In Vitro Diagnostics (IVD) in Malaysia, Singapore and Indonesia, 2022

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