Number of pages: 100 | Report Format: PDF | Published date: June 27, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global ELISA testing market was valued at US$ 2.55 billion in 2022 and is expected to register a revenue CAGR of 5% to reach US$ 3.95 billion by 2031.
ELISA Testing Market Fundamentals
ELISA stands for Enzyme-Linked Immunosorbent Assay. It is a widely used laboratory technique to detect and measure the presence of specific substances, such as proteins, antibodies, hormones, and antigens, in a biological sample. The ELISA test relies on the principle of specific binding between an antigen and an antibody. The assay involves immobilizing the antigen of interest onto a solid surface, such as a microplate well. Then, a sample containing the target antibody or antigen is added to the well. If the target substance is present in the sample, it will bind to the immobilized antigen. After the initial binding step, a secondary antibody is introduced. This secondary antibody is specific to a different epitope on the target antigen or antibody, and it is conjugated to an enzyme, such as horseradish peroxidase (HRP). The secondary antibody binds to the antigen-antibody complex formed in the first step. Once the secondary antibody is bound, a substrate specific to the enzyme is added. The enzyme converts the substrate into a detectable signal, such as a colored product or fluorescence, which can be measured using a spectrophotometer or a plate reader. The intensity of the signal is proportional to the amount of target substance present in the sample.
ELISA Testing Market Dynamics
ELISA testing is crucial in diagnosing infectious diseases such as HIV/AIDS, hepatitis, malaria, and dengue fever. The increasing global incidence of these diseases drives the ELISA testing market demand. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), 4000 persons develop HIV daily, including 1100 young people (15 to 24 years old). If current trends continue, an additional 1.2 million HIV infections will occur by 2025. In 2021, 650,000 people died due to AIDS-related causes, or one every minute. Continuous advancements in biotechnology, including developing new antibodies, enzymes, and detection technologies, have improved the sensitivity, specificity, and speed of ELISA tests. These advancements have expanded the applications of ELISA in research, drug discovery, and clinical diagnostics. Early detection of diseases can significantly improve patient outcomes and reduce healthcare costs. ELISA testing provides a reliable method for the early detection of biomarkers associated with various diseases, allowing for timely intervention and treatment and boosting the ELISA testing market growth. Point-of-care testing (POCT) allows for rapid and convenient diagnosis at the patient's location, eliminating the need for sending samples to a central laboratory. ELISA-based POCT devices are being developed and commercialized, catering to the increasing demand for immediate and on-site diagnostics. ELISA testing enables the detection and measuring of specific biomarkers associated with various diseases. With the rise of personalized medicine, there is an increasing need for accurate diagnostic tools like ELISA to identify biomarkers for targeted therapies and patient stratification.
However, ELISA testing is widely used and reliable. It may have limitations in terms of sensitivity and specificity compared to other advanced diagnostic techniques. False-positive or false-negative results can occur, potentially leading to misdiagnosis or delayed treatment, restricting the growth of ELISA testing. Developing and commercializing ELISA testing kits and assays are subject to stringent regulatory requirements. Compliance with these regulatory requirements can be time-consuming and costly for manufacturers, potentially hindering the ELISA testing market growth.
ELISA Testing Market Ecosystem
The global ELISA testing market is analyzed from three perspectives: method, application, and region.
ELISA Testing Market by Method
Based on the method, the global ELISA testing market is segmented into direct ELISA, competitive ELISA, indirect ELISA, and sandwich ELISA.
The sandwich ELISA segment accounted for a prominent ELISA testing market share in 2022. The Sandwich ELISA method is highly versatile and can be used to detect and quantify various analytes, including proteins, peptides, hormones, and antigens. It is applicable in clinical diagnostics and research settings, making it suitable for various applications. The Sandwich ELISA method offers high sensitivity and specificity, allowing for accurate detection and quantification of target analytes. The presence of two antibodies (capture and detection antibodies) binding to different epitopes on the target analyte enhances the assay's specificity. There is a vast availability of antibodies specifically designed for Sandwich ELISA applications. Antibodies against a wide range of analytes are commercially available, facilitating the implementation of Sandwich ELISA assays for various targets. The Sandwich ELISA method can be easily adapted for multiplexing, allowing the simultaneous detection of multiple analytes in a single sample. This capability is advantageous when a comprehensive analysis of multiple targets is desired, reducing time, sample volume, and cost. The Sandwich ELISA method has been widely used and established as a reliable and well-understood technique. Researchers and clinicians are familiar with the methodology, making it easier to adopt and implement in laboratories, boosting segmental growth.
ELISA Testing Market by Application
Based on the applications, the global ELISA testing market is segmented into disease diagnosis, vaccine development, immunology, toxicology, and others.
The disease diagnosis segment accounted for the largest revenue share of the ELISA testing market in 2022. Disease diagnosis is one of the primary applications of ELISA testing. ELISA assays are widely used to detect and diagnose various diseases, including infectious diseases, autoimmune disorders, cancer, allergies, and hormonal imbalances. The high prevalence of these diseases and the need for accurate and reliable diagnostic tools drive the demand for ELISA testing in disease diagnosis. According to the National Stem Cell Foundation, around 4% of the world’s population is affected by one of more than 80 different autoimmune diseases. ELISA testing can be designed to detect a wide range of disease-related analytes, such as antibodies, antigens, proteins, and hormones. This versatility allows ELISA to be used to diagnose numerous diseases across different medical specialties. ELISA assays have undergone extensive validation and have been widely adopted as diagnostic tools in clinical settings. There is a significant body of research and clinical evidence supporting the use of ELISA testing for disease diagnosis. ELISA testing plays a crucial role in disease screening and early detection. Many diseases, such as infectious diseases and certain types of cancer, are more treatable when detected early. ELISA assays provide a sensitive and specific method for the early detection of disease biomarkers, allowing for timely intervention and improved patient outcomes.
ELISA Testing Market by Region
Geographically, the global ELISA testing market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America region has the largest ELISA testing market size in terms of revenue generation accounting for around 36.2% share of the market. North America faces a high burden of chronic diseases like cardiovascular diseases, diabetes, and cancer. ELISA testing plays a vital role in the diagnosis, management, and monitoring of these diseases. Additionally, the region experiences outbreaks of infectious diseases, and ELISA testing is crucial in detecting and monitoring infections like HIV/AIDS, hepatitis, and Lyme disease. According to the Centers for Disease Control and Prevention's 2022 National Diabetes Statistics Report, more than 130 million adults in the U.S. are diabetes or prediabetes. North America is a hub for technological innovation and advancements in the field of healthcare and diagnostics. The region witnesses significant investments in research and development, leading to the development of advanced ELISA testing technologies, automation solutions, and improved assay performance. North America has a robust biopharmaceutical and biotechnology industry that drives the demand for ELISA testing. ELISA assays are extensively used in drug discovery, development, and clinical trials for the detection and quantification of drug targets, antibodies, and biomarkers. Early disease detection and prevention are key priorities in North America's healthcare system. ELISA testing allows for early disease detection, timely intervention, improved patient outcomes, and cost savings. Government initiatives, public health campaigns, and increased awareness about the benefits of early disease detection drive the demand for ELISA testing.
ELISA Testing Market Competitive Landscape
The prominent players operating in the global ELISA testing market are:
ELISA Testing Market Strategic Developments
ELISA stands for Enzyme-Linked Immunosorbent Assay. It is a widely used laboratory technique to detect and measure the presence of specific substances, such as proteins, antibodies, hormones, and antigens, in a biological sample.
Asia Pacific can be considered the key growth region due to the surge in ELISA testing industry trends in China, Japan, and the Indian subcontinent.
The prominent players operating in the global ELISA testing market are Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Agilient Technologies, Inc., Abbott Laboratories, and Merck KGaA.
Market players focus on continuous product development and innovation to introduce new and improved ELISA testing solutions. They invest in research and development activities to enhance assay performance, increase sensitivity and specificity, develop multiplexing capabilities, and expand the range of analytes that can be detected.
The global ELISA testing market growth is estimated to grow at a revenue CAGR of 5% during the forecast period from 2023 to 2031.
*Insights on financial performance are subject to the availability of information in the public domain