Immunoassays are bioanalytical methods in which the quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody. Immunoassays have been widely used in many important areas of pharmaceutical analysis such as diagnosis of diseases, therapeutic drug monitoring, clinical pharmacokinetic and bioequivalence studies in drug discovery and pharmaceutical industries. The importance and widespread of immunoassay methods in pharmaceutical analysis are attributed to their inherent specificity, high-throughput, and high sensitivity for the analysis of wide range of analytes in biological samples. Recently, marked improvements were achieved in the field of immunoassay development for the purposes of pharmaceutical analysis. These improvements involved the preparation of the unique immunoanalytical reagents, analysis of new categories of compounds, methodology, and instrumentation. In addition, novel techniques are developed to enable the rapid production of specific antibodies. These techniques resulted in dramatic shortening of the time required for developing of immunoassay methods. These potential advantages of immunoassay methods, in addition to the relatively low cost of the instruments, tools, or the reagents made immunoassays the methods of choice in many areas of pharmaceutical analysis. Moreover, a considerable rise in the cases of infectious and chronic disease and the rise in the use of immunoassays in oncology are likely as the main factors that are projected to support the development of the market in the coming years

Immunoassay Market Outlook

The immunoassay market has witnessed remarkable growth in past few years due to the increasing use of immunoassays in oncology, rising geriatric population, vital role of immunoassays in drug and alcohol testing. Furthermore, this market is also driven by technological advancements in immunoassay instruments and introduction of novel automated systems. However, complex assay procedures and stringent regulatory norms for the approval of immunoassay instruments & consumables are hindering the immunoassay market growth.

Immunoassay Market Segmental Overview

The immunoassay market is categorized by product & service, technology, application, end user and geography.

Immunoassay Market by Product & service

Various product & services are discussed in this reports such as reagents & kits, analyzers and software & services. Reagents & kits are further bifurcated into ELISA reagents & kits, rapid test reagents & kits, ELISPOT reagents & kits and western blot reagents & kits. Moreover, analyzers is classified into Open-Ended Systems and Closed-Ended Systems. The reagents and kits segment accounted for the largest share of the immunoassays market in 2018, owing to the requirement of the repeat purchase of kits and reagents, along with the increasing number of immunoassay tests being executed in consequence of the rising incidence of chronic and infectious diseases.

Immunoassay Market by Technology

Based on technology, the immunoassay market is classified into enzyme-linked immunosorbent assays, rapid tests, enzyme-linked immunospot, western blotting, immuno-PCR, chemiluminescence immunoassays, fluorescence immunoassays, colorimetric immunoassays and radioimmunoassays. Enzyme Linked Immunosorbent Assay (ELISA) is immunoassay used to identify proteins, peptides, antibodies, and hormones. ELISA assay has application in biotechnology medicine, as a diagnostic tool, which detects color change to identify a target substance and measures its concentration in the test sample. The common diagnostic applications of ELISA are HIV infection, pregnancy tests, and measurement of cytokines, soluble proteins, and others.

Immunoassay Market by Application

By application, the immunoassay market is bifurcated into infectious diseases, endocrinology, oncology, bone & mineral disorders, cardiology, hematology & blood screening, autoimmune disorders, toxicology and neonatal screening. Due to the increasing prevalence of infectious diseases, there is increasing application in the diagnosis of infectious diseases. While oncology segment is expected to be the fastest growing segment owing to increasing incidences of cancer in the global population and technological developments such as innovative wide arrays for cancer biomarkers.

Immunoassay Market by End User

Based on end user, the immunoassay market is segmented into hospitals, clinical laboratories, pharmaceutical and biotechnology companies, blood banks and research & academic laboratories. The hospitals segment accounted for the largest share of the immunoassays market in 2018. The large share of this segment is primarily accredited to the fact that most diagnostic tests are performed in hospitals or hospital-attached laboratories due to easy access to reports and smooth logistics.

Immunoassay Market by Geography

Geographically, the market is segmented into North America, Europe, Asia-Pacific, Rest of the World which includes Middle East & Africa and Latin America. Due to the collective application of immunoassay techniques in cancer research, increasing implementation of low cost and compact immunoassay instruments in clinical diagnostics & research laboratories and increasing quality of infrastructure for laboratory & clinical research, North America dominated the market in 2018. Whereas, in Asia-Pacific, China had the largest market share of immunoassay in 2017 and is also anticipated to mount rapidly.

Immunoassay Market Key Players

The key market players that are dominating the immunoassay market include Abbott Laboratories, Roche Diagnostics Ltd, Siemens Healthcare, Beckman Coulter, Ortho Clinical Diagnostics, BioMrieux, Bio-Rad Laboratories Inc., Alere Inc., Sysmex Corporation, Beckton, Dickinson & Co., Hologing Inc., Luminex Corp., Meridian Life Science Inc., Qiagen etc. Leading companies have invested massive capital in research & development and mergers & acquisitions activities to develop innovative products in the market.







