Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2
List of Figures 11
2 Introduction 13
2.1 What Is This Report About?
13
3 Definitions of Markets Covered in the Report 14
3.1 Wound Care
Management 14
3.2 Advanced Wound Management 14
3.2.1 Alginates 14
3.2.2 Collagens 14
3.2.3 Foams 14
3.2.4 Hydrocolloids 14
3.2.5
Hydrofibres 14
3.2.6 Hydrogels 14
3.2.7 Semi-Permeable Films 14
3.3 Compression Therapy 14
3.3.1 Compression Bandages 15
3.3.2 Dynamic
Compression Therapy 15
3.4 Ostomy Drainage Bags 15
3.4.1 Colostomy
15
3.4.2 Ileostomy 15
3.4.3 Urostomy 15
3.5 Pressure Relief
Devices 16
3.5.1 Mattress Overlays 16
3.5.2 Mattresses 16
3.5.3
Speciality Beds 16
3.6 Traditional Wound Management 16
3.7 Wound
Closure Devices 16
3.7.1 Hemostats 16
3.7.2 Ligating Clips 16
3.7.3 Mechanical Stapling Devices 16
3.7.4 Tissue Sealants 16
3.7.5
Wound Closure Strips 17
4 Healthcare Sector Review 18
4.1 Healthcare
Sector Review 18
4.2 Healthcare Expenditure 18
4.3 Healthcare
Infrastructure 22
4.4 Healthcare Policy 24
5 Regulation System 26
5.1 Medical Equipment Approval Process 26
5.1.1 Classification of Medical
Devices 26
5.1.2 Conformity Assessment Process 35
5.2 Classificazione
Nazionale Dispositivi (CND) - New Medical Device Classification 38
5.3
Post Market Surveillance 39
6 Pricing and Reimbursement 40
6.1 Market
Pricing 40
6.2 Government Policies for Reimbursement 40
7 Distribution
Structure 41
8 Wound Care Management In Italy 42
8.1 Wound Care
Management, Cross Country Comparison, Revenue ($ mn), 2000-2015 42
8.2
Wound Care Management, Italy, Overall Revenue ($ mn), 2000-2015 44
8.3
Wound Care Management, Italy, Category Volume (Units), 2000-2015 50
8.4
Wound Care Management, Italy, Company Share (2007-2008) 55
9 Advanced
Wound Management In Italy 56
9.1 Advanced Wound Management Overall Revenue
(2000-2015) 56
9.2 Advanced Wound Management Overall Volume (2000-2015)
60
9.3 Advanced Wound Management Average Price (2000-2015) 64
9.4
Advanced Wound Management Distribution Share (2007-2008) 65
9.5 Advanced
Wound Management, Italy, Company Share (2007-2008) 66
10 Compression
Therapy In Italy 68
10.1 Compression Therapy Overall Revenue (2000-2015)
68
10.1.1 Dynamic Compression Therapy Revenue (2000-2015) 70
10.2
Compression Therapy Overall Volume (2000-2015) 72
10.2.1 Dynamic
Compression Therapy Volume (2000-2015) 73
10.3 Compression Therapy Average
Price (2000-2015) 75
10.4 Compression Therapy Distribution Share
(2007-2008) 76
10.5 Compression Therapy, Italy, Company Share (2007-2008)
77
11 Negative Pressure Wound Therapy (NPWT) In Italy 78
11.1 Negative
Pressure Wound Therapy (NPWT) Overall Revenue (2000-2015) 78
11.2 Negative
Pressure Wound Therapy (NPWT) Overall Volume (2000-2015) 80
11.3 Negative
Pressure Wound Therapy (NPWT) Average Price (2000-2015) 82
11.4 Negative
Pressure Wound Therapy (NPWT) Distribution Share (2007-2008) 83
11.5
Negative Pressure Wound Therapy (NPWT), Italy, Company Share (2007-2008)
84
12 Ostomy Drainage Bags In Italy 85
12.1 Ostomy Drainage Bags
Overall Revenue (2000-2015) 85
12.2 Ostomy Drainage Bags Overall Volume
(2000-2015) 87
12.3 Ostomy Drainage Bags Average Price (2000-2015) 89
12.4 Ostomy Drainage Bags Distribution Share (2007-2008) 90
12.5 Ostomy
Drainage Bags, Italy, Company Share (2007-2008) 91
13 Pressure Relief
Devices In Italy 92
13.1 Pressure Relief Devices Overall Revenue
(2000-2015) 92
13.2 Pressure Relief Devices Overall Volume (2000-2015)
94
13.3 Pressure Relief Devices Average Price (2000-2015) 95
13.4
Pressure Relief Devices Distribution Share (2007-2008) 96
13.5 Pressure
Relief Devices, Italy, Company Share (2007-2008) 97
14 Traditional Wound
Management In Italy 98
14.1 Traditional Wound Management Overall Revenue
(2000-2015) 98
14.2 Traditional Wound Management Overall Volume
(2000-2015) 100
14.3 Traditional Wound Management Average Price
(2000-2015) 102
14.4 Traditional Wound Management Distribution Share
(2007-2008) 103
14.5 Traditional Wound Management, Italy, Company Share
(2007-2008) 104
15 Wound Closure Devices In Italy 105
15.1 Wound
Closure Devices Overall Revenue (2000-2015) 105
15.2 Wound Closure Devices
Overall Volume (2000-2015) 109
15.3 Wound Closure Devices Average Price
(2000-2015) 111
15.4 Wound Closure Devices Distribution Share (2007-2008)
112
15.5 Wound Closure Devices, Italy, Company Share (2007-2008) 113
16 Overview of Key Companies in Italy Wound Care Management Market 114
16.1 Talley Group Limited 114
16.1.1 Company Overview 114
16.2 Smith &
Nephew Plc 115
16.2.1 Company Overview 115
16.2.2 Smith & Nephew Plc
Pipeline Products 115
16.3 Nycomed International Management GmbH 118
16.3.1 Company Overview 118
16.3.2 Nycomed International Management GmbH
Pipeline Products 118
16.4 Molnlycke Health Care AB 120
16.4.1 Company
Overview 120
16.5 Kinetic Concepts, Inc. 121
16.5.1 Company Overview
121
16.5.2 Kinetic Concepts, Inc. Pipeline Products 121
16.6 Johnson &
Johnson 123
16.6.1 Company Overview 123
16.7 Invacare Corporation
123
16.7.1 Company Overview 123
16.8 Hollister Incorporated 124
16.8.1 Company Overview 124
16.9 Hill-Rom Holdings, Inc. 124
16.9.1
Company Overview 124
16.10 HARTMANN GROUP 125
16.10.1 Company Overview
125
16.11 Ethicon, Inc. 125
16.11.1 Company Overview 125
16.12
Covidien plc 126
16.12.1 Company Overview 126
16.12.2 Covidien
Ltd./Tyco Healthcare Pipeline Products 126
16.13 ConvaTec 128
16.13.1
Company Overview 128
16.14 Coloplast A/S 128
16.14.1 Company Overview
128
16.15 BSN medical GmbH 128
16.15.1 Company Overview 128
16.16
Baxter International Inc. 129
16.16.1 Company Overview 129
16.17 B.
Braun Melsungen AG 130
16.17.1 Company Overview 130
16.18 Advanced
Medical Solutions Group plc 131
16.18.1 Company Overview 131
16.18.2
Advanced Medical Solutions Group Plc Pipeline Products 131
16.19 3M Health
Care 133
16.19.1 Company Overview 133
16.20 EURORESEARCH s.r.l.
133
16.20.1 Company Overview 133
16.21 Gloria Med S.p.A. 133
16.21.1 Company Overview 133
17 APPENDIX 134
17.1 Global Markets
Direct Research Methodology 134
17.2 Secondary Research 135
17.3
Primary Research 135
17.4 Models 136
17.5 Forecasts 136
17.6
Expert Panel Validation 136
17.7 Currency Conversion 137
17.8 Contact
Us 138
17.9 Disclaimer 138
1.1 List of Tables
Table 1:
Healthcare Expenditure in Italy, 2000 - 2007 19
Table 2: Number of Doctors
by Specialty in Italy, 2003-2007 23
Table 3: Number of Hospital Wards by
Specialty in Italy, 2003-2007 24
Table 4: Wound Care Management,
Cross Country Comparison, Revenue ($ mn), 2000-2015 43
Table 5: Wound
Care Management, Italy, Overall Revenue ($ mn), 2000-2015 44
Table 6:
Wound Care Management, Italy, Cross-Category Analysis, 2000-2015 45
Table
7: Wound Care Management, Italy, Overall Revenue ($ mn), Historic,
2000-2008 47
Table 8: Wound Care Management, Italy, Overall Revenue
($ mn), Forecast, 2008-2015 49
Table 9: Wound Care Management, Italy,
Category Volume (Units), 2000-2015 50
Table 10: Wound Care
Management, Italy, Category Volume (Units), Historic, 2000-2008 52
Table
11: Wound Care Management, Italy, Category Volume (Units), Forecast,
2008-2015 54
Table 12: Wound Care Management, Italy, Company Share by
Revenue ($ mn), 2007-2008 55
Table 13: Advanced Wound Management,
Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 57
Table 14:
Advanced Wound Management, Italy, Revenue ($ mn) by Segment, Forecast,
2008-2015 59
Table 15: Advanced Wound Management, Italy, Volume
(Units) by Segment, Historic, 2000-2008 61
Table 16: Advanced Wound
Management, Italy, Volume (Units) by Segment, Forecast, 2008-2015 63
Table
17: Advanced Wound Management, Italy, Average Price ($), Historic,
2000-2008 64
Table 18: Advanced Wound Management, Italy, Average
Price ($), Forecast, 2008-2015 64
Table 19: Advanced Wound
Management, Italy, Distribution Share by Revenue ($mn), 2007-2008 65
Table
20: Advanced Wound Management, Italy, Company Share by Revenue ($ mn),
2007-2008 67
Table 21: Compression Therapy, Italy, Revenue ($ mn) by
Segment, Historic, 2000-2008 68
Table 22: Compression Therapy, Italy,
Revenue ($ mn) by Segment, Forecast, 2008-2015 69
Table 23: Dynamic
Compression Therapy, Italy, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
70
Table 24: Dynamic Compression Therapy, Italy, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 71
Table 25: Compression Therapy,
Italy, Volume (Units) by Segment, Historic, 2000-2008 72
Table 26:
Compression Therapy, Italy, Volume (Units) by Segment, Forecast, 2008-2015
72
Table 27: Dynamic Compression Therapy, Italy, Volume (Units) by
Sub-Segment, Historic, 2000-2008 73
Table 28: Dynamic Compression
Therapy, Italy, Volume (Units) by Sub-Segment, Forecast, 2008-2015 74
Table 29: Compression Therapy, Italy, Average Price ($), Historic,
2000-2008 75
Table 30: Compression Therapy, Italy, Average Price ($),
Forecast, 2008-2015 75
Table 31: Compression Therapy, Italy,
Distribution Share by Revenue ($mn), 2007-2008 76
Table 32:
Compression Therapy, Italy, Company Share by Revenue ($ mn), 2007-2008 77
Table 33: Negative Pressure Wound Therapy (NPWT), Italy, Revenue ($ mn)
by Segment, Historic, 2000-2008 78
Table 34: Negative Pressure Wound
Therapy (NPWT), Italy, Revenue ($ mn) by Segment, Forecast, 2008-2015 79
Table 35: Negative Pressure Wound Therapy (NPWT), Italy, Volume (Units)
by Segment, Historic, 2000-2008 80
Table 36: Negative Pressure Wound
Therapy (NPWT), Italy, Volume (Units) by Segment, Forecast, 2008-2015 81
Table 37: Negative Pressure Wound Therapy (NPWT), Italy, Average Price
($), Historic, 2000-2008 82
Table 38: Negative Pressure Wound Therapy
(NPWT), Italy, Average Price ($), Forecast, 2008-2015 82
Table 39:
Negative Pressure Wound Therapy (NPWT), Italy, Distribution Share by Revenue
($mn), 2007-2008 83
Table 40: Negative Pressure Wound Therapy (NPWT),
Italy, Company Share by Revenue ($ mn), 2007-2008 84
Table 41: Ostomy
Drainage Bags, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 85
Table 42: Ostomy Drainage Bags, Italy, Revenue ($ mn) by Segment,
Forecast, 2008-2015 86
Table 43: Ostomy Drainage Bags, Italy, Volume
(Units) by Segment, Historic, 2000-2008 87
Table 44: Ostomy Drainage
Bags, Italy, Volume (Units) by Segment, Forecast, 2008-2015 88
Table 45:
Ostomy Drainage Bags, Italy, Average Price ($), Historic, 2000-2008 89
Table 46: Ostomy Drainage Bags, Italy, Average Price ($), Forecast,
2008-2015 89
Table 47: Ostomy Drainage Bags, Italy, Distribution
Share by Revenue ($mn), 2007-2008 90
Table 48: Ostomy Drainage Bags,
Italy, Company Share by Revenue ($ mn), 2007-2008 91
Table 49:
Pressure Relief Devices, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008
92
Table 50: Pressure Relief Devices, Italy, Revenue ($ mn) by
Segment, Forecast, 2008-2015 93
Table 51: Pressure Relief Devices,
Italy, Volume (Units) by Segment, Historic, 2000-2008 94
Table 52:
Pressure Relief Devices, Italy, Volume (Units) by Segment, Forecast, 2008-2015
94
Table 53: Pressure Relief Devices, Italy, Average Price ($),
Historic, 2000-2008 95
Table 54: Pressure Relief Devices, Italy,
Average Price ($), Forecast, 2008-2015 95
Table 55: Pressure Relief
Devices, Italy, Distribution Share by Revenue ($mn), 2007-2008 96
Table
56: Pressure Relief Devices, Italy, Company Share by Revenue ($ mn),
2007-2008 97
Table 57: Traditional Wound Management, Italy, Revenue
($ mn), Historic, 2000-2008 98
Table 58: Traditional Wound
Management, Italy, Revenue ($ mn), Forecast, 2008-2015 99
Table 59:
Traditional Wound Management, Italy, Volume (Units), Historic, 2000-2008
100
Table 60: Traditional Wound Management, Italy, Volume (Units),
Forecast, 2008-2015 101
Table 61: Traditional Wound Management,
Italy, Average Price ($), Historic, 2000-2008 102
Table 62:
Traditional Wound Management, Italy, Average Price ($), Forecast, 2008-2015
102
Table 63: Traditional Wound Management, Italy, Distribution Share
by Revenue ($mn), 2007-2008 103
Table 64: Traditional Wound
Management, Italy, Company Share by Revenue ($ mn), 2007-2008 104
Table
65: Wound Closure Devices, Italy, Revenue ($ mn) by Segment, Historic,
2000-2008 106
Table 66: Wound Closure Devices, Italy, Revenue ($ mn)
by Segment, Forecast, 2008-2015 108
Table 67: Wound Closure Devices,
Italy, Volume (Units) by Segment, Historic, 2000-2008 109
Table 68:
Wound Closure Devices, Italy, Volume (Units) by Segment, Forecast, 2008-2015
110
Table 69: Wound Closure Devices, Italy, Average Price ($),
Historic, 2000-2008 111
Table 70: Wound Closure Devices, Italy,
Average Price ($), Forecast, 2008-2015 111
Table 71: Wound Closure
Devices, Italy, Distribution Share by Revenue ($mn), 2007-2008 112
Table
72: Wound Closure Devices, Italy, Company Share by Revenue ($ mn),
2007-2008 113
Table 73: Smith & Nephew Plc Pipeline Products by
Equipment Type 115
Table 74: Smith & Nephew Plc Pipeline Products By
Development Stage 116
Table 75: Smith & Nephew Plc Pipeline Products
By Therapy Area 117
Table 76: Smith & Nephew Plc Pipeline Products By
News Summary 117
Table 77: Nycomed International Management GmbH
Pipeline Products by Equipment Type 118
Table 78: Nycomed
International Management GmbH Pipeline Products By Development Stage 118
Table 79: Nycomed International Management GmbH Pipeline Products By
Therapy Area 119
Table 80: Nycomed International Management GmbH
Pipeline Products By News Summary 119
Table 81: Kinetic Concepts,
Inc. Pipeline Products by Equipment Type 121
Table 82: Kinetic
Concepts, Inc. Pipeline Products By Development Stage 122
Table 83:
Kinetic Concepts, Inc. Pipeline Products By Therapy Area 122
Table 84:
Kinetic Concepts, Inc. Pipeline Products By Clinical Trials 122
Table 85:
Kinetic Concepts, Inc. Pipeline Products By News Summary 122
Table
86: Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type
126
Table 87: Covidien Ltd./Tyco Healthcare Pipeline Products By
Development Stage 126
Table 88: Covidien Ltd./Tyco Healthcare
Pipeline Products By Therapy Area 127
Table 89: Covidien Ltd./Tyco
Healthcare Pipeline Products By Clinical Trials 127
Table 90:
Covidien Ltd./Tyco Healthcare Pipeline Products By News Summary 127
Table
91: Advanced Medical Solutions Group Plc Pipeline Products by Equipment
Type 131
Table 92: Advanced Medical Solutions Group Plc Pipeline
Products By Development Stage 131
Table 93: Advanced Medical
Solutions Group Plc Pipeline Products By Therapy Area 132
Table 94: USD
to Local Currency, Average Exchange Rate 2008 137
1.2 List of
Figures
Figure 1: Total Healthcare Expenditure in Italy, 2000 - 2007
19
Figure 2: Government and Private Healthcare Expenditure in Italy, 2007
20
Figure 3: Healthcare Financing Framework in Italy, 2007 21
Figure
4: Flowchart for Classification of Non-invasive Devices in Italy, 2007 27
Figure 5: Flowchart for Classification of Invasive Devices in Italy, 2007
28
Figure 6: Flowchart for Classification of Invasive Devices in Italy,
2007 29
Figure 7: Flowchart for Classification of Invasive Devices in
Italy, 2007 30
Figure 8: Flowchart for Classification of Invasive Devices
in Italy, 2007 31
Figure 9: Flowchart for Classification of Active Devices
in Italy, 2007 32
Figure 10: Flowchart for Classification of Active
Devices in Italy, 2007 33
Figure 11: Flowchart for Classification of
Devices except Non-invasive, Invasive and Active Devices in Italy, 2007 34
Figure 12: Conformity Assessment of Class-I Medical Devices in Italy, 2007
35
Figure 13: Conformity Assessment of Class-IIa Medical Devices in Italy,
2007 36
Figure 14: Conformity Assessment of Class-IIb Medical Devices in
Italy, 2007 37
Figure 15: Conformity Assessment of Class-III Medical
Devices in Italy, 2007 38
Figure 16: Wound Care Management, Cross
Country Comparison, Revenue ($ mn), 2000-2015 42
Figure 17: Wound
Care Management, Italy, Overall Revenue ($ mn), 2000-2015 44
Figure 18:
Wound Care Management, Italy, Cross-Category Analysis, 2000-2015 45
Figure
19: Wound Care Management, Italy, Overall Revenue ($ mn), Historic,
2000-2008 46
Figure 20: Wound Care Management, Italy, Overall Revenue
($ mn), Forecast, 2008-2015 48
Figure 21: Wound Care Management,
Italy, Category Volume (Units), 2000-2015 50
Figure 22: Wound Care
Management, Italy, Category Volume (Units), Historic, 2000-2008 51
Figure
23: Wound Care Management, Italy, Category Volume (Units), Forecast,
2008-2015 53
Figure 24: Wound Care Management, Italy, Company Share
(%), 2008 55
Figure 25: Advanced Wound Management, Italy, Revenue ($
mn) by Segment, Historic, 2000-2008 56
Figure 26: Advanced Wound
Management, Italy, Revenue ($ mn) by Segment, Forecast, 2008-2015 58
Figure 27: Advanced Wound Management, Italy, Volume (Units) by Segment,
Historic, 2000-2008 60
Figure 28: Advanced Wound Management, Italy,
Volume (Units) by Segment, Forecast, 2008-2015 62
Figure 29: Advanced
Wound Management, Italy, Company Share (%), 2008 66
Figure 30:
Compression Therapy, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008
68
Figure 31: Compression Therapy, Italy, Revenue ($ mn) by Segment,
Forecast, 2008-2015 69
Figure 32: Dynamic Compression Therapy, Italy,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 70
Figure 33:
Dynamic Compression Therapy, Italy, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 71
Figure 34: Dynamic Compression Therapy, Italy, Volume
(Units) by Sub-Segment, Historic, 2000-2008 73
Figure 35: Dynamic
Compression Therapy, Italy, Volume (Units) by Sub-Segment, Forecast, 2008-2015
74
Figure 36: Compression Therapy, Italy, Company Share (%), 2008
77
Figure 37: Negative Pressure Wound Therapy (NPWT), Italy, Revenue
($ mn) by Segment, Historic, 2000-2008 78
Figure 38: Negative
Pressure Wound Therapy (NPWT), Italy, Revenue ($ mn) by Segment, Forecast,
2008-2015 79
Figure 39: Negative Pressure Wound Therapy (NPWT),
Italy, Volume (Units) by Segment, Historic, 2000-2008 80
Figure 40:
Negative Pressure Wound Therapy (NPWT), Italy, Volume (Units) by Segment,
Forecast, 2008-2015 81
Figure 41: Negative Pressure Wound Therapy
(NPWT), Italy, Company Share (%), 2008 84
Figure 42: Ostomy Drainage
Bags, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 85
Figure 43:
Ostomy Drainage Bags, Italy, Revenue ($ mn) by Segment, Forecast,
2008-2015 86
Figure 44: Ostomy Drainage Bags, Italy, Volume (Units)
by Segment, Historic, 2000-2008 87
Figure 45: Ostomy Drainage Bags,
Italy, Volume (Units) by Segment, Forecast, 2008-2015 88
Figure 46:
Ostomy Drainage Bags, Italy, Company Share (%), 2008 91
Figure 47:
Pressure Relief Devices, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008
92
Figure 48: Pressure Relief Devices, Italy, Revenue ($ mn) by
Segment, Forecast, 2008-2015 93
Figure 49: Pressure Relief Devices,
Italy, Company Share (%), 2008 97
Figure 50: Traditional Wound
Management, Italy, Revenue ($ mn) by, Historic, 2000-2008 98
Figure 51:
Traditional Wound Management, Italy, Revenue ($ mn), Forecast, 2008-2015
99
Figure 52: Traditional Wound Management, Italy, Volume (Units),
Historic, 2000-2008 100
Figure 53: Traditional Wound Management,
Italy, Volume (Units), Forecast, 2008-2015 101
Figure 54: Traditional
Wound Management, Italy, Company Share (%), 2008 104
Figure 55: Wound
Closure Devices, Italy, Revenue ($ mn) by Segment, Historic, 2000-2008 105
Figure 56: Wound Closure Devices, Italy, Revenue ($ mn) by Segment,
Forecast, 2008-2015 107
Figure 57: Wound Closure Devices, Italy,
Volume (Units) by Segment, Historic, 2000-2008 109
Figure 58: Wound
Closure Devices, Italy, Volume (Units) by Segment, Forecast, 2008-2015 110
Figure 59: Wound Closure Devices, Italy, Company Share (%), 2008 113
Figure 60: Global Markets Direct Methodology 134
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