The North America enzyme-linked immunosorbent assay (ELISA) testing market size was valued at USD 750 million in 2024 and is expanding at a CAGR of 6.33% during the forecast period. The market sizing and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year.
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Key Takeaways
🔹 North America led the global market with the highest market share in 2024.
🔹 Asia Pacific is anticipated to witness a rapid growth in the near future.
🔹 The sandwich ELISA segment held the major share of the market in 2024.
🔹The multiple and portable ELISA segment is projected to grow at the highest CAGR through the forecast period.
🔹 The infectious diseases segment dominated the Market in 2024.
🔹 The cancer segment is expected to expand rapidly during the forecast period.
Market Overview and Industry Potential
Enzyme-linked immunosorbent assay (ELISA) testing is one of the diagnostics techniques, standardized for the diagnosis and detection of different diseases occurring in human bodies. ELISA uses several fluorescent chemical compounds, enzymes, substrates, reaction buffer components, and reaction chemicals to identify antigen-antibody interactions in human bodies. ELISA testing is mainly performed in clinical research laboratories, hospitals, research institutes, and industrial research laboratories on a large scale. The enzyme-linked immunosorbent assay (ELISA) testing market is growing significantly due to the tremendous innovations in the immunodiagnostics fields.
The outstanding research and development through biotechnology and pharmaceutical knowledge contribute to the emergence of new therapies, treatments, and scientific innovations. The Immunodiagnostic Kit and Molecular Diagnostic Laboratory is comprised within the National Institute of Biologicals. This laboratory conducts quality control testing of molecular diagnostic test kits related to ELISA, RIA, CLIA, etc. Thermo Fisher Scientific Inc., Bio-Rad Laboratories Inc., Ortho Clinical Diagnostics, R&D Systems Inc., etc. are the leading competitors in this market.
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Major Trends in the Enzyme-Linked Immunosorbent Assay (ELISA) Testing Market
ELISA-Derived Technologies:
The solid substrates are utilized for the immobilization of capture antibodies in ELISA. The different solid substrates used are microwell plates, paper material, etc. Moreover, antibodies are also used as recognition elements in traditional ELISA. The other things used are nucleic acid molecules and molecularly imprinted polymers which offer benefits in terms of cost, stability, affinity, and specificity. The new signal amplification strategies in ELISA technology are nano-enzyme, plasmonic signals, enhanced labels, and CRISPR-Cas system.
Nanoparticle-Based and Smartphone-Based ELISA:
For performing the nano-ELISA, different nanomaterials like nanoprobes, nano carriers, nano substrates, and nano coloring agents are used to detect antibodies linked to nanoparticles. Nano ELISA offers improved selectivity, enhanced sensitivity, adaptability, and multiplexing. In smartphone-based ELISA, the generated signal by the detection reagent is captured by the camera of a smartphone and analysis is done by using a smartphone application. It is applicable in clinical diagnostics, environmental monitoring, and food safety testing. It offers portability, cost-effectiveness, user-friendliness, and multiplexing.
Role of Artificial Intelligence in the Enzyme-Linked Immunosorbent Assay (ELISA) Testing Market
Artificial intelligence plays a vital role in immunodiagnostics, biomedical research, and immunogenetics. AI algorithms help in the analysis of immunogenetic data and enhance the prediction of the immune system. AI also helps in the development of innovative algorithms for epitope discovery, and optimization of immunotherapy strategies. AI can also identify novel immunological targets.
AI can interpret clinical proteomics data, and identify cancerous and normal tissues using gene expression data. It assists in the modeling of the structure and function of cells with the help of machine learning and deep learning tools of AI. It also assists clinicians in providing personalized cancer immunotherapies to patients.
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ELISA Market Scope
|
Report Highlights |
Details |
|
CAGR 2025 to 2034 |
CAGR of 6.32% |
|
Market Size in 2024 |
USD 2.27 Billion |
|
Market Size in 2025 |
USD 2.42 Billion |
|
Market Size by 2034 |
USD 4.19 Billion |
|
Dominating Region |
North America |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
Test Type, Application, and Region |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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Enzyme-Linked Immunosorbent Assay Testing Market Regional Analysis:
U.S. Enzyme-Linked Immunosorbent Assay (ELISA) Testing Market Size to Achieve USD 980 Mn by 2034
The U.S. enzyme-linked immunosorbent assay (ELISA) testing market size surpassed USD 530 million in 2024 and is expected to hit around USD 980 million by 2034, with a CAGR of 6.34% between 2025 and 2034.
North America dominated the enzyme-linked immunosorbent assay (ELISA) testing market in 2023 due to the increasing investments in research and development activities along with the skillfulness of scientists all around the world. The growing elderly population and the increasing number of cancer cases drive the regional market’s growth. The growing awareness among people about the need for early detection and diagnosis of infectious diseases drives the market’s growth in this region.
The rising prevalence of chronic and infectious diseases is contributing to the expansion of immunodiagnostic tests for early disease management. The division of bacterial and viral diseases is comprised within the National Center for Immunization and Respiratory Diseases (NCIRD). This division works on preventing and controlling vaccine-preventable health disorders caused by viruses and bacteria. The immunization services division in the U.S. offers funding for immunization information systems. The region also arranges research programs, training, and education activities for children's vaccination.
• In March 2024, Thermo Fisher Scientific Inc. announced the launch of its Thermo Fisher Phadia product catalog associated with ImmunoCAP tests and EliA assays.
Asia Pacific is expected to be the fastest-growing region in the enzyme-linked immunosorbent assay (ELISA) testing market during the forecast period due to the increased per capita income of the region and recommendable healthcare expenditure. Japan is expected to showcase prominent growth in this market due to developed healthcare infrastructure and advancements in healthcare policies.
The presence of leading industries and their exciting innovations drive the regional market’s growth. The National Institute of Communicable Diseases and the National Center for Disease Control established by the Government of India are involved in the organization and expansion of different activities to control communicable diseases. Industries are focusing on obtaining regulatory approvals for their innovative products and trying to give the best affordable and easily available services and solutions to mankind.
• In June 2024, the Government of Singapore announced an investment of about S$300 million to develop and deploy quantum computer technology through the National Research Foundation (NRF) over the next 5 years.
Enzyme-Linked Immunosorbent Assay (ELISA) Testing Market Segmentation:
Test Type Insights
The sandwich ELISA segment dominated the enzyme-linked immunosorbent assay (ELISA) testing market in 2023 due to the high use of ELISA testing kits and tests for performing sandwich ELISA technique. Advancements in this technology contribute to make these tests more efficient and beneficial to the end users. The portability and accountability of these tests upsurge their demand and need in the market.
The multiple and portable ELISA segment is expected to be the fastest-growing in the enzyme-linked immunosorbent assay (ELISA) testing market during the forecast period due to its high expected CAGR in the coming years. The use of a multicatcher device with 8 or 12 immunosorbent protruding pins that can be immersed in collected samples surges this segmental growth. The high efficiency of this technique and its complex sample pre-treatment methods impact the growth of this segment in the market. It enables simultaneous detection of multiple analytes within a single sample which increases its efficiency.
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Application Insights
The infectious diseases segment dominated the enzyme-linked immunosorbent assay (ELISA) testing market in 2023 due to the increasing prevalence of infectious disorders such as tuberculosis, salmonella infections, Lyme disease, etc. The growing awareness of the public regarding the early diagnosis and detection of these diseases accelerates the growth of the enzyme-linked immunosorbent assay (ELISA) testing market. The pandemic and epidemic cases all over the world uplift the percentage of infectious cases of patients and boost the market’s growth noticeably.
The cancer segment is anticipated to be the fastest-growing in the enzyme-linked immunosorbent assay (ELISA) testing market over the forecast period due to the growing demand of ELISA tests and test kits for the early diagnosis and testing of infected patients. The potential of ELISA to diagnose various cancer types such as breast cancer and ovarian cancer drives this segmental growth. These immunodiagnostic tests can detect certain proteins and their overexpression in prostate cancer. This rising incidence of cancer all around the world surges this segmental growth.
Competitive Landscape and Major Breakthroughs in the Enzyme-Linked Immunosorbent Assay (ELISA) Testing Market
The enzyme-linked immunosorbent assay (ELISA) testing market continues to evolve rapidly and showcases significant advancements through innovations in 2023 and 2024, with a dynamic competitive landscape. Major players such as Thermo Fisher Scientific, Inc., American Laboratory Products Company (ALPCO), Bio-Rad Laboratories, Inc., BD, BioMérieux SA, Ortho Clinical Diagnostics, R&D Systems, Inc., ZEUS Scientific, Inc., etc. hold a prominent position in the enzyme-linked immunosorbent assay (ELISA) testing market. These companies exhibit promising resources and technical expertise to conduct clinical research, R&D activities, formulation, marketing, etc. in diverse research areas and provide fruitful immunodiagnostic outcomes.
What is Going Around the Globe?
• In August 2024, QuidelOrtho Corporation announced the approval from the U.S. FDA for its VITROS Syphilis assay to strengthen infectious disease testing.
• In January 2024, Antech, one of the veterinary diagnostics companies announced the launch of an immunodiagnostic analyzer which is an in-hospital platform to assist veterinarians in the rapid and efficient prediction, diagnosis, and monitoring of diseases.
Segments Covered in the Report:
By Test Type
• Sandwich ELISA
• Indirect ELISA
• Multiple and Portable ELISA
• Competitive ELISA
• Others
By Application
• Immunology
• Inflammation
• Infectious diseases
• Cancer
• Protein quantification
• Other
By Regions
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
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