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 Executive Summary
12
4 Definitions of Markets Covered in the Report 13
4.1 Diabetic Care
Devices 13
4.2 Glucose Monitoring Devices 13
4.2.1 Blood Glucose
Meters 13
4.2.2 Blood Glucose Strips 13
4.3 Insulin Delivery 13
4.3.1 Insulin Pens 13
4.3.2 Insulin Syringes 14
4.3.3 Insulin Pumps
14
4.3.4 Traditional Insulin Pump Accessories 14
5 Healthcare Sector
Review 15
5.1 Healthcare Sector Review 15
5.2 Healthcare Expenditure
15
5.3 Healthcare Infrastructure 18
5.4 Healthcare Policy 20
6
Regulation System 21
6.1 Medical Equipment Approval Process 21
6.1.1
Classification of Medical Devices 21
6.1.2 Conformity Assessment Process
30
6.2 Classificazione Nazionale Dispositivi (CND) - New Medical Device
Classification 33
6.3 Post Market Surveillance 34
7 Pricing and
Reimbursement 35
7.1 Market Pricing 35
7.2 Government Policies for
Reimbursement 35
8 Distribution Structure 36
9 Diabetes Care Devices
In Italy 37
9.1 Diabetes Care Devices, Italy, Overall Revenue ($ m),
2000-2015 37
9.2 Diabetes Care Devices, Italy, Category Volume (Units),
2000-2015 40
9.3 Diabetes Care Devices, Italy, Cross-Category Analysis,
2000-2015 42
9.4 Diabetes Care Devices, Italy, Company Share (2007-2008)
43
10 Glucose Monitoring In Italy 45
10.1 Glucose Monitoring Overall
Revenue (2000-2015) 45
10.1.1 Blood Glucose Meters Overall Revenue
(2000-2015) 47
10.2 Glucose Monitoring Overall Volume (2000-2015) 49
10.2.1 Blood Glucose Meters Overall Volume (2000-2015) 51
10.3 Glucose
Monitoring, Italy, Cross-Segment Analysis, 2000-2015 52
10.4 Glucose
Monitoring Average Price (2000-2015) 53
10.5 Glucose Monitoring Market
Dynamics 54
10.5.1 Market Drivers 54
10.5.2 Market Restraints 54
10.6 Glucose Monitoring Distribution Share (2007-2008) 54
10.7 Glucose
Monitoring, Italy, Company Share (2007-2008) 55
11 Insulin Delivery In
Italy 57
11.1 Insulin Delivery Overall Revenue (2000-2015) 57
11.1.1
Insulin Pens Overall Revenue (2000-2015) 61
11.2 Insulin Delivery Overall
Volume (2000-2015) 63
11.2.1 Insulin Pens Overall Volume (2000-2015)
64
11.3 Insulin Delivery, Italy, Cross-Segment Analysis, 2000-2015 66
11.4 Insulin Delivery Average Price (2000-2015) 67
11.5 Insulin Delivery
Market Dynamics 68
11.6 Insulin Delivery Distribution Share (2007-2008)
68
11.7 Insulin Delivery, Italy, Company Share (2007-2008) 69
12
Overview of Key Companies in Italy Diabetes Care Devices Market 70
12.1 F.
Hoffmann-La Roche Ltd. 70
12.1.1 Company Overview 70
12.1.2 Value
Chain Analysis 70
12.1.3 F. Hoffmann-La Roche Ltd Pipeline Products 72
12.2 LifeScan, Inc. 73
12.2.1 Company Overview 73
12.2.2 LifeScan,
Inc. Pipeline Products 74
12.3 Bayer HealthCare AG 75
12.3.1 Company
Overview 75
12.3.2 Value Chain Analysis 75
12.3.3 Bayer HealthCare AG
Pipeline Products 77
12.4 Abbott Laboratories 79
12.4.1 Company
Overview 79
12.4.2 Value Chain Analysis 79
12.4.3 Abbott Laboratories
Pipeline Products 81
12.5 Becton, Dickinson and Company 83
12.5.1
Company Overview 83
12.5.2 Value Chain Analysis 83
12.6 Novo Nordisk
A/S 85
12.6.1 Company Overview 85
12.6.2 Novo Nordisk A/S Pipeline
Products 85
12.7 Eli Lilly and Company 87
12.7.1 Company Overview
87
12.7.2 Value Chain Analysis 87
12.7.3 Eli Lilly and Company
Pipeline Products 89
12.8 Medtronic, Inc. 90
12.8.1 Company Overview
90
12.8.2 Medtronic, Inc. Pipeline Products 92
12.9 ARKRAY, Inc.
100
12.9.1 Company Overview 100
12.9.2 ARKRAY, Inc. Pipeline Products
100
12.10 Terumo Corporation 102
12.10.1 Company Overview 102
12.10.2 Value Chain Analysis 102
12.11 Animas Corporation 104
12.11.1
Company Overview 104
12.12 Sanofi-Aventis 104
12.12.1 Company Overview
104
12.13 Smiths Medical 105
12.13.1 Company Overview 105
12.13.2
Value Chain Analysis 105
13 Appendix 108
13.1 GlobalData Research
Methodology 108
13.2 Coverage 109
13.3 Secondary Research 110
13.4
Primary Research 110
13.5 Models 111
13.6 Forecasts 111
13.7
Expert Panel Validation 112
13.8 Currency Conversion 113
13.9 Contact
Us 114
13.10 Disclaimer 114
1.1 List of Tables
Table 1: Number of Doctors by Specialty in Italy, 2003-2007 18
Table 2:
Number of Hospital Wards by Specialty in Italy, 2003-2007 19
Table 3:
Diabetes Care Devices, Italy, Overall Revenue ($ m), Historic, 2000-2008
37
Table 4: Diabetes Care Devices, Italy, Overall Revenue ($ m),
Forecast, 2008-2015 39
Table 5: Diabetes Care Devices, Italy,
Category Volume (Units), Historic, 2000-2008 40
Table 6: Diabetes
Care Devices, Italy, Category Volume (Units), Forecast, 2008-2015 41
Table
7: Diabetes Care Devices, Italy, Cross-Category Analysis, 2000-2015 42
Table 8: Diabetes Care Devices, Italy, Company Share by Revenue ($m),
2007-2008 44
Table 9: Glucose Monitoring, Italy, Revenue ($ m) by
Segment, Historic, 2000-2008 45
Table 10: Glucose Monitoring, Italy,
Revenue ($ m) by Segment, Forecast, 2008-2015 46
Table 11: Blood
Glucose Meters, Italy, Revenue ($m) by Sub-Segment, Historic, 2000-2008 47
Table 12: Blood Glucose Meters, Italy, Revenue ($m) by Sub-Segment,
Forecast, 2008-2015 48
Table 13: Glucose Monitoring, Italy, Volume
(Units) by Segment, Historic, 2000-2008 49
Table 14: Glucose
Monitoring, Italy, Volume (Units) by Segment, Forecast, 2008-2015 50
Table
15: Blood Glucose Meters, Italy, Volume (Units) by Sub-Segment, Historic,
2000-2008 51
Table 16: Blood Glucose Meters, Italy, Volume (Units) by
Sub-Segment, Forecast, 2008-2015 51
Table 17: Glucose Monitoring,
Italy, Cross-Segment Analysis, 2000-2015 52
Table 18: Glucose
Monitoring, Italy, Average Price ($), Historic, 2000-2008 53
Table 19:
Glucose Monitoring, Italy, Average Price ($), Forecast, 2008-2015 53
Table 20: Glucose Monitoring, Italy, Distribution Share by Revenue ($ m),
2007-2008 54
Table 21: Glucose Monitoring, Italy, Company Share by
Revenue ($m), 2007-2008 55
Table 22: Insulin Delivery, Italy, Revenue
($ m) by Segment, Historic, 2000-2008 57
Table 23: Insulin Delivery,
Italy, Revenue ($ m) by Segment, Forecast, 2008-2015 59
Table 24:
Insulin Pens, Italy, Revenue ($ m) by Sub-Segment, Historic, 2000-2008 61
Table 25: Insulin Pens, Italy, Revenue ($ m) by Sub-Segment, Forecast,
2008-2015 62
Table 26: Insulin Delivery, Italy, Volume (Units) by
Segment, Historic, 2000-2008 63
Table 27: Insulin Delivery, Italy,
Volume (Units) by Segment, Forecast, 2008-2015 63
Table 28: Insulin
Pens, Italy, Volume (Units) by Sub-Segment, Historic, 2000-2008 64
Table
29: Insulin Pens, Italy, Volume (Units) by Sub-Segment, Forecast,
2008-2015 65
Table 30: Insulin Delivery, Italy, Cross-Segment
Analysis, 2000-2015 66
Table 31: Insulin Delivery, Italy, Average
Price ($), Historic, 2000-2008 67
Table 32: Insulin Delivery, Italy,
Average Price ($), Forecast, 2008-2015 67
Table 33: Insulin Delivery,
Italy, Distribution Share by Revenue ($ m), 2007-2008 68
Table 34:
Insulin Delivery, Italy, Company Share by Revenue ($m), 2007-2008 69
Table
35: F. Hoffmann-La Roche Ltd Pipeline Products by Equipment Type 72
Table 36: F. Hoffmann-La Roche Ltd Pipeline Products by Development Stage
73
Table 37: F. Hoffmann-La Roche Ltd Pipeline Products by Therapy
Area 73
Table 38: LifeScan, Inc. Pipeline Products by Equipment Type
74
Table 39: LifeScan, Inc. Pipeline Products by Development Stage
74
Table 40: LifeScan, Inc. Pipeline Products by Therapy Area 74
Table 41: LifeScan, Inc. Pipeline Products by Clinical Trials 74
Table 42: LifeScan, Inc. Pipeline Products by News Summary 74
Table
43: Bayer HealthCare AG Pipeline Products by Equipment Type 77
Table
44: Bayer HealthCare AG Pipeline Products by Development Stage 77
Table 45: Bayer HealthCare AG Pipeline Products by Therapy Area 78
Table 46: Bayer HealthCare AG Pipeline Products by News Summary 78
Table 47: Abbott Laboratories Pipeline Products by Equipment Type 81
Table 48: Abbott Laboratories Pipeline Products by Development Stage
82
Table 49: Abbott Laboratories Pipeline Products by Therapy Area
82
Table 50: Abbott Laboratories Pipeline Products by Clinical
Trials 82
Table 51: Abbott Laboratories Pipeline Products by News
Summary 82
Table 52: Novo Nordisk A/S Pipeline Products by Equipment
Type 85
Table 53: Novo Nordisk A/S Pipeline Products By Development
Stage 85
Table 54: Novo Nordisk A/S Pipeline Products By Therapy Area
86
Table 55: Novo Nordisk A/S Pipeline Products By Clinical Trials
86
Table 56: Eli Lilly and Company Pipeline Products by Equipment
Type 89
Table 57: Eli Lilly and Company Pipeline Products by
Development Stage 89
Table 58: Eli Lilly and Company Pipeline
Products by Therapy Area 90
Table 59: Eli Lilly and Company Pipeline
Products by Clinical Trials 90
Table 60: Eli Lilly and Company
Pipeline Products by News Summary 90
Table 61: Medtronic, Inc.
Pipeline Products by Equipment Type 92
Table 62: Medtronic, Inc.
Pipeline Products By Development Stage 94
Table 63: Medtronic, Inc.
Pipeline Products By Therapy Area 96
Table 64: Medtronic, Inc.
Pipeline Products By Clinical Trials 98
Table 65: Medtronic, Inc.
Pipeline Products By News Summary 99
Table 66: ARKRAY, Inc. Pipeline
Products by Equipment Type 100
Table 67: ARKRAY, Inc. Pipeline
Products by Development Stage 100
Table 68: ARKRAY, Inc. Pipeline
Products by Clinical Trials 101
Table 69: ARKRAY, Inc. Pipeline
Products by News Summary 101
Table 70: USD to Local Currency, Average
Exchange Rate 2008 113
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 22
Figure 4:
Flowchart for Classification of Invasive Devices in Italy, 2007 23
Figure
5: Flowchart for Classification of Invasive Devices in Italy, 2007 24
Figure 6: Flowchart for Classification of Invasive Devices in Italy, 2007
25
Figure 7: Flowchart for Classification of Invasive Devices in Italy,
2007 26
Figure 8: Flowchart for Classification of Active Devices in Italy,
2007 27
Figure 9: Flowchart for Classification of Active Devices in Italy,
2007 28
Figure 10: Flowchart for Classification of Devices except
Non-invasive, Invasive and Active Devices in Italy, 2007 29
Figure 11:
Conformity Assessment of Class-I Medical Devices in Italy, 2007 30
Figure
12: Conformity Assessment of Class-IIa Medical Devices in Italy, 2007 31
Figure 13: Conformity Assessment of Class-IIb Medical Devices in Italy, 2007
32
Figure 14: Conformity Assessment of Class-III Medical Devices in Italy,
2007 33
Figure 15: Diabetes Care Devices, Italy, Overall Revenue ($
m), Historic, 2000-2008 37
Figure 16: Diabetes Care Devices, Italy,
Overall Revenue ($ m), Forecast, 2008-2015 39
Figure 17: Diabetes
Care Devices, Italy, Category Volume (Units), Historic, 2000-2008 40
Figure 18: Diabetes Care Devices, Italy, Category Volume (Units),
Forecast, 2008-2015 41
Figure 19: Diabetes Care Devices, Italy,
Cross-Category Analysis, 2000-2015 42
Figure 20: Diabetes Care
Devices, Italy, Company Share (%), 2008 43
Figure 21: Glucose
Monitoring, Italy, Revenue ($ m) by Segment, Historic, 2000-2008 45
Figure
22: Glucose Monitoring, Italy, Revenue ($ m) by Segment, Forecast,
2008-2015 46
Figure 23: Blood Glucose Meters, Italy, Revenue ($m) by
Sub-Segment, Historic, 2000-2008 47
Figure 24: Blood Glucose Meters,
Italy, Revenue ($m) by Sub-Segment, Forecast, 2008-2015 48
Figure 25:
Glucose Monitoring, Italy, Volume (Units) by Segment, Historic, 2000-2008
49
Figure 26: Glucose Monitoring, Italy, Volume (Units) by Segment,
Forecast, 2008-2015 50
Figure 27: Glucose Monitoring, Italy,
Cross-Segment Analysis, 2000-2015 52
Figure 28: Glucose Monitoring,
Italy, Company Share (%), 2008 55
Figure 29: Insulin Delivery, Italy,
Revenue ($ m) by Segment, Historic, 2000-2008 57
Figure 30: Insulin
Delivery, Italy, Revenue ($ m) by Segment, Forecast, 2008-2015 59
Figure
31: Insulin Pens, Italy, Revenue ($ m) by Sub-Segment, Historic,
2000-2008 61
Figure 32: Insulin Pens, Italy, Revenue ($ m) by
Sub-Segment, Forecast, 2008-2015 62
Figure 33: Insulin Pens, Italy,
Volume (Units) by Sub-Segment, Historic, 2000-2008 64
Figure 34:
Insulin Pens, Italy, Volume (Units) by Sub-Segment, Forecast, 2008-2015 65
Figure 35: Insulin Delivery, Italy, Cross-Segment Analysis, 2000-2015
66
Figure 36: Insulin Delivery, Italy, Company Share (%), 2008 69
Figure 37: GlobalData Methodology 109
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