North America Immunodiagnostic Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Product [Enzyme-Linked Immunosorbent Assays, Chemiluminescence Immunoassays (Vitamin D Assay, HIV Detection, HIV Ag/Ab Combo Assay, and Others), Radioimmun

North America Immunodiagnostic Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Product [Enzyme-Linked Immunosorbent Assays, Chemiluminescence Immunoassays (Vitamin D Assay, HIV Detection, HIV Ag/Ab Combo Assay, and Others), Radioimmunoassays, and Others], Clinical Indication [Infectious Diseases (COVID-19, Lyme, Zika, Infection Management, TORCH, Tuberculosis, Treponema, Measles & Mumps, EBV, and VZV), Hepatitis+HIV, Gastrointestinal, Metabolics[PL1] , Endocrinology (Hypertension, GROWTH, Diabetes, Thyroid, and Reproductive Endocrinology), and Others], and End User (Hospitals, Clinics, Diagnostic Laboratories, Academic & Research Institutes, and Others) [PL2] 

The North America immunodiagnostic market is expected to reach US$ 15,040.40 million in 2028 from US$ 9,188.19 million in 2021. The market is estimated to grow with a CAGR of 7.3% from 2022 to 2028.

The market growth is mainly attributed to factors such as the increasing prevalence of infectious diseases and the rising use of point-of-care immunodiagnostics. However, the inadequate reimbursement scenario hinders the market growth.

Research and development (R&D) are an essential part of pharmaceutical and biopharmaceutical businesses. R&D enables them to develop new products for various diagnostic applications with significant medical and commercial potential. Due to the increasing prevalence of infectious diseases, companies are investing and generating huge revenues, which further helps them in expansion activities. Thermo Fisher Scientific Inc. witnessed a 48% increase in sales in its Specialty Diagnostics segment (sub-segmented into clinical diagnostics, immunodiagnostics, microbiology, transplant diagnostics, and healthcare market channels) in 2020. Its segmental revenue further increased in 2021 due to higher demand, particularly for immunodiagnostics products used in the treatment of COVID-19. Additionally, in May 2021, PerkinElmer agreed to acquire Immunodiagnostic Systems (IDS), a UK-based in-vitro diagnostics company, for ~US$ 155 million. With this acquisition, PerkinElmer aims to expand its overall diagnostics business and immunodiagnostics division.

The growing R&D environment for developing innovative products opens several opportune doors for small players and start-ups. The table below displays the annual support levels for various research and disease categories based on contracts, grants, and other funding mechanisms used across the National Institutes of Health (NIH ):

Table 1. Infectious Diseases and Funding

Research/Disease Areas 2019 2020 2021 2022

Emerging Infectious Diseases US$ 2,950
US$ 4,867
US$ 5,069 US$ 4,318

Infectious Diseases US$ 6,313

US$ 8,301

US$ 8,599 US$ 8,019

Sexually Transmitted Infections US$ 354
9US$ 394
US$ 404 US$ 419

Note: Current conversion rates have been considered for the representing currencies.

Source: Annual Reports and The Insight Partners Analysis.

Cisco Systems, a global technology leader, invested US$ 225 million to back its efforts for combating the COVID-19 pandemic. This initiative enabled the company to expand significantly and encouraged new players to enter the market, which are likely to aid the market's growth in the near future.

Based on product, the immunodiagnostic market is segmented into enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), radioimmunoassays (RIA), and others. The chemiluminescence immunoassay (CLIA) is further categorized into vitamin D assay, HIV detection, HIV Ag/Ab combo assay, and others. The enzyme-linked immunosorbent assays (ELISA) segment held the largest market share in 2021. However, the chemiluminescence immunoassay (CLIA) segment is expected to grow at the highest CAGR during the forecast period. Advancements in the ELISA technique have led to the development of quantitative PCR, fluorogenic, and electrochemiluminescent reporters to generate signals. Also, the nanotechnology boom has yielded some developments in designing nanomaterial-based improved ELISA in recent years.

Based on clinical indication, the immunodiagnostic market is segmented into infectious diseases, hepatitis+HIV, gastrointestinal, metabolic diseases, endocrinology, and others. The infectious disease segment is further divided into COVID-19, Tuberculosis, Lyme, Infection Management, Zika, Treponema, TORCH, Measles & Mumps, VZV, and EBV. The infectious diseases segment held the largest share of the market in 2021 and is further anticipated to register the highest CAGR during the forecast period. Several target biomarkers and biomarker combinations are available for infectious diseases. Immunodiagnostics complements molecular assays in the study of infectious diseases. There are many immunodiagnostic tests that can be used to assist in the diagnosis of infectious, endocrine, and neoplastic diseases as well as to measure blood drug concentrations.

Based on end user, the immunodiagnostic market is segmented into hospitals, clinics, diagnostics laboratories, academic & research institutes, and others. The hospitals segment held the largest share of the market in 2021. However, the clinics segment is anticipated to register the highest CAGR during the forecast period. Immunodiagnostics tests are performed in different hospital departments, including clinical microbiology departments, pathological labs, serological labs, histopathology and hematology sections, clinical biochemistry laboratories, and hospital wards. Some of the immunodiagnostic instruments provide quick results, while in the case of complex tests, the samples are sent to the concerned laboratories. Various tests performed in hospitals include enzyme-linked immunosorbent assays (ELISA), Wstern Blot, infectious tests, and other immunological assays.

On the basis of region, the immunodiagnostic market is segmented into North America (the US, Canada, and Mexico)

ABBOTT; PerkinElmer Inc.; bioMérieux SA; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; Siemens Healthineers AG; Thermo Fisher Scientific Inc; Danaher Corp; DiaSorin S.p.A.; and F. Hoffmann-La Roche Ltd . are the key companies operating in the North America iImmunodiagnostic immunodiagnostic market.

The World Health Organization (WHO), National Health Service (NHS), Centers for Disease Control and Prevention (CDC), American Society for Clinical Pathology, American Diabetes Association, and Biotechnology Innovation Organization (BIO) are among the major primary and secondary sources referred to while preparing the report on the North America immunodiagnostics market.

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