THE U.S. CLINICAL LABORATORY TEST MARKET TO REACH USD 106.05 BILLION BY 2026, GROWING AT A CAGR OF 1.97% DURING THE PERIOD 2021-2026

U.S. Clinical Laboratory Test Market Size, Share, & Trends Analysis Report by Test Complexity (Routine and Specialty Tests), Providers (Hospital-Based Laboratories, Independent Reference Laboratories, Physician Office Laboratories, and Other Laboratories), and Test Type (Clinical and Immunochemistry, Microbiology and Cytology, Genetics and Cytogenetics (Molecular Diagnostics), Hematology, and Toxicology) Industry Analysis Report, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast 2021–2026

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178 Pages

26 Tables

80 Charts

1 Regions

1 Countries

13 Companies

3 Market Segment

U.S. CLINICAL LABORATORY TEST MARKET REPORT SCOPE

Report Attribute Details
MARKET SIZE (REVENUE) USD 106.05 BILLION (2026)
CAGR 1.97% (2021-2026)
Base Year 2020
Forecast Year 2021-2026
Market Segments Test Complexity (Routine and Specialty Tests), Providers (Hospital Based Laboratories, Independent Reference Laboratories, Physician Office laboratories, and Other Laboratories), and Test Type (Clinical and Immunochemistry, Microbiology and Cytology, Genetics and Cytogenetics (Molecular Diagnostics), Hematology, and Toxicology)
Geographic Analysis US
Countries Covered United States

U.S. CLINICAL LABORATORY TEST INDUSTRY INSIGHTS

The U.S. clinical laboratory test market size to reach around USD 106.05 billion by 2026, growing at a CAGR of approximately 1.97% during the forecast period. The dominant model of clinical laboratory testing remains the centralized model for diagnosing and treating several acute and chronic diseases. The emerging trend in the clinical lab testing market, such as lab automation and the incorporation of AI and machine learning into diagnostic services, is boosting the market's growth rate. 

Digital pathology solutions have been adopted by most pharmaceutical companies and clinical research institutions. Direct to consumer tests are performed from home, have greater accessibility in giving the samples to the clinical laboratories, and payments are directly collected from the consumers, thereby creating ease in the payments process. Many laboratories in the global market are offering these tests now to consumers. Many vendors ranging from major to emerging clinical laboratories vendors in the U.S. are extending their focus on direct access testing services. 

Laboratory Corporation of America and Quest Diagnostics are the dominant vendors in the U.S. clinical laboratory testing market. During the emergence of the COVID-19 pandemic, clinical laboratories shifted their investments into defense mechanisms to tackle the coronavirus by expanding their COVID-19 testing volumes. For instance, LabCorp steadily increased its capacity to perform the tests, and by the end of the year 2020, the company started performing 2,75,000 tests per day.

SNIPPETS

  • It is estimated that nearly 70% of the laboratory test market is automated, and the rest of the laboratories are also planning to implement automated technology during the forecast period.
  • In 2020, the specialty segment occupied a share of around 58% of the overall market.
  • The U.S. Department of Health and the Human Service aims to reduce HIV infections to less than 3,000 per year by 2030, which is expected to positively impact the growth of the U.S. clinical laboratory test market share. 
  • BioReference Laboratories serves around 19 million patients annually through a network of 11 laboratory locations.

U.S. CLINICAL LABORATORY TEST MARKET GROWTH FACTORS

  • The U.S. clinical laboratory testing market companies create considerable investments in IVD devices and the software used with advanced technologies. 
  • The acceptance of technological advancements such as AI and the Internet of Things (IoT) assist in remote monitoring and managing the devices in the laboratory testing services industry.
  • Approximately 1.5 million patients are diagnosed with diabetes every year and is the major factor driving the market's growth. 
  • Healthcare in the US is shifting toward early detection of infectious diseases and prevention, soaring the U.S. clinical laboratory test market demand. 

U.S. CLINICAL LABORATORY TEST MARKET SEGMENTATION

This research report includes a detailed segmentation by

  • Test complexity
  • Providers
  • Test type

INSIGHTS BY TEST COMPLEXITY

The routine testing segment in the US clinical laboratory test market accounted for over 42% in 2020.

Providers including POLs, hospital-based laboratories, and independent laboratories that perform CLIA-waived tests are gaining popularity in the country. An increasing number of innovative CLIA-waived tests will greatly expand access to beneficial clinical diagnostic testing across the US. From patient presentation to result in availability, the CBC test sets a standard for speed, with more than 16+ tests available in under five minutes, making it the most utilized lab test in the US. 

The rapid increase of various diseases is fueling the growth of specialty tests in clinical laboratories, which will witness huge demand in the US during the forecast period. Biopharma companies are rapidly seeking partners to co-develop the tests for their manufactured drugs. Reimbursements under Medicare and Medicaid services are also favorable factors increasing the adoption of specialty tests among the US population.

INSIGHTS BY PROVIDERS

Around 55% of hospital-based laboratories perform maximum test volumes in the clinical lab testing setting in the US.

According to the estimations of CMS, there are approximately 9,100 hospital-based laboratories in the country. The hospitals maintain on-site laboratories and perform laboratory tests for in-patient and outpatients with a significant majority. The profitability of the hospital laboratories rose to 85% due to the hospital outreach programs. Approximately 80% of the tests performed in the physician office labs are waived tests, and the provider performed microscopy. According to the American Academy of Family Physicians, physician office laboratories have a mild positive impact due to COVID-19.

INSIGHTS BY TEST TYPE

The U.S. clinical laboratory test services market by clinical chemistry segment is projected to post an absolute growth of around 14% by 2026.

Immunology and serology tests are witnessing increasing demand during the COVID-19 pandemic. The trend of early diagnosis and the disease management awareness among the population in the US are the major factors attributing to the increase in test volumes in the clinical and immunochemistry segment. The U.S. clinical laboratory test market by clinical and immunochemistry is expected to reach around USD 55 billion by 2026. The advancement in technology in the hematology lab testing services is driving the market. Over the past few years, several new products and technologies have emerged in the hematology testing market

COMPETITIVE LANDSCAPE

Laboratory Corporation of America and Quest diagnostics is the dominant vendors in the U.S. clinical laboratory testing market.

The US is home to many global and international standard clinical reference laboratories. The competition is emerging from new technologies such as digital pathology and growing from non-traditional competitors such as government agencies or employers establishing their clinical laboratory for testing. LabCorp, Quest Diagnostics, Siemens Healthineers, BioReference Laboratories, Sonic Healthcare, Eurofins Scientific, and Mayo Clinic Laboratories are the major players in the market.

New entrants with extensive resources are likely to adopt acquisition as an expanding strategy into traditional operations in the laboratory testing services industry. Siemens Healthineers upgrades its technical operations by incorporating artificial intelligence and consistently improving its core business. 

The U.S. clinical laboratory test market research report includes in-depth coverage of industry analysis with revenue and forecast insights for the following:

  • Segmented by Test Complexity
    • Routine Tests
    • Specialty Tests
  • Segmented by Providers
    • Hospital Based Laboratories
    • Independent Reference Laboratories
    • Physician office laboratories
    • Other laboratories
  • Segmented by Test Type
    • Clinical and Immunochemistry
    • Microbiology and Cytology
    • Genetics and Cytogenetics (Molecular Diagnostics)
    • Hematology
    • Toxicology

Frequently Asked Questions

The U.S. clinical laboratory test market size to reach around USD 106.05 billion by 2026.
The U.S. clinical laboratory tests market to grow at a CAGR of approximately 1.97% during the forecast period.
Around 50% of hospital-based laboratories perform the maximum test volumes in the clinical lab testing in the U.S.
LabCorp, Quest Diagnostics, Siemens Healthineers, BioReference Laboratories, Sonic Healthcare, Eurofins Scientific, and Mayo Clinic Laboratories are the major players in the market.
The acceptance of advanced technologies such as AI and the Internet of Things (IoT) assists in remote monitoring and the management of the devices in the laboratory testing services industry.
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