Table of Contents
———————-UNITED STATES IVD MARKET
1: Executive Summary
Introduction
Market Metrics – Utilization
Market Metrics – Aging
Market Metrics – Disease
Market Metrics – U.S. Total Health and Clinical Lab Expenditures and Payers
Market Metrics – U.S. Clinical Testing by Channel
Impacts of the Affordable Care Act
Impacts of PAMA and LDT Reform
U.S. IVD Market
Top Tier U.S. IVD Market Participants and Rankings
Conclusions
2: Introduction to U.S. Health Care
The United States and In Vitro Diagnostics
U.S. Patient Population
Healthcare System Utilization
Aging
Disease Prevalence and Incidence
Health Insurance in the United States and the Affordable Care Act
U.S. Health Expenditure
U.S. Clinical Lab Expenditure
Affordable Care Act (ACA)
Clinical Testing under Medicare – Reimbursement Cuts and Market-Based Pricing 55
Protecting Access to Medicare Act of 2014 (PAMA)
Molecular Diagnostics and Medicare Policy
Laboratory-Developed Tests (LDTs) Invigorate Market, Challenge Regulators
U.S. Healthcare Infrastructure and Testing Channels
Hospitals
Independent Labs
Physician Office Laboratories
Self-Testing
Retail Clinics
Conclusions
3: U.S. IVD Market Analysis
Clinical Chemistry
Microbiology and Virology – ID/AST and Molecular
Point-of-Care Testing
Immunoassays
Urinalysis
Molecular Diagnostics
Coagulation
Histology
Hematology
Blood Testing and Typing
Flow Cytometry
Total U.S. IVD Market
4: Top Tier U.S. IVD Market Players
Abbott Diagnostics
Core Lab
Hematology
Molecular
Blood Testing
Mass Spectrometry ID/AST
Diabetes Testing
Point-of-Care (POC) Diagnostics
Alere
Critical Care
Lipids and Cardiac Markers
Diabetes Testing
Coagulation
Toxicology / Drugs of Abuse
Infectious Diseases
Beckman Coulter (Danaher)
Immunoassays
Clinical Chemistry
Hematology
Microbiology
Urinalysis
Flow Cytometry
Molecular
Becton, Dickinson and Company (BD)
Microbiology
Mass Spectrometry
Immunoassays
Molecular
Histology/Cytology
Flow Cytometry
bioMérieux
Microbiology
Mass Spectrometry
Immunoassays
Molecular
Sequencing
Bio-Rad Laboratories
Microbiology
Hemoglobinopathy and Diabetes Testing
Immunoassays
Blood Typing and Testing
Tissue Typing
Sequencing
Cepheid
Molecular Hospital-Acquired Infection (HAI) Testing
Molecular Sexual Health and Women’s Health Testing
Molecular Critical Infectious Disease Testing
Molecular Oncology Testing
Danaher Corporation
Histology
Point-of-Care Testing
Hologic
Molecular Cytology / Histology (HPV)
Other Molecular (STIs, HIV, HCV, TB, Respiratory)
Microbiology (AccuProbe Molecular Culture ID Tests)
Blood Testing (Molecular PROCLEIX Tests)
Johnson & Johnson (Incl. Janssen Diagnostics)
Ortho-Clinical Diagnostics
Core Lab
Blood Testing and Typing
QIAGEN
Molecular Infectious Disease
Companion Diagnostics
Immunoassays
Next-Generation Sequencing
Roche Diagnostics
Professional Diagnostics
Immunoassays
Point-of-Care Diagnostics
Diabetes Care
Tissue Diagnostics
Molecular Diagnostics
Blood Testing
Sequencing
Microbiology (GeneWeave)
Siemens Healthcare Diagnostics
Clinical Chemistry
Immunoassays
Hematology
Molecular Diagnostics and Histology
Urinalysis
Coagulation
Point-of-Care Diagnostics
Sysmex Corporation
Hematology
Coagulation
Urinalysis
Thermo Fisher Scientific
Immunoassays
Drug Testing
Histology
Mass Spectrometry
Microbiology
Molecular
Sequencing
L I S T O F E X H I B I T S
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: U.S. Commercially Insured Members’ Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
Table 1-2: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
Table 1-3: U.S. IVD Market by Segment (2015/2020)
Table 1-4: U.S. IVD Market Rankings by Estimated 2015 Revenue – Top 15 Companies
CHAPTER TWO: INTRODUCTION
Figure 2-1: U.S. IVD Market (2015/2020)
Table 2-1: U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1994-2013)
Table 2-2: U.S. Commercially Insured Members’ Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
Table 2-3: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
Table 2-4: U.S. Cancer Incidence – Aggregate, Lung, Colon, Prostate, Breast (per 100,000 persons) (2002-2012)
Table 2-5: Selected Notifiable Infectious Disease Incidences in the United States (per 100,000 persons) (2003-2013)
Table 2-6: U.S. National Health Expenditure by Payer (Out-of-Pocket, Private Health Insurance, Medicare, Medicaid) (2013-2020)
Table 2-7: U.S. Clinical Laboratory Market by Segment – Hospital, Independent, Physician Office (2013-2020)
Figure 3-1: U.S. Clinical Chemistry Market (2015/2020)
Figure 3-2: U.S. ID/AST Microbiology Market (2015/2020)
Figure 3-3: U.S. Molecular Microbiology / Virology Market (2015/2020)
CHAPTER THREE: MARKET ANALYSIS
Table 3-1: U.S. ID/AST Microbiology Market – Automated ID/AST, Manual/Semi-Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020)
Table 3-2: U.S. Molecular Microbiology / Virology Market – HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020)
Figure 3-4: U.S. Point-of-Care (POC) Diagnostics Markets – Professional, OTC Diabetes, OTC Other (2015/2020)
Table 3-3: U.S. Point-of-Care (POC) Diagnostics Markets – Professional (Drugs of Abuse, Infectious Disease, Pregnancy, Glucose, HbA1c, Lipids, Cardiac Markers, FOB, Critical Care, Coagulation, Hematology, Other), OTC Diabetes, OTC Other (2015/2020)
Figure 3-5: U.S. Immunoassays Markets – Infectious and Non-Infectious (2015/2020)
Table 3-4a: U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020)
Table 3-4b: U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others)
Figure 3-6: U.S. Urinalysis Lab Diagnostics Market (2015/2020)
Figure 3-7: U.S. Molecular Diagnostics Market (2015/2020)
Figure 3-8: U.S. Coagulation Diagnostics Market (2015/2020)
Figure 3-9: U.S. Histology and Cytology Diagnostics Market (2015/2020)
Figure 3-10: U.S. Hematology Diagnostics Market (2015/2020)
Figure 3-11: U.S. Blood Testing and Typing Diagnostics Market (2015/2020)
Figure 3-12: U.S. Clinical Flow Cytometry Market (2015/2020)
Table 3-5: U.S. IVD Market by Segment (2015/2020)
CHAPTER FOUR: COMPANY PROFILES
Table 4-1: Abbott Diagnostics Revenue (2012-2015)
Table 4-2: Alere Revenue (2012-2015)
Table 4-3: Beckman Coulter Revenue (2012-2015)
Table 4-4: BD Revenue (FY 2012-FY 2015)
Table 4-5: bioMérieux Revenue (2012-2015)
Table 4-6: Bio-Rad Laboratories Revenue (2012-2015)
Table 4-7: Cepheid Revenue (2012-2015)
Table 4-8: Danaher Diagnostics Group Subsidiary Revenue (Beckman Coulter, Radiometer, Leica Biosystems) (2012-2015)
Table 4-9: Hologic Revenue (FY 2012-FY 2015)
Table 4-10: Johnson & Johnson Diagnostics Revenue (2012-2015)
Table 4-11: QIAGEN Revenue (2012-2015)
Table 4-12: Roche Diagnostics Revenue (2012-2015)
Table 4-13: Siemens Healthcare Diagnostics Revenue (FY 2012-FY 2015)
Table 4-14: Sysmex Corporation Revenue (FY 2012-FY 2015)
Table 4-15: Thermo Fisher Scientific Revenue (2012-2015)
———————————BRAZIL MARKET ANALYSIS
CHAPTER 1: EXECUTIVE SUMMARY
INDUSTRY OVERVIEW
SCOPE AND METHODOLOGY
BRAZIL IVD MARKET SUMMARY
Figure 1-1: Brazil In Vitro Diagnostic Sales by Market Segment, 2016-2021 (Clinical Chemistry, Immunoassay, Microbiology, POC, Histology, Other)
CHAPTER 2: BRAZIL OVERVIEW
POPULATION
Table 2-1: Total Midyear Population by Broad Age Group: Brazil (million persons), 2010-2050 (0-14, 15-64, 65+)
Figure 2-1: Total Midyear Population by Broad Age Group: Brazil (million persons), 2010-2050 (0-14, 15-64, 65+)
Figure 2-2: Total Number of Births in Brazil by Year, 1970-2010, and Forecast 2020-2050
Figure 2-3: Brazil Life Expectancy at Birth in Years, 2010-2050
Population Urbanization
ECONOMY AND HEALTH SPENDING
Figure 2-4: Brazil GDP, GDP (PPP) and Health Spending, 1990-2015
Figure 2-5: Brazil Distribution of Income or Consumption by Quintile, 1990-2014
CHAPTER 3: THE HEALTH SYSTEM IN BRAZIL
HEALTH INFRASTRUCTURE
Figure 3-1: Brazilian Coverage Rate (%) for Private Health Plans and Public Health Plans, 2003-2015 (Private Medical Aid Plan Beneficiaries with or without Dental Care, Public Health Plan Beneficiaries)
Figure 3-2: Health Expenditures, Public vs. Private as a % of Total Health Expenditures, 2015 (Private, Public)
Medical Facilities
Figure 3-3: Distribution of JCI Accredited Facilities by Metropolitan Area (%) (Sao Paulo, Rio de Janeiro, Recife, Brasilia, Porto Alegre, Others)
Figure 3-4: Distribution of JCI Accredited Facilities by Type (%) (Hospital Program, Academic Medical Center, Ambulatory Care, Home Care, Medical Transport, Primary Care)
Figure 3-5: Hospital Bed Density per 1,000 Population by Country, 2016 Estimates (US, UK, Singapore, Japan, Germany, China, Canada, Brazil, Australia)
Physicians and Health Professionals
Figure 3-6: Physician Density per 1,000 Population by Country, 2016 Estimates (US, UK, Singapore, Japan, Germany, China, Canada, Brazil, Australia)
Figure 3-7: Nurse/Midwife Density per 1,000 Population by Country, 2016 Estimates (US, UK, Singapore, Japan, Germany, China, Canada, Brazil, Australia)
The Brazilian Diagnostic Laboratory Environment
Figure 3-8: Laboratories and Collection Sites in Brazil by Type (%), 2016 (Collection Sites, all types; Commercial Laboratories; Hospital-based Laboratories)
Figure 3-9: Distribution of Volume, Brazil’s Leading Clinical Laboratory Service Providers (%), 2016
Medical Device Regulation
Table 3-1: Market Divers and Inhibitors for Entering Brazil’s Medical Device Market
Figure 3-10: Market Entry Complexity for Foreign Operators in Brazil
Brazil’s Growing Medical Tourism Industry
HEALTH INDICATORS
General Health
Disease Profiles in Brazil
Table 3-2: Top 5 Cancers Affecting Brazilian Population (ranked by total number of cases), 2010-2016 (Male, Female, Total [both sexes])
Figure 3-11: Highly Prevalent Medical Conditions/Diseases in Brazil (Zika virus, Tuberculosis, Malaria, Leprosy, HIV, Diabetes, Dengue, Chagas disease, Cardiovascular diseases, Cancer)
Surgical Procedures in Brazil
Table 3-3: Surgical Procedures in Brazil as Compared to Rest of Latin America (%) (Cardiovascular procedures, Digestive/Gastrointestinal procedures, Obstetrical/Gynecological procedures, Orthopedic procedures, ENT/Respiratory procedures, Urinary surgical procedures, Cosmetic/Aesthetic procedures, Other procedures, Total)
Figure 3-12: Brazil, Mexico and Rest of LATAM Distribution of Population Compared to Surgical Procedures (%)
CHAPTER 4: IVD MARKETS IN BRAZIL
BRAZIL IVD MARKET SUMMARY
Table 4-1: Brazil In Vitro Diagnostic Sales by Market Segment, 2016-2021 (Clinical Chemistry, Immunoassay, Microbiology/Molecular, POC, Histology, Other, Total)
Figure 4-1: Brazil In Vitro Diagnostic Sales by Market Segment, 2016-2021 (Clinical Chemistry, Immunoassay, Microbiology, POC, Histology, Other)
Figure 4-2: Brazil In Vitro Diagnostic Sales by Market Segment, 2016 Market Distribution (%) (Clinical Chemistry, Immunoassays, Microbiology/Molecular, POC, Histology, Other)
CLINICAL CHEMISTRY
Figure 4-3: Brazil – Clinical Chemistry Market, 2016-2021
IMMUNOASSAY
Table 4-2: Brazil – Immunoassay Market Distribution, 2016-2021 (%) (Infectious Disease, Other, Total Immunoassay)
Figure 4-4: Brazil – Immunoassay Market Value by Segment, 2016 vs. 2021 (Infectious Disease, Other)
MICROBIOLOGY/MOLECULAR
Table 4-3: Brazil – Microbiology/Molecular Testing Market Distribution, 2016-2021 (%) (Infectious Disease, Other, Total Microbiology/Molecular Testing)
Figure 4-5: Brazil Microbiology/Molecular Testing Market Value by Segment, 2016 vs. 2021 (Infectious Disease, Other)
POINT-OF-CARE
Table 4-4: Brazil – POC Market Distribution, 2016-2021 (%) (POC Glucose, POC Infectious Disease, POC Other, Total POC)
Figure 4-6: Brazil POC Market Value by Segment, 2016 vs. 2021 (POC Glucose, POC Infectious Disease, Others)
HISTOLOGY
Figure 4-7: Brazil – Histology Market, 2016-2021
CHAPTER 5: COMPETITIVE ANALYSIS AND PROFILES
COMPETITIVE SUMMARY
Table 5-1: Leading IVD Market Suppliers in Brazil, Market Share Percentage, 2016
Figure 5-1: Leading IVD Market Suppliers in Brazil, 2016 (%)
ABBOTT LABORATORIES
Table 5-2: Abbott Laboratories Company Summary
Company Overview
Company Performance
Product Summary
ALERE
Table 5-3: Alere Company Summary
Company Overview
Performance Review
Product Summary
BECTON, DICKINSON AND COMPANY
Table 5-4: Becton, Dickinson and Company Summary
Company Overview
Company Performance
Product Summary
BIOMÉRIEUX SA
Table 5-5: bioMerieux Summary
Company Overview
Company Performance
Product Summary
DANAHER CORPORATION
Table 5-6: Danaher Corporation Summary
Company Overview
Company Performance
Product Summary
ROCHE (F. HOFFMAN-LA ROCHE, LTD.)
Table 5-7: Roche Group Summary
Company Overview
Company Performance
Product Summary
SIEMENS HEALTHINEERS
Table 5-8: Siemens Healthineers Company Summary
Company Overview
Company Performance
Product Summary
SYSMEX CORPORATION
Table 5-9: Sysmex Corporation Summary
Company Overview
Company Performance
Product Summary
———————————INDONESIA MARKET ANALYSIS
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
———————————MEXICO MARKET ANALYSIS
CHAPTER 1: EXECUTIVE SUMMARY
INDUSTRY OVERVIEW
SCOPE AND METHODOLOGY
MEXICO IVD MARKET SUMMARY
Figure 1-1: Mexico In Vitro Diagnostic Sales by Market Segment, 2016-2021 (Clinical Chemistry, Immunoassay Infectious Disease, Immunoassay Other, Microbiology/Molecular, POC Glucose, POC Other, Histology, Other)
CHAPTER 2: MEXICO OVERVIEW
POPULATION
Table 2-1: Total Midyear Population by Broad Age Group: Mexico (million persons), 2010-2050 (0-14, 15-64, 65+, Total Population)
Figure 2-1: Total Midyear Population by Broad Age Group: Mexico (million persons), 2010-2050 (0-14, 15-64, 65+)
Figure 2-2: Total Number of Births in Mexico by Year, 1980-2010 and Forecast 2020-2050
Figure 2-3: Mexico Life Expectancy at Birth in Years, 2010-2050
Population Urbanization
ECONOMY AND HEALTH SPENDING
Figure 2-4: Mexico GDP, GDP (PPP) and Health Spending, 1990-2015
Figure 2-5: Mexico Distribution of Income or Consumption by Quintile, 1990-2014 (Income share held by highest 20%, Income share held by fourth 20%, Income share held by third 20%, Income share held by second 20%, Income share held by lowest 20%)
CHAPTER 3: THE HEALTH SYSTEM IN MEXICO
HEALTH INFRASTRUCTURE
Figure 3-1: Health Expenditures, Public vs. Private, as a % of Total Health Expenditures, 2015
Medical Facilities
Figure 3-2: Distribution of JCI Accredited Facilities by Metropolitan Area (Culiacan, Tijuana, Cancun, Chihuahua, Mexico City)
Figure 3-3: Distribution of JCI Accredited Facilities by Type (%; Hospital Program, Ambulatory Care)
Figure 3-4: Distribution of JCI Accredited Facilities by Length of Time from First Accreditation (Withdrawn/Expired, 5+ Years, 2-5 Years, Less Than 2 Years)
Figure 3-5: Hospital Bed Density per 1,000 Population by Country,2016 Estimates (United States, UnitedKingdom, Singapore, Mexico, Japan, Germany, China, Canada, Brazil, Australia) Physicians and Health Professionals
Figure 3-6: Physician Density per 1,000 Population by Country, 2016 Estimates (United States, United
Kingdom, Singapore, Mexico, Japan, Germany, China, Canada, Brazil, Australia)
Figure 3-7: Nurse/Midwife Density per 1,000 Population by Country, 2016 Estimates (United States,United Kingdom, Singapore, Mexico, Japan, Germany, China, Canada, Brazil, Australia)
The Mexican Diagnostic Laboratory Environment
Figure 3-8: Laboratories and Collection Sites in Mexico by Type, 2016 (%; Commercial Laboratories,Collection Sites/Patient Service Centers)
Figure 3-9: Distribution of Volume, Mexico’s Leading Clinical Laboratory Service Providers, 2016 (%) Medical Device Regulation
Table 3-1: Market Drivers and Inhibitors for Entering Mexico’s Medical Device Market Mexico’s Growing Medical Tourism Industry
HEALTH INDICATORS
General Health
Disease Profiles in Mexico
Table 3-2: Top 5 Cancers Affecting Mexican Population (ranked by total number of cases), 2010-2016
Figure 3-10: Medical Conditions/Diseases Prevalence in Mexico (Tuberculosis, Malaria, HIV, Diabetes,Dengue, Cardiovascular Diseases, Cancer)
CHAPTER 4: IVD MARKETS IN MEXICO
MEXICO IVD MARKET SUMMARY
Table 4-1: Mexico In Vitro Diagnostic Sales by Market Segment, 2016-2021 (Clinical Chemistry,Immunoassay Infectious Disease, Immunoassay Other, Microbiology/Molecular, POC Glucose, POC Other, Histology, Other, Total)
Figure 4-1: Mexico In Vitro Diagnostic Sales by Market Segment, 2016-2021 (Clinical Chemistry,
Immunoassay Infectious Disease, Immunoassay Other, Microbiology/Molecular, POC Glucose, POC Other,
Histology, Other)
Figure 4-2: Mexico In Vitro Diagnostic Sales by Market Segment, 2016 Market Distribution (%) (Clinical Chemistry, Immunoassay Infectious Disease, Immunoassay Other, Microbiology/Molecular, POC GlucosePOC Other, Histology, Other)
CLINICAL CHEMISTRY
Figure 4-3: Mexico – Clinical Chemistry Market, 2016-2021
IMMUNOASSAY
Table 4-2: Mexico – Immunoassay Market Distribution, 2016-2021 (%) (Infectious Disease, Other, Total Immunoassay)
Figure 4-4: Mexico – Immunoassay Market Value by Segment, 2016 vs. 2021 (Infectious Disease, Other)
MICROBIOLOGY/MOLECULAR
Table 4-3: Mexico – Microbiology/Molecular Testing Market Distribution, 2016-2021 (%) (Infectious Disease, Other, Total Microbiology/Molecular Testing)
Figure 4-5: Mexico Microbiology/Molecular Testing Market Value by Segment, 2016 vs. 2021 (Infectious Disease, Other)
POINT-OF-CARE
Table 4-4: Mexico – POC Market Distribution, 2016-2021 (%) (POC Glucose, POC Other, Total POC)
Figure 4-6: Mexico POC Market Value by Segment, 2016 vs. 2021 (POC Glucose, POC Other)
HISTOLOGY
Figure 4-7: Mexico – Histology Market, 2016-2021
CHAPTER 5: COMPETITIVE ANALYSIS AND PROFILES
COMPETITIVE SUMMARY
Table 5-1: Leading IVD Market Suppliers in Mexico, Market Share Percentage, 2016
Figure 5-1: Leading IVD Market Suppliers in Mexico, 2016 (%)
ABBOTT LABORATORIES
Table 5-2: Abbott Laboratories Company Summary
Company Overview
Company Performance
Product Summary
BECTON, DICKINSON AND COMPANY
Table 5-3: Becton, Dickinson and Company Summary
Company Overview
Company Performance
Product Summary
BIOMÉRIEUX S.A.
Table 5-4: bioMerieux Summary
Company Overview
Company Performance
Product Summary
DANAHER
Table 5-5: Danaher Summary
Company Overview
Company Performance
Product Summary
DIASORIN S.P.A.
Table 5-6: DiaSorin S.p.A. Summary
Company Overview
Company Performance
Product Summary
LIFESCAN, INC
Table 5-7: LifeScan Summary
Company Overview
Company Performance
Product Summary
ROCHE (F. HOFFMAN-LA ROCHE, LTD.)
Table 5-8: Roche Group Summary
Company Overview
Company Performance
Product Summary
SIEMENS HEALTHINEERS
Table 5-9: Siemens Healthineers Company Summary
Company Overview
Company Performance
Product Summary
SYSMEX CORPORATION
Table 5-10: Sysmex Corporation Summary
Company Overview
Company Performance
Product Summary
THERMO FISHER SCIENTIFIC
Table 5-11: Thermo Fisher Summary
Company Overview
Company Performance
Product Summary
APPENDIX: SOURCES OF INFORMATION
———————————IVD IN INDI
ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Major Findings of the Report
India in Context – A Rapidly Developing Economy with Major Demographic
Challenges
Demographic Aging
Disease Drivers
Infectious Disease Threats
Indian Economy
IVD Market in the BRIC Countries
IVD Market in India
SWOT Analysis
Leading Players
TWO: INTRODUCTION TO HEALTH CARE AND DIAGNOSTICS IN THE DEVELOPING WORLD – INDIA IN CONTEXT
Background
Population Trends and Disease Demographics
Obesity
Disease Trends
Diabetes
Cancer
Allergy and Asthma
Cardiovascular Disease
Emerging Viruses and Diseases
Antimicrobial Drug Resistance
Clinical Lab Tests
Types of Tests
Venues for Test Usage
Market Segment Opportunities
Point-of-Care (POC) Testing
Core Lab Tests
Molecular Assays
Hematology
Coagulation
Microbiology
Tests Used in Blood Banking
Histology and Cytology
The Future of Indian Economic Growth
Rising Standards of Living
Young, English-Speaking Labor Force
Corruption and Bribery
Exchange Rate
BRIC Metrics – Indian IVD Market in Context
Available Markets – Urban Populations in BRIC Countries
Paying for Healthcare – Government Expenditures and the Culture of Spending
Healthcare Capacities in BRIC Nations – A Work in Progress
IVD Spending
THREE: INDIA IVD SWOT ANALYSIS
Introduction
Strengths – Conditions That Support Market Growth
Government Support of the Emerging Indian Healthcare Market
Expanding Medical Education
Increasing Health Insurance Penetration
Improving Intellectual Property Protection
Thriving Biotech Industry
Contract Research and High Technology
Returning Scientists
Growing Hospital Sector
Expanding Clinical Labs
Medical Tourism
Strong IT Sector
Weaknesses – Factors That Pose Barriers to Market Success and Entry
Traditional Medicine
Resource Constraints in Hospitals
Culture and Business Environment
Quality and Safety Concerns
Lack of Medical Device and Diagnostics Regulation
Lack of IVD R&D
High Out of Pocket Consumer Expenditures
Healthcare Pricing
Opportunities – Rural Healthcare and Technology Partnerships
Threats – Domestic and Chinese Competition
Domestic Competition
Chinese Competition
FOUR: INDIA IVD MARKET SIZE
Introduction
The Market
Total Indian IVD Market
Immunoassays
Clinical Chemistry
Hematology
Point of Care/OTC
Molecular
Urinalysis
Other IVD Tests
FIVE: INDUSTRY AND COMPANY ACTIVITY IN INDIA
Introduction
Market Leaders in India
Indian IVD Players
International IVD Companies – Recent Activity
Abbott Laboratories
Affymetrix, Inc.
Alere
Arkray
Beckman Coulter, Inc./Danaher
Becton, Dickinson & Co
Biohit Oy
bioMérieux, Inc.
Bio-RAD Laboratories, Inc.
Daan Gene Co., Ltd.
Danaher Corp.
Gen-Probe, Inc.
Grifols
Hologic, Inc.
Horiba Medical
Instrumentation Laboratory
Laboratory Corporation of America
Luminex Corporation
MedMira
Mindray Medical International, Ltd.
Myriad Genetics
Ortho Clinical Diagnostics
PerkinElmer
Promega Corporation
QIAGEN N.V.
Quest Diagnostics
Radiometer A/S
Roche
Shanghai Fosun Pharmaceutical Co. Ltd.
Shanghai Kehua Bio-engineering
Siemens
SRL Diagnostics
Sysmex Corp.
Thermo Fisher Scientific
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Exhibit 1-1: Global Map of India
Table 1-1: BRIC IVD Markets by Country, 2015 – 2020
Table 1-2: IVD Sales in India by Market Segment (Immunoassays, Clinical
Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2015
Table 1-3: Indian IVD Growth Rates of Market Segments (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other), 2015-2020,2015-2025 and 2020-2025
Exhibit 1-2: IVD Market Share in India by Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2015, 2020 and 2025
Exhibit 1-3: IVD Sales in India by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2015, 2020 and 2025
Exhibit 1-4: Indian Life Expectancy by State, 2014
TWO: INTRODUCTION TO HEALTH CARE AND DIAGNOSTICS IN THE DEVELOPING WORLD – INDIA IN CONTEXT
Table 2-1: Elderly Support Ratio in India, Other BRIC and Selected Countries(2010/2050) (Niger, Uganda, Pakistan, India, Egypt, Guatemala, Morocco, Mexico,Brazil, China, Russia, United States, France, Japan, World)
Table 2-2: Selected Worldwide Disease Statistics, 2015 (Respiratory Infections,Malaria, HIV/AIDS, Chlamydia, Gonorrhea, Maternal Conditions, Asthma,Cardiac Disease, Diabetes, Cancer, Syphilis, Tuberculosis, Hepatitis)
Exhibit 2-1: Diabetes Population by Country, 2015
Exhibit 2-2: Cardiovascular Disease Death as a Percentage of Total Deaths, 2015
Table 2-3: Types of IVD and Clinical Laboratory Tests, 2015
Table 2-4: Clinical Lab Counts and Lab Automation Penetration in BRIC Countries
Exhibit 2-3: Countries by Nominal per Capita GDP in 2014
Exhibit 2-4: Per Capita GDP by Indian Province in 2014
Exhibit 2-5: Linguistic Map of India
Table 2-5: Available (Urban) Market Development in BRIC Countries(2003/2015)
Table 2-6: Government and Total Health Expenditures in BRIC and Comparison Countries, 2013 (United States, France, Germany, Italy, Japan, United Kingdom,Australia, Brazil, South Africa, Argentina, South Korea, Vietnam, Poland,Turkey, Mexico, Russia, Nigeria, China, Thailand, India, Indonesia)
Table 2-7: Growth Rates of Government and Total Healthcare Expenditures and Real GDP (BRIC and Comparison Countries; 2003-2013) (India, Nigeria,Argentina, Vietnam, Indonesia, Turkey, Russia, Poland, Thailand, Brazil, South Korea, South Africa, Australia, Mexico, United States, Germany, United Kingdom, France, Japan, Italy)
Table 2-8: Healthcare System Capacities – BRIC and Comparison Countries (Argentina, Australia, Brazil, China, France, Germany, India, Indonesia, Italy, Japan, South Korea, Mexico, Nigeria, Poland, Russia, South Africa, Thailand,Turkey, United Kingdom, United States, Vietnam)
Table 2-9: Per Capita IVD Expenditures and IVD Markets by Country, 2015(United States, Japan, Germany, France, Italy, China, Spain, United Kingdom,Brazil, Russia, India)
Table 2-10: BRIC IVD Markets by Country, 2015 – 2020 ($ millions)
THREE: INDIA IVD SWOT ANALYSIS
Table 3-1: Cost Savings from Medical Tourism for Various Procedures, 2015(Rhinoplasty, Face-Lift, Breast Augmentation, Breast Reduction, Complete Liposuction, Gluteal Augmentation)
Exhibit 3-1: Ayurvedic Medicine Doshas
Exhibit 3-2: Ayurvedic Medicine vs. Western Medicine
Exhibit 3-3: Common Homeopathic Remedies
Table 3-2: Out-Of-Pocket, Other Private and Government Healthcare Expenditures in BRIC and Comparison Countries (% of Total Expenditures) (South Africa,France, United Kingdom, United States, Germany, Thailand, Turkey, Japan,Australia, Italy, Poland, Argentina, Brazil, South Korea, China, Russia, Mexico,Indonesia, Vietnam, India, Nigeria)
Table 3-3: Chinese IVD Companies
FOUR: INDIA IVD MARKET SIZE
Exhibit 4-1: Global IVD and Clinical Lab Market, 2015 (India, Russia, Brazil,United Kingdom, Spain, China, Italy, France, Germany, Japan, United States)
Exhibit 4-2: Global IVD and Clinical Lab Market, 2020 (India, Russia, Brazil,United Kingdom, Spain, China, Italy, France, Germany, Japan, United States)
Exhibit 4-3: Global IVD and Clinical Lab Market, 2025 (India, Russia, Brazil,United Kingdom, Spain, China, Italy, France, Germany, Japan, United States)
Table 4-1: Total IVD Sales in India, 2015-2025
Exhibit 4-4: Total IVD Sales in India, 2015-2025
Table 4-2: IVD Sales in India by Market Segment (Immunoassays, Clinical
Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2015
Exhibit 4-5: IVD Sales in China by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2015
Table 4-3: IVD Sales in India by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2020
Exhibit 4-6: IVD Sales in India by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2020
Table 4-4: IVD Sales in India by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2025
Exhibit 4-7: IVD Sales in India by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2025
Table 4-5: Immunoassay Sales in India, 2015-2025
Exhibit 4-8: Immunoassay Sales in India, 2015-2025
Table 4-6: Clinical Chemistry Sales in India, 2015-2025
Exhibit 4-9: Clinical Chemistry Sales in India, 2015-2025
Table 4-7: Hematology Sales in India, 2015-2025
Exhibit 4-10: Hematology Sales in India, 2015-2025
Table 4-8: Point of Care/OTC Sales in India, 2015-2025
Exhibit 4-11: Point of Care/OTC Sales in India, 2015-2025
Table 4-9: Molecular Test Sales in India, 2015-2025
Exhibit 4-12: Molecular Test Sales in India, 2015-2025
Table 4-10: Urinalysis Test Sales in India, 2015-2025
Exhibit 4-13: Urinalysis Test Sales in India, 2015-2025
Exhibit 4-14: uChek Urinalysis Test
Table 4-11: Other IVD Test Sales in India, 2015-2025
Exhibit 4-15: Other IVD Test Sales in India, 2015-2025
FIVE: INDUSTRY AND COMPANY ACTIVITY IN INDIA
Table 5-1: Leading Global IVD Companies in India
Table 5-2: Selected Domestic IVD Companies in India
