Italy - Healthcare, Regulatory and Reimbursement Landscape

Italy - Healthcare, Regulatory and Reimbursement Landscape

Summary

GlobalData, the industry analysis specialist, has released its latest report, “Italy - Healthcare, Regulatory and Reimbursement Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Italy. 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 GlobalData’s team of industry experts.

Italy is one of the most significant pharmaceutical markets in Europe based on pharmaceutical production, exportation, innovative medicines, and biosimilar substitution. Universal healthcare coverage, high levels of innovation, and increasing use of biologics and biosimilars are factors driving the pharmaceutical and healthcare market. However, generic substitution and drug pricing agreements may impede market growth. The market value, in terms of euros, increased from €19.5B in 2013 to €22.9B in 2020 at a Compound Annual Growth Rate (CAGR) of 2.3%. In terms of US dollars, the market increased from $25.8B in 2013 to $26.2B in 2020 at a CAGR of 0.8%. The medical devices market of Italy was $8.57B in 2017, which increased at a CAGR of 2.2% to reach $9.16B in 2020. The market is expected to grow at a CAGR of 4.65% from $10.77B in 2021 to reach $11.50B in 2025.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Italy, 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, Bayer, Boehringer Ingelheim, Merck, and Chiesi
  • Profiles and SWOT analyses of the major players in the medical device market: Abbott, Medtronic, GE Healthcare, Roche Diagnostics, and Amplifon
  • An insightful review of the COVID-19 epidemiology, COVID-19 impact, and developments in healthcare market, HealthTech landscape, 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 country’s healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the Italian 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 Italy’s healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the Italian 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


1 Table of Contents
1.1 List of Figures
1.2 List of Tables
2. Executive Summary
2.1 Executive Summary
2.2 Key Highlights: Facts about the Italian Healthcare Market
2.3 Key Highlights: Healthcare Startups in Italy
2.4 Key Events: Italian Healthcare Timeline, 2014-2021
2.5 Key Events: Italian Pharmaceutical Market
2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2020-2021
2.7 Key Events: Mergers and Acquisitions
2.8 Country Profile, Italy, 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, Italy
3.5 Pharmaceutical Market - Market Segments
3.6 Major Therapeutic Areas, Italy
3.7 COVID-19 Epidemiology, Italy
3.8 COVID-19 Impact and Developments in the Healthcare Market, Italy
3.9 COVID-19 Clinical Trials Landscape, Italy
3.10 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, Italy, 2020-2021
6.2 Deal Analysis: Medical Device Market, Italy, 2020-2021
7. HealthTech Landscape
7.1 HealthTech Landscape, Italy
7.2 HealthTech Deals Landscape, Italy
7.3 Key HealthTech Deals, Italy
7.4 Adoption of Technology in Healthcare, Italy
7.5 Digital Health Regulations, Italy
7.6 Digital Health - Benefits and Risks, Italy
8. Market Access
8.1 Overview of Healthcare System, Italy
8.2 Reimbursement Process, Italy
8.3 Reimbursement of Medical Devices, Italy
8.4 Overview of Public Insurance Providers, Italy
8.5 Overview of Private Insurance Providers, Italy
8.6 Out-of-Pocket Spending and Pharmaceutical Price Index, Italy
8.7 Pricing Policies, Italy
8.8 Regulatory Landscape, Italy
8.8.1 Overview of Regulatory Agencies, Italy
8.8.2 Marketing Authorization for Pharmaceutical Products (National Procedure), Italy
8.8.3 Market Authorization for Pharmaceutical Products (Centralized Procedure), Italy
8.8.4 Market Authorization for Pharmaceutical Products (Mutual Recognition Procedure), Italy
8.8.5 Market Authorization for Pharmaceutical Products (Decentralized Procedure), Italy
8.8.6 Marketing Authorization for Medical Devices, Italy
8.8.7 Intellectual Property Rights, Patent, Italy
8.8.8 Intellectual Property Rights, Trademark, Italy
8.8.9 Clinical Trial Regulation, Italy
8.8.10 Pharmaceutical Clinical Trials Landscape, Italy
8.8.11 Medical Devices Clinical Trials Landscape, Italy
8.8.12 Pharmaceutical Advertising Regulations, Italy
8.8.13 Labeling and Packaging Regulations, Italy
9. Country Healthcare Landscape
9.1 Healthcare Policy Highlights, Italy
9.2 Healthcare Facilities, Italy
9.3 Healthcare Parameters, Italy
9.4 Life Expectancy and Immunization Rate, Italy
9.5 Environmental Health, Italy
9.6 Healthcare Personnel, Italy
9.7 Disease Burden, Italy
9.8 Healthcare Expenditure, Italy
9.9 Healthcare Spending Components and Pharmaceutical Spending, Italy
10. Trade Associations, Italy
11.Trade Fairs, Italy
12. 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 GlobalData
13.4 Contact Us
13.5 Disclaimer
List of Tables
Table 1: Key Events: Top Completed Deals by Value, 2020-2021
Table 2: Number of Products Assigned Under Orphan Drug Designation, Italy, 2019
Table 3: Number of Biotech Companies Located in Parks or Incubators, Italy, 2020
Table 4: COVID-19 Indicators (Number of Cases), Italy and Global, 2020-2021
Table 5: COVID-19-Related Ban & Restrictions, Italy, 2020-2021
Table 6: Medical Devices Market, Italy, Major Segments ($B), 2020
Table 7: Cardiovascular Devices Market, Italy, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 8: Hospital Supplies Market, Italy, Revenue ($M) and Market Share (%) of Major Companies, 2017
Table 9: Orthopedic Devices Market, Italy, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 10: General Surgery Devices Market, Italy, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 11: Wound Care Management Market, Italy, Revenue ($M) and Market Share (%) of Major Companies, 2020
Table 12: Reimbursement Categorization, Italy, 2019
Table 13: Managed Entry Agreements, Italy, 2019
Table 14: Type of VHI Providers, Italy, 2013-2021
Table 15: Patent Fees, Italy, 2020
Table 16: Trademark Fees, Italy, 2020
Table 17: Label of a Pharmaceutical Product, Italy, 2020
Table 18: Minimum Particulars to Appear on Blisters or Strips, Italy, 2020
Table 19: Minimum Particulars to Appear on Small Primary Packaging, Italy, 2020
Table 20: Trade Associations, Italy, 2021
Table 21: Conferences and Trade Fairs, Italy, 2021
List of Figures
Figure 1: Pharmaceutical Market, Italy, Revenue ($B and €B), 2013-2020
Figure 2: Medical Devices Market, Italy, Revenue ($B), 2017-2022
Figure 3: Healthcare Startups in Italy, 2020
Figure 4: Country Profile, Italy, 2020
Figure 5: Pharmaceutical Market, Italy, Revenue ($B), 2012-2020
Figure 6: Pharmaceutical Market, Italy, Revenue Forecast ($B), 2021-2026
Figure 7: Pharmaceutical Exports ($B), Italy, 2012-2020
Figure 8: Top Export Partners, Italy, 2020
Figure 9: Pharmaceutical Imports ($B), Italy, 2012-2020
Figure 10: Top Import Partners, Italy, 2020
Figure 11: Pharmaceutical Supply Chain, Italy, 2020
Figure 12: Generic Drugs (Market Share % by Value and Volume), Italy, 2012-2020
Figure 13: Generic Drug Market Authorization Applications (Number), EU, 2015-2021
Figure 14: Number of Biotech Companies Located in Parks or Incubators, Italy, 2020
Figure 15: Therapeutic Product Analysis by Developing Phase, Italy, 2019
Figure 16: Therapeutic Project Analysis by Molecule Type, Italy, 2019
Figure 17: OTC Medicines Market, Revenue ($B), Italy, 2013-2020
Figure 18: OTC Medicines Market, Major Categories ($M), Italy, 2019
Figure 19: OTC Medicines Market, Major Distribution Channels ($M), Italy, 2020
Figure 20: Pharmaceutical Sales by Drug Category ($B), Italy, 2020
Figure 21: Major Therapeutic Areas by Pharmaceutical Consumption (DDD per 1,000 inhabitants per day), Italy, 2018-2020
Figure 22: COVID-19 (Number of Cases), Italy, 2020-2021
Figure 23: COVID-19 (Number of Deaths), Italy, 2020-2021
Figure 24: COVID-19-Related Travel Restrictions, Italy, 2020-2021
Figure 25: COVID-19 Fiscal Stimulus Timeline, Italy, 2020-2021
Figure 26: COVID-19 Vaccine Administration, Number of People, Italy, 2020-2021
Figure 27: Total COVID-19 Vaccine Doses Administration by Vaccine Brand, Italy, 2021
Figure 28: Number of People Fully Vaccinated in Italy by COVID-19 Vaccine, Italy, 2021
Figure 29: Top COVID-19 Marketed Products by Category (Number of Available Marketed Products), Italy, 2020-2021
Figure 30: Top COVID-19 IVD Products by Equipment Type (Number of Available Marketed Products), Italy, 2020-2021
Figure 31: Top COVID-19 Marketed Products by Product Class (Number of Available Marketed Products), Italy, 2020-2021
Figure 32: Top COVID-19 Anesthesia and Respiratory Devices Products by Equipment Type (Number of Available Marketed Products), Italy, 2020-2021
Figure 33: COVID-19 Clinical Trials Count by Trial Status, Italy, 2020-2021
Figure 34: Top Five COVID-19 Clinical Trials Sponsors by Count, Italy, 2020-2021
Figure 35: COVID-19 Clinical Trials Count by Phase, Italy, 2020-2021
Figure 36: Pharmaceutical Market, Major Players, Italy
Figure 37: Medical Devices Market, Italy, Revenue ($B), 2015-2020
Figure 38: Medical Devices Market, Italy, Revenue Forecast ($B), 2021-2025
Figure 39: Medical Devices Market, Italy, Major Segments (%), 2020
Figure 40: Cardiovascular Devices Market, Italy, Revenue ($B), 2017-2025
Figure 41: Cardiovascular Devices Market, Italy, Market Share of Major Players (%), 2020
Figure 42: Hospital Supplies Market, Italy, Revenue ($B), 2017-2025
Figure 43: Hospital Supplies Market, Italy, Market Share of Major Players (%), 2017
Figure 44: Orthopedic Devices Market, Italy, Revenue ($B), 2017-2025
Figure 45: Orthopedic Devices Market, Italy, Market Share of Major Players (%), 2020
Figure 46: General Surgery Devices Market, Italy, Revenue ($B), 2017-2025
Figure 47: General Surgery Devices Market, Italy, Market Share of Major Players (%), 2020
Figure 48: Wound Care Management Market, Italy, Revenue ($B), 2017-2025
Figure 49: Wound Care Management Market, Italy, Market Share of Major Players (%), 2020
Figure 50: Diagnostic Market, Italy, Revenue ($B), 2015-2020
Figure 51: Diagnostic Market, Italy, Revenue ($B), 2021-2025
Figure 52: Medical Devices Market, Italy, Revenue ($B) of Major Companies, 2020
Figure 53: Deal Value and Deal Count, Pharmaceutical Market, Italy, 2020-2021
Figure 54: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, Italy, 2020-2021
Figure 55: Deal Value and Deal Count Sub-types, Pharmaceutical Market, Italy, 2020-2021
Figure 56: Top Therapy Areas by Deal Value, Pharmaceutical Market, Italy, 2020-2021
Figure 57: Top Therapy Areas by Deal Count, Pharmaceutical Market, Italy, 2020-2021
Figure 58: M&A Deals by Quarter, Pharmaceutical Market, Italy, 2020-2021 (by Value and by Number)
Figure 59: VC Deals by Quarter, Pharmaceutical Market, Italy, 2020-2021 (by Value and by Number)
Figure 60: Deal Value and Deal Count, Medical Devices Market, Italy, 2020-2021
Figure 61: Deal Value and Deal Count, Quarterly, Medical Devices Market, Italy, 2020-2021
Figure 62: Deal Value and Deal Count Sub-types, Medical Devices Market, Italy, 2020-2021
Figure 63: Top Equipment Sectors by Deal Value, Medical Devices Market, Italy, 2020-2021
Figure 64: Top Equipment Sectors by Deal Count, Medical Devices Market, Italy, 2020-2021
Figure 65: M&A Deals by Equipment Sector, Medical Devices Market, Italy, 2020-2021 (by Number)
Figure 66: VC Deals by Quarter, Medical Devices Market, Italy, 2020-2021 (by Value and by Number)
Figure 67: Deal Value ($M), HealthTech, Italy, 2020-2021
Figure 68: Deal Count (Number of Deals), HealthTech, Italy, 2020-2021
Figure 69: GDPR Compliance Checklist, EU, 2021
Figure 70: Organizational Structure of Ministry of Health, Italy, 2020
Figure 71: Overview of Healthcare System, Italy, 2020
Figure 72: Reimbursement of Medicinal Products, Italy, 2019

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