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Malaysia Healthcare, Regulatory and Reimbursement Landscape – CountryFocus

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 of Malaysia. 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.

The Malaysian pharmaceutical market is one of the major markets in the South East Asian region. It was valued at $1.55B in 2010, which increased to $3.46 in 2013. However, since 2015 it decreased to reach an estimated $1.94B in 2018. The decline was due to the launch of several generic drugs in the market along with the depreciation of the Malaysian Ringgit against the US Dollar. However, rising income, demographic changes and high incidence of non-communicable diseases (NCDs) are expected to drive the market in the future. The Malaysian medical device market was worth $1.28B in 2015, which increased to $1.55B in 2018. It is expected to grow at a CAGR of 9.5% from $1.74B in 2019 to $2.28B in 2022


The report provides information on the healthcare, regulatory, and reimbursement landscape in the 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 (Sanofi, Pfizer, Novartis, GSK, and Duopharma).

• Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Malaysia

• Porter’s five forces analysis for pharmaceutical and medical devices market of Malaysia

• An 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

• Information regarding the health-tech landscape of the country along with the major health-tech deals

• Information regarding recent healthcare policies along with healthcare infrastructure and healthcare expenditure

• An overview of the opportunities 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 the Malaysian 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 the Malaysian healthcare market

Table of Contents

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key Events: Malaysia Pharmaceutical News, 2010–2019

2.4 Key Events: Malaysian Pharmaceutical Market

2.5 Key Highlights: Healthcare Start-Ups in Malaysia

2.6 Key Events: M&A, VF & PE Deals, Global Pharmaceutical Market, 2018–2019

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, Malaysia, 2018

3 Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Product Launches

3.3 Pharmaceutical Market – Exports

3.4 Pharmaceutical Market – Imports

3.5 Pharmaceutical Market – Supply Channels

3.6 Pharmaceutical Market – Market Segments

3.7 Medical Tourism, Malaysia

3.8 Pharmaceutical Market – Major Players

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Device Market – Major Segments and Trade Partners

5 Pharmaceutical and Medical Device Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6 Deal analysis

6.1 Deal Analysis: M&A, VF and PE Deals, Pharmaceutical Market, Malaysia

7 HealthTech Landscape

7.1 HealthTech Deals Landscape, Malaysia

7.1.1 Key HealthTech Deals, Malaysia

7.2 Adoption of Technology in Healthcare, Malaysia

7.3 Key Developments: Technology in Healthcare, Malaysia

7.4 Regulatory Scenario Covering Use of Technology in Healthcare

7.5 HealthTech Landscape- Malaysia- Benefits and Risks

8 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis

8.1 Pharmaceutical Market, Malaysia – Porter’s Five Forces Analysis

8.2 Medical Device Market, Malaysia – Porter’s Five Forces Analysis

9 Market Access

9.1 Overview of Healthcare System, Malaysia

9.2 Reimbursement Process, Malaysia

9.2 Overview of Health Insurance, Malaysia

9.2.1 Healthcare Spending and Health Price Index, Malaysia

9.2.2 Pricing Policies, Malaysia

9.3 Regulatory Landscape, Malaysia

9.3.1 Market Authorization of Medical Products, Malaysia

9.3.2 Market Authorization of Medical Devices, Malaysia

9.3.3 Intellectual Property Rights, Patent, Malaysia

9.3.4 Intellectual Property Rights, Trademark, Malaysia

9.3.5 Clinical Trial Regulations, Malaysia

9.3.6 Pharmaceutical Clinical Trials Landscape, Malaysia

9.3.7 Medical Devices Clinical Trials Landscape, Malaysia

9.3.8 Clinical Trial Sites, Malaysia

9.3.9 Pharmaceutical Advertising Regulations, Malaysia

9.3.10 Pharmacy Regulations, Malaysia

9.3.11 Labeling and Packaging Regulations, Malaysia

10 Country Healthcare Landscape

10.1 Malaysian Healthcare Policy Highlights

10.2 Healthcare Facilities

10.3 Healthcare Parameters

10.4 Life Expectancy and Immunization Rate, Malaysia

10.5 Environmental Health

10.6 Healthcare Personnel

10.7 Disease Burden

10.8 Healthcare Expenditure

11 Trade Associations, Malaysia

12 Trade Fairs, Malaysia

13 Opportunities and Challenges

14 Appendix

14.1 Research Methodology

14.1.1 Coverage

14.1.2 Secondary Research

14.1.3 Forecasts

14.1.4 Expert Panel

14.2 Bibliography

14.3 Contact Us

14.4 Disclaimer

List of Tables

Table 1: Patent Fees, Malaysia, 2019

Table 2: Trademark Fees, Malaysia, 2019

Table 3: Trade Fairs

List of Figures

Figure 1: Pharmaceutical Market, Colombia, Revenue, 2011-2016

Figure 2: Pharmaceutical Market, Colombia, Revenue, 2017-2022

Figure 3: Healthcare Start-Ups in Colombia, 2019

Figure 4: Number of Deals (2017–2018)

Figure 5: 2017–2018 Deal Overview By Region

Figure 6: Country Profile, Colombia, 2018

Figure 7: Pharmaceutical Market, Colombia, Revenue, 2011–2016

Figure 8: Pharmaceutical Market, Colombia, Revenue Forecast, 2017–2022

Figure 9: Pharmaceutical Market, Colombia, Pharmaceutical Exports, 2018

Figure 10: Pharmaceutical Market, Colombia, Top Export Partners, 2018

Figure 11: Pharmaceutical Market, Colombia, Pharmaceutical Imports, 2018

Figure 12: Pharmaceutical Market, Colombia, Top Import Partners, 2018

Figure 13: Pharmaceutical Market, Pharmaceutical Supply Channel, Colombia, 2018

Figure 14: Pharmaceutical Market, OTC Market, Colombia, Revenue ($M), 2010–2018

Figure 15: Pharmaceutical Market, OTC Product Group Sales ($M), Colombia, 2018

Figure 16: Pharmaceutical Market, Colombia, Major Players

Figure 17:Deal Value and Deal Count, Pharmaceutical Market, Colombia, 2018–2019

Figure 18: Deal Value and Deal Count Quarterly, Pharmaceutical Market, Colombia, 2018–2019

Figure 19: Deal Value and Deal Count Sub-Types, Pharmaceutical Market, Colombia, 2018–2019

Figure 20: Deal Value($M) , HealthTech, Colombia, 2018–2019

Figure 21: Deal Count, HealthTech, Colombia, 2018–2019

Figure 22: Adoption of Technology in Healthcare, Colombia, 2019

Figure 23: Market Access, Overview of Healthcare System, Colombia, 2019

Figure 24: Market Access, OOP Expenditure (% of Total Expenditure on Health), Colombia

Figure 25: Market Access, Annual Average Rates of Price Change (%), Consumer Price Index, Colombia, 2014–2018

Figure 26: Market Access, SISMED Monitoring Process, Colombia, 2018

Figure 27: Market Access, Structure of INVIMA, Colombia, 2018

Figure 28: Market Access, Registration Process for New Drugs, 2019

Figure 29: Market Access, Regulatory Landscape, Generic Drug Approval Process, Colombia, 2018

Figure 30: Medical Device (Class I, IIa, IIb, III) Registration Requirements, Colombia

Figure 31: Medical Device (Class I, IIa, IIb, III) Registration Requirements, Colombia

Figure 32: Licensing Process for Manufacturing, Colombia, 2018

Figure 33: Patent Approval Process, Colombia, 2018

Figure 34: Pharmaceutical Clinical Trials Count By Trial Status, Colombia, 2018–2019

Figure 35: Pharmaceutical Clinical Trials Count By Phase, Colombia, 2018–2019

Figure 36: Pharmaceutical Clinical Trials Count By Therapy Area, Colombia, 2018–2019

Figure 37: Pharmaceutical Clinical Trials Site, Colombia, 2018–2019

Figure 38: Colombia Healthcare Policy Highlights, Colombia, 2019

Figure 39: Hospital Beds (per 1,000 Population), Colombia, 2010–2018

Figure 40: Diagnostic Equipment (per million population), Colombia, 2011–2018

Figure 41: Life Expectancy, 2010–2018, Colombia

Figure 42: Immunization Rate (%), 2010–2018, Colombia

Figure 43: PM2.5 (µg per m3), Colombia, 2010–2018

Figure 44: CO2 Emissions (Million Tons), Colombia, 2010–2018

Figure 45: Physicians (per 1,000 Population), Colombia, 2011–2018

Figure 46: Nurses (per 1,000 Population), Colombia, 2011–2018

Figure 47: Dentists (per 1,000 Population), Colombia, 2011–2018

Figure 48: Major Causes of Mortality (per 1,000 Population), Colombia, 2016

Figure 49: Major Causes of Male Mortality, Colombia, 2016

Figure 50: Major Causes of Female Mortality, Colombia, 2016

Figure 51: Disability-Adjusted Life Years by Major Disease (‘000), Colombia, 2016

Figure 52: Healthcare Expenditure as Percentage of GDP (%), Colombia, 2011–2018

Figure 53: Public–Private Share (%), Colombia, 2011–2018

Figure 54: Opportunities and Challenges, Colombia


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