HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN · reference code gdhc0076chr |...

REFERENCE CODE GDHC0076CHR | PUBLICATION DATE FEBRUARY 2015

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –

SPAIN

Healthcare, Regulatory and Reimbursement Landscape – Spain 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN

Executive Summary

The implementation of austerity measures by the Spanish government has negated the effect of drivers such as the increasingly elderly population and free healthcare services, resulting in a decline in the pharmaceutical market.

In 2013, the percentage of elderly in the population

was XX%, and this is expected to reach XX% by

2020 (INE, 2014d). Despite the rise in the elderly

population and the provision of free healthcare, the

Spanish pharmaceutical market has been declining

since 2008 due to the implementation of austerity

measures, such as the promotion of generics and

new pricing policies (BOE, 2011; BOE, 2012a).

In 2011 and 2012, new pricing policies were

implemented such that manufacturers had to price

their product lower than the reference price. The

reference prices for pharmaceutical products in

Spain are based on the indication, rather than the

active molecule. Additionally, the government’s

policy for the promotion of generics mandates that

pharmacists should dispense the cheapest

available drugs (BOE, 2011; BOE, 2012a).

In 2008, the pharmaceutical market was valued at

approximately $XX billion. This declined to $XX

billion in 2013 at a negative Compound Annual

Growth Rate (CAGR) of XX% (in US dollar terms).

It is expected to continue this decline, at a negative

CAGR of XX% during the 2014–2020 period, to

reach an estimated $XX billion by 2020 (AESGP,

2011; AESGP, 2014a).

Pharmaceutical Market, Spain, Revenue ($bn), 2008–2020

2008 2013 2015 2020R

even

ue (

$bn)

CAGR (2008–2020): XX%

Source: AESGP, 2011; AESGP, 2014a

The medical device market was worth

approximately $XX billion in 2008, and increased

to approximately $XX billion by 2013 at a CAGR of

XX%. It is expected to reach $XX billion by 2020.

In 2013, the In Vitro Diagnostics (IVD) and diabetic

care device segments were the largest contributors

to the market, with shares of XX% and XX%

respectively. Other segments with significant

shares were orthopedic devices (XX%),

cardiovascular devices (XX%) and ophthalmic

devices (XX%).


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 6

1.1 List of Tables .................................................................................................................... 10

1.2 List of Figures ................................................................................................................... 15

2 Introduction ............................................................................................................................... 20

2.1 GlobalData Report Guidance ............................................................................................ 20

3 Overview of the Pharmaceutical and Medical Device Markets .................................................. 21

3.1 Pharmaceutical Market ..................................................................................................... 21

3.1.1 Market Overview ........................................................................................................... 21

3.1.2 Pharmaceutical Exports and Imports ............................................................................. 24

3.1.3 Supply Channels ........................................................................................................... 25

3.1.4 Market Segments .......................................................................................................... 27

3.1.5 Overview of Top Five Disease Areas ............................................................................ 33

3.1.6 Major Players ................................................................................................................ 35

3.2 Medical Device Market ...................................................................................................... 78

3.2.1 Market Overview ........................................................................................................... 78

3.2.2 Overview of Top Five Segments.................................................................................... 80

3.2.3 Diagnostic Market ......................................................................................................... 94

3.2.4 Major Players ................................................................................................................ 96

3.3 Market Drivers and Barriers ............................................................................................ 131

3.3.1 Drivers......................................................................................................................... 131

3.3.2 Barriers ....................................................................................................................... 132


Table of Contents


4 Market Access ........................................................................................................................ 134

4.1 Reimbursement and Payer Landscape ........................................................................... 134

4.1.1 Overview of Healthcare System .................................................................................. 134

4.1.2 Reimbursement Process ............................................................................................. 137

4.1.3 Overview of Insurance Providers ................................................................................. 141

4.1.4 Patient Share in Healthcare Spending ......................................................................... 143

4.1.5 Price Trend in Healthcare Services ............................................................................. 144

4.1.6 Pricing Policies ............................................................................................................ 145

4.2 Regulatory Landscape .................................................................................................... 148

4.2.1 Overview of Regulatory Agencies................................................................................ 148

4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 150

4.2.3 Market Authorization Procedure for Medical Devices .................................................. 166

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 171

4.2.5 Licensing Process for Pharmaceutical Exports and Imports ........................................ 174

4.2.6 Intellectual Property Rights.......................................................................................... 176

4.2.7 Clinical Trial Regulations ............................................................................................. 181

4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 183

4.2.9 Pharmacy Regulations ................................................................................................ 188

4.2.10 Labeling and Packaging Regulations .......................................................................... 189

5 Country Analysis ..................................................................................................................... 192

5.1 Political Environment....................................................................................................... 192

5.1.1 Political Structure ........................................................................................................ 192

5.1.2 Analysis of the Current Political Environment .............................................................. 193


Table of Contents


5.1.3 Healthcare Policy Initiatives ......................................................................................... 195

5.2 Economic Landscape ...................................................................................................... 197

5.3 Economic Indicators ........................................................................................................ 201

5.3.1 Gross Domestic Product ............................................................................................. 201

5.3.2 Gross National Income ................................................................................................ 206

5.3.3 Inflation ....................................................................................................................... 207

5.3.4 Currency Exchange Rate ............................................................................................ 210

5.3.5 Foreign Direct Investment ........................................................................................... 211

5.3.6 Foreign Exchange Reserves ....................................................................................... 212

5.3.7 Trade Balance ............................................................................................................. 213

5.3.8 General Government Structural Balance ..................................................................... 215

5.3.9 General Government Net Debt .................................................................................... 216

5.3.10 Major Industries ........................................................................................................... 218

5.4 Demographics ................................................................................................................. 219

5.4.1 Population ................................................................................................................... 219

5.4.2 Education and Literacy ................................................................................................ 237

5.4.3 Employment ................................................................................................................ 241

5.4.4 Disease Burden ........................................................................................................... 242

5.5 Healthcare Infrastructure ................................................................................................. 245

5.5.1 Healthcare Facilities .................................................................................................... 245

5.5.2 Healthcare Parameters ............................................................................................... 250

5.5.3 Environmental Health .................................................................................................. 254

5.5.4 Healthcare Personnel .................................................................................................. 257


Table of Contents


5.6 Healthcare Expenditure ................................................................................................... 260

5.6.1 Overview ..................................................................................................................... 260

5.6.2 Major Components of Healthcare Spending ................................................................ 261

5.6.3 Public and Private Sector Share .................................................................................. 262

5.6.4 Spending in Healthcare, R&D ...................................................................................... 264

5.7 Trade Associations ......................................................................................................... 265

5.7.1 Farmaindustria ............................................................................................................ 265

5.7.2 The Spanish Society of Public Health and Health Services Administration .................. 265

5.7.3 The Spanish Society of Health Informatics .................................................................. 266

5.7.4 Spanish Generic Medicines Association ...................................................................... 266

5.8 Trade Fairs ..................................................................................................................... 267

6 Opportunities and Challenges ................................................................................................. 268

6.1 Opportunities .................................................................................................................. 268

6.2 Challenges ...................................................................................................................... 269

7 Appendix................................................................................................................................. 271

7.1 Abbreviations .................................................................................................................. 271

7.2 Bibliography .................................................................................................................... 276

7.3 Research Methodology ................................................................................................... 294

7.3.1 Coverage .................................................................................................................... 294

7.3.2 Secondary Research ................................................................................................... 295

7.3.3 Forecasts .................................................................................................................... 295

7.3.4 Expert Panel................................................................................................................ 296

7.4 Disclaimer ....................................................................................................................... 296


Table of Contents


1.1 List of Tables

Table 1: Pharmaceutical Market, Spain, Revenue ($bn), 2008–2013 ........................................................... 22

Table 2: Pharmaceutical Market, Spain, Revenue Forecast ($bn), 2014–2020 ............................................. 23

Table 3: Pharmaceutical Market, Spain, Pharmaceutical Exports and Imports ($bn), 2008–2013 ................. 25

Table 4: Pharmaceutical Market, Spain, Pharmaceutical Mark-Ups, 2014 .................................................... 26

Table 5: Pharmaceutical Market, Spain, Generics Market, Drug Consumption by Volume (%), 2008–2013 .. 28

Table 6: Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area

(%), 2014 ....................................................................................................................................... 30

Table 7: Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease Area

(%), 2014 ....................................................................................................................................... 32

Table 8: Over the Counter Pharmaceutical Market, Spain, Share by Segment (%), 2011 ............................. 33

Table 9: Pharmaceutical Market, Spain, Top Five Therapeutic Areas by Share of Drug Consumption (%),

2013 .............................................................................................................................................. 34

Table 10: Pharmaceutical Market, Pfizer, Major Products, Revenue ($bn) and Annual Growth (%), 2013 ....... 36

Table 11: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 .................................................. 37

Table 12: Pharmaceutical Market, Roche, Global, Major Products, Revenue ($bn) and Annual Growth (%),

2013 .............................................................................................................................................. 45

Table 13: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2014 ................................................. 46

Table 14: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%),

2013 .............................................................................................................................................. 54

Table 15: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014≥2018 ........................................... 55

Table 16: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), 2013 ............................... 64

Table 17: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014 ................................................. 65

Table 18: Pharmaceutical Market, GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual

Growth (%), 2013 ........................................................................................................................... 70


Table of Contents


Table 19: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, 2014 ................................. 71

Table 20: Medical Device Market, Spain, Revenue ($bn), 2008–2013 ............................................................ 78

Table 21: Medical Device Market, Spain, Revenue Forecast ($bn), 2014–2020 ............................................. 79

Table 22: Medical Device Market, Spain, Top Five Segments, Revenue ($m) and Market Share (%), 2013 ... 81

Table 23: Medical Device Market, Spain, In Vitro Diagnostics Revenue ($m), 2008–2013 .............................. 82

Table 24: Medical Device Market, Spain, In Vitro Diagnostics, Sales Trend for Major Players, 2012 ............... 83

Table 25: Medical Device Market, Spain, Diabetes Care Devices Revenue ($m), 2008–2013 ........................ 85

Table 26: Medical Device Market, Spain, Diabetes Care Devices, Sales Trend for Major Players, 2012 ......... 86

Table 27: Medical Device Market, Spain, Orthopedic Devices Revenue ($m), 2008–2013 ............................. 87

Table 28: Medical Device Market, Spain, Orthopedic Devices, Sales Trend for Major Players, 2012 .............. 88

Table 29: Medical Device Market, Spain, Cardiovascular Devices Market ($m), 2008–2013 ........................... 90

Table 30: Medical Device Market, Spain, Cardiovascular Devices Market, Sales Trend for Major Players, 2012

...................................................................................................................................................... 91

Table 31: Medical Device Market, Spain, Ophthalmic Devices Revenue ($m), 2008–2013 ............................. 92

Table 32: Medical Device Market, Spain, Ophthalmic Devices, Sales Trend for Major Players, 2012 .............. 93

Table 33: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), 2008–2013 .............................. 94

Table 34: Medical Device Market, Spain, Diagnostic Market, Revenue Forecast ($bn), 2014–2020................ 95

Table 35: Medical Device Market, Spain, Major Medical Device Companies Revenue, 2012 .......................... 96

Table 36: Medical Device Market, Roche, Global, Major Products, 2014 ...................................................... 103

Table 37: Medical Device Market, Medtronic, Global, Major Products, 2013 ................................................. 110

Table 38: Medical Device Market, Abbott, Global, Major Products, 2014 ...................................................... 117

Table 39: Medical Device Market, Abbott, Global, Late-Stage Pipeline, 2014 ............................................... 118

Table 40: Healthcare System, Spain, Pharmaceutical Reimbursement Categories, 2014 ............................. 138

Table 41: Healthcare Spending, Spain, Out-of-Pocket Expenditure (%), 2008–2013 .................................... 143

Table 42: Market Access, Spain, Change in Average Price of Healthcare Services (%), 2008–2013 ............ 144


Table of Contents


Table 43: Pricing Policies, Spain, Wholesaler and Pharmacist Margin on Drug Price, 2010 .......................... 148

Table 44: Economic Indicators, Spain, Gross Domestic Product per Capita ($), 2008–2013 ......................... 202

Table 45: Economic Indicators, Spain, Gross Domestic Product per Capita Forecast ($), 2014–2020 .......... 203

Table 46: Economic Indicators, Spain, Gross Domestic Product Annual Growth (%), 2008–2013 ................. 204

Table 47: Economic Indicators, Spain, Gross Domestic Product Annual Growth Forecast (%), 2014–2020 .. 205

Table 48: Economic Indicators, Spain, Gross National Income per Capita ($), 2008–2013 ........................... 206

Table 49: Economic Indicators, Spain, Average Consumer Price Index, 2008–2013 .................................... 207

Table 50: Economic Indicators, Spain, Average Consumer Price Index Forecast, 2014–2020 ...................... 208

Table 51: Economic Indicators, Spain, Average Consumer Price Index Annual Change (%), 2008–2013 ..... 209

Table 52: Economic Indicators, Spain, Euro to Dollar Currency Exchange Rate, 2008–2013 ........................ 210

Table 53: Economic Indicators, Spain, Foreign Direct Investment ($bn), 2008–2013 .................................... 211

Table 54: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), 2008–2013 ................................ 212

Table 55: Economic Indicators, Spain, Imports of Goods and Services ($bn), 2008–2013 ............................ 214

Table 56: Economic Indicators, Spain, Exports of Goods and Services ($bn), 2008–2013 ............................ 214

Table 57: Economic Indicators, Spain, Government Structural Balance ($bn), 2008–2013 ........................... 215

Table 58: Economic Indicators, Spain, General Government Net Debt (% of GDP), 2008–2013 ................... 216

Table 59: Economic Indicators, Spain, General Government Net Debt Forecast (% of GDP), 2014–2020 .... 217

Table 60: Economic Indicators, Spain, Major Industries by Revenue ($bn) and Share (%), 2013 .................. 219

Table 61: Demographics, Spain, Population (million), 2008–2013 ................................................................ 220

Table 62: Demographics, Spain, Population Forecast (million), 2014–2020 ................................................. 221

Table 63: Demographics, Spain, Population, Urban and Rural Population Share (%), 2008–2013 ................ 222

Table 64: Demographics, Spain, Population, Urban and Rural Population Share Forecast (%), 2014–2020 . 223

Table 65: Demographics, Spain, Population Distribution by Age Group (%), 2008–2013 .............................. 225

Table 66: Demographics, Spain, Population Distribution by Age Group Forecast (%), 2014–2020................ 225


Table of Contents


Table 67: Demographics, Spain, Births (per 1,000 Population), 2008–2013 ................................................. 226

Table 68: Demographics, Spain, Mortality (per 1,000 Population), 2008–2013 ............................................. 227

Table 69: Demographics, Spain, Major Causes of Mortality, 2012 ................................................................ 229

Table 70: Demographics, Spain, Children <5 Years Age, Mortality Rate (%), 2008–2013 ............................. 230

Table 71: Demographics, Spain, Immunization Rate (%), 2008–2013 .......................................................... 231

Table 72: Demographics, Spain, Major Causes of Male Mortality, 2012 ....................................................... 233

Table 73: Demographics, Spain, Major Causes of Female Mortality, 2012 ................................................... 234

Table 74: Demographics, Spain, Gender Ratio (Male to Female), 2008–2013.............................................. 235

Table 75: Demographics, Spain, Life Expectancy at Birth (Years), 2008–2013 ............................................. 236

Table 76: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), 2012–

2013 ............................................................................................................................................ 239

Table 77: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), 2012–2013

.................................................................................................................................................... 240

Table 78: Demographics, Spain, Unemployment Rate (%), 2008–2013 ....................................................... 241

Table 79: Demographics, Spain, Distribution of Employment by Sectors (%), 2013 ...................................... 242

Table 80: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, 2012 ............... 243

Table 81: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (per 100,000 Population),

2004 ............................................................................................................................................ 245

Table 82: Healthcare Infrastructure, Spain, Number of Hospitals, 2008–2013 .............................................. 246

Table 83: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, 2008–2013 ............ 247

Table 84: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, 2008–2013 ............................... 248

Table 85: Healthcare Infrastructure, Spain, Diagnostic Units (per 1,000,000 Population), 2008–2013 .......... 249

Table 86: Healthcare Infrastructure, Spain, Hospital Beds (per 1,000 Population), 2008–2013 ..................... 250

Table 87: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, 2008–2013 ....................... 251

Table 88: Healthcare Infrastructure, Spain, Hospital Beds by type of treatment, 2008–2013......................... 252


Table of Contents


Table 89: Healthcare Infrastructure, Spain, Doctors (per 100,000 Population), 2008–2013........................... 253

Table 90: Healthcare Infrastructure, Spain, PM10 (µg/m3), 2008–2013 ........................................................ 255

Table 91: Healthcare Infrastructure, Spain, CO2 Emissions (Million Metric Tons), 2008–2013 ...................... 257

Table 92: Healthcare Infrastructure, Spain, Nurses (per 1,000 Population), 2008–2013 ............................... 258

Table 93: Healthcare Infrastructure, Spain, Pharmacists (per 1,000 Population), 2008–2013 ....................... 259

Table 94: Healthcare Infrastructure, Spain, Dentists (per 1,000 Population), 2008–2013 .............................. 260

Table 95: Healthcare Expenditure, Spain, Healthcare Expenditure (% of GDP), 2008–2013 ......................... 261

Table 96: Healthcare Expenditure, Spain, Major Components of Healthcare Expenditure (%), 2008-2013.... 262

Table 97: Healthcare Expenditure, Spain, Healthcare Expenditure, Public-Private Share (%), 2008–2013 ... 263

Table 98: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012 ....... 264

Table 99: Healthcare Expenditure, Spain, Major Healthcare Trade Fairs, 2015 ............................................ 267


Table of Contents


1.2 List of Figures

Figure 1: Pharmaceutical Market, Spain, Revenue ($bn), 2008–2013 .......................................................... 22

Figure 2: Pharmaceutical Market, Spain, Revenue Forecast ($bn), 2014–2020 ........................................... 23

Figure 3: Pharmaceutical Market, Spain, Pharmaceutical Exports and Imports ($bn), 2008–2013 ................ 24

Figure 4: Pharmaceutical Market, Spain, Supply Channel, 2010 .................................................................. 26

Figure 5: Pharmaceutical Market, Spain, Generics Market, Drug Consumption by Volume (%), 2008–2013 . 28

Figure 6: Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area

(%), 2014 ..................................................................................................................................... 30

Figure 7: Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease

Area, 2014 ................................................................................................................................... 31

Figure 8: OTC Pharmaceutical Market, Spain, Segment Share (%), 2011 .................................................... 33

Figure 9: Medical Device Market, Spain, Revenue ($bn), 2008–2013 .......................................................... 78

Figure 10: Medical Device Market, Spain, Revenue Forecast ($bn), 2014–2020 ............................................ 79

Figure 11: Medical Device Market, Spain, Top Five Segments, Revenue ($m), 2013 ..................................... 80

Figure 12: Medical Device Market, Spain, In Vitro Diagnostics Revenue ($m), 2008–2013 ............................ 82

Figure 13: Medical Device Market, Spain, In Vitro Diagnostics, Sales Trend for Major Players, Revenue ($m),

2008–2012 ................................................................................................................................... 83

Figure 14: Medical Device Market, Spain, Diabetes Care Devices Revenue ($m), 2008–2013 ....................... 84

Figure 15: Medical Device Market, Spain, Diabetes Care Devices, Sales Trend for Major Players, Revenue

($m), 2008–2012 .......................................................................................................................... 85

Figure 16: Medical Device Market, Spain, Orthopedic Devices Revenue ($m), 2008–2013 ............................ 87

Figure 17: Medical Device Market, Spain, Orthopedic Devices, Sales Trend for Major Players, Revenue ($m),

2008–2012 ................................................................................................................................... 88

Figure 18: Medical Device Market, Spain, Cardiovascular Devices Market ($m), 2008–2013 ......................... 89

Figure 19: Medical Device Market, Spain, Cardiovascular Devices Market, Sales Trend for Major Players,

Revenue ($m), 2008–2012 ........................................................................................................... 90


Table of Contents


Figure 20: Medical Device Market, Spain, Ophthalmic Devices Revenue ($m), 2008–2013 ........................... 92

Figure 21: Medical Device Market, Spain, Ophthalmic Devices, Sales Trend for Major Players, Revenue ($m),

2008–2012 ................................................................................................................................... 93

Figure 22: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), 2008–2013............................. 94

Figure 23: Medical Device Market, Spain, Diagnostic Market, Revenue Forecast ($bn), 2014–2020 .............. 95

Figure 24: Medical Device Market, Spain, Major Medical Device Companies, Revenue ($m), 2012 ............... 96

Figure 25: Healthcare Market, Spain, Drivers and Barriers, 2014 ................................................................. 133

Figure 26: Healthcare System, Spain, Organization of the Spanish National Health System, 2014............... 134

Figure 27: Healthcare System, Spain, Health Technology Assessment Process, 2014 ................................ 140

Figure 28: Healthcare Spending, Spain, Out-of-Pocket Expenditure (%), 2008–2013 ................................... 143

Figure 29: Market Access, Spain, Change in Average Price of Healthcare Services (%), 2008–2013 ........... 144

Figure 30: Regulatory Landscape, Spain, AEMPS Organization, 2014 ........................................................ 150

Figure 31: Market Authorization, Spain, National Procedure, 2014 .............................................................. 154

Figure 32: Market Authorization, Spain, Centralized Procedure, Pre-Submission, 2014 ............................... 157

Figure 33: Market Authorization, Spain, Centralized Procedure, Pre-Opinion Phase, 2014 .......................... 159

Figure 34: Market Authorization, Spain, Centralized Procedure, Post-Opinion Phase, 2014 ......................... 161

Figure 35: Market Authorization, Spain, Decentralized Procedure, 2014 ...................................................... 163

Figure 36: Market Authorization, Spain, Mutual Recognition Procedure, 2014 ............................................. 165

Figure 37: Market Authorization, Spain, Conformity Assessment of Class I Medical Devices, 2014 .............. 167

Figure 38: Market Authorization, Spain, Conformity Assessment of Class IIa Medical Devices, 2014 ........... 168

Figure 39: Market Authorization, Spain, Conformity Assessment of Class IIb Medical Devices, 2014 ........... 169

Figure 40: Market Authorization, Spain, Conformity Assessment of Class III Medical Devices, 2014 ............ 170

Figure 41: Economic Indicators, Spain, Gross Domestic Product per Capita ($), 2008–2013 ....................... 202

Figure 42: Economic Indicators, Spain, Gross Domestic Product per Capita Forecast ($), 2014–2020 ......... 203

Figure 43: Economic Indicators, Spain, Gross Domestic Product Annual Growth (%), 2008–2013 ............... 204


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Figure 44: Economic Indicators, Spain, Gross Domestic Product Annual Growth Forecast (%), 2014–2020 . 205

Figure 45: Economic Indicators, Spain, Gross National Income per Capita ($), 2008–2013 .......................... 206

Figure 46: Economic Indicators, Spain, Average Consumer Price Index, 2008–2013 ................................... 207

Figure 47: Economic Indicators, Spain, Average Consumer Price Index Forecast, 2014–2020 .................... 208

Figure 48: Economic Indicators, Spain, Average Consumer Price Index Annual Change (%), 2008–2013.... 209

Figure 49: Economic Indicators, Spain, Euro to Dollar Currency Exchange Rate, 2008–2013 ...................... 210

Figure 50: Economic Indicators, Spain, Foreign Direct Investment ($bn), 2008–2013 .................................. 211

Figure 51: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), 2008–2013 .............................. 212

Figure 52: Economic Indicators, Spain, Imports of Goods and Services ($bn), 2008–2013 .......................... 213

Figure 53: Economic Indicators, Spain, Exports of Goods and Services ($bn), 2008–2013 .......................... 214

Figure 54: Economic Indicators, Spain, Government Structural Balance ($bn), 2008–2013.......................... 215

Figure 55: Economic Indicators, Spain, General Government Net Debt (% of GDP), 2008–2013 ................. 216

Figure 56: Economic Indicators, Spain, General Government Net Debt Forecast (% of GDP), 2014–2020 ... 217

Figure 57: Economic Indicators, Spain, Major Industries by Revenue ($bn), 2013 ....................................... 218

Figure 58: Demographics, Spain, Population (million), 2008–2013 .............................................................. 220

Figure 59: Demographics, Spain, Population Forecast (million), 2014–2020 ................................................ 221

Figure 60: Demographics, Spain, Population, Urban and Rural Population Share (%), 2008–2013 .............. 222

Figure 61: Demographics, Spain, Population, Urban and Rural Population Share Forecast (%), 2014–2020 223

Figure 62: Demographics, Spain, Population Distribution by Age Group (%), 2008–2013 ............................ 224

Figure 63: Demographics, Spain, Population Distribution by Age Group Forecast (%), 2014–2020 .............. 225

Figure 64: Demographics, Spain, Births (per 1,000 Population), 2008–2013 ................................................ 226

Figure 65: Demographics, Spain, Mortality (per 1,000 Population), 2008–2013............................................ 227

Figure 66: Demographics, Spain, Major Causes of Mortality, 2012 .............................................................. 228

Figure 67: Demographics, Spain, Children <5 Years Age, Mortality Rate (%), 2008–2013 ........................... 230


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Figure 68: Demographics, Spain, Immunization Rate (%), 2008–2013 ......................................................... 231

Figure 69: Demographics, Spain, Major Causes of Male Mortality, 2012 ...................................................... 232

Figure 70: Demographics, Spain, Major Causes of Female Mortality, 2012 .................................................. 233

Figure 71: Demographics, Spain, Gender Ratio (Male to Female), 2008–2013 ............................................ 235

Figure 72: Demographics, Spain, Life Expectancy at Birth (Years), 2008–2013 ........................................... 236

Figure 73: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), 2012–

2013 ........................................................................................................................................... 238

Figure 74: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), 2012–2013

.................................................................................................................................................. 240

Figure 75: Demographics, Spain, Unemployment Rate (%), 2008–2013 ...................................................... 241

Figure 76: Demographics, Spain, Distribution of Employment by Sector (%), 2013 ...................................... 242

Figure 77: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, 2012 .............. 243

Figure 78: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (per 100,000 Population),

2004 ........................................................................................................................................... 244

Figure 79: Healthcare Infrastructure, Spain, Number of Hospitals, 2008–2013 ............................................. 246

Figure 80: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, 2008–2013 ........... 247

Figure 81: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, 2008–2013 ............................. 248

Figure 82: Healthcare Infrastructure, Spain, Diagnostic Units (per 1,000,000 Population), 2008–2013 ......... 249

Figure 83: Healthcare Infrastructure, Spain, Hospital Beds (per 1,000 Population), 2008–2013 ................... 250

Figure 84: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, 2008–2013 ...................... 251

Figure 85: Healthcare Infrastructure, Spain, Hospital Beds by Type of Treatment Provided, 2008–2013 ...... 252

Figure 86: Healthcare Infrastructure, Spain, Doctors (per 100,000 Population), 2008–2013 ......................... 253

Figure 87: Healthcare Infrastructure, Spain, PM10 (µg/m3), 2008–2013 ....................................................... 255

Figure 88: Healthcare Infrastructure, Spain, CO2 Emissions (Million Metric Tons), 2008–2013 ..................... 256

Figure 89: Healthcare Infrastructure, Spain, Nurses (per 1,000 Population), 2008–2013 .............................. 257


Table of Contents


Figure 90: Healthcare Infrastructure, Spain, Pharmacists (per 1,000 Population), 2008–2013 ...................... 258

Figure 91: Healthcare Infrastructure, Spain, Dentists (per 1,000 Population), 2008–2013 ............................ 259

Figure 92: Healthcare Expenditure, Spain, Healthcare Expenditure (% of GDP), 2008–2013 ....................... 260

Figure 93: Healthcare Expenditure, Spain, Major Components of Healthcare Expenditure (%), 2008–2013 . 261

Figure 94: Healthcare Expenditure, Spain, Healthcare Expenditure, Public-Private Share (%), 2008–2013 .. 263

Figure 95: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012 ...... 264

Figure 96: Healthcare Market, Spain, Opportunities and Challenges, 2014 .................................................. 270



Introduction

2 Introduction

2.1 GlobalData Report Guidance

Chapter starts with an executive summary, which gives an overview of the healthcare market

and its key driving factors. It also gives a snapshot of the demographic, regulatory and

reimbursement landscape and healthcare infrastructure.

Chapter three provides an overview of the pharmaceutical and medical device markets,

covering market size, Over-The-Counter (OTC) products, biologic/biosimilar products and the

market shares of generics, as well as the key drivers and barriers for the market as a whole. It

also includes profiles of the major players, as well as SWOT assessments.

Chapter four covers the reimbursement and payer landscape, and includes details of the

reimbursement process, insurance providers, pricing policies and drug price trends. It also

looks at the regulatory landscape and gives an overview of the regulatory agencies and

approval processes for new drugs and medical devices. Also covered is the licensing process

for the manufacture, export and import of pharmaceuticals; regulations for pharmaceutical

advertising, labeling, packaging and clinical trials; and an overview of intellectual property

rights.

Chapter five provides detailed analysis of the political and economic environment, and

analyses economic indicators, demographics, and healthcare infrastructure and expenditure.

Chapter six provides an overview of the opportunities for and challenges to growth in the

healthcare market.


Overview of the Pharmaceutical and Medical Device Markets


3.2 Medical Device Market

3.2.1 Market Overview

The market for medical devices is large, due to the increasingly elderly population and the

subsequent increase in the demand for healthcare products and services. The medical device

market was valued at approximately $XX billion in 2008 and grew at a CAGR of XX% to $XX billion

in 2013. It is expected to reach $XX billion in 2020.

Figure 9: Medical Device Market, Spain, Revenue ($bn), 2008–2013

2008 2009 2010 2011 2012 2013

Rev

enue

($bn

)

CAGR (2008–2013): XX%

Source: GlobalData, Medical eTrack [Accessed on December 3, 2014]

Table 20: Medical Device Market, Spain, Revenue ($bn), 2008–2013 Year 2008 2009 2010 2011 2012 2013

Revenue

Source: GlobalData, Medical eTrack [Accessed on December 3, 2014]


Country Analysis


5.6.4 Spending in Healthcare, R&D

Gross domestic expenditure on R&D is divided into two sectors: the business sector and public

administration. In 2012, R&D activities were financed mostly by the business sector (XX%),

followed by public administration (XX%). In 2012, R&D expenditure was €XXm ($XXm) (INE, press

release, November 14, 2013).

The expenditure on R&D was highest in the field of R&D services, which accounted for XX% of the

funds, followed by scientific and technical activities, which accounted for XX%. R&D expenditure

was lowest in motor vehicles (XX%) and chemicals (XX%) (INE, press release, November 14,

2013).

Figure 95: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012

R & D services

Scientific and technical activitiesIT related activities

Pharmaceuticals

Aerospace

Motor vehiclesChemicals

Source: INE, Press release, November 14, 2013

Table 98: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012 Field Share

R&D services

Scientific and technical activities

IT related activities

Pharmaceuticals

Aerospace

Motor vehicles

Chemicals

Source: INE, press release, November 14, 2013


Appendix


7 Appendix

7.1 Abbreviations

AC: Autonomous Community

ACL: Anterior Cruciate Ligament

AEC: Association of Community Nursing (Asociación de Enfermería Comunitaria)

AEMPS: Spanish Agency for Medicines and Healthcare Products

(Agencia Espanola del Medicamento y Productos Sanitarios)

AES: Association of Health Economics (Asociación de Economía de la Salud)

AESEG: Spanish Generic Medicines Association (Asociacion Española de Medicamentos)

AJS: Association of Health Lawyers (Asociación de Juristas de la Salud)

ALK+: Anaplastic Lymphoma Kinase Positive

AMAS: Madrid Association of Health Administration

(Asociación Madrileña de Administración Sanitaria)

AMC: Asset Management Company

CA: Conformity Assessment

CAGR: Compound Annual Growth Rate

CC-CEIC: Co-ordinating Center of the Research Ethics Committee

(Centro Coordinador de los Comités Éticos de Investigación Clínica)

CE: Conformité Européenne

CEIC: Research Ethics Committee (Comité Ético de Investigación Clínica)

CHMP: Committee for Medicinal Products for Human Use

CIPM: Interministerial Commission on Pharmaceutical Prices

(Comisión Interministerial de Precios de los Medicamentos)

CMDh Co-ordination group for Mutual recognition and Decentralised procedures – human


Appendix


CMH/CODEM Committee for Medicinal Products for Human Use

(Comité de Medicamentos de Uso Humano)

CMHS: Safety Committee for Medicinal products for Human Use

CMS: Centers for Medicare and Medicaid Services

CNS: Central Nervous System

CODEM: Comité de Medicamentos de Uso Humano

COMP: Committee for Orphan Medicinal Products

COPD: Chronic Obstructive Pulmonary Disease

CPI: Consumer Price Index

CRDM: Cardiac Rhythm Disease Management

CRL: Complete Response Letter

CT: Computed Tomography

CT/NG Chlamydia Trachomatis/Neisseria Gonorrhoeae

CVS: Cardiovascular System

DALY: Disability-Adjusted Life Year

DGFPS: Directorate General of Pharmacy and Health Products

(Dirección General de Farmacia y Productos Sanitarios)

DPT: Diphtheria, Pertussis and Tetanus

DRG: Diagnostic Related Groups

eCR: electronic Clinical Records

EFP: Advertisable Over-The-Counter Drugs

(Especialidades Farmaceuticas Publicitarias)

EMA: European Medicines Agency

EMAP: Emerging Markets and Asia-Pacific


Appendix


ENT: Ear, Nose and Throat

FDA: Food and Drug Administration

FFPC: Fiscal and Financial Policy Council

Forex: Foreign exchange

FROB: Fund for Orderly Restructuring of Banks

(Fondo De Reestructuración Ordenada Bancaria)

GDP: Gross Domestic Product

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GNI: Gross National Income

GSK: GlaxoSmithKline

HBV: Hepatitis B Virus

HCV: Hepatitis C Virus

HeFH: Heterozygous Familial Hypercholesterolemia

HIPATIA: Andalusian Public Health Association (Asociación Andaluza de Salud Pública)

HOM: Hospital Only Medicines

HPV: Human Papillomavirus

HTA: Health Technology Assessment

IMSERSO: Instituto de Mayores y Servicios Sociales

(National Institute of Health Management)

INGESA: Instituto Nacional de Gestión Sanitaria (National Institute of Health Management)

INSALUD: Instituto Nacional de la Salud (National Institute of Health)

IPC: Interministerial Pricing Committee

IPR: Intellectual Property Rights


Appendix


ISCIII: Instituto de Salud Carlos III

ISFAS: Social Institute for the Armed Forces (Instituto Social de las Fuerzas Armadas)

ITB: Inter-Territorial Board

IVD: In Vitro Diagnostics

MA: Marketing Authorization

MDD: Medical Device Directives

MESS: Ministry of Employment and Social Security

MHLW: Ministry of Health, Labour and Welfare

MOU: Memorandum of Understanding

MRI: Magnetic Resonance Imaging

MSO: Medtronic Singapore Operations

MSPS: Ministerio de Sanidad Política Social (Ministry of Health and Social Policy)

MSSSI: Ministerio de Sanidad, Servicios Sociales e Igualdad

(Ministry of Health, Social Services and Equality)

MUFACE: Mutual Fund for State Civil Servants

(La Mutualidad General de Funcionarios Civiles del Estado, MUFACE

MUGEJU: General Justice Mutual Company (Mutualidad General Judicial, MUGEJU)

NDA: New Drug Application

NIBR: Novartis Institutes for Biomedical Research

non-EFP: non-advertizable OTC

OA: Osteoarthritis

OEPM: Oficina Espanola de Patentes y Marcas

OOP: Out-Of-Pocket

OTC: Over-The-Counter


Appendix


PCR: Polymerase Chain Reactions

PM10: Particulate Matter with an aerodynamic diameter of less than 10 micrometers

pRED: pharma Research and Early Development

PSOE: Partido Socialista Obrero Español (Spanish Socialist Workers’ Party)

QC: Quality Control

QRD: Quality Review of Documents Group

REAP: Spanish Network of Primary Care (Red Española de Atención Primaria)

RMS: Reference Member State

RP: Reference Pricing

SAREB: Company for the Management of Assets proceeding from Restructuring of the

Banking System

(Sociedad de Gestión de Activos procedentes de la Reestructuración Bancaria)

SCSP: Society of Public Health Canaria (Sociedad Canaria de Salud Pública)

SEE: Spanish Society of Epidemiology

SEEP: Spanish Society of Psychiatric Epidemiology

(Sociedad Española de Epidemiología Psiquiatrita)

SEIS: The Spanish Society of Health Informatics

(Sociedad Española De Informática de la Salud)

SESA: Spanish Society of Environmental Health

(Sociedad Española de Sanidad Ambiental)

SESPAS: Spanish Society of Public Health and Health Services Administration

(The Sociedad Espanola de Salud Pública y Administración Sanitaria)

SNS: National Health System (Sistema Nacional de Salud)


Appendix


SSPCiB: Society of Public Health Catalunya i Balears

(Societat de Salut Publica de Catalunya i de Balears)

TCRC: Translational and Clinical Research Center

UNICEF: United Nations Children’s Fund

VAT: Value Added Tax

WHO : World Health Organization

7.2 Bibliography

10times (2014). Medical and Pharmaceutical Trade Shows in South Africa. 10times. Available

from: http://10times.com/southafrica/medical-pharma/tradeshows [Accessed on November 11,

2014].

Abbott (2013). 2013 Investor Relations. Abbott. Available from:

http://www.abbottinvestor.com/phoenix.zhtml?c=94004&p=irol-irhome [Accessed on

September 12, 2014]

Abbott (2014). Abbott initiates absorb iv trial to evaluate quality of life and cost savings of

dissolving heart device. Abbott. Available from: http://abbott.mediaroom.com/2014-09-15-

Abbott-Initiates-ABSORB-IV-Trial-to-Evaluate-Quality-of-Life-and-Cost-Savings-of-Dissolving-

Heart-Device [Accessed on September 12, 2014]

AEMPS (2010). How are medicines and medical devices regulated in Spain? Agencia

Española de Medicamentos y Productos Sanitarios. Available from:

http://www.aemps.gob.es/en/publicaciones/publica/regulacion_med-PS/docs/folleto-

regulacion_Med-PS.pdf.

AEMPS (2012a). Presentación del Comité de Seguridad de Medicamentos de Uso Humano

(CSMH). Agencia Española de Medicamentos y Productos Sanitarios. Available from:

http://www.aemps.gob.es/en/laAEMPS/estructura/csmh/presentacion.htm. [Accessed on

November 21, 2014].


Appendix


World Bank (2014f). PM10 country level (micrograms per cubic meter). World Bank. Available

from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3 [Accessed on October 17,

2014].

World Bank (2014g). CO2 emissions (metric tons per capita). World Bank. Available from:

http://data.worldbank.org/indicator/EN.ATM.CO2E.PC [Accessed on October 17, 2014].

World Bank (2014h). Out-of-pocket health expenditure (% of private expenditure on health).

World Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.OOPC.ZS [Accessed

on November 14, 2014].

7.3 Research Methodology

GlobalData’s dedicated research and analysis teams consist of experienced professionals with

advanced statistical expertise and marketing, market research and consulting backgrounds in the

pharmaceutical industry.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and

Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research

methodology is followed for all databases and reports.

7.3.1 Coverage

The objective of updating GlobalData’s coverage is to ensure that it represents the most up-to-date

vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company,

association and competitor sources.

Company coverage is based on three key factors: revenue; products; and media attention,

innovation and market potential.

The estimated revenue of all major companies, including private and governmental, are gathered

and used to prioritize coverage.

Companies that are making the news or are of particular interest due to their innovative approach

are prioritized.


Appendix


GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated

on a daily basis.

The coverage is further streamlined and strengthened with additional input from GlobalData’s

expert panel (see below).

7.3.2 Secondary Research

The research process begins with extensive secondary research using internal and external

sources to gather qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and

SEC filings

Industry trade journals, scientific journals and other technical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market

The CountryFocus reports are largely based on secondary research and use reliable and

authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA,

MHLW and NHS, among others.

7.3.3 Forecasts

The CountryFocus reports use the data available from the secondary sources to forecast and

validate the future trends for a country’s healthcare market, as well as parameters related to the

economy and healthcare infrastructure and expenditure.


Appendix


7.3.4 Expert Panel

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData’s expert panel comprises marketing managers, product specialists, international sales

managers from pharmaceutical companies, academics from research universities, consultants from

venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.

Historic data and forecasts are relayed to GlobalData’s expert panel and adjusted in accordance

with their feedback.

7.4 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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