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
Expenditure 18
4.2 Healthcare Infrastructure 21
4.3 Healthcare Policy
25
5 Regulation System 26
5.1 Medical Equipment Approval Process
26
5.1.1 Market Authorization Holder (MAH) 26
5.1.2 Classification and
Pre-Market Approval of Medical Devices 27
5.1.3 Third Party Certification
for Controlled Medical Devices 28
5.1.4 PMDA Approval for Highly
Controlled Medical Devices 29
5.1.5 Registration Time 30
5.1.6
Registration Fee 30
5.1.7 Post Marketing Surveillance 31
5.1.8
Labeling and Packaging 31
6 Pricing and Reimbursement 32
6.1 Market
Pricing 32
6.2 Reimbursement Policies 32
6.3 Reimbursement Classes
33
6.3.1 Class A 33
6.3.2 Class B 34
6.3.3 Class C 34
6.3.4
Class F 34
6.4 Request for Reimbursement 34
6.5 Reduction in
Reimbursement for Medical Devices and Drugs 34
7 Distribution Structure
35
8 Wound Care Management In Japan 36
8.1 Wound Care Management,
Cross Country Comparison, Revenue ($ mn), 2000-2015 36
8.2 Wound Care
Management, Japan, Overall Revenue ($ mn), 2000-2015 38
8.3 Wound Care
Management, Japan, Category Volume (Units), 2000-2015 44
8.4 Wound Care
Management, Japan, Company Share (2007-2008) 49
9 Advanced Wound
Management In Japan 50
9.1 Advanced Wound Management Overall Revenue
(2000-2015) 50
9.2 Advanced Wound Management Overall Volume (2000-2015)
54
9.3 Advanced Wound Management Average Price (2000-2015) 58
9.4
Advanced Wound Management Distribution Share (2007-2008) 59
9.5 Advanced
Wound Management, Japan, Company Share (2007-2008) 60
10 Compression
Therapy In Japan 62
10.1 Compression Therapy Overall Revenue (2000-2015)
62
10.1.1 Dynamic Compression Therapy Revenue (2000-2015) 64
10.2
Compression Therapy Overall Volume (2000-2015) 66
10.2.1 Dynamic
Compression Therapy Volume (2000-2015) 67
10.3 Compression Therapy Average
Price (2000-2015) 69
10.4 Compression Therapy Distribution Share
(2007-2008) 70
10.5 Compression Therapy, Japan, Company Share (2007-2008)
71
11 Ostomy Drainage Bags In Japan 72
11.1 Ostomy Drainage Bags
Overall Revenue (2000-2015) 72
11.2 Ostomy Drainage Bags Overall Volume
(2000-2015) 74
11.3 Ostomy Drainage Bags Average Price (2000-2015) 76
11.4 Ostomy Drainage Bags Distribution Share (2007-2008) 77
11.5 Ostomy
Drainage Bags, Japan, Company Share (2007-2008) 78
12 Pressure Relief
Devices In Japan 79
12.1 Pressure Relief Devices Overall Revenue
(2000-2015) 79
12.2 Pressure Relief Devices Overall Volume (2000-2015)
81
12.3 Pressure Relief Devices Average Price (2000-2015) 82
12.4
Pressure Relief Devices Distribution Share (2007-2008) 83
12.5 Pressure
Relief Devices, Japan, Company Share (2007-2008) 84
13 Traditional Wound
Management In Japan 85
13.1 Traditional Wound Management Overall Revenue
(2000-2015) 85
13.2 Traditional Wound Management Overall Volume
(2000-2015) 87
13.3 Traditional Wound Management Average Price (2000-2015)
89
13.4 Traditional Wound Management Distribution Share (2007-2008) 90
13.5 Traditional Wound Management, Japan, Company Share (2007-2008) 91
14
Wound Closure Devices In Japan 92
14.1 Wound Closure Devices Overall
Revenue (2000-2015) 92
14.2 Wound Closure Devices Overall Volume
(2000-2015) 96
14.3 Wound Closure Devices Average Price (2000-2015) 98
14.4 Wound Closure Devices Distribution Share (2007-2008) 99
14.5 Wound
Closure Devices, Japan, Company Share (2007-2008) 100
15 Overview of Key
Companies in Japan Wound Care Management Market 101
15.1 ConvaTec 101
15.1.1 Company Overview 101
15.2 Smith & Nephew Plc 102
15.2.1 Company
Overview 102
15.2.2 Smith & Nephew Plc Pipeline Products 102
15.3
Ethicon, Inc. 105
15.3.1 Company Overview 105
15.4 Baxter
International Inc. 105
15.4.1 Company Overview 105
15.5 3M Health Care
106
15.5.1 Company Overview 106
15.6 Covidien plc 106
15.6.1
Company Overview 106
15.6.2 Covidien Ltd./Tyco Healthcare Pipeline
Products 107
15.7 Coloplast A/S 109
15.7.1 Company Overview 109
15.8 Molnlycke Health Care AB 109
15.8.1 Company Overview 109
15.9 BSN
medical GmbH 109
15.9.1 Company Overview 109
15.10 B. Braun Melsungen
AG 110
15.10.1 Company Overview 110
15.11 HARTMANN GROUP 110
15.11.1 Company Overview 110
15.12 Hollister Incorporated 111
15.12.1
Company Overview 111
15.13 Johnson & Johnson 111
15.13.1 Company
Overview 111
15.14 Invacare Corporation 112
15.14.1 Company Overview
112
15.15 Hill-Rom Holdings, Inc. 112
15.15.1 Company Overview 112
15.16 Nycomed International Management GmbH 113
15.16.1 Company Overview
113
15.17 Kawamoto Corporation 113
15.17.1 Company Overview 113
16
Financial Deals Landscape 114
16.1 Partnerships 114
16.1.1 Advanced
Medical Solutions Group Enters Into Global Distribution Agreement with Stryker
114
16.1.2 Smith & Nephew Signs Agreement with Coloplast 115
17
Appendix 116
17.1 Global Markets Direct Research Methodology 116
17.2
Secondary Research 117
17.3 Primary Research 117
17.4 Models 118
17.5 Forecasts 118
17.6 Expert Panel Validation 118
17.7 Currency
Conversion 119
17.8 Contact Us 120
17.9 Disclaimer 120
1.1
List of Tables
Table 1: Healthcare Expenditure in Japan, 2000 - 2007
19
Table 2: Number of Healthcare Institutions in Japan, 2000 – 2006
22
Table 3: Number of Hospital Beds in Japan, 2000 – 2006 22
Table 4: Number of Medical Personnel in Japan, 1998 - 2006 22
Table 5:
Number of Doctors by Specialty in Japan, 2003-2007 23
Table 6: Number of
Medical Care Institutions and Beds in Japan, 2000 - 2006 24
Table 7:
Registration Processing Time for Medical Devices in Japan, 2007 30
Table
8: Product Registration Fee for Medical Devices in Japan, 2007 30
Table 9:
Wound Care Management, Cross Country Comparison, Revenue ($ mn),
2000-2015 37
Table 10: Wound Care Management, Japan, Overall Revenue
($ mn), 2000-2015 38
Table 11: Wound Care Management, Japan,
Cross-Category Analysis, 2000-2015 39
Table 12: Wound Care
Management, Japan, Overall Revenue ($ mn), Historic, 2000-2008 41
Table
13: Wound Care Management, Japan, Overall Revenue ($ mn), Forecast,
2008-2015 43
Table 14: Wound Care Management, Japan, Category Volume
(Units), 2000-2015 44
Table 15: Wound Care Management, Japan,
Category Volume (Units), Historic, 2000-2008 46
Table 16: Wound Care
Management, Japan, Category Volume (Units), Forecast, 2008-2015 48
Table
17: Wound Care Management, Japan, Company Share by Revenue ($ mn),
2007-2008 49
Table 18: Advanced Wound Management, Japan, Revenue ($
mn) by Segment, Historic, 2000-2008 51
Table 19: Advanced Wound
Management, Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 53
Table
20: Advanced Wound Management, Japan, Volume (Units) by Segment,
Historic, 2000-2008 55
Table 21: Advanced Wound Management, Japan,
Volume (Units) by Segment, Forecast, 2008-2015 57
Table 22: Advanced
Wound Management, Japan, Average Price ($), Historic, 2000-2008 58
Table
23: Advanced Wound Management, Japan, Average Price ($), Forecast,
2008-2015 58
Table 24: Advanced Wound Management, Japan, Distribution
Share by Revenue ($mn), 2007-2008 59
Table 25: Advanced Wound
Management, Japan, Company Share by Revenue ($ mn), 2007-2008 61
Table 26:
Compression Therapy, Japan, Revenue ($ mn) by Segment, Historic,
2000-2008 62
Table 27: Compression Therapy, Japan, Revenue ($ mn) by
Segment, Forecast, 2008-2015 63
Table 28: Dynamic Compression
Therapy, Japan, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 64
Table 29: Dynamic Compression Therapy, Japan, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 65
Table 30: Compression Therapy,
Japan, Volume (Units) by Segment, Historic, 2000-2008 66
Table 31:
Compression Therapy, Japan, Volume (Units) by Segment, Forecast, 2008-2015
66
Table 32: Dynamic Compression Therapy, Japan, Volume (Units) by
Sub-Segment, Historic, 2000-2008 67
Table 33: Dynamic Compression
Therapy, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 68
Table 34: Compression Therapy, Japan, Average Price ($), Historic,
2000-2008 69
Table 35: Compression Therapy, Japan, Average Price ($),
Forecast, 2008-2015 69
Table 36: Compression Therapy, Japan,
Distribution Share by Revenue ($mn), 2007-2008 70
Table 37:
Compression Therapy, Japan, Company Share by Revenue ($ mn), 2007-2008 71
Table 38: Ostomy Drainage Bags, Japan, Revenue ($ mn) by Segment,
Historic, 2000-2008 72
Table 39: Ostomy Drainage Bags, Japan, Revenue
($ mn) by Segment, Forecast, 2008-2015 73
Table 40: Ostomy Drainage
Bags, Japan, Volume (Units) by Segment, Historic, 2000-2008 74
Table 41:
Ostomy Drainage Bags, Japan, Volume (Units) by Segment, Forecast, 2008-2015
75
Table 42: Ostomy Drainage Bags, Japan, Average Price ($),
Historic, 2000-2008 76
Table 43: Ostomy Drainage Bags, Japan, Average
Price ($), Forecast, 2008-2015 76
Table 44: Ostomy Drainage Bags,
Japan, Distribution Share by Revenue ($mn), 2007-2008 77
Table 45:
Ostomy Drainage Bags, Japan, Company Share by Revenue ($ mn), 2007-2008 78
Table 46: Pressure Relief Devices, Japan, Revenue ($ mn) by Segment,
Historic, 2000-2008 79
Table 47: Pressure Relief Devices, Japan,
Revenue ($ mn) by Segment, Forecast, 2008-2015 80
Table 48: Pressure
Relief Devices, Japan, Volume (Units) by Segment, Historic, 2000-2008 81
Table 49: Pressure Relief Devices, Japan, Volume (Units) by Segment,
Forecast, 2008-2015 81
Table 50: Pressure Relief Devices, Japan,
Average Price ($), Historic, 2000-2008 82
Table 51: Pressure Relief
Devices, Japan, Average Price ($), Forecast, 2008-2015 82
Table 52:
Pressure Relief Devices, Japan, Distribution Share by Revenue ($mn), 2007-2008
83
Table 53: Pressure Relief Devices, Japan, Company Share by Revenue
($ mn), 2007-2008 84
Table 54: Traditional Wound Management, Japan,
Revenue ($ mn), Historic, 2000-2008 85
Table 55: Traditional Wound
Management, Japan, Revenue ($ mn), Forecast, 2008-2015 86
Table 56:
Traditional Wound Management, Japan, Volume (Units), Historic, 2000-2008
87
Table 57: Traditional Wound Management, Japan, Volume (Units),
Forecast, 2008-2015 88
Table 58: Traditional Wound Management, Japan,
Average Price ($), Historic, 2000-2008 89
Table 59: Traditional Wound
Management, Japan, Average Price ($), Forecast, 2008-2015 89
Table 60:
Traditional Wound Management, Japan, Distribution Share by Revenue ($mn),
2007-2008 90
Table 61: Traditional Wound Management, Japan, Company
Share by Revenue ($ mn), 2007-2008 91
Table 62: Wound Closure
Devices, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 93
Table
63: Wound Closure Devices, Japan, Revenue ($ mn) by Segment, Forecast,
2008-2015 95
Table 64: Wound Closure Devices, Japan, Volume (Units)
by Segment, Historic, 2000-2008 96
Table 65: Wound Closure Devices,
Japan, Volume (Units) by Segment, Forecast, 2008-2015 97
Table 66:
Wound Closure Devices, Japan, Average Price ($), Historic, 2000-2008 98
Table 67: Wound Closure Devices, Japan, Average Price ($), Forecast,
2008-2015 98
Table 68: Wound Closure Devices, Japan, Distribution
Share by Revenue ($mn), 2007-2008 99
Table 69: Wound Closure Devices,
Japan, Company Share by Revenue ($ mn), 2007-2008 100
Table 70: Smith
& Nephew Plc Pipeline Products by Equipment Type 102
Table 71: Smith
& Nephew Plc Pipeline Products By Development Stage 103
Table 72:
Smith & Nephew Plc Pipeline Products By Therapy Area 104
Table 73:
Smith & Nephew Plc Pipeline Products By News Summary 104
Table 74:
Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 107
Table 75: Covidien Ltd./Tyco Healthcare Pipeline Products By Development
Stage 107
Table 76: Covidien Ltd./Tyco Healthcare Pipeline Products
By Therapy Area 107
Table 77: Covidien Ltd./Tyco Healthcare Pipeline
Products By Clinical Trials 108
Table 78: Covidien Ltd./Tyco
Healthcare Pipeline Products By News Summary 108
Table 79: Advanced
Medical Solutions Group Enters Into Global Distribution Agreement With Stryker
114
Table 80: Smith & Nephew Signs Agreement With Coloplast 115
Table 81: USD to Local Currency, Average Exchange Rate 2008 119
1.2
List of Figures
Figure 1: Healthcare Expenditure in Japan, 2000 –
2007 19
Figure 2: Government and Private Healthcare Expenditure in Japan,
2007 20
Figure 3: Medical Device Classification in Japan, 2007 27
Figure 4: Approval Process for Controlled Medical Devices in Japan, 2007
28
Figure 5: Approval Process for Highly Controlled Medical Devices in
Japan, 2007 29
Figure 6: Health Insurance Reimbursement Process in Japan,
2007 33
Figure 7: Distribution Structure for Medical Equipment in Japan,
2007 35
Figure 8: Wound Care Management, Cross Country Comparison,
Revenue ($ mn), 2000-2015 36
Figure 9: Wound Care Management, Japan,
Overall Revenue ($ mn), 2000-2015 38
Figure 10: Wound Care
Management, Japan, Cross-Category Analysis, 2000-2015 39
Figure 11:
Wound Care Management, Japan, Overall Revenue ($ mn), Historic, 2000-2008
40
Figure 12: Wound Care Management, Japan, Overall Revenue ($ mn),
Forecast, 2008-2015 42
Figure 13: Wound Care Management, Japan,
Category Volume (Units), 2000-2015 44
Figure 14: Wound Care
Management, Japan, Category Volume (Units), Historic, 2000-2008 45
Figure
15: Wound Care Management, Japan, Category Volume (Units), Forecast,
2008-2015 47
Figure 16: Wound Care Management, Japan, Company Share
(%), 2008 49
Figure 17: Advanced Wound Management, Japan, Revenue ($
mn) by Segment, Historic, 2000-2008 50
Figure 18: Advanced Wound
Management, Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 52
Figure 19: Advanced Wound Management, Japan, Volume (Units) by Segment,
Historic, 2000-2008 54
Figure 20: Advanced Wound Management, Japan,
Volume (Units) by Segment, Forecast, 2008-2015 56
Figure 21: Advanced
Wound Management, Japan, Company Share (%), 2008 60
Figure 22:
Compression Therapy, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008
62
Figure 23: Compression Therapy, Japan, Revenue ($ mn) by Segment,
Forecast, 2008-2015 63
Figure 24: Dynamic Compression Therapy, Japan,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 64
Figure 25:
Dynamic Compression Therapy, Japan, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 65
Figure 26: Dynamic Compression Therapy, Japan, Volume
(Units) by Sub-Segment, Historic, 2000-2008 67
Figure 27: Dynamic
Compression Therapy, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015
68
Figure 28: Compression Therapy, Japan, Company Share (%), 2008
71
Figure 29: Ostomy Drainage Bags, Japan, Revenue ($ mn) by Segment,
Historic, 2000-2008 72
Figure 30: Ostomy Drainage Bags, Japan,
Revenue ($ mn) by Segment, Forecast, 2008-2015 73
Figure 31: Ostomy
Drainage Bags, Japan, Volume (Units) by Segment, Historic, 2000-2008 74
Figure 32: Ostomy Drainage Bags, Japan, Volume (Units) by Segment,
Forecast, 2008-2015 75
Figure 33: Ostomy Drainage Bags, Japan,
Company Share (%), 2008 78
Figure 34: Pressure Relief Devices, Japan,
Revenue ($ mn) by Segment, Historic, 2000-2008 79
Figure 35: Pressure
Relief Devices, Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 80
Figure 36: Pressure Relief Devices, Japan, Company Share (%), 2008 84
Figure 37: Traditional Wound Management, Japan, Revenue ($ mn), Historic,
2000-2008 85
Figure 38: Traditional Wound Management, Japan, Revenue
($ mn), Forecast, 2008-2015 86
Figure 39: Traditional Wound
Management, Japan, Volume (Units), Historic, 2000-2008 87
Figure 40:
Traditional Wound Management, Japan, Volume (Units), Forecast, 2008-2015
88
Figure 41: Traditional Wound Management, Japan, Company Share (%),
2008 91
Figure 42: Wound Closure Devices, Japan, Revenue ($ mn) by
Segment, Historic, 2000-2008 92
Figure 43: Wound Closure Devices,
Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 94
Figure 44:
Wound Closure Devices, Japan, Volume (Units) by Segment, Historic, 2000-2008
96
Figure 45: Wound Closure Devices, Japan, Volume (Units) by
Segment, Forecast, 2008-2015 97
Figure 46: Wound Closure Devices,
Japan, Company Share (%), 2008 100
Figure 47: Global Markets Direct
Methodology 116
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