Global Serological Testing Market 2024–2033

Reports Description

As per the current market research conducted by the CMI Team, the global Serological Testing Market is expected to record a CAGR of 6.70% from 2024 to 2033. In 2024, the market size is projected to reach a valuation of USD 5,150 Million. By 2033, the valuation is anticipated to reach USD 8,100 Million.

The growing geriatric population contributes significantly to the expansion of the serological testing market by increasing demand for diagnostic tools that detect age-related diseases. As elderly individuals are more prone to chronic conditions like cancer, autoimmune disorders, and infectious diseases, there is a heightened need for accurate serological tests to diagnose and monitor these ailments.

This demographic shift drives innovation in serological testing technologies and fuels market growth as healthcare providers seek reliable methods to address the complex health challenges associated with aging populations.

Serological Testing Market – Significant Growth Factors

The Serological Testing Market presents significant growth opportunities due to several factors:

• Increasing Demand for Diagnostic Testing: There is an increasing demand for accurate and reliable diagnostic tests throughout the healthcare sector, fueled by the need for early detection and effective management of diseases.

• Rising Incidence of Infectious Diseases: The prevalence of infectious illnesses such as HIV, hepatitis, and COVID-19 has fuelled the demand for serological testing to diagnose, screen, and monitor these medical conditions.

• Advancements in Technology: Technological developments in serological testing procedures have enhanced test accuracy, speed, and efficiency, making them more accessible and reliable to healthcare practitioners.

• Growing Awareness and Screening Programs: Public health initiatives and awareness campaigns have boosted the acceptance of serological testing as a component of routine health check-ups and disease prevention programs.

• Expanding Applications in Research and Development: Serological testing is critical in research and development efforts, such as vaccine development, epidemiological investigations, and understanding disease prevalence and transmission trends.

• Increased Healthcare Expenditure: Rising worldwide healthcare spending has prompted investments in diagnostic technology, such as serological testing platforms, consequently expanding the market.

• Point-of-Care Testing (POCT) Advancements: Advances in POCT technology have made serological tests more accessible in a variety of healthcare settings, including clinics, emergency departments, and remote locations, resulting in market expansion.

Serological Testing Market – Facility Expansion and Product Launch

The Serological Testing Market has seen several facility expansions and testing kit developments in recent years, with companies seeking to expand their market presence and leverage synergies to improve their product offerings and profitability. Some notable examples of facility expansion and product launch in the Serological Testing Market include:

• In August 2023, the American Institute of Pathology & Laboratory Sciences Pvt Ltd (Ampath) opened its first reference laboratory in Gurgaon, expanding its presence in North India. This 7,000 sqft lab, Ampath’s second in India, boasts advanced technology for quick, high-quality reports. Serving Delhi and neighbouring states, it offers over 2,500 tests in various specialties, supervised by experienced pathologists, creating an independent diagnostic ecosystem.

• In November 2023, Agilus Diagnostics, a Fortis Healthcare Limited subsidiary, launched a cutting-edge laboratory in Bongaigaon, Assam. Covering 2,000 square feet, the lab can process over 25,000 samples monthly and offers over 3,000 tests, including routine and specialized diagnostics. The facility includes divisions such as Hematology, Biochemistry, Clinical Pathology, Serology, and Microbiology, meeting the region’s growing demand for high-quality diagnostic services and preventive healthcare packages.

• In October 2022, LordsMed, part of Lord’s Mark Industries, inaugurated an IVD manufacturing facility in Vasai near Mumbai. The 20,000 sq ft facility features advanced technologies and infrastructure meeting global standards. It will produce various IVD and point-of-care diagnostic solutions, including analyzers, reagents for clinical biochemistry, haematology, serology, immunology, rapid testing kits (ICMR approved antigen kits), and lab consumables.

• In November 2023, Roche launched the Elecsys® Anti-HEV IgM and Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections in CE mark-accepting countries. The Anti-HEV IgM assay detects acute or recent HEV infections, while the Anti-HEV IgG assay identifies recent or past infections. Both assays can be used with cobas® e 411, e 601/602, e 402, and e 801 analyzers.

• In February 2022, Thermo Fisher Scientific introduced two bead-based ELISA solutions for faster and simpler detection of SARS-CoV-2 antibodies. Unlike traditional methods with lengthy protocols, the Invitrogen Dynabeads SARS-CoV-2 Spike ELISA kits detect and quantify human antibodies from serum or plasma in just 45 minutes. The new plates-to-beads concept enhances binding kinetics by capturing antibodies in suspension, streamlining the serological research process.

These facility expansions and testing kit development drive the growth of the Serological Testing Market by enhancing production capacity, ensuring rapid and accurate diagnostics, and meeting increasing demand. These advancements facilitate broader testing availability, improved disease detection, and effective management, thereby boosting market expansion and technological innovation.

COMPARATIVE ANALYSIS OF THE RELATED MARKET

Serological Testing Market – Significant Threats

The Serological Testing Market faces several significant threats that could impact its growth and profitability in the future. Some of these threats include:

• Accuracy and Reliability Concerns: Serological test accuracy and reliability can be challenging, particularly when dealing with complicated diseases or populations with various genetic backgrounds. False positives and false negatives may affect confidence in test results.

• Regulatory Challenges: Stringent regulatory requirements can delay the approval and market entry of new serological tests. Changes in regulatory guidelines or unexpected regulatory hurdles can also affect the market landscape.

• Competitive Market Dynamics: The market for serological testing is competitive, with numerous companies offering similar products. This competition can lead to pricing pressures and innovation becoming a key factor in maintaining market share.

• Emergence of Alternative Technologies: Advances in alternative diagnostic technologies, such as molecular diagnostics (PCR-based tests) or point-of-care testing (rapid diagnostic tests), pose a threat to traditional serological testing methods. These alternatives may offer faster results or higher sensitivity and specificity.

• Public Perception and Acceptance: Public perception of serological tests, especially during public health crises or outbreaks, can influence their adoption and use. Negative perceptions or misinformation can impact testing rates and market demand.

• Emergence of New Diseases: The unpredictability of new disease outbreaks or pandemics can shift focus away from existing serological tests towards developing tests for emerging infectious agents, impacting market dynamics.

Category-Wise Insights:

By Technology

• ELISA: ELISA (Enzyme-Linked Immunosorbent Assay) is an important tool in serological testing that detects antibodies or antigens in biological samples. It includes supplying a target antigen or antibody to a solid surface, followed by a succession of enzyme-linked events that result in a visible signal. ELISA is commonly used to diagnose viral infections (such as HIV and COVID-19), monitor autoimmune disorders, and detect allergens in food. Its sensitivity and specificity make it indispensable in clinical and research environments.

• NAT: NAT (Nucleic Acid Testing) in serological testing detects viral genetic material (RNA/DNA) instead of antibodies. It is critical for the early diagnosis of infections such as HIV, hepatitis, and COVID-19, with excellent sensitivity and specificity. NAT is used to screen blood donations, diagnose acute infections, and track patients’ viral loads. Its accuracy in detecting low virus levels makes it critical for blood safety and timely medical interventions.

• CLIA/CMIA: NAT (Nucleic Acid Testing) in serological testing detects viral genetic material (RNA/DNA) instead of antibodies. It is critical for the early diagnosis of infections such as HIV, hepatitis, and COVID-19, with excellent sensitivity and specificity. NAT is used to screen blood donations, diagnose acute infections, and track patients’ viral infections. Its accuracy in detecting low virus levels makes it critical for blood safety and timely medical interventions.

By Product

• Instruments: Serological testing instruments are machines that analyse blood serum for antibodies or antigens associated with certain infections or illnesses. These tools are critical in identifying infectious infections, and autoimmune disorders, and evaluating immunological responses to immunisations They allow healthcare workers to detect and identify antibodies produced by the immune system, which helps with illness surveillance, patient management, and epidemiological investigations. Serological testing instruments are critical tools in clinical and research settings to examine immunity and treat infectious diseases.

• Consumables: Serological testing consumables include a variety of instruments and supplies for performing tests that detect antibodies or antigens in blood serum. These consumables usually include test kits, reagents, sample collection devices, and assay plates. They play an important role in diagnostics, helping to identify infectious infections, autoimmune disorders, and immunological responses to vaccinations. Serological testing consumables serve an important role in healthcare as they allow for accurate disease identification and surveillance via antibody-antigen interactions in patient samples.

• Reagents: Serological testing reagents are substances used to detect specific antibodies or antigens in biological samples like blood. These reagents play a crucial role in diagnosing infectious diseases, and autoimmune disorders, and monitoring immune responses to vaccines. By identifying antibodies produced in response to pathogens or other substances, serological testing helps in determining a person’s immune status, aiding in disease diagnosis, epidemiological studies, and vaccine efficacy assessments.

By Application

• Rotavirus Infections: Serological testing in rotavirus infections is essential for diagnosis and monitoring. It helps in the detection of antibodies against certain rotavirus strains, which helps doctors understand transmission patterns. Serology also contributes to vaccine efficacy assessments by assessing immune responses after vaccination. Furthermore, it contributes to public health efforts by identifying vulnerable people and measuring the effectiveness of immunisation campaigns. Overall, serological testing is critical for monitoring rotavirus infection dynamics and evaluating methods of treatment.

• Hepatitis: Serological testing in hepatitis is crucial for diagnosis and management. It detects specific antibodies and antigens related to hepatitis viruses (A, B, C, etc.), aiding in accurate diagnosis of the infection stage, immunity status, and potential for chronicity. This information guides treatment decisions, patient counselling, and epidemiological studies. Serology also plays a key role in screening blood donations to prevent transmission and in evaluating vaccine effectiveness.

• HIV: Serological testing for HIV is crucial for diagnosing infection by finding antibodies to the virus in blood. It helps in the screening of high-risk individuals, monitoring disease development, and evaluating therapy response. Serology also helps epidemiologists track the prevalence and dissemination of HIV. It also helps public health programmes by identifying individuals with diseases who could benefit from counselling, preventative measures, and early medical intervention to reduce transmission and improve outcomes.

• Endotoxins: Serological testing for endotoxins involves detecting antibodies produced in response to exposure to bacterial endotoxins. It finds applications in pharmaceutical and biomedical industries to ensure product safety. By identifying endotoxin-specific antibodies in serum samples, serological testing helps monitor contamination levels in manufacturing processes and assesses immune responses in research settings. This method aids in the quality control of medical devices, pharmaceuticals, and biological products, ensuring compliance with regulatory standards.

• Therapeutic Drug Monitoring: Serological testing plays a crucial role in therapeutic drug monitoring by determining drug levels and detecting antibodies against therapeutic agents. This helps optimize dosage regimens, make sure drug efficacy, and minimize toxicity in patients undergoing long-term treatment. Monitoring medication concentrations in serum allows doctors to make educated decisions about personalising therapy, modifying doses, and assessing patient adherence to treatment guidelines, ultimately enhancing therapeutic outcomes and patient safety.

By End-user

• Diagnostic Laboratories: Serological testing in diagnostic laboratories is crucial for detecting antibodies in patient serum or plasma. It helps diagnose infectious diseases such as HIV, hepatitis, and COVID-19 by identifying specific antibodies produced in response to pathogens. This method aids in determining past infections, immune status, and monitoring vaccine efficacy. Serological tests also play a role in autoimmune disease diagnosis by detecting autoantibodies targeting the body’s tissues, aiding in appropriate treatment and management strategies.

• Hospitals: Serological testing in hospitals is crucial for diagnosing infectious diseases by detecting antibodies produced in response to pathogens like viruses or bacteria. It helps determine a patient’s immune status, track disease progression, and assess vaccine efficacy. These tests aid in confirming diagnoses, guiding treatment decisions, and assessing population-level immunity during outbreaks. Serological testing also plays a pivotal role in monitoring the spread of diseases like COVID-19 and informs public health strategies for disease control and prevention.

Report Scope

Serological Testing Market – Regional Analysis

The Serological Testing Market is segmented into various regions, including North America, Europe, Asia-Pacific, and LAMEA. Here is a brief overview of each region:

• North America: In North America, the serological testing market is witnessing several key trends. Firstly, there is an increasing demand for COVID-19 antibody testing, which is being driven by continuing surveillance initiatives and vaccine effectiveness examinations. Second, advances in assay technology, such as automated platforms and multiplex assays, improve testing efficiency and accuracy. Third, there is a shift towards point-of-care testing solutions that enable quick and decentralised testing capabilities. Furthermore, more awareness and adoption of personalised medicine approaches are influencing the industry, particularly targeted therapies and patient-specific treatment regimens. These trends influence the changing environment of serological testing in North America.

• Europe: The growth of the Serological Testing Market in Europe is supported by several key factors. These include rising disease rates, increased demand for early detection, advances in laboratory technology, and a strong healthcare infrastructure. Furthermore, the region’s emphasis on preventive healthcare measures and proactive screening programmes promotes market growth. Furthermore, the increasing use of serological testing in vaccine and pharmaceutical research and development drives market expansion in Europe.

• Asia-Pacific: The Serological Testing Market in Asia-Pacific is driven by several key trends. These include the increasing prevalence of infectious diseases necessitating reliable diagnostic tools, rising healthcare expenditure and infrastructure development, and growing awareness and adoption of advanced medical technologies. Additionally, expanding initiatives for early disease detection and management, alongside robust investments in healthcare R&D, further bolster market growth. Moreover, the COVID-19 pandemic has underscored the importance of serological testing, fostered innovation and enhanced market opportunities in the region.

• LAMEA (Latin America, Middle East, and Africa): In the LAMEA region, the growth of the Serological Testing Market is supported by a number of important factors. These include increased awareness of infectious diseases, expanding healthcare infrastructure, increasing healthcare costs, and a growing desire for precision diagnostic technologies. Furthermore, technological improvements, especially in immunodiagnostics and antibody testing, help to drive market growth. Furthermore, government measures to improve healthcare access and the incidence of chronic diseases drive the demand for serological testing in the LAMEA area.

Competitive Landscape – Serological Testing Market

The Serological Testing Market is highly competitive, with a large number of manufacturers and retailers operating globally. Some of the key players in the market include:

• Serological Research Institute (SERI)
• Chembio Diagnostics Inc
• Randox Laboratories Ltd
• Abbott Laboratories
• Bio-Rad Laboratories Inc.
• Thermo Fisher Scientific Inc.
• Ortho Clinical Diagnostics
• Quest Diagnostics Incorporated
• Abcam Plc
• Hoffmann-La Roche Ltd.
• ELITechGroup
• Teleflex Incorporated
• Grifols S.A.
• Global Scientific Company
• Beckman Coulter Inc.
• Biomedomics Inc.
• Others

These companies operate in the market through various strategies such as facility expansion and testing kit development.

New players in the serological testing market focus on innovation, offering advanced assay technologies with high sensitivity and specificity. They emphasize cost-effectiveness, rapid results, and scalability, targeting niche applications and strategic partnerships to expand their market presence and drive growth.

Key players in the serological testing market focus on expanding product portfolios, enhancing R&D efforts for innovative tests, strengthening distribution networks, and strategic collaborations to foster market growth and meet evolving healthcare demands.

The 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

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America