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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Poland

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Poland

Summary

Pharmaceutical industry plays a key role in Poland’s healthcare system and economy. The value of the Polish pharmaceuticals market (at manufacturer’s selling price) increased from $7.64 Billion in 2009 to $9.4 Billion in 2016 at a Compound Annual Growth Rate (CAGR) of 3%. It is expected to reach $11 Billion by 2021 (AESGP, 2017). This is despite the introduction of a new reimbursement act in 2012, which caused the value of the market to fall from $8.1 Billion to $7.7 Billion.

In 2014, total healthcare expenditures amounted to PLN108.7 Billion ($33.3 Billion), with public expenditure of PLN77.2 Billion ($23.7 Billion) and private expenditure of PLN31.5 Billion ($9.7 Billion) (CSO, 2017a). Healthcare expenditure in Poland accounted for 6.3% of GDP in 2015, less than the OECD average of 8.8%. The per capita healthcare expenditure in the country was $914.1 in 2015, less than the OECD average of $3,814 (OECD, 2015; OECD, 2017a). The prices of pharmaceuticals are lower in Poland than in other EU member countries.

Polish medical device market increased to $2.3 Billion in 2016 from $1.6 Billion in 2009, and is expected to grow at a CAGR of 5% from 2017-2021. The main segments (cardiovascular devices, ophthalmic devices, orthopedic devices, and diagnostic imaging and hospital supplies) will drive market growth. The market is driven by increasing awareness regarding early disease detection and diagnosis, advances in medical technology and the increasing elderly population.

Healthcare system in Poland is based on the general health insurance system. Healthcare services have been financed, supervised, and controlled by the MoH, the National Health Fund (NHF) and local governments since 2003. The government wants to remove the NHF, and change the existing Bismarck model of health insurance system to the Beveridge system, starting from January 2018.

The report CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Poland is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Poland. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Poland.

In particular, this report -

  • Provides an overview of the Poland pharmaceutical and medical device markets, covering market size; the market shares of generic, Over-The-Counter (OTC) and biologic/biosimilar products; and the key drivers and barriers for the overall market. It also includes profiles of the major players, as well as SWOT assessments.
  • Covers the reimbursement and payer landscape, and includes details of the reimbursement process, insurance providers, pricing policies and drug price trends in Poland. It also looks at the regulatory landscape, and gives an overview of the regulatory agencies and approval processes for new drugs and medical devices.
  • Provides detailed analysis of the political and economic environment in Poland, and analyzes economic indicators, demographics, and healthcare infrastructure and expenditure.
  • Provides an overview of the opportunities for and challenges to growth in the Polish healthcare market.
Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Poland, 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 (Sanofi, Novartis, GSK, Roche and Polpharma) and profiles and SWOT analyses of the major players in the medical device market (Baxter, Fresenius, GSK and Astrazeneca)
  • 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 and medical devices
  • Detailed analysis of the 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 Polish 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 Polish 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 Polish healthcare market


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 the Pharmaceutical and Medical Device Markets
4.1 Pharmaceutical Market
4.1.1 Market Overview
4.1.2 Pharmaceutical Imports and Exports
4.1.3 Supply Channels
4.1.4 Market Segments
4.1.5 Overview of Top Five Disease 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 Reimbursement and Payer Landscape
5.1.1 Overview of Healthcare System
5.1.2 Reimbursement Process
5.1.3 Overview of Insurance Providers
5.1.4 Patient Share in Healthcare Spending
5.1.5 Price Trend in Healthcare Services
5.1.6 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 Market Authorization Procedure for Medical Devices
5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
5.2.5 Licensing Process for Pharmaceutical 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 Analysis of the 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 General Government Structural Balance
6.3.9 General 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 Public-Private Sector Share
6.6.3 Major Components of Healthcare Spending
6.6.4 Spending in Science and Technology Research and Development
6.7 Trade Associations
6.7.1 The Employers' Association of Innovative Pharmaceutical Companies
6.7.2 Polish Association of Pharmaceutical industry Employers
6.7.3 Polish Association of Self Medication industry
6.7.4 Polish Chamber of Pharmaceutical Industries and Medical Devices
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
1.1 List of Tables
Table 1: Pharmaceutical Market, Poland, Revenue ($bn), 2009-2016
Table 2: Pharmaceutical Market, Poland, Revenue Forecast ($bn), 2017-2021
Table 3: Pharmaceutical Market, Poland, Pharmaceutical Imports and Exports ($bn), 2009-2016
Table 4: Pharmaceutical Market, Poland, OTC Drug Market Revenue ($bn), 2009-2016
Table 5: Sanofi, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 6: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2017
Table 7: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 8: Pharmaceutical Market, Novartis, Planned Filings, 2017-2020
Table 9: Pharmaceutical Market, Roche, Global, Revenue ($m) and Annual Growth (%) of Major Products, 2016
Table 10: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2017
Table 11: Pharmaceutical Market, Polpharma, Global, Revenue ($m) and Annual Growth (%) of Major Products, 2017
Table 12: Pharmaceutical Market, Polpharma, Global, Advanced Pipeline, 2017
Table 13: Medical Device Market, Poland, Revenue ($bn), 2009-2016
Table 14: Medical Device Market, Poland, Revenue Forecast ($bn), 2017-2021
Table 15: Medical Device Market, Poland, Revenue by Segment ($m), 2016
Table 16: Cardiovascular Devices Market, Poland, Revenue ($m), 2009-2016
Table 17: Cardiovascular Devices Market, Poland, Revenue ($m) and Market Share (%) of Major Companies, 2016
Table 18: Ophthalmic Devices Market, Poland, Revenue ($m), 2009-2016
Table 19: Ophthalmic Devices Market, Poland, Revenue ($m) and Market Share (%) of Major Companies, 2015
Table 20: Orthopedic Devices Market, Poland, Revenue ($m), 2009-2016
Table 21: Orthopedic Devices Market, Poland, Revenue ($m) and Market Share (%) of Major Companies, 2016
Table 22: Diagnostic Imaging Market, Poland, Revenue of Major Players ($m), 2009-2016
Table 23: Diagnostic Imaging Market, Poland, Revenue ($m) and Market Share (%) of Major Companies, 2015
Table 24: Hospital Supplies, Poland, Revenue ($m), 2009-2016
Table 25: Hospital Supplies, Poland, Revenue ($m) and Market Share (%) of Major Companies, 2014
Table 26: Medical Device Market, Poland, Revenue ($m) and Market Share (%) of Major Companies, 2012
Table 27: Baxter, Global, Major Products, 2017
Table 28: Market Access, Poland, Out-of-Pocket Expenditure (%), 2009-2015
Table 29: Market Access, Poland, Healthcare Price Index, Annual Change (%), 2009-2015
Table 30: Economic Indicators, Poland, Gross Domestic Product per Capita ($), 2009-2016
Table 31: Economic Indicators, Poland, Gross Domestic Product per Capita Forecast ($), 2017-2021
Table 32: Economic Indicators, Poland, Gross Domestic Product Annual Growth (%), 2009-2016
Table 33: Economic Indicators, Poland, Gross Domestic Product Annual Growth Forecast (%), 2017-2021
Table 34: Economic Indicators, Poland, Gross National Income per Capita ($), 2009-2016
Table 35: Economic Indicators, Poland, Average Consumer Price Index, 2009-2016
Table 36: Economic Indicators, Poland, Average Consumer Price Annual Change (%), 2009-2016
Table 37: Economic Indicators, Poland, Currency Exchange Rate (PLN per $), 2009-2016
Table 38: Economic Indicators, Poland, Foreign Direct Investment ($bn), 2009-2015
Table 39: Economic Indicators, Poland, Foreign Exchange Reserves ($bn), 2009-2015
Table 40: Economic Indicators, Poland, Imports of Goods and Services ($bn), 2009-2015
Table 41: Economic Indicators, Poland, Exports of Goods and Services ($bn), 2009-2015
Table 42: Economic Indicators, Poland, Government Structural Balance ($bn), 2009-2016
Table 43: Economic Indicators, Poland, General Government Net Debt ($bn), 2009-2016
Table 44: Economic Indicators, Poland, Major Industries by Revenue ($bn), 2016
Table 45: Demographics, Poland, Population (million), 2009-2016
Table 46: Demographics, Poland, Population (million), 2017-2021
Table 47: Demographics, Poland, Urban-Rural Population Share (%), 2009-2016
Table 48: Demographics, Poland, Population Distribution by Age Group (%), 2009-2016
Table 49: Demographics, Poland, Population Distribution by Age Group Forecast (%), 2017-2021
Table 50: Demographics, Poland, Births (per 1,000 population), 2009-2016
Table 51: Demographics, Poland, Mortality (per 1,000 population), 2009-2016
Table 52: Economic Indicators, Poland, Major Causes of Mortality (per 100,000 population), 2014
Table 53: Demographics, Poland, Infant Mortality (per 1,000 live births), 2009-2016
Table 54: Demographics, Poland, Immunization Rate (%), 2009-2016
Table 55: Demographics, Poland, Major Causes of Male Mortality (per 100, 000 population), 2014
Table 56: Demographics, Poland, Major Causes of Female Mortality (per 100,000 population), 2014
Table 57: Demographics, Poland, Gender Ratio (M/F), 2009-2016
Table 58: Demographics, Poland, Life Expectancy at Birth (years), 2009-2016
Table 59: Demographics, Poland, Student Enrolment by Education (%), 2009-2016
Table 60: Demographics, Poland, Unemployment Rate (%), 2009-2016
Table 61: Demographics, Poland, Most Frequently Diagnosed Diseases (‘000), 2015
Table 62: Demographics, Poland, Disability-Adjusted Life Years by Major Disease (‘000), 2012
Table 63: Healthcare Infrastructure, Poland, Number of Hospitals, 2009-2015
Table 64: Healthcare Infrastructure, Poland, Acute Care Hospitals (per 100,000 population), 2009-2015
Table 65: Healthcare Infrastructure, Poland, Diagnostic Equipment (per million population), 2009-2015
Table 66: Healthcare Infrastructure, Poland, Hospital Beds (per 1,000 population), 2009-2015
Table 67: Healthcare Infrastructure, Poland, Acute Care Hospital Beds (per 1,000 population), 2009-2015
Table 68: Healthcare Infrastructure, Poland, Psychiatric Hospital Beds (per 1,000 population), 2009-2015
Table 69: Healthcare Infrastructure, Poland, PM2.5 (µg per m3), 2009-2015
Table 70: Healthcare Infrastructure, Poland, CO2 Emissions (million tons), 2009-2015
Table 71: Healthcare Infrastructure, Poland, Healthcare Personnel (million), 2009-2015
Table 72: Healthcare Infrastructure, Poland, Doctors (per 10,000 population), 2009-2015
Table 73: Healthcare Infrastructure, Poland, Dentists (per 10,000 population), 2009-2015
Table 74: Healthcare Infrastructure, Poland, Pharmacists (per 10,000 population), 2009-2015
Table 75: Healthcare Infrastructure, Poland, Nurses (per 10,000 population), 2009-2015
Table 76: Healthcare Expenditure, Poland, Healthcare Expenditure as a Percentage of GDP (%), 2009-2015
Table 77: Healthcare Expenditure, Poland, Public-Private Share (%), 2009-2015
Table 78: Healthcare Expenditure, Poland, Major Components of Healthcare Spending (%), 2015
Table 79: Healthcare Expenditure, Poland, R&D Expenditure as a Percentage of GDP (%), 2009-2015
Table 80: Healthcare Expenditure, Poland, Major Healthcare Trade Fairs, 2017
1.2 List of Figures
Figure 1: Pharmaceutical Market, Poland, Revenue ($bn), 2009-2021 9
Figure 2: Medical Device Market, Poland, Revenue ($bn), 2009-2021 10
Figure 3: Country Profile, Poland, 2017 12
Figure 4: Pharmaceutical Market, Poland, Revenue ($bn), 2009-2016 16
Figure 5: Pharmaceutical Market, Poland, Revenue Forecast ($bn), 2017-2021 17
Figure 6: Pharmaceutical Market, Poland, Pharmaceutical Imports and Exports ($bn), 2009-2016 18
Figure 7: Pharmaceutical Market, Poland, OTC Drug Market Revenue ($bn), 2009-2016 21
Figure 8: Medical Device Market, Poland, Revenue ($bn), 2009-2016 55
Figure 9: Medical Device Market, Poland, Revenue Forecast ($bn), 2017-2021 56
Figure 10: Medical Device Market, Poland, Revenue by Segment ($m), 2016 57
Figure 11: Cardiovascular Devices Market, Poland, Revenue ($m), 2009-2016 58
Figure 12: Cardiovascular Devices Market, Poland, Market Share of Major Players (%), 2016 59
Figure 13: Ophthalmic Devices Market, Poland, Revenue ($m), 2009-2016 60
Figure 14: Ophthalmic Devices Market, Poland, Market Share of Major Players (%), 2016 61
Figure 15: Orthopedic Devices Market, Poland, Revenue ($m), 2009-2016 62
Figure 16: Orthopedic Devices Market, Poland, Market Share of Major Players (%), 2016 63
Figure 17: Diagnostic Imaging Market, Poland, Revenue ($m), 2009-2016 64
Figure 18: Diagnostic Imaging Market, Poland, Market Share of Major Players (%), 2015 65
Figure 19: Hospital Supplies, Poland, Revenue ($m), 2009-2016 66
Figure 20: Hospital Supplies, Poland, Market Share of Major Companies (%), 2014 67
Figure 21: Medical Device Market, Poland, Revenue of Major Companies ($m), 2012 68
Figure 22: Healthcare Market, Poland, Drivers and Barriers, 2017 91
Figure 23: Market Access, Poland, Out-of-Pocket Expenditure (%), 2009-2015 98
Figure 24: Market Access, Poland, Healthcare Price Index, Annual Change (%), 2009-2015 99
Figure 25: Market Access, EU, Centralized Procedure, Market Authorization, Pre-submission Phase, 2017 105
Figure 26: Market Access, EU, Centralized Procedure, Market Authorization, Pre-opinion Phase, 2017 106
Figure 27: Market Access, EU, Centralized Procedure, Market Authorization, Post-Opinion Phase, 2017 107
Figure 28: Market Access, EU, Decentralized Procedure, Market Authorization, 2017 108
Figure 29: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2017 111
Figure 30: Market Access, EU, Conformity Assessment of Class IIa Medical Devices, 2017 112
Figure 31: Market Access, EU, Conformity Assessment of Class IIb Medical Devices, 2017 113
Figure 32: Market Access, EU, Conformity Assessment of Class III Medical Devices, 2017 114
Figure 33: Economic Indicators, Poland, Gross Domestic Product Per Capita ($), 2009-2016 132
Figure 34: Economic Indicators, Poland, Gross Domestic Product per Capita Forecast ($), 2017-2021 133
Figure 35: Economic Indicators, Poland, Gross Domestic Product Annual Growth (%), 2009-2016 134
Figure 36: Economic Indicators, Poland, Gross Domestic Product Annual Growth Forecast (%), 2017-2021 135
Figure 37: Economic Indicators, Poland, Gross National Income per Capita ($), 2009-2016 136
Figure 38: Economic Indicators, Poland, Average Consumer Price Index, 2009-2016 137
Figure 39: Economic Indicators, Poland, Average Consumer Price Annual Change (%), 2009-2016 138
Figure 40: Economic Indicators, Poland, Currency Exchange Rate (PLN per $), 2009-2016 139
Figure 41: Economic Indicators, Poland, Foreign Direct Investment ($bn), 2009-2015 140
Figure 42: Economic Indicators, Poland, Foreign Exchange Reserves ($bn), 2009-2015 141
Figure 43: Economic Indicators, Poland, Imports of Goods and Services ($bn), 2009-2015 142
Figure 44: Economic Indicators, Poland, Exports of Goods and Services ($bn), 2009-2015 143
Figure 45: Economic Indicators, Poland, Government Structural Balance ($bn), 2009-2016 144
Figure 46: Economic Indicators, Poland, General Government Net Debt ($bn), 2009-2016 145
Figure 47: Economic Indicators, Poland, Major Industries by Revenue ($bn), 2016 146
Figure 48: Demographics, Poland, Population (million), 2009-2016 147
Figure 49: Demographics, Poland, Population (million), 2017-2021 148
Figure 50: Demographics, Poland, Urban-Rural Population Share (%), 2009-2015 149
Figure 51: Demographics, Poland, Population Distribution by Age Group (%), 2009-2016 150
Figure 52: Demographics, Poland, Population Distribution by Age Group Forecast (%), 2017-2021 151
Figure 53: Demographics, Poland, Births (per 1,000 population), 2009-2016 152
Figure 54: Demographics, Poland, Mortality (per 1,000 population), 2009-2016 153
Figure 55: Demographics, Poland, Major Causes of Mortality (per 100,000 population), 2014 154
Figure 56: Demographics, Poland, Infant Mortality (per 1,000 live births), 2009-2016 156
Figure 57: Demographics, Poland, Immunization Rate (%), 2009-2016 157
Figure 58: Demographics, Poland, Major Causes of Male Mortality (per 100,000 population), 2014 158
Figure 59: Demographics, Poland, Major Causes of Female Mortality (per 100,000 population), 2014 159
Figure 60: Demographics, Poland, Gender Ratio (M/F), 2009-2016 160
Figure 61: Demographics, Poland, Life Expectancy at Birth (years), 2009-2016 161
Figure 62: Demographics, Poland, Student Enrolment by Education (%), 2009-2016 162
Figure 63: Demographics, Poland, Unemployment Rate (%), 2009-2016 163
Figure 64: Demographics, Poland, Most Frequently Diagnosed Diseases (‘000), 2015 164
Figure 65: Demographics, Poland, Disability-Adjusted Life Years by Major Disease (‘000), 2012 166
Figure 66: Healthcare Infrastructure, Poland, Number of Hospitals, 2009-2015 167
Figure 67: Healthcare Infrastructure, Poland, Acute Care Hospitals (per 100,000 population), 2009-2015 168
Figure 68: Healthcare Infrastructure, Poland, Diagnostic Equipment (per million population), 2009-2015 169
Figure 69: Healthcare Infrastructure, Poland, Hospital Beds (per 1,000 population), 2009-2015 170
Figure 70: Healthcare Infrastructure, Poland, Acute Care Hospital Beds (per 1,000 population), 2009-2015 171
Figure 71: Healthcare Infrastructure, Poland, Psychiatric Hospital Beds (per 1,000 population), 2009-2015 172
Figure 72: Healthcare Infrastructure, Poland, PM2.5 (µg per m3), 2009-2015 174
Figure 73: Healthcare Infrastructure, Poland, CO2 Emissions (million tons), 2009-2015 175
Figure 74: Healthcare Infrastructure, Poland, Healthcare Personnel (million), 2009-2015 176
Figure 75: Healthcare Infrastructure, Poland, Physicians (per 10,000 population), 2009-2015 177
Figure 76: Healthcare Infrastructure, Poland, Dentists (per 10,000 population), 2009-2015 178
Figure 77: Healthcare Infrastructure, Poland, Pharmacists (per 10,000 population), 2009-2015 179
Figure 78: Healthcare Infrastructure, Poland, Nurses (per 10,000 population), 2009-2015 180
Figure 79: Healthcare Expenditure, Poland, Healthcare Expenditure as Percentage of GDP (%), 2009-2015 182
Figure 80: Healthcare Expenditure, Poland, Public-Private Share (%), 2009-2015 183
Figure 81: Healthcare Expenditure, Poland, Major Components of Healthcare Spending (%), 2015 184
Figure 82: Healthcare Expenditure, Poland, R&D Expenditure as a Percentage of GDP (%), 2009-2015 185
Figure 83: Healthcare Market, Poland, Opportunities and Challenges, 2017 189

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