Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2
List of Figures 10
2 Introduction 11
2.1 What Is This Report About?
11
3 Definitions of the Markets Covered in the Report 12
3.1 Patient
Monitoring 12
3.2 Micro-Electromechanical Systems 12
3.3
Multiparameter Patient Monitoring 12
3.3.1 Critical Care Monitors 12
3.3.2 Perioperative Care Monitors 12
3.4 Non-Invasive Blood Pressure
Monitors 12
3.4.1 Aneroid Sphygmomanometer 12
3.4.2 Automatic
Sphygmomanometer 12
3.4.3 Mercury Sphygmomanometer 13
3.5 Remote
Patient Monitoring 13
3.6 Wireless and Ambulatory Monitoring 13
3.6.1
Cardiac Rehabilitation Ambulatory 13
3.6.2 Hospital Ambulatory 13
4
Healthcare Sector Review 14
4.1 Healthcare Expenditure 14
4.2
Healthcare Infrastructure 16
4.3 Healthcare Policy 21
5 Regulation
System 22
5.1 Medical Equipment Approval Process 22
5.1.1 Market
Authorization Holder (MAH) 22
5.1.2 Classification and Pre-Market Approval
of Medical Devices 23
5.1.3 Third Party Certification for Controlled
Medical Devices 24
5.1.4 PMDA Approval for Highly Controlled Medical
Devices 25
5.1.5 Registration Time 26
5.1.6 Registration Fee 26
5.1.7 Post Marketing Surveillance 27
5.1.8 Labeling and Packaging 27
6
Pricing and Reimbursement 28
6.1 Market Pricing 28
6.2 Reimbursement
Policies 28
6.3 Reimbursement Classes 29
6.3.1 Class A 29
6.3.2
Class B 30
6.3.3 Class C 30
6.3.4 Class F 30
6.4 Request for
Reimbursement 30
6.5 Reduction in Reimbursement for Medical Devices and
Drugs 30
7 Distribution Structure 31
8 Patient Monitoring In Japan
32
8.1 Patient Monitoring, Cross Country Comparison, Revenue ($ mn),
2000-2015 32
8.2 Patient Monitoring, Japan, Overall Revenue ($ mn),
2000-2015 34
8.3 Patient Monitoring, Japan, Category Volume (Units),
2000-2015 40
8.4 Patient Monitoring, Japan, Company Share (2007-2008)
42
9 Micro-Electromechanical Systems In Japan 43
9.1
Micro-Electromechanical Systems Overall Revenue (2000-2015) 43
9.2
Micro-Electromechanical Systems Overall Volume (2000-2015) 45
9.3
Micro-Electromechanical Systems Average Price (2000-2015) 47
9.4
Micro-Electromechanical Systems Distribution Share (2007-2008) 48
9.5
Micro-Electromechanical Systems, Japan, Company Share (2007-2008) 49
10
Multiparameter Patient Monitoring In Japan 50
10.1 Multiparameter Patient
Monitoring Overall Revenue (2000-2015) 50
10.2 Multiparameter Patient
Monitoring Overall Volume (2000-2015) 52
10.3 Multiparameter Patient
Monitoring Average Price (2000-2015) 54
10.4 Multiparameter Patient
Monitoring Distribution Share (2007-2008) 55
10.5 Multiparameter Patient
Monitoring, Japan, Company Share (2007-2008) 56
11 Non-Invasive Blood
Pressure Monitors In Japan 57
11.1 Non-Invasive Blood Pressure Monitors
Overall Revenue (2000-2015) 57
11.2 Non-Invasive Blood Pressure Monitors
Overall Volume (2000-2015) 58
11.3 Non-Invasive Blood Pressure Monitors
Average Price (2000-2015) 60
11.4 Non-Invasive Blood Pressure Monitors
Distribution Share (2007-2008) 61
11.5 Non-Invasive Blood Pressure
Monitors, Japan, Company Share (2007-2008) 62
12 Remote Patient Monitoring
In Japan 63
12.1 Remote Patient Monitoring Overall Revenue (2000-2015)
63
12.2 Remote Patient Monitoring Overall Volume (2000-2015) 65
12.3
Remote Patient Monitoring Average Price (2000-2015) 67
12.4 Remote Patient
Monitoring Distribution Share (2007-2008) 68
12.5 Remote Patient
Monitoring, Japan, Company Share (2007-2008) 69
13 Wireless and Ambulatory
Monitoring In Japan 70
13.1 Wireless and Ambulatory Monitoring Overall
Revenue (2000-2015) 70
13.2 Wireless and Ambulatory Monitoring Overall
Volume (2000-2015) 72
13.3 Wireless and Ambulatory Monitoring Average
Price (2000-2015) 74
13.4 Wireless and Ambulatory Monitoring Distribution
Share (2007-2008) 75
13.5 Wireless and Ambulatory Monitoring, Japan,
Company Share (2007-2008) 76
14 Overview of Key Companies in Japan Patient
Monitoring Market 77
14.1 OMRON HEALTHCARE Co., Ltd. 77
14.1.1 Company
Overview 77
14.1.2 OMRON HEALTHCARE Co., Ltd. Pipeline Products 77
14.1.2.1 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Equipment Type 77
14.1.2.2 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Development Stage
77
14.1.2.3 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Therapy Area
78
14.1.2.4 OMRON HEALTHCARE Co., Ltd. Pipeline Products By News Summary
78
14.2 Nihon Kohden Corporation 79
14.2.1 Company Overview 79
14.3 Philips Healthcare 80
14.3.1 Company Overview 80
14.4 GE
Healthcare 81
14.4.1 Company Overview 81
14.4.2 GE Healthcare Pipeline
Products 81
14.4.2.1 GE Healthcare Pipeline Products By Equipment Type
81
14.4.2.2 GE Healthcare Pipeline Products By Development Stage 81
14.4.2.3 GE Healthcare Pipeline Products By Therapy Area 82
14.4.2.4 GE
Healthcare Pipeline Products By Clinical Trials 82
14.4.2.5 GE Healthcare
Pipeline Products By News Summary 82
14.5 Terumo Corporation 83
14.5.1
Company Overview 83
14.6 Edwards Lifesciences Corporation 84
14.6.1
Company Overview 84
14.7 GE Sensing & Inspection Technologies 84
14.7.1 Company Overview 84
14.8 Draegerwerk AG & Co. KGaA 85
14.8.1
Company Overview 85
14.8.2 Drager Medical AG & Co. KG Pipeline Products
85
14.8.2.1 Drager Medical AG & Co. KG Pipeline Products By Equipment Type
85
14.8.2.2 Drager Medical AG & Co. KG Pipeline Products By Development
Stage 85
14.8.2.3 Drager Medical AG & Co. KG Pipeline Products By Therapy
Area 85
14.9 OSI Systems, Inc. 86
14.9.1 Company Overview 86
14.10
Fukuda Denshi Co., Ltd. 86
14.10.1 Company Overview 86
14.11 Mindray
Medical International Limited 87
14.11.1 Company Overview 87
14.12
Welch Allyn Inc. 88
14.12.1 Company Overview 88
14.13 Microlife
Corporation 88
14.13.1 Company Overview 88
14.14 St. Jude Medical,
Inc. 89
14.14.1 Company Overview 89
14.15 Medtronic, Inc. 89
14.15.1 Company Overview 89
14.16 HARTMANN GROUP 90
14.16.1 Company
Overview 90
14.17 A&D Medical / LifeSource 91
14.17.1 Company Overview
91
14.18 Schiller AG 91
14.18.1 Company Overview 91
14.19 Siemens
Healthcare 92
14.19.1 Company Overview 92
14.20 Boston Scientific
Corporation 92
14.20.1 Company Overview 92
14.21 BIOTRONIK GmbH & Co.
KG 93
14.21.1 Company Overview 93
14.22 Datascope Corporation 93
14.22.1 Company Overview 93
14.23 KENZMEDIKO Co.,Ltd. 94
14.23.1
Company Overview 94
15 Financial Deals Landscape 95
15.1 Partnerships
95
15.1.1 Masimo Enters Into Licensing Agreement with GS Electro Medical
Equipment 95
16 Appendix 96
16.1 Global Markets Direct Research
Methodology 96
16.2 Secondary Research 97
16.3 Primary Research 97
16.4 Models 98
16.5 Forecasts 98
16.6 Expert Panel Validation 98
16.7 Currency Conversion 99
16.8 Contact Us 100
16.9 Disclaimer
100
1.1 List of Tables
Table 1: Healthcare Expenditure in Japan,
2000 - 2007 15
Table 2: Number of Healthcare Institutions in Japan, 2000
– 2006 17
Table 3: Number of Hospital Beds in Japan, 2000 –
2006 18
Table 4: Number of Medical Personnel in Japan, 1998 - 2006 18
Table 5: Number of Doctors by Specialty in Japan, 2003-2007 19
Table 6:
Number of Medical Care Institutions and Beds in Japan, 2000 - 2006 20
Table 7: Registration Processing Time for Medical Devices in Japan, 2007
26
Table 8: Product Registration Fee for Medical Devices in Japan, 2007
26
Table 9: Patient Monitoring, Cross Country Comparison, Revenue ($
mn), 2000-2015 33
Table 10: Patient Monitoring, Japan, Overall
Revenue ($ mn), 2000-2015 34
Table 11: Patient Monitoring, Japan,
Cross-Category Analysis, 2000-2015 35
Table 12: Patient Monitoring,
Japan, Overall Revenue ($ mn), Historic, 2000-2008 37
Table 13:
Patient Monitoring, Japan, Overall Revenue ($ mn), Forecast, 2008-2015 39
Table 14: Patient Monitoring, Japan, Category Volume (Units), 2000-2015
40
Table 15: Patient Monitoring, Japan, Category Volume (Units),
Historic, 2000-2008 40
Table 16: Patient Monitoring, Japan, Category
Volume (Units), Forecast, 2008-2015 41
Table 17: Patient Monitoring,
Japan, Company Share by Revenue ($ mn), 2007-2008 42
Table 18:
Micro-Electromechanical Systems, Japan, Revenue ($ mn), Historic, 2000-2008
43
Table 19: Micro-Electromechanical Systems, Japan, Revenue ($ mn),
Forecast, 2008-2015 44
Table 20: Micro-Electromechanical Systems,
Japan, Volume (Units), Historic, 2000-2008 45
Table 21:
Micro-Electromechanical Systems, Japan, Volume (Units), Forecast, 2008-2015
46
Table 22: Micro-Electromechanical Systems, Japan, Average Price
($), Historic, 2000-2008 47
Table 23: Micro-Electromechanical
Systems, Japan, Average Price ($), Forecast, 2008-2015 47
Table 24:
Micro-Electromechanical Systems, Japan, Distribution Share by Revenue ($mn),
2007-2008 48
Table 25: Micro-Electromechanical Systems, Japan,
Company Share by Revenue ($ mn), 2007-2008 49
Table 26:
Multiparameter Patient Monitoring, Japan, Revenue ($ mn) by Segment, Historic,
2000-2008 50
Table 27: Multiparameter Patient Monitoring, Japan,
Revenue ($ mn) by Segment, Forecast, 2008-2015 51
Table 28:
Multiparameter Patient Monitoring, Japan, Volume (Units) by Segment, Historic,
2000-2008 52
Table 29: Multiparameter Patient Monitoring, Japan,
Volume (Units) by Segment, Forecast, 2008-2015 53
Table 30:
Multiparameter Patient Monitoring, Japan, Average Price ($), Historic,
2000-2008 54
Table 31: Multiparameter Patient Monitoring, Japan,
Average Price ($), Forecast, 2008-2015 54
Table 32: Multiparameter
Patient Monitoring, Japan, Distribution Share by Revenue ($mn), 2007-2008
55
Table 33: Multiparameter Patient Monitoring, Japan, Company Share
by Revenue ($ mn), 2007-2008 56
Table 34: Non-Invasive Blood Pressure
Monitors, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 57
Table
35: Non-Invasive Blood Pressure Monitors, Japan, Revenue ($ mn) by
Segment, Forecast, 2008-2015 57
Table 36: Non-Invasive Blood Pressure
Monitors, Japan, Volume (Units) by Segment, Historic, 2000-2008 58
Table
37: Non-Invasive Blood Pressure Monitors, Japan, Volume (Units) by
Segment, Forecast, 2008-2015 59
Table 38: Non-Invasive Blood Pressure
Monitors, Japan, Average Price ($), Historic, 2000-2008 60
Table 39:
Non-Invasive Blood Pressure Monitors, Japan, Average Price ($), Forecast,
2008-2015 60
Table 40: Non-Invasive Blood Pressure Monitors, Japan,
Distribution Share by Revenue ($mn), 2007-2008 61
Table 41:
Non-Invasive Blood Pressure Monitors, Japan, Company Share by Revenue ($ mn),
2007-2008 62
Table 42: Remote Patient Monitoring, Japan, Revenue ($
mn), Historic, 2000-2008 63
Table 43: Remote Patient Monitoring,
Japan, Revenue ($ mn), Forecast, 2008-2015 64
Table 44: Remote
Patient Monitoring, Japan, Volume (Units), Historic, 2000-2008 65
Table
45: Remote Patient Monitoring, Japan, Volume (Units), Forecast, 2008-2015
66
Table 46: Remote Patient Monitoring, Japan, Average Price ($),
Historic, 2000-2008 67
Table 47: Remote Patient Monitoring, Japan,
Average Price ($), Forecast, 2008-2015 67
Table 48: Remote Patient
Monitoring, Japan, Distribution Share by Revenue ($mn), 2007-2008 68
Table
49: Remote Patient Monitoring, Japan, Company Share by Revenue ($ mn),
2007-2008 69
Table 50: Wireless and Ambulatory Monitoring, Japan,
Revenue ($ mn) by Segment, Historic, 2000-2008 70
Table 51: Wireless
and Ambulatory Monitoring, Japan, Revenue ($ mn) by Segment, Forecast,
2008-2015 71
Table 52: Wireless and Ambulatory Monitoring, Japan,
Volume (Units) by Segment, Historic, 2000-2008 72
Table 53: Wireless
and Ambulatory Monitoring, Japan, Volume (Units) by Segment, Forecast,
2008-2015 73
Table 54: Wireless and Ambulatory Monitoring, Japan,
Average Price ($), Historic, 2000-2008 74
Table 55: Wireless and
Ambulatory Monitoring, Japan, Average Price ($), Forecast, 2008-2015 74
Table 56: Wireless and Ambulatory Monitoring, Japan, Distribution Share
by Revenue ($mn), 2007-2008 75
Table 57: Wireless and Ambulatory
Monitoring, Japan, Company Share by Revenue ($ mn), 2007-2008 76
Table 58:
OMRON HEALTHCARE Co., Ltd. Pipeline Products by Equipment Type 77
Table 59: OMRON HEALTHCARE Co., Ltd. Pipeline Products By Development
Stage 77
Table 60: OMRON HEALTHCARE Co., Ltd. Pipeline Products By
Therapy Area 78
Table 61: OMRON HEALTHCARE Co., Ltd. Pipeline
Products By News Summary 78
Table 62: GE Healthcare Pipeline Products
by Equipment Type 81
Table 63: GE Healthcare Pipeline Products By
Development Stage 81
Table 64: GE Healthcare Pipeline Products By
Therapy Area 82
Table 65: GE Healthcare Pipeline Products By Clinical
Trials 82
Table 66: GE Healthcare Pipeline Products By News Summary
82
Table 67: Drager Medical AG & Co. KG Pipeline Products by
Equipment Type 85
Table 68: Drager Medical AG & Co. KG Pipeline
Products By Development Stage 85
Table 69: Drager Medical AG & Co. KG
Pipeline Products By Therapy Area 85
Table 70: Masimo Enters Into
Licensing Agreement With GS Electro Medical Equipment 95
Table 71: USD
to Local Currency, Average Exchange Rate 2008 99
1.2 List of
Figures
Figure 1: Healthcare Expenditure in Japan, 2000 – 2007
15
Figure 2: Government and Private Healthcare Expenditure in Japan, 2007
16
Figure 3: Medical Device Classification in Japan, 2007 23
Figure 4:
Approval Process for Controlled Medical Devices in Japan, 2007 24
Figure
5: Approval Process for Highly Controlled Medical Devices in Japan, 2007
25
Figure 6: Health Insurance Reimbursement Process in Japan, 2007 29
Figure 7: Distribution Structure for Medical Equipment in Japan, 2007 31
Figure 8: Patient Monitoring, Cross Country Comparison, Revenue ($ mn),
2000-2015 32
Figure 9: Patient Monitoring, Japan, Overall Revenue ($
mn), 2000-2015 34
Figure 10: Patient Monitoring, Japan, Cross-Category
Analysis, 2000-2015 35
Figure 11: Patient Monitoring, Japan, Overall
Revenue ($ mn), Historic, 2000-2008 36
Figure 12: Patient Monitoring,
Japan, Overall Revenue ($ mn), Forecast, 2008-2015 38
Figure 13:
Patient Monitoring, Japan, Company Share (%), 2008 42
Figure 14:
Micro-Electromechanical Systems, Japan, Revenue ($ mn), Historic, 2000-2008
43
Figure 15: Micro-Electromechanical Systems, Japan, Revenue ($ mn),
Forecast, 2008-2015 44
Figure 16: Micro-Electromechanical Systems,
Japan, Volume (Units), Historic, 2000-2008 45
Figure 17:
Micro-Electromechanical Systems, Japan, Volume (Units), Forecast, 2008-2015
46
Figure 18: Micro-Electromechanical Systems, Japan, Company Share
(%), 2008 49
Figure 19: Multiparameter Patient Monitoring, Japan,
Revenue ($ mn) by Segment, Historic, 2000-2008 50
Figure 20:
Multiparameter Patient Monitoring, Japan, Revenue ($ mn) by Segment, Forecast,
2008-2015 51
Figure 21: Multiparameter Patient Monitoring, Japan,
Volume (Units) by Segment, Historic, 2000-2008 52
Figure 22:
Multiparameter Patient Monitoring, Japan, Volume (Units) by Segment, Forecast,
2008-2015 53
Figure 23: Multiparameter Patient Monitoring, Japan,
Company Share (%), 2008 56
Figure 24: Non-Invasive Blood Pressure
Monitors, Japan, Volume (Units) by Segment, Historic, 2000-2008 58
Figure
25: Non-Invasive Blood Pressure Monitors, Japan, Volume (Units) by
Segment, Forecast, 2008-2015 59
Figure 26: Non-Invasive Blood
Pressure Monitors, Japan, Company Share (%), 2008 62
Figure 27:
Remote Patient Monitoring, Japan, Revenue ($ mn), Historic, 2000-2008 63
Figure 28: Remote Patient Monitoring, Japan, Revenue ($ mn), Forecast,
2008-2015 64
Figure 29: Remote Patient Monitoring, Japan, Volume
(Units), Historic, 2000-2008 65
Figure 30: Remote Patient Monitoring,
Japan, Volume (Units), Forecast, 2008-2015 66
Figure 31: Remote
Patient Monitoring, Japan, Company Share (%), 2008 69
Figure 32:
Wireless and Ambulatory Monitoring, Japan, Revenue ($ mn) by Segment,
Historic, 2000-2008 70
Figure 33: Wireless and Ambulatory Monitoring,
Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 71
Figure 34:
Wireless and Ambulatory Monitoring, Japan, Volume (Units) by Segment,
Historic, 2000-2008 72
Figure 35: Wireless and Ambulatory Monitoring,
Japan, Volume (Units) by Segment, Forecast, 2008-2015 73
Figure 36:
Wireless and Ambulatory Monitoring, Japan, Company Share (%), 2008 76
Figure 37: Global Markets Direct Methodology 96
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