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
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
