1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 10
2.1 What Is This Report About? 10
3 Definitions of the Markets Covered in the Report 11
3.1 Surgical Equipment 11
3.2 Electrosurgical Devices 11
3.2.1 Electrosurgical Generator 11
3.2.2 Electrosurgical Disposables and Accessories 11
3.3 Surgical sutures 11
3.3.1 Absorbable Sutures 11
3.3.2 Non-Absorbable Sutures 12
3.4 Hand Instrument 12
4 Healthcare Sector Review 13
4.1 Healthcare Expenditure 13
4.2 Healthcare Infrastructure 16
4.3 Healthcare Policy 20
5 Regulation System 21
5.1 Medical Equipment Approval Process 21
5.1.1 Classification 21
5.1.2 Premarket Notification for Class I Devices 22
5.1.3 Pre-market Approval for Class II, III and IV Devices 22
5.1.3.1 Technical Review: 22
5.1.3.2 Type Testing: 23
5.1.3.3 Applying for Product License: 23
5.1.3.4 KGMP Certification 23
5.1.4 License Fee 23
5.1.5 License Application Processing Duration 23
5.2 Post-market Surveillance 24
6 Pricing and Reimbursement 25
7 Distribution Structure 28
7.1 Distribution Structure 28
8 Surgical Equipment In Republic of Korea 29
8.1 Surgical Equipment Cross Country Comparison (2000-2012) 29
8.2 Surgical Equipment, Republic of Korea, Overall Revenues ($ mn), 2000-2012 30
8.3 Surgical Equipment, Republic of Korea, Category Volume (Units), 2000-2012 34
8.4 Surgical Equipment, Republic of Korea Company share (2006-2007) 37
9 Electrosurgical Devices In Republic of Korea 38
9.1 Electrosurgical Devices Overall Revenue (2000-2012) 38
9.2 Electrosurgical Devices Overall Volume (2000-2012) 40
9.3 Electrosurgical Devices Average Price (2000-2012) 41
9.4 Electrosurgical Devices Distribution Share (2006-2007) 41
9.5 Electrosurgical Devices, Republic of Korea, Company Share (2006-2007) 42
10 Hand Instruments In Republic of Korea 43
10.1 Hand Instruments Overall Revenue (2000-2012) 43
10.2 Hand Instruments Overall Volume (2000-2012) 45
10.3 Hand Instruments Average Price (2000-2012) 47
10.4 Hand Instruments Distribution Share (2006-2007) 47
10.5 Hand Instruments, Republic of Korea, Company Share (2006-2007) 48
11 Surgical Sutures In Republic of Korea 49
11.1 Surgical Sutures Overall Revenue (2000-2012) 49
11.2 Surgical Sutures Overall Volume (2000-2012) 51
11.3 Surgical Sutures Average Price (2000-2012) 53
11.4 Surgical Sutures Distribution Share (2006-2007) 53
11.5 Surgical Sutures, Republic of Korea, Company Share (2006-2007) 54
12 Ethicon, Inc. Company Profile 55
12.1 Company Overview 55
12.1.1 Ethicon, Inc. Pipeline Products by Equipment Type 55
12.1.2 Ethicon, Inc. Pipeline Products by Development Stage 55
12.1.3 Ethicon, Inc. Pipeline Products by Therapy Area 55
12.1.4 Ethicon, Inc. Pipeline Products by Clinical Trials 55
13 Covidien Ltd./Tyco Healthcare Company Profile 56
13.1 Company Overview 56
13.2 Value Chain Analysis 56
13.2.1 Manufacturing 57
13.2.1.1 In House Manufacturing 57
13.2.1.2 Outsourcing 57
13.2.2 Product Development 57
13.2.2.1 Regulatory Approvals 57
13.2.2.2 Clinical Trials 57
13.2.2.3 Research and Development 58
13.2.3 Sales and Marketing 58
13.2.3.1 Partnerships and Alliances 58
13.2.3.2 Licensing Agreements 58
13.2.4 Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 58
13.2.5 Covidien Ltd./Tyco Healthcare Pipeline Products by Development Stage 58
13.2.6 Covidien Ltd./Tyco Healthcare Pipeline Products by Therapy Area 59
13.2.7 Covidien Ltd./Tyco Healthcare Pipeline Products by Clinical Trials 59
13.2.8 Covidien Ltd./Tyco Healthcare Pipeline Products by News Summary 59
14 B. Braun Melsungen AG Company Profile 60
14.1 Company Overview 60
14.2 Value Chain Analysis 60
14.2.1 Manufacturing 61
14.2.1.1 In House Manufacturing 61
14.2.1.2 Outsourcing 61
14.2.2 Product Development 61
14.2.2.1 Regulatory Approvals 61
14.2.2.2 Clinical Trials 62
14.2.2.3 Research and Development 62
14.2.3 Sales and Marketing 62
14.2.3.1 Partnerships and Alliances 62
14.2.3.2 Licensing Agreements 63
14.2.4 B. Braun Melsungen AG Pipeline Products by Equipment Type 63
14.2.5 B. Braun Melsungen AG Pipeline Products by Development Stage 63
14.2.6 B. Braun Melsungen AG Pipeline Products by Therapy Area 63
14.2.7 B. Braun Melsungen AG Pipeline Products by Clinical Trials 64
14.2.8 B. Braun Melsungen AG Pipeline Products by News Summary 64
15 KLS Martin, L.P. Company Profile 65
15.1 Company Overview 65
16 CONMED Corporation Company Profile 66
16.1 Company Overview 66
16.2 Value Chain Analysis 66
16.2.1 Manufacturing 67
16.2.1.1 In House Manufacturing 67
16.2.2 Product Development 67
16.2.2.1 Regulatory Approvals 67
16.2.2.2 Research and Development 67
16.2.2.3 Clinical Trials 67
16.2.3 Sales and Marketing 68
16.2.3.1 Partnerships and Alliances 68
17 MEDICON eG Company Profile 69
17.1 Company Overview 69
18 AILEE COMPANY LIMITED Company Profile 70
18.1 Company Overview 70
19 Samyang Corporation Company Profile 71
19.1 Company Overview 71
20 Appendix 72
20.1 Global Markets Direct Research Methodology 72
20.2 Coverage 73
20.3 Secondary Research 73
20.4 Primary Research 74
20.5 Models 74
20.6 Forecasts 75
20.7 Expert Panels 75
20.8 Currency Conversion 76
20.9 Contact Us 77
20.10 Disclaimer 77
1.1 List of Tables
Table 1: Hospital Wards by Specialty in Republic of Korea, 2003-2007 17
Table 2: Doctors by Specialty in Republic of Korea, 2003-2007 18
Table 3: Healthcare Institutions in Republic of Korea, 2001-2005 19
Table 4: Healthcare Personnel in Republic of Korea, 1975-2002 19
Table 5: Classification of Medical Equipment in Republic of Korea 21
Table 6: Surgical Equipment Cross Country Comparison (2000-2012) 29
Table 7: Surgical Equipment, Republic of Korea, Overall Revenues ($ mn), 2000-2012 30
Table 8: Surgical Equipment, Republic of Korea, Portfolio Analysis, 2007 31
Table 9: Surgical Equipment, Republic of Korea, Overall Revenues ($ mn), Historic, 2000-2007 32
Table 10: Surgical Equipment, Republic of Korea, Overall Revenues ($ mn), Forecast, 2007-2012 33
Table 11: Surgical Equipment, Republic of Korea, Category Volume (Units), 2000-2012 34
Table 12: Surgical Equipment, Republic of Korea, Category Volume (Units), Historic, 2000-2007 35
Table 13: Surgical Equipment, Republic of Korea, Category Volume (Units), Forecast, 2007-2012 36
Table 14: Surgical Equipment, Republic of Korea, Company Share by Revenue ($ mn), 2006-2007 37
Table 15: Electrosurgical Devices, Republic of Korea, Revenue ($ mn) by Segment , Historic, 2000-2007 38
Table 16: Electrosurgical Devices, Republic of Korea, Revenue ($ mn) by Segment , Forecast, 2007-2012 39
Table 17: Electrosurgical Devices, Republic of Korea, Overall Volume (Units), Historic, 2000-2007 40
Table 18: Electrosurgical Devices, Republic of Korea, Overall Volume (Units), Forecast, 2007-2012 40
Table 19: Electrosurgical Devices, Republic of Korea, Average Price ($), Historic, 2000-2007 41
Table 20: Electrosurgical Devices, Republic of Korea, Average Price ($), Forecast,, 2007-2012 41
Table 21: Electrosurgical Devices, Republic of Korea, Distribution Share by Revenue ($mn), 2006-2007 41
Table 22: Electrosurgical Devices, Republic of Korea, Company Share by Revenue ($ mn), 2006-2007 42
Table 23: Hand Instruments, Republic of Korea, Revenue ($ mn) by Segment , Historic, 2000-2007 43
Table 24: Hand Instruments, Republic of Korea, Revenue ($ mn) by Segment , Forecast, 2007-2012 44
Table 25: Hand Instruments, Republic of Korea, Overall Volume (Units), Historic, 2000-2007 45
Table 26: Hand Instruments, Republic of Korea, Overall Volume (Units), Forecast, 2007-2012 46
Table 27: Hand Instruments, Republic of Korea, Average Price ($), Historic, 2000-2007 47
Table 28: Hand Instruments, Republic of Korea, Average Price ($), Forecast,, 2007-2012 47
Table 29: Hand Instruments, Republic of Korea, Distribution Share by Revenue ($mn), 2006-2007 47
Table 30: Hand Instruments, Republic of Korea, Company Share by Revenue ($ mn), 2006-2007 48
Table 31: Surgical Sutures, Republic of Korea, Revenue ($ mn) by Segment , Historic, 2000-2007 49
Table 32: Surgical Sutures, Republic of Korea, Revenue ($ mn) by Segment , Forecast, 2007-2012 50
Table 33: Surgical Sutures, Republic of Korea, Overall Volume (Units), Historic, 2000-2007 51
Table 34: Surgical Sutures, Republic of Korea, Overall Volume (Units), Forecast, 2007-2012 52
Table 35: Surgical Sutures, Republic of Korea, Average Price ($), Historic, 2000-2007 53
Table 36: Surgical Sutures, Republic of Korea, Average Price ($), Forecast,, 2007-2012 53
Table 37: Surgical Sutures, Republic of Korea, Distribution Share by Revenue ($mn), 2006-2007 53
Table 38: Surgical Sutures, Republic of Korea, Company Share by Revenue ($ mn), 2006-2007 54
Table 39: Ethicon, Inc. Pipeline Products by Equipment Type 55
Table 40: Ethicon, Inc. Pipeline Products By Development Stage 55
Table 41: Ethicon, Inc. Pipeline Products By Therapy Area 55
Table 42: Ethicon, Inc. Pipeline Products By Clinical Trials 55
Table 43: Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 58
Table 44: Covidien Ltd./Tyco Healthcare Pipeline Products By Development Stage 58
Table 45: Covidien Ltd./Tyco Healthcare Pipeline Products By Therapy Area 59
Table 46: Covidien Ltd./Tyco Healthcare Pipeline Products By Clinical Trials 59
Table 47: Covidien Ltd./Tyco Healthcare Pipeline Products By News Summaries 59
Table 48: B. Braun Melsungen AG Pipeline Products by Equipment Type 63
Table 49: B. Braun Melsungen AG Pipeline Products By Development Stage 63
Table 50: B. Braun Melsungen AG Pipeline Products By Therapy Area 63
Table 51: B. Braun Melsungen AG Pipeline Products By Clinical Trials 64
Table 52: B. Braun Melsungen AG Pipeline Products By News Summaries 64
Table 53: Currency Conversion from USD to Local Currency at 2007 Constant Rate 76
1.2 List of Figures
Figure 1: Healthcare Financing in Republic of Korea, 2007 14
Figure 2: Healthcare Expenditure in Republic of Korea, 2000 - 2006 15
Figure 3: Evaluation (Value Appraisal) Criteria for Medical Device Reimbursement in Republic of Korea, 2007 26
Figure 4: Medical Device Pricing System in Republic of Korea, 2007 27
Figure 5: Surgical Equipment Cross Country Comparison (2000-2012) 29
Figure 6: Surgical Equipment, Republic of Korea, Overall Revenues ($ mn), 2000-2012 30
Figure 7: Surgical Equipment, Republic of Korea, Portfolio Analysis, 2007 31
Figure 8: Surgical Equipment, Republic of Korea, Overall Revenues ($ mn), Historic, 2000-2007 32
Figure 9: Surgical Equipment, Republic of Korea, Overall Revenues ($ mn), Forecast, 2007-2012 33
Figure 10: Surgical Equipment, Republic of Korea, Category Volume (Units), 2000-2012 34
Figure 11: Surgical Equipment, Republic of Korea, Category Volume (Units), Historic, 2000-2007 35
Figure 12: Surgical Equipment, Republic of Korea, Category Volume (Units), Forecast, 2007-2012 36
Figure 13: Surgical Equipment, Republic of Korea, Company Share (%), 2007 37
Figure 14: Electrosurgical Devices, Republic of Korea, Revenue ($ mn) by Segment , Historic, 2000-2007 38
Figure 15: Electrosurgical Devices, Republic of Korea, Revenue ($ mn) by Segment , Forecast, 2007-2012 39
Figure 16: Electrosurgical Devices, Republic of Korea, Company Share (%), 2007 42
Figure 17: Hand Instruments, Republic of Korea, Revenue ($ mn) by Segment , Historic, 2000-2007 43
Figure 18: Hand Instruments, Republic of Korea, Revenue ($ mn) by Segment , Forecast, 2007-2012 44
Figure 19: Hand Instruments, Republic of Korea, Overall Volume (Units), Historic, 2000-2007 45
Figure 20: Hand Instruments, Republic of Korea, Overall Volume (Units), Forecast, 2007-2012 46
Figure 21: Hand Instruments, Republic of Korea, Company Share (%), 2007 48
Figure 22: Surgical Sutures, Republic of Korea, Revenue ($ mn) by Segment , Historic, 2000-2007 49
Figure 23: Surgical Sutures, Republic of Korea, Revenue ($ mn) by Segment , Forecast, 2007-2012 50
Figure 24: Surgical Sutures, Republic of Korea, Overall Volume (Units), Historic, 2000-2007 51
Figure 25: Surgical Sutures, Republic of Korea, Overall Volume (Units), Forecast, 2007-2012 52
Figure 26: Surgical Sutures, Republic of Korea, Company Share (%), 2007 54
Figure 27: Covidien Ltd./Tyco Healthcare Value Chain Analysis 56
Figure 28: B. Braun Melsungen AG Value Chain Analysis 60
Figure 29: CONMED Corporation Value Chain Analysis 66
Figure 30: Global Markets Direct Methodology 72