Germany – Healthcare, Regulatory and Reimbursement Landscape

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Published: June 30, 2021 Report Code: GDHC0079CHR-ST

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GlobalData, the industry analysis specialist, has released its latest report, "Germany – Healthcare, Regulatory and Reimbursement Landscape". The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Germany. 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 German pharmaceutical market is the largest by value and second largest by volume in Europe. Globally, it is the fourth largest market by value after the US, China, and Japan. The market value, in terms of Euros, increased from €42.1B in 2013 to an estimated €62.4B in 2020 at a Compound Annual Growth Rate (CAGR) of 5.8%. In terms of US dollars, the market increased from $56B in 2013 to an estimated $71.3B in 2020 at a CAGR of 3.7%. The medical devices market of Germany was $21.6B in 2017, which increased at a CAGR of 3% to reach $23.5B in 2020. The market is expected to grow at a CAGR of 4.7% from $26.6B in 2021 to reach $29.6B in 2025.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Germany, 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: Bayer, Boehringer Ingelheim, GlaxoSmithKline, Merck KGaA, and Pfizer.

Profiles and SWOT analyses of the major players in the medical device market: Abbott, Alcon, GE Healthcare, Fresenius, and Roche Diagnostics

An insightful review of the COVID-19 epidemiology, COVID-19 impact, and developments in healthcare market, HealthTech landscape, 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 healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure

An overview of the opportunities for and challenges to growth in the German 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 German healthcare market

Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the German 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

1.1List of Figures

1.2 List of Tables

2. Executive Summary

2.1 Executive Summary

2.2 Key Highlights – Facts about the German Healthcare Market

2.3 Key Highlights: Healthcare Startups in Germany

2.4 Key Events: German Healthcare Industry, 2015-2021

2.5 Key Events: German Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2019-2020

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, Germany, 2020

3. Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Impact of Brexit on the German Health Sector

3.3 Pharmaceutical Market – Exports

3.4 Pharmaceutical Market – Imports

3.5 Pharmaceutical Market – Supply Channels, Germany

3.6 Pharmaceutical Market – Market Segments

3.7 Major Therapeutic Areas, Germany

3.8 COVID-19 Epidemiology, Germany

3.9 COVID-19 Impact and Developments, Germany

3.10 COVID-19 Impact and Developments in the Healthcare Market, Germany

3.11 COVID-19 Clinical Trials Landscape, Germany

3.12 Pharmaceutical Market – Major Players

4. Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Devices Market – Major Players

5. Pharmaceutical and Medical Devices Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6. Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, Germany, 2020-2021

6.2 Deal Analysis: Medical Device Market, Germany, 2020-2021

7. HealthTech Landscape

7.1 HealthTech Landscape, Germany

7.2 HealthTech Deals Landscape, Germany

7.3 Key HealthTech Deals, Germany

7.4 Adoption of Technology in Healthcare, Germany

7.5 Digital Health Regulations, Germany

7.6 Digital Health: Benefits and Risks, Germany

8. Market Access

8.1 Overview of Healthcare System, Germany

8.2 Reimbursement Process, Germany

8.3 Overview of Insurance Providers, Germany

8.4 Out-of-Pocket Spending and Pharmaceutical Price Index, Germany

8.5 Pricing Policies, Germany

8.6 Regulatory Landscape, Germany

8.6.1 Overview of Regulatory Agencies, Germany

8.6.2 Marketing Authorization for Pharmaceutical Products, EU

8.6.3 Marketing Authorization for Pharmaceutical Products, Centralized Procedure, Germany

8.6.4 Marketing Authorization for Pharmaceutical Products, Mutual Recognition Procedure, Germany

8.6.5 Marketing Authorization for Pharmaceutical Products, Decentralized Procedure, Germany

8.6.6 Marketing Authorization for Pharmaceutical Products, National Procedure, Germany

8.6.7 Marketing Authorization for Generic Drugs, Germany

8.6.8 Marketing Authorization for Biosimilars, Germany

8.6.9 Marketing Authorization for Medical Devices, Germany

8.6.10 Exports and Imports, Germany

8.6.11 Intellectual Property Rights, Patent, Germany

8.6.12 Intellectual Property Rights, Trademark, Germany

8.6.13 Clinical Trial Regulations, Germany

8.6.14 Pharmaceutical Clinical Trials Landscape, Germany

8.6.15 Medical Devices Clinical Trials Landscape, Germany

8.6.16 Pharmacy License Regulations, Germany

8.6.17 Online Pharmacy Regulations, Germany

8.6.18 Pharmaceutical Advertising Regulations, Germany

8.6.19 Labeling and Packaging Regulations, Germany

9. Country Healthcare Landscape

9.1 Healthcare Policy Highlights, Germany

9.2 Healthcare Facilities, Germany

9.3 Healthcare Parameters, Germany

9.4 Life Expectancy and Immunization Rate, Germany

9.5 Environmental Health, Germany

9.6 Healthcare Personnel, Germany

9.7 Disease Burden, Germany

9.8 Healthcare Expenditure, Germany

9.9 Healthcare Spending Components and Pharmaceutical Spending, Germany

10 Trade Associations, Germany

11 Trade Fairs, Germany

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.2 Bibliography

13.3 About GlobalData

13.4 Contact Us

13.5 Disclaimer

Table

Table 1: Biotechnology Companies General Data, Germany, 2018-2019

Table 2: Biosimilars approved in 2021, Germany, 2021

Table 3: COVID-19 Indicators (Number of cases), Germany and Global, 2020-2021

Table 4: COVID-19 Vaccines, Germany, 2020-2021

Table 5: Medical Devices Market, Germany, Major Segments ($B), 2020

Table 6: General Surgery Devices Market, Germany, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 7: Cardiovascular Devices Market, Germany, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 8: Healthcare IT Market, Germany, Revenue ($M) and Market Share (%) of Major Companies, 2018

Table 9: Orthopedic Devices Market, Germany, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 10: In Vitro Diagnostics Market, Germany, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 11: New Drug Application Information, Germany, 2021

Table 12: Patent Fees, Germany, 2020

Table 13: Trademark Fees, Germany, 2020

Table 14: Clinical Trial Fees, Germany, 2020

Table 15: Label of a Pharmaceutical Product, Germany, 2020

Table 16: Label of Radiopharmaceutical Product, Germany, 2020

Table 17: Labeling of Small Packages, Germany, 2020

Table 18: Labeling and Packaging Leaflet, Germany, 2020

Table 19: Conferences and Trade Fairs, Germany, 2021

Figures

Figure 1: Pharmaceutical Market, Germany, Revenue ($B and €B), 2013-2020

Figure 2: Medical Devices Market, Germany, Revenue ($B), 2017-2022

Figure 3: Healthcare Startups in Germany, 2020

Figure 4: Country Profile, Germany, 2020

Figure 5: Pharmaceutical Market, Germany, Revenue ($B), 2012-2019

Figure 6: Pharmaceutical Market, Germany, Revenue Forecast ($B), 2020-2025

Figure 7: Pharmaceutical Exports ($B), Germany, 2012-2020

Figure 8: Top Export Partners, Germany, 2020

Figure 9: Pharmaceutical Imports ($B), Germany, 2012-2020

Figure 10: Top Import Partners, Germany, 2020

Figure 11: Generic Drugs (Market share % by value and volume), Germany, 2010-2018

Figure 12: Generic Drug Marketing Authorization Applications (Number), EU, 2015-2021

Figure 13: Biotechnology SME Share (%), Germany, 2020

Figure 14: OTC Medicines Market, Revenue ($B), Germany, 2013-2020

Figure 15: OTC Medicines Market, Major Categories ($M), Germany, 2020

Figure 16: OTC Medicines Market, Major Distribution Channels ($M), Germany, 2017

Figure 17: Pharmaceutical Sales by Drug Category ($B), Germany, 2019

Figure 18: Major Therapeutic Areas by Pharmaceutical Consumption (DDD per million inhabitants), Germany, 2016-2018

Figure 19: COVID-19 (Number of cases), Germany, 2020-2021

Figure 20: COVID-19 (Number of deaths), Germany, 2020-2021

Figure 21: COVID-19 Risk Areas Classification, Germany, 2020-2021

Figure 22: COVID-19 Fiscal Stimulus Timeline, Germany, 2020-2021

Figure 23: COVID-19 Vaccination Priority Groups, Germany, 2020-2021

Figure 24: COVID-19 Vaccine Administration, Number of People, Germany, 2020-2021

Figure 25: Top COVID-19 Marketed Products by Category (Number of available marketed products), Germany, 2020-2021

Figure 26: Top COVID-19 IVD Products by Equipment Type (Number of available marketed products), Germany, 2020-2021

Figure 27: Top COVID-19 Marketed Products by Product Class (Number of available marketed products), Germany, 2020-2021

Figure 28: Top COVID-19 Anesthesia and Respiratory Devices Products by Equipment Type (Number of available marketed products), Germany, 2020-2021

Figure 29: COVID-19 Clinical Trials Count by Phase, Germany, 2020-2021

Figure 30: COVID-19 Clinical Trials Count by Trial Status, Germany, 2020-2021

Figure 31: Top Five COVID-19 Clinical Trials Sponsors by Count, Germany, 2020-2021

Figure 32: Pharmaceutical Market, Major Players, 2020

Figure 33: Medical Devices Market, Germany, Revenue ($B), 2015-2020

Figure 34: Medical Devices Market, Germany, Revenue Forecast ($B), 2021-2025

Figure 35: Medical Devices Market, Germany, Major Segments (%), 2020

Figure 36: General Surgery Devices Market, Germany, Revenue ($B), 2017-2025

Figure 37: General Surgery Devices Market, Germany, Market Share of Major Players (%), 2020

Figure 38: Cardiovascular Devices Market, Germany, Revenue ($B), 2017-2025

Figure 39: Cardiovascular Devices Market, Germany, Market Share of Major Players (%), 2020

Figure 40: Healthcare IT Market, Germany, Revenue ($B), 2017-2025

Figure 41: Healthcare IT Market, Germany, Market Share of Major Players (%), 2018

Figure 42: Orthopedic Devices Market, Germany, Revenue ($B), 2017-2025

Figure 43: Orthopedic Devices Market, Germany, Market Share of Major Players (%), 2020

Figure 44: In Vitro Diagnostics Market, Germany, Revenue ($B), 2017-2025

Figure 45: In Vitro Diagnostics Market, Germany, Market Share of Major Players (%), 2020

Figure 46: Diagnostic Market, Germany, Revenue ($B), 2015-2020

Figure 47: Diagnostic Market, Germany, Revenue ($B), 2021-2025

Figure 48: Medical Devices Market, Germany, Revenue ($B) of Major Companies, 2020

Figure 49: Deal Value and Deal Count, Pharmaceutical Market, Germany, 2020-2021

Figure 50: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, Germany, 2020-2021

Figure 51: Deal Value and Deal Count Sub-types, Pharmaceutical Market, Germany, 2020-2021

Figure 52: Top Therapy Areas by Deal Value, Pharmaceutical Market, Germany, 2020-2021

Figure 53: Top Therapy Areas by Deal Count, Pharmaceutical Market, Germany, 2020-2021

Figure 54: M&A Deals by Quarter, Pharmaceutical Market, Germany, 2020-2021 (by value and by number)

Figure 55: VC Deals by Quarter, Pharmaceutical Market, Germany, 2020-2021 (by value and by number)

Figure 56: Deal Value and Deal Count, Medical Devices Market, Germany, 2020-2021

Figure 57: Deal Value and Deal Count, Quarterly, Medical Devices Market, Germany, 2020-2021

Figure 58: Deal Value and Deal Count Sub-types, Medical Devices Market, Germany, 2020-2021

Figure 59: Top Equipment Sectors by Deal Value, Medical Devices Market, Germany, 2020-2021

Figure 60: Top Equipment Sectors by Deal Count, Medical Devices Market, Germany, 2020-2021

Figure 61: M&A Deals by Equipment Sector, Medical Devices Market, Germany, 2020-2021 (by value and by number)

Figure 62: VC Deals by Quarter, Medical Devices Market, Germany, 2020-2021 (by value and by number)

Figure 63: Digital Hubs under the Digital Initiative, Germany, 2021

Figure 64: Deal Value ($M), HealthTech, Germany, 2020-2021

Figure 65: Deal Count (Number of Deals), HealthTech, Germany, 2020-2021

Figure 66: DiGA Approval Process, Germany, 2021

Figure 67: GDPR Compliance Checklist, EU, 2021

Figure 68: Overview of Healthcare System, Germany, 2020

Figure 69: Key Reimbursement Stakeholders, Germany, 2020

Figure 70: Six-level Benefit Scale, Germany, 2020

Figure 71: Drug Reimbursement Process, Germany, 2020

Figure 72: Medical Device Reimbursement Process, Germany, 2020

Figure 73: Health Insurance Covered Population (% of population), Germany, 2020

Figure 74: Number of SHI Providers, Germany, 2013-2021

Figure 75: Additional Contribution Rate (%), Germany, 2015-2021

Figure 76: Private Health Insurance Coverage (% of population), Germany, 2015-2019

Figure 77: Out-of-Pocket Spending ($ per capita), Germany, 2012-2019

Figure 78: Health Price Index (2015 = 100), Germany, 2012-2021

Figure 79: AMNOG Process, Germany, 2020

Figure 80: Federal Institute for Drugs and Medical Devices, Organization Chart, 2021

Figure 81: Drug Authorization Procedures, EU, 2020

Figure 82: Centralized Procedure, Germany, 2020

Figure 83: Mutual Recognition Procedure, Germany, 2019

Figure 84: Decentralized Procedure, Germany, 2019

Figure 85: Generic Drug Authorization Procedures, EU, 2020

Figure 86: Biologic vs Biosimilar Approval Process, Germany, 2020

Figure 87: Conformity Assessment of Class I Medical Devices, EU, 2019

Figure 88: Conformity Assessment of Class IIa Medical Devices, EU, 2019

Figure 89: Conformity Assessment of Class IIb Medical Devices, EU, 2019

Figure 90: Conformity Assessment of Class III Medical Devices, EU, 2019

Figure 91: Patent Approval Process, Germany, 2020

Figure 92: Clinical Trial Approval Process, Germany, 2020

Figure 93: Pharmaceutical Clinical Trials Count by Trial Status, Germany, 2020-2021

Figure 94: Pharmaceutical Clinical Trials Count by Trial Status, Germany, 2020-2021

Figure 95: Pharmaceutical Clinical Trials Count by Therapy Area, Germany, 2020-2021

Figure 96: Top Five Pharmaceutical Clinical Trials Sponsors by Count, Germany, 2020-2021

Figure 97: Medical Devices Clinical Trials Count by Trial Status, Germany, 2020-2021

Figure 98: Medical Devices Clinical Trials Count by Indication, Germany, 2020-2021

Figure 99: Medical Devices Clinical Trials Count by Device Category, Germany, 2020-2021

Figure 100: Top Medical Devices Clinical Trials Sponsors by Count, Germany, 2020-2021

Figure 101: Number of Hospitals, Germany, 2011-2018

Figure 102: Number of Diagnostic Equipment Units (installed base), Germany, 2015-2020

Figure 103: Number of Hospital Beds (per 1,000 Population), Germany, 2011-2018

Figure 104: Number of Acute Care Beds (per 1,000 Population), Germany, 2011-2018

Figure 105: Number of Psychiatric Care Beds (per 1,000 Population), Germany, 2011-2018

Figure 106: Life Expectancy at Birth (Years), Germany, 2011-2018

Figure 107: Immunization Rate (% of children immunized), Germany, 2011-2018

Figure 108: PM2.5 (µg per m3), Germany, 2011-2019

Figure 109: CO2 Emissions (Mt CO2), Germany, 2011-2019

Figure 110: Physicians (per 1,000 Population), Germany, 2011-2019

Figure 111: Dentists (per 1,000 Population), Germany, 2011-2018

Figure 112: Pharmacists (per 1,000 Population), Germany, 2011-2018

Figure 113: Nurses (per 1,000 Population), Germany, 2011-2018

Figure 114: Major Causes of Mortality (number of deaths), Germany, 2019

Figure 115: Major Causes of Male Mortality (number of deaths), Germany, 2019

Figure 116: Major Causes of Female Mortality (number of deaths), Germany, 2019

Figure 117: Disability-Adjusted Life Years by Major Disease (per 100,000 population), Germany, 2019

Figure 118: Healthcare Expenditure as Percentage of GDP (%), Germany, 2011-2019

Figure 119: Healthcare Spending (Government vs. Voluntary Share), Germany, 2011-2019

Figure 120: Healthcare Expenditure Components by Function (% of Total Health Expenditure), Germany, 2018

Figure 121: Pharmaceutical Spending ($ per capita), Germany, 2011-2018

Figure 122: Opportunities and Challenges

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