Healthcare, Regulatory and Reimbursement Landscape - Malaysia



Summary



GlobalData, the industry analysis specialist, has released its new report, “Healthcare, Regulatory and Reimbursement Landscape - Malaysia”. The report is an essential source of information and an analysis on the healthcare, regulatory and reimbursement landscape of Malaysia. The report identifies the key trends in the healthcare market of Malaysia. The report also provides insights on the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Malaysia. Most importantly, the report provides valuable insights on the trends and segmentation of pharmaceutical market. This report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData’s team of industry experts.

Malaysia was the 43rd most populated country in the world with a population of approximately 28 million in 2010. The population of Malaysia is increasing due to high birth rate and low mortality rate as well as increase in life expectancy. The increase in the population of the working age group supports the country in development while increasing elderly population is a matter of concern for the policy planners. The pharmaceutical market in Malaysia was estimated at $1.2 billion in 2010 and is expected to reach approximately $3.4 billion by 2020 at a projected compound annual growth rate (CAGR) of 10.9% between 2011 and 2020.

The positive trend in the healthcare market of Malaysia can be attributed primarily to -
- Increasing elderly population
- Increase in prevalence of chronic disease due to sedentary lifestyle
- Increase in medical tourism
- Easy access to healthcare facilities
- Initiatives of the government for the prevention and management of chronic diseases
- Easy regulatory guidlenes for registration of new drug



Scope


The report provides information on the healthcare, regulatory and reimbursement landscape of Malaysia. The scope includes -
- Overview of the pharmaceutical market of Malaysia including the market size, market segmentation, key drivers and barriers for the market.
- Profile and SWOT analysis of the major players in the pharmaceutical market. Key players covered for the pharmaceutical market are Chemical Company of Malaysia, Pharmaniaga and Hovid.
- Insightful review on the reimbursement and regulatory landscape. Analysis includes details of the healthcare reimbursement process, regulatory agencies and marketing authorization process for new drug and medical devices for Malaysia.
- A detailed analysis of the political and economic environment of Malaysia including the economic indicators, demographics, healthcare infrastructure and healthcare expenditure.
- An overview of the opportunities and challenges for growth that exist in the healthcare market of Malaysia.



Reasons to buy


The report on Malaysia comprehensively covers both the pharmaceutical market of Malaysia. The report will enhance your decision making capability. It will allow you to -
- Develop business strategies by understanding the trends shaping and driving the healthcare market of Malaysia.
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the Malaysian healthcare market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- Identify, understand and capitalize on the opportunities and challenges in the healthcare market of Malaysia.

Table Of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 9
2 Overview of the Pharmaceutical and Medical Devices Market 11
2.1 Pharmaceutical Market 11
2.1.1 Market Overview 11
2.1.2 Supply Channels 15
2.1.3 Market Segments 16
2.1.4 Major Therapeutic Areas 21
2.1.5 Major Players 27
2.2 Medical Device Market 51
2.2.1 Market Overview 51
2.3 Market Drivers and Barriers 52
2.3.1 Drivers 52
2.3.2 Barriers 53
3 Market Access 55
3.1 Reimbursement and Payer Landscape 55
3.1.1 Reimbursement Process 56
3.1.2 Overview of Insurance Providers 59
3.1.3 Patient Share in Healthcare Spending 61
3.1.4 Price Trend in Healthcare Services 62
3.1.5 Pricing Policies 62
3.2 Regulatory Landscape 63
3.2.1 Overview of Regulatory Agencies 63
3.2.2 Marketing Authorization Procedure for Pharmaceutical Products 63
3.2.3 Medical Device Approval Process 66
3.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 70
3.2.5 Licensing Process for Pharmaceutical Exports and Imports 73
3.2.6 Intellectual Property Rights 74
3.2.7 Clinical Trial Regulations 78
3.2.8 Pharmaceutical Advertising Regulations 82
3.2.9 Pharmacy Regulations 83
3.2.10 Labeling and Packaging Regulations 84
4 Country Analysis 86
4.1 Political Environment 86
4.1.1 Political Structure 86
4.1.2 Analysis of the Current Political Environment 87
4.1.3 Healthcare Policy Initiatives 88
4.2 Economic Landscape 89
4.3 Economic Indicators 92
4.3.1 Gross Domestic Product 92
4.3.2 Gross National Income 96
4.3.3 Inflation 97
4.3.4 Currency Exchange Rate 101
4.3.5 Foreign Direct Investment 102
4.3.6 Foreign Exchange Reserves 103
4.3.7 Trade Balance 104
4.3.8 Government Structural Balance 106
4.3.9 Government Net Debt 108
4.3.10 External Debt 109
4.3.11 Major Industries 110
4.4 Demography 111
4.4.1 Population 111
4.4.2 Education and Literacy 126
4.4.3 Employment 127
4.4.4 Disease Burden 129
4.5 Healthcare Infrastructure 132
4.5.1 Healthcare Facilities 132
4.5.2 Healthcare Parameters 140
4.5.3 Environmental Health 142
4.5.4 Healthcare Personnel 148
4.6 Healthcare Expenditure 149
4.6.1 Overview 149
4.6.2 Major Components of Healthcare Spending 150
4.6.3 Share of Public and Private Sectors 152
4.6.4 Spending in Pharmaceutical RandD 153
4.7 Trade Associations 154
4.7.1 Pharmaceutical Association of Malaysia 154
4.7.2 Malaysian Organization of Pharmaceutical Industries 154
4.7.3 Association of Private Hospitals of Malaysia 154
4.7.4 Association of Malaysian Medical Industries 154
4.8 Trade Fairs 155
5 Opportunities and Challenges 156
5.1 Opportunities 156
5.2 Challenges 157
6 Appendix 159
6.1 Abbreviations 159
6.2 Methodology 162
6.2.1 Coverage 162
6.2.2 Secondary Research 163
6.2.3 Forecasting 163
6.2.4 Primary Research 163
6.2.5 Expert Panel Validation 164
6.3 Contact Us 164
6.4 Bibliography 164
6.5 Disclaimer 174

List of Tables

Table 1: Pharmaceutical Market ($bn), Malaysia, 2005-2010 13
Table 2: Pharmaceutical Market ($bn), Malaysia, Forecast, 2011-2020 14
Table 3: Distribution Channel, Pharmaceutical Mark-ups (%), Malaysia, 2011 16
Table 4: Generic Pharmaceuticals Market, Revenue ($m), Malaysia, 2005-2010 17
Table 5: Drugs Going Off-Patent, Revenue ($bn), Global, 2011-2014 18
Table 6: Products Registered by DCA, Malaysia, Share (%), 1985-2008 20
Table 7: Major Therapeutic Areas, Malaysia, Pharmaceutical Expenditure ($m), 2007 21
Table 8: Major Antibacterial Medicines, Malaysia, Pharmaceutical Expenditure ($m), 2007 22
Table 9: Major Anti-diabetic Medicines, Malaysia, Pharmaceutical Expenditure ($m), 2007 23
Table 10: Major Renin-Agiotensin Agents, Malaysia, Pharmaceutical Expenditure ($m), 2007 24
Table 11: Major Psycholeptics, Malaysia, Pharmaceutical Expenditure ($m), 2007 25
Table 12: Major Lipid Modifying Agents, Malaysia, Pharmaceutical Expenditure ($m), 2007 26
Table 13: Major Pharmaceutical Companies, Malaysia, Revenue ($m), 2010 27
Table 14: Major Products, Chemical Company of Malaysia Berhad, 2011 28
Table 15: Major Products, Pharmaniaga Berhad, 2011 33
Table 16: Major Products, Hovid Berhad, 2011 39
Table 17: Major Products, Apex Healthcare Berhad, 2011 43
Table 18: Major Products, Y.S.P. SAH Berhad, 2011 47
Table 19: Category of Physicians, Malaysia, 2011 57
Table 20: Healthcare Spending, Malaysia, Patient's Share (%), 2005-2010 61
Table 21: Price Trend in Healthcare Sector (%), Malaysia, 2006-2010 62
Table 22: Regulatory Review Time, Pharmaceutical Products, Malaysia, 2011 66
Table 23: Regulatory Fee Structure, Pharmaceutical Products, Malaysia, 2011 66
Table 24: GDP Per Capita ($), Malaysia, 2005-2010 92
Table 25: GDP Per Capita ($), Malaysia, Forecast, 2011-2020 93
Table 26: GDP, Malaysia, Annual Growth (%), 2005-2010 94
Table 27: GDP, Malaysia, Annual Growth (%), Forecast, 2011-2020 95
Table 28: GNI Per Capita ($), Malaysia, 2005-2010 96
Table 29: Average Consumer Price Index, Malaysia, 2005-2010 97
Table 30: Average Consumer Price Index, Malaysia, Forecast, 2011-2020 98
Table 31: Average Consumer Price, Malaysia, Annual Change (%), 2005-2010 99
Table 32: Average Consumer Price, Malaysia, Annual Change (%), Forecast, 2011-2020 100
Table 33: Currency Exchange Rate ($/MYR), Malaysia, 2005-2010 101
Table 34: Foreign Direct Investment ($bn), Malaysia, 2005-2010 102
Table 35: Foreign Exchange Reserves ($bn), Malaysia, 2005-2010 103
Table 36: Imports of Goods and Services ($bn), Malaysia, 2005-2010 104
Table 37: Exports of Goods and Services ($bn), Malaysia, 2005-2010 105
Table 38: General Government Structural Balance ($bn), Malaysia, 2005-2010 106
Table 39: General Government Structural Balance ($bn), Malaysia, Forecast, 2011-2020 107
Table 40: Government Debt ($bn), Malaysia, 2005-2010 108
Table 41: External Debt ($bn), Malaysia, 2005-2010 109
Table 42: Major Industries, Malaysia, Gross Output ($bn), 2009 110
Table 43: Population (m), Malaysia, 2005-2010 112
Table 44: Population (m), Malaysia, Forecast, 2011-2020 113
Table 45: Urban and Rural Population, Malaysia, Share (%), 2005-2010 114
Table 46: Age Groups, Malaysia, Population Distribution (%), 2005-2010 116
Table 47: Age Groups, Malaysia, Population Distribution (%), Forecast, 2011-2020 116
Table 48: Births (Per 1,000 Population), Malaysia, 2005-2010 117
Table 49: Mortality (Per 1,000 Population), Malaysia, 2005-2010 118
Table 50: Major Causes of Mortality (Number of Deaths, ‘000s), Malaysia, 2008 119
Table 51: Children Table 52: Immunization Rate (%), Malaysia, 2005-2010 121
Table 53: Major Causes of Male Mortality (Number of Deaths, ‘000s), Malaysia, 2008 122
Table 54: Major Causes of Female Mortality (Number of Deaths, ‘000s), Malaysia, 2008 123
Table 55: Gender Ratio (M/F), Malaysia, 2005-2010 124
Table 56: Life Expectancy at Birth (Years), Malaysia, 2005-2010 125
Table 57: Levels of Education, Malaysia, Student Enrolment Share (%), 2008 127
Table 58: Unemployment Rate (%), Malaysia, 2005-2010 127
Table 59: Employees, Malaysia, Segment Share (%), 2009 128
Table 60: Major Diseases, Malaysia, Prevalence (%), 2006 129
Table 61: Major Cancer Diseases, Malaysia, Incidence Rate (Per 100,000 Population), 2006 130
Table 62: Major Diseases, Malaysia, DALY (Per 100,000 Population), 2004 131
Table 63: Hospitals, Malaysia, 2005-2010 133
Table 64: Public and Private Hospitals, Malaysia, 2005-2010 134
Table 65: Hospitals by Standard of Care, Malaysia, Share (%), 2010 135
Table 66: Hospitals by Specialty, Malaysia, Share (%), 2009 136
Table 67: Hospitals by Bed Size, Malaysia, Share (%), 2009 137
Table 68: Hospitals by Type of Services, Malaysia, 2009 138
Table 69: Diagnostic Facilities, Malaysia, Share (%), 2009 139
Table 70: Hospital Beds (Per 1,000 Population), Malaysia, 2005-2010 140
Table 71: Number of Physicians (Per 1,000 Population), Malaysia, 2005-2010 141
Table 72: Environmental Attributable Deaths (Per 100,000 Population), Malaysia, 2004 142
Table 73: PM10 (micrograms per cubic meter), Malaysia, 2005-2010 143
Table 74: CO2 Emissions (Million Tons), Malaysia, 2005-2010 145
Table 75: Organic Water Pollutant Emissions (Metric Tons per Day), Malaysia, 2005-2010 146
Table 76: River Water Quality, Malaysia, Share (%), 2010 147
Table 77: Healthcare Personnel (Per 100,000 Population), Malaysia, 2005-2010 148
Table 78: Healthcare Expenditure (% of the GDP), Malaysia, 2005-2010 149
Table 79: Total Healthcare Expenditure, Malaysia, Share by Function of Care (%), 2006 150
Table 80: Healthcare Expenditure, Malaysia, Share by Service Providers (%), 2006 151
Table 81: Healthcare Expenditure, Malaysia, Public-Private Share (%), 2005-2010 152
Table 82: Public Research and Development Expenditure, Malaysia, Share (%), 2006 153
Table 83: Major Healthcare Trade Fairs, Malaysia, 2011-2012 155

List of Figures

Figure 1: Pharmaceutical Market ($bn), Malaysia, 2005-2010 13
Figure 2: Pharmaceutical Market ($bn), Malaysia, Forecast, 2011-2020 14
Figure 3: Distribution Channels, Malaysia, 2011 15
Figure 4: Generic Pharmaceuticals Market, Revenue ($m), Malaysia, 2005-2010 17
Figure 5: Products Registered by DCA, Malaysia, Share (%), 1985-2008 20
Figure 6: Major Therapeutic Areas, Malaysia, Pharmaceutical Expenditure ($m), 2007 21
Figure 7: Major Antibacterial Medicines, Malaysia, Pharmaceutical Expenditure ($m), 2007 22
Figure 8: Major Anti-diabetic Medicines, Malaysia, Pharmaceutical Expenditure ($m), 2007 23
Figure 9: Major Renin-Agiotensin Agents, Malaysia, Pharmaceutical Expenditure ($m), 2007 24
Figure 10: Major Psycholeptics, Malaysia, Pharmaceutical Expenditure ($m), 2007 25
Figure 11: Major Lipid Modifying Agents, Malaysia, Pharmaceutical Expenditure ($m), 2007 26
Figure 12: Major Pharmaceutical Companies, Malaysia, Revenue ($m), 2010 27
Figure 13: Drivers and Barriers, Healthcare Market, Malaysia, 2011 54
Figure 14: Financial Flow in the Healthcare System, Malaysia, 2011 56
Figure 15: Addition of Drug in MoH Drug Formulary, Malaysia, 2011 58
Figure 16: Proposed National Healthcare Finance Scheme, Malaysia, 2011 59
Figure 17: Healthcare Spending, Malaysia, Patient's Share (%), 2005-2010 61
Figure 18: Price Trend in Healthcare Sector (%), Malaysia, 2006-2010 62
Figure 19: Marketing Authorization Procedure, Malaysia, 2011 65
Figure 20: Medical Device Approval Process, Malaysia, 2011 68
Figure 21: New Process for the Approval of Medical Devices, Malaysia, 2012 69
Figure 22: Licensing Process for Pharmaceutical Manufacturing, Malaysia, 2011 70
Figure 23: New Licensing Process for Medical Device Manufacturing, Malaysia, 2012 72
Figure 24: Patent Approval Process, Malaysia, 2011 75
Figure 25: Trademark Approval Process, Malaysia, 2011 77
Figure 26: Clinical Trial Regulation Process, Malaysia, 2011 80
Figure 27: Process of Import License for New Drug for Clinical Trial, Malaysia, 2011 81
Figure 28: Pharmaceutical Advertisement Approval Process, Malaysia, 2011 83
Figure 29: GDP Per Capita ($), Malaysia, 2005-2010 92
Figure 30: GDP Per Capita ($), Malaysia, Forecast, 2011-2020 93
Figure 31: GDP, Malaysia, Annual Growth (%), 2005-2010 94
Figure 32: GDP, Malaysia, Annual Growth (%), Forecast, 2011-2020 95
Figure 33: GNI Per Capita ($), Malaysia, 2005-2010 96
Figure 34: Average Consumer Price Index, Malaysia, 2005-2010 97
Figure 35: Average Consumer Price Index, Malaysia, Forecast, 2011-2020 98
Figure 36: Average Consumer Price, Malaysia, Annual Change (%), 2005-2010 99
Figure 37: Average Consumer Price, Malaysia, Annual Change (%), Forecast, 2011-2020 100
Figure 38: Currency Exchange Rate ($/MYR), Malaysia, 2005-2010 101
Figure 39: Foreign Direct Investment ($bn), Malaysia, 2005-2010 102
Figure 40: Foreign Exchange Reserves ($bn), Malaysia, 2005-2010 103
Figure 41: Imports of Goods and Services ($bn), Malaysia, 2005-2010 104
Figure 42: Exports of Goods and Services ($bn), Malaysia, 2005-2010 105
Figure 43: General Government Structural Balance ($bn), Malaysia, 2005-2010 106
Figure 44: General Government Structural Balance ($bn), Malaysia, Forecast, 2011-2020 107
Figure 45: Government Debt ($bn), Malaysia, 2005-2010 108
Figure 46: External Debt ($bn), Malaysia, 2005-2010 109
Figure 47: Major Industries, Malaysia, Gross Output ($bn), 2009 110
Figure 48: Population (m), Malaysia, 2005-2010 112
Figure 49: Population (m), Malaysia, Forecast, 2011-2020 113
Figure 50: Urban and Rural Population, Malaysia, Share (%), 2005-2010 114
Figure 51: Age Groups, Malaysia, Population Distribution (%), 2005-2010 115
Figure 52: Age Groups, Malaysia, Population Distribution (%), Forecast, 2011-2020 116
Figure 53: Births (Per 1,000 Population), Malaysia, 2005-2010 117
Figure 54: Mortality (Per 1,000 Population), Malaysia, 2005-2010 118
Figure 55: Major Causes of Mortality (Number of Deaths, ‘000s), Malaysia, 2008 119
Figure 56: Children Figure 57: Immunization Rate (%), Malaysia, 2005-2010 121
Figure 58: Major Causes of Male Mortality (Number of Deaths, ‘000s), Malaysia, 2008 122
Figure 59: Major Causes of Female Mortality (Number of Deaths, ‘000s), Malaysia, 2008 123
Figure 60: Gender Ratio (M/F), Malaysia, 2005-2010 124
Figure 61: Life Expectancy at Birth (Years), Malaysia, 2005-2010 125
Figure 62: Levels of Education, Malaysia, Student Enrolment Share (%), 2008 126
Figure 63: Unemployment Rate (%), Malaysia, 2005-2010 127
Figure 64: Employees, Malaysia, Segment Share (%), 2009 128
Figure 65: Major Diseases, Malaysia, Prevalence (%), 2006 129
Figure 66: Major Cancer Diseases, Malaysia, Incidence Rate (Per 100,000 Population), 2006 130
Figure 67: Major Diseases, Malaysia, DALY (Per 100,000 Population), 2004 131
Figure 68: Hospitals, Malaysia, 2005-2010 133
Figure 69: Public and Private Hospitals, Malaysia, 2005-2010 134
Figure 70: Hospitals by Standard of Care, Malaysia, Share (%), 2010 135
Figure 71: Hospitals by Specialty, Malaysia, Share (%), 2009 136
Figure 72: Hospitals by Bed Size, Malaysia, Share (%), 2009 137
Figure 73: Hospitals by Type of Services, Malaysia, 2009 138
Figure 74: Diagnostic Facilities, Malaysia, Share (%), 2009 139
Figure 75: Hospital Beds (Per 1,000 Population), Malaysia, 2005-2010 140
Figure 76: Number of Physicians (Per 1,000 Population), Malaysia, 2005-2010 141
Figure 77: Environmental Attributable Deaths (Per 100,000 Population), Malaysia, 2004 142
Figure 78: PM10 (micrograms per cubic meter), Malaysia, 2005-2010 143
Figure 79: CO2 Emissions (Million Tons), Malaysia, 2005-2010 145
Figure 80: Organic Water Pollutant Emissions (Metric Tons per Day), Malaysia, 2005-2010 146
Figure 81: River Water Quality, Malaysia, Share (%), 2010 147
Figure 82: Healthcare Personnel (Per 100,000 Population), Malaysia, 2005-2010 148
Figure 83: Healthcare Expenditure (% of the GDP), Malaysia, 2005-2010 149
Figure 84: Total Healthcare Expenditure, Malaysia, Share by Function of Care (%), 2006 150
Figure 85: Healthcare Expenditure, Malaysia, Share by Service Providers (%), 2006 151
Figure 86: Healthcare Expenditure, Malaysia, Public-Private Share (%), 2005-2010 152
Figure 87: Public RandD Expenditure, Malaysia, Share (%), 2006 153
Figure 88: Opportunities and Challenges, Healthcare Market, Malaysia, 2011 158

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