GDHC0061CHR Healthcare, Regulatory and Reimbursement ...REFERENCE CODE GDHC0061CHR | PUBLICATION...

REFERENCE CODE GDHC0061CHR | PUBLICATION DATE JUNE 2014

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE -

VIETNAM

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

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE - VIETNAM

Executive Summary

An increasing disease burden, a widespread preference for imported, branded drugs and high prices for pharmaceuticals are driving the growth of Vietnam’s healthcare market, although restricted access to healthcare facilities and domestic manufacturers’ focus on generic drugs will also restrain market growth.

The pharmaceutical market was valued at an

estimated $XX billion in 2013 and is projected to

reach approximately $XX billion by 2020, at a

Compound Annual Growth Rate (CAGR) of XX%,

due to growing awareness among the population of

the importance of early detection and diagnosis of

disease, increasing drug consumption and the

government’s focus on improving the healthcare

sector by the government (EUECC, 2011).

Although Vietnam has an attractive pharmaceutical

market, prices are relatively high in comparison to

average incomes, which may act as a barrier to

access to medicine.

In 2005, generic medicines constituted

approximately XX% of the drugs available in the

public sector. Among publicly procured drugs, the

cost of the lowest priced generics was XX times

higher than international reference prices, and

innovator drug prices were XX times higher than

international reference prices. A lack of low-priced

generics in the public sector has resulted in a vast

increase in the price of some medicines in

comparison to international reference prices

because pharmaceutical companies are free to set

the prices of their products.

In Vietnam, foreign pharmaceutical companies

maintain premium revenue not only because of

patent protection, but also because doctors believe

imported drugs are much more effective and

consequently prefer them over generics.

The Vietnamese government enacted the New

Health Insurance Law in 2009, which aims to

provide healthcare insurance coverage to all

citizens by 2020. According to the circular number

22/2009/TT-BYT, published in 2009, all

pharmaceutical production facilities must possess

Good Manufacturing Practice (GMP) certificates to

operate in Vietnam. This requirement will lead to

the production of high-quality pharmaceutical

products by domestic Vietnamese manufacturers

and should increase the value of pharmaceutical

exports.

The healthcare system faces substantial burdens

from both communicable and Non-Communicable

Diseases (NCD). However, the prevalence of

NCDs is increasing compared to communicable

diseases due to unhealthy lifestyles, smoking and

alcoholism. Cancer, mental disorders,

cardiovascular diseases and gastrointestinal

diseases are some of the major NCDs prevalent in

Vietnam. There was a XX% increase in the number

of new cancer cases diagnosed each year in the

2001–2003 period compared to the number in

2010 (WHO, 2011). As of 2010, approximately

XX% of the population was affected by

gastrointestinal diseases. A rising disease burden

presents a challenge to policy-makers in terms of



Executive Summary

the resources required to care for the larger

disease population. Although this will impose a

financial and logistical burden on the healthcare

system, it will also act as a driver for growth.

In Vietnam, rural areas face restricted access to

healthcare services due to inefficient infrastructure

and high out-of-pocket healthcare expenditure. In

some rural areas physical accessibility to

healthcare centers is also an issue, which acts as

an additional, non-financial barrier to healthcare.

Domestic pharmaceutical companies focus mainly

on generic drugs with very low expenditure on

Research and Development (R&D) activities and

thus restrict the scope of domestic companies to

establish themselves either within Vietnam or

through exports. The top five pharmaceutical

companies in Vietnam are Sanofi,

GlaxoSmithKline, DHG Pharmaceutical JSC,

Novartis and AstraZeneca.

The Vietnamese medical device market was

valued at approximately $XXm in 2010 and is

expected to reach approximately $350m by 2015,

driven by a significant increase in private hospitals

and rising demand for healthcare services.

Approximately XX% of medical equipment is

imported from other countries and regions such as

Japan, the European Union (EU) and the US.

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

2008 2013* 2015 2020

Rev

enue

($bn

)

CAGR (2008–2020): XX%

Source: EUECC, 2011 *Estimated figure

Vietnam is moving towards universal health coverage by 2020 by increasing subsidies on healthcare insurance premiums and by covering all segments of the population, though despite this aim out-of-pocket expenditure remains high.

By implementing the Health Insurance Law in

2009, the Vietnamese government has signaled

that it aims to provide healthcare insurance to all

citizens by 2020. On 26 January 2012, a

Memorandum of Understanding (MoU) was signed

between the governments of Thailand and

Vietnam, under which the Thailand government

would guide the implementation of the Universal

Health Coverage scheme in Vietnam. In 2012,

XX% of the population was covered by healthcare

insurance. Funding for insurance coverage comes

from employers, employees, individuals,

households and external aid.


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 7

1.1 List of Tables .................................................................................................................... 11

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

2 Introduction ............................................................................................................................... 18

2.1 GlobalData Report Guidance ............................................................................................ 18

3 Overview of the Pharmaceutical and Medical Device Markets .................................................. 19

3.1 Pharmaceutical Market ..................................................................................................... 19

3.1.1 Market Overview ........................................................................................................... 19

3.1.2 Pharmaceutical Imports and Exports ............................................................................. 23

3.1.3 Supply Channels ........................................................................................................... 24

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

3.1.5 Overview of Major Disease Areas ................................................................................. 30

3.1.6 Major Players ................................................................................................................ 35

3.2 Medical Device Market ...................................................................................................... 71

3.3 Market Drivers and Barriers .............................................................................................. 72

3.3.1 Drivers........................................................................................................................... 72

3.3.2 Barriers ......................................................................................................................... 74

4 Market Access .......................................................................................................................... 76

4.1 Reimbursement and Payer Landscape ............................................................................. 76

4.1.1 Overview of Healthcare System .................................................................................... 76

4.1.2 Reimbursement Process ............................................................................................... 77


Table of Contents


4.1.3 Overview of Insurance Providers ................................................................................... 79

4.1.4 Patient Share in Healthcare Spending ........................................................................... 84

4.1.5 Drug Price Trend ........................................................................................................... 85

4.1.6 Pricing Policies .............................................................................................................. 86

4.2 Regulatory Landscape ...................................................................................................... 87

4.2.1 Overview of Regulatory Agencies.................................................................................. 87

4.2.2 Market Authorization Procedure for Pharmaceutical Products ....................................... 87

4.2.3 Licensing Process for Pharmaceutical Manufacturing ................................................... 94

4.2.4 Licensing Process for Pharmaceutical Exports and Imports .......................................... 95

4.2.5 Intellectual Property Rights............................................................................................ 97

4.2.6 Clinical Trial Regulations ............................................................................................. 101

4.2.7 Pharmaceutical Advertising Regulations ..................................................................... 103

4.2.8 Pharmacy Regulations ................................................................................................ 105

4.2.9 Labeling and Packaging Regulations .......................................................................... 106

5 Country Analysis ..................................................................................................................... 109

5.1 Political Environment....................................................................................................... 109

5.1.1 Political Structure ........................................................................................................ 109

5.1.2 Analysis of the Current Political Environment .............................................................. 109

5.1.3 Healthcare Policy Initiatives ......................................................................................... 111

5.2 Economic Landscape ...................................................................................................... 112

5.3 Economic Indicators ........................................................................................................ 115

5.3.1 Gross Domestic Product ............................................................................................. 115

5.3.2 Gross National Income ................................................................................................ 119


Table of Contents


5.3.3 Inflation ....................................................................................................................... 120

5.3.4 Currency Exchange Rate ............................................................................................ 124

5.3.5 Foreign Direct Investment ........................................................................................... 125

5.3.6 Foreign Exchange Reserves ....................................................................................... 126

5.3.7 Trade Balance ............................................................................................................. 127

5.3.8 Government Structural Balance................................................................................... 129

5.3.9 General Government Net Debt .................................................................................... 130

5.3.10 Major Industries ........................................................................................................... 131

5.4 Demographics ................................................................................................................. 132

5.4.1 Population ................................................................................................................... 132

5.4.2 Education and Literacy ................................................................................................ 150

5.4.3 Employment ................................................................................................................ 152

5.4.4 Disease Burden ........................................................................................................... 153

5.5 Healthcare Infrastructure ................................................................................................. 156

5.5.1 Healthcare Facilities .................................................................................................... 156

5.5.2 Healthcare Parameters ............................................................................................... 160

5.5.3 Environmental Health .................................................................................................. 162

5.5.4 Healthcare Personnel .................................................................................................. 166

5.5.5 Healthcare Expenditure ............................................................................................... 169

5.6 Trade Associations ......................................................................................................... 172

5.6.1 Vietnam Pharmaceutical Companies Association ........................................................ 172

5.6.2 Vietnam General Association of Medicine and Pharmacy............................................ 172

5.6.3 Vietnam Public Health Association .............................................................................. 173


Table of Contents


5.7 Trade Fairs ..................................................................................................................... 174

6 Opportunities and Challenges ................................................................................................. 175

6.1 Opportunities .................................................................................................................. 175

6.2 Challenges ...................................................................................................................... 176

7 Appendix................................................................................................................................. 178

7.1 Abbreviations .................................................................................................................. 178

7.2 Bibliography .................................................................................................................... 182

7.3 Research Methodology ................................................................................................... 192

7.3.1 Coverage .................................................................................................................... 192

7.3.2 Secondary Research ................................................................................................... 193

7.3.3 Forecasts .................................................................................................................... 193

7.3.4 Expert Panel................................................................................................................ 193

7.4 Disclaimer ....................................................................................................................... 194


Table of Contents


1.1 List of Tables

Table 1: Pharmaceutical Market, Vietnam, Revenue ($bn), 2008–2013 ....................................................... 21

Table 2: Pharmaceutical Market, Vietnam, Revenue Forecast ($bn), 2014–2020 ......................................... 22

Table 3: Pharmaceutical Market, Vietnam, Imports and Exports ($bn), 2008–2013 ...................................... 23

Table 4: Pharmaceutical Market, Vietnam, OTC, Major Segment Share (%), 2010 ....................................... 29

Table 5: Pharmaceutical Market, Vietnam, Major Disease Areas, Number of Cancer Cases, 2010 ............... 32

Table 6: Pharmaceutical Market, Vietnam, Major Disease Areas, Prevalence and Number of Mental Disorder

Cases, 2005 .................................................................................................................................. 33

Table 7: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), 2013 ............................... 36

Table 8: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014 ................................................. 37

Table 9: Pharmaceutical Market, GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual

Growth (%), 2013 ........................................................................................................................... 42

Table 10: Pharmaceutical Market, Global, Late-Stage Pipeline, GlaxoSmithKline, 2014 ................................. 43

Table 11: Pharmaceutical Market, AstraZeneca, Global, Major Products by Therapy Area, Revenue, 2013 .... 51

Table 12: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014.................................................. 52

Table 13: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013............................. 59

Table 14: Pharmaceutical Market, Global, Planned Filings, Novartis, 2014–2018 ........................................... 60

Table 15: Pharmaceutical Market, DHG Pharmaceutical JSC, Global, Major Products, 2014 .......................... 69

Table 16: Overview of Insurance Providers, Vietnam, Health Insurance Population Coverage (%), 2008–2013

...................................................................................................................................................... 83

Table 17: Overview of Insurance Providers, Vietnam, Health Insurance Population Coverage (million), 2008–

2013 .............................................................................................................................................. 84

Table 18: Overview of Insurance Providers, Vietnam, Patient Share of Healthcare Expenditure (%), 2008–2013

...................................................................................................................................................... 85

Table 19: Healthcare Spending, Vietnam, Price Change (%), 2008–2012 ...................................................... 86


Table of Contents


Table 20: Regulatory Landscape, Vietnam, List of the Generic Drugs Required to Submit BE/BA at the Time of

Approval, 2014............................................................................................................................... 92

Table 21: Regulatory Landscape, Vietnam, Patent Filing Fees and Charges, 2014 ...................................... 100

Table 22: Regulatory Landscape, Vietnam, Trademark Filing Fees and Charges, 2014................................ 100

Table 23: Regulatory Landscape, Vietnam, Labeling Guidelines, 2014 ......................................................... 107

Table 24: Economic Indicators, Vietnam, GDP per Capita ($), 2008–2013 ................................................... 115

Table 25: Economic Indicators, Vietnam, Forecast GDP per Capita ($), 2014–2020 ..................................... 116

Table 26: Economic Indicators, Vietnam, GDP Annual Growth (%), 2008–2013 ........................................... 117

Table 27: Economic Indicators, Vietnam, Forecast GDP Annual Growth (%), 2014–2020 ............................. 118

Table 28: Economic Indicators, Vietnam, GNI per Capita ($), 2008–2013 ..................................................... 119

Table 29: Economic Indicators, Vietnam, Average Consumer Price Index, 2008–2013 ................................. 120

Table 30: Economic Indicators, Vietnam, Average Consumer Price Index, Forecast, 2014–2020 ................. 121

Table 31: Economic Indicators, Vietnam, Average Consumer Price Index Annual Change (%), 2008–2013 . 122

Table 32: Economic Indicators, Vietnam, Average Consumer Price Index Annual Change (%), Forecast, 2014–

2020 ............................................................................................................................................ 123

Table 33: Economic Indicators, Vietnam, Currency Exchange Rate (VND/$), 2008–2013 ............................. 124

Table 34: Economic Indicators, Vietnam, Foreign Direct Investment ($bn), 2008–2013 ................................ 125

Table 35: Economic Indicators, Vietnam, Foreign Exchange Reserves ($bn), 2008–2013 ............................ 126

Table 36: Economic Indicators, Vietnam, Imports of Goods and Services ($bn), 2008–2013 ........................ 127

Table 37: Economic Indicators, Vietnam, Exports of Goods and Services ($bn), 2008–2013 ........................ 128

Table 38: Economic Indicators, Vietnam, General Government Structural Balance ($bn), 2008–2013 .......... 129

Table 39: Economic Indicators, Vietnam, General Government Net Debt (% of GDP), 2008–2013 ............... 130

Table 40: Economic Indicators, Vietnam, Major Industries, Turnover ($bn), 2011, 2012 ............................... 131

Table 41: Demographics, Vietnam, Population (million), 2008–2013 ............................................................ 132

Table 42: Demographics, Vietnam, Forecast Population (million), 2014–2020 .............................................. 133


Table of Contents


Table 43: Demographics, Vietnam, Urban and Rural Population Share (%), 2008–2013 .............................. 134

Table 44: Demographics, Vietnam, Forecast Urban and Rural Population Share (%), 2014–2020 ................ 135

Table 45: Demographics, Vietnam, Distribution by Age Group (%), 2008–2013 ............................................ 136

Table 46: Demographics, Vietnam, Forecast Distribution by Age Group (%), 2014–2020 ............................. 137

Table 47: Demographics, Vietnam, Births (per 1,000 Population), 2008–2013 .............................................. 139

Table 48: Demographics, Vietnam, Mortality (per 1,000 Population), 2008–2013 ......................................... 140

Table 49: Demographics, Vietnam, Major Causes of Mortality (‘000), 2008 .................................................. 141

Table 50: Demographics, Vietnam, Children <5 Mortality Rate (per 1,000 Live Births), 2008–2013............... 142

Table 51: Demographics, Vietnam, Immunization Rate (%), 2008–2013....................................................... 143

Table 52: Demographics, Vietnam, Major Causes of Male Mortality (‘000), 2008 .......................................... 145

Table 53: Demographics, Vietnam, Major Causes of Female Mortality (‘000), 2008 ...................................... 146

Table 54: Demographics, Vietnam, Gender Ratio (M/F), 2008–2013 ............................................................ 147

Table 55: Demographics, Vietnam, Life Expectancy at Birth (Years), 2008–2013 ......................................... 148

Table 56: Demographics, Vietnam, Forecast Life Expectancy at Birth (Years), 2014–2020........................... 149

Table 57: Demographics, Vietnam, Gross Enrollment (%), 2008–2013 ......................................................... 151

Table 58: Demographics, Vietnam, Unemployment (%), 2008–2013 ............................................................ 152

Table 59: Demographics, Vietnam, Major Disease Prevalence (%), 2012 ..................................................... 154

Table 60: Demographics, Vietnam, DALY (per 100,000 Population), 2004 ................................................... 155

Table 61: Healthcare Infrastructure, Vietnam, Health Establishments, 2008–2013 ....................................... 158

Table 62: Healthcare Infrastructure, Vietnam, Number of Beds by Type of Establishment, 2008–2013 ......... 159

Table 63: Healthcare Infrastructure, Vietnam, Hospital Beds (per 1,000 Population), 2008–2013 ................. 161

Table 64: Healthcare Infrastructure, Vietnam, Practicing Physicians (per 1,000 Population), 2008–2013 ...... 162

Table 65: Environmental Health, Vietnam, PM10 (µg/m3), 2008–2013 .......................................................... 163

Table 66: Environmental Health, Vietnam, CO2 Emissions (million tons), 2008–2013 ................................... 164


Table of Contents


Table 67: Healthcare Personnel, Vietnam, Nurses (per 100,000 Population), 2008–2013 ............................. 167

Table 68: Healthcare Personnel, Vietnam, Midwives (per 100,000 Population), 2008–2013 ......................... 167

Table 69: Healthcare Personnel, Vietnam, Pharmacists (per 100,000 Population), 2008–2013..................... 168

Table 70: Healthcare Expenditure, Vietnam, Healthcare Expenditure (% of GDP), 2008–2013 ..................... 169

Table 71: Healthcare Expenditure, Vietnam, Share of Major Components (%), 2007 .................................... 170

Table 72: Healthcare Expenditure, Vietnam, Public–Private Share (%), 2008–2013 ..................................... 171

Table 73: Trade Fairs, Vietnam, Major Healthcare Trade Fairs, 2014 ........................................................... 174


Table of Contents


1.2 List of Figures

Figure 1: Pharmaceutical Market, Vietnam, Revenue ($bn), 2008–2013 ...................................................... 21

Figure 2: Pharmaceutical Market, Vietnam, Revenue Forecast ($bn), 2014–2020........................................ 22

Figure 3: Pharmaceutical Market, Vietnam, Imports and Exports ($bn), 2008–2013 ..................................... 23

Figure 4: Pharmaceutical Market, Vietnam, Distribution Chain, 2014 ........................................................... 24

Figure 5: Pharmaceutical Market, Vietnam, OTC, Major Segment Share (%), 2010 ..................................... 29

Figure 6: Healthcare Market, Indonesia, Drivers and Barriers, 2014 ............................................................. 75

Figure 7: Market Access, Vietnam, Healthcare System, 2014 ...................................................................... 77

Figure 8: Overview of Insurance Providers, Vietnam, Funding to Healthcare System, 2014 ......................... 81

Figure 9: Overview of Insurance Providers, Vietnam, Health Insurance Population Coverage (%), 2008–2013

.................................................................................................................................................... 82

Figure 10: Overview of Insurance Providers, Vietnam, Health Insurance Population Coverage (million), 2008–

2013 ............................................................................................................................................. 83

Figure 11: Overview of Insurance Providers, Vietnam, Patient Share of Healthcare Expenditure (%), 2008–

2013 ............................................................................................................................................. 84

Figure 12: Healthcare Spending, Vietnam, Price Change (%), 2008–2012 ..................................................... 85

Figure 13: Regulatory Landscape, Vietnam, New Drug Approval Process, 2014 ............................................ 91

Figure 14: Regulatory Landscape, Vietnam, Generic Drug Approval Process, 2014 ....................................... 94

Figure 15: Regulatory Landscape, Vietnam, Patent and Trademark Approval Process, 2014 ....................... 101

Figure 16: Economic Indicators, Vietnam, GDP per Capita ($), 2008–2013 .................................................. 115

Figure 17: Economic Indicators, Vietnam, Forecast GDP per Capita ($), 2014–2020.................................... 116

Figure 18: Economic Indicators, Vietnam, GDP Annual Growth (%), 2008–2013 .......................................... 117

Figure 19: Economic Indicators, Vietnam, Forecast GDP Annual Growth (%), 2014–2020 ........................... 118

Figure 20: Economic Indicators, Vietnam, GNI per Capita ($), 2008–2013 ................................................... 119

Figure 21: Economic Indicators, Vietnam, Average Consumer Price Index, 2008–2013................................ 120


Table of Contents


Figure 22: Economic Indicators, Vietnam, Average Consumer Price Index, Forecast, 2014–2020 ................ 121

Figure 23: Economic Indicators, Vietnam, Average Consumer Price Index Annual Change (%), 2008–2013 122

Figure 24: Economic Indicators, Vietnam, Average Consumer Price Index Annual Change (%), Forecast,

2014–2020 ................................................................................................................................. 123

Figure 25: Economic Indicators, Vietnam, Currency Exchange Rate (VND/$), 2008–2013............................ 124

Figure 26: Economic Indicators, Vietnam, Foreign Direct Investment ($bn), 2008–2013 ............................... 125

Figure 27: Economic Indicators, Vietnam, Foreign Exchange Reserves ($bn), 2008–2013 ........................... 126

Figure 28: Economic Indicators, Vietnam, Imports of Goods and Services ($bn), 2008–2013 ....................... 127

Figure 29: Economic Indicators, Vietnam, Exports of Goods and Services ($bn), 2008–2013 ....................... 128

Figure 30: Economic Indicators, Vietnam, General Government Structural Balance ($bn), 2008–2013 ......... 129

Figure 31: Economic Indicators, Vietnam, General Government Net Debt (%), 2008–2013 .......................... 130

Figure 32: Economic Indicators, Vietnam, Major Industries, Turnover ($bn), 2011 and 2012 ........................ 131

Figure 33: Demographics, Vietnam, Population (million), 2008–2013 ........................................................... 132

Figure 34: Demographics, Vietnam, Forecast Population (million), 2014–2020 ............................................. 133

Figure 35: Demographics, Vietnam, Urban and Rural Population Share (%), 2008–2013 ............................. 134

Figure 36: Demographics, Vietnam, Forecast Urban and Rural Population Share (%), 2014–2020 ............... 135

Figure 37: Demographics, Vietnam, Distribution by Age Group (%), 2008–2013........................................... 136

Figure 38: Demographics, Vietnam, Forecast Distribution by Age Group (%), 2014–2020 ............................ 137

Figure 39: Demographics, Vietnam, Births (per 1,000 Population), 2008–2013 ............................................ 138

Figure 40: Demographics, Vietnam, Mortality (per 1,000 Population), 2008–2013 ........................................ 139

Figure 41: Demographics, Vietnam, Major Causes of Mortality (‘000), 2008 ................................................. 140

Figure 42: Demographics, Vietnam, Children <5 Mortality Rate (per 1,000 Live Births), 2008–2013 ............. 142

Figure 43: Demographics, Vietnam, Immunization Rate (%), 2008–2013 ..................................................... 143

Figure 44: Demographics, Vietnam, Major Causes of Male Mortality (‘000), 2008 ......................................... 144

Figure 45: Demographics, Vietnam, Major Causes of Female Mortality (‘000), 2008 ..................................... 146


Table of Contents


Figure 46: Demographics, Vietnam, Gender Ratio (M/F), 2008–2013 ........................................................... 147

Figure 47: Demographics, Vietnam, Life Expectancy at Birth (Years), 2008–2013 ........................................ 148

Figure 48: Demographics, Vietnam, Forecast Life Expectancy at Birth (Years), 2014–2020 ......................... 149

Figure 49: Demographics, Vietnam, Gross Enrollment (%), 2008–2013 ....................................................... 151

Figure 50: Demographics, Vietnam, Unemployment (%), 2008–2013 ........................................................... 152

Figure 51: Demographics, Vietnam, Major Diseases Prevalence (%), 2012 .................................................. 153

Figure 52: Demographics, Vietnam, DALY (per 100,000 Population), 2004 .................................................. 155

Figure 53: Healthcare Infrastructure, Vietnam, Healthcare System, 2014 ..................................................... 157

Figure 54: Healthcare Infrastructure, Vietnam, Health Establishments, 2008–2013 ...................................... 158

Figure 55: Healthcare Infrastructure, Vietnam, Number of Beds by Type of Establishment, 2008–2013 ........ 159

Figure 56: Healthcare Infrastructure, Vietnam, Hospital Beds (per 1,000 Population), 2008–2013 ................ 160

Figure 57: Healthcare Infrastructure, Vietnam, Practicing Physicians (per 100,000 Population), 2008–2013 . 161

Figure 58: Environmental Health, Vietnam, PM10 (µg/m3), 2008–2013 ........................................................ 163

Figure 59: Environmental Health, Vietnam, CO2 Emissions (million tons), 2008–2013 .................................. 164

Figure 60: Healthcare Personnel, Vietnam, Nurses (per 100,000 Population), 2008–2013 ........................... 166

Figure 61: Healthcare Personnel, Vietnam, Midwives (per 100,000 Population), 2008–2013 ........................ 167

Figure 62: Healthcare Personnel, Vietnam, Pharmacists (per 100,000 Population), 2008–2013 ................... 168

Figure 63: Healthcare Expenditure, Vietnam, Healthcare Expenditure (% of GDP), 2008–2013 .................... 169

Figure 64: Healthcare Expenditure, Vietnam, Share of Major Components (%), 2007 ................................... 170

Figure 65: Healthcare Expenditure, Vietnam, Public–Private Share (%), 2008–2013 .................................... 171

Figure 66: Healthcare Market, Vietnam, Opportunities and Challenges, 2014 ............................................... 177



Introduction

2 Introduction

2.1 GlobalData Report Guidance

The report begins with an executive summary, which gives an overview of Vietnam’s

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

regulatory and reimbursement landscape and the healthcare infrastructure of the country.

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

covering size; the respective shares of generic, Over-The-Counter (OTC) and

biologic/biosimilar products 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 Vietnam.

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 Vietnam

and analyzes economic indicators, demographics and healthcare infrastructure and

expenditure data.

Chapter six gives an overview of the opportunities for and challenges to growth in Vietnam’s

healthcare market.


Overview of the Pharmaceutical and Medical Device Markets


3.1.2 Pharmaceutical Imports and Exports

In 2008, the value of pharmaceutical imports was approximately $XX billion, which increased to an

estimated $XX billion in 2013 with a CAGR of XX%. Pharmaceutical exports were valued at

approximately $XX billion in 2008, which increased to an estimated $XX billion in 2013 at a CAGR

of XX%.

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

2008 2009 2010 2011 2012 2013*

Rev

enue

($bn

)

Imports

Exports

Source: ITC, 2014 *Estimated figure

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

Imports

Exports

Source: ITC, 2014

*Estimated figure


Country Analysis


5.5.5.2 Major Components of Healthcare Spending

In Vietnam, household out-of-pocket expenditure accounted for approximately XX% of total

healthcare expenditure in 2007, followed by provincial government budget expenditure (XX%) and

social health insurance (XX%). The share of the central government was XX% (WHO, 2011a).

Figure 64: Healthcare Expenditure, Vietnam, Share of Major Components (%), 2007

Household out-of-pocket expenditure

Provincial government budget

Social health insurance

Other private spending

Central government budget

Official development assistance

Source: WHO, 2011b

Table 71: Healthcare Expenditure, Vietnam, Share of Major Components (%), 2007 Component Expenditure

Household out-of-pocket expenditure

Provincial government budget

Social health insurance

Other private spending

Central government budget

Official development assistance

Source: WHO, 2011b


Appendix


7 Appendix

7.1 Abbreviations

ADB: Asian Development Bank

AIDS: Acquired Immune Deficiency Syndrome

AFTA: ASEAN Free Trade Area

AMP: Agence de Médecine Préventive (Agency for Preventative Medicine)

ANSORP: Asian Network for Surveillance of Resistant Pathogens

APEC: Asia-Pacific Economic Cooperation

ASEAN: Association of Southeast Asian Nations

BE/BA: Bioequivalence/bioavailability

BTA: Bilateral Trade Agreement

CAGR: Compound Annual Growth Rate

CBS: Community-based Service

CDM: Clean Development Mechanism

CFS: Certificate of Free Sale

CHS: Commune Health Station

CIF: Cost Insurance and Freight

CNS: Central Nervous System

Comecon: Council for Mutual Economic Assistance

COPD: Chronic Obstructive Pulmonary Disease

CO2: Carbon Dioxide

CPI: Consumer Price Index

CPP: Certificate Pharmaceutical Product

CPV: Communist Party of Vietnam


Appendix


CPRGS: Comprehensive Poverty Reduction and Growth Strategy

CTD: Common Technical Document

DALY: Disability Adjusted Life Year

DAV: Drug Administration of Vietnam

DNA: Deoxyribonucleic Acid

DPT: Diphtheria, Pertussis and Tetanus

EMA: European Medicines Agency

ENT: Ear, Nose and Throat

FDA: Food and Drug Administration

FDI: Foreign Direct Investment

FSC: Free Sale Certificate

FTA: Free Trade Area

GMP: Good Manufacturer Practice

GPP: Good Pharmacy Practice

HBV: Hepatitis B Vaccine

HeFH: Heterozygous familial hypercholesterolemia

HEPR: Hunger Eradication and Poverty Reduction

HFA: Hydrofluoroalkane

HIPC: Heavily Indebted Poor Country

HIV: Human Immunodeficiency Virus

HPI: Health Policy Initiative

ICH: International Conference on Harmony

IDF: International Diabetes Federation

ISO: International Organization for Standardization


Appendix


mg: milligrams

ml: milliliter

MNC: Multinational Company

MoH: Ministry of Health

MoIT: Ministry of Industry and Trade

MoST: Ministry of Science and Technology

NCD: Non-communicable Disease

NHTP: National Health Target Program

NHE3: Sodium–Hydrogen Exchanger-3

NIBR: Novartis Institutes for Biomedical Research

NIHE: National Institute of Hygiene and Epidemiology

NITAG: National Immunization Technical Advisory Groups

NME: New Molecular Entity

NOIP: National Office of Intellectual Property

NRC: National Research Council

NSCLC: Non-Small-Cell Lung Carcinoma

NVGH: Novartis Vaccine Institute for Global Health

OA: Osteoarthritis

OECD: Organization for Economic Cooperation and Development

ODA: Official Development Assistance

OTC: Over-the-Counter

PCT: Patent Cooperation Treaty

PJICO: Petrolimex Joint Stock Insurance Company

pMDI: pressurized Metered Dose Inhaler


Appendix


PM10: Particulate Matter of ≤10µm diameter

PRSP: Poverty Reduction Strategy Paper

PSR: Proliferative Sickle Retinopathy

PVI: Petro Vietnam Insurance

RA: Rheumatoid Arthritis

RNA: Ribonucleic Acid

RSV: Respiratory Syncytial Virus

R&D: Research and Development

SARS: Severe Acute Respiratory Syndrome

SDR: Special Drawing Right

SHI: Social Health Insurance

SIVAC: Supporting National Independent Immunization and Vaccine Advisory Committee

TPPA: Trans-Pacific Partnership Agreement

TPP: Trans-Pacific Partnership

VHW: Village Health Worker

VHI: Voluntary Health Insurance

VND: Vietnamese Dong

VNGAMP: Vietnam General Association of Medicine and Pharmacy

VNPCA: Vietnam Pharmaceutical Companies Association

VPHA: Vietnam Public Health Association

WIPO: World Intellectual Property Organization

WTO: World Trade Organization

µg: microgram

µg/m3: microgram per cubic meter


Appendix


µm: micrometer

7.2 Bibliography

10times (2014). Medical & Pharmaceutical Trade Shows in Vietnam. 10times. Available from:

http://10times.com/vietnam/medical-pharma/tradeshows [Accessed on April 2, 2014]

AMP (2012). Healthcare Policy Initiatives. Agence de Médecine Préventive. Available from:

http://www.amp-vaccinology.org/asia [Accessed on April 5, 2014]

ASEAN (2014). ASEAN Labeling Requirements. Association of Southeast Asian

Nations. Available from: http://www.asean.org/images/archive/20605.pdf

ADRA (2014). Statistics. Adventist Development and Relief Agency. Available from:

http://www.adravietnam.org/index.php?option=com_content&view=article&id=48%3Astatistics&

catid=34%3Ageneral-articles&Itemid=56&lang=en [Accessed on April 3, 2014]

Asian Development Bank (2014). Unemployment rate. Asian Development Bank. Available

from: https://sdbs.adb.org/sdbs/jsp/index.jsp [Accessed on April 4, 2014]

AstraZeneca (2013). Annual Report 2013. AstraZeneca. Available from:

http://www.astrazeneca-

annualreports.com/2013/_assets/pdfs/AstraZeneca_Annual_Report_2013.pdf

AstraZeneca (2014). AstraZeneca Developmental Pipeline. AstraZeneca. Available from:

http://www.astrazeneca.com/cs/Satellite?blobcol=urldata&blobheader=application%2Fpdf&blob

headername1=Content-Disposition&blobheadername2=MDT-

Type&blobheadervalue1=inline%3B+filename%3DDevelopment-pipeline-

table.pdf&blobheadervalue2=abinary%3B+charset%3DUTF-

8&blobkey=id&blobtable=MungoBlobs&blobwhere=1285670352026&ssbinary=true

Business Times (2011). “Pharmaceutical Options Good Medicine For Firms”, Business Times,

August 25, 2011. Available from: http://businesstimes.com.vn/pharmaceutical-options-good-

medicine-for-firms/ [Accessed on April 4, 2014]

Dasgupta S (2014). "India warned against exploring oil in disputed South China Sea", The

Times of India, February 20, 2014. Available

from: http://timesofindia.indiatimes.com/world/china/India-warned-against-exploring-oil-in-

disputed-South-China-Sea/articleshow/30701439.cms [Accessed on April 15, 2014]


Appendix


WHO (2011c). Vietnam Non-communicable Disease Prevention and Control Program 2002–

2010. World Health Organization. Available from:

http://www.wpro.who.int/vietnam/topics/chronic_diseases/vietnam_noncommunicable_disease

_prevention_and_control_program_2002_2010_imple_review.pdf?ua=1

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

US Securities and Exchanges Commission (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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