North America Clinical Reference Laboratory Market Forecast to 2031 - Regional Analysis - by Service Provider (Hospital-Based, Standalone, and Clinic-Based) and Application (Laboratory Medicine, Clinical Trials, and Others)
The North America clinical reference laboratory market was valued at US$ 17,570.05 million in 2023 and is expected to reach US$ 29,104.42 million by 2031; it is estimated to register a CAGR of 6.5% from 2023 to 2031.
Rising Prevalence of Chronic and Infectious Diseases Fuels North America Clinical Reference Laboratory Market
The increasing prevalence of chronic diseases and the emergence and outbreak of various infectious diseases have fueled the demand for novel treatment options and newer therapeutic categories and created the need for better treatment options in existing therapeutic categories. According to the WHO data released in September 2023, noncommunicable diseases (NCDs), including heart disease, cancer, stroke, diabetes, and chronic lung disease, kill 41 million people each year. According to the United Health Foundation, more than 29 million US adults reported having three or more chronic conditions in 2022. Accurate diagnostics are critical for identifying disease biomarkers and detecting organisms, particularly in cancer and tuberculosis. Clinical reference laboratories play an important role in modern healthcare. The reference laboratories provide services for the quick diagnosis of infectious diseases that require specialized laboratory testing equipment and expertise, such as swine flu, hepatitis A and B. These laboratories also offer low-cost diagnostic testing for common chronic conditions such as cancer, diabetes, and cardiovascular disease. During the COVID-19 pandemic, it became evident that medical reference labs are critical for rapid testing, establishing novel techniques, generating and analyzing data, and serving as knowledge hubs. Reference labs are more than just high-volume testing facilities; they are the hubs of expertise and data. Thus, the rising prevalence of infectious and chronic diseases is driving the growth of the clinical reference laboratory market.
North America Clinical Reference Laboratory Market Overview
The US is one of the leading clinical research destinations. Nearly half of the total clinical trials are performed in the US. Additionally, most pharmaceutical research companies choose to perform clinical trials in the US owing to fast approval timelines, a favorable regulatory framework, and established medical infrastructure. Moreover, data generated for clinical trials in the US is accepted globally. According to the World Health Organization (WHO) report in 2021, the US registered the highest number of clinical trials (157,618).
The following table shows the number of clinical trials registered in the US, the number of total patients recruited in them, and the percentage share of the US for the given parameters globally.
2023
Registered Clinical Trial Studies
Patient Recruited in Studies
US
139,632 (31% of the global studies)
20,680 (32% of the worldwide headcount)
Source: ClinicalTrial.gov report
The expanding access of companies through mergers and acquisitions further boosts the growth of the clinical reference laboratory market in the US. For instance, in December 2020, Clinical Reference Laboratory (CRL)-a privately held clinical testing laboratory in the US-acquired Confirm BioSciences, a leading provider of comprehensive screening tools and solutions. Confirm will continue as a subsidiary under its current name. The acquisition expands Confirm's access to lab testing services and R&D capabilities. NCEZID laboratories, Mayo Clinic Laboratories, and CRL are among the leading reference laboratories for clinical trials. The growing number of clinical trials in the US favors the growth of the clinical reference laboratory market in the country.
North America Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million)
North America Clinical Reference Laboratory Market Segmentation
The North America clinical reference laboratory market is categorized into service provider, application, and country.
Based on service provider, the North America clinical reference laboratory market is segmented into hospital-based, standalone, and clinic-based. The hospital-based segment held the largest market share in 2023.
In terms of application, the North America clinical reference laboratory market is categorized into laboratory medicine, clinical trials, and others. The laboratory medicine segment held the largest market share in 2023.
By country, the North America clinical reference laboratory market is segmented into the US, Canada, and Mexico. The US dominated the North America clinical reference laboratory market share in 2023.
Sonic Healthcare Ltd, Laboratory Corp of America Holdings, Quest Diagnostics Inc, ARUP Laboratories Inc, Clinical Reference Laboratory Inc, SYNLAB International GmbH, Myraid Genetics Inc, Boca Biolistics LLC, and TOPLAB are some of the leading companies operating in the North America clinical reference laboratory market.
Rising Prevalence of Chronic and Infectious Diseases Fuels North America Clinical Reference Laboratory Market
The increasing prevalence of chronic diseases and the emergence and outbreak of various infectious diseases have fueled the demand for novel treatment options and newer therapeutic categories and created the need for better treatment options in existing therapeutic categories. According to the WHO data released in September 2023, noncommunicable diseases (NCDs), including heart disease, cancer, stroke, diabetes, and chronic lung disease, kill 41 million people each year. According to the United Health Foundation, more than 29 million US adults reported having three or more chronic conditions in 2022. Accurate diagnostics are critical for identifying disease biomarkers and detecting organisms, particularly in cancer and tuberculosis. Clinical reference laboratories play an important role in modern healthcare. The reference laboratories provide services for the quick diagnosis of infectious diseases that require specialized laboratory testing equipment and expertise, such as swine flu, hepatitis A and B. These laboratories also offer low-cost diagnostic testing for common chronic conditions such as cancer, diabetes, and cardiovascular disease. During the COVID-19 pandemic, it became evident that medical reference labs are critical for rapid testing, establishing novel techniques, generating and analyzing data, and serving as knowledge hubs. Reference labs are more than just high-volume testing facilities; they are the hubs of expertise and data. Thus, the rising prevalence of infectious and chronic diseases is driving the growth of the clinical reference laboratory market.
North America Clinical Reference Laboratory Market Overview
The US is one of the leading clinical research destinations. Nearly half of the total clinical trials are performed in the US. Additionally, most pharmaceutical research companies choose to perform clinical trials in the US owing to fast approval timelines, a favorable regulatory framework, and established medical infrastructure. Moreover, data generated for clinical trials in the US is accepted globally. According to the World Health Organization (WHO) report in 2021, the US registered the highest number of clinical trials (157,618).
The following table shows the number of clinical trials registered in the US, the number of total patients recruited in them, and the percentage share of the US for the given parameters globally.
2023
Registered Clinical Trial Studies
Patient Recruited in Studies
US
139,632 (31% of the global studies)
20,680 (32% of the worldwide headcount)
Source: ClinicalTrial.gov report
The expanding access of companies through mergers and acquisitions further boosts the growth of the clinical reference laboratory market in the US. For instance, in December 2020, Clinical Reference Laboratory (CRL)-a privately held clinical testing laboratory in the US-acquired Confirm BioSciences, a leading provider of comprehensive screening tools and solutions. Confirm will continue as a subsidiary under its current name. The acquisition expands Confirm's access to lab testing services and R&D capabilities. NCEZID laboratories, Mayo Clinic Laboratories, and CRL are among the leading reference laboratories for clinical trials. The growing number of clinical trials in the US favors the growth of the clinical reference laboratory market in the country.
North America Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million)
North America Clinical Reference Laboratory Market Segmentation
The North America clinical reference laboratory market is categorized into service provider, application, and country.
Based on service provider, the North America clinical reference laboratory market is segmented into hospital-based, standalone, and clinic-based. The hospital-based segment held the largest market share in 2023.
In terms of application, the North America clinical reference laboratory market is categorized into laboratory medicine, clinical trials, and others. The laboratory medicine segment held the largest market share in 2023.
By country, the North America clinical reference laboratory market is segmented into the US, Canada, and Mexico. The US dominated the North America clinical reference laboratory market share in 2023.
Sonic Healthcare Ltd, Laboratory Corp of America Holdings, Quest Diagnostics Inc, ARUP Laboratories Inc, Clinical Reference Laboratory Inc, SYNLAB International GmbH, Myraid Genetics Inc, Boca Biolistics LLC, and TOPLAB are some of the leading companies operating in the North America clinical reference laboratory market.
1. INTRODUCTION
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. EXECUTIVE SUMMARY
2.1 North America Key Insights
3. RESEARCH METHODOLOGY
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET - KEY MARKET DYNAMICS
4.1 Market Drivers
4.1.1 Rising Prevalence of Chronic and Infectious Diseases
4.1.2 Increasing Number of Clinical Trials
4.2 Market Restraints
4.2.1 Complications Related to Regulatory Framework and Adoption of Continuous Technological Developments
4.3 Market Opportunities
4.3.1 Strategic Initiatives with Reference Laboratories
4.4 Future Trends
4.4.1 Use of Artificial Intelligence in Clinical Reference Laboratories
4.5 Impact of Drivers and Restraints:
5. CLINICAL REFERENCE LABORATORY MARKET - NORTH AMERICA ANALYSIS
5.1 Clinical Reference Laboratory Market Revenue (US$ Million), 2021-2031
5.2 Clinical Reference Market Forecast and Analysis
6. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET ANALYSIS - BY SERVICE PROVIDER
6.1 Overview
6.2 Hospital-Based
6.2.1 Overview
6.2.2 Hospital-Based: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
6.3 Standalone
6.3.1 Overview
6.3.2 Standalone: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
6.4 Clinical Based
6.4.1 Overview
6.4.2 Clinical-Based: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
7. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET ANALYSIS - BY APPLICATION
7.1 Overview
7.2 Laboratory Medicine
7.2.1 Overview
7.2.2 Laboratory Medicine: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
7.3 Clinical Trials
7.3.1 Overview
7.3.2 Clinical Trials: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
7.4 Others
7.4.1 Overview
7.4.2 Others: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET - COUNTRY ANALYSIS
8.1 North America
8.1.1 North America: Clinical Reference Laboratory Market Breakdown, by Key Country, 2023 and 2031 (%)
8.1.1.1 US: Clinical Reference Laboratory Market - Overview
8.1.1.2 US: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8.1.1.2.1 US: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million), by Service Provider
8.1.1.2.2 US: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Application
8.1.1.3 Canada: Clinical Reference Laboratory Market - Overview
8.1.1.4 Canada: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8.1.1.4.1 Canada: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Service Provider
8.1.1.4.2 Canada: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Application
8.1.1.5 Mexico: Clinical Reference Laboratory Market - Overview
8.1.1.6 Mexico: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8.1.1.6.1 Mexico: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Service Provider
8.1.1.6.2 Mexico: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Application
9. CLINICAL REFERENCE LABORATORY MARKET-INDUSTRY LANDSCAPE
9.1 Overview
9.2 Growth Strategies in the Clinical Reference Laboratory Market
9.3 Inorganic Growth Strategies
9.3.1 Overview
9.4 Organic Growth Strategies
9.4.1 Overview
10. COMPANY PROFILES
10.1 Sonic Healthcare Ltd
10.1.1 Key Facts
10.1.2 Business Description
10.1.3 Products and Services
10.1.4 Financial Overview
10.1.5 SWOT Analysis
10.1.6 Key Developments
10.2 Laboratory Corp of America Holdings
10.2.1 Key Facts
10.2.2 Business Description
10.2.3 Products and Services
10.2.4 Financial Overview
10.2.5 SWOT Analysis
10.2.6 Key Developments
10.3 Quest Diagnostics Inc
10.3.1 Key Facts
10.3.2 Business Description
10.3.3 Products and Services
10.3.4 Financial Overview
10.3.5 SWOT Analysis
10.3.6 Key Developments
10.4 ARUP Laboratories Inc
10.4.1 Key Facts
10.4.2 Business Description
10.4.3 Products and Services
10.4.4 Financial Overview
10.4.5 SWOT Analysis
10.4.6 Key Developments
10.5 Clinical Reference Laboratory Inc
10.5.1 Key Facts
10.5.2 Business Description
10.5.3 Products and Services
10.5.4 Financial Overview
10.5.5 SWOT Analysis
10.5.6 Key Developments
10.6 SYNLAB International GmbH
10.6.1 Key Facts
10.6.2 Business Description
10.6.3 Products and Services
10.6.4 Financial Overview
10.6.5 SWOT Analysis
10.6.6 Key Developments
10.7 Myraid Genetics Inc
10.7.1 Key Facts
10.7.2 Business Description
10.7.3 Products and Services
10.7.4 Financial Overview
10.7.5 SWOT Analysis
10.7.6 Key Developments
10.8 Boca Biolistics LLC
10.8.1 Key Facts
10.8.2 Business Description
10.8.3 Products and Services
10.8.4 Financial Overview
10.8.5 SWOT Analysis
10.8.6 Key Developments
10.9 TOPLAB
10.9.1 Key Facts
10.9.2 Business Description
10.9.3 Products and Services
10.9.4 Financial Overview
10.9.5 SWOT Analysis
10.9.6 Key Developments
11. APPENDIX
11.1 About The Insight Partners
11.2 Glossary of Terms
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. EXECUTIVE SUMMARY
2.1 North America Key Insights
3. RESEARCH METHODOLOGY
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET - KEY MARKET DYNAMICS
4.1 Market Drivers
4.1.1 Rising Prevalence of Chronic and Infectious Diseases
4.1.2 Increasing Number of Clinical Trials
4.2 Market Restraints
4.2.1 Complications Related to Regulatory Framework and Adoption of Continuous Technological Developments
4.3 Market Opportunities
4.3.1 Strategic Initiatives with Reference Laboratories
4.4 Future Trends
4.4.1 Use of Artificial Intelligence in Clinical Reference Laboratories
4.5 Impact of Drivers and Restraints:
5. CLINICAL REFERENCE LABORATORY MARKET - NORTH AMERICA ANALYSIS
5.1 Clinical Reference Laboratory Market Revenue (US$ Million), 2021-2031
5.2 Clinical Reference Market Forecast and Analysis
6. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET ANALYSIS - BY SERVICE PROVIDER
6.1 Overview
6.2 Hospital-Based
6.2.1 Overview
6.2.2 Hospital-Based: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
6.3 Standalone
6.3.1 Overview
6.3.2 Standalone: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
6.4 Clinical Based
6.4.1 Overview
6.4.2 Clinical-Based: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
7. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET ANALYSIS - BY APPLICATION
7.1 Overview
7.2 Laboratory Medicine
7.2.1 Overview
7.2.2 Laboratory Medicine: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
7.3 Clinical Trials
7.3.1 Overview
7.3.2 Clinical Trials: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
7.4 Others
7.4.1 Overview
7.4.2 Others: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8. NORTH AMERICA CLINICAL REFERENCE LABORATORY MARKET - COUNTRY ANALYSIS
8.1 North America
8.1.1 North America: Clinical Reference Laboratory Market Breakdown, by Key Country, 2023 and 2031 (%)
8.1.1.1 US: Clinical Reference Laboratory Market - Overview
8.1.1.2 US: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8.1.1.2.1 US: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million), by Service Provider
8.1.1.2.2 US: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Application
8.1.1.3 Canada: Clinical Reference Laboratory Market - Overview
8.1.1.4 Canada: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8.1.1.4.1 Canada: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Service Provider
8.1.1.4.2 Canada: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Application
8.1.1.5 Mexico: Clinical Reference Laboratory Market - Overview
8.1.1.6 Mexico: Clinical Reference Laboratory Market - Revenue and Forecast to 2031 (US$ Million)
8.1.1.6.1 Mexico: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Service Provider
8.1.1.6.2 Mexico: Clinical Reference Laboratory Market Revenue and Forecast to 2031 (US$ Million), by Application
9. CLINICAL REFERENCE LABORATORY MARKET-INDUSTRY LANDSCAPE
9.1 Overview
9.2 Growth Strategies in the Clinical Reference Laboratory Market
9.3 Inorganic Growth Strategies
9.3.1 Overview
9.4 Organic Growth Strategies
9.4.1 Overview
10. COMPANY PROFILES
10.1 Sonic Healthcare Ltd
10.1.1 Key Facts
10.1.2 Business Description
10.1.3 Products and Services
10.1.4 Financial Overview
10.1.5 SWOT Analysis
10.1.6 Key Developments
10.2 Laboratory Corp of America Holdings
10.2.1 Key Facts
10.2.2 Business Description
10.2.3 Products and Services
10.2.4 Financial Overview
10.2.5 SWOT Analysis
10.2.6 Key Developments
10.3 Quest Diagnostics Inc
10.3.1 Key Facts
10.3.2 Business Description
10.3.3 Products and Services
10.3.4 Financial Overview
10.3.5 SWOT Analysis
10.3.6 Key Developments
10.4 ARUP Laboratories Inc
10.4.1 Key Facts
10.4.2 Business Description
10.4.3 Products and Services
10.4.4 Financial Overview
10.4.5 SWOT Analysis
10.4.6 Key Developments
10.5 Clinical Reference Laboratory Inc
10.5.1 Key Facts
10.5.2 Business Description
10.5.3 Products and Services
10.5.4 Financial Overview
10.5.5 SWOT Analysis
10.5.6 Key Developments
10.6 SYNLAB International GmbH
10.6.1 Key Facts
10.6.2 Business Description
10.6.3 Products and Services
10.6.4 Financial Overview
10.6.5 SWOT Analysis
10.6.6 Key Developments
10.7 Myraid Genetics Inc
10.7.1 Key Facts
10.7.2 Business Description
10.7.3 Products and Services
10.7.4 Financial Overview
10.7.5 SWOT Analysis
10.7.6 Key Developments
10.8 Boca Biolistics LLC
10.8.1 Key Facts
10.8.2 Business Description
10.8.3 Products and Services
10.8.4 Financial Overview
10.8.5 SWOT Analysis
10.8.6 Key Developments
10.9 TOPLAB
10.9.1 Key Facts
10.9.2 Business Description
10.9.3 Products and Services
10.9.4 Financial Overview
10.9.5 SWOT Analysis
10.9.6 Key Developments
11. APPENDIX
11.1 About The Insight Partners
11.2 Glossary of Terms
