electromechanical Systems, Italy, Company Share
(%), 2007 52
Figure 24: Multiparameter Patient Monitoring, Italy,
Overall Revenue ($ mn) by Segment, Historic, 2000-2008 53
Figure 25:
Multiparameter Patient Monitoring, Italy, Overall Revenue ($ mn) by Segment,
Forecast, 2008-2015 54
Figure 26: Multiparameter Patient Monitoring,
Italy, Overall Volume (Units) by Segment, Historic, 2000-2008 56
Figure
27: Multiparameter Patient Monitoring, Italy, Overall Volume (Units) by
Segment, Forecast, 2008-2015 57
Figure 28: Multiparameter Patient
Monitoring, Italy, Company Share (%), 2007 60
Figure 29: Non-Invasive
Blood Pressure Monitors, Italy, Company Share (%), 2007 66
Figure 30:
Remote Patient Monitoring, Italy, Revenue ($ mn), Historic, 2000-2008 67
Figure 31: Remote Patient Monitoring, Italy, Revenue ($ mn), Forecast,
2008-2015 68
Figure 32: Remote Patient Monitoring, Italy, Volume
(Units), Historic, 2000-2008 69
Figure 33: Remote Patient Monitoring,
Italy, Volume (Units), Forecast, 2008-2015 70
Figure 34: Remote
Patient Monitoring, Italy, Company Share (%), 2007 72
Figure 35:
Wireless and Ambulatory Monitoring, Italy, Overall Revenue ($ mn) by Segment,
Historic, 2000-2008 73
Figure 36: Wireless and Ambulatory Monitoring,
Italy, Overall Revenue ($ mn) by Segment, Forecast, 2008-2015 74
Figure
37: Wireless and Ambulatory Monitoring, Italy, Overall Volume (Units) by
Segment, Historic, 2000-2008 75
Figure 38: Wireless and Ambulatory
Monitoring, Italy, Overall Volume (Units) by Segment, Forecast, 2008-2015
76
Figure 39: Wireless and Ambulatory Monitoring, Italy, Company
Share (%), 2007 79
Figure 40: Philips Medical Systems Value Chain
Analysis 83
Figure 41: Drager Medical AG & Co. KG Value Chain
Analysis 87
Figure 42: Hartmann Group Value Chain Analysis 90
Figure 43: Abbott Laboratories Value Chain Analysis 92
Figure 44:
GlobalData Methodology 96
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