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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Australia

Summary

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

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Australia
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 13
2 Introduction 17
2.1 GlobalData Report Guidance 17
3 Overview of Pharmaceutical and Medical Device Markets 18
3.1 Pharmaceutical Market 18
3.1.1 Market Overview 18
3.1.2 Pharmaceutical Exports and Imports 21
3.1.3 Supply Channels 22
3.1.4 Market Segments 24
3.1.5 Overview of Top Five Disease Areas 27
3.1.6 Major Players 29
3.2 Medical Device Market 69
3.2.1 Market Overview 69
3.2.2 Overview of the Top Five Segments 72
3.2.3 Major Players 83
3.3 Market Drivers and Barriers 118
3.3.1 Drivers 118
3.3.2 Barriers 119
4 Market Access 121
4.1 Reimbursement and Payer Landscape 121
4.1.1 Overview of Healthcare System 121
4.1.2 Reimbursement Process 121
4.1.3 Overview of Insurance Providers 128
4.1.4 Patient Share in Healthcare Spending 134
4.1.5 Price Trend in Healthcare Services 135
4.1.6 Pricing Policies 136
4.2 Regulatory Landscape 138
4.2.1 Overview of Regulatory Agencies 138
4.2.2 Market Authorization Procedure for Pharmaceutical Products 139
4.2.3 New Medical Device Approval Process 143
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 149
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 150
4.2.6 Intellectual Property Rights 151
4.2.7 Clinical Trial Regulations 155
4.2.8 Pharmaceutical Advertising Regulations 157
4.2.9 Pharmacy Regulations 159
4.2.10 Labeling and Packaging Regulations 160
5 Country Analysis 163
5.1 Political Environment 163
5.1.1 Political Structure 163
5.1.2 Current Political Environment 165
5.1.3 Healthcare Policy Initiatives 165
5.2 Economic Landscape 167
5.3 Economic Indicators 170
5.3.1 Gross Domestic Product 170
5.3.2 Gross National Income 174
5.3.3 Inflation 175
5.3.4 Currency Exchange Rate 179
5.3.5 Foreign Direct Investment 180
5.3.6 Foreign Exchange Reserves 181
5.3.7 Trade Balance 182
5.3.8 Government Structural Balance 184
5.3.9 Government Net Debt 185
5.3.10 Major Industries 187
5.4 Demographics 188
5.4.1 Population 188
5.4.2 Education and Literacy 204
5.4.3 Employment 208
5.4.4 Disease Burden 209
5.5 Healthcare Infrastructure 210
5.5.1 Healthcare Facilities 210
5.5.2 Healthcare Parameters 215
5.5.3 Environmental Health 218
5.5.4 Healthcare Personnel 221
5.6 Healthcare Expenditure 224
5.6.1 Overview 224
5.6.2 Major Components of Healthcare Spending 225
5.6.3 Public and Private Sector Share 226
5.6.4 Spending in Pharmaceutical Research and Development 227
5.7 Trade Associations 228
5.7.1 Australian Pharmaceutical Marketing and Research Group 228
5.7.2 Pharmacy Guild of Australia 228
5.7.3 Generic Medicines Industry Association 228
5.8 Trade Fairs 229
6 Opportunities and Challenges 230
6.1 Opportunities 230
6.2 Challenges 231
7 Appendix 233
7.1 Abbreviations 233
7.2 Bibliography 237
7.3 Research Methodology 250
7.3.1 Coverage 250
7.3.2 Secondary Research 251
7.3.3 Forecasts 251
7.3.4 Expert Panel 251
7.4 Disclaimer 252

1.1 List of Tables
Table 1: Pharmaceutical Market, Australia, Revenue ($bn), 2008-2015 19
Table 2: Pharmaceutical Market, Australia, Revenue ($bn), 2016-2020 20
Table 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008-2015 21
Table 4: Pharmaceutical Market, Australia, Pharmacy and Wholesale Mark-up (%), 2016 23
Table 5: Pharmaceutical Market, Australia, Biotechnology Companies, Market Capitalization, Q4 2013 26
Table 6: Pharmaceutical Market, Australia, Top Five Therapeutic Areas, Pharmaceutical Expenditure $bn), 2015 28
Table 7: Pharmaceutical Market, Australia, Major Suppliers to PBS, Market Shares (%), 2015 30
Table 8: Pharmaceutical Market, Alphapharm, Global, Major Products, 2016 31
Table 9: Pharmaceutical Market, Apotex, Global, Major Products, 2016 34
Table 10: Pharmaceutical Market, Apotex, Global, Late-Stage Pipeline, 2016 35
Table 11: Pharmaceutical Market, Aspen, Global, Major Products, 2016 40
Table 12: Pharmaceutical Market, Pfizer, Global, Major Products, 2015 46
Table 13: Pharmaceutical Market, Pfizer, Global, Planned Filings, 2015 47
Table 14: Pharmaceutical Market, AstraZeneca, Global, Major Products, 2016 56
Table 15: Pharmaceutical Market, AstraZeneca, Global, Late-Stage Pipeline, 2016 57
Table 16: Medical Device Market, Australia, Revenue ($bn), 2008-2015 70
Table 17: Medical Device Market, Australia, Revenue ($bn), 2016-2020 71
Table 18: Medical Device Market, Australia, Revenue by Segment, 2015 72
Table 19: IVD Market, Australia, Revenue ($m), 2008-2015 73
Table 20: IVD Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2014 74
Table 21: Orthopedic Device Market, Australia, Revenue ($m), 2008-2015 75
Table 22: Orthopedic Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2015 76
Table 23: Cardiovascular Device Market, Australia, Revenue ($m), 2008-2015 77
Table 24: Cardiovascular Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2014 78
Table 25: Diagnostic Imaging Market, Australia, Revenue ($m), 2008-2015 79
Table 26: Diagnostic Imaging Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2012 80
Table 27: Ophthalmic Device Market, Australia, Revenue ($m), 2008-2015 81
Table 28: Ophthalmic Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2012 82
Table 29: Medical Device Market, Australia, Revenue ($m) and Market Share (%) of Major Players, 2012 83
Table 30: GE Healthcare, Global, Major Products, 2015 86
Table 31: GE Healthcare, Global, Pipeline Products, 2015 87
Table 32: Siemens Healthcare, Global, Major Products, 2015 95
Table 33: Philips Healthcare, Global, Major Products, 2015 103
Table 34: Major Products, Alcon, Major Products, 2015 117
Table 35: Market Access, Australia, Private Health Insurance Rate (%), 2014 132
Table 36: Market Access, Australia, Private Insurance Coverage Population (million), 2008-2015 133
Table 37: Healthcare Spending, Australia, Out-of-Pocket Expenditure (%), 2008-2015 134
Table 38: Market Access, Australia, Total Health Price Index (%), 2008-2014 135
Table 39: Market Access, Australia, Classification of Medical Devices, 2016 143
Table 40: Market Access, Australia, Conformity Assessment of a Medical Device, 2016 148
Table 41: Market Access, Australia, Regulation of Advertising of Therapeutic Goods, Australia, 2016 158
Table 42: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2008-2015 171
Table 43: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2016-2020 171
Table 44: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2008-2015 172
Table 45: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2016-2020 173
Table 46: Economic Indicators, Australia, Gross National Income per Capita ($), 2008-2014 174
Table 47: Economic Indicators, Australia, Average Consumer Price Index, 2008-2015 176
Table 48: Economic Indicators, Australia, Average Consumer Price Index, 2016-2020 176
Table 49: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2008-2015 177
Table 50: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2016-2020 178
Table 51: Economic Indicators, Australia, Currency Exchange Rate (AUD/$), 2008-2015 179
Table 52: Economic Indicators, Australia, Foreign Direct Investment ($bn), 2008-2014 180
Table 53: Economic Indicators, Australia, Foreign Exchange Reserves ($bn), 2008-2015 181
Table 54: Economic Indicators, Australia, Imports of Goods and Services ($bn), 2008-2014 182
Table 55: Economic Indicators, Australia, Exports of Goods and Services ($bn), 2008-2014 183
Table 56: Economic Indicators, Australia, General Government Structural Balance ($bn), 2008-2015 184
Table 57: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2008-2015 185
Table 58: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2016-2020 186
Table 59: Economic Indicators, Australia, Major Industries, Industry Value Added ($m), 2014-2015 188
Table 60: Demographics, Australia, Population (million), 2008-2015 189
Table 61: Demographics, Australia, Population (million), 2016-2020 190
Table 62: Demographics, Australia, Population, Urban and Rural Population Share (%), 2008-2015 191
Table 63: Demographics, Australia, Population, Urban and Rural Population Share Forecast (%), 2016-2020 192
Table 64: Demographics, Australia, Population Distribution by Age Group (%), 2008-2015 193
Table 65: Demographics, Australia, Population Distribution by Age Group (%), 2016-2020 194
Table 66: Demographics, Australia, Births (per 1,000 population), 2008-2015 195
Table 67: Demographics, Australia, Mortality (per 1,000 population), 2008-2015 196
Table 68: Demographics, Australia, Major Causes of Mortality, 2014 198
Table 69: Demographics, Australia, Mortality Rate of Children under Five (per 1,000 Live Births), 2008-2015 199
Table 70: Demographics, Australia, Immunization Rate (%), 2008-2015 199
Table 71: Demographics, Australia, Major Causes of Male Mortality (%), 2014 201
Table 72: Demographics, Australia, Major Causes of Female Mortality (‘000), 2014 202
Table 73: Demographics, Australia, Gender Ratio (M/F), 2008-2015 203
Table 74: Demographics, Australia, Life Expectancy at Birth (years), 2008-2015 204
Table 75: Demographics, Australia, Student Enrollment by Level of Education (% of Gross), 2008-2015 206
Table 76: Demographics, Australia, Overseas Students, 2015 207
Table 77: Demographics, Australia, Unemployment Rate (%), 2008-2013 208
Table 78: Major Diseases, Australia, Disability-Adjusted Life Years (as % of Total Burden), 2011 210
Table 79: Healthcare Infrastructure, Australia, Public and Private Hospitals, 2008-2015 211
Table 80: Healthcare Infrastructure, Australia, Public Acute and Psychiatric Hospitals (per 1,000 population), 2008-2015 212
Table 81: Healthcare Infrastructure, Australia, Private Free-Standing Day and Other Private Hospitals (per 1,000 population), 2008-2015 213
Table 82: Healthcare Infrastructure, Australia, Diagnostic Equipments (per million population), 2008-2013 214
Table 83: Healthcare Infrastructure, Australia, Hospital Beds (per 1,000 population), 2008-2015 215
Table 84: Healthcare Infrastructure, Australia, Public Hospital Beds by Type of Care (per 1,000 population), 2008-2015 216
Table 85: Healthcare Infrastructure, Australia, Doctors (per 100,000 population), 2008-2015 217
Table 86: Healthcare Infrastructure, Australia, PM10 (µg/m3), 2008-2015 219
Table 87: Healthcare Infrastructure, Australia, CO2 Emissions (million metric tons), 2008-2015 221
Table 88: Healthcare Infrastructure, Australia, Nurses (per 1,000 population), 2008-2015 221
Table 89: Healthcare Infrastructure, Australia, Pharmacists (per 1,000 population), 2008-2015 222
Table 90: Healthcare Infrastructure, Australia, Dentists (per 1,000 population), 2008-2015 223
Table 91: Healthcare Expenditure, Australia, Healthcare Expenditure (% of GDP), 2008-2015 224
Table 92: Healthcare Expenditure, Australia, Share of Major Components (%), 2014 225
Table 93: Healthcare Expenditure, Australia, Public-Private Share ($ per capita), 2008-2015 226
Table 94: Healthcare Expenditure, Australia, Pharmaceutical RandD ($bn), 2008-2015 227
Table 95: Healthcare Expenditure, Australia, Major Healthcare Trade Fairs, 2016 229

1.2 List of Figures
Figure 1: Pharmaceutical Market, Australia, Revenue ($bn), 2008-2015 19
Figure 2: Pharmaceutical Market, Australia, Revenue ($bn), 2016-2020 20
Figure 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008-2015 21
Figure 4: Pharmaceutical Market, Australia, Distribution Channels, 2016 22
Figure 5: Pharmaceutical Market, Australia, Top Five Therapeutic Areas, Pharmaceutical Expenditure ($bn), 2015 27
Figure 6: Pharmaceutical Market, Australia, Major Suppliers to PBS, Market Share (%), 2015 30
Figure 7: Medical Device Market, Australia, Revenue ($bn), 2008-2015 70
Figure 8: Medical Device Market, Australia, Revenue ($bn), 2016-2020 71
Figure 9: Medical Device Market, Australia, Revenue by Segment ($m), 2015 72
Figure 10: IVD Market, Australia, Revenue ($m), 2008-2015 73
Figure 11: IVD Market, Australia, Market Share of Major Players (%), 2014 74
Figure 12: Orthopedic Device Market, Australia, Revenue ($m), 2008-2015 75
Figure 13: Orthopedic Device Market, Australia, Market Share of Major Players (%), 2015 76
Figure 14: Cardiovascular Device Market, Australia, Revenue ($m), 2008-2015 77
Figure 15: Cardiovascular Device Market, Australia, Market Share of Major Players (%), 2014 78
Figure 16: Diagnostic Imaging Market, Australia, Revenue ($m), 2008-2015 79
Figure 17: Diagnostic Imaging Market, Australia, Market Share of Major Players (%), 2012 80
Figure 18: Ophthalmic Device Market, Australia, Revenue ($m), 2008-2015 81
Figure 19: Ophthalmic Device Market, Australia, Market Share of Major Players (%), 2012 82
Figure 20: Medical Device Market, Australia, Revenue of Major Players ($m), 2012 83
Figure 21: Healthcare Market, Australia, Drivers and Barriers, 2016 120
Figure 22: Healthcare System, Australia, Therapeutic Goods Administration, 2016 124
Figure 23: Healthcare System, Australia, Pharmaceuticals and Devices Reimbursement Process, 2014 125
Figure 24: Healthcare System, Australia, Pharmaceuticals Reimbursement Process, 2014 126
Figure 25: Healthcare System, Australia, Medical Devices Reimbursement Process, 2014 127
Figure 26: Market Access, Australia, Private Insurance Coverage Population (million), 2008-2015 133
Figure 27: Healthcare Spending, Australia, Out-of-Pocket Expenditure (%), 2008-2015 134
Figure 28: Market Access, Australia, Total Health Price Index (%), 2008-2014 135
Figure 29: Market Access, Australia, Registration Process Regulatory Phases, 2016 142
Figure 30: Market Access, Australia, Class I Non-sterile and Non-measuring Device Supply Process, 2016 144
Figure 31: Market Access, Australia, Supply Process for Medical Device Manufactured in Australia, 2016 145
Figure 32: Market Access, Australia, Supply Process for Medical Device Manufactured Overseas, 2016 146
Figure 33: Market Access, Australia, Supply Process for Medical Device Containing Medicine or Materials of Animal, Microbial Recombinant or Human Origin, 2016 147
Figure 34: Market Access, Australia, Patent Approval Process, 2015 153
Figure 35: Market Access, Australia, Trademark Approval Process, 2015 154
Figure 36: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2008-2015 170
Figure 37: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2016-2020 171
Figure 38: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2008-2015 172
Figure 39: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2016-2020 173
Figure 40: Economic Indicators, Australia, Gross National Income per Capita ($), 2008-2014 174
Figure 41: Economic Indicators, Australia, Average Consumer Price Index, 2008-2015 175
Figure 42: Economic Indicators, Australia, Average Consumer Price Index, 2016-2020 176
Figure 43: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2008-2015 177
Figure 44: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2016-2020 178
Figure 45: Economic Indicators, Australia, Currency Exchange Rate (AUD/$), 2008-2015 179
Figure 46: Economic Indicators, Australia, Foreign Direct Investment ($bn), 2008-2014 180
Figure 47: Economic Indicators, Australia, Foreign Exchange Reserves ($bn), 2008-2015 181
Figure 48: Economic Indicators, Australia, Imports of Goods and Services ($bn), 2008-2014 182
Figure 49: Economic Indicators, Australia, Exports of Goods and Services ($bn), 2008-2014 183
Figure 50: Economic Indicators, Australia, General Government Structural Balance ($bn), 2008-2015 184
Figure 51: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2008-2015 185
Figure 52: Economic Indicators, Australia, General Government Net Debt (% of GDP), 2016-2020 186
Figure 53: Economic Indicators, Australia, Major Industries, Industry Value Added ($m), 2014-2015 187
Figure 54: Demographics, Australia, Population (million), 2008-2015 189
Figure 55: Demographics, Australia, Population (million), 2016-2020 190
Figure 56: Demographics, Australia, Population, Urban and Rural Population Share (%), 2008-2015 191
Figure 57: Demographics, Australia, Population, Urban and Rural Population Share (%), 2016-2020 192
Figure 58: Demographics, Australia, Population Distribution by Age Group (%), 2008-2015 193
Figure 59: Demographics, Australia, Population Distribution by Age Group (%), 2016-2020 194
Figure 60: Demographics, Australia, Births (per 1,000 population), 2008-2015 195
Figure 61: Demographics, Australia, Mortality (per 1,000 population), 2008-2015 196
Figure 62: Demographics, Australia, Major Causes of Mortality (%), 2014 197
Figure 63: Demographics, Australia, Mortality Rate of Children under Five (per 1,000 live births), 2008-2015 198
Figure 64: Demographics, Australia, Immunization Rate (%), 2008-2015 199
Figure 65: Demographics, Australia, Major Causes of Male Mortality (%), 2014 200
Figure 66: Demographics, Australia, Major Causes of Female Mortality (%), 2014 201
Figure 67: Demographics, Australia, Gender Ratio (M/F), 2008-2015 202
Figure 68: Demographics, Australia, Life Expectancy at Birth (years), 2008-2015 203
Figure 69: Demographics, Australia, Student Enrollment by Level of Education (% of Gross), 2008-2015 206
Figure 70: Demographics, Australia, Overseas Student (%), 2015 207
Figure 71: Demographics, Australia, Unemployment Rate (%), 2008-2015 208
Figure 72: Major Diseases, Australia, Disability-Adjusted Life Years (as % of Total Burden), 2011 209
Figure 73: Healthcare Infrastructure, Australia, Public and Private Hospitals, 2008-2015 211
Figure 74: Healthcare Infrastructure, Australia, Public Acute and Psychiatric Hospitals (per 1,000 population), 2008-2015 212
Figure 75: Healthcare Infrastructure, Australia, Private Free-Standing Day and Other Private Hospitals (per 1,000 population), 2008-2015 213
Figure 76: Healthcare Infrastructure, Australia, Diagnostic Equipments (per million population), 2008-2015 214
Figure 77: Healthcare Infrastructure, Australia, Hospital Beds (per 1,000 population), 2008-2015 215
Figure 78: Healthcare Infrastructure, Australia, Hospital Beds by Type of Care (per 1,000 population), 2008-2015 216
Figure 79: Healthcare Infrastructure, Australia, Doctors (per 1,000 population), 2008-2015 217
Figure 80: Healthcare Infrastructure, Australia, PM2.5 (µg/m3), 2008-2015 219
Figure 81: Healthcare Infrastructure, Australia, CO2 Emissions (million metric tons), 2008-2015 220
Figure 82: Healthcare Infrastructure, Australia, Nurses (per 1,000 population), 2008-2015 221
Figure 83: Healthcare Infrastructure, Australia, Pharmacists (per 1,000 population), 2008-2015 222
Figure 84: Healthcare Infrastructure, Australia, Dentists (per 1,000 population), 2008-2015 223
Figure 85: Healthcare Expenditure, Australia, Healthcare Expenditure (% of GDP), 2008-2015 224
Figure 86: Healthcare Expenditure, Australia, Major Components (%), 2014 225
Figure 87: Healthcare Expenditure, Australia, Public-Private Share ($ per capita), 2008-2015 226
Figure 88: Healthcare Expenditure, Australia, Pharmaceutical RandD ($bn), 2008-2015 227
Figure 89: Healthcare Market, Australia, Opportunities and Challenges, 2016 232

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