U.S. Diagnostic Labs Market Size, Share, By Lab Type, Testing Services, Diseases, and Revenue Source - Trends, Analysis, and Forecast till 2035

• The market is estimated to grow at USD 51.1 billion in 2035.
• The U.S. diagnostic labs market size was evaluated at USD 33.0 Billion in 2024.
• The market is extending at a CAGR of 2.0%.

Diagnostic laboratory is a facility, which is equipped with reagents, apparatus for performing diagnostic test and for detecting human infection. The rise in healthcare industries, rapid test kits, and rising cases of chronic diseases are leading cause of the U.S. diagnostic labs market growth. Another elements driving the market diversification is increasing rates of allergic diseases. Additionally, throughout the forecast period, it is assessed that company alliances also generate possibilities for market augmentation.

Key Drivers of Target Market:

Rising Healthcare Spending Influencing the Market Growth

The U.S. spends more on health care than any other country. As healthcare spending rises, both government and private sectors typically allocate more funds to healthcare services which results in greater demand for diagnostic tests and procedures.

• For Instance, according to the data published by the U.S. Centers for Medicare & Medicaid Services, the U.S. health care spending grew 7.5% in 2023, reaching USD 4.9 trillion or USD 14,570 per person.  As a share of the nation's Gross Domestic Product, health spending accounted for 17.6%.
• For instance, according to the data published by Massachusetts Institute of Technology, on average, the U.S. spends more than twice as much per person on health compared to other wealthy countries in 2022.

Restraints:

Increasing Test Complexity to Impede Market Enlargement

Advances in diagnostic technologies have led to the development of more complex tests, including molecular diagnostics and genetic testing. While these tests provide valuable insights, their complexity can pose challenges in terms of interpretation, validation, and standardization.

Counterbalance Statements: Solutions for these problems are understanding the complexity, meet the regulatory requirements, train staff, assess infrastructure and equipment, implement quality assurance, and others.

Opportunities & Market Trends:

Technological Elevation Surge the Market Growth

Ongoing advancements in diagnostic technologies such as molecular diagnostics, genetic testing, imaging modalities, and others contribute to drive the target market growth. Additionally, the region’s continuous focus on innovative technologies, such as next-generation sequencing can drive market expansion.

• For instance, in March 2024, Naveris, Inc., the leader in precision oncology diagnostics for viral-related cancers, announced that the Centers for Medicare & Medicaid Services (CMS) has designated NavDx, the Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test that aids in the detection of HPV-driven cancer, as an Advanced Diagnostic Laboratory Test (ADLT).

The market is categorized into lab type, testing services, diseases, revenue source, and country.

Lab Type

Hospital-based labs, physician office labs, single/independent laboratories, and others are lab types into which market is sorted. The hospital-based labs clenched the largest share of the target market due to high volume of patient.

Testing Services

Regarding testing services, the market is distributed into physiological function testing, general & clinical testing, esoteric testing, specialized testing, non-invasive testing, COVID-19 testing, and others. The dominating segment in the market is the COVID-19 testing segment due to pandemic, which caused rapid growth in the infection cases.

• For instance, in March 2020, the Innovative Genomics Institute (IGI) was launched an ambitious efforts to establish a COVID-19 diagnostic testing laboratory on UC Berkeley Campus.

Diseases

Based on diseases, the market is segmented cardiology, oncology, neurology, orthopedics, gastroenterology, gynecology, odontology, and others. The largest U.S. diagnostic labs market share was held by the oncology segment due to the result of the increasing cancer cases brought on by bad lifestyle choices.

• For instance, in December 2024, Pharus Diagnostics LLC. (PharusDx), an innovator in non-invasive diagnostic tests, announced the availability of its OncoSweep Pancreas Spotlight, a liquid biopsy screening test that aids in the detection of Pancreatic Ductal Adenocarcinoma (PDAC) in people with elevated risk.

Revenue Source

The market is segmented public system, out-of-pocket, and healthcare plan based on the revenue source. The target market is dominated by the healthcare plans segment since these plans provide coverage for a wide range of illness & surgeries.

U.S. Diagnostic Labs Market Report Scope:

Segmentation:

By Lab Type:

• Single/Independent Laboratories
• Hospital-Based Labs
• Physician Office Labs
• Others

By Testing Services:

• Physiological Function Testing
• General & Clinical Testing
• Esoteric Testing
• Specialized Testing
• Non-Invasive Testing
• COVID-19 Testing
• Others

By Diseases:

• Cardiology
• Oncology
• Neurology
• Orthopedics
• Gastroenterology
• Gynecology
• Odontology
• Others

By Revenue Source:

• Healthcare Plan
• Out-of-Pocket
• Public System

The major companies in the market are ARUP LABORATORIES, Quest Diagnostics Incorporated, MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH (MFMER), MaineHealth, and others. The major firms are accomplishing tactics to expand market such as launching new tests, acquisitions, approval of diagnostic tests, opening new diagnostic centres, and others.

List of Key Players in the Market:

• ARUP LABORATORIES
• Quest Diagnostics Incorporated
• MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH (MFMER)
• MaineHealth
• NORTON HEALTHCARE
• RADNET INC.
• American Oncology Network
• NATERA, INC
• BIOREFERENCE HEALTH, LLC
• LifeLabs
• NeoGenomics Laboratories
• PRECISION BIO LABORATORIES INC.

• In October 2024, LabGenomics USA has successfully acquired Integrated Molecular Diagnostics (IMD) CLIA labs, bringing the total number of its CLIA-certified labs in the U.S. to four. This acquisition strengthens LabGenomics’ strategic development and expands its diagnostic services nationwide, particularly in molecular technology.
• In July 2024, The U.S. Food and Drug Administration (FDA) has approved a blood test that can help detect colorectal or colon cancer. This expands options for screening one of the most deadly diseases affecting younger populations worldwide.

More Related Reports

Healthcare Analytical Testing Services Market
Endocrine Testing Market
Hospital Acquired Disease Testing Market
Antimicrobial Susceptibility Testing Market
Genetic Testing Market