CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Italy

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

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the 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, Recordati, Menarini, Chiesi and Zambon) and profiles and SWOT analyses of the major players in the medical device market (Abbott, Medtronic, GE Healthcare, Roche and Esaote)
  • Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Italy
  • Porter’s five forces analysis for pharmaceutical and medical devices market of Italy
  • An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs
  • Information regarding recent healthcare policies along with healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities 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 the Italian healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the 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 most opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize on the opportunities and challenges in the Italian healthcare market

Table of Contents

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key ...

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key Events: Italian Pharmaceutical History, 2007–2019

2.4 Key Events: Italian Pharmaceutical Market

2.5 Impact of Brexit on the Italian Healthcare System

2.6 Key Events: M&A, VC & PE Deals, Global Pharmaceutical Market, 2018–2019

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, Italy, 2018

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

3.5 Pharmaceutical Market – Market Segments

3.6 Pharmaceutical Market – Top Five Disease Areas

3.7 Pharmaceutical Market – Major Players

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Device Market – Top Five Segments

4.3 Medical Device Market – Diagnostic Market

4.4 Medical Device Market – Major Players

5 Pharmaceutical and Medical Device Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6 Deal analysis

6.1 Deal Analysis: M&A, VF and PE Deals, Pharmaceutical Market, Italy

6.2 Deal Analysis: M&A, VF and PE Deals, Medical Device Market, Italy

7 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis

7.1 Pharmaceutical Market, Italy – Porter’s Five Forces Analysis

7.2 Medical Device Market, Italy – Porter’s Five Forces Analysis

8 Market Access

8.1 Overview of Healthcare System, Italy

8.2 Reimbursement Process, Italy

8.2.1 Overview of Insurance, Italy

8.2.2 Healthcare Spending and Medical Products Price Index, Italy

8.2.3 Pricing Policies, Italy

8.3 Regulatory Landscape, Italy

8.3.1 Marketing Authorization for Pharmaceutical Products, EU

8.3.2 Market Authorization for Pharmaceutical Drugs, Italy

8.3.3 Market Authorization for Medical Devices, Italy

8.3.4 Intellectual Property Rights, Patent, Italy

8.3.5 Intellectual Property Rights, Trademark, Italy

8.3.6 Clinical Trial Regulations, Italy

8.3.7 Pharmaceutical Advertising Regulations, Italy

8.3.8 Labeling and Packaging Regulations, Italy

9 Country Healthcare Landscape

9.1 Healthcare Policy Highlights

9.2 Healthcare Facilities

9.3 Healthcare Parameters

9.4 Environmental Health

9.5 Healthcare Personnel

9.6 Disease Burden

9.7 Healthcare Expenditure

9.7.1 Healthcare Expenditure – Overview

9.7.2 Share of Public and Private Sectors

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

13.1.4 Expert Panel

13.2 Bibliography

13.3 Contact Us

13.4 Disclaimer

List of Tables

Table 1: Discounts Charged to Pharmacies, Italy, 2019

Table 2: Top Five Therapeutic Areas by Incidence Rate (per 1000 person), Italy, 2017

Table 3: Medical ...

Table 1: Discounts Charged to Pharmacies, Italy, 2019

Table 2: Top Five Therapeutic Areas by Incidence Rate (per 1000 person), Italy, 2017

Table 3: Medical Device Market, Italy, Revenue by Segment ($B)

Table 4: IVD Market, Italy, Revenue ($M) and Market Share (%) of Major Companies

Table 5: Cardiovascular Devices , Italy, Revenue ($M) and Market Share (%) of Major Companies

Table 6: Nephrology and Urology Device Market, Italy, Revenue ($M) and Market Share (%) of Major Companies

Table 7: Orthopedic Devices Market, Italy, Revenue ($M) and Market Share (%) of Major Companies

Table 8: Hospital Supplies Market, Italy, Revenue ($M) and Market Share (%) of Major Companies

Table 9: Reimbursement Categorization, Italy, 2016

Table 10: Managed Entry Agreements, Italy, 2016

Table 11: Types of Private Insurance Providers, Italy, 2019

Table 12: Patent Fees, Italy, 2019

Table 13: Trademark Fees, Italy, 2019

Table 14: Label of a Pharmaceutical Product, Italy, 2017

Table 15: Minimum Particulars to Appear on Blisters or Strips

Table 16: Minimum Particulars to Appear on Small Primary Packaging

List of Figures

Figure 1: Pharmaceutical Market, Italy, Revenue ($B), 2010–2017

Figure 2: Medical Device Market, Italy, Revenue ($B), 2015–2020

Figure 3: Number of Deals (2018–2019)

Figure 4: ...

Figure 1: Pharmaceutical Market, Italy, Revenue ($B), 2010–2017

Figure 2: Medical Device Market, Italy, Revenue ($B), 2015–2020

Figure 3: Number of Deals (2018–2019)

Figure 4: 2018-19 Deal Overview By Region

Figure 5: Country Profile, Italy, 2018

Figure 6: Pharmaceutical Market, Italy, Revenue ($B), 2010–2017

Figure 7: Pharmaceutical Market, Italy, Revenue Forecast ($B), 2018–2022

Figure 8: Pharmaceutical Market, Italy, Pharmaceutical Exports

Figure 9: Pharmaceutical Market, Italy, Top Export Partners

Figure 10: Pharmaceutical Market, Italy, Pharmaceutical Imports

Figure 11: Pharmaceutical Market, Italy, Top Import Partners

Figure 12: Consumptions of In-patent and Off-patent Medicines, Italy, 2017

Figure 13: Consumption of Generics DDD/1,000, Italy, 2017

Figure 14: Funded Innovative Drugs, Italy, 2017

Figure 15: Biotechnology Groups, Italy, 2018

Figure 16: Biosimilars, Italy, 2018

Figure 17: Pharmaceutical OTC Market, Italy, Revenue ($B), 2010–2017

Figure 18: Major OTC Drug Classes (Share%), Italy, 2017

Figure 19: Pharmaceutical Market, Supply Chain, Italy, 2017

Figure 20: Top Five Therapeutic Areas by Incidence Rate (per 1000 person), Italy, 2017

Figure 21: Pharmaceutical Market, Major Players, Italy

Figure 22: Medical Device Market, Italy, Revenue ($B), 2015–2020

Figure 23: Medical Device Market, Italy, Revenue Forecast ($B), 2021–2025

Figure 24: Medical Device Market, Italy, Revenue by Segment ($B), 2018

Figure 25: IVD Market, Italy, Revenue ($B), 2015–2022

Figure 26: IVD Market, Italy, Market Share of Major Players (%)

Figure 27: Cardiovascular Devices Market, Italy, Revenue ($B), 2015–2022

Figure 28: Cardiovascular Devices Market, Italy, Market Share of Major Players (%)

Figure 29: Nephrology and Urology Device Market, Italy, Revenue ($B), 2015–2022

Figure 30: Nephrology and Urology Device Market, Italy, Market Share of Major Players (%)

Figure 31: Orthopedic Market, Italy, Revenue ($B), 2015–2022

Figure 32: Orthopedic Devices Market, Italy, Market Share of Major Players (%)

Figure 33: Hospital Supplies Market, Italy, Revenue ($B), 2015–2022

Figure 34: Hospital Supplies Market, Italy, Market Share of Major Players (%)

Figure 35: Diagnostic Market, Italy, Revenue ($B), 2015-2020

Figure 36: Diagnostic Market, Italy, Revenue ($B), 2021–2025

Figure 37: Medical Device Market – Major Players

Figure 38: Deal Value and Deal Count, Pharmaceutical Market, Italy, 2018–2019

Figure 39: Deal Value and Deal Count Quarterly, Pharmaceutical Market, Italy, 2018–2019

Figure 40: Deal Value and Deal Count Sub-Types, Pharmaceutical Market, Italy, 2018–2019

Figure 41: Top Five Therapy Areas by Deal Value, Pharmaceutical Market, Italy, 2018–2019

Figure 42: Top Five Therapy Areas by Deal Number, Pharmaceutical Market, Italy, 2018–2019

Figure 43: M&A Deals by Therapy Area, Pharmaceutical Market, Italy, 2018–2019(by value and by number)

Figure 44: Venture Financing Deals by Therapy Area, Pharmaceutical Market Italy, 2018–2019(by value and by number)

Figure 45: Medical Device Market Deals, Italy, 2018–2019(by deal value, $M)

Figure 46: Medical Device Market Deals, Italy, 2018 –2019(by deal count)

Figure 47: Medical Device Market Deals Share (by deal count), Italy, 2018 – 2019

Figure 48: Medical Device Market Deals Share (by deal value), Italy, 2018 – 2019

Figure 49: Top Five Therapy Areas by Deal Value, Medical Device, Italy, 2018–2019

Figure 50: Top Five Therapy Areas by Deal Number, Medical Device, Italy, 2018–2019

Figure 51: M&A Deals by Therapy Area, Medical Device, Italy, 2018–2019 (by number)

Figure 52: Venture Financing Deals by Therapy Area, Medical Device, Italy, 2018–2019(by value and by number)

Figure 53: Private Equity Deals by Therapy Area, Medical Device Italy, 2018–2019(By number)

Figure 54: Organizational Structure of Ministry of Health, Italy, 2019

Figure 55: Overview of Healthcare System, Italy, 2014

Figure 56: Reimbursement of Medicinal Products, Italy, 2016

Figure 57: Reimbursement Options, Italy, 2016

Figure 58: Reimbursement of Medical Devices in Hospital Setting, Italy

Figure 59: Reimbursement of Medical Devices in Ambulatory Setting, Italy

Figure 60: OOP Expenditure (% of total expenditure on health), Italy, 2010–2017

Figure 65: Centralized Procedure, 2019

Figure 66: Decentralized Procedure, 2019

Figure 67: Mutual Recognition Procedure, 2019

Figure 68: Conformity Assessment of Class I Medical Devices, EU, 2019

Figure 69: Conformity Assessment of Class IIa Medical Devices, EU, 2019

Figure 70: Conformity Assessment of Class IIb Medical Devices, EU, 2019

Figure 71: Conformity Assessment of Class III Medical Devices, EU, 2019

Figure 72: Patent Approval Process, Italy, 2019

Figure 73: European Patent Approval Process EU, 2017

Figure 74: Unitary Patent Approval Process EU, 2017

Figure 75: Trademark Approval Process, Italy, 2019

Figure 76: Clinical Trial Approval Process, Italy, 2019

Figure 77: Number of Hospitals, Italy, 2010–2016

Figure 78: Diagnostic Equipment

(per Million Population), Italy, 2010–2016

Figure 79: Hospital Beds (per 1,000 population), Italy

Figure 80: Acute Care Hospital Beds (per 1,000 population), Italy

Figure 81: Psychiatric Hospital Beds (per 1,000 population), Italy

Figure 82: Life Expectancy (Years), 2010–2017, Italy

Figure 83: Immunization Rate (%), Italy, 2010–2017

Figure 84: PM2.5 (µg per m3), Italy, 2010–2017

Figure 85: CO2 Emissions (million tons), Italy, 2010–2014

Figure 86: Physicians (per 1,000 population), Italy, 2009–2017

Figure 87: Dentists (per 1,000 population), Italy, 2010–2017

Figure 88: Nurses (per 1,000 population), Italy, 2010–2017

Figure 89: Pharmacists (per 1,000 population), Italy, 2010–2017

Figure 90:Major Causes of Mortality (number of deaths), Italy, 2016

Figure 91: Major Causes of Male Mortality (number of deaths), Italy, 2016

Figure 92: Major Causes of Female Mortality (number of deaths), Italy, 2016

Figure 93: Disability-Adjusted Life Years by Major Disease (millions), Italy, 2016

Figure 94: Healthcare Expenditure as Percentage of GDP (%), Italy,2010–2016

Figure 95: Public-Private Share (%), Italy, 2010–2017

Figure 96: Major Components of Healthcare Expenditure (%), Italy, 2017

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