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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Italy

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Italy

Summary

GlobalData, the industry analysis specialist, has released its new report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Italy”. The report is an essential source of information and analysis on Italy’s healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and the country’s healthcare infrastructure. Most importantly, it provides valuable insights into the trends and segmentation of the Italian pharmaceutical and medical device markets. The report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData’s team of industry experts.I

taly’s population was 61.78 million in 2015, and is increasing due to a positive balance between the birth and death rates, as well as through immigration. The country’s policymakers are currently faced with the challenge of an increasing unemployment rate due to a lack of clear monetary policies. The pharmaceutical market at the consumer price level (including Value Added Tax (VAT) and excluding hospital sales) was estimated at $22 billion in 2015, and is expected to decline to approximately $18 billion by 2020, at a negative Compound Annual Growth Rate (CAGR) of 3.3%. The medical devices market was estimated at approximately $13.2 billion in 2015, and is expected to reach $16.2 billion by 2020, at a CAGR of 4.2%. The decline of Italy’s pharmaceutical market can primarily be attributed to -

  • Owing to government measures to decrease healthcare expenditure
  • Falling sales of patented drugs,
  • Price cuts for drugs
  • Government initiatives to promote generics
  • The strict pricing of drugs through negotiations and through external reference pricing and internal reference pricing
Scope

The report provides information on Italy’s healthcare, regulatory and reimbursement landscape, and includes -
  • An overview of the pharmaceutical and medical devices markets, comprising size, segmentation and key drivers and barriers
  • Profiles and SWOT analyses of the major players in the pharmaceutical and medical devices market. The major players covered for the pharmaceutical market are Menarini, Angelini, Chiesi, Bracco and Recordati. The major players covered for the medical devices market are DePuy Synthes, GlaxoSmithKline (GSK), Baxter, Essilor and Siemens Healthcare
  • An insightful review of the country’s reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies and approval processes for new drugs
  • Detailed analysis of the political and economic environment, including economic indicators, demographics, and healthcare infrastructure and expenditure
  • An overview of the opportunities for and challenges to growth in the healthcare market
Reasons to buyThis 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 Italy’s 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 Tables
1.2 List of Figures
2 Introduction
2.1 GlobalData Report Guidance
3 Overview of Pharmaceutical and Medical Device Markets
3.1 Pharmaceutical Market
3.1.1 Market Overview
3.1.2 Pharmaceutical Import and Export
3.1.3 Supply Channels
3.1.4 Market Segments
3.1.5 Major Therapeutic Areas
3.1.6 Major Companies
3.2 Medical Device Market
3.2.1 Market Overview
3.2.2 Overview of Top Five Segments
3.2.3 Diagnostic Market
3.2.4 Major Companies
3.3 Market Drivers and Barriers
3.3.1 Drivers
3.3.2 Barriers
4 Market Access
4.1 Reimbursement and Payer Landscape
4.1.1 Overview of Healthcare system
4.1.2 Evolution of Healthcare System in Italy
4.1.3 Reimbursement Process
4.1.4 Overview of Insurance Providers
4.1.5 Patient Share in Healthcare Spending
4.1.6 Price Trends in the Healthcare Sector
4.1.7 Pricing Policies
4.2 Regulatory Landscape
4.2.1 Overview of Regulatory Agencies
4.2.2 Market Authorization Procedure for Pharmaceutical Products
4.2.3 New Medical Device Approval Process
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
4.2.5 Intellectual Property Rights
4.2.6 Clinical Trial Regulations
4.2.7 Pharmaceutical Advertising Regulations
4.2.8 Pharmacy Regulations
4.2.9 Labeling and Packaging Regulations
5 Country Analysis
5.1 Political Environment
5.1.1 Political Structure
5.1.2 Analysis of the Current Political Environment
5.1.3 Healthcare Policy Initiatives
5.2 Economic Landscape
5.3 Economic Indicators
5.3.1 Gross Domestic Product
5.3.2 Gross National Income
5.3.3 Inflation
5.3.4 Currency Exchange Rate
5.3.5 Foreign Direct Investment
5.3.6 Foreign Exchange Reserves
5.3.7 Trade Balance
5.3.8 Government Structural Balance
5.3.9 Government Net Debt
5.3.10 Major Industries
5.4 Demographics
5.4.1 Population
5.4.2 Education and Literacy
5.4.3 Employment
5.4.4 Disease Burden
5.5 Healthcare Infrastructure
5.5.1 Healthcare Facilities
5.5.2 Healthcare Parameters
5.5.3 Environmental Health
5.5.4 Healthcare Personnel
5.6 Healthcare Expenditure
5.6.1 Overview of Healthcare Expenditure
5.6.2 Major Components of Healthcare Expenditure
5.6.3 Healthcare Expenditure Distribution
5.6.4 Spending in Pharmaceutical R&D
5.7 Trade Associations
5.7.1 Pharmaceutical Industry Association
5.7.2 Farmindustria
5.7.3 Assogenerici
5.7.4 Confindustria
5.8 Trade Fairs
6 Opportunities and Challenges
6.1 Opportunities
6.2 Challenges
7 Appendix
7.1 Abbreviations
7.2 Bibliography
7.3 Research Methodology
7.3.1 Coverage
7.3.2 Secondary Research
7.3.3 Forecasts
7.3.4 Expert Panel
7.4 Disclaimer
1.1 List of Tables
Table 1: Pharmaceutical Market, Italy, Revenue ($bn), 2008-2015
Table 2: Pharmaceutical Market, Italy, Revenue ($bn), 2016-2020
Table 3: Pharmaceutical Market, Italy, Imports and Exports ($bn), 2008-2015
Table 4: Pharmaceutical Distribution Channel, Italy, Price Margins (%), 2014
Table 5: OTC Market, Italy, Revenue ($bn) 2008-2015
Table 6: OTC Market, Italy, Revenue ($m) and Market Share (%) by Segment, 2014
Table 7: Pharmaceutical Market, Italy, Healthcare Costs by Therapeutic Area ($bn), 2014
Table 8: Menarini, Global, Major Products
Table 9: Menarini, Late-Stage Pipeline, 2014
Table 10: Angelini, Global, Major Products
Table 11: Angelini, Late-Stage Pipeline, 2016
Table 12: Chiesi, Global, Major Products
Table 13: Chiesi, Late-Stage Pipeline, 2014
Table 14: Bracco, Global, Major Products
Table 15: Recordati, Global, Major Products
Table 16: Recordati, Late-Stage Pipeline, 2016
Table 17: Medical Device Market, Italy, Revenue ($bn), 2008-2015
Table 18: Medical Device Market, Italy, Revenue ($bn), 2016-2020
Table 19: Medical Device Market, Italy, Revenue ($m) and Market Share (%) by Segment, 2015
Table 20: In Vitro Diagnostics Market, Italy, Revenue ($m), 2008-2015
Table 21: In Vitro Diagnostics Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014
Table 22: Cardiovascular Device Market, Italy, Revenue ($m), 2008-2015
Table 23: Cardiovascular Disease Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014
Table 24: Orthopedic Device Market, Italy, Revenue ($m), 2008-2015
Table 25: Orthopedic Devices Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014
Table 26: Hospital Supplies Market, Italy, Revenue ($m), 2008-2015
Table 27: Hospital Supplies Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014
Table 28: Nephrology and Urology Devices Market, Italy, Revenue ($m), 2008-2015
Table 29: Nephrology and Urology Devices Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014
Table 30: Diagnostic Market, Italy, Revenue ($m), 2008-2015
Table 31: Diagnostic Market, Italy, Revenue ($m), 2016-2020
Table 32: Medical Device Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2012
Table 33: GlaxoSmithKline, Global, Major Products, Revenue and Annual Growth, 2014
Table 34: Baxter, Global, Major Products, 2016
Table 35: Siemens Healthcare, Global, Major Products, 2015
Table 36: Market Access, Italy, Out-of-Pocket Expenditure (%), 2008-2015
Table 37: Market Access, Italy, Average Price Change (%), 2008-2015
Table 38: Patent Application Fee ($), Italy, 2016
Table 39: Election Results, Italy, February 2013
Table 40: Economic Indicators, Italy, Gross Domestic Product per Capita ($), 2008-2015
Table 41: Economic Indicators, Italy, Gross Domestic Product per Capita Forecast ($), 2016-2020
Table 42: Economic Indicators, Italy, Gross Domestic Product Annual Growth (%), 2008-2015
Table 43: Economic Indicators, Italy, Gross Domestic Product Annual Growth Forecast (%), 2016-2020
Table 44: Economic Indicators, Italy, Gross National Income per Capita ($), 2008-2014
Table 45: Economic Indicators, Italy, Average Consumer Price Index, 2008-2015
Table 46: Economic Indicators, Italy, Average Consumer Price Index, Forecast 2016-2020
Table 47: Economic Indicators, Italy, Average Consumer Price Annual Change (%), 2008-2015
Table 48: Economic Indicators, Italy, Currency Exchange Rate (€/$), 2008-2015
Table 49: Economic Indicators, Italy, Foreign Direct Investment ($bn), 2008-2014
Table 50: Economic Indicators, Italy, Foreign Exchange Reserves ($bn), 2008-2014
Table 51: Economic Indicators, Italy, Imports of Goods and Services ($bn), 2008-2014
Table 52: Economic Indicators, Italy, Exports of Goods and Services ($bn), 2008-2014
Table 53: Economic Indicators, Italy, Government Structural Balance ($bn), 2008-2015
Table 54: Economic Indicators, Italy, General Government Net Debt (% of GDP), 2008-2015
Table 55: Economic Indicators, Italy, General Government Net Debt, Forecast (% of GDP), 2016-2020
Table 56: Economic Indicators, Italy, Major Industries, Annual Change in Gross Value Added Per Hour Worked at Constant Prices (%), 2013 and 2015
Table 57: Demographics, Italy, Population (million), 2008-2015
Table 58: Demographics, Italy, Population Forecast (million), 2016-2020
Table 59: Demographics, Italy, Population, Urban and Rural Population Share (%), 2008-2015
Table 60: Demographics, Italy, Population, Urban and Rural Population Share, Forecast (%), 2016-2020
Table 61: Demographics, Italy, Population Distribution by Age Group (%), 2008-2015
Table 62: Demographics, Italy, Population Distribution by Age Group, Forecast (%), 2016-2020
Table 63: Demographics, Italy, Births (per 1,000 Population), 2008-2015
Table 64: Demographics, Italy, Mortality (per 1,000 Population), 2008-2015
Table 65: Demographics, Italy, Major Causes of Mortality, 2014
Table 66: Demographics, Italy, Children Under Five Years of Age, Mortality (per 1,000 Live Births), 2008-2015
Table 67: Demographics, Italy, Immunization Rate (%), 2008-2015
Table 68: Demographics, Italy, Major Causes of Male Mortality, 2014
Table 69: Demographics, Italy, Major Causes of Female Mortality, 2015
Table 70: Demographics, Italy, Gender Ratio (M/F), 2008-2015
Table 71: Demographics, Italy, Life Expectancy at Birth (Years), 2008-2015
Table 72: Demographics, Italy, Life Expectancy at Birth Forecast (Years), 2016-2020
Table 73: Demographics, Italy, Student Enrollment for School Education (%), 2013
Table 74: Demographics, Italy, Student Enrollment for University Education (%), 2012
Table 75: Demographics, Italy, Unemployment Rate (%), 2008-2015
Table 76: Demographics, Italy, Major Diseases, DALYs (per 1,000 Population), 2009
Table 77: Healthcare Infrastructure, Italy, Hospitals, 2008-2015
Table 78: Healthcare Infrastructure, Italy, Beds (per 1,000 Population) by Type of Service, 2008-2015
Table 79: Healthcare Infrastructure, Italy, Diagnostic Equipment (per Million Population), 2008-2015
Table 80: Healthcare Infrastructure, Italy, Hospital Beds (per 1,000 Population), 2008-2015
Table 81: Healthcare Infrastructure, Italy, Doctors (per 1,000 Population), 2008-2015
Table 82: Healthcare Infrastructure, Italy, PM2.5 emissions (µgm/m³ ), 2008-2015
Table 83: Healthcare Infrastructure, Italy, SOx Emissions (thousand tons), 2008-2015
Table 84: Healthcare Infrastructure, Italy, NOx Emissions (Thousand Tons), 2008-2015
Table 85: Healthcare Infrastructure, Italy, CO2 Emissions (Million Tons), 2008-2015
Table 86: Healthcare Infrastructure, Italy, General Practitioners (per 1,000 Population), 2008-2015
Table 87: Healthcare Infrastructure, Italy, Nurses (per 100,000 Population), 2008-2015
Table 88: Healthcare Infrastructure, Italy, Dentists (per 100,000 Population), 2008-2015
Table 89: Healthcare Infrastructure, Italy, Pharmacist (per 100,000 Population), 2008-2015
Table 90: Italy, Healthcare Expenditure (% of GDP), 2008-2015
Table 91: Healthcare Expenditure, Italy, Major Components of Healthcare Expenditure (%), 2008-2015
Table 92: Healthcare Expenditure, Italy, Public-Private Share (%), 2008-2015
Table 93: Healthcare Expenditure, Italy, Pharmaceutical R&D Expenditure ($bn), 2008-2015
Table 94: Major Healthcare Trade Fairs, Italy, 2016
1.2 List of Figures
Figure 1: Pharmaceutical Market, Italy, Revenue ($bn), 2008-2015
Figure 2: Pharmaceutical Market, Italy, Revenue ($bn), 2016-2020
Figure 3: Pharmaceutical Market, Italy, Imports and Exports ($bn), 2008-2015
Figure 4: Pharmaceutical Distribution Channel, Italy, Price Margins (%), 2014
Figure 5: OTC Market, Italy, Revenue ($bn) 2008-2015
Figure 6: OTC Market, Italy, Revenue by Segment ($m), 2014
Figure 7: Pharmaceutical Market, Italy, Healthcare Costs by Therapeutic Area ($bn), 2014
Figure 8: Medical Device Market, Italy, Revenue ($bn), 2008-2015
Figure 9: Medical Device Market, Italy, Revenue ($bn), 2016-2020
Figure 10: Medical Device Market, Italy, Revenue by Segment ($m), 2015
Figure 11: In Vitro Diagnostics Market, Italy, Revenue ($m), 2008-2015
Figure 12: In Vitro Diagnostics Market, Italy, Market Shares of Major Players (%) 2014
Figure 13: Cardiovascular Device Market, Italy, Revenue ($m), 2008-2015
Figure 14: Cardiovascular Disease Market, Italy, Market Shares of Major Players (%), 2014
Figure 15: Orthopedic Device Market, Italy, Revenue ($m), 2008-2015
Figure 16: Orthopedic Device Market, Italy, Market Shares of Major Players (%), 2014
Figure 17: Hospital Supplies Market, Italy, Revenue ($m), 2008-2015
Figure 18: Hospital Supplies Market, Italy, Market Shares of Major Players (%), 2014
Figure 19: Nephrology and Urology Devices Market, Italy, Revenue ($m), 2008-2015
Figure 20: Nephrology and Urology Devices Market, Italy, Market Shares of Major Players (%), 2014
Figure 21: Diagnostic Market, Italy, Revenue ($m), 2008-2015
Figure 22: Diagnostic Market, Italy, Revenue ($m), 2016-2020
Figure 23: Medical Device Market, Italy, Revenue of Major Players ($m), 2012
Figure 24: Healthcare Market, Italy, Drivers and Barriers, 2016
Figure 25: Market Access, Italy, Overview of Healthcare System
Figure 26: Market Access, Italy, Evolution of Healthcare System
Figure 27: Market Access, Italy, Pricing and Reimbursement Process for Pharmaceuticals, 2012
Figure 28: Market Access, Italy, Pricing and Reimbursement Process for Medical Devices in Hospital Setting, 2012
Figure 29: Market Access, Italy, Pricing and Reimbursement Process for Medical Devices in Ambulatory Setting, 2012
Figure 30: Market Access, Italy, Out-of-Pocket Expenditure (%), 2008-2015
Figure 31: Market Access, Italy, Average Price Change (%), 2008-2015
Figure 32: Market Access, Italy, National Procedure for Marketing Authorization, 2013
Figure 33: Market Access, Centralized Procedure for Market Authorization, Pre-submission, EU, 2013
Figure 34: Market Access, Centralized Procedure, Market Authorization, Pre-opinion Phase, EU, 2013
Figure 35: Market Access, Centralized Procedure, Market Authorization, Post-opinion Phase, EU, 2013
Figure 36: Market Access, Decentralized Procedure, Market Authorization, EU, 2013
Figure 37: Market Access, Decentralized Procedure, Market Authorization, EU, 2013
Figure 38: Market Access, Conformity Assessment of Class I Medical Devices, EU, 2013
Figure 39: Market Access, Conformity Assessment of Class IIa Medical Devices, EU, 2013
Figure 40: Market Access, Conformity Assessment of Class IIb Medical Devices, EU, 2013
Figure 41: Market Access, Conformity Assessment of Class III Medical Devices, EU, 2013
Figure 42: Market Access, Licensing Process for Manufacturing, Italy, 2011
Figure 43: Market Access, Patent Approval Process, Italy, 2011
Figure 44: Market Access, Patent Approval Process, Italy, 2011
Figure 45: Political Structure, Italy
Figure 46: Economic Indicators, Italy, Gross Domestic Product per Capita ($), 2008-2015
Figure 47: Economic Indicators, Italy, Gross Domestic Product per Capita Forecast ($), 2016-2020
Figure 48: Economic Indicators, Italy, Gross Domestic Product Annual Growth (%), 2008-2015
Figure 49: Economic Indicators, Italy, Gross Domestic Product Annual Growth Forecast (%), 2016-2020
Figure 50: Economic Indicators, Italy, Gross National Income per Capita ($), 2008-2014
Figure 51: Economic Indicators, Italy, Average Consumer Price Index, 2008-2015
Figure 52: Economic Indicators, Indonesia, Average Consumer Price Index Forecast, 2016-2020
Figure 53: Economic Indicators, Italy, Average Consumer Price Annual Change (%), 2008-2015
Figure 54: Economic Indicators, Italy, Currency Exchange Rate (€/$), 2008-2015
Figure 55: Economic Indicators, Italy, Foreign Direct Investment ($bn), 2008-2014
Figure 56: Economic Indicators, Italy, Foreign Exchange Reserves ($bn), 2008-2014
Figure 57: Economic Indicators, Italy, Imports of Goods and Services ($bn), 2008-2014
Figure 58: Economic Indicators, Italy, Exports of Goods and Services ($bn), 2008-2014
Figure 59: Economic Indicators, Italy, Government Structural Balance ($bn), 2008-2015
Figure 60: Economic Indicators, Italy, General Government Net Debt (% of GDP), 2008-2015
Figure 61: Economic Indicators, Italy, General Government Net Debt Forecast (% of GDP), 2016-2020
Figure 62: Economic Indicators, Italy, Major Industries, Annual Change in Gross Value Added Per Hour Worked at Constant Prices (%), 2013 and 2015
Figure 63: Demographics, Italy, Population (million), 2008-2015
Figure 64: Demographics, Italy, Population Forecast (million), 2016-2020
Figure 65: Demographics, Italy, Population, Urban and Rural Population Share (%), 2008-2015
Figure 66: Demographics, Italy, Population, Urban and Rural Population Share Forecast (%), 2016-2020
Figure 67: Demographics, Italy, Population Distribution by Age Group (%), 2008-2015
Figure 68: Demographics, Italy, Population Distribution by Age Group, Forecast (%), 2016-2020
Figure 69: Demographics, Italy, Births (per 1,000 Population), 2008-2015
Figure 70: Demographics, Italy, Mortality (per 1,000 Population), 2008-2015
Figure 71: Demographics, Italy, Major Causes of Mortality (‘000), 2014
Figure 72: Demographics, Italy, Children Under Five Years of Age, Mortality (per 1,000 Live Births), 2008-2015
Figure 73: Demographics, Italy, Immunization Rate (%), 2008-2015
Figure 74: Demographics, Italy, Major Causes of Male Mortality (‘000), 2014
Figure 75: Demographics, Italy, Major Causes of Female Mortality (‘000), 2014
Figure 76: Demographics, Italy, Gender Ratio (M/F), 2008-2015
Figure 77: Demographics, Italy, Life Expectancy at Birth (Years), 2008-2015
Figure 78: Demographics, Italy, Life Expectancy at Birth Forecast (Years), 2016-2020
Figure 79: Demographics, Italy, Student Enrollment for School Education (%), 2013
Figure 80: Demographics, Italy, Student Enrollment for University Education (%), 2012
Figure 81: Demographics, Italy, Unemployment Rate (%), 2008-2015
Figure 82: Demographics, Italy, Major Diseases, DALYs (per 1,000 Population), 2009
Figure 83: Healthcare Infrastructure, Italy, Hospitals, 2008-2015
Figure 84: Healthcare Infrastructure, Italy, Beds (per 1,000 Population) by Type of Service, 2008-2015
Figure 85: Healthcare Infrastructure, Italy, Diagnostic Equipment (per Million Population), 2008-2015
Figure 86: Healthcare Infrastructure, Italy, Hospital Beds (per 1,000 Population), 2008-2015
Figure 87: Healthcare Infrastructure, Italy, Doctors (per 1,000 Population), 2008-2015
Figure 88: Healthcare Infrastructure, Italy, PM2.5 emissions (µgm/m³), 2008-2015
Figure 89: Healthcare Infrastructure, Italy, SOx Emissions (Thousand Tons), 2008-2015
Figure 90: Healthcare Infrastructure, Italy, NOx Emissions (Thousand Tons), 2008-2015
Figure 91: Healthcare Infrastructure, Italy, CO2 Emissions (Million Tons), 2008-2015
Figure 92: Healthcare Infrastructure, Italy, General Practitioners (per 1,000 Population), 2008-2015
Figure 93: Healthcare Infrastructure, Italy, Nurses (per 100,000 Population), 2008-2015
Figure 94: Healthcare Infrastructure, Italy, Dentists (per 100,000 Population), 2008-2015
Figure 95: Healthcare Infrastructure, Italy, Pharmacist (per 100,000 Population), 2008-2015
Figure 96: Italy, Healthcare Expenditure (% of GDP), 2008-2015
Figure 97: Healthcare Expenditure, Italy, Major Components Of Healthcare Expenditure (%), 2008-2015
Figure 98: Healthcare Expenditure, Italy, Public-Private Share (%), 2008-2015
Figure 99: Healthcare Expenditure, Italy, Pharmaceutical R&D Expenditure ($bn), 2008-2015
Figure 100: Healthcare Market, Italy, Opportunities and Challenges, 2016

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