Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 10
2 Introduction 12
2.1 What Is This Report About? 12
3 Definitions of
the Markets Covered in the Report 13
3.1 Endoscopy Devices 13
3.2
Capsule Endoscope System 13
3.2.1 Capsule Endoscopy Workstation 13
3.2.2 Capsule Endoscope 13
3.3 Endoscopic Instruments 13
3.4
Endoscopic Reprocessors 13
3.5 Flexible Endoscope 13
3.5.1
Fibroroscopes 14
3.5.2 Videoscopes 14
3.6 Endoscopy Fluid Management
System 14
3.7 Rigid Endoscope 14
3.7.1 Hysteroscopes 15
3.7.2
Laparoscopes 15
3.8 Endoscopy Visualization Systems 15
4 Healthcare
Sector Review 16
4.1 Healthcare Expenditure 16
4.2 Healthcare
Infrastructure 18
4.3 Healthcare Policy 22
5 Regulation System 23
5.1 Medical Equipment Approval Process 23
5.1.1 Market Authorization
Holder (MAH) 23
5.1.2 Classification and Pre-Market Approval of Medical
Devices 24
5.1.3 Third Party Certification for Controlled Medical Devices
25
5.1.4 PMDA Approval for Highly Controlled Medical Devices 26
5.1.5
Registration Time 27
5.1.6 Registration Fee 27
5.1.7 Post Marketing
Surveillance 28
5.1.8 Labeling and Packaging 28
6 Pricing and
Reimbursement 29
6.1 Market Pricing 29
6.2 Reimbursement Policies
29
6.3 Reimbursement Classes 30
6.3.1 Class A 30
6.3.2 Class B
31
6.3.3 Class C 31
6.3.4 Class F 31
6.4 Request for Reimbursement
31
6.5 Reduction in Reimbursement for Medical Devices and Drugs 31
7
Distribution Structure 32
8 Endoscopy Devices In Japan 33
8.1
Endoscopy Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 33
8.2 Endoscopy Devices, Japan, Overall Revenue ($ mn), 2000-2015 34
8.3
Endoscopy Devices, Japan, Category Volume (Units), 2000-2015 40
8.4
Endoscopy Devices, Japan, Company Share (2006-2007) 43
9 Capsule Endoscope
System In Japan 44
9.1 Capsule Endoscope System Overall Revenue
(2000-2015) 44
9.2 Capsule Endoscope System Overall Volume (2000-2015)
46
9.3 Capsule Endoscope System Average Price (2000-2015) 47
9.4
Capsule Endoscope System Distribution Share (2007-2008) 48
9.5 Capsule
Endoscope System, Japan, Company Share (2006-2007) 49
10 Endoscopic
Instruments In Japan 50
10.1 Endoscopic Instruments Overall Revenue
(2000-2015) 50
10.2 Endoscopic Instruments Distribution Share (2007-2008)
52
11 Endoscopic Reprocessors In Japan 53
11.1 Endoscopic Reprocessors
Overall Revenue (2000-2015) 53
11.2 Endoscopic Reprocessors Overall Volume
(2000-2015) 55
11.3 Endoscopic Reprocessors Average Price (2000-2015)
57
11.4 Endoscopic Reprocessors Distribution Share (2007-2008) 58
11.5
Endoscopic Reprocessors, Japan, Company Share (2006-2007) 59
12 Endoscopy
Fluid Management Systems In Japan 60
12.1 Endoscopy Fluid Management
Systems Overall Revenue (2000-2015) 60
12.2 Endoscopy Fluid Management
Systems Overall Volume (2000-2015) 62
12.3 Endoscopy Fluid Management
Systems Average Price (2000-2015) 64
12.4 Endoscopy Fluid Management
Systems Distribution Share (2007-2008) 65
13 Endoscopy Visualization
Systems In Japan 66
13.1 Endoscopy Visualization Systems Overall Revenue
(2000-2015) 66
13.2 Endoscopy Visualization Systems Overall Volume
(2000-2015) 68
13.3 Endoscopy Visualization Systems Average Price
(2000-2015) 70
13.4 Endoscopy Visualization Systems Distribution Share
(2007-2008) 71
14 Flexible Endoscope In Japan 72
14.1 Flexible
Endoscope Overall Revenue (2000-2015) 72
14.1.1 Fibroscope Revenue
(2000-2015) 74
14.2 Flexible Endoscope Overall Volume (2000-2015) 76
14.2.1 Fibroscope Volume (2000-2015) 78
14.3 Flexible Endoscope Average
Price (2000-2015) 80
14.4 Flexible Endoscope Distribution Share
(2007-2008) 81
14.5 Flexible Endoscope, Japan, Company Share (2006-2007)
82
15 Rigid Endoscope In Japan 83
15.1 Rigid Endoscope Overall Revenue
(2000-2015) 83
15.2 Rigid Endoscope Overall Volume (2000-2015) 85
15.3
Rigid Endoscope Average Price (2000-2015) 87
15.4 Rigid Endoscope
Distribution Share (2007-2008) 88
15.5 Rigid Endoscope, Japan, Company
Share (2006-2007) 89
16 Overview of Key Companies in Japan Endoscopy
Devices Market 90
16.1 OLYMPUS CORPORATION 90
16.1.1 Company Overview
90
16.1.2 Value Chain Analysis 90
16.1.3 Olympus Medical Systems Corp.
Pipeline Products 92
16.2 PENTAX of America, Inc. 93
16.2.1 Company
Overview 93
16.3 Fujinon Corporation 93
16.3.1 Company Overview 93
16.4 Given Imaging Ltd. 93
16.4.1 Company Overview 93
16.4.2 Given
Imaging Ltd. Pipeline Products 94
16.5 KARL STORZ GmbH & Co. KG 95
16.5.1 Company Overview 95
16.6 Minntech Corporation 95
16.6.1 Company
Overview 95
16.7 STERIS Corporation 95
16.7.1 Company Overview 95
16.7.2 Value Chain Analysis 96
16.8 B. Braun Melsungen AG 97
16.8.1
Company Overview 97
16.8.2 Value Chain Analysis 98
16.9 Stryker
Corporation 101
16.9.1 Company Overview 101
16.9.2 Value Chain
Analysis 102
17 Appendix 104
17.1 Global Markets Direct Research
Methodology 104
17.2 Coverage 105
17.3 Secondary Research 105
17.4
Primary Research 106
17.5 Models 106
17.6 Forecasts 107
17.7
Expert Panel Validation 107
17.8 Currency Conversion 108
17.9 Contact
Us 109
17.10 Disclaimer 109
1.1 List of Tables
Table 1:
Healthcare Expenditure in Japan, 2000 - 2005 17
Table 2: Number of
Healthcare Institutions in Japan, 1995 - 2004 19
Table 3: Number of
Hospital Beds in Japan, 1995 - 2004 20
Table 4: Number of Medical
Personnel in Japan, 1995 - 2004 20
Table 5: Number of Doctors by Specialty
in Japan, 2003-2007 21
Table 6: Number of Medical Care Institutions and
Beds in Japan, 2000 - 2004 22
Table 7: Registration Processing Time for
Medical Devices in Japan, 2007 27
Table 8: Product Registration Fee for
Medical Devices in Japan, 2007 27
Table 9: Endoscopy Devices Cross
Country Comparison, Revenue ($ mn), 2000-2015 33
Table 10: Endoscopy
Devices, Japan, Overall Revenue ($ mn), 2000-2015 34
Table 11:
Endoscopy Devices, Japan, Cross-Category Analysis, 2000-2015 35
Table 12:
Endoscopy Devices, Japan, Overall Revenue ($ mn), Historic, 2000-2008
37
Table 13: Endoscopy Devices, Japan, Overall Revenue ($ mn),
Forecast, 2008-2015 39
Table 14: Endoscopy Devices, Japan, Category
Volume (Units), 2000-2015 40
Table 15: Endoscopy Devices, Japan,
Category Volume (Units), Historic, 2000-2008 41
Table 16: Endoscopy
Devices, Japan, Category Volume (Units), Forecast, 2008-2015 42
Table 17:
Endoscopy Devices, Japan, Company Share by Revenue ($ mn), 2006-2007
43
Table 18: Capsule Endoscope System, Japan, Revenue ($ mn) by
Segment, Historic, 2000-2008 44
Table 19: Capsule Endoscope System,
Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 45
Table 20:
Capsule Endoscope System, Japan, Volume (Units) by Segment, Historic,
2000-2008 46
Table 21: Capsule Endoscope System, Japan, Volume
(Units) by Segment, Forecast, 2008-2015 46
Table 22: Capsule
Endoscope System, Japan, Average Price ($), Historic, 2000-2008 47
Table
23: Capsule Endoscope System, Japan, Average Price ($), Forecast,
2008-2015 47
Table 24: Capsule Endoscope System, Japan, Distribution
Share by Revenue ($mn), 2007-2008 48
Table 25: Capsule Endoscope
System, Japan, Company Share by Revenue ($ mn), 2006-2007 49
Table 26:
Endoscopic Instruments, Japan, Revenue ($ mn), Historic, 2000-2008 50
Table 27: Endoscopic Instruments, Japan, Revenue ($ mn), Forecast,
2008-2015 51
Table 28: Endoscopic Instruments, Japan, Distribution
Share by Revenue ($mn), 2007-2008 52
Table 29: Endoscopic
Reprocessors, Japan, Revenue ($ mn), Historic, 2000-2008 53
Table 30:
Endoscopic Reprocessors, Japan, Revenue ($ mn), Forecast, 2008-2015 54
Table 31: Endoscopic Reprocessors, Japan, Volume (Units), Historic,
2000-2008 55
Table 32: Endoscopic Reprocessors, Japan, Volume
(Units), Forecast, 2008-2015 56
Table 33: Endoscopic Reprocessors,
Japan, Average Price ($), Historic, 2000-2008 57
Table 34: Endoscopic
Reprocessors, Japan, Average Price ($), Forecast, 2008-2015 57
Table 35:
Endoscopic Reprocessors, Japan, Distribution Share by Revenue ($mn),
2007-2008 58
Table 36: Endoscopic Reprocessors, Japan, Company Share
by Revenue ($ mn), 2006-2007 59
Table 37: Endoscopy Fluid Management
Systems, Japan, Revenue ($ mn), Historic, 2000-2008 60
Table 38:
Endoscopy Fluid Management Systems, Japan, Revenue ($ mn), Forecast, 2008-2015
61
Table 39: Endoscopy Fluid Management Systems, Japan, Volume
(Units), Historic, 2000-2008 62
Table 40: Endoscopy Fluid Management
Systems, Japan, Volume (Units), Forecast, 2008-2015 63
Table 41:
Endoscopy Fluid Management Systems, Japan, Average Price ($), Historic,
2000-2008 64
Table 42: Endoscopy Fluid Management Systems, Japan,
Average Price ($), Forecast, 2008-2015 64
Table 43: Endoscopy Fluid
Management Systems, Japan, Distribution Share by Revenue ($mn), 2007-2008
65
Table 44: Endoscopy Visualization Systems, Japan, Revenue ($ mn),
Historic, 2000-2008 66
Table 45: Endoscopy Visualization Systems,
Japan, Revenue ($ mn), Forecast, 2008-2015 67
Table 46: Endoscopy
Visualization Systems, Japan, Volume (Units), Historic, 2000-2008 68
Table
47: Endoscopy Visualization Systems, Japan, Volume (Units), Forecast,
2008-2015 69
Table 48: Endoscopy Visualization Systems, Japan,
Average Price ($), Historic, 2000-2008 70
Table 49: Endoscopy
Visualization Systems, Japan, Average Price ($), Forecast, 2008-2015 70
Table 50: Endoscopy Visualization Systems, Japan, Distribution Share by
Revenue ($mn), 2007-2008 71
Table 51: Flexible Endoscope, Japan,
Revenue ($ mn) by Segment, Historic, 2000-2008 72
Table 52: Flexible
Endoscope, Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 73
Table
53: Fibroscope, Japan, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
74
Table 54: Fibroscope, Japan, Revenue ($ mn) by Sub-Segment,
Forecast, 2008-2015 75
Table 55: Flexible Endoscope, Japan, Volume
(Units) by Segment, Historic, 2000-2008 76
Table 56: Flexible
Endoscope, Japan, Volume (Units) by Segment, Forecast, 2008-2015 77
Table
57: Fibroscope, Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008
78
Table 58: Fibroscope, Japan, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 79
Table 59: Flexible Endoscope, Japan, Average
Price ($), Historic, 2000-2008 80
Table 60: Flexible Endoscope,
Japan, Average Price ($), Forecast, 2008-2015 80
Table 61: Flexible
Endoscope, Japan, Distribution Share by Revenue ($mn), 2007-2008 81
Table
62: Flexible Endoscope, Japan, Company Share by Revenue ($ mn), 2006-2007
82
Table 63: Rigid Endoscope, Japan, Revenue ($ mn) by Segment,
Historic, 2000-2008 83
Table 64: Rigid Endoscope, Japan, Revenue ($
mn) by Segment, Forecast, 2008-2015 84
Table 65: Rigid Endoscope,
Japan, Volume (Units) by Segment, Historic, 2000-2008 85
Table 66:
Rigid Endoscope, Japan, Volume (Units) by Segment, Forecast, 2008-2015 86
Table 67: Rigid Endoscope, Japan, Average Price ($), Historic, 2000-2008
87
Table 68: Rigid Endoscope, Japan, Average Price ($), Forecast,
2008-2015 87
Table 69: Rigid Endoscope, Japan, Distribution Share by
Revenue ($mn), 2007-2008 88
Table 70: Rigid Endoscope, Japan, Company
Share by Revenue ($ mn), 2006-2007 89
Table 71: Olympus Medical
Systems Corp. Pipeline Products by Equipment Type 92
Table 72:
Olympus Medical Systems Corp. Pipeline Products by Development Stage 92
Table 73: Olympus Medical Systems Corp. Pipeline Products by Therapy Area
92
Table 74: Olympus Medical Systems Corp. Pipeline Products by
Clinical Trials 92
Table 75: Olympus Medical Systems Corp. Pipeline
Products by News Summary 92
Table 76: Given Imaging Ltd. Pipeline
Products by Equipment Type 94
Table 77: Given Imaging Ltd. Pipeline
Products by Development Stage 94
Table 78: Given Imaging Ltd.
Pipeline Products by Therapy Area 94
Table 79: Given Imaging Ltd.
Pipeline Products by Clinical Trials 94
Table 80: Given Imaging Ltd.
Pipeline Products by News Summary 95
Table 81: USD to Local Currency,
Average Exchange Rate 2008 108
1.2 List of Figures
Figure 1:
Healthcare Expenditure in Japan, 2000 - 2005 17
Figure 2: Government and
Private Healthcare Expenditure in Japan, 2005 18
Figure 3: Medical Device
Classification in Japan, 2007 24
Figure 4: Approval Process for Controlled
Medical Devices in Japan, 2007 25
Figure 5: Approval Process for Highly
Controlled Medical Devices in Japan, 2007 26
Figure 6: Health Insurance
Reimbursement Process in Japan, 2007 30
Figure 7: Distribution Structure
for Medical Equipment in Japan, 2007 32
Figure 8: Endoscopy Devices
Cross Country Comparison, Revenue ($ mn), 2000-2015 33
Figure 9:
Endoscopy Devices, Japan, Overall Revenue ($ mn), 2000-2015 34
Figure 10:
Endoscopy Devices, Japan, Cross-Category Analysis, 2000-2015 35
Figure 11:
Endoscopy Devices, Japan, Overall Revenue ($ mn), Historic, 2000-2008
36
Figure 12: Endoscopy Devices, Japan, Overall Revenue ($ mn),
Forecast, 2008-2015 38
Figure 13: Endoscopy Devices, Japan, Category
Volume (Units), 2000-2015 40
Figure 14: Endoscopy Devices, Japan,
Category Volume (Units), Historic, 2000-2008 41
Figure 15: Endoscopy
Devices, Japan, Category Volume (Units), Forecast, 2008-2015 42
Figure 16:
Endoscopy Devices, Japan, Company Share (%), 2007 43
Figure 17:
Capsule Endoscope System, Japan, Revenue ($ mn) by Segment, Historic,
2000-2008 44
Figure 18: Capsule Endoscope System, Japan, Revenue ($
mn) by Segment, Forecast, 2008-2015 45
Figure 19: Endoscopic
Instruments, Japan, Revenue ($ mn), Historic, 2000-2008 50
Figure 20:
Endoscopic Instruments, Japan, Revenue ($ mn), Forecast, 2008-2015 51
Figure 21: Endoscopic Reprocessors, Japan, Revenue ($ mn), Historic,
2000-2008 53
Figure 22: Endoscopic Reprocessors, Japan, Revenue ($
mn), Forecast, 2008-2015 54
Figure 23: Endoscopic Reprocessors,
Japan, Volume (Units), Historic, 2000-2008 55
Figure 24: Endoscopic
Reprocessors, Japan, Volume (Units), Forecast, 2008-2015 56
Figure 25:
Endoscopic Reprocessors, Japan, Company Share (%), 2007 59
Figure 26:
Endoscopy Fluid Management Systems, Japan, Revenue ($ mn), Historic,
2000-2008 60
Figure 27: Endoscopy Fluid Management Systems, Japan,
Revenue ($ mn), Forecast, 2008-2015 61
Figure 28: Endoscopy Fluid
Management Systems, Japan, Volume (Units), Historic, 2000-2008 62
Figure
29: Endoscopy Fluid Management Systems, Japan, Volume (Units), Forecast,
2008-2015 63
Figure 30: Endoscopy Visualization Systems, Japan,
Revenue ($ mn), Historic, 2000-2008 66
Figure 31: Endoscopy
Visualization Systems, Japan, Revenue ($ mn), Forecast, 2008-2015 67
Figure 32: Endoscopy Visualization Systems, Japan, Volume (Units),
Historic, 2000-2008 68
Figure 33: Endoscopy Visualization Systems,
Japan, Volume (Units), Forecast, 2008-2015 69
Figure 34: Flexible
Endoscope, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 72
Figure
35: Flexible Endoscope, Japan, Revenue ($ mn) by Segment, Forecast,
2008-2015 73
Figure 36: Fibroscope, Japan, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 74
Figure 37: Fibroscope, Japan,
Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 75
Figure 38:
Flexible Endoscope, Japan, Volume (Units) by Segment, Historic, 2000-2008
76
Figure 39: Flexible Endoscope, Japan, Volume (Units) by Segment,
Forecast, 2008-2015 77
Figure 40: Fibroscope, Japan, Volume (Units)
by Sub-Segment, Historic, 2000-2008 78
Figure 41: Fibroscope, Japan,
Volume (Units) by Sub-Segment, Forecast, 2008-2015 79
Figure 42:
Flexible Endoscope, Japan, Company Share (%), 2007 82
Figure 43:
Rigid Endoscope, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 83
Figure 44: Rigid Endoscope, Japan, Revenue ($ mn) by Segment, Forecast,
2008-2015 84
Figure 45: Rigid Endoscope, Japan, Volume (Units) by
Segment, Historic, 2000-2008 85
Figure 46: Rigid Endoscope, Japan,
Volume (Units) by Segment, Forecast, 2008-2015 86
Figure 47: Rigid
Endoscope, Japan, Company Share (%), 2007 89
Figure 48: Olympus
Medical Systems Corp. Value Chain Analysis 90
Figure 49: STERIS
Corporation Value Chain Analysis 96
Figure 50: B. Braun Melsungen AG
Value Chain Analysis 98
Figure 51: Stryker Corporation Value Chain
Analysis 102
Figure 52: Global Markets Direct Methodology 104
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