The ELISA Diagnostic Test Market is projected to expand from US$ 1,285.49 million in 2022 to US$ 2,271.23 million by 2030, reflecting a compound annual growth rate (CAGR) of 7.37% during the period from 2022 to 2030.
Several key factors are propelling the growth of this market, including the rising prevalence of infectious diseases in both animals and humans.
An enzyme-linked immunosorbent assay (ELISA) is a diagnostic test that identifies and quantifies antibodies present in a patient's blood. This assay is instrumental in determining whether a patient has antibodies linked to specific infectious diseases. ELISA tests are commonly employed to diagnose conditions such as HIV, Lyme disease, pernicious anemia, and rotavirus, among others. ELISA kits serve as essential tools in research, providing rapid, convenient, and accurate detection and quantification of specific targets in various samples and cultures. These commercially available kits typically include pre-coated plates, capture and detection antibodies, standards, buffers, and other necessary reagents. Each kit undergoes thorough validation and stability assessments to guarantee accuracy, precision, sensitivity, specificity, and reproducibility.
Innovative Product Launches Present Opportunities in the ELISA Diagnostic Test Market.
ELISA is widely recognized as one of the leading immunoassay tests due to its numerous advantages, including flexibility, high sensitivity, and user-friendly design. The affordability of ELISA test kits, combined with their versatile applications in high-throughput testing, makes them an optimal choice for various research and in vitro diagnostic (IVD) needs. The low-cost nature of these tests, along with ongoing innovations in test kit development, is driving demand in both human and animal research sectors. Manufacturers are increasingly focusing on creating ELISA test kits using in-house production facilities.
Innovative Research, for instance, offers a diverse array of ELISA kits that can identify various coagulants, species, and antibodies. One notable product is the "Human Factor IX Kit," designed for the quantitative assessment of total Factor IX antigen in human plasma. This kit is intended solely for research purposes and can be utilized for up to 96 clinical tests.
Furthermore, the COVID-19 pandemic has spurred manufacturers to launch new ELISA tests, enhancing their adoption for human diagnostics. In December 2022, Pictor Limited introduced the "PictArray SARS-CoV-2 Antibody Test," which has shown significant clinical utility for both patients and healthcare providers. This product is designed to detect infections related to the COVID-19 virus, providing valuable clinical insights for managing SARS-CoV-2 infections. The introduction of innovative ELISA test kits is expected to yield effective clinical outcomes for diagnosing a variety of infections across different species, all while maintaining low costs and broad applicability. Consequently, these product innovations are anticipated to create lucrative opportunities for manufacturers in the long term.
Market Trends
Advancements in ELISA-Based Techniques
The application of ELISA in in-vitro diagnostics (IVD) has garnered significant interest in the global market. Researchers from various disciplines are increasingly drawn to the development and implementation of ELISA-based methodologies, utilizing techniques such as magnetic beads, paper-based platforms, and nanomaterials. Examples of advanced ELISA technologies include digital ELISA, multiplex ELISA, single-molecule ELISA, nanoparticle-based ELISA, and smartphone-based ELISA. Companies are launching ELISA testing kits that leverage these innovative techniques to deliver rapid and efficient clinical results. For instance, Enzo Life Sciences, Inc. has developed the "AMP'D ELISA Signal Amplification system," which enhances the sensitivity of sandwich ELISA tests using a single amplification kit, thereby offering improved sensitivity.
Another example is the "PathScan Phospho-RSK1 (Ser380) Sandwich ELISA Kit" from Cell Signaling Technology, Inc., which exemplifies the advanced technology incorporated into modern ELISA test kits. Such technologically advanced ELISA products are expected to see increased demand from veterinarians for detecting various species associated with both veterinary and human infections. Therefore, advancements in ELISA-based methodologies are likely to significantly contribute to the growth of the ELISA diagnostic test market from 2020 to 2030.
Application-Based Insights
The ELISA Diagnostic Test Market is segmented based on application into categories such as autoimmune diseases, infectious diseases, cancer diagnosis, protein quantification, and others. The infectious disease segment dominated the market in 2022 and is projected to exhibit the highest CAGR of 8.43% during the forecast period from 2022 to 2030. ELISA is a powerful immunological technique for detecting antibodies and antigens, as well as for conducting allergy tests and diagnosing autoimmune diseases. The increasing prevalence of autoimmune and viral diseases (including HIV, STIs, and hepatitis B) globally, driven by an aging population and shifts in demographics and lifestyle, is fueling the growth of the ELISA diagnostic testing market. According to the National Stem Cell Foundation, autoimmune diseases encompass over 80 different types and affect nearly 4% of the global population. Common autoimmune diseases include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, lupus, Crohn's disease, psoriasis, and scleroderma. In the United States, autoimmune diseases rank as the third most prevalent cause of chronic illness, collectively impacting between 5% and 8% of the population. For example, a study published in May 2022 in PubMed Central highlighted that conventional serological detection of autoimmune bullous disease (AIBD) specific antibodies typically involves initial screening with tissue substrates, followed by antigen-specific assays like ELISA.
Moreover, ongoing technological advancements, including the emergence of next-generation immunodiagnostic platforms, are expected to further propel market growth.
In terms of test types, the market is categorized into sandwich ELISA, indirect ELISA, competitive ELISA, and multiple & portable ELISA. The indirect ELISA segment held a significant market share in 2022 and is anticipated to experience a higher CAGR during the 2022-2030 period.
The ELISA diagnostic test market is also segmented by end user, which includes hospitals & diagnostic centers, pharmaceutical & biotechnology companies, veterinary hospitals & diagnostic laboratories, and others. The hospitals & diagnostic centers segment accounted for the largest market share from 2020 to 2030.