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In Vitro Diagnostics (IVD) in Malaysia, Singapore and Indonesia, 2022
Publication Date: October 18, 2022
Tags: APAC, Asia, Coagulation, Genetic Diseases, Hematology, Histology and Cytology, Immunoassay, In Vitro Diagnostics (IVD), Infectious Diseases, Molecular Diagnostics, Oncology and Cancer, Point-of-Care (POC) Testing
Pages: 345
SKU: 22-710
In Vitro Diagnostics (IVD) in Malaysia, Singapore and Indonesia, 2022 by Kalorama Information presents a comprehensive market research report focusing on the burgeoning IVD market in Southeast Asia. As part of the fast-growing Asia Pacific (APAC) region, Southeast Asia offers significant opportunities for IVD companies, with Malaysia, Indonesia, and Singapore at the forefront.
Report Highlights:
- Malaysia: With a population of about 32 million, Malaysia offers a balanced market for IVD companies, boasting growing healthcare service capabilities and promising growth potential.
- Singapore: Despite its smaller population of less than 6 million, Singapore’s advanced healthcare infrastructure and skilled workforce make it a lucrative market for IVD companies. Known as a medical tourism hub, Singapore provides world-class healthcare services.
- Indonesia: Home to approximately 275 million people, Indonesia presents vast opportunities for IVD companies. The country is actively enhancing its healthcare infrastructure, making it a key market in the region.
Segments Covered:
- Point-of-Care Testing (POC)
- Clinical Chemistry
- Immunoassays
- Molecular Assays
- Hematology
- Coagulation
- Microbiology and Virology
- Blood Testing and Typing
- Histology and Cytology
This report provides an in-depth analysis of the IVD markets in these three countries, highlighting the unique opportunities and challenges within each market. It also offers valuable insights into population demographics, healthcare infrastructure, and market trends, making it an essential resource for any IVD company looking to expand in Southeast Asia.
Table: Malaysia’s IVD Market, by Segment, 2022-2027 ($ Millions)
| Test Type | 2022 | 2027 | CAGR |
| POC | $XX Million | $XX Million | XX% |
| Clinical Chemistry | $XX Million | $XX Million | XX% |
| Immunoassays | $XX Million | $XX Million | XX% |
| Molecular Assays | $XX Million | $XX Million | XX% |
| Hematology | $XX Million | $XX Million | XX% |
| Coagulation | $XX Million | $XX Million | XX% |
| Microbiology and Virology | $XX Million | $XX Million | XX% |
| Blood Testing and Typing | $XX Million | $XX Million | XX% |
| Histology and Cytology | $XX Million | $XX Million | XX% |
| Total | $XX Million | $XX Million | XX% |
Source: Kalorama Information
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Table of Contents
Chapter 1: Executive Summary
Malaysia: Healthcare and Regulatory Landscape
Regulation of Medical devices in Malaysia
IVD Market Size Estimation and Forecast for Malaysia
- Table 1-1: Malaysia’s IVD Market, by Segment (POC, Clinical Chemistry, Immunoassays, Molecular Assays, Hematology, Coagulation, Microbiology and Virology, Blood Testing and Typing, & Histology and Cytology), 2022-2027 ($ Millions)
Indonesia: Healthcare and Regulatory Landscape
Market Drivers and Challenges
The Health Insurance System
- Table 1-2: Indonesia’s Medical Device Demand, Local Production, Exports, and Imports, 2018-2021, ($ Billions)
Policies on Procurement, Import, Market Authorization, and Halal Certification of IVDs
IVD Market Size Estimation and Forecast for Indonesia
- Table 1-3: Indonesia’s IVD Market, by Segment (POC, Clinical Chemistry, Immunoassays, Molecular Assays, Hematology, Coagulation, Microbiology and Virology, Blood Testing and Typing, & Histology and Cytology), 2022-2027 ($ Millions)
Singapore: Healthcare and Regulatory Landscape
The Health Insurance System
Policies on Import, Registration, and Distribution of IVDs in Singapore
Recovery of the Medical Tourism Sector
IVD Market Size Estimation and Forecast for Singapore
- Table 1-4: Indonesia’s IVD Market, by Segment (POC, Clinical Chemistry, Immunoassays, Molecular Assays, Hematology, Coagulation, Microbiology and Virology, Blood Testing and Typing, & Histology and Cytology), 2022-2027 ($ Millions)
The Combined IVD Markets of Malaysia, Indonesia, and Singapore
- Table 1-5: Total IVD Market Size in Malaysia, Indonesia, and Singapore and Forecasts, 2022-2027 ($ Millions)
- Table 1-6: Market Shares of the Leading IVD Companies (Roche, Abbott, Siemens Healthineers, Beckman Coulter, bioMérieux, Bio-Rad, Sysmex, and Others) in Malaysia, Indonesia, and Singapore, 2022
Chapter 2: COVID-19 Testing Market Trends
COVID-19 Testing Trends in Malaysia (2020-2022)
- Table 2-1: COVID-19 Self-Tests Approved in Malaysia (As of February 2022)
- Table 2-2: Covid-19 Testing Markets (Molecular Assays, Immunoassays, and POC Tests) in Malaysia, 2022-2027 ($ Millions)
- Table 2-3: COVID-19 Testing Types (Immunoassay Lab-based, Molecular Diagnostics Lab-based, and Rapid-POC) and their Shares in Malaysia, 2022, ($ Millions)
COVID-19 Testing Trends in Indonesia (2020-2022)
- Table 2-4: Covid-19 Testing Markets (Molecular Assays, Immunoassays, and POC Tests) in Indonesia, 2022-2027 ($ Millions)
- Table 2-5: COVID-19 Testing Market Segments (Immunoassay Lab-based, Molecular Diagnostics Lab-based, and Rapid-POC) and their Shares in Indonesia, 2022, ($ Millions)
COVID-19 Testing Trends in Singapore (2020-2022)
- Table 2-6: Covid-19 Testing Markets (Molecular Assays, Immunoassays, and POC Tests) in Singapore, 2022-2027 ($ Millions)
- Table 2-7: COVID-19 Testing Market Segments (Immunoassay Lab-based, Molecular Diagnostics Lab-based, and Rapid-POC) and their Shares in Singapore, 2022 ($ Millions)
- Table 2-8: COVID-19 Testing Market Segments (Immunoassay Lab-based, Molecular Diagnostics Lab-based, and Rapid-POC) and their Combined Shares in Malaysia, Indonesia, and Singapore, 2022 ($ Millions)
- Table 2-9: COVID-19 Testing Markets in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
Chapter 3: Point-of-Care Tests
Pregnancy and Fertility Testing
Cancer Testing
Lipid Testing
Drug of Abuse (DOA) Testing
Infectious Disease Testing
HIV
Hepatitis
- Table 3-1: Prevalence of Co-infection of HIV with HBV and HCV in Malaysia, Indonesia, and Singapore
Tuberculosis (TB)
Tropical Diseases
Dengue
Filariasis
Leptospirosis
Malaria
Typhoid
- Table 3-2: Selected List of Companies Offering POC Tests for Tropical Diseases in Malaysia, Indonesia, and Singapore
Respiratory Diseases
Sexual Health
Diabetes Testing – Blood Glucose Monitoring
Other POC tests
- Table 3-3: POC Test Sales by Category (Fertility/ Pregnancy, Covid-19, Other Infectious diseases, Glucose (self), Glucose Continuous, Glucose Professional, HbA1c POC, Fecal Occult Blood Critical care POC, Coagulation, Cardiac Markers, Hematology, Drug of Abuse, Cholesterol, and Other), Malaysia, 2022-2027 ($ Millions)
- Table 3-4: POC Test Sales by Category (Fertility/ Pregnancy, Covid-19, Other Infectious diseases, Glucose (self), Glucose Continuous, Glucose Professional, HbA1c POC, Fecal Occult Blood Critical care POC, Coagulation, Cardiac Markers, Hematology, Drug of Abuse, Cholesterol, and Other), Indonesia, 2022-2027 ($ Millions)
- Table 3-5: POC Test Sales by Category (Fertility/ Pregnancy, Covid-19, Other Infectious diseases, Glucose (self), Glucose Continuous, Glucose Professional, HbA1c POC, Fecal Occult Blood Critical care POC, Coagulation, Cardiac Markers, Hematology, Drug of Abuse, Cholesterol, and Other), Singapore, 2022-2027 ($ Millions)
- Table 3-6: POC Test Sales in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
- Table 3-7: Estimation of Market Shares of the Leading Companies (Abbott, Roche, and Siemens Healthineers) in the POC Testing Markets in Malaysia, Indonesia, and Singapore, 2022
Chapter 4: Core Lab and Clinical Chemistry
Workstation Consolidation and Laboratory Automation
Core Lab: Market Analysis
- Table 4-1: Core Lab Automation Solutions Used by a Selected List of Hospitals (MOH Hospitals [General Hospitals], MOH [District Hospitals], University Hospitals, and Private Hospitals) in Malaysia
- Table 4-2: Core Lab Solution Sales in Malaysia, Indonesia, and Singapore; 2022-2027 ($ Millions)
- Table 4-3: Leading Companies (Roche, Abbott, Siemens, Healthineers, Beckman Coulter, and Other) in the Core Lab Solutions Markets in Malaysia, Indonesia, and Singapore, 2022
Clinical Chemistry Market Analysis
Blood Gases and Electrolytes
Urinalysis
- Table 4-4: Clinical Chemistry Sales by Test Category (General Chemistry, Blood Gases, and Urinalysis), Malaysia, 2022-2027 ($ Millions)
- Table 4-5: Clinical Chemistry Sales by Test Category (General Chemistry, Blood Gases, and Urinalysis), Indonesia, 2022-2027 ($ Millions)
- Table 4-6: Clinical Chemistry Sales by Test Category (General Chemistry, Blood Gases, and Urinalysis), Singapore, 2022-2027 ($ Millions)
Chapter 5: Immunoassays
Cardiac Markers
Tumor Markers
Diabetes
Thyroid
Autoimmune Diseases
Other Immunoassay Segments
- Table 5-1: Immunoassay (Non-Infectious Diseases) Sales by Category (Diabetes, Tumor Markers, Thyroid, Proteins, Cardiac Markers, and Other), Malaysia, 2022-2027 ($ Millions)
- Table 5-2: Immunoassay (Non-Infectious Diseases) Sales by Category (Diabetes, Tumor Markers, Thyroid, Proteins, Cardiac Markers, and Other), Indonesia, 2022-2027 ($ Millions)
- Table 5-3: Immunoassay (Non-Infectious Diseases) Sales by Category (Diabetes, Tumor Markers, Thyroid, Proteins, Cardiac Markers, and Other), Singapore, 2022-2027 ($ Millions)
- Table 5-4: Immunoassay (Non-Infectious Diseases) Sales in Malaysia, Indonesia, and Singapore; 2022-2027 ($ Millions)
- Table 5-5: Leading Companies (Roche, Abbott, Siemens Healthineers, and Others) in the Immunoassays (Non-Infectious Diseases) Markets in Malaysia, Indonesia, and Singapore, 2022
Chapter 6: Molecular Assays
Oncology
- Table 6-1: Selected List of NGS-based Cancer Tests Approved for Clinical Use in Singapore
- Table 6-2: NGS-based Cancer Testing in Singapore: Key Challenges
Genetic Diseases and Disorders
Prenatal Testing, Pre-Implantation Genetic Testing, etc.
Transplant Diagnostics
- Table 6-3: Molecular Diagnostics (Non-Infectious Diseases) Sales* by Category (Oncology Assays, Genetic Diseases, and Transplant Testing), Malaysia, 2022-2027 ($ Millions)
- Table 6-4: Molecular Diagnostics (Non-Infectious Diseases) Sales* by Category (Oncology Assays, Genetic Diseases, and Transplant Testing), Indonesia, 2022-2027 ($ Millions)
- Table 6-5: Molecular Diagnostics (Non-Infectious Diseases) Sales* by Category (Oncology Assays, Genetic Diseases, and Transplant Testing), Singapore, 2022-2027 ($ Millions)
- Table 6-6: Molecular Diagnostics (Non-Infectious Diseases) Sales* in Malaysia, Indonesia, and Singapore; 2022-2027 ($ Millions)
- Table 6-7: Leading Companies (Roche, Abbott, QIAGEN, and Others) in the Molecular Diagnostics (Non-Infectious Diseases) Markets in Malaysia, Indonesia, and Singapore, 2022
Chapter 7: Hematology
Laboratory-based Hematology: Technology and Market Trends
- Table 7-1: Laboratory-based Hematology Sales in Malaysia, Indonesia, and Singapore; 2022-2027 ($ Millions)
- Table 7-2: Leading Companies (Sysmex, Beckman Coulter/Danaher, Mindray, Roche, and Others) in the Laboratory-based Hematology Markets in Malaysia, Indonesia, and Singapore, 2022
Chapter 8: Coagulation
Impact of COVID-19
Lab-based Coagulation Testing
- Table 8-1: Lab-based Coagulation Test Sales, Malaysia, 2022-2027 ($ Millions)
- Table 8-2: Lab-based Coagulation Test Sales, Indonesia, 2022-2027 ($ Millions)
- Table 8-3: Lab-based Coagulation Test Sales, Singapore, 2022-2027 ($ Millions)
- Table 8-4: Lab-based Coagulation Test Sales in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
- Table 8-5: Estimation of Market Shares of the Leading Companies in the Lab-based Coagulation Testing Markets in Malaysia, Indonesia, and Singapore, 2022
Chapter 9: Microbiology and Virology
Antibiotic Resistant Infections: Challenges and Solutions
Syndromic Testing
Diagnosis of Prevalent Infectious Diseases in Malaysia, Indonesia, and Singapore
Hepatitis Testing
- Table 9-1: Selected List of Commercial Clinical Microbiology Immunoassays and Molecular Assays for Hepatitis in Malaysia, Indonesia, and Singapore
Sepsis and Hospital Acquired Infections (HAI) Testing
HIV Testing
- Table 9-2: Selected List of Commercial Clinical Microbiology Immunoassays and Molecular Assays for HIV in Malaysia, Indonesia, and Singapore
Sexually Transmitted Diseases (STDs) Testing
- Table 9-3: Selected List of Commercial Clinical Microbiology Immunoassays and Molecular Assays for STDs* in Malaysia, Indonesia, and Singapore
ToRCH
Respiratory Infection Testing
Clinical Microbiology and Virology Market Segments
Tuberculosis (TB) Testing
Other Prevalent Infectious Diseases and their Diagnosis in Malaysia, Indonesia, and Singapore
ID/AST: Market Analysis
ID/AST Systems: Panels, Auto, and Supplies
- Table 9-4: ID/AST Systems Market Distribution by Product Type (Panels, Supplies, and Auto) in Malaysia, Indonesia, and Singapore
Blood Culture
Chromogenic Media
Rapid Tests Performed on Colonies from Culture Media
- Table 9-5: Microbiology ID/AST Markets in Malaysia, 2022-2027 ($ Millions)
- Table 9-6: Microbiology ID/AST Markets in Indonesia, 2022-2027 ($ Millions)
- Table 9-7: Microbiology ID/AST Markets in Singapore, 2022-2027 ($ Millions)
- Table 9-8: ID/AST Markets in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
Microbiology Immunoassays
- Table 9-9: Laboratory-based Microbiology Immunoassays Markets in Malaysia, 2022-2027 ($ Millions)
- Table 9-10: Market Shares of the Leading Companies in the Lab-based Microbiology Immunoassay Markets in Malaysia, 2022
- Table 9-11: Laboratory-based Microbiology Immunoassays Markets in Indonesia, 2022-2027 ($ Millions)
- Table 9-12: Market Shares of the Leading Companies in the Lab-based Microbiology Immunoassay Markets in Indonesia, 2022
- Table 9-13: Laboratory-based Microbiology Immunoassays Markets in Singapore, 2022-2027 ($ Millions)
- Table 9-14: Market Shares of the Leading Companies in the Lab-based Microbiology Immunoassay Markets in Singapore, 2022
- Table 9-15: Combined Clinical Laboratory-Based Microbiology Immunoassay Market by Pathogen in Malaysia, Indonesia, and Singapore, 2022 ($ millions)
- Table 9-16: Microbiology Immunoassays (Lab-based) Markets in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
Molecular Microbiology (Laboratory-based)
- Table 9-17: Laboratory-based Molecular Microbiology Markets in Malaysia, 2022-2027 ($ Millions)
- Table 9-18: Laboratory-based Molecular Microbiology Markets in Indonesia, 2022-2027 ($ Millions)
- Table 9-19: Laboratory-based Molecular Microbiology Markets in Singapore, 2022-2027 ($ Millions)
- Table 9-20: Combined Clinical Molecular Microbiology Market by Pathogen in Malaysia, Indonesia, and Singapore, 2022 ($ millions)
- Table 9-21: Microbiology Mole
- Table 9-22: Microbiology ancular Diagnostics Markets in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)d Virology Markets in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
Chapter 10: Blood Banking Services
Blood Typing and Grouping
Blood Testing
Market Trends Triggered by COVID-19 Pandemic
Blood Banking Service Markets in Malaysia
- Table 10-1: Blood Testing and Typing Market by Category, Malaysia, 2022-2027 ($ Millions)
- Table 10-2: Market Shares of the Leading Companies in the Blood Testing and Typing Markets in Malaysia, 2022
Blood Banking Service Markets in Indonesia
- Table 10-3: Distribution of Blood Centers (BCs) in Indonesia, by Province
- Table 10-4: Blood Testing and Typing Market by Category, Indonesia, 2022-2027 ($ Millions)
- Table 10-5: Market Shares of the Leading Companies in the Blood Testing and Typing Markets in Indonesia, 2022
Blood Banking Service Markets in Singapore
- Table 10-6: Blood Testing and Typing Market by Category, Singapore, 2022-2027 ($ Millions)
- Table 10-7: Blood Testing and Typing Markets in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
Chapter 11: Histology and Cytology
HPV Testing: A Fast-Growing Market Segment
Technological Advancements in Histology and Cytology
Market Trends
- Table 11-1: Cervical Cancer Incidences in Singapore, Malaysia, and Indonesia, 2020
- Table 11-2: Cervical Cancer Deaths in Singapore, Malaysia, and Indonesia, 2020
- Table 11-3: Leading Vendors Offering Cervical Cancer Screening Products in Malaysia, Indonesia, and Singapore
Histology and Cytology Markets in Malaysia
Digital Pathology Solutions in Malaysia
- Table 11-4: The Histology and Cytology IVD Markets in Malaysia, by Type: 2022 -2027
Histology and Cytology Markets in Indonesia
Digital Pathology Solutions in Indonesia
- Table 11-5: The Histology and Cytology IVD Markets in Indonesia, by Type: 2022 –2027
Histology and Cytology Markets in Singapore
Digitization of Histology Laboratories in Singapore
- Table: 11-6: The Histology and Cytology IVD Markets in Singapore, by Type: 2022 – 2027
- Table 11-7: Histology and Cytology Markets in Malaysia, Indonesia, and Singapore, 2022-2027 ($ Millions)
- Table 11-8: Market Shares of the Leading Companies in the Histology and Cytology Markets in Malaysia, Indonesia, and Singapore, 2022
Chapter 12: Company Profiles
The Top Tier IVD Companies in Malaysia, Indonesia, and Singapore
Abbott Diagnostics
Beckman Coulter, Inc. / Danaher
Clinical Chemistry
Immunoassays
Hematology
Microbiology and Blood Banking
Core Lab Systems
Flow Cytometry
COVID-19
Becton, Dickinson, and Company (BD)
Cytology
Molecular Microbiology
Traditional Microbiology and ID/AST
Blood Collection
Flow Cytometry
COVID-19
bioMérieux Inc.
Molecular Biology
Microbiology
Immunoassays
Blood Culture
Mass Spectrometry
COVID-19
Bio-Rad Laboratories, Inc.
Quality Control
Blood Bank
Diabetes
Immunoassays
Liquid Biopsy and Droplet Digital PCR
COVID-19
Cepheid / Danaher
COVID-19
Danaher Corporation
DiaSorin S.p.A
COVID-19
Grifols S.A.
Hologic, Inc.
Ortho Clinical Diagnostics (Ortho)
Blood Bank
Core Lab / Immunoassays
COVID-19
PerkinElmer, Inc. (PE)
COVID-19
QIAGEN
Prenatal Testing
Cervical Cancer
Transplant Medicine
COVID-19
Roche Diagnostics
Hematology
Immunoassays
HIV
Core Molecular
Diabetes Care
Coagulation
POC
HPV
Blood Bank
Transplant Medicine
Cancer Companion Testing
Prenatal
COVID-19
Siemens Healthineers
Core Lab
Lab Automation
Immunoassays
Hematology
Molecular
COVID-19
Sysmex Corporation
Hematology
Coagulation
Urinalysis
Immunoassays
Flow Cytometry
COVID-19
Company Profiles: The Second Tier – Multinationals, Regional Companies, etc.
ARKRAY
Dry Chemistry / Immunoassays
Urinalysis
Diabetes
Molecular
BioCytech Corporation
Caris Life Sciences
CTK Biotech Inc
Dexcom
New Manufacturing Facility in Malaysia
Healgen Scientific LLC
Horiba Medical
Lucence Diagnostics
Medical Innovation Ventures Sdn. Bhd. (Mediven)
Mindray (Shenzhen Mindray Bio-medical Electronics Co., Ltd.)
MiRXES Pte Ltd.
OraSure Technologies, Inc.
COVID-19
Reszon Diagnostics International
Vela Diagnostics
COVID-19
Veredus Laboratories Pte Ltd
COVID-19
IVD Distributors in Malaysia, Indonesia, and Singapore
- Table 12-1: Selected List of IVD Distributors in Malaysia
- Table 12-2: Selected List of IVD Distributors in Indonesia
- Table 12-3: Selected List of IVD Distributors in Singapore
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