Serological Testing Market

The global Serological Testing Market is valued at USD 4.66 Billion in 2023 and is projected to reach a value of USD 8.2 Billion by 2032 at a CAGR (Compound Annual Growth Rate) of 6.5% between 2024 and 2032. The global market is driven by the rising prevalence of infectious diseases, increasing awareness of early diagnosis, advancements in diagnostic technologies, and growing demand for rapid & accurate testing methods.

Key Highlights

• Europe dominated the market in 2023, with 43.5% market share due to the region's well-established healthcare infrastructure, high level of public health awareness, and significant investments in research & development
• Based on Test Type, the Primary Serological Tests segment dominated the market in 2023, driven by their high accuracy, reliability, and widespread use for initial disease diagnosis and antibody detection
• The integration of artificial intelligence (AI) and machine learning in Serological Testing is enhancing diagnostic accuracy, predictive capabilities, and personalized medicine approaches

Test Type Overview

Based on Test Type, the global market is segmented into Primary Serological Tests (Enzyme-Linked Immunosorbent Assay (ELISA), Immunofluorescent Antibody Technique (IFAT), Radio Immunoassay (RIA)), Secondary Serological Tests (Agglutination Tests, Complement Fixation Tests (CFT), Precipitation Tests, Serum Neutralization Tests (SNT), Toxin-antitoxin Tests), and Tertiary Binding Tests).

The Primary Serological Tests segment held the largest revenue share in 2023. Primary testing encompasses major subsegments like enzyme-linked immunosorbent assay (ELISA), immunofluorescent antibody technique (IFAT), and radioimmunoassay (RIA). The demand for ELISA test kits is driven by the need for HIV and pregnancy diagnoses, while IFAT's growth is attributed to the increasing prevalence of chronic diseases, and RIA tests are in demand for their high-quality and accurate results. Secondary Serological Testing, which includes agglutination tests, complement fixation tests (CFT), and precipitation tests, holds the second largest market share due to rising cases of rheumatoid arthritis, autoimmune disorders, and Hepatitis B infections. Primary Testing is expected to remain the fastest-growing segment and achieve the highest CAGR during the forecast period due to the increasing incidence of chronic and infectious diseases and the introduction of new immunoassay products by leading market players.

Regional Overview

Europe dominated the global market with 43.5% of revenue share in 2023. This is attributable to the rising prevalence of infectious diseases, a well-established healthcare infrastructure, and an increasing geriatric population. The growing incidence of coeliac disease is particularly driving market growth in the region. According to the Association of European Coeliac Societies (AOECS), in 2020, approximately 1 in 100 people in Europe were estimated to suffer from coeliac disease, affecting over 7 million people, with only about 25% receiving a diagnosis. Serological Testing plays a key role in screening patients with suspected coeliac disease, where early diagnosis is essential to prevent complications, further boosting the market demand.

The burden of chronic diseases in Europe is also contributing to market growth. According to the European Chronic Disease Alliance, chronic conditions such as heart disease, stroke, cancer, chronic respiratory diseases, and diabetes account for 77% of the total disease burden and 86% of all deaths in the region. In 2020, about 2.7 million people in the 27 European countries were diagnosed with cancer, and nearly 1.3 million died from it, as reported by the Joint Research Centre. This increasing burden of chronic diseases is driving the demand for Serological Testing.

Key Trends

1. Rising Demand for COVID-19 Serological Tests: The COVID-19 pandemic significantly boosted the demand for Serological Testing, particularly for detecting antibodies and assessing immunity levels. This trend is expected to continue as long as COVID-19 remains a public health concern.
2. Advancements in Serological Testing Technologies: Innovations such as multiplex assays, point-of-care testing, and automation in serological tests are driving market growth by improving accuracy, speed, and ease of use.
3. Increased Focus on Infectious Disease Diagnostics: With rising incidences of infectious diseases globally, there is a growing emphasis on Serological Testing for diseases like HIV, hepatitis, and dengue, which is boosting market demand.
4. Rising Awareness and Adoption of Preventive Healthcare: Increasing public awareness of the importance of early disease detection and prevention is leading to greater adoption of serological tests as part of routine health check-ups.
5. Regulatory Approvals and Support for New Tests: Supportive regulatory frameworks and faster approvals of new serological tests by health authorities like the FDA and EMA are accelerating the introduction of advanced tests in the market.

Market Dynamics

Significance of Serological Tests in COVID-19 Detection

Serological tests play a crucial role in providing additional insights into possible prior exposure to SARS-CoV-2, particularly since many infections are mild or asymptomatic. These tests analyze blood, serum, or plasma samples for the presence of immunoglobulin M (IgM) & Immunoglobulin G (IgG) antibodies associated with COVID-19. The detection of IgM antibodies typically indicates recent exposure to the virus, while the presence of IgG antibodies suggests a later stage of infection. This combined antibody test can also help determine the stage of the disease in patients.

Key Drivers and Restraints Shaping the Serology Testing Market

The serology testing market is mainly driven by the rising incidence of COVID-19 cases worldwide and increasing healthcare expenditures. However, the growth of the global serology testing market is expected to be hampered by a shortage of serology test kits. On the other hand, the presence of numerous market players offering serology products, growing R&D investments in COVID-19 analysis kits, and supportive government initiatives to advance research in this field are anticipated to drive market demand. For instance, the NCI Serological Sciences Network (SeroNet) represents the United States largest coordinated effort to study the immune response to COVID-19. This network focuses on developing, validating, improving, and implementing Serological Testing and related technologies, which is expected to fuel market growth during the forecast period.

ELISA: Dominating the Serology Testing Market

ELISA is in high demand and leads the market due to its quick turnaround time, long shelf life of reagents, affordability, and cost-effective reagents. It is widely used for infectious disease screenings, offering high specificity and sensitivity, while ELISA analyzers are also relatively inexpensive. The advancements in technology, simplified procedures, and the high precision in screening contribute to the growth of the ELISA testing segment.

Impact of Rising Tuberculosis Incidence on Serological Testing Demand

The rising incidence of tuberculosis (TB) has further driven the demand for Serological Testing. In recent years, TB cases have increased significantly; for instance, India reported a TB incidence of 210 per 100,000 population in 2023, compared to the baseline year of 2015. This marked an 18% deterioration, with an incidence of 256 per lakh population. TB is now the 13th leading cause of death globally and the second deadliest infectious disease after COVID-19.

Product Innovations Driving the Market Growth

The growth of the market is propelled by new product launches by major players in the region. For example, in 2020, F. Hoffmann-La Roche Ltd. introduced the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in individuals exposed to the virus. Also, in May 2020, IDvet launched a new serological test based on the ELISA technique to detect antibodies against COVID-19, designed for high-volume laboratory testing. In April 2020, Eurofins Technologies announced the CE-IVD marking of serology-based antibody detection kits by ELISA for patients exposed to COVID-19, developed by affiliate companies such as Gold Standard Diagnostics Inc., ENVIROTECH Diagnostics GmbH, NovaTec Immundiagnostica GmbH, and Ingenasa. Such innovative product launches for various bacterial and viral infections are expected to create significant growth opportunities for the Serological Testing market.

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Competitive Landscape

The market is fragmented, with numerous global & regional companies operating within it. The competitive landscape features an analysis of both international & local players who hold significant market shares and are well-recognized. To enhance their market presence, these companies are focused on developing and launching innovative products. For example, in July 2023, Siemens Healthineers launched the Atellica CI Analyzer, a compact system designed to tackle laboratory challenges. This analyzer incorporates unique features aimed at reducing downtime, boosting laboratory efficiency, and increasing profitability.

In 2020, Bio-Rad Laboratories, Inc. introduced its in vitro diagnostics VIROTROL SARS-CoV-2 and VIROCLEAR SARS-CoV-2 quality controls for antibody testing of SARS-CoV-2, the virus responsible for COVID-19. Furthermore, in 2021, a new serological test for COVID-19 antibodies was released, developed by researchers from the Spanish Council for Scientific Research (CSIC) in collaboration with Madrid's La Princesa and La Paz hospitals, and produced by the Spanish biotech firm Immunostep. Such product launches are anticipated to boost segment revenue throughout the forecast period.

Recent Market Developments

• In November 2023, Roche unveiled automated serology tests for the hepatitis E virus (HEV), encompassing a diagnostic assay designed to identify acute HEV infections. The test aligns with the recommendations outlined in the recently updated 2023 Essential Diagnostics List by the World Health Organization (WHO).
• In November 2023, Roche introduced Elecsys HBeAg quant, an immunoassay capable of simultaneously detecting the presence and measuring the quantity of the hepatitis B e antigen (HBeAg) in human serum and plasma. This new assay enables patients to receive confirmation regarding the presence and extent of hepatitis B (HBV) when combined with other laboratory results and clinical information.

The global Serological Testing market can be categorized as Test Type, Application, End-user, and Region.