IVD Procedure Volumes, 2021-2026

Table of Contents

Chapter One:  Executive Summary

• Figure 1-1: Global IVD Procedure Volumes, 2021 and 2026, (in millions $)

IVD Procedure Volume Estimate and Forecast

Scope & Methodology

About Kalorama Information

Chapter Two:  Introduction

Industry Trends

• Table 2-1 Global IVD Procedural Volume & Product Sales (includes glucose tests), 2021-2026

COVID 19

Chapter Three: Healthcare Trends

Overview

Demographic Trends

Global Population and Aging

• Table 3-1: Elderly Support Ratio in Various Countries (Australia; Brazil; Canada; China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; Saudi Arabia; Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World)

Workforce Reduction

• Table 3-2: Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World) 2020

Addressing the Aging Trend

Emerging and Emerged Markets

• Table 3-3: Market Potential by Total Population, and Percent Urban 2021 (China, India, United States, Brazil, Russia, Mexico, Nigeria, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Colombia, Ukraine, Egypt, Malaysia)

Chapter Four: IVD Testing Segments

IVD Testing Trends

• Table 4-1: IVD Procedural Volume including blood glucose tests (millions), 2021-2026
• Table 4-2: IVD Procedural Volume excluding blood glucose tests (millions), 2021-2026

Segment Growth Projections

POC Testing

Clinical Chemistry

Immunoassays

Mass Spectrometry (Immuno)

Molecular Assays

Hematology

Coagulation

Conventional Microbiology

Blood Grouping/Typing

Histology/Cytology

• Table 4-3: IVD Product Sales including blood glucose tests ($ millions), 2021-2026
• Table 4-4  IVD Product Sales excluding blood glucose tests ($ millions), 2021-2026

Chapter Five: Global IVD Markets

General

• Table 5-1: IVD Procedural Volume excluding blood glucose tests by Region (millions), 2021-2026
• Table 5-2: IVD Product Sales excluding blood glucose tests by Region ($ millions), 2021-2026

North America

United States

Canada

Mexico, Central & South America

Brazil

Mexico

Other Central & South America

Argentina

Colombia

Chile

Peru

Venezuela

All Other Countries & Territories

Western Europe

France

Germany

Italy

Spain

United Kingdom

Other Western Europe

Netherlands

Belgium

Austria

Sweden

Switzerland

Denmark

Portugal

Norway

Greece

Ireland

Finland

All Other Countries & Territories

Eastern Europe

Russia

Other Eastern Europe

Poland

Romania

Czech Republic

Ukraine

Hungary

All Other Countries

Asia/Pacific

China

Japan

Other Asian Countries and Territories

India

South Korea

Australia

Taiwan

Vietnam

Pakistan

Thailand

Malaysia

Indonesia

Hong Kong

Philippines

Singapore

New Zealand

All Other Countries & Territories

Middle East

Turkey

Other Middle East

Iran

Saudi Arabia

Iraq

Israel

United Arab Emirates

All Other Countries

Africa

Egypt

South Africa

Nigeria

All Other Countries & Territories

Chapter Six: Point-of-Care (POC) Procedures

Global POC Procedure Volume by Test Type

• Table 6-1: Total POC Procedural Volume & Product Sales including blood glucose tests, 2021-2026
• Table 6-2:  Total POC Procedural Volume & Product Sales excluding blood glucose tests, 2021-2026
• Figure 6-1: US/ROW POC Procedure Volumes excluding blood glucose tests by Percent 2026
• Figure 6-2: US/ROW POC Sales excluding blood glucose sales by Percent 2026

POC Self Tests

• Table 6-3: POC Self-Test Procedural Volume by Type (millions), 2021-2026

Traditional Blood Glucose Monitoring Activities

Continuous Blood Glucose Monitoring

Pregnancy and Fertility Testing

Coagulation Testing

Fecal Occult Blood Testing

Drugs of Abuse Testing

Pylori Testing

HIV Testing

Infectious Disease

Cholesterol Testing

POC Urinalysis Testing

Other POC Self-Testing

POC Self-Testing Product Sales

• Table 6-4: POC Self-Test Product Sales by Type ($ millions), 2021-2026

Pricing Trends

• Table 6-5:  POC Self-Test $ IVD Product Sales Per Procedure, 2021-2026

POC Professional Testing

• Table 6-6:  POC Professional Procedural Volume by Type (millions), 2021-2026

POC Professional Blood Glucose Testing Procedures

POC Professional Critical Care Testing

POC Fertility Testing

POC Professional Infectious Disease Testing

POC Professional Cardiac Marker Testing

POC Professional Cholesterol/Lipid Testing

POC Professional Coagulation Testing

POC Professional HbA1C Testing

POC Professional Hematology Testing

POC Professional Fecal Occult Blood Screening

POC Professional Drugs of Abuse Testing

POC Professional Urinalysis Testing

Other POC Professional Testing

POC IVD Product Sales

• Table 6-7:  POC Professional IVD Product Sales by Type ($ millions), 2021-2026

Pricing Trends

• Table 6-8:  POC Professional $ IVD Products Per Procedure by Type (millions), 2021-2026

Chapter Seven: Clinical Chemistry Procedures

• Table 7-1:  Clinical Chemistry Procedural Volume by Type (millions), 2021-2026
• Figure 7-1: US/ROW Clinical Chemistry Procedure Volumes by Percent 2026

Types of Tests

General Chemistry

Enzymes

Glucose

Lipids

Proteins

Other Compounds

Blood Gases & Electrolytes

Urinalysis

Global Sales of Clinical Chemistry Products

• Table 7-2:  Clinical Chemistry Product Sales by Type ($ millions), 2021-2026
• Figure 7-2: US/ROW Clinical Chemistry Sales by Percent 2026

Pricing Trends

• Table 7-3:  Clinical Chemistry $ IVD Product Sales Per Procedure ($), 2021-2026

Chapter Eight: Immunoassay Procedures

Technologies

Labeling Techniques

Enzyme Immunoassays

Fluorescence Polarization Immunoassays (FPIAs)

Radioimmunoassays (RIAs)

• Table 8-1:  Immunoassay Procedural Volume by Type (millions), 2021-2026
• Figure 8-1: US/ROW Immunoassay Procedure Volumes by Percent 2026

Testing Procedures & Product Sales

• Table 8-2: Immunoassay Product Sales by Type (millions), 2021-2026
• Figure 8-2: US/ROW Immunoassay Sales by Percent 2026

Cardiac Markers

Tumor Markers

Autoimmune Conditions

Allergy Conditions

Thyroid Conditions

Proteins

Anemia

Fertility Testing

Therapeutic Drug Monitoring

Vitamin D

Diabetes/HbA1c

Drugs of Abuse

Infectious Diseases

• Table 8-3: Immunoassay Infectious Disease  exc Blood Screening Immuno Procedural Volume by Type (millions), 2021-2026
• Table 8-4: Immunoassay Infectious Disease exc Blood Screening Immuno Product Sales by Type  ($ millions), 2021-2026

Instruments

Pricing Trends

• Table 8-5: Immunoassay $ Product Sales Per Procedure by Type, 2021-2026

Chapter Nine: Molecular Testing Procedures

• Table 9-1:  Molecular Assay Procedural Volume by Type (millions), 2021-2026
• Figure 9-1: US/ROW Molecular Assay Procedure Volumes by Percent 2026

Types of Test

Testing Technologies

Infectious Diseases

• Table 9-2:  Molecular Assay Infectious Disease Procedural Volume by Type (millions), 2021-2026

Blood Screening

Cancer

Transplant Matching

Thrombophilia SNPs

Inherited Diseases

Other Molecular Tests

Prenatal

Global Sales of Molecular IVD Products

• Table 9-3:  Molecular Assay Product Sales by Type ($ millions), 2021-2026
• Figure 9-2 : US/ROW Molecular Assay Sales by Percent 2026
• Table 9-4: Molecular Assay Infectious Disease Product Sales by Type ($ millions), 2021-2026

Pricing Trends

• Table 9-5: Molecular Assays $ Products per Procedure by Type, 2021-2026

Chapter Ten: Laboratory-Based Hematology Procedures

• Table 10-1:  Laboratory-Based Hematology Procedural Volume by Type (millions), 2021-2026
• Figure 10-1: US/ROW Laboratory-Based Hematology Procedure Volumes by Percent 2026

Types of Tests

Global Sales of Hematology Products

• Table 10-2:  Laboratory-Based Hematology Product Sales by Type ($ millions), 2021-2006
• Figure 10-2: US/ROW Hematology Sales by Percent 2026

Pricing Trends

• Table 10-3: Hematology $ Product Sales Per Procedure by Type, 2021-2026

Chapter Eleven: Coagulation Testing Procedures

• Table 11-1: Coagulation Procedural Volume (millions), 2021-2026
• Figure11-1: US/ROW Coagulation Procedure Volumes by Percent 2026

Types of Tests

Global Sales of Coagulation Products

• Table 11-2: Coagulation Product Sales ($ millions), 2021-2026
• Figure 11-2: US/ROW Coagulation Sales  by Percent 2026

Pricing Trends

• Table 11-3:  Coagulation $ Products per Procedure, 2021-2026

Chapter Twelve: Microbiology Procedures

• Table 12-1: Conventional Microbiology Procedural Volume by Type (millions), 2021-2026
• Figure 12-1: US/ROW Microbiology Procedure Volumes by Percent 2026

Types of Tests

ID/AST Automated Panels & Reagents

Manual Panels & Reagents

Blood Culture

Chromogenic Media

Rapid Microbiological Tests

Mass Spectrometry

Global Sales of Conventional IVD Microbiology Products

ID/AST Panels & Reagents

Blood Culture

Chromogenic Media

Rapid Microbiological Tests

Mass Spectrometry

• Table 12-2:  Conventional Microbiology Product Sales by Type ($ millions), 2021-2026
• Figure 12-2: US/ROW Microbiology Sales by Percent 2026

Pricing Trends

• Table 12-3:  Conventional Microbiology $ Product Sales Per Procedures by Type, 2021-2026

Chapter Thirteen: Blood Grouping/Typing Procedures

• Table 13-1: Blood Grouping/Typing Procedure Volumes ($ millions), 2021-2026
• Figure 13-1: US/ROW Blood Grouping/Typing Procedure Volumes by Percent 2026

Types of Tests

Blood Grouping/Typing Product Sales

• Table 13-2: Blood Grouping/Typing Product Sales ($ millions), 2021-2026
• Figure 13-2: US/ROW Blood Grouping/Typing Sales by Percent 2026

Pricing Trends

• Table 13-3:  Blood Grouping/Matching $ Product Sales/Procedure, 2021-2026

Chapter Fourteen: Histology/Cytology Procedures

• Table 14-1:  Histology/Cytology Procedural Volume by Type (millions), 2021-2026
• Figure 14-1:   US/ROW Histology/Cytology Procedure Volumes by Percent 2026

Types of Tests

Pap Tests

In Situ Hybridization Tests

Immunohistochemistry Tests

Traditional Non-Pap Stains

Circulating Tumor Cells

Flow Cytometry

Histology/Cytology IVD Product Sales

• Table 14-2:  Histology/Cytology Product Sales by Type ($ millions), 2021-2026
• Figure 14-2: US/ROW Histology/Cytology Sales by Percent 2026

Pricing Trends

• Table 14-3:  Histology/Cytology $ Product Sales Per Procedure by Type, 2021-2026

Chapter Fifteen: Company Profiles

• Table 15-1: Revenues of Selected Top 19 IVD Companies, 2017-2021 ($ million)

Abbott Diagnostics

Recent Revenue History

• Table 15-2: Abbott Diagnostic Revenues 2017-2021 (millions $)

Alere Acquisition Update and Point of Care

Core Lab

Hematology

Blood Banking

Infectious Diseases – Molecular

Diabetes

HIV Point of Care

i-STAT Business

Agilent Technologies

Recent Revenue History

• Table 15-3: Agilent Revenues 2017-20121 (millions $)

Agilent in Genomics

Cytogenetic Analysis

Sequencing

Flow Cytometry

Companion Diagnostics – Dako

COVID-19

Becton, Dickinson and Company (BD)

Recent Revenue History

• Table 15-4: BD Diagnostic Revenues 2017-2021 (millions $)

Cytology

Molecular Microbiology

Traditional Microbiology – ID/AST

Blood Culture

Hospital Acquired Infections

Blood Collection

Mass Spectrometry

Flow Cytometry

COVID-19

bioMérieux Inc.

Recent Revenue History

• Table 15-5:  bioMérieux IVD Revenues 2017-2021 (millions $)

Traditional Microbiology

Blood Culture

Immunoassays

Mass Spectrometry

BioFire Diagnostics Business

COVID-19

Bio-Rad Laboratories, Inc.

Recent Revenue History

• Table 15-6:  Bio-Rad Diagnostics Revenues 2017-2021 (millions $)

Blood Bank

Immunoassays

Danaher Corporation

• Table 15-7:  Danaher Global IVD Diagnostic Sales, 2017-2021 ($million)

Dexcom

Recent Revenue History

• Table 15-8:  Dexcom IVD Diagnostic Sales, 2017-2021 ($million)

DiaSorin

Recent Revenue History

• Table 15-9: DiaSorin Revenues 2017-2021 (millions $)

Immunoassays

Molecular

COVID-19

Exact Sciences

Recent Revenue History

• Table 15-10: Exact Sciences Revenues 2017-2021 (millions $)

COVID-19

Hologic, Inc.

Recent Revenue History

• Table 15-11: Hologic Revenues 2017-2021 (millions $)

PANTHER Molecular System

HIV Testing

Sexually Transmitted Infections

Infectious Diseases

Cytology

COVID-19

Illumina

Recent Revenue History

• Table 15-12: Illumina Diagnostics Revenues 2017-2021 (millions $)

COVID-19

Ortho Clinical Diagnostics (Ortho)

Recent Revenue History

• Table 15-13: Ortho Clinical Diagnostics Revenues 2017-2021 (millions $)

Blood Bank

Core Lab / Immunoassays

COVID-19

PerkinElmer, Inc

Recent Revenue History

• Table 15-14:  PerkinElmer IVD Revenues 2017-2021 (millions $)

Diagnostics

COVID-19

QIAGEN

Recent Revenue History

• Table 15-15:  QIAGEN IVD Revenues 2017-2021 (millions $)

Tuberculosis

Precision Medicine / Companion Diagnostics

Molecular Microbiology

Prenatal Testing

Next Generation Sequencing

Liquid Biopsy

COVID-19

Roche Diagnostics

Recent Revenue History

• Table 15-16:  Roche Diagnostics IVD Revenues 2017-2021 (millions $)

Hematology

Core Lab

Immunoassays

HIV

Core Molecular

Digital PCR

Diabetes Care

Coagulation

cobas Liat System – POC

HPV

Blood Bank

Transplant Medicine

Cancer Companion Testing

COVID-19

Siemens Healthineers (Siemens)

Recent Revenue History

• Table 15-17:  Siemens Healthineers IVD Revenues 2017-2021 (millions $)

Core Lab

Immunoassays

Hematology

Molecular

Acute Care – POC

COVID-19

Sysmex Corporation

Recent Revenue History

• Table 15-18:  Sysmex IVD Revenues 2017-20121(millions $)

Hematology

Coagulation

Urinalysis

Immunoassays

Flow Cytometry

Precision Medicine / Companion Test Diagnostics

Oncology

COVID-19

Thermo Fisher Scientific Inc.

Recent Revenue History

• Table 15-19:  Thermo Fischer IVD Revenues 2017-2021 (millions $)

Immunoassays

Microbiology

Next Generation Sequencing

qPCR

Mass Spectrometry

COVID-19

Werfen

Recent Revenue History

• Table 15-20:  Werfen IVD Revenues 2017-2021 (millions $)

Hematology

Advanced Cell Diagnostics (ACD)

Autoimmunity