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REFERENCE CODE GDHC0079CHR | PUBLICATION DATE FEBRUARY 2015

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE - GERMANY

Healthcare, Regulatory and Reimbursement Landscape - Germany 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Executive Summary

Germany has a mature healthcare market based on its high healthcare expenditure and pharmaceutical production. The increasingly elderly population and its associated disease burden are expected to drive the growth of the pharmaceutical market, while government initiatives to reduce healthcare expenditure will limit growth.

The value of the German pharmaceuticals market

increased from €XX billion ($XX billion) in 2008 to

€XX billion ($XX billion) in 2013 at a Compound

Annual Growth Rate (CAGR) of XX%. In US dollar

terms, the market declined from $XX billion in 2008

to $XX billion in 2012 at a negative CAGR of XX%

due to frequent currency devaluation. The value of

the pharmaceuticals market is expected to reach

$XX billion in 2020 from $XX billion in 2014,

increasing at a CAGR of XX% (Federal Health

Reporting, 2014c). Germany is the largest

healthcare market among the EU member states.

In 2012, healthcare expenditure in Germany was

€XX billion ($XX billion), an increase of about €XX

billion ($XX billion) compared with 2011. In 2008,

the healthcare expenditure as percentage of Gross

Domestic Product (GDP) was XX%, which

increased to an estimated XX% in 2013. In 2012,

health expenditure per capita was approximately

€XX ($XX) (Federal Health Reporting, 2014b).

The increasingly elderly population and its

associated disease have been driving the growth

of the pharmaceutical market. In 2013, the elderly

population accounted for XX% of the total

population, expected to increase at a CAGR of

XX% to XX% by 2020 (Federal Statistical Office,

2014d).

As part of the austerity measures in the eurozone,

the government is focused on reducing healthcare

expenditure by regulating reimbursement and

pricing policies through cost-benefit analysis,

Reference Pricing (RP), and analysis of the

therapeutic characteristics of medicines in an

attempt to maintain economic stability of Germany.

Furthermore, on January 1, 2011, a law on the

reorganization of the pharmaceutical market was

introduced: Arzneimittelmarkt-Neuordnungsgesetz

(AMNOG). The aim of AMNOG is to slow down

increasing drug expenditure in public health

insurance. This limits growth opportunities for the

market. In addition, the devaluation of the euro

against the US dollar due to the eurozone crisis

over the past two to three years has limited the

growth of the market in US dollar terms.



Executive Summary

Pharmaceutical Market, Germany, Revenue ($bn), 2008–2020

2008 2013 2015 2020

Rev

enue

($bn

)

CAGR (2008–2013) : XX%

Source: Federal Health Reporting, 2014c

The German medical device market was valued at

$XX billion in 2008, which increased to $XX billion

in 2013, and is expected to grow at a CAGR of

XX% from $XX billion in 2014 to $XX billion in

2020. The main segments (cardiovascular devices,

In Vitro Diagnostics (IVD) and orthopedics devices,

wound care management, and hospital supplies)

will drive market growth. The market is driven by

the following factors:

Increasing awareness regarding early disease

detection and diagnosis

Advances in medical technology

Increasingly elderly population

Medical Device Market, Germany, Revenue ($bn), 2008–2020

2008 2013 2015 2020R

even

ue ($

bn)

CAGR (2008–2013) : XX%

Source: GlobalData, Medical eTrack [Accessed December 22, 2014]

The regulatory authority provides a transparent, strong and efficient regulatory system to facilitate the approval of pharmaceutical products and medical devices, in turn attracting foreign pharmaceutical and medical device companies.

The Federal Institute for Drugs and Medical

Devices (Bundesinstitut für Arzneimittel und

Medizinische Produkte, BfArM) is the main

regulatory authority for pharmaceutical products,

working under the guidance of the Federal Ministry

of Health (Bundesministerium für Gesundheit,

BMG). The BfArM authorizes medicines based on

national procedures or on community procedures,

which are common to the member states of the EU

and are set out by the European Medicines Agency

(EMA).


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 6

1.1 List of Tables .................................................................................................................... 10

1.2 List of Figures ................................................................................................................... 15

2 Introduction ............................................................................................................................... 20

2.1 GlobalData Report Guidance ............................................................................................ 20

3 Overview of Pharmaceutical and Medical Device Market .......................................................... 21

3.1 Pharmaceutical Market ..................................................................................................... 21

3.1.1 Market Overview ........................................................................................................... 21

3.1.2 Pharmaceutical Exports and Imports ............................................................................. 24

3.1.3 Supply Channels ........................................................................................................... 25

3.1.4 Market Segments .......................................................................................................... 28

3.1.5 Major Therapeutic Areas ............................................................................................... 34

3.1.6 Major Players ................................................................................................................ 38

3.2 Medical Device Market ...................................................................................................... 80

3.2.1 Market Overview ........................................................................................................... 80

3.2.2 Overview of Top Five Segments.................................................................................... 83

3.2.3 Diagnostics Market ........................................................................................................ 97

3.2.4 Major Players ................................................................................................................ 98

3.3 Market Drivers and Barriers ............................................................................................ 134

3.3.1 Drivers......................................................................................................................... 134

3.3.2 Barriers ....................................................................................................................... 136


Table of Contents


4 Market Access ........................................................................................................................ 139

4.1 Reimbursement and Payer Landscape ........................................................................... 139

4.1.1 Overview of Healthcare system ................................................................................... 139

4.1.2 Reimbursement Process ............................................................................................. 140

4.1.3 Overview of Insurance Providers ................................................................................. 145

4.1.4 Patient Share in Healthcare Spending ......................................................................... 149

4.1.5 Price Trends in the Healthcare Sector ......................................................................... 151

4.1.6 Pricing Policies ............................................................................................................ 153

4.2 Regulatory Landscape .................................................................................................... 158

4.2.1 Overview of Regulatory Agencies................................................................................ 158

4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 159

4.2.3 New Medical Device Approval Process ....................................................................... 169

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 174

4.2.5 Exports and Imports .................................................................................................... 176

4.2.6 Intellectual Property Rights.......................................................................................... 176

4.2.7 Clinical Trial Regulations ............................................................................................. 182

4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 185

4.2.9 Pharmacy Regulations ................................................................................................ 186

4.2.10 Labeling and Packaging Regulations .......................................................................... 186

5 Country Analysis ..................................................................................................................... 189

5.1 Political Environment....................................................................................................... 189

5.1.1 Political Structure ........................................................................................................ 189

5.1.2 Analysis of Current Political Environment .................................................................... 191


Table of Contents


5.1.3 Healthcare Policy Initiatives ......................................................................................... 193

5.2 Economic Landscape ...................................................................................................... 196

5.3 Economic Indicators ........................................................................................................ 199

5.3.1 Gross Domestic Product ............................................................................................. 199

5.3.2 Gross National Income ................................................................................................ 203

5.3.3 Inflation ....................................................................................................................... 205

5.3.4 Currency Exchange Rate ............................................................................................ 208

5.3.5 Foreign Direct Investment ........................................................................................... 209

5.3.6 Foreign Exchange Reserves ....................................................................................... 211

5.3.7 Trade Balance ............................................................................................................. 212

5.3.8 Government Structural Balance................................................................................... 214

5.3.9 General Government Net Debt .................................................................................... 216

5.3.10 Major Industries ........................................................................................................... 217

5.4 Demographics ................................................................................................................. 219

5.4.1 Population ................................................................................................................... 219

5.4.2 Education and Literacy ................................................................................................ 236

5.4.3 Employment ................................................................................................................ 238

5.4.4 Disease Burden ........................................................................................................... 240

5.5 Healthcare Infrastructure ................................................................................................. 243

5.5.1 Healthcare Facilities .................................................................................................... 243

5.5.2 Healthcare Parameters ............................................................................................... 247

5.5.3 Environmental Health .................................................................................................. 250

5.5.4 Healthcare Personnel .................................................................................................. 253


Table of Contents


5.6 Healthcare Expenditure ................................................................................................... 259

5.6.1 Overview ..................................................................................................................... 259

5.6.2 Major Components of Healthcare Spending ................................................................ 261

5.6.3 Public and Private Sector Share .................................................................................. 262

5.6.4 Spending in Pharmaceutical Research and Development ........................................... 263

5.7 Trade Associations ......................................................................................................... 264

5.7.1 The Association of Research-based Pharmaceutical Companies ................................ 264

5.7.2 The Federation of Pharmaceutical Manufacture .......................................................... 264

5.7.3 The Federation of Pharmaceutical Industry ................................................................. 265

5.8 Trade Fairs ..................................................................................................................... 266

6 Opportunities and Challenges ................................................................................................. 267

6.1 Opportunities .................................................................................................................. 267

6.2 Challenges ...................................................................................................................... 267

7 Appendix................................................................................................................................. 269

7.1 Abbreviations .................................................................................................................. 269

7.2 Bibliography .................................................................................................................... 275

7.3 Research Methodology ................................................................................................... 294

7.3.1 Coverage .................................................................................................................... 294

7.3.2 Secondary Research ................................................................................................... 295

7.3.3 Forecasts .................................................................................................................... 295

7.3.4 Expert Panel................................................................................................................ 295

7.4 Disclaimer ....................................................................................................................... 296


Table of Contents


1.1 List of Tables

Table 1: Pharmaceutical Market, Germany, Revenue ($bn), 2008–2013 ................................................... 22

Table 2: Pharmaceutical Market, Germany, Revenue Forecast ($bn), 2014–2020 ..................................... 23

Table 3: Pharmaceutical Market, Germany, Exports and Imports ($bn), 2008–2013 .................................. 24

Table 4: Pharmaceutical Market, Germany, Wholesale Mark-up for Proprietary Medicinal Products, 2014 . 27

Table 5: Pharmaceutical Market, Germany, Pharmacy Mark-up for Proprietary Medicinal Products, 2014 . 28

Table 6: Pharmaceutical Market, Germany, Generic Pharmaceutical Market Share (%), 2008–2013 ......... 29

Table 7: Pharmaceutical Market, Germany Drugs Going Off-patent, Global, 2014–2015 ........................... 30

Table 8: Pharmaceutical Market, Germany, Biological Drugs in Pipeline, 2008–2013 ................................ 31

Table 9: Pharmaceutical Market, Germany, OTC Drug Market Revenue ($bn), 2008–2013 ....................... 32

Table 10: Pharmaceutical Market, Germany, Major OTC Drug Classes, Revenue and Share, 2013 ............ 33

Table 11: Pharmaceutical Market, Germany, Major Disease Areas, Total Cost of Illness ($bn), 2008 .......... 35

Table 12: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%),

2013............................................................................................................................................ 39

Table 13: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014–2018 ........................................ 40

Table 14: Pharmaceutical Market, Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%),

2013............................................................................................................................................ 50

Table 15: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 ............................................... 51

Table 16: Pharmaceutical Market, Teva, Global Revenue of Major Products, 2013 ..................................... 59

Table 17: Pharmaceutical Market, Teva, Late-Stage Pipeline, 2013 ............................................................ 59

Table 18: Pharmaceutical Market, Teva, Global, Major Products, 2013 ....................................................... 61

Table 19: Pharmaceutical Market, Sanofi, Global, Major Products, 2013 ..................................................... 66

Table 20: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014 ............................................... 67

Table 21: Pharmaceutical Market, F. Hoffmann-La Roche, Global, Major Products, Revenue ($m) and

Annual Growth (%), 2013 ............................................................................................................ 72


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Table 22: Pharmaceutical Market, F. Hoffmann-La Roche, Global, Late-stage Pipeline, 2013 ..................... 73

Table 23: Medical Device Market, Germany, Revenue ($bn), 2008–2013 .................................................... 81

Table 24: Medical Device Market, Germany, Revenue Forecast ($bn), 2014–2020 ..................................... 82

Table 25: Medical Device Market, Germany, Revenue by Segment, 2013 ................................................... 83

Table 26: Medical Device Market, Germany, Cardiovascular Device Market ($m), 2008–2013 .................... 85

Table 27: Medical Device Market, Germany, Cardiovascular Device Market, Sales Trend for Major Players,

2012............................................................................................................................................ 86

Table 28: Medical Device Market, Germany, IVD Market ($m), 2008–2013 ................................................. 88

Table 29: Medical Device Market, Germany, IVD Market, Sales Trend for Major Players, 2012 ................... 89

Table 30: Medical Device Market, Germany, Orthopedic Device Market ($m), 2008–2013........................... 90

Table 31: Medical Device Market, Germany, Orthopedic Device Market, Sales Trend for Major Players, 2012

................................................................................................................................................... 91

Table 32: Medical Device Market, Germany, Wound Care Management Market ($m), 2008–2013 .............. 93

Table 33: Medical Device Market, Germany, Wound Care Management Market, Sales Trend for Major

Players ($m), 2012 ...................................................................................................................... 94

Table 34: Medical Device Market, Germany, Hospital Supplies Market ($m), 2008–2013 ............................ 95

Table 35: Medical Device Market, Germany, Hospital Supplies Market, Sales Trend for Major Players ($m),

2012............................................................................................................................................ 96

Table 36: Medical Device Market, Germany, Diagnostics Market, Revenue ($bn), 2008–2013 .................... 97

Table 37: Medical Device Market, Germany, Diagnostic Market Revenue, Forecast ($bn), 2014–2020 ........ 98

Table 38: Medical Device Market, Germany, Major Medical Device Companies, Revenue, 2012 ................. 99

Table 39: Medical Device Market, Medtronic, Global, Major Products, 2013 .............................................. 101

Table 40: Medical Device Market, F. Hoffmann-La Roche, Global, Major Products, 2014 .......................... 115

Table 41: Medical Device Market, Philips Healthcare, Global, Major Products, 2013 ................................. 121

Table 42: Medical Device Market, Abbott, Global, Major Products, 2013 ................................................... 127


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Table 43: Medical Device Market, Abbott, Global, Late-Stage Pipeline, 2014 ............................................ 127

Table 44: Market Access, Germany, Reimbursement Rates by Age, 2014 ................................................ 144

Table 45: Market Access, Germany, Number of SHI Providers, 2008–2013............................................... 146

Table 46: Healthcare Spending, Germany, Out-of-Pocket Expenditure (%), 2008–2013 ............................ 150

Table 47: Healthcare Spending, Germany, Out-of-Pocket Expenditure (%), 2008–2013 ............................ 151

Table 48: Market Access, Germany, Prescription Drug Prices, Annual Change (%), 2008–2013 ............... 152

Table 49: Market Access, Germany, Healthcare Price Index, Annual Change (%), 2008–2013 .................. 153

Table 50: Market Access, Germany, Early Assessment of Drugs, 2013 ..................................................... 157

Table 51: Market Access, Germany, Patent Application Fees, 2014 .......................................................... 177

Table 52: Market Access, Germany, Trademark Registration Fees, 2014 .................................................. 179

Table 53: Market Access, Germany, Voluntary Harmonization Procedure, 2014 ........................................ 184

Table 54: Economic Indicators, Germany, Gross Domestic Product per Capita ($), 2008–2013 ................. 200

Table 55: Economic Indicators, Germany, Gross Domestic Product per Capita ($) Forecast, 2014–2020 .. 201

Table 56: Economic Indicators, Germany, Gross Domestic Product Annual Growth (%), 2008–2013 ......... 202

Table 57: Economic Indicators, Germany, Gross Domestic Product Annual Growth Forecast (%), 2014–2020

................................................................................................................................................. 203

Table 58: Economic Indicators, Germany, Gross National Income per Capita ($), 2008–2013 ................... 204

Table 59: Economic Indicators, Germany, Average Consumer Price Index, 2008–2013 ............................ 206

Table 60: Economic Indicators, Germany, Average Consumer Price Index Forecast, 2014–2020 .............. 206

Table 61: Economic Indicators, Germany, Average Consumer Price Annual Change (%), 2008–2013....... 207

Table 62: Economic Indicators, Germany, Currency Exchange Rate (€/$), 2008–2013 .............................. 209

Table 63: Economic Indicators, Germany, Foreign Direct Investment ($bn), 2008–2013 ............................ 210

Table 64: Economic Indicators, Germany, Foreign Exchange Reserves ($bn), 2008–2013 ........................ 211

Table 65: Economic Indicators, Germany, Imports of Goods and Services ($bn), 2008–2013 .................... 213

Table 66: Economic Indicators, Germany, Exports of Goods and Services ($bn), 2008–2013 .................... 214


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Table 67: Economic Indicators, Germany, Government Structural Balance ($bn), 2008–2013 ................... 215

Table 68: Economic Indicators, Germany, General Government Net Debt ($bn), 2008–2013 .................... 216

Table 69: Economic Indicators, Germany, General Government Net Debt ($bn) Forecast, 2014–2020 ...... 217

Table 70: Economic Indicators, Germany, Major Industries, Gross Value Added ($bn), 2013 .................... 218

Table 71: Demographics, Germany, Population (million), 2008–2013 ........................................................ 220

Table 72: Demographics, Germany, Population (million) Forecast, 2014–2020 ......................................... 221

Table 73: Demographics, Germany, Population, Urban and Rural Population Share (%), 2008–2013 ........ 222

Table 74: Demographics, Germany, Population Distribution by Age Group (%), 2008–2013 ...................... 223

Table 75: Demographics, Germany, Population Distribution by Age Group Forecast (%), 2014–2020........ 224

Table 76: Demographics, Germany, Births (per 1,000 Population), 2008–2013 ......................................... 225

Table 77: Demographics, Germany, Mortality (per 1,000 Population), 2008–2013 ..................................... 226

Table 78: Demographics, Germany, Major Causes of Mortality (‘000), 2013 .............................................. 228

Table 79: Demographics, Germany, Children ≤5 Years, Mortality Rate (per 1,000 Live Births), 2008–2013229

Table 80: Demographics, Germany, Major Causes of Male Mortality (‘000), 2013 ..................................... 230

Table 81: Demographics, Germany, Major Causes of Female Mortality (‘000), 2013 ................................. 232

Table 82: Demographics, Germany, Immunization Rate (%), 2008–2013 .................................................. 233

Table 83: Demographics, Germany, Gender Ratio (Male/Female), 2008–2013 ......................................... 234

Table 84: Demographics, Germany, Life Expectancy at Birth (Years), 2006–2011 ..................................... 235

Table 85: Demographics, Germany, Highest Level of General Education Completed, Share (%), 2013 ..... 237

Table 86: Demographics, Germany, Vocational Qualification, Share (%), 2013 ......................................... 238

Table 87: Demographics, Germany, Unemployment Rate (%), 2008–2013 ............................................... 239

Table 88: Demographics, Germany, Most Frequently Diagnosed Diseases, Patients (‘000), 2012 ............. 241

Table 89: Demographics, Germany, Major Diseases, DALY (Per 100,000 Population), 2004 ..................... 242

Table 90: Healthcare Infrastructure, Germany, Hospitals, 2008–2013 ....................................................... 244


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Table 91: Healthcare Infrastructure, Germany, Acute Care Hospitals (per 100,000 Population), 2008–2013

................................................................................................................................................. 245

Table 92: Healthcare Infrastructure, Germany, Diagnostic Equipment# (Units per Million Population), 2008–

2013.......................................................................................................................................... 246

Table 93: Healthcare Infrastructure, Germany, Hospital Beds (per 1,000 Population), 2008–2013 ............. 247

Table 94: Healthcare Infrastructure, Germany, Acute Care Hospitals Beds (per 1,000 Population), 2008–

2013.......................................................................................................................................... 249

Table 95: Healthcare Infrastructure, Germany, Psychiatric Hospital Beds (per 1,000 Population), 2008–2013

................................................................................................................................................. 250

Table 96: Healthcare Infrastructure, Germany, PM10 (µg/m3), 2008–2013 ................................................ 251

Table 97: Healthcare Infrastructure, Germany, CO2 (in million tons), 2008–2013 ....................................... 252

Table 98: Healthcare Infrastructure, Germany, Full-Time Healthcare Personnel (‘000), 2008–2013 ........... 254

Table 99: Healthcare Infrastructure, Germany, Physicians (per 1,000 Population), 2008–2013 .................. 256

Table 100: Healthcare Infrastructure, Germany, Dentists (per 1000 population), 2008–2013 ....................... 257

Table 101: Healthcare Infrastructure, Germany, Pharmacist (Per 1,000 Population), 2008–2013................. 258

Table 102: Healthcare Infrastructure, Germany, Nurses (per 1,000 Population), 2008–2013 ....................... 259

Table 103: Healthcare Infrastructure, Germany, Healthcare Expenditure (% of GDP), 2008–2013 ............... 260

Table 104: Healthcare Infrastructure, Germany, Healthcare Expenditure, Major Component Share (%), 2012

................................................................................................................................................. 261

Table 105: Healthcare Infrastructure, Germany, Healthcare Expenditure, Public–Private Share (%), 2008–

2013.......................................................................................................................................... 262

Table 106: Healthcare Infrastructure, Germany, Research and Development Expenditure ($bn), 2008–2013

................................................................................................................................................. 263

Table 107: Major Healthcare Trade Fairs, Germany, 2015 .......................................................................... 266


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1.2 List of Figures

Figure 1: Pharmaceutical Market, Germany, Revenue ($bn), 2008–2013 ................................................... 22

Figure 2: Pharmaceutical Market, Germany, Revenue Forecast ($bn), 2014–2020 ..................................... 23

Figure 3: Pharmaceutical Market, Germany, Exports and Imports ($bn), 2008–2013 .................................. 24

Figure 4: Pharmaceutical Market, Germany, Supply Channel, 2010............................................................ 26

Figure 5: Pharmaceutical Market, Germany, Generic Pharmaceutical Market Share (%), 2008–2013 ......... 29

Figure 6: Pharmaceutical Market, Germany, Biological Drugs in Pipeline, 2008–2013 ................................ 31

Figure 7: Pharmaceutical Market, Germany, OTC Drug Market Revenue ($bn), 2008–2013 ....................... 32

Figure 8: Pharmaceutical Market, Germany, Major OTC Drug Classes, Revenue ($m), 2013 ..................... 33

Figure 9: Pharmaceutical Market, Germany, Major Disease Areas, Total Cost of Illness ($bn), 2008 .......... 34

Figure 10: Medical Device Market, Germany, Revenue ($bn), 2008–2013 .................................................... 81

Figure 11: Medical Device Market, Germany, Revenue Forecast ($bn), 2014–2020 ..................................... 82

Figure 12: Medical Device Market, Germany, Revenue by Segment ($bn), 2013 .......................................... 83

Figure 13: Medical Device Market, Germany, Cardiovascular Device Market ($m), 2008–2013 .................... 85

Figure 14: Medical Device Market, Germany, Cardiovascular Device Market, Sales Trend for Major Players,

2008–2012 .................................................................................................................................. 86

Figure 15: Medical Device Market, Germany, IVD Market ($m), 2008–2013 ................................................. 87

Figure 16: Medical Device Market, Germany, IVD Market, Sales Trend for Major Players, 2008–2012.......... 88

Figure 17: Medical Device Market, Germany, Orthopedic Device Market ($m), 2008–2013........................... 90

Figure 18: Medical Device Market, Germany, Orthopedic Device Market, Sales Trend for Major Players,

2008–2012 .................................................................................................................................. 91

Figure 19: Medical Device Market, Germany, Wound Care Management Market ($m), 2008–2013 .............. 92

Figure 20: Medical Device Market, Germany, Wound Care Management Market, Sales Trend for Major

Players ($m), 2008–2012 ............................................................................................................ 93

Figure 21: Medical Device Market, Germany, Hospital Supplies Market ($m), 2008–2013 ............................ 95


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Figure 22: Medical Device Market, Germany, Hospital Supplies Market, Sales Trend for Major Players ($m),

2008–2012 .................................................................................................................................. 96

Figure 23: Medical Device Market, Germany, Diagnostics Market, Revenue ($bn), 2008–2013 .................... 97

Figure 24: Medical Device Market, Germany, Diagnostic Market Revenue, Forecast ($bn), 2014–2020 ........ 98

Figure 25: Medical Device Market, Germany, Major Medical Device Companies, Revenue ($m), 2012 ......... 99

Figure 26: Healthcare Market, Germany, Drivers and Barriers, 2014 .......................................................... 138

Figure 27: Market Access, Germany, Roles of Regulatory Bodies, 2014 ..................................................... 142

Figure 28: Market Access, Germany, Reimbursement Process, 2014 ......................................................... 143

Figure 29: Market Access, Germany, Number of SHI Providers, 2008–2013............................................... 146

Figure 30: Healthcare Spending, Germany, Out-of-Pocket Expenditure (%), 2008–2013 ............................ 149

Figure 31: Market Access, Germany, Prescription Drug Prices, Annual Change (%), 2008–2013 ............... 152

Figure 32: Market Access, Germany, Healthcare Price Index, Annual Change (%), 2008–2013 .................. 153

Figure 33: Market Access, Germany, AMNOG Reimbursement Process for Drugs, 2014 ........................... 157

Figure 34: Market Access, Germany, Organizational Structure of BfArM, 2014 ........................................... 158

Figure 35: Market Access, Germany, Organizational Structure of PEI, 2014 ............................................... 159

Figure 36: Market Access, EU, Centralized Procedure for Market Authorization, Pre-Submission, 2012 ..... 162

Figure 37: Market Access, EU, Centralized Procedure, Market Authorization, Pre-Opinion Phase, 2012 ..... 163

Figure 38: Market Access, EU, Centralized Procedure, Market Authorization, Post-Opinion Phase, 2012 ... 164

Figure 39: Market Access, EU, Decentralized Procedure, Market Authorization, 2012 ................................ 166

Figure 40: Market Access, EU, Mutual Recognition Procedure, Market Authorization, 2012 ........................ 167

Figure 41: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2014 .......................... 171

Figure 42: Market Access, EU, Conformity Assessment of Class IIa Medical Devices, 2014 ....................... 172

Figure 43: Market Access, EU, Conformity Assessment of Class IIb Medical Devices, 2014 ....................... 173

Figure 44: Market Access, EU, Conformity Assessment of Class III Medical Devices, 2014 ........................ 174

Figure 45: Market Access, Germany, Patent Approval Process, 2014......................................................... 178


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Figure 46: Market Access, Germany, Trademark Approval Process, 2014 .................................................. 181

Figure 47: Economic Indicators, Germany, Gross Domestic Product Per Capita ($), 2008–2013 ................ 200

Figure 48: Economic Indicators, Germany, Gross Domestic Product per Capita ($) Forecast, 2014–2020 .. 201

Figure 49: Economic Indicators, Germany, Gross Domestic Product Annual Growth (%), 2008–2013 ......... 202

Figure 50: Economic Indicators, Germany, Gross Domestic Product Annual Growth Forecast (%), 2014–2020

................................................................................................................................................. 203

Figure 51: Economic Indicators, Germany, Gross National Income per Capita ($), 2008–2013 ................... 204

Figure 52: Economic Indicators, Germany, Average Consumer Price Index, 2008–2013 ............................ 205

Figure 53: Economic Indicators, Germany, Average Consumer Price Index Forecast, 2014–2020 .............. 206

Figure 54: Economic Indicators, Germany, Average Consumer Price Annual Change (%), 2008–2013....... 207

Figure 55: Economic Indicators, Germany, Currency Exchange Rate (€/$), 2008–2013 .............................. 209

Figure 56: Economic Indicators, Germany, Foreign Direct Investment ($bn), 2008–2013 ............................ 210

Figure 57: Economic Indicators, Germany, Forex Reserve ($bn), 2008–2013 ............................................. 211

Figure 58: Economic Indicators, Germany, Imports of Goods and Services ($bn), 2008–2013 .................... 212

Figure 59: Economic Indicators, Germany, Exports of Goods and Services ($bn), 2008–2013 .................... 214

Figure 60: Economic Indicators, Germany, Government Structural Balance ($bn), 2008–2013 ................... 215

Figure 61: Economic Indicators, Germany, General Government Net Debt ($bn), 2008–2013 .................... 216

Figure 62: Economic Indicators, Germany, General Government Net Debt ($bn) Forecast, 2014–2020 ...... 217

Figure 63: Economic Indicators, Germany, Major Industries, Gross Value Added ($bn), 2013 .................... 218

Figure 64: Demographics, Germany, Population (million), 2008–2013 ........................................................ 220

Figure 65: Demographics, Germany, Population (million) Forecast, 2014–2020 ......................................... 221

Figure 66: Demographics, Germany, Urban-Rural Population Share (%), 2008–2013 ................................. 222

Figure 67: Demographics, Germany, Population Distribution by Age Group (%), 2008–2013 ...................... 223

Figure 68: Demographics, Germany, Population Distribution by Age Group (%) Forecast, 2014–2020........ 224

Figure 69: Demographics, Germany, Births (per 1,000 Population), 2008–2013 ......................................... 225


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Figure 70: Demographics, Germany, Mortality (per 1,000 Population), 2008–2013 ..................................... 226

Figure 71: Demographics, Germany, Major Causes of Mortality (‘000), 2013 .............................................. 227

Figure 72: Demographics, Germany, Children ≤5 Years, Mortality Rate (per 1,000 Live Births), 2008–2013229

Figure 73: Demographics, Germany, Major Causes of Male Mortality (‘000), 2013 ..................................... 230

Figure 74: Demographics, Germany, Major Causes of Female Mortality (‘000), 2013 ................................. 231

Figure 75: Demographics, Germany, Immunization Rate (%), 2008–2013 .................................................. 233

Figure 76: Demographics, Germany, Gender Ratio (Male/Female), 2008–2013 ......................................... 234

Figure 77: Demographics, Germany, Life Expectancy at Birth (Years), 2006–2011 ..................................... 235

Figure 78: Demographics, Germany, Highest Level of General Education Completed, Share (%), 2013 ..... 237

Figure 79: Demographics, Germany, Vocational Qualification, Share (%), 2013 ......................................... 238

Figure 80: Demographics, Germany, Unemployment Rate (%), 2008–2013 ............................................... 239

Figure 81: Demographics, Germany, Most Frequently Diagnosed Diseases (‘000), 2012 ............................ 240

Figure 82: Demographics, Germany, Major Diseases, DALY (Per 100,000 Population), 2004 ..................... 242

Figure 83: Healthcare Infrastructure, Germany, Hospitals, 2008–2013 ....................................................... 244

Figure 84: Healthcare Infrastructure, Germany, Acute Care Hospitals (per 100,000 Population), 2008–2013

................................................................................................................................................. 245

Figure 85: Healthcare Infrastructure, Germany, Diagnostic Equipment# (Units per Million Population), 2008–

2013.......................................................................................................................................... 246

Figure 86: Healthcare Infrastructure, Germany, Hospital Beds (per 1,000 Population), 2008–2013 ............. 247

Figure 87: Healthcare Infrastructure, Germany, Acute Care Hospital Beds (per 1,000 Population), 2008–2013

................................................................................................................................................. 248

Figure 88: Healthcare Infrastructure, Germany, Psychiatric Hospital Beds (per 1,000 Population), 2008–2013

................................................................................................................................................. 249

Figure 89: Healthcare Infrastructure, Germany, PM10 (µg/m3), 2008–2013 ................................................ 251

Figure 90: Healthcare Infrastructure, Germany, CO2 (in Million Tons), 2008–2013 ...................................... 252


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Figure 91: Healthcare Infrastructure, Germany, Full-Time Healthcare Personnel (‘000), 2008–2013 ........... 254

Figure 92: Healthcare Infrastructure, Germany, Physicians (per 1,000 Population), 2008–2013 .................. 255

Figure 93: Healthcare Infrastructure, Germany, Dentists (per 1,000 Population), 2008–2013 ...................... 256

Figure 94: Healthcare Infrastructure, Germany, Pharmacist s (per 1,000 Population), 2008–2013 .............. 257

Figure 95: Healthcare Infrastructure, Germany, Nurses (per 1,000 Population), 2008–2013 ....................... 258

Figure 96: Healthcare Infrastructure, Germany, Healthcare Expenditure (% of GDP), 2008–2013 ............... 260

Figure 97: Healthcare Infrastructure, Germany, Healthcare Expenditure, Major Component Share (%), 2012

................................................................................................................................................. 261

Figure 98: Healthcare Infrastructure, Germany, Healthcare Expenditure, Public–Private Share (%), 2008–

2013.......................................................................................................................................... 262

Figure 99: Healthcare Infrastructure, Germany, Research and Development Expenditure ($bn), 2008–2013

................................................................................................................................................. 263

Figure 100: Healthcare Market, Germany, Opportunities and Challenges, 2014 ........................................... 268



Introduction

2 Introduction

2.1 GlobalData Report Guidance

The report begins with an executive summary, which provides an overview of the healthcare

market in Germany and the key factors driving its development. It also includes a snapshot of

the country’s demographic, regulatory, and reimbursement landscape, as well as its healthcare

infrastructure.

Chapter three provides an overview of the pharmaceutical and medical device markets in

Germany, covering market size; generic, Over-The-Counter (OTC) and biologic/biosimilar

product shares; and key drivers and barriers. It also includes profiles for major players in the

country’s healthcare market, as well as SWOT assessments for each.

Chapter four covers the reimbursement and payer landscape, and provides details of the

reimbursement process, insurance providers, pricing policies and drug price trends in

Germany. It also looks at the regulatory landscape and provides an overview of the regulatory

agencies and approval processes for new drugs and medical devices. In addition, this chapter

covers the licensing process for the manufacture, export and import of pharmaceuticals, details

the regulations in place for pharmaceutical advertising, labeling, packaging, and clinical trials,

and provides an overview of the country’s legal framework for intellectual property rights.

Chapter five provides detailed analysis of the political and economic environment in Germany,

as well as economic indicators, demographics, and healthcare infrastructure and expenditure.

Chapter six provides an overview of the opportunities for and challenges facing the growth of

the healthcare market.


Overview of Pharmaceutical and Medical Device Market


3.1.2 Pharmaceutical Exports and Imports

The value of pharmaceutical exports in Germany amounted to approximately $XX billion in 2008,

which increased to approximately $XX billion in 2013. In 2008, the value of pharmaceutical imports

amounted to approximately $XX billion, which declined to approximately $XX billion in 2013. The

country’s major pharmaceutical import partners in 2013 were Switzerland (XX%), the US (XX%),

Netherlands (XX%), France (XX%) and Italy (XX%) (GPIA, 2014).

Figure 3: Pharmaceutical Market, Germany, Exports and Imports ($bn), 2008–2013

2008 2009 2010 2011 2012 2013

Rev

enue

($bn

)

Exports

Imports

Source: GPIA, 2014

Table 3: Pharmaceutical Market, Germany, Exports and Imports ($bn), 2008–2013 Year 2008 2009 2010 2011 2012 2013

Exports

Imports

Source: GPIA, 2014


Country Analysis


5.4.2 Education and Literacy

Germany is known for its world-class education system. German universities offer proficient

research, teaching and training facilities. The Max Planck Society in Germany has approximately

80 institutes dedicated to fundamental research in fields such as biology, medicine, chemistry,

physics and the humanities. Many research associations, such as the Fraunhofer Association, the

Helmholtz Association and the Leibniz Association, work closely with universities and the

healthcare industry to conduct advanced research and to discover new products. Due to its

reputable education and research facilities, students from all over the world attend German

universities.

In 2013, approximately XX% of the German population over XX years of age had a secondary

school-leaving certificate, XX% was university-entrance qualified, and XX% had an intermediate

school-leaving certificate.

In 2014, the education expenditure was €XX 6billion ($XX billion), which was €XX billion ($XX

billion) more than 2013 (Federal Statistical Office, 2014r).

Based on the level-lone survey in 2011, it was found that XX million people in Germany can read or

write single words but can’t write entire sentences. In 2012, the Federal Ministry of Education and

Research (BMBF) and Conference of Ministers of Education and Cultural Affairs announced a joint

national strategy for the basic education of the German people.

BMBF has also started many new initiatives for the development of literacy and education, with

funding of €XXm ($XXm) in the 2012–2015 period (Federal Statistical Office, 2014s).


Country Analysis


Figure 78: Demographics, Germany, Highest Level of General Education Completed, Share (%), 2013

Secondary general school-leaving certif icate

Fachhochschule/university entrance

qualif ication

Intermediate school-leaving certif icate

Certif icate of tenth-grade school of general education

in the former GDR

No secondary general school-leaving certif icate

Presently attending school

Type of general qualif ication not specif ied

Source: Federal Statistical Office, 2014s

Table 85: Demographics, Germany, Highest Level of General Education Completed, Share (%), 2013 Level of general education Share

Secondary general school-leaving certificate

Fachhochschule/university entrance qualification

Intermediate school-leaving certificate

Certificate of tenth-grade school of general education in the former GDR

No secondary general school-leaving certificate

Presently attending school

Type of general qualification not specified

Source: Federal Statistical Office, 2014s



Appendix

7 Appendix

7.1 Abbreviations

AI: Aromatase Inhibitor

AIDS: Acquired Immune Deficiency Syndrome

ALK+: Anaplastic Lymphoma Kinase Positive

AMG: German Medicines Act (Arzneimittelgesetz)

AMNOG: Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz)

AOK: Local Health Insurance Fund (Allgemeine Ortskrankenkassen)

API: Active Pharmaceutical Ingredient

BAH: Federation of Pharmaceutical Manufacture (Der Bundesverband der Arzneimittel-

Hersteller)

BfArM: Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel

und Medizinische Produkte)

BKK: Company Health Insurance Funds (Betriebskrankenkassen)

BMBF: Federal Ministry of Education and Research

BMELV: Federal Office of Consumer Protection and Food Safety (Das Bundesministerium

für Ernährung, Landwirtschaft und Verbraucherschutz)

BMG: Bundesministerium für Gesundheit (Federal Ministry of Health)

BPI: Federation of Pharmaceutical Industry (Der Bundesverband der Pharmazeutischen

Industrie)

BWE: German Wind Energy Association (Der Bundesverband WindEnergie e.V.)

CA: Conformity Assessment

CAGR: Compound Annual Growth Rate

CDI: Centrist Democrat International

CDRM: Cardiac Rhythm Disease Management



Appendix

CDU: Christian Democratic Union

CE: Conformité Européenne

CHMP: Committee for Medicinal Products for Human use

CMS: Concerned Member State

CMV: Cytomegalovirus

CNS: Central Nervous System

CO2: Carbon dioxide

COPD: Chronic Obstructive Pulmonary Disease

CPS: Counts Per Second

CRL: Complete Response Letter

CSU: Christian Social Union

CT: Computed Tomography

CTFG: Clinical Trials Facilitation Group

CVD: Cardiovascular Disease

DALY: Disability Adjusted Life Years

DEA: Drug Enforcement Administration

DHHS: Department of Health and Human Services

DKG: German Hospital Federation (Deutsche Krankenhausgesellschaft)

DPMA: German Patent and Trademark Office (Deutsches Patent und Markenamt)

DPT: Diphtheria, Pertussis and Tetanus

DR: Digital Radiography

EFSF: European Financial Stability Facility

EGFR: Epidermal Growth Factor Receptor

EK: Substitute Fund (Ersatzkassen)



Appendix

EMA: European Medicines Agency

ENT: Ear, Nose and Throat

EPP: European People Party

ER: Estrogen Receptor

EU: European Union

FDP: Free Democratic Party

forex: Foreign exchange

G-BA: Federal Joint Committee (Gemeinsamer Bundesausschuss)

GDP: Gross Domestic Product

GERD: Gastroesophageal Reflux Disease

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GNI: Gross National Income

GP: General Practitioner

gRED: Genentech Research and Early Development

GRMC: Georgia Regents Medical Center

HeFH: Heterozygous Familial Hypercholesterolemia

HER2: Human Epidermal growth factor Receptor 2

HIPAA: Health Insurance Portability & Accountability Act

HIV: Human Immunodeficiency Virus

HTA: Health Technology Assessment

HWG: Drug Advertising Law (Heilmittelwerbegesetz)

ICD: Implantable Cardioverter Defibrillator

ICH: International Conference on Harmonization



Appendix

IDU: International Democrat Union

IKK: Guild Health Insurance Funds (Innungskrankenkassen)

IMF: International Monetary Fund

INN: International Non-proprietary Name

IQWiG: Institute for Quality and Efficiency in Healthcare (Institut für Qualität und

Wirtschaftlichkeit im Gesundheitswesen)

ISO: International Standard Organization

IVD: In Vitro Diagnostics

KBS: Miners’, Rail and Maritime Insurance Institutions (Knappschaft-Bahn-See)

LIS: Laboratory Information System

LK: Agricultural Health Insurance Funds (Landwirtschaftliche Krankenkassen)

MA: Marketing Approval

mBC: metastatic Breast Cancer

mg: milligram

MHLW: Ministry of Health, Labor and Welfare

MNC: Multinational Company

MP AG: Molecular Partners AG

MRI: Magnetic Resonance Imaging

MS: Multiple Sclerosis

MSO: Medtronic Singapore Operations

mTOR: mammalian Target of Rapamycin

NAHIF: National Association of Statutory Health Insurance Funds

NIBR: Novartis Institutes for Biomedical Research

NRC: National Research Council

OECD: Organization for Economic Co-operation and Development



Appendix

OEM: Original Equipment Manufacturer

OHIM: Office for Harmonization in the Internal Market

OOP: Out-Of-Pocket

OSCE: Organization for Security and Co-operation in Europe

OTC: Over-The-Counter

PACS: Picture Archiving and Communication System

PCR: Polymerase Chain Reaction

PEI: Paul Ehrlich Institute

PET: Positron Emission Tomography

PHAGRO: Federal Association of Wholesalers (Bundesverband des pharmazeutischen

Großhandels)

PHI: Private Health Insurance

PIC: Pharmaceutical Inspection Convention

PM10: Particulate Matter with an aerodynamic diameter of less than 10 micrometers

pRED : pharma Research and Early Development

QC: Quality Control

R&D: Research and Development

RIS: Radiology Information System

RLI: Roche Laboratories Incorporated

RMS: Reference Member State

RP: Reference Pricing

RRMS: Relapsing Remitting Multiple Sclerosis

SHI: Statutory Health Insurance

SK: The Social Insurance Organization (Deutsche Sozialversicherung)

SPC: Summary of Product Characteristics



Appendix

TCRC: Translational and Clinical Research Center

TTIP: Transatlantic Trade and Investment Partnership

UBA: Federal Environmental Agency (Umweltbundesamt)

UN: United Nations

UNCTAD: United Nations Conference on Trading and Development

UNFCCC: United Nations Framework Convention on Climate Change

UNICEF: United Nations Children’s Fund

VAT: Value-Added Tax

VFA: Association of Research-Based Pharmaceutical Companies (Der Verband

Forschender Arzneimittelhersteller)

VHP: Voluntary Harmonization Procedure

WHO: World Health Organization

WIPO: World Intellectual Property Organization



Appendix

7.2 Bibliography

10times (2014). Medical & Pharmaceutical Events in Germany. 10times. Available from:

http://10times.com/germany/medical-pharma [Accessed on December 15, 2014]

Abbott (2013). 2013 Investor Relations. Abbott. Available from:

http://www.abbottinvestor.com/phoenix.zhtml?c=94004&p=irol-irhome [Accessed on December

12, 2014]

Abbott (2014). Abbott initiates absorb iv trial to evaluate quality of life and cost savings of

dissolving heart device. Abbott. Available from: http://abbott.mediaroom.com/2014-09-15-

Abbott-Initiates-ABSORB-IV-Trial-to-Evaluate-Quality-of-Life-and-Cost-Savings-of-Dissolving-

Heart-Device [Accessed on December 12, 2014]

AESGP (2014). Market Data. Association of European Self-Medication Industry Association.

Available from: http://www.aesgp.eu/facts-figures/market-data/product-groups/ [Accessed on

December 15, 2014]

ARBPC (2011). Statistics 2011: The Pharmaceutical Industry in Germany. Association of

Research Based Pharmaceutical Companies. Available from: http://www.vfa.de/en/download-

manager/_e-statistics-2011.pdf

Bundesbank (2014). German banks perform well in comprehensive assessment. Bundesbank.

Available from:

http://www.bundesbank.de/Redaktion/EN/Topics/2014/2014_10_26_comprehensive_assessm

ent.html?startpageId=Startseite-

EN&startpageAreaId=Teaserbereich&startpageLinkName=2014_10_26_comprehensive_asse

ssment+319926http://www.bundesbank.de/Redaktion/EN/Topics/2014/2014_10_26_comprehe

nsive_assessment.html?startpageId=Startseite-

EN&startpageAreaId=Teaserbereich&startpageLinkName=2014_10_26_comprehensive_asse

ssment+319926 [Accessed on December 15, 2014]

BWE (2014). WindEnergy Hamburg 2014: German renewables could be big as the car

industry. German Wind Energy Association. Available from: http://www.wind-

energie.de/en/infocenter/articles/windenergy-hamburg-2014-german-renewables-could-be-big-

car-industry [Accessed on December 12, 2014]



Appendix

7.3 Research Methodology

GlobalData’s dedicated research and analysis teams consist of experienced professionals with

advanced statistical expertise and marketing, market research and consulting backgrounds in the

pharmaceutical industry.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and

Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research

methodology is followed for all databases and reports.

7.3.1 Coverage

The objective of updating GlobalData’s coverage is to ensure that it represents the most up-to-date

vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company,

association and competitor sources.

Company coverage is based on three key factors: revenue; products; and media attention,

innovation and market potential.

The estimated revenue of all major companies, including private and governmental, are gathered

and used to prioritize coverage.

Companies that are making the news or are of particular interest due to their innovative approach

are prioritized.

GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated

on a daily basis.

The coverage is further streamlined and strengthened with additional input from GlobalData’s

expert panel (see below).



Appendix

7.3.2 Secondary Research

The research process begins with extensive secondary research using internal and external

sources to gather qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and

SEC filings

Industry trade journals, scientific journals and other technical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market

The CountryFocus reports are largely based on secondary research and use reliable and

authoritative sources such as the IMF, World Bank, OECD, WHO, UNICEF, UNStats, BEA, MHLW

and NHS, among others.

7.3.3 Forecasts

The CountryFocus reports use the data available from the secondary sources to forecast and

validate the future trends for a country’s healthcare market, as well as parameters related to the

economy and healthcare infrastructure and expenditure.

7.3.4 Expert Panel

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData’s expert panel comprises marketing managers, product specialists, international sales

managers from pharmaceutical companies, academics from research universities, consultants from

venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.

Historic data and forecasts are relayed to GlobalData’s expert panel and adjusted in accordance

with their feedback.



Appendix

7.4 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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