Immunoassay Market: New Product Development and High Prevalence of Chronic and Infectious Diseases to Boost Market Growth

The global immunoassay market is expanding at a rapid pace due to high prevalence and rise in incidence of chronic, acute, and infectious diseases across the globe. The market was valued at US$ 16.54 Bn in 2017 and is projected to expand at a CAGR of 6.2% from 2018 to 2026 to reach US$ 28.61 Bn by 2026. The global immunoassay market is driven by technological advancements in the development of new immunoassays and analyzers and demographic and life changes favoring rapid, preventive, and predictive diagnosis.

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An immunoassay is a biochemical test conducted in IVD laboratories for the detection of presence of specific molecules in a solution with the use of an antigen or antibody. Immunoassay diagnostics tests have been widely used for more than 40 years in hospitals, diagnostic laboratories, blood banks, and research laboratories. Immunoassays have a number of applications in in vitro diagnostics for the diagnosis of various chronic as well as infectious diseases, prediction of disease course, framing the treatment, and monitoring the effectiveness of the therapy. Immunoassays are widely used in the life science industry for studying various biological systems by means of analysis of different biological molecules such as proteins, hormones, and antibodies.

High prevalence and rise in incidence rate of chronic and infectious diseases across the globe are projected to be the key drivers of the global immunoassay market during the forecast period.

Endocrinological diseases such as thyroid dysfunction, diabetes mellitus, osteoporosis, and others are on the rise owing to changing lifestyles. According to the International Diabetes Federation (IDF), in 2015, 415 million people were affected with diabetes worldwide. Various chronic diseases such as chronic respiratory diseases (CRD), diabetes, chronic kidney diseases (CKD), cancer, cardiac stroke, and neurological disorders are leading causes of disability and mortality across the globe. According to the International Agency for Research on Cancer (IARC), more than 14.1 million new cancer cases were diagnosed in 2012, and the global burden is estimated to increase by 21.7 million new cancer cases by the end of 2030. Demographic and lifestyle changes are fueling demand for rapid, preventive, and predictive diagnosis in developed countries. As part of preventive health care, elderly people and people with lifelong diseases such as diabetes, respiratory disorders, and cancer frequently require various medical tests such as blood tests and urine test. Thus, rapidly growing geriatric population across the globe requiring frequent medical tests is likely to be a key driver of the immunoassay market during the forecast period.

Development of integrated systems with complete automation for diagnosis of viral structural changes and new viral epidemics are anticipated to present significant opportunities in the global immunoassay market during the forecast period. With a rise in consolidation among diagnostic laboratories, test volumes are projected to increase. This is expected to boost demand for more integrated multi component systems that can offer solutions such as complete automated sample handling & post process sample storage, data integration with lab automation platform, and remote access monitoring and control. There are few systems available in the market that offer these features. One such system is Siemens Healthineer’s Atellica analyzer system that was introduced in 2016 and received FDA approval in 2017. Recent approvals from the U.S. FDA reflect increasing investments from key players for the development of point-of-care automated immunoassay analyzer systems and the rise in demand from end-users.

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The global immunoassay market has been segmented based on technology, product, application, end-user, and region. In terms of technology, the global market has been classified into chemiluminescence immunoassay (CLIA), enzyme-linked immunoassay (ELISA), enzyme-linked immunofluorescent assay (ELFA), radioimmunoassay (RIA), and others. The others segment includes microarray, biochip assays, and counting immunoassay. The chemiluminescence immunoassay (CLIA) segment dominated the global market in 2017 and is projected to gain market share by the end of 2026. High sensitivity and lower cost of CLIA are estimated to drive the segment during the forecast period. Moreover, availability of a wide range of assays and high throughput of CLIA analyzers are likely to propel the segment from 2018 to 2026. In terms of product, the global market has been categorized into immunoassay analyzers and consumables. The consumables segment includes immunoassay kits and reagents, calibrators, controls, diluents, buffers, and wash solutions. The consumables segment is estimated to hold around 80% share of the global immunoassay market by the end of 2026.

Based on application, the global immunoassay market has been divided into infectious diseases, endocrinology, oncology, cardiology, orthopedics, and others. The others segment includes autoimmune disorders, therapeutic drug monitoring, gastrointestinal disorders and stool testing, and allergy testing. The infectious disease segment dominated the global immunoassay market in 2017 accounting for more than 25% of the market share. The endocrinology segment is projected to expand at a rapid CAGR during the forecast period.

In terms of end-user, the global immunoassay market has been divided into hospitals & diagnostics laboratories, blood banks, and others. The others segment includes academic and research institutes, pharmaceutical and biotechnology companies, and forensic laboratories. The hospitals & diagnostic laboratories segment accounted for a leading share of the global market and is projected to continue to dominate the market during the forecast period. Rapid increase in the number of health care institutions in emerging countries, large test volume for various diseases, and expansion of laboratory services contributed to the dominant share of the segment in 2017. The blood bank segment held a prominent share of the global immunoassay market in 2017.

Based on region, the global immunoassay market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for a dominant share of the global immunoassay market, accounting for more than 35% share in 2017. Europe held a prominent share of the global market in 2017. Well-established health care infrastructure, rapidly increasing geriatric population, and large base of pharmaceutical and biotechnology industries has led to dominant shares of North America and Europe. The market in Asia Pacific is projected to expand at a rapid CAGR during the forecast period owing to rise in foreign direct investment in the health care and life science industry, rapidly increasing number of hospitals and diagnostic laboratories in the region, and large patient population with chronic and infectious diseases.

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The global immunoassay market is fragmented, with a large number of companies accounting for majority share in respective regions. Major players operating in the global market include F. Hoffmann-La Roche Ltd., Danaher Corporation, Abbott Laboratories, and Siemens Healthineers. Manufacturers are adopting strategies of mergers and acquisitions with parallel companies to strengthen their product portfolio and geographic reach. Other prominent players operating in the global market include Becton, Dickinson and Company, Ortho Clinical Diagnostics, bioMérieux SA, Sysmex Corporation, and DiaSorin S.p.A.

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