North America Clinical Laboratory Test Market Size was valued at USD 19.54 Billion in 2023. The North America Clinical Laboratory Test market industry is projected to grow from USD 20.98 Billion in 2024 to USD 34.6 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 6.45% during the forecast period (2024 - 2032). Increased support from the government and a rise in capital expenditure for the development of healthcare facilities are the key market drivers enhancing market growth.
Neurocode USA, Inc., a specialized clinical laboratory that provides world-class neurological disorder testing solutions, is pleased to announce the clinical launch of ALZpath Dx, a novel blood test that diagnoses, screens, and monitors Alzheimer's disease (AD) based on blood pTau217 levels. Neurocode is the first US laboratory to provide this test as a Laboratory Developed Test (LDT) for clinical diagnostics, clinical trials, and research.
The pioneering Neurocode test analyzes phosphorylated tau at location 217. pTau217 is being touted as the most transformative blood-based biomarker that will enable earlier and more accurate AD diagnosis, better patient stratification for clinical trials, better patient care and treatment, and greater diagnostic specificity and sensitivity. Quanterix Corp.'s Simoa ® single-molecule assay powers the test.
The ALZpath Dx test is more scalable, accessible, and less intrusive for diagnosing individuals in early stages of the illness, when recently-approved disease-modifying medicines are most useful. Neurocode Medical Director Ryan Fortna, MD PhD, said patients and their families have unparalleled access to early, accurate diagnosis and quick treatment. "Additionally, this blood-based test is as accurate as brain imaging or CSF testing, but is faster, more accessible, less expensive, and less invasive, and it does not require radiation exposure."
ALZpath reported the findings of a 786-patient worldwide peer-reviewed research in JAMA Neurology testing their ALZpath Dx assay. All cohorts exhibited great diagnosis accuracy with the ultra-sensitive immunoassay for brain amyloid. It was more accurate than other blood-based biomarker combinations and comparable to spinal tap biomarkers. It accurately predicted AD brain pathology (amyloid-beta plaques and tau tangles) as detected by PET imaging, the gold standard diagnosis method.
Neurocode is the first CAP-accredited, CLIA-certified lab to provide the ALZpath Dx test for clinical usage. Their validation study tested over 1,700 samples with amyloid PET imaging and 150 subjects with post-mortem (autopsy) pathology. The AUC was 0.94, exceeding the Alzheimer's Association Workgroup's 2023 draft proposal for the Revised Criteria for Diagnosis and Staging of Alzheimer's Disease's 90% accuracy threshold for a standalone diagnostic AD test.
Market CAGR for North American clinical laboratory test market is being grown due to rising healthcare expenditures. Expanding regulatory backing and increased spending in clinical laboratory tests are expected to propel the market. The economies of North America are sophisticated, and there are strict regulations governing the approval of new tests. The FDA has authorized these experiments in accordance with the 510(k) medical device rule. Panel tests conducted on instruments must go through a similar FDA approval procedure in order to be authorized for commercialization. In Canada, these tests must have approval from Health Canada.
The market is expanding due to the result of favorable regulatory policies and high insurance coverage (almost 100%). If these tests are quickly invoiced to insurance providers, it is simpler for patients to estimate expenses. Urinalysis,
, and screening checks are covered by Medicaid. However, local hospital costs are more expensive than the price of tests.
Obesity and diabetes, which both raise illness risk and lead to metabolic imbalances, are two diseases for which aging has emerged as a prominent risk factor. The demand for clinical laboratory testing is expected to rise as a result. The majority of affluent countries now have life expectancies above 80 years, according to the World Health Organization. Aging is a vital risk factor for the emergence of infectious diseases because it is driven by the connection of numerous environmental and genetic factors that modify immunity, metabolism, and organ functions. Consequently, diagnostics and screening can be quite important in the overall management of health. The market for clinical laboratory testing is being driven by the increase in the worldwide geriatric population as well as the demand for acute and long-term healthcare. Thus, driving the North America Clinical Laboratory Test market revenue.
The North America Clinical Laboratory Test market segmentation, based on the type of laboratory includes Hospital-based, Central/Independent, Physician Office Laboratory, and Others. Over the projection period, the segment for central/independent laboratories is anticipated to increase at the quickest rate. The strong market penetration and procedure volumes are credited with the segment's growth. Another significant factor projected to propel the market is the rising number of efforts adopted by governments to offer various services, such as reimbursement for clinical laboratory testing.
The North America Clinical Laboratory Test market segmentation, based on type of test, includes CBC and Routine Blood Test, Anatomic Pathology, Molecular Test, Immunology Test, Drug Test, and Others. The molecular test category had the biggest revenue share and is anticipated to hold onto the top spot for the duration of the forecast. Additional factors driving the growth of the molecular testing market include the increasing prevalence of lifestyle-related disorders, including diabetes, high blood pressure, also growing public awareness of advanced clinical laboratory tests.
By region, the study provides the market insights into North America. The North American North America Clinical Laboratory Test market area will dominate this market, owing to an increase in the count of geriatric population. In addition, the growing spread of chronic diseases like cancer will boost market growth in this region. US held the fastest growth while Canada is expected to register fastest CAGR over the projected period.
The FDA and EMA's regulatory frameworks are extremely important to the US’s healthcare sector. Laboratory-designed tests (LDTs), which are tests developed internally by clinical laboratories that deliver accurate and quick findings, are governed by the Food and Drug Administration (FDA). The mentioned factors are expediting the growth of US Clinical Laboratory Test Market.
The Canada clinical laboratory test Market is expanding as more people become aware of the value of early disease identification and the advantages of early treatment. Some of the government measures that are to blame for the growth of the Canadian clinical diagnostics industry include the federal government's proposed Bill C-17 in the House of Commons, which would grant provinces and territories an additional $2 Bn as a one-time top-up, split evenly by population.
Further, the major countries studied in the market report are The US, and Canada.
Leading market players are aggressively adopting new business tactics to extend their product offerings, which will help the North America Clinical Laboratory Test market, grow faster. Market participants are also undergoing a range of strategic activities to expand their  presence, with important market developments including new product developments, contracts & agreements, mergers & acquisitions, increased investments, & collaboration with other similar organizations. To expand and survive in a more competitive and rising market climate, North America Clinical Laboratory Test industry must offer cost-effective items.
Manufacturing locally to minimize capital requirements is one of the key business tactics used by manufacturers in the North America Clinical Laboratory Test industry to benefit clients and increase the market sector. In recent years, the North America Clinical Laboratory Test industry has offered some of the most significant advantages to medicine. Major players in the North America Clinical Laboratory Test market, including Aurora Diagnostics, Laboratory Corporation of America, LifeLabs Medical Laboratories, Quest Diagnostics, and others, are attempting to enhance market demand by investing in research and development operations.
Quest Diagnostics Inc. (Quest Diagnostics) offers diagnostic information services to patients and physicians through a network of laboratories and business-owned patient service centers. It provides a variety of services, including anatomic pathology, clinical trial testing, life insurer services,
, gene-based testing, and other specialized tests, as well as a range of medical information technology and diagnostic devices. Among others, Quest Diagnostics offers its services to hospitals, clinics, managed care organizations, other health insurance companies, laboratories, and governmental organizations. In February 2023, Cleveland Diagnostics, Inc., a biotechnology business in commercial development that creates next-generation diagnostic tests for the early diagnosis of malignancies, today announced a deal intended to increase patient access to the firm's cutting-edge IsoPSA prostate cancer test. Patients will be able to access IsoPSA through an agreement with Quest Diagnostics (NYSE DGX), the country's top provider of diagnostic information services, and, after receiving a prescription from their doctor, provide a blood sample for testing at one of more than 2,100 Quest Diagnostics patient service centre locations nationwide.
Laboratory Corp of America Holdings (LabCorp) offers Clinical laboratory services and complete drug development assistance. It is concentrated on the creation and marketing of various diagnostic technologies and testing services. The business provides clinical diagnostics laboratory services, including standard, genomic, and specialized tests. Forensic identity services, clinical trials services, drug testing services, deoxyribonucleic acid (DNA) identification services, paternity testing services, general and specialty laboratory testing, bone marrow and human leukocyte antigen (HLA) testing, patient services, personalized medicine, and hospital services are just a few of the services it offers. Through Covance, it also provides medication development services. Through a network of primary laboratories and patient care facilities, it provides services to managed care organizations, physicians, hospitals, government agencies, and biotechnology and pharmaceutical businesses. In May 2022, AtlantiCare, the largest healthcare provider in southern New Jersey, and Labcorp (NYSE LH), a top  life sciences firm, announced today that they have completed a transaction to deepen their long-term strategic partnership. Select assets from AtlantiCare's clinical outreach business, which serves the patients of the AtlantiCare Physician Group and Affiliated Physicians throughout southern New Jersey, will be acquired by Labcorp. The deal is the latest in a string of fresh and expanded partnerships between Labcorp and health systems around the nation, highlighting the value Labcorp contributes to enhancing patient care and laboratory services.
| Attribute/Metric | Details |
| Market Size 2023 | USD 19.54 Billion |
| Market Size 2024 | USD 20.98 Billion |
| Market Size 2032 | USD 34.6 Billion |
| Compound Annual Growth Rate (CAGR) | 6.45% (2024-2032) |
| Base Year | 2023 |
| Market Forecast Period | 2024-2032 |
| Historical Data | 2018- 2022 |
| Market Forecast Units | Value (USD Billion) |
| Report Coverage | Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | Type of Test, Type of Laboratory, and Region |
| Geographies Covered | North America |
| Countries Covered | The US, Canada |
| Key Companies Profiled | Aurora Diagnostics, Laboratory Corporation of America, LifeLabs Medical Laboratories, Quest Diagnostics |
| Key Market Opportunities | Growing number of chronic diseases |
| Key Market Dynamics | Increase in health-related expenditures and government support |
Frequently Asked Questions (FAQ) :
The North America Clinical Laboratory Test market size was valued at USD 19.54 Billion in 2023.
The market is projected to grow at a CAGR of 6.45% during the forecast period, 2024-2032.
North America had the largest share in the market
The key players in the market are Aurora Diagnostics, Laboratory Corporation of America, LifeLabs Medical Laboratories, Quest Diagnostics.
The central/independent category dominated the market in 2022.
The molecular test had the largest share in the market.
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Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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