Poland Healthcare, Regulatory and Reimbursement Landscape – CountryFocus

GlobalData, the 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 GlobalData’s team of industry experts.

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

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 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 Us

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

Figure 54: Mutual Recognition Procedure, Poland, 2019

Figure 55: Conformity Assessment of Class I Medical Devices, EU, 2019

Figure 56: Conformity Assessment of Class IIa Medical Devices, EU, 2019

Figure 57: Conformity Assessment of Class IIb Medical Devices, EU, 2019

Figure 58: Conformity Assessment of Class III Medical Devices, EU, 2019

Figure 59: Patent Approval Process, Poland, 2019

Figure 60: European Patent Approval Process EU, 2019

Figure 61: Unitary Patent Approval Process EU, 2019

Figure 62: Trademark Approval Process, Poland, 2019

Figure 63: Clinical Trial Approval Process, Poland, 2019

Figure 64: Pharmaceutical Clinical Trials Count By Trial Status, Poland, 2018–2019

Figure 65: Pharmaceutical Clinical Trials Count By Phase, Poland, 2018–2019

Figure 66: Pharmaceutical Clinical Trials Count By Therapy Area, Poland, 2018–2019

Figure 67: Top Pharmaceutical Clinical Trials Sponsor By Count, Poland, 2018–2019

Figure 68: Medical Devices Clinical Trials Count By Trial Status, Poland, 2018–2019

Figure 69: Medical Devices Clinical Trials Count By Category, Poland, 2018–2019

Figure 70: Medical Devices Clinical Trials Count By Indication, Poland, 2018–2019

Figure 71: Top Five Medical Clinical Trials Sponsor By Count, Poland, 2018–2019

Figure 72: Poland Healthcare Policy Highlights, Poland, 2018

Figure 73: Hospitals (number),Poland, 2011–2019

Figure 74: Diagnostic Equipment (per million population), Poland, 2011–2019

Figure 75: PET Scanners (per million population), Poland, 2011–2019

Figure 76: Gamma Cameras (per million population), Poland, 2011–2019

Figure 77: Mammograph (per million population), Poland, 2011–2019

Figure 78: Hospital Beds (per 1,000 population), Poland, 2011–2019

Figure 79: Acute Care Beds (per 1,000 population), Poland, 2011–2019

Figure 80: Psychiatric Care Beds(per 1,000 population), Poland, 2011–2019

Figure 81: Rehabilitative Care Beds (per 1,000 population), Poland, 2011–2019

Figure 82: Long Term Care Beds (Total Number), Poland, 2011–2019

Figure 83: Life Expectancy (in years), Poland, 2010–2017

Figure 84: Immunization Rate (%), Poland, 2010–2018

Figure 85: PM2.5 (µg per m3), Poland, 2010–2019

Figure 86: CO2 Emissions (metric tons), Poland, 2010–2019

Figure 87: Doctors (per 1,000 population), Poland, 2010–2018

Figure 88: Dentists (per 1,000 population), Poland, 2010–2017

Figure 89: Nurses (per 1,000 population), Poland, 2010–2017

Figure 90: Pharmacists (per 1,000 population), Poland, 2010–2017

Figure 91: Major Causes of Mortality (Age adjusted rates /100,000 population), Poland, 2016

Figure 92: Major Causes of Male Mortality (Age adjusted rates /100,000 population), Poland, 2016

Figure 93: Major Causes of Female Mortality (Age adjusted rates /100,000 population), Poland, 2016

Figure 94: Disability-Adjusted Life Years by Major Disease (‘000), Poland, 2016

Figure 95: Healthcare Expenditure as a Percentage of GDP (%), Poland, 2010–2019

Figure 96: Health Expenditure Share (% of total health spending), Poland, 2010–2017

Figure 97: Opportunities and Challenges

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