Malaysia – Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape

Pages: 157 Published: March 22, 2022 Report Code: GDHC0059CHR

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The Malaysia pharmaceutical market was valued at $2.9 billion in the year 2020. The market grew at a CAGR of more than 9% during the period 2013 to 2020. According to Malaysia’s Investment Development Authority (MIDA), as of June 2021, the pharmaceutical industry’s aggregate annual earnings before interest, taxes, depreciation, and amortization (EBITDA) is expected to grow over the next 12 to 18 months due to rise in pharmaceutical use and COVID-19-related treatments and vaccines.

The Malaysia medical devices market was valued at $1.9 billion in the year 2020. The market grew at a CAGR of more than 11% during the period 2016 to 2020. Malaysia provides one of the strongest markets for foreign medical devices manufacturers in Southeast Asia. The medical devices industry was also identified as one of the significant growth areas under the healthcare National Key Economic Area (NKEA) 2020.

Malaysia pharmaceutical market overview

Malaysia pharmaceutical market overview

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Malaysia medical devices market overview

Malaysia medical devices market overview

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What are the key segments in the pharmaceutical market in Malaysia?

The key segments in the pharmaceutical market in Malaysia are generics, biologics, biosimilars, and over-the-counter (OTC).

Who are the major players in the pharmaceutical market in Malaysia?

The major players in the pharmaceutical market in Malaysia are Novartis, GlaxoSmithKline (GSK), Pfizer, Y.S.P. Southeast Asia (Y.S.P. SAH), and Kotra Pharma.

GlaxoSmithKline (GSK)

It is a healthcare company that focuses on the development, manufacture, and commercialization of pharmaceuticals, vaccines, and consumer healthcare products. It offers drugs for the treatment of respiratory diseases, cancer, cardiovascular diseases, human immunodeficiency virus (HIV), infectious diseases, immuno-inflammation, and rare diseases. It is headquartered in Brentford, London. In Malaysia, it operates from Selengor.

Novartis

It is a healthcare company that focuses on the discovery, development, manufacture, and marketing of prescription and generic pharmaceutical products, as well as eye care products. It provides drugs for the treatment of cancer and other diseases. Novartis is headquartered in Basel, Switzerland. In Malaysia, it operates from Seksyen/Selangor Darul Ehsan.

Pfizer

It is a research-based global biopharmaceutical company that discovers, develops, manufactures, and commercializes drugs for various conditions, consumer healthcare products, generics, and active pharmaceutical ingredients (APIs). Pfizer is headquartered in the US. In Malaysia, it operates from Kuala Lumpur.

Malaysia pharmaceutical market, by major players

Malaysia pharmaceutical market, by major players

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Who are the major market players in the medical devices market in Malaysia?

The major players in the medical devices market in Malaysia are Abbott, Medtronic, GE Healthcare, Stryker Corp (Stryker), and LKL International Berhad.

Abbott

It is a diversified health product company that manufactures and markets drugs, diagnostics, branded generics, vascular products, and nutritional products. The company’s products comprise specialized medicines; medical diagnostic instruments and tests; minimally invasive surgical devices; and products for veterinary care. Its Malaysia office is located in Shah Alam, Selangor.

Medtronic

It is a medical technology company. It provides a wide range of medical devices for the treatment of heart disease, spinal conditions, neurological disorders, vascular disease, orthopedic disorders, and diabetes. Medtronic is headquartered in Dublin, Ireland. In Malaysia, Medtronic is located at Petaling Jaya, Selangor, Malaysia.

GE Healthcare

It is a business unit of General Electric Company. It manufactures and sells medical imaging devices for diagnosis, as well as other medical devices. GE Healthcare is headquartered in Chicago, Illinois, US. In Malaysia, it operates from Kuala Lumpur.

Malaysia medical devices market, by major players

Malaysia medical devices market, by major players

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Market report scope (Malaysia Pharmaceutical Market)

Market size 2020 $2.9 billion
CAGR >9% (2013-2020)
Forecast Period 2021-2026
Key segments Generics, Biologics, Biosimilars, and Over-The-Counter (OTC)
Major players Novartis, GlaxoSmithKline (GSK), Pfizer, Y.S.P. Southeast Asia (Y.S.P. SAH), and Kotra Pharma

Market report scope (Malaysia Medical Devices Market)

Market size 2020 $1.9 billion
Forecast Period 2021-2026
CAGR >11% (2016-2020)
Major players Abbott, Medtronic, GE Healthcare, Stryker Corp (Stryker), and LKL International Berhad

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: Roche, Novartis, GlaxoSmithKline (GSK), Pfizer, YSP SAH and Kotra pharma.
  • Profiles and SWOT analyses of the major players in the medical device market: Abbott, Medtronic, GE Healthcare, Stryker, and LKL.
  • An insightful review of the COVID-19 epidemiology, COVID-19 impact and developments in healthcare market, HealthTech landscape, reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices.
  • Detailed analysis of the country’s healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure.
  • An overview of the opportunities for and challenges to growth in the Malaysia’s 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 Malaysia’s healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the Malaysia’s healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership

Table of Contents

1. Table of Contents

1.1 List of Figures

1.2 List of Tables

2. Executive Summary

2.1 Executive Summary

2.2 Key Highlights: Facts about the Malaysian Healthcare Market

2.3 Key Highlights: Healthcare Startups in Malaysia

2.4 Key Events: Malaysia Healthcare Timeline, 2015–21

2.5 Key Events: Malaysia Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2020–21

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, Malaysia, 2021

3. Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Exports

3.3 Pharmaceutical Market – Imports

3.4 Pharmaceutical Market – Supply Channels, Malaysia

3.5 Pharmaceutical Market – Market Segments

3.6 COVID-19 Epidemiology, Malaysia

3.7 COVID-19 Impact and Developments in the Healthcare Market, Malaysia

3.8 COVID-19 Clinical Trials Landscape, Malaysia

3.9 Pharmaceutical Market – Major Players

4. Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Devices Market – Major Players

5. Pharmaceutical and Medical Devices Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6. Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, Malaysia, 2019–21

6.2 Deal Analysis: Medical Device Market, Malaysia, 2019–21

7. HealthTech Landscape

7.1 HealthTech Landscape, Malaysia

7.2 HealthTech Deals Landscape, Malaysia

7.3 Key HealthTech Deals, Malaysia

7.4 Adoption of Technology in Healthcare Malaysia

7.5 Digital Regulations, Malaysia

7.6 HealthTech Landscape: Benefits and Risks, Malaysia

8. Market Access

8.1 Overview of Healthcare System, Malaysia

8.2 Reimbursement Process, Malaysia

8.3 Overview of Insurance Providers, Public Insurance, Malaysia

8.4 Overview of Insurance Providers, Private Insurance, Malaysia

8.5 Healthcare Spending and Prescription Drug Price Trend, Malaysia

8.6 Pricing Policies, Malaysia

8.7 Market Access: Key Events Timeline, Malaysia, 2010–21

8.8 Regulatory Landscape, Malaysia

8.8.1 Marketing Authorization for Pharmaceutical Products, Malaysia

8.8.2 Marketing Authorization for Medical Devices, Malaysia

8.8.3 Intellectual Property Rights, Patent, Malaysia

8.8.4 Intellectual Property Rights, Trademark, Malaysia

8.8.5 Clinical Trial Regulation Process, Malaysia

8.8.6 Pharmaceutical Clinical Trials Landscape, Malaysia

8.8.7 Medical Device Clinical Trials Landscape, Malaysia

8.8.8 Pharmaceutical Manufacturing and Licensing, Malaysia

8.8.9 Pharmaceutical Export and Import, Malaysia

8.8.10 Pharmaceutical Advertising Regulations, Malaysia

8.8.11 Pharmacy Regulations, Malaysia

8.8.12 Labeling and Packaging Regulations, Malaysia

9. Country Healthcare Landscape

9.1 Malaysia Healthcare Policy Highlights

9.2 Healthcare Facilities, Malaysia

9.3 Healthcare Parameters, Malaysia

9.4 Life Expectancy and Immunization Rate, Malaysia

9.5 Environmental Health, Malaysia

9.6 Healthcare Personnel, Malaysia

9.7 Disease Burden, Malaysia

9.8 Healthcare Expenditure, Malaysia

10 Trade Associations, Malaysia

11 Trade Fairs, Malaysia

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.2 Bibliography

13.3 About GlobalData

13.4 Contact Us

13.5 Disclaimer

List of Tables

Table 1: Approved biosimilars, Malaysia, 2022

Table 2: COVID-19 indicators, global and Malaysia, 2022

Table 3: Approved COVID-19 vaccines, Malaysia, 2020–21

Table 4: Available COVID-19 IVD products, Malaysia, 2020–21

Table 5: Pipeline COVID-19 IVD products, Malaysia, 2020–21

Table 6: Method of evaluation according to product categories, Malaysia, 2022

Table 7: NPRA document submission, Malaysia, 2022

Table 8: Priority review timelines, Malaysia, 2022

Table 9: Product registration timelines, Malaysia, 2022

Table 10: Registration fees, Malaysia, 2022

Table 11: Medical device classification and fees, Malaysia, 2022

Table 12: Medical device classification registration fees and review timeline, Malaysia, 2022

Table 13: Patent fees ($), Malaysia, 2022

Table 14: Trademark fees ($), Malaysia, 2022

Table 15: Documents required for CTIL/CTX submission, Malaysia, 2022

Table 16: Label of a pharmaceutical product, Malaysia, 2022

Table 17: Label of a pharmaceutical product, Malaysia, 2022

Table 18: Trade fairs, Malaysia, 2022

List of Figures

Figure 1: Pharmaceutical market, revenue ($B and MYRB), Malaysia, 2013–20

Figure 2: Medical devices market, revenue ($B), Malaysia, 2016–21

Figure 3: Healthcare start-ups in Malaysia, 2022

Figure 4: Country profile, Malaysia, 2022

Figure 5: Pharmaceutical market, revenue ($B), Malaysia, 2013–220

Figure 6: Pharmaceutical market, revenue forecast ($B), Malaysia, 2021–26

Figure 7: Pharmaceutical exports ($M), Malaysia, 2011–20

Figure 8: Top export partners, Malaysia, 2020

Figure 9: Pharmaceutical imports ($B), Malaysia, 2011–20

Figure 10: Top import partners, Malaysia, 2020

Figure 11: Pharmaceutical supply chain, Malaysia, 2022

Figure 12: Major biologics going off patent, Malaysia, (2023–27)

Figure 13: Number of prescribed medicines launched under major indications, Malaysia, 2010–16

Figure 14: Number of prescribed medicines projected to be launched under major indications, Malaysia, 2017–22

Figure 15: OTC medicines market (per capita expenditure, $B), Malaysia, 2011–20

Figure 16: OTC market, revenue ($M), Malaysia, 2011–21

Figure 17: OTC medicines market, major market value segmentation (%), Malaysia, 2019

Figure 18: Number of biopharmaceuticals launched in various segments, Malaysia, 2017–22

Figure 19: Medical tourism market, Malaysia, 2011–21

Figure 20: Key strategic pillars of medical tourism blueprint, Malaysia, 2021–25

Figure 21: SWOT analysis of medical tourism blueprint, Malaysia, 2021

Figure 22: COVID-19 (number of cases), Malaysia, 2020–22

Figure 23: COVID-19 (number of deaths), Malaysia, 2020–22

Figure 24: COVID-19-related travel restrictions, Malaysia, 2020–21

Figure 25: COVID-19 fiscal stimulus timeline, Malaysia, 2020–21

Figure 26: COVID-19 vaccine dose administration (number of administered vaccine doses), Malaysia, 2021–22

Figure 27: COVID-19 vaccine booster dose per capita (number of administered vaccine doses per hundred), Malaysia, 2021–22

Figure 28: COVID-19 vaccine booster dose by type (number of administered vaccine doses), Malaysia, 2021–22

Figure 29: COVID-19 vaccine booster dose by age group (% of administered vaccine doses), Malaysia, 2021–22

Figure 30: COVID-19 clinical trials sponsors by count, Malaysia, 2020–22

Figure 31: COVID-19 clinical trials count by phase, Malaysia, 2020–22

Figure 32: COVID-19 clinical trials count by trial status, Malaysia, 2020–22

Figure 33: Medical devices market, revenue ($B), Malaysia, 2016–20

Figure 34: Medical devices market, revenue forecast ($B), Malaysia, 2021–26

Figure 35: Medical devices market, major segments (%), Malaysia, 2022

Figure 36: Medical devices market, major trade partners, Malaysia, 2018

Figure 37: Medical devices market, revenue ($B) of major companies, Malaysia, 2020

Figure 38: Deals value and deal count, pharmaceutical market, Malaysia, 2019–22

Figure 39: Deals value and deal count, quarterly, pharmaceutical market, Malaysia, 2019–22

Figure 40: Deals value and deal count, subtypes, pharmaceutical market, Malaysia, 2019–22

Figure 41: Top therapy areas by deal value ($M), pharmaceutical market, Malaysia, 2019–22

Figure 42: Top therapy areas by deal count, pharmaceutical market, Malaysia, 2019–22

Figure 43: M&A deals by quarter, pharmaceutical market, Malaysia, 2019–22 (by value and by number)

Figure 44: VC deals by quarter, pharmaceutical market, Malaysia, 2019–22 (by value and by number)

Figure 45: Deals value and deal count, medical devices market, Malaysia, 2019–22

Figure 46: Deals value and deal count, quarterly, medical devices market, Malaysia, 2019–22

Figure 47: Deals value and deal count, subtypes, medical devices market, Malaysia, 2019–22

Figure 48: Top equipment sectors by deal value ($M), medical devices market, Malaysia, 2019–22

Figure 49: Top equipment sectors by deal count, medical devices market, Malaysia, 2019–22

Figure 50: M&A deals by quarter, medical devices market, Malaysia, 2019–22 (by value and by number)

Figure 51: DHM timeline, Malaysia, 2021

Figure 52: Key strategic pillars, Digital Health Malaysia (DHM), 2021

Figure 53: Deals value ($M), healthtech, Malaysia, 2019–22

Figure 54: Deal count (number of deals), healthtech, Malaysia, 2019–22

Figure 55: Healthtech regulatory and government policies, Malaysia, 2017–20

Figure 56: Structural overview of healthcare system, Malaysia, 2022

Figure 57: Formulary process, Malaysia, 2022

Figure 58: Health aid categories under PeKa B40, Malaysia, 2022

Figure 59: Critical illnesses under mySalam, Malaysia, 2019–20

Figure 60: Out-of-pocket spending ($ per capita), Malaysia, 2011–21

Figure 61: Annual rate of change (%), health price index, Malaysia, 2012–21

Figure 62: Proposed drug price control measures, Malaysia, 2022

Figure 63: NPRA product registration process, Malaysia, 2022

Figure 64: New drug product classification, registration requirement, and evaluation timeline, Malaysia, 2022

Figure 65: Drug registration process, Malaysia, 2022

Figure 66: Appeal process, Malaysia, 2022

Figure 67: Medical device regulatory framework, Malaysia, 2022

Figure 68: Medical device approval process, Malaysia, 2022

Figure 69: Patent approval process, Malaysia, 2022

Figure 70: Patent prosecution highway (PPH), Malaysia, 2022

Figure 71: Trademark approval process, Malaysia, 2022

Figure 72: CTIL/CTX application process, Malaysia, 2019

Figure 73: Pharmaceutical clinical trials count by trial status, Malaysia, 2020–22

Figure 74: Pharmaceutical clinical trials count by phase, Malaysia, 2020–22

Figure 75: Pharmaceutical clinical trials count by indication, Malaysia, 2020–22

Figure 76: Top five pharmaceutical clinical trials sponsors by count, Malaysia, 2020–22

Figure 77: Medical devices clinical trials count by trial status, Malaysia, 2020–22

Figure 78: Medical devices clinical trials count by indication, Malaysia, 2020–22

Figure 79: Medical devices clinical trials count by device category, Malaysia, 2020–22

Figure 80: Top five medical devices clinical trials sponsors by count, Malaysia, 2020–22

Figure 81: Major clinical trial sites and trial count, Malaysia, 2022

Figure 82: Advertising product claims, Malaysia, 2022

Figure 83: Pharmacy regulations, Malaysia, 2022

Figure 84: Outcomes of 11th Malaysia Plan, Malaysia, 2016–20

Figure 85: Number of hospitals (per 10,000 population), Malaysia, 2011–21

Figure 86: Hospital beds (per 1,000 population), Malaysia, 2011–21

Figure 87: Immunization rate (%), Malaysia, 2013–21

Figure 88: Life expectancy at birth (Years), Malaysia, 2013–21

Figure 89: CO2 emissions (million tons), Malaysia, 2011–21

Figure 90: PM2.5 (µg per m3), Malaysia, 2010–21

Figure 91: Physicians (per 1,000 population), Malaysia, 2011–21

Figure 92: Dentists (per 1,000 population), Malaysia, 2010–21

Figure 93: Nurses (per 1,000 population), Malaysia, 2011–21

Figure 94: Pharmacists (per 1,000 population), Malaysia, 2010–21

Figure 95: DALYs by major disease (per 100,000 population), Malaysia, 2019

Figure 96: Major causes of male mortality (per 100,000 population), Malaysia, 2019

Figure 97: Major causes of female mortality (per 100,000 population), Malaysia, 2019

Figure 98: Major causes of mortality (per 100,000 population), Malaysia, 2019

Figure 99: Healthcare expenditure as percentage of GDP (%), Malaysia, 2011–18

Figure 100: Health expenditure share (% of total health spending), Malaysia, 2011–18

Figure 101: Health expenditure by public sector sources of financing, (%), Malaysia, 2019

Figure 102: Healthcare expenditure components by function (% of total health expenditure), Malaysia, 2019

Frequently Asked Questions

The pharmaceutical market size in Malaysia was valued at $2.9 billion in the year 2020.

 

 

 

 

The pharmaceutical market in Malaysia grew at a CAGR of more than 9% during the review period.

Generics, biologics, biosimilars, and over-the-counter (OTC) are the key segments in the Malaysian pharmaceutical market.

Novartis, GlaxoSmithKline (GSK), Pfizer, Y.S.P. Southeast Asia (Y.S.P. SAH), and Kotra Pharma are the major players in the Malaysian pharmaceutical market.

The pharmaceutical market size in Malaysia was valued at $1.9 billion in the year 2021.

The medical devices market in Malaysia grew at a CAGR of more than 11% during the review period.

Abbott, Medtronic, GE Healthcare, Stryker Corp (Stryker), and LKL International Berhad are the major players in the Malaysian medical devices market.

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