Global Immunoassay Market - Forecasts from 2022 to 2027

The global immunoassay market was valued at US$28.815 billion in 2020 and is expected to grow at a CAGR of 6.31% over the forecast period to reach a total market size of US$44.222 billion by 2027.



An immunoassay is a bioanalytical method that employs antigen-antibody affinity to identify and quantify molecules of interest in biological samples. Immunoassays are quick and accurate tests that may be performed in the lab to identify particular substances.

Increased R & D efforts, as well as an increase in disease diagnostics, cancer markers, cardiac analysis, therapeutic medication monitoring, and clinical research methods, are projected to fuel market growth. In hospitals and medical laboratories, immunoassays can be used to perform automated biochemical tests to identify the presence and concentration of certain chemicals in samples. The use of immunoassays in numerous bioanalytical applications such as medical diagnostics, environmental monitoring, biopharmaceutical analysis, and food testing is propelling the market’s growth.

The key drivers driving market expansion are the escalation of occurrences and the prevalence of infectious illnesses. According to the World Health Organization (WHO), seven out of every hundred hospitalised patients in developed countries and ten in poor countries will contract at least one healthcare-related infection. As a result, the rising number of patients suffering from infectious illnesses is expected to result in a significant demand for immunoassay devices throughout the world.

However, inadequate reimbursement guidelines are anticipated to hinder the immunoassay market expansion.

North America is likely to lead the immunoassay market for a few more years. This can be attributed mostly to the soaring rates of chronic and infectious diseases and the expanding geriatric population, as well as the well-developed healthcare infrastructure of the region and the increasing penetration of medical technology. Six out of every ten Americans have at least one chronic condition, such as heart disease, stroke, cancer, or diabetes. Furthermore, increased R & D spending by government organisations and pharmaceutical companies for disorders and diseases such as chronic illnesses and diabetes are some of the key drivers driving the regional market.

Growth Factors

Increase in infectious disease prevalence and disease diagnostic research:

Chronic conditions, including diabetes, cardiovascular disease, and cancer, are on the increase all across the globe. Infectious diseases such as SARS-CoV2 (COVID-19), Dengue, Hepatitis B and C, HIV,  malaria,  tuberculosis, and others are also on the rise. Immunoassay diagnosis has become an important component of many diseases' diagnostic protocols. Immunoassay technology advancements are providing faster results with greater effectiveness, detection limits, sensitivity, and cost-efficiency. The widespread use of quick tests and point-of-care testing for disease diagnosis and drug and alcohol addiction has fueled the worldwide immunoassay market expansion.

Restraints:

Stringent regulatory requirements:

The licencing and marketing of immunoassay consumables and equipment has been subject to strict requirements by regulatory agencies in various countries. Furthermore, technological challenges faced by immunoassay kits and reagents, such as cross-reactivity of antibodies, limited detection limits of available antibodies, false negatives, and others, slow immunoassay market growth. The technicians encounter several design problems associated with immunoassays, such as misinterpretation of results. . Furthermore, a shortage of trained experts in the clinical diagnostics sector has created problems for several decades.

COVID-19's Impact on the Immunoassay Market:

The immunoassay product is essential in slowing the spread of COVID-19. In the absence of a vaccine or cure, the only effective way to prevent and manage virus outbreaks and their consequences is via diagnosis. Rapid testing has developed as an effective, quick, and simple molecular test for large-scale COVID-19 monitoring. Massive research, valuations, and approvals of several immunoassay consumables and analyzers have addressed the SARS-CoV2 detection problems. The usage of immunoassays such as chemiluminescence, enzyme-linked, lateral flow-based point of care testing, fast tests, and other technologies has increased. The market has been influenced by the demanding regulatory procedures for immunoassay product approval, as well as the technological challenges of immunoassay kits and reagents. Because of the widespread diagnosis of COVID-19, the immunoassay market in many countries has grown dramatically during the pandemic. Furthermore, the market is projected to rise further with the increase in the number of COVID-19 cases.

Key Developments

• The Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) label for Quanterix Corporation's Simoa® SARS-CoV-2 N Protein Antigen Test to enable testing using a nasal swab and saliva samples, as well as asymptomatic serial testing, as of September 2021.
• BioMérieux SA announced in January 2020 that its molecular biology subsidiary, BioFire Diagnostics, has applied to the Food and Drug Administration for clearance of the BIOFIRE Blood Culture Identification 2 (BCID2) Panel. When compared to the previous BIOFIRE BCID Panel, the BIOFIRE BCID2 Panel includes numerous more pathogens, an enlarged list of antibiotic resistance genes, and several revised targets.
• Snibe Diagnostic announced in April 2021 that its Maglumi HIV Ab/Ag Combi CLIA kit, a fourth-generation chemiluminescence immunoassay that detects HIV-1 and HIV-2 antibodies as well as the HIV-1 p24 antigen, had received CE marking, allowing it to be sold in the European Union and other regions that accept the designation.

Segmentation:

By Type

• Radioimmunoassay (RIA)
• Enzyme Immunoassays or Enzyme-linked immunosorbent assays (ELISA)
• Counting Immunoassay (CIA)
• Fluoroimmnoassay (FIA)
• Chemiluminescence immunoassay (CLIA)

By Therapeutic Area

• Infectious Diseases
• Bone Metabolism
• Immunology
• Neurobiology
• Others

By End-User

• Hospitals & Clinics
• Diagnostics
• Pharmaceutical & Biotechnology Companies
• Research & Academic Laboratories

By Geography

• North America
• United States
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• UK
• France
• Germany
• Italy
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Others
• Asia Pacific
• Japan
• China
• India
• Thailand
• Taiwan
• Indonesia
• Others