CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Australia

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GlobalData, the industry analysis specialist, has released its latest report: “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Australia”. The report is an essential source of information on and analysis of the healthcare, regulatory and reimbursement landscape in Australia. It identifies the key trends in the country’s healthcare market and provides insights into its demographic, regulatory, and reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of its pharmaceutical and medical device markets. It uses data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts. The population of Australia in 2015 was 23.86 million, having grown at a CAGR of 2% from 2008. Medicare is Australia’s public health insurance scheme, and provides free or subsidized healthcare services to the Australian population. The government is attempting to reduce the barriers to manufacturing drugs and encourage exports through the introduction of various new policies. In 2015, the government spent $22.03 billion on R&D on medical and health science and exported $3.53 billion of pharmaceutical products. The pharmaceutical market in Australia was worth $22.30 billion in 2015 and is projected to reach $25.20 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 2%. The medical device market was valued at $8.85 billion in 2015 and is projected to grow at a CAGR of 0.1% to $11.44 billion by 2020. These positive growth trends can be primarily attributed to: An increasingly elderly population Universal health coverage Government initiatives

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Australia, and includes:

An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers

Profiles and SWOT analyses of the major players in the pharmaceutical market: Alphapharm, Apotex, Aspen Pharmacare (Aspen), Pfizer and AstraZeneca; and profiles and SWOT analyses of the major players in the medical device market: GE Healthcare, Siemens Healthcare, Philips Healthcare, GSK and Alcon

An insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices

Detailed analysis of the country’s political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure

An overview of the opportunities for and challenges to growth in the Australian healthcare market

Reasons to Buy

This report will enhance your decision-making capability by allowing you to:

Develop business strategies by understanding the trends shaping and driving Australia’s healthcare market

Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact Australia’s healthcare market in the future

Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance

Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1GlobalData Report Guidance

3Overview of Pharmaceutical and Medical Device Markets

3.1Pharmaceutical Market

3.1.1Market Overview

3.1.2Pharmaceutical Exports and Imports

3.1.3Supply Channels

3.1.4Market Segments

3.1.5Overview of Top Five Disease Areas

3.1.6Major Players

3.2Medical Device Market

3.2.1Market Overview

3.2.2Overview of the Top Five Segments

3.2.3Major Players

3.3Market Drivers and Barriers

3.3.1Drivers

3.3.2Barriers

4Market Access

4.1Reimbursement and Payer Landscape

4.1.1Overview of Healthcare System

4.1.2Reimbursement Process

4.1.3Overview of Insurance Providers

4.1.4Patient Share in Healthcare Spending

4.1.5Price Trend in Healthcare Services

4.1.6Pricing Policies

4.2Regulatory Landscape

4.2.1Overview of Regulatory Agencies

4.2.2Market Authorization Procedure for Pharmaceutical Products

4.2.3New Medical Device Approval Process

4.2.4Licensing Process for Pharmaceutical and Medical Device Manufacturing

4.2.5Licensing Process for Pharmaceutical Exports and Imports

4.2.6Intellectual Property Rights

4.2.7Clinical Trial Regulations

4.2.8Pharmaceutical Advertising Regulations

4.2.9Pharmacy Regulations

4.2.10Labeling and Packaging Regulations

5Country Analysis

5.1Political Environment

5.1.1Political Structure

5.1.2Current Political Environment

5.1.3Healthcare Policy Initiatives

5.2Economic Landscape

5.3Economic Indicators

5.3.1Gross Domestic Product

5.3.2Gross National Income

5.3.3Inflation

5.3.4Currency Exchange Rate

5.3.5Foreign Direct Investment

5.3.6Foreign Exchange Reserves

5.3.7Trade Balance

5.3.8Government Structural Balance

5.3.9Government Net Debt

5.3.10Major Industries

5.4Demographics

5.4.1Population

5.4.2Education and Literacy

5.4.3Employment

5.4.4Disease Burden

5.5Healthcare Infrastructure

5.5.1Healthcare Facilities

5.5.2Healthcare Parameters

5.5.3Environmental Health

5.5.4Healthcare Personnel

5.6Healthcare Expenditure

5.6.1Overview

5.6.2Major Components of Healthcare Spending

5.6.3Public and Private Sector Share

5.6.4Spending in Pharmaceutical Research and Development

5.7Trade Associations

5.7.1Australian Pharmaceutical Marketing and Research Group

5.7.2Pharmacy Guild of Australia

5.7.3Generic Medicines Industry Association

5.8Trade Fairs

6Opportunities and Challenges

6.1Opportunities

6.2Challenges

7Appendix

7.1Abbreviations

7.2Bibliography

7.3Research Methodology

7.3.1Coverage

7.3.2Secondary Research

7.3.3Forecasts

7.3.4Expert Panel

7.4Disclaimer

Table

Table 1: Pharmaceutical Market, Australia, Revenue ($bn), 2008–2015

Table 2: Pharmaceutical Market, Australia, Revenue ($bn), 2016–2020

Table 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008–2015

Table 4: Pharmaceutical Market, Australia, Pharmacy and Wholesale Mark-up (%), 2016

Table 5: Pharmaceutical Market, Australia, Biotechnology Companies, Market Capitalization, Q4 2013

Table 6: Pharmaceutical Market, Australia, Top Five Therapeutic Areas, Pharmaceutical Expenditure $bn), 2015

Table 7: Pharmaceutical Market, Australia, Major Suppliers to PBS, Market Shares (%), 2015

Table 8: Pharmaceutical Market, Alphapharm, Global, Major Products, 2016

Table 9: Pharmaceutical Market, Apotex, Global, Major Products, 2016

Table 10: Pharmaceutical Market, Apotex, Global, Late-Stage Pipeline, 2016

Table 11: Pharmaceutical Market, Aspen, Global, Major Products, 2016

Table 12: Pharmaceutical Market, Pfizer, Global, Major Products, 2015

Table 13: Pharmaceutical Market, Pfizer, Global, Planned Filings, 2015

Table 14: Pharmaceutical Market, AstraZeneca, Global, Major Products, 2016

Table 15: Pharmaceutical Market, AstraZeneca, Global, Late-Stage Pipeline, 2016

Table 16: Medical Device Market, Australia, Revenue ($bn), 2008–2015

Table 17: Medical Device Market, Australia, Revenue ($bn), 2016–2020

Table 18: Medical Device Market, Australia, Revenue by Segment, 2015

Table 19: IVD Market, Australia, Revenue ($m), 2008–2015

Table 20: IVD Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2014

Table 21: Orthopedic Device Market, Australia, Revenue ($m), 2008–2015

Table 22: Orthopedic Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2015

Table 23: Cardiovascular Device Market, Australia, Revenue ($m), 2008–2015

Table 24: Cardiovascular Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2014

Table 25: Diagnostic Imaging Market, Australia, Revenue ($m), 2008–2015

Table 26: Diagnostic Imaging Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2012

Table 27: Ophthalmic Device Market, Australia, Revenue ($m), 2008–2015

Table 28: Ophthalmic Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2012

Table 29: Medical Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2012

Table 30: GE Healthcare, Global, Major Products, 2015

Table 31: GE Healthcare, Global, Pipeline Products, 2015

Table 32: Siemens Healthcare, Global, Major Products, 2015

Table 33: Philips Healthcare, Global, Major Products, 2015

Table 34: Major Products, Alcon, Major Products, 2015

Table 35: Market Access, Australia, Private Health Insurance Rate (%), 2014

Table 36: Market Access, Australia, Private Insurance Coverage Population (million), 2008–2015

Table 37: Healthcare Spending, Australia, Out-of-Pocket Expenditure (%), 2008–2015

Table 38: Market Access, Australia, Total Health Price Index (%), 2008–2014

Table 39: Market Access, Australia, Classification of Medical Devices, 2016

Table 40: Market Access, Australia, Conformity Assessment of a Medical Device, 2016

Table 41: Market Access, Australia, Regulation of Advertising of Therapeutic Goods, Australia, 2016

Table 42: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2008–2015

Table 43: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2016–2020

Table 44: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2008–2015

Table 45: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2016–2020

Table 46: Economic Indicators, Australia, Gross National Income per Capita ($), 2008–2014

Table 47: Economic Indicators, Australia, Average Consumer Price Index, 2008–2015

Table 48: Economic Indicators, Australia, Average Consumer Price Index, 2016–2020

Table 49: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2008–2015

Table 50: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2016–2020

Table 51: Economic Indicators, Australia, Currency Exchange Rate (AUD/$), 2008–2015

Table 52: Economic Indicators, Australia, Foreign Direct Investment ($bn), 2008–2014

Table 53: Economic Indicators, Australia, Foreign Exchange Reserves ($bn), 2008–2015

Table 54: Economic Indicators, Australia, Imports of Goods and Services ($bn), 2008–2014

Table 55: Economic Indicators, Australia, Exports of Goods and Services ($bn), 2008–2014

Table 56: Economic Indicators, Australia, General Government Structural Balance ($bn), 2008–2015

Table 57: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2008–2015

Table 58: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2016–2020

Table 59: Economic Indicators, Australia, Major Industries, Industry Value Added ($m), 2014–2015

Table 60: Demographics, Australia, Population (million), 2008–2015

Table 61: Demographics, Australia, Population (million), 2016–2020

Table 62: Demographics, Australia, Population, Urban and Rural Population Share (%), 2008–2015

Table 63: Demographics, Australia, Population, Urban and Rural Population Share Forecast (%), 2016–2020

Table 64: Demographics, Australia, Population Distribution by Age Group (%), 2008–2015

Table 65: Demographics, Australia, Population Distribution by Age Group (%), 2016–2020

Table 66: Demographics, Australia, Births (per 1,000 population), 2008–2015

Table 67: Demographics, Australia, Mortality (per 1,000 population), 2008–2015

Table 68: Demographics, Australia, Major Causes of Mortality, 2014

Table 69: Demographics, Australia, Mortality Rate of Children under Five (per 1,000 Live Births), 2008–2015

Table 70: Demographics, Australia, Immunization Rate (%), 2008–2015

Table 71: Demographics, Australia, Major Causes of Male Mortality (%), 2014

Table 72: Demographics, Australia, Major Causes of Female Mortality (‘000), 2014

Table 73: Demographics, Australia, Gender Ratio (M/F), 2008–2015

Table 74: Demographics, Australia, Life Expectancy at Birth (years), 2008–2015

Table 75: Demographics, Australia, Student Enrollment by Level of Education (% of Gross), 2008–2015

Table 76: Demographics, Australia, Overseas Students, 2015

Table 77: Demographics, Australia, Unemployment Rate (%), 2008–2013

Table 78: Major Diseases, Australia, Disability-Adjusted Life Years (as % of Total Burden), 2011

Table 79: Healthcare Infrastructure, Australia, Public and Private Hospitals, 2008–2015

Table 80: Healthcare Infrastructure, Australia, Public Acute and Psychiatric Hospitals (per 1,000 population), 2008–2015

Table 81: Healthcare Infrastructure, Australia, Private Free-Standing Day and Other Private Hospitals (per 1,000 population), 2008–2015

Table 82: Healthcare Infrastructure, Australia, Diagnostic Equipments (per million population), 2008–2013

Table 83: Healthcare Infrastructure, Australia, Hospital Beds (per 1,000 population), 2008–2015

Table 84: Healthcare Infrastructure, Australia, Public Hospital Beds by Type of Care (per 1,000 population), 2008–2015

Table 85: Healthcare Infrastructure, Australia, Doctors (per 100,000 population), 2008–2015

Table 86: Healthcare Infrastructure, Australia, PM10 (µg/m3), 2008–2015

Table 87: Healthcare Infrastructure, Australia, CO2 Emissions (million metric tons), 2008–2015

Table 88: Healthcare Infrastructure, Australia, Nurses (per 1,000 population), 2008–2015

Table 89: Healthcare Infrastructure, Australia, Pharmacists (per 1,000 population), 2008–2015

Table 90: Healthcare Infrastructure, Australia, Dentists (per 1,000 population), 2008–2015

Table 91: Healthcare Expenditure, Australia, Healthcare Expenditure (% of GDP), 2008–2015

Table 92: Healthcare Expenditure, Australia, Share of Major Components (%), 2014

Table 93: Healthcare Expenditure, Australia, Public–Private Share ($ per capita), 2008–2015

Table 94: Healthcare Expenditure, Australia, Pharmaceutical R&D ($bn), 2008–2015

Table 95: Healthcare Expenditure, Australia, Major Healthcare Trade Fairs, 2016

Figures

Figure 1: Pharmaceutical Market, Australia, Revenue ($bn), 2008–2015

Figure 2: Pharmaceutical Market, Australia, Revenue ($bn), 2016–2020

Figure 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008–2015

Figure 4: Pharmaceutical Market, Australia, Distribution Channels, 2016

Figure 5: Pharmaceutical Market, Australia, Top Five Therapeutic Areas, Pharmaceutical Expenditure ($bn), 2015

Figure 6: Pharmaceutical Market, Australia, Major Suppliers to PBS, Market Share (%), 2015

Figure 7: Medical Device Market, Australia, Revenue ($bn), 2008–2015

Figure 8: Medical Device Market, Australia, Revenue ($bn), 2016–2020

Figure 9: Medical Device Market, Australia, Revenue by Segment ($m), 2015

Figure 10: IVD Market, Australia, Revenue ($m), 2008–2015

Figure 11: IVD Market, Australia, Market Share of Major Players (%), 2014

Figure 12: Orthopedic Device Market, Australia, Revenue ($m), 2008–2015

Figure 13: Orthopedic Device Market, Australia, Market Share of Major Players (%), 2015

Figure 14: Cardiovascular Device Market, Australia, Revenue ($m), 2008–2015

Figure 15: Cardiovascular Device Market, Australia, Market Share of Major Players (%), 2014

Figure 16: Diagnostic Imaging Market, Australia, Revenue ($m), 2008–2015

Figure 17: Diagnostic Imaging Market, Australia, Market Share of Major Players (%), 2012

Figure 18: Ophthalmic Device Market, Australia, Revenue ($m), 2008–2015

Figure 19: Ophthalmic Device Market, Australia, Market Share of Major Players (%), 2012

Figure 20: Medical Device Market, Australia, Revenue of Major Players ($m), 2012

Figure 21: Healthcare Market, Australia, Drivers and Barriers, 2016

Figure 22: Healthcare System, Australia, Therapeutic Goods Administration, 2016

Figure 23: Healthcare System, Australia, Pharmaceuticals and Devices Reimbursement Process, 2014

Figure 24: Healthcare System, Australia, Pharmaceuticals Reimbursement Process, 2014

Figure 25: Healthcare System, Australia, Medical Devices Reimbursement Process, 2014

Figure 26: Market Access, Australia, Private Insurance Coverage Population (million), 2008–2015

Figure 27: Healthcare Spending, Australia, Out-of-Pocket Expenditure (%), 2008–2015

Figure 28: Market Access, Australia, Total Health Price Index (%), 2008–2014

Figure 29: Market Access, Australia, Registration Process Regulatory Phases, 2016

Figure 30: Market Access, Australia, Class I Non-sterile and Non-measuring Device Supply Process, 2016

Figure 31: Market Access, Australia, Supply Process for Medical Device Manufactured in Australia, 2016

Figure 32: Market Access, Australia, Supply Process for Medical Device Manufactured Overseas, 2016

Figure 33: Market Access, Australia, Supply Process for Medical Device Containing Medicine or Materials of Animal, Microbial Recombinant or Human Origin, 2016

Figure 34: Market Access, Australia, Patent Approval Process, 2015

Figure 35: Market Access, Australia, Trademark Approval Process, 2015

Figure 36: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2008–2015

Figure 37: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2016–2020

Figure 38: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2008–2015

Figure 39: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2016–2020

Figure 40: Economic Indicators, Australia, Gross National Income per Capita ($), 2008–2014

Figure 41: Economic Indicators, Australia, Average Consumer Price Index, 2008–2015

Figure 42: Economic Indicators, Australia, Average Consumer Price Index, 2016–2020

Figure 43: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2008–2015

Figure 44: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2016–2020

Figure 45: Economic Indicators, Australia, Currency Exchange Rate (AUD/$), 2008–2015

Figure 46: Economic Indicators, Australia, Foreign Direct Investment ($bn), 2008–2014

Figure 47: Economic Indicators, Australia, Foreign Exchange Reserves ($bn), 2008–2015

Figure 48: Economic Indicators, Australia, Imports of Goods and Services ($bn), 2008–2014

Figure 49: Economic Indicators, Australia, Exports of Goods and Services ($bn), 2008–2014

Figure 50: Economic Indicators, Australia, General Government Structural Balance ($bn), 2008–2015

Figure 51: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2008–2015

Figure 52: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2016–2020

Figure 53: Economic Indicators, Australia, Major Industries, Industry Value Added ($m), 2014–2015

Figure 54: Demographics, Australia, Population (million), 2008–2015

Figure 55: Demographics, Australia, Population (million), 2016–2020

Figure 56: Demographics, Australia, Population, Urban and Rural Population Share (%), 2008–2015

Figure 57: Demographics, Australia, Population, Urban and Rural Population Share (%), 2016–2020

Figure 58: Demographics, Australia, Population Distribution by Age Group (%), 2008–2015

Figure 59: Demographics, Australia, Population Distribution by Age Group (%), 2016–2020

Figure 60: Demographics, Australia, Births (per 1,000 population), 2008–2015

Figure 61: Demographics, Australia, Mortality (per 1,000 population), 2008–2015

Figure 62: Demographics, Australia, Major Causes of Mortality (%), 2014

Figure 63: Demographics, Australia, Mortality Rate of Children under Five (per 1,000 live births), 2008–2015

Figure 64: Demographics, Australia, Immunization Rate (%), 2008–2015

Figure 65: Demographics, Australia, Major Causes of Male Mortality (%), 2014

Figure 66: Demographics, Australia, Major Causes of Female Mortality (%), 2014

Figure 67: Demographics, Australia, Gender Ratio (M/F), 2008–2015

Figure 68: Demographics, Australia, Life Expectancy at Birth (years), 2008–2015

Figure 69: Demographics, Australia, Student Enrollment by Level of Education (% of Gross), 2008–2015

Figure 70: Demographics, Australia, Overseas Student (%), 2015

Figure 71: Demographics, Australia, Unemployment Rate (%), 2008–2015

Figure 72: Major Diseases, Australia, Disability-Adjusted Life Years (as % of Total Burden), 2011

Figure 73: Healthcare Infrastructure, Australia, Public and Private Hospitals, 2008–2015

Figure 74: Healthcare Infrastructure, Australia, Public Acute and Psychiatric Hospitals (per 1,000 population), 2008–2015

Figure 75: Healthcare Infrastructure, Australia, Private Free-Standing Day and Other Private Hospitals (per 1,000 population), 2008–2015

Figure 76: Healthcare Infrastructure, Australia, Diagnostic Equipments (per million population), 2008–2015

Figure 77: Healthcare Infrastructure, Australia, Hospital Beds (per 1,000 population), 2008–2015

Figure 78: Healthcare Infrastructure, Australia, Hospital Beds by Type of Care (per 1,000 population), 2008–2015

Figure 79: Healthcare Infrastructure, Australia, Doctors (per 1,000 population), 2008–2015

Figure 80: Healthcare Infrastructure, Australia, PM2.5 (µg/m3), 2008–2015

Figure 81: Healthcare Infrastructure, Australia, CO2 Emissions (million metric tons), 2008–2015

Figure 82: Healthcare Infrastructure, Australia, Nurses (per 1,000 population), 2008–2015

Figure 83: Healthcare Infrastructure, Australia, Pharmacists (per 1,000 population), 2008–2015

Figure 84: Healthcare Infrastructure, Australia, Dentists (per 1,000 population), 2008–2015

Figure 85: Healthcare Expenditure, Australia, Healthcare Expenditure (% of GDP), 2008–2015

Figure 86: Healthcare Expenditure, Australia, Major Components (%), 2014

Figure 87: Healthcare Expenditure, Australia, Public–Private Share ($ per capita), 2008–2015

Figure 88: Healthcare Expenditure, Australia, Pharmaceutical R&D ($bn), 2008–2015

Figure 89: Healthcare Market, Australia, Opportunities and Challenges, 2016

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