CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Spain

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Executive Summary 10
3 Introduction 16
3.1 GlobalData Report Guidance 16
4 Overview of Pharmaceutical and Medical Device Markets 17
4.1 Pharmaceutical Market 17
4.1.1 Market Overview 17
4.1.2 Pharmaceutical Exports and Imports 20
4.1.3 Supply Channels 22
4.1.4 Market Segments 23
4.1.5 Major Therapeutic Areas 31
4.1.6 Major Players 34
4.2 Medical Device Market 71
4.2.1 Market Overview 71
4.2.2 Overview of Top Five Segments 74
4.2.3 Diagnostic Market 84
4.2.4 Major Players 87
4.3 Market Drivers and Barriers 114
4.3.1 Drivers 114
4.3.2 Barriers 115
5 Market Access 117
5.1 Reimbursement and Payer Landscape 117
5.1.1 Overview of Healthcare System 117
5.1.2 Reimbursement Process 118
5.1.3 Overview of Insurance Providers 121
5.1.4 Patient Share in Healthcare Expenditure 123
5.1.5 Price Trends in the Healthcare Sector 124
5.1.6 Pricing Policies 125
5.2 Regulatory Landscape 128
5.2.1 Overview of Regulatory Agencies 128
5.2.2 Market Authorization Procedure for Pharmaceutical Products 130
5.2.3 New Medical Device Approval Process 142
5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 146
5.2.5 Licensing Process for Pharmaceutical Exports and Imports 149
5.2.6 Intellectual Property Rights 150
5.2.7 Clinical Trial Regulations 155
5.2.8 Pharmaceutical Advertising Regulations 156
5.2.9 Pharmacy Regulations 160
5.2.10 Labeling and Packaging Regulations 162
6 Country Analysis 164
6.1 Political Environment 164
6.1.1 Political Structure 164
6.1.2 Current Political Environment 165
6.1.3 Healthcare Policy Initiatives 166
6.2 Economic Landscape 168
6.3 Economic Indicators 173
6.3.1 Gross Domestic Product 173
6.3.2 Gross National Income 178
6.3.3 Inflation 179
6.3.4 Currency Exchange Rate 182
6.3.5 Foreign Direct Investment 183
6.3.6 Foreign Exchange Reserves 184
6.3.7 Trade Balance 185
6.3.8 Government Structural Balance 187
6.3.9 Government Net Debt 188
6.3.10 Major Industries 189
6.4 Demographics 191
6.4.1 Population 191
6.4.2 Education and Literacy 209
6.4.3 Employment 213
6.4.4 Disease Burden 214
6.5 Healthcare Infrastructure 217
6.5.1 Healthcare Facilities 217
6.5.2 Healthcare Parameters 224
6.5.3 Environmental Health 227
6.5.4 Healthcare Personnel 231
6.6 Healthcare Expenditure 235
6.6.1 Overview 235
6.6.2 Share of Public and Private Sectors 236
6.6.3 Major Components of Healthcare Expenditure 237
6.6.4 Spending in R&D 237
6.7 Trade Associations 238
6.7.1 Farmaindustria 238
6.7.2 The Spanish Society of Public Health and Health Services Administration 239
6.7.3 The Spanish Society of Health Informatics 239
6.7.4 Spanish Generic Medicines Association 240
6.8 Trade Fairs 240
7 Opportunities and Challenges 241
7.1 Opportunities 241
7.2 Challenges 242
8 Appendix 244
8.1 Abbreviations 244
8.2 Bibliography 248
8.3 Research Methodology 263
8.3.1 Coverage 263
8.3.2 Secondary Research 263
8.3.3 Forecasts 264
8.3.4 Expert Panel 264
8.4 Contact Us 264
8.5 Disclaimer 265

List of Tables
1.1 List of Tables
Table 1: Pharmaceutical Market, Spain, Revenue ($bn), 2009-2016 19
Table 2: Pharmaceutical Market, Spain, Revenue ($bn), 2017-2021 20
Table 3: Pharmaceutical Market, Spain, Exports and Imports ($bn), 2009-2016 21
Table 4: Pharmaceutical Market, Spain, Generic Pharmaceutical Market Share (%), 2009-2016 25
Table 8: Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area (%), 2016 27
Table 8: Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease Area (%), 2016 29
Table 7: Pharmaceutical Market, Spain, OTC Drug Market Revenue ($bn), 2009-2016 30
Table 8: Pharmaceutical Market, Spain, Major OTC Drug Classes, Revenue ($bn) and Market Share (%), 2015 31
Table 9: Pharmaceutical Market, Spain, Major Therapeutic Areas by Units Sold (millions) and Share (%), 2015 32
Table 10: Pharmaceutical Market, Pfizer, Late-Stage Pipeline, 2016 35
Table 11: Major Products, Novartis, Global, 2016 41
Table 12: Late-Stage Pipeline, Novartis, Global, 2015 42
Table 13: Major Products, Sanofi, Global, 2015 50
Table 14: Late-Stage Pipeline, Sanofi, Global, 2015 52
Table 15: Pharmaceutical Market, Merck & Co., Global, Major Products, 2015 64
Table 16: Pharmaceutical Market, Merck & Co., Global, Late-Stage Pipeline, 2016 66
Table 17: Medical Device Market, Spain, Revenue ($bn), 2009-2016 72
Table 18: Medical Device Market, Spain, Revenue ($bn), 2017-2021 73
Table 19: Medical Device Market, Spain, Revenue ($m) and Market Share (%) by Segment, 2016 74
Table 20: In Vitro Diagnostics Market, Spain, Revenue ($m), 2009-2016 76
Table 21: In Vitro Diagnostics, Spain, Revenue ($m) and Market Share (%) of Major Players, 2014 76
Table 22: Diabetes Care Device Market, Spain, Revenue ($m), 2009-2016 77
Table 23: Diabetes Care Devices, Spain, Revenue ($m) and Market Share (%) of Major Players, 2015 78
Table 24: Ophthalmic Device Market, Spain, Revenue ($m), 2009-2016 79
Table 25: Ophthalmic Devices, Spain, Revenue ($m) and Market Share (%) of Major Players, 2015 80
Table 26: Orthopedic Devices, Spain, Revenue ($m), 2009-2016 81
Table 27: Orthopedic Devices, Spain, Revenue ($m) and Market Share (%) of Major Players, 2016 82
Table 28: Hospital Supplies Market, Spain, Revenue ($m), 2009-2016 83
Table 29: Hospital Supplies Market, Spain, Revenue ($m) and Market Share (%) of Major Players, 2014 84
Table 30: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), 2009-2016 85
Table 31: Medical Device Market, Spain, Revenue ($bn), 2017-2021 86
Table 32: Medical Device Market, Spain, Revenue ($m) and Market Share (%) of Major Players, 2012 87
Table 33: Baxter International, Global, Major Products, 2016 95
Table 34: Paul Hartmann, Global, Major Products, 2016 110
Table 35: Healthcare System, Spain, Pharmaceutical Reimbursement Categories, 2014 119
Table 36: Healthcare Expenditure, Spain, Out-of-Pocket Expenditure as Percentage of Total Expenditure (%), 2009-2016 123
Table 37: Market Access, Spain, Healthcare Consumer Price Index Annual Change (%), 2009-2016 125
Table 38: Economic Indicators, Spain, GDP per Capita ($), 2009-2016 174
Table 39: Economic Indicators, Spain, GDP per Capita ($), 2017-2021 175
Table 40: Economic Indicators, Spain, GDP Annual Growth (%), 2009-2016 176
Table 41: Economic Indicators, Spain, GDP Annual Growth (%), 2017-2021 177
Table 42: Economic Indicators, Spain, GNI per Capita ($), 2009-2016 178
Table 43: Economic Indicators, Spain, Consumer Price Index, 2009-2016 179
Table 44: Economic Indicators, Spain, Average Consumer Price Index, 2017-2021 180
Table 45: Economic Indicators, Spain, Average Consumer Price Index Annual Change (%), 2009-2016 181
Table 46: Economic Indicators, Spain, Currency Exchange Rate (€/$), 2009-2016 182
Table 47: Economic Indicators, Spain, Foreign Direct Investment ($bn), 2009-2016 183
Table 48: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), 2009-2016 184
Table 49: Economic Indicators, Spain, Imports of Goods and Services ($bn), 2009-2016 185
Table 50: Economic Indicators, Spain, Exports of Goods and Services ($bn), 2009-2016 186
Table 51: Economic Indicators, Spain, General Government Structural Balance ($bn), 2009-2016 187
Table 52: Economic Indicators, Spain, Government Net Debt as Percentage of GDP (%), 2009-2016 188
Table 53: Economic Indicators, Spain, Government Net Debt as Percentage of GDP (%), 2017-2021 189
Table 54: Economic Indicators, Spain, Major Industries by Revenue ($bn), 2014 190
Table 55: Demographics, Spain, Population (million), 2009-2016 192
Table 56: Demographics, Spain, Population (million), 2017-2021 193
Table 57: Demographics, Spain, Urban-Rural Population Share (%), 2009-2016 194
Table 58: Demographics, Spain, Urban-Rural Population Share (%), 2017-2021 195
Table 59: Demographics, Spain, Population Distribution by Age Group (%), 2009-2016 196
Table 60: Demographics, Spain, Population Distribution by Age Group (%), 2017-2021 197
Table 61: Demographics, Spain, Births (per 1,000 population), 2009-2016 198
Table 62: Demographics, Spain, Mortality (per 1,000 population), 2009-2016 199
Table 63: Demographics, Spain, Major Causes of Mortality (%), 2013 201
Table 64: Demographics, Spain, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016 202
Table 65: Demographics, Spain, Immunization Rate (%), 2009-2016 203
Table 66: Demographics, Spain, Major Causes of Male Mortality, 2013 205
Table 67: Demographics, Spain, Major Causes of Female Mortality (%), 2012 206
Table 68: Demographics, Spain, Gender Ratio (M/F), 2009-2016 207
Table 69: Demographics, Spain, Life Expectancy at Birth (years), 2009-2016 209
Table 70: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), 2014-2015 211
Table 71: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), 2013-2014 212
Table 72: Demographics, Spain, Unemployment Rate (%), 2009-2016 213
Table 73: Demographics, Spain, Distribution of Employment by Sector (%), 2015 214
Table 74: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, 2015 215
Table 75: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (000’), 2014 217
Table 76: Healthcare Infrastructure, Spain, Hospitals, 2009-2016 218
Table 77: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, 2009-2016 219
Table 78: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, 2009-2016 220
Table 79: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, 2009-2016 221
Table 80: Healthcare Infrastructure, Spain, Hospital Beds by Type of Treatment Provided, 2009-2016 222
Table 81: Healthcare Infrastructure, Spain, Diagnostic Units (per 100,000 population), 2009-2016 224
Table 83: Healthcare Infrastructure, Spain, Hospital Beds (per 1,000 population), 2009-2016 225
Table 83: Healthcare Infrastructure, Spain, Doctors (per 1,000 population), 2009-2016 226
Table 84: Healthcare Infrastructure, Spain, PM2.5 (µg per m³), 2009-2016 228
Table 85: Healthcare Infrastructure, Spain, CO2 Emissions (metric tons per capita), 2009-2016 230
Table 86: Healthcare Infrastructure, Spain, Nurses, 2009-2016 231
Table 87: Healthcare Infrastructure, Spain, Pharmacists, 2009-2016 232
Table 88: Healthcare Infrastructure, Spain, Dentists, 2009-2016 233
Table 89: Healthcare Infrastructure, Spain, Qualified Midwives, 2009-2016 234
Table 90: Healthcare Infrastructure, Spain, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 235
Table 91: Healthcare Infrastructure, Spain, Public-Private Share of Expenditure (%), 2009-2016 236
Table 92: Healthcare Infrastructure, Spain, Major Components of Healthcare Expenditure (%), 2015 237
Table 93: Healthcare Infrastructure, Spain, R&D Expenditure by Field (%), 2013 238
Table 94: Healthcare Expenditure, Spain, Major Healthcare Trade Fairs, 2017 240

List of Figures
1.2 List of Figures
Figure 1: Pharmaceutical Market, Spain, Revenue ($bn), 2009-2021 11
Figure 2: Medical Device Market, Spain, Revenue ($bn), 2009-2021 12
Figure 3: Country Profile, Spain, 2017 15
Figure 4: Pharmaceutical Market, Spain, Revenue ($bn), 2009-2016 19
Figure 5: Pharmaceutical Market, Spain, Revenue ($bn), 2017-2021 20
Figure 6: Pharmaceutical Market, Spain, Exports and Imports ($bn), 2009-2016 21
Figure 7: Pharmaceutical Market, Spain, Distribution Channels for Pharmaceuticals (%), 2012 23
Figure 8: Pharmaceutical Market, Spain, Generic Pharmaceutical Market Share (%), 2009-2016 25
Figure 9 Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area (%), 2016 27
Figure 10 Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease Area (%), 2016 28
Figure 11: Pharmaceutical Market, Spain, OTC Drug Market Revenue ($bn), 2009-2016 30
Figure 12: Pharmaceutical Market, Spain, Market Share of Major OTC Drug Classes (%), 2015 31
Figure 13: Pharmaceutical Market, Spain, Major Therapeutic Areas by Units Sold (millions), 2015 32
Figure 14: Medical Device Market, Spain, Revenue ($bn), 2009-2016 72
Figure 15: Medical Device Market, Spain, Revenue ($bn), 2017-2021 73
Figure 16: Medical Device Market, Spain, Revenue by Segment ($m), 2016 74
Figure 17: In Vitro Diagnostics Market, Spain, Revenue ($m), 2009-2016 75
Figure 18: In Vitro Diagnostics, Spain, Market Share of Major Players (%), 2014 76
Figure 19: Diabetes Care Device Market, Spain, Revenue ($m), 2009-2016 77
Figure 20: : Diabetes Care Device Market, Spain, Market Share of Major Players (%), 2015 78
Figure 21: Ophthalmic Device Market, Spain, Revenue ($m), 2009-2016 79
Figure 22: Ophthalmic Devices, Spain, Market Share of Major Players (%), 2015 80
Figure 23: Orthopedic Devices, Spain, Revenue ($m), 2009-2016 81
Figure 24: Orthopedic Devices, Spain, Market Share of Major Players (%), 2016 82
Figure 25: Hospital Supplies Market, Spain, Revenue ($m), 2009-2016 83
Figure 26: Hospital Supplies Market, Spain, Market Share of Major Players (%), 2014 84
Figure 27: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), 2009-2016 85
Figure 28: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), 2017-2021 86
Figure 29: Medical Device Market, Spain, Revenue of Major Players ($m), 2012 87
Figure 30: Healthcare Market, Spain, Drivers and Barriers, 2017 116
Figure 31: Market Access, Spain, Healthcare System, 2014 117
Figure 32: Healthcare System, Spain, Health Technology Assessment Process, 2014 120
Figure 33: Healthcare Expenditure, Spain, Out-of-Pocket Expenditure as Percentage of Total Expenditure (%), 2009-2016 123
Figure 34: Market Access, Spain, Healthcare Consumer Price Index Annual Change (%), 2009-2016 124
Figure 35: Market Access, Spain, Organizational Structure of AEMPS, 2016 130
Figure 36: Market Access, Spain, National Procedure, 2014 133
Figure 37: Market Access, EU, Centralized Procedure for Market Authorization, Pre-submission, 2016 135
Figure 38: Market Access, EU, Centralized Procedure, Market Authorization, Pre-opinion Phase, 2016 137
Figure 39: Market Access, EU, Centralized Procedure, Market Authorization, Post-opinion Phase, 2016 138
Figure 40: Market Access, EU, Decentralized Procedure, Market Authorization, 2016 140
Figure 41: Market Access, EU, Mutual Recognition Procedure, 2016 141
Figure 42: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2016 143
Figure 43: Market Access, EU, Conformity Assessment of Class IIa Medical Devices, 2016 144
Figure 44: Market Access, EU, Conformity Assessment of Class IIb Medical Devices, 2016 145
Figure 45: Market Access, EU, Conformity Assessment of Class III Medical Devices, 2016 146
Figure 46: Economic Indicators, Spain, GDP per Capita ($), 2009-2016 174
Figure 47: Economic Indicators, Spain, GDP per Capita ($), 2017-2021 175
Figure 48: Economic Indicators, Spain, GDP Annual Growth (%), 2009-2016 176
Figure 49: Economic Indicators, Spain, GDP Annual Growth (%), 2017-2021 177
Figure 50: Economic Indicators, Spain, GNI per Capita ($), 2009-2016 178
Figure 51: Economic Indicators, Spain, Consumer Price Index, 2009-2016 179
Figure 52: Economic Indicators, Spain, Average Consumer Price Index, 2017-2021 180
Figure 53: Economic Indicators, Spain, Average Consumer Price Index, Annual Change (%), 2009-2016 181
Figure 54: Economic Indicators, Spain, Currency Exchange Rate (€/$), 2009-2016 182
Figure 55: Economic Indicators, Spain, Foreign Direct Investment ($bn), 2009-2016 183
Figure 56: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), 2009-2016 184
Figure 57: Economic Indicators, Spain, Imports of Goods and Services ($bn), 2009-2016 185
Figure 58: Economic Indicators, Spain, Exports of Goods and Services ($bn), 2009-2016 186
Figure 59: Economic Indicators, Spain, Government Structural Balance ($bn), 2009-2016 187
Figure 60: Economic Indicators, Spain, Government Net Debt as Percentage of GDP (%), 2009-2016 188
Figure 61: Economic Indicators, Spain, Government Net Debt as Percentage of GDP (%), 2017-2021 189
Figure 62: Economic Indicators, Spain, Major Industries by Revenue ($bn), 2014 190
Figure 63: Demographics, Spain, Population (million), 2009-2016 192
Figure 64: Demographics, Spain, Population (million), 2017-2021 193
Figure 65: Demographics, Spain, Urban-Rural Population Share (%), 2009-2016 194
Figure 66: Demographics, Spain, Urban-Rural Population Share (%), 2017-2021 195
Figure 67: Demographics, Spain, Population Distribution by Age Group (%), 2009-2016 196
Figure 68: Demographics, Spain, Population Distribution by Age Group (%), 2017-2021 197
Figure 69: Demographics, Spain, Births (per 1,000 population), 2009-2016 198
Figure 70: Demographics, Spain, Mortality (per 1,000 population), 2009-2016 199
Figure 71: Demographics, Spain, Major Causes of Mortality , 2013 200
Figure 72: Demographics, Spain, Mortality Rate of Children Under Five (per 1,000 live births), 2009-2016 202
Figure 73: Demographics, Spain, Immunization Rate (%), 2009-2016 203
Figure 74: Demographics, Spain, Major Causes of Male Mortality 2013 204
Figure 75: Demographics, Spain, Major Causes of Female Mortality, 2013 206
Figure 76: Demographics, Spain, Gender Ratio (M/F), 2009-2016 207
Figure 77: Demographics, Spain, Life Expectancy at Birth (years), 2009-2016 208
Figure 78: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), 2014-2015 210
Figure 79: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), 2013-2014 211
Figure 80: Demographics, Spain, Unemployment Rate (%), 2009-2016 213
Figure 81: Demographics, Spain, Distribution of Employment by Sector (%), 2015 214
Figure 82: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, 2015 215
Figure 83: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (000’), 2014 216
Figure 84: Healthcare Infrastructure, Spain, Hospitals, 2009-2016 218
Figure 85: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, 2009-2016 219
Figure 86: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, 2009-2016 220
Figure 87: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, 2009-2016 221
Figure 88: Healthcare Infrastructure, Spain, Hospital Beds by Type of Treatment Provided, 2009-2016 222
Figure 89: Healthcare Infrastructure, Spain, Diagnostic Units (per 100,000 population), 2009-2016 223
Figure 90: Healthcare Infrastructure, Spain, Hospitals Beds (per 1,000 population), 2009-2016 225
Figure 91: Healthcare Infrastructure, Spain, Doctors (per 1,000 population), 2009-2016 226
Figure 92: Healthcare Infrastructure, Spain, PM2.5 (µg per m³), 2009-2016 228
Figure 93: Healthcare Infrastructure, Spain, CO2 Emissions (metric tons per capita), 2009-2016 230
Figure 94: Healthcare Infrastructure, Spain, Nurses, 2009-2016 231
Figure 95: Healthcare Infrastructure, Spain, Pharmacists, 2009-2016 232
Figure 96: Healthcare Infrastructure, Spain, Dentists, 2009-2016 233
Figure 97: Healthcare Infrastructure, Spain, Qualified Midwives, 2009-2016 234
Figure 98: Healthcare Infrastructure, Spain, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 235
Figure 99: Healthcare Infrastructure, Spain, Public-Private Share of Expenditure (%), 2009-2016 236
Figure 100: Healthcare Infrastructure, Spain, Major Components of Healthcare Expenditure (%), 2015 237
Figure 101: Healthcare Infrastructure, Spain, R&D Expenditure by Field (%), 2013 238
Figure 102: Healthcare Market, Spain, Opportunities and Challenges, 2017 243