GVR Report cover U.S. In Vitro Diagnostics Market Size, Share & Trends Report

U.S. In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Reagents, Instruments), By Technology (Immunoassay, Molecular Diagnostics), By Application, By End-use, And Segment Forecasts, 2020 - 2027

  • Report ID: GVR-4-68039-256-6
  • Number of Pages: 100
  • Format: Electronic (PDF)
  • Historical Range: 2016 - 2018
  • Industry: Healthcare

Report Overview

The U.S. in vitro diagnostics market size was valued at USD 25.32 billion in 2019 and is expected to expand at a compound annual growth rate (CAGR) of 5.0% from 2020 to 2027. One of the major factors driving the market is increasing technological advancement in terms of accuracy, portability, and cost-effectiveness. For instance, Agena Bioscience and PerkinElmer collaborated to integrate LabChip GX Touch nucleic acid analyzer with the MassARRAY system to assess the quality and quantitation of DNA. Incorporation of systems is estimated to increase the sensitivity and robustness and decrease cost.

U.S. IVD market size, by product, 2016 - 2027 (USD Billion)

In addition, a favorable regulatory framework for IVD manufacturers during the pandemic situation is expected to boost the market growth. For instance, in February 2020, the Secretary of the Department of Health and Human Services (HHS) declared COVID-19 outbreak and hence, declared that circumstances exist justifying the Emergency Use Authorization (EUA) of IVD for the detection of COVID-19 and then, FDA had released Emergency Use Authorizations (EUAs) for test kits.

Furthermore, the increasing development of point-of-care tests to provide rapid, easy-to-use, and flexible testing are expected to fuel market growth. For instance, in July 2020, Becton, Dickinson and Company was granted EUA from the U.S. FDA for SARS-CoV-2 diagnostic test, which can be used on BD Veritor Plus System. The assay provides results within 15 minutes with the help of portable instruments. There are around 25,000 BD Veritor Plus System in the U.S. hospitals, pharmacies, clinics, and urgent care centers.

Organizations promote funding to support R&D and product development exercises pertaining to clinical diagnostics. For instance, Vela Diagnostics received USD 225,000 as the Biomedical Advanced Research and Development Authority (BARDA) fund to develop, verify, and validate ViroKey SARS-CoV-2 RT-PCR Test tests.

Product Insights

The reagents segment accounted for the largest revenue share of 64.88% in 2019. One of the key factors responsible for the dominance of this segment is the increasing volume of tests and the rise in the number of R&D initiatives pertaining to reagents. Furthermore, market players are undertaking strategic initiatives to increase their product capabilities and promote the outreach of their product offerings, thereby fueling the growth of the segment. For instance, in October 2019, QIAGEN N.V. and Illumina, Inc. partnered for 15 years to expand the availability and use of NGS-based IVD kits.

In addition, the reagents segment is estimated to be the fastest-growing segment, followed by instruments, during the forecast period owing to increasing approval of COVID-19 tests for emergency use by the regulatory authorities. For instance, in April 2020, Ortho Clinical Diagnostics received EUA from the U.S. FDA for VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. This approved test is used on the VITROS 3600 Immunodiagnostic system, VITROS 5600 Integrated system, and VITROS XT 7600 Integrated system.

Technology Insights

The immunoassays segment accounted for the largest revenue share of 28.72% in 2019 owing to the presence of key players, such as Siemens Healthineers, Abbott, F. Hoffmann-La Roche Ltd., Quidel Corporation, and DiaSorin S.p.A., which are developing and distributing immunoassay analyzers in the U.S. These companies have a significant share in the U.S. IVD market due to a large number of the installed base.

In addition, the rising partnership between key players to strengthen their position and increase in the number of installed systems and the volume of immunoassay tests are anticipated to fuel the market growth. For instance, in February 2020, Quest Diagnostics chose Siemens Healthineers to supply their immunoassay tests, along with Atellica Solutions in the U.S. Under the agreement, it is estimated that Quest Diagnostics will deploy approximately 120 Atellica Solutions analyzers in 19 esoteric and core laboratories across the country. This is expected to boost the adoption of Siemens’s immunoassay analyzer and increase Quest’s testing volume.

Application Insights

The infectious diseases application segment accounted for the largest revenue share of 26.29% in 2019 and is anticipated to maintain its lead over the forecast period. This is attributed to the introduction of new products and the rising prevalence of infectious diseases. Furthermore, key market players are entering into a collaboration to improve access to high-quality and innovative laboratory services for patients and healthcare providers.

For instance, in January 2020, Quest Diagnostics collaborated with Memorial Hermann Health System to provide improved, cost-efficient, high quality, and innovative diagnostic services for 21 hospital laboratories in Houston. Such initiatives by market players to strengthen their presence are expected to drive the market.

End-use Insights

The hospitals segment dominated the segment in 2019 with a revenue share of 45.20% owing to large space, developed infrastructure, and an increase in hospitalization. Furthermore, an increasing number of MRSA cases in hospitalized patients is expected to boost market growth. According to the CDC, around 5% of hospitalized patients suffer from MRSA infections and carry the bacteria. Therefore, in December 2019, the FDA authorized the marketing of the Cobas vivoDx MRSA diagnostic test, which can evaluate patients for bacterial colonization faster than conventional culture-based techniques. Such initiatives by the FDA to provide marketing authorization of diagnostic tests with new technologies and higher accuracy are anticipated to drive the market.

U.S. IVD market share, by end use, 2019 (%)

The home-care segment is projected to be the fastest-growing segment over the forecast period due to the rise in demand for affordable services, technological advancements, and increasing development of at-home tests. For instance, in April 2020, Laboratory Corporation of America Holdings received EUA for COVID-19 At-Home Test Kit. The nasal swabs are collected easily and safely using Pixel by LabCorp COVID-19 test home collection kit.

Key Companies & Market Share Insights

Companies are engaging in mergers & acquisitions, collaboration, and partnerships to strengthen their manufacturing capacities, expand their product portfolio, and offer competitive differentiation. In April 2020, Co-Diagnostics, Inc. entered into an agreement with Madison to manufacture the Logix Smart COVID-19 test to expand manufacturing capacity for producing the Logix Smart COVID-19 test in order to increase its presence in the U.S. Some prominent players in the U.S. in vitro diagnostics market include:

  • Abbott

  • F. Hoffmann-La Roche Ltd.

  • Bio-Rad Laboratories, Inc.

  • Siemens Healthineers

  • Agilent Technologies, Inc.

  • Qiagen

  • bioMérieux SA

  • Quidel Corporation

  • Becton Dickinson and Company

U.S. In Vitro Diagnostics Market Report Scope

Report Attribute


Market size value in 2020

USD 28.61 billion

Revenue forecast in 2027

USD 37.35 billion

Growth Rate

CAGR of 5.0% from 2020 to 2027

Base year for estimation


Historical data

2016 - 2018

Forecast period

2020 - 2027

Quantitative units

Revenue in USD million/billion and CAGR from 2020 to 2027

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Product, technology, application, end use, country

Country scope


Key companies profiled

Abbott; bioMérieux SA; Bio-Rad Laboratories, Inc.; Siemens Healthineers; Qiagen; Quidel Corporation; F. Hoffmann-La Roche Ltd.; Becton Dickinson and Company; Thermo Fisher Scientific, Inc.; Ortho Clinical Diagnostics; Danaher

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country & segment scope.

Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options

Segments Covered in the Report

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the U.S. in vitro diagnostics market report on the basis of product, technology, application, end use, and country:

  • Product Outlook (Revenue, USD Million, 2016 - 2027)

    • Instruments

    • Reagents

    • Services

  • Technology Outlook (Revenue, USD Million, 2016 - 2027)

    • Immunoassays

      • Instruments

      • Reagents

      • Services

    • Hematology

      • Instruments

      • Reagents

      • Services

    • Clinical Chemistry

      • Instruments

      • Reagents

      • Services

    • Molecular Diagnostics

      • Instruments

      • Reagents

      • Services

    • Coagulation

      • Instruments

      • Reagents

      • Services

    • Microbiology

      • Instruments

      • Reagents

      • Services

    • Others

      • Instruments

      • Reagents

      • Services

  • Application Outlook (Revenue, USD Million, 2016 - 2027)

    • Infectious Diseases

    • Diabetes

    • Oncology

    • Cardiology

    • Nephrology

    • Autoimmune Diseases

    • Drug Testing

    • Others

  • End-use Outlook (Revenue, USD Million, 2016 - 2027)

    • Hospitals

    • Laboratories

    • Home-care

    • Others

  • Country Outlook (Revenue, USD Million, 2016 - 2027)

    • U.S.

gvr icn


gvr icn

This FREE sample includes market data points, ranging from trend analyses to market estimates & forecasts. See for yourself.

gvr icn


We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports, as well as offer affordable discounts for start-ups & universities.

Contact us now to get our best pricing.

BBB icon D&B icon

We are GDPR and CCPA compliant! Your transaction & personal information is safe and secure.