Healthcare, Regulatory and Reimbursement Landscape - The Netherlands

Published: November 2012
No. of Pages: 188
  

Healthcare, Regulatory and Reimbursement Landscape - The Netherlands

Summary

GlobalData, the industry analysis specialist, has released its new report, “Healthcare, Regulatory and Reimbursement Landscape - The Netherlands”. The report is an essential source of information and analysis regarding the healthcare, regulatory, and reimbursement landscape in the Netherlands. It identifies key trends in the healthcare market and provides insights into the demographic, regulatory, and reimbursement landscape, and the 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 GlobalData’s team of industry experts. In 2011, the population of the Netherlands was 16.7 million. The population of the Netherlands is increasing due to a positive balance between the mortality and birth rates, an increasing fertility rate, and a high rate of immigration. Policymakers in the Netherlands are now faced with the problems of a Eurozone crisis, a declining population of the working-age group, and an increasing elderly population. The country’s pharmaceutical market was valued at $6.6 billion in 2010 and is expected to reach approximately $9.4 billion by 2020, increasing at a Compound Annual Growth Rate (CAGR) of 3.7%. The medical device market size was approximately $3.1 billion in 2011 and is expected to reach approximately $4.6 billion by 2020, with a projected CAGR of 4.8%.


The positive trends in the Dutch healthcare market can be attributed primarily to -
- An increasing elderly population
- Universal healthcare insurance
- A high degree of access to healthcare facilities

Scope

- An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
- Profiles and SWOT analyses of the major players in the pharmaceutical and medical device markets. The major players covered for the pharmaceutical market are Pfizer, Merck, GlaxoSmithKline (GSK), Royal DSM, and Qiagen. The major players covered for the medical device market are Medronic, Siemens Healthcare, F. Hoffmann-La Roche, Essilor International, and Abbott Labolatories.
- An insightful review of the reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies, and approval processes for new drugs
- A detailed analysis of the political and economic environment, including economic indicators, demographics, and the healthcare infrastructure and expenditures
- An overview of the opportunities for and challenges to growth in the healthcare market

Reasons to buy

- Develop business strategies by understanding the trends shaping and driving the healthcare market of the Netherlands
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market of the Netherlands 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 the Netherlands

Healthcare, Regulatory and Reimbursement Landscape - The Netherlands

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 GlobalData 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 Major Therapeutic Areas 20
3.1.5 Major Players 22
3.2 Medical Device Market 52
3.2.1 Market Overview 52
3.2.2 Overview of Top Five Segments 54
3.2.3 Major Players 65
3.3 Market Drivers and Barriers 84
3.3.1 Drivers 84
3.3.2 Barriers 85
4 Market Access 87
4.1 Reimbursement and Payer Landscape 87
4.1.1 Overview of Healthcare System 87
4.1.2 Reimbursement Process 88
4.1.3 Overview of Insurance Providers 90
4.1.4 Patients Share in Healthcare Spending 92
4.1.5 Healthcare Price Trends 93
4.1.6 Pricing Policies 94
4.2 Regulatory Landscape 95
4.2.1 Overview of Regulatory Agencies 95
4.2.2 Market Authorization Procedure for Pharmaceutical Products 96
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 112
4.2.9 Pharmacy Regulations 112
4.2.10 Labeling and Packaging Regulations 112
5 Country Analysis 114
5.1 Political Environment 114
5.1.1 Political Structure 114
5.1.2 Analysis of the Current Political Environment 114
5.1.3 Healthcare Policy Initiatives 115
5.2 Economic Landscape 116
5.3 Economic Indicators 117
5.3.1 Gross Domestic Product 117
5.3.2 Gross National Income 120
5.3.3 Inflation 121
5.3.4 Currency Exchange Rate 123
5.3.5 Foreign Direct Investment 124
5.3.6 Foreign Exchange Reserves 125
5.3.7 Trade Balance 126
5.3.8 General Government Structural Balance 128
5.3.9 General Government Gross Debt 130
5.3.10 Major Industries 132
5.4 Demographics 133
5.4.1 Population 133
5.4.2 Education and Literacy 149
5.4.3 Employment 150
5.4.4 Disease Burden 152
5.5 Healthcare Infrastructure 155
5.5.1 Healthcare Facilities 155
5.5.2 Healthcare Parameters 158
5.5.3 Environmental Health 160
5.5.4 Healthcare Personnel 166
5.6 Healthcare Expenditures 169
5.6.1 Overview 169
5.6.2 Major Components of Healthcare Spending 170
5.6.3 Share of Public and Private Sectors 171
5.6.4 Spending in Pharmaceutical and Healthcare R&D 172
5.7 Trade Associations 173
5.7.1 Nefarma 173
5.7.2 Neprofarm 173
5.7.3 Bogin 173
5.7.4 Diagned 173
5.8 Trade Fairs 174
6 Opportunities and Challenges 175
6.1 Opportunities 175
6.2 Challenges 175
7 Appendix 177
7.1 Abbreviations 177
7.2 Bibliography 181
7.3 Methodology 186
7.3.1 Coverage 187
7.3.2 Secondary Research 187
7.3.3 Forecasting 187
7.3.4 Primary Research 187
7.3.5 Expert Panel Validation 188
7.4 Contact Us 188
7.5 Disclaimer 188

1.1 List of Tables
Table 1: Pharmaceutical Market ($bn), the Netherlands, 2005-2010 12
Table 2: Pharmaceutical Market ($bn), the Netherlands, Forecast, 2011-2020 13
Table 3: Price Margins of Distribution Channel (%), the Netherlands, 2011 14
Table 4: Generic Pharmaceutical Market ($m), the Netherlands, 2005-2010 15
Table 5: Drugs Going Off Patent, Revenue ($m), Global, 2011-2015 16
Table 6: Approved Biosimilar Drugs, the Netherlands, 2012 17
Table 7: OTC Pharmaceutical Market ($m), the Netherlands, 2006-2011 18
Table 8: Major OTC Drug Classes, the Netherlands, Market Share (%), 2011 19
Table 9: Major Therapeutic Areas, the Netherlands, Revenue ($m), 2009 20
Table 10: Major Products, Pfizer, Global, Revenue ($m), 2011 23
Table 11: Late-Stage Pipeline, Pfizer, 2012 24
Table 12: Major Products, Merck, Global, Revenue ($m), 2011 29
Table 13: Late-Stage Pipeline, Merck, 2012 30
Table 14: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 34
Table 15: Late-Stage Pipeline, GlaxoSmithKline, 2012 34
Table 16: Major Healthcare Products, DSM, 2012 40
Table 17: Major Products, Qiagen, 2012 46
Table 18: Medical Device Market ($bn), the Netherlands, 2006-2011 52
Table 19: Medical Device Market ($bn), the Netherlands, Forecast, 2012-2020 53
Table 20: Medical Device Market, the Netherlands, Segments, Revenue ($m), 2011 54
Table 21: Ophthalmic Devices Market ($m), the Netherlands, 2006-2011 55
Table 22: Sales Trends for Major Players*, Ophthalmic Devices, the Netherlands, 2010 56
Table 23: In-Vitro Diagnostics Market ($m), the Netherlands, 2006-2011 57
Table 24: Sales Trends for Major Players*, In-Vitro Diagnostics, the Netherlands, 2010 58
Table 25: Cardiovascular Devices Market ($m), the Netherlands, 2006-2011 59
Table 26: Sales Trends for Major Players*, Cardiovascular Devices, the Netherlands, 2010 60
Table 27: Orthopedic Devices Market ($m), the Netherlands, 2006-2011 61
Table 28: Sales Trends for Major Players*, Orthopedic Devices, Netherlands, 2010 62
Table 29: Hospital Supplies Market ($m), the Netherlands, 2006-2011 63
Table 30: Sales Trends for Major Players*, Hospital Supplies, the Netherlands, 2010 64
Table 31: Major Medical Device Companies, the Netherlands, Revenue ($m), 2010 65
Table 32: Major Products, Medtronic, Global, Revenue ($m), 2011 66
Table 33: Major Products, Siemens, Global, Revenue ($m), 2010 70
Table 34: Major Products, Roche, Global, Revenue ($m), 2010 73
Table 35: Late-Stage Pipeline, Roche, 2012 74
Table 36: Major Segments, Essilor International, Global, Revenue ($m), 2010 77
Table 37: Major Products, Abbott, Global, Revenue ($m), 2010 81
Table 38: Drug Reimbursement Categories, the Netherlands, 2012 89
Table 39: Major Health Insurers, Market Share (%), the Netherlands, 2012 91
Table 40: Healthcare Spending, the Netherlands, Patient''s Share (%), 2005-2010 92
Table 41: Healthcare Consumer Price Index, the Netherlands, Annual Change (%), 2006-2011 93
Table 42: GDP per Capita ($), the Netherlands, 2006-2011 117
Table 43: GDP per Capita ($), the Netherlands, Forecast, 2012-2020 118
Table 44: GDP, the Netherlands, Annual Growth (%), 2006-2011 119
Table 45: GNI per Capita ($), the Netherlands, 2006-2011 120
Table 46: Average Consumer Price Index, the Netherlands, 2006-2011 121
Table 47: Average Consumer Price, the Netherlands, Annual Change (%), 2006-2011 122
Table 48: Currency Exchange Rate (€/$), the Netherlands, 2006-2011 123
Table 49: Foreign Direct Investment ($bn), the Netherlands, 2006-2011 124
Table 50: Foreign Exchange Reserves ($bn), the Netherlands, 2005-2010 125
Table 51: Imports of Goods and Services ($bn), the Netherlands, 2006-2011 126
Table 52: Exports of Goods and Services ($bn), the Netherlands, 2006-2011 127
Table 53: General Government Structural Balance ($bn), the Netherlands, 2006-2011 128
Table 54: General Government Structural Balance ($bn), the Netherlands, Forecast, 2012-2020 129
Table 55: General Government Gross Debt ($bn), the Netherlands, 2006-2011 130
Table 56: General Government Gross Debt ($bn), the Netherlands, Forecast, 2012-2020 131
Table 57: Major Industries, the Netherlands, Output ($bn), 2010 132
Table 58: Population (m), the Netherlands, 2006-2011 133
Table 59: Population (m), the Netherlands, Forecast, 2012-2020 134
Table 60: Urban and Rural Population, the Netherlands, Share (%), 2005-2010 135
Table 61: Urban and Rural Population, the Netherlands, Share (%), 2011-2020 136
Table 62: Age Groups, the Netherlands, Population Distribution (%), 2006-2011 137
Table 63: Age Groups, the Netherlands, Population Distribution (%), Forecast, 2012-2020 138
Table 64: Births (per 1,000 Population), the Netherlands, 2005-2010 139
Table 65: Mortality (per 1,000 Population), the Netherlands, 2005-2010 140
Table 66: Major Causes of Mortality, the Netherlands, 2010 141
Table 67: Children <5 Years Age, the Netherlands, Mortality Rate (per 1,000 Live Births), 2005-2010 142
Table 68: Immunization Rate (%), the Netherlands, 2005-2010 143
Table 69: Major Causes of Male Mortality (’000s), the Netherlands, 2008 144
Table 70: Major Causes of Female Mortality (’000s), the Netherlands, 2008 145
Table 71: Gender Ratio (M/F), the Netherlands, 2005-2010 146
Table 72: Life Expectancy at Birth (Years), the Netherlands, 2005-2010 147
Table 73: Life Expectancy at Birth (Years), the Netherlands, Forecast, 2011-2020 148
Table 74: School Enrollment by Age Group (’000s), the Netherlands, 2010 149
Table 75: Unemployment (%), the Netherlands, 2006-2011 150
Table 76: Employment Sectors, the Netherlands, Share (%), 2010 151
Table 77: Major Causes of Hospitalization, the Netherlands, Male Patients (per 10,000 Population), 2008 152
Table 78: Major Causes of Hospitalization, the Netherlands, Female Patients (per 10,000 Population), 2008 153
Table 79: Major Diseases, the Netherlands, DALYs (per 100,000 Population), 2004 154
Table 80: Hospitals, the Netherlands, 2005-2010 155
Table 81: Hospital Beds (’000s), the Netherlands, 2005-2010 156
Table 82: Diagnostic Units (per 1,000,000 Population), the Netherlands, 2005-2010 157
Table 83: Hospital Beds (per 1,000 Population), the Netherlands, 2005-2010 158
Table 84: Physicians (per 1,000 Population), the Netherlands, 2005-2010 159
Table 85: CO2 Emissions (Million Tons), the Netherlands, 2005-2010 160
Table 86: PM10 Emissions (Million kg), the Netherlands, 2005-2010 161
Table 87: SO2 Emissions (Million kg), the Netherlands, 2005-2010 162
Table 88: Biochemical Oxygen Demand (mg/l), the Netherlands, 2005-2010 163
Table 89: Municipal Waste per Capita (kg), the Netherlands, 2005-2010 164
Table 90: Waste Handling, the Netherlands, Share (%), 2010 165
Table 91: Nurses (per 1,000 Population), the Netherlands, 2005-2010 166
Table 92: Pharmacists (per 100,000 Population), the Netherlands, 2005-2010 167
Table 93: Dentists (per 100,000 Population), the Netherlands, 2005-2010 168
Table 94: Healthcare Expenditures (% of GDP), the Netherlands, 2005-2010 169
Table 95: Healthcare Expenditures, the Netherlands, Share of Components (%), 2011 170
Table 96: Healthcare Expenditures, the Netherlands, Public-Private Share (%), 2005-2010 171
Table 97: R&D Expenditures ($bn), the Netherlands, 2005-2010 172
Table 98: Major Healthcare Trade Fairs, the Netherlands, 2013 174

1.2 List of Figures
Figure 1: Pharmaceutical Market ($bn), the Netherlands, 2005-2010 12
Figure 2: Pharmaceutical Market ($bn), the Netherlands, Forecast, 2011-2020 13
Figure 3: Distribution Channels, the Netherlands, 2012 14
Figure 4: Generic Pharmaceutical Market ($m), the Netherlands, 2005-2010 15
Figure 5: OTC Pharmaceutical Market ($m), the Netherlands, 2006-2011 18
Figure 6: Major OTC Drug Classes, The Netherlands, Market Share (%), 2011 19
Figure 7: Major Therapeutic Areas, the Netherlands, Revenue ($m), 2009 20
Figure 8: Medical Device Market ($bn), the Netherlands, 2006-2011 52
Figure 9: Medical Device Market ($bn), the Netherlands, Forecast, 2012-2020 53
Figure 10: Medical Device Market, the Netherlands, Segments, Revenue ($m), 2011 54
Figure 11: Ophthalmic Devices Market ($m), the Netherlands, 2006-2011 55
Figure 12: Sales Trends for Major Players, Ophthalmic Devices, the Netherlands, 2006-2010 56
Figure 13: In-Vitro Diagnostics Market ($m), the Netherlands, 2006-2011 57
Figure 14: Sales Trends for Major Players, In-Vitro Diagnostics, the Netherlands, 2006-2010 58
Figure 15: Cardiovascular Devices Market ($m), the Netherlands, 2006-2011 59
Figure 16: Sales Trends for Major Players*, Cardiovascular Devices, the Netherlands, 2006-2010 60
Figure 17: Orthopedic Devices Market ($m), the Netherlands, 2006-2011 61
Figure 18: Sales Trends for Major Players, Orthopedic Devices, the Netherlands, 2006-2010 62
Figure 19: Hospital Supplies Market ($m), the Netherlands, 2006-2011 63
Figure 20: Sales Trends for Major Players, Hospital Supplies, the Netherlands, 2006-2010 64
Figure 21: Major Medical Device Companies, the Netherlands, Revenue ($m), 2010 65
Figure 22: Drivers and Barriers, Healthcare Market, the Netherlands, 2012 86
Figure 23: Organizational Structure of Healthcare System, the Netherlands, 2012 87
Figure 24: Drug Reimbursement Process, the Netherlands, 2012 88
Figure 25: Structure of Health Insurance, the Netherlands, 2012 90
Figure 26: Major Health Insurers, Market Share (%), the Netherlands, 2012 91
Figure 27: Healthcare Spending, the Netherlands, Patient''s Share (%), 2005-2010 92
Figure 28: Healthcare Consumer Price Index, the Netherlands, Annual Change (%), 2006-2011 93
Figure 29: Organizational Structure of the Medicine Evaluation Board (MEB), the Netherlands, 2012 95
Figure 30: National Procedure for Market Authorization, the Netherlands, 2012 96
Figure 31: Centralized Procedure for Market Authorization, Pre-Submission, EU, 2012 98
Figure 32: Centralized Procedure, Market Authorization, Pre-Opinion Phase, EU, 2012 99
Figure 33: Centralized Procedure, Market Authorization, Post-Opinion Phase, EU, 2012 100
Figure 34: Decentralized Procedure, Market Authorization, EU, 2012 101
Figure 35: Mutual Recognition Procedure, Market Authorization, EU, 2012 102
Figure 36: Conformity Assessment of Class I Medical Devices, EU, 2012 104
Figure 37: Conformity Assessment of Class IIa Medical Devices, EU, 2012 105
Figure 38: Conformity Assessment of Class IIb Medical Devices, EU, 2012 106
Figure 39: Conformity Assessment of Class III Medical Devices, EU, 2012 107
Figure 40: Clinical Trial Approval Process, the Netherlands, 2012 111
Figure 41: GDP per Capita ($), the Netherlands, 2006-2011 117
Figure 42: GDP per Capita ($), the Netherlands, Forecast, 2012-2020 118
Figure 43: GDP, the Netherlands, Annual Growth (%), 2006-2011 119
Figure 44: GNI per Capita ($), the Netherlands, 2006-2011 120
Figure 45: Average Consumer Price Index, the Netherlands, 2006-2011 121
Figure 46: Average Consumer Price, the Netherlands, Annual Change (%), 2006-2011 122
Figure 47: Currency Exchange Rate (€/$), the Netherlands, 2006-2011 123
Figure 48: Foreign Direct Investment ($bn), the Netherlands, 2006-2011 124
Figure 49: Foreign Exchange Reserves ($bn), the Netherlands, 2005-2010 125
Figure 50: Imports of Goods and Services ($bn), the Netherlands, 2006-2011 126
Figure 51: Exports of Goods and Services ($bn), the Netherlands, 2006-2011 127
Figure 52: General Government Structural Balance ($bn), the Netherlands, 2006-2011 128
Figure 53: General Government Structural Balance ($bn), the Netherlands, Forecast, 2012-2020 129
Figure 54: General Government Gross Debt ($bn), the Netherlands, 2006-2011 130
Figure 55: General Government Gross Debt ($bn), the Netherlands, Forecast, 2012-2020 131
Figure 56: Major Industries, the Netherlands, Output ($bn), 2010 132
Figure 57: Population (m), the Netherlands, 2006-2011 133
Figure 58: Population (m), the Netherlands, Forecast, 2012-2020 134
Figure 59: Urban and Rural Population, the Netherlands, Share (%), 2005-2010 135
Figure 60: Urban and Rural Population, the Netherlands, Share (%), 2011-2020 136
Figure 61: Age Groups, the Netherlands, Population Distribution (%), 2006-2011 137
Figure 62: Age Groups, the Netherlands, Population Distribution (%), Forecast, 2012-2020 138
Figure 63: Births (per 1,000 Population), the Netherlands, 2005-2010 139
Figure 64: Mortality (per 1,000 Population), the Netherlands, 2005-2010 140
Figure 65: Major Causes of Mortality, the Netherlands, 2010 141
Figure 66: Children <5 Years Age, the Netherlands, Mortality Rate (per 1,000 Live Births), 2005-2010 142
Figure 67: Immunization Rate (%), the Netherlands, 2005-2010 143
Figure 68: Major Causes of Male Mortality (’000s), the Netherlands, 2008 144
Figure 69: Major Causes of Female Mortality (’000s), the Netherlands, 2008 145
Figure 70: Gender Ratio (M/F), the Netherlands, 2005-2010 146
Figure 71: Life Expectancy at Birth (Years), the Netherlands, 2005-2010 147
Figure 72: Life Expectancy at Birth (Years), the Netherlands, Forecast, 2011-2020 148
Figure 73: School Enrollment by Age Group (’000s), the Netherlands, 2010 149
Figure 74: Unemployment (%), the Netherlands, 2006-2011 150
Figure 75: Employment Sectors, the Netherlands, Share (%), 2010 151
Figure 76: Major Causes of Hospitalization, the Netherlands, Male Patients (per 10,000 Population), 2008 152
Figure 77: Major Causes of Hospitalization, the Netherlands, Female Patients (per 10,000 Population), 2008 153
Figure 78: Major Diseases, the Netherlands, DALYs (per 100,000 Population), 2004 154
Figure 79: Hospitals, the Netherlands, 2005-2010 155
Figure 80: Hospital Beds (’000s), the Netherlands, 2005-2010 156
Figure 81: Diagnostic Units (per 1,000,000 Population), the Netherlands, 2005-2010 157
Figure 82: Hospital Beds (per 1,000 Population), the Netherlands, 2005-2010 158
Figure 83: Physicians (per 1,000 Population), the Netherlands, 2005-2010 159
Figure 84: CO2 Emissions (Million Tons), the Netherlands, 2005-2010 160
Figure 85: PM10 Emissions (Million kg), the Netherlands, 2005-2010 161
Figure 86: SO2 Emissions (Million kg), the Netherlands, 2005-2010 162
Figure 87: Biochemical Oxygen Demand (mg/l), the Netherlands, 2005-2010 163
Figure 88: Municipal Waste per Capita (kg), the Netherlands, 2005-2010 164
Figure 89: Waste Handling, the Netherlands, Share (%), 2010 165
Figure 90: Nurses (per 1,000 Population), the Netherlands, 2005-2010 166
Figure 91: Pharmacists (per 100,000 Population), the Netherlands, 2005-2010 167
Figure 92: Dentists (per 100,000 Population), the Netherlands, 2005-2010 168
Figure 93: Healthcare Expenditures (% of GDP), the Netherlands, 2005-2010 169
Figure 94: Healthcare Expenditures, the Netherlands, Share of Components (%), 2011 170
Figure 95: Healthcare Expenditures, the Netherlands, Public-Private Share (%), 2005-2010 171
Figure 96: R&D Expenditures ($bn), the Netherlands, 2005-2010 172
Figure 97: Opportunities and Challenges, Healthcare Market, the Netherlands, 2012 176

Published By: GlobalData
Product Code: GlobalData26532


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