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 Disposables and 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 16
4.2.1 Healthcare Personnel Data 17
4.2.2 Healthcare Facilities Data 18
4.3 Healthcare Policy 19
5 Regulation System 21
5.1 Medical Equipment Approval Process 21
5.1.1 Classification 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 Notification Fee 35
6 Pricing and Reimbursement 36
6.1 Reimbursement Policies 36
7 Distribution Structure 37
8 Surgical Equipment in Belgium 38
8.1 Surgical Equipment Cross Country Comparison (2000-2012) 38
8.2 Surgical Equipment, Belgium, Overall Revenues ($ mn), 2000-2012 39
8.3 Surgical Equipment, Belgium, Category Volume (Units), 2000-2012 43
8.4 Surgical Equipment, Belgium Company share (2006-2007) 46
9 Electrosurgical Devices in Belgium 47
9.1 Electrosurgical Devices Overall Revenue (2000-2012) 47
9.2 Electrosurgical Devices Overall Volume (2000-2012) 49
9.3 Electrosurgical Devices Average Price (2000-2012) 50
9.4 Electrosurgical Devices Distribution Share (2006-2007) 50
9.5 Electrosurgical Devices, Belgium, Company Share (2006-2007) 51
10 Hand Instruments In Belgium 52
10.1 Hand Instruments Overall Revenue (2000-2012) 52
10.2 Hand Instruments Overall Volume (2000-2012) 54
10.3 Hand Instruments Average Price (2000-2012) 56
10.4 Hand Instruments Distribution Share (2006-2007) 56
10.5 Hand Instruments, Belgium, Company Share (2006-2007) 57
11 Surgical Sutures In Belgium 58
11.1 Surgical Sutures Overall Revenue (2000-2012) 58
11.2 Surgical Sutures Overall Volume (2000-2012) 60
11.3 Surgical Sutures Average Price (2000-2012) 62
11.4 Surgical Sutures Distribution Share (2006-2007) 62
11.5 Surgical Sutures, Belgium, Company Share (2006-2007) 63
12 Ethicon, Inc. Company Profile 64
12.1 Company Overview 64
12.1.1 Ethicon, Inc. Pipeline Products by Equipment Type 64
12.1.2 Ethicon, Inc. Pipeline Products by Development Stage 64
12.1.3 Ethicon, Inc. Pipeline Products by Therapy Area 64
12.1.4 Ethicon, Inc. Pipeline Products by Clinical Trials 64
13 Covidien Ltd./Tyco Healthcare Company Profile 65
13.1 Company Overview 65
13.2 Value Chain Analysis 65
13.2.1 Manufacturing 66
13.2.1.1 In House Manufacturing 66
13.2.1.2 Outsourcing 66
13.2.2 Product Development 66
13.2.2.1 Regulatory Approvals 66
13.2.2.2 Clinical Trials 66
13.2.2.3 Research and Development 67
13.2.3 Sales and Marketing 67
13.2.3.1 Partnerships and Alliances 67
13.2.3.2 Licensing Agreements 67
13.2.4 Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 67
13.2.5 Covidien Ltd./Tyco Healthcare Pipeline Products by Development Stage 67
13.2.6 Covidien Ltd./Tyco Healthcare Pipeline Products by Therapy Area 68
13.2.7 Covidien Ltd./Tyco Healthcare Pipeline Products by Clinical Trials 68
13.2.8 Covidien Ltd./Tyco Healthcare Pipeline Products By News Summary 68
14 B. Braun Melsungen AG Company Profile 69
14.1 Company Overview 69
14.2 Value Chain Analysis 69
14.2.1 Manufacturing 70
14.2.1.1 In House Manufacturing 70
14.2.1.2 Outsourcing 70
14.2.2 Product Development 70
14.2.2.1 Regulatory Approvals 70
14.2.2.2 Clinical Trials 71
14.2.2.3 Research and Development 71
14.2.3 Sales and Marketing 71
14.2.3.1 Partnerships and Alliances 71
14.2.3.2 Licensing Agreements 72
14.2.4 B. Braun Melsungen AG Pipeline Products by Equipment Type 72
14.2.5 B. Braun Melsungen AG Pipeline Products by Development Stage 72
14.2.6 B. Braun Melsungen AG Pipeline Products by Therapy Area 72
14.2.7 B. Braun Melsungen AG Pipeline Products by Clinical Trials 73
14.2.8 B. Braun Melsungen AG Pipeline Products By News Summary 73
15 KLS Martin, L.P. Company Profile 74
15.1 Company Overview 74
16 MEDICON eG Company Profile 75
16.1 Company Overview 75
17 ERBE Elektromedizin GmbH Company Profile 76
17.1 Company Overview 76
18 Medsys s.a. Company Profile 77
18.1 Company Overview 77
19 Appendix 78
19.1 Global Markets Direct Research Methodology 78
19.2 Coverage 79
19.3 Secondary Research 79
19.4 Primary Research 80
19.5 Models 80
19.6 Forecasts 81
19.7 Expert Panels 81
19.8 Currency Conversion 82
19.9 Contact Us 83
19.10 Disclaimer 83
1.1 List of Tables
Table 1: Hospitals and Hospital Beds in Belgium, 2005 16
Table 2: Number of Doctors by Specialty in Belgium, 2003-2007 17
Table 3: Number of Hospital Wards by Specialty in Belgium, 2003-2007 18
Table 4: Medical Equipment Notification Fee in Belgium, 2007 35
Table 5: Surgical Equipment Cross Country Comparison (2000-2012) 38
Table 6: Surgical Equipment, Belgium, Overall Revenues ($ mn), 2000-2012 39
Table 7: Surgical Equipment, Belgium, Portfolio Analysis, 2007 40
Table 8: Surgical Equipment, Belgium, Overall Revenues ($ mn), Historic, 2000-2007 41
Table 9: Surgical Equipment, Belgium, Overall Revenues ($ mn), Forecast, 2007-2012 42
Table 10: Surgical Equipment, Belgium, Category Volume (Units), 2000-2012 43
Table 11: Surgical Equipment, Belgium, Category Volume (Units), Historic, 2000-2007 44
Table 12: Surgical Equipment, Belgium, Category Volume (Units), Forecast, 2007-2012 45
Table 13: Surgical Equipment, Belgium Company share by Revenue ($ mn), 2006-2007 46
Table 14: Electrosurgical Devices, Belgium, Revenue ($ mn) by Segment, Historic, 2000-2007 47
Table 15: Electrosurgical Devices, Belgium, Revenue ($ mn) by Segment, Forecast, 2007-2012 48
Table 16: Electrosurgical Devices, Belgium, Overall Volume (Units), Historic, 2000-2007 49
Table 17: Electrosurgical Devices, Belgium, Overall Volume (Units), Forecast, 2007-2012 49
Table 18: Electrosurgical Devices, Belgium, Average Price ($), Historic, 2000-2007 50
Table 19: Electrosurgical Devices, Belgium, Average Price ($), Forecast, 2007-2012 50
Table 20: Electrosurgical Devices, Belgium, Distribution Share by Revenue ($mn), 2006-2007 50
Table 21: Electrosurgical Devices, Belgium, Company Share by Revenue ($ mn), 2006-2007 51
Table 22: Hand Instruments, Belgium, Revenue ($ mn), Historic, 2000-2007 52
Table 23: Hand Instruments, Belgium, Revenue ($ mn), Forecast, 2007-2012 53
Table 24: Hand Instruments, Belgium, Overall Volume (Units), Historic, 2000-2007 54
Table 25: Hand Instruments, Belgium, Overall Volume (Units), Forecast, 2007-2012 55
Table 26: Hand Instruments, Belgium, Average Price ($), Historic, 2000-2007 56
Table 27: Hand Instruments, Belgium, Average Price ($), Forecast, 2007-2012 56
Table 28: Hand Instruments, Belgium, Distribution Share by Revenue ($mn), 2006-2007 56
Table 29: Hand Instruments, Belgium, Company Share by Revenue ($ mn), 2006-2007 57
Table 30: Surgical Sutures, Belgium, Revenue ($ mn) by Segment, Historic, 2000-2007 58
Table 31: Surgical Sutures, Belgium, Revenue ($ mn) by Segment, Forecast, 2007-2012 59
Table 32: Surgical Sutures, Belgium, Overall Volume (Units), Historic, 2000-2007 60
Table 33: Surgical Sutures, Belgium, Overall Volume (Units), Forecast, 2007-2012 61
Table 34: Surgical Sutures, Belgium, Average Price ($), Historic, 2000-2007 62
Table 35: Surgical Sutures, Belgium, Average Price ($), Forecast, 2007-2012 62
Table 36: Surgical Sutures, Belgium, Distribution Share by Revenue ($mn), 2006-2007 62
Table 37: Surgical Sutures, Belgium, Company Share by Revenue ($ mn), 2006-2007 63
Table 38: Ethicon, Inc. Pipeline Products by Equipment Type 64
Table 39: Ethicon, Inc. Pipeline Products By Development Stage 64
Table 40: Ethicon, Inc. Pipeline Products By Therapy Area 64
Table 41: Ethicon, Inc. Pipeline Products By Clinical Trials 64
Table 42: Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 67
Table 43: Covidien Ltd./Tyco Healthcare Pipeline Products By Development Stage 67
Table 44: Covidien Ltd./Tyco Healthcare Pipeline Products By Therapy Area 68
Table 45: Covidien Ltd./Tyco Healthcare Pipeline Products By Clinical Trials 68
Table 46: Covidien Ltd./Tyco Healthcare Pipeline Products By News Summaries 68
Table 47: B. Braun Melsungen AG Pipeline Products by Equipment Type 72
Table 48: B. Braun Melsungen AG Pipeline Products By Development Stage 72
Table 49: B. Braun Melsungen AG Pipeline Products By Therapy Area 72
Table 50: B. Braun Melsungen AG Pipeline Products By Clinical Trials 73
Table 51: B. Braun Melsungen AG Pipeline Products By News Summaries 73
Table 52: Currency Conversion from USD to Local Currency at 2007 Constant Rate 82
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Belgium, 2000 – 2006 15
Figure 2: Structure of Healthcare System in Belgium, 2007 20
Figure 3: Flowchart for Classification of Non-invasive Devices in Belgium, 2007 23
Figure 4: Flowchart for Classification of Invasive Devices in Belgium, 2007 24
Figure 5: Flowchart for Classification of Invasive Devices in Belgium, 2007 25
Figure 6: Flowchart for Classification of Invasive Devices in Belgium, 2007 26
Figure 7: Flowchart for Classification of Invasive Devices in Belgium, 2007 27
Figure 8: Flowchart for Classification of Active Devices in Belgium, 2007 28
Figure 9: Flowchart for Classification of Active Devices in Belgium, 2007 29
Figure 10: Flowchart for Classification of Devices except Non-invasive, Invasiveand Active Devices in Belgium, 2007 30
Figure 11: Conformity Assessment of Class-I Medical Devices in Belgium, 2007 31
Figure 12: Conformity Assessment of Class-IIa Medical Devices in Belgium, 2007 32
Figure 13: Conformity Assessment of Class-IIb Medical Devices in Belgium, 2007 33
Figure 14: Conformity Assessment of Class-III Medical Devices in Belgium, 2007 34
Figure 15: Surgical Equipment Cross Country Comparison (2000-2012) 38
Figure 16: Surgical Equipment, Belgium, Overall Revenues ($ mn), 2000-2012 39
Figure 17: Surgical Equipment, Belgium, Portfolio Analysis, 2007 40
Figure 18: Surgical Equipment, Belgium, Overall Revenues ($ mn), Historic, 2000-2007 41
Figure 19: Surgical Equipment, Belgium, Overall Revenues ($ mn), Forecast, 2007-2012 42
Figure 20: Surgical Equipment, Belgium, Category Volume (Units), 2000-2012 43
Figure 21: Surgical Equipment, Belgium, Category Volume (Units), Historic, 2000-2007 44
Figure 22: Surgical Equipment, Belgium, Category Volume (Units), Forecast, 2007-2012 45
Figure 23: Surgical Equipment, Belgium Company share (%), 2007 46
Figure 24: Electrosurgical Devices, Belgium, Revenue ($ mn) by Segment, Historic, 2000-2007 47
Figure 25: Electrosurgical Devices, Belgium, Revenue ($ mn) by Segment, Forecast, 2007-2012 48
Figure 26: Electrosurgical Devices, Belgium, Company Share (%), 2007 51
Figure 27: Hand Instruments, Belgium, Revenue ($ mn), Historic, 2000-2007 52
Figure 28: Hand Instruments, Belgium, Revenue ($ mn), Forecast, 2007-2012 53
Figure 29: Hand Instruments, Belgium, Overall Volume (Units), Historic, 2000-2007 54
Figure 30: Hand Instruments, Belgium, Overall Volume (Units), Forecast, 2007-2012 55
Figure 31: Hand Instruments, Belgium, Company Share (%), 2007 57
Figure 32: Surgical Sutures, Belgium, Revenue ($ mn) by Segment, Historic, 2000-2007 58
Figure 33: Surgical Sutures, Belgium, Revenue ($ mn) by Segment, Forecast, 2007-2012 59
Figure 34: Surgical Sutures, Belgium, Overall Volume (Units), Historic, 2000-2007 60
Figure 35: Surgical Sutures, Belgium, Overall Volume (Units), Forecast, 2007-2012 61
Figure 36: Surgical Sutures, Belgium, Company Share (%), 2007 63
Figure 37: Covidien Ltd./Tyco Healthcare Value Chain Analysis 65
Figure 38: B. Braun Melsungen AG Value Chain Analysis 69
Figure 39: Global Markets Direct Methodology 78