U.S. In Vitro Diagnostics Market To Reach $57.43 Billion By 2030

U.S. In Vitro Diagnostics Market Growth & Trends

The U.S. in vitro diagnostics market size is estimated to reach USD 57.43 billion by 2030, expanding at a CAGR of 5.6% from 2025 to 2030, according to a new report by Grand View Research, Inc. Medical instruments that perform diagnostic tests on bio-fluids including blood, urine, and tissues are known as in vitro diagnostics (IVD). The IVD tests are used to study pharmacological therapy and to identify and evaluate infectious diseases, autoimmune disorders, and a variety of medical ailments.

The rising prevalence of chronic and pathogenic diseases, the aging population, the increasing popularity of point-of-care testing, and personalized medicine are anticipated to increase the demand for IVD testing in the country. Moreover, with developments in genomics & proteomics, this industry is seeing new prospects as molecular diagnostics expands its reach and introduces a new variety of condition-specific indicators and tests.

Several ailments, such as genetic, cardiovascular, and neurological disorders, are becoming more common. Cardiovascular diseases (CVDs) are the major cause of death in the U.S., killing an estimated 659,000 people each year, as per the Centers for Disease Control and Prevention (CDC). This has resulted in a significant public awareness about early diagnosis and a rise in routine diagnosis, both of which support the market's overall development.

The launch of new advanced IVD products is assisting the market's rapid expansion. Moreover, market players and research institutes are actively involved in the development of novel products to reduce the overall disease burden in the country. For instance, in May 2021, the University of California developed an ultrasensitive molecular test. This test is based on a chip technology that can detect the presence of influenza A and SARS-CoV-2 antigens. The test is under further study for conversion into a Point-of-Care (PoC) test.

The adoption of IVD testing at the point-of-care testing facilities is increasing rapidly. As several players are focusing on launching tests for home care facilities, there has been a shift in the industry dynamics. Moreover, in 2021, FDA also prioritized home-based molecular diagnostics tests. In March 2021, BATM Advanced Communications Limited announced the launch of its molecular diagnostics self-test kit for the detection of COVID-19.

The market is gaining strength as diagnostic laboratories increasingly employ fully automated tools. Automated instruments, as opposed to manual and semi-automated equipment, are more expandable, meet high level of performance, reduce technologists' hands-on time, eliminate batch testing, and provide faster results to physicians. Market participants are increasingly working on building automated instruments as a result of these benefits.

Furthermore, laboratory automation facilitates, expedites, and improves the efficiency and efficacy of diagnostic tests. From loading specimen tubes to providing findings for all major laboratory disciplines, a total lab automated system can handle all parts of the testing process. As more manufacturers enter the market with broader automation choices, the evolution of lab automation in the clinical diagnostics business is continuing to accelerate.

Since it is utilized to detect the SARS-CoV-2 virus, the COVID-19 pandemic has increased the demand for molecular diagnostics tools. Additionally, among hospitalized patients suffering from COVID-19, there was a surge in demand for test kits and consumables for measuring blood glucose levels, troponin levels, and a variety of other parameters. As a result, the usage of IVD devices increased during the pandemic and propelled the market growth.

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U.S. In Vitro Diagnostics Market Report Highlights

• By product, the reagent segment held a larger share of the U.S. IVD market owing to the increasing demand for genetic testing and the availability of advanced cancer diagnostic tests in the country.

• The coagulation segment is expected to be the fastest-growing segment. The rising prevalence of cardiovascular diseases, blood-related disorders, and autoimmune diseases is expected to boost the demand for coagulation testing.

• The oncology segment is anticipated to grow at the fastest CAGR over the forecast period owing to the increasing prevalence of disease and increasing awareness among people about early diagnosis of diseases.

• A few of the key market players include QIAGEN; F. Hoffman-La Roche Ltd.; Abbott.; Agilent Technologies, Inc.; bioMérieux; Quidel Corporation.

U.S. In Vitro Diagnostics Market Segmentation

Grand View Research has segmented the U.S. in vitro diagnostics market based on product, technology, application, test location and end-use:

U.S. In Vitro Diagnostics Product Outlook (Volume, Number of Tests and Instruments; Revenue, USD Billion, 2018 - 2030)

• Instruments

• Reagents

• Services

U.S. In Vitro Diagnostics Technology Outlook (Volume, Number of Tests and Instruments; Revenue, USD Billion, 2018 - 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

U.S. In Vitro Diagnostics Application Outlook (Revenue, USD Billion, 2018 - 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

U.S. In Vitro Diagnostics Test location Outlook (Revenue, USD Billion, 2018 - 2030)

• Point of Care

• Home-care

• Others

U.S. In Vitro Diagnostics End Use Outlook (Volume, Number of Tests and Instruments; Revenue, USD Billion, 2018 - 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

List Of Key Players in the U.S. In Vitro Diagnostics Market

• 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)