Global Serological Testing Market Size Likely to Grow at a CAGR of 6.70% By 2033

As per the current market research conducted by the CMI Team, the global Serological Testing Market size 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.

Serological Testing Market: Growth Factors and Dynamics

• 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 fueled 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: Partnership and Acquisitions

• 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.

Report Scope

Serological Testing Market: COVID-19 Analysis

The COVID-19 pandemic has significantly impacted the Serological Testing Market, with the industry experiencing both positive and negative effects. Here are some of the key impacts:

• Supply Chain Disruptions: Early in the pandemic, there were disruptions in the supply chain for serological testing kits, affecting availability and distribution globally.

• Quality Concerns: With the rush to meet demand, some serological tests initially had issues with accuracy and reliability. This raised concerns about false positives/negatives and quality control.

• Regulatory Challenges: Rapidly changing regulatory requirements and approvals posed challenges for manufacturers, delaying market entry for some products and increasing compliance costs.

• Market Saturation: As the initial surge in demand subsides and vaccination rates increase, the market for COVID-19 serological tests may experience saturation, impacting future growth prospects.

• Increased Demand: The pandemic led to a surge in demand for serological tests to detect antibodies against SARS-CoV-2, the virus causing COVID-19. This sudden demand boosted the market size and revenue for companies producing serological testing kits.

• Technological Advancements: The urgency of the pandemic accelerated research and development in serological testing technologies. This has led to innovations in assay sensitivity, specificity, and rapid test development, benefiting the overall market.

• Market Expansion: The pandemic highlighted the importance of serological testing not only for COVID-19 but also for other infectious diseases and immune-related conditions. This awareness has expanded the potential market beyond infectious diseases.

In conclusion, the COVID-19 pandemic has had a mixed impact on the Serological Testing Market, with some challenges and opportunities arising from the pandemic.

List of the prominent players in the Serological Testing Market:

• 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

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