Immunoassays Market - Growth, Trends, COVID-19 and Forecasts (2023-2028)

The Immunoassays Market is projected to register a CAGR of 7.7% during the forecast period.

During the COVID-19 pandemic, the need for diagnostic solutions for the accurate and rapid diagnosis of SARS-CoV-2 infection increased significantly. In particular, serological and immunological testing of infected asymptomatic and symptomatic individuals was in high demand. Though RT-PCR for the detection of COVID-19 disease was widely used there was also a great demand for immunological assays. The results provided by immunological tests play an important role in the development of the COVID-19 vaccine, which also increased the need for immunoassay testing. Furthermore, post-pandemic, immunoassays are still in demand due to their significance in the development of vaccines and the diagnosis of various diseases. For instance, according to the article published in 'SelectScience' in January 2021, the use of vaccines as immunotherapies for various disorders, such as some malignancies and Alzheimer's disease, has led to increased development of advanced immunotherapies. This has led to increased adoption of immunoassays during the testing of immunotherapies, driving market growth.

The major factors that are driving the market growth include the rising prevalence and incidence of chronic as well as infectious diseases along with the technological advancements in immunoassay instruments and the high sensitivity and specificity of the immunoassays. Immunoassays are also suitable for diagnosing asymptomatic diseases, which otherwise cannot be diagnosed. The ultrasensitive immunoassay has been proven to detect HIV and is demonstrated to detect limits of less than 1fg/ml. This high sensitivity helps to detect one virus particle per 25 μl of the sample. The versatile applications and ease of automation have made immunoassay quite popular which is supporting the market growth.

The rising number of people affected by these infectious diseases is further contributing to the market growth. According to the WHO’s key facts on HIV published in July 2022, around 38.4 million people around the world were affected by HIV in 2021 with around 1.5 million new cases being registered in 2021 alone. Therefore, the rising number of infectious diseases is expected to drive market growth due to the increased adoption of immunoassays for the diagnosis of infectious diseases.

Besides, the launch of products by the key market players is also aiding in the growth of the market. For instance, in November 2021, Boditech Med launched its new automated immunoassay analyzer with a blood collection tube, including an all-in-one cartridge system, at MEDICA 2021. The immunoassay analyzer, AFIAS-10, is a unique integrated Sample-to-Answer system that can execute 10 parallel tests for each different parameter. Such progress in immune analyzers is expected to propel the growth of the market over the forecast period due to the increased adoption of parallel testing of different parameters at once.

Thus, the high sensitivity, specificity, and cost-saving nature of immunoassays are driving the growth of the immunoassays market. However, factors, such as complex assay procedures and stringent regulatory scenarios for the approval of immunoassays, may hinder market growth.

Immunoassays Market Trends

Enzyme Immunoassays (EIA) Segment is Expected to Hold Significant Market Share in Immunoassay Market

An enzyme immunoassay commonly known as enzyme-linked immunosorbent assay (ELISA) is used to detect the presence of a target protein in a biological sample. These assays serve as the foundation for the majority of well-established clinical tests and are frequently the most accurate way to make diagnoses. ELISA tests can also be used for the detection of viral components. ELISA is compatible with various samples increasing its demand for COVID-19 testing. Besides, enzyme immunoassays are also the most affordable of all immunoassays, which is the major factor behind the market growth.

The rising launches in EIA by key market players are also expected to propel 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 to determine therapeutic efficacy, from development through clinical phases and also in postmarket surveillance studies.

Furthermore, 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. Therefore, the significance of enzyme immunoassays in R&D for the development of vaccines and other therapeutics is expected to drive this segment's growth.

North America Holds a Major Share and is Expected to do Same during the Forecast Period

This can be majorly attributed to the increasing incidence rates of chronic disorders, infectious diseases, and the increasing geriatric population, as well as due to the well-developed healthcare infrastructure and increasing penetration of medical devices in the region.

The increase in per capita health expenditures, the advancement in healthcare infrastructure, and the increase in the number of infectious diseases and cancer cases in the United States have led to an increased demand for immunoassays driving the market growth in the region. For instance, according to the ACS 'Cancer Facts & Figures 2022', around 1,918,030 new cancer cases are estimated to be reported in the United States in the year 2022. Such a high incidence of cancers in the United States is anticipated to rise in the adoption of immunoassays for the diagnosis of cancer, driving the market growth in the region.

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.

Furthermore, the increasing launches, collaborations, and acquisitions between the companies are boosting the market growth in the country. For instance, in May 2022, Abbott launched HBsAg Next Assay in India to accelerate the early and enhanced detection of Hepatitis B. In addition, Thermo Fisher Scientific, Inc. acquired the private point-of-care molecular diagnostic company Mesa Biotech, in February 2021, making it more strong in the field of immunoassays in the country. Such launches and acquisitions help in the increased development and adoption of innovative immunoassays, thereby expected to drive market growth.

Immunoassays Market Competitor Analysis

The immunoassays market is highly competitive and consists of several major players. In terms of market share, few of the major players currently dominate the market. With the rising need for healthcare development and the advances in immunoassays, a few other smaller players are expected to enter the market. Some of the players operating in the market include Abbott Laboratories Inc., Becton Dickinson and Company, Danaher Corporation, Hologic Inc., and Qiagen NV, among others.

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