The ELISA Diagnostic Test Market is expected to grow from US$ 1,285.49 million in 2022 to US$ 2,271.23 million by 2030; it is estimated to register a CAGR of 7.37% from 2022 to 2030.
Key driving factors behind the market development are the rising infectious diseases among animals and the increasing incidence of human infections are the key driving factors behind the market development.
An enzyme-linked immunosorbent assay (ELISA) is a test that detects and measures antibodies in a patient's blood. This test can be used to determine if the patient has antibodies related to certain infectious conditions. An ELISA test is used to diagnose HIV causing AIDS, Lyme disease, pernicious anemia, rotavirus, and among others. ELISA kits are a valuable research tool that offer quick, convenient, and precise detection and quantitation of specific targets in samples and cultures. Commercially available ELISA kits come with pre-coated plates, capture/detection antibodies, standards, buffers, and other necessary reagents. Each kit undergoes rigorous validation and stability testing to ensure accuracy, precision, sensitivity, specificity, and reproducibility.
Innovative Product Launches Creates Opportunities in ELISA Diagnostic Test Market.
ELISA is one of the most popular immunoassay tests owing to its various advantages such as flexibility, sensitivity, and easy-to-use features. Also, low cost of ELISA test kit and multifaceted applicability associated with high-throughput testing make it an ideal solution for various research and IVD requirements. With low-cost applicability, product innovations in the test kits enhance the demand for human and animal research. Also, manufacturers focus on developing ELISA test kits with in-house facilities.
Innovative Research company sells a wide range of ELISA kits with selectivity to a broad range in identifying coagulants, species, and antibodies. "Human Factor IX Kit" is one such example manufactured by Innovative Research. The human coagulation Factor IX antigen assay is intended for the quantitative determination of total Factor IX antigen in human plasma. The kit is recommended to use only for research purposes, and reagents can be utilized for up to 96 clinical tests.
Additionally, innovative product launches for ELISA tests by the manufacturers amid the COVID-19 pandemic accelerate the adoption of ELISA testing among humans.
In December 2022, Pictor Limited announced a new product launch of the "PictArray SARS-CoV-2 Antibody Test," which has demonstrated real clinical utility intended for patients and doctors. The new product detects the infection associated with the COVID-19 virus, and the clinical results produced assist the patients and doctors in treating and managing SARS-CoV-2 infection. Launches of innovative ELISA test kits by manufacturers are expected to provide effective clinical results for diagnosing varied infections associated with different types of species with low cost and multifaceted applications. Thus, innovative product launches would provide lucrative opportunities for manufacturers in the long run.
Advancements in ELISA-Based Procedures
The use of ELISA for in-vitro diagnostics (IVD) has gained considerable attention in the global market. Researchers from various fields have been attracted to the development and application of ELISA-based procedures through techniques such as magnetic beads, paper-based platforms, and nanomaterials. Other examples of technology-based ELISA kits are digital ELISA, Multiplex ELISA, Single-Molecule ELISA, Nanoparticle-Based ELISA, and Smartphone-Based ELISA. Also, companies launch ELISA testing kits based on several techniques for fast and efficient clinical results. The "AMP'D ELISA Signal Amplification system" is manufactured by Enzo Life Sciences, Inc. The AMP'D Technology efficiently improves the sensitivity of sandwich ELISA test type with a single amplification kit and offers high sensitivity.
Cell Signaling Technology, Inc.'s "PathScan Phospho-RSK1 (Ser380) Sandwich ELISA Kit," designed by Cell Signaling Technology, is another example of a technology-advanced ELISA test kit product. Such advanced technology-based ELISA test kit products will have a high demand in the future by veterinarians for the detection of different species responsible for veterinary and human-associated infections or diseases. Therefore, advancements in ELISA-based procedures are expected to bolster the ELISA diagnostic test market growth during 2020–2030.
In terms of Application, the ELISA Diagnosis Test Market is categorized into autoimmune diseases, infectious disease, cancer diagnosis, protein quantification, and others. The infectious disease segment held the largest share of the market in 2022 and is anticipated to register the highest CAGR of 8.43% in the market during the 2022-2030. ELISA is a powerful technique in immunology for detecting antibodies and antigens and performing allergy testing and autoimmune disease diagnosis. The growing incidence of autoimmune diseases, and viral diseases (HIV, STI, hepatitis B, and others) across the world owing to the aged population and changes in demographics and lifestyle is driving the growth of the global ELISA diagnostic testing market. As per the statistics given by National Stem Cell Foundation in 2023, autoimmune diseases affect more than 80 different types of diseases and nearly 4% of the world's population. The most common autoimmune diseases include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, lupus, Crohn's disease, psoriasis, and scleroderma. In the United States, autoimmune diseases are the third most common cause of chronic illness. Although rare, collectively, these diseases affect between 5% and 8% of the US population. For instance, according to an article published by PubMed Central in May 2022, conventional serological detection of Autoimmune bullous disease (AIBD) specific antibodies involves an initial screening using tissue substrates, followed by an antigen-specific assay such as ELISA.
Moreover, various technological advancements, such as the development of next-generation immunodiagnostics platforms, are anticipated to drive the market growth.
Based on test type, is segregated as sandwich ELISA, indirect ELISA, competitive ELISA, and multiple & portable ELISA. The indirect ELISA segment held a larger market share in 2022 and the same segment is anticipated to register a higher CAGR during 2022-2030.
The ELISA diagnostic test market, by end user, is categorized as hospitals & diagnostic centers, pharmaceutical & biotechnology companies, veterinary hospital & diagnostic laboratories, and others. The hospital & diagnostic centers segment held the largest share of the market during 2020-2030.