Report Information More information from: https://www.wiseguyreports.com/reports/33804
CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Germany Report / Search Code: WGR33804
Price
Description:
1-user PDF : $ 1995.0
Publish Date: 1 May, 2017
Site PDF : $ 3990.0
Enterprise PDF : $ 5985.0
CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Germany Summary 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
Contents:
1 Table of Contents 1 Table of Contents 2 1.1 List of Tables 4 1.2 List of Figures 6 2 Executive Summary 9 3 Introduction 14 3.1 GlobalData Report Guidance 14 4 Overview of the Pharmaceutical and Medical Device Markets 15 4.1 Pharmaceutical Market 15 4.1.1 Market Overview 15 4.1.2 Pharmaceutical Imports and Exports 17 4.1.3 Supply Channels 18 4.1.4 Market Segments 21 4.1.5 Overview of Top Five Disease Areas 25 4.1.6 Major Players 28 4.2 Medical Device Market 60 4.2.1 Market Overview 60 4.2.2 Overview of Top Five Segments 62 4.2.3 Major Players 73 4.3 Market Drivers and Barriers 96 4.3.1 Drivers 96 4.3.2 Barriers 97 5 Market Access 100 5.1 Reimbursement and Payer Landscape 100 5.1.1 Overview of Healthcare System 100 5.1.2 Reimbursement Process 101 5.1.3 Overview of Insurance Providers 104 5.1.4 Patient Share in Healthcare Spending 107 5.1.5 Price Trend in Healthcare Services 109 5.1.6 Pricing Policies 110 5.2 Regulatory Landscape 114 5.2.1 Overview of Regulatory Agencies 114 5.2.2 Market Authorization Procedure for Pharmaceutical Products 116 5.2.3 Market Authorization Procedure for Medical Devices 123 5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 127 5.2.5 Licensing Process for Pharmaceutical Exports and Imports 128 5.2.6 Intellectual Property Rights 129 5.2.7 Clinical Trial Regulations 134 5.2.8 Pharmaceutical Advertising Regulations 136 5.2.9 Pharmacy Regulations 138 5.2.10 Labeling and Packaging Regulations 138 6 Country Analysis 141 6.1 Political Environment 141 6.1.1 Political Structure 141 6.1.2 Analysis of the Current Political Environment 143 6.1.3 Healthcare Policy Initiatives 145 6.2 Economic Landscape 147 6.3 Economic Indicators 150 6.3.1 Gross Domestic Product 150 6.3.2 Gross National Income 153 6.3.3 Inflation 155 6.3.4 Currency Exchange Rate 156 6.3.5 Foreign Direct Investment 158 6.3.6 Foreign Exchange Reserves 159 6.3.7 Trade Balance 159 6.3.8 General Government Structural Balance 161 6.3.9 General Government Net Debt 163 6.3.10 Major Industries 164 6.4 Demographics 165 6.4.1 Population 165 6.4.2 Urban-Rural Share 167 6.4.3 Distribution by Age Group 168 6.4.4 Birth Rate 170
6.4.5 Mortality 171 6.4.6 Causes of Mortality 171 6.4.7 Health Status by Gender and Age 173 6.4.8 Education and Literacy 178 6.4.9 Employment 181 6.4.10 Disease Burden 181 6.5 Healthcare Infrastructure 185 6.5.1 Healthcare Facilities 185 6.5.2 Healthcare Parameters 188 6.5.3 Environmental Health 190 6.5.4 Healthcare Personnel 193 6.6 Healthcare Expenditure 197 6.6.1 Overview 197 6.6.2 Public-Private Sector Share 199 6.6.3 Major Components of Healthcare Spending 199 6.6.4 Spending in Science and Technology Research and Development 201 6.7 Trade Associations 201 6.7.1 The Association of Research Based Pharmaceutical Companies 201 6.7.2 The Federation of Pharmaceutical Manufacture 202 6.7.3 The Federation of Pharmaceutical Industry 202 6.8 Trade Fairs 203 7 Opportunities and Challenges 204 7.1 Opportunities 204 7.2 Challenges 204 8 Appendix 206 8.1 Abbreviations 206 8.2 Bibliography 211 8.3 Research Methodology 226 8.3.1 Coverage 226 8.3.2 Secondary Research 227 8.3.3 Forecasts 227 8.3.4 Expert Panel 228 8.4 Contact Us 228 8.5 Disclaimer 228 1.1 List of Tables Table 1: Pharmaceutical Market, Germany, Revenue ($bn), 2009-2016 16 Table 2: Pharmaceutical Market, Germany, Revenue Forecast ($bn), 2017-2021 17 Table 3: Pharmaceutical Market, Germany, Pharmaceutical Imports and Exports ($bn), 2009-2 1.2 List of Figures Figure 1: Pharmaceutical Market, Germany, Revenue ($bn), 2009-2021 10 Figure 2: Medical Device Market, Germany, Revenue ($bn), 2009-2021 11 Figure 3: Country Profile, Germany, 2016 13 Figure 4: Pharmaceutical Market, Germany, Revenue ($bn), 2009-2016 16 Figure 5: Pharmaceutical Market, Germany, Revenue Forecast ($bn), 2017-2021 17 Figure 6: Pharmaceutical Market, Germany, Pharmaceutical Imports and Exports ($bn), 2009-2015 18 Figure 7: Pharmaceutical Market, Germany, Supply Channel, 2017 19 Figure 8: Pharmaceutical Market, Germany, Generic Pharmaceutical Market Revenue ($bn), 20082016 22 Figure 9: Pharmaceutical Market, Germany, Biological Drugs in Pipeline and Approved, 2009-2015 23 Figure 10: Pharmaceutical Market, Germany, OTC Drug Market Revenue ($bn), 2009-2016 24 Figure 11: Pharmaceutical Market, Germany, Major OTC Drug Classes, Revenue ($m), 2015 25 Figure 12: Pharmaceutical Market, Germany, Major Disease Areas, Total Cost of Illness ($bn), 2008 26 Figure 13: Medical Device Market, Germany, Revenue ($bn), 2009-2016 61 Figure 14: Medical Device Market, Germany, Revenue Forecast ($bn), 2017-2021 62 Figure 15: Medical Device Market, Germany, Revenue by Segment ($bn), 2016 63 Figure 16: Wound Care Management Market, Germany, Revenue ($bn), 2009-2016 64 Figure 17: Wound Care Management Market, Germany, Market Share of Major Players (%), 2012 65 Figure 18: Orthopedic Devices Market, Germany, Revenue ($bn), 2009-2016 66 Figure 19: Orthopedic Devices Market, Germany, Market Share of Major Players (%), 2016 67 Figure 20: Ophthalmic Devices Market, Germany, Revenue ($bn), 2009-2016 68 Figure 21: Ophthalmic Devices Market, Germany, Market Share of Major Players (%), 2015 68 Figure 22: Cardiovascular Devices Market, Germany, Revenue ($bn), 2009-2016 70 Figure 23: Cardiovascular Devices Market, Germany, Market Share of Major Players (%), 2015 71 Figure 24: IVD Market, Germany, Revenue ($bn), 2009-2016 72
Figure 25: IVD Market, Germany, Market Share of Major Companies (%), 2014 72 Figure 26: Medical Device Market, Germany, Revenue of Major Companies ($m), 2012 73 Figure 27: Healthcare Market, Germany, Drivers and Barriers, 2017 99 Figure 28: Market Access, Germany, Roles of Regulatory Bodies, 2017 102 Figure 29: Market Access, Germany, Reimbursement Process, 2017 103 Figure 30: Market Access, Germany, Number of SHI Providers, 2009-2017 105 Figure 31: Market Access, Germany, Out-of-Pocket Expenditure (%), 2009-2015 108 Figure 32: Market Access, Germany, Healthcare Price Index, Annual Change (%), 2009-2016 110 Figure 33: Market Access, Germany, AMNOG Reimbursement Process for Drugs, 2017 114 Figure 34: Market Access, Germany, Organizational Structure of BfArM, 2017 115 Figure 35: Market Access, Germany, Organizational Structure of PEI, 2017 116 Figure 36: Market Access, EU, Centralized Procedure, Market Authorization, Pre-submission Phase, 2017 118 Figure 37: Market Access, EU, Centralized Procedure, Market Authorization, Pre-opinion Phase, 2017 119 Figure 38: Market Access, EU, Centralized Procedure, Market Authorization, Post-opinion Phase, 2017 120 Figure 39: Market Access, EU, Decentralized Procedure, Market Authorization, 2017 121 Figure 40: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2017 124 Figure 41: Market Access, EU, Conformity Assessment of Class IIa Medical Devices, 2017 125 Figure 42: Market Access, EU, Conformity Assessment of Class IIb Medical Devices, 2017 126 Figure 43: Market Access, EU, Conformity Assessment of Class III Medical Devices, 2017 127 Figure 44: Market Access, Germany, Patent Approval Process, 2017 130 Figure 45: Market Access, Germany, Trademark Approval Process, 2017 133 Figure 46: Economic Indicators, Germany, Gross Domestic Product per Capita ($), 2009-2016 150 Figure 47: Economic Indicators, Germany, Gross Domestic Product per Capita Forecast ($), 20172021 151 Figure 48: Economic Indicators, Germany, Gross Domestic Product Annual Growth (%), 2009-2016 152 Figure 49: Economic Indicators, Germany, Gross Domestic Product Annual Growth Forecast (%), 2017-2021 153 Figure 50: Economic Indicators, Germany, Gross National Income per Capita ($), 2009-2016 154 Figure 51: Economic Indicators, Germany, Average Consumer Price Index, 2009-2016 155 Figure 52: Economic Indicators, Germany, Average Consumer Price Annual Change (%), 20092016 156 Figure 53: Economic Indicators, Germany, Currency Exchange Rate (€ per $), 2009-2016 157 Figure 54: Economic Indicators, Germany, Foreign Direct Investment ($bn), 2009-2015 158 Figure 55: Economic Indicators, Germany, Foreign Exchange Reserves ($bn), 2009-2016 159 Figure 56: Economic Indicators, Germany, Imports of Goods and Services ($bn), 2009-2016 160 Figure 57: Economic Indicators, Germany, Exports of Goods and Services ($bn), 2009-2016 161 Figure 58: Economic Indicators, Germany, Government Structural Balance ($bn), 2009-2016 162 Figure 59: Economic Indicators, Germany, General Government Net Debt ($bn), 2009-2016 163 Figure 60: Economic Indicators, Germany, Major Industries by Revenue ($bn), 2015 164 Figure 61: Demographics, Germany, Population (million), 2009-2016 165 Figure 62: Demographics, Germany, Population (million), 2017-2021 166 Figure 63: Demographics, Germany, Urban-Rural Population Share (%), 2009-2016 167 Figure 64: Demographics, Germany, Population Distribution by Age Group (%), 2009-2016 168 Figure 65: Demographics, Germany, Population Distribution by Age Group Forecast (%), 20172021 169 Figure 66: Demographics, Germany, Births (per 1,000 population), 2009-2016 170 Figure 67: Demographics, Germany, Mortality (per 1,000 population), 2009-2016 171 Figure 68: Demographics, Germany, Major Causes of Mortality, 2015 172 Figure 69: Demographics, Germany, Infant Mortality (per 1,000 live births), 2009-2016 173 Figure 70: Demographics, Germany, Immunization Rate (%), 2009-2016 174 Figure 71: Demographics, Germany, Major Causes of Male Mortality, 2015 175 Figure 72: Demographics, Germany, Major Causes of Female Mortality, 2015 176 Figure 73: Demographics, Germany, Gender Ratio (M/F), 2009-2016 177 Figure 74: Demographics, Germany, Life Expectancy at Birth (years), 2009-2016 178 Figure 75: Demographics, Germany, Highest Level of General Education Completed, Share (%), 2015 179 Figure 76: Demographics, Germany, Vocational Qualification, Share (%), 2015 180 Figure 77: Demographics, Germany, Unemployment Rate (%), 2009-2016 181 Figure 78: Demographics, Germany, Most Frequently Diagnosed Diseases (‘000), 2015 182 Figure 79: Demographics, Germany, Disability-Adjusted Life Years by Major Disease (‘000), 2012 184 Figure 80: Healthcare Infrastructure, Germany, Number of Hospitals, 2009-2015 185 Figure 81: Healthcare Infrastructure, Germany, Acute Care Hospitals (per 10,000 population), 2009-2015 186
Figure 82: Healthcare Infrastructure, Germany, Diagnostic Equipment (per million population), 2009-2015 187 Figure 83: Healthcare Infrastructure, Germany, Hospital Beds (per 1,000 population), 2009-2015 188 Figure 84: Healthcare Infrastructure, Germany, Acute Care Hospital Beds (per 1,000 population), 2009-2015 189 Figure 85: Healthcare Infrastructure, Germany, Psychiatric Hospital Beds (per 1,000 population), 2009-2015 190 Figure 86: Healthcare Infrastructure, Germany, PM2.5 (Âľg per mP3P), 2009-2015 191 Figure 87: Healthcare Infrastructure, Germany, CO2 Emissions (million metric tons), 2009-2015 192 Figure 88: Healthcare Infrastructure, Germany, Healthcare Personnel (‘000), 2009-2015 193 Figure 89: Healthcare Infrastructure, Germany, Physicians (per 1,000 population), 2009-2015 194 Figure 90: Healthcare Infrastructure, Germany, Dentists (per 1,000 population), 2009-2015 195 Figure 91: Healthcare Infrastructure, Germany, Pharmacists (per 1,000 population), 2009-2015 196 Figure 92: Healthcare Infrastructure, Germany, Nurses (per 1,000 population), 2009-2015 197 Figure 93: Healthcare Expenditure, Germany, Healthcare Expenditure as Percentage of GDP (%), 2009-2015 198 Figure 94: Healthcare Expenditure, Germany, Public-Private Share (%), 2009-2015 199 Figure 95: Healthcare Expenditure, Germany, Public-Private Share (%), 2015 200 Figure 96: Healthcare Expenditure, Germany, R&D Expenditure as Percentage of GDP (%), 20092015 201 Figure 97: Healthcare Market, Germany, Opportunities and Challenges, 2017 205
wiseguyreports.com / Phone (US) + 1-646-845-9349 (UK) +44 208 133 9349