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Australia – Healthcare, Regulatory and Reimbursement Landscape

GlobalData, the industry analysis specialist, has released its latest report: “Australia – Healthcare, Regulatory and Reimbursement Landscape”. The report is an essential source of information on 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 Australian pharmaceutical market is one of the most developed markets in the Asia-Pacific region. It is jointly run by all levels of the Australian government – federal, state and territorial, and local. The growth in the pharmaceutical market is attributed to the growing and aging population, excellent access to medicines, rapidly improving economy, faster-developing technologies, and chronic and lifestyle diseases. Australia’s pharmaceutical market, based on production value, increased from AUD11.82B in 2013 to AUD15.56B in 2019 at a Compound Annual Growth Rate (CAGR) of 4.69%. In terms of US Dollars, the market decreased from $11.41B in 2013 to $10.82B in 2019 at a negative CAGR of 0.89%. It is forecast to reach about $10.16B in 2026. The medical devices market of Australia was valued at $6.19B in 2016, which increased to $7.63B in 2020 at a CAGR of 5.37%. It is expected to grow to $10.32B in 2027.

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: Roche, Pfizer, Sanofi, CSL, and Sonic Healthcare.

•Profiles and SWOT analyses of the major players in the medical device market: Medtronic, Stryker, Boston Scientific, Ansell, and Nanosonics.

•An insightful review of the COVID-19 epidemiology, COVID-19 impact and developments in healthcare market, HealthTech landscape, 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 healthcare policy highlights, 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 the Australian healthcare market

•Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the Australian 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

1. Table of Contents

1.1 List of Figures

1.2 List of Tables

2. Executive Summary

2.1 Executive Summary

2.2 Key Highlights – Facts about the Australian Healthcare Market

2.3 Key Highlights: Healthcare Startups in Australia

2.4 Key Events: Australian Healthcare Timeline, 2015–2021

2.5 Key Events: Australian Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2020–2021

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, Australia, 2020

3. Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Exports

3.3 Pharmaceutical Market – Imports

3.4 Pharmaceutical Market – Supply Channels, Australia

3.5 Pharmaceutical Market – Market Segments

3.6 Major Therapeutic Areas, Australia

3.7 COVID-19 Epidemiology, Australia

3.8 COVID-19 Impact and Developments in the Healthcare Market, Australia

3.9 COVID-19 Clinical Trials Landscape, Australia

3.10 Pharmaceutical Market – Major Players

4. Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Devices Market – Major Players

5. Pharmaceutical and Medical Devices Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6. Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, Australia, 2020–2021

6.2 Deal Analysis: Medical Device Market, Australia, 2020–2021

7. HealthTech Landscape

7.1 HealthTech Landscape, Australia

7.2 HealthTech Deals Landscape, Australia

7.3 Key HealthTech Deals, Australia

7.4 Adoption of Technology in Healthcare, Australia

7.5 HealthTech Landscape, Australia

7.6 HealthTech Landscape: Benefits and Risks, Australia

8. Market Access

8.1 Overview of Healthcare System, Australia

8.2 Reimbursement Process, Australia

8.3 Overview of Insurance Providers, Public Insurance, Australia

8.4 Overview of Insurance Providers, Private Insurance, Australia

8.5 Healthcare Spending and Prescription Drug Price Trend, Australia

8.5 Pricing Policies, Australia

8.6 Regulatory Landscape, Australia

8.6.1 Marketing Authorization for Pharmaceutical Products, Australia

8.6.2 Marketing Authorization for Medical Devices, Australia

8.6.3 Intellectual Property Rights, Patent, Australia

8.6.4 Intellectual Property Rights, Trademark, Australia

8.6.5 Clinical Trial Regulation Process, Australia

8.6.6 Pharmaceutical Clinical Trials Landscape, Australia

8.6.7 Medical Device Clinical Trials Landscape, Australia

8.6.8 Pharmaceutical Manufacturing and Licensing, Australia

8.6.9 Pharmaceutical Export and Import, Australia

8.6.10 Pharmaceutical Advertising Regulations, Australia

8.6.11 Pharmacy Regulations, Australia

8.6.12 Labeling and Packaging Regulations, Australia

9. Country Healthcare Landscape

9.1 Australian Healthcare Policy Highlights

9.2 Healthcare Facilities, Australia

9.3 Healthcare Resources, Australia

9.4 Life Expectancy and Immunization Rate, Australia

9.5 Environmental Health, Australia

9.6 Healthcare Personnel, Australia

9.7 Disease Burden, Australia

9.8 Healthcare Expenditure, Australia

10 Trade Associations, Australia

11 Trade Fairs, Australia

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.2 Bibliography

13.3 About GlobalData

13.4 Contact Us

13.5 Disclaimer

List of Tables

Table 1: Approved Biosimilars, Australia, 2021

Table 2: Major Therapeutic Areas by Pharmaceutical Sales ($B), Australia, 2019

Table 3: COVID-19 Indicators (Number of Cases), Global and Australia, 2020–2021

Table 4: COVID-19-Related Travel Restrictions, Australia, 2020–2021

Table 5: COVID-19 Vaccine Trials, Australia, 2020–2021

Table 6: COVID-19 Approved Vaccines, Australia, 2021

Table 7: COVID-19 Vaccines Undergoing Evaluation, Australia, 2021

Table 8: COVID-19 Treatments: Provisional Determinations, Australia, 2021

Table 9: COVID-19 Treatments: Provisional Registrations, Australia, 2021

Table 10: COVID-19 Drugs: Drugs Undergoing Evaluation, Australia, 2021

Table 11: Pipeline Medical Devices for COVID-19, Australia, 2020–2021

Table 12: COVID-19 Rapid Self Tests, Australia, 2021

Table 13: Medical Devices Market, Australia, Major Segments ($B), 2020

Table 14: Hospital Supplies Market, Australia, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 15: Orthopedic Devices Market, Australia, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 16: General Surgery Devices Market, Australia, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 17: Cardiovascular Devices Market, Australia, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 18: Anesthesia and Respiratory Devices Market, Australia, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 19: Principles of Australian Government HTA Processes, Australia, 2021

Table 20: MSN Thresholds, Australia, 2021

Table 21: Customer Made Payment Before and After Thresholds, Australia, 2021

Table 22: Medicare Levy Surcharge Rate, Australia, 2021

Table 23: Difference in the Services offered by Public and Private Insurance, Australia, 2021

Table 24: Costs of Wholesale Mark-Up, Australia, 2020

Table 25: Dispensing Price for Highly Specialized Drugs, Australia, 2013–2020

Table 26: AHI Fee, Australia, 2020

Table 27: Annual Charges for Prescription Medicines, Australia, 2021

Table 28: Priority Review Pathway for Prescription Medicines, Australia, 2021

Table 29: Standard Prescription Medicine Fees, Australia, 2021

Table 30: Fees for Applications, Australia, 2021

Table 31: Classification of Medial Devices (Not IVD Medical Devices), Australia, 2021

Table 32: Classification of IVD Medial Devices, Australia, 2021

Table 33: Application Fees for Medical Devices, Australia, 2021

Table 34: Annual Charges for IVD Medical Devices, Australia, 2021

Table 35: Annual Charges of Medical Devices, Australia, 2021

Table 36: Patent Examination Fees, Australia, 2021

Table 37: Application Fee for Patent Filing, Australia, 2021

Table 38: International Patent Fees, Australia, 2021

Table 39: Opposition and Hearing Fees, Australia, 2021

Table 40: Application Fee for the Trademark using the TM Headstart, Australia, 2021

Table 41: Trademark Application Fee through the Standard Filing Procedure, Australia, 2021

Table 42: Fees for Trademark Renewal, Australia, 2021

Table 43: Annual Charges of Manufacturing License, Australia, 2021

Table 44: Fees of Australian Manufacturing License, Australia, 2021

Table 45: GMP Clearance Fees, Australia, 2021

Table 46: Fees for Export Only Listed Medicines, Australia, 2021

Table 47: Fees for Export Certification for Medicines, Australia, 2021

Table 48: Fees for Export Certification for Medical Devices, Australia, 2021

Table 49: Fees for Export Only Devices, Australia, 2021

Table 50: Trade Fairs, Australia

List of Figures

Figure 1: Pharmaceutical Market, Australia, Revenue ($B and AUDB), 2013–2020

Figure 2: Medical Devices Market, Australia, Revenue ($B), 2016–2020

Figure 3: Healthcare Startups in Australia, 2020

Figure 4: Country Profile, Australia, 2020

Figure 5: Pharmaceutical Market, Australia, Revenue ($B and AUDB), 2013–2020

Figure 6: Pharmaceutical Market, Australia, Revenue Forecast ($B and AUDB), 2021–2026

Figure 7: Pharmaceutical Exports ($B), Australia, 2013–2020

Figure 8: Top Export Partners, Australia, 2020

Figure 9: Pharmaceutical Imports ($B), Australia, 2013–2020

Figure 10: Top Import Partners, Australia, 2020

Figure 11: Pharmaceutical Supply Channel, Australia, 2021

Figure 12: Process of eTP, Australia, 2021

Figure 13: Principles of GBMA, Australia, 2021

Figure 14: Facts Regarding Generics, Australia, 2021

Figure 15: Working of Price Disclosure, Australia, 2021

Figure 16: Number of Biosimilars Approved, Australia, 2010-2021

Figure 17: OTC Market, Revenue ($B), Australia, 2013–2020

Figure 18: OTC Medicines Market, Major Distribution Channels ($M), Australia, 2020

Figure 19: OTC Medicines Market, Major Categories ($M), Australia, 2020

Figure 20: Major Therapeutic Areas by Production Value, Australia, 2019

Figure 21: COVID-19 Cases, Australia, 2020–2021

Figure 22: COVID-19 Deaths, Australia, 2020–2021

Figure 23: COVID-19 Stringency Index, Australia, 2020–2021

Figure 24: Containment and Health Index, COVID-19, Australia, 2020–2021

Figure 25: COVID-19 Fiscal Stimulus Timeline, Australia, 2020–2021

Figure 26: COVID-19 Vaccine Doses Administration, Number of Vaccine Doses Administered, Australia, 2021

Figure 27: Five Key Areas of Australia’s COVID-19 Vaccine and Treatment Strategy, Australia, 2020–2021

Figure 28: COVID-19 Vaccine Plan, Australia, 2021

Figure 29 Objectives of COVID-19 Vaccine Safety Monitoring Plan, Australia, 2021

Figure 30: Vaccine Doses, Australia, 2021

Figure 31: National Plan to Transition Australia’s National COVID-19 Response, Australia, 2021

Figure 32: Top COVID-19 Markets by Product Categories (Number of Available Marketed Products), Australia, 2020–2021

Figure 33: Top COVID-19 Products by Device Class (Number of Available Marketed Products), Australia, 2020–2021

Figure 34: Top COVID-19 IVD Products by Equipment Type (Number of Available Marketed Products), Australia, 2020–2021

Figure 35: Top COVID-19 Hospital Supplies Products by Equipment Type (Number of Available Marketed Products), Australia, 2020–2021

Figure 36: COVID-19 Clinical Trials Count by Trial Status, Australia, 2020–2021

Figure 37: COVID-19 Clinical Trials Count by Market Categories, Australia, 2020–2021

Figure 38: Top COVID-19 Clinical Trials Sponsors by Trial Count, Australia, 2020–2021

Figure 39: Medical Devices Market, Australia, Revenue ($B), 2016–2020

Figure 40: Medical Devices Market, Australia, Revenue ($B), 2021–2027

Figure 41: Medical Devices Market, Australia, Major Segments (%), 2020

Figure 42: Hospital Supplies Market, Australia, Revenue ($B), 2017–2025

Figure 43: Hospital Supplies Market, Australia, Market Share of Major Players (%), 2020

Figure 44: Orthopedic Devices Market, Australia, Revenue ($B), 2017–2025

Figure 45: Orthopedic Devices Market, Australia, Market Share of Major Players (%), 2020

Figure 46: General Surgery Devices Market, Australia, Revenue ($B), 2017-2025

Figure 47: General Surgery Devices Market, Australia, Market Share of Major Players (%), 2020

Figure 48: Cardiovascular Devices Market, Australia, Revenue ($B), 2017–2025

Figure 49: Cardiovascular Devices Market, Australia, Market Share of Major Players (%), 2020

Figure 50: Anesthesia and Respiratory Devices Market, Australia, Revenue ($B), 2017–2025

Figure 51: Anesthesia and Respiratory Devices Market, Australia, Market Share of Major Players (%), 2020

Figure 52: Diagnostic Market, Australia, Revenue ($B), 2015–2020

Figure 53: Diagnostic Market, Australia, Revenue ($B), 2021–2025

Figure 54: Medical Devices Market, Australia, Revenue ($B) of Major Companies, 2020

Figure 55: Deal Value and Deal Count, Pharmaceutical Market, Australia, 2020–2021

Figure 56: Deal Value and Deal Count Subtypes, Pharmaceutical Market, Australia, 2020–2021

Figure 57: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, Australia, 2020–2021

Figure 58: Top Therapy Areas by Deal Value, Pharmaceutical Market, Australia, 2020–2021

Figure 59: Top Therapy Areas by Deal Count, Pharmaceutical Market, Australia, 2020–2021

Figure 60: M&A Deals by Quarter, Pharmaceutical Market, Australia, 2020–2021 (by Value and by Number)

Figure 61: VC Deals by Quarter, Pharmaceutical Market, Australia, 2020–2021 (by Value and by Number)

Figure 62: Deal Value and Deal Count, Medical Devices Market, Australia, 2020–2021

Figure 63: Deal Value and Deal Count Subtypes, Medical Devices Market, Australia, 2020–2021

Figure 64: Deal Value and Deal Count, Quarterly, Medical Devices Market, Australia, 2020–2021

Figure 65: Top Equipment Sectors by Deal Value, Medical Devices Market, Australia, 2020–2021

Figure 66: Top Equipment Sectors by Deal Count, Medical Devices Market, Australia, 2020–2021

Figure 67: M&A Deals by Quarter, Medical Devices Market, Australia, 2020–2021 (by Value and by Number)

Figure 68: VC Deals by Quarter, Medical Devices Market, Australia, 2020–2021 (by Value and by Number)

Figure 69: Benefits of Digital Health, Australia, 2020

Figure 70: Deal Value ($M) and Deal Count, HealthTech, Australia, 2020–2021

Figure 71: Deal Value and Deal Count (Number of Deals) by sector, HealthTech, Australia, 2020–2021

Figure 72: Key Themes of Australia’s National Digital Health Strategy, Australia, 2020

Figure 73: Strategic Priorities of Australia’s National Digital Health Strategy, Australia, 2020

Figure 74: Digital Health Today and Future Timeline as per the Digital Health Strategy, Australia, 2020

Figure 75: Organization of Healthcare System, Australia, 2021

Figure 76: HTA Process of Market Entry and Reimbursement, Australia, 2021

Figure 77: Proportion of Benefits Paid by Hospital Cover Private Health Insurance by Service Type, (in $M) Australia, 2018–2019

Figure 78: Proportion of Benefits Paid by General Cover Private Health Insurance by Service Type (in $M), Australia, 2018–2019

Figure 79: OOP Expenditure (% of Total Expenditure on Health), Australia, 2013–2020

Figure 80: Annual Rate of Change (%), Consumer Price Index, Australia, 2013–2021

Figure 81: Organization of TGA, Australia, 2021

Figure 82: Phases and Milestones of Registration of Prescription Medicines, Australia, 2021

Figure 83 Process of Registration of OTC, Australia, 2021

Figure 84: Process of Registration of Complimentary Medicines, Australia, 2021

Figure 85: Process of Registration of Medical Devices, Australia, 2021

Figure 86: Patent Approval Process, Australia, 2021

Figure 87: Trademark Approval Process, Australia, 2021

Figure 88: Fees for the CTN and CTA schemes of Clinical Trials, Australia, 2021

Figure 89: Pharmaceutical Clinical Trials Count by Trial Status, Australia, 2020–2021

Figure 90: Pharmaceutical Clinical Trials Count by Therapy Area, Australia, 2020–2021

Figure 91: Pharmaceutical Clinical Trials Count by Phase, Australia, 2020–2021

Figure 92: Pharmaceutical Clinical Trials Count by Sponsors, Australia, 2020–2021

Figure 93: Medical Devices Clinical Trials Count by Trial Status, Australia, 2020–2021

Figure 94: Medical Devices Clinical Trials Count by Device Category, Australia, 2020–2021

Figure 95: Medical Devices Clinical Trials Count by Indication, Australia, 2020–2021

Figure 96: Medical Devices Clinical Trials Sponsors by Count, Australia, 2020–2021

Figure 97: Process of Licensing of Pharmaceutical Products, Australia, 2021

Figure 98: Export Procedure, Australia, 2021

Figure 99: Necessary Labelling on the Package, Australia, 2021

Figure 100: Types of Packaging of Drugs, Australia, 2021

Figure 101: Number of Hospitals, Australia, 2012–2019

Figure 102: Number of Diagnostic Equipment, Australia, 2013–2019

Figure 103: Hospital Beds (per 1,000 population), Australia, 2012–2019

Figure 104: Acute Care Hospital Beds (per 1,000 population), Australia, 2012–2019

Figure 105: Psychiatric Care Hospital Beds (per 1,000 population), Australia, 2012–2019

Figure 106: Life Expectancy at Birth (Years), Australia, 2012–2019

Figure 107: Immunization Rate (%), Australia, 2012–2018

Figure 108: PM2.5 (µg per m3), Australia, 2013–2019

Figure 109: CO2 Emissions (Million Tons), Australia, 2013–2020

Figure 110: Physicians (per 1,000 Population), Australia, 2013–2019

Figure 111: Dentists (per 1,000 Population), Australia, 2013–2019

Figure 112: Pharmacists (per 1,000 Population), Australia, 2013–2019

Figure 113: Nurses (per 1,000 Population), Australia, 2013–2019

Figure 114: Major Causes of Mortality (per 100,000 Population), Australia, 2019

Figure 115: Major Causes of Male Mortality (per 100,000 Population), Australia, 2019

Figure 116: Major Causes of Female Mortality (per 100,000 Population), Australia, 2019

Figure 117: DALYs by Major Disease (per 100,000 population), Australia, 2019

Figure 118: Healthcare Expenditure as Percentage of GDP (%), Australia, 2012–2019

Figure 119: Health Expenditure Share (% of Health Spending), Australia, 2013–2019

Figure 120: Healthcare Expenditure Components by Function (% of Total Health Expenditure), Australia, 2018

Figure 121: Pharmaceutical Spending (% of Total Health Spending), Australia, 2012–2018

Figure 122: Opportunities and Challenges

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