Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 11
1.2 List of Figures 16
2 Introduction 19
2.1 What Is This Report
About? 19
3 Definitions of Markets Covered in This Report 20
3.1
Cardiovascular Devices 20
3.2 Cardiac Rhythm Management 20
3.2.1
Pacemakers 20
3.2.2 Implantable Cardioverter Defibrillator (ICD) 20
3.2.3 Cardiovascular Pacing and ICD Leads 21
3.2.4 Cardiac
Resynchronization Therapy 21
3.3 Cardiovascular monitoring and diagnostic
devices 21
3.3.1 ECG Monitoring Equipment 21
3.3.2 ECG Stress Testing
Systems 21
3.3.3 Holter Monitoring Systems 21
3.3.4 Event Monitoring
Systems 21
3.4 Cardiovascular prosthetic device 22
3.4.1 Prosthetic
heart valves 22
3.4.2 Cardiac Valve Repair 22
3.4.3 Cardiac assist
devices (Ventricular Assist Device (VAD)) 22
3.5 Cardiovascular Surgery
23
3.5.1 Beating Heart Systems 23
3.5.2 Perfusion Systems 23
3.5.3
Cardiac Ablation Devices 23
3.5.4 Cardiopulmonary Bypass Equipment 23
3.5.5 Perfusion Disposables 23
3.6 Electrophysiology 23
3.6.1
Electrophysiology diagnostic catheter 24
3.6.2 Electrophysiology ablation
catheter 24
3.6.3 Electrophysiology lab systems 24
3.7 Interventional
cardiology 24
3.7.1 Coronary Stents 24
3.7.2 Cardiac Catheters 24
3.7.3 Percutaneous Transluminal Coronary Balloon (PTCA) Balloon Catheters
25
3.7.4 Coronary Guidewire 25
3.7.5 Arteriotomy Closure Devices
25
3.8 Peripheral vascular devices 25
3.8.1 Peripheral Vascular Stents
25
3.8.2 Inferior Vena Cava Filter 26
3.8.3 PTA Balloon 26
3.8.4
Aortic Stent Graft 26
3.8.5 Embolic Protection Device 26
3.8.6
Synthetic Surgical Grafts 26
3.8.7 Peripheral Guidewire 26
4
Healthcare Sector Review 27
4.1 Healthcare Expenditure 27
4.2
Healthcare Infrastructure 29
4.3 Healthcare Policy 33
5 Regulation
System 34
5.1 Medical Equipment Approval Process 34
5.1.1 Market
Authorization Holder (MAH) 34
5.1.2 Classification and Pre-Market Approval
of Medical Devices 35
5.1.3 Third Party Certification for Controlled
Medical Devices 36
5.1.4 PMDA Approval for Highly Controlled Medical
Devices 37
5.1.5 Registration Time 38
5.1.6 Registration Fee 38
5.1.7 Post Marketing Surveillance 39
5.1.8 Labeling and Packaging 39
6
Pricing and Reimbursement 40
6.1 Market Pricing 40
6.2 Reimbursement
Policies 40
6.3 Reimbursement Classes 41
6.3.1 Class A 41
6.3.2
Class B 42
6.3.3 Class C 42
6.3.4 Class F 42
6.4 Request for
Reimbursement 42
6.5 Reduction in Reimbursement for Medical Devices and
Drugs 42
7 Distribution Structure 43
8 Cardiovascular Devices In Japan
44
8.1 Cardiovascular Devices, Cross Country Comparison, Revenue ($ mn),
2000-2015 44
8.2 Cardiovascular Devices, Japan, Overall Revenue ($ mn),
2000-2015 45
8.3 Cardiovascular Devices, Japan, Category Volume (Units),
2000-2015 51
8.4 Cardiovascular Devices, Japan, Company Share (2007-2008)
56
9 Cardiac Rhythm Management In Japan 57
9.1 Cardiac Rhythm
Management Overall Revenue (2000-2015) 57
9.1.1 Cardiac Resynchronisation
Therapy Revenue (2000-2015) 59
9.1.2 Implantable Cardioverter
Defibrillator Revenue (2000-2015) 61
9.1.3 Pacemaker Revenue (2000-2015)
63
9.2 Cardiac Rhythm Management Overall Volume (2000-2015) 65
9.2.1
Cardiac Resynchronisation Therapy Volume (2000-2015) 67
9.2.2 Implantable
Cardioverter Defibrillator Volume (2000-2015) 69
9.2.3 Pacemaker Volume
(2000-2015) 71
9.3 Cardiac Rhythm Management Average Price (2000-2015)
73
9.4 Cardiac Rhythm Management Distribution Share (2007-2008) 74
9.5
Cardiac Rhythm Management, Japan, Company Share (2007-2008) 75
10
Cardiovascular Monitoring and Diagnostic Devices In Japan 76
10.1
Cardiovascular Monitoring and Diagnostic Devices Overall Revenue (2000-2015)
76
10.2 Cardiovascular Monitoring and Diagnostic Devices Overall Volume
(2000-2015) 80
10.3 Cardiovascular Monitoring and Diagnostic Devices
Average Price (2000-2015) 82
10.4 Cardiovascular Monitoring and Diagnostic
Devices Distribution Share (2007-2008) 83
10.5 Cardiovascular Monitoring
and Diagnostic Devices, Japan, Company Share (2007-2008) 84
11
Cardiovascular Prosthetic Devices In Japan 85
11.1 Cardiovascular
Prosthetic Devices Overall Revenue (2000-2015) 85
11.1.1 Prosthetic Heart
Valve Revenue (2000-2015) 87
11.2 Cardiovascular Prosthetic Devices
Overall Volume (2000-2015) 89
11.2.1 Prosthetic Heart Valve Volume
(2000-2015) 91
11.3 Cardiovascular Prosthetic Devices Average Price
(2000-2015) 93
11.4 Cardiovascular Prosthetic Devices Distribution Share
(2007-2008) 94
11.5 Cardiovascular Prosthetic Devices, Japan, Company
Share (2007-2008) 95
12 Cardiovascular Surgery In Japan 96
12.1
Cardiovascular Surgery Overall Revenue (2000-2015) 96
12.1.1 Perfusion
Disposables Revenue (2000-2015) 99
12.2 Cardiovascular Surgery Overall
Volume (2000-2015) 101
12.2.1 Perfusion Disposables Volume (2000-2015)
102
12.3 Cardiovascular Surgery Average Price (2000-2015) 104
12.4
Cardiovascular Surgery Distribution Share (2007-2008) 105
12.5
Cardiovascular Surgery, Japan, Company Share (2007-2008) 106
13
Electrophysiology In Japan 107
13.1 Electrophysiology Overall Revenue
(2000-2015) 107
13.2 Electrophysiology Overall Volume (2000-2015) 109
13.3 Electrophysiology Average Price (2000-2015) 110
13.4
Electrophysiology, Japan, Company Share (2007-2008) 111
14 Interventional
Cardiology In Japan 112
14.1 Interventional Cardiology Overall Revenue
(2000-2015) 112
14.1.1 Cardiac Catheter Revenue (2000-2015) 116
14.1.2
Coronary Stent Revenue (2000-2015) 118
14.1.3 PTCA Balloon Revenue
(2000-2015) 120
14.2 Interventional Cardiology Overall Volume (2000-2015)
122
14.2.1 Cardiac Catheter Volume (2000-2015) 124
14.2.2 Coronary
Stent Volume (2000-2015) 126
14.2.3 PTCA Balloon Volume (2000-2015)
128
14.3 Interventional Cardiology Average Price (2000-2015) 130
14.4
Interventional Cardiology Distribution Share (2007-2008) 131
14.5
Interventional Cardiology, Japan, Company Share (2007-2008) 132
15
Peripheral Vascular Devices In Japan 133
15.1 Peripheral Vascular Devices
Overall Revenue (2000-2015) 133
15.2 Peripheral Vascular Devices Overall
Volume (2000-2015) 137
15.3 Peripheral Vascular Devices Average Price
(2000-2015) 141
15.4 Peripheral Vascular Devices Distribution Share
(2007-2008) 142
15.5 Peripheral Vascular Devices, Japan, Company Share
(2007-2008) 143
16 Overview of Key Companies in Japan Cardiovascular
Devices Market 144
16.1 Terumo Corporation 144
16.1.1 Company Overview
144
16.1.2 Value Chain Analysis 144
16.1.3 Terumo Corporation Pipeline
Products 146
16.2 St. Jude Medical, Inc. 149
16.2.1 Company Overview
149
16.2.2 Value Chain Analysis 150
16.2.3 St. Jude Medical Inc.
Pipeline Products 152
16.3 Sorin S.p.A. 156
16.3.1 Company Overview
156
16.3.2 Value Chain Analysis 157
16.3.3 Sorin Group Pipeline
Products 160
16.4 Philips Healthcare 162
16.4.1 Company Overview
162
16.4.2 Value Chain Analysis 162
16.4.3 Philips Medical Systems
Pipeline Products 165
16.5 OSI Systems, Inc. 167
16.5.1 Company
Overview 167
16.5.2 Value Chain Analysis 167
16.6 Nihon Kohden
Corporation 169
16.6.1 Company Overview 169
16.6.2 Value Chain
Analysis 170
16.7 Medtronic, Inc. 172
16.7.1 Company Overview 172
16.7.2 Value Chain Analysis 173
16.7.3 Medtronic, Inc. Pipeline Products
174
16.8 MAQUET GmbH & Co. KG 183
16.8.1 Company Overview 183
16.9
JMS CO., LTD. 183
16.9.1 Company Overview 183
16.10 GE Healthcare
184
16.10.1 Company Overview 184
16.11 Fukuda Denshi Co., Ltd. 184
16.11.1 Company Overview 184
16.12 ev3 Inc. 185
16.12.1 Company
Overview 185
16.12.2 Value Chain Analysis 186
16.12.3 ev3 Inc.
Pipeline Products 188
16.13 Edwards Lifesciences Corporation 190
16.13.1 Company Overview 190
16.13.2 Value Chain Analysis 190
16.13.3
Edwards Lifesciences Corporation Pipeline Products 192
16.14 Datascope
Corporation 195
16.14.1 Company Overview 195
16.14.2 Value Chain
Analysis 195
16.15 Cordis Corporation 198
16.15.1 Company Overview
198
16.15.2 Cordis Corporation Pipeline Products 198
16.16 Cardiac
Science Corporation 200
16.16.1 Company Overview 200
16.16.2 Value
Chain Analysis 201
16.17 C.R. Bard, Inc. 203
16.17.1 Company Overview
203
16.17.2 Value Chain Analysis 203
16.17.3 C.R. Bard, Inc. Pipeline
Products 205
16.18 Boston Scientific Corporation 207
16.18.1 Company
Overview 207
16.18.2 Value Chain Analysis 208
16.18.3 Boston
Scientific Corporation Pipeline Products 210
16.19 BIOTRONIK GmbH & Co. KG
216
16.19.1 Company Overview 216
16.19.2 BIOTRONIK GmbH & Co. KG
Pipeline Products 216
16.20 Biosense Webster, Inc. 218
16.20.1 Company
Overview 218
16.21 AtriCure, Inc. 219
16.21.1 Company Overview 219
16.21.2 AtriCure, Inc. Pipeline Products 219
16.22 Arrow International,
Inc. 221
16.22.1 Company Overview 221
16.22.2 Value Chain Analysis
222
16.22.3 Arrow International, Inc. Pipeline Products 224
16.23
ABIOMED, Inc. 225
16.23.1 Company Overview 225
16.23.2 Value Chain
Analysis 225
16.23.3 ABIOMED, Inc. Pipeline Products 227
16.24 Abbott
Laboratories 229
16.24.1 Company Overview 229
16.24.2 Value Chain
Analysis 230
16.25 ASAHI INTECC CO., LTD. 232
16.25.1 Company Overview
232
16.26 USCI Japan, Ltd. 232
16.26.1 Company Overview 232
16.27
Goodman Co., Ltd. 233
16.27.1 Company Overview 233
16.27.2 Goodman
Co., Ltd. Pipeline Products 233
16.28 Medikit Co., Ltd. 234
16.28.1
Company Overview 234
16.29 Sun Medical Technology Research Corp. 234
16.29.1 Company Overview 234
16.30 Japan Lifeline Co., Ltd. 235
16.30.1 Company Overview 235
16.31 DVx, Inc. 235
16.31.1 Company
Overview 235
17 Recent Developments 236
17.1 Product Approvals 236
17.1.1 Apr 16, 2009: ATS Medical Receives Japanese Approval For ATS Open Pivot
AP360 Mechanical Heart Valve 236
17.1.2 Apr 14, 2009: Medtronic Announces
Japanese Approval For Talent Thoracic Stent Graft 236
17.1.3 Mar 30, 2009:
Medtronic Receives Regulatory Approval For Endeavor Drug-Eluting Coronary
Stent In Japan 237
17.1.4 Jan 28, 2009: TAXUS Liberte Drug-Eluting Stent
System Of Boston Scientific Gains Japanese Approval 238
17.1.5 Jan 14,
2009: St. Jude Medical Receives Japanese Approval For Atlas II Implantable
Cardioverter Defibrillator 238
17.1.6 Jan 07, 2009: AGA Medical' s
AMPLATZER Duct Occluder Receives Japanese Approval 239
18 Appendix 240
18.1 Global Markets Direct Research Methodology 240
18.2 Coverage 241
18.3 Secondary Research 241
18.4 Primary Research 242
18.5 Models
242
18.6 Forecasts 243
18.7 Expert Panel Validation 243
18.8
Currency Conversion 244
18.9 Contact Us 245
18.10 Disclaimer 245
1.1 List of Tables
Table 1: Healthcare Expenditure in
Japan, 2000 - 2005 28
Table 2: Number of Healthcare Institutions in Japan,
1995 - 2004 30
Table 3: Number of Hospital Beds in Japan, 1995 - 2004
31
Table 4: Number of Medical Personnel in Japan, 1995 - 2004 31
Table
5: Number of Doctors by Specialty in Japan, 2003-2007 32
Table 6: Number
of Medical Care Institutions and Beds in Japan, 2000 - 2004 33
Table 7:
Registration Processing Time for Medical Devices in Japan, 2007 38
Table
8: Product Registration Fee for Medical Devices in Japan, 2007 38
Table 9:
Cardiovascular Devices Cross Country Comparison, Revenue ($ mn),
2000-2015 44
Table 10: Cardiovascular Devices, Japan, Overall Revenue
($ mn), 2000-2015 45
Table 11: Cardiovascular Devices, Japan,
Cross-Category Analysis, 2000-2015 46
Table 12: Cardiovascular
Devices, Japan, Overall Revenue ($ mn), Historic, 2000-2008 48
Table 13:
Cardiovascular Devices, Japan, Overall Revenue ($ mn), Forecast, 2008-2015
50
Table 14: Cardiovascular Devices, Japan, Category Volume (Units),
2000-2015 51
Table 15: Cardiovascular Devices, Japan, Category Volume
(Units), Historic, 2000-2008 53
Table 16: Cardiovascular Devices,
Japan, Category Volume (Units), Forecast, 2008-2015 55
Table 17:
Cardiovascular Devices, Japan, Company Share by Revenue ($ mn), 2007-2008
56
Table 18: Cardiac Rhythm Management, Japan, Revenue ($ mn) by
Segment, Historic, 2000-2008 57
Table 19: Cardiac Rhythm Management,
Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015 58
Table 20:
Cardiac Resynchronisation Therapy, Japan, Revenue ($ mn) by Sub-Segment,
Historic, 2000-2008 59
Table 21: Cardiac Resynchronisation Therapy,
Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 60
Table 22:
Implantable Cardioverter Defibrillator, Japan, Revenue ($ mn) by Sub-Segment,
Historic, 2000-2008 61
Table 23: Implantable Cardioverter
Defibrillator, Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
62
Table 24: Pacemaker, Japan, Revenue ($ mn) by Sub-Segment,
Historic, 2000-2008 63
Table 25: Pacemaker, Japan, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 64
Table 26: Cardiac Rhythm
Management, Japan, Volume (Units) by Segment, Historic, 2000-2008 65
Table
27: Cardiac Rhythm Management, Japan, Volume (Units) by Segment,
Forecast, 2008-2015 66
Table 28: Cardiac Resynchronisation Therapy,
Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 67
Table 29:
Cardiac Resynchronisation Therapy, Japan, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 68
Table 30: Implantable Cardioverter
Defibrillator, Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008
69
Table 31: Implantable Cardioverter Defibrillator, Japan, Volume
(Units) by Sub-Segment, Forecast, 2008-2015 70
Table 32: Pacemaker,
Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 71
Table 33:
Pacemaker, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 72
Table 34: Cardiac Rhythm Management, Japan, Average Price ($), Historic,
2000-2008 73
Table 35: Cardiac Rhythm Management, Japan, Average
Price ($), Forecast, 2008-2015 73
Table 36: Cardiac Rhythm
Management, Japan, Distribution Share by Revenue ($mn), 2007-2008 74
Table
37: Cardiac Rhythm Management, Japan, Company Share by Revenue ($ mn),
2007-2008 75
Table 38: Cardiovascular Monitoring and Diagnostic
Devices, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 77
Table
39: Cardiovascular Monitoring and Diagnostic Devices, Japan, Revenue ($
mn) by Segment, Forecast, 2008-2015 79
Table 40: Cardiovascular
Monitoring and Diagnostic Devices, Japan, Volume (Units) by Segment, Historic,
2000-2008 80
Table 41: Cardiovascular Monitoring and Diagnostic
Devices, Japan, Volume (Units) by Segment, Forecast, 2008-2015 81
Table
42: Cardiovascular Monitoring and Diagnostic Devices, Japan, Average
Price ($), Historic, 2000-2008 82
Table 43: Cardiovascular Monitoring
and Diagnostic Devices, Japan, Average Price ($), Forecast, 2008-2015 82
Table 44: Cardiovascular Monitoring and Diagnostic Devices, Japan,
Distribution Share by Revenue ($mn), 2007-2008 83
Table 45:
Cardiovascular Monitoring and Diagnostic Devices, Japan, Company Share by
Revenue ($ mn), 2007-2008 84
Table 46: Cardiovascular Prosthetic
Devices, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 85
Table
47: Cardiovascular Prosthetic Devices, Japan, Revenue ($ mn) by Segment,
Forecast, 2008-2015 86
Table 48: Prosthetic Heart Valve, Japan,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 87
Table 49:
Prosthetic Heart Valve, Japan, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 88
Table 50: Cardiovascular Prosthetic Devices, Japan,
Volume (Units) by Segment, Historic, 2000-2008 89
Table 51:
Cardiovascular Prosthetic Devices, Japan, Volume (Units) by Segment, Forecast,
2008-2015 90
Table 52: Prosthetic Heart Valve, Japan, Volume (Units)
by Sub-Segment, Historic, 2000-2008 91
Table 53: Prosthetic Heart
Valve, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 92
Table
54: Cardiovascular Prosthetic Devices, Japan, Average Price ($),
Historic, 2000-2008 93
Table 55: Cardiovascular Prosthetic Devices,
Japan, Average Price ($), Forecast, 2008-2015 93
Table 56:
Cardiovascular Prosthetic Devices, Japan, Distribution Share by Revenue ($mn),
2007-2008 94
Table 57: Cardiovascular Prosthetic Devices, Japan,
Company Share by Revenue ($ mn), 2007-2008 95
Table 58:
Cardiovascular Surgery, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008
97
Table 59: Cardiovascular Surgery, Japan, Revenue ($ mn) by
Segment, Forecast, 2008-2015 98
Table 60: Perfusion Disposables,
Japan, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 99
Table 61:
Perfusion Disposables, Japan, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 100
Table 62: Cardiovascular Surgery, Japan, Volume (Units)
by Segment, Historic, 2000-2008 101
Table 63: Cardiovascular Surgery,
Japan, Volume (Units) by Segment, Forecast, 2008-2015 101
Table 64:
Perfusion Disposables, Japan, Volume (Units) by Sub-Segment, Historic,
2000-2008 102
Table 65: Perfusion Disposables, Japan, Volume (Units)
by Sub-Segment, Forecast, 2008-2015 103
Table 66: Cardiovascular
Surgery, Japan, Average Price ($), Historic, 2000-2008 104
Table 67:
Cardiovascular Surgery, Japan, Average Price ($), Forecast, 2008-2015 104
Table 68: Cardiovascular Surgery, Japan, Distribution Share by Revenue
($mn), 2007-2008 105
Table 69: Cardiovascular Surgery, Japan, Company
Share by Revenue ($ mn), 2007-2008 106
Table 70: Electrophysiology,
Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 107
Table 71:
Electrophysiology, Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015
108
Table 72: Electrophysiology, Japan, Volume (Units) by Segment,
Historic, 2000-2008 109
Table 73: Electrophysiology, Japan, Volume
(Units) by Segment, Forecast, 2008-2015 109
Table 74:
Electrophysiology, Japan, Average Price ($), Historic, 2000-2008 110
Table
75: Electrophysiology, Japan, Average Price ($), Forecast, 2008-2015
110
Table 76: Electrophysiology, Japan, Company Share by Revenue ($
mn), 2007-2008 111
Table 77: Interventional Cardiology, Japan,
Revenue ($ mn) by Segment, Historic, 2000-2008 113
Table 78:
Interventional Cardiology, Japan, Revenue ($ mn) by Segment, Forecast,
2008-2015 115
Table 79: Cardiac Catheter, Japan, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 116
Table 80: Cardiac Catheter,
Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 117
Table 81:
Coronary Stent, Japan, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
118
Table 82: Coronary Stent, Japan, Revenue ($ mn) by Sub-Segment,
Forecast, 2008-2015 119
Table 83: PTCA Balloon, Japan, Revenue ($ mn)
by Sub-Segment, Historic, 2000-2008 120
Table 84: PTCA Balloon,
Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 121
Table 85:
Interventional Cardiology, Japan, Volume (Units) by Segment, Historic,
2000-2008 122
Table 86: Interventional Cardiology, Japan, Volume
(Units) by Segment, Forecast, 2008-2015 123
Table 87: Cardiac
Catheter, Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 124
Table 88: Cardiac Catheter, Japan, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 125
Table 89: Coronary Stent, Japan, Volume
(Units) by Sub-Segment, Historic, 2000-2008 126
Table 90: Coronary
Stent, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 127
Table
91: PTCA Balloon, Japan, Volume (Units) by Sub-Segment, Historic,
2000-2008 128
Table 92: PTCA Balloon, Japan, Volume (Units) by
Sub-Segment, Forecast, 2008-2015 129
Table 93: Interventional
Cardiology, Japan, Average Price ($), Historic, 2000-2008 130
Table 94:
Interventional Cardiology, Japan, Average Price ($), Forecast, 2008-2015
131
Table 95: Interventional Cardiology, Japan, Distribution Share by
Revenue ($mn), 2007-2008 131
Table 96: Interventional Cardiology,
Japan, Company Share by Revenue ($ mn), 2007-2008 132
Table 97:
Peripheral Vascular Devices, Japan, Revenue ($ mn) by Segment, Historic,
2000-2008 134
Table 98: Peripheral Vascular Devices, Japan, Revenue
($ mn) by Segment, Forecast, 2008-2015 136
Table 99: Peripheral
Vascular Devices, Japan, Volume (Units) by Segment, Historic, 2000-2008
138
Table 100: Peripheral Vascular Devices, Japan, Volume (Units) by
Segment, Forecast, 2008-2015 140
Table 101: Peripheral Vascular
Devices, Japan, Average Price ($), Historic, 2000-2008 141
Table 102:
Peripheral Vascular Devices, Japan, Average Price ($), Forecast, 2008-2015
141
Table 103: Peripheral Vascular Devices, Japan, Distribution Share
by Revenue ($mn), 2007-2008 142
Table 104: Peripheral Vascular
Devices, Japan, Company Share by Revenue ($ mn), 2007-2008 143
Table 105:
Terumo Corporation Pipeline Products by Equipment Type 146
Table 106:
Terumo Corporation Pipeline Products By Development Stage 146
Table
107: Terumo Corporation Pipeline Products By Therapy Area 147
Table
108: Terumo Corporation Pipeline Products By Clinical Trials 147
Table 109: Terumo Corporation Pipeline Products By News Summary 148
Table 110: St. Jude Medical Inc. Pipeline Products by Equipment Type
152
Table 111: St. Jude Medical Inc. Pipeline Products By Development
Stage 153
Table 112: St. Jude Medical Inc. Pipeline Products By
Therapy Area 154
Table 113: St. Jude Medical Inc. Pipeline Products
By Clinical Trials 155
Table 114: St. Jude Medical Inc. Pipeline
Products By News Summary 155
Table 115: Sorin Group Pipeline Products
by Equipment Type 160
Table 116: Sorin Group Pipeline Products By
Development Stage 160
Table 117: Sorin Group Pipeline Products By
Therapy Area 161
Table 118: Sorin Group Pipeline Products By Clinical
Trials 161
Table 119: Sorin Group Pipeline Products By News Summary
161
Table 120: Philips Medical Systems Pipeline Products by Equipment
Type 165
Table 121: Philips Medical Systems Pipeline Products By
Development Stage 165
Table 122: Philips Medical Systems Pipeline
Products By Therapy Area 165
Table 123: Philips Medical Systems
Pipeline Products By Clinical Trials 166
Table 124: Philips Medical
Systems Pipeline Products By News Summary 166
Table 125: Medtronic,
Inc. Pipeline Products by Equipment Type 174
Table 126: Medtronic,
Inc. Pipeline Products By Development Stage 176
Table 127: Medtronic,
Inc. Pipeline Products By Therapy Area 178
Table 128: Medtronic, Inc.
Pipeline Products By Clinical Trials 180
Table 129: Medtronic, Inc.
Pipeline Products By News Summary 181
Table 130: ev3 Inc. Pipeline
Products by Equipment Type 188
Table 131: ev3 Inc. Pipeline Products
By Development Stage 188
Table 132: ev3 Inc. Pipeline Products By
Therapy Area 189
Table 133: ev3 Inc. Pipeline Products By Clinical
Trials 189
Table 134: ev3 Inc. Pipeline Products By News Summary
189
Table 135: Edwards Lifesciences Corporation Pipeline Products by
Equipment Type 192
Table 136: Edwards Lifesciences Corporation
Pipeline Products By Development Stage 193
Table 137: Edwards
Lifesciences Corporation Pipeline Products By Therapy Area 193
Table 138:
Edwards Lifesciences Corporation Pipeline Products By Clinical Trials
194
Table 139: Edwards Lifesciences Corporation Pipeline Products By
News Summary 194
Table 140: Cordis Corporation Pipeline Products by
Equipment Type 198
Table 141: Cordis Corporation Pipeline Products By
Development Stage 198
Table 142: Cordis Corporation Pipeline Products
By Therapy Area 199
Table 143: Cordis Corporation Pipeline Products
By Clinical Trials 199
Table 144: Cordis Corporation Pipeline
Products By News Summary 199
Table 145: C.R. Bard, Inc. Pipeline
Products by Equipment Type 205
Table 146: C.R. Bard, Inc. Pipeline
Products By Development Stage 206
Table 147: C.R. Bard, Inc. Pipeline
Products By Therapy Area 206
Table 148: C.R. Bard, Inc. Pipeline
Products By Clinical Trials 206
Table 149: Boston Scientific
Corporation Pipeline Products by Equipment Type 210
Table 150: Boston
Scientific Corporation Pipeline Products By Development Stage 212
Table
151: Boston Scientific Corporation Pipeline Products By Therapy Area
213
Table 152: Boston Scientific Corporation Pipeline Products By
Clinical Trials 214
Table 153: Boston Scientific Corporation Pipeline
Products By News Summary 215
Table 154: BIOTRONIK GmbH & Co. KG
Pipeline Products by Equipment Type 216
Table 155: BIOTRONIK GmbH &
Co. KG Pipeline Products By Development Stage 216
Table 156:
BIOTRONIK GmbH & Co. KG Pipeline Products By Therapy Area 217
Table 157:
BIOTRONIK GmbH & Co. KG Pipeline Products By Clinical Trials 217
Table
158: BIOTRONIK GmbH & Co. KG Pipeline Products By News Summary 217
Table 159: AtriCure, Inc. Pipeline Products by Equipment Type 219
Table 160: AtriCure, Inc. Pipeline Products By Development Stage 219
Table 161: AtriCure, Inc. Pipeline Products By Therapy Area 219
Table
162: AtriCure, Inc. Pipeline Products By Clinical Trials 220
Table
163: AtriCure, Inc. Pipeline Products By News Summary 220
Table 164:
Arrow International, Inc. Pipeline Products by Equipment Type 224
Table 165: Arrow International, Inc. Pipeline Products By Development
Stage 224
Table 166: Arrow International, Inc. Pipeline Products By
Therapy Area 224
Table 167: Arrow International, Inc. Pipeline
Products By Clinical Trials 224
Table 168: ABIOMED, Inc. Pipeline
Products by Equipment Type 227
Table 169: ABIOMED, Inc. Pipeline
Products By Development Stage 227
Table 170: ABIOMED, Inc. Pipeline
Products By Therapy Area 227
Table 171: ABIOMED, Inc. Pipeline
Products By Clinical Trials 228
Table 172: ABIOMED, Inc. Pipeline
Products By News Summary 228
Table 173: Goodman Co., Ltd. Pipeline
Products by Equipment Type 233
Table 174: Goodman Co., Ltd. Pipeline
Products By Development Stage 233
Table 175: Goodman Co., Ltd.
Pipeline Products By Therapy Area 233
Table 176: Goodman Co., Ltd.
Pipeline Products By Clinical Trials 233
Table 177: USD to Local
Currency, Average Exchange Rate 2008 244
1.2 List of
Figures
Figure 1: Healthcare Expenditure in Japan, 2000 - 2005 28
Figure 2: Government and Private Healthcare Expenditure in Japan, 2005 29
Figure 3: Medical Device Classification in Japan, 2007 35
Figure 4:
Approval Process for Controlled Medical Devices in Japan, 2007 36
Figure
5: Approval Process for Highly Controlled Medical Devices in Japan, 2007
37
Figure 6: Health Insurance Reimbursement Process in Japan, 2007 41
Figure 7: Distribution Structure for Medical Equipment in Japan, 2007 43
Figure 8: Cardiovascular Devices Cross Country Comparison, Revenue ($
mn), 2000-2015 44
Figure 9: Cardiovascular Devices, Japan, Overall
Revenue ($ mn), 2000-2015 45
Figure 10: Cardiovascular Devices, Japan,
Cross-Category Analysis, 2000-2015 46
Figure 11: Cardiovascular
Devices, Japan, Overall Revenue ($ mn), Historic, 2000-2008 47
Figure 12:
Cardiovascular Devices, Japan, Overall Revenue ($ mn), Forecast, 2008-2015
49
Figure 13: Cardiovascular Devices, Japan, Category Volume (Units),
2000-2015 51
Figure 14: Cardiovascular Devices, Japan, Category
Volume (Units), Historic, 2000-2008 52
Figure 15: Cardiovascular
Devices, Japan, Category Volume (Units), Forecast, 2008-2015 54
Figure 16:
Cardiovascular Devices, Japan, Company Share (%), 2008 56
Figure 17:
Cardiac Rhythm Management, Japan, Revenue ($ mn) by Segment, Historic,
2000-2008 57
Figure 18: Cardiac Rhythm Management, Japan, Revenue ($
mn) by Segment, Forecast, 2008-2015 58
Figure 19: Cardiac
Resynchronisation Therapy, Japan, Revenue ($ mn) by Sub-Segment, Historic,
2000-2008 59
Figure 20: Cardiac Resynchronisation Therapy, Japan,
Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 60
Figure 21:
Implantable Cardioverter Defibrillator, Japan, Revenue ($ mn) by Sub-Segment,
Historic, 2000-2008 61
Figure 22: Implantable Cardioverter
Defibrillator, Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
62
Figure 23: Pacemaker, Japan, Revenue ($ mn) by Sub-Segment,
Historic, 2000-2008 63
Figure 24: Pacemaker, Japan, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 64
Figure 25: Cardiac Rhythm
Management, Japan, Volume (Units) by Segment, Historic, 2000-2008 65
Figure 26: Cardiac Rhythm Management, Japan, Volume (Units) by Segment,
Forecast, 2008-2015 66
Figure 27: Cardiac Resynchronisation Therapy,
Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 67
Figure 28:
Cardiac Resynchronisation Therapy, Japan, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 68
Figure 29: Implantable Cardioverter
Defibrillator, Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008
69
Figure 30: Implantable Cardioverter Defibrillator, Japan, Volume
(Units) by Sub-Segment, Forecast, 2008-2015 70
Figure 31: Pacemaker,
Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 71
Figure 32:
Pacemaker, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 72
Figure 33: Cardiac Rhythm Management, Japan, Company Share (%), 2008
75
Figure 34: Cardiovascular Monitoring and Diagnostic Devices,
Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 76
Figure 35:
Cardiovascular Monitoring and Diagnostic Devices, Japan, Revenue ($ mn) by
Segment, Forecast, 2008-2015 78
Figure 36: Cardiovascular Monitoring
and Diagnostic Devices, Japan, Volume (Units) by Segment, Historic, 2000-2008
80
Figure 37: Cardiovascular Monitoring and Diagnostic Devices,
Japan, Volume (Units) by Segment, Forecast, 2008-2015 81
Figure 38:
Cardiovascular Monitoring and Diagnostic Devices, Japan, Company Share (%),
2008 84
Figure 39: Cardiovascular Prosthetic Devices, Japan, Revenue
($ mn) by Segment, Historic, 2000-2008 85
Figure 40: Cardiovascular
Prosthetic Devices, Japan, Revenue ($ mn) by Segment, Forecast, 2008-2015
86
Figure 41: Prosthetic Heart Valve, Japan, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 87
Figure 42: Prosthetic Heart
Valve, Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 88
Figure
43: Cardiovascular Prosthetic Devices, Japan, Volume (Units) by Segment,
Historic, 2000-2008 89
Figure 44: Cardiovascular Prosthetic Devices,
Japan, Volume (Units) by Segment, Forecast, 2008-2015 90
Figure 45:
Prosthetic Heart Valve, Japan, Volume (Units) by Sub-Segment, Historic,
2000-2008 91
Figure 46: Prosthetic Heart Valve, Japan, Volume (Units)
by Sub-Segment, Forecast, 2008-2015 92
Figure 47: Cardiovascular
Prosthetic Devices, Japan, Company Share (%), 2008 95
Figure 48:
Cardiovascular Surgery, Japan, Revenue ($ mn) by Segment, Historic, 2000-2008
96
Figure 49: Cardiovascular Surgery, Japan, Revenue ($ mn) by
Segment, Forecast, 2008-2015 98
Figure 50: Perfusion Disposables,
Japan, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 99
Figure 51:
Perfusion Disposables, Japan, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 100
Figure 52: Perfusion Disposables, Japan, Volume (Units)
by Sub-Segment, Historic, 2000-2008 102
Figure 53: Perfusion
Disposables, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 103
Figure 54: Cardiovascular Surgery, Japan, Company Share (%), 2008 106
Figure 55: Electrophysiology, Japan, Revenue ($ mn) by Segment, Historic,
2000-2008 107
Figure 56: Electrophysiology, Japan, Revenue ($ mn) by
Segment, Forecast, 2008-2015 108
Figure 57: Electrophysiology, Japan,
Company Share (%), 2008 111
Figure 58: Interventional Cardiology,
Japan, Revenue ($ mn) by Segment, Historic, 2000-2008 112
Figure 59:
Interventional Cardiology, Japan, Revenue ($ mn) by Segment, Forecast,
2008-2015 114
Figure 60: Cardiac Catheter, Japan, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 116
Figure 61: Cardiac Catheter,
Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 117
Figure 62:
Coronary Stent, Japan, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
118
Figure 63: Coronary Stent, Japan, Revenue ($ mn) by Sub-Segment,
Forecast, 2008-2015 119
Figure 64: PTCA Balloon, Japan, Revenue ($
mn) by Sub-Segment, Historic, 2000-2008 120
Figure 65: PTCA Balloon,
Japan, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 121
Figure 66:
Interventional Cardiology, Japan, Volume (Units) by Segment, Historic,
2000-2008 122
Figure 67: Interventional Cardiology, Japan, Volume
(Units) by Segment, Forecast, 2008-2015 123
Figure 68: Cardiac
Catheter, Japan, Volume (Units) by Sub-Segment, Historic, 2000-2008 124
Figure 69: Cardiac Catheter, Japan, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 125
Figure 70: Coronary Stent, Japan, Volume
(Units) by Sub-Segment, Historic, 2000-2008 126
Figure 71: Coronary
Stent, Japan, Volume (Units) by Sub-Segment, Forecast, 2008-2015 127
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