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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Poland

  • ID: 2909401
  • Report
  • April 2020
  • Region: Poland
  • 162 pages
  • GlobalData
1h Free Analyst Time

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Summary

The publisher, an industry analysis specialist, has released its latest report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Poland”. The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in the Poland. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of the Poland. 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 the publisher's team of industry experts.

The Poland healthcare market is one of the major emerging markets in Central Europe, with a strong focus on healthcare reforms and R&D. The pharmaceutical market of Poland increased from €6.34B in 2011 to €7.54B in 2017 at a Compound Annual Growth Rate (CAGR) of 2.92%. However, in terms of USD, the pharmaceutical market decreased from $8.82B in 2011 to $8.52B in 2017, at a negative CAGR of 0.57%. The Poland medical devices market was valued at $2.79B in 2015, which increased at a CAGR of 4% to reach $3.27B in 2019.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the Poland, and includes -
  • An overview of the pharmaceutical markets, comprising market size, segmentation, COVID-19 epidemiology and key drivers and barriers
  • Profiles and SWOT analyses of the major players in the pharmaceutical market (Novartis, GSK, Sanofi, Teva and PolPharma)
  • Profiles and SWOT analyses of the major players in the medical device market (Abbott, Medtronic, GE Healthcare, Stryker, and Mercator Medical)
  • Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Poland
  • Information regarding the health-tech landscape of the country along with the major health-tech deals
  • 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
  • Information regarding recent healthcare policies along with healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities 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 the 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 analysing 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 Polish healthcare market
Note: Product cover images may vary from those shown
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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 Highlights: Healthcare Start-Ups in Poland
2.4 Key Events: Poland Pharmaceutical Timeline, 2014-2020
2.5 Key Events: Poland Pharmaceutical Market
2.6 Key Events: M&A, VF & PE Deals, Global Pharmaceutical Market, 2019-2020
2.7 Key Events: Mergers and Acquisitions
2.8 Country Profile, Poland, 2019

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 - COVID-19 Epidemiology
3.6.1 Pharmaceutical Market- Government Response to Mitigate COVID-19 Impact
3.6.2 Pharmaceutical Market- COVID-19 Impact and Developments in Healthcare Market
3.7 Pharmaceutical Market - Major Players

4 Overview of Medical Device Market
4.1 Medical Device Market - Overview
4.2 Medical Devices Market - Major Segments
4.2.1 Medical Devices Market - Cardiovascular Devices
4.2.2 Medical Devices Market - Ophthalmic Devices
4.2.3 Medical Devices Market - Hospital Supplies Devices
4.2.4 Medical Devices Market - Orthopedic Devices
4.2.5 Medical Devices Market - Diagnostic Imaging
4.3 Medical Devices Market - Diagnostics Market
4.4 Medical Devices 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, Poland, 2019-2020
6.2 Deal Analysis: M&A, VC, and PE Deals, Medical Devices Market, Poland, 2019-2020

7 HealthTech Landscape
7.1 HealthTech Deals Landscape, Poland
7.1.1 Key HealthTech Deals, Poland
7.1.2 Digital Health Companies, Poland
7.2 Adoption of Technology in Healthcare, Poland
7.2.1 Healthcare Funding Covering the Use of Technology, Poland
7.2.2 Government eHealth Initiative, Poland
7.2.3 Regulatory Scenario Covering Use of Technology in Healthcare, Poland
7.3 HealthTech Landscape- Poland- Benefits and Risks

8 Market Access
8.1 Overview of Healthcare System, Poland
8.2 Reimbursement Process, Poland
8.2.1 Overview of Insurance Providers, Public Insurance, Poland
8.2.2 Overview of Insurance Providers, Private Insurance, Poland
8.3 Overview of Health Insurance, Poland
8.3.1 Healthcare Spending and Health Price Index, Poland
8.3.2 Pricing Policies, Poland
8.4 Regulatory Landscape, Poland
8.4.1 Overview of Regulatory Agencies
8.4.2 Market Authorization for Pharmaceutical Products, National Procedure, Poland
8.4.3 Market Authorization for Pharmaceutical Products, Centralized Procedure, Poland
8.4.4 Market Authorization for Pharmaceutical Products, Decentralized Procedure, Poland
8.4.5 Market Authorization for Pharmaceutical Products, Mutual Recognition Procedure, Poland
8.4.6 Market Authorization for Generics and Biosimilars, Poland
8.4.7 Market Authorization for Medical Devices, Poland
8.4.8 Licensing Process for Pharmaceutical and Medical Device Manufacturing, Poland
8.4.9 Licensing Process for Pharmaceutical Exports and Imports, Poland
8.4.9.1 Parallel Import
8.4.10 Intellectual Property Rights, Patent, Poland
8.4.10.1 Intellectual Property Rights, European Patent, Poland
8.4.10.2 Intellectual Property Rights, Unitary Patent, Poland
8.4.11 Intellectual Property Rights, Trademark, Poland
8.4.12 Clinical Trial Regulations, Poland
8.4.12.1 Pharmaceutical Clinical Trials Landscape, Poland
8.4.12.2 Medical Device Clinical Trials Landscape, Poland
8.4.13 Pharmaceutical Advertising Regulations, Poland
8.4.14 Labeling and Packaging Regulations, Poland

9 Country Healthcare Landscape
9.1 Healthcare Policy Highlights
9.2 Healthcare Facilities
9.3 Healthcare Parameters
9.4 Life Expectancy and Immunization Rate, Poland
9.5 Environmental Health
9.6 Healthcare Personnel
9.7 Disease Burden
9.8 Healthcare Expenditure

10 Trade Associations, Poland

11 Trade Fairs, Poland

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
13.4 Disclaimer

List of Tables
Table 1: COVID-19 Indicators (Number of Cases), Global and Poland, 2020
Table 2: COVID-19 Clinical Trial, Poland, 2020
Table 3: COVID-19 PCR Systems Available for Diagnosis of COVID-19 , Poland, 2020
Table 4: COVID-19 Test Kits and Assays Available for COVID-19 Gene Sequencing, Poland, 2020
Table 5: Medical Devices Market, Major Segments by Revenue, Poland, 2019
Table 6: Cardiovascular Devices Market, Poland, Revenue ($M) and Market Share (%) of Major Companies, 2018
Table 7: Ophthalmic Devices Market, Poland, Revenue ($M) and Market Share (%) of Major Companies, 2015
Table 8: Hospital Supplies Devices Market, Poland, Revenue ($M) and Market Share (%) of Major Companies, 2016
Table 9: Orthopaedic Devices Market, Poland, Revenue ($M) and Market Share (%) of Major Companies, 2019
Table 10: Diagnostic Imaging Market, Poland, Revenue ($M) and Market Share (%) of Major Companies, 2015
Table 11: Calculation of the product cost, Poland, 2019
Table 12: Trade Fairs, Poland

List of Figures
Figure 1: Pharmaceutical Market, Poland, Revenue ($B), 2011-2019
Figure 2: Medical Device Market, Poland, Revenue ($B), 2015-2020
Figure 3: Healthcare Startups in Poland, Poland, 2019
Figure 4: Country Profile, Poland, 2019
Figure 5: Pharmaceutical Market, Poland, Revenue ($B), 2011-2018
Figure 6: Pharmaceutical Market, Poland, Revenue Forecast ($B), 2019-2025
Figure 7: Pharmaceutical Exports ($B), Poland, 2010-2018
Figure 8: Top Export Partners, Poland, 2018
Figure 9: Pharmaceutical Imports ($B), Poland, 2010-2018
Figure 10: Top Import Partners, Poland, 2018
Figure 11: Major Generic Drug Companies, Poland, 2019
Figure 12: OTC Market, Poland, Major Category (%), 2019
Figure 13: OTC Market, Poland, Revenue ($M), 2013-2020
Figure 14: COVID-19 (Number of cases), Poland, 2020
Figure 15: COVID-19 (Number of deaths), Poland, 2020
Figure 16: Government Response to Mitigate COVID-19 Impact , Poland
Figure 17: Pharmaceutical Market, Major Players, 2018
Figure 18: Medical Device Market, Poland, Revenue ($B), 2015-2020
Figure 19: Medical Device Market, Poland, Revenue Forecast ($B), 2021-2025
Figure 20: Medical Devices Market, Major Segments (%), Poland, 2019
Figure 21: Cardiovascular Devices Market, Poland, Revenue ($M), 2015-2022
Figure 22: Cardiovascular Devices Market, Poland, Market Share of Major Players (%), 2018
Figure 23: Ophthalmic Devices Market, Poland, Revenue ($M), 2015-2022
Figure 24: Ophthalmic Devices Market, Poland, Market Share of Major Players (%), 2015
Figure 25: Hospital Supplies Devices Market, Poland, Revenue ($M), 2015-2022
Figure 26: Hospital Supplies Devices Market, Poland, Market Share of Major Players (%), 2016
Figure 27: Orthopaedic Devices Market, Poland, Revenue ($M), 2015-2022
Figure 28: Orthopaedic Devices Market, Poland, Market Share of Major Players (%), 2019
Figure 29: Diagnostic Imaging Market, Poland, Revenue ($M), 2015-2022
Figure 30: Diagnostic Imaging Market, Poland, Market Share of Major Players (%), 2015
Figure 31: Diagnostic Market, Poland, Revenue ($M), 2015-2020
Figure 32: Diagnostic Market, Poland, Revenue ($M), 2021-2025
Figure 33: Medical Device Market, Poland, Revenue ($B) of Major Companies, 2017
Figure 34: Deal Value and Deal Count, Pharmaceutical Market, Poland, 2019-2020
Figure 35: Deal Value and Deal Count Quarterly, Pharmaceutical Market, Poland, 2019-2020
Figure 36: Deal Value and Deal Count Sub-Types, Pharmaceutical Market, Poland, 2019-2020
Figure 37: Top Five Therapy Areas by Deal Value, Pharmaceutical Market, Poland, 2019-2020
Figure 38: Top Five Therapy Areas by Deal Number, Pharmaceutical Market, Poland, 2019-2020
Figure 39: Deal Value and Deal Count, HealthTech, Poland, 2019-2020
Figure 40: Deal Count by Technology Theme (Number of Deals), HealthTech , Poland, 2019
Figure 41: Digital Health Companies, Poland, 2019
Figure 42:Digital Health Funding, Poland, 2019
Figure 43: Polish Government Initiatives, AI Collaborations of Poland Globally, 2019
Figure 44: Polish Government Initiatives, Grants and Collaborations, Poland, 2019
Figure 45: HealthTech Policy Initiatives, Poland, 2019
Figure 46: Objectives of National AI Strategy, Poland, 2019
Figure 47: Key agencies subordinated to the Ministry of Health (MOH), Poland, 2019
Figure 48: Poland Reimbursement Approval Process, Poland, 2019
Figure 49: Out-of-Pocket Expenditure ($ per capita), Poland, 2010-2018
Figure 50: Health Price Index, Poland, 2014-2018
Figure 51: Market Authorization for Pharmaceutical Products (National Procedure), Poland, 2019
Figure 52: Centralized Procedure, Poland, 2019
Figure 53: Decentralized Procedure, Poland, 2019
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Factors such as the growing elderly population, increasing availability of affordable medicines, and transparent regulatory guidelines will provide the necessary impetus for the growth of the Polish pharmaceutical market, but a decrease in mark-up prices and the country’s stringent drug reimbursement budget will hinder growth

The pharmaceutical industry plays a key role in Poland’s healthcare system and economy. It was valued at $8.6 billion in 2013 and is projected to reach $15 billion in 2020 at a Compound Annual Growth Rate (CAGR) of 8.3% (AESGP, 2014). The pharmaceutical market had decreased from $8.8 billion in 2011 to $7.1 billion in 2012 due to the implementation of the new Reimbursement Act by Poland government in 2012, but has since partially recovered. According to the new act, the prices of the reimbursed drugs were decreased and the profit margins for wholesalers and retailers were also reduced, which impacted the pharmaceutical market negatively. The highest mark-up possible for reimbursed medicines was reduced from 9.78% in 2011 to 7% in 2012 and then to 6% in 2013. The VAT on pharmaceuticals and medical devices was 8% (ISPOR, 2013; EC, 2014). In 2013, the pharmaceutical market recovered and reached $8.6 billion due to an increase in demand for and consumption of pharmaceuticals (ISPOR, 2013).

Generic drugs have a dominant position in the pharmaceutical market. In 2012, the share of generic drugs was 66% of the pharmaceutical market, which increased from 62.2% of the total pharmaceutical market in 2011.

The prices of pharmaceuticals are lower in Poland than in other European Union (EU) member countries. These low prices enhance the affordability of pharmaceuticals, boosting the pharmaceutical market.

The cap on the reimbursement budget for drugs was decreased from 21% in 2010 to 17% in 2011 of the National Health Fund (Narodowy Fundusz Zdrowia, NFZ), so patients now have to pay more for their treatment. The NFZ administers funding and contracts providers to provide healthcare services, both for prophylaxis and therapy. The majority of resources are allotted to in-patient treatment, followed by reimbursement of medications, out-patient general care and specialized out-patient care. The value of the NFZ’s total drugs reimbursement decreased from PLN8.8 billion ($3 billion) in 2011 to PLN6.9 billion ($2.1 billion) in 2012. The decrease in the reimbursement budget would negatively affect the overall pharmaceutical market.

In Poland, the government has taken steps to increase R&D expenditure. In 2013, the expenditure on research in healthcare has been estimated at $633.5m, from $300.8m in 2008. The healthcare R&D increased at a CAGR of 22.6% over the 2008-2013 period (CSO, 2014c).

The major multi-national pharmaceutical companies in Poland are Sanofi, Novartis, GlaxoSmithKline (GSK), and Roche. Polpharma is the major local player in Poland. In Poland, imports of pharmaceuticals accounted for $4.9 billion of the total pharmaceutical market in 2013.

The medical device market was worth $2.2 billion in 2013 and is projected to reach $2.8 billion by 2020, at a projected CAGR of 3.6%. In Vitro Diagnostics (IVD) (20.3%), ophthalmic devices (18.3%), and cardiovascular devices (13.4%) were the major segments in the medical device market in 2013. With a rapidly growing elderly population and awareness of chronic diseases rising, the medical care and diagnostic markets are expected to see strong growth in the future.
Note: Product cover images may vary from those shown
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