The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Australia. It identifies key trends, and most importantly, provides valuable insights into the trends and segmentation of the pharmaceutical and medical devices market. It is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData’s team of industry experts.In 2010, Australia’s population was 22.4 million, largely due to a positive balance between the birth rate and mortality rate and net overseas immigration. The mortality rate is almost steady due to Australia’s strong healthcare infrastructure and medical and diagnostic services. The pharmaceutical market was estimated at $14.9 billion in 2010 and is expected to reach $30.5 billion by 2020 at a projected CAGR of 7.4%. The medical device market size was worth approximately $6.5 billion in 2011 and is expected to reach $10 billion by 2020 at a projected CAGR of 4.8%.Buy Your Copy of Report: http://www.reportsnreports.com/reports/182679-healthcare-regulatory-and-reimbursement-landscape-australia.htmlReport Details:Published: July 2012Price Single User License: US $ 39995 Price Corporate User License: US $ 7995The positive trends in the healthcare market can be attributed primarily to - - Easy market access to pharmaceutical drugs- Increasing awareness of the need for the early detection of lifestyle and chronic diseases- Government-subsidized prescription medicines through the Pharmaceutical Benefit Scheme (PBS) for all eligible, general or concessional patients- Annual review and addition of expensive innovative drugs to the PBS drug listScopeThe report provides information on the Australian healthcare, regulatory and reimbursement landscape, and includes - - Overview of the pharmaceutical and medical devices market, including size, segmentation, and key drivers and barriers.- Profiles and SWOT analyses of the major players in the pharmaceutical and medical devices market. The key players covered for the pharmaceutical market are Pfizer, AstraZeneca, Novartis, Sanofi and GlaxoSmithKline, and the key players covered for the medical devices market are Siemens Healthcare, GE Healthcare, DePuy Inc, F. Hoffmann-la Roche and Stryker Corporation.- Insightful review of the reimbursement and regulatory landscape, with details of the healthcare reimbursement process, regulatory agencies and market authorization processes for new drug and medical devices.- Detailed analysis of Australia’s political and economic environment, including the economic indicators, demographics, healthcare infrastructure and healthcare expenditure.- An overview of the opportunities for and challenges to growth in the healthcare market.Reasons to buyThis report comprehensively covers both the pharmaceutical and the medical devices market in Australia. It will enhance your decision-making capability and allow you to - - Develop business strategies by understanding the trends shaping and driving the healthcare market.- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical and medical devices market segments and companies likely to impact the healthcare market in the future.- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors.- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnerships.- Identify, understand and capitalize on the opportunities and challenges in the healthcare market.
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 8
2 Introduction 10
2.1 Report Guidance 10
3 Overview of the Pharmaceutical and Medical Device Market 11
3.1 Pharmaceutical Market 11
3.1.1 Supply Channels 14
3.1.2 Market Segments 16
3.1.3 Major Disease Areas 19
3.1.4 Major Players 21
3.2 Medical Device Market 49
3.2.1 Market Overview 49
3.2.2 Overview of the Top Five Segments 52
3.2.3 Major Players 63
3.3 Market Drivers and Barriers 80
3.3.1 Drivers 80
3.3.2 Barriers 81
4 Market Access 82
4.1 Reimbursement and Payers Landscape 82
4.1.1 Reimbursement Process 82
4.1.2 Overview of Insurance Providers 84
4.1.3 Patient Share in Healthcare Spending 87
4.1.4 Drug Price Trend 88
4.1.5 Pricing Policies 88
4.2 Regulatory Landscape 89
4.2.1 Overview of Regulatory Agencies 89
4.2.2 New Drug Approval Process 91
4.2.3 New Medical Device Approval Process 94
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 98
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 99
4.2.6 Intellectual Property Rights 100
4.2.7 Clinical Trial Regulations 101
4.2.8 Pharmaceutical and Medical Devices Advertising Regulations 102
4.2.9 Pharmacy Regulations 103
4.2.10 Labeling and Packaging Regulations 104
5 Country Analysis 105
5.1 Political Environment 105
5.1.1 Political Structure 105
5.1.2 Analysis of Current Political Environment 106
5.1.3 Healthcare Policy Initiatives 106
5.2 Economic Landscape 107
5.3 Economic Indicators 108
5.3.1 Gross Domestic Product 108
5.3.2 Gross National Income 111
5.3.3 Inflation 112
5.3.4 Currency Exchange Rate 115
5.3.5 Foreign Direct Investment 116
5.3.6 Foreign Exchange Reserves 117
5.3.7 Trade Balance 118
5.3.8 Government Structural Balance 120
5.3.9 Government Net Debt 121
5.3.10 Major Industries 123
5.4 Demography 124
5.4.1 Population 124
5.4.2 Education and Literacy 140
5.4.3 Employment 145
5.4.4 Disease Burden 146
5.4.5 Healthcare Facilities 148
5.4.6 Healthcare Parameters 154
5.4.7 Healthcare Personnel 156
5.4.8 Environmental Health 159
5.5 Healthcare Expenditure 162
5.5.1 Major Components of Healthcare Spending 163
5.5.2 Share of Public and Private Sector in Healthcare 164
5.5.3 Spending in Pharmaceutical R&D 165
5.6 Trade Associations 166
5.6.1 Australian Pharmaceutical Marketing and Research Group 166
5.6.2 Pharmacy Guild of Australia 166
5.6.3 Generic Medicines Industry Association 166
5.7 Trade Fairs 167
6 Opportunities and Challenges 168
6.1 Opportunities 168
6.2 Challenges 168
7 Appendix 170
7.1 Abbreviations 170
7.2 Bibliography 172
7.3 Methodology 175
7.3.1 Coverage 175
7.3.2 Secondary Research 175
7.3.3 Forecasting 176
7.3.4 Primary Research 176
7.3.5 Expert Panel Validation 176
7.4 Contact Us 176
7.5 Disclaimer 177
1.1 List of Tables
Table 1: Pharmaceutical Market ($bn), Australia, 2005–2010 11
Table 2: Pharmaceutical Market ($bn), Australia, Forecast, 2011–2020 12
Table 3: Pharmaceutical Sales Under PBS ($bn), Australia, 2005–2010 13
Table 4: Pharmacy and Wholesale Mark-up, Australia, 2011 15
Table 5: Biotechnology Companies, Market Capitalization ($m), Australian, 2011 Q4 17
Table 6: Over-the-counter Medicine Market ($bn), Australia, 2005–2010 18
Table 7: Major Disease Areas, Australia, Pharmaceutical Expenditure under Pharmaceutical Benefits Scheme ($bn), 2010 19
Table 8: Top Five Suppliers to the Pharmaceutical Benefit Scheme, Australia, ($m), 2010 21
Table 9: Major Products, Pfizer, Global, Revenue ($m), 2011 22
Table 10: Late-stage Pipeline, Pfizer, 2012 23
Table 11: Major Products, AstraZeneca, Global, Revenue ($m), 2011 28
Table 12: Late-stage Pipeline, AstraZeneca, 2012 28
Table 13: Major Products, Novartis, Global, Revenue ($m), 2011 33
Table 14: Planned Filings, Novartis, 2012 to = 2016 33
Table 15: Major Products, Sanofi, Global, Revenue ($m), 2011 39
Table 16: Late-stage Pipeline, Sanofi, 2012 40
Table 17: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 44
Table 18: Late-stage Pipeline, GlaxoSmithKline, 2012 44
Table 19: Medical Device Market ($bn), Australia, 2006–2011 50
Table 20: Medical Device Market ($bn), Australia, Forecast, 2011-2020 51
Table 21: Medical Device Market, Australia, Segments, Revenue ($m), 2011 52
Table 22: In Vitro Diagnostics Market ($m), Australia, 2006–2011 53
Table 23: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Australia, 2010 54
Table 24: Orthopedic Devices Market ($m), Australia, 2006–2011 55
Table 25: Sales Trends for Major Players*, Orthopedic Devices, Australia, 2010 56
Table 26: Ophthalmic Devices Market ($m), Australia, 2006–2011 57
Table 27: Sales Trends for Major Players*, Ophthalmic Devices, Australia, 2010 58
Table 28: Diagnostic Imaging Market ($m), Australia, 2006–2011 59
Table 29: Sales Trends for Major Players*, Diagnostic Imaging, Australia, 2010 60
Table 30: Cardiovascular Devices Market ($m), Australia, 2006–2011 61
Table 31: Sales Trends for Major Players*, Cardiovascular Devices, Australia, 2010 62
Table 32: Major Products, Siemens, Global, Revenue ($m), 2010 63
Table 33: Major Products, DePuy, 2012 70
Table 34: Major Products, Roche, Global, Revenue ($m), 2010 73
Table 35: Late-stage Pipeline, F. Hoffmann-La Roche Ltd., 2012 74
Table 36: Major Products, Stryker, Global, Revenue ($m), 2010 77
Table 37: Medicare Safety Net Original Threshold, Australia, 2012 85
Table 38: Extended Medicare Safety Net Medicare Safety Threshold, Australia, 2012 85
Table 39: Healthcare Spending, Australia, Patient''s Share (%), 2005–2010 87
Table 40: Change in Average Annual Price of Pharmaceutical Benefit Scheme Drugs (%), Australia, 2005–2010 88
Table 41: Classification of Medical Devices, Australia, 2012 94
Table 42: Regulation of Advertising of Therapeutic Goods, Australia, 2012 102
Table 43: GDP Per Capita ($), Australia, 2005–2010 108
Table 44: GDP Per Capita ($), Australia, Forecast, 2011–2020 109
Table 45: GDP, Annual Growth (%), Australia, 2005–2010 110
Table 46: GDP, Annual Growth (%), Australia, Forecast, 2011–2020 110
Table 47: GNI Per Capita ($), Australia, 2005–2010 111
Table 48: Average Consumer Price Index, Australia, 2005–2010 112
Table 49: Average Consumer Price Index, Australia, Forecast, 2011–2020 113
Table 50: Average Consumer Price, Australia, Annual Change (%), 2005–2010 114
Table 51: Currency Exchange Rate (AUD$/$), Australia, 2005–2010 115
Table 52: Foreign Direct Investment ($bn), Australia, 2005–2010 116
Table 53: Foreign Exchange Reserves ($bn), Australia, 2005–2010 117
Table 54: Imports of Goods and Services ($bn), Australia, 2005–2010 118
Table 55: Exports of Goods and Services ($bn), Australia, 2005–2010 119
Table 56: General Government Structural Balance ($bn), Australia, 2005–2010 120
Table 57: General Government Net Debt ($bn), Australia, 2005–2010 121
Table 58: General Government Net Debt ($bn), Australia, Forecast, 2011–2020 122
Table 59: Major Industry Sectors*, GVA ($bn), Australia, 2008 123
Table 60: Population (m), Australia, 2005–2010 124
Table 61: Population (m), Australia, Forecast, 2011–2020 125
Table 62: Urban and Rural Population, Australia, Share (%), 2005–2010 126
Table 63: Age Groups, Australia, Population Distribution (%), 2005–2010 127
Table 64: Births (Per 1,000 Population), Australia, 2005–2010 128
Table 65: Births (Per 1,000 Population), Australia, Forecast, 2011–2020 129
Table 66: Mortality (Per 1,000 Population), Australia, 2005–2010 130
Table 67: Mortality (Per 1,000 Population), Australia, Forecast, 2011–2020 131
Table 68: Major Causes of Mortality (‘000), Australia, 2009 132
Table 69: Children <5 Years Age, Mortality (Per 1,000 Live Births), Australia, 2005–2010 133
Table 70: Immunization Rate for DTP, Measles, Hepatitis B (%), Australia, 2005–2010 134
Table 71: Major Causes of Male Mortality (‘000), Australia, 2009 135
Table 72: Major Causes of Female Mortality (‘000), Australia, 2009 136
Table 73: Gender Ratio (M/F), Australia, 2005–2010 137
Table 74: Life Expectancy at Birth (Years), Australia, 2005–2010 138
Table 75: Life Expectancy at Birth (Years), Australia, Forecast, 2011–2020 139
Table 76: Schools, Australia, 2005–2010 140
Table 77: School Students (‘000), Australia, 2005–2010 141
Table 78: Education Participation (%), 15–24 Year Olds, Australia, 2005–2010 142
Table 79: Overseas Students (%), Australia, 2005–2010 143
Table 80: Tertiary and Higher-education Students (‘000), Australia, 2005–2010 144
Table 81: Unemployment Rate (%), Australia, 2005–2010 145
Table 82: Most Frequently Diagnosed Diseases (‘000), Australia, 2007–2008 146
Table 83: Major Diseases, Australia, DALY (Per 100,000 Population), 2004 147
Table 84: Public Hospitals, Australia, 2005–2010 148
Table 85: Public Acute Care Hospitals, Australia, 2005–2010 149
Table 86: Public Psychiatric Hospitals, Australia, 2005–2010 150
Table 87: Private Hospitals, Australia, 2005–2010 151
Table 88: Private Free-standing Day Hospital Facilities, Australia, 2005–2010 152
Table 89: Other Private Hospitals, Australia, 2005–2010 153
Table 90: Public Hospital Beds (Per 1,000 Population), Australia, 2005–2010 154
Table 91: Private Hospital Beds (Per 1000 Population), Australia, 2005–2010 155
Table 92: Physicians (Per 1,000 Population), Australia, 2005–2010 156
Table 93: Healthcare Personnel (Per 1,000 Population), Australia, 2005–2010 157
Table 94: Nurses (Per 1000 Population), Australia, 2005–2010 158
Table 95: PM10 (Micrograms Per Cubic Meter), Australia, 2005–2010 159
Table 96: CO2 Emissions (000’s Tons), Australia, 2005–2010 160
Table 97: NO2 Emissions (000’s Tons), Australia, 2005–2010 161
Table 98: Healthcare Expenditure (% of GDP), Australia, 2005–2010 162
Table 99: Healthcare Expenditure, Australia, Share of Major Components (%), 2009–2010 163
Table 100: Healthcare Expenditure, Australia, Public-Private Share (%), 2005–2010 164
Table 101: Pharmaceutical R&D Expenditure ($m), Australia, 2005–2010 165
Table 102: Major Healthcare Trade Fairs, Australia, 2012 167
1.2 List of Figures
Figure 1: Pharmaceutical Market ($bn), Australia, 2005–2010 11
Figure 2: Pharmaceutical Market ($bn), Australia, Forecast, 2011–2020 12
Figure 3: Pharmaceutical Sales under PBS ($bn), Australia, 2005–2010 13
Figure 4: Pharmaceutical Supply Chain, Australia, 2011 14
Figure 5: Over-the-counter Medicine Market ($bn), Australia, 2005–2010 18
Figure 6: Major Disease Areas, Australia, Pharmaceutical Expenditure under Pharmaceutical Benefits Scheme ($bn), 2010 19
Figure 7: Top Five Suppliers to the Pharmaceutical Benefit Scheme, Australia, ($m), 2010 21
Figure 8: Medical Device Market ($bn), Australia, 2006–2011 50
Figure 9: Medical Device Market ($bn), Australia, Forecast, 2012-2020 51
Figure 10: Medical Device Market, Australia, Segments, Revenue ($m), 2011 52
Figure 11: In Vitro Diagnostics Market ($m), Australia, 2006–2011 53
Figure 12: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Australia, 2005–2010 54
Figure 13: Orthopedic Devices Market ($m), Australia, 2006–2011 55
Figure 14: Sales Trends for Major Players*, Orthopedic Devices, Australia, 2005–2010 56
Figure 15: Ophthalmic Devices Market ($m), Australia, 2006–2011 57
Figure 16: Sales Trends for Major Players*, Ophthalmic Devices, Australia, 2005–2010 58
Figure 17: Diagnostic Imaging Market ($m), Australia, 2006–2011 59
Figure 18: Sales Trends for Major Players*, Diagnostic Imaging, Australia, 2005–2010 60
Figure 19: Cardiovascular Devices Market ($m), Australia, 2006–2011 61
Figure 20: Sales Trends for Major Players*, Cardiovascular Devices, Australia, 2005–2010 62
Figure 21: Drivers and Barriers, Healthcare Market, Australia, 2011 81
Figure 22: Pharmaceuticals and Devices Reimbursement Process, Australia 83
Figure 23: Healthcare Spending, Australia, Patient''s Share (%), 2005–2010 87
Figure 24: Change in Average Annual Price of Pharmaceutical Benefit Scheme Drugs (%), Australia, 2005–2010 88
Figure 25: Therapeutic Goods Administration Structure, 2012 90
Figure 26: New Drug Approval Process, Australia, 2012 93
Figure 27: Class I Non-sterile And Non-measuring Device Supply Process, Australia, 2012 95
Figure 28: Supply Process for Medical Device Manufactured in Australia, 2012 96
Figure 29: Supply Process for Medical Device Manufactured Overseas, Australia, 2012 97
Figure 30: Supply Process for Medical Device Containing Medicine or Materials of Animal, Microbial Recombinant or Human Origin, Australia, 2012 98
Figure 31: GDP Per Capita ($), Australia, 2005–2010 108
Figure 32: GDP Per Capita ($), Australia, Forecast, 2011–2020 109
Figure 33: GDP, Annual Growth (%), Australia, 2005–2010 110
Figure 34: GDP, Annual Growth (%), Australia, Forecast, 2011–2020 110
Figure 35: GNI Per Capita ($), Australia, 2005–2010 111
Figure 36: Average Consumer Price Index, Australia, 2005–2010 112
Figure 37: Average Consumer Price Index, Australia, Forecast, 2011–2020 113
Figure 38: Average Consumer Price, Australia, Annual Change (%), 2005–2010 114
Figure 39: Currency Exchange Rate (AUD$/$), Australia, 2005–2010 115
Figure 40: Foreign Direct Investment ($bn), Australia, 2005–2010 116
Figure 41: Foreign Exchange Reserves ($bn), Australia, 2005–2010 117
Figure 42: Imports of Goods and Services ($bn), Australia, 2005–2010 118
Figure 43: Exports of Goods and Services ($bn), Australia, 2005–2010 119
Figure 44: General Government Structural Balance ($bn), Australia, 2005–2010 120
Figure 45: General Government Net Debt ($bn), Australia, 2005–2010 121
Figure 46: General Government Net Debt ($bn), Australia, Forecast, 2011–2020 122
Figure 47: Major Industry Sectors*, GVA ($bn), Australia, 2008 123
Figure 48: Population (m), Australia, 2005–2010 124
Figure 49: Population (m), Australia, Forecast, 2011–2020 125
Figure 50: Urban and Rural Population, Australia, Share (%), 2005–2010 126
Figure 51: Age Groups, Australia, Population Distribution (%), 2005–2010 127
Figure 52: Births (Per 1,000 Population), Australia, 2005–2010 128
Figure 53: Births (Per 1,000 Population), Australia, Forecast, 2011–2020 129
Figure 54: Mortality (Per 1,000 Population), Australia, 2005–2010 130
Figure 55: Mortality (Per 1,000 Population), Australia, Forecast, 2011–2020 131
Figure 56: Major Causes of Mortality (‘000), Australia, 2009 132
Figure 57: Children <5 Years Age, Mortality (Per 1,000 Live Births), Australia, 2005–2010 133
Figure 58: Immunization Rate for DTP, Measles, Hepatitis B (%), Australia, 2005–2010 134
Figure 59: Major Causes of Male Mortality (‘000), Australia, 2009 135
Figure 60: Major Causes of Female Mortality (‘000), Australia, 2009 136
Figure 61: Gender Ratio (M/F), Australia, 2005–2010 137
Figure 62: Life Expectancy at Birth (Years), Australia, 2005–2010 138
Figure 63: Life Expectancy at Birth (Years), Australia, Forecast, 2011–2020 139
Figure 64: Schools, Australia, 2005–2010 140
Figure 65: School Students (‘000), Australia, 2005–2010 141
Figure 66: Education Participation (%), 15–24 Years Old, Australia, 2005–2010 142
Figure 67: Overseas Students (%), Australia, 2005–2010 143
Figure 68: Tertiary and Higher-education Students (‘000), Australia, 2005–2010 144
Figure 69: Unemployment Rate (%), Australia, 2005–2010 145
Figure 70: Most Frequently Diagnosed Diseases (‘000), Australia, 2007–2008 146
Figure 71: Major Diseases, Australia, DALY (Per 100,000 Population), 2004 147
Figure 72: Public Hospitals, Australia, 2005–2010 148
Figure 73: Public Acute Care Hospitals, Australia, 2005–2010 149
Figure 74: Public Psychiatric Hospitals, Australia, 2005–2010 150
Figure 75: Private Hospitals, Australia, 2005–2010 151
Figure 76: Private Free-standing Day Hospital Facilities, Australia, 2005–2010 152
Figure 77: Other Private Hospitals, Australia, 2005–2010 153
Figure 78: Public Hospital Beds (Per 1,000 Population), Australia, 2005–2010 154
Figure 79: Private Hospital Beds (Per 1,000 Population), Australia, 2005–2010 155
Figure 80: Physicians (Per 1,000 Population), Australia, 2005–2010 156
Figure 81: Healthcare Personnel (Per 1,000 Population), Australia, 2005–2010 157
Figure 82: Nurses (Per 1,000 Population), Australia, 2005–2010 158
Figure 83: PM10 (Micrograms Per Cubic Meter), Australia, 2005–2010 159
Figure 84: CO2 Emissions (000’s Tons), Australia, 2005–2010 160
Figure 85: NO2 Emissions (000’s Tons), Australia, 2005–2010 161
Figure 86: Healthcare Expenditure (% of GDP), Australia, 2005–2010 162
Figure 87: Healthcare Expenditure, Australia, Share of Major Components (%), 2009–2010 163
Figure 88: Healthcare Expenditure, Australia, Public-Private Share (%), 2005–2010 164
Figure 89: Pharmaceutical R&D Expenditure ($m), Australia, 2005–2010 165
Figure 90: Opportunities and Challenges, Healthcare Market, Australia, 2011 169
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