GDHC0042CHR Healthcare, Regulatory and Reimbursement ... · Reference Code: GDHC0042CHR Publication...

Reference Code: GDHC0042CHR Publication Date: March 2013

Healthcare, Regulatory and Reimbursement Landscape Austria


GDHC0042CHR / Published MAR 2013

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form

Increasing Demand for Innovative Medicines, Investments in Research and Development (R&D) and the Launch of New Products will Drive the Growth of the Pharmaceutical Market in Austria.

The value of the pharmaceutical market in Austria was estimated at $XX billion, at consumer price level (including Value Added Tax (VAT), but excluding hospital sales) in 2012. Increasing demand for innovative medicines has been fueling the market growth. R&D investment in Austria was XX% of Gross Domestic Product (GDP) in 2012, which itself is higher than the average for the EU25 countries, which was XX% of GDP in 2010. In order to decrease the healthcare deficit, the government is focusing on the use of generics as a cost-containment tool. The generics market in Austria, at ex-factory prices, has increased from XX% in 2005 to XX% in 2010 (EFPIA, 2012).

Based on the country’s increasing elderly population, the increasing incidence of chronic diseases, and growing medical unmet needs, the pharmaceutical market in Austria is expected to grow at a Compound Annual Growth Rate (CAGR) of XX%, from approximately $XX billion in 2007 to $XX billion in 2020, as illustrated in below figure.

Pharmaceutical Market ($bn), Austria, 2007–2020

2007 2012* 2015* 2020*

Rev

enue

($bn

)

Year

CAGR (2007–2020): XX%

Source: GlobalData; AESGP, 2012 * Estimated figure

In 2007, the medical device market in Austria was valued at $XX billion, as illustrated in below figure. This market is forecast to grow at a CAGR of XX% from $XX billion in 2013 to $XX billion in 2020. In 2011, the major segments of the medical device market were In Vitro Diagnostics (IVD) devices (XX%), orthopedic devices (XX%), cardiovascular devices (XX%), wound care management (XX%), and ophthalmic devices (XX%). The market is driven by factors such as increasing awareness regarding the early detection and diagnosis of disease, advancements in medical technology, and an increase in the elderly population.

Medical Device Market ($bn), Austria, 2007–2020

2007 2012* 2015* 2020*

Rev

enue

($bn

)

Year

CAGR (2007–2020): XX%

Source: GlobalData, Medical eTrack [Accessed on December 24, 2012] * Estimated figure

As a Member of the European Union (EU), Austria Shares a Common Regulatory Platform with Other Member States, Thereby Offering a Strong and Transparent Regulatory System to Facilitate the Approval of Pharmaceutical Products and Medical Devices

The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG)/the Austrian Agency for Health and Food Safety (Agentur für Gesundheit und Ernährungssicherheit, AGES) is the main regulatory authority for the marketing authorization of medicinal products in Austria. Apart from authorizations, BASG/AGES also conduct the assessment of medicinal products and medical devices, which are already available in the market, regarding efficacy, adverse reactions, production, shipment and storage. The BASG/AGES work under the supervision of the Federal Ministry of Health (Bundesministerium für Gesundheit (BMG)), Austria.

The BASG/AGES makes the final decision on drug approval based on the Austrian Medicinal Product Act 2005 (Arzneimittelgesetz, AMG) and grant the marketing authorization within seven months of receiving the application. The Austrian Medicinal Product Act 2005 provides the basis for various regulatory activities.


GDHC0042CHR / Published MAR 2013 Page 4


1 Table of Contents 1 Table of Contents ............................................................................................................................ 4

1.1 List of Tables ............................................................................................................................. 6 1.2 List of Figures............................................................................................................................ 8

2 Introduction ................................................................................................................................... 10 2.1 Report Guidance ..................................................................................................................... 10

3 Overview of the Pharmaceutical and Medical Device Market ........................................................... 11 3.1 Pharmaceutical Market ............................................................................................................ 11

3.1.1 Market Overview ............................................................................................................. 11 3.1.2 Pharmaceutical Import and Export ................................................................................... 14 3.1.3 Supply Channels ............................................................................................................ 15 3.1.4 Market Segments ........................................................................................................... 16 3.1.5 Major Players ................................................................................................................. 20

3.2 Medical Device Market ............................................................................................................ 51 3.2.1 Market Overview ............................................................................................................. 51 3.2.2 Overview of Top Five Segments ...................................................................................... 53 3.2.3 Major Players ................................................................................................................. 64

3.3 Market Drivers and Barriers ..................................................................................................... 82 3.3.1 Drivers ........................................................................................................................... 82 3.3.2 Barriers .......................................................................................................................... 82

4 Market Access ............................................................................................................................... 84 4.1 Reimbursement and Payer Landscape ..................................................................................... 84

4.1.1 Overview of Healthcare System ...................................................................................... 84 4.1.2 Reimbursement Process ................................................................................................. 84 4.1.3 Overview of Insurance Providers ..................................................................................... 86 4.1.4 Patient Share in Healthcare Spending ............................................................................. 88 4.1.5 Healthcare Price Trends ................................................................................................. 89 4.1.6 Pricing Policies ............................................................................................................... 90

4.2 Regulatory Landscape ............................................................................................................. 91 4.2.1 Overview of Regulatory Agencies .................................................................................... 91 4.2.2 Market Authorization Procedure for Pharmaceutical Products .......................................... 93 4.2.3 New Medical Device Approval Process .......................................................................... 103 4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing ...................... 108 4.2.5 Licensing Process for Pharmaceutical Exports and Imports ............................................ 108 4.2.6 Intellectual Property Rights ........................................................................................... 109 4.2.7 Clinical Trial Regulation ................................................................................................ 110 4.2.8 Pharmaceutical Advertising Regulations ........................................................................ 110 4.2.9 Pharmacy Regulations .................................................................................................. 111 4.2.10 Labeling and Packaging Regulations ............................................................................. 111

5 Country Analysis .......................................................................................................................... 113 5.1 Political Environment ............................................................................................................. 113

5.1.1 Political Structure .......................................................................................................... 113 5.1.2 Analysis of the Current Political Environment ................................................................. 113 5.1.3 Healthcare Policy Initiatives........................................................................................... 114

5.2 Economic Indicators .............................................................................................................. 116 5.2.1 Gross Domestic Product ............................................................................................... 116 5.2.2 Gross National Income.................................................................................................. 119 5.2.3 Inflation ........................................................................................................................ 120 5.2.4 Currency Exchange Rate .............................................................................................. 122 5.2.5 Foreign Direct Investment ............................................................................................. 123 5.2.6 Foreign Exchange Reserves ......................................................................................... 124 5.2.7 Trade Balance .............................................................................................................. 125 5.2.8 General Government Structural Balance........................................................................ 127 5.2.9 General Government Gross Debt .................................................................................. 129 5.2.10 Major Industries ............................................................................................................ 131

5.3 Demographics ....................................................................................................................... 132 5.3.1 Population .................................................................................................................... 132 5.3.2 Education and Literacy.................................................................................................. 148 5.3.3 Employment ................................................................................................................. 150




5.3.4 Disease Burden ............................................................................................................ 152 5.4 Healthcare Infrastructure ....................................................................................................... 155

5.4.1 Healthcare Facilities ..................................................................................................... 155 5.4.2 Healthcare Parameters ................................................................................................. 158 5.4.3 Healthcare Personnel ................................................................................................... 162 5.4.4 Environmental Health .................................................................................................... 167

5.5 Healthcare Expenditures........................................................................................................ 172 5.5.1 Overview ...................................................................................................................... 172 5.5.2 Major Components of Healthcare Spending ................................................................... 173 5.5.3 Share of Public and Private Sectors .............................................................................. 174 5.5.4 Spending in Pharmaceutical and Healthcare R&D.......................................................... 175

5.6 Trade Associations ................................................................................................................ 176 5.6.1 The Association of the Austrian Chemical Industry ......................................................... 176 5.6.2 The Austrian Chamber of Pharmacists .......................................................................... 176 5.6.3 The Austrian Pharmaceutical Industries Association ...................................................... 176 5.6.4 Austrian Generics Association ....................................................................................... 176

5.7 Trade Fairs ........................................................................................................................... 177 6 Opportunities and Challenges ...................................................................................................... 178

6.1 Opportunities ......................................................................................................................... 178 6.2 Challenges ............................................................................................................................ 178

7 Appendix ..................................................................................................................................... 180 7.1 Abbreviations ........................................................................................................................ 180 7.2 Bibliography .......................................................................................................................... 183 7.3 Methodology ......................................................................................................................... 187

7.3.1 Coverage ..................................................................................................................... 187 7.3.2 Secondary Research .................................................................................................... 187 7.3.3 Forecasting .................................................................................................................. 187 7.3.4 Expert Panel Validation ................................................................................................. 188

7.4 Contact Us ............................................................................................................................ 188 7.5 Disclaimer ............................................................................................................................. 188




1.1 List of Tables Table 1: Pharmaceutical Market ($bn), Austria, 2007–2012 .................................................................. 12 Table 2: Pharmaceutical Market ($bn), Austria, Forecast, 2013–2020 ................................................... 13 Table 3: Drugs Going Off-patent, Revenue ($m), Global, 2011–2015 .................................................... 16 Table 4: OTC Pharmaceutical Market ($m), Austria, 2007–2012 ........................................................... 18 Table 5: Major OTC Drug Classes, Austria, Market Share (%), 2012 ..................................................... 19 Table 6: Major Products, Bayer AG, Global, Revenue ($m), 2011 ......................................................... 25 Table 7: Late-stage Pipeline, Bayer AG, 2011 ...................................................................................... 26 Table 8: Boehringer Ingelheim, Product Portfolio, 2012 ........................................................................ 32 Table 9: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 ............................................... 38 Table 10: Late-Stage Pipeline, GlaxoSmithKline, 2012 ......................................................................... 39 Table 11: Major Products, Novartis, Global, Revenue ($m), 2012 ......................................................... 45 Table 12: Planned Filings, Novartis, 2012 to ≥2016 .............................................................................. 46 Table 13: Medical Device Market ($m), Austria, 2007–2012 .................................................................. 51 Table 14: Medical Device Market ($m), Austria, Forecast, 2013–2020 .................................................. 52 Table 15: Medical Device Market, Austria, Segments, Revenue ($m), 2012 .......................................... 53 Table 16: In Vitro Diagnostics Devices Market ($m), Austria, 2007–2012 .............................................. 54 Table 17: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Austria, 2011 ......................... 55 Table 18: Orthopedic Devices Market ($m), Austria, 2007–2012 ........................................................... 56 Table 19: Sales Trends for Major Players*, Orthopedic Devices, Austria, 2011 ...................................... 57 Table 20: Cardiovascular Devices Market ($m), Austria, 2007–2012 ..................................................... 58 Table 21: Sales Trends for Major Players*, Cardiovascular Devices, Austria, 2011 ................................ 59 Table 22: Wound Care Management Market ($m), Austria, 2007–2012 ................................................. 60 Table 23: Sales Trends for Major Players*, Wound Care Management, Austria, 2011 ........................... 61 Table 24: Ophthalmic Devices Market ($m), Austria, 2007–2012 .......................................................... 62 Table 25: Sales Trends for Major Players*, Hospital Supplies, Austria, 2011 ......................................... 63 Table 26: Major Medical Device Companies, Austria, Revenue ($m), 2010 ........................................... 64 Table 27: Major Products, Medtronic, Global, Revenue ($m), 2012 ....................................................... 65 Table 28: Major Products, Roche, Global, Revenue ($m), 2010 ............................................................ 69 Table 29: Late-Stage Pipeline, Roche, 2012......................................................................................... 70 Table 30: Major Products, Siemens, Global, Revenue ($m), 2012 ......................................................... 73 Table 31: Major Products, Abbott, Global, Revenue ($m), 2010 ............................................................ 76 Table 32: Patient Share in Healthcare Spending (% of Total Expenditure), Austria, 2007–2012 ............. 88 Table 33: Drug Price Trends (%), Austria, 2007–2012 .......................................................................... 89 Table 34: Criteria for Establishment of New Pharmacies ..................................................................... 111 Table 35: GDP per Capita ($), Austria, 2007–2012 ............................................................................. 116 Table 36: GDP per Capita ($), Austria, Forecast, 2013–2020 .............................................................. 117 Table 37: GDP, Austria, Annual Growth (%), 2007–2012 .................................................................... 118 Table 38: GNI per Capita ($), Austria, 2007–2012 .............................................................................. 119 Table 39: Average Consumer Price Index, Austria, 2007–2012 ........................................................... 120 Table 40: Average Consumer Price, Austria, Annual Change (%), 2007–2012 .................................... 121 Table 41: Currency Exchange Rate (€/$), Austria, 2007–2012 ............................................................ 122 Table 42: Foreign Direct Investment ($bn), Austria, 2007–2011 .......................................................... 123 Table 43: Foreign Exchange Reserves ($bn), Austria, 2007–2012 ...................................................... 124 Table 44: Imports of Goods and Services ($bn), Austria, 2007–2012 .................................................. 125 Table 45: Exports of Goods and Services ($bn), Austria, 2007–2012 .................................................. 126 Table 46: General Government Structural Balance ($bn), Austria, 2007–2012 .................................... 127 Table 47: General Government Structural Balance ($bn), Austria, Forecast, 2013–2020 ..................... 128 Table 48: General Government Gross Debt ($bn), Austria, 2007–2012 ............................................... 129 Table 49: General Government Gross Debt ($bn), Austria, Forecast, 2013–2020 ................................ 130 Table 50: Major Industries, Austria, Output ($bn), 2011 ...................................................................... 131 Table 51: Population (m), Austria, 2007–2012 .................................................................................... 132 Table 52: Population (m), Austria, Forecast, 2013–2020 ..................................................................... 133 Table 53: Urban and Rural Population, Austria, Share (%), 2007–2012 ............................................... 134 Table 54: Urban and Rural Population, Austria, Share (%), 2013–2020 ............................................... 135 Table 55: Age Groups, Austria, Population Distribution (%), 2007–2012.............................................. 136 Table 56: Age Groups, Austria, Population Distribution (%), Forecast, 2013–2020 .............................. 137 Table 57: Births (per 1,000 Population), Austria, 2007–2012 ............................................................... 138 Table 58: Mortality (per 1,000 Population), Austria, 2007–2012 .......................................................... 139 Table 59: Major Causes of Mortality, Austria, 2011 ............................................................................. 140 Table 60: Children <5 Years Age, Austria, Mortality Rate (per 1,000 Live Births), 2007–2012 .............. 141 Table 61: Immunization Rate (%), Austria, 2005–2010 ....................................................................... 142 Table 62: Major Causes of Male Mortality, Austria, 2011..................................................................... 143




Table 63: Major Causes of Female Mortality, Austria, 2011................................................................. 144 Table 64: Gender Ratio (M/F), Austria, 2007–2012 ............................................................................. 145 Table 65: Life Expectancy at Birth (Years), Austria, 2007–2012 .......................................................... 146 Table 66: Life Expectancy at Birth (Years), Austria, Forecast, 2013–2020 ........................................... 147 Table 67: Enrolments by Level of Education, Austria, 2011 ................................................................. 149 Table 68: Unemployment (%), Austria, 2007–2012 ............................................................................. 150 Table 69: Employment Sectors, Austria, Share (%), 2011 ................................................................... 151 Table 70: Most Frequent Diagnoses at Hospital Discharges, 2008 ...................................................... 152 Table 71: Healthcare Costs of CVD ($m), Austria, 2009 ..................................................................... 153 Table 72: Age-standardized DALYs (per 100,000 population), Austria, 2004 ....................................... 154 Table 73: Hospitals, Austria, 2007–2012 ............................................................................................ 155 Table 74: Hospital Beds, Austria, 2007–2012 ..................................................................................... 156 Table 75: Diagnostic Units (per 1,000,000 Population), Austria, 2007–2012 ........................................ 157 Table 76: Hospital Beds (per 1,000 Population), Austria, 2007–2012 .................................................. 158 Table 77: Psychiatric Care Hospital Beds, Austria, 2007–2012 ........................................................... 159 Table 78: Curative (Acute) Care Hospital Beds, Austria, 2007–2012 ................................................... 160 Table 79: Chronic Care Hospital Beds, Austria, 2007–2012 ................................................................ 161 Table 80: Doctors (‘000), Austria, 2007–2012 ..................................................................................... 162 Table 81: Dentists (‘000), Austria, 2007–2012 .................................................................................... 163 Table 82: Pharmacists (‘000), Austria, 2007–2012 .............................................................................. 164 Table 83: Nurses (‘000), Austria, 2007–2012...................................................................................... 165 Table 84: Midwives, Austria, 2007–2012 ............................................................................................ 166 Table 85: PM10 Emissions (µgm/m3), Austria, 2007–2012 .................................................................. 168 Table 86: SO2 Emissions (‘000 Tons), Austria, 2007–2012 ................................................................. 169 Table 87: NOx Emissions (‘000 Tons), Austria, 2007–2012 ................................................................. 170 Table 88: CO2 Emissions (‘000 Tons), Austria, 2007–2012 ................................................................. 171 Table 89: Healthcare Expenditures (% of GDP), Austria, 2005–2010 .................................................. 172 Table 90: Healthcare Expenditures, Austria, Share of Components (%), 2010 ..................................... 173 Table 91: Healthcare Expenditures, Austria, Public–Private Share (%), 2005–2010 ............................. 174 Table 92: R&D Expenditures ($m), Austria, 2005–2010 ...................................................................... 175 Table 93: Major Healthcare Trade Fairs, Austria, 2013 ....................................................................... 177




1.2 List of Figures Figure 1: Pharmaceutical Market ($bn), Austria, 2007–2012 ................................................................. 12 Figure 2: Pharmaceutical Market ($bn), Austria, Forecast, 2013–2020 .................................................. 13 Figure 3: Import & Export of Pharmaceutical, Austria, Revenue ($bn), 2007–2012 ................................ 14 Figure 4: Distribution Channels, Austria, 2012 ...................................................................................... 15 Figure 5: OTC Pharmaceutical Market ($m), Austria, 2007–2012 .......................................................... 18 Figure 6: Major OTC Drug Classes, Austria, Market Share (%), 2012.................................................... 19 Figure 7: Medical Device Market ($m), Austria, 2007–2012 .................................................................. 51 Figure 8: Medical Device Market ($m), Austria, Forecast, 2013–2020 ................................................... 52 Figure 9: Medical Device Market, Austria, Segments, Revenue ($m), 2012 ........................................... 53 Figure 10: In Vitro Diagnostics Devices Market ($m), Austria, 2007–2012 ............................................. 54 Figure 11: Sales Trends for Major Players, In Vitro Diagnostics Devices, Austria, 2006–2011 ................ 55 Figure 12: Orthopedic Devices Market ($m), Austria, 2007–2012 .......................................................... 56 Figure 13: Sales Trends for Major Players, Orthopedic Devices, Austria, 2006–2011 ............................ 57 Figure 14: Cardiovascular Devices Market ($m), Austria, 2007–2012 .................................................... 58 Figure 15: Sales Trends for Major Players*, Cardiovascular Devices, Austria, 2006–2011 ..................... 59 Figure 16: Wound Care Management Market ($m), Austria, 2007–2012................................................ 60 Figure 17: Sales Trends for Major Players, Wound Care Management, Austria, 2006–2011 .................. 61 Figure 18: Ophthalmic Devices Market ($m), Austria, 2007–2012 ......................................................... 62 Figure 19: Sales Trends for Major Players, Ophthalmic Devices, Austria, 2006–2011 ............................ 63 Figure 20: Major Medical Device Companies, Austria, Revenue ($m), 2010 .......................................... 64 Figure 21: Drivers and Barriers, Healthcare Market, Austria, 2012 ........................................................ 83 Figure 22: Reimbursement Process, Austria, 2012 ............................................................................... 86 Figure 23: Patient Share in Healthcare Spending (% of Total Expenditure), Austria, 2007–2012 ............ 88 Figure 24: Drug Price Trends (%), Austria, 2007–2012 ......................................................................... 89 Figure 25: Organizational Structure of the Federal Ministry of Health (BMG), Austria, 2012 ................... 91 Figure 26: Activities of Austrian Medicines and Medical Devices Agency ............................................... 92 Figure 27: Centralized Procedure for Market Authorization, Pre-submission, EU, 2012 .......................... 95 Figure 28: Centralized Procedure, Market Authorization, Pre-opinion Phase, EU, 2012 ......................... 97 Figure 29: Centralized Procedure, Market Authorization, Post-opinion Phase, EU, 2012 ........................ 99 Figure 30: Decentralized Procedure, Market Authorization, EU, 2012 .................................................. 101 Figure 31: Mutual Recognition Procedure, Market Authorization, EU, 2012 ......................................... 102 Figure 32: Conformity Assessment of Class I Medical Devices, EU, 2012 ........................................... 104 Figure 33: Conformity Assessment of Class IIa Medical Devices, EU, 2012 ........................................ 105 Figure 34: Conformity Assessment of Class IIb Medical Devices, EU, 2012 ........................................ 106 Figure 35: Conformity Assessment of Class III Medical Devices, EU, 2012 ......................................... 107 Figure 36: GDP per Capita ($), Austria, 2007–2012 ............................................................................ 116 Figure 37: GDP per Capita ($), Austria, Forecast, 2013–2020............................................................. 117 Figure 38: GDP, Austria, Annual Growth (%), 2007–2012 ................................................................... 118 Figure 39: GNI per Capita ($), Austria, 2007–2012 ............................................................................. 119 Figure 40: Average Consumer Price Index, Austria, 2007–2012 ......................................................... 120 Figure 41: Average Consumer Price, Austria, Annual Change (%), 2007–2012 ................................... 121 Figure 42: Currency Exchange Rate (€/$), Austria, 2007–2012 ........................................................... 122 Figure 43: Foreign Direct Investment ($bn), Austria, 2007–2011 ......................................................... 123 Figure 44: Foreign Exchange Reserves ($bn), Austria, 2007–2012 ..................................................... 124 Figure 45: Imports of Goods and Services ($bn), Austria, 2007–2012 ................................................. 125 Figure 46: Exports of Goods and Services ($bn), Austria, 2007–2012 ................................................. 126 Figure 47: General Government Structural Balance ($bn), Austria, 2007–2012 ................................... 127 Figure 48: General Government Structural Balance ($bn), Austria, Forecast, 2013–2020 .................... 128 Figure 49: General Government Gross Debt ($bn), Austria, 2007–2012 .............................................. 129 Figure 50: General Government Gross Debt ($bn), Austria, Forecast, 2013–2020 ............................... 130 Figure 51: Major Industries, Austria, Output ($bn), 2011 ..................................................................... 131 Figure 52: Population (m), Austria, 2007–2012 ................................................................................... 132 Figure 53: Population (m), Austria, Forecast, 2013–2020.................................................................... 133 Figure 54: Urban and Rural Population, Austria, Share (%), 2007–2012.............................................. 134 Figure 55: Urban and Rural Population, Austria, Share (%), 2013–2020.............................................. 135 Figure 56: Age Groups, Austria, Population Distribution (%), 2007–2012 ............................................ 136 Figure 57: Age Groups, Austria, Population Distribution (%), Forecast, 2013–2020 ............................. 137 Figure 58: Births (per 1,000 Population), Austria, 2007–2012 ............................................................. 138 Figure 59: Mortality (per 1,000 Population), Austria, 2007–2012 ......................................................... 139 Figure 60: Major Causes of Mortality, Austria, 2011 ............................................................................ 140 Figure 61: Children <5 Years Age, Austria, Mortality Rate (per 1,000 Live Births), 2007–2012 ............. 141




Figure 62: Immunization Rate (%), Austria, 2005–2010 ...................................................................... 142 Figure 63: Major Causes of Male Mortality, Austria, 2011 ................................................................... 143 Figure 64: Major Causes of Female Mortality, Austria, 2011 ............................................................... 144 Figure 65: Gender Ratio (M/F), Austria, 2007–2012............................................................................ 145 Figure 66: Life Expectancy at Birth (Years), Austria, 2007–2012 ......................................................... 146 Figure 67: Life Expectancy at Birth (Years), Austria, Forecast, 2013–2020 .......................................... 147 Figure 68: Unemployment (%), Austria, 2007–2012 ............................................................................ 150 Figure 69: Employment Sectors, Austria, Share (%), 2011 .................................................................. 151 Figure 70: Healthcare Costs of CVD ($m), Austria, 2009 .................................................................... 153 Figure 71: Hospitals, Austria, 2007–2012 ........................................................................................... 155 Figure 72: Hospital Beds, Austria, 2007–2012 .................................................................................... 156 Figure 73: Diagnostic Units (per 1,000,000 Population), Austria, 2007–2012 ....................................... 157 Figure 74: Hospital Beds (per 1,000 Population), Austria, 2007–2012 ................................................. 158 Figure 75: Psychiatric Care Hospital Beds, Austria, 2007–2012 .......................................................... 159 Figure 76: Curative (Acute) Care Hospital Beds, Austria, 2007–2012 .................................................. 160 Figure 77: Chronic Care Hospital Beds, Austria, 2007–2012 ............................................................... 161 Figure 78: Doctors (‘000), Austria, 2007–2012 ................................................................................... 162 Figure 79: Dentists (‘000), Austria, 2007–2012 ................................................................................... 163 Figure 80: Pharmacists (‘000), Austria, 2007–2012 ............................................................................ 164 Figure 81: Nurses (‘000), Austria, 2007–2012 .................................................................................... 165 Figure 82: Midwives, Austria, 2007–2012 ........................................................................................... 166 Figure 83: PM10 Emissions (µgm/m3), Austria, 2007–2012................................................................. 168 Figure 84: SO2 Emissions (‘000 Tons), Austria, 2007–2012 ................................................................ 169 Figure 85: NOX Emissions (‘000 Tons), Austria, 2007–2012 ................................................................ 170 Figure 86: CO2 Emissions (‘000 Tons), Austria, 2007–2012 ................................................................ 171 Figure 87: Healthcare Expenditures (% of GDP), Austria, 2005–2010 ................................................. 172 Figure 88: Healthcare Expenditures, Austria, Share of Components (%), 2010 .................................... 173 Figure 89: Healthcare Expenditures, Austria, Public–Private Share (%), 2005–2010 ............................ 174 Figure 90: R&D Expenditures ($m), Austria, 2005–2010 ..................................................................... 175 Figure 91: Opportunities and Challenges, Healthcare Market, Austria, 2012 ........................................ 179




2 Introduction 2.1 Report Guidance The report begins with an Executive Summary, which gives an overview of the healthcare market of

Austria and the key factors driving this market. It also gives a snapshot of the demographic, regulatory, and reimbursement landscape, as well as the healthcare infrastructure of Austria.

The Overview of the Pharmaceutical and Medical Device Market chapter provides an overview of the pharmaceutical and medical device market of Austria, including the market size, market segmentation by generics, Over-the-Counter (OTC) drugs, and biologics/biosimilar products, as well as key market drivers and barriers. This section also includes profiles of the major players, including SWOT assessments.

The Market Access chapter covers the reimbursement and payer landscape, as well as the regulatory landscape in Austria. The section on the reimbursement and payer landscape elaborates on the features of the healthcare reimbursement process, including details of the reimbursement process, insurance providers, pricing policies, and drug price trends. The regulatory landscape section provides an overview of the regulatory agencies and approval processes for new drugs and medical devices. The licensing process for the manufacturing and export/import of pharmaceuticals, the regulations for pharmaceutical advertising, labeling and packaging, and clinical trials, and an overview of the landscape for Intellectual Property Rights (IPR) are also covered in this chapter.

The “Country Analysis” chapter provides a detailed analysis of the political and economic environment of Austria. It analyses the economic indicators, demographics, healthcare infrastructure, and healthcare expenditures of Austria.

The “Opportunities and Challenges” chapter provides an overview of the opportunities and challenges for growth that exist in the healthcare market of Austria.




5.2 Economic Indicators 5.2.1 Gross Domestic Product 5.2.1.1 GDP Per Capita

The GDP refers to the market value of all goods and services produced within a country during a given time period, It is often considered as an indicator of a country’s standard of living. In 2007, Austria recorded a GDP per capita (at current prices) of approximately $XX, which increased steadily to $XX in 2008, as illustrated in Figure 36. After 2008, GDP per capita declined significantly and was estimated to reach $XX in 2012. Overall, GDP per capita increased from 2007 to 2012 at CAGR of XX%.

In 2011, Austria delivered a positive foreign trade balance. Exports and imports rose by XX% and XX% respectively, compared to the previous year. The increase in exports and imports resulted in a positive trade balance of $XX billion.

In 2011, in the industry sector, the manufacturing sector recorded a growth of XX%, followed by the energy supply (XX%) and construction (XX%) sector. Among the service sectors, real estate activities accounted for a growth of XX%, followed by financial and insurance activities (XX%). Some sectors that recorded negative growth include mining and quarrying (XX%) and public administration and defense (XX%) (Statistics Austria, 2012a).

Figure 36: GDP per Capita ($), Austria, 2007–2012

2007 2008 2009 2010 2011 2012

Year

GD

P P

er C

apita

($)

CAGR (2007–2012): XX%

Source: GlobalData; Statistics Austria, 2012a

Table 35: GDP per Capita ($), Austria, 2007–2012 Year 2007 2008 2009 2010 2011 2012*

GDP per capita

Source: GlobalData; Statistics Austria, 2012a * Estimated figure


GDHC0042CHR / Published MAR 2013 7


It is projected that the GDP per capita of Austria will grow at a CAGR of XX% from $XX in 2013 to $XX in 2020, as shown in Figure 37.

Figure 37: GDP per Capita ($), Austria, Forecast, 2013–2020

2013 2014 2015 2016 2017 2018 2019 2020

Year

GD

P P

er C

apita

($)

CAGR (2013–2020): XX%


Table 36: GDP per Capita ($), Austria, Forecast, 2013–2020 Year 2013 2014 2015 2016 2017 2018 2019 2020

GDP per capita





5.5.2 Major Components of Healthcare Spending In 2010, the main components of healthcare spending were curative and rehabilitative care (with a share of XX%), medical goods (XX%), long-term nursing care (XX%), capital formation of healthcare providers (XX%), health administration and health insurance (XX%), ancillary services to healthcare (XX%) and prevention and public health services (XX%).

Figure 88: Healthcare Expenditures, Austria, Share of Components (%), 2010

Curative and Rehabilitative care

Medical Goods

Long-term Nursing Care

Capital Formation of Health Care Providers

Health Administration and Health Insurance

Ancillary Services to Health Care

Prevention and Public Health Services

Source: GlobalData; OECD, 2012b

Table 90: Healthcare Expenditures, Austria, Share of Components (%), 2010 Component Share (%)

Curative and rehabilitative care

Medical goods

Long-term nursing care

Capital formation of health care providers

Health administration and health insurance

Ancillary services to health care

Prevention and public health services

Source: GlobalData; OECD, 2012b




7 Appendix 7.1 Abbreviations µgm/m3: Microgram per cubic meter

ADC: Austrian Development Cooperation

AEG: Apothekeneinkaufsgremium (Pharmacy Purchase Committee)

AESGP: Association Européenne Des Spécialités Pharmaceutiques Grand Public (Association of the European Self-Medication Industry)

AF: Atrial Fibrillation

AGES: Agentur für Gesundheit und Ernährungssicherheit (Austrian Agency for Health and Food Safety)

AMG: Arzneimittelgesetz (Austrian Medicines Act)

API: Active Pharmaceutical Ingredient

ASVG: Allgemeines Sozialversicherungsgesetz (General Social Insurance Act)

BASG: Bundesamt für Sicherheit im Gesundheitswesen (The Federal Office for Safety in Health Care)

BMFSJF: Bundesministerium für Familie, Senioren, Frauen und Jugend (Federal Ministry for Family Affairs, Senior Citizens, Women and Youth)

BMG: Bundesministerium für Gesundheit (Austrian Federal Ministry of Health)

BMGFJ: Bundesministerium für Gesundheit, Familie und Jugend (Federal Ministry of Health, Family and Youth)

BMS: Bristol-Myers Squibb

bn: Billion

BRIC: Brazil, Russia, India and China

BVS: Bioresorbable Vascular Scaffold

BZO: Bündnis Zukunft Österreich (Alliance for Austria's Future)

CA: Conformity Assessment

CAGR: Compound Annual Growth Rate

CBL: Casitas B-cell Lymphoma gene

CDM: Clean Development Mechanism

CE: Conformité Européenne (European Conformity)

CGM: Continuous Glucose Monitor

CHD: Coronary Heart Disease

CHMP: Committee for Medicinal Products for Human use

CMDh: Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human

CMS: Concerned Member State

CNS: Central Nervous System

CO2: Carbon Dioxide

COMP: Committee for Orphan Medicinal Products

COPD: Chronic Obstructive Pulmonary Disease

CPI: Consumer Price Index

CROs: Contract Research Organizations

CT/NG: Chlamydia Trachomatis/Neisseria Gonorrhea

CT: Computed Tomography




CT: Computed Tomography

CTA: Clinical Trial Application

cTnl: Cardiac Troponin

CVD: Cardiovascular Disease

DALYs: Disability-Adjusted Life Years

DCA: Development Cooperation Act

DEA: Drug Enforcement Administration

DHHS: Department of Health and Human Services

DPT: Diphtheria, Pertussis, and Tetanus

DRG: Diagnosis Related Group

EC: European Commission

EEA: European Economic Area

EEC: European Economic Community

EFTA: European Free Trade Area

EGA: European Generic medicines Association

EHR: Electronic Health Record

EMA: European Medicines Agency

EPC: European Patent Convention

EPO: European Patent Office

ER: Estrogen Receptor

ESRD: End Stage Renal Disease

ETH: Eidgenössische Technische Hochschule (Federal Institute of Technology)

EU: European Union

FCIO: Der Fachverband der Chemischen Industrie Österreichs (The Association of the Chemical Industry)

FDA: Food and Drug Administration

FDI: Foreign Direct Investment

FOL: Finsbury Orthopaedics Limited

FTA: Free Trade Agreement

GAVI: Global Alliance for Vaccines and Immunization

GDP: Gross Domestic Product

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GMS: Global Manufacturing and Supply

GNI: Gross National Income

GNP: Gross National Product

GS: Genome Sequencer

GSK: GlaxoSmithKline

HBV: Hepatitis B Virus

HCV: Hepatitis C Virus

HE4: Human Epididymis secretory protein E4

HGF: Hepatocyte Growth Factor

ICD: Implantable Cardioverter Defibrillator




ICT: Information and Communications Technology

IDA: Industrial Development Agency

IHC: Immunohistochemistry

IMF: International Monetary Fund

IMP: Investigational Medicinal Product

IP: Intellectual Property

IPR: Intellectual Property Rights

ISCED: International Standard Classification of Education

ISMP: Institute for Safe Medication Practices

IT: Information Technology

IVD: In Vitro Diagnostics

kg: kilogram

KRAS: member of the Ras family of oncogenes

M&As: Mergers and Acquisitions

m: million

MA: Market Authorization

MAA: Market Authorization Application

mg/l: milligrams per liter

MIS: Minimally Invasive Spine

MMR: Maternal Mortality Ratio

MNCs: Multinational Companies

MoHWS: Ministry of Health, Welfare and Sport

MPG: Medizinproduktegesetz (Medical Devices Act)

MRI: Magnetic Resonance Imaging

NME: New Molecular Entity

NNAP: National Nutrition Action Plan

NOx: Nitrogen Oxide

NRC: National Research Council

NSCLC: Non-Small Cell Lung Cancer

ÖAK: Österreichische Apothekerkammer (Austrian Chamber of Pharmacists)

OECD: The Organization for Economic Cooperation and Development

ÖEGV: Österreichischer Generikaverband (Austrian Generics Association)

ÖENB: Öesterreichische Nationalbank (Austrian National Bank)

OOP: Out-of-Pocket

OTC: Over-the-Counter

ÖVP: Österreichische Volkspartei (Austrian People's Party)

P/E ratio: Price-Earnings ratio

PCR: Polymerase Chain Reaction

PD: Peritoneal Dialysis

PE: Pharmacoeconomics Evidence

PEB: Pricing Evolution Board

PET: Positron Emission Tomography




PHARMIG: Verband der pharmazeutischen Industrie Österreich (Pharmaceutical Industry Association Austria)

PIP: Pediatric Investigation Plan

PK: Preiskommission (Price Commission)

PMA: Pre-Market Approval

PMS: Premenstrual syndrome

PR: Progesterone Receptor

R&D: Research and Development

RC: Reimbursement Code

RMS: Reference Member State

RUNX1: Runt-related transcription factor 1

SHI: Social Health Insurance

SO2: Sulfur Dioxide

SPC: Summary of Product Characteristics

SPÖ: Sozialdemokratische Partei Österreich (Social Democratic Party of Austria)

TET2: member of the TET family of oncogenes

TF: Titanium Foam

TRIPS: Trade-Related Intellectual Property Rights

TU: Technische Universitat (University of Technology)

UNICEF: United Nations International Children's Emergency Fund

USP: United States Pharmacopoeia

VAT: Value-Added Tax

VHI: Voluntary Health Insurance

WHO: World Health Organization

WIPO: World Intellectual Property Organization

WTO: World Trade Organization

WW: World Wide

7.2 Bibliography AESGP (2012a). Over-the-Counter Drugs. Association of the European Self-Medication Industry.

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AESGP (2012b). AESGP comments on the concept paper on the delegated act for safety features submitted for consultation by the European Commission. Available from; http://ec.europa.eu/health/files/falsified_medicines/2012-06_safety-features/aesgp_en.pdf.

Austrian Chamber of Pharmacists (2012). Pharmaceutical Distribution Channel. Austrian Chamber of Pharmacists. Available from: http://www.apotheker.or.at/internet/oeak/home_1_0_0a.nsf. [Accessed on February 8, 2013].

Austrian Foreign Ministry (2013). Environmental Protection. Austrian Foreign Ministry. Available from: http://www.bmeia.gv.at/en/foreign-ministry/austria/facts-and-figures/environmental-protection.html./. [Accessed on March 18, 2013].

Biztradeshows (2013). Medical & Pharmaceutical Trade Shows in Austria. Biztradeshows. Available from: http://www.biztradeshows.com/austria/austria-tradeshows.mp?industry=medical-pharma. [Accessed on January 16, 2013].

BMEIA (2012). The Political System. BMEIA. Available from: http://www.bmeia.gv.at/en/foreign-ministry/austria/government-and-politics/political-system.html. [Accessed on December 28, 2012].




BMG (2012a). The Austrian Health Care System, 2010. Bundesministeriums für Gesundheit. Available from: http://bmg.gv.at/home/EN/Topics/The_Austrian_Health_Care_System. [Accessed on December 28, 2012].

BMG (2012b). Hospitals. Bundesministeriums für Gesundheit. Available from: http://www.kaz.bmg.gv.at/ressourcen-inanspruchnahme/krankenanstalten.html. [Accessed on December 28, 2012].

BMG (2012c). Beds in Hospitals. Bundesministeriums für Gesundheit. Available from: http://www.kaz.bmg.gv.at/ressourcen-inanspruchnahme/betten.html. [Accessed on December 28, 2012]

BMUKK (2012). Statistical Guide, 2011. Bundesministerium für Unterricht, Kunst und Kultur. Available from: http://www.bmukk.gv.at/medienpool/22289/statisticalguide_2011.pdf.

BMVIT (2012). Austrian Research and Technology Report, 2011. Bundesministerium für Verkehr, Innovation und Technologie. Available from: http://www.bmvit.gv.at/en/service/publications/downloads/downloads_ftb/ftb_2011_en.pdf.

Brand H and Monnet J (2012). Public Health Capacities in Europe (preliminary results). Available from: http://www.mz.gov.si/fileadmin/mz.gov.si/pageuploads/konferenca_nadgradnja_261012/Helmut_Brand_301012.pdf.

CMDh (2011). Decentralized procedure member states’ standard operating procedure. Heads of Medicine Agency. Available from: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh-078-2005-Rev3-Clean_2011_09.pdf.

CMDh (2012). Recommendations on submission dates for applicants of the mutual recognition procedure. Heads of Medicine Agency. Available from: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/MRP/CMDh_082_2012_Rev5_2012_10.pdf.

EFPIA (2012). E-Library: Publication. European Federation of Pharmaceutical Industry and Association. European Federation of Pharmaceutical Industry and Association. Available from: http://www.efpia.eu/e-library/1. [Accessed on December 7, 2012].

EMA (2012). Centralised Procedure. European Commission. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000278.jsp&mid=WC0b01ac05800b5ca1. [Accessed on July 18, 2012].

Encyclopedia of Earth (EOE) (2012). Economics of climate change. Available from: http://www.eoearth.org/article/Economics_of_climate_change. [Accessed on March 12, 2013].

European Commission (2006). Surveying, Assessing, and Analyzing the Pharmaceutical Sector in the 25 EU Member States. European Commission. Available from: http://ec.europa.eu/competition/mergers/studies_reports/oebig.pdf.

European Commission (2010). Employers’ perception of graduate employability. European Commission. Available from: http://ec.europa.eu/public_opinion/flash/fl_304_en.pdf.

IMF (2012). World Economic Outlook Database, April 2012. International Monetary Fund. Available from: http://www.imf.org/external/pubs/ft/weo/2012/01/weodata/weorept.aspx?pr.x=41&pr.y=10&sy=2005&ey=2017&scsm=1&ssd=1&sort=country&ds=.&br=1&c=138&s=NGDP_R%2CNGDP_RPCH%2CNGDP%2CNGDPD%2CNGDP_D%2CNGDPRPC%2CNGDPPC%2CNGDPDPC%2CNGAP_NPGDP%2CPPPGDP%2CPPPPC%2CPPPSH%2CPPPEX%2CNID_NGDP%2CNGSD_NGDP%2CPCPI%2CPCPIPCH%2CPCPIE%2CPCPIEPCH%2CTM_RPCH%2CTMG_RPCH%2CTX_RPCH%2CTXG_RPCH%2CTXGO%2CTMGO%2CLUR%2CLE%2CLP%2CGGR%2CGGR_NGDP%2CGGX%2CGGX_NGDP%2CGGXCNL%2CGGXCNL_NGDP%2CGGSB%2CGGSB_NPGDP%2CGGXONLB%2CGGXONLB_NGDP%2CGGXWDN%2CGGXWDN_NGDP%2CGGXWDG%2CGGXWDG_NGDP%2CNGDP_FY%2CBCA%2CBCA_NGDPD&grp=0&a=. [Accessed on July 18, 2012].


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ISPOR (2012). Drug Reimbursement Process. International Society for Pharmacoeconomics and Outcomes Research. Available from: http://www.ispor.org/htaroadmaps/Austria.asp. [Accessed on December 3, 2012].

Krause, K and Liebig T (2011).The Labor Market Integration of Immigrants and their Children in Austria. Available from: http://dx.doi.org/10.1787/5kg264fz6p8w-en. [Accessed on March 8, 2013].

LISA (2012). Advancing Austrian life science at the heart of Europe. Life Science in Austria. Available from: http://www.lifescienceaustria.at/life-science-in-austria/?lang=en. [Accessed on December 10, 2012]

Nicholas M, et al. (2012). European Cardiovascular Disease Statistics 2012. European Heart Network, Brussels, European Society of Cardiology, Sophia Antipolis. [Accessed on March 10, 2013]

OANDA (2012). Historical Exchange Rates. OANDA. Available from: http://www.oanda.com/currency/historical-rates/. [Accessed on June 18, 2012].

OECD (2012a). OECD Health Data 2012 - Frequently Requested Data. Organization for Economic Co-operation and Development. Available from: http://www.oecd.org/els/healthpoliciesanddata/oecdhealthdata2012-frequentlyrequesteddata.htm. [Accessed on December 28, 2012].

OeNB, 2012. Economic Outlook for Austria from 2012 to 2014. Oesterreichische Nationalbank. Available from: http://www.oenb.at/en/img/prognose_mop_2_12_tcm16-248405.pdf.

Organization for Economic Co-operation and Development (OECD) (2012b). OECD Stat Extracts. Organization for Economic Co-operation and Development. Available from: http://stats.oecd.org/. [Accessed December 12, 2012].

Sabine V, et al (2008). Pharmaceutical pricing and reimbursement information, Austria. Available from: http://ppri.oebig.at/Downloads/Results/Austria_PPRI_2008_Englih_Version.pdf.

Statistics Austria (2012a). Austria's Economy 2011: 2.7% Growth Despite the Difficult International Environment. Statistics Austria. Available from: http://www.statistik.at/web_en/statistics/national_accounts/gross_domestic_product/annual_data/index.html. [Accessed on January 7, 2013].

Statistics Austria (2012b). Consumer Price Index. Statistics Austria. Available from: http://www.statistik.at/web_en/statistics/Prices/consumer_price_index_cpi_hcpi/028929.html. [Accessed on December 24, 2012].

Statistics Austria (2012c). Import and Export of Goods and Services. Statistical Database of Statistics Austria. Available from: http://statcube.at/statistik.at/ext/superweb/loadDatabase.do?db=devgr001. [Accessed on December 24, 2012].

Statistics Austria (2012d). Population. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=debevjahresanf. [Accessed on December 27, 2012].

Statistics Austria (2012e). Age Group Distribution. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=debevjahresanf. [Accessed on December 27, 2012].

Statistics Austria (2012f). Live Births. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=degeborene_ext. [Accessed on December 27, 2012].

Statistics Austria (2012g). Mortality. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=degestorbene_ext. [Accessed on December 27, 2012].

Statistics Austria (2012h). Major Causes of Mortality. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=def1197. [Accessed on December 27, 2012].




Statistics Austria (2012i). Infant Mortality. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=degestorbene_ext. [Accessed on December 27, 2012].

Statistics Austria (2012j). Causes of Male Mortality. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=def1197. [Accessed on December 27, 2012].

Statistics Austria (2012k). Causes of Female Mortality. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=def1197. [Accessed on December 27, 2012].

Statistics Austria (2012l). Gender Ratio. Statistical Database of Statistics Austria. Available from: http://statcube.com/statistik.at/ext/superweb/loadDatabase.do?db=def1197. [Accessed on December 27, 2012].

Statistics Austria (2012m). Demographic Indicators. Statistics Austria. Available from: http://www.statistik.at/web_en/statistics/population/demographic_indices/demographic_indicators/index.html. [Accessed on December 27, 2012].

Statistics Austria (2012n). National Accounting Matrix including Environmental Accounts. Statistics Austria. http://www.statistik.at/web_en/statistics/energy_environment/environment/namea/index.html. [Accessed on December 28, 2012].

Statistics Austria (2012o). Health Expenditure in Austria. Statistics Austria. Available from: http://www.statistik.at/web_en/statistics/health/health_expenditure/index.html. [Accessed on December 28, 2012].

The US Census Bureau (2012). Population. US Census Bureau. Available from: http://www.census.gov/population/international/data/idb/informationGateway.php. [Accessed on July 18, 2012].

The World Bank (2012a). GNI per capita, Atlas method (US$). The World Bank. Available from: http://data.worldbank.org/indicator/NY.GNP.PCAP.CD. [Accessed on December 10, 2012].

The World Bank (2012b). Foreign Direct Investment, net inflows (BoP, current US$). The World Bank. Available from: http://data.worldbank.org/indicator/BX.KLT.DINV.CD.WD. [Accessed on December 24, 2012].

The World Bank (2012c). Total Reserves (includes gold, current US. The World Bank. Available from: http://data.worldbank.org/indicator/FI.RES.TOTL.CD. [Accessed on December 24, 2012].

The World Bank (2012d). Urban Population (% of total). The World Bank. Available from: http://data.worldbank.org/indicator/SP.URB.TOTL.IN.ZS. [Accessed on December 27, 2012].

UNFCCC (2011). Kyoto Protocol. United Nations Framework Convention on Climate Change. Available from: http://unfccc.int/kyoto_protocol/items/2830.php. [Accessed on July 17, 2012].

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WHO (2013). Substandard and counterfeit medicines. World Health Organization. Available from: http://dx.doi.org/10.1787/5kg264fz6p8w-en. [Accessed on March 18, 2013].

WKO (2012b). Statistical Year Book, 2012. Wirtschaftskammer Österreich. Available from: http://portal.wko.at/wk/startseite_ch.wk?dstid=0&chid=96. [Accessed on December 27, 2012].




7.3 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 the 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/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 which 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 inputs from GlobalData’s expert panel (see below).

7.3.2 Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source 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 US Securities and Exchanges Commission (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 country reports are largely based on secondary research and make use of reliable and authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, MHLW, NHS, and BEA, among others.

7.3.3 Forecasting For the country reports, GlobalData uses the data available from reliable and authoritative secondary sources to forecast the future trends for the healthcare market for the country, as well as the parameters related to the economy and healthcare infrastructure and expenditure of the country. The trends are further validated through the secondary sources.




7.3.4 Expert Panel Validation 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 for feedback and adjusted in accordance with their feedback.

7.5 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.

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