Toll Free: 1-888-928-9744

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Italy

Published: Apr 13, 2016 | Pages: 287 | Publisher: GlobalData | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

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.

Italy'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 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 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
 Table of Contents
1 Table of Contents 7 1.1 List of Tables 11 1.2 List of Figures 15 2 Introduction 20 2.1 GlobalData Report Guidance 20 3 Overview of Pharmaceutical and Medical Device Markets 21 3.1 Pharmaceutical Market 21 3.1.1 Market Overview 21 3.1.2 Pharmaceutical Import and Export 23 3.1.3 Supply Channels 25 3.1.4 Market Segments 26 3.1.5 Major Therapeutic Areas 31 3.1.6 Major Companies 34 3.2 Medical Device Market 74 3.2.1 Market Overview 74 3.2.2 Overview of Top Five Segments 76 3.2.3 Diagnostic Market 87 3.2.4 Major Companies 89 3.3 Market Drivers and Barriers 125 3.3.1 Drivers 125 3.3.2 Barriers 127 4 Market Access 130 4.1 Reimbursement and Payer Landscape 130 4.1.1 Overview of Healthcare system 130 4.1.2 Evolution of Healthcare System in Italy 135 4.1.3 Reimbursement Process 138 4.1.4 Overview of Insurance Providers 144 4.1.5 Patient Share in Healthcare Spending 146 4.1.6 Price Trends in the Healthcare Sector 149 4.1.7 Pricing Policies 150 4.2 Regulatory Landscape 152 4.2.1 Overview of Regulatory Agencies 152 4.2.2 Market Authorization Procedure for Pharmaceutical Products 153 4.2.3 New Medical Device Approval Process 166 4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 170 4.2.5 Intellectual Property Rights 173 4.2.6 Clinical Trial Regulations 176 4.2.7 Pharmaceutical Advertising Regulations 180 4.2.8 Pharmacy Regulations 183 4.2.9 Labeling and Packaging Regulations 184 5 Country Analysis 187 5.1 Political Environment 187 5.1.1 Political Structure 187 5.1.2 Analysis of the Current Political Environment 193 5.1.3 Healthcare Policy Initiatives 195 5.2 Economic Landscape 196 5.3 Economic Indicators 199 5.3.1 Gross Domestic Product 199 5.3.2 Gross National Income 203 5.3.3 Inflation 204 5.3.4 Currency Exchange Rate 207 5.3.5 Foreign Direct Investment 208 5.3.6 Foreign Exchange Reserves 210 5.3.7 Trade Balance 211 5.3.8 Government Structural Balance 214 5.3.9 Government Net Debt 215 5.3.10 Major Industries 216 5.4 Demographics 218 5.4.1 Population 218 5.4.2 Education and Literacy 237 5.4.3 Employment 240 5.4.4 Disease Burden 241 5.5 Healthcare Infrastructure 243 5.5.1 Healthcare Facilities 243 5.5.2 Healthcare Parameters 247 5.5.3 Environmental Health 249 5.5.4 Healthcare Personnel 253 5.6 Healthcare Expenditure 257 5.6.1 Overview of Healthcare Expenditure 257 5.6.2 Major Components of Healthcare Expenditure 259 5.6.3 Healthcare Expenditure Distribution 260 5.6.4 Spending in Pharmaceutical R&D 262 5.7 Trade Associations 263 5.7.1 Pharmaceutical Industry Association 263 5.7.2 Farmindustria 263 5.7.3 Assogenerici 263 5.7.4 Confindustria 264 5.8 Trade Fairs 264 6 Opportunities and Challenges 265 6.1 Opportunities 265 6.2 Challenges 267 7 Appendix 270 7.1 Abbreviations 270 7.2 Bibliography 272 7.3 Research Methodology 284 7.3.1 Coverage 285 7.3.2 Secondary Research 285 7.3.3 Forecasts 286 7.3.4 Expert Panel 286 7.4 Disclaimer 286
List of Tables
Table 1: Pharmaceutical Market, Italy, Revenue ($bn), 2008-2015 22 Table 2: Pharmaceutical Market, Italy, Revenue ($bn), 2016-2020 23 Table 3: Pharmaceutical Market, Italy, Imports and Exports ($bn), 2008-2015 24 Table 4: Pharmaceutical Distribution Channel, Italy, Price Margins (%), 2014 26 Table 5: OTC Market, Italy, Revenue ($bn) 2008-2015 29 Table 6: OTC Market, Italy, Revenue ($m) and Market Share (%) by Segment, 2014 30 Table 7: Pharmaceutical Market, Italy, Healthcare Costs by Therapeutic Area ($bn), 2014 31 Table 8: Menarini, Global, Major Products 36 Table 9: Menarini, Late-Stage Pipeline, 2014 37 Table 10: Angelini, Global, Major Products 43 Table 11: Angelini, Late-Stage Pipeline, 2016 45 Table 12: Chiesi, Global, Major Products 51 Table 13: Chiesi, Late-Stage Pipeline, 2014 54 Table 14: Bracco, Global, Major Products 61 Table 15: Recordati, Global, Major Products 70 Table 16: Recordati, Late-Stage Pipeline, 2016 74 Table 17: Medical Device Market, Italy, Revenue ($bn), 2008-2015 75 Table 18: Medical Device Market, Italy, Revenue ($bn), 2016-2020 76 Table 19: Medical Device Market, Italy, Revenue ($m) and Market Share (%) by Segment, 2015 77 Table 20: In Vitro Diagnostics Market, Italy, Revenue ($m), 2008-2015 78 Table 21: In Vitro Diagnostics Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014 79 Table 22: Cardiovascular Device Market, Italy, Revenue ($m), 2008-2015 80 Table 23: Cardiovascular Disease Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014 81 Table 24: Orthopedic Device Market, Italy, Revenue ($m), 2008-2015 82 Table 25: Orthopedic Devices Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014 83 Table 26: Hospital Supplies Market, Italy, Revenue ($m), 2008-2015 84 Table 27: Hospital Supplies Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014 85 Table 28: Nephrology and Urology Devices Market, Italy, Revenue ($m), 2008-2015 86 Table 29: Nephrology and Urology Devices Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2014 87 Table 30: Diagnostic Market, Italy, Revenue ($m), 2008-2015 88 Table 31: Diagnostic Market, Italy, Revenue ($m), 2016-2020 89 Table 32: Medical Device Market, Italy, Revenue ($m) and Market Shares (%) of Major Players, 2012 90 Table 33: GlaxoSmithKline, Global, Major Products, Revenue and Annual Growth, 2014 98 Table 34: Baxter, Global, Major Products, 2016 105 Table 35: Siemens Healthcare, Global, Major Products, 2015 118 Table 36: Market Access, Italy, Out-of-Pocket Expenditure (%), 2008-2015 147 Table 37: Market Access, Italy, Average Price Change (%), 2008-2015 150 Table 38: Patent Application Fee ($), Italy, 2016 174 Table 39: Election Results, Italy, February 2013 193 Table 40: Economic Indicators, Italy, Gross Domestic Product per Capita ($), 2008-2015 200 Table 41: Economic Indicators, Italy, Gross Domestic Product per Capita Forecast ($), 2016-2020 201 Table 42: Economic Indicators, Italy, Gross Domestic Product Annual Growth (%), 2008-2015 202 Table 43: Economic Indicators, Italy, Gross Domestic Product Annual Growth Forecast (%), 2016-2020 203 Table 44: Economic Indicators, Italy, Gross National Income per Capita ($), 2008-2014 204 Table 45: Economic Indicators, Italy, Average Consumer Price Index, 2008-2015 205 Table 46: Economic Indicators, Italy, Average Consumer Price Index, Forecast 2016-2020 206 Table 47: Economic Indicators, Italy, Average Consumer Price Annual Change (%), 2008-2015 207 Table 48: Economic Indicators, Italy, Currency Exchange Rate (€/$), 2008-2015 208 Table 49: Economic Indicators, Italy, Foreign Direct Investment ($bn), 2008-2014 210 Table 50: Economic Indicators, Italy, Foreign Exchange Reserves ($bn), 2008-2014 211 Table 51: Economic Indicators, Italy, Imports of Goods and Services ($bn), 2008-2014 212 Table 52: Economic Indicators, Italy, Exports of Goods and Services ($bn), 2008-2014 213 Table 53: Economic Indicators, Italy, Government Structural Balance ($bn), 2008-2015 214 Table 54: Economic Indicators, Italy, General Government Net Debt (% of GDP), 2008-2015 215 Table 55: Economic Indicators, Italy, General Government Net Debt, Forecast (% of GDP), 2016-2020 216 Table 56: Economic Indicators, Italy, Major Industries, Annual Change in Gross Value Added Per Hour Worked at Constant Prices (%), 2013 and 2015 217 Table 57: Demographics, Italy, Population (million), 2008-2015 219 Table 58: Demographics, Italy, Population Forecast (million), 2016-2020 220 Table 59: Demographics, Italy, Population, Urban and Rural Population Share (%), 2008-2015 221 Table 60: Demographics, Italy, Population, Urban and Rural Population Share, Forecast (%), 2016-2020 222 Table 61: Demographics, Italy, Population Distribution by Age Group (%), 2008-2015 224 Table 62: Demographics, Italy, Population Distribution by Age Group, Forecast (%), 2016-2020 225 Table 63: Demographics, Italy, Births (per 1,000 Population), 2008-2015 226 Table 64: Demographics, Italy, Mortality (per 1,000 Population), 2008-2015 227 Table 65: Demographics, Italy, Major Causes of Mortality, 2014 229 Table 66: Demographics, Italy, Children Under Five Years of Age, Mortality (per 1,000 Live Births), 2008-2015 230 Table 67: Demographics, Italy, Immunization Rate (%), 2008-2015 231 Table 68: Demographics, Italy, Major Causes of Male Mortality, 2014 232 Table 69: Demographics, Italy, Major Causes of Female Mortality, 2015 233 Table 70: Demographics, Italy, Gender Ratio (M/F), 2008-2015 234 Table 71: Demographics, Italy, Life Expectancy at Birth (Years), 2008-2015 236 Table 72: Demographics, Italy, Life Expectancy at Birth Forecast (Years), 2016-2020 237 Table 73: Demographics, Italy, Student Enrollment for School Education (%), 2013 239 Table 74: Demographics, Italy, Student Enrollment for University Education (%), 2012 240 Table 75: Demographics, Italy, Unemployment Rate (%), 2008-2015 241 Table 76: Demographics, Italy, Major Diseases, DALYs (per 1,000 Population), 2009 243 Table 77: Healthcare Infrastructure, Italy, Hospitals, 2008-2015 244 Table 78: Healthcare Infrastructure, Italy, Beds (per 1,000 Population) by Type of Service, 2008-2015 245 Table 79: Healthcare Infrastructure, Italy, Diagnostic Equipment (per Million Population), 2008-2015 246 Table 80: Healthcare Infrastructure, Italy, Hospital Beds (per 1,000 Population), 2008-2015 247 Table 81: Healthcare Infrastructure, Italy, Doctors (per 1,000 Population), 2008-2015 248 Table 82: Healthcare Infrastructure, Italy, PM2.5 emissions (


List of Figures
Figure 1: Pharmaceutical Market, Italy, Revenue ($bn), 2008-2015 22 Figure 2: Pharmaceutical Market, Italy, Revenue ($bn), 2016-2020 23 Figure 3: Pharmaceutical Market, Italy, Imports and Exports ($bn), 2008-2015 24 Figure 4: Pharmaceutical Distribution Channel, Italy, Price Margins (%), 2014 25 Figure 5: OTC Market, Italy, Revenue ($bn) 2008-2015 29 Figure 6: OTC Market, Italy, Revenue by Segment ($m), 2014 30 Figure 7: Pharmaceutical Market, Italy, Healthcare Costs by Therapeutic Area ($bn), 2014 31 Figure 8: Medical Device Market, Italy, Revenue ($bn), 2008-2015 75 Figure 9: Medical Device Market, Italy, Revenue ($bn), 2016-2020 76 Figure 10: Medical Device Market, Italy, Revenue by Segment ($m), 2015 77 Figure 11: In Vitro Diagnostics Market, Italy, Revenue ($m), 2008-2015 78 Figure 12: In Vitro Diagnostics Market, Italy, Market Shares of Major Players (%) 2014 79 Figure 13: Cardiovascular Device Market, Italy, Revenue ($m), 2008-2015 80 Figure 14: Cardiovascular Disease Market, Italy, Market Shares of Major Players (%), 2014 81 Figure 15: Orthopedic Device Market, Italy, Revenue ($m), 2008-2015 82 Figure 16: Orthopedic Device Market, Italy, Market Shares of Major Players (%), 2014 83 Figure 17: Hospital Supplies Market, Italy, Revenue ($m), 2008-2015 84 Figure 18: Hospital Supplies Market, Italy, Market Shares of Major Players (%), 2014 85 Figure 19: Nephrology and Urology Devices Market, Italy, Revenue ($m), 2008-2015 86 Figure 20: Nephrology and Urology Devices Market, Italy, Market Shares of Major Players (%), 2014 87 Figure 21: Diagnostic Market, Italy, Revenue ($m), 2008-2015 88 Figure 22: Diagnostic Market, Italy, Revenue ($m), 2016-2020 89 Figure 23: Medical Device Market, Italy, Revenue of Major Players ($m), 2012 90 Figure 24: Healthcare Market, Italy, Drivers and Barriers, 2016 129 Figure 25: Market Access, Italy, Overview of Healthcare System 134 Figure 26: Market Access, Italy, Evolution of Healthcare System 137 Figure 27: Market Access, Italy, Pricing and Reimbursement Process for Pharmaceuticals, 2012 140 Figure 28: Market Access, Italy, Pricing and Reimbursement Process for Medical Devices in Hospital Setting, 2012 143 Figure 29: Market Access, Italy, Pricing and Reimbursement Process for Medical Devices in Ambulatory Setting, 2012 144 Figure 30: Market Access, Italy, Out-of-Pocket Expenditure (%), 2008-2015 147 Figure 31: Market Access, Italy, Average Price Change (%), 2008-2015 150 Figure 32: Market Access, Italy, National Procedure for Marketing Authorization, 2013 155 Figure 33: Market Access, Centralized Procedure for Market Authorization, Pre-submission, EU, 2013 157 Figure 34: Market Access, Centralized Procedure, Market Authorization, Pre-opinion Phase, EU, 2013 159 Figure 35: Market Access, Centralized Procedure, Market Authorization, Post-opinion Phase, EU, 2013 161 Figure 36: Market Access, Decentralized Procedure, Market Authorization, EU, 2013 163 Figure 37: Market Access, Decentralized Procedure, Market Authorization, EU, 2013 165 Figure 38: Market Access, Conformity Assessment of Class I Medical Devices, EU, 2013 167 Figure 39: Market Access, Conformity Assessment of Class IIa Medical Devices, EU, 2013 168 Figure 40: Market Access, Conformity Assessment of Class IIb Medical Devices, EU, 2013 169 Figure 41: Market Access, Conformity Assessment of Class III Medical Devices, EU, 2013 170 Figure 42: Market Access, Licensing Process for Manufacturing, Italy, 2011 172 Figure 43: Market Access, Patent Approval Process, Italy, 2011 175 Figure 44: Market Access, Patent Approval Process, Italy, 2011 179 Figure 45: Political Structure, Italy 190 Figure 46: Economic Indicators, Italy, Gross Domestic Product per Capita ($), 2008-2015 200 Figure 47: Economic Indicators, Italy, Gross Domestic Product per Capita Forecast ($), 2016-2020 201 Figure 48: Economic Indicators, Italy, Gross Domestic Product Annual Growth (%), 2008-2015 202 Figure 49: Economic Indicators, Italy, Gross Domestic Product Annual Growth Forecast (%), 2016-2020 203 Figure 50: Economic Indicators, Italy, Gross National Income per Capita ($), 2008-2014 204 Figure 51: Economic Indicators, Italy, Average Consumer Price Index, 2008-2015 205 Figure 52: Economic Indicators, Indonesia, Average Consumer Price Index Forecast, 2016-2020 206 Figure 53: Economic Indicators, Italy, Average Consumer Price Annual Change (%), 2008-2015 207 Figure 54: Economic Indicators, Italy, Currency Exchange Rate (€/$), 2008-2015 208 Figure 55: Economic Indicators, Italy, Foreign Direct Investment ($bn), 2008-2014 210 Figure 56: Economic Indicators, Italy, Foreign Exchange Reserves ($bn), 2008-2014 211 Figure 57: Economic Indicators, Italy, Imports of Goods and Services ($bn), 2008-2014 212 Figure 58: Economic Indicators, Italy, Exports of Goods and Services ($bn), 2008-2014 213 Figure 59: Economic Indicators, Italy, Government Structural Balance ($bn), 2008-2015 214 Figure 60: Economic Indicators, Italy, General Government Net Debt (% of GDP), 2008-2015 215 Figure 61: Economic Indicators, Italy, General Government Net Debt Forecast (% of GDP), 2016-2020 216 Figure 62: Economic Indicators, Italy, Major Industries, Annual Change in Gross Value Added Per Hour Worked at Constant Prices (%), 2013 and 2015 217 Figure 63: Demographics, Italy, Population (million), 2008-2015 219 Figure 64: Demographics, Italy, Population Forecast (million), 2016-2020 220 Figure 65: Demographics, Italy, Population, Urban and Rural Population Share (%), 2008-2015 221 Figure 66: Demographics, Italy, Population, Urban and Rural Population Share Forecast (%), 2016-2020 222 Figure 67: Demographics, Italy, Population Distribution by Age Group (%), 2008-2015 224 Figure 68: Demographics, Italy, Population Distribution by Age Group, Forecast (%), 2016-2020 225 Figure 69: Demographics, Italy, Births (per 1,000 Population), 2008-2015 226 Figure 70: Demographics, Italy, Mortality (per 1,000 Population), 2008-2015 227 Figure 71: Demographics, Italy, Major Causes of Mortality ('000), 2014 228 Figure 72: Demographics, Italy, Children Under Five Years of Age, Mortality (per 1,000 Live Births), 2008-2015 230 Figure 73: Demographics, Italy, Immunization Rate (%), 2008-2015 231 Figure 74: Demographics, Italy, Major Causes of Male Mortality ('000), 2014 232 Figure 75: Demographics, Italy, Major Causes of Female Mortality ('000), 2014 233 Figure 76: Demographics, Italy, Gender Ratio (M/F), 2008-2015 234 Figure 77: Demographics, Italy, Life Expectancy at Birth (Years), 2008-2015 236 Figure 78: Demographics, Italy, Life Expectancy at Birth Forecast (Years), 2016-2020 237 Figure 79: Demographics, Italy, Student Enrollment for School Education (%), 2013 239 Figure 80: Demographics, Italy, Student Enrollment for University Education (%), 2012 240 Figure 81: Demographics, Italy, Unemployment Rate (%), 2008-2015 241 Figure 82: Demographics, Italy, Major Diseases, DALYs (per 1,000 Population), 2009 242 Figure 83: Healthcare Infrastructure, Italy, Hospitals, 2008-2015 244 Figure 84: Healthcare Infrastructure, Italy, Beds (per 1,000 Population) by Type of Service, 2008-2015 245 Figure 85: Healthcare Infrastructure, Italy, Diagnostic Equipment (per Million Population), 2008-2015 246 Figure 86: Healthcare Infrastructure, Italy, Hospital Beds (per 1,000 Population), 2008-2015 247 Figure 87: Healthcare Infrastructure, Italy, Doctors (per 1,000 Population), 2008-2015 248 Figure 88: Healthcare Infrastructure, Italy, PM2.5 emissions (

To request a free sample copy of this report, please complete the form below.

This website is secure and your personal details are safe. Privacy policy

Global Bio polyethylene terephthalate (PET) market size is likely to be valued at USD 12.6 billion by 2020; as per a new research report by Radiant Insights, Inc. Growing preference of biopolymers in numerous applications coupled with favorable gover

Read More...

Global lignin market size is expected to exceed USD 6 billion by 2022, growing at 4.9% from 2015 to 2022. Rising demand for animal feed and potential as a feedstock substitute to crude oil are expected to drive lignin market demand over the forecast

Read More...

Global adhesives & sealants market size is expected to reach USD 43.19 billion by 2020, as per a new research report by Radiant Insights, Inc. Strong demand from packaging, construction and automotive industries is expected drive adhesives and sealan

Read More...

Global embedded system market is projected to be valued at USD 214.39 billion by 2020, as per a new research report by Radiant Insights, Inc. Rising demand from end-use industries such as automotive and healthcare coupled with emergence of Internet o

Read More...

Global fingerprint access control systems market size is estimated to reach USD 4.4 billion by 2022, as per a new research report by Radiant Insights, Inc. Growing safety and security concerns of individual as well as organization is projected to dri

Read More...
Choose License Type
Single User - US $1995
Multi User - US $3990
Why Choose Us

24/5 Research support

Get your queries resolved from an industry expert. Request for a free product review before report purchase.

Phone: 1-415-349-0054

Toll Free: 1-888-928-9744

Email: [email protected]

Custom research service

Speak to the report author to design an exclusive study to serve your research needs.

Quality assurance

A testimonial for service excellence represented in the form of BBB "A" Accreditation.

Information security

Your personal and confidential information is safe and secure.

verify