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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Germany

Published By :

GlobalData

Published Date : Jun 2017

Category :

Pharmaceutical

No. of Pages : 254 Pages

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.

In 2016, Germany population was approximately at 82.2 million. The German pharmaceutical market is the largest in Europe and the third largest in the world after the US and Japan. The market value increased from €37.8 billion ($48.6 billion) in 2009 to €52.9 billion ($67.9 billion) in 2016, at a Compound Annual Growth Rate (CAGR) of 4.9%. The market value comprises revenues from drug stores and discount stores, including taxes. The value of the market is expected to reach €67.2 billion ($86.3 billion) in 2021. The medical device market was valued at $21.1 billion in 2009 and increased to $27.5 billion in 2016. It is expected to grow at a CAGR of 4.5% from $28.8 billion in 2017 to $34.4 billion in 2021. These positive trends can primarily be attributed to:

  • An increasing elderly population in Germany, leading to increases in disease incidence and prevalence as well as higher need for long-term care and medical devices
  • Increasing awareness in the medical community and the general population regarding early disease detection and diagnosis, leading to higher rates of adoption of treatments and healthcare

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 (Novartis, Sanofi, Bayer, Roche and Pfizer) and profiles and SWOT analyses of the major players in the medical device market (Johnson & Johnson, Medtronic, Baxter International and B.Braun)
  • 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 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 German 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 German healthcare market

Table of Contents
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 No table of figures entries found.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 Urban–Rural Share
6.4.3 Distribution by Age Group
6.4.4 Birth Rate
6.4.5 Mortality
6.4.6 Causes of Mortality
6.4.7 Health Status by Gender and Age
6.4.8 Education and Literacy
6.4.9 Employment
6.4.10 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 Association of Research Based Pharmaceutical Companies
6.7.2 The Federation of Pharmaceutical Manufacture
6.7.3 The Federation of Pharmaceutical Industry
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

 

List of Table

Table 1: Pharmaceutical Market, Germany, Revenue ($bn), 2009–2016
Table 2: Pharmaceutical Market, Germany, Revenue Forecast ($bn), 2017–2021
Table 3: Pharmaceutical Market, Germany, Pharmaceutical Imports and Exports ($bn), 2009–2015
Table 4: Pharmaceutical Market, Germany, Wholesale Mark-up for Proprietary Medicinal Products ($bn), 2017
Table 5: Pharmaceutical Market, Germany, Retail Pharmacy Mark-up for Proprietary Medicinal Products ($bn), 2017
Table 6: Pharmaceutical Market, Germany, Generic Pharmaceutical Market Revenue ($bn), 2009–2016
Table 7: Pharmaceutical Market, Germany, Biological Drugs in Pipeline and Approved, 2009–2015
Table 8: Pharmaceutical Market, Germany, OTC Drug Market Revenue ($bn), 2009–2016
Table 9: Pharmaceutical Market, Germany, Major OTC Drug Classes, Revenue ($m), 2015
Table 10: Pharmaceutical Market, Germany, Major Disease Areas, Total Cost of Illness ($bn), 2008
Table 11: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 12: Pharmaceutical Market, Novartis, Planned Filings, 2017–2020
Table 13: Sanofi, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 14: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2017
Table 15: Bayer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2016
Table 16: Pharmaceutical Market, Roche, Global, Revenue ($m) and Annual Growth (%) of Major Products, 2016
Table 17: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2017
Table 18: Pharmaceutical Market, Pfizer, Global, Revenue ($m) and Annual Growth (%) of Major Products, 2016
Table 19: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2017
Table 20: Medical Device Market, Germany, Revenue ($bn), 2009–2016
Table 21: Medical Device Market, Germany, Revenue Forecast ($bn), 2017–2021
Table 22: Medical Device Market, Germany, Revenue by Segment ($bn), 2016
Table 23: Ophthalmic Devices Market, Germany, Revenue ($bn), 2009–2016
Table 24: Wound Care Management Market, Germany, Revenue ($m) and Market Share (%) of Major Companies, 2012
Table 25: Orthopedic Devices Market, Germany, Revenue ($bn), 2009–2016
Table 26: Orthopedic Devices Market, Germany, Revenue ($m) and Market Share (%) of Major Companies, 2016
Table 27: Ophthalmic Devices Market, Germany, Revenue ($bn), 2009–2016
Table 28: Ophthalmic Devices Market, Germany, Revenue ($m) and Market Share (%) of Major Companies, 2015
Table 29: Cardiovascular Devices Market, Germany, Revenue of Major Players ($bn), 2009–2016
Table 30: Cardiovascular Devices Market, Germany, Revenue ($m) and Market Share (%) of Major Companies, 2015
Table 31: IVD Market, Germany, Revenue ($bn), 2009–2016
Table 32: IVD Market, Germany, Revenue ($m) and Market Share (%) of Major Companies, 2014
Table 33: Medical Device Market, Germany, Revenue ($m) and Market Share (%) of Major Companies, 2012
Table 34: Medical Device Market, Medtronic, Major Products, 2016
Table 35: Baxter International, Global, Major Products, 2017
Table 36: Market Access, Germany, Number of SHI Providers, 2009-2017
Table 37: Market Access, Germany, Out-of-Pocket Expenditure (%), 2009–2015
Table 38: Market Access, Germany, Healthcare Price Index, Annual Change (%), 2009–2016
Table 39: Market Access, Germany, Early Assessment of Drugs, 2013
Table 40: Market Access, Germany, Patent Application Fees, 2017
Table 41: Market Access, Germany, Trademark Registration Fees, 2017
Table 42: Market Access, Germany, Voluntary Harmonization Procedure, 2017
Table 43: Economic Indicators, Germany, Gross Domestic Product per Capita ($), 2009–2016
Table 44: Economic Indicators, Germany, Gross Domestic Product per Capita Forecast ($), 2017–2021
Table 45: Economic Indicators, Germany, Gross Domestic Product Annual Growth (%), 2009–2016
Table 46: Economic Indicators, Germany, Gross Domestic Product Annual Growth Forecast (%), 2017–2021
Table 47: Economic Indicators, Germany, Gross National Income per Capita ($), 2009–2016
Table 48: Economic Indicators, Germany, Average Consumer Price Index, 2009–2016
Table 49: Economic Indicators, Germany, Average Consumer Price Annual Change (%), 2009–2016
Table 50: Economic Indicators, Germany, Currency Exchange Rate (€ per $), 2009–2016
Table 51: Economic Indicators, Germany, Foreign Direct Investment ($bn), 2009–2015
Table 52: Economic Indicators, Germany, Foreign Exchange Reserves ($bn), 2009–2016
Table 53: Economic Indicators, Germany, Imports of Goods and Services ($bn), 2009–2016
Table 54: Economic Indicators, Germany, Exports of Goods and Services ($bn), 2009–2016
Table 55: Economic Indicators, Germany, Government Structural Balance ($bn), 2009–2016
Table 56: Economic Indicators, Germany, General Government Net Debt ($bn), 2009–2016
Table 57: Economic Indicators, Germany, Major Industries by Revenue ($bn), 2015
Table 58: Demographics, Germany, Population (million), 2009–2016
Table 59: Demographics, Germany, Population (million), 2017–2021
Table 60: Demographics, Germany, Urban–Rural Population Share (%), 2009–2016
Table 61: Demographics, Germany, Population Distribution by Age Group (%), 2009–2016
Table 62: Demographics, Germany, Population Distribution by Age Group Forecast (%), 2017–2021
Table 63: Demographics, Germany, Births (per 1,000 population), 2009–2016
Table 64: Demographics, Germany, Mortality (per 1,000 population), 2009–2016
Table 65: Economic Indicators, Germany, Major Causes of Mortality, 2015
Table 66: Demographics, Germany, Infant Mortality (per 1,000 live births), 2009–2016
Table 67: Demographics, Germany, Immunization Rate (%), 2009–2016
Table 68: Demographics, Germany, Major Causes of Male Mortality, 2015
Table 69: Demographics, Germany, Major Causes of Female Mortality, 2015
Table 70: Demographics, Germany, Gender Ratio (M/F), 2009–2016
Table 71: Demographics, Germany, Life Expectancy at Birth (years), 2009–2016
Table 72: Demographics, Germany, Highest Level of General Education Completed, Share (%), 2015
Table 73: Demographics, Germany, Vocational Qualification, Share (%), 2015
Table 74: Demographics, Germany, Unemployment Rate (%), 2009–2016
Table 75: Demographics, Germany, Most Frequently Diagnosed Diseases (‘000), 2015
Table 76: Demographics, Germany, Disability-Adjusted Life Years by Major Disease (‘000), 2012
Table 77: Healthcare Infrastructure, Germany, Number of Hospitals, 2009–2015
Table 78: Healthcare Infrastructure, Germany, Acute Care Hospitals (per 10,000 population), 2009–2015
Table 79: Healthcare Infrastructure, Germany, Diagnostic Equipment (per million population), 2009–2015
Table 80: Healthcare Infrastructure, Germany, Hospital Beds (per 1,000 population), 2009–2015
Table 81: Healthcare Infrastructure, Germany, Acute Care Hospital Beds (per 1,000 population), 2009–2015
Table 82: Healthcare Infrastructure, Germany, Psychiatric Hospital Beds (per 1,000 population), 2009–2015
Table 83: Healthcare Infrastructure, Germany, PM2.5 (µg per m3), 2009–2015
Table 84: Healthcare Infrastructure, Germany, CO2 Emissions (million metric tons), 2009–2015
Table 85: Healthcare Infrastructure, Germany, Healthcare Personnel (‘000), 2009–2015
Table 86: Healthcare Infrastructure, Germany, Doctors (per 1,000 population), 2009–2015
Table 87: Healthcare Infrastructure, Germany, Dentists (per 1,000 population), 2009–2015
Table 88: Healthcare Infrastructure, Germany, Pharmacists (per 1,000 population), 2009–2015
Table 89: Healthcare Infrastructure, Germany, Nurses (per 1,000 population), 2009–2015
Table 90: Healthcare Expenditure, Germany, Healthcare Expenditure as Percentage of GDP (%), 2009–2015
Table 91: Healthcare Expenditure, Germany, Public–Private Share (%), 2009–2015
Table 92: Healthcare Expenditure, Germany, Public–Private Share (%), 2015
Table 93: Healthcare Expenditure, Germany, R&D Expenditure as Percentage of GDP (%), 2009–2015
Table 94: Healthcare Expenditure, Germany, Major Healthcare Trade Fairs, 2017

 

List of Chart

Figure 1: Pharmaceutical Market, Germany, Revenue ($bn), 2009–2021
Figure 2: Medical Device Market, Germany, Revenue ($bn), 2009–2021
Figure 3: Country Profile, Germany, 2016
Figure 4: Pharmaceutical Market, Germany, Revenue ($bn), 2009–2016
Figure 5: Pharmaceutical Market, Germany, Revenue Forecast ($bn), 2017–2021
Figure 6: Pharmaceutical Market, Germany, Pharmaceutical Imports and Exports ($bn), 2009–2015
Figure 7: Pharmaceutical Market, Germany, Supply Channel, 2017
Figure 8: Pharmaceutical Market, Germany, Generic Pharmaceutical Market Revenue ($bn), 2008–2016
Figure 9: Pharmaceutical Market, Germany, Biological Drugs in Pipeline and Approved, 2009–2015
Figure 10: Pharmaceutical Market, Germany, OTC Drug Market Revenue ($bn), 2009-2016
Figure 11: Pharmaceutical Market, Germany, Major OTC Drug Classes, Revenue ($m), 2015
Figure 12: Pharmaceutical Market, Germany, Major Disease Areas, Total Cost of Illness ($bn), 2008
Figure 13: Medical Device Market, Germany, Revenue ($bn), 2009–2016
Figure 14: Medical Device Market, Germany, Revenue Forecast ($bn), 2017–2021
Figure 15: Medical Device Market, Germany, Revenue by Segment ($bn), 2016
Figure 16: Wound Care Management Market, Germany, Revenue ($bn), 2009–2016
Figure 17: Wound Care Management Market, Germany, Market Share of Major Players (%), 2012
Figure 18: Orthopedic Devices Market, Germany, Revenue ($bn), 2009–2016
Figure 19: Orthopedic Devices Market, Germany, Market Share of Major Players (%), 2016
Figure 20: Ophthalmic Devices Market, Germany, Revenue ($bn), 2009–2016
Figure 21: Ophthalmic Devices Market, Germany, Market Share of Major Players (%), 2015
Figure 22: Cardiovascular Devices Market, Germany, Revenue ($bn), 2009–2016
Figure 23: Cardiovascular Devices Market, Germany, Market Share of Major Players (%), 2015
Figure 24: IVD Market, Germany, Revenue ($bn), 2009–2016
Figure 25: IVD Market, Germany, Market Share of Major Companies (%), 2014
Figure 26: Medical Device Market, Germany, Revenue of Major Companies ($m), 2012
Figure 27: Healthcare Market, Germany, Drivers and Barriers, 2017
Figure 28: Market Access, Germany, Roles of Regulatory Bodies, 2017
Figure 29: Market Access, Germany, Reimbursement Process, 2017
Figure 30: Market Access, Germany, Number of SHI Providers, 2009-2017
Figure 31: Market Access, Germany, Out-of-Pocket Expenditure (%), 2009–2015
Figure 32: Market Access, Germany, Healthcare Price Index, Annual Change (%), 2009–2016
Figure 33: Market Access, Germany, AMNOG Reimbursement Process for Drugs, 2017
Figure 34: Market Access, Germany, Organizational Structure of BfArM, 2017
Figure 35: Market Access, Germany, Organizational Structure of PEI, 2017
Figure 36: Market Access, EU, Centralized Procedure, Market Authorization, Pre-submission Phase, 2017
Figure 37: Market Access, EU, Centralized Procedure, Market Authorization, Pre-opinion Phase, 2017
Figure 38: Market Access, EU, Centralized Procedure, Market Authorization, Post-opinion Phase, 2017
Figure 39: Market Access, EU, Decentralized Procedure, Market Authorization, 2017
Figure 40: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2017
Figure 41: Market Access, EU, Conformity Assessment of Class IIa Medical Devices, 2017
Figure 42: Market Access, EU, Conformity Assessment of Class IIb Medical Devices, 2017
Figure 43: Market Access, EU, Conformity Assessment of Class III Medical Devices, 2017
Figure 44: Market Access, Germany, Patent Approval Process, 2017
Figure 45: Market Access, Germany, Trademark Approval Process, 2017
Figure 46: Economic Indicators, Germany, Gross Domestic Product per Capita ($), 2009–2016
Figure 47: Economic Indicators, Germany, Gross Domestic Product per Capita Forecast ($), 2017–2021
Figure 48: Economic Indicators, Germany, Gross Domestic Product Annual Growth (%), 2009–2016
Figure 49: Economic Indicators, Germany, Gross Domestic Product Annual Growth Forecast (%), 2017–2021
Figure 50: Economic Indicators, Germany, Gross National Income per Capita ($), 2009–2016
Figure 51: Economic Indicators, Germany, Average Consumer Price Index, 2009–2016
Figure 52: Economic Indicators, Germany, Average Consumer Price Annual Change (%), 2009–2016
Figure 53: Economic Indicators, Germany, Currency Exchange Rate (€ per $), 2009–2016
Figure 54: Economic Indicators, Germany, Foreign Direct Investment ($bn), 2009–2015
Figure 55: Economic Indicators, Germany, Foreign Exchange Reserves ($bn), 2009–2016
Figure 56: Economic Indicators, Germany, Imports of Goods and Services ($bn), 2009–2016
Figure 57: Economic Indicators, Germany, Exports of Goods and Services ($bn), 2009–2016
Figure 58: Economic Indicators, Germany, Government Structural Balance ($bn), 2009–2016
Figure 59: Economic Indicators, Germany, General Government Net Debt ($bn), 2009–2016
Figure 60: Economic Indicators, Germany, Major Industries by Revenue ($bn), 2015
Figure 61: Demographics, Germany, Population (million), 2009–2016
Figure 62: Demographics, Germany, Population (million), 2017–2021
Figure 63: Demographics, Germany, Urban–Rural Population Share (%), 2009–2016
Figure 64: Demographics, Germany, Population Distribution by Age Group (%), 2009–2016
Figure 65: Demographics, Germany, Population Distribution by Age Group Forecast (%), 2017–2021
Figure 66: Demographics, Germany, Births (per 1,000 population), 2009–2016
Figure 67: Demographics, Germany, Mortality (per 1,000 population), 2009–2016
Figure 68: Demographics, Germany, Major Causes of Mortality, 2015
Figure 69: Demographics, Germany, Infant Mortality (per 1,000 live births), 2009–2016
Figure 70: Demographics, Germany, Immunization Rate (%), 2009–2016
Figure 71: Demographics, Germany, Major Causes of Male Mortality, 2015
Figure 72: Demographics, Germany, Major Causes of Female Mortality, 2015
Figure 73: Demographics, Germany, Gender Ratio (M/F), 2009–2016
Figure 74: Demographics, Germany, Life Expectancy at Birth (years), 2009–2016
Figure 75: Demographics, Germany, Highest Level of General Education Completed, Share (%), 2015
Figure 76: Demographics, Germany, Vocational Qualification, Share (%), 2015
Figure 77: Demographics, Germany, Unemployment Rate (%), 2009–2016
Figure 78: Demographics, Germany, Most Frequently Diagnosed Diseases (‘000), 2015
Figure 79: Demographics, Germany, Disability-Adjusted Life Years by Major Disease (‘000), 2012
Figure 80: Healthcare Infrastructure, Germany, Number of Hospitals, 2009–2015
Figure 81: Healthcare Infrastructure, Germany, Acute Care Hospitals (per 10,000 population), 2009–2015
Figure 82: Healthcare Infrastructure, Germany, Diagnostic Equipment (per million population), 2009–2015
Figure 83: Healthcare Infrastructure, Germany, Hospital Beds (per 1,000 population), 2009–2015
Figure 84: Healthcare Infrastructure, Germany, Acute Care Hospital Beds (per 1,000 population), 2009–2015
Figure 85: Healthcare Infrastructure, Germany, Psychiatric Hospital Beds (per 1,000 population), 2009–2015
Figure 86: Healthcare Infrastructure, Germany, PM2.5 (µg per m3), 2009–2015
Figure 87: Healthcare Infrastructure, Germany, CO2 Emissions (million metric tons), 2009–2015
Figure 88: Healthcare Infrastructure, Germany, Healthcare Personnel (‘000), 2009-2015
Figure 89: Healthcare Infrastructure, Germany, Physicians (per 1,000 population), 2009–2015
Figure 90: Healthcare Infrastructure, Germany, Dentists (per 1,000 population), 2009–2015
Figure 91: Healthcare Infrastructure, Germany, Pharmacists (per 1,000 population), 2009–2015
Figure 92: Healthcare Infrastructure, Germany, Nurses (per 1,000 population), 2009–2015
Figure 93: Healthcare Expenditure, Germany, Healthcare Expenditure as Percentage of GDP (%), 2009–2015
Figure 94: Healthcare Expenditure, Germany, Public–Private Share (%), 2009–2015
Figure 95: Healthcare Expenditure, Germany, Public–Private Share (%), 2015
Figure 96: Healthcare Expenditure, Germany, R&D Expenditure as Percentage of GDP (%), 2009–2015
Figure 97: Healthcare Market, Germany, Opportunities and Challenges, 2017

 

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