Store
United States Market for In Vitro Diagnostic (IVD) Tests, 4th Edition
Publication Date: October 6, 2022
Tags: Coagulation, COVID-19, Diagnostic Instruments, Genetic Diseases, Hematology, Histology and Cytology, Immunoassay, In Vitro Diagnostics (IVD), Infectious Diseases, Molecular Diagnostics, Oncology and Cancer, Point-of-Care (POC) Testing, US and Canada
Pages: 220
SKU: 22-047
Discover the dynamic landscape of the U.S. IVD market with Kalorama Information’s latest comprehensive report, United States Market for In Vitro Diagnostic (IVD) Tests, 4th Edition. As the dominant force in the global IVD industry, the U.S. market continues to evolve, facing numerous challenges and opportunities in a highly complex healthcare system.
Report Highlights:
- Market Overview:
- The U.S. IVD market remains the core geographical market in the world, leading the industry with its size and influence.
- Despite its dominance, the market is in a state of flux, managing a myriad of issues including an aging population and the lingering impact of COVID-19.
- In-Depth Market Segmentation:
- Detailed analysis of various IVD market segments in the United States, including:
- Clinical Chemistry
- Traditional Microbiology – Identification and Antibiotic Susceptibility Testing (ID/AST)
- Molecular Microbiology – Infectious Disease
- Point-of-Care (POC) Tests – Diabetes
- Point-of-Care (POC) Tests – All Other
- Immunoassays – Infectious Disease (non-POC)
- Immunoassays – Other
- Molecular Diagnostics – Non-infectious Disease
- Hematology
- Coagulation (non-POC)
- Histology
- Blood Testing and Typing
- Other IVD Segments
- Detailed analysis of various IVD market segments in the United States, including:
- Industry Trends and Drivers:
- Exploration of key trends shaping the present and future of the U.S. IVD market, such as:
- The aging population and its impact on healthcare demand.
- The lasting effects of the COVID-19 pandemic on IVD market growth and the increased need for testing.
- Exploration of key trends shaping the present and future of the U.S. IVD market, such as:
Top Company Profiles:
- Leading Players:
- Profiles of top companies in the U.S. IVD market, highlighting notable corporate events and recent developments.
- Insight into the strategies and innovations of industry leaders driving the market forward.
Table: U.S. IVD Market, by Segment, 2022-2027 (in millions $)
| Segment | 2022 | 2027 | CAGR |
| Clinical Chemistry | $XX Million | $XX Million | XX% |
| Microbiology – ID/AST | $XX Million | $XX Million | XX% |
| Molecular | $XX Million | $XX Million | XX% |
| Molecular Infectious Disease (with NAT & mass spec) |
$XX Million | $XX Million | XX% |
| Molecular – non-Infectious Disease |
$XX Million | $XX Million | XX% |
| POC Diabetes (all) | $XX Million | $XX Million | XX% |
| POC – Other | $XX Million | $XX Million | XX% |
| Immunoassay | $XX Million | $XX Million | XX% |
| Immunoassay Infectious Disease | $XX Million | $XX Million | XX% |
| Immunoassay non-Infectious | $XX Million | $XX Million | XX% |
| Coagulation | $XX Million | $XX Million | XX% |
| Histology | $XX Million | $XX Million | XX% |
| Hematology | $XX Million | $XX Million | XX% |
| Blood Typing | $XX Million | $XX Million | XX% |
| Others | $XX Million | $XX Million | XX% |
| Total | $XX Million | $XX Million | XX% |
Source: Kalorama Information
For further details and to purchase directly, please contact us.
Table of Contents
Chapter 1: Executive Summary
U.S. IVD Market
- Table 1-1: U.S. IVD Market by Segment (Clinical Chemistry, Microbiology – ID/AST, Molecular, Molecular Infectious Disease Molecular – non, Infectious Disease, POC Diabetes, POC – Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022-2027 (in millions $)
- Figure 1-1: U.S. IVD Market Segments (Clinical Chemistry, Microbiology – ID/AST, Molecular, Molecular Infectious Disease Molecular – non, Infectious Disease, POC Diabetes, POC – Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Grouping, and Others), by % of the total U.S. IVD Market, 2022
Top 12 U.S. IVD Market Participants and Rankings
- Table 1-2: U.S. IVD Market Rankings, by Estimated 2022 US Revenue – Top 12 Companies (Abbott Diagnostics, Roche Diagnostics, Danaher Corporation, Siemens Healthcare Diagnostics, Thermo Fisher Scientific, Becton, Dickinson & Co. (BD), Hologic, Illumina, Dexcom, bioMérieux, Exact Sciences, and Ortho Clinical)
Conclusions
Chapter 2: Introduction to U.S. Health Care
The United States and In Vitro Diagnostics
U.S. Patient Population
Healthcare System Utilization
Aging
- Figure 2-1: U.S. Projects of Older Adult Population, 2016-2060
Disease Prevalence and Incidence
- Table 2-1: U.S. New Cancer Cases 2022 Estimates, by Type (Female Breast, Prostate, Lung and Bronchus, Colon and Rectum, Corpus and Uterus, Melanomas of the Skin, Urinary Bladder, Non-Hodgkin Lymphoma, Kidney and Renal Pelvis, Thyroid, and Pancreas)
- Table 2-2 U.S. Estimated Cancer Deaths, by Cancer Type (Lung and Bronchus, Female Breast, Prostate, Colon and Rectum, Pancreas, Ovary, Liver and Intrahepatic Bile Duct, Leukemias, Non-Hodgkin Lymphoma, and Corpus and Uterus), 2022
- Table 2-3: Reported Cases of Selected Notifiable Diseases (Arboviral Diseases [incl. West Nile], Babesiosis, Brucellosis, Chlamydia, Cholera, Coccidiodomycosis, Cryptosporidiosis, Dengue, Ehrlichiosis/Anaplasmosis, Giardiasis, Gonorrhea, Hepatitis A, Hepatitis B, Hepatitis C, HIV/AIDS, Legionellosis, Listeriosis, Lyme Disease, Malaria, Meningococcal Disease, Pertussis, Q Fever, Salmonellosis, Shiga toxin-producing E Coli, Shigellosis, Spotted Fever Rickettsiosis, Syphilis, Tuberculosis, Vancomycin-intermediate Staphylococcus aureus, Vibriosis), U.S., 2016-2019, by Case Count
U.S. Clinical Lab Expenditure
- Table 2-4: U.S. Clinical Lab Market by Channel (Hospital Labs/Acute Care Labs, Independent Labs, and Physician Office Labs/Outpatient Labs), 2021-2026 (% of Market)
Preventive Health Care
Product Innovation from Value-Based Pricing
Clinical Testing Under Medicare – Reimbursement Cuts and Market-Based Pricing
Protecting Access to Medicare Act of 2014 (PAMA)
- Table 2-5: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
Impact of CARES Act on PAMA
Precision Medicine and NGS
Laboratory-Developed Tests (LDTs)
Changes Resulting from COVID-19 Pandemic
COVID-19 Impact
U.S. Healthcare Infrastructure and Testing Channels
Hospitals
Independent Labs
Physician Office Laboratories
At-Home Testing
Home Collection Trend
Retail Clinics
Conclusions
Chapter 3: U.S. IVD Market Analysis
Clinical Chemistry
- Table 3-1: U.S. Clinical Chemistry Market (General Chemistry, Blood Gases, and Urinalysis) 2022-2027 (in millions $) est
- Figure 3-1: U.S. Clinical Chemistry Market, 2022-2027 ($ millions)
Microbiology and Virology – ID/AST and Molecular
- Table 3-2: US ID/AST Microbiology ID/AST Market (ID/AST Auto, ID/AST Panels, Blood Culture, Chromogenic Media, and Rapid Micro) 2022-2027 ($ millions)
- Figure 3-2: U.S. ID/AST Microbiology Market (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro) 2022-2027 ($ millions)
Molecular Infectious Disease
- Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Molecular including Parasitology, Mycology, Malaria, Chagas, Dengue, etc.), 2022-2027 (%)
- Figure 3-3: U.S. Molecular Microbiology / Virology Market Distribution Estimates by Segment, (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology), 2022 (%)
Point-of-Care Testing
- Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets (Glucose, Blood & Electrolytes, Coagulation, Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous), 2022 and 2027 ($ millions)
- Figure 3-4: U.S. POC Diabetes Market, 2022-2027 (in millions $)
- Figure 3-5: U.S. POC Market without Diabetes, 2022-2027 (in millions $)
Immunoassays
Non-Infectious Disease Immunoassay
- Table 3-5: U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others) 2022-2027 ($ millions)
- Figure 3-6: U.S. Immunoassay-Non-infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others), 2022-2027 (in millions) $)
Infectious Disease Immunoassay
- Table 3-6: U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others), 2022-2027 (in millions $)
- Figure 3-7: U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAI/Sepsis, Others), 2022-2027 (in millions $)
Molecular Non-Infectious Disease Diagnostics
- Figure 3-8: U.S. Molecular Non-Infectious Disease Diagnostics Market, 2022-2027 ($ millions)
Coagulation
- Table 3-7: U.S. Coagulation Diagnostics Market by Segment , PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer, 2022-2027 (in millions $)
- Figure 3-9: U.S. Coagulation Diagnostics Market, 2022-2027 ($ millions)
Histology
- Table 3-8: U.S. Histology/Cytology IVD Market by Segment (Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular) 2022-2027 ($ millions)
- Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2022-2027 ($ millions)
Hematology
- Table 3-9: U.S. Lab-based Hematology Market by Analyte Segment (CBC, Hemoglobin, and Other), 2022-2027 (in millions $)
- Figure 3-11: U.S. Hematology Diagnostics Market, 2022-2027 ($ millions)
Blood Testing and Typing
- Table 3-10: U.S. Blood Testing and Typing by Segment (ABO Grouping/Typing and Screening), 2022-2027 (in millions $)
- Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2022-2027 ($ millions)
- Figure 3-13: U.S. Blood Screening Diagnostics Market (Immunoassay Blood Screening and NAT Blood Screening), 2022-2027 ($ millions)
Total U.S. IVD Market
- Table 3-11: U.S. IVD Market including COVID-19, by Segment (Clinical Chemistry, Microbiology – ID/AST, Molecular, Molecular Infectious Disease Molecular – non, Infectious Disease, POC Diabetes, POC – Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022-2027 (in millions $)
- Figure 3-14: U.S. IVD Market Segments (Clinical Chemistry, Microbiology – ID/AST, Molecular, Molecular Infectious Disease Molecular – non, Infectious Disease, POC Diabetes, POC – Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022 (%)
Chapter 4: Top Tier U.S. IVD Market Players
- Table 4-1: 2021 U.S. IVD Competitor Revenues ($ millions)
Abbott Diagnostics
Recent Revenue History
- Table 4-2: Abbott Diagnostic Revenues 2017-2021 (millions $)
- Figure 4-1: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-3: Global Abbott Diagnostic Revenues, 2017-2021 (millions $)
Core Lab
Hematology
Blood Banking
Infectious Diseases – Molecular
Diabetes
HIV Point of Care
i-STAT Business
COVID-19
Beckman Coulter, Inc. / Danaher
Recent Revenue History
- Table 4-4: Beckman Coulter Diagnostic Revenues 2017-2021 (millions $)
- Figure 4-2: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-5: Global Beckman Coulter Revenues in Selected Test Segments 2019-2021 (millions $) estimated
Hematology
Hematology IT
Clinical Chemistry
Immunoassays
Microbiology
Molecular Tissue Analysis
Flow Cytometry
Beckman Coulter Life Sciences
COVID-19
Becton, Dickinson and Company (BD)
Recent Revenue History
- Table 4-6: BD Diagnostic Revenues 2017-2021 (millions $)
- Figure 4-3: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-7: Global BD Revenues in Flow Cytometry 2017- 2021 (millions $)
Cytology
Molecular Microbiology
Traditional Microbiology – ID/AST
Blood Culture
Hospital Acquired Infections
Blood Collection
Mass Spectrometry
Flow Cytometry
COVID-19
bioMérieux
Recent Revenue History
- Table 4-8: bioMérieux IVD Revenues, 2017-2021 (millions $)
- Figure 4-4: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-9: bioMérieux Revenues in Selected Test Segments, 2017-2021 (millions $)
Traditional Microbiology
Blood Culture
Immunoassays
BIOFIRE Diagnostics Business
COVID-19
Bio-Rad Laboratories, Inc.
Recent Revenue History
- Table 4-10: Bio-Rad Diagnostics Revenues 2017-2021 (millions $)
- Figure 4-5: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-11: Global Bio-Rad Revenues in Selected Test Segments 2017-2021 (millions $)
Blood Bank
Diabetes
Immunoassays
COVID-19
Cepheid / Danaher
Recent Revenue History
- Table 4-12: Cepheid Revenues 2017-2021 (millions $)
GeneXpert Xpress Line
Tuberculosis
Microbiology
POC Testing
Cancer
COVID-19
Danaher Corporation
Recent Revenue History
- Table 4-13: Danaher Diagnostics Revenues 2017-2021 (millions $)
- Figure 4-6: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
Dexcom
- Table 4-14: 2017-2021 Dexcom Revenue History ($ million)
- Figure 4-7: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
Exact Sciences
- Table 4-15: Exact Sciences Revenue History, 2017-2021 (in $ millions)
- Figure 4-8: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions)estimated
COVID-19
Hologic, Inc.
Recent Revenue History
- Table 4-16: Hologic Revenues 2017-2021 (millions $)
- Figure 4-9: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-17: Global Hologic Revenues in Selected Test Segments 2017-2021 (millions $)
PANTHER Molecular System
Panther Fusion
Infectious Diseases
Sexually Transmitted Infections
Cytology
COVID-19
Illumina
- Table 4-18: Illumina Revenue History ($ million – not all revenues are for clinical products and services; estimated)
- Figure 4-10: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-19: Illumina Diagnostic Revenues by Segment ($ million) est
COVID-19
Ortho Clinical Diagnostics (QuidelOrtho)
Recent Revenue History
- Table 4-20: Ortho Clinical Diagnostics Revenues 2017-2021 (millions $)
- Figure 4-11: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-21: Global Ortho Clinical Diagnostics Revenues in Selected Test Segments 2021 (millions $)
Blood Bank
Core Lab / Immunoassays
COVID-19
QIAGEN N.V.
Recent Revenue History
- Table 4-22: QIAGEN N.V. IVD Revenues 2017-2021 (millions $)
- Figure 4-12: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-23: Global QIAGEN IVD Revenues by Type, 2017-2021 (million)
Tuberculosis
Lyme Disease
Molecular Expansion
Precision Medicine / Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next Generation Sequencing
Digital PCR
Liquid Biopsy
COVID-19
Quidel Corporation (QuidelOrtho)
- Table 4-24: Quidel Revenue History ($ million)
- Figure 4-13: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-25: Quidel Diagnostic Revenues by Segment ($ million) est
Immunoassays
Rapid Immunoassays
The Solana Business
Molecular – Savanna
COVID-19
PerkinElmer
- Table 4-26: PerkinElmer Revenue History, 2017-2021 ($ million, estimated)
- Figure 4-14: 2021 PerkinElmer IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-27: PerkinElmer Diagnostic Revenues by Segment, 2017-2021 ($ million) est
Diagnostics
Sequencing /Genomics
Liquid Biopsy
Histology
Prenatal Business
Lab Services
Mass Spectrometry
COVID-19
Roche Diagnostics
Recent Revenue History
- Table 4-28: Roche IVD Diagnostics Revenues 2017-2021 (millions $)
- Figure 4-15: 2021 Roche IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-29: Global Roche IVD Diagnostics Revenues by Type, 2017-2021 (million)
Hematology
Immunoassays
Core Molecular
Digital PCR
Diabetes Care
cobas Liat System – POC
HPV
Blood Bank
Cancer Companion Testing
COVID-19
Siemens Healthineers (Siemens)
Recent Revenue History
- Table 4-30: Siemens Healthineers IVD Revenues 2017-2021 (millions $)
- Figure 4-16: 2021 Siemens Healthineers IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-31: Global Siemens Healthineers IVD Revenues by Type, 2021 (million)
Core Lab
Immunoassays
Hematology
Molecular
Acute Care – POC
COVID-19
Sysmex Corporation
Recent Revenue History
- Table 4-32: Sysmex IVD Revenues 2017-2021 (millions $)
- Figure 4-17: 2021 Sysmex IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-33: Global Sysmex IVD Revenues by Type, 2017-2021 (million)
Hematology
Coagulation
Urinalysis
Flow Cytometry
Precision Medicine / Companion Test Diagnostics
Thermo Fisher Scientific Inc.
Recent Revenue History
- Table 4-34: Thermo Fischer IVD Revenues 2017-2021 (millions $)
- Figure 4-18: 2021 Thermo Fisher IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-35: Global Thermo Fisher IVD Revenues by Type, 2017-2021 (million)
Immunoassays
Microbiology
Molecular Test Business
Next Generation Sequencing
qPCR
Oncology Companion Diagnostics
Mass Spectrometry
COVID-19
Related products
Hematology and Coagulation Markets, 2023
April 5, 2023
Discover the lucrative $10 billion-dollar market for hematology and coagulation in vitro diagnostic (IVD) testing with Kalorama’s comprehensive report, Hematology and Coagulation Markets, 2023. This analysis delves into the dynamic growth factors driving this market, including new technologies, the aging population, and the increasing demand for decentralized testing.
Key Insights Provided:
- Market sizing…
$3,000.00 – $4,500.00
The Worldwide Market for Clinical Laboratory Services, 9th Edition
June 25, 2024
Understanding the clinical laboratory market is crucial for effective business planning. The Worldwide Market for Clinical Laboratory Services, 9th Edition answers essential questions such as the size of the service market for clinical testing, the types of tests that are in demand, and the future trajectory of this market 2023-2028. It also identifies the companies…
$5,000.00 – $7,500.00
The Market and Future Potential for Molecular Point-of-Care (mPOC), 11th Edition
March 7, 2024
Explore the cutting-edge world of molecular point-of-care (mPOC) diagnostic solutions with our latest report, offering a detailed analysis of the market and future growth potential from 2023-2028. mPOC technology revolutionizes diagnostic capabilities, providing enhanced sensitivity and specificity compared to traditional near-patient tests. These solutions are instrumental in critical care units, physician offices, outpatient clinics,…
$5,000.00 – $7,875.00
