Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

INTRODUCTION

Figure 1-1: Map of Indonesia, with Provinces

Figure 1-2: Total Population of Indonesia (2000-2016)

Table 1-1: GDP Growth in Indonesia, 2012-2015

HEALTH STATUS OF INDONESIANS

HEALTHCARE DELIVERY SYSTEM

REGULATION OF IVD DEVICES AND DISTRIBUTION

SCOPE AND METHODOLOGY

SIZE AND GROWTH OF THE IVD MARKET

Figure 1-3: IVD Market in Indonesia, 2017 and 2022

CHAPTER TWO: INDONESIA – A GROWING IVD MARKET

HEALTHCARE EXPENDITURE IN INDONESIA

Figure 2-1: Growth of Health Expenditure per Capita (USD) in Indonesia, 2000-2014

Figure 2-2: Growth of Health Expenditure per Capita in PPP Terms (USD), Indonesia, 2000-2014

HEALTH INDICATORS IN INDONESIA

Figure 2-3: Top 10 Causes of Death in Indonesia

Table 2-1: Life Expectancy and Mortality Rates in Indonesia, 2000-2014 (Life Expectancy, Total; Life Expectancy at Birth, Male; Life Expectancy at Birth, Female; Total Mortality Rate, Adult, Male; Total Mortality Rate, Adult, Female)

PREVALENT INFECTIOUS DISEASES IN INDONESIA

Tuberculosis (TB)

Table 2-2: Assessment of TB Burden in Indonesia, WHO

Table 2-3: Pulmonary Tuberculosis Cases by Province, Indonesia

HIV/AIDS

Table 2-4: The Number of New Cases of HIV and AIDS between 2011 and 2015, Indonesia

Table 2-5: HIV and AIDS Cases in Indonesia, by Province

Malaria

Table 2-6: Incidence of Malaria in Indonesia, by Province

Dengue

Table 2-7: Dengue Hemorrhagic Fever (DHF) Cases in Indonesia, by Province

Filariasis

Table 2-8: Filariasis in Indonesia, 2011-2015

Table 2-9: Filariasis Cases in Indonesia, by Province, 2012-2014

Leptospirosis

Table 2-10: Leptospirosis Cases in Indonesia, by Province, 2011-2015

Typhoid

Table 2-11: Typhoid Prevalence in Indonesia, by Province

Human Papilloma Virus (HPV)

INDONESIAN HEALTHCARE INDUSTRY LANDSCAPE

Figure 2-4: Healthcare Delivery in Indonesia

Healthcare Delivery System

Public Healthcare System: General and Specialty Hospitals

Table 2-12: General and Specialty Hospitals in Indonesia, 2011-2015

Public Healthcare System: Community Healthcare Centers (CHCs/Puskesmas)

Table 2-13: Community Healthcare Centers in Indonesia, 2011-2015

Table 2- 14: Distribution of Puskesmas (CHCs) in Indonesia across 34 Provinces

Hospital Classification in Indonesia

Table 2-15: Selected General and Specialty Hospitals in Indonesia

Private Healthcare System

Table 2-16: Selected Leading Private Hospitals in Indonesia, by Province

Private Labs in Indonesia

Table 2-17: Selected Private Laboratories in Indonesia

FINANCIAL ASPECTS OF THE HEALTHCARE INDUSTRY IN INDONESIA

Table 2-18: Indonesia Healthcare Spending Compared to Southeast Asia Neighbors (New Zealand, Japan, Australia, South Korea,

Vietnam, China, Singapore, India, Malaysia, Thailand)

Table 2-19: Indonesia Healthcare Expenditure, 2000-2014 (Total Health Expenditure as % of GDP, Public Health Expenditure, Private

Health Expenditure)

Implementation of UHC

Private Health Insurance

E-CATALOGUE PRICING SYSTEM

KEY MARKET DRIVERS OF THE INDONESIAN HEALTHCARE MARKET

KEY CHALLENGES IN THE INDONESIAN HEALTHCARE MARKET

Uncertainty among Private Insurers

Rigid Reference Model Hampering Healthcare Accessibility

Limited Access to Quality Healthcare Facilities

Gap between Supply and Demand of Medical Professionals

Impact of the E-Catalogue Pricing System

Impact of Government’s Policies on Foreign Direct Investments (FDI)

Logistics Challenges

IVD PRODUCT REGULATION IN INDONESIA

Table 2-20: Classification of Medical Devices

IMPORTANT FACTORS TO CONSIDER WHILE CHOOSING AN IVD DISTRIBUTOR IN INDONESIA

Trade-Off between Small and Big Distributors

Table 2-21: Selected Foreign Companies and Their Key Distributors in Indonesia

PROCESSES FOR DISTRIBUTION LICENSE, COMPANY AND PRODUCT REGISTRATIONS

Company/Product Registration

Table 2-22: Licenses Required for IVD Distribution in Indonesia

REGULATORY TRENDS AND INSIGHTS RELEVANT FOR THE IVD SECTOR

Market Transition to E-Catalogue and Related Regulations

REGULATIONS FOR FOREIGN DIRECT INVESTMENTS (FDI)

Table 2-23: Indonesia Investment Coordinating Board (BKPM) Offices

SETTING UP A COMPANY IN INDONESIA

Table 2-24: Options for a Foreign IVD Company to Enter the Indonesian Market

Assessing Option 1: Opening an Affiliated Branch Office in Indonesia

Assessing Option 2: Select a Suitable Exclusive Distributor

Assessing Option 3: Set up OEM Operations; Invest in Local Manufacturing within 3 years

BUSINESS STRATEGIES ADOPTED BY MULTINATIONAL COMPANIES (MNCS): CASE STUDIES

Roche

bioMerieux

Thermo Fisher Scientific

Conclusion

CHAPTER THREE: IVD MARKET ANALYSIS

MICROBIOLOGY

LFIA Tests (Rapid Tests) for Infectious Diseases

Table 3-1: Sales of Rapid Tests for Infectious Diseases by Category, Indonesia, 2017-2022 (HIV; STDs; Hepatitis [HBV, HCV, etc.]; Other [includes Dengue, Malaria, Typhoid, RSV, Filariasis, etc.]; Rapid Tests-Infectious Diseases, Total)

Table 3-2: Popular Rapid Test Brands and Their Distributors in Indonesia

Lab-based Immunoassays for Infectious Diseases

Table 3-3: STD Test Costs at Selected Clinics and Hospitals in Indonesia

Table 3-4: Major Diseases and Demand for Lab-based Immunoassay Diagnostics in Indonesia, 2017-2022 (HIV; STDs; Hepatitis [HBV, HCV, etc.]; Other [includes Dengue, Malaria, Typhoid, RSV, Filariasis, etc.]; Lab-based Immunoassays – Infectious Diseases, Total)

ID/AST

Molecular Diagnostics

Table 3-5: Microbiology Sales in Indonesia, 2017-2022 (Rapid Tests-Infectious Diseases; Lab-based Immunoassays – Infectious Diseases; Molecular Diagnostics – Microbiology; Other [includes supplies, reagents, etc.]; Microbiology, Total)

HEMATOLOGY

Table 3-6: List of Major Players in the Indonesian Hematology Market

Table 3-7: Hematology Sales by Category, Indonesia, 2017-2022 (Hematology Systems; Hematology POC; Other [Digital imaging, analysis software, etc.]; Hematology, Total)

CLINICAL CHEMISTRY

Table 3-8: List of Major Players in the Indonesian Clinical Chemistry Market

Table 3-9: Clinical Chemistry Analyzer Sales by Category, Indonesia, 2017-2022 (General Chemistry; Blood Gas Analyzers; Critical Care POC; Clinical Chemistry, Total)

POINT-OF-CARE TESTS

POC – OTC/ Self-Testing

POC – Professional-Testing

POC Hand-Held Devices

POC Bench-Top Analyzers

Table 3-10: POC Sales by Category, Indonesia, 2017-2022 (POC-Diabetes; POC-OTC/Self-Testing, Other; POC-OTC/Self Testing, Total;

Cardiac Markers; DOA/Toxicology; Other; POC-Professional, Total; POC, Total)

IMMUNOASSAYS

Point-of-Care (POC) Immunoassays

Immunoassays for Non-Infectious Diseases

Table 3-11: Immunoassay (Non-Infectious) Sales by Category, Indonesia, 2017-2022 (Diabetes; Cardiac markers; Other [Cancer

Markers, DOA tests; cholesterol, RIAs for thyroid, hormones, endocrine markers, etc.]; Total, Lab-based Immunoassays – Non-

Infectious; DOA testing – rapid tests; Cancer markers – Rapid tests; Cardiac markers – Rapid tests; Others [Pregnancy, Cancer markers,

etc.]; Total, POC – Immunoassays – Non-Infectious; Total – Immunoassays – Non-Infectious)

BLOOD TESTING AND TYPING

Table 3-12: Distribution of Blood Centers in Indonesia, by Province

Non-Standardized Evaluation Protocol

Table 3-13: Blood Testing and Typing Sales by Category (ABO Grouping, Immunoassays [ELISA and Rapid Tests], NAT), Indonesia,

2017-2022

URINALYSIS

Table 3-14: List of Major Players in the Indonesian Urinalysis Market

COAGULATION

Table 3-15: List of Major Players in the Indonesian Coagulation Market

Table 3-16: Hemostasis Sales by Category (Lab-based Coagulation Tests, POC Coagulation Tests), Indonesia, 2017-2022

HISTOLOGY

Table 3-17: List of Major Players in the Indonesian Histology Market

Table 3-18: Histology Sales by Category (Traditional Non-Pap Stains, Pap Tests, HPV, Other [includes ISH, IHC, Digital Imaging, CTC,

and Flow Cytometry]), Indonesia, 2017-2022

TOTAL IVD MARKETS IN INDONESIA

Table 3-19: Total IVD Market in Indonesia by Segment (Microbiology, Hematology, Clinical Chemistry, POC, Immunoassays – Non-

Infectious Diseases, Blood Testing and Typing, Urinalysis, Coagulation, Histology, Others [includes Molecular Diagnostics (Non-

Infectious), Supplies, Reagents, IT, Imaging, Automation, etc.]), 2017-2022

CHAPTER FOUR: IVD COMPANIES, PRIVATE LABS AND DISTRIBUTOR PROFILES

IVD COMPANY PROFILES

Abbott Laboratories

Alere

Arkray Healthcare

Beckman Coulter

Becton, Dickinson and Company (BD)

bioMerieux

Bio-Rad

Cellavision

Cepheid

Critical Diagnostics

DiaSorin S.p.A.

EKF Diagnostics

ERBA Diagnostics

HemoCue AB

Hologic, Inc.

Horiba, Ltd.

Instrumentation Laboratory Company

Luminex Corporation

Mindray Medical International Limited

Nihon Kohden Corporation

Ortho Clinical Diagnostics

Qiagen N.V.

Radiometer Medical ApS

Randox Laboratories

Roche Diagnostics

Siemens Healthineers

Sysmex Corporation

Thermo Fisher Scientific

Tosoh Corporation

Trinity Biotech

LEADING PRIVATE LABS IN INDONESIA

Laboratorium Klinik Utama Bio Medika

PT Cito Putra Utama

PT Kimia Farma Diagnostika

Laboratorium Klinik Pramita

PT Prodia Widyahusada Tbk

PROFILES OF SELECTED IVD DISTRIBUTORS IN INDONESIA

Table 4-1: Profiles of Selected IVD Distributors in Indonesia