Immunoassay in R D Market Analysis

Global Immunoassays in R&D Market Overview

The Immunoassay In R D Market Size was valued at USD 10.05 Billion in 2023. The Global Immunoassay In R D industry is projected to grow from USD 10.45 Billion in 2024 to USD 14.38 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 4.06% during the forecast period (2024 - 2032). Immunoassays are bioanalytical procedures, in which the quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody. Immunoassays have been extensively used in several areas of pharmaceutical analysis such as diagnosis of diseases, therapeutic drug monitoring, and clinical pharmacokinetics and bioequivalence studies in drug discoveries.

Factors such as the increasing incidence rate of chronic and infectious diseases, increased research and development investment (R&D), and technological advancements are the major drivers propelling market growth. However, the high cost of immunoassay procedures and the high price of immunoassay systems constrain the growth of the global Immunoassay Market.

Roche is introducing a novel immunoassay in November 2023 to facilitate the diagnosis of hepatitis. The recently introduced test is intended to detect the hepatitis B e antigen (HBeAg) in human serum and plasma samples. The test, which was introduced in Europe, is capable of detecting the antigen's presence and quantifying its quantity. Consequently, it can assist in determining the severity of a patient's condition and their response to therapy. The Elecsys HBeAg quant test is accessible in all countries that recognize CE mark approval and is conducted on Roche's Cobas e-series analyzers. The test is intended for continued use even after the initial diagnosis of hepatitis B has been made. Firstly, it can be used to monitor the effects of various treatments by quantifying the antigen's presence. In addition, Roche suggests that it may be implemented in conjunction with other hepatitis B diagnostics to ascertain the disease's progression, the virus's impact on the liver, and the likelihood of liver malignancy or other complications. Roche observed that the immunoassay's prospective impact could be particularly significant, as hepatitis B is the most prevalent form of viral hepatitis worldwide.

Immunoassays in R&D Market Trends

The number of patients suffering from diseases is growing globally, and the complexity and severity of such conditions are also increasing. For instance, according to a 2016 study published in the Journal of Translational Medicine, nearly 12,000 patients are newly diagnosed with bladder cancer annually. Additionally, around 5000 patients die from the same on an annual basis in Japan. The demand for advanced diagnostic methods is rising with the growing number of patients. Presently, top companies are involved in developing immunoassay platforms with improved capabilities such as higher sensitivity and specificity, and a broad menu of tests. Other major advances introduced to researchers include shorter turnaround times (TAT), higher productivity, and smooth operation, thereby ensuring efficient detection and determination with accurate results. For instance, in January 2017, Siemens Healthineers announced the Novagnost Zika Virus IgM µ-capture Assay. Also, in December 2018, Thermo Fisher Scientific received the Food and Drug Administration (FDA) clearance for its de novo submission of its QMS Plazomicin Immunoassay. This complementary diagnostic immunoassay measures the concentration of a novel therapeutic antibiotic, plazomicin.

Immunoassays in R&D Market Share, by Type, 2023 (%)

Source: MRFR Analysis

Immunoassays in R&D Market Segment Insights

Immunoassays in R&D Product & Services Insights

Based on product & service, the global Immunoassay Market has been segmented into kits and reagents, analyzers, and software and services.

Immunoassays in R&D Type Insights

Based on type, has been segmented into enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunospot assay (ELISpot), radioimmunoassay (RIA), chemiluminescence (CLIA), fluoroimmunoassay, and others.

Immunoassays in R&D Applications Insights

Based on application, the global Immunoassay Market has been segmented into infectious diseases, cancer research, endocrinology, autoimmune diseases, and others.

Immunoassays in R&D End User Insights

Based on end user, the global market has been segmented into pharmaceutical and biotechnology companies, academic institutions and laboratories, and others.   

Key Players

The prominent players in the immunoassays in R&D market are 

• Bio-Rad Laboratories Inc., 


• Thermo Fisher Scientific Inc.


• Siemens Healthineers


• Becton Dickinson and Company


• Danaher Corporation


• bioMérieux Inc


• Abbott Laboratories


• F. Hoffmann-La Roche Ltd


• Sysmex Corporation


• Abcam plc

Source: MRFR Analysis

Immunoassays in R&D Regional Insights

The immunoassays in R&D market, based on region, has been segmented into the Americas, Europe, Asia-Pacific, and the Middle East & Africa.

The Americas is estimated to dominate the immunoassay in R&D market during the forecast period. This is attributed to the increasing number of research projects in laboratories, as research laboratories play a vital role in the growth of the regional market. Besides, several research grants are given by governmental agencies. Furthermore, research labs and academic institutions are involved in strategic partnerships and collaborations to come up with innovative diagnostic and treatment alternatives. For instance, the American Research Laboratories, based in Florida, the US, works in a partnership with clinicians to provide knowledge of, and access to the latest testing guidance.

The European Immunoassay Market is expected to be the second-largest during the review period. Their growing adoption in diagnostic measures is expected to boost the growth of the regional market. Additionally, the companies operating in the market are mainly focusing on mergers and acquisitions. For instance, in March 2017, bioMérieux, Inc. acquired Astute Medical, Inc. to expand its product portfolio.

Asia-Pacific is estimated to be the fastest-growing market owing to the developing healthcare infrastructure and increasing disposable income. Improving healthcare infrastructure has increased the number of research activities in the region. Moreover, the increase in the number of research and development centers and focus on strategic agreements of the companies operating in the market are the other factors expected to boost the growth of the regional market. For instance, in November 2018, bioMérieux, Inc. announced the acquisition of Suzhou Hybiome Biomedical Engineering Co. Ltd, which strengthened its presence in China.

The market in the Middle East & Africa is expected to witness steady growth due to limited access to healthcare. The growing awareness regarding healthcare and the availability of new advanced treatment options are factors expected to drive the growth of the market in the region. Additionally, many pharmaceutical companies are targeting the developing and underdeveloped countries in the region to expand their reach and increase the target audience. For instance, F. Hoffmann-La Roche Ltd marks the presence in 11 countries in Africa.

Key Updates

• In May 2018, Bio-Rad Laboratories, Inc. launched StarBright Blue 520Fluorescent Secondary Antibodies, which are fluorescent dye-labeled secondary antibodies, for use in multiplex western blotting.

• In December 2017, BD acquired C. R. Bard, Inc. for USD 24 billion. With this acquisition, the company aimed to become a leader in the healthcare industry. Due to this acquisition, BD generated annual revenue of approximately USD 16 billion in 2017.

• In December 2018, Thermo Fisher Scientific Inc. launched Thermo Scientific QMS Plazomicin Immunoassay, which is a complementary diagnostic immunoassay for measuring plazomicin concentrations. This quantitative immunoassay measures the concentration of plazomicin, using an automated clinical chemistry analyzer known as Beckman Coulter AU 680

Immunoassays in R&D Market Segmentation

Immunoassays in R&D Product & Service Outlook

• Kits and Reagents


• Analyzers


• Software and Services

Immunoassays in R&D Type Outlook

• Enzyme-Linked Immunosorbent Assay (ELISA)


• Enzyme-Linked Immunospot Assay (ELISpot)


• RadioImmunoassay (RIA)


• Chemiluminescence (CLIA)


• Fluoroimmunoassay


• Others

Immunoassays in R&D Application Outlook

• Infectious Diseases


• Cancer Research


• Endocrinology


• Autoimmune Diseases


• Others

Immunoassays in R&D End User Outlook

• Pharmaceutical and Biotechnology Companies


• Academic Institutions and Laboratories


• Others

Immunoassays in R&D Region Outlook

• Americas




• North America




• US


• Canada




• Latin America

• Europe




• Western Europe




• Germany


• UK


• France


• Italy


• Spain


• Switzerland


• Rest of Western Europe




• Nordic Countries


• Norway


• Sweden


• Denmark


• Rest of Nordic Countries


• Eastern Europe

• Asia-Pacific




• China


• Japan


• India


• Australia


• South Korea


• Rest of Asia-Pacific

• Middle East & Africa




• Middle East


• Africa

Intended Audience

• Medical research laboratories


• Research and development (R&D) companies


• Market research and consulting service providers


• Potential investors