United States In Vitro Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

The United States In Vitro Diagnostics Market is segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Haematology, and Other Test Types), Product (Instruments, Reagents, and Other Products), Usability (Disposable IVD and Reusable IVD), Application (Infectious Diseases, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Diseases, Nephrology, and Other Applications), and End User (Diagnostic Laboratories, Hospitals and Clinics, and Other End Users).

Market Snapshot

Study Period: 2018 - 2026
Base Year: 2020
CAGR: 4.8 %

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Market Overview

Key factors propelling the growth of the market are high prevalence of chronic diseases, increasing the use of POC (Point-of-care) diagnostics, advanced technologies, increasing awareness, and acceptance of personalized medicines. The increasing government healthcare expenditure and consumer's healthcare spending are also responsible for the growth of the market.

The increase in the US in vitro diagnostics market is majorly due to the high prevalence of chronic diseases, such as heart diseases, cancer, asthma, and diabetes, along with COVID -19 in 2020. It is estimated that these diseases are responsible for majority of deaths in the United States, killing more than 1.7 million citizens, annually. Thus, IVDs have proved to be beneficial in managing these chronic conditions. IVDs help in the detection of early warning signs and individual risk factors, creating new opportunities for prevention and early intervention.

There are also emerging technological innovations, such as lab-on-a-chip, wearable devices, and POC diagnostics, that are increasingly becoming an important part of the healthcare landscape. These POC diagnostic products have been developed to be used on a patient’s bedside in hospitals to get instant results, without the need of sending the samples to the lab. Thus, owing to the ease of use and the ability to provide instant results, the use of POC diagnostics in the United States is increasing rapidly, thereby, boosting the growth of the market studied.

Scope of the Report

As per the scope of the report, in vitro diagnostics are the medical devices and consumables utilized to perform in vitro tests on various biological samples. They are used for the diagnosis of various medical conditions. These in vitro diagnostic products can be instruments, reagents, or any system used for the diagnosis of diseases.

By Test Type
Clinical Chemistry
Molecular Diagnostics
Immuno Diagnostics
Other Test Types
By Product
Other Products
By Usability
Disposable IVD
Reusable IVD
By Application
Infectious Diseases
Autoimmune Diseases
Other Applications
By End User
Diagnostic Laboratories
Hospitals and Clinics
Other End Users

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Key Market Trends

Cancer/Oncology Segment is Expected to Grow the Fastest over the Forecast Period

  • Oncology is expected to witness the fastest CAGR, due to the rising number of cancer cases in the United States. There is also an increasing demand for self-care devices and POC diagnostics in the United States for the treatment of chronic diseases that are expected to boost the market growth in the future. In 2018, it was noted that 17 million new cases of cancers were identified, as per the Cancer Research UK. This shows the growing demand regarding the oncology-based diagnostics tests across the world.
  • The infectious disease segment also holds the largest market share, due to a high prevalence of pneumonia, tuberculosis, and HIV/AIDS. Thus, with the increasing cases of infectious diseases, it is expected to contribute to the growth of the US in vitro diagnostics market.
Estimated Number of Incident Cancer Cases, Global, 2020 to 2040

Hospitals and Clinics Segment is Expected to Grow over the Forecast Period

  • Hospitals and Clinics hold the largest market share, in terms of revenue, owing to the large volume of diagnostic tests carried out in hospitals and the rising volumes of Class II and Class III IVD medical devices that are being readily used for diagnostic testing. The healthcare professionals present in hospitals utilize in vitro diagnostics for disease detection and to get the best results for each patient.
US invitro.png

Competitive Landscape

Companies, like Abbott Laboratories, Becton, Dickinson and Company, and Danaher Corporation, are adopting strategic actions, mergers and acquisitions, and continued technological advancements, in order to retain their market share in the future. The companies are focusing on increasing technological advancements, in order to address the customer needs, like fully automated systems, that provide fast and accurate results.

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 High Burden of Chronic Diseases

      2. 4.2.2 Increasing Use of Point-of-care (POC) Diagnostics Spurring the IVD Market

      3. 4.2.3 Increasing Government Healthcare Expenditure and Consumer's Healthcare Spending

      4. 4.2.4 Advanced Technologies Fueling the IVD Market

      5. 4.2.5 Increasing Awareness and Acceptance of Personalized Medicine and Companion Diagnostics

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Proper Reimbursement

      2. 4.3.2 Stringent Regulatory Framework

      3. 4.3.3 Need For High Complexity Testing Centers

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 By Test Type

      1. 5.1.1 Clinical Chemistry

      2. 5.1.2 Molecular Diagnostics

      3. 5.1.3 Immuno Diagnostics

      4. 5.1.4 Haematology

      5. 5.1.5 Other Test Types

    2. 5.2 By Product

      1. 5.2.1 Instruments

      2. 5.2.2 Reagents

      3. 5.2.3 Other Products

    3. 5.3 By Usability

      1. 5.3.1 Disposable IVD

      2. 5.3.2 Reusable IVD

    4. 5.4 By Application

      1. 5.4.1 Infectious Diseases

      2. 5.4.2 Diabetes

      3. 5.4.3 Cancer/Oncology

      4. 5.4.4 Cardiology

      5. 5.4.5 Autoimmune Diseases

      6. 5.4.6 Nephrology

      7. 5.4.7 Other Applications

    5. 5.5 By End User

      1. 5.5.1 Diagnostic Laboratories

      2. 5.5.2 Hospitals and Clinics

      3. 5.5.3 Other End Users


    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 F Hoffmann-La Roche AG

      3. 6.1.3 Becton, Dickinson and Company

      4. 6.1.4 Danaher Corporation

      5. 6.1.5 bioMerieux SA

      6. 6.1.6 Bio-Rad Laboratories Inc.

      7. 6.1.7 Thermo Fisher Scientific Inc.

      8. 6.1.8 Qiagen

      9. 6.1.9 Siemens Healthcare GmbH

      10. 6.1.10 Sysmex Corporation

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The US In Vitro Diagnostics Market market is studied from 2018 - 2026.

The US In Vitro Diagnostics Market is growing at a CAGR of 4.8% over the next 5 years.

Abbott Laboratories, Danaher Corporation, bioMerieux SA, F Hoffmann-La Roche AG, Becton, Dickinson and Company are the major companies operating in US In Vitro Diagnostics Market.

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