CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Malaysia

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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

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1GlobalData Report Guidance

3Executive Summary

4Overview of the Pharmaceutical and Medical Device Markets

4.1Pharmaceutical Market

4.1.1Market Overview

4.1.2Pharmaceutical Exports and Imports

4.1.3Supply Channels

4.1.4Market Segments

4.1.5Major Disease Areas

4.1.6Major Companies

4.2Medical Device Market

4.3Market Drivers and Barriers

4.3.1Drivers

4.3.2Barriers

5Market Access

5.1Reimbursement and Payer Landscape

5.1.1Overview of Healthcare System

5.1.2Reimbursement Process

5.1.3Overview of Insurance Providers

5.1.4Patient Share in Healthcare Spending

5.1.5Price Trends in the Healthcare Sector

5.1.6Pricing Policies

5.2Regulatory Landscape

5.2.1Overview of Regulatory Agencies

5.2.2Market Authorization Procedure for Pharmaceutical Products

5.2.3Market Authorization Procedure for Medical Devices

5.2.4Licensing Process for Pharmaceutical and Medical Device Manufacturing

5.2.5Licensing Process for Pharmaceutical Exports and Imports

5.2.6Halal Certification Process

5.2.7Intellectual Property Rights

5.2.8Clinical Trial Regulations

5.2.9Pharmaceutical Advertising Regulations

5.2.10Pharmacy Regulations

5.2.11Labeling and Packaging Regulations

6Country Analysis

6.1Political Environment

6.1.1Political Structure

6.1.2Analysis of the Current Political Environment

6.1.3Healthcare Policy Initiatives

6.2Economic Landscape

6.3Economic Indicators

6.3.1Gross Domestic Product

6.3.2Gross National Income

6.3.3Inflation

6.3.4Currency Exchange Rate

6.3.5Foreign Direct Investment

6.3.6Foreign Exchange Reserves

6.3.7Trade Balance

6.3.8General Government Structural Balance

6.3.9General Government Gross Debt

6.3.10Major Industries

6.4Demographics

6.4.1Population

6.4.2Education and Literacy

6.4.3Employment

6.4.4Disease Burden

6.5Healthcare Infrastructure

6.5.1Healthcare Facilities

6.5.2Healthcare Parameters

6.5.3Environmental Health

6.5.4Healthcare Personnel

6.6Healthcare Expenditure

6.6.1Overview

6.6.2Major Components of Healthcare Spending

6.6.3Public and Private Sector Share

6.6.4Spending in Healthcare R&D

6.7Trade Associations

6.7.1Pharmaceutical Association of Malaysia

6.7.2Malaysian Organization of Pharmaceutical Industries

6.7.3Association of Private Hospital Malaysia

6.7.4Association of Malaysian Medical Industries

6.8Trade Fairs

7Opportunities and Challenges

7.1Opportunities

7.2Challenges

8Appendix

8.1Abbreviations

8.2Bibliography

8.3Research Methodology

8.3.1Coverage

8.3.2Secondary Research

8.3.3Forecasts

8.3.4Expert Panel

8.4Contact Us

8.5Disclaimer

Table

1.1List 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 7: Pharmaceutical Market, Pharmaniaga, Major Products, 2016

Table 8: Pharmaceutical Market, Chemical Company of Malaysia, Global, Major Products, 2016

Table 9: Pharmaceutical Market, Major Products, YSP, 2014

Table 9: Pharmaceutical Market, Major Products, Hovid, 2016

Table 7: Pharmaceutical Market, Kotra Pharma Major Products, 2015

Table 11: Medical Device Market, Malaysia, Revenue ($bn), 2008–2015

Table 12: Medical Device Market, Malaysia, Revenue ($bn), 2016–2020

Table 12: Healthcare System, Malaysia, Contribution to Insurance Fund (%), 2013

Table 14: Market Access, Malaysia, Out-of-Pocket Expenditure (%), 2008–2015

Table 15: Market Access, Price of Healthcare Products, Malaysia, Change in Average Price of Healthcare Services (%), 2008–2015

Table 16: Regulatory Landscape, Malaysia, Patent Fees, 2015

Table 18: Analysis of Current Political Environment, Malaysia, National Key Results Areas

Table 19: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008–2015

Table 20: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2016–2020

Table 21: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008–2015

Table 22: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2016–2020

Table 23: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008–2015

Table 24: Economic Indicators, Malaysia, Consumer Price Index, 2008–2015

Table 25: Economic Indicators, Malaysia, Consumer Price Index, 2016–2020

Table 26: Economic Indicators, Malaysia, Consumer Price Annual Change (%), 2008–2015

Table 27: Economic Indicators, Malaysia Currency Exchange Rate ($/MYR) 2008–2015

Table 28: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008–2015

Table 29: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008–2015

Table 30: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008–2015

Table 31: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008–2015

Table 32: Economic Indicators, Malaysia, Government Structural Balance ($bn), 2008–2015

Table 33: Economic Indicators, Malaysia, General Government Gross Debt ($bn), 2008–2015

Table 34: Economic Indicators, Malaysia, General Government Net Debt ($bn), 2016–2020

Table 35: Economic Indicators, Malaysia, Major Industries, Population Employed (million), 2015

Table 36: Demographics, Malaysia, Population (million), 2008–2015

Table 37: Demographics, Malaysia, Population (million), 2016–2020

Table 38: Demographics, Malaysia, Population, Urban–Rural Population Share (%), 2008–2015

Table 39: Demographics, Malaysia, Population, Urban–Rural Population Share (%), 2016–2020

Table 40: Demographics, Malaysia, Population Distribution by Age Group (%), 2008–2015

Table 41: Demographics, Malaysia, Population Distribution by Age Group Forecast (%), 2016–2020

Table 42: Demographics, Malaysia, Births (per 1,000 population), 2008–2015

Table 43: Demographics, Malaysia, Mortality (per 1,000 population), 2008–2015

Table 44: Demographics, Malaysia, Major Causes of Mortality (%), 2011

Table 45: Demographics, Malaysia, Mortality Rate in Children under Five (per 1,000 live births), 2008–2015

Table 46: Demographics, Malaysia, Immunization Rate (%), 2008–2015

Table 47: Demographics, Malaysia, Major Causes of Mortality in Males (%), 2013

Table 48: Demographics, Malaysia, Major Causes of Mortality in Females (%), 2013

Table 49: Demographics, Malaysia, Gender Ratio (M/F), 2008–2015

Table 50: Demographics, Malaysia, Life Expectancy at Birth (years), 2008–2015

Table 51: Demographics, Malaysia, Gross Enrollment by Level of Education (%), 2008–2015

Table 52: Demographics, Malaysia, Unemployment Rate (%), 2008–2015

Table 53: Demographics, Malaysia, Patients Hospitalized (%), 2013

Table 54: Demographics, Malaysia, Disability-Adjusted Life Years by Major Disease (‘000), 2012

Table 55: Healthcare Infrastructure, Malaysia, Health Establishments, 2008–2015

Table 56: Healthcare Infrastructure, Malaysia, Public and Private Hospitals, 2008–2015

Table 56: Healthcare Infrastructure, Malaysia, Diagnostic Units (per million population), 2008–2015

Table 57: Healthcare Infrastructure, Malaysia, Hospital Beds (per 1,000 population), 2008–2015

Table 58: Healthcare Infrastructure, Malaysia, Doctors (per 1,000 population), 2008–2015

Table 59: Healthcare Infrastructure, Malaysia, PM2.5 (µg/m3), 2008–2015

Table 60: Healthcare Infrastructure, Malaysia, CO2 Emissions (metric tons per capita), 2008–2015

Table 61: Healthcare Infrastructure, Malaysia, Nurses (per 1,000 population), 2008–2015

Table 62: Healthcare Infrastructure, Malaysia, Dentists (per 1,000 population), 2008–2015

Table 63: Healthcare Infrastructure, Malaysia, Pharmacists (per 1,000 population), 2008–2015

Table 64: Healthcare Expenditure, Malaysia, Healthcare Expenditure (% of GDP), 2008–2015

Table 65: Public Healthcare Expenditure, Malaysia, Share of Major Components (%), 2006

Table 66: Healthcare Expenditure, Malaysia, Healthcare Expenditure, Public–Private Share (%), 2008–2015

Table 67: Healthcare Expenditure, Malaysia, R&D Expenditure by Field of Research (%), 2012

Table 68: Healthcare Expenditure, Malaysia, Major Healthcare Trade Fairs, 2016

Figures

1.2List of Figures

Figure 1: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008–2020

Figure 2: Medical Device Market, Malaysia, Revenue ($m), 2008–2020

Figure 3: Pharmaceutical Market, Malaysia, Country Profile, 2016

Figure 4: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008–2015

Figure 5: Pharmaceutical Market, Malaysia, Revenue Forecast ($bn), 2016–2020

Figure 6: Pharmaceutical Market, Malaysia, Exports and Imports ($m), 2008–2015

Figure 7: Pharmaceutical Market, Malaysia, Supply Channels, 2014

Figure 11: Medical Device Market, Malaysia, Revenue ($bn), 2008–2015

Figure 12: Medical Device Market, Malaysia, Revenue ($bn), 2016–2020

Figure 13: Healthcare Market, Malaysia, Drivers and Barriers, 2016

Figure 14: Market Access, Malaysia, Overview of Healthcare System

Figure 17: Market Access, Malaysia, Out-of-Pocket Expenditure (%), 2008–2015

Figure 18: Market Access, Price of Healthcare Products, Malaysia, Change in Average Price of Healthcare Services, 2008–2015

Figure 20: Market Access, Malaysia, Generic Drug Marketing Authorization, 2014

Figure 20: Market Access, Malaysia, New Drug Marketing Authorization Procedure, 2014

Figure 20: Regulatory Landscape, Malaysia, Medical Device Approval Process, 2015

Figure 20: Regulatory Landscape, Malaysia, Licensing Process for Pharmaceutical Manufacturing, 2015

Figure 20: Regulatory Landscape, Malaysia, Licensing Process for Medical Device Manufacturing, 2015

Figure 21: Market Access, Malaysia, Patent Approval Process, 2014

Figure 21: Market Access, Malaysia, Trademark Approval Process, 2014

Figure 20: Market Access, Malaysia, Clinical Trial Regulation Process, 2011

Figure 20: Market Access, Malaysia, Clinical Trial Regulation Process, 2011

Figure 22: Market Access, Malaysia, Pharmaceutical Advertisement Approval Process, 2014

Figure 22: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008–2015

Figure 23: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2016–2020

Figure 24: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008–2015

Figure 25: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2016–2020

Figure 26: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008–2015

Figure 27: Economic Indicators, Malaysia, Consumer Price Index, 2008–2015

Figure 28: Economic Indicators, Malaysia, Consumer Price Index, 2016–2020

Figure 29: Economic Indicators, Malaysia, Consumer Price Annual Change (%), 2008–2015

Figure 30: Economic Indicators, Malaysia, Currency Exchange Rate ($/MYR) 2008–2015

Figure 31: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008–2015

Figure 32: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008–2015

Figure 33: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008–2015

Figure 34: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008–2015

Figure 35: Economic Indicators, Malaysia, Government Structural Balance ($bn), 2008–2015

Figure 36: Economic Indicators, Malaysia, General Government Gross Debt ($bn), 2008–2015

Figure 37: Economic Indicators, Malaysia, General Government Net Debt ($bn), 2016–2020

Figure 38: Economic Indicators, Malaysia, Major Industries, Population Employed (million), 2015

Figure 39: Demographics, Malaysia, Population (million), 2008–2015

Figure 40: Demographics, Malaysia, Population (million), 2016–2020

Figure 41: Demographics, Malaysia, Population, Urban–Rural Population Share (%), 2008–2015

Figure 42: Demographics, Malaysia, Population, Urban–Rural Population Share (%), 2016–2020

Figure 43: Demographics, Malaysia, Population Distribution by Age Group (%), 2008–2015

Figure 44: Demographics, Malaysia, Population Distribution by Age Group (%), 2016–2020

Figure 45: Demographics, Malaysia, Births (per 1,000 population), 2008–2015

Figure 46: Demographics, Malaysia, Mortality (per 1,000 population), 2008–2015

Figure 47: Demographics, Malaysia, Major Causes of Mortality (%), 2011

Figure 48: Demographics, Malaysia, Mortality Rate in Children under Five (per 1,000 live births), 2008–2015

Figure 49: Demographics, Malaysia, Immunization Rate (%), 2008–2015

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

Figure 51: Demographics, Malaysia, Major Causes of Mortality in Females (%), 2013

Figure 52: Demographics, Malaysia, Gender Ratio (M/F), 2008–2015

Figure 53: Demographics, Malaysia, Life Expectancy at Birth (years), 2008–2015

Figure 54: Demographics, Malaysia, Gross Enrollment by Level of Education (%), 2008–2015

Figure 55: Demographics, Malaysia, Unemployment Rate (%), 2008–2015

Figure 56: Demographics, Malaysia, Patients Hospitalized (%), 2013

Figure 57: Demographics, Malaysia, Disability-Adjusted Life Years by Major Disease (‘000), 2014

Figure 58: Healthcare Infrastructure, Malaysia, Hospitals, 2008–2015

Figure 59: 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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