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
2.2 Definitions
13
2.2.1 Drug delivery devices 13
3 Healthcare Sector Review 15
3.1 Healthcare Sector Review 15
3.2 Healthcare Expenditure 15
3.3
Healthcare Infrastructure 17
3.4 Healthcare Policy 20
4 Drug Delivery
Devices in Japan 21
4.1 Drug Delivery Devices Overall Revenues (2000-2012)
21
4.2 Drug Delivery Devices Overall Volume (2000-2012) 27
4.3 Drug
Delivery Devices Company Shares (2005-2006) 30
5 Inhalation Systems in
Japan 31
5.1 Inhalation Systems Overall Revenues (2000-2012) 31
5.1.1
Metered Dose Inhaler Devices Overall Revenues (2000-2012) 35
5.1.2 Dry
Powder Inhaler Devices Overall Revenues (2000-2012) 37
5.2 Inhalation
Systems Overall Volume (2000-2012) 39
5.2.1 Metered Dose Inhaler Devices
Overall Volume (2000-2012) 41
5.2.2 Dry Powder Inhaler Devices Overall
Volume (2000-2012) 43
5.3 Inhalation Systems Average Price (2000-2012)
45
5.3.1 Metered Dose Inhaler Devices Average Price (2000-2012) 45
5.3.2 Dry Powder Inhaler Devices Average Price (2000-2012) 47
5.4
Inhalation Systems Distribution Share (2005-2006) 49
5.5 Inhalation
Systems Company Share (2005-2006) 50
6 Infusion Systems in Japan 51
6.1 Infusion Systems Overall Revenues (2000-2012) 51
6.1.1 Infusion
Disposable Sets Overall Revenue (2000-2012) 55
6.1.2 Syringe Pumps Overall
Revenue (2000-2012) 57
6.1.3 Infusion Pumps Overall Revenues (2000-2012)
59
6.2 Infusion Systems Overall Volume (2000-2012) 61
6.2.1 Infusion
Disposable Sets Overall Volume (2000-2012) 62
6.2.2 Syringe Pumps Overall
Volume (2000-2012) 64
6.2.3 Infusion Pumps Overall Volume (2000-2012)
66
6.3 Infusion Systems Average Price (2000-2012) 68
6.3.1 Infusion
Pumps Average Price (2000-2012) 68
6.3.2 Syringe Pumps Average Price
(2000-2012) 70
6.3.3 Infusion Disposable Sets Average Price (2000-2012)
72
6.4 Infusion Systems Distribution Share (2005-2006) 74
6.5 Infusion
Systems Company Share (2005-2006) 75
7 Needle Free Injections in Japan
76
7.1 Needle Free Injections Overall Revenue (2000-2012) 76
7.2
Needle Free Injections Overall Volume (2000-2012) 78
7.3 Needle Free
Injections Average Price (2000-2012) 80
7.4 Needle Free Injections
Distribution Share (2005-2006) 82
7.5 Needle Free Injections Company Share
(2005-2006) 83
8 AstraZeneca PLC Company Profile 84
8.1 Company
Overview 84
8.2 Business Overview 84
8.2.1 Products 85
8.2.2
History 86
8.3 Locations And Subsidiaries 86
9 3M Company Profile
88
9.1 Company Overview 88
9.2 Business Overview 88
9.2.1 Consumer
and Office 88
9.2.2 Display and Graphics 89
9.2.3 Electro and
Communications 89
9.2.4 Health Care 90
9.2.5 Industrial and
Transportation 91
9.2.6 Safety, Security and Protection Services 91
9.2.7 Products 92
9.3 Value Chain Analysis 94
9.3.1 Manufacturing
94
9.3.2 Product Development 94
9.3.3 Sales and Marketing 95
9.4
SWOT Analysis 96
9.4.1 3M Company Strengths 96
3M Company Weaknesses
97
3M Company Opportunities 97
3M Company Threats 98
9.5 Revenue
Analysis 99
9.5.1 Revenue by Segment 99
9.5.2 Revenue by Geography
100
9.6 Financial and Operational Review 101
9.6.1 Financial
Statements 101
9.6.2 Financial Ratios 102
9.7 Locations And
Subsidiaries 103
10 Baxter International Company Profile 104
10.1
Company Overview 104
10.2 Business Overview 104
10.2.1 BioScience
104
10.2.2 Medication Delivery 104
10.2.3 Renal 105
10.2.4
Products 105
10.2.5 History 106
10.3 Value Chain Analysis 108
10.3.1 Manufacturing 109
10.3.2 Product Development 109
10.3.3 Sales
and Marketing 110
10.4 SWOT Analysis 110
10.4.1 Baxter International
Inc. Strengths 111
10.4.2 Baxter International Inc. Weaknesses 111
10.4.3 Baxter International Inc. Opportunities 112
10.4.4 Baxter
International Inc. Threats 112
10.5 Revenue Analysis 113
10.5.1
Revenue by Segment 113
10.5.2 Revenue by Geography 114
10.6 Financial
and Operational Review 115
10.6.1 Financial Statements 115
10.6.2
Financial Ratios 116
10.7 Locations And Subsidiaries 117
10.8 Baxter
International Inc. Pipeline Products 119
10.8.1 Next-Generation Home
Hemodialysis Machine 119
11 GlaxoSmithKline plc Company Profile 121
11.1 Company Overview 121
11.2 Business Overview 121
11.2.1 Products
122
11.2.2 History 122
11.3 Locations And Subsidiaries 125
12
Novartis AG Company Profile 127
12.1 Company Overview 127
12.2
Business Overview 127
12.2.1 Major Products and Services 127
12.3
Locations And Subsidiaries 128
13 Regulation System 130
13.1 Medical
Equipment Approval Process 130
13.1.1 Market Authorization Holder (MAH)
130
13.1.2 Classification and Pre-Market Approval of Medical Devices
131
13.1.3 Third Party Certification for Controlled Medical Devices
132
13.1.4 PMDA Approval for Highly Controlled Medical Devices 133
13.1.5 Registration Time 135
13.1.6 Registration Fee 135
13.1.7 Post
Marketing Surveillance 136
13.1.8 Labeling and Packaging 136
14
Pricing and Reimbursement 137
14.1 Market Pricing 137
14.2
Reimbursement Policies 137
14.3 Reimbursement Classes 138
14.3.1 Class
A 138
14.3.2 Class B 139
14.3.3 Class C 139
14.3.4 Class F 139
14.4 Request for Reimbursement 139
14.5 Reduction in Reimbursement for
Medical Devices and Drugs 139
15 Distribution Structure 140
16
Appendix 141
16.1 Global Markets Direct Research Methodology 141
16.2
Coverage 142
16.3 Secondary Research 142
16.4 Primary Research 143
16.5 Models 143
16.6 Forecasts 144
16.7 Expert Panels 144
16.8
Currency Conversion 145
16.9 Contact Us 146
16.10 Disclaimer 146
1.1 List of Tables
Table 1: Healthcare Expenditure in Japan, 2000 -
2005 16
Table 2: Number of Healthcare Institutions in Japan, 1995 -- 2004
18
Table 3: Number of Hospital Beds in Japan, 1995 -- 2004 19
Table 4:
Number of Medical Personnel in Japan, 1995 - 2004 19
Table 5: Number of
Medical Care Institutions and Beds in Japan, 2000 - 2004 20
Table 6: Drug
Delivery Devices, Japan, Overall Revenues ($ mn), 2000-2012 21
Table 7:
Drug Delivery Devices, Japan, Overall Revenues ($ mn), Historic, 2000-2007
22
Table 8: Drug Delivery Devices, Japan, Overall Revenues ($ mn),
Forecast, 2007-2012 23
Table 9: Drug Delivery Devices, Japan, Category
Revenues ($ mn), 2000-2012 24
Table 10: Drug Delivery Devices, Japan,
Category Revenues ($ mn), Historic, 2000-2007 25
Table 11: Drug Delivery
Devices, Japan, Category Revenues ($ mn), Forecast, 2007-2012 26
Table 12:
Drug Delivery Devices, Japan, Category Volume (Units), 2000-2012 27
Table
13: Drug Delivery Devices, Japan, Category Volume (Units), Historic, 2000-2007
28
Table 14: Drug Delivery Devices, Japan, Category Volume (Units),
Forecast, 2007-2012 29
Table 15: Drug Delivery Devices, Japan, Company
Share by Revenue ($ mn), 2005-2006 30
Table 16: Inhalation Systems, Japan,
Overall Revenues ($ mn), Historic, 2000-2007 31
Table 17: Inhalation
Systems, Japan, Overall Revenues ($ mn), Forecast, 2007-2012 32
Table 18:
Inhalation Systems, Japan, Revenue by Segment ($ mn), Historic, 2000-2007
33
Table 19: Inhalation Systems, Japan, Revenue by Segment ($ mn),
Forecast, 2007-2012 34
Table 20: Metered Dose Inhaler Devices, Japan,
Overall Revenues ($ mn), Historic, 2000-2007 35
Table 21: Metered Dose
Inhaler Devices, Japan, Overall Revenues ($ mn), Forecast, 2007-2012 36
Table 22: Dry Powder Inhaler Devices, Japan, Overall Revenues ($ mn),
Historic, 2000-2007 37
Table 23: Dry Powder Inhaler Devices, Japan,
Overall Revenues ($ mn), Forecast, 2007-2012 38
Table 24: Inhalation
Systems, Japan, Overall Volume (Units), Historic, 2000-2007 39
Table 25:
Inhalation Systems, Japan, Overall Volume (Units), Forecast, 2007-2012 40
Table 26: Metered Dose Inhaler Devices, Japan, Overall Volume (Units),
Historic, 2000-2007 41
Table 27: Metered Dose Inhaler Devices, Japan,
Overall Volume (Units), Forecast, 2007-2012 42
Table 28: Dry Powder
Inhaler Devices, Japan, Overall Volume (Units), Historic, 2000-2007 43
Table 29: Dry Powder Inhaler Devices, Japan, Overall Volume (Units), Forecast,
2007-2012 44
Table 30: Metered Dose Inhaler Devices, Japan, Average Price
($), Historic, 2000-2007 45
Table 31: Metered Dose Inhaler Devices, Japan,
Average Price ($), Forecast, 2007-2012 46
Table 32: Dry Powder Inhaler
Devices, Japan, Average Price ($), Historic, 2000-2007 47
Table 33: Dry
Powder Inhaler Devices, Japan, Average Price ($), Forecast, 2007-2012 48
Table 34: Inhalation Systems, Japan, Distribution Share by Revenue ($ mn),
2005-2006 49
Table 35: Inhalation Systems, Japan, Company Share by Revenue
($ mn), 2005-2006 50
Table 36: Infusion Systems, Japan, Overall Revenues
($ mn), Historic, 2000-2007 51
Table 37: Infusion Systems, Japan, Overall
Revenues ($ mn), Forecast, 2007-2012 52
Table 38: Infusion Systems, Japan,
Revenue by Segment ($ mn), Historic, 2000-2007 53
Table 39: Infusion
Systems, Japan, Revenue by Segment ($ mn), Forecast, 2007-2012 54
Table
40: Infusion Disposable Sets, Japan, Overall Revenues ($ mn), Historic,
2000-2007 55
Table 41: Infusion Disposable Sets, Japan, Overall Revenues
($ mn), Forecast, 2007-2012 56
Table 42: Syringe Pumps, Japan, Overall
Revenues ($ mn), Historic, 2000-2007 57
Table 43: Syringe Pumps, Japan,
Overall Revenues ($ mn), Forecast, 2007-2012 58
Table 44: Infusion Pumps,
Japan, Overall Revenues ($ mn), Historic, 2000-2007 59
Table 45: Infusion
Pumps, Japan, Overall Revenues ($ mn), Forecast, 2007-2012 60
Table 46:
Infusion Systems, Japan, Overall Volume (Units), Historic, 2000-2007 61
Table 47: Infusion Systems, Japan, Overall Volume (Units), Forecast, 2007-2012
61
Table 48: Infusion Disposable Sets, Japan, Overall Volume (Units),
Historic, 2000-2007 62
Table 49: Infusion Disposable Sets, Japan, Overall
Volume (Units), Forecast, 2007-2012 63
Table 50: Syringe Pumps, Japan,
Overall Volume (Units), Historic, 2000-2007 64
Table 51: Syringe Pumps,
Japan, Overall Volume (Units), Forecast, 2007-2012 65
Table 52: Infusion
Pumps, Japan, Overall Volume (Units), Historic, 2000-2007 66
Table 53:
Infusion Pumps, Japan, Overall Volume (Units), Forecast, 2007-2012 67
Table 54: Infusion Pumps, Japan, Average Price ($), Historic, 2000-2007 68
Table 55: Infusion Pumps, Japan, Average Price ($), Forecast, 2007-2012 69
Table 56: Syringe Pumps, Japan, Average Price ($), Historic, 2000-2007 70
Table 57: Syringe Pumps, Japan, Average Price ($), Forecast, 2007-2012 71
Table 58: Infusion Disposable Sets, Japan, Average Price ($), Historic,
2000-2007 72
Table 59: Infusion Disposable Sets, Japan, Average Price ($),
Forecast, 2007-2012 73
Table 60: Infusion Systems, Japan, Distribution
Share by Revenue ($ mn), 2005-2006 74
Table 61: Infusion Systems, Japan,
Company Share by Revenue ($ mn), 2005-2006 75
Table 62: Needle Free
Injections, Japan, Overall Revenues ($ mn), Historic, 2000-2007 76
Table
63: Needle Free Injections, Japan, Overall Revenues ($ mn), Forecast,
2007-2012 77
Table 64: Needle Free Injections, Japan, Overall Volume
(Units), Historic, 2000-2007 78
Table 65: Needle Free Injections, Japan,
Overall Volume (Units), Forecast, 2007-2012 79
Table 66: Needle Free
Injections, Japan, Average Price ($), Historic, 2000-2007 80
Table 67:
Needle Free Injections, Japan, Average Price ($), Forecast, 2007-2012 81
Table 68: Needle Free Injections, Japan, Distribution Share by Revenue ($ mn),
2005-2006 82
Table 69: Needle Free Injections, Japan, Company Share by
Revenue ($ mn), 2005-2006 83
Table 70: AstraZeneca PLC, Subsidiaries
87
Table 71: 3M Company, SWOT Analysis, 2006 96
Table 72: 3M
Company, Revenue by Segment, USD Million, 2003-2007 99
Table 73: 3M
Company, Revenue by Geography, USD Million, 2003-2007 100
Table 74:
3M Company, Financial Statements, USD Million, 2003-2007 101
Table 75:
3M Company, Financial Ratios, USD Million, 2003-2007 102
Table 76:
3M Company, Subsidiaries 103
Table 77: Baxter International Inc.,
SWOT Analysis, 2006 110
Table 78: Baxter International Inc., Revenue
by Segment, USD Million, 2003-2007 113
Table 79: Baxter International
Inc., Revenue by Geography, USD Million, 2003-2007 114
Table 80:
Baxter International Inc., Financial Statements, USD Million, 2003-2007
115
Table 81: Baxter International Inc., Financial Ratios, USD
Million, 2003-2007 116
Table 82: Baxter International Inc., Other
Locations 117
Table 83: Baxter International Inc., Subsidiaries
118
Table 84: GlaxoSmithKline plc, Subsidiaries 125
Table 85:
GlaxoSmithKline plc, Subsidiaries(Contd..) 126
Table 86: Novartis
Medical Nutrition, Other Locations 128
Table 87: Novartis Medical
Nutrition, Other Locations(Contd..) 129
Table 88: Registration Processing
Time for Medical Devices in Japan, 2007 135
Table 89: Product Registration
Fee for Medical Devices in Japan, 2007 135
Table 90: Currency Conversion
from USD to Local Currency at 2007 Constant Rate 145
1.2 List of
Figures
Figure 1: Healthcare Expenditure in Japan, 2000 -- 2005 16
Figure 2: Government and Private Healthcare Expenditure in Japan, 2005 17
Figure 3: Drug Delivery Devices, Japan, Overall Revenues ($ mn), 2000-2012
21
Figure 4: Drug Delivery Devices, Japan, Overall Revenues ($ mn),
Historic, 2000-2007 22
Figure 5: Drug Delivery Devices, Japan, Overall
Revenues ($ mn), Forecast, 2007-2012 23
Figure 6: Drug Delivery Devices,
Japan, Category Revenues ($ mn), 2000-2012 24
Figure 7: Drug Delivery
Devices, Japan, Category Revenues ($ mn), Historic, 2000-2007 25
Figure 8:
Drug Delivery Devices, Japan, Category Revenues ($ mn), Forecast, 2007-2012
26
Figure 9: Drug Delivery Devices, Japan, Category Volume (Units),
2000-2012 27
Figure 10: Drug Delivery Devices, Japan, Category Volume
(Units), Historic, 2000-2007 28
Figure 11: Drug Delivery Devices, Japan,
Category Volume (Units), Forecast, 2007-2012 29
Figure 12: Drug Delivery
Devices, Japan, Company Share (%), 2006 30
Figure 13: Inhalation Systems,
Japan, Overall Revenues ($ mn), Historic, 2000-2007 31
Figure 14:
Inhalation Systems, Japan, Overall Revenues ($ mn), Forecast, 2007-2012 32
Figure 15: Inhalation Systems, Japan, Revenue by Segment ($ mn), Historic,
2000-2007 33
Figure 16: Inhalation Systems, Japan, Revenue by Segment ($
mn), Forecast, 2007-2012 34
Figure 17: Metered Dose Inhaler Devices,
Japan, Overall Revenues ($ mn), Historic, 2000-2007 35
Figure 18: Metered
Dose Inhaler Devices, Japan, Overall Revenues ($ mn), Forecast, 2007-2012
36
Figure 19: Dry Powder Inhaler Devices, Japan, Overall Revenues ($ mn),
Historic, 2000-2007 37
Figure 20: Dry Powder Inhaler Devices, Japan,
Overall Revenues ($ mn), Forecast, 2007-2012 38
Figure 21: Inhalation
Systems, Japan, Overall Volume (Units), Historic, 2000-2007 39
Figure 22:
Inhalation Systems, Japan, Overall Volume (Units), Forecast, 2007-2012 40
Figure 23: Metered Dose Inhaler Devices, Japan, Overall Volume (Units),
Historic, 2000-2007 41
Figure 24: Metered Dose Inhaler Devices, Japan,
Overall Volume (Units), Forecast, 2007-2012 42
Figure 25: Dry Powder
Inhaler Devices, Japan, Overall Volume (Units), Historic, 2000-2007 43
Figure 26: Dry Powder Inhaler Devices, Japan, Overall Volume (Units),
Forecast, 2007-2012 44
Figure 27: Metered Dose Inhaler Devices, Japan,
Average Price ($), Historic, 2000-2007 45
Figure 28: Metered Dose Inhaler
Devices, Japan, Average Price ($), Forecast, 2007-2012 46
Figure 29: Dry
Powder Inhaler Devices, Japan, Average Price ($), Historic, 2000-2007 47
Figure 30: Dry Powder Inhaler Devices, Japan, Average Price ($), Forecast,
2007-2012 48
Figure 31: Inhalation Systems, Japan, Distribution Share (%),
2006 49
Figure 32: Inhalation Systems, Japan, Company Share (%), 2006
50
Figure 33: Infusion Systems, Japan, Overall Revenues ($ mn), Historic,
2000-2007 51
Figure 34: Infusion Systems, Japan, Overall Revenues ($ mn),
Forecast, 2007-2012 52
Figure 35: Infusion Systems, Japan, Revenue by
Segment ($ mn), Historic, 2000-2007 53
Figure 36: Infusion Systems, Japan,
Revenue by Segment ($ mn), Forecast, 2007-2012 54
Figure 37: Infusion
Disposable Sets, Japan, Overall Revenues ($ mn), Historic, 2000-2007 55
Figure 38: Infusion Disposable Sets, Japan, Overall Revenues ($ mn), Forecast,
2007-2012 56
Figure 39: Syringe Pumps, Japan, Overall Revenues ($ mn),
Historic, 2000-2007 57
Figure 40: Syringe Pumps, Japan, Overall Revenues
($ mn), Forecast, 2007-2012 58
Figure 41: Infusion Pumps, Japan, Overall
Revenues ($ mn), Historic, 2000-2007 59
Figure 42: Infusion Pumps, Japan,
Overall Revenues ($ mn), Forecast, 2007-2012 60
Figure 43: Infusion
Disposable Sets, Japan, Overall Volume (Units), Historic, 2000-2007 62
Figure 44: Infusion Disposable Sets, Japan, Overall Volume (Units), Forecast,
2007-2012 63
Figure 45: Syringe Pumps, Japan, Overall Volume (Units),
Historic, 2000-2007 64
Figure 46: Syringe Pumps, Japan, Overall Volume
(Units), Forecast, 2007-2012 65
Figure 47: Infusion Pumps, Japan, Overall
Volume (Units), Historic, 2000-2007 66
Figure 48: Infusion Pumps, Japan,
Overall Volume (Units), Forecast, 2007-2012 67
Figure 49: Infusion Pumps,
Japan, Average Price ($), Historic, 2000-2007 68
Figure 50: Infusion
Pumps, Japan, Average Price ($), Forecast, 2007-2012 69
Figure 51: Syringe
Pumps, Japan, Average Price ($), Historic, 2000-2007 70
Figure 52: Syringe
Pumps, Japan, Average Price ($), Forecast, 2007-2012 71
Figure 53:
Infusion Disposable Sets, Japan, Average Price ($), Historic, 2000-2007 72
Figure 54: Infusion Disposable Sets, Japan, Average Price ($), Forecast,
2007-2012 73
Figure 55: Infusion Systems, Japan, Distribution Share (%),
2006 74
Figure 56: Infusion Systems, Japan, Company Share (%), 2006 75
Figure 57: Needle Free Injections, Japan, Overall Revenues ($ mn), Historic,
2000-2007 76
Figure 58: Needle Free Injections, Japan, Overall Revenues ($
mn), Forecast, 2007-2012 77
Figure 59: Needle Free Injections, Japan,
Overall Volume (Units), Historic, 2000-2007 78
Figure 60: Needle Free
Injections, Japan, Overall Volume (Units), Forecast, 2007-2012 79
Figure
61: Needle Free Injections, Japan, Average Price ($), Historic, 2000-2007
80
Figure 62: Needle Free Injections, Japan, Average Price ($), Forecast,
2007-2012 81
Figure 63: Needle Free Injections, Japan, Distribution Share
(%), 2006 82
Figure 64: 3M Company, Value Chain Analysis 94
Figure 65: Baxter International Inc., Value Chain Analysis 108
Figure
66: Medical Device Classification in Japan, 2007 132
Figure 67: Approval
Process for Controlled Medical Devices in Japan, 2007 133
Figure 68:
Approval Process for Highly Controlled Medical Devices in Japan, 2007 134
Figure 69: Health Insurance Reimbursement Process in Japan, 2007 138
Figure 70: Distribution Structure for Medical Equipment in Japan, 2007 140
Figure 71: Global Markets Direct Methodology 141
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