In-depth Analysis and Data-driven Insights on the Impact of COVID-19 Included in this U.S. Clinical Laboratory Test Market Report

The U.S. clinical laboratory test market is expected to grow at a CAGR of approximately 2% during 2021-2026.

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.

The following factors are likely to contribute to the growth of the U.S. clinical laboratory test market during the forecast period:

  • High Penetration of Digital Pathology Testing Solutions
  • Increasing Availability of DTC Diagnostics Services by Clinical Laboratories
  • Rising of Periodic Occurrence of Epidemics and Pandemics
  • Technological Advancements in IVD Fueling Laboratory Diagnosis Volumes

The report considers the present scenario of the U.S. clinical laboratory test market and its market dynamics for the period 2021?2026. It covers a detailed overview of several market growth enablers, restraints, and trends. The study covers both the demand and supply sides of the market. It also profiles and analyzes leading companies and several other prominent companies operating in the market.

The U.S. clinical laboratory test market research report includes a detailed segmentation by test complexity, providers, test type. 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.

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.

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.

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

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.

Key Vendors

  • BioReference Laboratories
  • Eurofins Scientific
  • Laboratory Corporation of America
  • Mayo Clinic Laboratories
  • Quest Diagnostics
  • Siemens Healthineers
  • Sonic Healthcare

Other Prominent Vendors

  • ARUP Laboratories
  • Clinical Reference Laboratory
  • DaVita
  • Fresenius Medical Care
  • Laboratory of Florida
  • US Speciality Labs

1. How big is the U.S. clinical laboratory test market?
2. What is the clinical laboratory test market growth?
3. Which segment accounted for the largest U.S. clinical laboratory test market share?
4. Who are the leading players in the clinical lab testing market?
5. What are the factors driving the U.S. clinical laboratory test market?