North America Diagnostic Labs Market Size, Share, By Lab Type, Testing Services, Diseases, Revenue Source, and Country - Trends, Analysis, and Forecast till 2034

North America Diagnostic Labs Market Size, Share, By Lab Type, Testing Services, Diseases, Revenue Source, and Country - Trends, Analysis, and Forecast till 2034

Diagnostic laboratory is a facility 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, and increasing rates of allergic diseases are factors, which bequeath to market expansion. Also, partnerships between firms help to accomplish diagnostic labs market growth in Europe over the forecast period.

North America Diagnostic Labs Market Report Highlights:

The target market is calculated to expand at USD 55.7 billion by 2035.

In 2024, the North America diagnostic labs market size benefited at USD 36.0 billion.

The market is growing at a CAGR of 4.0%.

The U.S. region of North America dominates the market.

By lab type, the market is dominated by the hospital-based labs segment.

On the basis of testing services, the COVID-19 testing segment is leading the market.

Based on diseases, the oncology segment holds the largest market share.

The healthcare plan revenue source segment is expected to lead the market during the forecast period.

Key Benefits of Purchasing This Report

• Gain valuable insights into revenue projections for the overall market and its sub-segments, benefiting industry leaders and new entrants.
• Enhance your understanding of the competitive landscape to refine business positioning and optimize go-to-market strategies.
• Stay informed on the latest trends in the North America Diagnostics Labs Market, including key drivers, challenges, opportunities, and barriers.

North America Diagnostic Labs Market Key Highlights:

In September 2024, MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH N.V. announced the launch of the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics. The instrument and accessories are 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe.

In October 2024, the World Health Organization (WHO) has granted emergency use authorization for Abbott Laboratories’ Mpox diagnostic test, marking the first approval under the agency’s initiative to strengthen testing capabilities in regions experiencing Mpox outbreaks.

North America Diagnostic Labs Market Report Analysis:

Clinical Laboratory Improvement Amendments (CLIA)-

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing. Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. There are different types of CLIA certificates, as well as different regulatory requirements, based on the types and complexity of clinical laboratory tests a laboratory conducts.

Three federal agencies are responsible for administering the CLIA program: the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role.

1. CMS-

• Issues laboratory certificates.
• Collects user fees.
• Conducts inspections and enforces regulatory compliance.

1. FDA-

• Categorizes tests based on complexity.
• Reviews requests for CLIA Waiver by Application.
• Develops rules/guidance for CLIA complexity categorization.

1. CDC-

• Provides analysis, research, and technical assistance.
• Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology.
• Conducts laboratory quality improvement studies.

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

By Region:

• North America
• U.S.
• Canada

North America Diagnostic Labs Market Competitive Landscape

• BioReference Health, LLC
• Quest Diagnostics Incorporated
• Sonic Healthcare Limited
• Empire City Laboratories, Inc.
• AGILENT TECHNOLOGIES, INC.
• UNILABS
• ARUP LABORATORIES
• EXACT SCIENCES CORPORATION
• LIFELABS
• Precision Bio Laboratories Inc.
• PathGroup.
• MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH

Key Questions Answered in This Report

1. What was the size of the North America Diagnostics Labs Market in 2024?

2. What is the expected growth rate of the North America Diagnostics Labs Market during 2025-2035?

3. What are the key factors driving the North America Diagnostics Labs Market?

4. What is the breakup of the North America Diagnostics Labs Market based on the distribution channel?

5. What are the key regions in the North America Diagnostics Labs Market?

6. Who are the key players/companies in the North America Diagnostics Labs Market?

7. What are the drivers, restraints, and opportunities in the North America Diagnostics Labs Market?