North America Diagnostic Labs Market Size, Share, By Lab Type, Testing Services, Diseases, Revenue Source, and Country - Trends, Analysis, and Forecast till 2034
Description
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
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-
By Lab Type:
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?
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.
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.
- Categorizes tests based on complexity.
- Reviews requests for CLIA Waiver by Application.
- Develops rules/guidance for CLIA complexity categorization.
- Provides analysis, research, and technical assistance.
- Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology.
- Conducts laboratory quality improvement studies.
By Lab Type:
- Single/Independent Laboratories
- Hospital-Based Labs
- Physician Office Labs
- Others
- Physiological Function Testing
- General & Clinical Testing
- Esoteric Testing
- Specialized Testing
- Non-Invasive Testing
- COVID-19 Testing
- Others
- Cardiology
- Oncology
- Neurology
- Orthopedics
- Gastroenterology
- Gynecology
- Odontology
- Others
- Healthcare Plan
- Out-of-Pocket
- Public System
- North America
- U.S.
- Canada
- 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
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?
Table of Contents
187 Pages
- Research Objective and Assumption
- Research Objectives
- Assumptions
- Abbreviations
- Market Preview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snippet, By Lab Type
- Market Snippet, By Testing Services
- Market Snippet, By Diseases
- Market Snippet, By Revenue Source
- Market Snippet, By Country
- Opportunity Map Analysis
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Market Opportunities
- Market Trends
- Product Launch
- Merger and Acquisitions
- Impact Analysis
- PEST Analysis
- Porter’s Analysis
- Diagnostic Testing in Laboratories
- Classification of Laboratories & Diagnostics
- Standards for Medical Diagnostic Laboratories
- Collaboration and Partnership Scenarios
- New Product Launch
- Advance Technologies
- Market Segmentation, By Lab Type, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
- Segment Trends
- Single/Independent Laboratories
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Hospital-Based Labs
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Physician Office Labs
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Others
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Market Segmentation, By Testing Services, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
- Segment Trends
- Physiological Function Testing
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- General & Clinical Testing
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Esoteric Testing
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Specialized Testing
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Non-Invasive Prenatal Testing
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- COVID-19 Testing
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Others
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Market Segmentation, By Diseases, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
- Segment Trends
- Cardiology
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Oncology
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Neurology
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Orthopedics
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Gastroenterology
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Gynecology
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Odontology
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Others
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Market Segmentation, By Revenue Source, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
- Segment Trends
- Healthcare Plan
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Out-of-Pocket
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Public System
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Market Segmentation, By Region, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
- Regional Trends
- North America
- Market Size and Forecast (USD Bn), By Lab Type, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Testing Services, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Diseases, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Revenue Source, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
- U.S.
- Canada
Pricing
Currency Rates
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