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2023 U.S. Laboratory Market Report

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  • 73 Pages
  • September 2023
  • Region: United States
  • Health Industry Distributors Association (HIDA)
  • ID: 5693132

The U.S. laboratory market was valued at $93 billion in 2022 with over 319,000 Clinical Laboratory Improvement Amendment (CLIA) certified laboratories. The advances in laboratory equipment and procedures, the aging U.S. population, and an increase in healthcare spending and investments in diagnostic services drove the growth of the laboratory market. The 2023 Laboratory Market Report analyzes new laboratory services, technological innovations, sustainable practices in clinical laboratories, and the impact of regulatory changes on the overall market.

Key Findings
  • Top Budget Priority: Technology investments to ease the labor shortage were cited as the top budget priority by 48% of laboratory executives.
  • Top Direct-To-Consumer Test Type: Genetic testing became the top direct-to-consumer test type in 2022, with over 3,000 new genetic tests introduced in the U.S.
  • Market Projection: The U.S. physician office lab market is projected to reach $18.3 billion by 2030.

Table of Contents

  • Executive Summary
  • Laboratory Market Overview
  • COVID-19 And Routine Testing Volume Fluctuate Around Pre-Pandemic Baseline
  • Lack Of Qualified Applicants Exacerbate Laboratory Job Vacancies
  • Pay And Burnout Are Leading Factors For Laboratory turnover
  • Laboratories Utilize Technology Innovations To Lessen Demands On Workforce
  • Modern LIMS Adopted To Enable Seamless Data Access
  • Technology Proves Essential As Labs Pursue Sustainability Goal
  • Testing Volume Increased For 18 Of Top 25 Lab Test
  • 20% Of Labs Perform Non-Waived Tests
  • End Of Public Health Emergency Signals Changes For Testing And Laboratories
  • Medicare Spending On Lab Tests Increases Despite PAMA Reimbursement Cuts
  • Average Charge For Hospital Lab Tests Above Those Of POLs And Independent Lab
  • Site-Of-Care Shifts And Technology Advancements Drive Growth Of Physician Office Labs
  • Number Of Post-Acute Facilities Performing Testing Decreased Slightly Post-Pandemic
  • Independent Lab Patient Volumes Increase Year-Over-Year
  • Independent Laboratories Experience Decreases In Number Of Facilities And Profits
  • Medicare Coverage Of Genetic Tests Risen
  • Innovative Diagnostic And Treatment Techniques Personalize Oncology Care
  • FDA Authorizes First Over-The-Counter Test To Detect COVID-19 And Influenza 
  • Point-Of-Care Advancements Challenge Traditional Laboratory Testing
  • Market Consolidation Persists As Laboratory Companies Chase Benefits Of Scale
  • Clarivate Lists Top Laboratory Products Sold Through Distribution



Executive Summary


The U.S. laboratory market was valued at $93 billion in 2022, a 17% decrease from $112.1 billion in 2021 when COVID-19 testing drove market growth. Post-pandemic, the major factors impacting the laboratory market include increased demand for personalized medicine, the aging population, the high rate of chronic diseases, and laboratory innovations.

In 2022, there were 319,000 Clinical Laboratory Improvement Amendment (CLIA) certified labs in the U.S., including physician offices, nursing homes, and other non-acute settings.

Digital Transformation Is Enabling Lab Efficiency And Productivity

From investing in artificial intelligence (AI) and automation to adopting mobile-friendly tools, laboratories are taking steps toward modernization in 2023. Technological advancements are helping laboratories enable remote work, alleviate inventory management challenges, and cut waste to support sustainability goals.

Laboratory Job Vacancies Increasing Amid Skills Shortage

As retirement rates rose and laboratory staff hiring fell, the U.S. faced a shortage of 20,000 to 25,000 medical laboratory science professionals in 2022. The lack of candidates led to extended job vacancies as unsuitable pay and burnout drove down staff morale and increased employee turnover. Technology advancements and greater remote work flexibility for pathologists is expected to help lessen the burden of the labor shortage.

New Lab Tests Emerge As Demand For Convenient And Personalized Care Escalates

The global market for custom cancer treatments is projected to see double-digital growth in the coming years due largely to the research and development of new laboratory tests and diagnostic procedures. Genetic testing was the top direct-to-consumer (DTC) test type in 2022, as more than 3,000 genetic tests were introduced in the U.S. The Food and Drug Administration also issued an emergency-use authorization in 2022 for a new over-the-counter lab test that could detect and differentiate between COVID-19 and influenza, expanding accessible care options.

End Of Public Health Emergency Creates Future Laboratory Changes

The U.S. government ending the federal public health emergency (PHE) on May 11, 2023, impacted all healthcare markets including laboratories. For laboratories, the end of the PHE changes the expiration date on mandatory coverage of over-the-counter COVID-19 tests and ends the U.S. Department of Health and Human Services’ ability to require laboratories to report COVID-19 test results and immunization data.