North America Clinical Reference Laboratory Market Forecast to 2031
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)
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Description
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.
Summary Info
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According to Business Market Insights’ research, 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, registering a CAGR of 6.5% from 2023 to 2031. Use of artificial intelligence in clinical reference laboratories and strategic initiatives with reference laboratories are among the critical factors attributed to drive the North America clinical reference laboratory market growth.
One of the most significant changes in modern research laboratories is the increasing use of automation. Artificial intelligence (AI) is becoming increasingly important in laboratory medicine. One significant advantage of AI for laboratory professionals is the ability to automate normal and repetitive tasks in the lab. AI can extract data from various sources, including test results and observations from handwritten notes, and populate electronic records, decreasing the need for laboratory personnel to enter data manually. AI effectively provides the opportunity to increase quality, particularly in the pre- and post-analytical phases. AI systems can automatically schedule repairs and maintenance based on past data and usage patterns, preventing equipment breakdowns. Furthermore, AI will accelerate the evolution of personalized medicine. For instance, laboratories can use AI algorithms to analyze genetic sequences and detect disease-causing mutations in patient samples. When paired with patient data such as medical history, lifestyle, and symptoms, this information will enable clinicians to provide more personalized diagnoses and treatment suggestions. AI, machine learning (ML), and data analytics (DA) will soon be integrated into laboratory medicine. Diagnostic laboratories are rapidly digitizing with the installation of laboratory information management systems (LIMS) and research instrument management systems (RIMS). Thus, the advantages related to AI are likely to boost the use of AI and bring new clinical reference laboratory market trends in the coming years.
On the contrary, complications related to regulatory framework and adoption of continuous technological developments hamper the growth of North America clinical reference laboratory market.
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 60.1% market share in 2023, amassing US$ 10,567.09 million. It is projected to garner US$ 17,282.65 million by 2031 to register 6.5% CAGR during 2023-2031.
In terms of application, the North America clinical reference laboratory medicine market is categorized into laboratory medicine, clinical trials, and others. The laboratory medicine segment held 71.1% share of North America clinical reference laboratory market in 2023, amassing US$ 12,491.47 million. It is anticipated to garner US$ 20,256.94 million by 2031 to expand at 6.2% CAGR during 2023-2031.
By country, the North America clinical reference laboratory market is segmented into the US, Canada, and Mexico. Our regional analysis states that the US captured 83.4% share of North America clinical reference laboratory market in 2023. It was assessed at US$ 14,653.42 million in 2023 and is likely to hit US$ 24,519.23 million by 2031, registering a CAGR of 6.6% during 2023-2031.
Key players operating in the North America clinical reference laboratory market are 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, among others.
In May 2023, Proteomics International Laboratories Ltd has signed an exclusive license agreement with Sonic Healthcare USA, a Division of Sonic Healthcare Ltd for the use and commercialization of the Company’s PromarkerD test for diabetic kidney disease in the US. Under the agreement, Sonic Healthcare USA will be offering PromarkerD to physicians and healthcare systems through its client engagement teams across the US.
In April 2024, Quest Diagnostics and Broad Clinical Labs, the world expert in whole genome sequencing (WGS), announced a research collaboration designed to demonstrate the clinical value of WGS as a first-line genetic test for postnatal diagnosis of developmental delay disorders.
o Highlights key business priorities to assist companies to realign their business strategies.
o The key findings and recommendations highlight crucial progressive industry trends in the North America clinical reference laboratory market, thereby allowing players across the value chain to develop effective long-term strategies.
o Develop/modify business expansion plans by using substantial growth offering developed and emerging markets.
o Scrutinize in-depth North America market trends and outlook coupled with the factors driving the North America clinical reference laboratory market, as well as those hindering it.
o Enhance the decision-making process by understanding the strategies that underpin commercial interest with respect to client products, segmentation, pricing, and distribution.
1. Introduction
1.1 The Research Team 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 Research Team
11.2 Glossary of Terms
Table 1. North America Clinical Reference Laboratory Market Segmentation
Table 2. Clinical Reference Market – Revenue and Forecast to 2031 (US$ Million)
Table 3. US: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million) – by Service Provider
Table 4. US: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million) – by Application
Table 5. Canada: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million) – by Service Provider
Table 6. Canada: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million) – by Application
Table 7. Mexico: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million) – by Service Provider
Table 8. Mexico: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million) – by Application
Table 9. Recent Inorganic Growth Strategies in the Clinical Reference Laboratory Market
Table 10. Recent Organic Growth Strategies in the Clinical Reference Laboratory Market
Table 11. Glossary of Terms
Figure 1. North America Clinical Reference Laboratory Market Segmentation, by Country
Figure 2. Clinical Reference Laboratory Market – Key Market Dynamics
Figure 3. Impact Analysis of Drivers and Restraints
Figure 4. Clinical Reference Laboratory Market Revenue (US$ Million), 2021-2031
Figure 5. Clinical Reference Laboratory Market Share (%) – by Service Provider (2023 and 2031)
Figure 6. Hospital-Based: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 7. Standalone: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 8. Clinical-Based: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 9. Clinical Reference Laboratory Market Share (%) – by Application (2023 and 2031)
Figure 10. Laboratory Medicine: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 11. Clinical Trials: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 12. Others: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 13. North America: Clinical Reference Laboratory Market, by Key Country – Revenue (2023) (US$ Million)
Figure 14. North America: Clinical Reference Laboratory Market Breakdown, by Key Countries, 2023 and 2031 (%)
Figure 15. US: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 16. Canada: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 17. Mexico: Clinical Reference Laboratory Market – Revenue and Forecast to 2031 (US$ Million)
Figure 18. Growth Strategies in the Clinical Reference Laboratory Market
The List of Companies – North America Clinical Reference Laboratory Market
o Sonic Healthcare Ltd
o Laboratory Corp of America Holdings
o Quest Diagnostics Inc
o ARUP Laboratories Inc
o Clinical Reference Laboratory Inc
o SYNLAB International GmbH
o Myraid Genetics Inc
o Boca Biolistics LLC
o TOPLAB
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