CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Germany

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

Germany is a mature healthcare market, with a strong focus on pharma R&D, production, and government policies supporting higher healthcare expenditure. In 2017, Germany spent $5,728 per capita on healthcare, which was higher than the OECD average of $4,069 per capita. In 2010, Germany had pharmaceutical sales of $39.4B. This increased to $40B in 2016. The market value is expected to reach $40.5B in 2022, growing at a Compounded Annual Growth Rate (CAGR) of 0.25%. The German medical device market was valued at $28B in 2015, which increased to $33.7B in 2020, growing at a CAGR of 3.7%.The increasing elderly population and associated disease burden are expected to drive the growth of the pharmaceutical market. However, the government initiated price-cap agreements to reduce healthcare expenditure have limited growth. The German healthcare system is characterized by universal insurance coverage, good accessibility to healthcare facilities, and adequate healthcare reimbursement. Germany offers more than 30 specialized cluster networks focusing on continuous innovation and R&D.

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 (Merck, Bayer, Pfizer, Boehringer Ingelheim and Novartis) and profiles and SWOT analyses of the major players in the medical device market (Medtronic, Fresenius, GE Healthcare, Essilor and B Braun)

• Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Germany

• Porter’s five forces analysis for pharmaceutical and medical devices market of Germany

• An insightful review of the reimbursement and regulatory landscape, of which analysis include 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 for and challenges to growth in Germany 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 Germany 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 Germany 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 Events: German Pharmaceutical History, 2011–2019

2.4 Key Events: German Pharmaceutical Market

2.5 Key Events: M&A, VF & PE Deals, Global Pharmaceutical Market, 2017–2018

2.6 Key Events: Mergers and Acquisitions

2.7 Country Profile, Germany, 2018

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 – Top Five Disease Areas

3.7 Impact of Brexit on German Pharmaceutical Market

3.8 Pharmaceutical Market – Major Players

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Device Market – Top Five Segments

4.3 Medical Device Market – Diagnostic Market

4.4 Medical Device 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, Germany

6.2 Deal Analysis: M&A, VF and PE Deals, Medical Device Market, Germany

7 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis

7.1 Pharmaceutical Market, Germany – Porter’s Five Forces Analysis

7.2 Medical Device Market, Germany – Porter’s Five Forces Analysis

8 Market Access

8.1 Overview of Healthcare System, Germany

8.2 Reimbursement Process, Germany

8.2.1 Overview of Insurance Providers (Public), Germany

8.2.2 Overview of Insurance Providers (Private), Germany

8.2.3 Healthcare Spending and Consumer Price Index, Germany

8.2.4 Pricing Policies, Germany

8.3 Regulatory Landscape, Germany

8.3.1 Market Authorization for Pharmaceutical Products, Germany

8.3.2 Market Authorization for Medical Devices, Germany

8.3.6 Intellectual Property Rights, Patent, Germany

8.3.7 Intellectual Property Rights, Trademark, Germany

8.3.8 Clinical Trial Regulation Process, Germany

8.3.9 Pharmaceutical Advertising Regulations, Germany

8.3.10 Labeling and Packaging Regulations, Germany

9 Country Healthcare Landscape

9.1 Healthcare Policy Highlights

9.2 Healthcare Facilities

9.3 Healthcare Parameters

9.4 Environmental Health

9.5 Healthcare Personnel

9.6 Disease Burden

9.7 Healthcare Expenditure

9.7.1 Healthcare Expenditure – Overview

9.7.2 Share of Public and Private Sectors

9.7.3 Major Components of Healthcare Expenditure

10 Trade Associations

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

13.1.4 Expert Panel

13.2 Bibliography

13.3 Contact Us

13.4 Disclaimer

List of Tables

Table 1: Pharmaceutical Market, Germany, Sales of Patented Drug Products by Major Therapeutic Class ($m), 2016

Table 2: Medical Device Market, Germany, Revenue by Segment ($B), 2018

Table 3: Cardiovascular Devices , Germany, Revenue ($M) and Market Share (%) of Major Companies

Table 4: IVD Market, Germany, Revenue ($M) and Market Share (%) of Major Companies

Table 5: Wound Care Management Market, Germany, Revenue ($M) and Market Share (%) of Major Companies

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

Table 7: Patent Fees, Germany, 2018

Table 8: Trademark Fees, Germany, 2018

Table 9: Requirements of Advertising of Pharmaceutical Products Through Mass Media

Table 10: Label of a Pharmaceutical Product

Table 11: Labeling and Packaging Leaflet

List of Figures

Figure 1: Pharmaceutical Market, Germany, Revenue ($B), 2010–2017

Figure 2: Medical Device Market, Germany, Revenue ($B), 2015–2020

Figure 3: Number of Deals (2018–2019)

Figure 4: 2018-19 Deal Overview By Region

Figure 5: Country Profile, Germany, 2018

Figure 6: Pharmaceutical Market, Germany, Revenue ($B), 2010–2017

Figure 7: Pharmaceutical Market, Germany, Revenue Forecast ($B), 2018–2022

Figure 8: Pharmaceutical Market, Germany, Pharmaceutical Exports

Figure 9: Pharmaceutical Market, Germany, Top Export Partners

Figure 10: Pharmaceutical Market, Germany, Pharmaceutical Imports

Figure 11: Pharmaceutical Market, Germany, Top Import Partners

Figure 12: Pharmaceutical Market, Germany, Supply Channels

Figure 13: Generics Market, Germany, Revenue ($B), 2010–2016

Figure 14: Pharmaceutical OTC Market, Germany, Revenue ($B), 2010–2017

Figure 15: Major OTC Drug Classes (Share%), Germany, 2017

Figure 16: Government Funded Biosimilars, Germany, 2017

Figure 17: Pharmaceutical Market, Germany, Sales of Patented Drug Products by Major Therapeutic Class ($B), 2016

Figure 18: Pharmaceutical Market, Major Players, Germany

Figure 19: Medical Device Market, Germany, Revenue ($B), 2015–2020

Figure 20: Medical Device Market, Germany, Revenue Forecast ($B), 2021–2025

Figure 21: Medical Device Market, Germany, Revenue by Segment ($B), 2018

Figure 22: Cardiovascular Devices Market, Germany, Revenue ($B), 2015–2022

Figure 23: Cardiovascular Devices Market, Germany, Market Share of Major Players (%)

Figure 24: IVD Market, Germany, Revenue ($B), 2015–2022

Figure 25: IVD Market, Germany, Market Share of Major Players (%)

Figure 26: Wound Care Management Market, Germany, Revenue ($B), 2015–2022

Figure 27: Wound Care Management Market, Germany, Market Share of Major Players (%)

Figure 28: Orthopedic Market, Germany, Revenue ($B), 2015–2022

Figure 29: Orthopedic Devices Market, Germany, Market Share of Major Players (%)

Figure 30: Ophthalmic Devices Market, Germany, Revenue ($B), 2015–2022

Figure 31: Ophthalmic Devices Market, Germany, Market Share of Major Players (%)

Figure 32: Diagnostic Market, Germany, Revenue ($B), 2015–2018

Figure 33:Diagnostic Market, Germany, Revenue Forecast ($B), 2019–2022

Figure 34: Medical Device Market – Major Players

Figure 35: Deal Value and Deal Count, Pharmaceutical Market,Germany, 2018–2019

Figure 36: Deal Value and Deal Count Quarterly, Pharmaceutical Market,Germany, 2018–2019

Figure 37: Deal Value and Deal Count Sub-Types, Pharmaceutical Market, Germany, 2018–2019

Figure 38: Top Five Therapy Areas by Deal Value, Pharmaceutical Market, Germany, 2018–2019

Figure 39: Top Five Therapy Areas by Deal Number, Pharmaceutical Market,Germany, 2018–2019

Figure 40: M&A Deals by Therapy Area, Pharmaceutical Market, Germany, 2018–2019(by value and by number)

Figure 41: Venture Financing Deals by Therapy Area, Pharmaceutical Market, Germany, 2018–2019(by value and by number)

Figure 42: Medical Device Market Deals, Germany, 2018–2019(by deal value, $M)

Figure 43: Medical Device Market Deals, Germany, 2018 –2019(by deal count)

Figure 44: Medical Device Market Deals Share (by deal count), Germany, 2018 – 2019

Figure 45: Medical Device Market Deals Share (by deal value), Germany, 2018 – 2019

Figure 46: Top Five Therapy Areas by Deal Value, Medical Device, Germany, 2018–2019

Figure 47: Top Five Therapy Areas by Deal Number, Medical Device, Germany, 2018–2019

Figure 48: M&A Deals by Therapy Area, Medical Device, Germany, 2018–2019 (by number)

Figure 49: Venture Financing Deals by Therapy Area, Medical Device, Germany, 2018–2019(by value and by number)

Figure 50: Private Equity Deals by Therapy Area, Medical Device

Germany, 2018–2019(By number)

Figure 51: Healthcare System, Germany, 2018

Figure 52: Regulatory Authorities, Reimbursement Process, 2018

Figure 53: Reimbursement Process, Germany, 2018

Figure 54: Number of SHI Providers , Germany, 2010–2018

Figure 55: PKV-Aging Provisions ($B), 2006-2016, Germany

Figure 56: OOP Expenditure (% of total expenditure on health)

Figure 57: Annual Rate of Change (%), Consumer Price Index

Figure 58: AMNOG – Evaluation of New Pharmaceuticals

Figure 59: Germany Pricing and Reimbursement

Figure 60: BfArM, Organization Chart, Germany, 2018

Figure 61: Requirements for Granting Market Authorization, 2018

Figure 62: Centralized Procedure, 2018

Figure 63: Decentralized Procedure, 2018

Figure 64: Mutual Recognition Procedure, 2018

Figure 65: Requirements for Registration of Biosimilars, Germany

Figure 66: Conformity Assessment of Class I Medical Devices, EU, 2018

Figure 67: Conformity Assessment of Class IIa Medical Devices, EU, 2018

Figure 68: Conformity Assessment of Class IIb Medical Devices, EU, 2018

Figure 69: Conformity Assessment of Class III Medical Devices, EU, 2018

Figure 70: Licensing Requirements for Pharmaceutical and Medical Device Manufacturing, Germany, 2018

Figure 71: European Patent Approval Process, 2018

Figure 72:Unitary Patent Approval Process, EU, 2018

Figure 73:Trademark Fees, Germany, 2018

Figure 74:Voluntary Harmonization Procedure, 2017

Figure 75: Requirements of Advertising of Pharmaceutical Products Through Mass Media

Figure 76: Label of a Pharmaceutical Product

Figure 77: Labeling and Packaging Leaflet

Figure 78: Number of Hospitals, Germany, 2009–2018

Figure 79: Diagnostic Equipment

(per 100,000 population), Germany, 2009–2015

Figure 80: Hospital Beds (per million population), Germany, 2010–2018

Figure 81: Curative Care Hospital Beds (per million population), Germany, 2010–2018

Figure 82: Psychiatric Hospital Beds (per million population), Germany, 2010–2018

Figure 83:Life Expectancy, Germany, 2010–2016

Figure 84: Immunization Rate (%), Germany, 2010–2017

Figure 85: PM2.5 (µg per m3), Germany, 2010–2016

Figure 86: CO2 Emissions (million tons), Germany, 2010–2016

Figure 87: Immunization Rate (%), Germany, 2010–2017

Figure 88: Physicians (per 1,000 population), Germany, 2009–2018

Figure 89: Dentists (per 1,000 population), Germany, 2010–2018

Figure 90: Nurses (per 1,000 population), Germany, 2010–2018

Figure 91: Pharmacists (per 1,000 population), Germany, 2010–2018

Figure 92:Major Causes of Mortality (number of deaths), Germany, 2016

Figure 93:Major Causes of Male Mortality (number of deaths), Germany, 2016

Figure 94:Major Causes of Female Mortality (number of deaths), Germany, 2016

Figure 95:Disability-Adjusted Life Years by Major Disease (thousands), Germany, 2016

Figure 96:Healthcare Expenditure as Percentage of GDP (%), Germany, 2009–2016

Figure 97:Public-Private Share (%), Germany, 2010–2017

Figure 98:Major Components of Healthcare Expenditure (%), Germany, 2016

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