United States Market for In Vitro Diagnostic (IVD) Tests

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from $4,000	187 Pages	Kalorama Information	June, 2021	KLI16717620

Attention: There is an updated edition available for this report.

Best Price Guarantee
Price	from $4,000
Length	187 Pages
Publisher	Kalorama Information
Published Date	June, 2021
SKU	KLI16717620

United States Market for In Vitro Diagnostic (IVD) Tests

The U.S. market dominates the IVD industry AND remains the core geographical IVD market in the world. Yet this major multi-billion-dollar IVD market is in a state of flux, trying to manage a myriad of issues, all of which collide with a huge system that costs more than any other in the world.

COVID-19 had a profound effect on the IVD diagnostic industry – some segments exploded and others languished. At this point in time, it is hard to predict how the coronavirus will impact the forecast years to 2025, but Kalorama has attempted to provide insight into the industry by conversing with market participants and government entities. It is realistic to assume the market for COVID-19 will remain a component of the IVD market as the continued prevalence of the virus and the evolving variants are expected to remain. It should be noted that the market can be uncertain and ongoing research will help determine the long-term path of the segment in the coming months to years.

Demographic aging is also one of the primary market influencing trends for IVD in the United States. Aging is associated with rising incidences and rates of prevalence for several non-infectious diseases including diabetes and cancer. Individuals over the age of 60 are estimated to average at least four times the number of clinical tests of younger individuals.

This latest report from Kalorama Information, United States Market for In Vitro Diagnostic Tests, discusses these and other trends shaping the present and future of the IVD market in America. The report discusses the following IVD market segments in the United States:

Clinical Chemistry
Microbiology (Traditional) – Identification and Antibiotic Susceptibility Testing (ID/AST)
Microbiology – Molecular- Infectious Disease
Point-of-Care (POC) Tests – Diabetes
Point-of-Care (POC) Tests – All Other
Immunoassays – Infectious Disease (non-POC)
Immunoassays – Other
Molecular - Non-infectious Disease
Hematology
Coagulation (non-POC)
Histology
Blood Testing and Typing
Others

In addition, the report profiles the top players in the U.S. IVD market. The profiles cover notable corporate events and developments from 2018, 2019 and 2020. Featured companies include:

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

Executive Summary
- U.S. IVD Market
  - Table U.S. IVD Market by Segment 2020-2025 (in millions $)
  - Table U.S. IVD Market Segments by % of the total U.S. IVD Market 2020
- Top Tier U.S. IVD Market Participants and Rankings
  - Table U.S. IVD Market Rankings by Estimated 2020 Revenue – Top 12 Companies
- Conclusions
Introduction to U.S. Health Care
- The United States and In Vitro Diagnostics
- U.S. Patient Population
  - Healthcare System Utilization
  - Aging
    - Table Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
  - Disease Prevalence and Incidence
    - Table Rate of New Cancers by Age Group , All Types US 2013-2017
    - Table U.S. Cancer Deaths 2013-2017 per 100,000 by Type
    - Table Reported Cases of Selected Notifiable Diseases , U.S. 2016-2018 by Case Count
  - U.S. Clinical Lab Expenditure
    - Table U.S. Clinical Lab Market by Channel 2020-2025 by % of Market
  - Hospital-Acquired Infections (HAIs)
  - Preventive Health Care
  - Product Innovation from Value-Based Pricing
- Clinical Testing under Medicare – Reimbursement Cuts and Market-Based Pricing
  - Protecting Access to Medicare Act of 2014 (PAMA)
    - Table Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2023
  - Impact of CARES Act on PAMA
- Personalized Medicine and NGS
- Laboratory-Developed Tests (LDTs)
  - Changes Resulting from COVID-19 Pandemic
- U.S. Healthcare Infrastructure and Testing Channels
  - Hospitals
  - Independent Labs
  - Physician Office Laboratories
  - Self-Testing
  - Retail Clinics
- Conclusions
U.S. IVD Market Analysis
- Clinical Chemistry
  - Table U.S. Clinical Chemistry Market (General Chemistry, Blood Gases, Urinalysis) 2020-2025 ($ millions)
  - Table U.S. Clinical Chemistry Market (2020-2025) ($ millions)
- Microbiology and Virology – ID/AST and Molecular
  - Table US ID/AST Microbiology ID/AST Market (ID/AST Auto, ID/AST Panels, Blood Culture, Chromogenic Media, Rapid Micro 2020-2025 ($ millions)
  - Table U.S. ID/AST Microbiology Market (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro, COVID-19(2020-2025) ($ millions)
  - Molecular Infectious Disease
    - Table U.S. Molecular Infectious Disease by Segment ( HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, COVID-19, Other Molecular including Parasitology, Mycology, Malaria, Chagas, Dengue etc.) 2020-2025 ($ millions)
    - Table U.S. Molecular Microbiology / Virology Market (2020-2025) ($ millions)
- Point-of-Care Testing
  - Table 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 ($ millions)
  - Table U.S. POC Diabetes Market 2020-2025 ($ millions)
  - Table U.S. POC Market without Diabetes 2020-2025 ($ millions)
- Immunoassays
  - Non-Infectious Disease Immunoassay
    - Table U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D) and Others including HbA1c Lab, Drugs of Abuse (2020-2025) ($ millions)
    - Table U.S. Immunoassay-Non-infectious including Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D and others (inc. HbA1c lab and Drugs of Abuse) ($ millions)
  - Infectious Disease Immunoassay
    - Table U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others including Parasitology, Mycology, Others) 2020-2025 ($ millions)
    - Table U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAI/Sepsis, COVID-19, Others) 2020-2025 ($ millions)
- Molecular Non-Infectious Disease Diagnostics
  - Table U.S. Molecular Non-Infectious Disease Diagnostics Market (2020-2025) ($ millions)
- Coagulation
  - Table U.S. Coagulation Diagnostics Market by Segment , PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer, 2020-2025 ($ millions)
  - Table U.S. Coagulation Diagnostics Market (2020-2025) ($ millions)
- Histology
  - Table U.S. Histology/Cytology IVD Market by Segment including Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular) 2020-2025 ($ millions)
  - Table U.S. Histology and Cytology Diagnostics Market (2020-2025) ($ millions)
- Hematology
  - Table U.S. Lab-based Hematology Market by Analyte 2020-2025 ($ millions)
  - Table U.S. Hematology Diagnostics Market (2020-2025) ($ millions)
- Blood Testing and Typing
  - Table U.S. Blood Testing and Typing by Segment 2020-2025 ( ($ millions))
  - Table U.S. Blood Testing and Typing Diagnostics Market (2020-2025) ($ millions)
- Total U.S. IVD Market
  - Table U.S. IVD Market including COVID-19 by Segment 2020-2025 (in millions $)
  - Table U.S. IVD Market Segments by % 2020
Top Tier U.S. IVD Market Players
- Abbott Diagnostics
  - Recent Revenue History
    - Table Abbott Diagnostic Revenues 2016-2020 (millions $)
    - Table 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Abbott Diagnostic Revenues 2016-2020 (millions $)
  - Alere Acquisition Update and Point of Care
  - 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 Beckman Coulter Diagnostic Revenues 2016-2020 (millions $)
    - Table 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Beckman Coulter Revenues in Selected Test Segments 2017-2020 (millions $) estimated
  - Hematology
  - Hematology IT
  - Clinical Chemistry
  - Immunoassays
  - Coagulation
  - Microbiology
  - Urinalysis
  - Clinical Information Technology
  - Molecular Tissue Analysis
  - Flow Cytometry
  - A Fight for Brain Natriuretic Peptide (BNP) Assay Rights
  - Beckman Coulter Life Sciences
  - Collaborations
  - COVID-19
- Becton, Dickinson and Company (BD)
  - Recent Revenue History
    - Table BD Diagnostic Revenues 2016-2020 (millions $)
    - Table 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global BD Revenues in Selected Test Segments 2019-2020 (millions $) estimated
    - Table Global BD Revenues in Flow Cytometry 2016-2020 (millions $)
  - Cytology
  - Molecular Microbiology
  - Traditional Microbiology - ID/AST
  - Blood Culture
  - Blood culture collection products for the preanalytical phase
  - Hospital Acquired Infections
  - Blood Collection
  - Mass Spectrometry
  - Flow Cytometry
  - COVID-19
- bioMérieux
  - Recent Revenue History
    - Table bioMérieux IVD Revenues 2016-2020 (millions $)
    - Table 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table bioMérieux Revenues in Selected Test Segments 2016-2020 (millions $)
  - Traditional Microbiology
  - Blood Culture
  - Immunoassays
  - BIOFIRE Diagnostics Business
  - COVID-19
- Bio-Rad Laboratories, Inc.
  - Recent Revenue History
    - Table Bio-Rad Diagnostics Revenues 2016-2020 (millions $)
    - Table 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Bio-Rad Revenues in Selected Test Segments 2016-2020 (millions $)
  - Blood Bank
  - Diabetes
  - Immunoassays
  - COVID-19
- Cepheid / Danaher
  - Recent Revenue History
    - Table Cepheid Revenues 2016-2020 (millions $)
  - GeneXpert Xpress Line
  - High Burden Expansion
  - India
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
  - COVID-19
- Danaher Corporation
  - Recent Revenue History
    - Table Danaher Diagnostics Revenues 2015-2019 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Danaher Revenues in Business Segments 2016-2020 (millions $)
- Hologic, Inc.
  - Recent Revenue History
    - Table Hologic Revenues 2016-2020 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Hologic Revenues in Selected Test Segments 2016-2020 (millions $)
  - PANTHER Molecular System
  - HIV Testing
  - Sexually Transmitted Infections
  - Cytology
  - COVID-19
- Ortho Clinical Diagnostics (Ortho)
  - Recent Revenue History
    - Table Ortho Clinical Diagnostics Revenues 2016-2020 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Ortho Clinical Diagnostics Revenues in Selected Test Segments 2019-2020 (millions $)
  - Blood Bank
  - Core Lab / Immunoassays
  - COVID-19
- QIAGEN N.V.
  - Recent Revenue History
    - Table QIAGEN N.V. IVD Revenues 2016-2020 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global QIAGEN IVD Revenues by Type, 2016-2020 (million)
  - Tuberculosis
  - Lyme Disease
  - Molecular Expansion
  - Precision Medicine / Companion Diagnostics
  - Molecular Microbiology
  - Prenatal Testing
  - Next Generation Sequencing
  - Digital PCR
  - Liquid Biopsy
  - COVID-19
- Roche Diagnostics
  - Recent Revenue History
    - Table Roche IVD Diagnostics Revenues 2016-2020 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Roche IVD Diagnostics Revenues by Type, 2016-2020 (million)
  - Hematology
  - Core Lab
  - Immunoassays
  - Core Molecular
  - Digital PCR
  - Diabetes Care
  - Coagulation
  - cobas Liat System – POC
  - HPV
  - Blood Bank
  - Cancer Companion Testing
  - COVID-19
- Siemens Healthineers (Siemens)
  - Recent Revenue History
    - Table Siemens Healthineers IVD Revenues 2016-2020 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Siemens Healthineers IVD Revenues by Type, 2020 (million)
  - Core Lab
  - Immunoassays
  - Hematology
  - Molecular
  - Coagulation
  - Acute Care – POC
  - COVID-19
- Sysmex Corporation
  - Recent Revenue History
    - Table Sysmex IVD Revenues 2016-2020 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Sysmex IVD Revenues by Type, 2016-2020 (million)
  - Hematology
  - Coagulation
  - Urinalysis
  - Immunoassays
  - Flow Cytometry
  - Precision Medicine / Companion Test Diagnostics
  - Oncology
  - COVID-19
- Thermo Fisher Scientific Inc.
  - Recent Revenue History
    - Table Thermo Fischer IVD Revenues 2016-2020 (millions $)
    - Table 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
    - Table Global Thermo Fisher IVD Revenues by Type, 2016-2020 (million)
  - Immunoassays
  - Microbiology
  - Next Generation Sequencing
  - qPCR
  - Mass Spectrometry
  - COVID-19