Clinical Laboratory Test Market

The growing prevalence of target diseases to drive market growth

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.

The rising prevalence of lifestyle-related diseases such as obesity, the 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 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%. his 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.

The Global Clinical Laboratory Test Market Industry is projected to experience substantial growth in the coming years. With a market value of 123.3 USD Billion in 2024, it is anticipated to reach 290.8 USD Billion by 2035. This growth trajectory suggests a compound annual growth rate of 8.11 percent from 2025 to 2035, indicating a robust demand for clinical laboratory services. Factors contributing to this growth include advancements in technology, increasing chronic disease prevalence, and a focus on preventive healthcare. The market's expansion reflects the critical role of laboratory testing in modern healthcare.

The Global Clinical Laboratory Test Market Industry is experiencing growth due to the increasing prevalence of chronic diseases such as diabetes, cardiovascular disorders, and cancer. As populations age, the demand for diagnostic testing rises, leading to a greater need for laboratory services. For instance, the World Health Organization indicates that chronic diseases account for approximately 71 percent of all deaths globally. This trend necessitates advanced laboratory testing to monitor and manage these conditions effectively, thus driving market expansion. By 2024, the market is projected to reach 123.3 USD Billion, reflecting the urgent need for reliable diagnostic solutions.

Regulatory frameworks and standardization efforts are crucial drivers of the Global Clinical Laboratory Test Market Industry. Governments and health authorities are implementing stringent regulations to ensure the quality and reliability of laboratory tests. These regulations not only enhance patient safety but also foster trust in laboratory services. For example, the establishment of guidelines for laboratory accreditation and proficiency testing is promoting uniformity in testing procedures. This regulatory support is likely to encourage investment in laboratory infrastructure and technology, further propelling market growth as stakeholders seek to comply with evolving standards.

The Global Clinical Laboratory Test Market Industry is increasingly influenced by the demand for personalized medicine. As healthcare shifts towards tailored treatment approaches, laboratory tests that provide insights into individual genetic profiles are becoming essential. This trend is supported by advancements in genomics and biotechnology, enabling healthcare providers to offer customized therapies based on specific patient needs. The rise of personalized medicine is expected to drive significant growth in the market, with an anticipated compound annual growth rate of 8.11 percent from 2025 to 2035. This evolution underscores the importance of laboratory testing in the future of healthcare.

The Global Clinical Laboratory Test Market Industry is benefiting from a heightened emphasis on preventive healthcare. Governments and health organizations are advocating for regular health screenings and early detection of diseases to reduce healthcare costs and improve population health. This shift towards preventive measures is reflected in various public health initiatives aimed at increasing awareness and accessibility of laboratory tests. For instance, campaigns promoting routine blood tests and screenings for specific conditions are gaining traction. This trend is likely to contribute to the market's growth, as more individuals seek laboratory services to monitor their health proactively.

Technological innovations play a pivotal role in shaping the Global Clinical Laboratory Test Market Industry. The introduction of advanced diagnostic tools, such as molecular diagnostics and point-of-care testing, enhances the accuracy and speed of laboratory tests. For example, the integration of artificial intelligence in laboratory processes is streamlining workflows and improving patient outcomes. These advancements not only facilitate early disease detection but also reduce the overall cost of healthcare. As a result, the market is expected to grow significantly, with projections indicating a value of 290.8 USD Billion by 2035, driven by continuous technological evolution.

By Region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. The North American clinical laboratory test market is anticipated to expand at a significant CAGR during the study period, accounting for USD 97.11 billion in 2021. 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 tests, blood tests, and screening tests are all covered by Medicaid. The cost of tests is low; nevertheless, hospital fees in the area are more.

Moreover, the major countries covered in the market report include the United States, Germany, Canada, France, the United Kingdom, Italy, Spain, India, Japan, Australia, China, South Korea, and Brazil.

Figure 3: Global Clinical Laboratory Test Market Size, By Region 2023 & 2032 (USD Billion)

The European clinical laboratory test market is the world's second-largest owing to the huge amounts of technology and digitizing data. Rising penetration of advanced diagnostic techniques and increasing test volumes support the dominance of the regional market. In addition, increasing geriatric population, rising incidences of cancer, and growing penetration of advanced diagnostic techniques are expected to drive the demand for clinical laboratory tests. Further, the German market of clinical laboratory test held the largest market share, and the France market of clinical laboratory test was the fastest-growing market in the European region.

The Asia Pacific market of clinical laboratory test is expected to grow at the fastest rate of CAGR during the forecast period. 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. Moreover, China’s market of clinical laboratory test held the largest market share, and the Indian market of clinical laboratory test was the fastest-growing market in the Asia-Pacific region.

The market for clinical laboratory services is highly competitive, and various and local companies are present in the market. A major share of the market is grabbed by the players, and local companies are also focusing on delivering innovative services to the people, which is allowing these companies to establish their considerable place in this market. With a rising need for technology, it is expected that few new entrants will be seen in the market in the future, and these players will gain a substantial share.

The key market players operating in the industry are further focusing on geographic expansion, partnerships, and strategic collaborations with other companies, particularly in emerging and economically favorable regions.

Bionano Genomics Inc provides a platform to analyze the long segments of genomic DNA and other biomolecules structural variations. The Company offers proprietary nanochannel chips, automated imaging instrument, integrated primary and secondary software, and application specific reagents. Bionano Genomics serves customers in the United States. 

In September 2022, Bionano Genomics Inc announced the launch of Bionano Laboratories, a new organization that combines Bionano’s optical genome mapping (OGM) data services with the clinical testing services previously offered by Lineagen. It also announced the launch of Bionano Laboratories’ first OGM-based laboratory-developed test (LDT).