NAICS 621511 Quarterly Industry Report
Medical Laboratories
Comprehensive industry research for valuation professionals, business owners, buyers, and lenders
NAICS Code: 621511Sector: Health Care and Social Assistance (62)Updated: Q1 2026
About This Report
This industry profile for Medical Laboratories (NAICS 621511) draws on data from the U.S. Census Bureau[6], Centers for Medicare and Medicaid Services[8], Bureau of Labor Statistics[9], and SBA size standards database[7]. Published by Fair Market Value and updated quarterly, it provides valuation professionals, laboratory industry analysts, and healthcare investors with current market data. All quantitative claims are sourced to publicly verifiable databases.
Industry Snapshot
Key metrics for the medical laboratories industry.
NAICS Sector
62
Health Care and Social Assistance
Industry Definition & Overview
Medical Laboratories (NAICS 621511) encompasses establishments known as medical laboratories primarily engaged in providing analytic or diagnostic services, including body fluid analysis and diagnostic imaging, generally to the medical profession or to the patient on referral from a health practitioner per the U.S. Census Bureau[5]. Services include clinical chemistry, hematology, microbiology, pathology, cytology, toxicology, and molecular diagnostics performed on patient specimens.
Industry revenue reached $36.4 billion with 191,404 employees across roughly 6,800 establishments per Census Bureau[6] economic survey data. Quest Diagnostics and Labcorp dominate the commercial laboratory market, together processing hundreds of millions of patient specimens annually. Regional reference laboratories and hospital-affiliated outreach programs compete for physician office referral volume, while specialty laboratories focusing on genetic testing, oncology, and infectious disease panels have grown rapidly.
Per the SBA Table of Size Standards[7], the size standard is $41.5 million in average annual receipts. All laboratories performing testing on human specimens must hold Clinical Laboratory Improvement Amendments (CLIA) certification from CMS[8], with certificate types ranging from waived testing to high-complexity laboratory operations. CLIA regulations establish quality standards for proficiency testing, patient test management, personnel qualifications, and quality control procedures. Medicare reimburses clinical laboratory services under the Clinical Laboratory Fee Schedule, which sets national payment limits. Molecular diagnostics and genetic testing represent the fastest-growing segments, with next-generation sequencing, pharmacogenomics, and liquid biopsy panels expanding the scope of laboratory medicine beyond traditional clinical chemistry.
What's Included in This Industry
- Clinical chemistry and blood analysis testing services
- Hematology and coagulation laboratory testing
- Microbiology culture and sensitivity testing
- Anatomic pathology and histology examination services
- Cytology screening including Pap smear analysis
- Molecular diagnostics and genetic testing panels
- Toxicology and drug screening laboratory services
- Point-of-care testing device management and oversight
- Reference laboratory specimen processing and reporting
- CLIA compliance and quality assurance program management
NAICS Classification Hierarchy
| Level | Description | Code |
|---|---|---|
| Sector | Health Care and Social Assistance | 62 |
| Subsector | Ambulatory Health Care Services | 621 |
| Industry Group | Medical and Diagnostic Laboratories | 6215 |
| NAICS Industry | Medical and Diagnostic Laboratories | 62151 |
| National Industry | Medical Laboratories | 621511 |
Related NAICS Codes
| Code | Description | Relationship |
|---|---|---|
| 621512 | Diagnostic Imaging Centers | Diagnostic Imaging Centers provide radiology and imaging services that complement laboratory diagnostic testing, with many physician offices ordering both laboratory and imaging studies as part of coordinated patient diagnostic workup protocols |
| 621111 | Offices of Physicians (except Mental Health Specialists) | Offices of Physicians (General) serve as primary referral sources for laboratory testing, with physician-ordered blood work, cultures, and pathology specimens generating the majority of commercial laboratory testing volume |
| 622110 | General Medical and Surgical Hospitals | General Medical and Surgical Hospitals operate inpatient laboratories and compete with commercial laboratories for outreach testing volume from community physicians, with hospital lab outreach programs representing a growing market share |
| 339113 | Surgical Appliance and Supplies Manufacturing | Surgical and Medical Instrument Manufacturing produces laboratory analyzers, specimen processing equipment, and point-of-care testing devices that represent primary capital expenditures for laboratory facility buildout and technology upgrades |
| 541714 | Research and Development in Biotechnology (except Nanobiotechnology) | Research and Development in Biotechnology drives demand for clinical laboratory testing through new diagnostic assay development, with molecular diagnostics and genetic testing panels originating from biotechnology research programs |
| 621492 | Kidney Dialysis Centers | Kidney Dialysis Centers require routine laboratory monitoring of dialysis patients including blood chemistry panels, anemia markers, and adequacy testing that generates ongoing specimen volume for clinical laboratories |
Geographic Concentration
Top states by share of national establishments.
| # | State | % Est. | Total Est. |
|---|---|---|---|
| 1 | California | 13.5% | 1,746 |
| 2 | Texas | 8.0% | 1,027 |
| 3 | Florida | 7.8% | 1,001 |
| 4 | New Jersey | 5.3% | 685 |
| 5 | New York | 5.2% | 670 |
| 6 | Pennsylvania | 3.8% | 487 |
| 7 | North Carolina | 3.2% | 414 |
| 8 | Arizona | 3.1% | 405 |
| 9 | Georgia | 2.9% | 371 |
| 10 | Maryland | 2.9% | 369 |
% Of Establishments
0%
14%
Source: County Business Patterns, U.S. Census Bureau[3]
SBA Lending Summary
400
Total SBA Loans
$173.6M
Total Loan Volume
$434K
Average Loan Size
10 yrs
Average Loan Term
10.36%
Average Interest Rate
4,824
Jobs Supported
Source: SBA 7(a) Program Data, U.S. Small Business Administration — FY 2025[4]
Key Insight: Per the SBA Table of Size Standards[7], Medical Laboratories (NAICS 621511) has a size standard of $41.5 million in average annual receipts for federal contracting purposes. SBA lending programs[10] support laboratory acquisition, diagnostic equipment investment, and testing capacity expansion for qualifying medical laboratory operators. Eligible businesses can access SBA 7(a) loans[11] for working capital, equipment, and acquisition financing, while 504 loans[12] support major fixed-asset purchases including real estate and heavy machinery.
Top SBA Lenders
| # | Lender | Loans | Volume | Avg Loan |
|---|---|---|---|---|
| 1 | American Bank | 16 | $34.4M | $2.1M |
| 2 | T Bank, National Association | 8 | $29.8M | $3.7M |
| 3 | Millennium Bank | 8 | $22.9M | $2.9M |
| 4 | Northeast Bank | 48 | $13.0M | $270K |
| 5 | KeyBank National Association | 8 | $10.0M | $1.3M |
Frequently Asked Questions
Common questions about this industry.
What is the NAICS code for medical laboratories?
NAICS 621511 covers medical laboratories providing analytic and diagnostic testing services including clinical chemistry, hematology, pathology, and molecular diagnostics per the U.S. Census Bureau[5].
How large is the medical laboratory industry?
Industry revenue reached $36.4 billion with 191,404 employees across roughly 6,800 establishments per Census Bureau[6] economic survey data, with Quest Diagnostics and Labcorp as dominant commercial operators.
What is the SBA size standard for medical laboratories?
The SBA size standard[7] is $41.5 million in average annual receipts, determining eligibility for federal small business contracting programs and SBA lending products.
What is CLIA certification?
All laboratories performing testing on human specimens must hold CLIA certification from CMS[8], with certificate types ranging from waived testing to high-complexity operations, establishing quality standards for proficiency testing, personnel, and quality control.
How does Medicare reimburse laboratory tests?
Medicare reimburses clinical laboratory services under the Clinical Laboratory Fee Schedule, which sets national payment limits per CMS[8] reimbursement guidelines, with rates adjusted periodically based on market pricing surveys.
What are the fastest-growing laboratory segments?
Molecular diagnostics and genetic testing represent the fastest-growing segments, with next-generation sequencing, pharmacogenomics, and liquid biopsy panels expanding laboratory medicine scope per Bureau of Labor Statistics[9] industry data.
Who are the largest commercial laboratory companies?
Quest Diagnostics and Labcorp dominate the commercial market, together processing hundreds of millions of specimens annually per industry tracking data, with regional reference laboratories and hospital outreach programs competing for physician office referral volume.
What quality requirements apply to laboratories?
CLIA regulations establish standards for proficiency testing, patient test management, personnel qualifications, and quality control per CMS[8] laboratory certification requirements, with state licensing adding additional facility and operational mandates.
Sources & References
Government datasets and editorial sources used in this report.
- [1]U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages bls.gov
- [2]U.S. Census Bureau, Economic Census census.gov
- [3]U.S. Census Bureau, County Business Patterns census.gov
- [4]U.S. Small Business Administration, SBA 7(a) Loan Program Data data.sba.gov
- [5]U.S. Census Bureau census.gov
- [6]Census Bureau data.census.gov
- [7]SBA Table of Size Standards sba.gov
- [8]CMS cms.gov
- [9]Bureau of Labor Statistics bls.gov
- [10]SBA lending programs sba.gov
- [11]SBA 7(a) loans sba.gov
- [12]504 loans sba.gov
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