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スペインのヘルスケア、規制、医療費償還制度の状況

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Spain

発行 GlobalData 商品コード 274737
出版日 ページ情報 英文 265 Pages
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スペインのヘルスケア、規制、医療費償還制度の状況 CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Spain
出版日: 2017年04月11日 ページ情報: 英文 265 Pages
概要

当レポートでは、スペインのヘルスケア、規制、医療費償還制度の状況について調査分析し、医薬品・医療機器市場の概要、主要企業のプロファイルとSWOT分析、国の医療費償還制度・規制情勢、政治・経済環境について検証し、市場機会と課題も含めてお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 医薬品・医療機器市場の概要

  • 医薬品市場
  • 医療機器市場
  • 市場促進要因と障壁

第4章 市場参入

  • 医療費償還・保険料払込者の状況
  • 規制の状況

第5章 国の分析

  • 政策環境
  • 経済情勢
  • 経済指標
  • 人口統計
  • 医療インフラ
  • 医療費
  • 産業団体
  • 見本市

第6章 機会と課題

  • 機会
  • 課題

第7章 付録

図表

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次

Spain apart from having good healthcare infrastructure and undergoing regular modernization to incorporate the latest technological advances also provides free healthcare for all citizens. Spain also has a strong network of healthcare facilities, with primary healthcare centers located within 15 minutes of any place of residence. The ratio of healthcare personnel to population is also good, with 5.3 doctors per 1,000 population in 2016.

Spanish pharmaceutical market grew to US$23.7 Billion in 2016 at a CAGR of 1% from 2014, due to the introduction of tax incentives for R&D spending. In 2015, the pharmaceutical industry invested €953m (US$1.2 billion) in R&D. This accounted for 20.9% of all private R&D spending in Spain (Invest in Spain, 2016). Spain spent approximately US$1.2 Billion on R&D, and exported approximately US$11.5 Billion of pharmaceuticals.

In 2011 and 2012, new pricing policies were implemented forcing manufacturers to sell their products below 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.

The market in Spain is expected to reach US$25.1 billion in 2021, registering a CAGR of 0.9% between 2017 and 2021. The driving factors for the growth of the market are the consolidation of the biotechnology sector, government support, excellent infrastructure for innovation, a highly qualified workforce and a favorable cost benefit ratio of human capita.

The report "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Spain" is an essential source of information on and analysis of the healthcare, regulatory and reimbursement landscape in Spain.

In particular, this report provides the following analysis -

  • Provides an overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers.
  • Provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets.
  • It identifies the key trends in the country's healthcare market, and provides insights into its demographic, regulatory, and reimbursement landscape and healthcare infrastructure.
  • Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure.

Companies mentioned in this report: Pfizer, Novartis, Sanofi, GSK and Merck & Co,GSK,Baxter International, Johnson & Johnson, Svenska Cellulosa Aktiebolaget and Paul Hartmann.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Spain, and includes -

  • 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 market: Pfizer, Novartis, Sanofi, GSK and Merck & Co., as well as profiles and SWOT analyses of the major players in the medical device market: GSK,Baxter International, Johnson & Johnson, Svenska Cellulosa Aktiebolaget and Paul Hartmann
  • Insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country's healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices
  • Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the healthcare market

Reasons to buy

This report will enhance your decision-making capability by allowing you to -

  • Develop business strategies by understanding the trends shaping and driving the Spanish healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect the Spanish healthcare market 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 best opportunities for consolidation, investment, and strategic partnerships
  • Identify, understand, and capitalize on the opportunities and challenges in the Spanish healthcare market

Table of Contents

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), 20
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