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1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 11
1.2 List of Figures 16
2 Introduction 21
2.1 GlobalData Report Guidance 21
3 Overview of the Pharmaceutical and Medical Device Markets 22
3.1 Pharmaceutical Market 22
3.1.1 Market Overview 22
3.1.2 Pharmaceutical Imports and Exports 25
3.1.3 Supply Channels 26
3.1.4 Market Segments 27
3.1.5 Major Therapeutic Areas 34
3.1.6 Major Companies 36
3.2 Medical Device Market 71
3.2.1 Market Overview 71
3.2.2 Overview of Top Five Segments 73
3.2.3 Major Players 86
3.3 Market Drivers and Barriers 127
3.3.1 Drivers 127
3.3.2 Barriers 128
4 Market Access 131
4.1 Reimbursement and Payer Landscape 131
4.1.1 Healthcare System 131
4.1.2 Reimbursement Process 134
4.1.3 Overview of Insurance Providers 137
4.1.4 Patient Share in Healthcare Spending 142
4.1.5 Pricing Policies 144
4.2 Regulatory Landscape 147
4.2.1 Overview of Regulatory Agencies 147
4.2.2 Drug Approval Process 151
4.2.3 New Device Approval Process 152
4.2.4 Licensing Process for Manufacturing 158
4.2.5 Licensing Process for Exports and Imports 160
4.2.6 Intellectual Property Rights Landscape 161
4.2.7 Clinical Trial Regulations 163
4.2.8 Pharmaceutical Advertising Regulations 165
4.2.9 Pharmacy Regulations 167
4.2.10 Labeling and Packing Regulations 168
5 Country Analysis 169
5.1 Political Environment 169
5.1.1 Political Structure 169
5.1.2 Domestic Political Situation 171
5.1.3 Analysis of the Current Political Environment 172
5.1.4 Healthcare Policy Initiatives 173
5.2 Economic Landscape 176
5.3 Economic Indicators 179
5.3.1 Gross Domestic Product 179
5.3.2 Gross National Income 183
5.3.3 Inflation 184
5.3.4 Currency Exchange Rate 187
5.3.5 Foreign Direct Investment 189
5.3.6 Foreign Exchange Reserves 190
5.3.7 Trade Balance 192
5.3.8 Government Structural Balance 194
5.3.9 Government Net Debt 195
5.3.10 Gross Debt 197
5.3.11 Major Industries 198
5.4 Demographics 200
5.4.1 Population 200
5.4.2 Education and Literacy 219
5.4.3 Employment 221
5.4.4 Disease Burden 223
5.5 Healthcare Infrastructure 224
5.5.1 Healthcare Facilities 224
5.5.2 Healthcare Infrastructure 226
5.5.3 Healthcare Parameters 228
5.5.4 Environmental Health 230
5.5.5 Healthcare Personnel 234
5.6 Healthcare Expenditure 238
5.6.1 Overview 238
5.6.2 Major Components of Healthcare Spending 240
5.6.3 Shares of the Public and Private Sectors 241
5.6.4 Spending in Pharmaceutical R&D 243
5.7 Trade Associations 244
5.7.1 Korean Pharmaceutical Association 244
5.7.2 Korea Pharmaceutical Manufacturers Association 245
5.7.3 Korean Hospital Association 245
5.8 Trade Fairs 246
6 Opportunities and Challenges 247
6.1 Opportunities 247
6.2 Challenges 248
7 Appendix 250
7.1 Abbreviations 250
7.2 Bibliography 255
7.3 Research Methodology 273
7.3.1 Coverage 273
7.3.2 Secondary Research 274
7.3.3 Forecasts 274
7.3.4 Expert Panel 274
7.4 Disclaimer 275
1.1 List of Tables
Table 1: Pharmaceutical Market, South Korea, Revenue ($bn), 2008-2015 24
Table 2: Pharmaceutical Market, South Korea, Revenue Forecast ($bn), 2016-2020 25
Table 3: Pharmaceutical Market, South Korea, Imports and Exports ($bn), 2008-2015 26
Table 4: Pharmaceutical Market, South Korea, Generic Pharmaceutical Market ($bn), 2008-2014 28
Table 5: Pharmaceutical Market, South Korea, Biologics Market, Production ($bn), 2008-2014 30
Table 6: Pharmaceutical Market, South Korea, Biopharmaceutical Market by Type (%), 2012 31
Table 7: Pharmaceutical Market, South Korea, Prescription and OTC Drugs Market Share (%), 2008-2014 33
Table 8: Pharmaceutical Market, South Korea, Major Therapeutic Areas, Healthcare cost ($bn), 2013 34
Table 9: Yuhan Corporation, Global, Major Products, 2016 37
Table 10: Yuhan Corporation, Global, Late-Stage Pipeline, 2016 38
Table 11: Green Cross Corporation, Global, Major Products, 2014 44
Table 12: Green Cross Corporation, Global, Late-stage Pipeline, 2014 45
Table 13: Dong-A Pharmaceuticals, Global, Major Products, 2014 52
Table 14: Dong-A Pharmaceuticals, Global, Late-stage Pipeline, 2014 53
Table 15: Hanmi Pharmaceuticals, Global, Major Products, 2014 59
Table 16: Hanmi Pharmaceuticals, Global, Late-Stage Pipeline, 2014 60
Table 17: Daewoong Pharmaceuticals, Global, Major Products, 2014 65
Table 18: Daewoong Pharmaceuticals, Global, Late-Stage Pipeline, 2014 66
Table 19: Medical Device Market, South Korea, Revenue ($bn), 2008-2015 72
Table 20: Medical Device Market, South Korea, Revenue Forecast ($bn), 2016-2020 73
Table 21: Medical Device Market, South Korea, Revenue by Segment ($m), 2015 74
Table 22: Medical Device Market, South Korea, Diagnostic Imaging, Revenue ($m), 2008-2015 76
Table 23: Medical Device Market, South Korea, Diagnostic Imaging, Sales Trends for Major Players, 2012* 76
Table 24: Medical Device Market, South Korea, Ophthalmic Devices, Revenue ($m), 2008-2015 78
Table 25: Medical Device Market, South Korea, Ophthalmic Devices, Sales Trends for Major Players, 2012* 79
Table 26: Medical Device Market, South Korea, In-Vitro Diagnostics, Revenue ($m), 2008-2015 81
Table 27: Medical Device Market, South Korea, In Vitro Diagnostics, Sales Trends for Major Players, 2014 81
Table 28: Medical Device Market, South Korea, Wound Care Management, Revenue ($m), 2008-2015 83
Table 29: Medical Device Market, South Korea, Wound Care Management, Sales Trends for Major Players, 2012* 84
Table 30: Medical Device Market, South Korea, Orthopedic Devices, Revenue ($m), 2008-2015 85
Table 31: Medical Device Market, South Korea, Orthopedic Devices, Sales Trends for Major Players, 2014 86
Table 32: Medical Device Market, South Korea, Major Players, 2014 87
Table 33: Siemens Healthcare, Global, Major Products, 2015 88
Table 34: Johnson & Johnson, Global, Major Products, 2016 97
Table 35: Baxter International, Global, Major Products, 2016 112
Table 36: Philips Healthcare, Global, Major Products, 2016 122
Table 37: National Health Insurance Expenditure, South Korea, NHI Expenditure ($bn), 2008-2014 140
Table 38: Private and Public Healthcare Schemes, South Korea, 2015 142
Table 39: Co-payments, South Korea, 2014 143
Table 40: Healthcare Spending, South Korea, Out-of-Pocket Expenditure (%), 2008-2015 144
Table 41: Healthcare System, Medical Device Classification and Approval Process, South Korea, 2014 154
Table 42: Healthcare System, Patent Application Fees (KRW) ($), South Korea, 2014 162
Table 43: Healthcare System, Trademark Application Fees (KRW) ($), South Korea, 2014 163
Table 44: Economic Indicators, South Korea, Gross Domestic Product per Capita ($), 2008-2015 180
Table 45: Economic Indicators, South Korea, Gross Domestic Product per Capita Forecast ($), 2016-2020 181
Table 46: Economic Indicators, South Korea, GDP Annual Growth (%), 2008-2015 182
Table 47: Economic Indicators, South Korea, Gross Domestic Product Annual Growth Forecast (%), 2016-2020 183
Table 48: Economic Indicators, South Korea, Gross National Income per Capita ($), 2008-2014 184
Table 49: Economic Indicators, South Korea, Average Consumer Price Index, 2008-2015 185
Table 50: Economic Indicators, South Korea, Average Consumer Price Index Forecast, 2016-2020 186
Table 51: Economic Indicators, South Korea, Average Consumer Price Annual Change (%), 2008-2015 187
Table 52: Economic Indicators, South Korea, Currency Exchange Rate (KRW/$), 2008-2015 188
Table 53: Economic Indicators, South Korea, Foreign Direct Investment ($bn), 2008-2015 190
Table 54: Economic Indicators, South Korea, Foreign Exchange Reserves ($bn), 2008-2014 191
Table 55: Economic Indicators, South Korea, Exports of Goods and Services ($bn), 2008-2014 193
Table 56: Economic Indicators, South Korea, Imports of Goods and Services ($bn), 2008-2014 194
Table 57: Economic Indicators, South Korea, Government Structural Balance ($bn), 2008-2015 195
Table 58: Economic Indicators, South Korea, General Government Net Debt (% of GDP), 2008-2015 196
Table 59: Economic Indicators, South Korea, General Government Net Debt Forecast (% of GDP), 2016-2020 197
Table 60: Economic Indicators, South Korea, Gross Debt ($bn), 2008-2015 198
Table 61: Economic Indicators, South Korea, Major Industries, Annual Sales ($bn), 2013 and 2014 200
Table 62: Demographics, South Korea, Population (million), 2008-2015 201
Table 63: Demographics, South Korea, Population Forecast (million), 2016-2020 202
Table 64: Demographics, South Korea, Population, Urban and Rural Population Share (%), 2008-2015 203
Table 65: Demographics, South Korea, Population, Urban and Rural Population Share, Forecast (%), 2016-2020 204
Table 66: Demographics, South Korea, Population Distribution by Age Group (%), 2008-2015 206
Table 67: Demographics, South Korea, Population Distribution by Age Group Forecast (%), 2016-2020 207
Table 68: Demographics, South Korea, Births (per 1,000 Population), 2008-2015 208
Table 69: Demographics, South Korea, Mortality (per 1,000 Population), 2008-2015 209
Table 70: Demographics, South Korea, Major Causes of Mortality, 2012 211
Table 71: Demographics, South Korea, Children <5 Years Age, Mortality (per 1,000 Live Births), 2008-2015 212
Table 72: Demographics, South Korea, Immunization Rate (%), 2008-2015 213
Table 73: Demographics, South Korea, Major Causes of Male Mortality, 2015 215
Table 74: Demographics, South Korea, Causes of Female Mortality, 2015 216
Table 75: Demographics, South Korea, Gender Ratio (M/F), 2008-2015 217
Table 76: Demographics, South Korea, Life Expectancy at Birth (Years), 2008-2015 218
Table 77: Demographics, South Korea, Life Expectancy at Birth, Forecast (Years), 2016-2020 219
Table 78: Demographics, South Korea, Gross Enrollment by Level of Education (%), 2008-2014 221
Table 79: Demographics, South Korea, Unemployment Rate (%), 2008-2015 222
Table 80: Demographics, South Korea, Major Diseases, DALYs (per 1,000 Population), 2009 224
Table 81: Healthcare Infrastructure, South Korea, Hospitals, 2008-2014 226
Table 82: Healthcare Infrastructure, South Korea, Beds (per 1,000 Population) by Type of Service, 2008-2015 227
Table 83: Healthcare Infrastructure, South Korea, Diagnostic Equipment (Per Million Population), 2008-2015 228
Table 84: Healthcare Infrastructure, South Korea, Hospital Beds (per 1,000 Population), 2008-2015 229
Table 85: Healthcare Infrastructure, South Korea, Practicing Physicians (per 1,000 Population), 2008-2015 230
Table 86: Healthcare Infrastructure, South Korea, CO2 Emissions (Million Tons), 2008-2015 232
Table 87: Healthcare Infrastructure, South Korea, PM2.5 emissions (µgm/m³ ), 2008-2015 233
Table 88: Healthcare Infrastructure, South Korea, General Practitioners (per 1,000 Population), 2008-2015 235
Table 89: Healthcare Infrastructure, South Korea, Nurses (per 1,000 Population), 2008-2015 236
Table 90: Healthcare Infrastructure, South Korea, Dentists (per 1,000 Population), 2008-2015 237
Table 91: Healthcare Infrastructure, South Korea, Pharmacists (per 1,000 Population), 2008-2015 238
Table 92: Healthcare Expenditure, South Korea, Healthcare Expenditure (% of GDP), 2008-2015 239
Table 93: Healthcare Expenditure, South Korea, Share of Healthcare Expenditure by Type of Service (%), 2013 240
Table 94: Healthcare Expenditure, South Korea, Healthcare Expenditure, Public-Private Share (%), 2008-2015 242
Table 95: Healthcare Expenditure, South Korea, Pharmaceutical R&D Expenditure (% of Sales), 2008-2014 244
Table 96: Major Healthcare Trade Fairs, South Korea, 2014 246
1.2 List of Figures
Figure 1: Pharmaceutical Market, South Korea, Revenue ($bn), 2008-2015 24
Figure 2: Pharmaceutical Market, South Korea, Revenue Forecast ($bn), 2016-2020 25
Figure 3: Pharmaceutical Market, South Korea, Imports and Exports ($bn), 2008-2015 26
Figure 4: Pharmaceutical Market, South Korea, Generic Pharmaceutical Market ($bn), 2008-2014 28
Figure 5: Pharmaceutical Market, South Korea, Biologics Market, Production ($bn), 2008-2014 30
Figure 6: Pharmaceutical Market, South Korea, Biopharmaceutical Market by Type (%), 2012 31
Figure 7: Pharmaceutical Market, South Korea, Prescription and OTC Drugs Market Share (%), 2008-2014 33
Figure 8: Pharmaceutical Market, South Korea, Major Therapeutic Areas, Healthcare cost ($bn), 2013 34
Figure 9: Medical Device Market, South Korea, Revenue ($bn), 2008-2015 72
Figure 10: Medical Device Market, South Korea, Revenue Forecast ($bn), 2016-2020 73
Figure 11: Medical Device Market, South Korea, Revenue by Segment ($m), 2015 74
Figure 12: Medical Device Market, South Korea, Diagnostic Imaging, Revenue ($m), 2008-2015 75
Figure 13: Medical Device Market, South Korea, Diagnostic Imaging, Sales Trends for Major Players ($m), 2012* 76
Figure 14: Medical Device Market, South Korea, Ophthalmic Devices, Revenue ($m), 2008-2015 78
Figure 15: Medical Device Market, South Korea, Ophthalmic Devices, Sales Trends for Major Players ($m), 2012* 79
Figure 16: Medical Device Market, South Korea, In-Vitro Diagnostics, Revenue ($m), 2008-2015 80
Figure 17: Medical Device Market, South Korea, In-Vitro Diagnostics, Sales Trends for Major Players ($m), 2014 81
Figure 18: Medical Device Market, South Korea, Wound Care Management, Revenue ($m), 2008-2015 83
Figure 19: Medical Device Market, South Korea, Wound Care Management, Sales Trends for Major Players ($m), 2012* 84
Figure 20: Medical Device Market, South Korea, Orthopedic Devices, Revenue ($m), 2008-2015 85
Figure 21: Medical Device Market, South Korea, Orthopedic Devices, Sales Trends for Major Players ($m), 2014 86
Figure 22: Medical Device Market, South Korea, Major Players, Revenue ($m), 2012 87
Figure 23: Healthcare Market, South Korea, Drivers and Barriers, 2014 130
Figure 24: Health Security System, South Korea, 2014 132
Figure 25: Evolution of the Healthcare System, South Korea, 1963-2013 133
Figure 26: Healthcare System, South Korea, 2016 134
Figure 27: Reimbursement Approval Process for Pharmaceutical Products, South Korea, 2014 136
Figure 28: Reimbursement Approval Process for Medical Devices, South Korea, 2014 137
Figure 29: Structure of National Health Insurance, South Korea, 2014 139
Figure 30: National Health Insurance Expenditure, South Korea, NHI Expenditure ($bn), 2008-2014 140
Figure 31: Healthcare Spending, South Korea, Out-of-Pocket Expenditure (%), 2008-2015 143
Figure 32: Drug Pricing and Reimbursement Decision-Making Process, South Korea, 2014 147
Figure 33: Healthcare System, Offices for Medical Devices, South Korea, 2015 148
Figure 34: Healthcare System, Organization of Ministry of Food and Drug Safety, South Korea, 2016 149
Figure 35: Healthcare System, Organization of National Institute of Food and Drug Safety Evaluation, South Korea, 2015 150
Figure 36: Healthcare System, Drug Approval Process, South Korea, 2015 152
Figure 37: Healthcare System, Medical Pre-market Approval Pathway Process, South Korea, 2014 157
Figure 38: Healthcare System, Clinical Trial Approval Process, South Korea, 2014 165
Figure 39: Economic Indicators, South Korea, Gross Domestic Product per Capita ($), 2008-2015 180
Figure 40: Economic Indicators, South Korea, Gross Domestic Product per Capita Forecast ($), 2016-2020 181
Figure 41: Economic Indicators, South Korea, Gross Domestic Product Annual Growth (%), 2008-2015 182
Figure 42: Economic Indicators, South Korea, Gross Domestic Product Annual Growth Forecast (%), 2016-2020 183
Figure 43: Economic Indicators, South Korea, Gross National Income per Capita ($), 2008-2014 184
Figure 44: Economic Indicators, South Korea, Average Consumer Price Index, 2008-2015 185
Figure 45: Economic Indicators, Indonesia, Average Consumer Price Index Forecast, 2016-2020 186
Figure 46: Economic Indicators, South Korea, Average Consumer Price Annual Change (%), 2008-2015 187
Figure 47: Economic Indicators, South Korea, Currency Exchange Rate (KRW/$), 2008-2015 188
Figure 48: Economic Indicators, South Korea, Foreign Direct Investment ($bn), 2008-2015 190
Figure 49: Economic Indicators, South Korea, Foreign Exchange Reserves ($bn), 2008-2014 191
Figure 50: Economic Indicators, South Korea, Exports of Goods and Services ($bn), 2008-2014 192
Figure 51: Economic Indicators, South Korea, Imports of Goods and Services ($bn), 2008-2014 193
Figure 52: Economic Indicators, South Korea, Government Structural Balance ($bn), 2008-2015 194
Figure 53: Economic Indicators, South Korea, General Government Net Debt (% of GDP), 2008-2015 196
Figure 54: Economic Indicators, South Korea, General Government Net Debt Forecast (% of GDP), 2016-2020 197
Figure 55: Economic Indicators, South Korea, Gross Debt ($bn), 2008-2015 198
Figure 56: Economic Indicators, South Korea, Major Industries, Annual Sales ($bn), 2013 and 2014 199
Figure 57: Demographics, South Korea, Population (million), 2008-2015 201
Figure 58: Demographics, South Korea, Population Forecast (million), 2016-2020 202
Figure 59: Demographics, South Korea, Population, Urban and Rural Population Share (%), 2008-2015 203
Figure 60: Demographics, South Korea, Population, Urban and Rural Population Share, Forecast (%), 2016-2020 204
Figure 61: Demographics, South Korea, Population Distribution by Age Group (%), 2008-2015 206
Figure 62: Demographics, South Korea, Population Distribution by Age Group Forecast (%), 2016-2020 207
Figure 63: Demographics, South Korea, Births (per 1,000 Population), 2008-2015 208
Figure 64: Demographics, South Korea, Mortality (per 1,000 Population), 2008-2015 209
Figure 65: Demographics, South Korea, Causes of Mortality, 2012 210
Figure 66: Demographics, South Korea, Children <5 Years, Mortality (per 1,000 Live Births), 2008-2015 212
Figure 67: Demographics, South Korea, Immunization Rate (%), 2008-2015 213
Figure 68: Demographics, South Korea, Major Causes of Male Mortality (‘000), 2015 214
Figure 69: Demographics, South Korea, Causes of Female Mortality (‘000), 2015 215
Figure 70: Demographics, South Korea, Gender Ratio (M/F), 2008-2015 217
Figure 71: Demographics, South Korea, Life Expectancy at Birth (Years), 2008-2015 218
Figure 72: Demographics, South Korea, Life Expectancy at Birth Forecast (Years), 2016-2020 219
Figure 73: Demographics, South Korea, Gross Enrollment by Level of Education (%), 2008-2014 221
Figure 74: Demographics, South Korea, Unemployment Rate (%), 2008-2015 222
Figure 75: Demographics, South Korea, Major Diseases, DALYs (per 1,000 Population), 2009 223
Figure 76: Healthcare Infrastructure, South Korea, Hospitals, 2008-2014 225
Figure 77: Healthcare Infrastructure, South Korea, Beds (per 1,000 Population) by Type of Service, 2008-2015 226
Figure 78: Healthcare Infrastructure, South Korea, Diagnostic Equipment (Per Million Population), 2008-2015 227
Figure 79: Healthcare Infrastructure, South Korea, Hospital Beds (per 1,000 Population), 2008-2015 229
Figure 80: Healthcare Infrastructure, South Korea, Practicing Physicians (per 1,000 Population), 2008-2015 230
Figure 81: Healthcare Infrastructure, South Korea, CO2 Emissions (Million Tons), 2008-2015 232
Figure 82: Healthcare Infrastructure, South Korea, PM2.5 emissions (µgm/m³), 2008-2015 233
Figure 83: Healthcare Infrastructure, South Korea, General Practitioners (per 1,000 Population), 2008-2015 234
Figure 84: Healthcare Infrastructure, South Korea, Nurses (per 1,000 Population), 2008-2015 235
Figure 85: Healthcare Infrastructure, South Korea, Dentists (per 1,000 Population), 2008-2015 237
Figure 86: Healthcare Infrastructure, South Korea, Pharmacists (per 1,000 Population), 2008-2015 238
Figure 87: Healthcare Expenditure, South Korea, Healthcare Expenditure (% of GDP), 2008-2015 239
Figure 88: Healthcare Expenditure, South Korea, Share of Healthcare Expenditure by Type of Service (%), 2013 240
Figure 89: Healthcare Expenditure, South Korea, Healthcare Expenditure, Public-Private Share (%), 2008-2015 242
Figure 90: Healthcare Expenditure, South Korea, Pharmaceutical R&D Expenditure (% of Sales), 2008-2014 243
Figure 91: Healthcare Market, South Korea, Opportunities and Challenges, 2014 249