CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – France

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GlobalData, the industry analysis specialist, has released its latest report: “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – France”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in France. 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.

The population of France in 2016 was 64.6 million, which increased gradually from 62.5 million in 2009. The French National Authority for Health (Haute Autorité de Santé or HAS) and the Commission for Economic Evaluation and Public Health (Commission d’Évaluation Économique et de Santé Publique; CEESP) started an economic evaluation in October 2013, for the assessment or reassessment of drugs and medical devices under certain circumstances.

In 2016, the government spent 11.6% of GDP on healthcare expenditure and exported $29.4 billion of pharmaceutical products. The pharmaceutical market in France was worth $35.59 billion in 2016, with a growth in generic drugs market. The volume of generic drug market increased from 23.6% in 2009 to 36.3% in 2016. The medical device market was valued at $18.2 billion in 2016 and is projected to grow at a CAGR of 4% to $22.5 billion by 2021. These positive growth trends can be primarily attributed to:

  • An increasingly elderly population
  • Universal health coverage
  • Government initiatives

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in France, 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: Novartis, Sanofi, Pfizer, Merck & Co. and Mylan; and profiles and SWOT analyses of the major players in the medical device market: B. Braun Melsungen, Medtronic, Roche, Johnson & Johnson and GlaxoSmithKline (GSK)
  • An insightful review of the 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 political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the French 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 French healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact France’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

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

3 Introduction

3.1 GlobalData Report Guidance

4 ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

3 Introduction

3.1 GlobalData Report Guidance

4 Overview of Pharmaceutical and Medical Device Markets

4.1 Pharmaceutical Market

4.1.1 Market Overview

4.1.2 Pharmaceutical Exports and Imports

4.1.3 Supply Channels

4.1.4 Market Segments

4.1.5 Major Therapeutic Areas

4.1.6 Major Players

4.2 Medical Device Market

4.2.1 Market Overview

4.2.2 Overview of Top Five Segments

4.2.3 Major Players

4.3 Market Drivers and Barriers

4.3.1 Drivers

4.3.2 Barriers

5 Market Access

5.1 Overview of Healthcare system

5.1.1 Reimbursement Process

5.1.2 Overview of Insurance Providers

5.1.3 Patient Share in Healthcare Expenditure

5.1.4 Price Trends in the Healthcare Sector

5.1.5 Pricing Policies

5.2 Regulatory Landscape

5.2.1 Overview of Regulatory Agencies

5.2.2 Market Authorization Procedure for Pharmaceutical Products

5.2.3 New Medical Device Approval Process

5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing

5.2.5 Exports and Imports

5.2.6 Intellectual Property Rights

5.2.7 Clinical Trial Regulations

5.2.8 Pharmaceutical Advertising Regulations

5.2.9 Pharmacy Regulations

5.2.10 Labeling and Packaging Regulations

6 Country Analysis

6.1 Political Environment

6.1.1 Political Structure

6.1.2 Current Political Environment

6.1.3 Healthcare Policy Initiatives

6.2 Economic Landscape

6.3 Economic Indicators

6.3.1 Gross Domestic Product

6.3.2 Gross National Income

6.3.3 Inflation

6.3.4 Currency Exchange Rate

6.3.5 Foreign Direct Investment

6.3.6 Foreign Exchange Reserves

6.3.7 Trade Balance

6.3.8 Government Structural Balance

6.3.9 Government Net Debt

6.3.10 Major Industries

6.4 Demographics

6.4.1 Population

6.4.2 Education and Literacy

6.4.3 Employment

6.4.4 Disease Burden

6.5 Healthcare Infrastructure

6.5.1 Healthcare Facilities

6.5.2 Healthcare Parameters

6.5.3 Environmental Health

6.5.4 Healthcare Personnel

6.6 Healthcare Expenditure

6.6.1 Overview

6.6.2 Share of Public and Private Sectors

6.6.3 Major Components of Healthcare Expenditure

6.6.4 Spending in Pharmaceutical R&D

6.7 Trade Associations

6.7.1 France Biotech

6.7.2 French Medical Device Association

6.7.3 French Pharmaceutical Association

6.8 Trade Fairs

7 Opportunities and Challenges

7.1 Opportunities

7.2 Challenges

8 Appendix

8.1 Abbreviations

8.2 Bibliography

8.3 Research Methodology

8.3.1 Coverage

8.3.2 Secondary Research

8.3.3 Forecasts

8.3.4 Expert Panel

8.4 Contact Us

8.5 Disclaimer

List of tables

Table 1: Pharmaceutical Market, France, Revenue ($bn), 2009–2016

Table 2: Pharmaceutical Market, France, Revenue ($bn), 2017–2021

Table 3: Pharmaceutical Market, France, Exports and ...

Table 1: Pharmaceutical Market, France, Revenue ($bn), 2009–2016

Table 2: Pharmaceutical Market, France, Revenue ($bn), 2017–2021

Table 3: Pharmaceutical Market, France, Exports and Imports ($bn), 2009–2016

Table 4: Pharmaceutical Market, France, Generic Pharmaceutical Market Share (%), 2009–2016

Table 5: Pharmaceutical Market, France, Market Share of Generics Sold in City Pharmacies (%), 2015

Table 6: Pharmaceutical Market, France, Authorized Biosimilars 2015

Table 7: Pharmaceutical Market, France, OTC Drug Market Revenue ($bn), 2009–2016

Table 8: Pharmaceutical Market, France, Major OTC Drug Classes, Revenue ($bn) and Share (%), 2015

Table 9: Pharmaceutical Market, France, Revenue by Major Therapeutic Areas ($bn), 2013

Table 10: Major Products, Novartis, Global, 2016

Table 11: Late-Stage Pipeline, Novartis, Global, 2015

Table 12: Major Products, Sanofi, Global, 2015

Table 13: Late-Stage Pipeline, Sanofi, Global, 2015

Table 14: Pharmaceutical Market, Pfizer, Late-Stage Pipeline, 2016

Table 15: Pharmaceutical Market, Merck & Co., Global, Major Products, 2015

Table 16: Pharmaceutical Market, Merck & Co., Global, Late-Stage Pipeline, 2016

Table 17: Medical Device Market, France, Revenue ($bn), 2009–2016

Table 18: Medical Device Market, France, Revenue ($bn), 2017–2021

Table 19: Medical Device Market, France, Revenue ($m) and Market Share (%) by Segment, 2016

Table 20: In Vitro Diagnostics Market, France, Revenue ($m), 2009–2016

Table 21: In Vitro Diagnostics, France, Revenue ($m) and Market Share (%) of Major Players, 2014

Table 22: Orthopedic Device Market, France, Revenue ($m), 2009–2016

Table 23: Orthopedic Devices, France, Revenue ($m) and Market Share (%) of Major Players, 2015

Table 24: Cardiovascular Device Market, France, Revenue ($m), 2009–2016

Table 25: Cardiovascular Devices, France, Revenue ($m) and Market Share (%) of Major Players, 2015

Table 26: Wound Care Management Devices, France, Revenue ($m), 2009–2016

Table 27: Wound Care Management Devices, France, Revenue ($m) and Market Share (%) of Major Players, 2012

Table 28: Ophthalmic Device Market, France, Revenue ($m), 2009–2016

Table 29: Ophthalmic Device Market, France, Revenue ($m) and Market Share (%) of Major Players, 2015

Table 30: Medical Device Market, France, Revenue ($m) and Market Share (%) of Major Players, 2012

Table 31: Medical Device Market, Medtronic, Major Products, 2015

Table 32: Roche, Global, Major Products, 2016

Table 33: Medical Device Market, Roche, Global, Late-Stage Pipeline, 2016

Table 34: Market Access, France, Drug Reimbursement Categories and Rates (%), 2014

Table 35: Market Access, France, Source of Public Health Insurance Funding (%), 2015

Table 36: Healthcare Expenditure, France, Out-of-Pocket Expenditure (%), 2009–2016

Table 37: Market Access, France, Healthcare Consumer Price Index Annual Change (%), 2009–2015

Table 38: Economic Indicators, France, GDP per Capita ($), 2009–2016

Table 39: Economic Indicators, France, GDP per Capita ($), 2017–2021

Table 40: Economic Indicators, France, GDP Annual Growth (%), 2009–2016

Table 41: Economic Indicators, France, GDP Annual Growth (%), 2017–2021

Table 42: Economic Indicators, France, GNI per Capita ($), 2009–2016

Table 43: Economic Indicators, France, Consumer Price Index, 2009–2016

Table 44: Economic Indicators, France, Average Consumer Price Index, 2017–2021

Table 45: Economic Indicators, France, Average Consumer Price Index Annual Change (%), 2009–2016

Table 46: Economic Indicators, France, Average Consumer Price Index, Annual Change (%), 2017–2021

Table 47: Economic Indicators, France, Currency Exchange Rate (€/$), 2009–2016

Table 48: Economic Indicators, France, Foreign Direct Investment ($bn), 2009–2016

Table 49: Economic Indicators, France, Foreign Exchange Reserves ($bn), 2009–2016

Table 50: Economic Indicators, France, Imports of Goods and Services ($bn), 2009–2016

Table 51: Economic Indicators, France, Exports of Goods and Services ($bn), 2009–2016

Table 52: Economic Indicators, France, General Government Structural Balance ($bn), 2009–2016

Table 53: Economic Indicators, France, Government Net Debt as a Percentage of GDP (%), 2009–2016

Table 54: Economic Indicators, France, Government Net Debt as a Percentage of GDP (%), 2017–2021

Table 55: Economic Indicators, France, Value Added by Major Industries ($bn), 2014

Table 56: Demographics, France, Population (million), 2009–2016

Table 57: Demographics, France, Population (million), 2017–2021

Table 58: Demographics, France, Urban–Rural Population Share (%), 2009–2016

Table 59: Demographics, France, Urban–Rural Population Share (%), 2017–2021

Table 60: Demographics, France, Population Distribution by Age Group (%), 2009–2016

Table 61: Demographics, France, Population Distribution by Age Group (%), 2017–2021

Table 62: Demographics, France, Births (per 1,000 Population), 2009–2016

Table 63: Demographics, France, Mortality (per 1,000 Population), 2009–2016

Table 64: Demographics, France, Major Causes of Mortality (%), 2013

Table 65: Demographics, France, Mortality Rate of Children Under Five (per 1,000 live births), 2009–2016

Table 66: Demographics, France, Immunization Rate (%), 2009–2016

Table 67: Demographics, France, Major Causes of Male Mortality (%), 2012

Table 68: Demographics, France, Major Causes of Female Mortality (%), 2012

Table 69: Demographics, France, Gender Ratio (M/F), 2009–2016

Table 70: Demographics, France, Life Expectancy at Birth (years), 2009–2016

Table 71: Demographics, France, Life Expectancy at Birth (years), 2017–2021

Table 72: Demographics, France, Number of Students by Level of Education (million), 2009–2016

Table 73: Demographics, France, Student Enrollment by Specialization (%), 2015

Table 74: Demographics, France, Unemployment Rate (%), 2009–2016

Table 75: Demographics, France, Disability-Adjusted Life Years by Major Disease (‘000), 2012

Table 76: Healthcare Infrastructure, France, Hospitals, 2009–2016

Table 77: Healthcare Infrastructure, France, Public and Private Hospitals, 2009–2016

Table 78: Healthcare Infrastructure, France, Private Sector Hospitals, 2009–2016

Table 79: Healthcare Infrastructure, France, Hospitals Beds by Sector, 2009–2016

Table 80: Healthcare Infrastructure, France, Diagnostic Units, 2009–2016

Table 81: Healthcare Infrastructure, France, Diagnostic Centers, 2009–2016

Table 82: Healthcare Infrastructure, France, Hospitals Beds (per 1,000 population), 2009–2016

Table 83: Healthcare Infrastructure, France, Doctors (per 1,000 population), 2009–2016

Table 84: Healthcare Infrastructure, France, PM2.5 (µg per m³), 2009–2016

Table 85: Healthcare Infrastructure, France, CO2 Emissions (metric tons per capita), 2009–2016

Table 86: Healthcare Infrastructure, France, Nurses (per 1,000 population), 2009–2016

Table 87: Healthcare Infrastructure, France, Pharmacists, 2009–2016

Table 88: Healthcare Infrastructure, France, Dentists, 2009–2016

Table 89: Healthcare Infrastructure, France, Healthcare Expenditure as Percentage of GDP (%), 2009–2016

Table 90: Healthcare Infrastructure, France, Public–Private Share of Expenditure (%), 2009–2016

Table 91: Healthcare Infrastructure, France, Major Components of Healthcare Expenditure (%), 2015

Table 92: Healthcare Infrastructure, France, Pharmaceutical R&D Expenditure ($ per capita), 2009–2016

Table 92: Healthcare Expenditure, France, Major Healthcare Trade Fairs, 2017

List of figures

Figure 1: Pharmaceutical Market, France, Revenue ($bn), 2009–2021

Figure 2: Medical Device Market, France, Revenue ($bn), 2009–2021

Figure 3: Country Profile, France, 2016 ...

Figure 1: Pharmaceutical Market, France, Revenue ($bn), 2009–2021

Figure 2: Medical Device Market, France, Revenue ($bn), 2009–2021

Figure 3: Country Profile, France, 2016

Figure 4: Pharmaceutical Market, France, Revenue ($bn), 2009–2016

Figure 5: Pharmaceutical Market, France, Revenue ($bn), 2017–2021

Figure 6: Pharmaceutical Market, France, Exports and Imports ($bn), 2009–2016

Figure 7: Pharmaceutical Market, France, Distribution Channels (%), 2016

Figure 8: Pharmaceutical Market, France, Generic Pharmaceutical Market Share (%), 2009–2016

Figure 9: Pharmaceutical Market, France, OTC Drug Market Revenue ($bn), 2009–2016

Figure 10: Pharmaceutical Market, France, Major OTC Drug Classes (Share%), 2015

Figure 11: Pharmaceutical Market, France, Revenue by Major Therapeutic Areas ($bn), 2013

Figure 12: Medical Device Market, France, Revenue ($bn), 2009–2016

Figure 13: Medical Device Market, France, Revenue ($bn), 2017–2021

Figure 14: Medical Device Market, France, Revenue by Segment ($m), 2016

Figure 15: In Vitro Diagnostics Market, France, Revenue ($m), 2009–2016

Figure 16: In Vitro Diagnostics, France, Market Share of Major Players (%), 2014

Figure 17: Orthopedic Device Market, France, Revenue ($m), 2009–2016

Figure 18: Orthopedic Device Market, France, Market Share of Major Players (%), 2015

Figure 19: Cardiovascular Device Market, France, Revenue ($m), 2009–2016

Figure 20: Cardiovascular Devices, France, Market Share of Major Players (%), 2015

Figure 21: Wound Care Management Devices, France, Revenue ($m), 2009–2016

Figure 22: Wound Care Management Devices, France, Market Share of Major Players (%), 2012

Figure 23: Ophthalmic Device Market, France, Revenue ($m), 2009–2016

Figure 24: Ophthalmic Device Market, France, Market Share of Major Players (%), 2015

Figure 25: Medical Device Market, France, Revenue of Major Players ($m), 2012

Figure 26: Healthcare Market, France, Drivers and Barriers, 2017

Figure 27: Market Access, France, Healthcare System, 2014

Figure 28: Market Access, France, Key Influencers in Reimbursement Procedure, 2016

Figure 29: Market Access, France, Pricing and Reimbursement Process, 2016

Figure 30: Market Access, France, Roles of Transparency Commission in Reimbursement Procedure, 2014

Figure 31: Market Access, France, Pricing Procedure, 2016

Figure 32: Market Access, France, Public Health Insurance Schemes, 2015

Figure 35: Market Access, France, Source of Public Health Insurance Funding (%), 2015

Figure 34: Healthcare Expenditure, France, Out-of-Pocket Expenditure (%), 2009–2016

Figure 35: Market Access, France, Healthcare Consumer Price Index Annual Change (%), 2009–2015

Figure 36: Market Access, France, Organizational Structure of the Drug Regulatory Authority, 2016

Figure 37: Market Access, EU, Centralized Procedure for Market Authorization, Pre-Submission, 2016

Figure 38: Market Access, EU, Centralized Procedure, Market Authorization, Pre-opinion Phase, 2016

Figure 39: Market Access, EU, Centralized Procedure, Market Authorization, Post-opinion Phase, 2016

Figure 40: Market Access, EU, Decentralized Procedure, Market Authorization, 2016

Figure 41: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2016

Figure 42: Market Access, EU, Conformity Assessment of Class IIa Medical Devices, 2016

Figure 43: Market Access, EU, Conformity Assessment of Class IIb Medical Devices, 2016

Figure 44: Market Access, EU, Conformity Assessment of Class III Medical Devices, 2016

Figure 45: Market Access, France, Patent Approval Process, 2016

Figure 46: Market Access, France, Trademark Approval Process, 2016

Figure 47: Economic Indicators, France, GDP Per Capita ($), 2009–2016

Figure 48: Economic Indicators, France, GDP per Capita ($), 2017–2021

Figure 49: Economic Indicators, France, GDP Annual Growth (%), 2009–2016

Figure 50: Economic Indicators, France, GDP Annual Growth (%), 2017–2021

Figure 51: Economic Indicators, France, GNI per Capita ($), 2009–2016

Figure 52: Economic Indicators, France, Consumer Price Index, 2009–2016

Figure 53: Economic Indicators, France, Average Consumer Price Index, 2017–2021

Figure 54: Economic Indicators, France, Average Consumer Price Index, Annual Change (%), 2009–2016

Figure 55: Economic Indicators, France, Average Consumer Price Index, Annual Change (%), 2017–2021

Figure 56: Economic Indicators, France, Currency Exchange Rate (€/$), 2009–2016

Figure 57: Economic Indicators, France, Foreign Direct Investment ($bn), 2009–2016

Figure 58: Economic Indicators, France, Foreign Exchange Reserves ($bn), 2009–2016

Figure 59: Economic Indicators, France, Imports of Goods and Services ($bn), 2009–2016

Figure 60: Economic Indicators, France, Exports of Goods and Services ($bn), 2009–2016

Figure 61: Economic Indicators, France, Government Structural Balance ($bn), 2009–2016

Figure 62: Economic Indicators, France, Government Net Debt as a Percentage of GDP (%), 2009–2016

Figure 63: Economic Indicators, France, Government Net Debt as a Percentage of GDP (%), 2017–2021

Figure 64: Economic Indicators, France, Value Added by Major Industries ($bn), 2014

Figure 65: Demographics, France, Population (million), 2009–2016

Figure 66: Demographics, France, Population (million), 2017–2021

Figure 67: Demographics, France, Urban–Rural Population Share (%), 2009–2016

Figure 68: Demographics, France, Urban–Rural Population Share (%), 2017–2021

Figure 69: Demographics, France, Population Distribution by Age Group (%), 2009–2016

Figure 70: Demographics, France, Population Distribution by Age Group (%), 2017–2021

Figure 71: Demographics, France, Births (per 1,000 Population), 2009–2016

Figure 72: Demographics, France, Mortality (per 1,000 Population), 2009–2016

Figure 73: Demographics, France, Major Causes of Mortality (%), 2013

Figure 74: Demographics, France, Mortality Rate of Children Under Five (per 1,000 live births), 2009–2016

Figure 75: Demographics, France, Immunization Rate (%), 2009–2016

Figure 76: Demographics, France, Major Causes of Male Mortality (%), 2012

Figure 77: Demographics, France, Major Causes of Female Mortality (%), 2012

Figure 78: Demographics, France, Gender Ratio (M/F), 2009–2016

Figure 79: Demographics, France, Life Expectancy at Birth (years), 2009–2016

Figure 80: Demographics, France, Life Expectancy at Birth (years), 2017–2021

Figure 81: Demographics, France, Number of Students by Level of Education (million), 2009–2016

Figure 82: Demographics, France, Student Enrollment by Specialization (%), 2015

Figure 83: Demographics, France, Unemployment Rate (%), 2009–2016

Figure 84: Demographics, France, Major Diseases, Disability-Adjusted Life Years by Major Disease (‘000s), 2012

Figure 85: Healthcare Infrastructure, France, Hospitals, 2009–2016

Figure 86: Healthcare Infrastructure, France, Public and Private Hospitals, 2009–2016

Figure 87: Healthcare Infrastructure, France, Private Sector Hospitals, 2009–2016

Figure 88: Healthcare Infrastructure, France, Hospitals Beds by Sector, 2009–2016

Figure 89: Healthcare Infrastructure, France, Diagnostic Units (per million population), 2009–2016

Figure 90: Healthcare Infrastructure, France, Diagnostic Centers, 2009–2016

Figure 91: Healthcare Infrastructure, France, Hospitals Beds (per 1,000 population), 2009–2016

Figure 92: Healthcare Infrastructure, France, Doctors (per 1,000 population), 2009–2016

Figure 93: Healthcare Infrastructure, France, PM2.5 (µg per m³), 2009–2016

Figure 94: Healthcare Infrastructure, France, CO2 Emissions (metric tons per capita), 2009–2016

Figure 95: Healthcare Infrastructure, France, Nurses (per 1,000 population), 2009–2016

Figure 96: Healthcare Infrastructure, France, Pharmacists, 2009–2016

Figure 97: Healthcare Infrastructure, France, Dentists, 2009–2016

Figure 98: Healthcare Infrastructure, France, Healthcare Expenditure as Percentage of GDP (%), 2009–2016

Figure 99: Healthcare Infrastructure, France, Public–Private Share of Expenditure (%), 2009–2016

Figure 100: Healthcare Infrastructure, France, Major Components of Healthcare Expenditure (%), 2015

Figure 101: Healthcare Infrastructure, France, Pharmaceutical R&D Expenditure ($ per capita), 2009–2016

Figure 102: Healthcare Market, France, Opportunities and Challenges, 2017

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