Global Serological Testing Market Size, Share, Analysis, Forecasts, 2032

Serological Testing Industry Prospective:

The global serological testing market size was worth around USD 4.8 billion in 2023 and is predicted to grow to around USD 8.7 billion by 2032, with a compound annual growth rate (CAGR) of roughly 6.8% between 2024 and 2032. 

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Serological Testing Market: Overview

A patient's sample is searched for antigens and antibodies using diagnostic methods known as serological testing. Among many other purposes, serological tests can be used to ascertain a person's blood type, detect infections and autoimmune illnesses, and find whether one is immune to particular diseases. To investigate evidence from crime scenes, forensic serology could also use serological testing. Among the techniques available to detect antibodies and antigens are ELISA, agglutination, precipitation, complement-fixation, fluorescent antibodies, and, more recently, chemiluminescence.

Key Insights

• As per the analysis shared by our research analyst, the global serological testing market is estimated to grow annually at a CAGR of around 6.8% over the forecast period (2024-2032).
• In terms of revenue, the global serological testing market size was valued at around USD 4.8 billion in 2023 and is projected to reach USD 8.7 billion by 2032.
• The increasing prevalence of infectious diseases is expected to drive the serological testing market over the forecast period.
• Based on the technology, the ELISA segment is expected to dominate the market over the forecast period.
• Based on the product, the consumables and reagents segment is expected to hold the largest market share over the forecast period.
• Based on the application, the hepatitis segment is expected to hold the largest market share over the forecast period.
• Based on the end user, the hospital segment is expected to hold the largest market share over the forecast period.
• Based on region, Europe is expected to dominate the market during the forecast period.

Serological Testing Market: Growth Drivers

Growing cases of COVID-19 drive market growth

Europe was deemed the active center of the coronavirus pandemic in 2019–2020 by the World Health Organization (WHO). Over periods of three to four days, the number of cases by country in Europe doubled; in other countries, mainly those in the early phases of detection, the number doubled every two days.

Therefore, preventing the infection from spreading to the entire population is crucial. Testing is the only way to combat the virus in the face of lockdowns and economic instability. The most accurate method of testing for the virus is serological testing. Serological assays are also making it easier to screen for HIV and hepatitis B. It is anticipated that the rising incidence of viral infections, rising investments from major industry participants and government funds, and rising public awareness of these illnesses will propel the trends of the serological testing market over the forecast period.

Serological Testing Market: Restraints

The high cost of advanced testing technology hinders market growth

One major factor limiting the serological testing industry expansion, particularly in low- and middle-income nations, is the high expense of sophisticated serological testing technology. Complex equipment and proprietary reagents are needed for advanced techniques, including automated ELISA platforms, multiplex assays, and chemiluminescence immunoassays (CLIA), which result in high initial and ongoing expenses. Furthermore, the adoption of advanced testing technology in areas with expanding healthcare requirements is limited since many healthcare facilities in developing nations lack the funding necessary to make such investments.

Serological Testing Market: Opportunities

Increasing product launches offers a lucrative opportunity for market growth

The increasing product launch is expected to offer a lucrative opportunity to the serological testing market during the analysis period. For instance, in November 2023, to detect hepatitis E virus (HEV) infections in nations that recognize the CE mark, Roche announced the introduction of the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays. By testing for HEV infection, doctors can help their patients find the source of their symptoms, choose the best course of action, keep an eye out for the development of severe acute HEV, and stop the condition from getting worse with antiviral therapy.

Serological Testing Market: Challenges

Competition from molecular testing poses a major challenge to market expansion

The serological testing industry is severely constrained by competition from molecular testing techniques. While serological tests rely on identifying antibodies or antigens, which may take years to develop in measurable quantities, molecular tests can identify infections by identifying their genetic material (DNA or RNA) soon after infection. Additionally, compared to certain serological tests, molecular diagnostics—in particular, real-time PCR—have higher sensitivity and specificity, which lowers the possibility of false positives or negatives.

Furthermore, molecular approaches have an advantage in outbreak settings since they may identify a variety of diseases, including rare or emerging types, frequently in a single test. Therefore, the increasing competition from molecular testing poses a major challenge for the industry expansion.

Serological Testing Market: Report Scope

Serological Testing Market: Segmentation

The global serological testing industry is segmented based on technology, product, application, end-user, and region.

Based on technology, the global serological testing market is segmented into ELISA, NAT, CLIA/CMIA and Others. The ELISA segment is expected to dominate the market over the forecast period. Rising cases of diseases such as HIV, hepatitis, and COVID-19 are boosting the demand for ELISA tests due to their reliability in detecting infections.

Based on the product, the global serological testing industry is bifurcated into instruments and consumables & reagents. The consumables and reagents segment is expected to hold the largest market share over the forecast period. Reagents and consumables are essential parts of the serological testing industry and are a major factor in its expansion. Test kits, antibodies, antigens, buffers, enzymes, and detecting systems needed for different serological tests, such as chemiluminescence immunoassays (CLIA), lateral flow assays, and ELISA, are among these products.

Based on the application, the global serological testing market is bifurcated into Hepatitis, Coronavirus (COVID-19), Human Immunodeficiency Virus (HIV), Rotavirus infections, and Others. The Hepatitis segment is expected to dominate the market during the forecast period. The World Health Organization (WHO) estimates that 58 million individuals worldwide have chronic hepatitis C, and over 296 million have chronic hepatitis B, which has led to a significant need for diagnostic tools. The need for testing is further supported by the rise of hepatitis A and E cases in low-resource areas brought on by inadequate sanitation.

Based on the end user, the global serological testing industry is bifurcated into diagnostic laboratories, hospitals, and other end users. The hospital segment is expected to dominate the market during the projected period. Numerous diagnostic tests are performed in hospitals for a range of illnesses, such as autoimmune disorders and infectious diseases such as COVID-19, HIV, and hepatitis. Hospital labs can manage high patient traffic because of their central location. Furthermore, hospitals frequently include sophisticated serological testing equipment, such as chemiluminescent immunoassay (CLIA) systems and automated ELISA, allowing high-sensitivity and high-throughput testing.

Serological Testing Market: Regional Analysis

Europe dominates the market over the projected period

Europe is expected to represent a substantial share of the serological testing market considering the region's well-established healthcare infrastructure, growing incidence of infectious diseases, and aging demographics. Celiac disease cases are driving expansion in the market of the area.

For instance, the Association of European Coeliac Societies (AOECS) projected that 1 in every 100 Europeans would have celiac disease. That ratio led to estimates of over 7 million persons in Europe having celiac disease, although only roughly 25% of them were diagnosed. Serologic testing is rather helpful for patient screening for suspected celiac disease. Early identification is quite important to prevent issues related to celiac disease.

Serological Testing Market: Competitive Analysis

The global serological testing market is dominated by players like:

• Serological Research Institute (SERI)
• Chembio Diagnostics Inc.
• Cellex
• Randox Laboratories Ltd
• Abbott
• Bio-Rad Laboratories Inc.
• BD
• Thermo Fisher Scientific Inc.
• Ortho Clinical Diagnostics
• Quest Diagnostics Incorporated
• Abcam Plc
• F. Hoffmann-La Roche Ltd.
• ELITech Group
• Teleflex Incorporated
• Grifols S.A.
• Global Scientific Company
• Beckman Coulter Inc.
• BIOMEDOMICS INC.
• Creative Diagnostics

The global serological testing market is segmented as follows:

By Technology

• ELISA
• NAT
• CLIA/CMIA
• Others

By Product

• Instruments
• Consumables and Reagents

By Application

• Hepatitis
• Coronavirus (COVID-19)
• Human Immunodeficiency Virus (HIV)
• Rotavirus infections
• Others

By End User

• Diagnostic Laboratories
• Hospitals
• Other End Users

By Region

• North America
  • The U.S.
  • Canada
• Europe
  • France 
  • The UK
  • Spain
  • Germany
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa