Enzyme-Linked Immunosorbent Assay (ELISA) Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028)

The enzyme-linked immunosorbent assay (ELISA) market is projected to register a CAGR of 8% during the forecast period.

COVID-19 has increased the demand for immunoassays like ELISA across the globe. This is mainly due to the increase in infection rates, which increased the necessity for effective diagnosis. According to the data published in the NCBI Journal in March 2020 titled 'Diagnosing COVID-19: The Disease and Tools for Detection', SARS-CoV-2 can be detected by the ELISA with high accuracy. Moreover, in February 2021, Agilent Technologies Inc. launched the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit to detect immunoglobulin G (IgG) antibodies qualitatively to SARS-CoV-2 in human serum or plasma. Thus, the increasing demand for cost-effective diagnoses to get the appropriate treatment is expected to drive the market's growth.

The increasing incidence of infectious diseases such as HIV, dengue, hepatitis, malaria, influenza, and various other infections is a significant factor contributing to the market's growth. According to the WHO data updated in July 2022, an estimated 37.7 million people were living with HIV globally at the end of 2020, and over two-thirds (25.6 million) of them are in the African region. Also, the same source stated that dengue fever is one of the top ten global health threats. There has been a 30-fold increase in global dengue incidence over the past 50 years. According to World Health Organization updates from June 2022, over 354 million people across the globe live with Hepatitis B or C infections. Such an increasing incidence of infectious diseases increased the demand for diagnosis. The increased usage of advanced diagnostic tools, such as enzyme-linked immunosorbent assays for screening diseases, is attributed to the market's growth.

Furthermore, the increase in the geriatric population at risk of developing various infections and chronic disorders also plays a crucial role in driving the market's growth. as per the data updated by NCBI in July 2021, potentially serious infections are quite common in older patients than in younger ones. Such factors are expected to significantly increase the demand for the enzyme-linked immunosorbent assay market, thereby increasing the market's growth.

Moreover, key market players' innovations in enzyme immunoassays also add to the market growth. For instance, in September 2021, Bio-Rad launched the Bio-PlexPro Human IgA and IgM SARS-CoV-2 panels to detect IgA and IgM antibodies against four SARS-CoV-2 antigens. The multiplex immunoassay panels helped the vaccine developers determine therapeutic efficacy from development through clinical phases and postmarket surveillance studies. Also, in December 2021, ArcticZymes Technologies launched a new ELISA immunoassay product, an essential support product for consumers which used the M-SAN HQ enzyme in biomanufacturing processes for gene therapy and viral vaccine production. Such product launches are boosting market growth.

However, stringent regulations for approval and a lack of skilled personnel handling equipment are restraining the market’s growth.

Enzyme-Linked Immunosorbent Assay Market Trends

Disease Diagnosis Application Segment is Expected to Hold a Major Market Share

The disease diagnosis segment is expected to hold a significant share due to the increasing application of enzyme-linked immunosorbent assay tests in diagnosing tumor antigens. According to the World Health Organization's key facts on cancer published in February 2022, around 400,000 children worldwide develop cancer every year. According to the GLOBOCAN 2020 report, the total number of people in the world affected by cancer in 2020 accounts for around 19,292,789 cases. The number is estimated to rise to 28,887,940 cases by 2040. According to the article published in Nature Scientific report in May 2020, ELISA can also be used to detect prostate cancer antigens and breast cancer antigens. This increase in cancer cases across the globe increased the demand for ELISA. It can serve as an effective tool for measuring cancer markers or antigens.

Also, according to the Global Tuberculosis Report 2021 published by the WHO, around 9.87 million people worldwide were estimated to be affected by tuberculosis in 2020. Also, the WHO, in its July 2022 key facts on HIV, estimated that around 38.4 million people worldwide would be affected by HIV by the end of the year 2021, with about 1.5 million new cases being registered in 2021 alone. Thus, the increasing cases of infectious diseases are expected to increase the demand for early detection, which is further expected to boost the segment's growth over the forecast period.

Moreover, in September 2022, PerkinElmer’s Oxford Immunotec announced that the US FDA had approved using the T-Cell select reagent kit to automate its T-Spot. Cost-effective diagnosis coupled with the accuracy of detection in antigens increased the demand for ELISA and propelled the market's growth.

North America is Expected to Hold a Significant Share in the Market

Currently, North America dominates the market for enzyme-linked immunosorbent assay and is expected to continue its stronghold during the forecast period. The pandemic affecting the region has also increased the need for these immunoassays. The United States holds the largest market share in the North American region.

This can be attributed to the increasing incidence rates of chronic disorders, infectious diseases, and the increasing geriatric population, as well as the well-developed healthcare infrastructure and increasing penetration of medical devices in the region. Cancer is one of the leading causes of hospitalization in the United States. According to the GLOBOCAN 2020 report, the total number of people in the United States affected by cancer in 2020 accounts for around 2,281,658 cases. The number is estimated to rise to 3,123,452 cases by 2040. According to the National Diabetes Statistics Report, in 2020, about 37.3 million people in the United States were found to have diabetes; around 96 million adults were found to have pre-diabetes. ​The National Kidney Foundation 2020 estimated that about 36 million adults in the United States have chronic kidney diseases. ​A report by the CDC in 2020 showed that around 15.7 million Americans are affected by chronic lower respiratory diseases. Hence, with the increase in the prevalence of chronic diseases, there is an increasing demand for immunoassays, driving the market.

Moreover, high expenditure on R&D by government organizations and pharmaceutical companies for disorders and diseases, such as chronic ailments and diabetes, are some of the primary factors driving the regional market. For instance, as per Pharmaceutical Research and Manufacturers of America, the biopharmaceutical industry invested an estimated USD 102.3 billion in R&D in 2021.

Thus, all factors above are expected to boost the market in the region over the forecast period.

Enzyme-Linked Immunosorbent Assay Market Competitor Analysis

The enzyme-linked immunosorbent assay (ELISA) market is fragmented and competitive and consists of several major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Thermo Fisher Scientific, Abcam PLC, Merck kGaA, Bio-Rad Laboratories, Inc, Cell Biolabs, Inc, Promega Corporation, Zeus Scientific, Inc, Enzo Life Sciences, Inc, Arbor Assays, Inc, Biolegend, Agilient Technologies, Inc, J. Mitra & Co. Pvt Ltd, and others.

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