Clinical Laboratory Tests Market Size, Share & Trends Analysis Report By Test Type (Clinical Chemistry Tests, Hematology Tests, Microbiology Tests, Immunology Tests, Molecular Diagnostics, Urinalysis), By End-User (Hospitals, Diagnostic Laboratories, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global clinical laboratory tests market size was valued at USD 136.78 billion in 2023 and is expected to exhibit a CAGR of 6.49%, generating a revenue of USD 398.90 billion by 2032.

 Clinical laboratories are healthcare institutions that offer a variety of laboratory tests such as samples of blood, urine, or other bodily fluids to assist physicians with patient diagnosis, treatment, and management. Medical technologists (clinical laboratory scientists) work in these labs and are educated to perform numerous tests on samples of biological specimens gathered from patients. The majority of clinical laboratories are located within or near hospital facilities to enable access to physicians and their patients.

Market Dynamics

Clinical Laboratory Tests Market Drivers

Rapidly-Growing Geriatric Population

Globally, the geriatric population is growing swiftly. According to UN projections, there were around 727 million individuals aged 65 and up in the world in 2020. Furthermore, by 2050, the number of people aged 80 and up is expected to double to nearly 1.5 billion. Aging has become a significant risk factor for various diseases, including obesity and diabetes, both of which raise disease risk and cause metabolic imbalances. The need for clinical laboratory testing is expected to increase due to this.

According to the World Health Organization, life expectancy in most developed economies has surpassed 80 years. Aging is controlled by the interaction of various environmental and genetic factors that alter immunity, metabolism, and organ functions and is regarded as a significant risk factor for the development of infectious diseases. As a result, screening and diagnostics can play an important role in overall health management. As the world's geriatric population grows, so does the demand for acute and long-term healthcare, propelling the clinical laboratory testing market worldwide.

The most critical risk factor in the development of disorders like cardiovascular disease and renal impairment is aging. The expanding geriatric population is expected to be a high-impact driving force for this market over the projected period. Furthermore, during the projected period, an increasing geriatric population in Asian countries such as Japan, India, and China, along with vast unexplored prospects, is expected to fuel market expansion. According to estimates, more than 20% of Japan's population is over 65 years old. Furthermore, the market is being driven by the increased availability of clinical tests.

Growing Prevalence of Target Diseases

Over the forecast period, the market is expected to benefit from the rising prevalence of target diseases such as cardiovascular disease and diabetes. Cardiovascular disorders are the biggest cause of death around the world. Unmet medical needs related to cardiovascular illnesses and increased patient awareness are projected to drive demand for point-of-care lipid testing. According to the World Health Organization, cardiovascular illnesses will be the leading cause of mortality and morbidity in 2021. 17.7 million people have died from cardiovascular diseases in the last three decades, accounting for 31% of fatalities globally.

The rising prevalence of lifestyle-related diseases such as obesity, the global trend of smoking, and an unhealthy diet are among the causes contributing to the worldwide increase in the incidence of renal and lipid-related disorders. Furthermore, as the global prevalence of diabetes rises, the patient pool requiring clinical laboratory tests expands.

Sedentary behavior contributes to the prevalence of several metabolic illnesses. Hormone imbalances resulting from lifestyle changes are becoming more of a problem. Sexual and thyroid hormone imbalances are among these issues. According to the BMC Journal, in 2020, hypothyroidism affected 5.3% of Europeans, whereas hyperthyroidism affected 1.3%. 

The market is also likely to be driven by hormone-dependent aging disorders. According to NCBI, reducing female sex hormones after menopause is linked to disease and incapacity in older women. In 2016, approximately 27 million women in the United States went through menopause, rising to 31 million in 2018. This increase in target diseases is expected to drive market growth during the forecast period. The increased number of tests performed in clinical laboratories can also be linked to rising awareness of certain illnesses. Furthermore, the industry is fueled by simple access to workplace testing and insurance-based examinations.

Clinical Laboratory Tests Market Restraints

Ambiguous Regulatory Framework

The healthcare business is heavily reliant on regulatory frameworks set by organizations like the FDA and EMA in the United States. In emerging countries like China and India, there are no precise regulatory requirements for the diagnostic business. The FDA regulates laboratory-designed tests (LDTs), which are tests created in-house clinical laboratories that provide accurate and timely findings. The risks associated with LDTs could reduce profit margins and cause delays in the marketing of newly designed tests. This factor is hindering the market growth of the global clinical laboratory tests market.

Clinical Laboratory Tests Market Opportunities

Innovative Solutions in Clinical Laboratory Tests

Innovative solutions for optimizing efficiency and eliminating errors are predicted to serve as a high-impact rendering driver in this industry. With organizations processing 100 to 150 billion samples each year, integrated workflow management systems, database management tools, and patient test records are becoming increasingly important in the healthcare industry. The market is predicted to rise due to the implementation and development of data management and informatics solutions for supporting smooth operations.

In addition, the market is likely to grow during the forecast period due to the increasing implementation of laboratory automation systems. DASA, for example, uses Siemens' technology to provide higher-quality treatment throughout Brazil. Automation's benefits, such as its capacity to improve efficacy, reduce errors, and improve patient safety by combining mechanical, electronic, and informatics technologies, are projected to drive market expansion.

In addition, Eurofins Scientific bought Paster Group, a major participant in clinical diagnostics in Brazil, in 2017. Eurofins has expanded its global network of analytical services laboratories due to this expansion in Latin America. Innovative solutions are more likely to emerge for tests that provide faster answers and can examine numerous factors at once. New Troponin biomarker tests, for example, are being used in clinical laboratories. The enormous volume of testing performed through clinical laboratory tests can also be contributed to the market's rapid expansion.

Regional Analysis

The market is divided into five regions, namely North America, Latin America, Europe, Asia-Pacific, and the Middle East and Africa. 

Significant Growth in North America and Asia-Pacific 

North America and Asia-Pacific dominate the global clinical laboratory tests market. North America held the greatest clinical laboratory test market share and is expected to maintain its position throughout the forecast period. It is anticipated to grow at a CAGR of 7.23%, generating a revenue of USD 94,842.45 million by 2030.

The market is expected to be fueled by growing regulatory backing and increased investments in clinical laboratory tests. North America has sophisticated economies and a strict regulatory structure for new test approval. The FDA has approved these tests under the 510(k) medical device regulation. Panel tests performed on instruments must also go through a similar FDA clearance process to be approved for commercialization. Health Canada oversees the approval of these tests in Canada.

Routine examinations are being encouraged by high insurance coverage (almost 100%) and favorable regulatory measures, growing the market. These tests are immediately billed to insurance companies, making it easier for patients to estimate costs. Urinalysis, blood tests, and screening tests are all covered by Medicaid. The cost of tests is low; nevertheless, hospital fees in the area are more.

Asia-Pacific is the fastest-growing in the global clinical laboratory tests market. It is anticipated to grow at a CAGR of 12.92% generating a revenue of USD 53,852.71 million by 2030. Over the forecast period, Asia-Pacific is expected to increase at the fastest rate. The presence of significant untapped prospects in the form of unmet medical requirements, expanding lines of scientific study, and favorable economic growth are the market's key growth drivers. 

Furthermore, as the regulatory environment in high-growth countries improves, multinational players are expected to invest and take advantage of current opportunities. Positive improvements, such as government-provided healthcare, increased awareness, and the desire to receive high-end medical treatment, will likely propel regional market expansion.

Segmental Analysis

The global clinical laboratory tests market share is divided based on test type, end-use, and region.

By Test Type

In the clinical laboratory tests market, Clinical Chemistry Tests dominate, specifically the Comprehensive Metabolic Panel (CMP). The CMP is widely used due to its extensive diagnostic capability, providing a broad overview of a patient’s metabolic state by measuring glucose, proteins, electrolytes, and liver enzymes. This panel helps in assessing various conditions such as diabetes, liver disease, and kidney function. Its comprehensive nature and ability to offer a detailed snapshot of overall health drive its widespread adoption, making it a key segment in the clinical chemistry test market.

By End User

In the clinical laboratory tests market, hospitals dominate, particularly the inpatient testing segment. Inpatient testing is crucial because hospitals manage patients with acute conditions requiring frequent and comprehensive testing for accurate diagnosis and monitoring. This high-volume testing need drives the demand for advanced laboratory services within hospitals. The ability to conduct a wide range of tests and obtain immediate results for critical care and ongoing patient management makes inpatient testing a key segment in the market. Hospitals' extensive facilities and resources ensure that they remain the primary end-user of clinical laboratory tests.

Impact of covid-19

The outbreak of the novel coronavirus has positively affected the growth of the bakery ingredients market. According to the American Bakers Association, in the US, the baking industry employs almost 800,000 skilled individuals, generates over USD 44 billion in direct wages, and has an overall economic impact of over USD 153 billion.

According to the Annual Food & Health Survey from the International Food Information Council, more than four out of five consumers say that the coronavirus pandemic has changed their food habits, driving them to cook, eat, shop, and think about food differently. A higher proportion of people said they were eating healthier and protein-based food products than they usually do due to the pandemic. All these factors have dramatically increased the sales of protein-based and natural ingredients products during the pandemic, and it is expected to follow over the forecast period.

Recent Developments

• March 2023 - Quest Diagnostics introduced the post-COVID-19 Expanded Test Panel, which features a Comprehensive Blood Count (CBC), Basic Metabolic Panel (BMP), and Hepatic Function Panel. This launch enhances the clinical laboratory test market by offering a comprehensive tool for monitoring and managing post-COVID-19 health conditions, thereby expanding diagnostic capabilities and improving patient care.
• January 2023 -QIAGEN launched the EZ2 Connect MDx, an in vitro diagnostics platform designed for automated sample processing in diagnostic laboratories. This device enables labs to purify RNA and DNA samples within 30 minutes. This advancement streamlines laboratory workflows, enhancing efficiency and accuracy in genetic testing, thereby supporting growth and innovation in the clinical laboratory test market.