REFERENCE CODE GDHC0068CHR | PUBLICATION DATE SEPTEMBER 2014 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
REFERENCE CODE GDHC0068CHR | PUBLICATION DATE SEPTEMBER 2014
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
Healthcare, Regulatory and Reimbursement Landscape – Australia 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
Executive Summary
The Australian healthcare market is a mature market driven by universal healthcare coverage and good access to facilities such as government-subsidized medicines. The growing elderly population and its associated disease burden, well-defined regulatory guidelines, the usage of substitute drugs and the introduction of a new manufacturing policy will drive the growth of the pharmaceutical market in future. However, a focus on generic substitution and price cuts will restrict the growth of the market.
The pharmaceuticals market in Australia was worth
approximately $XX billion in 2008. This total is
expected to reach approximately $XX billion in
2020, increasing at a Compound Annual Growth
Rate (CAGR) of XX% (Department of Industry,
2013a). The segments that dominated the market
in 2013 were the drugs for the diseases of the
Central Nervous System (CNS), cardiovascular,
and respiratory system.
In June 2013, the largest firm by Pharmaceutical
Benefits Scheme (PBS) sales was Pfizer, with
sales equivalent to XX% of the value of total sales
made to the PBS. The leading XX suppliers by
sales contributed more than XX% of the value of
total sales made to the PBS. In June 2013,
Alphapharm was the largest firm in terms of the
number of prescriptions dispensed under the PBS,
accounting for XX% (PBS, 2013).
The population of Australia amounted to
approximately XX million in 2013, having grown at
a CAGR of XX% from 2008. The elderly population
is increasing in size and, as of 2013, accounted for
XX% of the entire population. This population
segment is growing at higher rate (XX%) than the
global average of XX% and the European average
of XX% (UN, 2013). The prevalence of non-
communicable diseases, such as cardiovascular
disease, respiratory, metabolic disorder and
cancer, has increased due to an increasingly
sedentary way of life.
In 2013, the government spent approximately $XX
billion on R&D on medical and health science and
exported $XX billion in pharmaceuticals. The
government is taking initiatives to reduce the
barriers restricting the manufacture of drugs and
encourage exports by introducing new policies.
Medicare, which is Australia’s public health
insurance scheme, provides free or subsidized
healthcare services to the Australian population.
The PBS component of Medicare provides access
to a wide range of necessary and cost-effective
prescription medicines. Medicare is funded
primarily from general taxes and the Medicare
Levy, which is based on taxable income.
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
Executive Summary
The increasing generic substitution and cost-
cutting measures adopted by the government have
had a negative impact on market growth. Since
2012, the government has reduced the prices of
medicines listed on the PBS eight times, by
percentages ranging from XX% to XX% (PBS,
2014a). On April 1, 2012, the biggest cut on the
prices of medicines listed on the PBS was
introduced, and the prices of approximately XX
brands of XX popular prescription medicines were
reduced (Maiden, 2012). Generic substitution by
pharmacists has been permitted since 1994 and
has reduced the overall value of the
pharmaceutical market.
Pharmaceutical Market, Australia, Revenue ($bn), 2008–2020
2008 2013 2015 2020
Rev
enue
($b
n)
CAGR (2008–2020) : XX%
Source: Department of Industry, 2013a
The value of the Australian medical devices market
amounted to $XX billion in 2008 and is expected to
grow at a CAGR of XX% to reach an estimated
$XX billion in 2020. Major segments in the medical
devices market in 2013 were In Vitro Diagnostics
(IVD) with a XX% share, orthopedic devices with
XX%, and ophthalmic devices with XX%. The
market is driven by factors such as increasing
awareness regarding early detection and diagnosis
of disease, advancements in medical technology,
and an increase in the size of the elderly
population.
Medical Device Market, Australia, Revenue ($bn), 2008–2020
2008 2013 2015 2020
Rev
enue
($b
n)
CAGR (2008–2020) : XX%
Source: GlobalData, Medical eTrack [Accessed, July 11, 2014]
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
1 Table of Contents
1 Table of Contents ....................................................................................................................... 6
1.1 List of Tables .................................................................................................................... 11
1.2 List of Figures ................................................................................................................... 15
2 Introduction ............................................................................................................................... 20
2.1 GlobalData Report Guidance ............................................................................................ 20
3 Overview of Pharmaceutical and Medical Device Markets ........................................................ 21
3.1 Pharmaceutical Market ..................................................................................................... 21
3.1.1 Market Overview ........................................................................................................... 21
3.1.2 Pharmaceutical Exports and Imports ............................................................................. 24
3.1.3 Supply Channels ........................................................................................................... 25
3.1.4 Market Segments .......................................................................................................... 27
3.1.5 Overview of Top Five Disease Areas ............................................................................ 30
3.1.6 Major Players ................................................................................................................ 32
3.1.7 Pfizer ............................................................................................................................. 34
3.1.8 AstraZeneca .................................................................................................................. 42
3.1.9 Novartis ......................................................................................................................... 51
3.1.10 Sanofi ............................................................................................................................ 62
3.1.11 Alphapharm ................................................................................................................... 68
3.2 Medical Device Market ...................................................................................................... 70
3.2.1 Market Overview ........................................................................................................... 70
3.2.2 Overview of the Top Five Segments .............................................................................. 73
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3.2.3 Diagnostic Market ......................................................................................................... 88
3.2.4 Major Players ................................................................................................................ 90
3.2.5 Siemens Healthcare ...................................................................................................... 91
3.2.6 GE Healthcare............................................................................................................... 96
3.2.7 Medtronic .................................................................................................................... 105
3.2.8 DePuy Companies ...................................................................................................... 113
3.2.9 F. Hoffmann-La Roche ................................................................................................ 119
3.3 Market Drivers and Barriers ............................................................................................ 126
3.3.1 Drivers......................................................................................................................... 126
3.3.2 Barriers ....................................................................................................................... 127
4 Market Access ........................................................................................................................ 129
4.1 Reimbursement and Payer Landscape ........................................................................... 129
4.1.1 Overview of Healthcare System .................................................................................. 129
4.1.2 Reimbursement Process ............................................................................................. 129
4.1.3 Overview of Insurance Providers ................................................................................. 133
4.1.4 Patient Share in Healthcare Spending ......................................................................... 140
4.1.5 Price Trend in Healthcare Services ............................................................................. 141
4.1.6 Pricing Policies ............................................................................................................ 142
4.2 Regulatory Landscape .................................................................................................... 144
4.2.1 Overview of Regulatory Agencies................................................................................ 144
4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 145
4.2.3 New Medical Device Approval Process ....................................................................... 150
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 156
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4.2.5 Licensing Process for Pharmaceutical Exports and Imports ........................................ 157
4.2.6 Intellectual Property Rights.......................................................................................... 158
4.2.7 Clinical Trial Regulations ............................................................................................. 161
4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 163
4.2.9 Pharmacy Regulations ................................................................................................ 165
4.2.10 Labeling and Packaging Regulations .......................................................................... 166
5 Country Analysis ..................................................................................................................... 168
5.1 Political Environment....................................................................................................... 168
5.1.1 Political Structure ........................................................................................................ 168
5.1.2 Analysis of Current Political Environment .................................................................... 169
5.1.3 Healthcare Policy Initiatives ......................................................................................... 170
5.2 Economic Landscape ...................................................................................................... 172
5.3 Economic Indicators ........................................................................................................ 174
5.3.1 Gross Domestic Product ............................................................................................. 174
5.3.2 Gross National Income ................................................................................................ 179
5.3.3 Inflation ....................................................................................................................... 180
5.3.4 Currency Exchange Rate ............................................................................................ 183
5.3.5 Foreign Direct Investment ........................................................................................... 184
5.3.6 Foreign Exchange Reserves ....................................................................................... 186
5.3.7 Trade Balance ............................................................................................................. 187
5.3.8 Government Structural Balance................................................................................... 189
5.3.9 Government Net Debt ................................................................................................. 191
5.3.10 Major Industries ........................................................................................................... 192
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5.4 Demographics ................................................................................................................. 193
5.4.1 Population ................................................................................................................... 193
5.4.2 Education and Literacy ................................................................................................ 212
5.4.3 Employment ................................................................................................................ 216
5.4.4 Disease Burden ........................................................................................................... 217
5.5 Healthcare Infrastructure ................................................................................................. 221
5.5.1 Healthcare Facilities .................................................................................................... 221
5.5.2 Healthcare Parameters ............................................................................................... 228
5.5.3 Environmental Health .................................................................................................. 232
5.5.4 Healthcare Personnel .................................................................................................. 236
5.6 Healthcare Expenditure ................................................................................................... 239
5.6.1 Overview ..................................................................................................................... 239
5.6.2 Major Components of Healthcare Spending ................................................................ 241
5.6.3 Public and Private Sector Share .................................................................................. 242
5.6.4 Spending in Pharmaceutical Research and Development ........................................... 243
5.7 Trade Associations ......................................................................................................... 244
5.7.1 Australian Pharmaceutical Marketing and Research Group......................................... 244
5.7.2 Pharmacy Guild of Australia ........................................................................................ 244
5.7.3 Generic Medicines Industry Association ...................................................................... 244
5.8 Trade Fairs ..................................................................................................................... 245
6 Opportunities and Challenges ................................................................................................. 246
6.1 Opportunities .................................................................................................................. 246
6.2 Challenges ...................................................................................................................... 246
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7 Appendix................................................................................................................................. 248
7.1 Abbreviations .................................................................................................................. 248
7.2 Bibliography .................................................................................................................... 251
7.3 Research Methodology ................................................................................................... 261
7.3.1 Coverage .................................................................................................................... 261
7.3.2 Secondary Research ................................................................................................... 262
7.3.3 Forecasts .................................................................................................................... 262
7.3.4 Expert Panel................................................................................................................ 262
7.4 Disclaimer ....................................................................................................................... 263
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1.1 List of Tables
Table 1: Pharmaceutical Market, Australia, Revenue* ($bn), 2008–2013........................................................ 22
Table 2: Pharmaceutical Market, Australia, Revenue* Forecast ($bn), 2014–2020 ......................................... 23
Table 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008–2013 ........................................ 24
Table 4: Pharmaceutical Market, Australia, Pharmacy and Wholesale Mark-up (%), 2014 .............................. 26
Table 5: Pharmaceutical Market, Australia, Biotechnology Companies, Market Capitalization ($m), Q4 2013 . 28
Table 6: Pharmaceutical Market, Australia, Over-the-Counter Drugs Market ($bn), 2008–2013 ...................... 29
Table 7: Pharmaceutical Market, Australia, Top Five Therapeutic Areas, Pharmaceutical Expenditure ($bn),
2013............................................................................................................................................ 31
Table 8: Pharmaceutical Market, Australia, Major Suppliers to PBS, Revenue ($m), 2013 .............................. 33
Table 9: Pharmaceutical Market, Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013
................................................................................................................................................... 35
Table 10: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014*................................................. 36
Table 11: Pharmaceutical Market, AstraZeneca, Global, Major Products by Therapy Area, Revenue ($bn) and
Annual Growth (%), 2013 ............................................................................................................ 44
Table 12: Pharmaceutical Market, AstraZeneca, Global, Late-stage Pipeline, 2014 ........................................ 45
Table 13: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%),
2013............................................................................................................................................ 52
Table 14: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014–2018* .......................................... 53
Table 15: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), 2013 ............................... 63
Table 16: Pharmaceutical Market, Sanofi, Global, Late-Stage Pipeline, 2014* ................................................ 64
Table 17: Pharmaceutical Market, Alphapharm, Global, Major Products,2013 ................................................ 68
Table 18: Medical Device Market, Australia, Revenue ($bn), 2008–2013 ....................................................... 72
Table 19: Medical Device Market, Australia, Revenue Forecast ($bn), 2014–2020 ......................................... 73
Table 20: Medical Device Market, Australia, Revenue by Segment, 2013....................................................... 74
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Table 21: Medical Device Market, Australia, IVD Devices Market, Revenue ($m), 2008–2013 ........................ 76
Table 22: Medical Device Market, Australia, IVD Devices Market, Sales Trends for Major Players, 2012 ........ 77
Table 23: Medical Device Market, Australia, Orthopedics Devices Market ($m), 2008–2013 ........................... 78
Table 24: Medical Device Market, Australia, Orthopedics Devices Market, Sales Trends for Major Players,
2008–2012 .................................................................................................................................. 79
Table 25: Medical Device Market, Australia, Ophthalmic Devices Market, Revenue ($m), 2008–2013 ............ 81
Table 26: Medical Device Market, Australia, Ophthalmic Devices Market, Sales Trends for Major Players, 2012
................................................................................................................................................... 82
Table 27: Medical Device Market, Australia, Cardiovascular Devices Market, Revenue ($m), 2008–2013 ...... 83
Table 28: Medical Device Market, Australia, Cardiovascular Devices Market, Sales Trends for Major Players,
2008–2012 .................................................................................................................................. 84
Table 29: Medical Device Market, Australia, Diagnostic Imaging Market, Sales Trends for Major Players, 2012
................................................................................................................................................... 87
Table 30: Medical Device Market, Australia, Diagnostic Market, Revenue ($bn), 2008–2013 .......................... 89
Table 31: Medical Device Market, Australia, Diagnostic Market, Revenue Forecast ($bn), 2014–2020 ........... 89
Table 32: Medical Device Market, Australia, Major Medical Device Companies’ Revenue, 2012 ..................... 90
Table 33: Medical Device Market, Medtronic, Global, Major Products, Revenue ($bn), 2013 ........................ 106
Table 34: Medical Device Market, F. Hoffmann-La Roche, Global, Major Products, 2014 ............................. 120
Table 35: Market Access, Australia, Private Health Insurance Rate (%), 2014 .............................................. 138
Table 36: Market Access, Australia, Private Insurance Coverage (million), 2008–2013 ................................ 139
Table 37: Healthcare Spending, Australia, Out-of-Pocket Expenditure (%), 2008–2013 ................................ 140
Table 38: Market Access, Australia, Average Price of Healthcare Services (%), 2008–2013 ......................... 141
Table 39: Market Access, Australia, Classification of Medical Devices,, 2013 ............................................... 150
Table 40: Market Access, Australia, Trademark Fees by E-services, 2014 ................................................... 160
Table 41: Market Access, Australia, Trademark Fees by Other Means, 2014 ............................................... 161
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Table 42: Market Access, Australia, Regulation of Advertising of Therapeutic Goods, Australia, 2013 .......... 164
Table 43: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2008–2013 .................... 176
Table 44: Economic Indicators, Australia, Gross Domestic Product per Capita ($), Forecast, 2014–2020 ..... 176
Table 45: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2008–2013 ............ 177
Table 46: Economic Indicators, Australia, Gross Domestic Product Annual Growth Forecast (%), 2014–2020
................................................................................................................................................. 178
Table 47: Economic Indicators, Australia, Gross National Income per Capita ($), 2008–2013 ....................... 179
Table 48: Economic Indicators, Australia, Average Consumer Price Index, 2008–2013 ................................ 181
Table 49: Economic Indicators, Australia, Average Consumer Price Index Forecast, 2014–2020 ................. 182
Table 50: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2008–2013 ......... 183
Table 51: Economic Indicators, Australia, Currency Exchange Rate (AUD/$), 2008–2013 ............................ 184
Table 52: Economic Indicators, Australia, Foreign Direct Investment ($bn), 2008–2013 ............................... 185
Table 53: Economic Indicators, Australia, Foreign Exchange Reserves ($bn), 2008–2013 ........................... 186
Table 54: Economic Indicators, Australia, Imports of Goods and Services ($bn), 2008–2013 ....................... 188
Table 55: Economic Indicators, Australia, Exports of Goods and Services ($bn), 2008–2013 ....................... 189
Table 56: Economic Indicators, Australia, General Government Structural Balance ($bn),2008–2013 .......... 190
Table 57: Economic Indicators, Australia, General Government Net Debt ($bn), 2008–2013 ........................ 191
Table 58: Economic Indicators, Australia, Major Industries, Gross Value Added (%), 2012–2013 ................. 193
Table 59: Demographics, Australia, Population (million), 2008–2013 ........................................................... 194
Table 60: Demographics, Australia, Population Forecast (million), 2014–2020 ............................................. 195
Table 61: Demographics, Australia, Population, Urban and Rural Population Share (%), 2008–2013 ........... 197
Table 62: Demographics, Australia, Population, Urban and Rural Population Share Forecast (%), 2014–2020
................................................................................................................................................. 198
Table 63: Demographics, Australia, Population Distribution by Age Group (%), 2008–2013.......................... 199
Table 64: Demographics, Australia, Population Distribution by Age Group Forecast (%), 2014–2020 ........... 200
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Table 65: Demographics, Australia, Births (per 1,000 Population), 2008–2013 ............................................. 201
Table 66: Demographics, Australia, Mortality (per 1,000 Population), 2008–2013 ......................................... 202
Table 67: Demographics, Australia, Major Causes of Mortality, 2012 ........................................................... 204
Table 68: Demographics, Australia, Children ≤5 Years, Mortality Rate (per 1,000 Live Births), 2008–2013 ... 205
Table 69: Demographics, Australia, Immunization Rate (%), 2008–2013 ...................................................... 206
Table 70: Demographics, Australia, Major Causes of Male Mortality (‘000), 2012 ......................................... 208
Table 71: Demographics, Australia, Major Causes of Female Mortality (‘000), 2012 ..................................... 209
Table 72: Demographics, Australia, Gender Ratio (M/F), 2008–2013 ........................................................... 210
Table 73: Demographics, Australia, Life Expectancy at Birth (Years), 2008–2013 ........................................ 212
Table 74: Demographics, Australia, Student Enrollment by Level of Education (% of Gross), 2008–2013 ..... 214
Table 75: Demographics, Australia, Overseas Students (%), 2008–2013 ..................................................... 216
Table 76: Demographics, Australia, Unemployment Rate (%), 2008–2013 ................................................... 217
Table 77: Demographics, Australia, Major Causes of Hospitalization, 2012–2013 ........................................ 219
Table 78: Demographics, Australia, Major Diseases, DALYs (per 100,000 Population), 2004 ....................... 220
Table 79: Healthcare Infrastructure, Australia, Hospitals, 2008–2013 ........................................................... 221
Table 80: Healthcare Infrastructure, Australia, Public and Private Hospitals, 2008–2013 .............................. 223
Table 81: Healthcare Infrastructure, Australia, Public Acute Care Hospitals, 2008–2013 .............................. 224
Table 82: Healthcare Infrastructure, Australia, Public Psychiatric Hospitals, 2008–2013 ............................... 225
Table 83: Healthcare Infrastructure, Australia, Private Free-standing Day Hospitals, 2008–2013 .................. 226
Table 84: Healthcare Infrastructure, Australia, Other Private Hospitals, 2008–2013...................................... 226
Table 85: Healthcare Infrastructure, Australia, Diagnostic Equipment (per Million Population), 2008–2013 ... 227
Table 86: Healthcare Infrastructure, Australia, Total Hospital Beds (per 1,000 Population), 2008–2013 ........ 229
Table 87: Healthcare Infrastructure, Australia, Public Hospital Beds (per 1,000 Population), 2008–2013 ...... 229
Table 88: Healthcare Infrastructure, Australia, Private Hospital Beds (per 1,000 Population), 2008–2013 ..... 230
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Table 89: Healthcare Infrastructure, Australia, Doctors (per 100,000 Population), 2008–2013 ...................... 231
Table 90: Healthcare Infrastructure, Australia, PM10 (µg/m3), 2008–2013 .................................................... 233
Table 91: Healthcare Infrastructure, Australia, CO2 Emissions (Million Metric Tons), 2008–2013 .................. 235
Table 92: Healthcare Infrastructure, Australia, Nurses (per 1,000 Population), 2008–2013 ........................... 236
Table 93: Healthcare Infrastructure, Australia, Pharmacists (per 1,000 Population), 2008–2013 ................... 237
Table 94: Healthcare Infrastructure, Australia, Dentists (per 1,000 Population), 2008–2013 ......................... 238
Table 95: Healthcare Expenditure, Australia, Healthcare Expenditure (% of GDP), 2008–2013 .................... 240
Table 96: Healthcare Expenditure, Australia, Healthcare Expenditure, Share of Major Components (%), 2012
................................................................................................................................................. 241
Table 97: Healthcare Expenditure, Australia, Healthcare Expenditure, Public–Private Share (%), 2008–2013
................................................................................................................................................. 242
Table 98: Healthcare Expenditure, Australia, Research and Development Expenditure in Medical and Health
Sciences ($m), 2008–2013 ........................................................................................................ 243
Table 99: Healthcare Expenditure, Australia, Major Healthcare Trade Fairs, 2014–2015 .............................. 245
1.2 List of Figures
Figure 1: Pharmaceutical Market, Australia, Revenue* ($bn), 2008–2013 ...................................................... 22
Figure 2: Pharmaceutical Market, Australia, Revenue* Forecast ($bn), 2014–2020 ........................................ 23
Figure 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008–2013....................................... 24
Figure 4: Pharmaceutical Market, Australia, Distribution Channels, 2013 ....................................................... 25
Figure 5: Pharmaceutical Market, Australia, Over-the-Counter Drugs Market ($bn), 2008–2013 ..................... 29
Figure 6: Pharmaceutical Market, Australia, Top Five Therapeutic Areas, Pharmaceutical Expenditure ($bn),
2013............................................................................................................................................ 30
Figure 7: Pharmaceutical Market, Australia, Major Suppliers to PBS, Revenue ($m), 2013............................. 33
Figure 8: Medical Device Market, Australia, Revenue ($bn), 2008–2013 ........................................................ 72
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Figure 9: Medical Device Market, Australia, Revenue Forecast ($bn), 2014–2020 .......................................... 73
Figure 10: Medical Device Market, Australia, Revenue by Segment ($m), 2013 ............................................. 74
Figure 11: Medical Device Market, Australia, IVD Market, Revenue ($m), 2008–2013 .................................... 75
Figure 12: Medical Device Market, Australia, IVD Devices Market, Sales Trends for Major Players, 2008–2012
................................................................................................................................................... 76
Figure 13: Medical Device Market, Australia, Orthopedics Devices Market, Revenue ($m), 2008–2013 .......... 78
Figure 14: Medical Device Market, Australia, Orthopedics Devices Market, Sales Trends for Major Players,
2008–2012 .................................................................................................................................. 79
Figure 15: Medical Device Market, Australia, Ophthalmic Devices Market, Revenue ($m), 2008–2013 ........... 80
Figure 16: Medical Device Market, Australia, Ophthalmic Devices Market, Sales Trends for Major Players,
2008–2012 .................................................................................................................................. 81
Figure 17: Medical Device Market, Australia, Cardiovascular Devices Market, Revenue ($m), 2008–2013 ..... 83
Figure 18: Medical Device Market, Australia, Cardiovascular Devices Market, Sales Trends for Major Players,
2008–2012 .................................................................................................................................. 84
Figure 19: Medical Device Market, Australia, Diagnostic Imaging Market, Revenue ($m), 2008–2013 ............ 86
Figure 20: Medical Device Market, Australia, Diagnostic Market, Revenue ($bn), 2008–2013......................... 88
Figure 21: Medical Device Market, Australia, Diagnostic Market, Revenue Forecast ($bn), 2014–2020 .......... 89
Figure 22: Medical Device Market, Australia, Major Medical Device Companies’ Revenue ($m), 2012 ........... 90
Figure 23: Healthcare Market, Australia, Drivers and Barriers, 2014 ............................................................. 128
Figure 24: Healthcare System, Australia, Pharmaceuticals and Devices Reimbursement Process, 2014 ...... 132
Figure 25: Market Access, Australia, Private Insurance Coverage (million), 2008–2013 ............................... 139
Figure 26: Healthcare Spending, Australia, Out-of-Pocket Expenditure (%), 2008–2013............................... 140
Figure 27: Market Access, Australia, Healthcare Services, Average Price Change (%), 2008–2013 ............. 141
Figure 28: Market Access, Australia, Therapeutic Goods Administration Structure, 2014 .............................. 145
Figure 29: Market Access, Australia, Registration Process Regulatory Phases, 2013 ................................... 149
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Figure 30: Market Access, Australia, Class I Non-sterile and Non-measuring Device Supply Process, 2013 . 152
Figure 31: Market Access, Australia, Supply Process for Medical Device Manufactured in Australia, 2013 ... 153
Figure 32: Market Access, Australia, Supply Process for Medical Device Manufactured Overseas, 2013...... 154
Figure 33: Market Access, Australia, Supply Process for Medical Device Containing Medicine or Materials of
Animal, Microbial Recombinant or Human Origin, 2013 ............................................................. 155
Figure 34: Economic Indicators, Australia, Gross Domestic Product per Capita ($), 2008–2013 ................... 175
Figure 35: Economic Indicators, Australia, Gross Domestic Product per Capita Forecast ($), 2014–2020 ..... 176
Figure 36: Economic Indicators, Australia, Gross Domestic Product Annual Growth (%), 2008–2013 ........... 177
Figure 37: Economic Indicators, Australia, Gross Domestic Product Annual Growth Forecast (%), 2014–2020
................................................................................................................................................. 178
Figure 38: Economic Indicators, Australia, Gross National Income per Capita ($), 2008–2013 ..................... 179
Figure 39: Economic Indicators, Australia, Average Consumer Price Index, 2008–2013 ............................... 180
Figure 40: Economic Indicators, Australia, Average Consumer Price Index, Forecast, 2014–2020 ............... 181
Figure 41: Economic Indicators, Australia, Average Consumer Price, Annual Change (%), 2008–2013 ........ 182
Figure 42: Economic Indicators, Australia, Currency Exchange Rate (AUD/$), 2008–2013 ........................... 184
Figure 43: Economic Indicators, Australia, Foreign Direct Investment ($bn), 2008–2013 .............................. 185
Figure 44: Economic Indicators, Australia, Foreign Exchange Reserves ($bn), 2008–2013 .......................... 186
Figure 45: Economic Indicators, Australia, Imports of Goods and Services ($bn), 2008–2013 ...................... 187
Figure 46: Economic Indicators, Australia, Exports of Goods and Services ($bn), 2008–2013 ...................... 189
Figure 47: Economic Indicators, Australia, General Government Structural Balance ($bn), 2008–2013 ........ 190
Figure 48: Economic Indicators, Australia, General Government Net Debt ($bn), 2008–2013 ....................... 191
Figure 49: Economic Indicators, Australia, Major Industries, Gross Value Added (%), 2012–2013 ................ 192
Figure 50: Demographics, Australia, Population (million), 2008–2013 .......................................................... 194
Figure 51: Demographics, Australia, Population Forecast (million), 2014–2020 ............................................ 195
Figure 52: Demographics, Australia, Population, Urban and Rural Population Share (%), 2008–2013 .......... 196
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Figure 53: Demographics, Australia, Population, Urban and Rural Population Share Forecast (%), 2014–2020
................................................................................................................................................. 197
Figure 54: Demographics, Australia, Population Distribution by Age Group (%), 2008–2013 ........................ 199
Figure 55: Demographics, Australia, Population Distribution by Age Group Forecast (%), 2014–2020 .......... 200
Figure 56: Demographics, Australia, Births (per 1,000 Population), 2008–2013 ............................................ 201
Figure 57: Demographics, Australia, Mortality (per 1,000 Population), 2008–2013 ....................................... 202
Figure 58: Demographics, Australia, Major Causes of Mortality, 2012 .......................................................... 203
Figure 59: Demographics, Australia, Children ≤5 Years, Mortality Rate (per 1,000 Live Births), 2008–2013 .. 205
Figure 60: Demographics, Australia, Immunization Rate (%), 2008–2013 ..................................................... 206
Figure 61: Demographics, Australia, Major Causes of Male Mortality (‘000), 2012 ........................................ 207
Figure 62: Demographics, Australia, Major Causes of Female Mortality (‘000), 2012 .................................... 208
Figure 63: Demographics, Australia, Gender Ratio (M/F), 2008–2013 .......................................................... 210
Figure 64: Demographics, Australia, Life Expectancy at Birth (Years), 2008–2013 ....................................... 211
Figure 65: Demographics, Australia, Student Enrollment by Level of Education (% of Gross), 2011 ............. 214
Figure 66: Demographics, Australia, Overseas Student (%), 2008–2013 ...................................................... 215
Figure 67: Demographics, Australia, Unemployment Rate (%), 2008–2013 .................................................. 217
Figure 68: Demographics, Australia, Major Causes of Hospitalization, 2012–2013 ....................................... 218
Figure 69: Demographics, Australia, Major Diseases, DALYs (per 100,000 Population), 2004 ...................... 220
Figure 70: Healthcare Infrastructure, Australia, Hospitals, 2008–2013 .......................................................... 221
Figure 71: Healthcare Infrastructure, Australia, Public and Private Hospitals, 2008–2013 ............................. 222
Figure 72: Healthcare Infrastructure, Australia, Public Acute Care Hospitals, 2008–2013 ............................. 223
Figure 73: Healthcare Infrastructure, Australia, Public Psychiatric Hospitals, 2008–2013 .............................. 224
Figure 74: Healthcare Infrastructure, Australia, Private Free-standing Day Hospitals, 2008–2013................. 225
Figure 75: Healthcare Infrastructure, Australia, Other Private Hospitals, 2008–2013 .................................... 226
Figure 76: Healthcare Infrastructure, Australia, Diagnostic Equipment (per Million Population), 2008–2013 .. 227
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Table of Contents
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
Figure 77: Healthcare Infrastructure, Australia, Total Hospital Beds (per 1,000 Population), 2008–2013 ....... 228
Figure 78: Healthcare Infrastructure, Australia, Public Hospital Beds (per 1,000 Population), 2008–2013 ..... 229
Figure 79: Healthcare Infrastructure, Australia, Private Hospital Beds (per 1,000 Population), 2008–2013.... 230
Figure 80: Healthcare Infrastructure, Australia, Doctors (per 100,000 Population), 2008–2013 ..................... 231
Figure 81: Healthcare Infrastructure, Australia, PM10 (µg/m3), 2008–2013 ................................................... 233
Figure 82: Healthcare Infrastructure, Australia, CO2 Emissions (Million Metric Tons), 2008–2013................. 235
Figure 83: Healthcare Infrastructure, Australia, Nurses (per 1,000 Population), 2008–2013 .......................... 236
Figure 84: Healthcare Infrastructure, Australia, Pharmacists (per 1,000 Population), 2008–2013 .................. 237
Figure 85: Healthcare Infrastructure, Australia, Dentists (per 1,000 Population), 2008–2013 ........................ 238
Figure 86: Healthcare Expenditure, Australia, Healthcare Expenditure (% of GDP), 2008–2013 ................... 240
Figure 87: Healthcare Expenditure, Australia, Healthcare Expenditure, Major Components (%), 2012 .......... 241
Figure 88: Healthcare Expenditure, Australia, Healthcare Expenditure, Public–Private Share (%), 2008–2013
................................................................................................................................................. 242
Figure 89: Healthcare Expenditure, Australia, Research and Development Expenditure in Medical and Health
Sciences ($m), 2008–2013 ........................................................................................................ 243
Figure 90: Healthcare Market, Australia, Opportunities and Challenges, 2014 .............................................. 247
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
Introduction
2 Introduction
2.1 GlobalData Report Guidance
Chapter three provides an overview of Australia’s pharmaceutical and medical device markets,
covering the market size and generic, Over-the-Counter (OTC) and biologic/biosimilar product
segment shares, as well as the market’s key drivers and barriers. It also includes SWOT
assessments and profiles of the major market players.
Chapter four analyzes the reimbursement and payer landscape, covering the reimbursement
process, insurance providers, pricing policies and drug price trends in Australia. It also looks at
the regulatory landscape and provides an overview of the regulatory agencies and approval
processes for new drugs and medical devices. Also covered are the licensing processes for the
manufacture, export and import of pharmaceuticals and the regulations in place for
pharmaceutical advertising, labeling, packaging and clinical trials. An overview of intellectual
property rights is also provided.
Chapter five analyzes the political and economic environment in Australia, covering economic
indicators, demographics, and healthcare infrastructure and expenditure.
Chapter six provides an overview of the opportunities for and challenges facing the growth of
Australia’s healthcare market.
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Overview of Pharmaceutical and Medical Device Markets
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
3.1.2 Pharmaceutical Exports and Imports
The value of Australia’s pharmaceutical imports amounted to $XX billion in 2008 and increased to
$XX billion in 2013 at a CAGR of XX%. Australia’s pharmaceutical exports totaled $XX billion in
2008, increasing to $XX billion in 2013 at a CAGR of XX%.
Figure 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008–2013
2008 2009 2010 2011 2012 2013
Rev
enue
($bn
)
ExportsImports
Source: Department of Industry, 2013a
Table 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008–2013 Year 2008 2009 2010 2011 2012 2013
Exports
Imports
Source: Department of Industry, 2013a
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Country Analysis
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
5.6.2 Major Components of Healthcare Spending
In 2011–2012, the major components of healthcare spending were public hospitals, medical
services, other health, medication, private hospitals, dental services, capital spending, and other
health practitioners.
Other healthcare services comprises patient transport services, community health, public health,
aids and appliances, other non-institutional health, administration and research. Paramedics,
physiotherapists, psychologists comprise other health practitioners.
Figure 87: Healthcare Expenditure, Australia, Healthcare Expenditure, Major Components (%), 2012
Aids and appliances Other health practitioners
Capital spendingDental services
Private hospitals
Medications
Other healthcare services
Medical services
Public hospital services
Source: AIHW, 2014b
Table 96: Healthcare Expenditure, Australia, Healthcare Expenditure, Share of Major Components (%), 2012
Area of expenditure Share
Public hospital services
Medical services
Other healthcare services
Medications
Private hospitals
Dental services
Capital spending
Other health practitioners
Aids and appliances
Source: AIHW, 2014b
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Appendix
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
7 Appendix
7.1 Abbreviations
AIM: Australian Innovation and Manufacturing
ALP: Australian Labor Party
API: Active Pharmaceutical Ingredient
ARGMD: Australian Regulatory Guidelines for Medical Devices
ANDA: Abbreviated New Drug Application
ANPHA: Australian National Preventive Health Agency
APCM: Advisory Committee on Prescription Medicines
APMRG: Australian Pharmaceutical Marketing and Research Group
ARTG: Australian Register of Therapeutic Goods
BBI: Biotech Business Indicator
CAGR: Compound Annual Growth Rate
CDBS: Child Dental Benefits Schedule
COPD: Chronic Obstructive Pulmonary Disease
CPI: Consumer Price Index
CPM: Cost Plus Method
CPP: Certificate of Pharmaceutical Product
CT: Computed Tomography
CTN: Clinical Trial Notification
CTX: Clinical Trial Exemption
DALY: Disability Adjusted Life Year
DoHA: Department of Health and Ageing
DSEB: Drug Safety and Evaluation Branch
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Appendix
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DVA: Department of Veterans Affairs
eBS: e-Business System
FDA: Food and Drug Administration
FDAAA: Food and Drug Administration Amendments Act
FDI: Foreign Direct Investment
GMIA: Generic Medicines Industry Association
GMP: Good Manufacturing Practice
GVA: Gross Value Added
HACC: Home and Community Care
HHF: Health and Hospital Funds
HREC: Human Research Ethics Committee
HTA: Health Technology Assessment
IDA: Industrial Development Agency
IVD: In Vitro Diagnostics
LHC: Lifetime Health Cover
MBS: Medicare Benefits Schedule
MDEC: Medical Devices Evaluation Committee
MLS: Medicare Levy Surcharge
MRI: Magnetic Resonance Imaging
MS: Multiple Sclerosis
MSAC: Medical Services Advisory Committee
MSI: Medicine Shortages Information Initiative
NIBR: Novartis Institutes for Biomedical Research
NIP: National Immunization Program
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
NME: New Molecular Entity
NSCLC: Non-Small Cell Lung Cancer
ODA: Office of Devices Authorization
OECD: Organisation for Economic Co-operation and Development
OOP: Out of Pocket
OTC: Over the Counter
PBAC: Pharmaceutical Benefits Advisory Committee
PBPA: Pharmaceutical Benefits Pricing Authority
PBS: Pharmaceutical Benefits Scheme
PDC: Prostheses and Devices Committee
PEI: Precision Engineering Industry
PLAC: Prostheses Library Advisory Committee
PM10: Particulate Matter with a diameter of ≤10 micrometers
RBA: Reserve Bank of Australia
RHCA: Reciprocal Health Care Agreement
SUSDP: Standard for the Uniform Scheduling of Drugs and Poisons
TGA: Therapeutic Goods Administration
TGO: Therapeutic Goods Order
UNFCC: United Nations Framework Convention on Climate Change
VET: Vocational Education and Training
WAMTC: Weighted Average Monthly Treatment Cost
WHO: World Health Organization
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Appendix
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – AUSTRALIA
7.2 Bibliography
10times (2014). Medical and pharmaceutical trade shows in Australia. 10times. Available from:
http://10times.com/australia/medical-pharma/tradeshows [Accessed on July 28, 2014]
ABS (2013a). Healthcare delivering and financing. Australian Bureau of Statistics. Available
from:
http://www.abs.gov.au/ausstats/[email protected]/Lookup/by%20Subject/1301.0~2012~Main%20Featu
res~Health%20care%20delivery%20and%20financing~235 [Accessed on July 28, 2014]
ABS (2013b). Australian system of national accounts. Australian Bureau of Statistics. Available
from:
http://www.ausstats.abs.gov.au/ausstats/subscriber.nsf/0/8E449E149D3CB34ACA257C16002
193B9/$File/52040_2012-13.pdf
ABS (2013c). Births, Australia, 2012. Australian Bureau of Statistics. Available from:
http://www.abs.gov.au/AUSSTATS/[email protected]/DetailsPage/3301.02012?OpenDocument
[Accessed on July 28, 2014]ABS (2013d). Deaths, Australia, 2012. Australian Bureau of
Statistics. Available from:
http://www.abs.gov.au/AUSSTATS/[email protected]/DetailsPage/3302.02012?OpenDocument
[Accessed on July 28, 2014]
ABS (2013e). Life expectancy, selected ages, states and territories, 2002 to 2012. Australian
Bureau of Statistics. Available from:
http://www.abs.gov.au/AUSSTATS/[email protected]/DetailsPage/3302.02012?OpenDocument
[Accessed on July 28, 2014]
ABS (2014a). International Investment Position, Australia: Supplementary Statistics, 2013.
Australian Bureau of Statistics. Available from:
http://www.abs.gov.au/AUSSTATS/[email protected]/DetailsPage/5352.02013?OpenDocument
[Accessed on July 6, 2014]
ABS (2014b). International Trade in Goods and Services, Australia, May 2014. Australian
Bureau of Statistics. Available
from:http://www.abs.gov.au/AUSSTATS/[email protected]/DetailsPage/5368.0May%202014?OpenDoc
ument [Accessed on June 4, 2014]
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World Bank (2014h).Mortality rate under–5 (per 1,000 live births). World Bank. Available from:
http://data.worldbank.org/indicator/SH.DYN.MORT [Accessed on June 3, 2014]
World Bank (2014i). Immunization, measles (% of children ages 12-23 months). World Bank.
Available from: http://data.worldbank.org/indicator/SH.IMM.MEAS [Accessed on May 27, 2014]
World Bank (2014j). Life expectancy at birth, total (years). World Bank. Available from:
http://data.worldbank.org/indicator/SP.DYN.LE00.IN [Accessed on May 27, 2014]
World Bank (2014k).School enrollment, pre-primary (% gross). World Bank. Available from:
http://data.worldbank.org/indicator/SE.PRE.ENRR [Accessed on May 27, 2014]
World Bank (2014l). PM10, country level (micrograms per cubic meter). World Bank. Available
from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3 [Accessed on May 27, 2014]
World Bank (2014m). CO2 emissions (metric tons per capita). World Bank. Available from:
http://data.worldbank.org/indicator/EN.ATM.CO2E.PC [Accessed on May 27, 2014]
World Bank (2014n). Health Expenditure, public (% of total health expenditure). World Bank.
Available from: http://data.worldbank.org/indicator/SH.XPD.PUBL [Accessed on May 27, 2014]
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7.3 Research Methodology
GlobalData’s dedicated research and analysis teams consist of experienced professionals with
advanced statistical expertise and marketing, market research and consulting backgrounds in the
pharmaceutical industry.
GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and
Strategic and Competitive Intelligence Professionals (www.scip.org).
All GlobalData databases are continuously updated and revised. The following research
methodology is followed for all databases and reports.
7.3.1 Coverage
The objective of updating GlobalData’s coverage is to ensure that it represents the most up-to-date
vision of the industry possible.
Changes to the industry taxonomy are built on the basis of extensive research of company,
association and competitor sources.
Company coverage is based on three key factors: revenue; products; and media attention,
innovation and market potential.
The estimated revenue of all major companies, including private and governmental, are gathered
and used to prioritize coverage.
Companies that are making the news or are of particular interest due to their innovative approach
are prioritized.
GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated
on a daily basis.
The coverage is further streamlined and strengthened with additional input from GlobalData’s
expert panel (see below).
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7.3.2 Secondary Research
The research process begins with extensive secondary research using internal and external
sources to gather qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and
SEC filings
Industry trade journals, scientific journals and other technical literature
Internal proprietary databases
Relevant patent and regulatory databases
National government documents, statistical databases and market reports
Procedure registries
News articles, press releases and web-casts specific to the companies operating in the market
The CountryFocus reports are largely based on secondary research and use reliable and
authoritative sources such as the IMF, World Bank, OECD, WHO, UNICEF, UNStats, BEA, MHLW
and NHS, among others.
7.3.3 Forecasts
The CountryFocus reports use the data available from the secondary sources to forecast and
validate the future trends for a country’s healthcare market, as well as parameters related to the
economy and healthcare infrastructure and expenditure.
7.3.4 Expert Panel
GlobalData uses a panel of experts to cross-verify its databases and forecasts.
GlobalData’s expert panel comprises marketing managers, product specialists, international sales
managers from pharmaceutical companies, academics from research universities, consultants from
venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.
Historic data and forecasts are relayed to GlobalData’s expert panel and adjusted in accordance
with their feedback.
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7.4 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, GlobalData.