Healthcare, Regulatory and Reimbursement Landscape - Australia

Introduction

Abstract

Healthcare, Regulatory and Reimbursement Landscape - Australia

Summary

GlobalData, the industry analysis specialist, has released its new report, "Healthcare, Regulatory and Reimbursement Landscape - Australia". 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%.

The 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 list

Scope

The 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 buy

This 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.

Table of Contents

TOC

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

List of Tables

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

List of Figures

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

Healthcare, Regulatory and Reimbursement Landscape - Australia published by GlobalData in July 24, 2012. This report consists of Pages: 177 and the price starts from US $ 1995.