Healthcare, Regulatory and Reimbursement Landscape - Denmark


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191pages

GlobalData

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Healthcare, Regulatory and Reimbursement Landscape Denmark

Summary

GlobalData, the industry analysis specialist, has released its new report, Healthcare, Regulatory and Reimbursement Landscape Denmark. The report is an essential source of information and analysis on Denmark`s healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and healthcare infrastructure. Most importantly, it provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets.

The report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalDatas team of industry experts.

In 2011, the population of Denmark was 5.6 million. The population of Denmark is increasing due to a positive net migration and positive balance of birth rate to mortality rate. Denmark policymakers are now presented with the problems of a declining population of the working age group and an increasing elderly population. The countrys pharmaceutical market was valued at $3.8 billion in 2010 and is expected to reach approximately $7.3 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 3.7%. The medical devices market size was approximately $1.4 billion in 2011 and is expected to reach approximately $2.3 billion by 2020 with a projected CAGR of 5.4%. 

The positive trends in the Danish healthcare market can be attributed primarily to 
Increasing elderly population
Increasing emphasis on quality and accessibility of medical care 

Scope

  • The report provides information on Denmark`s healthcare, regulatory and reimbursement landscape, and includes 
  • Overview of the pharmaceutical and medical devices markets, comprising market size, segmentation and key drivers and barriers
  • Profiles and SWOT analysis of the major players in the pharmaceutical and medical devices market. The major players covered for the pharmaceutical market are Novo Nordisk, Takeda, Lundbeck, LEO Pharma and Orifarm. The major players covered for the medical devices market are Siemens Healthcare, F. Hoffmann-La Roche, Medronic, GE Healthcare and Abbott Laboratories.
  • Insightful review of the reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies and approval processes for new drugs
  • Detailed analysis of the political and economic environment, including economic indicators, demographics, and healthcare infrastructure and expenditure
  • Overview of the opportunities for and challenges to growth in the healthcare market.

Reasons to buy

  • This report will enhance your decision-making capability by allowing you to 
  • Develop business strategies by understanding the trends shaping and driving healthcare market of Denmark
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the healthcare market of Denmark in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership
  • Identify, understand and capitalize on the opportunities and challenges in healthcare market of Denmark
Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 9

2 Introduction 11
2.1 Report Guidance 11

3 Overview of the Pharmaceutical and Medical Device Market 12
3.1 Pharmaceutical Market 12
3.1.1 Market Overview 12
3.1.2 Supply Channels 14
3.1.3 Market Segments 15
3.1.4 Overview of Major Therapeutic Areas 19
3.1.5 Major Players 25
3.2 Medical Device Market 50
3.2.1 Market Overview 50
3.2.2 Overview of the Top Five Segments 52
3.2.3 Major Players 68
3.3 Market Drivers and Barriers 88
3.3.1 Drivers 88
3.3.2 Barriers 89

4 Market Access 91
4.1 Reimbursement and Payer Landscape 91
4.1.1 Overview of Healthcare System 91
4.1.2 Reimbursement Process 93
4.1.3 Overview of Insurance Providers 96
4.1.4 Patients Share in Healthcare Spending 97
4.1.5 Drug Price Trends 98
4.1.6 Pricing Policies 99
4.2 Regulatory Landscape 100
4.2.1 Overview of Regulatory Agencies 100
4.2.2 Market Authorization Procedure for Pharmaceutical Products 101
4.2.3 New Medical Device Approval Process 109
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 113
4.2.5 Exports and Imports 114
4.2.6 Intellectual Property Rights 115
4.2.7 Clinical Trial Regulations 116
4.2.8 Pharmaceutical Advertising Regulations 116
4.2.9 Pharmacy Regulations 117
4.2.10 Labeling and Packaging Regulations 118

5 Country Analysis 120
5.1 Political Environment 120
5.1.1 Political Structure 120
5.1.2 Analysis of Current Political Environment 120
5.1.3 Healthcare Policy Initiatives 121
5.2 Economic Landscape 123
5.3 Economic Indicators 125
5.3.1 Gross Domestic Product 125
5.3.2 Gross National Income 130
5.3.3 Inflation 131
5.3.4 Currency Exchange Rate 134
5.3.5 Foreign Direct Investment 135
5.3.6 Foreign Exchange Reserves 136
5.3.7 Trade Balance 137
5.3.8 General Government Structural Balance 139
5.3.9 General Government Gross Debt 141
5.3.10 External Debt 142
5.3.11 Major Industries 143
5.4 Demographics 144
5.4.1 Population 144
5.4.2 Education and Literacy 160
5.4.3 Employment 161
5.4.4 Disease Burden 162
5.5 Healthcare Infrastructure 165
5.5.1 Healthcare Facilities 165
5.5.2 Healthcare Parameters 168
5.5.3 Environmental Health 170
5.5.4 Healthcare Personnel 173
5.6 Healthcare Expenditures 174
5.6.1 Overview 174
5.6.2 Major Components of Healthcare Spending 175
5.6.3 Share of Public and Private Sectors 176
5.6.4 Pharmaceutical and Healthcare R&D Expenditures 177
5.7 Trade Associations 178
5.7.1 The Danish Association of the Pharmaceutical Industry 178
5.7.2 Association of Danish Pharmacies 178
5.7.3 The Danish Generic Medicines Industry Association 178
5.7.4 Danish Medical Association 178
5.8 Trade Fairs 179

6 Opportunities and Challenges 180
6.1 Opportunities 180
6.2 Challenges 181

7 Appendix 183
7.1 Abbreviations 183
7.2 Bibliography 184
7.3 Methodology 189
7.3.1 Coverage 189
7.3.2 Secondary Research 190
7.3.3 Forecasting 190
7.3.4 Primary Research 190
7.3.5 Expert Panel Validation 190
7.4 Contact Us 191
7.5 Disclaimer 191

Table 1: Pharmaceutical Market, Denmark, Revenue ($bn), 2005-2010 12
Table 2: Pharmaceutical Market, Denmark, Revenue Forecast ($bn), 2011-2020 13
Table 3: Price Margins of Distribution Channel (%), Denmark, 2011 14
Table 4: Generic Pharmaceutical Market, Denmark, Revenue ($m), 2005-2010 15
Table 5: Drugs Going off Patent, Global, Revenue ($bn), 2011-2015 16
Table 6: Over-the-Counter Drugs Market, Denmark, Revenue ($m), 2006-2010 18
Table 7: Major Therapeutic Areas, Denmark, Revenue ($m), 2010 19
Table 8: Nervous System Drugs Market, Denmark, Revenue ($m), 2006-2010 20
Table 9: Anti-Cancer Drugs Market, Denmark, Revenue ($m), 2006-2010 21
Table 10: Anti-Infectives Market, Denmark, Revenue ($m), 2006-2010 22
Table 11: Respiratory Drugs Market, Denmark, Revenue ($m), 2006-2010 23
Table 12: Gastrointestinal Drugs Market, Denmark, Revenue ($m), 2006-2010 24
Table 13: Major Products, Novo Nordisk, Global, Revenue ($m), 2011 25
Table 14: Late-Stage Pipeline, Novo Nordisk, 2012 26
Table 15: Major Products, Takeda, Global, Revenue ($m), 2011 31
Table 16: Late-Stage Pipeline, Takeda, 2012 32
Table 17: Major Products, Lundbeck, Global, Revenue ($m), 2011 37
Table 18: Late-Stage Pipeline, Lundbeck, 2012 38
Table 19: Major Products, LEO Pharma, Global, 2011 42
Table 20: Late-Stage Pipeline, LEO Pharma, 2012 42
Table 21: Medical Device Market, Denmark, Revenue ($bn), 2006-2011 50
Table 22: Medical Device Market, Denmark, Revenue Forecast ($bn), 2012-2020 51
Table 23: Medical Device Market, Denmark, Segments, Revenue ($m), 2011 52
Table 24: In-Vitro Diagnostics Market, Denmark, Revenue ($m), 2006-2011 53
Table 25: In-Vitro Diagnostics Market, Denmark, Revenue Forecast ($m), 2012-2020 54
Table 26: Sales Trends for Major Players, In-Vitro Diagnostics, Denmark, 2010 55
Table 27: Orthopedic Devices Market, Denmark, Revenue ($m), 2006-2011 56
Table 28: Orthopedic Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 57
Table 29: Sales Trends for Major Players, Orthopedic Devices, Denmark, 2011 58
Table 30: Ophthalmic Devices Market, Denmark, Revenue ($m), 2006-2011 59
Table 31: Ophthalmic Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 60
Table 32: Sales Trends for Major Players, Ophthalmic Devices, Denmark, 2010 61
Table 33: Diagnostic Imaging Devices Market, Denmark, Revenue ($m), 2006-2011 62
Table 34: Diagnostic Imaging Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 63
Table 35: Sales Trends for Major Players, Diagnostic Imaging Devices, Denmark, 2010 64
Table 36: Cardiovascular Devices Market, Denmark, Revenue ($m), 2006-2011 65
Table 37: Cardiovascular Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 66
Table 38: Sales Trends for Major Players, Cardiovascular Devices, Denmark, 2011 67
Table 39: Major Medical Device Companies, Denmark, Revenue ($m), 2010 68
Table 40: Major Products, Siemens, Global, Revenue ($m), 2010 69
Table 41: Major Products, Roche, Global, Revenue ($m), 2010 73
Table 42: Late-Stage Pipeline, Roche, 2012 74
Table 43: Major Products, Medtronic, Global, Revenue ($m), 2011 77
Table 44: Late-Stage Pipeline, GE Healthcare, 2012 81
Table 45: Major Products, Abbott, Global, Revenue ($m), 2010 85
Table 46: Applications for General Reimbursement Approval, Denmark, 2008-2011 94
Table 47: Reimbursement Thresholds, Denmark, 2012 95
Table 48: Benefits Covered by Health Insurance Denmark, Denmark, 2012 96
Table 49: Healthcare Spending, Denmark, Out-of-Pocket Expenditure (%), 2005-2010 97
Table 50: Change in Average Price of Drugs (%), Denmark, 2006-2011 98
Table 51: Net Assessment Times and Clock Stop Periods, Denmark, 2012 101
Table 52: GDP per Capita ($), Denmark, 2006-2011 125
Table 53: GDP per Capita ($), Denmark, Forecast, 2012-2020 126
Table 54: GDP ($bn), Denmark, 2006-2011 127
Table 55: GDP ($bn), Denmark, Forecast, 2012-2020 128
Table 56: GDP, Denmark, Annual Growth (%), 2006-2011 129
Table 57: GNI per Capita ($), Denmark, 2006-2011 130
Table 58: Average Consumer Price Index, Denmark, 2006-2011 131
Table 59: Average Consumer Price, Denmark, Annual Change (%), 2006-2011 132
Table 60: Average Consumer Price, Denmark, Annual Change (%), Forecast, 2012-2020 133
Table 61: Currency Exchange Rate (DKK/$), Denmark, 2006-2011 134
Table 62: Foreign Direct Investment ($bn), Denmark, 2006-2011 135
Table 63: Foreign Exchange Reserves ($bn), Denmark, 2006-2011 136
Table 64: Exports of Goods and Services ($bn), Denmark, 2006-2011 137
Table 65: Imports of Goods and Services ($bn), Denmark, 2006-2011 138
Table 66: General Government Structural Balance ($bn), Denmark, 2006-2011 139
Table 67: General Government Structural Balance ($bn), Forecast, Denmark, 2012-2020 140
Table 68: General Government Gross Debt (% of GDP), Denmark, 2005-2010 141
Table 69: External Debt ($bn), Denmark, 2006-2011 142
Table 70: Major Industries, Denmark, Gross Value Added ($bn), 2010-2011 143
Table 71: Population (m), Denmark, 2006-2011 144
Table 72: Population (m), Denmark, Forecast, 2012-2020 145
Table 73: Urban and Rural Population, Denmark, Share (%), 2006-2011 146
Table 74: Urban and Rural Population, Denmark, Share (%), Forecast, 2012-2020 147
Table 75: Age Groups, Denmark, Population Distribution (%), 2006-2011 148
Table 76: Age Groups, Denmark, Population Distribution (%), Forecast, 2012-2020 149
Table 77: Births (per 1,000 Population), Denmark, 2006-2011 150
Table 78: Mortality (per 1,000 Population), Denmark, 2006-2011 151
Table 79: Major Causes of Mortality, Denmark, 2010 152
Table 80: Infant Mortality, Denmark, Mortality Rate (per 1,000 Live Births), 2005-2010 153
Table 81: Immunization Rate for DPT, Measles (%), Denmark, 2005-2010 154
Table 82: Major Causes of Male Mortality, Denmark, 2010 155
Table 83: Major Causes of Female Mortality, Denmark, 2010 156
Table 84: Gender Ratio (M/F), Denmark, 2006-2011 157
Table 85: Life Expectancy at Birth (Years), Denmark, 2005-2010 158
Table 86: Life Expectancy at Birth (Years), Denmark, Forecast, 2011-2020 159
Table 87: Students, Denmark, Gross Enrollment (%), 2005-2010 160
Table 88: Unemployment Rate (%), Denmark, 2005-2010 161
Table 89: Major Causes of Hospitalization, Denmark, Male Patients (per 1,000 Population), 2010 162
Table 90: Major Causes of Hospitalization, Denmark, Female Patients (per 1,000 Population), 2010 163
Table 91: Major Diseases, Denmark, DALYs (per 100,000 Population), 2004 164
Table 92: Number of Hospitals, Denmark, 2005-2010 166
Table 93: Diagnostic Equipment Units (per 1,000,000 Population), Denmark, 2006-2011 167
Table 94: Hospital Beds (per 1,000 Population), Denmark, 2005-2010 168
Table 95: Physicians (per 1,000 Population), Denmark, 2005-2010 169
Table 96: CO2 Emissions (kilotons), Denmark, 2005-2010 170
Table 97: PM10 (Micrograms per Cubic Meter), Denmark, 2005-2010 172
Table 98: Healthcare Personnel (per 1,000 Population), Denmark, 2005-2010 173
Table 99: Healthcare Expenditures (% of GDP), Denmark, 2005-2010 174
Table 100: Healthcare Expenditures, Denmark, Share of Major Components (%), 2010 175
Table 101: Healthcare Expenditures, Denmark, Public-Private Share (%), 2005-2010 176
Table 102: R&D Expenditures ($bn), Denmark, 2006-2011 177
Table 103: Major Healthcare Trade Fairs, Denmark, 2012 179
Figure 1: Pharmaceutical Market, Denmark, Revenue ($bn), 2005-2010 12
Figure 2: Pharmaceutical Market, Denmark, Revenue Forecast ($bn), 2011-2020 13
Figure 3: Pharmaceutical Distribution Channel, Denmark, 2012 14
Figure 4: Generic Pharmaceutical Market, Denmark, Revenue ($m), 2005-2010 15
Figure 5: Over-the-Counter Drugs Market, Denmark, Revenue ($m), 2006-2010 18
Figure 6: Major Therapeutic Areas, Denmark, Revenue ($m), 2010 19
Figure 7: Nervous System Drugs Market, Denmark, Revenue ($m), 2006-2010 20
Figure 8: Anti-Cancer Drugs Market, Denmark, Revenue ($m), 2006-2010 21
Figure 9: Anti-Infectives Market, Denmark, Revenue ($m), 2006-2010 22
Figure 10: Respiratory Drugs Market, Denmark, Revenue ($m), 2006-2010 23
Figure 11: Gastrointestinal Drugs Market, Denmark, Revenue ($m), 2006-2010 24
Figure 12: Medical Device Market, Denmark, Revenue ($bn), 2006-2011 50
Figure 13: Medical Device Market, Denmark, Revenue Forecast ($bn), 2012-2020 51
Figure 14: Medical Device Market, Denmark, Segments, Revenue ($m), 2011 52
Figure 15: In-Vitro Diagnostics Market, Denmark, Revenue ($m), 2006-2011 53
Figure 16: In-Vitro Diagnostics Market, Denmark, Revenue Forecast ($m), 2012-2020 54
Figure 17: Sales Trends for Major Players, In-Vitro Diagnostics, Denmark, 2006-2010 55
Figure 18: Orthopedic Devices Market, Denmark, Revenue ($m), 2006-2011 56
Figure 19: Orthopedic Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 57
Figure 20: Sales Trends for Major Players, Orthopedic Devices, Denmark, 2006-2011 58
Figure 21: Ophthalmic Devices Market, Denmark, Revenue ($m), 2006-2011 59
Figure 22: Ophthalmic Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 60
Figure 23: Sales Trends for Major Players, Ophthalmic Devices, Denmark, 2006-2010 61
Figure 24: Diagnostic Imaging Devices Market, Denmark, Revenue ($m), 2006-2011 62
Figure 25: Diagnostic Imaging Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 63
Figure 26: Sales Trends for Major Players, Diagnostic Imaging Devices, Denmark, 2006-2010 64
Figure 27: Cardiovascular Devices Market, Denmark, Revenue ($m), 2006-2011 65
Figure 28: Cardiovascular Devices Market, Denmark, Revenue Forecast ($m), 2012-2020 66
Figure 29: Sales Trends for Major Players, Cardiovascular Devices, Denmark, 2006-2011 67
Figure 30: Major Medical Device Companies, Denmark, Revenue ($m), 2010 68
Figure 31: Drivers and Barriers, Healthcare Market, Denmark, 2012 90
Figure 32: Healthcare System Financing, Denmark, 2012 91
Figure 33: Healthcare System Key Players, Denmark, 2012 92
Figure 34: Applications for General Reimbursement Approval, Denmark, 2008-2011 94
Figure 35: Healthcare Spending, Denmark, Out-of-Pocket Expenditure (%), 2005-2010 97
Figure 36: Change in Average Price of Drugs (%), Denmark, 2006-2011 98
Figure 37: Healthcare Administration, Denmark, 2012 100
Figure 38: National Procedure for Market Authorization, Denmark, 2012 103
Figure 39: Centralized Procedure for Market Authorization, Pre-Submission, EU, 2012 104
Figure 40: Centralized Procedure for Market Authorization, Pre-Opinion Phase, EU, 2012 105
Figure 41: Centralized Procedure for Market Authorization, Post-Opinion Phase, EU, 2012 106
Figure 42: Decentralized Procedure for Market Authorization, EU, 2012 107
Figure 43: Mutual Recognition Procedure for Market Authorization, EU, 2012 108
Figure 44: Conformity Assessment of Class I Medical Devices, EU, 2012 110
Figure 45: Conformity Assessment of Class IIa Medical Devices, EU, 2012 111
Figure 46: Conformity Assessment of Class IIb Medical Devices, EU, 2012 112
Figure 47: Conformity Assessment of Class III Medical Devices, EU, 2012 113
Figure 48: Major Healthcare Reforms, Denmark, 1995-2011 122
Figure 49: GDP per Capita ($), Denmark, 2006-2011 125
Figure 50: GDP Per Capita ($), Denmark, Forecast, 2012-2020 126
Figure 51: GDP ($bn), Denmark, 2006-2011 127
Figure 52: GDP ($bn), Denmark, Forecast, 2012-2020 128
Figure 53: GDP, Denmark, Annual Growth (%), 2006-2011 129
Figure 54: GNI per Capita ($), Denmark, 2006-2011 130
Figure 55: Average Consumer Price Index, Denmark, 2006-2011 131
Figure 56: Average Consumer Price, Denmark, Annual Change (%), 2006-2011 132
Figure 57: Average Consumer Price, Denmark, Annual Change (%), Forecast, 2012-2020 133
Figure 58: Currency Exchange Rate (DKK/$), Denmark, 2006-2011 134
Figure 59: Foreign Direct Investment ($bn), Denmark, 2006-2011 135
Figure 60: Foreign Exchange Reserves ($bn), Denmark, 2006-2011 136
Figure 61: Exports of Goods and Services ($bn), Denmark, 2006-2011 137
Figure 62: Imports of Goods and Services ($bn), Denmark, 2006-2011 138
Figure 63: General Government Structural Balance ($bn), Denmark, 2006-2011 139
Figure 64: General Government Structural Balance ($bn), Forecast, Denmark, 2012-2020 140
Figure 65: General Government Gross Debt (% of GDP), Denmark, 2005-2010 141
Figure 66: External Debt ($bn), Denmark, 2006-2011 142
Figure 67: Major Industries, Denmark, Gross Value Added ($bn), 2010-2011 143
Figure 68: Population (m), Denmark, 2006-2011 144
Figure 69: Population (m), Denmark, Forecast, 2012-2020 145
Figure 70: Urban and Rural Population, Denmark, Share (%), 2006-2011 146
Figure 71: Urban and Rural Population, Denmark, Share (%), Forecast, 2012-2020 147
Figure 72: Age Groups, Denmark, Population Distribution (%), 2006-2011 148
Figure 73: Age Groups, Denmark, Population Distribution (%), Forecast, 2012-2020 149
Figure 74: Births (per 1,000 Population), Denmark, 2006-2011 150
Figure 75: Mortality (per 1,000 Population), Denmark, 2006-2011 151
Figure 76: Major Causes of Mortality, Denmark, 2010 152
Figure 77: Infant Mortality, Denmark, Mortality Rate (per 1,000 Live Births), 2005-2010 153
Figure 78: Immunization Rate for DPT, Measles (%), Denmark, 2005-2010 154
Figure 79: Major Causes of Male Mortality, Denmark, 2010 155
Figure 80: Major Causes of Female Mortality, Denmark, 2010 156
Figure 81: Gender Ratio (M/F), Denmark, 2006-2011 157
Figure 82: Life Expectancy at Birth (Years), Denmark, 2005-2010 158
Figure 83: Life Expectancy at Birth (Years), Denmark, Forecast, 2011-2020 159
Figure 84: Students, Denmark, Gross Enrollment (%), 2005-2010 160
Figure 85: Unemployment Rate (%), Denmark, 2005-2010 161
Figure 86: Major Causes of Hospitalization, Denmark, Male Patients (per 1,000 Population), 2010 162
Figure 87: Major Causes of Hospitalization, Denmark, Female Patients (per 1,000 Population), 2010 163
Figure 88: Major Diseases, Denmark, DALYs (per 100,000 Population), 2004 164
Figure 89: Number of Hospitals, Denmark, 2005-2010 166
Figure 90: Diagnostic Equipment Units (per 1,000,000 Population), Denmark, 2006-2011 167
Figure 91: Hospital Beds (per 1,000 Population), Denmark, 2005-2010 168
Figure 92: Physicians (per 1,000 Population), Denmark, 2005-2010 169
Figure 93: CO2 Emissions (kilotons), Denmark, 2005-2010 170
Figure 94: PM10 (Micrograms per Cubic Meter), Denmark, 2005-2010 172
Figure 95: Healthcare Personnel (per 1,000 Population), Denmark, 2005-2010 173
Figure 96: Healthcare Expenditures (% of GDP), Denmark, 2005-2010 174
Figure 97: Healthcare Expenditures, Denmark, Share of Major Components (%), 2010 175
Figure 98: Healthcare Expenditures, Denmark, Public-Private Share (%), 2005-2010 176
Figure 99: R&D Expenditures ($bn), Denmark, 2006-2011 177
Figure 100: Opportunities and Challenges, Healthcare Market, Denmark, 2012 182