healthcare, regulatory and reimbursement landscape ... · pdf filemedical device market, ......

REFERENCE CODE GDHC0080CHR | PUBLICATION DATE JUNE 2015

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Executive Summary

An increasingly elderly population and a declining birth rate pose a demographic challenge for the government. Good access to health insurance, a growing healthcare burden and government initiatives are expected to drive market growth, although periodic price cuts have presented a major challenge.

In 2013, the number of people above the age of XX

accounted for XX% of the population of Taiwan

(officially the Republic of China) (NDC, 2014a). It is

increasing significantly, and this will increase the

disease burden. Medical expenditure for chronic

diseases has also increased, although the

government is attempting to reduce the financial

burden through comprehensive healthcare

reforms. The overall population increased slightly

between 2008 and 2013 from XX to XX million,

mainly due to a rising life expectancy. However,

the birth rate decreased at a negative Compound

Annual Growth Rate (CAGR) of XX% between

2008 and 2013 (NDC, 2014a).

Although, at $XX billion, Taiwan’s pharmaceutical

market was smaller than those of Japan, China,

India and South Korea, in 2013, its per-capita

expenditure on medicines was significantly higher,

at $XX. The pharmaceutical market grew at a

CAGR of XX% from 2008 to 2013. The

government is taking various steps to ensure

investment in and the growth of the pharmaceutical

industry. According to the Act for the Development

of Biotech and New Pharmaceuticals Industry, the

government is providing incentives for new

pharmaceutical companies, such as reductions in

income tax.

The Global Budget Payment System was

implemented in 2002, since which the price of

National Health Insurance (NHI)-funded drugs has

been reduced seven times, impacting both

domestic companies and their foreign

counterparts. The last price cut took place in 2011

and led to price cuts on XX drugs amounting to

$XXm. The Ministry of Health and Welfare (MoHW)

introduced the Drug Expenditure System in 2013

on a trial basis. According to this system, prices

would be adjusted, based on the deficits caused by

the difference between the healthcare budget and

the actual spending. If the actual spending for a

particular year were more than the healthcare

budget, a price cut would be brought into effect the

following year. In 2014, there was a deficit of

TWDXX billion ($XXm) that resulted in a price cut

on XX drugs at an average cut rate of XX%. This

went into effect in April 2015 (IRPMA, 2013).

Pharmaceutical prices in Taiwan are on average

approximately XX% of the price of the original

industry developed products marketed in the US

(USTR, 2013). The continual price cuts are a major

challenge for the growth of the pharmaceutical

market.



Executive Summary

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

2008 2013 2017 2020

Rev

enue

($bn

)

Source: Chen, 2010; MOEAIDB, 2013

The Taiwanese market for medical devices is one

of the largest in Asia due to the growing elderly

population and consequent increase in the demand

for healthcare products and services. It was valued

at approximately $XX billion in 2008 and grew at a

CAGR of XX% to $XX billion in 2013. By 2020, it is

expected to have reached $XX billion.

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

2008 2013 2017 2020R

even

ue ($

m)

Source: GlobalData, Medical eTrack [Accessed on April 26, 2015]

Universal healthcare coverage and access to healthcare facilities and reimbursement are the distinguishing features of the healthcare system.

Taiwan has a compulsory NHI system with

universal coverage: approximately XX% of the

population (NHI, 2014a). The second-generation

NHI system was implemented in January 2013,

and in July 2013, the name Bureau of NHI (BNHI)

was changed to National Health Insurance

Administration (NHIA). Owing to the reforms in the

NHIA system, the NHIA no longer has a deficit in

funding (NHI, 2014a). In 2013, approximately XX%

of all healthcare facilities were contracted by the

NHI system. The government receives funds for

health insurance from general tax revenue.


Table of Contents


1 Table of Contents

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

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

1.2 List of Figures ................................................................................................................... 14

2 Introduction ............................................................................................................................... 19

2.1 GlobalData Report Guidance ............................................................................................ 19

3 Overview of Pharmaceutical and Medical Device Markets ........................................................ 20

3.1 Pharmaceutical Market ..................................................................................................... 20

3.1.1 Market Overview ........................................................................................................... 20

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

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

3.1.4 Market Segments .......................................................................................................... 25

3.1.5 Overview of Top Five Disease Areas ............................................................................ 28

3.1.6 Major Players ................................................................................................................ 31

3.2 Medical Device Market ...................................................................................................... 64

3.2.1 Market Overview ........................................................................................................... 64

3.2.2 Overview of Top Five Segments.................................................................................... 66

3.2.3 Diagnostic market ......................................................................................................... 77

3.2.4 Major Players ................................................................................................................ 78

3.3 Market Drivers and Barriers ............................................................................................ 108

3.3.1 Drivers......................................................................................................................... 108

3.3.2 Barriers ....................................................................................................................... 109


Table of Contents


4 Market Access ........................................................................................................................ 111

4.1 Reimbursement and Payer Landscape ........................................................................... 111

4.1.1 Overview of Healthcare System .................................................................................. 111

4.1.2 Reimbursement Process ............................................................................................. 114

4.1.3 Overview of Insurance Providers ................................................................................. 117

4.1.4 Patient Share in Healthcare Spending ......................................................................... 121

4.1.5 Price Trend in Healthcare Services ............................................................................. 122

4.1.6 Pricing Policies ............................................................................................................ 124

4.2 Regulatory Landscape .................................................................................................... 125

4.2.1 Overview of Regulatory Agencies................................................................................ 125

4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 126

4.2.3 Market Authorization Procedure for Medical Devices .................................................. 131

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 134

4.2.5 Licensing Process for Pharmaceutical Exports and Imports ........................................ 137

4.2.6 Intellectual Property Rights.......................................................................................... 138

4.2.7 Clinical Trial Regulations ............................................................................................. 140

4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 142

4.2.9 Pharmacy Regulations ................................................................................................ 143

4.2.10 Labeling and Packaging Regulations .......................................................................... 144

5 Country Analysis ..................................................................................................................... 145

5.1 Political Environment....................................................................................................... 145

5.1.1 Political Structure ........................................................................................................ 145

5.1.2 Analysis of the Current Political Environment .............................................................. 146


Table of Contents


5.1.3 Healthcare Policy Initiatives ......................................................................................... 147

5.2 Economic Landscape ...................................................................................................... 149

5.3 Economic Indicators ........................................................................................................ 150

5.3.1 Gross Domestic Product ............................................................................................. 150

5.3.2 National Income per Capita ......................................................................................... 154

5.3.3 Inflation ....................................................................................................................... 155

5.3.4 Currency Exchange Rate ............................................................................................ 159

5.3.5 Foreign Direct Investment ........................................................................................... 160

5.3.6 Foreign Exchange Reserves ....................................................................................... 161

5.3.7 Trade Balance ............................................................................................................. 163

5.3.8 Government Structural Balance................................................................................... 165

5.3.9 General Government Gross Debt ................................................................................ 167

5.3.10 Major Industries ........................................................................................................... 169

5.4 Demographics ................................................................................................................. 170

5.4.1 Population ................................................................................................................... 170

5.4.2 Education and Literacy ................................................................................................ 186

5.4.3 Employment ................................................................................................................ 187

5.4.4 Disease Burden ........................................................................................................... 190

5.5 Healthcare Infrastructure ................................................................................................. 191

5.5.1 Healthcare Facilities .................................................................................................... 191

5.5.2 Healthcare Parameters ............................................................................................... 202

5.5.3 Environmental Health .................................................................................................. 204

5.5.4 Healthcare Personnel .................................................................................................. 207


Table of Contents


5.6 Healthcare Expenditure ................................................................................................... 211

5.6.1 Overview ..................................................................................................................... 211

5.6.2 Major Components of Healthcare Spending ................................................................ 212

5.6.3 Public and Private Sector Share .................................................................................. 214

5.6.4 Spending in Pharmaceutical Research and Development ........................................... 216

5.7 Trade Associations ......................................................................................................... 217

5.7.1 Taiwan Medical and Biotech Industry Association ....................................................... 217

5.7.2 Taiwan Public Health Association................................................................................ 217

5.7.3 Taiwan Medical Association ........................................................................................ 217

5.7.4 Taiwan Generic Pharmaceutical Association ............................................................... 217

5.8 Trade Fairs ..................................................................................................................... 218

6 Opportunities and Challenges ................................................................................................. 219

6.1 Opportunities .................................................................................................................. 219

6.2 Challenges ...................................................................................................................... 220

7 Appendix................................................................................................................................. 222

7.1 Abbreviations .................................................................................................................. 222

7.2 Bibliography .................................................................................................................... 226

7.3 Research Methodology ................................................................................................... 239

7.3.1 Coverage .................................................................................................................... 239

7.3.2 Secondary Research ................................................................................................... 240

7.3.3 Forecasts .................................................................................................................... 240

7.3.4 Expert Panel................................................................................................................ 240

7.4 Disclaimer ....................................................................................................................... 241


Table of Contents


1.1 List of Tables

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

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

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

Table 4: Pharmaceutical Device Market, Taiwan, Market Segments of Newly Emerging Biotech Industry by

Share (%), 2009 .......................................................................................................................... 28

Table 5: Pharmaceutical Device Market, Taiwan, Top Five Therapeutic Areas by Expenditure on Personal

Health Care, 2013 ....................................................................................................................... 29

Table 6: Pfizer, Global, Major Products, Revenue, 2014 ............................................................................ 32

Table 7: Pharmaceutical Market, Global, Late-Stage Pipeline, Pfizer, 2015 ............................................... 33

Table 8: Sanofi, Global, Major Products, Revenue ($m), 2013 ................................................................... 40

Table 9: Sanofi, Global, Late-stage Pipeline, 2015 .................................................................................... 41

Table 10: GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2014 ............. 48

Table 11: Pharmaceutical Market, Global, Late-Stage Pipeline, GlaxoSmithKline, 2014 .............................. 49

Table 12: Major Products, China Chemical and Pharmaceutical Co., 2013 .................................................. 60

Table 13: Medical Device Market, Taiwan, Revenue ($bn), 2008–2013 ....................................................... 65

Table 14: Medical Device Market, Taiwan, Revenue Forecast ($bn), 2014–2020 ........................................ 66

Table 15: Medical Device Market, Taiwan, Nephrology and Urology Device Market ($m), 2008–2013 ......... 68

Table 16: Medical Device Market, Taiwan, Nephrology and Urology Device Market, Sales Trend for Major

Players, 2012 .............................................................................................................................. 68

Table 17: Medical Device Market, Taiwan, Ophthalmic Device Market ($m), 2008–2013 ............................. 70

Table 18: Medical Device Market, Taiwan, Ophthalmic Device Market, Sales Trend for Major Players, 2012

................................................................................................................................................... 70

Table 19: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market ($m), 2008–2013 ................. 72


Table of Contents


Table 20: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market, Sales Trend for Major

Players, 2012 .............................................................................................................................. 72

Table 21: Medical Device Market, Taiwan, Cardiovascular Device Market ($m), 2008–2013 ....................... 74

Table 22: Medical Device Market, Taiwan, Cardiovascular Device Market, Sales Trend for Major Players,

2012............................................................................................................................................ 74

Table 23: Medical Device Market, Taiwan, Orthopedic Device Market ($m), 2008–2013 .............................. 76

Table 24: Medical Device Market, Taiwan, Orthopedic Device Market, Sales Trend for Major Players, 2012 76

Table 25: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($bn), 2008–2013 ......................... 77

Table 26: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($bn), 2014–2020 ......................... 78

Table 27: Major Products, Baxter International, Global, Revenue, 2014 ...................................................... 79

Table 28: Major Products, Fresenius Medical Care, 2014 ............................................................................ 86

Table 29: Major Products, Medtronic, 2014 ............................................................................................... 103

Table 30: Healthcare System, Taiwan, NHI Premium Formulas, 2014 ....................................................... 119

Table 31: Healthcare System, Taiwan, Basic Outpatient Care Co-payments, 2014 .................................... 120

Table 32: Healthcare System, Taiwan, Basic Outpatient Care Co-payments, 2014 .................................... 121

Table 33: Healthcare Spending, Taiwan, Out-of-Pocket Expenditure (%), 2008–2013 ............................... 122

Table 34: Price of Prescription Drugs, Taiwan, Price Trend in Healthcare Services (%), 2008–2013 .......... 123

Table 35: Healthcare System, Taiwan, Registration Fee Structure for New Drug Application ($), 2014 ...... 130

Table 36: Healthcare System, Taiwan, Regulatory Requirement for Medical Devices, 2013 ...................... 131

Table 37: Market Access, Taiwan, Schedule of Patent Fees, 2014 ............................................................ 139

Table 38: Market Access, Taiwan, Schedule of Trademark Fees, 2014 ..................................................... 140

Table 39: Economic Indicators, Taiwan, Gross Domestic Product per Capita ($), 2008–2013 .................... 151

Table 40: Economic Indicators, Taiwan, Gross Domestic Product per Capita Forecast ($), 2014–2020 ..... 152

Table 41: Economic Indicators, Taiwan, Gross Domestic Product Annual Growth (%), 2008–2013 ............ 153


Table of Contents


Table 42: Economic Indicators, Taiwan, Gross Domestic Product Annual Growth Forecast (%), 2014–2020

................................................................................................................................................. 154

Table 43: Economic Indicators, Taiwan, National Income per Capita ($), 2008–2013 ................................ 155

Table 44: Economic Indicators, Taiwan, Average Consumer Price Index, 2008–2013 ............................... 156

Table 45: Economic Indicators, Taiwan, Average Consumer Price Index Forecast, 2014–2020 ................. 157

Table 46: Economic Indicators, Taiwan, Average Consumer Price Annual Change (%), 2008–2013 .......... 158

Table 47: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), 2008–2013 ........................... 159

Table 48: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), 2008–2013 ............................... 161

Table 49: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), 2008–2013 ........................... 162

Table 50: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), 2008–2013 ....................... 163

Table 51: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), 2008–2013 ....................... 165

Table 52: Economic Indicators, Taiwan, Government Structural Balance ($bn), 2008–2013 ...................... 166

Table 53: Economic Indicators, Taiwan, General Government Gross Debt (% of GDP), 2008–2013 .......... 167

Table 54: Economic Indicators, Taiwan, General Government Gross Debt Forecast (% of GDP), 2014–2020

................................................................................................................................................. 168

Table 55: Economic Indicators, Taiwan, Major Industries, Gross Domestic Product by Industry ($bn), 2013

................................................................................................................................................. 170

Table 56: Demographics, Taiwan, Population (million), 2008–2013 ........................................................... 171

Table 57: Demographics, Taiwan, Population Forecast (million), 2014–2020 ............................................. 172

Table 58: Demographics, Taiwan, Urban-Rural Population (%), 2008–2013 .............................................. 173

Table 59: Demographics, Taiwan, Population Distribution by Age Group (%), 2008–2013 ......................... 175

Table 60: Demographics, Taiwan, Population Distribution by Age Group Forecast (%), 2014–2020 ........... 175

Table 61: Demographics, Taiwan, Births (per 1,000 population), 2008–2013 ............................................. 177

Table 62: Demographics, Taiwan, Mortality (per 1,000 population), 2008–2013 ........................................ 178

Table 63: Demographics, Taiwan, Major Causes of Mortality (per 100,000 population), 2013 .................... 179


Table of Contents


Table 64: Demographics, Taiwan, Children under Five, Infant Mortality Rate (per 1,000 live births), 2008–

2013.......................................................................................................................................... 180

Table 65: Demographics, Taiwan, Immunization Rate (%), 2013 ............................................................... 182

Table 66: Demographics, Taiwan, Gender Ratio (M/F), 2008–2013 ........................................................... 184

Table 67: Demographics, Taiwan, Life Expectancy at Birth (years), 2008–2013 ........................................ 185

Table 68: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), 2013 ...................... 187

Table 69: Demographics, Taiwan, Unemployment Rate (%), 2008–2013................................................... 188

Table 70: Demographics, Taiwan, Employment by Sector (‘000), 2013 ..................................................... 190

Table 71: Demographics, Taiwan, Personal Health Expenditure by Disease (%), 2013.............................. 191

Table 72: Healthcare Infrastructure, Taiwan, Hospitals, 2008–2013 .......................................................... 192

Table 73: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2008–2013 ............................. 193

Table 74: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership, 2013 ........................ 194

Table 75: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership, 2013 ....................... 195

Table 76: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, 2008–2013

................................................................................................................................................. 196

Table 77: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered, 2013 ................................. 197

Table 78: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, 2008–2013 .................................. 198

Table 79: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, 2013 .............................................. 200

Table 80: Healthcare Infrastructure, Taiwan, Diagnostic Equipment, 2008–2013 ....................................... 201

Table 81: Healthcare Infrastructure, Taiwan, Hospital Beds (per 1,000 population), 2008–2013 ................ 202

Table 82: Healthcare Infrastructure, Taiwan, Doctors (per 1,000 population), 2008–2013 .......................... 203

Table 83: Healthcare Infrastructure, Taiwan, PM10 (µgm/m3), 2008–2013 ................................................ 205

Table 84: Healthcare Infrastructure, Taiwan, CO2 emissions (million tons), 2008–2013 ............................. 207

Table 85: Healthcare Infrastructure, Taiwan, Nurses (per 1,000 population), 2008–2013 ........................... 208

Table 86: Healthcare Infrastructure, Taiwan, Pharmacists (per 1,000 population), 2008–2013 ................... 209


Table of Contents


Table 87: Healthcare Infrastructure, Taiwan, Dentists (per 1,000 population), 2008–2013 ......................... 210

Table 88: Healthcare Expenditure, Taiwan, Healthcare Expenditure (% of GDP), 2008–2013 .................... 212

Table 89: Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by

Provider (%), 2011 .................................................................................................................... 213

Table 90: Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by

Mode of Production (%), 2011 ................................................................................................... 214

Table 91: Healthcare Expenditure, Taiwan, Healthcare Expenditure, Public-Private Share (%), 2008–2013

................................................................................................................................................. 215

Table 92: Healthcare Expenditure, Taiwan, Pharmaceutical R&D Expenditure, 2008–2013 ....................... 216

Table 93: Healthcare Expenditure, Taiwan, Major Healthcare Trade Fairs, 2015 ....................................... 218

1.2 List of Figures

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

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

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

Figure 4: Pharmaceutical Market, Taiwan, Market Segments of Newly Emerging Biotech Industry by Share

(%), 2009 .................................................................................................................................... 27

Figure 5: Medical Device Market, Taiwan, Revenue ($bn), 2008–2013 ....................................................... 65

Figure 6: Medical Device Market, Taiwan, Revenue Forecast ($bn), 2014–2020 ........................................ 66

Figure 7: Medical Device Market, Taiwan, Nephrology and Urology Device Market ($m), 2008–2013 ......... 67

Figure 8: Medical Device Market, Taiwan, Nephrology and Urology Device Market, Sales Trend for Major

Players ($m), 2008–2012 ............................................................................................................ 68

Figure 9: Medical Device Market, Taiwan, Ophthalmic Device Market ($m), 2008–2013 ............................. 69

Figure 10: Medical Device Market, Taiwan, Ophthalmic Device Market, Sales Trend for Major Players ($m),

2008–2012 .................................................................................................................................. 70

Figure 11: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market ($m), 2008–2013 ................. 71


Table of Contents


Figure 12: Medical Device Market, Taiwan, In Vitro Diagnostics Device Market, Sales Trend for Major Players

($m), 2008–2012 ......................................................................................................................... 72

Figure 13: Medical Device Market, Taiwan, Cardiovascular Device Market ($m), 2008–2013 ....................... 73

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

($m), 2008–2012 ......................................................................................................................... 74

Figure 15: Medical Device Market, Taiwan, Orthopedic Device Market ($m), 2008–2013 .............................. 75

Figure 16: Medical Device Market, Taiwan, Orthopedic Device Market, Sales Trend for Major Players ($m),

2008–2012 .................................................................................................................................. 76

Figure 17: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($m), 2008–2013 .......................... 77

Figure 18: Medical Device Market, Taiwan, Diagnostic Market, Revenue ($bn), 2014–2020 ......................... 78

Figure 19: Healthcare Market, Taiwan, Drivers and Barriers, 2014 ............................................................. 110

Figure 20: Healthcare System, Taiwan, Financial Flow in Healthcare System, 2014 ................................... 113

Figure 21: Healthcare System, Taiwan, Evolution of Healthcare System, 2014 ........................................... 114

Figure 22: Healthcare System, Taiwan, Reimbursement Process, 2013 ..................................................... 116

Figure 23: Market Access, Taiwan, Process for Coverage and Reimbursement of Medical Devices, 2013 .. 117

Figure 24: Healthcare System, Taiwan, Premium Collection under Second-Generation NHI System, 2014 . 119

Figure 25: Healthcare Spending, Taiwan, Out-of-Pocket Expenditure (%), 2008–2013 ............................... 122

Figure 26: Price of Prescription Drugs, Taiwan, Price Trend in Healthcare Services (%), 2008–2013 .......... 123

Figure 27: Market Access, Taiwan, Organization Structure of Center for Drug Evaluation, 2014 ................. 126

Figure 28: Market Access, Taiwan, Marketing Authorization Procedure for New Drug, 2014 ....................... 128

Figure 29: Market Access, Taiwan, New Drug Evaluation Process, 2014 .................................................... 129

Figure 30: Market Access, Taiwan, HTA Process for New Drug Listing Application with the NHIA, 2014 ..... 130

Figure 31: Market Access, Taiwan, Marketing Authorization Procedure for Medical Devices, 2013 ............. 134

Figure 32: Market Access, Taiwan, Clinical Trial Regulation Process for an Investigational New Drug, 2014

................................................................................................................................................. 142


Table of Contents


Figure 33: Economic Indicators, Taiwan, Gross Domestic Product per Capita ($), 2008–2013 .................... 151

Figure 34: Economic Indicators, Taiwan, Gross Domestic Product per Capita Forecast ($), 2014–2020 ..... 152

Figure 35: Economic Indicators, Taiwan, GDP Annual Growth (%), 2008–2013 .......................................... 153

Figure 36: Economic Indicators, Taiwan, Gross Domestic Product Annual Growth Forecast (%), 2014–2020

................................................................................................................................................. 154

Figure 37: Economic Indicators, Taiwan, National Income per Capita ($), 2008–2013 ................................ 155

Figure 38: Economic Indicators, Taiwan, Average Consumer Price Index, 2008–2013 ............................... 156

Figure 39: Economic Indicators, Taiwan, Average Consumer Price Index Forecast, 2014–2020 ................. 157

Figure 40: Economic Indicators, Taiwan, Average Consumer Price Annual Change (%), 2008–2013 .......... 158

Figure 41: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), 2008–2013 ........................... 159

Figure 42: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), 2008–2013 ............................... 161

Figure 43: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), 2008–2013 ........................... 162

Figure 44: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), 2008–2013 ....................... 163

Figure 45: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), 2008–2013 ....................... 165

Figure 46: Economic Indicators, Taiwan, Government Structural Balance ($bn), 2008–2013 ...................... 166

Figure 47: Economic Indicators, Taiwan, General Government Gross Debt (% of GDP), 2008–2013 .......... 167

Figure 48: Economic Indicators, Taiwan, General Government Gross Debt Forecast (% of GDP), 2014–2020

................................................................................................................................................. 168

Figure 49: Economic Indicators, Taiwan, Major Industries, Gross Domestic Product by Industry ($bn), 2013

................................................................................................................................................. 169

Figure 50: Demographics, Taiwan, Population (million), 2008–2013 ........................................................... 171

Figure 51: Demographics, Taiwan, Population Forecast (million), 2014–2020 ............................................. 172

Figure 52: Demographics, Taiwan, Urban-Rural Population (%), 2008–2013 .............................................. 173

Figure 53: Demographics, Taiwan, Population Distribution by Age Group (%), 2008–2013 ......................... 174

Figure 54: Demographics, Taiwan, Population Distribution by Age Group Forecast (%), 2014–2020 ........... 175


Table of Contents


Figure 55: Demographics, Taiwan, Births (per 1,000 population), 2008–2013 ............................................. 176

Figure 56: Demographics, Taiwan, Mortality (per 1,000 population), 2008–2013 ........................................ 177

Figure 57: Demographics, Taiwan, Major Causes of Mortality (per 100,000 population), 2013 .................... 178

Figure 58: Demographics, Taiwan, Children under Five, Infant Mortality Rate (per 1,000 live births), 2008–

2013.......................................................................................................................................... 180

Figure 59: Demographics, Taiwan, Immunization Rate (%), 2013 ............................................................... 182

Figure 60: Demographics, Taiwan, Gender Ratio (M/F), 2008–2013 ........................................................... 183

Figure 61: Demographics, Taiwan, Life Expectancy at Birth (years), 2008–2013 ........................................ 185

Figure 62: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), 2013 ...................... 187

Figure 63: Demographics, Taiwan, Unemployment Rate (%), 2008–2013................................................... 188

Figure 64: Demographics, Taiwan, Employment by Sector (‘000), 2013 ..................................................... 189

Figure 65: Demographics, Taiwan, Personal Health Expenditure by Disease (%), 2013.............................. 190

Figure 66: Healthcare Infrastructure, Taiwan, Hospitals, 2008–2013 .......................................................... 192

Figure 67: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2008–2013 ............................. 193

Figure 68: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), 2013 .................. 194

Figure 69: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership (%), 2013................. 195

Figure 70: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, 2008–2013

................................................................................................................................................. 196

Figure 71: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered (%), 2013 ........................... 197

Figure 72: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, 2008–2013 .................................. 198

Figure 73: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, 2013 .............................................. 199

Figure 74: Healthcare Infrastructure, Taiwan, Diagnostic Equipment, 2008–2013 ....................................... 201

Figure 75: Healthcare Infrastructure, Taiwan, Hospital Beds (per 1,000 population), 2008–2013 ................ 202

Figure 76: Healthcare Infrastructure, Taiwan, Doctors (per 1,000 population), 2008–2013 .......................... 203

Figure 77: Healthcare Infrastructure, Taiwan, PM10 (µgm/m3), 2008–2013 ................................................ 205


Table of Contents


Figure 78: Healthcare Infrastructure, Taiwan, CO2 emissions (million tons), 2008–2013 ............................. 206

Figure 79: Healthcare Infrastructure, Taiwan, Nurses (per 1,000 population), 2008–2013 ........................... 208

Figure 80: Healthcare Infrastructure, Taiwan, Pharmacists (per 1,000 population), 2008–2013 ................... 209

Figure 81: Healthcare Infrastructure, Taiwan, Dentists (per 1,000 population), 2008–2013 ......................... 210

Figure 82: Healthcare Expenditure, Taiwan, Healthcare Expenditure (% of GDP), 2008–2013 .................... 211

Figure 83: Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by

Provider (%), 2011 .................................................................................................................... 212

Figure 84: Healthcare Expenditure, Taiwan, Primary Healthcare Expenditure, Current Health Expenditure by

Mode of Production (%), 2011 ................................................................................................... 213

Figure 85: Healthcare Expenditure, Taiwan, Healthcare Expenditure, Public-Private Share (%), 2008–2013

................................................................................................................................................. 215

.Figure 86: Healthcare Expenditure, Taiwan, Pharmaceutical R&D Expenditure ($m), 2008–2013 ............... 216

Figure 87: Healthcare Market, Taiwan, Opportunities and Challenges, 2014 .............................................. 221



Introduction

2 Introduction

2.1 GlobalData Report Guidance

The chapter begins with an executive summary, which gives an overview of the Taiwan’s

healthcare market and the key driving factors. It also gives a snapshot of the demographic,

regulatory, and reimbursement landscape, and the healthcare infrastructure.

Chapter three provides an overview of Taiwan’s pharmaceutical and medical device markets,

covering size; generic, Over-the-Counter (OTC) and biologic/biosimilar product shares; and the

key drivers and barriers. It also includes profiles of the major players, as well as SWOT

assessments.

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

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

It also looks at the regulatory landscape, and gives an overview of the regulatory agencies and

approval processes for new drugs and medical devices. Also covered is the licensing process

for the manufacture, export and import of pharmaceuticals; regulations for pharmaceutical

advertising, labeling, packaging and clinical trials; and an overview of intellectual property

rights.

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

and analyses economic indicators, demographics, and healthcare infrastructure and

expenditure.

Chapter six provides an overview of the opportunities for and challenges to growth in Taiwan’s

healthcare market.


Country Analysis


5.5.1.1 Public and Private Hospitals

From 2008 to 2013, the number of private institutions decreased at a negative CAGR of XX%,

owing to consolidation, yet they still dominated the market. The number of public hospitals

increased slightly from XX hospitals in 2008 to XX hospitals in 2013 (MoHW, 2014b).

Even though the number of private hospitals decreased, the number of corporate owned hospitals

increased from XX to XX. This was due to the tax breaks given to hospitals, which made them ideal

for corporate investment.

Figure 67: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2008–2013

2008 2009 2010 2011 2012 2013

Hos

pita

ls

Public

Private

Source: MoHW, 2014b

Table 73: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2008–2013 2008 2009 2010 2011 2012 2013

Government

Private

Source: MoHW, 2014b


Country Analysis


Figure 68: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), 2013

MoHW hospital and municipality hospital

County and city hospitalsHospitals af f iliated to public medical schools

Civilian clinics of military hospitals

Hospitals of VACRS

Hospitals af f iliated to organization (institution)

Public chinese medicine hospitals

Source: MoHW, 2014b VACRS: Vocational Assistance Commission for Retired Servicemen

Table 74: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership, 2013

Type of hospital Number of facilities Share (%)

DoH and municipality hospitals

Vocational Assistance Commission for Retired Servicemen hospitals

Civilian clinics of military hospitals

Hospitals affiliated to public medical schools

County and city hospitals

Hospitals affiliated to an organization

Public Chinese medicine hospitals

Source: MoHW, 2014b


Appendix


7 Appendix

7.1 Abbreviations

µgm/m3: micrograms per cubic meter

5in1: DTaP-Hib-IPV

AC: Advisory Committee

ANDA: Abbreviated New Drug Application

API: Active Pharmaceutical Ingredients

ASEAN: Association of Southeast Asian Nations

BACE: Beta Secretase

BNHI: Bureau of NHI

BOPA: Bureau of Pharmaceutical Affairs

CAGR: Compound Annual Growth Rate

CCPC: China Chemical & Pharmaceutical Co.

CDE: Center for Drug Evaluation

CDI: Clostridium Difficile Infection

cGMP: Current Good Manufacturing Practice

CKD: Chronic Kidney Disease

CMO: Contract Manufacturing Outsourcing

CNS: Central Nervous System

CE: Conformité Européenne

COPD: Chronic Obstructive Pulmonary Disease

CPI: Consumer Price Index

CRAMS: Contract Research and Manufacturing Services

CRL: Complete Response Letter


Appendix


CRO: Contract Research Outsourcing

CT: Computed Tomography

DBC: Drug Benefit Committee

DET: Drug Expenditure Target

DoH: Department of Health

DP: Doctors-to-Population

DPP: Democratic Progressive Party

ECFA: Economic Cooperation Framework Agreement

EMA: European Medicines Agency EMA

EMAP: Emerging Markets Asia-Pacific

EPA: Environmental Protection Administration

ESRD: End-Stage Renal Disease

FDA: Food and Drug Administration

FDI: Foreign Direct Investments

Forex: Foreign exchange

FEPZ Free Economic Pilot Zones

GCP: Good Clinical Practice

GCRC: General Clinical Research Center

GDP: Gross Domestic Product

GMP: Good Manufacturing Practice

HBP: Hospital-Beds-to-Population

HPA Health Promotion Agency

HepB: Hepatitis B vaccine

HIV: Human Immunodeficiency Virus


Appendix


HTA: Health Technology Assessment

ICD: Implantable Cardioverter-Defibrillators

IDEA: International Design Excellence Awards

IDSA: Industrial Designers Society of America

IMF: International Monetary Fund

iMPRO: Integrated Medicinal Products Review Office

IPR : Intellectual Property Right

IRB: Institutional Review Boards

IVD: In Vitro Diagnostics

JE: Japan Encephalitis vaccine

JIRB: Joint Institutional Review Boards

KMT: Nationalist Party (Kuomintang)

LIS: Laboratory Information System

MMR: Measles, Mumps and Rubella combination vaccine

MoHW: Ministry of Health and Welfare

MRI: Magnetic Resonance Imaging

NCE: New Chemical Entity

NDA: New Drug Application

NHE: National Health Expenditure

NHI: National Health Insurance

NHIA: National Health Insurance Administration

NRPB: National Research Program for Biopharmaceuticals

OECD: Organization for Economic Co-operation and Development

OTC: Over-the-Counter


Appendix


PACS: Picture Archiving Communication Systems

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

PET) Positron Emission Tomography

PMF: Plant Master Files

PUD: Peptic Ulcer Disease

QSD: Quality Systems Documentation

R&D: Research and Development

ROC: Republic of China

CDC Taiwan Center for Disease Control

TCM: Traditional Chinese Medicine

TEPA: Taiwan Environmental Protection Agency

TFDA: Taiwan Food and Drug Administration

TGPA: Taiwan Generic Pharmaceutical Association

TIPO: Taiwan Intellectual Property Office

UNFCCC: United Nations Framework Convention on Climate Change

UNICEF: United Nations Children’s Fund

VACRS: Vocational Assistance Commission for Retired Servicemen

VAR: Varicella vaccine

WTO: World Trade Organization

YSP: Yung Shin Pharmaceutical


Appendix


7.2 Bibliography

10times (2015). Medical and pharmaceutical trade shows in Taiwan. 10times. Available from:

http://10times.com/taiwan/medical-pharma [Accessed on April 22, 2015]

Baxter (2014). Baxter 10k filings. Baxter. Available from:

http://www.baxter.com/downloads/investors/reports_and_financials/annual_report/2014/2014_

baxter_form10-K.pdf

CBC (2015). Monthly Releases: Foreign Exchange Reserves. Central Bank of the Republic of

China (Taiwan). Available from: http://www.cbc.gov.tw/ct.asp?xItem=1866&ctNode=511&mp=2

[Accessed on April 21, 2015]

CCPC (2014). China Chemical & Pharmaceutical company info. China Chemical &

Pharmaceutical. Available from:

http://www.ccpc.com.tw/english/01_person/02_detail.aspx?MID2=25 [Accessed on May 13,

2015]

CDC (2014). Annual report 2013–2014. Center for Disease Control. Available from:

http://www.cdc.gov.tw/uploads/files/201408/533702a2-eedd-40da-8570-c2e15369825d.pdf

CDE (2014a). Organization. Center for Drug Evaluation. Available from:

http://www.cde.org.tw/English/Pages/Organization.aspx [Accessed on May 6, 2015]

CDE (2014b). Drug Review and Registration Guideline. Center for Drug Evaluation. Available

from: http://www.cde.org.tw/eng/drugs/ [Accessed on May 6, 2015]

CDE (2014c). Fee schedule for the application of examination and registration of

pharmaceuticals and medical equipment. Center for Drug Evaluation. Available from:

http://www2.cde.org.tw/English/Regulations/Pages/Drug%20Registration.aspx [Accessed on

May 6, 2015]

CDE (2014d). Guideline for Registration of Medical Devices. Center for Drug Evaluation.

Available from: http://www2.cde.org.tw/English/Regulations/SubLink/Document%2014.pdf

CDE (2014e). Guideline for Good Clinical Practice. Center for Drug Evaluation. Available from:

http://www2.cde.org.tw/English/Regulations/SubLink/Document%2015.pdf [Accessed on May

6, 2015].


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, the 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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