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Spain - Healthcare, Regulatory and Reimbursement Landscape

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    Report

  • 173 Pages
  • September 2021
  • Region: Spain
  • GlobalData
  • ID: 2585935
The publisher, the industry analysis specialist, has released its latest report, "Spain - Healthcare, Regulatory and Reimbursement Landscape". The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Spain. It identifies the key trends in the country’s healthcare market and provides insights into its demographic, regulatory and reimbursement landscape, and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of its pharmaceutical and medical device markets. It uses data and information sourced from proprietary databases, secondary research, and in-house analysis by the publisher's team of industry experts.

The Spanish pharmaceutical market is one of the major markets of the EU Region. The market value, in terms of Euros, increased from €10.7B in 2013 to €20.5B in 2020 at a Compound Annual Growth Rate (CAGR) of 8%. In terms of US dollars, the market increased from $10.7B in 2013 to $23.4B in 2020 at a CAGR of 6.4%. The medical devices market of Spain was $7.71B in 2017, which increased at a CAGR of 5% to reach $8.93B in 2020. The market is expected to grow at a CAGR of 1.2% from $9.35B in 2021 to reach $9.83B in 2025. Universal healthcare coverage, high pharmaceutical exports, and a strong clinical research environment are some of the factors driving the market. However, the introduction of a new action plan in 2020 by the Ministry of Health to promote the use of generic drugs may impede market growth.

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: Almirall, Bayer, Boehringer Ingelheim, Grifols, and Merck KGaA.
  • Profiles and SWOT analyses of the major players in the medical device market: Abbott, Alcon, GE Healthcare, Fresenius, and Roche Diagnostics
  • An insightful review of the COVID-19 epidemiology, COVID-19 impact, and developments in healthcare market, healthtech landscape, reimbursement landscape, 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 country’s healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the Spanish 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 impact the Spanish healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership

Table of Contents

1 Table of Contents
2. Executive Summary
2.1 Executive Summary
2.2 Key Highlights - Facts about the Spanish Healthcare Market
2.3 Key Highlights: Healthcare Startups in Spain
2.4 Key Events: Spanish Healthcare Industry, 2015-2021
2.5 Key Events: Spanish Pharmaceutical Market
2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2019-2020
2.7 Key Events: Top Completed Deals by Value, 2019-2020
2.8 Country Profile, Spain, 2020
3. Overview of Pharmaceutical Market
3.1 Pharmaceutical Market - Overview
3.2 Pharmaceutical Market - Exports
3.3 Pharmaceutical Market - Imports
3.4 Pharmaceutical Market - Supply Channels, Spain
3.5 Pharmaceutical Market - Market Segments
3.6 Major Therapeutic Areas, Spain
3.7 COVID-19 Epidemiology, Spain
3.8 COVID-19 Impact and Developments, Spain
3.9 COVID-19 Impact and Developments in the Healthcare Market, Spain
3.10 COVID-19 Clinical Trials Landscape, Spain
3.11 Pharmaceutical Market - Major Players
4. Overview of Medical Devices Market
4.1 Medical Device Market - Overview
4.2 Medical Devices Market - Major Players
5. Pharmaceutical and Medical Devices Market - Drivers and Barriers
5.1 Drivers
5.2 Barriers
6. Deal Analysis
6.1 Deal Analysis: Pharmaceutical Market, Spain, 2020-2021
6.2 Deal Analysis: Medical Device Market, Spain, 2020-2021
7. HealthTech Landscape
7.1 HealthTech Landscape, Spain
7.2 HealthTech Deals Landscape, Spain
7.3 Key HealthTech Deals, Spain
7.4 Adoption of Technology in Healthcare, Spain
7.5 Digital Health Regulations, Spain
7.6 Digital Health: Benefits and Risks, Spain
8. Market Access
8.1 Overview of Healthcare System, Spain
8.2 Reimbursement Process, Spain
8.3 Overview of Insurance Providers, Spain
8.4 Out-of-Pocket Spending and Pharmaceutical Price Index, Spain
8.5 Pricing Policies, Spain
8.6 Regulatory Landscape, Spain
8.6.1 Overview of Regulatory Agencies, Spain
8.6.2 Marketing Authorization for Pharmaceutical Products, EU
8.6.3 Marketing Authorization for Pharmaceutical Products, Centralized Procedure, Spain
8.6.4 Marketing Authorization for Pharmaceutical Products, Mutual Recognition Procedure, Spain
8.6.5 Marketing Authorization for Pharmaceutical Products, Decentralized Procedure, Spain
8.6.6 Marketing Authorization for Pharmaceutical Products, National Procedure, Spain
8.6.7 Marketing Authorization for Generic Drugs, Spain
8.6.8 Marketing Authorization for Biosimilars, Spain
8.6.9 Marketing Authorization for Medical Devices, Spain
8.6.10 Trade Regulations, Spain
8.6.11 Intellectual Property Rights, Patent, Spain
8.6.12 Intellectual Property Rights, European Patent, Spain
8.6.13 Intellectual Property Rights, Trademark, Spain
8.6.14 Clinical Trial Regulations, Spain
8.6.15 Pharmaceutical Clinical Trials Landscape, Spain
8.6.16 Medical Devices Clinical Trials Landscape, Spain
8.6.17 Pharmacy License Regulations, Spain
8.6.18 Online Pharmacy Regulations, Spain
8.6.19 Pharmaceutical Advertising Regulations, Spain
8.6.20 Labeling and Packaging Regulations, Spain
9. Country Healthcare Landscape
9.1 Healthcare Policy Highlights, Spain
9.2 Healthcare Facilities, Spain
9.3 Healthcare Parameters, Spain
9.4 Life Expectancy and Immunization Rate, Spain
9.5 Environmental Health, Spain
9.6 Healthcare Personnel, Spain
9.7 Disease Burden, Spain
9.8 Healthcare Expenditure, Spain
9.9 Healthcare Spending Components and Pharmaceutical Spending, Spain
10 Trade Associations, Spain11 Trade Fairs, Spain12 Opportunities and Challenges
13 Appendix
13.1 Research Methodology
13.1.1 Coverage
13.1.2 Secondary Research
13.1.3 Forecasts
13.2 Bibliography
13.3 About the Publisher
13.4 Contact the Publisher
13.5 Disclaimer
List of Tables
Table 1: SNS Biosimilar Savings ($M), Spain, 2020-2022
Table 2: Biosimilars approved in 2021, Spain, 2021
Table 3: COVID-19 Indicators (Number of cases), Spain and Global, 2020-2021
Table 4: COVID-19 Vaccines, Spain, 2020-2021
Table 5: Medical Devices Market, Spain, Major Segments ($M), 2020
Table 6: Hospital Supplies Market, Spain, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 7: General Surgery Devices Market, Spain, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 8: Cardiovascular Devices Market, Spain, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 9: Orthopedic Devices Market, Spain, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 10: Wound Care Management Devices Market, Spain, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 11: Patent Fees, Spain, 2021
Table 12: Trademark Fees, Spain, 2021
Table 13: Clinical Trial Fees, Spain, 2021
Table 14: Packaging information, Spain, 2019
Table 15: Conferences and Trade Fairs, Spain, 2021
List of Figures
Figure 1: Pharmaceutical Market, Spain, Revenue ($B and €B), 2013-2020
Figure 2: Medical Devices Market, Spain, Revenue ($B), 2017-2022
Figure 3: Healthcare Startups in Spain, 2020
Figure 4: Country Profile, Spain, 2020
Figure 5: Pharmaceutical Market, Spain, Revenue ($B), 2012-2020
Figure 6: Pharmaceutical Market, Spain, Revenue Forecast ($B), 2021-2025
Figure 7: Pharmaceutical Exports ($B), Spain, 2012-2020
Figure 8: Top Export Partners, Spain, 2020
Figure 9: Pharmaceutical Imports ($B), Spain, 2012-2020
Figure 10: Top Import Partners, Spain, 2020
Figure 11: securPharm System, EU, 2020
Figure 12: Generic Drugs (Market share % by value and volume), Spain, 2012-2020
Figure 13: Biotechnology R&D Breakdown, Spain, 2019
Figure 14: Biotechnology Companies Turnover ($B), Spain, 2011-2019
Figure 15: OTC Medicines Market, Revenue ($B), Spain, 2013-2021
Figure 16: OTC Medicines Market, Major Categories ($M), Spain, 2020
Figure 17: OTC Medicines Market, Major Distribution Channels ($M), Spain, 2017
Figure 18: Pharmaceutical Sales by Drug Category ($B), Spain, 2020
Figure 19: Major Therapeutic Areas by Pharmaceutical Consumption (Defined daily dosage per 1,000 inhabitants per day), Spain, 2018-2020
Figure 20: COVID-19 (Number of cases), Spain, 2020-2021
Figure 21: COVID-19 (Number of deaths), Spain, 2020-2021
Figure 22: Major COVID-19 Fiscal Stimulus Packages, Spain, 2020-2021
Figure 23: COVID-19 Vaccination Priority Groups, Spain, 2020-2021
Figure 24: Average Cumulative Number of Fully Vaccinated People, Spain, 2021
Figure 25: Top COVID-19 Marketed Products by Category (Number of available marketed products), Spain, 2020-2021
Figure 26: Top COVID-19 Marketed Products by Product Class (Number of available marketed products), Spain, 2020-2021
Figure 27: Top COVID-19 IVD Products by Equipment Type (Number of available marketed products), Spain, 2020-2021
Figure 28: Top COVID-19 Anesthesia and Respiratory Devices Products by Equipment Type (Number of available marketed products), Spain, 2020-2021
Figure 29: COVID-19 Clinical Trials Count by Phase, Spain, 2020-2021
Figure 30: COVID-19 Clinical Trials Count by Trial Status, Spain, 2020-2021
Figure 31: Top Five COVID-19 Clinical Trials Sponsors by Count, Spain, 2020-2021
Figure 32: Pharmaceutical Market, Major Players, 2020
Figure 33: Medical Devices Market, Spain, Revenue ($B), 2015-2020
Figure 34: Medical Devices Market, Spain, Revenue Forecast ($B), 2021-2025
Figure 35: Medical Devices Market, Spain, Major Segments (%), 2020
Figure 36: Hospital Supplies Market, Spain, Revenue ($B), 2017-2025
Figure 37: Hospital Supplies Market, Spain, Market Share of Major Players (%), 2020
Figure 38: General Surgery Devices Market, Spain, Revenue ($M), 2017-2025
Figure 39: General Surgery Devices Market, Spain, Market Share of Major Players (%), 2020
Figure 40: Cardiovascular Devices Market, Spain, Revenue ($M), 2017-2025
Figure 41: Cardiovascular Devices Market, Spain, Market Share of Major Players (%), 2020
Figure 42: Orthopedic Devices Market, Spain, Revenue ($M), 2017-2025
Figure 43: Orthopedic Devices Market, Spain, Market Share of Major Players (%), 2020
Figure 44: Wound Care Management Devices Market, Spain, Revenue ($M), 2017-2025
Figure 45: Wound Care Management Devices Market, Spain, Market Share of Major Players (%), 2020
Figure 46: Diagnostic Market, Spain, Revenue ($B), 2015-2020
Figure 47: Diagnostic Market, Spain, Revenue ($B), 2021-2025
Figure 48: Medical Devices Market, Spain, Revenue ($B) of Major Companies, 2020
Figure 49: Deal Value and Deal Count, Pharmaceutical Market, Spain, 2020-2021
Figure 50: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, Spain, 2020-2021
Figure 51: Deal Value and Deal Count Subtypes, Pharmaceutical Market, Spain, 2020-2021
Figure 52: Top Therapy Areas by Deal Value, Pharmaceutical Market, Spain, 2020-2021
Figure 53: Top Therapy Areas by Deal Count, Pharmaceutical Market, Spain, 2020-2021
Figure 54: M&A Deals by Quarter, Pharmaceutical Market, Spain, 2020-2021 (by Value and by Number)
Figure 55: VC Deals by Quarter, Pharmaceutical Market, Spain, 2020-2021 (by Value and by Number)
Figure 56: Deal Value and Deal Count, Medical Devices Market, Spain, 2020-2021
Figure 57: Deal Value and Deal Count, Quarterly, Medical Devices Market, Spain, 2020-2021
Figure 58: Deal Value and Deal Count Subtypes, Medical Devices Market, Spain, 2020-2021
Figure 59: Top Equipment Sectors by Deal Value, Medical Devices Market, Spain, 2020-2021
Figure 60: Top Equipment Sectors by Deal Count, Medical Devices Market, Spain, 2020-2021
Figure 61: M&A Deals by Equipment Sector, Medical Devices Market, Spain, 2020-2021 (by Value and by Number)
Figure 62: VC Deals by Quarter, Medical Devices Market, Spain, 2020-2021 (by Value and by Number)
Figure 63: Spain Digital 2025, Spain, 2021
Figure 64: BioRegion Catalonia Digital Health Startups Investment ($M), Spain, 2016-2020
Figure 65: Deal Value ($M), HealthTech, Spain, 2020-2021
Figure 66: Deal Count (Number of Deals), HealthTech, Spain, 2020-2021
Figure 67: Qualification of Software as MDSW (Medical Device Software), Spain, 2021
Figure 68: GDPR Compliance Checklist, EU, 2021
Figure 69: Overview of Healthcare System, Spain, 2020
Figure 70: Drug Reimbursement Process, Spain, 2020
Figure 71: Health Insurance Penetration (%), 2011-2019
Figure 72: Private Insurance Coverage (% of population), Spain, 2011-2020
Figure 73: Private Insurance Coverage (Annual turnover $B), Spain, 2011-2020
Figure 74: Private Insurance Players, Spain, 2020
Figure 75: Out-of-Pocket Spending ($ per capita), Spain, 2012-2018
Figure 76: Change in Pharmaceutical Products Price Index (2015 = 100), Spain, 2012-2020
Figure 77: Spanish Agency of Medicines and Medical Devices (AEMPS), Organization Chart, 2021
Figure 78: Drug Authorization Procedures, EU, 2021
Figure 79: Centralized Procedure, Spain, 2020
Figure 80: Mutual Recognition Procedure, Spain, 2020
Figure 81: Decentralized Procedure, Spain, 2020
Figure 82: Drug Approval Process, National Procedure, Spain, 2020
Figure 83: Data Exclusivity Timeline, Spain, 2020