IVD Test Procedure Volumes, 2019-2024

IVD Test Procedure Volumes, 2019-2024

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’s IVD Test Procedure Volumes, 2019-2024 saves time with calculations and estimates of the 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.

IVD Test Procedure Volumes estimates IVD test procedure volume and IVD pricing for the following segments:

• Worldwide IVD Market and Test Volume
• Point-of-Care Market and Test Volume
• Clinical Chemistry Market and Test Volume
• Molecular Market and Test Volume
• Hematology Market and Test Volume
• Coagulation Market and Test Volume
• Microbiology Market and Test Volume
• Blood Screening Market and Test Volume
• Histology/Cytology Market and Test Volume
• Immunoassay Market and Test Volume

IVD Testing Segments and Global IVD Markets

The range of IVD procedures includes point-of-care and laboratory tests that are categorized according to the testing technology employed. Approximately 20 different technologies have been adapted to IVD applications. The pursuit of needed improvements in healthcare resources and capabilities will boost growth opportunities for IVD procedures and products in the majority of developing countries. The report provides the following IVD testing data points:

• Global IVD Procedure Volumes, 2019 and 2024
• Global IVD Procedural Volume & Product Sales (excludes glucose tests), 2019-2024 (IVD Procedures [million], $ products/procedures, IVD Product Sales [$ millions])
• IVD Procedural Volume including blood glucose tests (millions), 2019-2024 (POC Self Testing, POC Professional Tests, Clinical Chemistry, Immunoassays, Molecular, Hematology, Coagulation, Conventional Microbiology, Blood Grouping/Typing, Histology/Cytology)
• IVD Procedural Volume excluding blood glucose tests (millions), 2019-2024 (POC Self Testing, POC Professional Tests, Clinical Chemistry, Immunoassays, Molecular, Hematology, Coagulation, Conventional Microbiology, Blood Grouping/Typing, Histology/Cytology)
• IVD Product Sales including blood glucose tests ($ millions), 2019-2024 (POC Self Testing, POC Professional Tests, Clinical Chemistry, Immunoassays, Molecular, Hematology, Coagulation, Conventional Microbiology, Blood Grouping/Typing, Histology/Cytology)
• IVD Product Sales excluding blood glucose tests ($ millions), 2019-2024 (POC Self Testing, POC Professional Tests, Clinical Chemistry, Immunoassays, Molecular, Hematology, Coagulation, Conventional Microbiology, Blood Grouping/Typing, Histology/Cytology)
• IVD Procedural Volume excluding blood glucose tests by Region (millions), 2019-2024 (North America: United States, Canada & Mexico; Central & South America; Western Europe; Eastern Europe; Asia/Pacific: China, Japan, Other Countries & Territories; Middle East; Africa; World)
• IVD Product Sales excluding blood glucose tests by Region ($ millions), 2019-2024 (North America: United States, Canada & Mexico; Central & South America; Western Europe; Eastern Europe; Asia/Pacific: China, Japan, Other Countries & Territories; Middle East; Africa; World)

Point-of-Care (POC) Procedures

Point-of-care (POC) testing encompasses diagnostic procedures performed in physicians’ offices, hospital rooms and departments (ICU, emergency, etc.), clinics, ambulances, nursing homes, pharmacies, private residences, and other venues where patients interact directly with medical professionals. This activity also includes the self-monitoring and self-detection of diseases, disorders, and other health conditions by individuals. Growth in the global volume of POC procedures will build upward momentum from several trends and factors. The report provides the following POC data points:

• Total POC Procedural Volume & Product Sales including blood glucose tests, 2019-2024 (Self-Tests, Professional Tests)
• Total POC Procedural Volume & Product Sales excluding blood glucose tests, 2019-2024 (Self-Tests, Professional Tests)
• POC Self-Test Procedural Volume by Type (millions), 2019-2024 (Conventional Glucose, Continuous Glucose, Pregnancy/Ovulation, Fecal Occult Blood, Coagulation, Drugs of Abuse, Urinalysis, Cholesterol/Lipids, H. pylori, HIV, Other, Total, Total w/o glucose)
• POC Self-Test Product Sales by Type ($ millions), 2019-2024 (Conventional Glucose, Continuous Glucose, Pregnancy/Ovulation, Fecal Occult Blood, Coagulation, Drugs of Abuse, Urinalysis, Cholesterol/Lipids, H. pylori, HIV, Other, Total, Total w/o glucose)
• POC Self-Test $ IVD Product Sales Per Procedure, 2019-2024 (Conventional Glucose, Continuous Glucose, Pregnancy/Ovulation, Fecal Occult Blood, Coagulation, Drugs of Abuse, Urinalysis, Cholesterol/Lipids, H. pylori, HIV, Other, Average, Average w/o glucose)
• POC Professional Procedural Volume by Type (millions), 2019-2024 (Glucose, Infectious Diseases, Critical Care, Coagulation, Fecal Occult Blood, Cardiac Markers, Hematology, Drugs of Abuse, Cholesterol/Lipids, HbA1c, Fertility, Other, Total, Total w/o glucose)
• POC Professional IVD Product Sales by Type ($ millions), 2019-2024 (Glucose, Infectious Diseases, Critical Care, Coagulation, Fecal Occult Blood, Cardiac Markers, Hematology, Drugs of Abuse, Cholesterol/Lipids, HbA1c, Fertility, Other, Total, Total w/o glucose)
• POC Professional $ IVD Products Per Procedure by Type (millions), 2019-2024 (Glucose, Infectious Diseases, Critical Care, Coagulation, Fecal Occult Blood, Cardiac Markers, Hematology, Drugs of Abuse, Cholesterol/Lipids, HbA1c, Fertility, Other, Total, Total w/o glucose)

Clinical Chemistry Procedures

Clinical chemistry enables the measurement of naturally produced and externally consumed compounds in the body. Increasing applications in basic physical examinations, routine patient check-ups, and the pre-admission and pre-discharge testing of hospital patients are predicted to boost the total global volume of laboratory clinical chemistry procedures. IVD Test Procedure Volumes provides the following data points with respect to clinical chemistry procedures:

• Clinical Chemistry Procedural Volume by Type (millions), 2019-2024 (General Chemistry, Blood Gas Analysis, Urinalysis)
• Clinical Chemistry Product Sales by Type ($ millions), 2019-2024 (General Chemistry, Blood Gas Analysis, Urinalysis)
• Clinical Chemistry $ IVD Product Sales Per Procedure ($), 2019-2024 (General Chemistry, Blood Gas Analysis, Urinalysis)

Molecular Testing Procedures

The science of molecular diagnostics compares DNA, RNA, genes, or proteins found in extracted human specimens to reference probes containing genetic matter linked to specific diseases, disorders or other medical conditions. Molecular assays continue to penetrate new and existing applications based on selectivity, sensitivity, speed, and accuracy advantages over alternative diagnostics. Molecular technologies will assume an increasingly important role in patient testing as breakthroughs in human genomic and proteomic fields are leading to the discovery of new genetic disease markers. The report provides the following molecular assay data points:

• Molecular Assay Procedural Volume by Type (millions), 2019-2024 (Infectious Diseases, Blood Screening, Cancer Testing, Transplant Testing, Thrombophilia SNPs, Pharmacodiagnostics, Inherited Diseases)
• Molecular Assay Infectious Disease Procedural Volume by Type (millions), 2019-2024 (HAIs, Hepatitis, HIV, HPV, GC/Chlamydia, Respiratory, Mycobacteria/TB, Organism ID, Other)
• Molecular Assay Product Sales by Type ($ millions), 2019-2024 (Infectious Diseases, Blood Screening, Cancer Testing, Transplant Testing, Thrombophilia SNPs, Pharmacodiagnostics, Inherited Diseases)
• Molecular Assay Infectious Disease Product Sales by Type ($ millions), 2019-2024 (HAIs, Hepatitis, HIV, HPV, GC/Chlamydia, Respiratory, Mycobacteria/TB, Organism ID, Other)
• Molecular Assays $ Products per Procedure by Type, 2019-2024 (Infectious Diseases, Blood Screening, Cancer Testing, Transplant Testing, Thrombophilia SNPs, Pharmacodiagnostics, Inherited Diseases)

Hematology Procedures

Hematology testing is widely implemented as part of basic patient examinations, pre-hospital admission screens, and initial emergency room evaluations. The report provides the following data points with respect to hematology procedures:

• Hematology Procedural Volume by Type (millions), 2019-2024 (Complete Blood Count, Other Hematology Tests)
• Hematology Product Sales by Type ($ millions), 2019-2024 (Complete Blood Count, Other Hematology Tests)
• Hematology $ Product Sales Per Procedure by Type, 2019-2024 (Complete Blood Count, Other Hematology Tests)

Coagulation Testing Procedures

Coagulation tests diagnose and monitor various bleeding disorders and evaluate the effectiveness of blood-related therapies, notably anticoagulant agents such as heparin and warfarin, with increasing applications in surgical, inpatient, and emergency care underlying gains. The report provides the following coagulation testing data points:

• Coagulation Procedural Volume (millions), 2019-2024
• Coagulation Product Sales ($ millions), 2019-2024
• Coagulation $ Products per Procedure, 2019-2024

Microbiology Procedures

Conventional microbiology testing is implemented globally to detect and analyze infectious diseases and related conditions. Spurred by upward trends in the incidence of infectious diseases, the global volume of conventional microbiology procedures is forecast to increase. IVD Test Procedure Volumes provides the following data points with respect to microbiology procedures:

• Conventional Microbiology Procedural Volume by Type (millions), 2019-2024 (Chromogenic Media, ID/AST Automated Panels/Reagents, ID/AST Manual Panels/Reagents, Blood Culture, Rapid Microbiological Tests)
• Conventional Microbiology Product Sales by Type ($ millions), 2019-2024 (Chromogenic Media, ID/AST Automated Panels/Reagents, ID/AST Manual Panels/Reagents, Blood Culture, Rapid Microbiological Tests)
• Conventional Microbiology $ Product Sales Per Procedures by Type, 2019-2024 (Chromogenic Media, ID/AST Automated Panels/Reagents, ID/AST Manual Panels/Reagents, Blood Culture, Rapid Microbiological Tests)

Blood Grouping/Typing Procedures

The blood banking segment applies IVD products to three major applications: the screening of donated blood for viral antigens, the matching of blood types between organ donors and recipients, and the identification of blood grouping and platelet antibodies. The report provides estimates of procedures, product sales, and prices appearing applying to blood grouping and typing functions only:

• Blood Grouping/Matching Procedural Volume (millions), 2019-2024
• Blood Grouping/Matching Product Sales ($ millions), 2019-2024
• Blood Grouping/Matching $ Product Sales/Procedure, 2019-2024

Histology/Cytology Procedures

Histology and cytology are branches of clinical pathology that provide for the in vitro detection and analysis of various diseases and disorders. Histology procedures involve the examination of tissues, while cytology testing is performed on cells. Gains in these two disciplines reflect expanding use in cancer screening and diagnosis and, to a lesser extent, in the detection of infectious diseases and genetic disorders. The report provides the following histology/cytology data points:

• Histology/Cytology Procedural Volume by Type (millions), 2019-2024 (In Situ Hybridization, Immunohistochemistry, Pap Tests, Traditional Non-Pap Stains, Circulating Tumor Cells)
• Histology/Cytology Product Sales by Type ($ millions), 2019-2024 (In Situ Hybridization, Immunohistochemistry, Pap Tests, Traditional Non-Pap Stains, Circulating Tumor Cells)
• Histology/Cytology $ Product Sales Per Procedure by Type, 2019-2024 (In Situ Hybridization, Immunohistochemistry, Pap Tests, Traditional Non-Pap Stains, Circulating Tumor Cells)

Immunoassay Procedures

Immunoassays tests can be used to identify any medical condition that triggers an in vivo immune response, including cancer, cardiovascular damage, drug abuse, infectious and viral diseases, infertility, pregnancy, and thyroid disorders. They are also employed widely in therapeutic drug monitoring to evaluate the effectiveness of medicines against various tumors and pathogenic microorganisms. IVD Test Procedure Volumes provides the following data points with respect to immunoassay procedures:

• Immunoassay Procedural Volume by Type (millions), 2019-2024 (Cardiac Markers, Tumor Markers, Autoimmune Markers, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Other Analytes; Total Lab-Based Immunoassays, Infectious Diseases, Blood Screening)
• Immunoassay Product Sales by Type ($ millions), 2019-2024 (Cardiac Markers, Tumor Markers, Autoimmune Markers, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Other Analytes; Total Lab-Based Immunoassays, Infectious Diseases, Blood Screening)
• Immunoassay $ Product Sales Per Procedure by Type, 2019-2024 (Cardiac Markers, Tumor Markers, Autoimmune Markers, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Other Analytes; Total Lab-Based Immunoassays, Infectious Diseases, Blood Screening)

Company Profiles

IVD Test Procedure Volumes, 2019-2024 includes profiles of the top twelve IVD market competitors, looking in detail where possible at procedural volume by type. The companies covered are the following:

• Abbott Laboratories
• Becton, Dickinson and Company (BD)
• bioMérieux Inc.
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• Hologic, Inc.
• Ortho Clinical Diagnostics (Ortho)
• QIAGEN N.V.
• Roche
• Siemens Healthineers
• Sysmex Corporation
• Thermo Fisher Scientific Inc.

The report includes estimates of average fees paid to clinical laboratories and medical establishments for specific groups of IVD procedures. In addition, list prices published by producers are provided for selected IVD tests, reagents, and instruments. 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. The IVD market, defined in procedure volume and pricing tables, makes up the market data in this report. Procedure volume estimates are provided for various categories, and average selling price (ASP) for tests are calculated.