The global clinical laboratory tests market size was valued at USD 115.19 billion in 2023 and is anticipated to reach around USD 258.57 billion by 2033, growing at a CAGR of 9.4% from 2024 to 2033.
The clinical laboratory tests market is witnessing growth due to factors such as the rising geriatric population, growing prevalence of target diseases, and introduction of innovative solutions to meet the growing demand of market for clinical lab testing. The increasing prevalence of diseases such as cardiovascular diseases and diabetes is expected to be a significant driver of market growth over the forecast period.
According to the WHO, globally cardiovascular diseases cause approximately 17.9 million deaths each year, primarily due to heart disease and stroke as of 2021. Additionally, the prevalence of diabetes is constantly increasing, creating a substantial patient pool for the clinical laboratory test market. Drastic lifestyle changes, such as a growing number of smokers globally, rising obesity rates, and dietary irregularities, are major contributors to the high global prevalence of cardiovascular diseases. The added risk of developing cardiovascular conditions due to SARS-CoV-2 emphasizes the significant use of clinical laboratory tests for risk stratification. The increasing disease burden indicates market growth during the forecasted period.
According to WHO, life expectancy is now exceeding 80 years in most developed economies. Aging is influenced by the interaction of several environmental and genetic factors that affect immunity and metabolism, affecting the function of organs, and is characterized as a substantial risk factor for infectious disease development. The general purpose of clinical laboratory tests is to assist in identifying signs of nutrient deficiencies, detecting changes in health, evaluating bodily functions such as those of the kidney, liver, or thyroid, and monitoring the progression of treatment or disease. Thus, screening and diagnostics can play important role in the management of overall health. Thus, with an increase in the geriatric population, the need for acute and long-term healthcare is also rising, thereby driving the growth of market globally.
Moreover, introduction of innovative solutions for maximizing efficiency and minimizing errors is expected to serve this market as a high-impact rendering driver. Integrated workflow management systems, database management tools, and patient test records are gaining importance in healthcare industry with companies processing as many as 100 to 150 billion samples per year. Implementation and development of data management and informatics solutions for facilitating smooth operations are expected to drive the growth of this market. Additionally, technological innovation is expected to reduce the cost of tests in clinical medical laboratories.
However, the market growth is being restrained by the ambiguous regulatory framework associated with clinical laboratory tests. The healthcare industry is largely dependent upon regulatory frameworks established by organizations such as the U.S. FDA and EMA. There are no clear regulatory guidelines for diagnostic sector in developing countries such as China and India. The FDA has authority of regulation over laboratory-developed tests that refer to delivering efficient and rapid results and in-house clinical laboratories developing tests. Risks associated with LDTs may have a negative effect on profit margins and may lead to delays in commercialization of newly developed tests.
| Report Attribute | Details |
| Market Size in 2024 | USD 126.02 Billion |
| Market Size by 2033 | USD 258.57 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 9.4% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Type, end-use, region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Quest Diagnostics Incorporated., Abbott, Cinven, Laboratory Corporation of America Holdings, ARUP Laboratories, OPKO Health, Inc., UNILABS, Clinical Reference Laboratory, Inc., Synnovis Group LLP, Sonic Healthcare Limited. |
The U.S. Clinical Laboratory Tests market size was exhibited at USD 39.59 Billion in 2023 and is projected to hit around USD 98.71 Billion by 2033, growing at a CAGR of 9.6% during the forecast period 2024 to 2033.
North America held largest share of market in 2023 with a share of 49.01% and is expected to maintain its dominant position, in terms of share, throughout the forecast period. This can be attributed to the increasing geriatric population, rising prevalence of chronic diseases such as cancer, and high market penetration of technologically advanced diagnostic techniques are expected to drive market growth over the forecast period. According to the American Cancer Society, cancer is one of the leading causes of death in North America. The most commonly diagnosed cancers are prostate cancer in men and breast cancer in women. Increasing preference for novel approaches and rising patient awareness levels are also expected to drive the regional market. Moreover, key players are now focusing on improvised and software-enabled automated diagnostic systems that help in managing and processing hundreds of samples at a time and obtaining accurate results. Moreover, clinical laboratory tests save costs, lives, and time by enabling early detection and prevention of disease with U.S. performing more than 7 billion clinical lab tests per year.
Asia Pacific is estimated to show the fastest growth in clinical laboratory tests market over the forecast period. The growth of the market in the region is due to the presence of huge untapped opportunities in the form of unmet medical needs, increasing avenues of scientific research, rising awareness about bleeding disorder testing, and positive economic growth. Asia Pacific region comprises over one-third of the global population and has been affected the most by the COVID-19 pandemic. Due to this, clinical laboratories have gained importance owing to their crucial role in conducting tests. China and India have conducted the highest number of tests for SARS-CoV-2. However, testing capacity needs to increase to fulfill the unmet needs in the clinical laboratory segment.
There are various types of clinical laboratory tests such as HGB/ HCT testing, basic metabolic panel testing, BUN creatinine testing, electrolytes testing, HbA1c testing, comprehensive metabolic panel testing, liver panel testing, renal panel testing, lipid panel testing, and cardiovascular panel tests among others. HbA1c tests segment held the largest share of 13.09% in 2023. The rise in patient population with diabetes and cholesterol abnormalities is anticipated to propel segment growth as patients with fluctuations in HbA1c increase the risk of complications related to diabetes. Moreover, launch of newer laboratory tests is expected to further propel the market growth. For instance, in October 2023, Healthyr launched six at-home tests available at Walmart, making them the first to offer at-home dried blood spot tests in physical Walmart stores. The tests cover general health, cholesterol, HbA1c + glucose, thyroid, cholesterol and blood sugar, and STI. Such novel launches enable better access to a wide range of laboratory blood testing for evaluating sugar levels. In addition, in April 2023, FIND partnered with Abbott, i-SENS Inc, and Siemens Healthineers to enhance access to HbA1c testing for diabetes in low- and middle-income countries. The initiative aims to offer affordable point-of-care test kits, addressing limited access and improving diagnosis and management in these regions. Such initiatives by key players contribute to market expansion and growth during the forecasted period.
HGB/HCT tests segment is expected to show fastest growth rate over the forecast period. The growth of the segment is attributed to the occurrence of anemia and blood-related diseases among the population.The test is used to diagnose the presence of anemia or polycythemia. HGB/HCT test is also performed to monitor the drug responses and make decisions pertaining to blood transfusions or evaluation of dehydration. Increasing incidence rate of anemia & other blood disorders and introduction of noninvasive & technologically advanced products are expected to drive market growth during the forecast period.
Central laboratories segment held the largest share of clinical laboratory tests market in 2023. The dominance of the segment is attributed to theprocedure volumes and high market penetration. An increasing number of initiatives carried out by government to provide various services, such as reimbursement for clinical laboratory tests, is another major factor anticipated to drive the market. Many healthcare institutions are working with laboratories to integrate different tests, such as microbiology testing. Moreover, large number of laboratories in emerging and underdeveloped economies can be accounted for a large share. Furthermore, regulatory authorities are undertaking initiatives to improve laboratory services and ease the process of diagnosis.
Primary clinics segment is expected to show fastest growth over the forecast period. Primary clinics include standalone laboratories, laboratories in physician clinics & primary healthcare centers receiving samples directly from physicians, clinical research centers, and insurance companies. The test is made available to patients immediately with ease and the result is obtained quickly by care team, physician, and patients, enabling them to take clinical management decisions spontaneously. They provide a smaller test portfolio than hospital-based or standalone laboratories. These laboratories cater to the needs of a few specialties, and, hence, have a small share of revenue. Though these are smaller contributors, they are expected to make consistent contributions to market growth.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Clinical Laboratory Tests market.
By Type
By End-use
By Region
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
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Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers