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Healthcare, Regulatory and Reimbursement Landscape - Australia
Date:8/2/2012

NEW YORK, Aug. 2, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Healthcare, Regulatory and Reimbursement Landscape - Australia

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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.

1 Table of Contents1 Table of Contents 41.1 List of Tables 61.2 List of Figures 82 Introduction 102.1 Report Guidance 103 Overview of the Pharmaceutical and Medical Device Market 113.1 Pharmaceutical Market 113.1.1 Supply Channels 143.1.2 Market Segments 163.1.3 Major Disease Areas 193.1.4 Major Players 213.2 Medical Device Market 493.2.1 Market Overview 493.2.2 Overview of the Top Five Segments 523.2.3 Major Players 633.3 Market Drivers and Barriers 803.3.1 Drivers 803.3.2 Barriers 814 Market Access 824.1 Reimbursement and Payers Landscape 824.1.1 Reimbursement Process 824.1.2 Overview of Insurance Providers 844.1.3 Patient Share in Healthcare Spending 874.1.4 Drug Price Trend 884.1.5 Pricing Policies 884.2 Regulatory Landscape 894.2.1 Overview of Regulatory Agencies 894.2.2 New Drug Approval Process 914.2.3 New Medical Device Approval Process 944.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 984.2.5 Licensing Process for Pharmaceutical Exports and Imports 994.2.6 Intellectual Property Rights 1004.2.7 Clinical Trial Regulations 1014.2.8 Pharmaceutical and Medical Devices Advertising Regulations 1024.2.9 Pharmacy Regulations 1034.2.10 Labeling and Packaging Regulations 1045 Country Analysis 1055.1 Political Environment 1055.1.1 Political Structure 1055.1.2 Analysis of Current Political Environment 1065.1.3 Healthcare Policy Initiatives 1065.2 Economic Landscape 1075.3 Economic Indicators 1085.3.1 Gross Domestic Product 1085.3.2 Gross National Income 1115.3.3 Inflation 1125.3.4 Currency Exchange Rate 1155.3.5 Foreign Direct Investment 1165.3.6 Foreign Exchange Reserves 1175.3.7 Trade Balance 1185.3.8 Government Structural Balance 1205.3.9 Government Net Debt 1215.3.10 Major Industries 1235.4 Demography 1245.4.1 Population 1245.4.2 Education and Literacy 1405.4.3 Employment 1455.4.4 Disease Burden 1465.4.5 Healthcare Facilities 1485.4.6 Healthcare Parameters 1545.4.7 Healthcare Personnel 1565.4.8 Environmental Health 1595.5 Healthcare Expenditure 1625.5.1 Major Components of Healthcare Spending 1635.5.2 Share of Public and Private Sector in Healthcare 1645.5.3 Spending in Pharmaceutical R&D 1655.6 Trade Associations 1665.6.1 Australian Pharmaceutical Marketing and Research Group 1665.6.2 Pharmacy Guild of Australia 1665.6.3 Generic Medicines Industry Association 1665.7 Trade Fairs 1676 Opportunities and Challenges 1686.1 Opportunities 1686.2 Challenges 1687 Appendix 1707.1 Abbreviations 1707.2 Bibliography 1727.3 Methodology 1757.3.1 Coverage 1757.3.2 Secondary Research 1757.3.3 Forecasting 1767.3.4 Primary Research 1767.3.5 Expert Panel Validation 1767.4 Contact Us 1767.5 Disclaimer 177

List of Tables

Table 1: Pharmaceutical Market ($bn), Australia, 2005–2010 11Table 2: Pharmaceutical Market ($bn), Australia, Forecast, 2011–2020 12Table 3: Pharmaceutical Sales Under PBS ($bn), Australia, 2005–2010 13Table 4: Pharmacy and Wholesale Mark-up, Australia, 2011 15Table 5: Biotechnology Companies, Market Capitalization ($m), Australian, 2011 Q4 17Table 6: Over-the-counter Medicine Market ($bn), Australia, 2005–2010 18Table 7: Major Disease Areas, Australia, Pharmaceutical Expenditure under Pharmaceutical Benefits Scheme ($bn), 2010 19Table 8: Top Five Suppliers to the Pharmaceutical Benefit Scheme, Australia, ($m), 2010 21Table 9: Major Products, Pfizer, Global, Revenue ($m), 2011 22Table 10: Late-stage Pipeline, Pfizer, 2012 23Table 11: Major Products, AstraZeneca, Global, Revenue ($m), 2011 28Table 12: Late-stage Pipeline, AstraZeneca, 2012 28Table 13: Major Products, Novartis, Global, Revenue ($m), 2011 33Table 14: Planned Filings, Novartis, 2012 to ? 2016 33Table 15: Major Products, Sanofi, Global, Revenue ($m), 2011 39Table 16: Late-stage Pipeline, Sanofi, 2012 40Table 17: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 44Table 18: Late-stage Pipeline, GlaxoSmithKline, 2012 44Table 19: Medical Device Market ($bn), Australia, 2006–2011 50Table 20: Medical Device Market ($bn), Australia, Forecast, 2011-2020 51Table 21: Medical Device Market, Australia, Segments, Revenue ($m), 2011 52Table 22: In Vitro Diagnostics Market ($m), Australia, 2006–2011 53Table 23: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Australia, 2010 54Table 24: Orthopedic Devices Market ($m), Australia, 2006–2011 55Table 25: Sales Trends for Major Players*, Orthopedic Devices, Australia, 2010 56Table 26: Ophthalmic Devices Market ($m), Australia, 2006–2011 57Table 27: Sales Trends for Major Players*, Ophthalmic Devices, Australia, 2010 58Table 28: Diagnostic Imaging Market ($m), Australia, 2006–2011 59Table 29: Sales Trends for Major Players*, Diagnostic Imaging, Australia, 2010 60Table 30: Cardiovascular Devices Market ($m), Australia, 2006–2011 61Table 31: Sales Trends for Major Players*, Cardiovascular Devices, Australia, 2010 62Table 32: Major Products, Siemens, Global, Revenue ($m), 2010 63Table 33: Major Products, DePuy, 2012 70Table 34: Major Products, Roche, Global, Revenue ($m), 2010 73Table 35: Late-stage Pipeline, F. Hoffmann-La Roche Ltd., 2012 74Table 36: Major Products, Stryker, Global, Revenue ($m), 2010 77Table 37: Medicare Safety Net Original Threshold, Australia, 2012 85Table 38: Extended Medicare Safety Net Medicare Safety Threshold, Australia, 2012 85Table 39: Healthcare Spending, Australia, Patient's Share (%), 2005–2010 87Table 40: Change in Average Annual Price of Pharmaceutical Benefit Scheme Drugs (%), Australia, 2005–2010 88Table 41: Classification of Medical Devices, Australia, 2012 94Table 42: Regulation of Advertising of Therapeutic Goods, Australia, 2012 102Table 43: GDP Per Capita ($), Australia, 2005–2010 108Table 44: GDP Per Capita ($), Australia, Forecast, 2011–2020 109Table 45: GDP, Annual Growth (%), Australia, 2005–2010 110Table 46: GDP, Annual Growth (%), Australia, Forecast, 2011–2020 110Table 47: GNI Per Capita ($), Australia, 2005–2010 111Table 48: Average Consumer Price Index, Australia, 2005–2010 112Table 49: Average Consumer Price Index, Australia, Forecast, 2011–2020 113Table 50: Average Consumer Price, Australia, Annual Change (%), 2005–2010 114Table 51: Currency Exchange Rate (AUD$/$), Australia, 2005–2010 115Table 52: Foreign Direct Investment ($bn), Australia, 2005–2010 116Table 53: Foreign Exchange Reserves ($bn), Australia, 2005–2010 117Table 54: Imports of Goods and Services ($bn), Australia, 2005–2010 118Table 55: Exports of Goods and Services ($bn), Australia, 2005–2010 119Table 56: General Government Structural Balance ($bn), Australia, 2005–2010 120Table 57: General Government Net Debt ($bn), Australia, 2005–2010 121Table 58: General Government Net Debt ($bn), Australia, Forecast, 2011–2020 122Table 59: Major Industry Sectors*, GVA ($bn), Australia, 2008 123Table 60: Population (m), Australia, 2005–2010 124Table 61: Population (m), Australia, Forecast, 2011–2020 125Table 62: Urban and Rural Population, Australia, Share (%), 2005–2010 126Table 63: Age Groups, Australia, Population Distribution (%), 2005–2010 127Table 64: Births (Per 1,000 Population), Australia, 2005–2010 128Table 65: Births (Per 1,000 Population), Australia, Forecast, 2011–2020 129Table 66: Mortality (Per 1,000 Population), Australia, 2005–2010 130Table 67: Mortality (Per 1,000 Population), Australia, Forecast, 2011–2020 131Table 68: Major Causes of Mortality ('000), Australia, 2009 132Table 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 134Table 71: Major Causes of Male Mortality ('000), Australia, 2009 135Table 72: Major Causes of Female Mortality ('000), Australia, 2009 136Table 73: Gender Ratio (M/F), Australia, 2005–2010 137Table 74: Life Expectancy at Birth (Years), Australia, 2005–2010 138Table 75: Life Expectancy at Birth (Years), Australia, Forecast, 2011–2020 139Table 76: Schools, Australia, 2005–2010 140Table 77: School Students ('000), Australia, 2005–2010 141Table 78: Education Participation (%), 15–24 Year Olds, Australia, 2005–2010 142Table 79: Overseas Students (%), Australia, 2005–2010 143Table 80: Tertiary and Higher-education Students ('000), Australia, 2005–2010 144Table 81: Unemployment Rate (%), Australia, 2005–2010 145Table 82: Most Frequently Diagnosed Diseases ('000), Australia, 2007–2008 146Table 83: Major Diseases, Australia, DALY (Per 100,000 Population), 2004 147Table 84: Public Hospitals, Australia, 2005–2010 148Table 85: Public Acute Care Hospitals, Australia, 2005–2010 149Table 86: Public Psychiatric Hospitals, Australia, 2005–2010 150Table 87: Private Hospitals, Australia, 2005–2010 151Table 88: Private Free-standing Day Hospital Facilities, Australia, 2005–2010 152Table 89: Other Private Hospitals, Australia, 2005–2010 153Table 90: Public Hospital Beds (Per 1,000 Population), Australia, 2005–2010 154Table 91: Private Hospital Beds (Per 1000 Population), Australia, 2005–2010 155Table 92: Physicians (Per 1,000 Population), Australia, 2005–2010 156Table 93: Healthcare Personnel (Per 1,000 Population), Australia, 2005–2010 157Table 94: Nurses (Per 1000 Population), Australia, 2005–2010 158Table 95: PM10 (Micrograms Per Cubic Meter), Australia, 2005–2010 159Table 96: CO2 Emissions (000's Tons), Australia, 2005–2010 160Table 97: NO2 Emissions (000's Tons), Australia, 2005–2010 161Table 98: Healthcare Expenditure (% of GDP), Australia, 2005–2010 162Table 99: Healthcare Expenditure, Australia, Share of Major Components (%), 2009–2010 163Table 100: Healthcare Expenditure, Australia, Public-Private Share (%), 2005–2010 164Table 101: Pharmaceutical R&D Expenditure ($m), Australia, 2005–2010 165Table 102: Major Healthcare Trade Fairs, Australia, 2012 167

List of Figures

Figure 1: Pharmaceutical Market ($bn), Australia, 2005–2010 11Figure 2: Pharmaceutical Market ($bn), Australia, Forecast, 2011–2020 12Figure 3: Pharmaceutical Sales under PBS ($bn), Australia, 2005–2010 13Figure 4: Pharmaceutical Supply Chain, Australia, 2011 14Figure 5: Over-the-counter Medicine Market ($bn), Australia, 2005–2010 18Figure 6: Major Disease Areas, Australia, Pharmaceutical Expenditure under Pharmaceutical Benefits Scheme ($bn), 2010 19Figure 7: Top Five Suppliers to the Pharmaceutical Benefit Scheme, Australia, ($m), 2010 21Figure 8: Medical Device Market ($bn), Australia, 2006–2011 50Figure 9: Medical Device Market ($bn), Australia, Forecast, 2012-2020 51Figure 10: Medical Device Market, Australia, Segments, Revenue ($m), 2011 52Figure 11: In Vitro Diagnostics Market ($m), Australia, 2006–2011 53Figure 12: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Australia, 2005–2010 54Figure 13: Orthopedic Devices Market ($m), Australia, 2006–2011 55Figure 14: Sales Trends for Major Players*, Orthopedic Devices, Australia, 2005–2010 56Figure 15: Ophthalmic Devices Market ($m), Australia, 2006–2011 57Figure 16: Sales Trends for Major Players*, Ophthalmic Devices, Australia, 2005–2010 58Figure 17: Diagnostic Imaging Market ($m), Australia, 2006–2011 59Figure 18: Sales Trends for Major Players*, Diagnostic Imaging, Australia, 2005–2010 60Figure 19: Cardiovascular Devices Market ($m), Australia, 2006–2011 61Figure 20: Sales Trends for Major Players*, Cardiovascular Devices, Australia, 2005–2010 62Figure 21: Drivers and Barriers, Healthcare Market, Australia, 2011 81Figure 22: Pharmaceuticals and Devices Reimbursement Process, Australia 83Figure 23: Healthcare Spending, Australia, Patient's Share (%), 2005–2010 87Figure 24: Change in Average Annual Price of Pharmaceutical Benefit Scheme Drugs (%), Australia, 2005–2010 88Figure 25: Therapeutic Goods Administration Structure, 2012 90Figure 26: New Drug Approval Process, Australia, 2012 93Figure 27: Class I Non-sterile And Non-measuring Device Supply Process, Australia, 2012 95Figure 28: Supply Process for Medical Device Manufactured in Australia, 2012 96Figure 29: Supply Process for Medical Device Manufactured Overseas, Australia, 2012 97Figure 30: Supply Process for Medical Device Containing Medicine or Materials of Animal, Microbial Recombinant or Human Origin, Australia, 2012 98Figure 31: GDP Per Capita ($), Australia, 2005–2010 108Figure 32: GDP Per Capita ($), Australia, Forecast, 2011–2020 109Figure 33: GDP, Annual Growth (%), Australia, 2005–2010 110Figure 34: GDP, Annual Growth (%), Australia, Forecast, 2011–2020 110Figure 35: GNI Per Capita ($), Australia, 2005–2010 111Figure 36: Average Consumer Price Index, Australia, 2005–2010 112Figure 37: Average Consumer Price Index, Australia, Forecast, 2011–2020 113Figure 38: Average Consumer Price, Australia, Annual Change (%), 2005–2010 114Figure 39: Currency Exchange Rate (AUD$/$), Australia, 2005–2010 115Figure 40: Foreign Direct Investment ($bn), Australia, 2005–2010 116Figure 41: Foreign Exchange Reserves ($bn), Australia, 2005–2010 117Figure 42: Imports of Goods and Services ($bn), Australia, 2005–2010 118Figure 43: Exports of Goods and Services ($bn), Australia, 2005–2010 119Figure 44: General Government Structural Balance ($bn), Australia, 2005–2010 120Figure 45: General Government Net Debt ($bn), Australia, 2005–2010 121Figure 46: General Government Net Debt ($bn), Australia, Forecast, 2011–2020 122Figure 47: Major Industry Sectors*, GVA ($bn), Australia, 2008 123Figure 48: Population (m), Australia, 2005–2010 124Figure 49: Population (m), Australia, Forecast, 2011–2020 125Figure 50: Urban and Rural Population, Australia, Share (%), 2005–2010 126Figure 51: Age Groups, Australia, Population Distribution (%), 2005–2010 127Figure 52: Births (Per 1,000 Population), Australia, 2005–2010 128Figure 53: Births (Per 1,000 Population), Australia, Forecast, 2011–2020 129Figure 54: Mortality (Per 1,000 Population), Australia, 2005–2010 130Figure 55: Mortality (Per 1,000 Population), Australia, Forecast, 2011–2020 131Figure 56: Major Causes of Mortality ('000), Australia, 2009 132Figure 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 134Figure 59: Major Causes of Male Mortality ('000), Australia, 2009 135Figure 60: Major Causes of Female Mortality ('000), Australia, 2009 136Figure 61: Gender Ratio (M/F), Australia, 2005–2010 137Figure 62: Life Expectancy at Birth (Years), Australia, 2005–2010 138Figure 63: Life Expectancy at Birth (Years), Australia, Forecast, 2011–2020 139Figure 64: Schools, Australia, 2005–2010 140Figure 65: School Students ('000), Australia, 2005–2010 141Figure 66: Education Participation (%), 15–24 Years Old, Australia, 2005–2010 142Figure 67: Overseas Students (%), Australia, 2005–2010 143Figure 68: Tertiary and Higher-education Students ('000), Australia, 2005–2010 144Figure 69: Unemployment Rate (%), Australia, 2005–2010 145Figure 70: Most Frequently Diagnosed Diseases ('000), Australia, 2007–2008 146Figure 71: Major Diseases, Australia, DALY (Per 100,000 Population), 2004 147Figure 72: Public Hospitals, Australia, 2005–2010 148Figure 73: Public Acute Care Hospitals, Australia, 2005–2010 149Figure 74: Public Psychiatric Hospitals, Australia, 2005–2010 150Figure 75: Private Hospitals, Australia, 2005–2010 151Figure 76: Private Free-standing Day Hospital Facilities, Australia, 2005–2010 152Figure 77: Other Private Hospitals, Australia, 2005–2010 153Figure 78: Public Hospital Beds (Per 1,000 Population), Australia, 2005–2010 154Figure 79: Private Hospital Beds (Per 1,000 Population), Australia, 2005–2010 155Figure 80: Physicians (Per 1,000 Population), Australia, 2005–2010 156Figure 81: Healthcare Personnel (Per 1,000 Population), Australia, 2005–2010 157Figure 82: Nurses (Per 1,000 Population), Australia, 2005–2010 158Figure 83: PM10 (Micrograms Per Cubic Meter), Australia, 2005–2010 159Figure 84: CO2 Emissions (000's Tons), Australia, 2005–2010 160Figure 85: NO2 Emissions (000's Tons), Australia, 2005–2010 161Figure 86: Healthcare Expenditure (% of GDP), Australia, 2005–2010 162Figure 87: Healthcare Expenditure, Australia, Share of Major Components (%), 2009–2010 163Figure 88: Healthcare Expenditure, Australia, Public-Private Share (%), 2005–2010 164Figure 89: Pharmaceutical R&D Expenditure ($m), Australia, 2005–2010 165Figure 90: Opportunities and Challenges, Healthcare Market, Australia, 2011 169

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