North America Clinical Laboratory Tests Market Size & Outlook, 2025-2033

Market Overview

The North America clinical laboratory tests market size was valued at USD 20.28 billion in 2024 and is projected to reach from USD 21.72 billion in 2025 to USD 37.61 billion by 2033, growing at a CAGR of 7.1% during the forecast period (2025-2033). 

Clinical laboratories are healthcare institutions that provide physicians with a variety of laboratory tests, such as blood, urine, and other bodily fluid samples, to aid in the diagnosis, treatment, and management of patients. In these laboratories, medical technologists (clinical laboratory scientists) are trained to conduct a variety of tests on patients' biological specimens. The majority of clinical laboratories are situated within or close to hospital facilities to facilitate physician and patient access.

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Market Dynamics

North America Clinical Laboratory Tests Market Drivers

The largest market share for clinical laboratory tests was held by North America, and it is anticipated that this dominance will persist throughout the forecast period. The market is anticipated to be fueled by expanding regulatory support and rising investments in clinical laboratory tests. North America has advanced economies and a stringent regulatory framework for the approval of new tests. Under the 510(k) medical device regulation, the FDA has approved these tests. In order to be approved for commercialization, panel tests performed on instruments must undergo a similar FDA clearance process. Health Canada is responsible for approving these tests within Canada.

The market is expanding as a result of the high insurance coverage (nearly one hundred per cent) and the favorable regulatory measures. It is easier for patients to estimate costs when these tests are immediately billed to insurance companies. Medicaid provides coverage for urinalysis, blood tests, and screening exams. However, hospital fees in the area are higher than the cost of tests.

Ageing has become a significant risk factor for a variety of diseases, including obesity and diabetes, which both increase disease risk and cause metabolic imbalances. It is anticipated that the demand for clinical laboratory testing will increase as a result. According to the World Health Organization, life expectancy has surpassed 80 years in the majority of developed nations. Controlled by the interaction of multiple environmental and genetic factors that alter immunity, metabolism, and organ functions, ageing is a major risk factor for the development of infectious diseases. Consequently, screening and diagnostics can play a significant role in the overall management of health. As the global geriatric population grows, so does the demand for acute and long-term healthcare, driving the market for clinical laboratory testing.

The rising prevalence of lifestyle-related diseases such as obesity, the trend of smoking, and an unhealthy diet are among the factors contributing to the rise in renal and lipid-related disorders. In addition, as the incidence of diabetes rises, the number of patients requiring clinical laboratory tests increases. Increased sedentary behavior could lead to an increase in the prevalence of several metabolic diseases. In addition, according to the American Thyroid Association, 20 million people in the United States suffer from thyroidal imbalance. In the vast majority of nations, hormonal imbalance is a growing concern. Consequently, the market for clinical laboratory tests is anticipated to expand at a healthy rate throughout the period covered by this forecast.

Also likely to drive the market are hormone-dependent ageing disorders. According to the NCBI, the decline in female sex hormones following menopause is associated with disease and incapacity in older women. In 2016, approximately 27 million American women went through menopause, with that number rising to 31 million in 2018. This rise in target diseases is anticipated to fuel market expansion over the forecast period. The increased number of clinical laboratory tests can also be attributed to the increased awareness of certain diseases. In addition, the industry is supported by easy access to workplace testing and insurance-based exams.

North America Clinical Laboratory Tests Market Restraints

In the United States, the healthcare industry is highly dependent on regulatory frameworks established by the FDA and EMA. The Food and Drug Administration (FDA) regulates laboratory-designed tests (LDTs), which are tests created in-house by clinical laboratories that provide accurate and timely results. The risks associated with LDTs could reduce profit margins and cause marketing delays for newly designed tests. This factor is inhibiting the expansion of the clinical laboratory test market.

The spread of COVID-19 had a substantial impact on the healthcare and testing industries. The pandemic negatively impacted the clinical laboratory test market. In 2020, Lab Corporation, for instance, experienced an 8.9 per cent decline in total sales. This may be the result of a decline in routine health checkups during the pandemic, which led to a decrease in the number of clinical chemistry tests performed.

North America Clinical Laboratory Tests Market Opportunities

Innovative strategies for maximizing productivity and eradicating errors are anticipated to serve as a major rendering driver in this industry. Integrated workflow management systems, database management tools, and patient test records are gaining importance in the healthcare industry as organizations process between 100 and 150 billion samples annually. It is anticipated that the market will expand as a result of the implementation and development of data management and informatics solutions for supporting efficient operations.

In addition, the market is anticipated to expand during the forecast period as a result of the rising adoption of laboratory automation systems. Automation's advantages, such as its capacity to improve efficacy, reduce errors, and increase patient safety by combining mechanical, electronic, and informatics technologies, are anticipated to fuel market growth.

Regional Analysis

Segmental Analysis

Impact of Covid-19

List of key players in North America Clinical Laboratory Tests Market

1. Abbott
2. Quest Diagnostics
3. Laboratory Corporation of America
4. ARUP Laboratories

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Recent Developments

• ARUP Healthcare Advisory Services is the new name for the specialized team of healthcare advisors at ARUP Laboratories as of March 2022. The new name, which replaces Consultative Services, more accurately reflects the vast array of services the team can provide to ARUP's current and prospective clients, such as lab stewardship, revenue cycle, quality management, lab operations, and business strategy solutions, among others.
• Laboratory Corporation of America (NYSE: LH) declared a quarterly dividend of $0.72 per share in April 2022.
• April 2022 - The Secaucus, New Jersey-based Quest Diagnostics has announced a number of organizational changes and senior leadership appointments to better support the company's two-point business strategy of accelerating growth and driving operational excellence.