Global Serological Testing Market Research Report 2024

Serological Testing Market Synopsis

The Serological Testing Market Size Was Valued at USD 4820.35 Million in 2023 and is Projected to Reach USD 8736.10 Million by 2032, Growing at a CAGR of 6.83% From 2024-2032.

Serological testing is the Laboratory Test that is used to check the presence of antibodies or other substances present in a blood sample.

• Serological testing is useful for diagnosing different types of infectious diseases, including viral, bacterial, and parasitic infections. Through the identification of certain antibodies generated by the immune system as a reaction to an infection, serology can detect the existence of a specific pathogen within the body. This helps in identifying illnesses such as HIV, Hepatitis, Lyme disease, and numerous other conditions.
• Serological testing can discover if a person has had previous infections with a particular pathogen. Antibodies may remain in the bloodstream for a long time post-infection, which helps serology detect past exposures. This information is especially beneficial for diseases that have persistent or hidden infections, like tuberculosis.
• Serology Immunity Assessment assists in evaluating individuals' immunity to infectious diseases. Healthcare professionals can use antibody levels to determine if someone has gained immunity from past infection or receiving a vaccine. This data is crucial for comprehending population-wide immunity and for making informed choices regarding public health interventions, like vaccination drives.
• Vaccine effectiveness is essential and serological testing plays a critical role in this process. By examining the levels of antibodies in vaccinated people, researchers can evaluate the vaccine's ability to generate an immune response and determine if it has offered sufficient defense against the specific disease. This assists in the creation of vaccines, improving them, and tracking their effectiveness as time passes. Serological testing is used in organ and blood transplant procedures to establish compatibility between the donor and the recipient.

Top Active Players Involved Are:

“Roche Diagnostics (Switzerland), Abbott Laboratories (United States), Thermo Fisher Scientific (United States), Siemens Healthineers (Germany), Bio-Rad Laboratories (United States), Beckman Coulter (United States), Ortho Clinical Diagnostics (United States), Grifols (Spain), BioMerieux (France), DiaSorin (Italy), Becton, Dickinson and Company (United States), PerkinElmer (United States), Sysmex Corporation (Japan), QIAGEN (Germany), Luminex Corporation (United States), Enzo Life Sciences (United States), Chembio Diagnostic Systems (United States), Fujirebio (Japan), Trinity Biotech (Ireland), Bio-Techne (United States), Meridian Bioscience (United States), Omega Diagnostics Group (United Kingdom), Zeptometrix Corporation (United States), Creative Diagnostics (United States), Viramed Biotech (Germany)  and Other Active Players.”

Serological Testing Market Trend Analysis

Increasing usage of chemiluminescence immunoassay

• chemiluminescence is quickly becoming a favored serological testing method because of its improved accuracy, quick processing, and cost-efficiency. The rising need for accurate and dependable diagnostic tests is fueling the growing adoption of CLIA in the serological testing sector.
• CLIA relies on the detection of light emission. In contrast to other techniques involving radiolabelled substances, CLIA eliminates the risk of radiation exposure for patients and lab personnel. Instead, it uses bioluminescence principles to produce a measurable signal that accurately detects antibodies, antigens, or other analytes of interest. CLIA is very accurate, being able to identify small amounts of substances, which is beneficial for diagnosing infections, detecting hormones, and measuring levels of pharmaceuticals in blood, urine, or saliva samples.
• The rapid turnaround time of CLIA is also contributing to its growing popularity in serological testing. CLIA offers fast results, allowing healthcare workers to quickly start treatments for patients who are found to be positive.
• CLIA machines do not need frequent maintenance, which saves costs compared to other tests like ELISA. The CLIA test equipment is very automated, enabling the conducting of bulk testing for long periods without requiring extra expenses or more workers.
• CLIA demonstrates impressive performance features, such as improved accuracy and consistency, which make it a highly desirable option for serological testing in various clinical environments like major medical facilities, clinics, and labs.
• Chemiluminescence immunoassay is gaining popularity in the serological testing market because of its improved accuracy, quick processing time, and cost efficiency. Its use in identifying infectious diseases, evaluating hormones, and gauging pharmaceutical levels in blood, urine, or saliva samples makes the technology well-regarded in the medical field. Hence, in this way Increasing the usage of chemiluminescence immunoassay acts as a Driver in the Serological Testing Market.

Opportunity

Growing Demand for ELISA

• Enzyme-linked immunosorbent Assay (ELISA) in the serological testing market, creating significant opportunities within the industry. ELISA is a well-known and established diagnostic method that provides many benefits, leading to its widespread use and fostering possibilities for growth and creativity.
• ELISA offers excellent sensitivity, specificity, and precision when identifying and quantifying antibodies or antigens in biological samples. This feature makes it a useful instrument for identifying different infectious diseases, and autoimmune conditions, monitoring hormone levels, and identifying biomarkers linked to cancer or other illnesses. Its widespread use in clinical laboratories and research institutions is due to its reliable results generation.
• ELISA provides versatility when it comes to target analytes and sample varieties. It is possible to personalize it to identify various types of molecules such as proteins, peptides, hormones, antibodies, and others. ELISA is also compatible with different types of samples, such as blood, serum, plasma, urine, and saliva, allowing for a wide range of uses in various medical areas.
• ELISA is a widely recognized method with a strong foundation in terms of supplies, packages, and automated systems offered by multiple companies. The presence and uniformity help simplify adoption, allowing ELISA to be used by various healthcare providers, clinics, and research labs globally.
• ELISA is its ability to easily adjust or increase in size. Efficient analysis of large sample sizes can be carried out in a high-throughput format. This ability to scale up is especially advantageous for large-scale serological studies, epidemiological surveys, and evaluations of vaccine effectiveness that involve processing a substantial quantity of samples.
• The progress in ELISA technology, including the creation of multiplex ELISA systems, has increased its functions. Multiplex ELISA allows for the concurrent identification of numerous analytes in one sample, leading to time and resource savings while decreasing the necessary sample volume. Hence, in this way, the Growing Demand for ELISA acts as an opportunity In Serological Testing Market.

Serological Testing Market Segment Analysis:

The serological Testing market is segmented on the basis of Type, Product, Technology, Application, and End-User.

By Type, Primary Serological Tests Segment Is Expected to Dominate the Market During the Forecast Period

• The serological tests segment is projected to lead the serological testing market because it is favored for diagnostic purposes. Primary serological tests also referred to as screening tests, are created to identify the existence of antibodies or antigens in a patient's blood or other bodily fluids. These examinations are vital in the early detection and identification of different infectious illnesses, like HIV, hepatitis, syphilis, and others. Therefore, they are vital in regular healthcare exams, prenatal screenings, blood donation screenings, and disease surveillance programs at a population level.
• One key factor for the primary serological tests segment being dominant is its capability to offer extensive coverage. These tests are created to identify various antibodies or antigens linked to various illnesses or situations. Their adaptability makes them a top choice for initial screening, enabling healthcare providers to identify possible infections or diseases early on, which helps with prompt treatment and intervention.
• Initial serological tests also provide a high level of sensitivity and specificity, which improves their accuracy in identifying infections. This assists in reducing inaccurate positive or negative results and guarantees trustworthy diagnostic results. Primary serological tests must be accurate to provide reliable health information and help determine subsequent diagnostic and treatment measures.
• Serological tests are frequently more affordable and readily available in comparison to advanced or specialized diagnostic tests. They are easily accessible and their simplicity makes them suitable for use in a range of healthcare environments such as hospitals, clinics, laboratories, and remote or underserved areas. Primary serological tests are ideal for broad usage and mass screening programs due to their simple administration and interpretation. Hence, in this way By Type, Primary Serological Tests Segment Is Expected to Dominate the Serological Testing Market.

By Application, the HIV Segment Held the Largest Share In 2023

• The HIV category dominates the serological testing market because of various factors that drive the high demand for HIV serological tests because companies decided to implement new policies to increase productivity and efficiency. HIV (Human Immunodeficiency Virus) continues to be a significant issue in public health on a worldwide scale, impacting millions of individuals. Timely and precise diagnosis of HIV infections is crucial for managing the disease effectively, preventing transmission, and starting proper treatment. Consequently, there is a high demand for serological tests that are specifically made to detect HIV antibodies or antigens.
• Serological tests are essential in HIV screening and diagnosis processes. They are commonly utilized in the beginning stages of testing to identify the existence of HIV antibodies in the blood, suggesting a possible HIV infection. These assessments are critical in different healthcare environments such as clinics, hospitals, and public health initiatives, facilitating prompt identification and treatment.
• Serological testing for HIV plays a vital role in strategies for prevention and control. Testing high-risk individuals, establishing regular screening programs, and detecting infections early is key in halting the transmission of HIV to sexual partners, infants born to infected mothers, and via blood transfusions. Serological tests are crucial for identifying people who might need pre-exposure prophylaxis or other preventive measures.
• Precise serological testing assists in the appropriate management and treatment of individuals with HIV. Early detection allows for the timely administration of antiretroviral therapy, which effectively manages the disease's advancement and enhances overall health results. Keeping track of HIV antibodies and viral load with serological tests is important for evaluating treatment effectiveness and making necessary therapy adjustments.
• HIV serological tests are essential tools for studying, tracking diseases, and conducting epidemiological research. They assist in monitoring the frequency of HIV in the population. Hence, in this way By Application, the HIV Segment Held the Largest in the Serological Testing Market.

• The total number of people globally living with HIV IN 2019 was 38 million people where it has reached 40.2 million people in 2022. It has become easier for those infected with HIV to live longer lives. Death rates for HIV-positive people are decreasing, mostly due to antiretroviral drugs that have turned the infection into a chronic disease.
  Nevertheless, those with HIV are at a higher risk for conditions such as liver disease, heart disease, and cancer. Medication for HIV has become more widespread and has made HIV a more manageable condition. However, medicine is not widely accessible in the developing world and treatment is still lacking. In Eswatini, around 28 percent of all people between 15 and 49 years are living with HIV, while the percentage is around 18 in South Africa. HIV infections are still especially widespread in Eastern and Southern Africa with 20.8 million people living with the conditionin 2022. In the same year, there were around 2.2 million people in Latin America living with HIV.

Serological Testing Market Regional Insights:

Europe is Expected to Dominate the Market Over the Forecast Period

• Europe is dominating the serological testing market due to the presence of advanced healthcare infrastructure and established healthcare systems in European nations allows for the effective execution of initiatives for serological testing. The area has a strong system of hospitals, labs, and diagnostic centers, making it easier for people to get serological testing services.
• Europe places a significant focus on research and development, with many well-known academic institutions and pharmaceutical companies leading the way in advancing serological testing technologies. This promotes creativity, enabling the ongoing enhancement of testing precision, sensitivity, and specificity. The cooperative spirit within the European scientific community enhances these initiatives, resulting in groundbreaking findings and innovative testing approaches.
• Europe has a tradition of taking early preventative actions in public health, emphasizing the importance of monitoring and managing diseases. European countries are leading the way in the use of serological testing for infectious diseases, such as the current COVID-19 pandemic. Through the use of comprehensive testing methods, Europe hopes to detect and monitor the transmission of infections, direct public health measures, and reduce the consequences of outbreaks.
• European countries focus on investing in healthcare, especially allocating significant funds towards diagnostic technologies. This funding helps set up advanced labs, buy testing equipment, and train healthcare workers to ensure dependable serological testing services are accessible in the area.
• Europe's interconnection through institutions such as the European Union promotes cooperation, exchange of information, and alignment of healthcare policies and regulations. This unity promotes the implementation and uniformity of serological testing methods, guaranteeing reliable and top-notch testing results throughout European nations. Hence, in this way Europe is Expected to Dominate the Serological testing Market.

Serological Testing Market Active Players

• Roche Diagnostics (Switzerland)
• Abbott Laboratories (United States)
• Thermo Fisher Scientific (United States)
• Siemens Healthineers (Germany)
• Bio-Rad Laboratories (United States)
• Beckman Coulter (United States)
• Ortho Clinical Diagnostics (United States)
• Grifols (Spain)
• Biomerieux (France)
• Diasorin (Italy)
• Becton, Dickinson and Company (United States)
• Perkinelmer (United States)
• Sysmex Corporation (Japan)
• Qiagen (Germany)
• Luminex Corporation (United States)
• Enzo Life Sciences (United States)
• Chembio Diagnostic Systems (United States)
• Fujirebio (Japan)
• Trinity Biotech (Ireland)
• Bio-Techne (United States)
• Meridian Bioscience (United States)
• Omega Diagnostics Group (United Kingdom)
• Zeptometrix Corporation (United States)
• Creative Diagnostics (United States)
• Viramed Biotech (Germany) And Other Active Players

Key Industry Developments in the Serological Testing Market:

• In November 2023, Roche announced the launch of the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus (HEV) infections in countries accepting the CE mark. Clinicians can assist their patients in identifying the cause of their symptoms and deciding on the right treatment by conducting tests for HEV infection, monitoring for severe acute HEV progression, and preventing the advancement of severe disease with antiviral medication.
• In May 2023, Pfizer and Thermo Fisher Scientific Inc. announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable. Pfizer will explore ways to enable affordable patient access to NGS testing for these types of cancer and work to raise healthcare provider awareness regarding the benefits of advanced testing.