The 2024 Laboratory Market Report highlights new laboratory tests, technological advancements, and the post-pandemic decline in Medicare spending on laboratory tests.
12% of laboratories are implementing vendor-managed ordering programs to improve inventory control in 2024.
Key Topics
- Final laboratory-developed test rule
- Direct-to-consumer laboratory testing
- Independent laboratory patient volumes
Table of Contents
- Executive Summary
- Laboratory Market Overview
- Laboratories Enhance Inventory Control Practices
- Laboratories Plan to Modernize Technologies in 2024
- FDA Widens Oversight of Laboratory-Developed Tests
- FDA Authorizes First At-Home Test for Chlamydia and Gonorrhea
- Blood Test for Colon Cancer Nears FDA Approval
- Drug Tests Dominate List of Most Recently Waived Tests
- Medicare Spending on COVID-19 Tests Drops as Demand Declines
- Medicare Spent Almost $1 Billion Less on Lab Tests in 2022
- Congress Delays PAMA Payment Cuts for Fifth Year In A Row
- Medicare Part B Expenditure Decrease Alongside Testing Volume
- Genetic Tests Lead the Way in Growing the Direct-to-Consumer Testing Market
- Number of Physicians Office and Post-Acute Labs Decline in 2024
- Independent Laboratory Patient Volumes Remain Below Pre-Pandemic Levels
- LabCorp Experiences Increase in Revenue While Quest Diagnostics' Earnings Fail
- Labs Work Towards Quality Improvements While Diversifying Test Menus
- Advancements in Lab Testing Improving Precision Oncology
- Lab Inspection Highest issues with Personnel and Documentation
- Fewer Labs are Offering Financial Incentives to Recruit and Retain Staff in 2024
- National Laboratories Target Growth by Acquiring Hospital Lab Assets
- Clarivate Lists Top Laboratory Products Sold Through Distribution
Executive Summary
Market-At-A-Glance
The U.S. clinical laboratory market was valued at $95.9 billion in 2023, a 3% increase from $93 billion in 2022. Major factors influencing the market include the increasing demand for genetic testing and preventative diagnoses, as well as innovations in medicine and technology. There were more than 317,000 Clinical Laboratory Improvement Amendment (CLIA) certified laboratory facilities nationwide, including physician-owned labs, hospital labs, and independent labs in 2023.
New FDA Approved Laboratory Tests Projected To Transform Diagnostic Testing
The Food and Drug Administration (FDA) authorized the first at-home chlamydia and gonorrhea diagnostic test, Simple 2, in November 2023. Additionally, an FDA advisory panel recommended approval of a new blood-based test for colorectal cancer screening in adults in May 2024. Noninvasive blood-based tests that screen for colon cancer and Alzheimer’s disease have shown great potential for enabling earlier cancer
detection and treatment.
Laboratories Alter Recruitment And Retention Strategies As Staffing Challenges Continue
Nearly all hospital CEOs identified the medical and laboratory technician shortage as the top challenge facing their organization in 2023. The need for additional laboratory employees is expected to rise through 2024 as the aging population drives an increase in the demand for diagnostic testing. The share of laboratory professionals offering financial incentives as part of their hiring and retention efforts has fallen 11% between 2023 and 2024. Instead of offering financial incentives, laboratories are providing continuing education opportunities and flexible scheduling to help recruit and retain staff.
National Laboratories Prioritize Acquisition Of Hospital Laboratory Assets
In 2023 and 2024, Quest Diagnostics and LabCorp together finalized eight acquisitions of small assets from within hospital systems. The two organizations combined completed 36 hospital mergers or acquisitions between 2017 and 2022. The trend toward small and targeted mergers and acquisitions indicates a strategy shift, in which national laboratories prioritize expanding their geographic footprint and technological capabilities.
Medicare Part B Payments Decrease After Years-Long Rise
Although Medicare Part B spending on laboratory tests had trended upward since 2016, the laboratory market experienced a decline of nearly $1 billion in 2022 compared to 2021. The decrease in Medicare Part B spending is primarily due to decreases in the volume of COVID-19, genetic, and chemistry tests paid for by Medicare Part B. In the midst of declining Medicare Part B spending on laboratory tests, Congress passed a bill in November 2023 to delay Protecting Access to Medicare Act (PAMA) payment cuts until 2025.
Companies Mentioned
- Clarivate
- LabCorp
- Quest Diagnostics
