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 Surgical Equipment 12
3.2 Electrosurgical Devices 12
3.2.1 Electrosurgical Generator 12
3.2.2 Electrosurgical Disposablesand Accessories 12
3.3 Surgical sutures 12
3.3.1 Absorbable Sutures 12
3.3.2 Non-Absorbable Sutures 13
3.4 Hand Instrument 13
4 Healthcare Sector Review 14
4.1 Healthcare Expenditure 14
4.2 Healthcare Infrastructure 17
4.3 Healthcare Policy 19
4.3.1 Health Insurance Act 20
4.3.2 Healthcare Allowance Act 20
4.3.3 The Exceptional Medical Expenses Act 20
5 Regulation System 21
5.1 Medical Equipment Approval Process 21
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 Post Market Surveillance (PMS) 34
6 Pricingand Reimbursement 35
6.1 Pricing and Reimbursement in Netherlands 35
7 Distribution Structure 36
7.1 Distribution Structure in Netherlands 36
8 Surgical Equipment in Netherlands 37
8.1 Surgical Equipment Cross Country Comparison (2000-2012) 37
8.2 Surgical Equipment, Netherlands, Overall Revenues ($ mn), 2000-2012 38
8.3 Surgical Equipment, Netherlands, Category Volume (Units), 2000-2012 42
8.4 Surgical Equipment, Netherlands Company share (2006-2007) 45
9 Electrosurgical Devices in Netherlands 46
9.1 Electrosurgical Devices Overall Revenue (2000-2012) 46
9.2 Electrosurgical Devices Overall Volume (2000-2012) 48
9.3 Electrosurgical Devices Average Price (2000-2012) 49
9.4 Electrosurgical Devices Distribution Share (2006-2007) 49
9.5 Electrosurgical Devices, Netherlands, Company Share (2006-2007) 50
10 Hand Instruments in Netherlands 51
10.1 Hand Instruments Overall Revenue (2000-2012) 51
10.2 Hand Instruments Overall Volume (2000-2012) 53
10.3 Hand Instruments Average Price (2000-2012) 55
10.4 Hand Instruments Distribution Share (2006-2007) 55
10.5 Hand Instruments, Netherlands, Company Share (2006-2007) 56
11 Surgical Sutures in Netherlands 57
11.1 Surgical Sutures Overall Revenue (2000-2012) 57
11.2 Surgical Sutures Overall Volume (2000-2012) 59
11.3 Surgical Sutures Average Price (2000-2012) 61
11.4 Surgical Sutures Distribution Share (2006-2007) 61
11.5 Surgical Sutures, Netherlands, Company Share (2006-2007) 62
12 Ethicon, Inc. Company Profile 63
12.1 Company Overview 63
12.1.1 Ethicon, Inc. Pipeline Products by Equipment Type 63
12.1.2 Ethicon, Inc. Pipeline Products by Development Stage 63
12.1.3 Ethicon, Inc. Pipeline Products by Therapy Area 63
12.1.4 Ethicon, Inc. Pipeline Products By Clinical Trials 63
13 Covidien Ltd./Tyco Healthcare Company Profile 64
13.1 Company Overview 64
13.2 Value Chain Analysis 64
13.2.1 Manufacturing 65
13.2.1.1 In House Manufacturing 65
13.2.1.2 Outsourcing 65
13.2.2 Product Development 65
13.2.2.1 Regulatory Approvals 65
13.2.2.2 Clinical Trials 65
13.2.2.3 Researchand Development 66
13.2.3 Salesand Marketing 66
13.2.3.1 Partnershipsand Alliances 66
13.2.3.2 Licensing Agreements 66
13.2.4 Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 66
13.2.5 Covidien Ltd./Tyco Healthcare Pipeline Products by Development Stage 66
13.2.6 Covidien Ltd./Tyco Healthcare Pipeline Products by Therapy Area 67
13.2.7 Covidien Ltd./Tyco Healthcare Pipeline Products by Clinical Trials 67
13.2.8 Covidien Ltd./Tyco Healthcare Pipeline Products by News Summary 67
14 B. Braun Melsungen AG Company Profile 68
14.1 Company Overview 68
14.2 Value Chain Analysis 68
14.2.1 Manufacturing 69
14.2.1.1 In House Manufacturing 69
14.2.1.2 Outsourcing 69
14.2.2 Product Development 69
14.2.2.1 Regulatory Approvals 69
14.2.2.2 Clinical Trials 70
14.2.2.3 Researchand Development 70
14.2.3 Salesand Marketing 70
14.2.3.1 Partnershipsand Alliances 70
14.2.3.2 Licensing Agreements 71
14.2.4 B. Braun Melsungen AG Pipeline Products by Equipment Type 71
14.2.5 B. Braun Melsungen AG Pipeline Products By Development Stage 71
14.2.6 B. Braun Melsungen AG Pipeline Products By Therapy Area 71
14.2.7 B. Braun Melsungen AG Pipeline Products by Clinical Trials 72
14.2.8 B. Braun Melsungen AG Pipeline Products by News Summary 72
15 KLS Martin, L.P. Company Profile 73
15.1 Company Overview 73
16 MEDICON eG Company Profile 74
16.1 Company Overview 74
17 ERBE Elektromedizin GmbH Company Profile 75
17.1 Company Overview 75
18 Baat Medical Company Profile 76
18.1 Company Overview 76
19 Diortho B.V. Company Profile 77
19.1 Company Overview 77
20 Entermed BV Company Profile 78
20.1 Company Overview 78
21 Eye4Vision Ophthalmics Int'l. Company Profile 79
21.1 Company Overview 79
21.1.1 Eye4Vision Ophthalmics Int'l. Pipeline Products by Equipment Type 79
21.1.2 Eye4Vision Ophthalmics Int'l. Pipeline Products by Development Stage 79
21.1.3 Eye4Vision Ophthalmics Int'l. Pipeline Products by Therapy Area 79
22 HealthLink Europe BV Company Profile 80
22.1 Company Overview 80
23 Appendix 81
23.1 Global Markets Direct Research Methodology 81
23.2 Coverage 82
23.3 Secondary Research 82
23.4 Primary Research 83
23.5 Models 83
23.6 Forecasts 84
23.7 Expert Panels 84
23.8 Currency Conversion 85
23.9 Contact Us 86
23.10 Disclaimer 86
1.1 List of Tables
Table 1: Doctors by Specialty in Netherlands, 2000-2006 18
Table 2: Hospital Wards by Type in Netherlands, 2000-2006 19
Table 3: Surgical Equipment Cross Country Comparison (2000-2012) 37
Table 4: Surgical Equipment, Netherlands, Overall Revenues ($ mn), 2000-2012 38
Table 5: Surgical Equipment, Netherlands, Portfolio Analysis, 2007 39
Table 6: Surgical Equipment, Netherlands, Overall Revenues ($ mn), Historic, 2000-2007 40
Table 7: Surgical Equipment, Netherlands, Overall Revenues ($ mn), Forecast, 2007-2012 41
Table 8: Surgical Equipment, Netherlands, Category Volume (Units), 2000-2012 42
Table 9: Surgical Equipment, Netherlands, Category Volume (Units), Historic, 2000-2007 43
Table 10: Surgical Equipment, Netherlands, Category Volume (Units), Forecast, 2007-2012 44
Table 11: Surgical Equipment, Netherlands, Company Share by Revenue ($ mn), 2006-2007 45
Table 12: Electrosurgical Devices, Netherlands, Revenue ($ mn) by Segment, Historic, 2000-2007 46
Table 13: Electrosurgical Devices, Netherlands, Revenue ($ mn) by Segment, Forecast, 2007-2012 47
Table 14: Electrosurgical Devices, Netherlands, Overall Volume (Units), Historic, 2000-2007 48
Table 15: Electrosurgical Devices, Netherlands, Overall Volume (Units), Forecast, 2007-2012 48
Table 16: Electrosurgical Devices, Netherlands, Average Price ($), Historic, 2000-2007 49
Table 17: Electrosurgical Devices, Netherlands, Average Price ($), Forecast, 2007-2012 49
Table 18: Electrosurgical Devices, Netherlands, Distribution Share by Revenue ($mn), 2006-2007 49
Table 19: Electrosurgical Devices, Netherlands, Company Share by Revenue ($ mn), 2006-2007 50
Table 20: Hand Instruments, Netherlands, Revenue ($ mn), Historic, 2000-2007 51
Table 21: Hand Instruments, Netherlands, Revenue ($ mn), Forecast, 2007-2012 52
Table 22: Hand Instruments, Netherlands, Overall Volume (Units), Historic, 2000-2007 53
Table 23: Hand Instruments, Netherlands, Overall Volume (Units), Forecast, 2007-2012 54
Table 24: Hand Instruments, Netherlands, Average Price ($), Historic, 2000-2007 55
Table 25: Hand Instruments, Netherlands, Average Price ($), Forecast, 2007-2012 55
Table 26: Hand Instruments, Netherlands, Distribution Share by Revenue ($mn), 2006-2007 55
Table 27: Hand Instruments, Netherlands, Company Share by Revenue ($ mn), 2006-2007 56
Table 28: Surgical Sutures, Netherlands, Revenue ($ mn) by Segment, Historic, 2000-2007 57
Table 29: Surgical Sutures, Netherlands, Revenue ($ mn) by Segment, Forecast, 2007-2012 58
Table 30: Surgical Sutures, Netherlands, Overall Volume (Units), Historic, 2000-2007 59
Table 31: Surgical Sutures, Netherlands, Overall Volume (Units), Forecast, 2007-2012 60
Table 32: Surgical Sutures, Netherlands, Average Price ($), Historic, 2000-2007 61
Table 33: Surgical Sutures, Netherlands, Average Price ($), Forecast, 2007-2012 61
Table 34: Surgical Sutures, Netherlands, Distribution Share by Revenue ($mn), 2006-2007 61
Table 35: Surgical Sutures, Netherlands, Company Share by Revenue ($ mn), 2006-2007 62
Table 36: Ethicon, Inc. Pipeline Products by Equipment Type 63
Table 37: Ethicon, Inc. Pipeline Products By Development Stage 63
Table 38: Ethicon, Inc. Pipeline Products By Therapy Area 63
Table 39: Ethicon, Inc. Pipeline Products By Clinical Trials 63
Table 40: Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 66
Table 41: Covidien Ltd./Tyco Healthcare Pipeline Products By Development Stage 66
Table 42: Covidien Ltd./Tyco Healthcare Pipeline Products By Therapy Area 67
Table 43: Covidien Ltd./Tyco Healthcare Pipeline Products By Clinical Trials 67
Table 44: Covidien Ltd./Tyco Healthcare Pipeline Products By News Summaries 67
Table 45: B. Braun Melsungen AG Pipeline Products by Equipment Type 71
Table 46: B. Braun Melsungen AG Pipeline Products By Development Stage 71
Table 47: B. Braun Melsungen AG Pipeline Products By Therapy Area 71
Table 48: B. Braun Melsungen AG Pipeline Products By Clinical Trials 72
Table 49: B. Braun Melsungen AG Pipeline Products By News Summaries 72
Table 50: Eye4Vision Ophthalmics Int'l. Pipeline Products by Equipment Type 79
Table 48: Eye4Vision Ophthalmics Int'l. Pipeline Products by Development Stage 79
Table 51: Eye4Vision Ophthalmics Int'l. Pipeline Products By Therapy Area 79
Table 52: Currency Conversion from USD to Local Currency at 2007 Constant Rate 85
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Netherlands, 2000 - 2006 15
Figure 2: Healthcare Financing Framework in Netherlands, 2005 16
Figure 3: Flowchart for Classification of Non-invasive Devices in Netherlands, 2007 23
Figure 4: Flowchart for Classification of Invasive Devices in Netherlands, 2007 24
Figure 5: Flowchart for Classification of Invasive Devices in Netherlands, 2007 25
Figure 6: Flowchart for Classification of Invasive Devices in Netherlands, 2007 26
Figure 7: Flowchart for Classification of Invasive Devices in Netherlands, 2007 27
Figure 8: Flowchart for Classification of Active Devices in Netherlands, 2007 28
Figure 9: Flowchart for Classification of Active Devices in Netherlands, 2007 29
Figure 10: Flowchart for Classification of Devices except Non-invasive, Invasiveand Active Devices in Netherlands, 2007 30
Figure 11: Conformity Assessment of Class-I Medical Devices in Netherlands, 2007 31
Figure 12: Conformity Assessment of Class-IIa Medical Devices in Netherlands, 2007 32
Figure 13: Conformity Assessment of Class-IIb Medical Devices in Netherlands, 2007 33
Figure 14: Conformity Assessment of Class-III Medical Devices in Netherlands, 2007 34
Figure 15: Surgical Equipment Cross Country Comparison (2000-2012) 37
Figure 16: Surgical Equipment, Netherlands, Overall Revenues ($ mn), 2000-2012 38
Figure 17: Surgical Equipment, Netherlands, Portfolio Analysis, 2007 39
Figure 18: Surgical Equipment, Netherlands, Overall Revenues ($ mn), Historic, 2000-2007 40
Figure 19: Surgical Equipment, Netherlands, Overall Revenues ($ mn), Forecast, 2007-2012 41
Figure 20: Surgical Equipment, Netherlands, Category Volume (Units), 2000-2012 42
Figure 21: Surgical Equipment, Netherlands, Category Volume (Units), Historic, 2000-2007 43
Figure 22: Surgical Equipment, Netherlands, Category Volume (Units), Forecast, 2007-2012 44
Figure 23: Surgical Equipment, Netherlands, Company Share (%), 2007 45
Figure 24: Electrosurgical Devices, Netherlands, Revenue ($ mn) by Segment, Historic, 2000-2007 46
Figure 25: Electrosurgical Devices, Netherlands, Revenue ($ mn) by Segment, Forecast, 2007-2012 47
Figure 26: Electrosurgical Devices, Netherlands, Company Share (%), 2007 50
Figure 27: Hand Instruments, Netherlands, Revenue ($ mn), Historic, 2000-2007 51
Figure 28: Hand Instruments, Netherlands, Revenue ($ mn), Forecast, 2007-2012 52
Figure 29: Hand Instruments, Netherlands, Overall Volume (Units), Historic, 2000-2007 53
Figure 30: Hand Instruments, Netherlands, Overall Volume (Units), Forecast, 2007-2012 54
Figure 31: Hand Instruments, Netherlands, Company Share (%), 2007 56
Figure 32: Surgical Sutures, Netherlands, Revenue ($ mn) by Segment, Historic, 2000-2007 57
Figure 33: Surgical Sutures, Netherlands, Revenue ($ mn) by Segment, Forecast, 2007-2012 58
Figure 34: Surgical Sutures, Netherlands, Overall Volume (Units), Historic, 2000-2007 59
Figure 35: Surgical Sutures, Netherlands, Overall Volume (Units), Forecast, 2007-2012 60
Figure 36: Surgical Sutures, Netherlands, Company Share (%), 2007 62
Figure 37: Covidien Ltd./Tyco Healthcare Value Chain Analysis 64
Figure 38: B. Braun Melsungen AG Value Chain Analysis 68
Figure 39: Global Markets Direct Methodology 81