Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 10
2 Introduction 11
2.1 What Is This Report About? 11
3 Executive
Summary 12
4 Definitions of Markets Covered in the Report 13
4.1
Diabetic Care Devices 13
4.2 Glucose Monitoring Devices 13
4.2.1 Blood
Glucose Meters 13
4.2.2 Blood Glucose Strips 13
4.3 Insulin Delivery
13
4.3.1 InsulinPens 13
4.3.2 Insulin Syringes 14
4.3.3 Insulin
Pumps 14
4.3.4 Traditional Insulin Pump Accessories 14
5 Healthcare
Sector Review 15
5.1 Healthcare Expenditure 15
5.2 Healthcare
Infrastructure 18
5.3 Healthcare Policy 22
6 Regulation System 23
6.1 Medical Equipment Approval Process 23
6.1.1 Classification 23
6.1.2 Registration and Conformity Assessment 30
6.2 Advertising 32
6.3
Labeling and Packaging 33
6.4 Post-market Surveillance 34
6.5
Registration Fee 34
7 Pricing and Reimbursement 41
8 Distribution
Structure 42
9 Diabetes Care Devices In Australia 43
9.1 Diabetes Care
Devices, Australia, Overall Revenue ($ m), 2000-2015 43
9.2 Diabetes Care
Devices, Australia, Category Volume (Units), 2000-2015 46
9.3 Diabetes
Care Devices, Australia, Cross-Category Analysis, 2000-2015 48
9.4
Diabetes Care Devices, Australia, Company Share (2007-2008) 49
10 Glucose
Monitoring In Australia 51
10.1 Glucose Monitoring Overall Revenue
(2000-2015) 51
10.1.1 Blood Glucose Meters Overall Revenue (2000-2015)
54
10.2 Glucose Monitoring Overall Volume (2000-2015) 56
10.2.1 Blood
Glucose Meters Overall Volume (2000-2015) 58
10.3 Glucose Monitoring,
Australia, Cross-Segment Analysis, 2000-2015 59
10.4 Glucose Monitoring
Average Price (2000-2015) 60
10.5 Glucose Monitoring Market Dynamics
61
10.5.1 Market Drivers 61
10.5.2 Market Restraints 61
10.6
Glucose Monitoring Distribution Share (2007-2008) 61
10.7 Glucose
Monitoring, Australia, Company Share (2007-2008) 62
11 Insulin Delivery In
Australia 64
11.1 Insulin Delivery Overall Revenue (2000-2015) 64
11.1.1 Insulin Pens Overall Revenue (2000-2015) 68
11.2 Insulin Delivery
Overall Volume (2000-2015) 70
11.2.1 Insulin Pens Overall Volume
(2000-2015) 71
11.3 Insulin Delivery, Australia, Cross-Segment Analysis,
2000-2015 73
11.4 Insulin Delivery Average Price (2000-2015) 74
11.5
Insulin Delivery Market Dynamics 75
11.6 Insulin Delivery Distribution
Share (2007-2008) 75
11.7 Insulin Delivery, Australia, Company Share
(2007-2008) 76
12 Overview of Key Companies in Australia Diabetes Care
Devices Market 78
12.1 F. Hoffmann-La Roche Ltd. 78
12.1.1 Company
Overview 78
12.1.2 Value Chain Analysis 78
12.1.3 F. Hoffmann-La Roche
Ltd Pipeline Products 80
12.2 LifeScan, Inc. 81
12.2.1 Company
Overview 81
12.2.2 LifeScan, Inc. Pipeline Products 82
12.3 Bayer
HealthCare AG 83
12.3.1 Company Overview 83
12.3.2 Value Chain
Analysis 83
12.3.3 Bayer HealthCare AG Pipeline Products 85
12.4
Abbott Laboratories 87
12.4.1 Company Overview 87
12.4.2 Value Chain
Analysis 87
12.4.3 Abbott Laboratories Pipeline Products 89
12.5 Novo
Nordisk A/S 91
12.5.1 Company Overview 91
12.5.2 Novo Nordisk A/S
Pipeline Products 91
12.6 Sanofi-Aventis 92
12.6.1 Company Overview
92
12.7 ARKRAY, Inc. 92
12.7.1 Company Overview 92
12.7.2 ARKRAY,
Inc. Pipeline Products 92
12.8 Terumo Corporation 94
12.8.1 Company
Overview 94
12.8.2 Value Chain Analysis 94
12.9 Animas Corporation
96
12.9.1 Company Overview 96
12.10 Eli Lilly and Company 96
12.10.1 Company Overview 96
12.10.2 Value Chain Analysis 97
12.10.3
Eli Lilly and Company Pipeline Products 99
12.11 AiMedics Pty Ltd 100
12.11.1 Company Overview 100
12.11.2 AiMedics Pty Ltd Pipeline Products
100
12.12 Medtronic, Inc. 102
12.12.1 Company Overview 102
12.12.2
Value Chain Analysis 102
12.12.3 Medtronic, Inc. Pipeline Products 103
12.13 Becton, Dickinson and Company 112
12.13.1 Company Overview 112
12.13.2 Value Chain Analysis 112
12.14 Smiths Medical 114
12.14.1
Company Overview 114
12.14.2 Value Chain Analysis 115
12.15 Apex
Biotechnology Corp. 117
12.15.1 Company Overview 117
12.16 National
Diagnostics Products Pty. Limited 117
12.16.1 Company Overview 117
13
Appendix 118
13.1 GlobalData Research Methodology 118
13.2 Coverage
119
13.3 Secondary Research 120
13.4 Primary Research 120
13.5
Models 121
13.6 Forecasts 121
13.7 Expert Panel Validation 122
13.8 Currency Conversion 123
13.9 Contact Us 124
13.10 Disclaimer
124
1.1 List of Tables
Table 1: Healthcare Infrastructure in
Australia, 2005 18
Table 2: Healthcare Personnel in Australia, 2005 19
Table 3: Hospital Wards by Specialty in Australia, 2003-2007 20
Table 4:
Doctors by Specialty in Australia, 2003-2007 21
Table 5: Conformity
Assessment of Medical Devices based Device Class, in Australia, 2007 32
Table 6: Fee for Registered Device in Australia, 2007 34
Table 7: Fee for
Device Clinical Trial in Australia, 2007 35
Table 8: Evaluation Fee for
High and Low Level Registration of Medical Device in Australia, 2007 35
Table 9: Evaluation Fee for Variation Registration of Medical Device in
Australia, 2007 36
Table 10: Fee for Registration of Listed Devices in
Australia, 2007 36
Table 11: Fee for Registration of Listed Devices for
Export Only in Australia, 2007 37
Table 12: Fee for Registration of
Included Devices in Australia, 2007 37
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 38
Table 15: Fee for Medical Device Conformity Assessment Surveillance Audit in
Australia, 2007 38
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 39
Table 18: Fee for Conformity Assessment of Changes in Medical Device
Components in Australia, 2007 39
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 40
Table 21: Fee for ARTG Inclusion for Medical Device in Australia, 2007 40
Table 22: Diabetes Care Devices, Australia, Overall Revenue ($ m),
Historic, 2000-2008 43
Table 23: Diabetes Care Devices, Australia,
Overall Revenue ($ m), Forecast, 2008-2015 45
Table 24: Diabetes Care
Devices, Australia, Category Volume (Units), Historic, 2000-2008 46
Table
25: Diabetes Care Devices, Australia, Category Volume (Units), Forecast,
2008-2015 47
Table 26: Diabetes Care Devices, Australia,
Cross-Category Analysis, 2000-2015 48
Table 27: Diabetes Care
Devices, Australia, Company Share by Revenue ($m), 2007-2008 49
Table 28:
Glucose Monitoring, Australia, Revenue ($ m) by Segment, Historic,
2000-2008 51
Table 29: Glucose Monitoring, Australia, Revenue ($ m)
by Segment, Forecast, 2008-2015 53
Table 30: Blood Glucose Meters,
Australia, Revenue ($ m) by Sub-Segment, Historic, 2000-2008 54
Table 31:
Blood Glucose Meters, Australia, Revenue ($ m) by Sub-Segment, Forecast,
2008-2015 55
Table 32: Glucose Monitoring, Australia, Volume (Units)
by Segment, Historic, 2000-2008 56
Table 33: Glucose Monitoring,
Australia, Volume (Units) by Segment, Forecast, 2008-2015 57
Table 34:
Blood Glucose Meters, Australia, Volume (Units) by Sub-Segment, Historic,
2000-2008 58
Table 35: Blood Glucose Meters, Australia, Volume
(Units) by Sub-Segment, Forecast, 2008-2015 58
Table 36: Glucose
Monitoring, Australia, Cross-Segment Analysis, 2000-2015 59
Table 37:
Glucose Monitoring, Australia, Average Price ($), Historic, 2000-2008 60
Table 38: Glucose Monitoring, Australia, Average Price ($), Forecast,
2008-2015 60
Table 39: Glucose Monitoring, Australia, Distribution
Share by Revenue ($ m), 2007-2008 61
Table 40: Glucose Monitoring,
Australia, Company Share by Revenue ($m), 2007-2008 62
Table 41:
Insulin Delivery, Australia, Revenue ($ m) by Segment, Historic, 2000-2008
64
Table 42: Insulin Delivery, Australia, Revenue ($ m) by Segment,
Forecast, 2008-2015 66
Table 43: Insulin Pens, Australia, Revenue
($m) by Sub-Segment, Historic, 2000-2008 68
Table 44: Insulin Pens,
Australia, Revenue ($ m) by Sub-Segment, Forecast, 2008-2015 69
Table 45:
Insulin Delivery, Australia, Volume (Units) by Segment, Historic,
2000-2008 70
Table 46: Insulin Delivery, Australia, Volume (Units) by
Segment, Forecast, 2008-2015 70
Table 47: Insulin Pens, Australia,
Volume (Units) by Sub-Segment, Historic, 2000-2008 71
Table 48:
Insulin Pens, Australia, Volume (Units) by Sub-Segment, Forecast, 2008-2015
72
Table 49: Insulin Delivery, Australia, Cross-Segment Analysis,
2000-2015 73
Table 50: Insulin Delivery, Australia, Average Price
($), Historic, 2000-2008 74
Table 51: Insulin Delivery, Australia,
Average Price ($), Forecast, 2008-2015 74
Table 52: Insulin Delivery,
Australia, Distribution Share by Revenue ($ m), 2007-2008 75
Table 53:
Insulin Delivery, Australia, Company Share by Revenue ($m), 2007-2008 76
Table 54: F. Hoffmann-La Roche Ltd Pipeline Products by Equipment Type
80
Table 55: F. Hoffmann-La Roche Ltd Pipeline Products by
Development Stage 81
Table 56: F. Hoffmann-La Roche Ltd Pipeline
Products by Therapy Area 81
Table 57: LifeScan, Inc. Pipeline
Products by Equipment Type 82
Table 58: LifeScan, Inc. Pipeline
Products by Development Stage 82
Table 59: LifeScan, Inc. Pipeline
Products by Therapy Area 82
Table 60: LifeScan, Inc. Pipeline
Products by Clinical Trials 82
Table 61: LifeScan, Inc. Pipeline
Products by News Summary 82
Table 62: Bayer HealthCare AG Pipeline
Products by Equipment Type 85
Table 63: Bayer HealthCare AG Pipeline
Products by Development Stage 86
Table 64: Bayer HealthCare AG
Pipeline Products by Therapy Area 86
Table 65: Bayer HealthCare AG
Pipeline Products by News Summary 86
Table 66: Abbott Laboratories
Pipeline Products by Equipment Type 89
Table 67: Abbott Laboratories
Pipeline Products by Development Stage 90
Table 68: Abbott
Laboratories Pipeline Products by Therapy Area 90
Table 69: Abbott
Laboratories Pipeline Products by Clinical Trials 90
Table 70: Abbott
Laboratories Pipeline Products by News Summary 90
Table 71: Novo
Nordisk A/S Pipeline Products by Equipment Type 91
Table 72: Novo
Nordisk A/S Pipeline Products by Development Stage 91
Table 73: Novo
Nordisk A/S Pipeline Products by Therapy Area 91
Table 74: Novo
Nordisk A/S Pipeline Products by Clinical Trials 91
Table 75: ARKRAY,
Inc. Pipeline Products by Equipment Type 92
Table 76: ARKRAY, Inc.
Pipeline Products by Development Stage 93
Table 77: ARKRAY, Inc.
Pipeline Products by Clinical Trials 93
Table 78: ARKRAY, Inc.
Pipeline Products by News Summary 93
Table 79: Eli Lilly and Company
Pipeline Products by Equipment Type 99
Table 80: Eli Lilly and
Company Pipeline Products by Development Stage 99
Table 81: Eli Lilly
and Company Pipeline Products by Therapy Area 99
Table 82: Eli Lilly
and Company Pipeline Products by Clinical Trials 100
Table 83: Eli
Lilly and Company Pipeline Products by News Summary 100
Table 84:
AiMedics Pty Ltd Pipeline Products by Equipment Type 100
Table 85:
AiMedics Pty Ltd Pipeline Products by Development Stage 101
Table 86:
AiMedics Pty Ltd Pipeline Products by Therapy Area 101
Table 87:
AiMedics Pty Ltd Pipeline Products by Clinical Trials 101
Table 88:
AiMedics Pty Ltd Pipeline Products by News Summary 101
Table 89:
Medtronic, Inc. Pipeline Products by Equipment Type 104
Table 90:
Medtronic, Inc. Pipeline Products By Development Stage 106
Table 91:
Medtronic, Inc. Pipeline Products By Therapy Area 108
Table 92:
Medtronic, Inc. Pipeline Products By Clinical Trials 110
Table 93:
Medtronic, Inc. Pipeline Products By News Summary 111
Table 94: USD to
Local Currency, Average Exchange Rate 2008 123
1.2 List of
Figures
Figure 1: Total Healthcare Expenditure in Australia, 2000 –
2005 16
Figure 2: Healthcare Financing Framework in Australia, 2007 17
Figure 3: Healthcare System in Australia, 2007 22
Figure 4: Classification
of Medical Devices in Australia, 2007 25
Figure 5: Classification of
Noninvasive Devices in Australia, 2007 26
Figure 6: Classification of
Invasive Devices in Australia, 2007 27
Figure 7: Classification of
Invasive Devices in Australia, 2007 28
Figure 8: Classification of Active
Devices in Australia, 2007 29
Figure 9: Classification of Special Medical
Devices in Australia, 2007 30
Figure 10: Conformity Assessment Procedure
for Medical Devices in Australia, 2007 31
Figure 11: Diabetes Care
Devices, Australia, Overall Revenue ($ m), Historic, 2000-2008 43
Figure
12: Diabetes Care Devices, Australia, Overall Revenue ($ m), Forecast,
2008-2015 45
Figure 13: Diabetes Care Devices, Australia, Category
Volume (Units), Historic, 2000-2008 46
Figure 14: Diabetes Care
Devices, Australia, Category Volume (Units), Forecast, 2008-2015 47
Figure
15: Diabetes Care Devices, Australia, Cross-Category Analysis, 2000-2015
48
Figure 16: Diabetes Care Devices, Australia, Company Share (%),
2008 49
Figure 17: Glucose Monitoring, Australia, Revenue ($ m) by
Segment, Historic, 2000-2008 51
Figure 18: Glucose Monitoring,
Australia, Revenue ($ m) by Segment, Forecast, 2008-2015 53
Figure 19:
Blood Glucose Meters, Australia, Revenue ($ m) by Sub-Segment, Historic,
2000-2008 54
Figure 20: Blood Glucose Meters, Australia, Revenue ($
m) by Sub-Segment, Forecast, 2008-2015 55
Figure 21: Glucose
Monitoring, Australia, Volume (Units) by Segment, Historic, 2000-2008 56
Figure 22: Glucose Monitoring, Australia, Volume (Units) by Segment,
Forecast, 2008-2015 57
Figure 23: Glucose Monitoring, Australia,
Cross-Segment Analysis, 2000-2015 59
Figure 24: Glucose Monitoring,
Australia, Company Share (%), 2008 62
Figure 25: Insulin Delivery,
Australia, Revenue ($ m) by Segment, Historic, 2000-2008 64
Figure 26:
Insulin Delivery, Australia, Revenue ($ m) by Segment, Forecast, 2008-2015
66
Figure 27: Insulin Pens, Australia, Revenue ($ m) by Sub-Segment,
Historic, 2000-2008 68
Figure 28: Insulin Pens, Australia, Revenue ($
m) by Sub-Segment, Forecast, 2008-2015 69
Figure 29: Insulin Pens,
Australia, Volume (Units) by Sub-Segment, Historic, 2000-2008 71
Figure
30: Insulin Pens, Australia, Volume (Units) by Sub-Segment, Forecast,
2008-2015 72
Figure 31: Insulin Delivery, Australia, Cross-Segment
Analysis, 2000-2015 73
Figure 32: Insulin Delivery, Australia,
Company Share (%), 2008 76
Figure 33: GlobalData Methodology 119
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