In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029

Best Price Guarantee	Length	Publisher	Published Date	SKU
from $5,000	210 Pages	Kalorama Information	November, 2024	KLI19343379

Best Price Guarantee
Price	from $5,000
Length	210 Pages
Publisher	Kalorama Information
Published Date	November, 2024
SKU	KLI19343379

In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029

The U.S. IVD market is a cornerstone of global healthcare innovation—but it is also a market in transition In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029, the fifth edition in Kalorama’s ongoing series, offers unparalleled access to insights on the trends and technologies that will define the industry's future.

This report is essential for:

Identifying market gaps and opportunities for product innovation.

Gaining a competitive edge with strategic insights into the U.S. diagnostic landscape.
Making informed decisions by understanding market dynamics and future potential.
Staying updated on how evolving regulations are shaping the IVD market.

The U.S. in vitro diagnostics (IVD) market remains the largest and most influential in the world This multi-billion-dollar industry serves as the incubator for cutting-edge medical technologies, driving innovation and setting the benchmark for diagnostic standards worldwide. Yet, this dynamic market faces a period of transformation, balancing challenges such as cost pressures, regulatory changes, and the lingering impacts of COVID-19—all while adapting to a rapidly aging population and increasing demand for precision diagnostics.

Kalorama Information's latest report, In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029, delivers a comprehensive analysis of the trends, technologies, and players driving this critical sector. With data-backed insights, this report is your definitive guide to understanding the complexities of the U.S. IVD market.

What’s in the Report

Comprehensive Market Analysis: Gain detailed insights into key U.S. IVD segments, including:
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
Stay Ahead of the Curve: Understand how demographic shifts, technological advancements, and public health challenges are reshaping the market.
Competitive Intelligence: Explore profiles of leading IVD companies, such as Roche Diagnostics, Abbott, Siemens Healthineers, and Thermo Fisher Scientific, and stay informed about their latest developments.
Data-Driven Insights: With market data spanning 2024–2029, this report equips readers with the knowledge to identify growth opportunities and make informed decisions.
Extensive Market Coverage: Dive deep into U.S. IVD segments, from microbiology and hematology to histology and blood typing.
Top Company Profiles: Learn about the strategies and innovations of 20+ key players, including emerging trends and M&A activities.
Actionable Insights: Leverage the report's findings to assess the current standard of care, forecast future trends, and anticipate market penetration for new tests and technologies.

Chapter 1: Executive Summary: U.S. IVD Market; Table 1-1: U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others); Figure 1-1: U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others); Top 12 U.S. IVD Market Participants and Rankings; Table 1-2: U.S. IVD Market Rankings by Estimated 2024 US Revenue – Top 12 Companies (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMérieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific); Scope and Methodology; 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 (million); Disease Prevalence and Incidence; Table 2-1: U.S. Cancer Cases, Estimates 2024; Table 2-2: Reported Cases of Selected Notifiable Diseases, U.S., 2022; U.S. Clinical Lab Expenditure; Table 2-3: U.S. Clinical Lab Market, by Channel, 2023 (% 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 2-4: Implemented and Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027; Impact of CARES Act on PAMA; Saving Access to Laboratory Service Act (SALSA); Advanced Laboratory Tests (ADLT); Table 2-5: List of Approved ADLTs, March 2024; Personalized Medicine; Companion Diagnostics; Table 2-6: FDA Approved Companion Cancer Diagnostics, 2024; AI Use in U.S. Liquid Biopsy Segment; Table 2-7: Selected U.S. AI/Liquid Biopsy Initiatives; Telehealth; Laboratory-Developed Tests (LDTs); FDA; U.S. Healthcare Infrastructure and Testing Channels; Hospitals; Independent Labs; Physician Office Laboratories; At-Home Testing; Home Collection Trend; Table 2-8: Home Collection Test Kit Market, by Category, Worldwide, 2022 (% Estimated Share) (Cholesterol, Drug of Abuse, Fertility Testing, Genetic, Infectious Disease [COVID-19, STDs, HIV, etc.], Tumor DNA Markers, Other [Hormone, Allergies, HbA1c, Heavy Metals, etc.]); Table 2-9: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests, 2020-2024; Retail Clinics; Conclusions
Chapter 3: U.S. IVD Market Analysis: Clinical Chemistry; Table 3-1: U.S. Clinical Chemistry Market, by Segment, 2024-2029 ($ million) (Blood Gases, General Chemistry, Urinalysis); Figure 3-1: U.S. Clinical Chemistry Market, 2024-2029 ($ million); Microbiology and Virology – ID/AST and Molecular; Table 3-2: US ID/AST Microbiology ID/AST Market, by Segment, 2024-2029 ($ million) (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro); Figure 3-2: U.S. ID/AST Microbiology Market, 2024-2029 ($ million); Molecular Infectious Disease; Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology); Figure 3-3: U.S. Molecular Microbiology/Virology Market Distribution Estimates, by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology); Point-of-Care Testing; Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets by Segment, 2024-2029 ($ million) (Glucose, Blood & Electrolytes, Coagulation, Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous); Figure 3-4: U.S. POC Diabetes Market, 2024-2029 ($ million); Figure 3-5: U.S. POC Market without Diabetes, 2024-2029 ($ million); Immunoassays; Non-Infectious Disease Immunoassay; Table 3-5: U.S. Immunoassays Market – Non Infectious, by Segment, 2024-2029 ($ million) (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, Others); Figure 3-6: U.S. Immunoassays Market – Non Infectious, 2024-2029 ($ million); Infectious Disease Immunoassay; Table 3-6: U.S. Immunoassays Market – Infectious, 2024-2029 ($ million) (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others); Figure 3-7: U.S. Immunoassay Infectious Disease, 2024-2029 ($ million); Molecular Non-Infectious Disease Diagnostics; Figure 3-8: U.S. Molecular – Non-Infectious Disease Diagnostics Market, 2024-2029 ($ million); Coagulation; Table 3-7: U.S. Coagulation Diagnostics Market, by Segment, 2024-2029 ($ million) (PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer); Figure 3-9: U.S. Coagulation Diagnostics Market, 2024-2029 ($ million); Histology; Table 3-8: U.S. Histology/Cytology IVD Market, by Segment, 2024-2029 ($ million) Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular); Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2024-2029 ($ million); Hematology; Table 3-9: U.S. Lab-based Hematology Market, by Analyte 2024-2029 ($ million); Figure 3-11: U.S. Hematology Diagnostics Market, 2024-2029 ($ million); Blood Testing and Typing; Table 3-10: U.S. Blood Testing and Typing, by Segment, 2024-2029 ($ million) (ABO Grouping/Typing, Screening); Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2024-2029 ($ million); Figure 3-13: U.S. Blood Screening Diagnostics Market, 2024-2029 ($ million); Total U.S. IVD Market; Table 3-11: U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others); Figure 3-14: U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
Chapter 4: Competitor U.S. IVD Market Players: Table 4-1: Top 12 U.S. IVD Competitor Revenues, 2024 ($ million) (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMérieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific); Abbott Diagnostics; Abbott Diagnostic Recent Revenue History; Table 4-2: Global Abbott Diagnostics (and Diabetes Management) Revenues, 2019-2023 ($ million); Figure 4-1: Abbott Diagnostics - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Table 4-3: Global Abbott Diagnostics Revenues, 2019-2023 ($ million); Core Lab; Hematology; Blood Banking; Infectious Diseases - Molecular; Diabetes; HIV Point of Care; i-STAT Business; Becton, Dickinson and Company (BD); Recent Revenue History; Table 4-4: Global BD Life Sciences Revenues, 2019-2023 ($ million); Figure 4-2: BD - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Cytology; Molecular Microbiology; Traditional Microbiology - ID/AST; Blood Culture; Hospital Acquired Infections; Blood Collection; Mass Spectrometry; Flow Cytometry; bioMérieux; Table 4-5: Global bioMérieux IVD Revenues, 2019-2023 ($ million); Figure 4-3: bioMérieux - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Table 4-6: Global bioMérieux Revenues in Selected Test Segments, 2019-2023 ($ million); Traditional Microbiology; Immunoassays; BIOFIRE Diagnostics Business; Danaher Corporation; Recent Revenue History; Table 4-7: Global Danaher Diagnostics Revenues, 2019-2023 ($ million); Figure 4-4: Danaher - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Beckman Coulter; Cepheid; Dexcom; Table 4-8: Global Dexcom Revenue History 2019-2023 ($ million); Figure 4-5: Dexcom - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Exact Sciences; Recent Revenue History; Table 4-9: Global Exact Sciences Revenue History, 2019-2023 ($ million); Figure 4-6: Exact Sciences - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Hologic, Inc.; Recent Revenue History; Table 4-10: Hologic Revenues, 2019-2023 ($ million); Figure 4-7: Hologic - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Table 4-11: Global Hologic Revenues in Selected Test Segments, 2019-2023 ($ million) estimated; Panther Molecular System; Panther Fusion; Infectious Diseases; Sexually Transmitted Infections; Cytology; Illumina; Table 4-12: Global Illumina Revenue History, 2019-2023 ($ million – not all revenues are for clinical products and services; estimated); Figure 4-8: IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated; Table 4-13: Global Illumina Diagnostic Revenues, by Segment, 2019-2023 ($ million) estimated; Natera; Recent Revenue History; Table 4-14: Natera Revenue History, 2019-2023 ($ million); Figure 4-9: Natera - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated; QuidelOrtho Corporation; Table 4-15: Global QuidelOrtho Revenue History, 2019-2023 ($ million); Figure 4-10: QuidelOrtho - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated; Table 4-16: Global QuidelOrtho Diagnostic Revenues, by Segment, 2020-2023 ($ million) estimated; Immunoassays; Rapid Immunoassays; The Solana Business; Molecular – Savanna; Blood Bank; Roche Diagnostics; Recent Revenue History; Table 4-17: Global Roche IVD Diagnostics Revenues, 2019-2023 ($ million); Figure 4-11: Roche - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated; Table 4-18: Global Roche IVD Diagnostics Revenues, by Type, 2019-2023 (million) estimated; Immunoassays; Core Molecular; Digital PCR; Diabetes Care; cobas Liat System – POC; HPV; Blood Bank; Cancer Companion Testing; Siemens Healthineers (Siemens); Recent Revenue History; Table 4-19: Global Siemens Healthineers IVD Revenues, 2019-2023 ($ million); Figure 4-12: Siemens Healthineers - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Table 4-20: Global Siemens Healthineers Diagnostic Revenues, by Segment, 2021-2023 ($ million) estimated; Core Lab; Immunoassays; Hematology; Molecular; Thermo Fisher Scientific Inc.; Recent Revenue History; Table 4-21: Global Thermo Fisher IVD Revenues, 2019-2023 ($ million); Figure 4-13: Thermo Fisher - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million); Table 4-22: Global Thermo Fisher IVD Revenues, by Type, 2019-2023 (million) estimated; Immunoassays; Microbiology; Molecular Test Business; Next Generation Sequencing; qPCR; Oncology Companion Diagnostics; Mass Spectrometry