Body Fluid Collection And Diagnostics Market (2025 - 2033) Size, Share & Trends Analysis Report By Sample (Blood, Saliva, Urine, Cerebrospinal Fluid), By Product (Tests/Services), By Technology, By Application, By Region, And Segment Forecasts

Body Fluid Collection And Diagnostics Market Summary

The global body fluid collection and diagnostics market size was estimated at USD 34.35 billion in 2024 and is anticipated to reach USD 61.99 billion by 2033, growing at a CAGR of 6.87% from 2025 to 2033. Rapid results, cost-effectiveness, and early prognosis of diseases are some of the factors contributing to the growth of the body fluid collection and diagnostics industry.

Advances in in-vitro diagnostic techniques are also playing a big role, as they make testing more accurate and efficient, encouraging wider use. For instance, in May 2022, TECHKON GmbH introduced a new method for analyzing body fluids that can assess medical parameters and diagnose diseases at the same time, making testing faster and more comprehensive.

The growing number of blood-related disorders is a key factor driving the demand for blood collection devices. Diseases such as anemia, sickle cell disease, hemophilia, and clotting disorders are becoming more common, along with blood cancers such as myeloma, lymphoma, and leukemia. In the U.S., blood cancer is particularly devastating, taking a life every nine minutes, which adds up to about 157 deaths each day or more than six every hour. In 2023, it’s estimated that nearly 57,380 people in the U.S. will die from leukemia, lymphoma, or myeloma, accounting for almost 9.4% of all cancer-related deaths.

An estimated 437,337 individuals in the U.S. are either living with or in remission from leukemia, while around 879,242 people are in the same condition with lymphoma. Blood clots affect approximately 900,000 Americans each year, leading to about 100,000 deaths annually. Notably, fewer than one in four people show any noticeable signs or symptoms of a blood clot, underscoring the silent but significant impact of this condition.

The growing focus on early disease detection has significantly driven demand in the body fluid collection and diagnostics industry. Samples such as saliva, blood, urine, and semen are increasingly used to analyze biomarkers and other indicators for accurate and timely diagnosis. Moreover, numerous advancements and innovations have been made globally, further enhancing testing capabilities and expanding the range of conditions that can be detected through fluid-based diagnostics. For instance, in July 2021, Abbott announced of launching Panbio COVID-19 Antigen Self-Test in India to strengthen its rapid diagnostics product portfolio. It would support testing needs at work, at clinics, and at home. Further recently, In May 2024, the U.S. FDA approved the Rika Plasma Donation System featuring the iNomi Nomogram developed by Terumo Corporation. This product helps determine plasma collection volume based on an individual donor's weight, height, and hematocrit level at the time of donation.

Alzheimer's Disease (AD) is a severe neurodegenerative disease that requires the identification of precise biomarkers. The development and validation of early-stage biomarkers is a high research priority for existing diagnostics that can detect AD. Body-fluid biomarkers accurately reflect a synaptic failure in the brain and, as a result, could help improve diagnostic accuracy, track the course of the disease, and act as indicators for evaluating the effectiveness of early-onset disease-modifying therapies. In May 2022, the FDA authorized the marketing of a new test that could improve the diagnosis of AD. The Lumipulse test evaluates the ratio of -amyloid 1-40 and-amyloid 1-42 concentrations found in the human cerebral spinal fluid, which can help doctors in determining if a patient is expected to have amyloid plaques, a characteristic symptom of AD.

Body fluid samples contain a large number of naturally occurring biomarker proteins, which effectively show cancer progression. They are also utilized to find these biomarkers in order to validate the presence of cancer. For instance, in January 2022, scientists from the University of Illinois developed a tool that could detect cancer biomarkers in the body fluid samples. The quantification and detection of cancer-associated molecular biomarkers in such body fluids would help for minimally invasive cancer detection.

Furthermore, technological innovations in in-vitro diagnostics, such as high-throughput testing, automation, and integration of AI, have significantly enhanced diagnostic accuracy and efficiency. These advancements enable faster turnaround times and improved sensitivity, making body fluid diagnostic tools indispensable for modern healthcare. The availability of such innovative solutions supports the global adoption of these technologies.

Market Concentration & Characteristics

The body fluid collection and diagnostics market is experiencing a moderate pace of innovation, mainly driven by the need for safer, more efficient, and user-friendly collection methods. Many companies are focusing on developing advanced collection devices that not only keep samples stable but also work smoothly with digital health platforms. Improvements in automation, ease of use, and portability are helping laboratories and healthcare providers deliver faster and more accurate results. For example, in September 2025, Exact Sciences launched its Cancerguard multi-cancer blood test, priced at USD 690 and available online from October 2025. The test analyzes altered DNA in the bloodstream to detect multiple cancers at an early stage. With this move, Exact Sciences joins players like Grail and Guardant Health in a market expected to surpass USD 25 billion annually as adoption of early detection solutions grows.

The market holds a moderate level of M&A activity, as companies look to expand their product portfolios and grow their technological capabilities. For example, in July 2025, Waters Corporation’s announced the acquisition of Becton, Dickinson and Company’s (BDX.N) Biosciences & Diagnostic Solutions division. The USD 17.5 billion deal is set to significantly expand Waters’ footprint, nearly doubling its total addressable market to USD 40 billion.

The regulatory agencies, the U.S. FDA, EMA and other regional health authorities have very stringent regulations that make the collection devices and diagnostic solutions of high quality in terms of safety, accuracy and reliability. It is important to comply with such regulations not only to obtain product approvals but also to receive reimbursement and the trust of the market. One such recent development is the acceptance of the Shield test, created by Guardant Health, to detect colorectal cancer by the U.S. FDA, another important advancement in liquid biopsy diagnostics. This authority is likely to promote the increased adoption of non-invasive cancer screening protocols and the further development of the industry.

Companies are focusing on expanding their product portfolios by introducing novel collection tools, integrated diagnostic kits, and solutions designed for home-based or remote testing. There is a growing demand for minimally invasive and non-invasive collection methods, as well as devices compatible with a range of body fluids including blood, saliva, urine, cerebrospinal fluid, and others.

Regional expansion is a critical characteristic shaping market growth. While North America and Europe dominate due to advanced infrastructure and established healthcare systems, companies are increasingly focusing on emerging regions such as Asia Pacific, Latin America, and the Middle East & Africa.

Sample Insights

The blood sample segment held the largest revenue share at 75.68% in 2024.  Body fluid traces recovered at crime scenes are important evidence for forensic researchers. They contain useful DNA evidence which can identify a victim or suspect. Crime scene investigation is one of the main fields in forensics. The introduction of advanced techniques such as single-nucleotide polymorphism (SNP) analysis, short tandem repeat (STR) recognition, mitochondrial deoxyribonucleic acid (DNA) analysis, and microfluid system for genetic material analysis extracted from the blood sample assists scientists in forensic investigations. In May 2022, BD expanded its partnership with Babson Diagnostics to advance diagnostic blood collection. The new care setting would allow patients to collect blood samples at home.

The urine segment is expected to exhibit considerable growth in the body fluid collection and diagnostics industry over the forecast period. Medical tests are becoming an important tool for the diagnosis and treatment of diseases. Urine collection is used for the metabolic evaluation of proteinuria, urinary stone disease, renal function estimation, and others. The testing is performed in an outpatient setting. In November 2022, researchers from the University of Tokyo stated that they are deriving new tests that could help diagnose chronic kidney disease early. Continuous developments in this field would further drive the segment’s growth.

Product Insights

The kits & consumables segment captured the largest revenue share at 67.74% in 2024.  The segment is also expected to experience the fastest growth of 7.0% during the forecast period. The increasing demand for rapid and cost-effective kits and easing government regulations for COVID-19 kits have contributed to the segment’s growth. For instance, in May 2021, COVID-19 home test kits received approval from the Indian Council of Medical Research, which issued detailed guidelines on how and who can use the kits. Mylab Discovery Solutions Ltd developed the CoviSelfTM COVID-19 OTC device whose process should be conducted according to the mobile app.

The tests/services are expected to exhibit considerable growth of 4.85% over the forecast period. The rising adoption of advanced in-vitro technologies, such as high-sensitivity blood tests, urine analysis, and point-of-care solutions, has enhanced diagnostic accuracy and accessibility. This demand is further fueled by growing awareness and the global emphasis on preventive healthcare practices. Furthermore, specialized tests, such as cerebrospinal fluid analysis for neurological disorders and sweat tests for metabolic diseases, play pivotal roles in targeted diagnostics. In addition, point-of-care testing enhances accessibility, offering rapid and reliable solutions, thus driving the growth of this essential healthcare sector.

Technology Insights

The polymerase chain reaction (PCR) segment captured the largest revenue share at 57.48% in 2024. Body fluid DNA sequencing is a noninvasive technique for infectious diseases and genetic defects diagnosis. T Oligo-Primed Polymerase Chain Reaction is a robust technique that can be used for the minute DNA fragments amplification in body fluids. In August 2022, the Ministry of Health of the Democratic Republic of the Congo announced the recent Ebola Virus Disease outbreak. This has boosted the demand for RT-PCR in laboratories for virus detection. The sample is taken from oropharyngeal secretions.

The next generation sequencing (NGS) is expected to exhibit the fastest growth in the market, with a projected CAGR of 7.59% over the forecast period. NGS has revolutionized every field of biological science. It has significantly reduced the sequencing costs. Several developments have been happening in this segment, which is contributing to the segment’s growth. In September 2021, Selux Diagnostics, Inc. received FDA authorization for its NGS “phenotyping” platform for sterile body fluid samples and positive blood cultures. It is a single-platform solution for rapid antimicrobial susceptibility testing (AST) for specific sample types.

Application Insights

The diagnostics & monitoring segment captured the largest revenue share at 41.74% in 2024. The advantages of body fluid testing for disease diagnosis and monitoring are low cost, low invasiveness, and quick sample collection and processing. In addition, molecular expression level profiles in body fluid can aid in identifying changes to cellular networks and physiological conditions in diseased tissues. Body fluid analysis is now considered to be one of the most suitable techniques for the early diagnosis, monitoring, management, and evaluation of the early response to chronic diseases, as well as for identifying the possible pathogenesis of such abnormalities.

The therapeutic decision making is expected to exhibit the fastest growth of 7.42% over the forecast period. Therapeutic decision-making is a pivotal driver of the body fluid collection and diagnostics industry as it underscores the need for precise and actionable diagnostic data to guide treatment strategies. Diagnostic tools ensure optimized therapeutic outcomes by enabling early disease detection, monitoring of treatment efficacy, and personalized medicine approaches. The increasing reliance on biomarkers and advanced testing technologies further highlights their role in minimizing trial-and-error treatment, reducing healthcare costs, and improving patient care.

Regional Insights

North America body fluid collection and diagnostics market dominated and accounted for a 44.45% share in 2024. Such factors as high chronic disease rates such as cancer and diabetes and a highly developed healthcare system also play a major role. Innovative technologies liquid biopsies and molecular diagnostics also aid in further accelerating growth in the area. Increasing approval rate region, In December 2023, BD cleared 510(k) with the U.S. FDA with the BD MiniDraw Capillary Blood Collection System. The BD MiniDraw Capillary Blood Collection System is an alternative to a traditional venous blood draw that is less invasive.

U.S. Body Fluid Collection And Diagnostics Market Trends

The U.S. body fluid collection and diagnostics market is projected to grow significantly during the forecast period, driven by the presence of key players. Their focus on launching cutting-edge diagnostic tools also boost market expansion. The increasing incidence of lifestyle-related diseases and advancements in precision medicine play pivotal roles. Several developments such as product launches and strategic initiatives between companies have impacted the market positively. In May 2022, KDx Diagnostics Inc entered into a partnership agreement with UroGPO to offer a non-invasive urine test, URO17, for bladder cancer in the U.S. Similarly, in July 2021, Psomagen Inc. expanded its COVID-19 diagnostic services to expand its product portfolio by adding at-home saliva collection kits.

Europe Body Fluid Collection And Diagnostics Market Trends

The Europe body fluid collection and diagnostics market is likely to emerge as a lucrative region in the industry, driven by technological advancements, strong collaboration between academic institutions and diagnostic companies, and favorable reimbursement policies. Regulatory frameworks in the EU support innovation while ensuring patient safety, making the region attractive for diagnostic developments.

The UK body fluid collection and diagnostics market is projected to grow during the forecast period. Increasing investments in advanced diagnostic facilities and public-private partnerships strengthen its growth trajectory. The rising prevalence of diseases requiring regular diagnostic monitoring also drives demand.

The France body fluid collection and diagnostics market is expected to show steady growth over the forecast period, driven by government initiatives to enhance diagnostic capabilities and the availability of state-of-the-art healthcare facilities. The focus on patient-centric healthcare and expanding molecular diagnostics further propels the market.

The Germany body fluid collection and diagnostics market is projected to expand during the forecast period. Germany's established medical device industry and widespread adoption of in-vitro diagnostics position it as a growth leader in Europe. High investments in automation and integration of AI in diagnostic tools are additional factors contributing to market expansion.

Asia Pacific Body Fluid Collection And Diagnostics Market Trends

The Asia Pacific body fluid collection and diagnostics marketis expected to experience the highest growth rate of 9.00% CAGR during the forecast period, driven by increasing healthcare investments, improving infrastructure, and rising demand for affordable diagnostic solutions. High disease prevalence, coupled with growing awareness about early diagnostics, boosts market penetration. The increasing prevalence of diseases such as cancer, cardiovascular diseases, and other rare diseases has boosted the demand for the body fluid diagnostics and collection market. In November 2022, Roche Diagnostics announced launching its first automated cerebrospinal fluid (CSF)-based test in India for Alzheimer's disease.

The China body fluid collection and diagnostics market is projected to expand throughout the forecast period, driven by several key factors, including the rising prevalence of chronic diseases, and increased adoption of advanced diagnostics. The country is also investing heavily in research and development, further solidifying its position in the global market.

The Japan body fluid collection and diagnostics market is anticipated to grow during the forecast period, driven by focus on innovation, an aging population requiring regular diagnostics, and government support for technological advancements in healthcare. Increased adoption of genetic testing and biomarker analysis also drives demand.

Latin America Body Fluid Collection And Diagnostics Market Trends

The Latin America body fluid collection and diagnostics market is expected to experience significant growth throughout the forecast period. The market is growing steadily due to rising healthcare spending and increasing demand for advanced diagnostics. Efforts to address healthcare inequities and introduce cost-effective diagnostic solutions are fostering regional development.

The Brazil body fluid collection and diagnostics market is anticipated to grow during the forecast period. Brazil leads the Latin American market, supported by growing awareness about disease prevention, expanding diagnostic laboratories, and government efforts to improve access to healthcare in rural areas. Partnerships with international diagnostic companies further enhance growth prospects.

Saudi Arabia Body Fluid Collection And Diagnostics Market Trends

The Saudi Arabia body fluid collection and diagnostics market is anticipated to experience substantial growth during the forecast period. Saudi Arabia stands out in the MEA region with a focus on healthcare modernization, rapid adoption of innovative diagnostics, and regulatory frameworks encouraging technological advancements. The increasing prevalence of diseases such as diabetes and cancer further drives the need for effective diagnostic tools.

Key Body Fluid Collection And Diagnostics Company Insights

The global body fluid collection and diagnostics industry is highly competitive, with numerous players striving to maintain market leadership through innovation, product diversification, and strategic investments. These companies boast extensive product portfolios, a broad geographic presence, and robust distribution networks, allowing them to cater to a wide range of customer needs across both clinical and direct-to-consumer markets. Many industry leaders have made substantial investments in research and development to stay ahead of the competition, enabling them to introduce advanced and cutting-edge body fluid collection and diagnostics solutions. Key market players operating in this market are entering into several strategic collaborations and partnerships to expand their existing diagnostics and collection product portfolio. For instance, in August 2022, Mount Sinai entered into a partnership agreement with Exosome Diagnostics to accelerate research and development of real-time nucleic acid-based body-fluid diagnostics to promote personalized medicine.

Recent Developments

• In September 2024, Guardant Health and Policlinico Gemelli announced a partnership to create a dedicated in-house liquid biopsy testing service in Italy. The partnership is focused on improving cancer detection and treatment by bringing advanced diagnostic technologies directly to patients. By leveraging Guardant Health’s cutting-edge solutions, the service aims to deliver more accurate and faster results, helping doctors make better-informed decisions and ultimately enhancing patient care in the region.

• In July 2024, Guardant Health's Shield blood test received U.S.FDA approval as a primary colorectal cancer screening method, making it the first FDA-cleared blood test for this purpose. This approval is a major step forward, as it opens the door for Medicare reimbursement and makes non-invasive cancer screening more accessible to eligible patients. Designed for average-risk individuals aged 45 and older, the Shield test offers a new approach to colorectal cancer prevention and early detection, helping more people get screened with greater ease and confidence.

• In March 2024, Spectrum Solutions introduced a new saliva-based diagnostic testing solution designed for faster and non-invasive health assessments. This innovation leverages saliva's potential for detecting a wide range of health conditions, offering convenience and reliability for patients and clinicians. The development reflects a broader shift in healthcare towards more patient-friendly diagnostic tools that make it easier to monitor health without discomfort or complexity.

• In May 2023, Siemens Healthineers launched next-gen hematology analyzers products. The products include Atellica HEMA 580 and 570 analyzers. The analyzer provides intuitive interfaces & multi-analyzer automation connectivity to remove workflow roadblocks supporting faster results.

Body Fluid Collection And Diagnostics Market Report Scope

Global Body Fluid Collection And Diagnostics Market Segmentation

This report forecasts revenue growth at global, regional & country levels and provides an analysis on the industry trends in each of the sub-segments from 2021 to 2033. For the purpose of this study, Grand View Research has segmented the global body fluid collection and diagnostics market report on the basis of sample, technology, application, product and region: 

• Sample Outlook (Revenue, USD Million, 2021 - 2033)

  • Blood

  • Saliva

  • Urine

  • Cerebrospinal Fluid

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Tests/Services

  • Kits & Consumables

  • Instruments

• Technology Outlook (Revenue, USD Million, 2021 - 2033)

  • Next Generation Sequencing (NGS)

  • Polymerase Chain Reaction (PCR)

  • Fluorescence in situ hybridization (FISH)

  • Others

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Diagnostics & Monitoring

  • Therapeutic Decision Making

  • Prognostics & Screening

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait