Global Enzyme-Linked Immunosorbent Assay (ELISA) Tests Market – Industry Trends and Forecast to 2031

Enzyme-Linked Immunosorbent Assay (ELISA) Tests Market Analysis and Size

The rising prevalence of infectious diseases, such as HIV/AIDS, hepatitis, and Lyme disease, is fueling the demand for ELISA tests for early and accurate diagnosis. The rising prevalence of infectious diseases, as highlighted by WHO data updated in July 2022, has led to an increased demand for diagnostic tools such as ELISA test. An estimated 37.7 million people were living with HIV globally at the end of 2020, with over two-thirds of them (25.6 million) residing in the African region. In addition, dengue fever has emerged as one of the top ten global health threats, with a 30-fold increase in global incidence over the past 50 years. World Health Organization updates from June 2022 indicate that over 354 million people worldwide are affected by Hepatitis B or C infections. This escalating incidence of infectious diseases underscores the growing need for accurate and timely diagnosis.

Global enzyme-linked immunosorbent assay (ELISA) tests market size was valued at USD 2.52 billion in 2023 and is projected to reach USD 4.40 billion by 2031, with a CAGR of 7.23% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation       

Market Definition

ELISA (Enzyme-Linked Immunosorbent Assay) tests are a type of biochemical assay technique used to detect the presence of an antigen or antibody in a sample. This highly sensitive method relies on the interaction between an enzyme-linked antibody or antigen and a substrate to produce a measurable signal, typically a color change. ELISA tests are widely used in medical diagnostics, research laboratories, and the pharmaceutical industry for various purposes, including the detection of infectious diseases, monitoring of drug levels in the blood, and quantification of specific proteins.      

Enzyme-Linked Immunosorbent Assay (ELISA) Tests Market Dynamics

Drivers

• Increasing Prevalence of Chronic and Infectious Diseases 

The increasing prevalence of chronic and infectious diseases such as HIV/AIDS, hepatitis, cancer, and autoimmune disorders highlights the critical need for accurate and early diagnosis, a role in which ELISA tests excel. The GLOBOCAN 2020 report indicates that approximately 2,281,658 cases of cancer were recorded in the U.S. in 2020. This number is projected to increase to 3,123,452 cases by 2040. According to the National Diabetes Statistics Report, approximately 37.3 million individuals in the U.S. were diagnosed with diabetes in 2020, with approximately 96 million adults found to have pre-diabetes. As the burden of these diseases continues to rise worldwide, ELISA tests such as elisa test for hiv play a crucial role in disease management and monitoring, making them a fundamental tool in healthcare systems. These diseases require timely and precise monitoring for effective management and treatment, driving the demand for ELISA tests globally.

• Rising Demand for Early and Accurate Disease Diagnosis

There is a rising demand for early and accurate disease diagnosis across various medical fields. ELISA tests are renowned for their high sensitivity and specificity, making them indispensable for early disease detection and monitoring treatment efficacy and increasing application of elisa test. This growing demand for precise diagnostic tools is a major driver for the expansion of the ELISA tests market, as healthcare providers and patients alike seek reliable methods for detecting and managing diseases at their earliest stages.

Opportunities

• Development of Multiplex ELISA Assays   

Multiplex assays offer advantages such as reduced sample volume, lower costs, and increased efficiency, making them attractive for various clinical and research applications. The ability to simultaneously measure multiple biomarkers is particularly beneficial in disease profiling and personalized medicine. The development of multiplex ELISA assays, which can detect multiple analytes in a single sample, presents a significant opportunity for market growth.                

• Integration of Artificial Intelligence (AI) and Machine Learning 

The integration of AI and machine learning technologies in ELISA testing is poised to revolutionize the field. These technologies can improve assay performance, data analysis, and result interpretation, leading to more accurate and efficient ELISA tests. AI and machine learning can also help in identifying complex patterns and trends in large datasets, enhancing the diagnostic capabilities of ELISA test process and driving their adoption in clinical and research settings.

Restraints/Challenges

• High Cost of ELISA Tests

The cost associated with ELISA tests, especially for specialized assays and reagents, is a significant barrier to market growth. The high Elisa test cost may limit their adoption, particularly in resource-limited settings and for routine screening purposes. Efforts to reduce the cost of ELISA tests, such as the development of cost-effective assay kits and reagents, could help overcome this barrier and expand the market reach of ELISA testing.

• Availability of Alternative Technologies

 The availability of alternative technologies, such as PCR, next-generation sequencing, and point-of-care testing, poses a challenge to the ELISA tests market. These alternative technologies offer advantages such as faster turnaround times, higher sensitivity, and lower costs, which may limit the growth of the ELISA test market in certain applications. However, continued innovation and advancements in ELISA technology could help maintain its competitiveness in the diagnostic testing landscape.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In December 2022, bispecific antibodies emerged as a notable advancement in the field, targeting two epitopes simultaneously. This approach gained rapid traction among scientists and pharmaceutical manufacturers, with the US FDA and EMA approving four different BsAb drugs for therapeutic use. These bispecific antibodies are primarily aimed at cancer targets, specifically the CD3 pathways
• In September 2022, Neogen Corporation introduced its Veratox VIP assay for cashew detection, marking the second assay in the company's new Veratox VIP line of advanced quantitative ELISA products. Also in September 2022, J Mitra launched its 4th Generation Elisa-based HCV Test, named the HCV Gen 4 Ag & Ab Microlisa. This test is designed for the qualitative detection of HCV core antigen and antibodies against HCV (anti-HCVs) in human serum or plasma

Enzyme-Linked Immunosorbent Assay (ELISA) Tests Market Scope

The market is segmented on the basis of method, application, technology, and end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications. 

Method

• Direct ELISA
• Indirect ELISA
• Sandwich ELISA
• Competitive ELISA

Application

• Vaccine Development
• Immunology
• Diagnostics
• Toxicology
• Drug Monitoring and Pharmaceutical Industry
• Transplantation
• Infectious Diseases
• Cancer
• Protein Quantitation
• Others

Technology

• Chemiluminescent
• Colorimetric
• Fluorescent

End User

• Hospitals and Diagnostic Centers
• Research Laboratories

Enzyme-Linked Immunosorbent Assay (ELISA) Tests Market Regional Analysis/Insights

The market is analyzed and market size insights and trends are provided by country, method, application, technology, and end user as referenced above.

The countries covered in the market are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, rest of Middle East and Africa, Brazil, Argentina, and rest of South America.

North America is expected to dominate the market due to

Asia-Pacific is expected to witness significant growth during the forecast period due to

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure Growth Installed base and New Technology Penetration

The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.

Competitive Landscape and Enzyme-Linked Immunosorbent Assay (ELISA)Tests Market Share Analysis

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Some of the major players operating in the market are:

• • Ortho-Clinical Diagnostics (U.S.)
  • Thermo Fisher Scientific (U.S.)
  • ZEUS Scientific, Inc. (U.S.)
  • ALPCO (U.S.)
  • BD (U.S.)
  • Bio-Rad Laboratories, Inc. (U.S.)
  • bioMérieux SA (France)
  • Enzo Life Sciences, Inc. (U.S.)
  • Merck KGaA (Germany)
  • BioLegend, Inc. (U.S.)
  • LOEWE Biochemica GmbH (Germany)
  • Creative Diagnostics (U.S.)
  • Arigo biolaboratories Corp. (U.S.)
  • ELISA Technologies, Inc. (U.S.)
  • RayBiotech, Inc. (U.S.)
  • R&D Systems, Inc. (U.S.)
  • AESKU.GROUP GmbH & Co. KG (Germany)
  • Cell Technology (U.S.)
  • Arbor Assays (U.S.)
  • Eurofins Scientific (Luxembourg)
  • Biogenuix (India)
  • F. Hoffmann-La Roche Ltd (Switzerland)
  • Abbott (U.S.)
  • Danaher (U.S.)
  • Sysmex Corporation (Japan)
  • PerkinElmer Inc. (U.S.)
  • Agilent Technologies (U.S.)

SKU-52683