CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia

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Date: 13-Sep-2016
No. of pages: 167
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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

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia

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

1.1 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 (µg/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

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 (µg/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
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