HEALTHCARE, REGULATORY AND REIMBURSEMENT ...Healthcare, Regulatory and Reimbursement Landscape –...

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.


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.



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]


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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



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.


Overview of Pharmaceutical and Medical Device Markets


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


Table 3: Pharmaceutical Market, Australia, Exports and Imports ($bn), 2008–2013 Year 2008 2009 2010 2011 2012 2013

Exports

Imports



Country Analysis


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


Appendix


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


Appendix


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


Appendix


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


Appendix


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:


[Accessed on July 28, 2014]

ABS (2013e). Life expectancy, selected ages, states and territories, 2002 to 2012. Australian

Bureau of Statistics. Available from:



ABS (2014a). International Investment Position, Australia: Supplementary Statistics, 2013.

Australian Bureau of Statistics. Available from:



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]


Appendix


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]


Appendix


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).


Appendix


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.


Appendix


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.

Date post:	14-Aug-2020
Category:	Documents
Upload:	others
View:	4 times
Download:	0 times

HEALTHCARE, REGULATORY AND REIMBURSEMENT ...Healthcare, Regulatory and Reimbursement Landscape –...

Documents