Kalorama Information 2017 Regional IVD Market Bundle

Publisher Kalorama Information

Published Sep 21, 2017

Length 845 Pages

SKU # KLI15481266

Description

This report contains five separate market research studies that combine for 840 pages of market information about emerging IVD markets, including: Kalorama Information has:

United States IVD Market (2016)
Brazil IVD Markets (2017)
Indonesia IVD Markets (2017
Mexico IVD Markets (2017)
India IVD Market (2016)

This Kalorama Information Bundle is designed to provide cost savings to market researchers by providing several of our popular reports in one package. This report, consisting of a combined PDF with five reports, each with their own TOC provides regional IVD markets, company profiles and more.

----------------------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; Health Insurance in the United States and the Affordable Care Act; Clinical Testing under Medicare – Reimbursement Cuts and Market-Based Pricing 55; Molecular Diagnostics and Medicare Policy; Laboratory-Developed Tests (LDTs) Invigorate Market, Challenge Regulators; U.S. Healthcare Infrastructure and Testing Channels; 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; Alere; Beckman Coulter (Danaher); Becton, Dickinson and Company (BD); bioMérieux; Bio-Rad Laboratories; Cepheid; Danaher Corporation; Hologic; Johnson & Johnson (Incl. Janssen Diagnostics); Ortho-Clinical Diagnostics; QIAGEN; Roche Diagnostics; Siemens Healthcare Diagnostics; Sysmex Corporation; Thermo Fisher Scientific

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

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