×
  • Cat-intel
  • MedIntelliX
  • Resources
  • About Us
  • Request Free Sample ×

    Kindly complete the form below to receive a free sample of this Report

    Leading companies partner with us for data-driven Insights

    clients tt-cursor
    Hero Background

    Serological Testing Market

    ID: MRFR/HC/41804-HCR
    200 Pages
    Rahul Gotadki
    October 2025

    Serological Testing Market Research Report By Test Type (Enzyme-Linked Immunosorbent Assay, Western Blot, Radioimmunoassay, Immunofluorescence Assay), By Application (Infectious Diseases, Autoimmune Disorders, Transplant Rejection, Blood Donations Screening), By End User (Clinical Laboratories, Hospitals, Diagnostic Centers, Research Institutions), By Technology (Traditional Serological Testing, Point-of-Care Testing, Microfluidics Technology) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa)- Forec...

    Share:
    Download PDF ×

    We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

    Serological Testing Market Infographic
    Purchase Options

    Serological Testing Market Summary

    As per MRFR analysis, the Serological Testing Market Size was estimated at 6.84 USD Billion in 2024. The Serological Testing industry is projected to grow from 7.093 USD Billion in 2025 to 10.2 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 3.7 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The Serological Testing Market is poised for substantial growth driven by technological advancements and increasing healthcare demands.

    • North America remains the largest market for serological testing, driven by advanced healthcare infrastructure and high demand for diagnostic solutions.
    • The Asia-Pacific region is currently the fastest-growing market, reflecting a surge in healthcare investments and rising awareness of preventive healthcare.
    • Enzyme-Linked Immunosorbent Assay (ELISA) continues to dominate the market, while the Western Blot method is experiencing rapid growth due to its specificity and reliability.
    • Key market drivers include the rising incidence of infectious diseases and growing awareness of preventive healthcare, which are shaping the demand for innovative testing solutions.

    Market Size & Forecast

    2024 Market Size 6.84 (USD Billion)
    2035 Market Size 10.2 (USD Billion)
    CAGR (2025 - 2035) 3.7%

    Major Players

    Abbott Laboratories (US), Roche Diagnostics (CH), Siemens Healthineers (DE), Thermo Fisher Scientific (US), Ortho Clinical Diagnostics (US), bioMérieux (FR), Quidel Corporation (US), Hologic, Inc. (US)

    Serological Testing Market Trends

    The Serological Testing Market is currently experiencing a dynamic evolution, driven by advancements in technology and an increasing emphasis on preventive healthcare. The integration of innovative methodologies, such as point-of-care testing and automated platforms, appears to enhance the efficiency and accuracy of serological assays. This shift not only streamlines laboratory workflows but also facilitates timely diagnosis, which is crucial in managing various health conditions. Furthermore, the growing awareness of the importance of early detection and monitoring of diseases is likely to propel the demand for serological tests across diverse healthcare settings. In addition, the Serological Testing Market seems to be influenced by the rising prevalence of infectious diseases and autoimmune disorders. As healthcare providers seek reliable diagnostic tools, the market is likely to expand, with a focus on developing tests that are both sensitive and specific. Moreover, collaborations between research institutions and diagnostic companies may foster innovation, leading to the introduction of novel serological tests. Overall, the Serological Testing Market is poised for growth, driven by technological advancements and an increasing focus on health management strategies.

    Technological Advancements

    The Serological Testing Market is witnessing a surge in technological innovations, particularly in the development of rapid testing methods. These advancements facilitate quicker results, which are essential for effective patient management. Automated systems are also becoming more prevalent, enhancing the accuracy and efficiency of testing processes.

    Increased Demand for Preventive Healthcare

    There is a noticeable shift towards preventive healthcare, which is influencing the Serological Testing Market. As individuals and healthcare providers prioritize early detection of diseases, the demand for serological tests is likely to rise. This trend underscores the importance of regular health screenings and monitoring.

    Focus on Personalized Medicine

    The concept of personalized medicine is gaining traction within the Serological Testing Market. Tailoring diagnostic tests to individual patient profiles may improve treatment outcomes. This trend suggests a move towards more specific and targeted testing approaches, aligning with broader healthcare goals.

    Serological Testing Market Drivers

    Expansion of Healthcare Infrastructure

    The expansion of healthcare infrastructure is a significant driver for the Serological Testing Market. As healthcare facilities grow and evolve, there is an increasing need for reliable diagnostic tools, including serological tests. This expansion is particularly evident in emerging markets, where investments in healthcare are on the rise. Enhanced healthcare infrastructure not only improves access to testing but also facilitates the integration of advanced diagnostic technologies. As a result, the Serological Testing Market is likely to experience growth as more healthcare providers adopt serological testing as a standard practice in patient care.

    Rising Incidence of Infectious Diseases

    The Serological Testing Market is experiencing growth due to the rising incidence of infectious diseases. As the prevalence of conditions such as hepatitis, HIV, and other viral infections increases, the demand for serological tests is likely to rise. According to recent data, the incidence of infectious diseases has shown a steady increase, prompting healthcare providers to seek effective diagnostic solutions. This trend indicates a growing need for accurate and timely serological testing, which can aid in early detection and treatment. Consequently, the Serological Testing Market is poised for expansion as healthcare systems prioritize the implementation of advanced testing methodologies to combat these diseases.

    Growing Awareness of Preventive Healthcare

    The increasing awareness of preventive healthcare is a key driver for the Serological Testing Market. As individuals become more proactive about their health, there is a rising demand for diagnostic tests that can identify potential health issues before they escalate. Serological tests play a crucial role in preventive healthcare by providing insights into immune status and exposure to various pathogens. This trend is reflected in the growing number of health campaigns and initiatives aimed at educating the public about the importance of regular testing. Consequently, the Serological Testing Market is likely to see a surge in demand as more individuals seek out these essential diagnostic tools.

    Technological Innovations in Testing Methods

    Technological advancements are significantly influencing the Serological Testing Market. Innovations such as automated testing systems, point-of-care testing devices, and enhanced assay techniques are improving the accuracy and efficiency of serological tests. For instance, the introduction of high-throughput screening methods has enabled laboratories to process a larger volume of tests in a shorter time frame. This not only enhances diagnostic capabilities but also reduces the burden on healthcare facilities. As a result, the Serological Testing Market is likely to benefit from these technological improvements, which are expected to drive demand for more sophisticated testing solutions.

    Regulatory Support and Funding for Diagnostic Solutions

    Regulatory support and increased funding for diagnostic solutions are pivotal factors driving the Serological Testing Market. Governments and health organizations are recognizing the importance of robust diagnostic capabilities in managing public health. This has led to the establishment of favorable regulatory frameworks and increased investment in research and development for serological testing. For example, funding initiatives aimed at enhancing laboratory infrastructure and supporting innovative testing methods are becoming more prevalent. Such support is expected to foster growth within the Serological Testing Market, as it encourages the development and adoption of new testing technologies.

    Market Segment Insights

    By Type: Enzyme-Linked Immunosorbent Assay (Largest) vs. Western Blot (Fastest-Growing)

    In the Serological Testing Market, the distribution of market share among various types of tests reveals a dominant presence of Enzyme-Linked Immunosorbent Assay (ELISA). ELISA holds a significant share thanks to its versatility, cost-effectiveness, and widespread application in various clinical settings. Meanwhile, Western Blot, although possessing a smaller share, is recognized for its specificity and robustness in confirming certain infections, leading to its rapid uptake among labs focused on precise diagnostics.

    ELISA (Dominant) vs. Western Blot (Emerging)

    The Enzyme-Linked Immunosorbent Assay (ELISA) remains a staple in the Serological Testing Market due to its high throughput, efficiency, and adaptability in diagnosing a range of diseases. It is widely used for both qualitative and quantitative measurements, making it integral to numerous laboratory environments. Conversely, the Western Blot technique has gained traction as an emerging method primarily due to its specific antigen-antibody interactions, which provide confirmatory testing in cases of infectious diseases. The increasing demand for precise diagnostics bolsters the position of Western Blot, establishing it as a preferred method for specialists seeking reliability in test results.

    By Application: Infectious Diseases (Largest) vs. Autoimmune Disorders (Fastest-Growing)

    In the Serological Testing Market, the application segment reveals a diverse array of focus areas, predominantly characterized by infectious diseases, which hold the largest share of the market. Infectious disease testing largely dominates due to the rising incidence of viral and bacterial infections worldwide. Autoimmune disorders are quickly gaining ground and are increasingly recognized for their significant impact on public health, leading to heightened awareness and demand for diagnostic solutions within this sub-segment. Growth trends in the serological testing application segment are driven by the increasing prevalence of various infectious diseases and the advancing understanding of autoimmune conditions. Technological advancements are fueling innovation in testing methodologies, improving accuracy and patient outcomes. Furthermore, rising healthcare investments and a push toward proactive health management are bolstering the growth of autoimmune disorder testing, making it the fastest-growing area in this market.

    Infectious Diseases (Dominant) vs. Blood Donations Screening (Emerging)

    Infectious diseases remain the dominant application in the Serological Testing Market due to the critical need for timely and accurate diagnostics to manage outbreaks effectively. This segment includes tests for diseases such as HIV, hepatitis, and COVID-19, which are essential for public health monitoring. In contrast, blood donation screening represents an emerging application segment, playing a crucial role in ensuring the safety of blood supplies. As awareness of the importance of safe blood donation practices grows, so too does the demand for effective screening tests. Both segments are essential to the overall strategy of enhancing healthcare delivery, with infectious disease testing leading the way in terms of volume, while blood donation screening continues to expand its footprint in response to evolving health needs.

    By End User: Clinical Laboratories (Largest) vs. Hospitals (Fastest-Growing)

    In the Serological Testing Market, clinical laboratories hold the largest share, driven by their extensive adoption of serological tests for various diagnostics and monitoring purposes. Hospitals follow closely, tapping into an increasing demand for rapid testing solutions amidst the rise of infectious diseases. Diagnostic centers and research institutions also contribute significantly but lag behind in market share distribution, showcasing marked differences in resource allocation and test offerings.

    Clinical Laboratories (Dominant) vs. Hospitals (Emerging)

    Clinical laboratories have established themselves as the dominant players in the Serological Testing Market due to their ability to handle high volumes of samples and their integration of advanced testing technologies. These laboratories are essential in providing timely diagnostic results, which are crucial for patient management. In contrast, hospitals are emerging as a vital segment, capitalizing on the need for efficient testing within acute care settings. The demand for point-of-care testing in hospitals has been accelerated by the ongoing pandemic, making them a rapidly growing segment as they enhance their testing capabilities to address urgent public health challenges.

    By Technology: Traditional Serological Testing (Largest) vs. Point-of-Care Testing (Fastest-Growing)

    The Serological Testing Market showcases a diverse landscape within its Technology segment. Traditional Serological Testing holds the largest market share due to its established use in various diagnostic applications. It remains the gold standard for many serological assays, making it the most recognized and trusted method among healthcare professionals. Point-of-Care Testing, while smaller in market share, is rapidly gaining traction, specifically driven by the increasing demand for timely diagnostics in various healthcare settings.

    Traditional Serological Testing (Dominant) vs. Point-of-Care Testing (Emerging)

    Traditional Serological Testing primarily encompasses laboratory-based methods that provide highly accurate results through serological assays. Its dominance stems from the reliability and comprehensive data it offers, particularly in complex diagnostic cases. On the other hand, Point-of-Care Testing is becoming increasingly popular for its convenience and speed, catering to the rising need for immediate results. Patients benefit from this emerging technology as it allows for on-site testing in various environments, including clinics and hospitals. This shift highlights a significant trend towards more efficient patient care and the growing role of innovative diagnostic solutions.

    Get more detailed insights about Serological Testing Market

    Regional Insights

    The Global Serological Testing Market experienced steady growth, with North America leading the way, valued at 2.92 USD Billion in 2024 and projected to reach 4.32 USD Billion by 2035, thereby maintaining a majority holding in the market.

    Europe followed, with a valuation of 1.54 USD Billion in 2024 and increasing to 2.11 USD Billion in 2035, making it a significant contributor due to its advanced healthcare infrastructure and rising demand for accurate diagnostic tools.

    The APAC region was also noteworthy, starting at 1.65 USD Billion in 2024 and anticipated to grow to 2.41 USD Billion by 2035, driven by increasing awareness and healthcare expenditure in emerging markets. Meanwhile, South America and MEA showed more modest valuations, with 0.52 USD Billion and 0.21 USD Billion respectively in 2024, highlighting the growing but still limited demand for serological testing in these regions.

    Overall, the Global Serological Testing Market data indicated robust opportunities for growth across regions as healthcare continues to evolve, supported by innovative technologies and heightened public health initiatives. 

     

    Serological Testing Market Segment

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    The competitive landscape within the Global Serological Testing Market is characterized by a blend of established players and innovative new entrants, each vying for market share through advanced product offerings and strategic initiatives.

    As demand for serological tests continues to surge, largely driven by the increasing prevalence of infectious diseases and significant public health initiatives, companies are focusing on innovation and technological advancements to enhance their product portfolios.

    Market players are investing heavily in research and development to improve the accuracy, efficiency, and overall convenience of serological testing methods. This competitiveness is further intensified by the need for rapid and reliable test results, particularly in the wake of global health crises, which has compelled companies to push boundaries in serological testing capabilities and expand their market reach through effective distribution networks and partnerships.

    Furthermore, regulatory compliance and adherence to quality standards have become paramount, making competition not only a battle of innovation but also one of regulatory agility and operational excellence. Ortho Clinical Diagnostics holds a prominent position in the Global Serological Testing Market, leveraging its extensive experience in in vitro diagnostics to strengthen its market presence.

    The company is known for its robust portfolio of serological testing solutions that target various infectious diseases and blood screening applications. One of its strengths is its commitment to innovation, as reflected in its continuous investment in research and development, which has resulted in numerous advancements in test accuracy and throughput.

    By emphasizing user-friendly technology and automation, Ortho Clinical Diagnostics enhances laboratory efficiency, thereby appealing to a broad customer base comprised of hospitals, reference labs, and blood banks. The company's strong focus on customer support and service also fortifies its competitive edge, as clients increasingly demand not just products but expert guidance and training.

    Serological Testing Market Region

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Furthermore, its global footprint allows Ortho Clinical Diagnostics to serve and respond effectively to the diverse needs of different regions, ensuring it remains a formidable contender in the serological testing arena. Hologic has carved out a significant niche within the Global Serological Testing Market, known for its high-quality diagnostic solutions and dedication to women's health diagnostics.

    The company is recognized for its innovative approach to serological testing, frequently introducing advanced technologies that improve testing accuracy and reduce turnaround times. Hologic excels in the realm of molecular diagnostic testing, which complements its serological testing offerings, thus providing a comprehensive suite of diagnostic tools that enhance clinical decision-making.

    Its strengths lie in its ability to fuse cutting-edge technology with a deep understanding of evolving healthcare needs. Additionally, Hologic's strategic partnerships and collaborations further extend its reach and effectiveness in the marketplace, allowing for the rapid adaptation of its products to meet emerging public health challenges.

    The company’s ongoing commitment to research and development ensures that it stays at the forefront of innovation, addressing the growing demands for rapid and reliable serological tests in various healthcare settings, establishing Hologic as a strong player within the global landscape.

    Key Companies in the Serological Testing Market market include

    Industry Developments

    Recent developments in the Global Serological Testing Market have been notable, particularly with advancements and innovations from leading companies. Ortho Clinical Diagnostics and Abbott Laboratories are focusing on expanding their product lines, enhancing their capabilities in serological testing to better address emerging health concerns.

    Hologic and Thermo Fisher Scientific have increased their investments in R&D, aiming to improve the accuracy and efficiency of their serological assays. Additionally, Roche Holding AG recently strengthened its market position through collaborations that aim to broaden its testing portfolio.

    In terms of mergers and acquisitions, Danaher Corporation announced a strategic acquisition that is expected to enhance its technological capabilities within the serological space, thereby improving its competitive edge. Siemens Healthineers has also been in the spotlight with its acquisition of a smaller diagnostics firm, which aims to augment its serologic testing capabilities.

    The market is witnessing significant growth, driven by an increase in demand for diagnostic tests due to ongoing public health challenges, including pandemic response efforts. Becton Dickinson continues to see substantial growth in its serology offerings, reflecting the wider expansion of this market segment.

    Future Outlook

    Serological Testing Market Future Outlook

    The Serological Testing Market is projected to grow at a 3.7% CAGR from 2024 to 2035, driven by technological advancements, increasing disease prevalence, and rising demand for rapid diagnostics.

    New opportunities lie in:

    • Development of point-of-care testing devices for remote diagnostics.
    • Expansion of telehealth services integrating serological testing.
    • Partnerships with pharmaceutical companies for drug efficacy testing.

    By 2035, the Serological Testing Market is expected to be robust, driven by innovation and strategic partnerships.

    Market Segmentation

    Serological Testing Market Type Outlook

    • Enzyme-Linked Immunosorbent Assay
    • Western Blot
    • Radioimmunoassay
    • Immunofluorescence Assay

    Serological Testing Market End User Outlook

    • Clinical Laboratories
    • Hospitals
    • Diagnostic Centers
    • Research Institutions

    Serological Testing Market Technology Outlook

    • Traditional Serological Testing
    • Point-of-Care Testing
    • Microfluidics Technology

    Serological Testing Market Application Outlook

    • Infectious Diseases
    • Autoimmune Disorders
    • Transplant Rejection
    • Blood Donations Screening

    Report Scope

    MARKET SIZE 20246.84(USD Billion)
    MARKET SIZE 20257.093(USD Billion)
    MARKET SIZE 203510.2(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)3.7% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledMarket analysis in progress
    Segments CoveredMarket segmentation analysis in progress
    Key Market OpportunitiesIntegration of advanced technologies enhances accuracy and efficiency in the Serological Testing Market.
    Key Market DynamicsTechnological advancements and regulatory changes drive innovation and competition in the serological testing market.
    Countries CoveredNorth America, Europe, APAC, South America, MEA

    Leave a Comment

    FAQs

    What is the expected market size of the Global Serological Testing Market by 2024?

    The expected market size of the Global Serological Testing Market by 2024 is 6.84 USD Billion.

    What is the projected market value of the Global Serological Testing Market by 2035?

    The projected market value of the Global Serological Testing Market by 2035 is 10.2 USD Billion.

    What is the expected CAGR for the Global Serological Testing Market from 2025 to 2035?

    The expected CAGR for the Global Serological Testing Market from 2025 to 2035 is 3.7%.

    Which region holds the largest market share in the Global Serological Testing Market as of 2024?

    North America holds the largest market share in the Global Serological Testing Market with a valuation of 2.92 USD Billion in 2024.

    What is the estimated market value for the 'Enzyme-Linked Immunosorbent Assay' test type by 2024?

    The estimated market value for the 'Enzyme-Linked Immunosorbent Assay' test type by 2024 is 2.4 USD Billion.

    Who are the key players in the Global Serological Testing Market?

    Some key players in the Global Serological Testing Market include Ortho Clinical Diagnostics, Hologic, and Abbott Laboratories.

    What is the anticipated market value for the 'Western Blot' test type by 2035?

    The anticipated market value for the 'Western Blot' test type by 2035 is 2.3 USD Billion.

    What is the growth rate for the Global Serological Testing Market in the APAC region by 2035?

    The growth rate for the Global Serological Testing Market in the APAC region is projected to yield a value of 2.41 USD Billion by 2035.

    What market value is expected for the 'Immunofluorescence Assay' test type by 2024?

    The market value expected for the 'Immunofluorescence Assay' test type by 2024 is 1.64 USD Billion.

    What challenges and opportunities exist in the Global Serological Testing Market?

    The Global Serological Testing Market faces challenges such as regulatory hurdles but also presents opportunities due to increasing demand for advanced diagnostic testing.

    Download Free Sample

    Kindly complete the form below to receive a free sample of this Report

    Case Study
    Chemicals and Materials

    Compare Licence

    ×
    Features License Type
    Single User Multiuser License Enterprise User
    Price $4,950 $5,950 $7,250
    Maximum User Access Limit 1 User Upto 10 Users Unrestricted Access Throughout the Organization
    Free Customization
    Direct Access to Analyst
    Deliverable Format
    Platform Access
    Discount on Next Purchase 10% 15% 15%
    Printable Versions