1 Table of Contents 2
1.1 List of Tables 9
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 Executive Summary 18
5 Healthcare Sector Review 19
5.1 Healthcare Expenditure 19
5.2 Healthcare Infrastructure 22
5.3 Healthcare Policy 26
6 Regulation System 27
6.1 Medical Equipment Approval Process 27
6.1.1 Market Authorization Holder (MAH) 27
6.1.2 Classification and Pre-Market Approval of Medical Devices 28
6.1.3 Third Party Certification for Controlled Medical Devices 30
6.1.4 PMDA Approval for Highly Controlled Medical Devices 31
6.1.5 Registration Time 32
6.1.6 Registration Fee 32
6.1.7 Post Marketing Surveillance 33
6.1.8 Labeling and Packaging 33
7 Pricing and Reimbursement 34
7.1 Market Pricing 34
7.2 Reimbursement Policies 34
7.3 Reimbursement Classes 35
7.3.1 Class A 35
7.3.2 Class B 36
7.3.3 Class C 36
7.3.4 Class F 36
7.4 Request for Reimbursement 36
7.5 Reduction in Reimbursement for Medical Devices and Drugs 36
8 Distribution Structure 37
9 Wound Care Management in Japan 38
9.1 Wound Care Management, Japan, Overall Revenue ($m), 2000-2015 38
9.2 Wound Care Management, Japan, Category Volume (Units), 2000-2015 42
9.3 Wound Care Management, Japan, Cross Category Analysis, 2000-2015 45
9.4 Wound Care Management Market Dynamics 46
9.4.1 Market Drivers 46
9.4.2 Market Restraints 46
9.5 Wound Care Management, Japan, Company Share (2007-2008) 47
10 Advanced Wound Management in Japan 48
10.1 Advanced Wound Management Overall Revenue (2000-2015) 48
10.2 Advanced Wound Management Overall Volume (2000-2015) 52
10.3 Advanced Wound Management Average Price (2000-2015) 56
10.4 Advanced Wound Care Market Dynamics 57
10.4.1 Market Drivers 57
10.4.2 Market Restraints 57
10.5 Advanced Wound Management Distribution Share (2007-2008) 58
10.6 Advanced Wound Management, Japan, Company Share (2007-2008) 59
11 Compression Therapy in Japan 60
11.1 Compression Therapy Overall Revenue (2000-2015) 60
11.1.1 Dynamic Compression Therapy Revenue (2000-2015) 62
11.2 Compression Therapy Overall Volume (2000-2015) 64
11.2.1 Dynamic Compression Therapy Volume (2000-2015) 65
11.3 Compression Therapy Average Price (2000-2015) 67
11.4 Compression Therapy Market Dynamics 68
11.4.1 Market Drivers 68
11.4.2 Market Restraints 68
11.5 Compression Therapy Distribution Share (2007-2008) 68
11.6 Compression Therapy, Japan, Company Share (2007-2008) 69
12 Ostomy Drainage Bags in Japan 70
12.1 Ostomy Drainage Bags Overall Revenue (2000-2015) 70
12.2 Ostomy Drainage Bags Overall Volume (2000-2015) 72
12.3 Ostomy Drainage Bags Average Price (2000-2015) 74
12.4 Ostomy Market Dynamics 75
12.4.1 Market Drivers 75
12.4.2 Market Restraints 75
12.5 Ostomy Drainage Bags Distribution Share (2007-2008) 75
12.6 Ostomy Drainage Bags, Japan, Company Share (2007-2008) 76
13 Pressure Relief Devices in Japan 77
13.1 Pressure Relief Devices Overall Revenue (2000-2015) 77
13.2 Pressure Relief Devices Overall Volume (2000-2015) 79
13.3 Pressure Relief Devices Average Price (2000-2015) 80
13.4 Pressure Relief Devices Market Dynamics 81
13.4.1 Market Drivers 81
13.5 Pressure Relief Devices Distribution Share (2007-2008) 81
13.6 Pressure Relief Devices, Japan, Company Share (2007-2008) 82
14 Traditional Wound Management in Japan 83
14.1 Traditional Wound Management Overall Revenue (2000-2015) 83
14.2 Traditional Wound Management Overall Volume (2000-2015) 85
14.3 Traditional Wound Management Average Price (2000-2015) 87
14.4 Traditional Wound Management Market Dynamics 88
14.4.1 Market Drivers 88
14.4.2 Market Restraints 88
14.5 Traditional Wound Management Distribution Share (2007-2008) 88
14.6 Traditional Wound Management, Japan, Company Share (2007-2008) 89
15 Wound Closure Devices in Japan 90
15.1 Wound Closure Devices Overall Revenue (2000-2015) 90
15.2 Wound Closure Devices Overall Volume (2000-2015) 94
15.3 Wound Closure Devices Average Price (2000-2015) 96
15.4 Wound Closure Devices Market Trends 97
15.4.1 Market Drivers 97
15.4.2 Market Restraints 97
15.5 Wound Closure Devices Distribution Share (2007-2008) 97
15.6 Wound Closure Devices, Japan, Company Share (2007-2008) 98
16 Overview of Key Companies in Japan Wound Care Management Market 99
16.1 ConvaTec 99
16.1.1 Company Overview 99
16.2 Smith & Nephew Plc 99
16.2.1 Company Overview 99
16.2.2 Smith & Nephew Plc Pipeline Products 100
16.3 Ethicon, Inc. 103
16.3.1 Company Overview 103
16.4 Baxter International Inc. 103
16.4.1 Company Overview 103
16.5 3M Health Care 104
16.5.1 Company Overview 104
16.6 Covidien plc 104
16.6.1 Company Overview 104
16.6.2 Covidien Ltd./Tyco Healthcare Pipeline Products 105
16.7 Coloplast A/S 106
16.7.1 Company Overview 106
16.8 Molnlycke Health Care AB 106
16.8.1 Company Overview 106
16.9 BSN medical GmbH 107
16.9.1 Company Overview 107
16.10 B. Braun Melsungen AG 107
16.10.1 Company Overview 107
16.11 HARTMANN GROUP 108
16.11.1 Company Overview 108
16.12 Hollister Incorporated 108
16.12.1 Company Overview 108
16.13 Johnson & Johnson 109
16.13.1 Company Overview 109
16.14 Invacare Corporation 109
16.14.1 Company Overview 109
16.15 Hill-Rom Holdings, Inc. 110
16.15.1 Company Overview 110
16.16 Nycomed International Management GmbH 110
16.16.1 Company Overview 110
16.17 Kawamoto Corporation 111
16.17.1 Company Overview 111
17 Financial Deals Landscape 112
17.1 Partnerships 112
17.1.1 Advanced Medical Solutions Group Enters into Global Distribution Agreement with Stryker 112
17.1.2 Smith & Nephew Signs Agreement with Coloplast 113
18 Appendix 114
18.1 Research Methodology 114
18.2 Secondary Research 115
18.3 Primary Research 116
18.4 Models 116
18.5 Forecasts 117
18.6 Expert Panels 117
18.7 GlobalData Consulting 117
18.8 Contact Us 117
18.9 Disclaimer 1181.1 List of Tables
Table 1: Healthcare Expenditure in Japan, 2000 - 2007 20
Table 2: Number of Healthcare Institutions in Japan, 2000 – 2006 23
Table 3: Number of Hospital Beds in Japan, 2000 – 2006 23
Table 4: Number of Medical Personnel in Japan, 1998 - 2006 23
Table 5: Number of Doctors by Specialty in Japan, 2003-2007 24
Table 6: Number of Medical Care Institutions and Beds in Japan, 2000 - 2006 25
Table 7: Registration Processing Time for Medical Devices in Japan, 2007 32
Table 8: Product Registration Fee for Medical Devices in Japan, 2007 32
Table 9: Wound Care Management, Japan, Overall Revenue ($m), Historic, 2000-2008 38
Table 10: Wound Care Management, Japan, Overall Revenue ($m), Forecast, 2008-2015 40
Table 11: Wound Care Management, Japan, Category Volume (Units), Historic, 2000-2008 43
Table 12: Wound Care Management, Japan, Category Volume (Units), Forecast, 2008-2015 44
Table 13: Wound Care Management, Japan, Cross-Category Analysis, 2000-2015 45
Table 14: Wound Care Management, Japan, Company Share by Revenue ($m), 2007-2008 47
Table 15: Advanced Wound Management, Japan, Revenue ($m) by Segment, Historic, 2000-2008 49
Table 16: Advanced Wound Management, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 50
Table 17: Advanced Wound Management, Japan, Volume (Units) by Segment, Historic, 2000-2008 53
Table 18: Advanced Wound Management, Japan, Volume (Units) by Segment, Forecast, 2008-2015 55
Table 19: Advanced Wound Management, Japan, Average Price ($), Historic, 2000-2008 56
Table 20: Advanced Wound Management, Japan, Average Price ($), Forecast, 2008-2015 56
Table 21: Advanced Wound Management, Japan, Distribution Share by Revenue ($m), 2007-2008 58
Table 22: Advanced Wound Management, Japan, Company Share by Revenue ($m), 2007-2008 59
Table 23: Compression Therapy, Japan, Revenue ($m) by Segment, Historic, 2000-2008 60
Table 24: Compression Therapy, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 61
Table 25: Dynamic Compression Therapy, Japan, Revenue ($m) by Sub-Segment, Historic, 2000-2008 62
Table 26: Dynamic Compression Therapy, Japan, Revenue ($m) by Sub-Segment, Forecast, 2008-2015 63
Table 27: Compression Therapy, Japan, Volume (Units) by Segment, Historic, 2000-2008 64
Table 28: Compression Therapy, Japan, Volume (Units) by Segment, Forecast, 2008-2015 64
Table 29: Dynamic Compression Therapy, Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 65
Table 30: Dynamic Compression Therapy, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 66
Table 31: Compression Therapy, Japan, Average Price ($), Historic, 2000-2008 67
Table 32: Compression Therapy, Japan, Average Price ($), Forecast, 2008-2015 67
Table 33: Compression Therapy, Japan, Distribution Share by Revenue ($m), 2007-2008 68
Table 34: Compression Therapy, Japan, Company Share by Revenue ($m), 2007-2008 69
Table 35: Ostomy Drainage Bags, Japan, Revenue ($m) by Segment, Historic, 2000-2008 70
Table 36: Ostomy Drainage Bags, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 71
Table 37: Ostomy Drainage Bags, Japan, Volume (Units) by Segment, Historic, 2000-2008 72
Table 38: Ostomy Drainage Bags, Japan, Volume (Units) by Segment, Forecast, 2008-2015 73
Table 39: Ostomy Drainage Bags, Japan, Average Price ($), Historic, 2000-2008 74
Table 40: Ostomy Drainage Bags, Japan, Average Price ($), Forecast, 2008-2015 74
Table 41: Ostomy Drainage Bags, Japan, Distribution Share by Revenue ($m), 2007-2008 75
Table 42: Ostomy Drainage Bags, Japan, Company Share by Revenue ($m), 2007-2008 76
Table 43: Pressure Relief Devices, Japan, Revenue ($m) by Segment, Historic, 2000-2008 77
Table 44: Pressure Relief Devices, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 78
Table 45: Pressure Relief Devices, Japan, Volume (Units) by Segment, Historic, 2000-2008 79
Table 46: Pressure Relief Devices, Japan, Volume (Units) by Segment, Forecast, 2008-2015 79
Table 47: Pressure Relief Devices, Japan, Average Price ($), Historic, 2000-2008 80
Table 48: Pressure Relief Devices, Japan, Average Price ($), Forecast, 2008-2015 80
Table 49: Pressure Relief Devices, Japan, Distribution Share by Revenue ($m), 2007-2008 81
Table 50: Pressure Relief Devices, Japan, Company Share by Revenue ($ m), 2007-2008 82
Table 51: Traditional Wound Management, Japan, Revenue ($m), Historic, 2000-2008 83
Table 52: Traditional Wound Management, Japan, Revenue ($m), Forecast, 2008-2015 84
Table 53: Traditional Wound Management, Japan, Volume (Units), Historic, 2000-2008 85
Table 54: Traditional Wound Management, Japan, Volume (Units), Forecast, 2008-2015 86
Table 55: Traditional Wound Management, Japan, Average Price ($), Historic, 2000-2008 87
Table 56: Traditional Wound Management, Japan, Average Price ($), Forecast, 2008-2015 87
Table 57: Traditional Wound Management, Japan, Distribution Share by Revenue ($m), 2007-2008 88
Table 58: Traditional Wound Management, Japan, Company Share by Revenue ($m), 2007-2008 89
Table 59: Wound Closure Devices, Japan, Revenue ($m) by Segment, Historic, 2000-2008 90
Table 60: Wound Closure Devices, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 92
Table 61: Wound Closure Devices, Japan, Volume (Units) by Segment, Historic, 2000-2008 94
Table 62: Wound Closure Devices, Japan, Volume (Units) by Segment, Forecast, 2008-2015 95
Table 63: Wound Closure Devices, Japan, Average Price ($), Historic, 2000-2008 96
Table 64: Wound Closure Devices, Japan, Average Price ($), Forecast, 2008-2015 96
Table 65: Wound Closure Devices, Japan, Distribution Share by Revenue ($m), 2007-2008 97
Table 66: Wound Closure Devices, Japan, Company Share by Revenue ($m), 2007-2008 98
Table 67: Smith & Nephew Plc Pipeline Products by Equipment Type 100
Table 68: Smith & Nephew Plc Pipeline Products By Development Stage 101
Table 69: Smith & Nephew Plc Pipeline Products By Therapy Area 102
Table 70: Smith & Nephew Plc Pipeline Products By News Summary 102
Table 71: Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 105
Table 72: Covidien Ltd./Tyco Healthcare Pipeline Products By Development Stage 105
Table 73: Covidien Ltd./Tyco Healthcare Pipeline Products By Therapy Area 105
Table 74: Covidien Ltd./Tyco Healthcare Pipeline Products By Clinical Trials 106
Table 75: Covidien Ltd./Tyco Healthcare Pipeline Products By News Summary 106
Table 76: Advanced Medical Solutions Group Enters into Global Distribution Agreement With Stryker 112
Table 77: Smith & Nephew Signs Agreement with Coloplast 1131.2 List of Figures
Figure 1: Healthcare Expenditure in Japan, 2000 – 2007 20
Figure 2: Government and Private Healthcare Expenditure in Japan, 2007 21
Figure 3: Medical Device Classification in Japan, 2007 29
Figure 4: Approval Process for Controlled Medical Devices in Japan, 2007 30
Figure 5: Approval Process for Highly Controlled Medical Devices in Japan, 2007 31
Figure 6: Health Insurance Reimbursement Process in Japan, 2007 35
Figure 7: Distribution Structure for Medical Equipment in Japan, 2007 37
Figure 8: Wound Care Management, Japan, Overall Revenue ($m), Historic, 2000-2008 38
Figure 9: Wound Care Management, Japan, Overall Revenue ($m), Forecast, 2008-2015 40
Figure 10: Wound Care Management, Japan, Category Volume (Units), Historic, 2000-2008 42
Figure 11: Wound Care Management, Japan, Category Volume (Units), Forecast, 2008-2015 44
Figure 12: Wound Care Management, Japan, Cross-Category Analysis, 2000-2015 45
Figure 13: Wound Care Management, Japan, Company Share (%), 2008 47
Figure 14: Advanced Wound Management, Japan, Revenue ($m) by Segment, Historic, 2000-2008 48
Figure 15: Advanced Wound Management, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 50
Figure 16: Advanced Wound Management, Japan, Volume (Units) by Segment, Historic, 2000-2008 52
Figure 17: Advanced Wound Management, Japan, Volume (Units) by Segment, Forecast, 2008-2015 54
Figure 18: Advanced Wound Management, Japan, Company Share (%), 2008 59
Figure 19: Compression Therapy, Japan, Revenue ($m) by Segment, Historic, 2000-2008 60
Figure 20: Compression Therapy, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 61
Figure 21: Dynamic Compression Therapy, Japan, Revenue ($m) by Sub-Segment, Historic, 2000-2008 62
Figure 22: Dynamic Compression Therapy, Japan, Revenue ($m) by Sub-Segment, Forecast, 2008-2015 63
Figure 23: Dynamic Compression Therapy, Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 65
Figure 24: Dynamic Compression Therapy, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 66
Figure 25: Compression Therapy, Japan, Company Share (%), 2008 69
Figure 26: Ostomy Drainage Bags, Japan, Revenue ($m) by Segment, Historic, 2000-2008 70
Figure 27: Ostomy Drainage Bags, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 71
Figure 28: Ostomy Drainage Bags, Japan, Volume (Units) by Segment, Historic, 2000-2008 72
Figure 29: Ostomy Drainage Bags, Japan, Volume (Units) by Segment, Forecast, 2008-2015 73
Figure 30: Ostomy Drainage Bags, Japan, Company Share (%), 2008 76
Figure 31: Pressure Relief Devices, Japan, Revenue ($m) by Segment, Historic, 2000-2008 77
Figure 32: Pressure Relief Devices, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 78
Figure 33: Pressure Relief Devices, Japan, Company Share (%), 2008 82
Figure 34: Traditional Wound Management, Japan, Revenue ($m), Historic, 2000-2008 83
Figure 35: Traditional Wound Management, Japan, Revenue ($m), Forecast, 2008-2015 84
Figure 36: Traditional Wound Management, Japan, Volume (Units), Historic, 2000-2008 85
Figure 37: Traditional Wound Management, Japan, Volume (Units), Forecast, 2008-2015 86
Figure 38: Traditional Wound Management, Japan, Company Share (%), 2008 89
Figure 39: Wound Closure Devices, Japan, Revenue ($m) by Segment, Historic, 2000-2008 90
Figure 40: Wound Closure Devices, Japan, Revenue ($m) by Segment, Forecast, 2008-2015 92
Figure 41: Wound Closure Devices, Japan, Volume (Units) by Segment, Historic, 2000-2008 94
Figure 42: Wound Closure Devices, Japan, Volume (Units) by Segment, Forecast, 2008-2015 95
Figure 43: Wound Closure Devices, Japan, Company Share (%), 2008 98