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As per Cognative Market Research's latest report, The Global immunoassay market was valued at USD 34.29 billion in 2022 and will reach USD 51.44 billion by 2030, registering a CAGR of 5.2% for the forecast period 2023-2030.
|Historical Data Time Period||2018-2023|
Immunoassays Market is Segmented as below. Particular segment of your interest can be provided without any additional cost. Download the Sample Pages!
An immunoassay (IA) is a biochemical test that uses an antigen or an antibody to detect the presence or concentration of a macromolecule or a small molecule in a solution.
Immunoassays have been extensively employed in the drug research and pharmaceutical industries in many critical areas of pharmaceutical evaluation, such as illness diagnostics, therapeutic medication monitoring, and clinical pharmacology and biological equivalent investigations. Due to their natural accuracy, quickness, and high adaptability for the examination of a broad spectrum of analytical agents in biological materials, immunoassay techniques are crucial and popular in pharmaceutical analysis.
The diagnosis and treatment of diseases is one area where immunoassays are crucial. For instance, immunoassays are utilized in therapeutic medication monitoring, pregnancy tests, and cancer diagnostics. Immunoassays are essential instruments used in the development of biopharmaceutical products, such as vaccines, gene, and cell therapies. Immunoassay is frequently used in the research and manufacture of food to identify potentially harmful pollutants or allergens. For instance, immunoassay tests may be used to check for the presence of pathogens like E. coli, hazardous compounds, gluten, or heavy metal contamination. Immunoassays have more recently made their way into the environmental field. Utilizing immunoassay technology, pollutants in the environment can be found.
The increasing prevalence of infectious diseases, Technological advancement in immunoassay, and benefits offered by immunoassay are the major driving factors that fuel the immunoassay market.
Infectious diseases brought on by microorganisms like diphtheria, Ebola, flu, hepatitis, HIV/AIDS, human papillomavirus, tuberculosis, and outbreaks like dengue, Zika virus, Swine flu, and Covid-19 affect most of the population. Chronic diseases like cancer, diabetes, cardiovascular disorders, obesity, etc. also affect a large portion of the population. The primary approach for identifying viruses such as HIV, Epstein-Barr, dengue, hepatitis C, influenza, and the majority of other viruses is immunoassay. Through early diagnosis and treatment monitoring and modification based on diagnostic data, the immunoassay industry has a significant opportunity to hinder the route of rising illness rates. Immunoassays have benefits including straightforward methods, high accuracy, rapid results, effective, secure, secure, and are secure as well as environmentally friendly. Reagents are in high demand because they are affordable and do not need elaborate procedures.
The variety and scope of immunoassays' uses are growing phenomenally. To satisfy the demands of sensitivity, accuracy, and ease of use, a wide variety of various labels and test techniques have been developed. The sensitivity of immunoassay systems has significantly increased with the introduction of more sensitive labels and detection tools, enabling accurate measurement of a wider variety of analytes. Simultaneously, easy-to-use, affordable assay systems have been built that have the essential reliability, precision, and sensitivity to adapt immunoassay technology to a far wider range of applications including at-home testing, close patient monitoring, and extensive screening programs in developing nations. The creation of fusion antibody conjugates is now achievable because of recent advancements in molecular biology techniques, which may also transform the manufacturing of monoclonal antibodies by enhancing sensitivity and reducing the cost of reagents.
The launch of new products and the increasing interest of competitors in this industry is expected to boost the growth of the immunoassay market. For instance, in April 2022 Bio-Techne Corporation and Cygnus Technologies to detect process impurity on the Ella immunoassay platform launched the Simple Plex HEK 293 HCP 3 G assay. Impurity clearance is performed according to regulatory criteria to guarantee HCP and accurate quantification is required throughout the process phases.
Interference in immunoassays is a major issue that has the potential to have negative clinical outcomes for patients. It can result in superfluous clinical inquiry as well as ineffective treatment. There is not a single method that can completely rule out interferences. It is crucial to be aware of the possibility of interference in immunoassays and to set up protocols to spot them wherever possible.
The high probability of producing false positives is a significant disadvantage of immunoassay. Along with these issues, there are others including antibody disorder, expensive media for cultures, expensive and time-consuming labor for antibody synthesis, inadequate sensitivity, and enzymes reducing activity after conjugation. This all issues hamper the demand and market growth of immunoassay.
The COVID-19 pandemic urgently required increasing testing services, providing diagnoses, and implementing test-trace-isolate techniques essential to delivering proper care and halting the virus's transmission. There were nearly hundreds of new tests on the market, but there was scant to no independent data on how effectively they responded.
The COVID-19 pandemic's terrible effects remain evident across the world. This respiratory disease's high spreading makes it challenging for sophisticated viral diagnostic technology to offer quick, scalable, inexpensive, and accurate tests. While molecular testing has been the preferred method for precisely identifying viral RNA in suspect patients, immunoassays were used to monitor people by detecting antibodies against SARS-CoV-2. Immunoassays are indirect techniques of detecting viral infection than molecular testing. As a result, the COVID-19 pandemic had a favorable effect on the immunoassay market.
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The first Enzyme-Linked Immunosorbent Assay (ELISA) Kit from Charles River Laboratories International, Inc. has been made available for identifying and measuring residual host cell proteins (HCP) in CHO-based biotherapeutics. The HCP ELISA kit from Charles River reaches rates for sensitivity and specificity that are among the highest in the industry, at 0.1 ng/mL and 90% antibody coverage, respectively. The different chicken immunoglobulin Y (IgY) antibodies used can be credited with this increase in sensitivity and specificity.
American Laboratory Products Company, Ltd. ("ALPCO") is a renowned molecular diagnostics firm headquartered in Brno, Czech Republic, and GeneProof a.s. ("GeneProof") have announced a merger. In their respective areas, ALPCO and GeneProof have both established strong reputations: ALPCO in the field of immunodiagnostics and GeneProof in the field of molecular diagnostics.
An in vitro quantitative test for the detection of allergen-specific IgE in human serum is the NOVEOS Specific IgE test. The NOVEOS Immunoassay Analyzer must be used with the NOVEOS Specific IgE Assay. It is meant to be used in clinical laboratories as an in vitro diagnostic assistance in the clinical diagnosis of IgE-mediated allergy diseases in conjunction with other clinical findings.
Agilent Technologies Inc. introduced the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit. It is intended for the qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma. The kit has successfully undergone FDA notification in compliance with Section IV.D of the FDA's "Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised)". This marks Agilent's entry into SARS-CoV-2 testing in the US.
Abbott announced it has received CE Mark for two new uses of its Panbio COVID-19 Ag Rapid Test Device for the detection of the SARS-CoV-2 virus such as asymptomatic testing and self-swabbing. By allowing patients to maintain distance during the testing process, self-swabbing with a patient-friendly nose swab enhances patient comfort and lowers the possibility of healthcare staff unintentionally contracting the virus.
Top Companies Market Share in Immunoassays Industry: (In no particular order of Rank)
Global Immunoassays Market Report 2023 talks about crucial market insights with the help of segments and sub-segments analysis. In this section, we reveal an in-depth analysis of the key factors influencing Immunoassays Industry growth. Immunoassays market has been segmented with the help of its Product Type, Application Technology, and others. Immunoassays market analysis helps to understand key industry segments, and their global, regional, and country-level insights. Furthermore, this analysis also provides information pertaining to segments that are going to be most lucrative in the near future and their expected growth rate and future market opportunities. The report also provides detailed insights into factors responsible for the positive or negative growth of each industry segment.
The immunoassay market is segmented into reagents & kits, analyzers, software, and services, in which reagents and kits hold the largest share of the immunoassay market.
Solutions, buffers, reagents, and kits used in immunoassays are used to identify and measure biological targets in serum, plasma, cell culture media, and other samples. Immunoassay kits come in various forms utilized in laboratories, clinical settings, and industry. The basis of immunoassay kits is the ability of an antibody to attach to and recognize a particular macromolecule, usually a protein, and produce a quantifiable signal in response to the binding. To determine the number of proteins present in biological samples like urine, serum, or cell extracts, assay kits are frequently employed. The assays could be presented in colorimetric, fluorescent, or chemiluminescent formats.
Immunoassay reagents include antibodies, labels that produce signals, and separation matrices. The essential components necessary for any immunoassay are antibodies. There are two types of antibodies: polyclonal and monoclonal. However, monoclonal antibodies are preferable to polyclonal ones for the production of immunoassays for pharmaceutical analysis applications. This is explained by their greater degree of specificity and affinity for the analyte. Therefore increasing the use of reagents and kits in immunoassay can drive the market. In addition, the approval and launch of novel immunoassay kits are expected to support segment growth.
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This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities for each application of Immunoassays from 2018 to 2030. This will also help to analyze the demand for Immunoassays across different end-use industries. Our research team will also help acquire additional data such as Value Chain, Patent analysis, Company Evaluation Quadrant (Matrix), and much more confidential analysis and data insights.
Some of the key Application of Immunoassays are:
The above Graph is for representation purposes only. This chart does not depict actual Market share. Please purchase the Immunoassays market report 2023 Edition by contacting our team.
The immunoassay market is segmented into Enzyme-Linked Immunosorbent Assay (ELISA), chemiluminescence immunoassay, rapid tests, Enzyme-Linked Fluorescent Assay (ELFA), ELISpot, western blotting, and a radioimmunoassay; in which Enzyme-Linked Immunosorbent Assay (ELISA) hold the largest share of the immunoassay market.
The analytical biochemistry technique known as the enzyme-linked immunosorbent assay (ELISA) is frequently employed. The assay uses a solid-phase form of enzyme immunoassay (EIA), utilizing antibodies against the target protein to find the presence of a ligand (frequently a protein) in a sample of liquid. In addition to being utilized as quality assurance in numerous industries, ELISA has been applied as a diagnostic tool across biotechnology, plant pathology, and medicine.
The ELISA is a helpful technique for figuring out serum antibody concentrations since it may be used to assess either the amount of antigen or the availability of antibodies in a sample (as with the HIV test or West Nile virus). As a serological blood test for celiac disease, it additionally has found use in the food business for identifying probable food allergens such as milk, peanuts, walnuts, almonds, and eggs. Additionally, ELISA can be utilized in toxicology to provide a quick presumptive screening method for specific drug classes. Numerous infections, including dengue, malaria, Chagas disease, and others, can be detected using ELISA tests. In vitro diagnostics using ELISA assays is also widely used in medical labs. Therefore, increasing demand for ELISA in various pharmaceutical activities boosts the market.
The expansion of the market in the region is being driven by increasing demand for immunoassays because of rising per capita health expenditures, improvements in healthcare infrastructure, and an increase in the prevalence of infectious diseases and cancer cases in the United States. For instance, the American Cancer Society (ACS) 'Cancer Facts & Figures 2023', estimates that 1,958,310 new instances of cancer will be reported in the United States in 2023, caused by smoking, carrying too much body weight, consuming alcohol, eating poorly, and engaging in insufficient physical exercise. Due to the rising incidence of cancer in the United States, The usage of immunoassays for cancer diagnosis is predicted to increase.
Because of the rising use of medical technologies, rising rates of the incidence of chronic diseases, infectious diseases, and geriatric populations, and significant spending on R&D by pharmaceutical companies and government agencies for disorders and diseases including diabetes and chronic illnesses is one of the main drivers of the regional market.
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Research Associate at Cognitive Market Research
Anushka Gore is a seasoned market researcher specializing in the dynamic landscape of the Pharmaceutical industry. With a keen analytical mind and a deep passion for healthcare advancements, she has dedicated herself unraveling the intricate market trends and consumer behaviors that shape the future of medical technologies and services.
Our study will explain complete manufacturing process along with major raw materials required to manufacture end-product. This report helps to make effective decisions determining product position and will assist you to understand opportunities and threats around the globe.
The Global Immunoassays Market is witnessing significant growth in the near future.
In 2023, the Reagents & Kits segment accounted for noticeable share of global Immunoassays Market and is projected to experience significant growth in the near future.
The Cardiology segment is expected to expand at the significant CAGR retaining position throughout the forecast period.
Some of the key companies Abbott Laboratories , Thermo Fisher Scientific and others are focusing on its strategy building model to strengthen its product portfolio and expand its business in the global market.
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