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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia

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


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 GlobalData Report Guidance
3 Overview of the Pharmaceutical and Medical Device Markets
3.1 Pharmaceutical Market
3.1.1 Market Overview
3.1.2 Pharmaceutical Exports and Imports
3.1.3 Supply Channels
3.1.4 Market Segments
3.1.5 Major Disease Areas
3.1.6 Major Companies
3.2 Medical Device Market
3.3 Market Drivers and Barriers
3.3.1 Drivers
3.3.2 Barriers
4 Market Access
4.1 Reimbursement and Payer Landscape
4.1.1 Overview of Healthcare System
4.1.2 Reimbursement Process
4.1.3 Overview of Insurance Providers
4.1.4 Patient Share in Healthcare Spending
4.1.5 Price Trends in the Healthcare Sector
4.1.6 Pricing Policies
4.2 Regulatory Landscape
4.2.1 Overview of Regulatory Agencies
4.2.2 Market Authorization Procedure for Pharmaceutical Products
4.2.3 Market Authorization Procedure for Medical Devices
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
4.2.5 Licensing Process for Pharmaceutical Exports and Imports
4.2.6 Halal Certification Process
4.2.7 Intellectual Property Rights
4.2.8 Clinical Trial Regulations
4.2.9 Pharmaceutical Advertising Regulations
4.2.10 Pharmacy Regulations
4.2.11 Labeling and Packaging Regulations
5 Country Analysis
5.1 Political Environment
5.1.1 Political Structure
5.1.2 Analysis of the Current Political Environment
5.1.3 Healthcare Policy Initiatives
5.2 Economic Landscape
5.3 Economic Indicators
5.3.1 Gross Domestic Product
5.3.2 Gross National Income
5.3.3 Inflation
5.3.4 Currency Exchange Rate
5.3.5 Foreign Direct Investment
5.3.6 Foreign Exchange Reserves
5.3.7 Trade Balance
5.3.8 General Government Structural Balance
5.3.9 General Government Gross Debt
5.3.10 Major Industries
5.4 Demographics
5.4.1 Population
5.4.2 Education and Literacy
5.4.3 Employment
5.4.4 Disease Burden
5.5 Healthcare Infrastructure
5.5.1 Healthcare Facilities
5.5.2 Healthcare Parameters
5.5.3 Environmental Health
5.5.4 Healthcare Personnel
5.6 Healthcare Expenditure
5.6.1 Overview
5.6.2 Major Components of Healthcare Spending
5.6.3 Public and Private Sector Share
5.6.4 Spending in Healthcare R&D
5.7 Trade Associations
5.7.1 Pharmaceutical Association of Malaysia
5.7.2 Malaysian Organization of Pharmaceutical Industries
5.7.3 Association of Private Hospital Malaysia
5.7.4 Association of Malaysian Medical Industries
5.8 Trade Fairs
6 Opportunities and Challenges
6.1 Opportunities
6.2 Challenges
7 Appendix
7.1 Abbreviations
7.2 Bibliography
7.3 Research Methodology
7.3.1 Coverage
7.3.2 Secondary Research
7.3.3 Forecasts
7.3.4 Expert Panel
7.4 Disclaimer
1.1 List of Tables
Table 1: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008-2015
Table 2: Pharmaceutical Market, Malaysia, Revenue Forecast ($bn), 2016-2020
Table 3: Pharmaceutical Market, Malaysia, Exports and Imports ($m), 2008-2015
Table 4: Pharmaceutical Market, Pharmaniaga, Major Products, 2016
Table 5: Pharmaceutical Market, Chemical Company of Malaysia, Global, Major Products, 2016
Table 6: Pharmaceutical Market, Major Products, YSP, 2014
Table 7: Pharmaceutical Market, Major Products, Hovid, 2016
Table 8: Pharmaceutical Market, Kotra Pharma Major Products, 2015
Table 9: Medical Device Market, Malaysia, Revenue ($bn), 2008-2015
Table 10: Medical Device Market, Malaysia, Revenue ($bn), 2016-2020
Table 11: Healthcare System, Malaysia, Contribution to Insurance Fund (%), 2013
Table 12: Market Access, Malaysia, Out-of-Pocket Expenditure (%), 2008-2015
Table 13: Market Access, Price of Healthcare Products, Malaysia, Change in Average Price of Healthcare Services (%), 2008-2015
Table 14: Regulatory Landscape, Malaysia, Patent Fees, 2015
Table 15: Analysis of Current Political Environment, Malaysia, National Key Results Areas
Table 16: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008-2015
Table 17: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2016-2020
Table 18: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008-2015
Table 19: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2016-2020
Table 20: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008-2015
Table 21: Economic Indicators, Malaysia, Consumer Price Index, 2008-2015
Table 22: Economic Indicators, Malaysia, Consumer Price Index, 2016-2020
Table 23: Economic Indicators, Malaysia, Consumer Price Annual Change (%), 2008-2015
Table 24: Economic Indicators, Malaysia Currency Exchange Rate ($/MYR) 2008-2015
Table 25: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008-2015
Table 26: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008-2015
Table 27: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008-2015
Table 28: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008-2015
Table 29: Economic Indicators, Malaysia, Government Structural Balance ($bn), 2008-2015
Table 30: Economic Indicators, Malaysia, General Government Gross Debt ($bn), 2008-2015
Table 31: Economic Indicators, Malaysia, General Government Net Debt ($bn), 2016-2020
Table 32: Economic Indicators, Malaysia, Major Industries, Population Employed (million), 2015
Table 33: Demographics, Malaysia, Population (million), 2008-2015
Table 34: Demographics, Malaysia, Population (million), 2016-2020
Table 35: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2008-2015
Table 36: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2016-2020
Table 37: Demographics, Malaysia, Population Distribution by Age Group (%), 2008-2015
Table 38: Demographics, Malaysia, Population Distribution by Age Group Forecast (%), 2016-2020
Table 39: Demographics, Malaysia, Births (per 1,000 population), 2008-2015
Table 40: Demographics, Malaysia, Mortality (per 1,000 population), 2008-2015
Table 41: Demographics, Malaysia, Major Causes of Mortality (%), 2011
Table 42: Demographics, Malaysia, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015
Table 43: Demographics, Malaysia, Immunization Rate (%), 2008-2015
Table 44: Demographics, Malaysia, Major Causes of Mortality in Males (%), 2013
Table 45: Demographics, Malaysia, Major Causes of Mortality in Females (%), 2013
Table 46: Demographics, Malaysia, Gender Ratio (M/F), 2008-2015
Table 47: Demographics, Malaysia, Life Expectancy at Birth (years), 2008-2015
Table 48: Demographics, Malaysia, Gross Enrollment by Level of Education (%), 2008-2015
Table 49: Demographics, Malaysia, Unemployment Rate (%), 2008-2015
Table 50: Demographics, Malaysia, Patients Hospitalized (%), 2013
Table 51: Demographics, Malaysia, Disability-Adjusted Life Years by Major Disease (‘000), 2012
Table 52: Healthcare Infrastructure, Malaysia, Health Establishments, 2008-2015
Table 53: Healthcare Infrastructure, Malaysia, Public and Private Hospitals, 2008-2015
Table 54: Healthcare Infrastructure, Malaysia, Diagnostic Units (per million population), 2008-2015
Table 55: Healthcare Infrastructure, Malaysia, Hospital Beds (per 1,000 population), 2008-2015
Table 56: Healthcare Infrastructure, Malaysia, Doctors (per 1,000 population), 2008-2015
Table 57: Healthcare Infrastructure, Malaysia, PM2.5 (µg/m3), 2008-2015
Table 58: Healthcare Infrastructure, Malaysia, CO2 Emissions (metric tons per capita), 2008-2015
Table 59: Healthcare Infrastructure, Malaysia, Nurses (per 1,000 population), 2008-2015
Table 60: Healthcare Infrastructure, Malaysia, Dentists (per 1,000 population), 2008-2015
Table 61: Healthcare Infrastructure, Malaysia, Pharmacists (per 1,000 population), 2008-2015
Table 62: Healthcare Expenditure, Malaysia, Healthcare Expenditure (% of GDP), 2008-2015
Table 63: Public Healthcare Expenditure, Malaysia, Share of Major Components (%), 2006
Table 64: Healthcare Expenditure, Malaysia, Healthcare Expenditure, Public-Private Share (%), 2008-2015
Table 65: Healthcare Expenditure, Malaysia, R&D Expenditure by Field of Research (%), 2012
Table 66: Healthcare Expenditure, Malaysia, Major Healthcare Trade Fairs, 2016
1.2 List of Figures
Figure 1: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008-2015
Figure 2: Pharmaceutical Market, Malaysia, Revenue Forecast ($bn), 2016-2020
Figure 3: Pharmaceutical Market, Malaysia, Exports and Imports ($m), 2008-2015
Figure 4: Pharmaceutical Market, Malaysia, Supply Channels, 2014
Figure 5: Medical Device Market, Malaysia, Revenue ($bn), 2008-2015
Figure 6: Medical Device Market, Malaysia, Revenue ($bn), 2016-2020
Figure 7: Healthcare Market, Malaysia, Drivers and Barriers, 2016
Figure 8: Market Access, Malaysia, Overview of Healthcare System
Figure 9: Market Access, Malaysia, Out-of-Pocket Expenditure (%), 2008-2015
Figure 10: Market Access, Price of Healthcare Products, Malaysia, Change in Average Price of Healthcare Services, 2008-2015
Figure 11: Market Access, Malaysia, Generic Drug Marketing Authorization, 2014
Figure 12: Market Access, Malaysia, New Drug Marketing Authorization Procedure, 2014
Figure 13: Regulatory Landscape, Malaysia, Medical Device Approval Process, 2015
Figure 14: Regulatory Landscape, Malaysia, Licensing Process for Pharmaceutical Manufacturing, 2015
Figure 15: Regulatory Landscape, Malaysia, Licensing Process for Medical Device Manufacturing, 2015
Figure 16: Market Access, Malaysia, Patent Approval Process, 2014
Figure 17: Market Access, Malaysia, Trademark Approval Process, 2014
Figure 18: Market Access, Malaysia, Clinical Trial Regulation Process, 2011
Figure 19: Market Access, Malaysia, Clinical Trial Regulation Process, 2011
Figure 20: Market Access, Malaysia, Pharmaceutical Advertisement Approval Process, 2014
Figure 21: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008-2015
Figure 22: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2016-2020
Figure 23: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008-2015
Figure 24: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2016-2020
Figure 25: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008-2015
Figure 26: Economic Indicators, Malaysia, Consumer Price Index, 2008-2015
Figure 27: Economic Indicators, Malaysia, Consumer Price Index, 2016-2020
Figure 28: Economic Indicators, Malaysia, Consumer Price Annual Change (%), 2008-2015
Figure 29: Economic Indicators, Malaysia, Currency Exchange Rate ($/MYR) 2008-2015
Figure 30: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008-2015
Figure 31: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008-2015
Figure 32: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008-2015
Figure 33: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008-2015
Figure 34: Economic Indicators, Malaysia, Government Structural Balance ($bn), 2008-2015
Figure 35: Economic Indicators, Malaysia, General Government Gross Debt ($bn), 2008-2015
Figure 36: Economic Indicators, Malaysia, General Government Net Debt ($bn), 2016-2020
Figure 37: Economic Indicators, Malaysia, Major Industries, Population Employed (million), 2015
Figure 38: Demographics, Malaysia, Population (million), 2008-2015
Figure 39: Demographics, Malaysia, Population (million), 2016-2020
Figure 40: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2008-2015
Figure 41: Demographics, Malaysia, Population, Urban-Rural Population Share (%), 2016-2020
Figure 42: Demographics, Malaysia, Population Distribution by Age Group (%), 2008-2015
Figure 43: Demographics, Malaysia, Population Distribution by Age Group (%), 2016-2020
Figure 44: Demographics, Malaysia, Births (per 1,000 population), 2008-2015
Figure 45: Demographics, Malaysia, Mortality (per 1,000 population), 2008-2015
Figure 46: Demographics, Malaysia, Major Causes of Mortality (%), 2011
Figure 47: Demographics, Malaysia, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015
Figure 48: Demographics, Malaysia, Immunization Rate (%), 2008-2015
Figure 49: Demographics, Malaysia, Major Causes of Mortality in Males (%), 2013
Figure 50: Demographics, Malaysia, Major Causes of Mortality in Females (%), 2013
Figure 51: Demographics, Malaysia, Gender Ratio (M/F), 2008-2015
Figure 52: Demographics, Malaysia, Life Expectancy at Birth (years), 2008-2015
Figure 53: Demographics, Malaysia, Gross Enrollment by Level of Education (%), 2008-2015
Figure 54: Demographics, Malaysia, Unemployment Rate (%), 2008-2015
Figure 55: Demographics, Malaysia, Patients Hospitalized (%), 2013
Figure 56: Demographics, Malaysia, Disability-Adjusted Life Years by Major Disease (‘000), 2014
Figure 57: Healthcare Infrastructure, Malaysia, Hospitals, 2008-2015
Figure 58: Healthcare Infrastructure, Malaysia, Public and Private Hospitals, 2008-2015
Figure 59: Healthcare Infrastructure, Malaysia, Diagnostic Units (per million population), 2008-2015
Figure 60: Healthcare Infrastructure, Malaysia, Hospital Beds (per 1,000 population), 2008-2015
Figure 61: Healthcare Infrastructure, Malaysia, Doctors (per 1,000 population), 2008-2015
Figure 62: Healthcare Infrastructure, Malaysia, PM2.5 (µg/m3), 2008-2015
Figure 63: Healthcare Infrastructure, Malaysia, CO2 Emissions (metric tons per capita), 2008-2015
Figure 64: Healthcare Infrastructure, Malaysia, Nurses (per 1,000 population), 2008-2015
Figure 65: Healthcare Infrastructure, Malaysia, Dentist (per 1,000 population), 2008-2015
Figure 66: Healthcare Infrastructure, Malaysia, Pharmacists (per 1,000 population), 2008-2015
Figure 67: Healthcare Expenditure, Malaysia, Healthcare Expenditure (% of GDP), 2008-2015
Figure 68: Public Healthcare Expenditure, Malaysia, Share of Major Components (%), 2011
Figure 69: Healthcare Expenditure, Malaysia, Public-Private Share of Healthcare Expenditure (%), 2008-2015
Figure 70: Healthcare Expenditure, Malaysia, R&D Expenditure by Field of Research (%), 2012
Figure 71: Healthcare Market, Malaysia, Opportunities and Challenges, 2016

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