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 14
3.5.1
Fibroroscopes 14
3.5.2 Videoscopes 14
3.6 Endoscopy Fluid Management
System 15
3.7 Rigid Endoscope 15
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 19
4.3 Healthcare Policy 23
5 Regulation System 24
5.1 Medical Equipment Approval Process 24
5.1.1 Classification 24
5.1.2 Registration and Conformity Assessment 31
5.2 Advertising 34
5.3
Labeling and Packaging 34
5.4 Post-market Surveillance 35
5.5
Registration Fee 35
6 Pricing and Reimbursement 42
7 Distribution
Structure 43
8 Endoscopy Devices In Australia 44
8.1 Endoscopy Devices
Cross Country Comparison, Revenue ($ mn), 2000-2015 44
8.2 Endoscopy
Devices, Australia, Overall Revenue ($ mn), 2000-2015 45
8.3 Endoscopy
Devices, Australia, Category Volume (Units), 2000-2015 51
8.4 Endoscopy
Devices, Australia, Company Share (2006-2007) 54
9 Capsule Endoscope
System In Australia 55
9.1 Capsule Endoscope System Overall Revenue
(2000-2015) 55
9.2 Capsule Endoscope System Overall Volume (2000-2015)
57
9.3 Capsule Endoscope System Average Price (2000-2015) 58
9.4
Capsule Endoscope System Distribution Share (2007-2008) 59
9.5 Capsule
Endoscope System, Australia, Company Share (2006-2007) 60
10 Endoscopic
Instruments In Australia 61
10.1 Endoscopic Instruments Overall Revenue
(2000-2015) 61
10.2 Endoscopic Instruments Distribution Share (2007-2008)
63
11 Endoscopic Reprocessors In Australia 64
11.1 Endoscopic
Reprocessors Overall Revenue (2000-2015) 64
11.2 Endoscopic Reprocessors
Overall Volume (2000-2015) 66
11.3 Endoscopic Reprocessors Average Price
(2000-2015) 68
11.4 Endoscopic Reprocessors Distribution Share (2007-2008)
68
11.5 Endoscopic Reprocessors, Australia, Company Share (2006-2007)
69
12 Flexible Endoscope In Australia 70
12.1 Flexible Endoscope
Overall Revenue (2000-2015) 70
12.1.1 Fibroscope Revenue (2000-2015)
72
12.2 Flexible Endoscope Overall Volume (2000-2015) 74
12.2.1
Fibroscope Volume (2000-2015) 76
12.3 Flexible Endoscope Average Price
(2000-2015) 78
12.4 Flexible Endoscope Distribution Share (2007-2008)
79
12.5 Flexible Endoscope, Australia, Company Share (2006-2007) 80
13
Endoscopy Fluid Management Systems In Australia 81
13.1 Endoscopy Fluid
Management Systems Overall Revenue (2000-2015) 81
13.2 Endoscopy Fluid
Management Systems Overall Volume (2000-2015) 83
13.3 Endoscopy Fluid
Management Systems Average Price (2000-2015) 85
13.4 Endoscopy Fluid
Management Systems Distribution Share (2007-2008) 85
14 Rigid Endoscope In
Australia 86
14.1 Rigid Endoscope Overall Revenue (2000-2015) 86
14.2
Rigid Endoscope Overall Volume (2000-2015) 88
14.3 Rigid Endoscope Average
Price (2000-2015) 90
14.4 Rigid Endoscope Distribution Share (2007-2008)
90
14.5 Rigid Endoscope, Australia, Company Share (2006-2007) 91
15
Endoscopy Visualization Systems In Australia 92
15.1 Endoscopy
Visualization Systems Overall Revenue (2000-2015) 92
15.2 Endoscopy
Visualization Systems Overall Volume (2000-2015) 94
15.3 Endoscopy
Visualization Systems Average Price (2000-2015) 96
15.4 Endoscopy
Visualization Systems Distribution Share (2007-2008) 96
16 Overview of Key
Companies in Australia Endoscopy Devices Market 97
16.1 OLYMPUS
CORPORATION 97
16.1.1 Company Overview 97
16.1.2 Value Chain Analysis
98
16.1.3 Olympus Medical Systems Corp. Pipeline Products 99
16.2
PENTAX of America, Inc. 101
16.2.1 Company Overview 101
16.3 Fujinon
Corporation 102
16.3.1 Company Overview 102
16.4 Given Imaging Ltd.
103
16.4.1 Company Overview 103
16.4.2 Given Imaging Ltd. Pipeline
Products 103
16.5 KARL STORZ GmbH & Co. KG 105
16.5.1 Company Overview
105
16.6 Stryker Corporation 106
16.6.1 Company Overview 106
16.6.2 Value Chain Analysis 107
16.7 Optiscan Imaging Limited 109
16.7.1 Company Overview 109
16.7.2 Optiscan Imaging Limited Pipeline
Products 109
16.8 Minntech Corporation 111
16.8.1 Company Overview
111
16.9 Advanced Sterilization Products 111
16.9.1 Company Overview
111
16.10 Richard Wolf Medical Instruments Corporation 111
16.10.1
Company Overview 111
17 Appendix 112
17.1 Global Markets Direct
Research Methodology 112
17.2 Coverage 113
17.3 Secondary Research
113
17.4 Primary Research 114
17.5 Models 114
17.6 Forecasts
115
17.7 Expert Panel Validation 115
17.8 Currency Conversion 116
17.9 Contact Us 117
17.10 Disclaimer 117
1.1 List of Tables
Table 1: Healthcare Infrastructure in Australia, 2005 19
Table 2:
Healthcare Personnel in Australia, 2005 20
Table 3: Hospital Wards by
Specialty in Australia, 2003-2007 21
Table 4: Doctors by Specialty in
Australia, 2003-2007 22
Table 5: Conformity Assessment of Medical Devices
based Device Class, in Australia, 2007 33
Table 6: Fee for Registered
Device in Australia, 2007 35
Table 7: Fee for Device Clinical Trial in
Australia, 2007 36
Table 8: Evaluation Fee for High and Low Level
Registration of Medical Device in Australia, 2007 36
Table 9: Evaluation
Fee for Variation Registration of Medical Device in Australia, 2007 37
Table 10: Fee for Registration of Listed Devices in Australia, 2007 37
Table 11: Fee for Registration of Listed Devices for Export Only in Australia,
2007 38
Table 12: Fee for Registration of Included Devices in Australia,
2007 38
Table 13: Fee for Initial Conformity Assessment of Medical Device
in Australia, 2007 38
Table 14: Fee for Medical Device Changes Conformity
Assessment in Australia, 2007 39
Table 15: Fee for Medical Device
Conformity Assessment Surveillance Audit in Australia, 2007 39
Table 16:
Fee for Medical Device Conformity Assessment Review Certificate in Australia,
2007 39
Table 17: Fee for Initial Conformity Assessment of Medical Device
Components in Australia, 2007 40
Table 18: Fee for Conformity Assessment
of Changes in Medical Device Components in Australia, 2007 40
Table 19:
Fee for Abridged Conformity Assessment of Medical Device Components in
Australia, 2007 40
Table 20: Fee for Inclusion of Medical Device in the
Register in Australia, 2007 41
Table 21: Fee for ARTG Inclusion for
Medical Device in Australia, 2007 41
Table 22: Endoscopy Devices
Cross Country Comparison, Revenue ($ mn), 2000-2015 44
Table 23:
Endoscopy Devices, Australia, Overall Revenue ($ mn), 2000-2015 45
Table
24: Endoscopy Devices, Australia, Cross-Category Analysis, 2000-2015
46
Table 25: Endoscopy Devices, Australia, Overall Revenue ($ mn),
Historic, 2000-2008 48
Table 26: Endoscopy Devices, Australia,
Overall Revenue ($ mn), Forecast, 2008-2015 50
Table 27: Endoscopy
Devices, Australia, Category Volume (Units), 2000-2015 51
Table 28:
Endoscopy Devices, Australia, Category Volume (Units), Historic, 2000-2008
52
Table 29: Endoscopy Devices, Australia, Category Volume (Units),
Forecast, 2008-2015 53
Table 30: Endoscopy Devices, Australia,
Company Share by Revenue ($ mn), 2006-2007 54
Table 31: Capsule
Endoscope System, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008
55
Table 32: Capsule Endoscope System, Australia, Revenue ($ mn) by
Segment, Forecast, 2008-2015 56
Table 33: Capsule Endoscope System,
Australia, Volume (Units) by Segment, Historic, 2000-2008 57
Table 34:
Capsule Endoscope System, Australia, Volume (Units) by Segment, Forecast,
2008-2015 57
Table 35: Capsule Endoscope System, Australia, Average
Price ($), Historic, 2000-2008 58
Table 36: Capsule Endoscope System,
Australia, Average Price ($), Forecast, 2008-2015 58
Table 37:
Capsule Endoscope System, Australia, Distribution Share by Revenue ($mn),
2007-2008 59
Table 38: Capsule Endoscope System, Australia, Company
Share by Revenue ($ mn), 2006-2007 60
Table 39: Endoscopic
Instruments, Australia, Revenue ($ mn), Historic, 2000-2008 61
Table 40:
Endoscopic Instruments, Australia, Revenue ($ mn), Forecast, 2008-2015
62
Table 41: Endoscopic Instruments, Australia, Distribution Share by
Revenue ($mn), 2007-2008 63
Table 42: Endoscopic Reprocessors,
Australia, Revenue ($ mn), Historic, 2000-2008 64
Table 43:
Endoscopic Reprocessors, Australia, Revenue ($ mn), Forecast, 2008-2015 65
Table 44: Endoscopic Reprocessors, Australia, Volume (Units), Historic,
2000-2008 66
Table 45: Endoscopic Reprocessors, Australia, Volume
(Units), Forecast, 2008-2015 67
Table 46: Endoscopic Reprocessors,
Australia, Average Price ($), Historic, 2000-2008 68
Table 47:
Endoscopic Reprocessors, Australia, Average Price ($), Forecast, 2008-2015
68
Table 48: Endoscopic Reprocessors, Australia, Distribution Share
by Revenue ($mn), 2007-2008 68
Table 49: Endoscopic Reprocessors,
Australia, Company Share by Revenue ($ mn), 2006-2007 69
Table 50:
Flexible Endoscope, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008
70
Table 51: Flexible Endoscope, Australia, Revenue ($ mn) by
Segment, Forecast, 2008-2015 71
Table 52: Fibroscope, Australia,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 72
Table 53:
Fibroscope, Australia, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
73
Table 54: Flexible Endoscope, Australia, Volume (Units) by
Segment, Historic, 2000-2008 74
Table 55: Flexible Endoscope,
Australia, Volume (Units) by Segment, Forecast, 2008-2015 75
Table 56:
Fibroscope, Australia, Volume (Units) by Sub-Segment, Historic, 2000-2008
76
Table 57: Fibroscope, Australia, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 77
Table 58: Flexible Endoscope, Australia,
Average Price ($), Historic, 2000-2008 78
Table 59: Flexible
Endoscope, Australia, Average Price ($), Forecast, 2008-2015 78
Table 60:
Flexible Endoscope, Australia, Distribution Share by Revenue ($mn),
2007-2008 79
Table 61: Flexible Endoscope, Australia, Company Share
by Revenue ($ mn), 2006-2007 80
Table 62: Endoscopy Fluid Management
Systems, Australia, Revenue ($ mn), Historic, 2000-2008 81
Table 63:
Endoscopy Fluid Management Systems, Australia, Revenue ($ mn), Forecast,
2008-2015 82
Table 64: Endoscopy Fluid Management Systems, Australia,
Volume (Units), Historic, 2000-2008 83
Table 65: Endoscopy Fluid
Management Systems, Australia, Volume (Units), Forecast, 2008-2015 84
Table 66: Endoscopy Fluid Management Systems, Australia, Average Price
($), Historic, 2000-2008 85
Table 67: Fluid Management Systems,
Australia, Average Price ($), Forecast, 2008-2015 85
Table 68:
Endoscopy Fluid Management Systems, Australia, Distribution Share by Revenue
($mn), 2007-2008 85
Table 69: Rigid Endoscope, Australia, Revenue ($
mn) by Segment, Historic, 2000-2008 86
Table 70: Rigid Endoscope,
Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 87
Table 71:
Rigid Endoscope, Australia, Volume (Units) by Segment, Historic, 2000-2008
88
Table 72: Rigid Endoscope, Australia, Volume (Units) by Segment,
Forecast, 2008-2015 89
Table 73: Rigid Endoscope, Australia, Average
Price ($), Historic, 2000-2008 90
Table 74: Rigid Endoscope,
Australia, Average Price ($), Forecast, 2008-2015 90
Table 75: Rigid
Endoscope, Australia, Distribution Share by Revenue ($mn), 2007-2008 90
Table 76: Rigid Endoscope, Australia, Company Share by Revenue ($ mn),
2006-2007 91
Table 77: Endoscopy Visualization Systems, Australia,
Revenue ($ mn), Historic, 2000-2008 92
Table 78: Endoscopy
Visualization Systems, Australia, Revenue ($ mn), Forecast, 2008-2015 93
Table 79: Endoscopy Visualization Systems, Australia, Volume (Units),
Historic, 2000-2008 94
Table 80: Endoscopy Visualization Systems,
Australia, Volume (Units), Forecast, 2008-2015 95
Table 81: Endoscopy
Visualization Systems, Australia, Average Price ($), Historic, 2000-2008
96
Table 82: Endoscopy Visualization Systems, Australia, Average
Price ($), Forecast, 2008-2015 96
Table 83: Endoscopy Visualization
Systems, Australia, Distribution Share by Revenue ($mn), 2007-2008 96
Table 84: Olympus Medical Systems Corp. Pipeline Products by Equipment
Type 99
Table 85: Olympus Medical Systems Corp. Pipeline Products by
Development Stage 100
Table 86: Olympus Medical Systems Corp.
Pipeline Products by Therapy Area 100
Table 87: Olympus Medical
Systems Corp. Pipeline Products by Clinical Trials 100
Table 88:
Olympus Medical Systems Corp. Pipeline Products by News Summary 100
Table
89: Given Imaging Ltd. Pipeline Products by Equipment Type 103
Table
90: Given Imaging Ltd. Pipeline Products by Development Stage 103
Table 91: Given Imaging Ltd. Pipeline Products by Therapy Area 103
Table 92: Given Imaging Ltd. Pipeline Products by Clinical Trials 104
Table 93: Given Imaging Ltd. Pipeline Products by News Summary 104
Table 94: Optiscan Imaging Limited Pipeline Products by Equipment Type
109
Table 95: Optiscan Imaging Limited Pipeline Products by
Development Stage 110
Table 96: Optiscan Imaging Limited Pipeline
Products by Therapy Area 110
Table 97: Optiscan Imaging Limited
Pipeline Products by Clinical Trials 110
Table 98: USD to Local
Currency, Average Exchange Rate 2008 116
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Australia, 2000 - 2005 17
Figure
2: Healthcare Financing Framework in Australia, 2007 18
Figure 3:
Healthcare System in Australia, 2007 23
Figure 4: Classification of
Medical Devices in Australia, 2007 26
Figure 5: Classification of
Noninvasive Devices in Australia, 2007 27
Figure 6: Classification of
Invasive Devices in Australia, 2007 28
Figure 7: Classification of
Invasive Devices in Australia, 2007 29
Figure 8: Classification of Active
Devices in Australia, 2007 30
Figure 9: Classification of Special Medical
Devices in Australia, 2007 31
Figure 10: Conformity Assessment Procedure
for Medical Devices in Australia, 2007 32
Figure 11: Endoscopy
Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 44
Figure 12:
Endoscopy Devices, Australia, Overall Revenue ($ mn), 2000-2015 45
Figure 13: Endoscopy Devices, Australia, Cross-Category Analysis, 2000-2015
46
Figure 14: Endoscopy Devices, Australia, Overall Revenue ($ mn),
Historic, 2000-2008 47
Figure 15: Endoscopy Devices, Australia,
Overall Revenue ($ mn), Forecast, 2008-2015 49
Figure 16: Endoscopy
Devices, Australia, Category Volume (Units), 2000-2015 51
Figure 17:
Endoscopy Devices, Australia, Category Volume (Units), Historic, 2000-2008
52
Figure 18: Endoscopy Devices, Australia, Category Volume (Units),
Forecast, 2008-2015 53
Figure 19: Endoscopy Devices, Australia,
Company Share (%), 2007 54
Figure 20: Capsule Endoscope System,
Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 55
Figure 21:
Capsule Endoscope System, Australia, Revenue ($ mn) by Segment, Forecast,
2008-2015 56
Figure 22: Capsule Endoscope System, Australia, Company
Share (%), 2007 60
Figure 23: Endoscopic Instruments, Australia,
Revenue ($ mn), Historic, 2000-2008 61
Figure 24: Endoscopic
Instruments, Australia, Revenue ($ mn), Forecast, 2008-2015 62
Figure 25:
Endoscopic Reprocessors, Australia, Revenue ($ mn), Historic, 2000-2008
64
Figure 26: Endoscopic Reprocessors, Australia, Revenue ($ mn),
Forecast, 2008-2015 65
Figure 27: Endoscopic Reprocessors, Australia,
Volume (Units), Historic, 2000-2008 66
Figure 28: Endoscopic
Reprocessors, Australia, Volume (Units), Forecast, 2008-2015 67
Figure 29:
Endoscopic Reprocessors, Australia, Company Share (%), 2007 69
Figure
30: Flexible Endoscope, Australia, Revenue ($ mn) by Segment, Historic,
2000-2008 70
Figure 31: Flexible Endoscope, Australia, Revenue ($ mn)
by Segment, Forecast, 2008-2015 71
Figure 32: Fibroscope, Australia,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 72
Figure 33:
Fibroscope, Australia, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
73
Figure 34: Flexible Endoscope, Australia, Volume (Units) by
Segment, Historic, 2000-2008 74
Figure 35: Flexible Endoscope,
Australia, Volume (Units) by Segment, Forecast, 2008-2015 75
Figure 36:
Fibroscope, Australia, Volume (Units) by Sub-Segment, Historic, 2000-2008
76
Figure 37: Fibroscope, Australia, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 77
Figure 38: Flexible Endoscope, Australia,
Company Share (%), 2007 80
Figure 39: Endoscopy Fluid Management
Systems, Australia, Revenue ($ mn), Historic, 2000-2008 81
Figure 40:
Endoscopy Fluid Management Systems, Australia, Revenue ($ mn), Forecast,
2008-2015 82
Figure 41: Endoscopy Fluid Management Systems,
Australia, Volume (Units), Historic, 2000-2008 83
Figure 42:
Endoscopy Fluid Management Systems, Australia, Volume (Units), Forecast,
2008-2015 84
Figure 43: Rigid Endoscope, Australia, Revenue ($ mn) by
Segment, Historic, 2000-2008 86
Figure 44: Rigid Endoscope,
Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 87
Figure 45:
Rigid Endoscope, Australia, Volume (Units) by Segment, Historic, 2000-2008
88
Figure 46: Rigid Endoscope, Australia, Volume (Units) by Segment,
Forecast, 2008-2015 89
Figure 47: Rigid Endoscope, Australia, Company
Share (%), 2007 91
Figure 48: Endoscopy Visualization Systems,
Australia, Revenue ($ mn), Historic, 2000-2008 92
Figure 49:
Endoscopy Visualization Systems, Australia, Revenue ($ mn), Forecast,
2008-2015 93
Figure 50: Endoscopy Visualization Systems, Australia,
Volume (Units), Historic, 2000-2008 94
Figure 51: Endoscopy
Visualization Systems, Australia, Volume (Units), Forecast, 2008-2015 95
Figure 52: Olympus Medical Systems Corp. Value Chain Analysis 98
Figure 53: Stryker Corporation Value Chain Analysis 107
Figure 54:
Global Markets Direct Methodology 112
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