CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Taiwan

Published : Aug-2017

No. of Pages : 191

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Executive Summary 9
3 Introduction 14
3.1 GlobalData Report Guidance 14
4 Overview of Pharmaceutical and Medical Device Markets 15
4.1 Pharmaceutical Market 15
4.1.1 Market Overview 15
4.1.2 Pharmaceutical Exports and Imports 18
4.1.3 Supply Channels 19
4.1.4 Market Segments 19
4.1.5 Overview of Top Five Disease Areas 22
4.1.6 Major Players 24
4.2 Medical Device Market 42
4.2.1 Market Overview 42
4.2.2 Overview of Top Five Segments 44
4.2.3 Major Players 55
4.3 Market Drivers and Barriers 75
4.3.1 Drivers 75
4.3.2 Barriers 75
5 Market Access 77
5.1 Overview of Healthcare system 77
5.1.1 Reimbursement Process 79
5.1.2 Overview of Insurance Providers 82
5.1.3 Patient Share in Healthcare Expenditure 87
5.1.4 Price Trends in the Healthcare Sector 88
5.1.5 Pricing Policies 89
5.2 Regulatory Landscape 89
5.2.1 Overview of Regulatory Agencies 89
5.2.2 Market Authorization Procedure for Pharmaceutical Products 91
5.2.3 Market Authorization Procedure for Medical Devices 96
5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 101
5.2.5 Licensing Process for Pharmaceutical Exports and Imports 104
5.2.6 Intellectual Property Rights 105
5.2.7 Clinical Trial Regulations 107
5.2.8 Pharmaceutical Advertising Regulations 109
5.2.9 Pharmacy Regulations 110
5.2.10 Labeling and Packaging Regulations 110
6 Country Analysis 112
6.1 Political Environment 112
6.1.1 Political Structure 112
6.1.2 Current Political Environment 113
6.1.3 Healthcare Policy Initiatives 114
6.2 Economic Landscape 116
6.3 Economic Indicators 118
6.3.1 Gross Domestic Product 118
6.3.2 Gross National Income 122
6.3.3 Inflation 123
6.3.4 Currency Exchange Rate 127
6.3.5 Foreign Direct Investment 128
6.3.6 Foreign Exchange Reserves 129
6.3.7 Trade Balance 130
6.3.8 Government Structural Balance 132
6.3.9 Government Net Debt 133
6.3.10 Major Industries 134
6.4 Demographics 136
6.4.1 Population 136
6.4.2 Education and Literacy 149
6.4.3 Employment 151
6.4.4 Disease Burden 153
6.5 Healthcare Infrastructure 154
6.5.1 Healthcare Facilities 154
6.5.2 Healthcare Parameters 163
6.5.3 Environmental Health 165
6.5.4 Healthcare Personnel 167
6.6 Healthcare Expenditure 170
6.6.1 Overview 170
6.6.2 Share of Public and Private Sectors 171
6.7 Trade Associations 172
6.7.1 Taiwan Medical and Biotech Industry Association 172
6.7.2 Taiwan Public Health Association 172
6.7.3 Taiwan Medical Association 172
6.7.4 Taiwan Generic Pharmaceutical Association 172
6.8 Trade Fairs 173
7 Opportunities and Challenges 174
7.1 Opportunities 174
7.2 Challenges 175
8 Appendix 176
8.1 Abbreviations 176
8.2 Bibliography 178
8.3 Research Methodology 189
8.3.1 Coverage 189
8.3.2 Secondary Research 190
8.3.3 Forecasts 190
8.3.4 Expert Panel 190
8.4 Contact Us 191
8.5 Disclaimer 191

1.1 List of Tables
Table 1: Pharmaceutical Market, Taiwan, Revenue ($bn), 2009-2016 16
Table 2: Pharmaceutical Market, Taiwan, Revenue ($bn), 2017-2021 17
Table 3: Pharmaceutical Market, Taiwan, Exports and Imports ($bn), 2009-2016 18
Table 4: Pharmaceutical Market, Taiwan, Revenue by Major Therapeutic Areas ($bn), 2014 22
Table 5: Major Products, CCPC, Taiwan, 2016 25
Table 6: Pharmaceutical Market, Standard, Taiwan, Major Products, 2016 35
Table 7: Pharmaceutical Market, Taiwan Biotech, Taiwan, Major Products, 2016 40
Table 8: Medical Device Market, Taiwan, Revenue ($bn), 2009-2016 42
Table 9: Medical Device Market, Taiwan, Revenue ($bn), 2017-2021 43
Table 10: Medical Device Market, Taiwan, Revenue ($m) and Market Share (%) by Segment, 2016 44
Table 11: Orthopedic Devices Market, Taiwan, Revenue ($m), 2009-2016 45
Table 12: Orthopedic Devices Market, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2016 46
Table 13: Healthcare IT Device Market, Taiwan, Revenue ($m), 2009-2016 47
Table 14: Healthcare IT Devices, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015 48
Table 15: Ophthalmic Device Market, Taiwan, Revenue ($m), 2009-2016 49
Table 16: Ophthalmic Devices, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015 50
Table 17: Diagnostic Imaging Devices, Taiwan, Revenue ($m), 2009-2016 51
Table 18: Diagnostic Imaging Devices, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015 52
Table 19: Cardiovascular Device Market, Taiwan, Revenue ($m), 2009-2016 53
Table 20: Cardiovascular Device Market, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015 54
Table 21: Medical Device Market, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2012 55
Table 22: Medical Device Market, Osstem, Major Products, Global, 2016 66
Table 23: Medical Device Market, Nobel Biocare, Major Products, Global, 2016 67
Table 24: Medical Device Market, Ivoclar Vivadent, Major Products, Asia, 2017 71
Table 25: Market Access, Healthcare System, Taiwan, Premium Contribution Ratios under NHI System, 2016 85
Table 26: Market Access, Healthcare System, Taiwan, Basic Outpatient Care Co-payments ($), 2016 86
Table 27: Healthcare Expenditure, Taiwan, Out-of-Pocket Expenditure (%), 2009-2016 88
Table 28: Market Access, Taiwan, Healthcare Consumer Price Index Annual Change (%), 2009-2016 88
Table 29: Healthcare System, Taiwan, Registration Fee Structure for New Drug Application ($), 2017 95
Table 30: Healthcare System, Taiwan, Regulatory Requirement for Medical Devices, 2013 97
Table 31: Healthcare System, Taiwan, Medical Equipment Classification, 2016 97
Table 32: Healthcare System, Taiwan, Schedule of Patent Fees, 2017 106
Table 33: Market Access, Taiwan, Schedule of Trademark Fees, 2017 107
Table 34: Economic Indicators, Taiwan, GDP per Capita ($), 2009-2016 119
Table 35: Economic Indicators, Taiwan, GDP per Capita ($), 2017-2021 119
Table 36: Economic Indicators, Taiwan, GDP Annual Growth (%), 2009-2016 120
Table 37: Economic Indicators, Taiwan, GDP Annual Growth (%), 2017-2021 121
Table 38: Economic Indicators, Taiwan, GNI per Capita ($), 2009-2016 122
Table 39: Economic Indicators, Taiwan, Consumer Price Index, 2009-2016 123
Table 40: Economic Indicators, Taiwan, Average Consumer Price Index, 2017-2021 124
Table 41: Economic Indicators, Taiwan, Average Consumer Price Index Annual Change (%), 2009-2016 125
Table 42: Economic Indicators, Taiwan, Average Consumer Price Index, Annual Change (%), 2017-2021 126
Table 43: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), 2009-2016 127
Table 44: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), 2009-2016 128
Table 45: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), 2009-2016 129
Table 46: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), 2009-2016 130
Table 47: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), 2009-2016 131
Table 48: Economic Indicators, Taiwan, General Government Structural Balance ($bn), 2009-2016 132
Table 49: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2009-2016 133
Table 50: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2017-2021 134
Table 51: Economic Indicators, Taiwan, Value Added by Major Industries ($bn), 2015 135
Table 52: Demographics, Taiwan, Population (million), 2009-2016 136
Table 53: Demographics, Taiwan, Population (million), 2017-2021 137
Table 54: Demographics, Taiwan, Urban-Rural Population Share (%), 2009-2016 138
Table 55: Demographics, Taiwan, Urban-Rural Population Share (%), 2017-2021 139
Table 56: Demographics, Taiwan, Population Distribution by Age Group (%), 2009-2016 140
Table 57: Demographics, Taiwan, Population Distribution by Age Group (%), 2017-2021 141
Table 58: Demographics, Taiwan, Births (per 1,000 Population), 2009-2016 142
Table 59: Demographics, Taiwan, Mortality (per 1,000 Population), 2009-2016 143
Table 60: Demographics, Taiwan, Major Causes of Mortality (%), 2015 144
Table 61: Demographics, Taiwan, Mortality Rate of Children Under One (per 1,000 live births), 2009-2016 145
Table 62: Demographics, Taiwan, Immunization Coverage (%), 2015 146
Table 63: Demographics, Taiwan, Gender Ratio (M/F), 2009-2016 147
Table 64: Demographics, Taiwan, Life Expectancy at Birth (years), 2009-2016 148
Table 65: Demographics, Taiwan, Life Expectancy at Birth (years), 2017-2021 149
Table 66: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), 2016 150
Table 67: Demographics, Taiwan, Unemployment Rate (%), 2009-2016 151
Table 68: Demographics, Taiwan, Employment by Sector (000), 2015 152
Table 69: Demographics, Taiwan, Personal Health Expenditure by Disease (%), 2014 153
Table 70: Healthcare Infrastructure, Taiwan, Hospitals, 2009-2016 154
Table 71: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2009-2016 155
Table 72: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), 2015 156
Table 73: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership (%), 2015 157
Table 74: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, 2009-2016 158
Table 75: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered, 2015 159
Table 76: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, 2009-2016 160
Table 77: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, 2015 161
Table 78: Healthcare Infrastructure, Taiwan, Diagnostic Centers, 2009-2016 162
Table 79: Healthcare Infrastructure, Taiwan, Hospitals Beds (per 10,000 population), 2009-2016 163
Table 80: Healthcare Infrastructure, Taiwan, Number of Doctors, 2009-2016 164
Table 81: Healthcare Infrastructure, Taiwan, CO2 Emissions (kilotons per year), 2009-2016 166
Table 82: Healthcare Infrastructure Taiwan, Nurses, 2009-2016 167
Table 83: Healthcare Infrastructure, Taiwan, Pharmacists, 2009-2016 168
Table 84: Healthcare Infrastructure, Taiwan, Dentists, 2009-2016 169
Table 85: Healthcare Infrastructure, Taiwan, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 170
Table 86: Healthcare Infrastructure, Taiwan, Public-Private Share of Expenditure (%), 2009-2016 171
Table 87: Healthcare Expenditure, Taiwan, Major Healthcare Trade Fairs, 2017 173

1.2 List of Figures
Figure 1: Pharmaceutical Market, Taiwan, Revenue ($bn), 2009-2021 10
Figure 2: Medical Device Market, Taiwan, Revenue ($bn), 2009-2021 11
Figure 3: Country Profile, Taiwan, 2017 13
Figure 4: Pharmaceutical Market, Taiwan, Revenue ($bn), 2009-2016 16
Figure 5: Pharmaceutical Market, Taiwan, Revenue ($bn), 2017-2021 17
Figure 6: Pharmaceutical Market, Taiwan, Exports and Imports ($bn), 2009-2016 18
Figure 7: Pharmaceutical Market, Taiwan, Revenue by Major Therapeutic Areas ($bn), 2014 22
Figure 8: Medical Device Market, Taiwan, Revenue ($bn), 2009-2016 42
Figure 9: Medical Device Market, Taiwan, Revenue ($bn), 2017-2021 43
Figure 10: Medical Device Market, Taiwan, Revenue by Segment ($m), 2016 44
Figure 11: Orthopedic Devices Market, Taiwan, Revenue ($m), 2009-2016 45
Figure 12: Orthopedic Devices Market, Taiwan, Market Share of Major Players (%), 2016 46
Figure 13: Healthcare IT Device Market, Taiwan, Revenue ($m), 2009-2016 47
Figure 14: Healthcare IT Device Market, Taiwan, Market Share of Major Players (%), 2015 48
Figure 15: Ophthalmic Device Market, Taiwan, Revenue ($m), 2009-2016 49
Figure 16: Ophthalmic Devices, Taiwan, Market Share of Major Players (%), 2015 50
Figure 17: Diagnostic Imaging Devices, Taiwan, Revenue ($m), 2009-2016 51
Figure 18: Diagnostic Imaging Devices, Taiwan, Market Share of Major Players (%), 2015 52
Figure 19: Cardiovascular Device Market, Taiwan, Revenue ($m), 2009-2016 53
Figure 20: Cardiovascular Device Market, Taiwan, Market Share of Major Players (%), 2016 54
Figure 21: Medical Device Market, Taiwan, Revenue of Major Players ($m), 2012 55
Figure 22: Healthcare Market, Taiwan, Drivers and Barriers, 2017 76
Figure 23: Market Access, Healthcare System, Taiwan, Organizational Structure of NHI, 2016 78
Figure 24: Market Access, Healthcare System, Taiwan, Evolution of Healthcare System, 2016 79
Figure 25: Market Access, Healthcare System, Taiwan, HTA Assessment for Application of NHI New Drug Listing, 2016 81
Figure 26: Market Access, Healthcare System, Taiwan, Process for Coverage and Reimbursement of Medical Devices, 2016 82
Figure 27: Market Access, Healthcare System, Taiwan, NHI System, 2016 83
Figure 28: Market Access, Healthcare System, Taiwan, Premium Collection under Second-Generation NHI System, 2016 84
Figure 29: Healthcare Expenditure, Taiwan, Out-of-Pocket Expenditure (%), 2009-2016 87
Figure 30: Market Access, Taiwan, Healthcare Consumer Price Index Annual Change (%), 2009-2016 88
Figure 31: Market Access, Taiwan, Organizational Structure of Center for Drug Evaluation, 2017 91
Figure 32: Market Access, Taiwan, Drug Review Process for NDA, 2017 95
Figure 33: Market Access, Taiwan, Total Product Life Cycle Management Process, 2017 96
Figure 34: Market Access, Taiwan, Marketing Authorization Procedure for Medical Devices, 2013 100
Figure 35: Market Access, Taiwan, IVD Registration Application Process, 2017 101
Figure 36: Market Access, Taiwan, Clinical Trial Regulation Process for an Investigational New Drug, 2014 109
Figure 37: Economic Indicators, Taiwan, GDP Per Capita ($), 2009-2016 118
Figure 38: Economic Indicators, Taiwan, GDP per Capita ($), 2017-2021 119
Figure 39: Economic Indicators, Taiwan, GDP Annual Growth (%), 2009-2016 120
Figure 40: Economic Indicators, Taiwan, GDP Annual Growth (%), 2017-2021 121
Figure 41: Economic Indicators, Taiwan, GNI per Capita ($), 2009-2016 122
Figure 42: Economic Indicators, Taiwan, Consumer Price Index, 2009-2016 123
Figure 43: Economic Indicators, Taiwan, Average Consumer Price Index, 2017-2021 124
Figure 44: Economic Indicators, Taiwan, Average Consumer Price Index, Annual Change (%), 2009-2016 125
Figure 45: Economic Indicators, Taiwan, Average Consumer Price Index, Annual Change (%), 2017-2021 126
Figure 46: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), 2009-2016 127
Figure 47: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), 2009-2016 128
Figure 48: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), 2009-2016 129
Figure 49: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), 2009-2016 130
Figure 50: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), 2009-2016 131
Figure 51: Economic Indicators, Taiwan, Government Structural Balance ($bn), 2009-2016 132
Figure 52: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2009-2016 133
Figure 53: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2017-2021 134
Figure 54: Economic Indicators, Taiwan, Value Added by Major Industries ($bn), 2015 135
Figure 55: Demographics, Taiwan, Population (million), 2009-2016 136
Figure 56: Demographics, Taiwan, Population (million), 2017-2021 137
Figure 57: Demographics, Taiwan, Urban-Rural Population Share (%), 2009-2016 138
Figure 58: Demographics, Taiwan, Urban-Rural Population Share (%), 2017-2021 139
Figure 59: Demographics, Taiwan, Population Distribution by Age Group (%), 2009-2016 140
Figure 60: Demographics, Taiwan, Population Distribution by Age Group (%), 2017-2021 141
Figure 61: Demographics, Taiwan, Births (per 1,000 Population), 2009-2016 142
Figure 62: Demographics, Taiwan, Mortality (per 1,000 Population), 2009-2016 143
Figure 63: Demographics, Taiwan, Major Causes of Mortality (%), 2015 144
Figure 64: Demographics, Taiwan, Mortality Rate of Children Under One (per 1,000 live births), 2009-2016 145
Figure 65: Demographics, Taiwan, Immunization Coverage (%), 2015 146
Figure 66: Demographics, Taiwan, Gender Ratio (M/F), 2009-2016 147
Figure 67: Demographics, Taiwan, Life Expectancy at Birth (years), 2009-2016 148
Figure 68: Demographics, Taiwan, Life Expectancy at Birth (years), 2017-2021 149
Figure 69: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), 2016 150
Figure 70: Demographics, Taiwan, Unemployment Rate (%), 2009-2016 151
Figure 71: Demographics, Taiwan, Employment by Sector (000), 2015 152
Figure 72: Demographics, Taiwan, Personal Health Expenditure by Disease (%), 2014 153
Figure 73: Healthcare Infrastructure, Taiwan, Hospitals, 2009-2016 154
Figure 74: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2009-2016 155
Figure 75: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), 2015 156
Figure 76: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership (%), 2015 157
Figure 77: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, 2009-2016 158
Figure 78: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered (%), 2015 159
Figure 79: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, 2009-2016 160
Figure 80: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, 2015 161
Figure 81: Healthcare Infrastructure, Taiwan, Diagnostic Centers, 2009-2016 162
Figure 82: Healthcare Infrastructure, Taiwan, Hospitals Beds (per 10,000 population), 2009-2016 163
Figure 83: Healthcare Infrastructure, Taiwan, Number of Doctors, 2009-2016 164
Figure 84: Healthcare Infrastructure, Taiwan, CO2 Emissions (kilotons per year), 2009-2016 166
Figure 85: Healthcare Infrastructure, Taiwan, Nurses, 2009-2016 167
Figure 86: Healthcare Infrastructure, Taiwan, Pharmacists, 2009-2016 168
Figure 87: Healthcare Infrastructure, Taiwan, Dentists, 2009-2016 169
Figure 88: Healthcare Infrastructure, Taiwan, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 170
Figure 89: Healthcare Infrastructure, Taiwan, Public-Private Share of Expenditure (%), 2009-2016 171
Figure 90: Healthcare Market, Taiwan, Opportunities and Challenges, 2017 175

Filed in: Pharmaceutical, Pharmaceuticals and Healthcare

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