U.S. In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Reagents, Instruments, Services), By Technology (Immunoassay, Molecular Diagnostics), By Application, By End-use, And Segment Forecasts, 2023 - 2030

Report Overview

The U.S. in vitro diagnostics market size was valued at USD 46.90 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of -3.27% from 2023 to 2030. The exponential reduction in demand for in vitro diagnostics (IVD) in the diagnosis of SARS-CoV-2 infection during the forecast period is anticipated to hinder the market growth. However, IVD is a cutting-edge technique that offers new ways to diagnose and treat diseases. The rising incidence of chronic and infectious diseases in the U.S. is anticipated to increase the adoption of IVD testing techniques.

During a pandemic, a favorable regulatory framework for IVD makers contributed to the market growth. For example, in February 2020, the Secretary of the Department of Health and Human Services (HHS) proclaimed a COVID-19 outbreak and so announced that circumstances exist supporting the use of IVD for COVID-19 detection, and FDA issued Emergency Use Authorizations (EUAs) for multiple test kits. Such government initiatives have increased the demand for molecular diagnostics and immunoassays tests significantly.

The market expansion is likely to be fueled by the increased development of point-of-care tests that enable speedy, easy-to-use, and flexible testing. For example, Becton, Dickinson and Company received EUA from the U.S. FDA in July 2020 for its rapid SARS-CoV-2 diagnostic test, which utilizes the BD Veritor Plus System and produces results in 15 minutes. In hospitals, pharmacies, clinics, and urgent care centers across the U. S., there are around 25,000 BD Veritor Plus Systems installed that have increased the access to COVID-19 testing in these healthcare settings.

In addition, factors such as an increase in the geriatric population across the U.S. is also increasing the demand for IVD testing. According to the U.S. Census Bureau, there are more than 54 million people aged 65 and above accounting for around 16.5% of the U.S. population. Moreover, it is expected to reach more than 85 million, around 20% of the country’s population in 2050.

Aging affects the immune system, which increases susceptibility to various diseases. Hence, a large geriatric population requires better healthcare, especially for chronic diseases. It was observed that over 80% of adults who are 60 years and above have at least one chronic disease. Some of the diseases associated with aging are Alzheimer’s disease, Parkinson’s disease, arthritis, and heart diseases. The increasing elderly population is expected to be one of the high-impact rendering drivers for the industry.

Increased research and development efforts utilizing these technologies, expanding use of IVD in clinical diagnosis, and discovery of applications that need IVD technology are expected to drive the market over the forecast period. The prevalence of various diseases such as autoimmune diseases, cancer, inflammatory conditions, and others is increasing in the U.S. and is expected to drive demand for IVD testing.

For instance, according to the American Cancer Society, in 2020, about 1.8 million new cancer cases were reported and around 606,520 individuals died due to cancer. Breast, prostate, colorectal, lung, stomach, and liver cancers are the most common types. Cancer-causing viruses such as Human Papillomavirus & Hepatitis B Virus/Hepatitis C Virus are also responsible for about 20% of cancer deaths. The number of cancer cases is expected to increase by around 70% over the next two decades, which is expected to increase the demand for clinical testing for early-stage diagnosis. 

Product Insights

The reagent segment held the highest market share of 65.51% in 2022, owing to the increasing demand for genetic testing and the availability of advanced cancer diagnostic tests. The high demand for testing for SARS-CoV-2 infection significantly increased the growth during the pandemic.

Increasing approval of COVID-19 tests for emergency use by regulatory authorities is anticipated to drive the market. For instance, in April 2020, the U.S. FDA approved the EUA for the VITROS Anti-SARS-CoV-2 Total reagent pack and calibrators of Ortho Clinical Diagnostics.

In 2022, the instruments accounted for 25.21% of the revenue share. Increasing technological advancements, such as the introduction of portable instruments like cobas 4800 developed by Roche Diagnostics and GeneXpert by Cepheid, and others are increasing market penetration of IVD instruments in the country.

Technology Insights

Molecular diagnostics held the largest share of 42.92% in 2022, attributed to the increasing adoption of point-of-care testing and rapid testing. The increasing product launches due to Emergency Use Authorization for various COVID-19 diagnostic tests have also contributed to the growth.

For instance, in March 2020, Abbott received EUA from the U.S. FDA for its molecular test, RealTime SARS-CoV-2 for COVID-19. Moreover, in November 2021, Roche announced the launch of the cobas 5800 System for molecular testing in infectious diseases such as sexually transmitted diseases and respiratory infections.

Coagulation is expected to be the fastest-growing segment with a CAGR of 6.36% over the forecast period, driven by an increase in the adoption of IVD assays and a rise in the demand for point-of-care diagnostics. The rising prevalence of cardiovascular diseases, blood-related disorders, and autoimmune diseases is expected to boost the demand for coagulation testing. 

Application Insights

In 2022, the infectious diseases segment held the highest revenue share of 61.70%, and this is expected to maintain its dominance throughout the projection period. The increased testing rate for COVID-19 is one of the major factors for the dominance of this segment. Moreover, the introduction of new products and an increase in the prevalence of infectious diseases have increased segment share in the market.

Prominent market participants are collaborating to promote patient and healthcare provider access to high-quality, innovative laboratory services. For instance, in January 2020, Quest Diagnostics partnered with Memorial Hermann Health System to provide 21 hospital laboratories in Houston with better, cost-effective, high-quality, and creative diagnostic services.

The oncology segment is anticipated to experience the fastest CAGR of 4.6% over the forecast period. Increasing prevalence of cancer, increasing awareness about early diagnosis of cancer, and government initiatives are anticipated to increase the segment growth over the forecast period.

For instance, in February 2022, Cancer Moonshot was initiated by the U.S. government to enhance the screening rate for cancer for identifying the missed cases due to the COVID-19 pandemic. In the next 25 years, the government aims to reduce the cancer death rate by 50% with early diagnosis and treatment.

End-use Insights

The hospitals segment dominated the U.S. in vitro diagnostics market in 2022 with a revenue share of 44.14%, due to huge & extensive infrastructure, and an increase in hospitalization. In addition, an increase in hospital-acquired infections among hospitalized patients has increased the segment share.

As per the CDC, around 5% of hospitalized individuals are infected with MRSA and carry germs. As a result, the FDA approved the Cobas vivoDx MRSA screening test in December 2019, which can screen patients for bacterial colonization faster than traditional culture-based procedures. The FDA's measures to allow diagnostic tests with technological advances and improved accuracy are expected to maintain their dominance throughout the forecast period.

Home care segment is expected to exhibit the fastest CAGR of 4.5% during the forecast period due to the rising geriatric population and increasing demand for home care IVD devices. A few of the home diagnostics tests are the Home Access Hepatitis C Test (Home Access Health Corp), ADEXUSDx HIV 1/2 Test, and Home Access Express HIV-1 Test (Home Access Health Corp).

Moreover, regulatory authorities rigorously evaluate the performance of diagnostic tests to meet standards of safety, performance, and quality. For instance, in July 2019, Mylan N.V. and Atomo Diagnostics received prequalification approval from WHO for Mylan HIV Self-Test.

Key Companies & Market Share Insights

Major players are opting for market strategies for strategic collaborations and partnerships through mergers & acquisitions in the country. For instance, in May 2021, Kroger announced the availability of Abbott’s BinaxNOW COVID-19 Ag Card for self-testing. This is anticipated to improve the adoption of the product and help manage SARS-CoV-2. Furthermore, in April 2021, Abbott announced the distribution of BinaxNOW COVID-19 Ag Self-Test to retailers, including Walgreens, Walmart, and CVS Pharmacy, in the U.S. market. Some prominent players in the U.S. in vitro diagnostics market include:

• Abbott

• F. Hoffmann-La Roche Ltd.

• Bio-Rad Laboratories, Inc.

• Siemens Healthcare GmbH

• Agilent Technologies, Inc.

• Qiagen

• bioMérieux

• Quidel Corporation

• BD (Becton Dickinson and Company)

U.S. In Vitro Diagnostics Market Report Scope

U.S. In Vitro Diagnostics Market Segmentation

This report forecasts the volume and revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Grand View Research has segmented the U.S. in vitro diagnostics market report based on product, technology, application, and end-use.

• Product Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2017 - 2030)

  • Instruments

  • Reagents

  • Services

• Technology Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2017 - 2030)

  • 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, 2017 - 2030)

  • Infectious Diseases

    • Upper respiratory

    • Gastrointestinal panel testing

    • Methicillin-resistant Staphylococcus Aureus (MRSA)

    • Clostridium difficile

    • Vancomycin-Resistant Enterococci (VRE)

    • Carbapenem-resistant bacteria

    • Flu

    • Respiratory Syncytial Virus (RSV)

    • Candida

    • Tuberculosis (TB) and drug-resistant TB

    • Meningitis

    • Chlamydia

    • Gonorrhoea

    • HIV

    • Hepatitis C

    • Hepatitis B

    • Other infectious disease

  • Diabetes

  • Oncology

  • Cardiology

  • Nephrology

  • Autoimmune Diseases

  • Drug Testing

  • Hematologic Diseases

  • Others

• End-use Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2017 - 2030)

  • Hospitals

    • 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

  • Laboratories

    • 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

  • Home-care

    • 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

  • Others