CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia


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Executive Summary

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia

Summary

GlobalData, the industry analysis specialist, has released its latest report, "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia". The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Malaysia. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData's team of industry experts.

In 2015, Malaysia's population stood at 31 million. The past five years have seen steady population growth, which is expected to continue in the future due to a high birth rate, low mortality rate and increased life expectancy. Government initiatives such as Entry Point Projects (EPPs), specifically EPP3, and National Key Economic Areas (NKEAs) to increase investment in the pharmaceutical industry have so far have been successful. The country's pharmaceutical market was estimated at $2.3 billion in 2015 and is projected to reach approximately $3.6 billion by 2020 at a CAGR of 9.5%. The medical device market was worth an estimated $1.7 billion in 2015, but is growing and currently constitutes approximately 25% of the healthcare expenditure.

These positive trends can primarily be attributed to -

- An increasing elderly population

- Government initiatives to improve healthcare facilities

- An increase in medical tourism

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Malaysia, and includes -

- An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers

- Profiles and SWOT analyses of the major players in the pharmaceutical market: Pharmaniaga Berhad, Chemical Company of Malaysia Berhad (CCM), Yung Shin Pharmaceutical, Hovid and Kotra Pharma

- Insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs and medical devices

- Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure

- An overview of the opportunities for and challenges to growth in the Malaysian healthcare market

Reasons to buy

This report will enhance your decision-making capability by allowing you to -

- Develop business strategies by understanding the trends shaping and driving Malaysia's healthcare market

- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market in the future

- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors

- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership

- Identify, understand, and capitalize on the opportunities and challenges in Malaysia's healthcare market



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1 Table of Contents

1 Table of Contents 6

1.1 List of Tables 9

1.2 List of Figures 12

2 Introduction 16

2.1 GlobalData Report Guidance 16

3 Overview of the Pharmaceutical and Medical Device Markets 17

3.1 Pharmaceutical Market 17

3.1.1 Market Overview 17

3.1.2 Pharmaceutical Exports and Imports 20

3.1.3 Supply Channels 21

3.1.4 Market Segments 22

3.1.5 Major Disease Areas 23

3.1.6 Major Companies 25

3.2 Medical Device Market 54

3.3 Market Drivers and Barriers 57

3.3.1 Drivers 57

3.3.2 Barriers 58

4 Market Access 60

4.1 Reimbursement and Payer Landscape 60

4.1.1 Overview of Healthcare System 60

4.1.2 Reimbursement Process 61

4.1.3 Overview of Insurance Providers 62

4.1.4 Patient Share in Healthcare Spending 65

4.1.5 Price Trends in the Healthcare Sector 66

4.1.6 Pricing Policies 67

4.2 Regulatory Landscape 67

4.2.1 Overview of Regulatory Agencies 67

4.2.2 Market Authorization Procedure for Pharmaceutical Products 68

4.2.3 Market Authorization Procedure for Medical Devices 73

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 74

4.2.5 Licensing Process for Pharmaceutical Exports and Imports 76

4.2.6 Halal Certification Process 77

4.2.7 Intellectual Property Rights 78

4.2.8 Clinical Trial Regulations 82

4.2.9 Pharmaceutical Advertising Regulations 86

4.2.10 Pharmacy Regulations 88

4.2.11 Labeling and Packaging Regulations 89

5 Country Analysis 91

5.1 Political Environment 91

5.1.1 Political Structure 91

5.1.2 Analysis of the Current Political Environment 93

5.1.3 Healthcare Policy Initiatives 94

5.2 Economic Landscape 96

5.3 Economic Indicators 98

5.3.1 Gross Domestic Product 98

5.3.2 Gross National Income 102

5.3.3 Inflation 103

5.3.4 Currency Exchange Rate 106

5.3.5 Foreign Direct Investment 107

5.3.6 Foreign Exchange Reserves 108

5.3.7 Trade Balance 109

5.3.8 General Government Structural Balance 111

5.3.9 General Government Gross Debt 112

5.3.10 Major Industries 114

5.4 Demographics 115

5.4.1 Population 115

5.4.2 Education and Literacy 130

5.4.3 Employment 131

5.4.4 Disease Burden 132

5.5 Healthcare Infrastructure 135

5.5.1 Healthcare Facilities 135

5.5.2 Healthcare Parameters 138

5.5.3 Environmental Health 140

5.5.4 Healthcare Personnel 142

5.6 Healthcare Expenditure 145

5.6.1 Overview 145

5.6.2 Major Components of Healthcare Spending 146

5.6.3 Public and Private Sector Share 147

5.6.4 Spending in Healthcare R&D 148

5.7 Trade Associations 149

5.7.1 Pharmaceutical Association of Malaysia 149

5.7.2 Malaysian Organization of Pharmaceutical Industries 149

5.7.3 Association of Private Hospital Malaysia 149

5.7.4 Association of Malaysian Medical Industries 149

5.8 Trade Fairs 150

6 Opportunities and Challenges 151

6.1 Opportunities 151

6.2 Challenges 151

7 Appendix 153

7.1 Abbreviations 153

7.2 Bibliography 157

7.3 Research Methodology 164

7.3.1 Coverage 165

7.3.2 Secondary Research 165

7.3.3 Forecasts 166

7.3.4 Expert Panel 166

7.4 Disclaimer 166

1.2 List of Figures

Figure 1: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008-2015 18

Figure 2: Pharmaceutical Market, Malaysia, Revenue Forecast ($bn), 2016-2020 19

Figure 3: Pharmaceutical Market, Malaysia, Exports and Imports ($m), 2008-2015 20

Figure 4: Pharmaceutical Market, Malaysia, Supply Channels, 2014 21

Figure 5: Medical Device Market, Malaysia, Revenue ($bn), 2008-2015 55

Figure 6: Medical Device Market, Malaysia, Revenue ($bn), 2016-2020 56

Figure 7: Healthcare Market, Malaysia, Drivers and Barriers, 2016 59

Figure 8: Market Access, Malaysia, Overview of Healthcare System 61

Figure 9: Market Access, Malaysia, Out-of-Pocket Expenditure (%), 2008-2015 65

Figure 10: Market Access, Price of Healthcare Products, Malaysia, Change in Average Price of Healthcare Services, 2008-2015 66

Figure 11: Market Access, Malaysia, Generic Drug Marketing Authorization, 2014 71

Figure 12: Market Access, Malaysia, New Drug Marketing Authorization Procedure, 2014 72

Figure 13: Regulatory Landscape, Malaysia, Medical Device Approval Process, 2015 74

Figure 14: Regulatory Landscape, Malaysia, Licensing Process for Pharmaceutical Manufacturing, 2015 75

Figure 15: Regulatory Landscape, Malaysia, Licensing Process for Medical Device Manufacturing, 2015 76

Figure 16: Market Access, Malaysia, Patent Approval Process, 2014 80

Figure 17: Market Access, Malaysia, Trademark Approval Process, 2014 82

Figure 18: Market Access, Malaysia, Clinical Trial Regulation Process, 2011 84

Figure 19: Market Access, Malaysia, Clinical Trial Regulation Process, 2011 86

Figure 20: Market Access, Malaysia, Pharmaceutical Advertisement Approval Process, 2014 88

Figure 21: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008-2015 98

Figure 22: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2016-2020 99

Figure 23: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008-2015 100

Figure 24: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2016-2020 101

Figure 25: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008-2015 102

Figure 26: Economic Indicators, Malaysia, Consumer Price Index, 2008-2015 103

Figure 27: Economic Indicators, Malaysia, Consumer Price Index, 2016-2020 104

Figure 28: Economic Indicators, Malaysia, Consumer Price Annual Change (%), 2008-2015 105

Figure 29: Economic Indicators, Malaysia, Currency Exchange Rate ($/MYR) 2008-2015 106

Figure 30: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008-2015 107

Figure 31: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008-2015 108

Figure 32: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008-2015 109

Figure 33: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008-2015 110

Figure 34: Economic Indicators, Malaysia, Government Structural Balance ($bn), 2008-2015 111

Figure 35: Economic Indicators, Malaysia, General Government Gross Debt ($bn), 2008-2015 112

Figure 36: Economic Indicators, Malaysia, General Government Net Debt ($bn), 2016-2020 113

Figure 37: Economic Indicators, Malaysia, Major Industries, Population Employed (million), 2015 114

Figure 38: Demographics, Malaysia, Population (million), 2008-2015 115

Figure 39: Demographics, Malaysia, Population (million), 2016-2020 116

Figure 40: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2008-2015 117

Figure 41: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2016-2020 118

Figure 42: Demographics, Malaysia, Population Distribution by Age Group (%), 2008-2015 119

Figure 43: Demographics, Malaysia, Population Distribution by Age Group (%), 2016-2020 120

Figure 44: Demographics, Malaysia, Births (per 1,000 population), 2008-2015 121

Figure 45: Demographics, Malaysia, Mortality (per 1,000 population), 2008-2015 122

Figure 46: Demographics, Malaysia, Major Causes of Mortality (%), 2011 123

Figure 47: Demographics, Malaysia, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015 124

Figure 48: Demographics, Malaysia, Immunization Rate (%), 2008-2015 125

Figure 49: Demographics, Malaysia, Major Causes of Mortality in Males (%), 2013 126

Figure 50: Demographics, Malaysia, Major Causes of Mortality in Females (%), 2013 127

Figure 51: Demographics, Malaysia, Gender Ratio (M/F), 2008-2015 128

Figure 52: Demographics, Malaysia, Life Expectancy at Birth (years), 2008-2015 129

Figure 53: Demographics, Malaysia, Gross Enrollment by Level of Education (%), 2008-2015 130

Figure 54: Demographics, Malaysia, Unemployment Rate (%), 2008-2015 131

Figure 55: Demographics, Malaysia, Patients Hospitalized (%), 2013 132

Figure 56: Demographics, Malaysia, Disability-Adjusted Life Years by Major Disease (000), 2014 134

Figure 57: Healthcare Infrastructure, Malaysia, Hospitals, 2008-2015 135

Figure 58: Healthcare Infrastructure, Malaysia, Public and Private Hospitals, 2008-2015 136

Figure 59: Healthcare Infrastructure, Malaysia, Diagnostic Units (per million population), 2008-2015 137

Figure 60: Healthcare Infrastructure, Malaysia, Hospital Beds (per 1,000 population), 2008-2015 138

Figure 61: Healthcare Infrastructure, Malaysia, Doctors (per 1,000 population), 2008-2015 139

Figure 62: Healthcare Infrastructure, Malaysia, PM2.5 (g/m3), 2008-2015 140

Figure 63: Healthcare Infrastructure, Malaysia, CO2 Emissions (metric tons per capita), 2008-2015 141

Figure 64: Healthcare Infrastructure, Malaysia, Nurses (per 1,000 population), 2008-2015 142

Figure 65: Healthcare Infrastructure, Malaysia, Dentist (per 1,000 population), 2008-2015 143

Figure 66: Healthcare Infrastructure, Malaysia, Pharmacists (per 1,000 population), 2008-2015 144

Figure 67: Healthcare Expenditure, Malaysia, Healthcare Expenditure (% of GDP), 2008-2015 145

Figure 68: Public Healthcare Expenditure, Malaysia, Share of Major Components (%), 2011 146

Figure 69: Healthcare Expenditure, Malaysia, Public-Private Share of Healthcare Expenditure (%), 2008-2015 147

Figure 70: Healthcare Expenditure, Malaysia, R&D Expenditure by Field of Research (%), 2012 148

Figure 71: Healthcare Market, Malaysia, Opportunities and Challenges, 2016 152

1.1 List of Tables

Table 1: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008-2015 18

Table 2: Pharmaceutical Market, Malaysia, Revenue Forecast ($bn), 2016-2020 19

Table 3: Pharmaceutical Market, Malaysia, Exports and Imports ($m), 2008-2015 20

Table 4: Pharmaceutical Market, Pharmaniaga, Major Products, 2016 26

Table 5: Pharmaceutical Market, Chemical Company of Malaysia, Global, Major Products, 2016 32

Table 6: Pharmaceutical Market, Major Products, YSP, 2014 38

Table 7: Pharmaceutical Market, Major Products, Hovid, 2016 44

Table 8: Pharmaceutical Market, Kotra Pharma Major Products, 2015 50

Table 9: Medical Device Market, Malaysia, Revenue ($bn), 2008-2015 55

Table 10: Medical Device Market, Malaysia, Revenue ($bn), 2016-2020 56

Table 11: Healthcare System, Malaysia, Contribution to Insurance Fund (%), 2013 63

Table 12: Market Access, Malaysia, Out-of-Pocket Expenditure (%), 2008-2015 65

Table 13: Market Access, Price of Healthcare Products, Malaysia, Change in Average Price of Healthcare Services (%), 2008-2015 66

Table 14: Regulatory Landscape, Malaysia, Patent Fees, 2015 80

Table 15: Analysis of Current Political Environment, Malaysia, National Key Results Areas 94

Table 16: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008-2015 99

Table 17: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2016-2020 99

Table 18: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008-2015 100

Table 19: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2016-2020 101

Table 20: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008-2015 102

Table 21: Economic Indicators, Malaysia, Consumer Price Index, 2008-2015 103

Table 22: Economic Indicators, Malaysia, Consumer Price Index, 2016-2020 104

Table 23: Economic Indicators, Malaysia, Consumer Price Annual Change (%), 2008-2015 105

Table 24: Economic Indicators, Malaysia Currency Exchange Rate ($/MYR) 2008-2015 106

Table 25: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008-2015 107

Table 26: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008-2015 108

Table 27: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008-2015 109

Table 28: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008-2015 110

Table 29: Economic Indicators, Malaysia, Government Structural Balance ($bn), 2008-2015 111

Table 30: Economic Indicators, Malaysia, General Government Gross Debt ($bn), 2008-2015 112

Table 31: Economic Indicators, Malaysia, General Government Net Debt ($bn), 2016-2020 113

Table 32: Economic Indicators, Malaysia, Major Industries, Population Employed (million), 2015 114

Table 33: Demographics, Malaysia, Population (million), 2008-2015 115

Table 34: Demographics, Malaysia, Population (million), 2016-2020 116

Table 35: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2008-2015 117

Table 36: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2016-2020 118

Table 37: Demographics, Malaysia, Population Distribution by Age Group (%), 2008-2015 119

Table 38: Demographics, Malaysia, Population Distribution by Age Group Forecast (%), 2016-2020 120

Table 39: Demographics, Malaysia, Births (per 1,000 population), 2008-2015 121

Table 40: Demographics, Malaysia, Mortality (per 1,000 population), 2008-2015 122

Table 41: Demographics, Malaysia, Major Causes of Mortality (%), 2011 123

Table 42: Demographics, Malaysia, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015 124

Table 43: Demographics, Malaysia, Immunization Rate (%), 2008-2015 125

Table 44: Demographics, Malaysia, Major Causes of Mortality in Males (%), 2013 126

Table 45: Demographics, Malaysia, Major Causes of Mortality in Females (%), 2013 127

Table 46: Demographics, Malaysia, Gender Ratio (M/F), 2008-2015 128

Table 47: Demographics, Malaysia, Life Expectancy at Birth (years), 2008-2015 129

Table 48: Demographics, Malaysia, Gross Enrollment by Level of Education (%), 2008-2015 131

Table 49: Demographics, Malaysia, Unemployment Rate (%), 2008-2015 132

Table 50: Demographics, Malaysia, Patients Hospitalized (%), 2013 133

Table 51: Demographics, Malaysia, Disability-Adjusted Life Years by Major Disease (000), 2012 134

Table 52: Healthcare Infrastructure, Malaysia, Health Establishments, 2008-2015 135

Table 53: Healthcare Infrastructure, Malaysia, Public and Private Hospitals, 2008-2015 136

Table 54: Healthcare Infrastructure, Malaysia, Diagnostic Units (per million population), 2008-2015 137

Table 55: Healthcare Infrastructure, Malaysia, Hospital Beds (per 1,000 population), 2008-2015 138

Table 56: Healthcare Infrastructure, Malaysia, Doctors (per 1,000 population), 2008-2015 139

Table 57: Healthcare Infrastructure, Malaysia, PM2.5 (g/m3), 2008-2015 140

Table 58: Healthcare Infrastructure, Malaysia, CO2 Emissions (metric tons per capita), 2008-2015 141

Table 59: Healthcare Infrastructure, Malaysia, Nurses (per 1,000 population), 2008-2015 142

Table 60: Healthcare Infrastructure, Malaysia, Dentists (per 1,000 population), 2008-2015 143

Table 61: Healthcare Infrastructure, Malaysia, Pharmacists (per 1,000 population), 2008-2015 144

Table 62: Healthcare Expenditure, Malaysia, Healthcare Expenditure (% of GDP), 2008-2015 145

Table 63: Public Healthcare Expenditure, Malaysia, Share of Major Components (%), 2006 146

Table 64: Healthcare Expenditure, Malaysia, Healthcare Expenditure, Public-Private Share (%), 2008-2015 147

Table 65: Healthcare Expenditure, Malaysia, R&D Expenditure by Field of Research (%), 2012 148

Table 66: Healthcare Expenditure, Malaysia, Major Healthcare Trade Fairs, 2016 150

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