Serological Testing Market Size, Share, Opportunities, And Trends By Test Type (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, Tertiary Binding Tests)), By Application (Rotavirus, Hepatitis, HIV, Endotoxins, Therapeutic Drug Monitoring, Other Infectious Diseases), By End-Users (Hospitals And Clinics, Diagnostic Laboratories, Blood Banks, Others), And By Geography - Forecasts From 2023 To 2028

  • Published : Dec 2023
  • Report Code : KSI061615692
  • Pages : 150

The serological testing market is estimated to grow at a CAGR of 4.50% during the forecast period.

Serological testing is a laboratory test that analyses a blood sample to detect the presence of antibodies or other substances, providing valuable information about a person's immune response. The serological testing industry caters to the needs of medical institutions such as hospitals, clinics, diagnostic laboratories, and blood banks that rely on such testing for accurate diagnoses, monitoring patient health, and ensuring the safety of blood transfusions. The growing establishment of new hospitals and blood banks play vital roles as prominent drivers in augmenting the serological testing market size.

Booming blood bank establishment bolsters the serological testing market growth.

 Serological testing is done in blood banks to ensure the safety of donated blood and blood products. These tests help identify the presence of specific antibodies or antigens in the blood samples. Blood banks are responsible for conducting serological tests to screen donated blood for infectious diseases, such as HIV, hepatitis B and C, syphilis, and other transfusion-transmissible infections.

The rise in hospitals' strength drives the serological market expansion.

 Serological testing is used in hospitals as it provides crucial information about a patient's immune response, aiding in accurate diagnoses and monitoring of various diseases. Hospitals rely on serological tests to identify antibodies, detect infectious agents, assess vaccination status, and determine immune system function. The increasing demand for serological testing in hospitals is driven by the growing prevalence of infectious diseases and as hospitals continue to expand, demand for serological testing rises. According to the American Hospital Association, the total number of hospitals in the United States experienced an increase in 2023, reaching 6,129, compared to the previous count of 6,090 hospitals in 2021.

An increase in public health initiatives drives the serological testing market growth.

Serological testing due to its ability to identify the presence of antibodies in blood samples is experiencing a boost in public health checkups. Governments worldwide are investing in testing infrastructure, research, and development, and screening programs to control disease outbreaks, monitor population immunity, and ensure blood safety which is accelerating the demand for serological testing. According to the World Health Organization, in 2020, the United States extended a significant contribution of $84 million to WHO and UNICEF which played a vital role in bolstering global surveillance, sustaining the laboratory network, procuring vaccines, providing technical assistance to countries, and fostering community mobilization efforts.

 Asia-Pacific is estimated to dominate the market.

 Asia-Pacific will hold a significant share of the serological testing market as the region is experiencing rapid expansion in its healthcare sector, infrastructure development, medical facilities, and technological advancements. This growth is fuelling the demand for serological testing as a critical diagnostic tool. Moreover, government investments in healthcare policies and public health campaigns further support the growth of the serological testing industry in Asia-Pacific. For instance, in the Union Budget 2023-24, the Ministry of Health and Family Welfare received an allocation of Rs. 89,155 crore representing a growth of 3.43% from the previous year's allocation of Rs. 86,200.65 crore in 2021-22.

High cost restrains the serological testing market growth.

 The cost of serological tests can be a significant hindrance to their adoption, particularly in regions with limited healthcare budgets or where reimbursement systems do not adequately cover these tests. This challenge is particularly pronounced when advanced technologies or multiplex assays are used, as they often involve higher expenses. The high cost of testing acts as a barrier, limiting access to serological testing and preventing its widespread utilization, especially in resource-constrained settings where budgetary constraints play a crucial role in healthcare decision-making.

 Key Developments

  • May 2020: Thermo Fisher Scientific Inc. revealed its plans to further expand its efforts in response to the COVID-19 pandemic through a collaboration with WuXi Diagnostics and Mayo Clinic. This collaboration aims to develop a comprehensive total antibodies test for COVID-19. The combined expertise of all three organizations, including the clinical evaluation and support provided by the Mayo Clinic, has been instrumental in the development of this new serology test. By leveraging their collective capabilities, Thermo Fisher Scientific, WuXi Diagnostics, and Mayo Clinic are working together to enhance diagnostic capabilities and contribute to the ongoing global response against COVID-19.
  • April 2020: Eurofins Technologies introduced a range of CE-IVD marked serologic products designed to detect antibodies in individuals who have been exposed to the SARS-CoV-2 virus, which causes COVID-19. These newly launched products provide reliable and validated testing solutions to assess the immune response in patients, aiding in the diagnosis, monitoring, and management of COVID-19 cases. Eurofins Technologies' expansion of its serologic product portfolio strengthens the global fight against the pandemic by enhancing the availability of accurate serological testing options for healthcare providers.
  • April 2020: Roche, a leading healthcare company, developed the Elecsys Anti-SARS-CoV-2 serology test, a cutting-edge diagnostic tool that enables the detection of antibodies against the SARS-CoV-2 virus, responsible for COVID-19. This innovative serology test plays a vital role in identifying individuals who have been exposed to the virus and assessing their immune response. By determining the presence of antibodies, healthcare professionals can gain insights into a person's potential immunity against COVID-19, aiding in treatment decisions and providing valuable information for public health strategies.
  • March 2020: BD (Becton, Dickinson, and Company), a renowned global medical technology company, unveiled the Rapid Serology Test, an innovative point-of-care test that swiftly detects antibodies in blood to confirm recent or prior exposure to COVID-19. This breakthrough test provides results within a mere 15 minutes, enabling healthcare professionals to swiftly diagnose and determine the immune response of individuals. BD's introduction of the Rapid Serology Test strengthens the fight against the pandemic by offering a rapid and efficient serological testing solution.

Serological Testing Market Scope:


Report Metric Details
Growth Rate CAGR of 4.50% from 2021 to 2028
Base Year 2021
Forecast Period 2023 – 2028
Forecast Unit (Value) USD Billion
Segments Covered Test Type, Application, End-Users, and Geography
Regions Covered North America, South America, Europe, Middle East and Africa, Asia Pacific
Companies Covered 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
Customization Scope Free report customization with purchase



  • By Test Type
    • 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
      • Tertiary Binding Tests
  • By Application
    • Rotavirus
    • Hepatitis
    • HIV
    • Endotoxins
    • Therapeutic Drug Monitoring
    • Other Infectious Diseases
  • By End-Users
    • Hospitals and Clinics
    • Diagnostic Laboratories
    • Blood Banks
    • Others
  • By Geography
    • North America
      • United States
      • Canada
      • Mexico
    • South America
      • Brazil
      • Argentina
      • Others
    • Europe
      • United Kingdom
      • Germany
      • France
      • Spain
      • Others
    • Middle East and Africa
      • Saudi Arabia
      • UAE
      • Israel
      • Others
    • Asia Pacific
      • Japan
      • China
      • India
      • South Korea
      • Indonesia
      • Thailand
      • Others


1.1. Market Overview

1.2. Market Definition

1.3. Scope of the Study

1.4. Market Segmentation

1.5. Currency

1.6. Assumptions

1.7. Base, and Forecast Years Timeline


2.1. Research Data

2.2. Assumptions


3.1. Research Highlights


4.1. Market Drivers

4.2. Market Restraints

4.3. Porter’s Five Force Analysis

4.3.1. Bargaining Power of Suppliers

4.3.2. Bargaining Power of Buyers

4.3.3. Threat of New Entrants

4.3.4. Threat of Substitutes

4.3.5. Competitive Rivalry in the Industry

4.4. Industry Value Chain Analysis


5.1. Introduction

5.2. Primary Serological Tests

5.2.1. Enzyme Linked Immunosorbent Assay (ELISA)

5.2.2. Immunofluorescent Antibody Technique (IFAT)

5.2.3. Radio Immunoassay (RIA)

5.3. Secondary Serological Tests

5.3.1. Agglutination Tests

5.3.2. Complement Fixation Tests (CFT)

5.3.3. Precipitation Tests

5.4. Serum Neutralization Tests (SNT)

5.4.1. Toxin-antitoxin Tests

5.4.2. Tertiary Binding Tests


6.1. Introduction

6.2. Rotavirus Infections

6.3. Hepatitis

6.4. HIV

6.5. Endotoxins

6.6. Therapeutic Drug Monitoring

6.7. Other Infectious Diseases


7.1. Introduction

7.2. Hospital and Clinics

7.3. Diagnostic Laboratories

7.4. Blood Banks

7.5. Diagnostic Laboratories

7.6. Others


8.1. Introduction

8.2. North America

8.2.1. United States

8.2.2. Canada

8.2.3. Mexico

8.3. South America

8.3.1. Brazil

8.3.2. Argentina

8.3.3. Others

8.4. Europe

8.4.1. United Kingdom

8.4.2. Germany

8.4.3. France

8.4.4. Spain

8.4.5. Others

8.5. The Middle East and Africa

8.5.1. Saudi Arabia

8.5.2. UAE

8.5.3. Israel

8.5.4. Others

8.6. Asia Pacific

8.6.1. Japan

8.6.2. China

8.6.3. India

8.6.4. South Korea

8.6.5. Indonesia

8.6.6. Thailand

8.6.7. Others


9.1. Major Players and Strategy Analysis

9.2. Market Share Analysis

9.3. Mergers, Acquisitions, Agreements, and Collaborations


10.1. Serological Research Institute (SERI) (U.K.)

10.2. Chembio Diagnostics, Inc (U.S.)

10.3. Cellex (U.S.)

10.4. Randox Laboratories Ltd (U.K.)

10.5.  Abbott (U.S.)

10.6. Bio-Rad Laboratories Inc. (U.S.)

10.7. BD (U.S.)

10.8. Thermo Fisher Scientific Inc. (U.S.)

10.9. Ortho Clinical Diagnostics (U.S.)

10.10. Quest Diagnostics Incorporated (U.S.)

Serological Research Institute (SERI) (U.K.)

Chembio Diagnostics, Inc (U.S.)

Cellex (U.S.)

Randox Laboratories Ltd (U.K.)

Abbott (U.S.)

Bio-Rad Laboratories Inc. (U.S.)

BD (U.S.)

Thermo Fisher Scientific Inc. (U.S.)

Ortho Clinical Diagnostics (U.S.)

Quest Diagnostics Incorporated (U.S.)