1 Table of Contents 2
1.1 List of Tables 9
1.2 List of Figures 12
2 Introduction 14
2.1 What Is This Report About? 14
3 Executive Summary 15
4 Definitions of Markets Covered in This Report 16
4.1 Anesthesia and Respiratory Devices 16
4.2 Anesthesia Machines 16
4.2.1 Anesthesia Work Station 16
4.2.2 Portable Anesthesia Delivery Machine 16
4.2.3 Stand Alone Anesthesia Delivery Machine 16
4.3 Anesthesia Disposables 16
4.3.1 Anesthesia Circuits 16
4.3.1.1 Closed Anesthesia Circuits 16
4.3.1.2 Open Anesthesia Circuits 17
4.3.2 Anesthesia Masks 17
4.3.3 Anesthesia Airway Management 17
4.3.3.1 Endotracheal Tubes 17
4.3.3.2 Laryngeal Mask Airways 17
4.3.3.3 Tracheostomy Tubes 17
4.4 Respiratory Disposables 17
4.4.1 Disposable Oxygen Masks 17
4.4.2 Oxygen Cannulae 17
4.5 Respiratory Devices 18
4.5.1 Humidifiers 18
4.5.2 Nebulizers 18
4.5.2.1 Portable Compressor Nebulizers 18
4.5.2.2 Portable Ultrasonic Nebulizers 18
4.5.3 Oxygen Concentrator 18
4.5.3.1 Fixed Oxygen Concentrators 18
4.5.3.2 Portable Oxygen Concentrators 19
4.5.4 Positive Airway Pressure Devices 19
4.5.4.1 Automatic Self-Adjusting Positive Airway Pressure (APAP) 19
4.5.4.2 Bilevel Positive Airway Pressure (BPAP) 19
4.5.4.3 Continuous Positive Airway Pressure (CPAP) 19
4.5.5 Reusable Resuscitators 19
4.5.6 Ventilators 19
4.5.6.1 Adult/Paediatric Ventilators 19
4.5.6.2 Neonatal Ventilators 20
4.6 Respiratory Measurement Devices 20
4.6.1 Pulse Oximetry Sensors 20
4.6.2 Capnographs 20
4.6.3 Spirometers 20
5 Healthcare Sector Review 21
5.1 Healthcare Expenditure 21
5.2 Healthcare Infrastructure 24
5.3 Healthcare Policy 28
6 Regulation System 29
6.1 Medical Equipment Approval Process 29
6.1.1 Classification 29
6.1.2 Registration and Conformity Assessment 36
6.2 Advertising 38
6.3 Labeling and Packaging 39
6.4 Post-market Surveillance 40
6.5 Registration Fee 40
7 Pricing and Reimbursement 47
8 Distribution Structure 48
9 Anesthesia and Respiratory Devices In Australia 49
9.1 Anesthesia and Respiratory Devices, Australia, Overall Revenue 49
9.2 Anesthesia and Respiratory Devices, Australia, Category Volume 53
9.3 Anesthesia and Respiratory Devices, Australia, Cross Category Analysis 55
9.4 Anesthesia and Respiratory Devices Market Dynamics 57
9.4.1 Market Drivers 57
9.4.2 Market Restraints 57
9.5 Anesthesia and Respiratory Devices, Australia, Competitive Landscape 58
10 Anesthesia Disposables In Australia 60
10.1 Anesthesia Disposables Overall Revenue 60
10.2 Anesthesia Disposables Overall Volume 63
10.3 Anesthesia Disposables Average Price 65
10.4 Anesthesia Disposables Distribution Share 66
10.5 Anesthesia Disposables, Australia, Competitive Landscape 67
11 Anesthesia Machines In Australia 68
11.1 Anesthesia Machines Overall Revenue 68
11.2 Anesthesia Machines Overall Volume 70
11.3 Anesthesia Machines Average Price 72
11.4 Anesthesia Machines Distribution Share 73
11.5 Anesthesia Machines, Australia, Competitive Landscape 74
12 Respiratory Devices In Australia 75
12.1 Respiratory Devices Overall Revenue 75
12.2 Respiratory Devices Overall Volume 79
12.3 Respiratory Devices Average Price 82
12.4 Respiratory Devices Distribution Share 84
12.5 Respiratory Devices, Australia, Competitive Landscape 84
13 Respiratory Disposables In Australia 86
13.1 Respiratory Disposables Overall Revenue 86
13.2 Respiratory Disposables Overall Volume 88
13.3 Respiratory Disposables Average Price 90
13.4 Respiratory Disposables Distribution Share 91
13.5 Respiratory Disposables, Australia, Competitive Landscape 92
14 Respiratory Measurement Devices In Australia 93
14.1 Respiratory Measurement Devices Overall Revenue 93
14.2 Respiratory Measurement Devices Overall Volume 96
14.3 Respiratory Measurement Devices Average Price 98
14.4 Respiratory Measurement Devices Distribution Share 99
14.5 Respiratory Measurement Devices, Australia, Competitive Landscape 100
15 Sleep Apnea Diagnostic Systems In Australia 101
15.1 Sleep Apnea Diagnostic Systems Overall Revenue 101
15.2 Sleep Apnea Diagnostic Systems Overall Volume 103
15.3 Sleep Apnea Diagnostic Systems Average Price 105
15.4 Sleep Apnea Diagnostic Systems Distribution Share 106
15.5 Sleep Apnea Diagnostic Systems, Australia, Competitive Landscape 107
16 Overview of Key Companies in The Australia Anesthesia and Respiratory Devices Market 108
16.1 GE Healthcare 108
16.1.1 Company Overview 108
16.2 Draegerwerk Aktiengesellschaft 108
16.2.1 Company Overview 108
16.2.2 Value Chain Analysis 109
16.2.2.1 Manufacturing 109
16.2.2.2 Product Development 110
16.2.2.3 Sales and Marketing 110
16.3 Cardinal Health, Inc. 111
16.3.1 Company Overview 111
16.3.2 Value Chain Analysis 111
16.3.2.1 Manufacturing 112
16.3.2.2 Product Development 112
16.3.2.3 Sales and Marketing 113
16.4 Philips Healthcare 114
16.4.1 Company Overview 114
16.4.2 Value Chain Analysis 115
16.4.2.1 Manufacturing 115
16.4.2.2 Product Development 116
16.4.2.3 Sales and Marketing 117
16.5 Smiths Medical 118
16.5.1 Company Overview 118
16.5.2 Value Chain Analysis 119
16.5.2.1 Manufacturing 119
16.5.2.2 Product Development 120
16.5.2.3 Sales and Marketing 120
16.5.2.4 Licensing Agreements 120
16.6 Covidien Ltd. 121
16.6.1 Company Overview 121
16.6.2 Value Chain Analysis 122
16.6.2.1 Manufacturing 122
16.6.2.2 Product Development 123
16.6.2.3 Sales and Marketing 124
16.6.3 Covidien Ltd./Tyco Healthcare Pipeline Products 124
16.6.3.1 Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 124
16.6.3.2 Covidien Ltd./Tyco Healthcare Pipeline Products by Development Stage 124
16.6.3.3 Covidien Ltd./Tyco Healthcare Pipeline Products by Therapy Area 125
16.6.3.4 Covidien Ltd./Tyco Healthcare Pipeline Products by Clinical Trials 125
16.6.3.5 Covidien Ltd./Tyco Healthcare Pipeline Products by News Summary 125
16.7 Intersurgical Ltd. 126
16.7.1 Company Overview 126
16.8 Spacelabs Healthcare, Inc. 126
16.8.1 Company Overview 126
16.9 ResMed Inc. 126
16.9.1 Company Overview 126
16.9.2 Value Chain Analysis 127
16.9.2.1 Manufacturing 127
16.9.2.2 Product Development 128
16.9.2.3 Sales and Marketing 129
16.9.3 ResMed Inc. Pipeline Products 130
16.9.3.1 ResMed Inc. Pipeline Products by Equipment Type 130
16.9.3.2 ResMed Inc. Pipeline Products by Development Stage 130
16.9.3.3 ResMed Inc. Pipeline Products by Therapy Area 131
16.9.3.4 ResMed Inc. Pipeline Products by Clinical Trials 131
16.10 MAQUET GmbH & Co. KG 132
16.10.1 Company Overview 132
16.11 Teleflex Incorporated 132
16.11.1 Company Overview 132
16.11.2 Value Chain Analysis 133
16.11.2.1 Manufacturing 133
16.11.2.2 Product Development 134
16.11.2.3 Sales and Marketing 134
16.12 Fisher & Paykel Healthcare Corporation Limited 135
16.12.1 Company Overview 135
16.12.2 Value Chain Analysis 135
16.12.2.1 Manufacturing 135
16.12.2.2 Product Development 136
16.12.2.3 Sales and Marketing 137
16.13 Laerdal Medical As 137
16.13.1 Company Overview 137
16.14 Masimo Corporation 137
16.14.1 Company Overview 137
16.15 Austvet Pty. Ltd. 138
16.15.1 Company Overview 138
16.16 Compumedics Limited 138
16.16.1 Company Overview 138
16.17 Parker Healthcare Pty Ltd 139
16.17.1 Company Overview 139
16.18 Unomedical Pty Ltd 139
16.18.1 Company Overview 139
17 Appendix 140
17.1 GlobalData Research Methodology 140
17.2 Coverage 141
17.3 Secondary Research 142
17.4 Primary Research 142
17.5 Models 143
17.6 Forecasts 143
17.7 Expert Panel Validation 144
17.8 Currency Conversion 145
17.9 Contact Us 146
17.10 Disclaimer 146
1.1 List of Tables
Table 1: Healthcare Infrastructure in Australia, 2005 24
Table 2: Healthcare Personnel in Australia, 2005 25
Table 3: Hospital Wards by Specialty in Australia, 2003-2007 26
Table 4: Doctors by Specialty in Australia, 2003-2007 27
Table 5: Conformity Assessment of Medical Devices based Device Class, in Australia, 2007 38
Table 6: Fee for Registered Device in Australia, 2007 40
Table 7: Fee for Device Clinical Trial in Australia, 2007 41
Table 8: Evaluation Fee for High and Low Level Registration of Medical Device in Australia, 2007 41
Table 9: Evaluation Fee for Variation Registration of Medical Device in Australia, 2007 42
Table 10: Fee for Registration of Listed Devices in Australia, 2007 42
Table 11: Fee for Registration of Listed Devices for Export Only in Australia, 2007 43
Table 12: Fee for Registration of Included Devices in Australia, 2007 43
Table 13: Fee for Initial Conformity Assessment of Medical Device in Australia, 2007 43
Table 14: Fee for Medical Device Changes Conformity Assessment in Australia, 2007 44
Table 15: Fee for Medical Device Conformity Assessment Surveillance Audit in Australia, 2007 44
Table 16: Fee for Medical Device Conformity Assessment Review Certificate in Australia, 2007 44
Table 17: Fee for Initial Conformity Assessment of Medical Device Components in Australia, 2007 45
Table 18: Fee for Conformity Assessment of Changes in Medical Device Components in Australia, 2007 45
Table 19: Fee for Abridged Conformity Assessment of Medical Device Components in Australia, 2007 45
Table 20: Fee for Inclusion of Medical Device in the Register in Australia, 2007 46
Table 21: Fee for ARTG Inclusion for Medical Device in Australia, 2007 46
Table 22: Anesthesia and Respiratory Devices, Australia, Overall Revenue ($ mn), Historic, 2000-2008 50
Table 23: Anesthesia and Respiratory Devices, Australia, Overall Revenue ($ mn), Forecast, 2008-2015 52
Table 24: Anesthesia and Respiratory Devices, Australia, Category Volume (Units) by Segment, Historic, 2000-2008 53
Table 25: Anesthesia and Respiratory Devices, Australia, Category Volume (Units) by Segment, Forecast, 2008-2015 54
Table 26: Anesthesia and Respiratory Devices, Australia, Cross -Category Analysis, 2000-2015 55
Table 27: Anesthesia and Respiratory Devices, Australia, Company Share by Revenue ($ mn), 2007-2008 59
Table 28: Anesthesia Disposables, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 60
Table 29: Anesthesia Disposables, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 62
Table 30: Anesthesia Disposables, Australia, Volume (Units) by Segment, Historic, 2000-2008 63
Table 31: Anesthesia Disposables, Australia, Volume (Units) by Segment, Forecast, 2008-2015 64
Table 32: Anesthesia Disposables, Australia, Average Price ($), Historic, 2000-2008 65
Table 33: Anesthesia Disposables, Australia, Average Price ($), Forecast, 2008-2015 65
Table 34: Anesthesia Disposables, Australia, Distribution Share by Revenue ($mn), 2007-2008 66
Table 35: Anesthesia Disposables, Australia, Company Share by Revenue ($ mn), 2007-2008 67
Table 36: Anesthesia Machines, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 68
Table 37: Anesthesia Machines, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 69
Table 38: Anesthesia Machines, Australia, Volume (Units) by Segment, Historic, 2000-2008 70
Table 39: Anesthesia Machines, Australia, Volume (Units) by Segment, Forecast, 2008-2015 71
Table 40: Anesthesia Machines, Australia, Average Price ($), Historic, 2000-2008 72
Table 41: Anesthesia Machines, Australia, Average Price ($), Forecast, 2008-2015 72
Table 42: Anesthesia Machines, Australia, Distribution Share by Revenue ($mn), 2007-2008 73
Table 43: Anesthesia Machines, Australia, Company Share by Revenue ($ mn), 2007-2008 74
Table 44: Respiratory Devices, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 76
Table 45: Respiratory Devices, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 78
Table 46: Respiratory Devices, Australia, Volume (Units) by Segment, Historic, 2000-2008 79
Table 47: Respiratory Devices, Australia, Volume (Units) by Segment, Forecast, 2008-2015 81
Table 48: Respiratory Devices, Australia, Average Price ($), Historic, 2000-2008 82
Table 49: Respiratory Devices, Australia, Average Price ($), Forecast, 2008-2015 83
Table 50: Respiratory Devices, Australia, Distribution Share by Revenue ($mn), 2007-2008 84
Table 51: Respiratory Devices, Australia, Company Share by Revenue ($ mn), 2007-2008 85
Table 52: Respiratory Disposables, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 86
Table 53: Respiratory Disposables, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 87
Table 54: Respiratory Disposables, Australia, Volume (Units) by Segment, Historic, 2000-2008 88
Table 55: Respiratory Disposables, Australia, Volume (Units) by Segment, Forecast, 2008-2015 89
Table 56: Respiratory Disposables, Australia, Average Price ($), Historic, 2000-2008 90
Table 57: Respiratory Disposables, Australia, Average Price ($), Forecast, 2008-2015 90
Table 58: Respiratory Disposables, Australia, Distribution Share by Revenue ($mn), 2007-2008 91
Table 59: Respiratory Disposables, Australia, Company Share by Revenue ($ mn), 2007-2008 92
Table 60: Respiratory Measurement Devices, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 93
Table 61: Respiratory Measurement Devices, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 95
Table 62: Respiratory Measurement Devices, Australia, Volume (Units) by Segment, Historic, 2000-2008 96
Table 63: Respiratory Measurement Devices, Australia, Volume (Units) by Segment, Forecast, 2008-2015 97
Table 64: Respiratory Measurement Devices, Australia, Average Price ($), Historic, 2000-2008 98
Table 65: Respiratory Measurement Devices, Australia, Average Price ($), Forecast, 2008-2015 98
Table 66: Respiratory Measurement Devices, Australia, Distribution Share by Revenue ($mn), 2007-2008 99
Table 67: Respiratory Measurement Devices, Australia, Company Share by Revenue ($ mn), 2007-2008 100
Table 68: Sleep Apnea Diagnostic Systems, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 101
Table 69: Sleep Apnea Diagnostic Systems, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 102
Table 70: Sleep Apnea Diagnostic Systems, Australia, Volume (Units) by Segment, Historic, 2000-2008 103
Table 71: Sleep Apnea Diagnostic Systems, Australia, Volume (Units) by Segment, Forecast, 2008-2015 104
Table 72: Sleep Apnea Diagnostic Systems, Australia, Average Price ($), Historic, 2000-2008 105
Table 73: Sleep Apnea Diagnostic Systems, Australia, Average Price ($), Forecast, 2008-2015 105
Table 74: Sleep Apnea Diagnostic Systems, Australia, Distribution Share by Revenue ($mn), 2007-2008 106
Table 75: Sleep Apnea Diagnostic Systems, Australia, Company Share by Revenue ($ mn), 22007-2008 107
Table 76: Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 124
Table 77: Covidien Ltd./Tyco Healthcare Pipeline Products by Development Stage 124
Table 78: Covidien Ltd./Tyco Healthcare Pipeline Products by Therapy Area 125
Table 79: Covidien Ltd./Tyco Healthcare Pipeline Products by Clinical Trials 125
Table 80: Covidien Ltd./Tyco Healthcare Pipeline Products by News Summaries 125
Table 81: ResMed Inc. Pipeline Products by Equipment Type 130
Table 82: ResMed Inc. Pipeline Products by Development Stage 130
Table 83: ResMed Inc. Pipeline Products by Therapy Area 131
Table 84: ResMed Inc. Pipeline Products by Clinical Trials 131
Table 85: USD to Local Currency, Average Exchange Rate 2008 145
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Australia, 2000 – 2005 22
Figure 2: Healthcare Financing Framework in Australia, 2007 23
Figure 3: Healthcare System in Australia, 2007 28
Figure 4: Classification of Medical Devices in Australia, 2007 31
Figure 5: Classification of Noninvasive Devices in Australia, 2007 32
Figure 6: Classification of Invasive Devices in Australia, 2007 33
Figure 7: Classification of Invasive Devices in Australia, 2007 34
Figure 8: Classification of Active Devices in Australia, 2007 35
Figure 9: Classification of Special Medical Devices in Australia, 2007 36
Figure 10: Conformity Assessment Procedure for Medical Devices in Australia, 2007 37
Figure 11: Anesthesia and Respiratory Devices, Australia, Overall Revenue ($ mn), Historic, 2000-2008 49
Figure 12: Anesthesia and Respiratory Devices, Australia, Overall Revenue ($ mn), Forecast, 2008-2015 51
Figure 13: Anesthesia and Respiratory Devices, Australia, Cross -Category Analysis, 2000-2015 55
Figure 14: Anesthesia and Respiratory Devices, Australia, Company Share (%), 2008 58
Figure 15: Anesthesia Disposables, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 60
Figure 16: Anesthesia Disposables, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 61
Figure 17: Anesthesia Disposables, Australia, Volume (Units) by Segment, Historic, 2000-2008 63
Figure 18: Anesthesia Disposables, Australia, Volume (Units) by Segment, Forecast, 2008-2015 64
Figure 19: Anesthesia Disposables, Australia, Company Share (%), 2008 67
Figure 20: Anesthesia Machines, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 68
Figure 21: Anesthesia Machines, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 69
Figure 22: Anesthesia Machines, Australia, Volume (Units) by Segment, Historic, 2000-2008 70
Figure 23: Anesthesia Machines, Australia, Volume (Units) by Segment, Forecast, 2008-2015 71
Figure 24: Anesthesia Machines, Australia, Company Share (%), 2008 74
Figure 25: Respiratory Devices, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 75
Figure 26: Respiratory Devices, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 77
Figure 27: Respiratory Devices, Australia, Volume (Units) by Segment, Historic, 2000-2008 79
Figure 28: Respiratory Devices, Australia, Volume (Units) by Segment, Forecast, 2008-2015 80
Figure 29: Respiratory Devices, Australia, Company Share (%), 2008 84
Figure 30: Respiratory Disposables, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 86
Figure 31: Respiratory Disposables, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 87
Figure 32: Respiratory Disposables, Australia, Volume (Units) by Segment, Historic, 2000-2008 88
Figure 33: Respiratory Disposables, Australia, Volume (Units) by Segment, Forecast, 2008-2015 89
Figure 34: Respiratory Disposables, Australia, Company Share (%), 2008 92
Figure 35: Respiratory Measurement Devices, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 93
Figure 36: Respiratory Measurement Devices, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 94
Figure 37: Respiratory Measurement Devices, Australia, Volume (Units) by Segment, Historic, 2000-2008 96
Figure 38: Respiratory Measurement Devices, Australia, Volume (Units) by Segment, Forecast, 2008-2015 97
Figure 39: Respiratory Measurement Devices, Australia, Company Share (%), 2008 100
Figure 40: Sleep Apnea Diagnostic Systems, Australia, Revenue ($ mn) by Segment, Historic, 2000-2008 101
Figure 41: Sleep Apnea Diagnostic Systems, Australia, Revenue ($ mn) by Segment, Forecast, 2008-2015 102
Figure 42: Sleep Apnea Diagnostic Systems, Australia, Volume (Units) by Segment, Historic, 2000-2008 103
Figure 43: Sleep Apnea Diagnostic Systems, Australia, Volume (Units) by Segment, Forecast, 2008-2015 104
Figure 44: Sleep Apnea Diagnostic Systems, Australia, Company Share (%), 2008 107
Figure 45: Drager Medical AG & Co. KG Value Chain Analysis 109
Figure 46: Cardinal Health, Inc. Value Chain Analysis 111
Figure 47: Philips Medical Systems Value Chain Analysis 115
Figure 48: Smiths Medical Value Chain Analysis 119
Figure 49: Covidien Ltd./Tyco Healthcare Value Chain Analysis 122
Figure 50: ResMed Inc. Value Chain Analysis 127
Figure 51: Teleflex Incorporated Value Chain Analysis 133
Figure 52: Fisher & Paykel Healthcare Corporation Limited Value Chain Analysis 135
Figure 53: GlobalData Methodology 141