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In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care), 2023-2028

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SKU: 23-025 Categories: Diagnostics Market Research, in vitro diagnostic, IVD Tags: blood banking, Clinical Chemistry, Coagulation, COVID-19, cytology, Hematology, histology, Infectious Disease, ivd, ivd procedure volumes, Microbiology, molecular assays, POC, point of care, test volumes Pages: 394
  • Description
  • Table of Contents
  • Latest reports

Description

In vitro diagnostic (IVD) test volumes are the gold standard for sizing the market opportunity for new entrants with diagnostic products, and they can be useful for existing product marketers. The market analysis in Kalorama Information’s In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care), 2023-2028 saves time with calculations and estimates of both the existing number of procedures for scores of diagnostic tests and the future potential. In the process, pricing analysis is also performed.

This report is an essential resource for the IVD business planner. It is intended to serve as a companion piece to Kalorama’s major IVD publication (i.e., The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition).

Kalorama’s IVD procedures report presents projections covering the 2023 to 2028 period for:

  • the global number of IVD procedures by type (self and professional point-of-care, clinical chemistry, immunoassay, molecular, hematology, coagulation, microbiology, blood banking, and histology/cytology)
  • the total number of IVD tests by region and selected countries
  • the average and total worldwide cost of various IVD tests

The report estimates IVD test procedure volume and IVD pricing for the following segments:

  • Worldwide IVD Market and Test Volume
  • Point-of-Care (POC) Market and Test Volume
  • Clinical Chemistry Market and Test Volume
  • Molecular Market and Test Volume
  • Laboratory-based Hematology Market and Test Volume
  • Coagulation Market and Test Volume
  • Microbiology Market and Test Volume
  • Blood Banking Market and Test Volume
  • COVID-19 Market and Test Volume
  • Histology/Cytology Market and Test Volume
  • Immunoassay Market and Test Volume

Global IVD markets covered in the report include:

  • North America:
    • United States
    • Canada
  • Mexico, Central & South America
  • Western Europe
  • Eastern Europe
  • Asia/Pacific:
    • China
    • Japan
    • Other Countries & Territories
  • Middle East
  • Africa

In Vitro Diagnostic (IVD) Procedure Volumes, 2023-2028 includes profiles of the top IVD market competitors, looking in detail where possible at procedural volume by type. The companies covered are the following:

  • Abbott Laboratories
  • Agilent Technologies
  • Beckman Coulter
  • Becton, Dickinson and Company (BD)
  • bioMérieux Inc.
  • Bio-Rad Laboratories, Inc.
  • Bruker Corporation
  • Cepheid
  • Danaher Corporation
  • Dexcom
  • DiaSorin
  • Exact Sciences
  • Hologic, Inc.
  • Illumina
  • Mindray
  • Natera
  • QIAGEN N.V.
  • Roche
  • Siemens Healthineers
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Ventana Medical Systems
  • Werfen

Scope

Data statistics appearing in this report correlate to IVD procedures based on commercially sold and distributed tests. Procedures that employ laboratory developed tests (LDTs) and tests implemented for research purposes only are excluded from the analysis.

Global volumes of various IVD procedures are presented in millions and reflect the evaluation of a single analyte, marker, or other variable of interest. It should be noted that some IVD tests involve more than one procedure as they provide for the analysis of multiple analytes.

Global sales of IVD products are expressed in current United States dollars and reflect sales for the year 2023 and forecasts  for the 2028 period. A table that measures the total amount of IVD product sales against the total volume of IVD procedures is presented for each major testing category.

Table of Contents

Chapter One: Executive Summary

Introduction

IVD Procedure Volume Estimate and Forecast

  • Figure 1-1: Global IVD Procedure Volumes, 2023 and 2028

Scope & Methodology

About Kalorama Information

 

Chapter Two: Introduction

Overview

Industry Trends

  • Table 2-1: Global IVD Procedural Volume & Product Sales (includes glucose tests), 2023-2028

COVID-19

Demographic Trends

Global Population and Aging

  • Figure 2-1: Global Fertility Rate vs. Population Size (BN). 1950-2050
  • Figure 2-2: Global Population Distribution, 2022
  • Table 2-2: 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), 2010 and 2050

Workforce Reduction

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

Increase in Chronic Diseases

  • Figure 2-3: Leading Causes of Death Globally, 2019

Personalized Medicine

New Infectious Disease Threats

  • Table 2-4: Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats

Tickborne Diseases (TBDs)

Zika

Chagas

Dengue

Ebola

Chikungunya

Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)

Marburg

SARS-CoV-2 (COVID-19)

  • Figure 2-4: Total COVID-19 Test Volume by Country, Average Estimates June-August 2023 (Thousands)
  • Figure 2-5: Estimated Market Distribution, COVID-19 Test Value, 2023

Monkeypox

Emerging and Emerged Markets

  • Table 2-5: Market Potential by Total Population, and Percent Urban 2020 (China, India, United States, Brazil, Russia, Mexico, Nigeria, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Colombia, Ukraine, Egypt, Malaysia)

 

Chapter Three: IVD Testing Segments

IVD Testing Trends

  • Table 3-1: IVD Procedural Volume including blood glucose tests (millions), 2023-2028
  • Table 3-2: IVD Procedural Volume excluding blood glucose tests (millions), 2023-2028

Segment Growth Projections

POC Testing

Clinical Chemistry

Immunoassays

Mass Spectrometry (Immuno)

Molecular Assays

Hematology

Coagulation

Conventional Microbiology

Blood Grouping/Typing

Histology/Cytology

  • Table 3-3: IVD Product Sales including blood glucose tests ($ millions), 2023-2028
  • Table 3-4: IVD Product Sales excluding blood glucose tests ($ millions), 2023-2028

 

Chapter Four: Global IVD Markets

General

  • Table 4-1: IVD Procedural Volume including blood glucose tests by Region (millions), 2023-2028

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

South Africa

Nigeria

All Other Countries & Territories

 

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

Global POC Procedure Volume by Test Type

  • Table 5-1: Total POC Procedural Volume & Product Sales including blood glucose tests, 2023-2028
  • Table 5-2: Total POC Procedural Volume & Product Sales excluding blood glucose tests, 2023-2028
  • Figure 5-1: Regional POC Procedure Volumes excluding blood glucose tests by Percent, 2023

POC Self Tests

  • Table 5-3: POC Self-Test Procedural Volume by Type (millions), 2023-2028

Traditional Blood Glucose Monitoring Activities

Continuous Blood Glucose Monitoring

Pregnancy and Fertility Testing

Coagulation Testing

Fecal Occult Blood Testing

Drugs of Abuse Testing

  1. Pylori Testing

HIV Testing

Infectious Disease

Cholesterol Testing

POC Urinalysis Testing

Other POC Self-Testing

POC Self-Testing Product Sales

  • Table 5-4: POC Self-Test Product Sales by Type ($ millions), 2023-2028

Pricing Trends

  • Table 5-5: POC Self-Test $ IVD Product Sales Per Procedure, 2023-2028

POC Professional Testing

  • Table 5-6: POC Professional Procedural Volume by Type (millions), 2023-2028

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 5-7: POC Professional IVD Product Sales by Type ($ millions), 2023-2028

Pricing Trends

  • Table 5-8: POC Professional $ IVD Products Per Procedure by Type (millions), 2023-2028

 

Chapter Six: Clinical Chemistry Procedures

  • Table 6-1: Clinical Chemistry Procedural Volume by Type (millions), 2023-2028
  • Figure 6-1: Regional Clinical Chemistry Procedure Volumes by Percent, 2023

Types of Tests

General Chemistry

Enzymes

Glucose

Lipids

Proteins

Other Compounds

Blood Gases & Electrolytes

Urinalysis

Global Sales of Clinical Chemistry Products

  • Table 6-2: Clinical Chemistry Product Sales by Type ($ millions), 2023-2028

Pricing Trends

  • Table 6-3: Clinical Chemistry $ IVD Product Sales Per Procedure ($), 2023-2028

 

Chapter Seven: Immunoassay Procedures

Technologies

Labeling Techniques

Enzyme Immunoassays

Fluorescence Polarization Immunoassays (FPIAs)

Radioimmunoassays (RIAs)

  • Table 7-1: Immunoassay Procedural Volume by Type (millions), 2023-2028
  • Figure 7-1: Regional Immunoassay Procedure Volumes by Percent, 2023

Testing Procedures & Product Sales

  • Table 7-2: Immunoassay Product Sales by Type (millions), 2023-2028

Cardiac Markers

Tumor Markers

Autoimmune Conditions

Allergy Conditions

Thyroid Conditions

Proteins

Alzheimer’s Disease

Anemia

Fertility Testing

Therapeutic Drug Monitoring

Vitamin D

Diabetes/HbA1c

Drugs of Abuse

Infectious Diseases

  • Table 7-3: Immunoassay Infectious Disease Procedural Volume by Type (millions), 2023-2028
  • Table 7-4: Immunoassay Infectious Disease Product Sales by Type ($ millions), 2023-2028

Instruments

Pricing Trends

  • Table 7-5: Immunoassay $ Product Sales Per Procedure by Type, 2023-2028

 

Chapter Eight: Molecular Testing Procedures

  • Table 8-1: Molecular Assay Procedural Volume by Type (millions), 2023-2028
  • Figure 8-1: Regional Molecular Assay Procedure Volumes by Percent, 2023

Types of Test

Testing Technologies

Infectious Diseases

  • Table 8-2: Molecular Assay Infectious Disease Procedural Volume by Type (millions), 2023-2028

Blood Screening

Cancer

Transplant Matching

Thrombophilia SNPs

Inherited Diseases

Other Molecular Tests

Prenatal

Global Sales of Molecular IVD Products

  • Table 8-3: Molecular Assay Product Sales by Type ($ millions), 2023-2028
  • Table 8-4: Molecular Assay Infectious Disease Product Sales by Type ($ millions), 2023-2028

Pricing Trends

  • Table 8-5: Molecular Assays $ Products per Procedure by Type, 2023-2028

 

Chapter Nine: Laboratory-Based Hematology Procedures

  • Table 9-1: Laboratory-Based Hematology Procedural Volume by Type (millions), 2023-2028
  • Figure 9-1: Regional Laboratory-Based Hematology Procedure Volumes by Percent, 2023

Types of Tests

Global Sales of Hematology Products

  • Table 9-2: Laboratory-Based Hematology Product Sales by Type ($ millions), 2023-2028

Pricing Trends

  • Table 9-3: Hematology $ Product Sales Per Procedure by Type, 2023-2028

 

Chapter Ten: Coagulation Testing Procedures

  • Table 10-1: Coagulation Procedural Volume (millions), 2023-2028
  • Figure 10-1: US/ROW Coagulation Procedure Volumes by Percent, 2023

Types of Tests

Global Sales of Coagulation Products

  • Table 10-2: Coagulation Product Sales ($ millions), 2023-2028

Pricing Trends

  • Table 10-3: Coagulation $ Products per Procedure, 2023-2028

 

Chapter Eleven: Microbiology Procedures

  • Table 11-1: Conventional Microbiology Procedural Volume by Type (millions), 2023-2028
  • Figure 11-1: Regional Microbiology Procedure Volumes by Percent, 2023

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 11-2: Conventional Microbiology Product Sales by Type ($ millions), 2023-2028

Pricing Trends

  • Table 11-3: Conventional Microbiology $ Product Sales Per Procedures by Type, 2023-2028

 

Chapter Twelve: Blood Grouping/Typing Procedures

  • Table 12-1: Blood Grouping/Typing Procedure Volumes ($ millions), 2023-2028
  • Figure 12-1: Regional Blood Grouping/Typing Procedure Volumes by Percent, 2023

Types of Tests

Blood Grouping/Typing Product Sales

  • Table 12-2: Blood Grouping/Typing Product Sales ($ millions), 2023-2028

Pricing Trends

  • Table 12-3: Blood Grouping/Matching $ Product Sales/Procedure, 2023-2028

 

Chapter Thirteen: Histology/Cytology Procedures

  • Table 13-1: Histology/Cytology Procedural Volume by Type (millions), 2023-2028
  • Figure 13-1: Regional Histology/Cytology Procedure Volumes by Percent, 2023

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 13-2: Histology/Cytology Product Sales by Type ($ millions), 2023-2028

Pricing Trends

  • Table 13-3: Histology/Cytology $ Product Sales Per Procedure by Type, 2023-2028

 

Chapter Fourteen: Company Profiles

  • Table 14-1: Revenues of Selected Top 20 IVD Companies, 2022 ($ million) est 2023

Abbott Diagnostics

Recent Revenue History

  • Table 14-2: Abbott Diagnostic Revenues, 2017-2022 ($ million)

Core Lab

Hematology

Blood Banking

Infectious Diseases – Molecular

Diabetes

HIV Point of Care

i-STAT Business

COVID-19

Agilent Technologies

Recent Revenue History

  • Table 14-3: Agilent Revenues, 2017-2022 ($ million)

Agilent in Genomics

Cytogenetic Analysis

Sequencing

Flow Cytometry

Companion Diagnostics – Dako

COVID-19

Beckman Coulter

Recent Revenue History

  • Table 14-4: Beckman Coulter Revenue History, 2017-2022 ($ million, estimated)

Hematology

Clinical Chemistry

Immunoassays

Microbiology

Blood Banking

COVID-19

Becton, Dickinson and Company (BD)

Recent Revenue History

  • Table 14-5: BD Diagnostic Revenues, 2017-2022 ($ million) FYE Sept 30

Cytology

Molecular Microbiology

Traditional Microbiology – ID/AST

Blood Culture

Hospital Acquired Infections

Blood Collection

Mass Spectrometry

COVID-19

bioMérieux Inc.

Recent Revenue History

  • Table 14-6: bioMerieux IVD Revenues, 2017-2022 ($ million)

Traditional Microbiology

Blood Culture

Immunoassays

Mass Spectrometry

BioFire Diagnostics Business

COVID-19

Bio-Rad Laboratories, Inc.

Recent Revenue History

  • Table 14-7: Bio-Rad Diagnostics Revenues, 2017-2022 ($ million)

Blood Bank

Immunoassays

COVID-19

Bruker Corporation

Recent Revenue History

  • Table 14-8: Bruker Revenue History Product Revenue, 2017-2022 (all; $ million)

Acquisitions and Collaborations

Mass Spectrometry

Microbiology

Molecular PCR

COVID-19

Cepheid / Danaher

Recent Revenue History

  • Table 14-9: Cepheid Revenue History, 2017-2022 ($ million, clinical product sales)

GeneXpert/ Xpress Line

Tuberculosis

Microbiology

POC Testing

Cancer

COVID-19

Danaher Corporation

Recent Revenue History

  • Table 14-10: Danaher Global IVD Diagnostic Sales, 2017-2022 ($ million)

Dexcom

Recent Revenue History

  • Table 14-11: Dexcom IVD Diagnostic Sales, 2017-2022 ($ million)

DiaSorin

Recent Revenue History

  • Table 14-12: DiaSorin Revenues, 2017-2022 ($ million)

Immunoassays

Molecular

COVID-19

Exact Sciences

Recent Revenue History

  • Table 14-13: Exact Sciences Revenues, 2017-2022 ($ million)

COVID-19

Hologic, Inc.

Recent Revenue History

  • Table 14-14: Hologic Revenues, 2017-2022 ($ million)

PANTHER Molecular System

HIV Testing

Sexually Transmitted Infections

Infectious Diseases

Cytology

COVID-19

Illumina

Recent Revenue History

  • Table 14-15: Illumina Diagnostics Revenues, 2017-2022 ($ million)

COVID-19

Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.

Recent Revenue History

  • Table 14-16: Mindray Revenue History, 2017-2022 ($ millions)

Natera

Recent Revenue History

  • Table 14-17: Natera Revenue History, 2017-2022 ($ millions)

Prenatal Paternity Testing

QIAGEN

Recent Revenue History

  • Table 14-18: QIAGEN IVD Revenues, 2017-2022 ($ million)

Tuberculosis

Precision Medicine / Companion Diagnostics

Molecular Microbiology

Prenatal Testing

Next Generation Sequencing

Liquid Biopsy

COVID-19

QuidelOrtho Corporation

Recent Revenue History

  • Table 14-19: QuidelOrtho Revenue History, 2018-2022 ($ million)

Immunoassays

Rapid Immunoassays

The Solana Business

Molecular – Savanna

Blood Bank

COVID-19

Radiometer A/S / Danaher

Recent Revenue History

  • Table 14-20: Radiometer A/S Revenue History, 2017-2022 (estimated, $ million)

Critical Care

Immunoassays

HemoCue

Roche Diagnostics

Recent Revenue History

  • Table 14-21: Roche Diagnostics IVD Revenues, 2017-2022 ($ million)

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 14-22: Siemens Healthineers IVD Revenues, 2017-2022 ($ million)

Core Lab

Immunoassays

Hematology

Molecular

Acute Care – POC

COVID-19

Sysmex Corporation

Recent Revenue History

  • Table 14-23: Sysmex IVD Revenues 2018-2022 ($ million) FY March 31

Hematology

Coagulation

Urinalysis

Immunoassays

Precision Medicine / Companion Test Diagnostics

Oncology

COVID-19

Thermo Fisher Scientific Inc.

Recent Revenue History

  • Table 14-24: Thermo Fischer IVD Revenues, 2017-2022 ($ million)

Immunoassays

Microbiology

Next Generation Sequencing

Molecular and qPCR

Mass Spectrometry

COVID-19

Ventana Medical Systems Inc. / Roche Tissue Diagnostics

Recent Revenue History

  • Table 14-25: Ventana Medical Systems Revenue History, 2017-2022 ($ millions)

Immunohistochemistry – IHC

Cervical Cancer Screening

Companion Diagnostics

Werfen

Recent Revenue History

  • Table 14-26: Werfen IVD Revenues, 2017-2022 ($ million)

Hematology and Coagulation

Autoimmunity

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