Serological Testing Market 2031 | Forecast Focused on Advanced Diagnostic Kits and Increasing Healthcare Expenditure in Emerging Economies

Global Serological Testing Market Overview

The global serological testing market is projected to grow at a compound annual growth rate (CAGR) of approximately 6–8% through 2027. Market expansion is primarily supported by the increasing burden of acute and infectious diseases, a steadily ageing global population, continuous technological innovation, and the growing use of point-of-care (POC) diagnostic solutions. Moreover, the widening scope of serological applications and the lasting effects of the COVID-19 pandemic have significantly accelerated demand for antibody-based diagnostic tests, further fueling market growth.

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Serological testing encompasses diagnostic techniques that analyze blood serum to identify antibodies, antigens, or other biomarkers associated with infections, immune responses, or disease states. Serum, the fluid portion of blood obtained after coagulation, contains antibodies and proteins produced by the immune system. These tests are extensively used to determine prior exposure to pathogens, confirm active or past infections, and evaluate immune responses following vaccination or disease recovery.

Beyond infectious disease detection, serological testing plays a vital role in assessing immune status, determining blood groups and Rh factors for transfusions and organ transplantation, and supporting disease monitoring. Commonly used techniques include enzyme-linked immunosorbent assay (ELISA), Western blotting, agglutination assays, and fluorescent antibody tests. Accurate interpretation of test results requires correlation with clinical symptoms, medical history, and complementary diagnostic findings.

Market Dynamics: Trends and Demographic Impact

Several key trends are reshaping the serological testing market. The rising incidence of infectious and acute diseases highlights the critical importance of serological diagnostics in disease detection and monitoring. At the same time, laboratories are increasingly adopting automated serological testing platforms that enhance throughput, precision, and operational efficiency.

Demographic changes, particularly the global rise in the elderly population, are also driving demand. Older individuals often require frequent diagnostic evaluations for chronic and immune-related conditions, making serological testing an essential component of geriatric healthcare. Additionally, the growing focus on preventive medicine has increased the incorporation of serological assays into routine health screenings and early disease detection programs.

Investments in healthcare infrastructure and diagnostic capabilities continue to strengthen market growth. The ability of healthcare systems to adapt to large-scale challenges, such as pandemics, has encouraged innovation and resilience within the serological testing industry, ensuring continued evolution to meet global healthcare needs.

Technological Advancements and Point-of-Care Expansion

The COVID-19 pandemic had a transformative impact on the diagnostics sector, significantly increasing the demand for serological assays to detect SARS-CoV-2 antibodies and assess population-level immunity. Beyond COVID-19, the need for accurate serological tools remains strong across infectious diseases, autoimmune disorders, and chronic conditions.

For example, in November 2023, Roche launched the Elecsys® HBeAg quant immunoassay, which enables both detection and quantification of hepatitis B e antigen in human serum and plasma. When used alongside other laboratory and clinical data, the assay supports more precise evaluation of hepatitis B infections.

Applications of serological testing continue to broaden, including cancer biomarker identification, inflammation monitoring, and vaccine immunity assessment. Ongoing research focuses on improving test sensitivity, specificity, and multiplexing capabilities. Notably, advancements in autoimmune disease diagnostics are enabling earlier detection and better disease management for conditions such as lupus and rheumatoid arthritis.

Point-of-care serological testing is gaining momentum due to its ability to deliver rapid results at or near the patient site, a critical advantage for infectious disease screening and remote healthcare settings. In August 2021, Mylab Discovery Solutions partnered with Hemex Health to develop advanced POC diagnostic solutions. Under this collaboration, Mylab focuses on assay development while Hemex provides its Gazelle POC testing platform and technical expertise.

Additionally, the integration of serological testing with healthcare IT systems is increasing, enabling streamlined data management, interoperability with electronic health records (EHRs), and improved connectivity across healthcare facilities.

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Market Challenges and Constraints

Despite strong growth prospects, the serological testing market faces several challenges. High equipment and implementation costs, shortages of skilled laboratory professionals, and concerns related to data security and patient privacy can hinder adoption. Maintaining quality control standards, keeping pace with rapid technological changes, and integrating testing platforms with existing EHR systems also present operational and technical difficulties that may limit market expansion.

Regional Insights

Geographically, the market is segmented into North America, Europe, Asia Pacific, and the Rest of the World. North America currently dominates the global serological testing market due to its advanced healthcare infrastructure, supportive regulatory environment, technological leadership, rising prevalence of infectious diseases, and growing elderly population.

Meanwhile, the Asia-Pacific region is expected to experience the fastest growth over the forecast period. Factors such as increasing disease incidence, greater public awareness of diagnostics, expanding healthcare access, and rising healthcare spending are driving rapid market development in this region.

Competitive Landscape

The serological testing market is highly competitive, with key players including Serological Research Institute (SERI), Chembio Diagnostic Systems, Cellex Inc., Advanced Diagnostics, Randox Laboratories, Eurofins Scientific, Abbott, BD, F. Hoffmann-La Roche, ELITechGroup, Immucor, Thermo Fisher Scientific, Beckman Coulter, BioMedomics, and Creative Diagnostics, among others.

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Growth Strategies and Future Outlook

Market participants are actively pursuing both organic and inorganic growth strategies, including product innovation, partnerships, acquisitions, and collaborations. For instance, in November 2023, Roche introduced automated serology tests for hepatitis E virus (HEV), supporting the diagnosis of acute infections in line with the World Health Organization’s 2023 Essential Diagnostics List. Similarly, Siemens Healthineers launched the Atellica CI Analyzer in July 2023, a compact and efficient system designed to optimize laboratory performance and turnaround times.

Overall, the serological testing market is expected to maintain steady growth, driven by increasing emphasis on preventive healthcare, expanding diagnostic applications, continuous technological advancements, and proactive strategic initiatives by key industry players.

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