The U.S. Anatomic Pathology Market: Forecast & Trends 2025-2028

by harrisonklipp@gmail.com | Nov 20, 2025 | Laboratory Market Research, AI, Artificial Intelligence, BioReference Labs, CAP, CLFS, CLIA, CMS, Laboratory Economics, NGS

The U.S. Anatomic Pathology Market: Forecast & Trends 2025-2028

Laboratory Economics has just released The U.S. Anatomic Pathology Market: Forecast & Trends 2025-2028. With this special report, you can tap into 100+ pages of proprietary market research that reveals critical data and information about key business trends affecting the anatomic pathology market.

The report reveals that the U.S. anatomic pathology market represented an estimated $37.1 billion of revenue in 2025 with a long-term annual growth rate of 10.1%. Growth is being driven almost entirely by increased molecular oncology testing, especially minimal residual disease (MRD) testing to monitor cancer treatment.

The U.S. anatomic pathology market faces unprecedented change, including the introduction of artificial intelligence tools that increase pathologist productivity, greater utilization management by private payers and persistent reimbursement pressure.

“The introduction of new higher-priced molecular oncology tests, including next-generation sequencing for tumor mutation profiling and MRD testing, should more than offset price and volume pressure on routine pathology tests,” according to Jondavid Klipp, President of Laboratory Economics.

In addition, the growing adoption of digital pathology and application of AI software tools to digitized slide images have the potential to profoundly change the way pathology is practiced within the next 3-5 years.

The greatest challenge comes from third-party payers, which are instituting prior authorization policies and laboratory benefit management programs designed to lower utilization of anatomic pathology services and genetic tests for cancer.

The report includes:

More than 100 charts and graphs
Pathology market size and growth rates
Detailed estimates for market subsets like uropathology, dermatopathology, and gastrointestinal pathology
In-depth analysis of the molecular oncology testing market size and growth rates
Medicare claims data for 60+ key pathology codes covering surgical pathology, molecular oncology, immunohistochemistry and special stains, tumor marker immunoassays, FISH testing and flow cytometry
Cervical cancer testing trends and pricing data
Detailed analysis of the emerging digital pathology & AI market
Results from Laboratory Economics Anatomic Pathology and Clinical Lab Trends Surveys from 2015 through 2025

Anatomic pathology companies highlighted include:

Adaptive Biotechnologies
Bako Diagnostics
Caris Life Sciences
CellNetix Pathology & Laboratories
Exact Sciences
Foundation Medicine
Fulgent Genetics/Inform Diagnostics
Guardant Health
Labcorp
Mayo Clinic Laboratories
Myriad Genetics
Natera Inc.
NeoGenomics
OPKO/BioReference Labs
PathGroup
Quest Diagnostics
Sonic Healthcare/Aurora Diagnostics/ProPath Services
Tempus AI
Versant Diagnostics

The U.S. Anatomic Pathology Market: Forecast & Trends 2025-2028 is published by Laboratory Economics (http://www.laboratoryeconomics.com), an independent market research firm focused exclusively on the business of pathology and laboratory medicine. Report author Jondavid Klipp has been covering key business trends affecting clinical lab testing and anatomic pathology services for 27 years.

BioReference Labs Goes Live With Digital Pathology Plus AI

by Jondavid Klipp | Feb 15, 2022 | AI, Artificial Intelligence, BioReference Labs, Digital Pathology

BioReference Labs Goes Live With Digital Pathology Plus AI

OPKO’s BioReference Labs (Elmwood Park, NJ) went live in December with new whole-slide imaging scanners from Leica Biosciences (Buffalo Grove, IL). The scanners have been integrated with a digital pathology solution, PathFlow, made by Gestalt Diagnostics (Spokane, WA). PathFlow is a cloud-based software system that has helped integrate BioReference’s LIS, workflow and scanned slide images with artificial intelligence algorithms developed by MindPeak (Hamburg, Germany). BioReference is also using PathFlow for slide image management and archival storage.

BioReference is using MindPeak’s AI tool (named BreastIHC) to detect and quantify breast cancer cells from digitized slide images with immunohistochemistry at its main laboratory in northern New Jersey. Pathologists can access their case and slide images securely on their computer monitors and use their mouse to outline regions of interest (ROI). All cells within this outlined ROI are instantly classified into positively stained tumor and unstained tumor cells. The panel of algorithms include five key tumor markers (ER, PR, Ki-67, HER2, and P53) which can be counted and scored.

Eventually, Dan Roark, Chief Executive Officer, Gestalt Diagnostics, expects the AI algorithms to both automatically identify the regions of interest in addition to performing IHC marker positivity scoring.

Digital Pathology & AI Market Growth
Separately, Roark says that after more than 10 years of limited adoption, digital pathology is finally starting to take off in the clinical market in the United States. Whole slide scanners have gotten quicker and less expensive. For example, it used to take 8-10 minutes to scan a slide but now takes as little as 30 seconds. But the biggest driver is the pathologist efficiency gains obtained when AI is applied to digitized slides. “The number of RFP requests we receive is exploding,” says Roark.

Worldwide Opportunities for U.S.-Based Pathologists
The U.S. has more working pathologists per capita than most other countries. For example, there are approximately 20,000 actively practicing pathologists in the United States, according to the American Medical Association. This works out to a ratio of one pathologist for every 17,000 people.

Publicly-Traded Lab Revenue Falls 1.4% In First-Half 2020

by Jondavid Klipp | Sep 15, 2020 | BioReference Labs, Labcorp, Quest Diagnostics, Sonic Healthcare

Publicly-Traded Lab Revenue Falls 1.4% In First-Half 2020

On a combined basis, 20 publicly-traded labs reported a revenue decrease of 1.4% to $9.8 billion during the first six months of 2020 (after adjusting for acquisitions), according to financial reports collected by Laboratory Economics.

Among five national clinic al labs (Quest Diagnostics, LabCorp, Sonic, BioReference and Enzo), combined revenue fell by 3.1% (after adjusting for acquisitions). BioReference had the strongest revenue growth, up 18% to $421.8 million, driven by Covid-19 PCR testing. BioReference processed approximately 2.2 million Covid-19 PCR tests during the first six months of 2020.

Among 15 specialty and genetic testing labs, combined pro-forma revenue increased by 7.3%.

Pro-forma revenue growth was fastest at DermTech, up 98.4% to $2.4 million. Other fast-growing companies included Castle Biosciences, up 54.9% to $30.1 million; Guardant Health, up 47.7% to $133.8 million; and CareDx, up 39.6% to $80.2 million.

Top 25 Fastest-Growing Labs by Medicare Part B Volume of Services

Top 25 Lab and Pathology Companies Receiving PRF Payments

by Jondavid Klipp | Jul 15, 2020 | BioReference Labs, Exact Sciences, Labcorp, Quest Diagnostics

Top 25 Lab and Pathology Companies Receiving PRF Payments

Not surprisingly, Quest Diagnostics ($65 million) and LabCorp ($56 million) top the list in terms of highest PRF payments received by lab and pathology companies. Exact Sciences, including Genomic Health, received $23.5 million, while Sonic Healthcare, including Aurora Diagnostics, received $12.4 million. In total, the top 25 lab and pathology companies received $222.6 million in PRF payments.

BioReference Wins Lab Contract With Westchester Medical Center

by Jondavid Klipp | Jul 15, 2020 | BioReference Labs

BioReference Wins Lab Contract With Westchester Medical Center

OPKO’s BioReference Laboratories (Elmwood Park, NJ) has signed a long-term service contract with the Westchester Medical Center Health Network (Valhalla, NY) to provide inpatient lab administrative services, reference testing and outreach testing services.

WMCHealth has 10 hospitals on eight campuses across the Hudson Valley Region of New York, including Westchester Medical Center (885 beds) and MidHudson Regional Hospital (243 beds). Altogether, WMCHealth has an annual laboratory department budget of approximately $65 million and performs over seven million lab tests per year.

Under the agreement, BioReference will provide inpatient lab administrative services and purchasing management services for lab equipment and supplies initially for Westchester Medical Center.

In addition, BioReference’s main lab in northern New Jersey will become the primary reference lab and perform clinical lab outreach testing for the entire hospital network. The agreement does not involve anatomic pathology services.

Jon Cohen, MD, Executive Chairman at BioReference, expects the company to sign similar agreements with other health systems in the future.

Majority Of NYC Nursing Home Employees Have Had Covid-19

by Jondavid Klipp | Jul 15, 2020 | BioReference Labs, Covid Testing, COVID-19

Majority Of NYC Nursing Home Employees Have Had Covid-19

BioReference Labs reports that Covid-19 antibody testing it performed on nursing home employees throughout New York State in May-June showed a 29% positivity rate. New York City nursing home employees were found to have the highest positivity rate (55%).

During the same time period, BioReference performed PCR-based molecular tests for active Covid-19 infection and found a 2.9% positive rate throughout the state, including a 4.6% positive rate for New York City nursing home employees.

The testing was performed as a result of a New York State mandate (effective May 10) that all personnel at nursing home and adult care facilities be tested for active Covid-19 infection using PCR-based molecular testing, twice per week. In addition, at the start of the program, many nursing homes asked that employees be tested for antibodies at the same time.

BioReference uses the Roche Elecsys Anti-Sars CoV-2 assay for antibody testing. Overall, BioReference tested 3,488 nursing home employees in New York State (primarily in May) for antibodies and found 1,010 positive cases. “With 29% of employees testing positive for antibodies, an extrapolated estimate for the 140,000 total nursing home staff in New York State suggests as many as 41,760 nursing home staff members in the state could have had Covid-19 prior to early May,” according to Jon Cohen, MD, Executive Chairman at BioReference.