Global Immunoassay Market Size, Share, Opportunities, And Trends 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), And By Geography - Forecasts From 2024 To 2029

The global immunoassay market was valued at US$32.713 billion in 2022 and is expected to grow at a CAGR of 6.45% over the forecast period to reach a total market size of US$50.703 billion by 2029.

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 hospitalized 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.

Market Drivers:

• An increase in infectious disease prevalence and disease diagnostic research is anticipated to drive the global immunoassay market.

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 fuelled the worldwide immunoassay market expansion.

• Enzyme Immunoassays (EIA) segment is anticipated to hold a sizable immunoassay market share.

The enzyme-linked immunosorbent assay (ELISA), a type of enzyme immunoassay, is used to find out whether a target protein is present in a biological sample. These assays are often the most accurate means of making a diagnosis and form the basis for most standard clinical diagnostics. Viral components can also be found via ELISA testing. Since ELISA works with a variety of samples, COVID-19 testing is becoming more and more necessary.

Enzyme immunoassays are also the least expensive of all immunoassays, which is a key driver of the market expansion. The growing number of EIA launches by major industry players is also anticipated to fuel market expansion.  Throughout the development and clinical stages of the vaccine, the multiplex immunoassay panels assisted the vaccine scientists in determining the therapeutic efficacy of the vaccines.

Market Restraints:

• Stringent regulatory requirements could hinder the market growth.

The licensing and marketing of immunoassay consumables and equipment have been subject to strict requirements by regulatory agencies in various countries. Furthermore, technological challenges that immunoassay kits and reagents face, 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.

The North American market is expected to share a significant marketplace.

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, the expanding geriatric population, the well-developed healthcare infrastructure, and the increasing penetration of medical technology in the region.

North America, including the United States and Canada, has a significant market share in the global immunoassay market due to its large healthcare infrastructure, technological advancements, high healthcare spending, and prevalence of diseases requiring immunoassay testing. The region's commitment to research and development can drive market growth in advanced immunoassay technologies.

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 organizations and pharmaceutical companies for disorders and diseases such as chronic illnesses and diabetes are some of the key factors driving the regional market growth.

The region's stringent regulatory environment enhances the credibility and reliability of immunoassay products, making them more widely accepted in the global market. Collaborations between academic institutions, research organizations, and industry players can further develop and commercialize immunoassay technologies. Overall, the North American market is a major player in the global immunoassay market due to its diverse and robust healthcare infrastructure.

Key Developments:

• March 2023- F. Hoffmann-La Roche Ltd. and Eli Lilly and Company partnered to develop the Elecsys Amyloid Plasma Panel (EAPP), a blood test designed to aid in early diagnosis and treatment of Alzheimer's disease. The EAPP aims to improve the journey to timely and accurate diagnosis and treatment, as 75% of people living with Alzheimer's symptoms without a diagnosis live without one. If approved, the EAPP test would help identify the low likelihood of amyloid pathology in symptomatic patients and determine if further evaluation and testing are necessary.
• February 2023- BioMérieux received FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its BIOFIRE SPOTFIRE system and respiratory panel. The system and panel are designed to provide rapid, actionable results for patients suspected of respiratory tract infections, especially during the COVID-19 pandemic. The system and panel can deliver results within 15 minutes during a patient's visit and can be used by non-lab professionals at the point-of-care. The system detects 15 common bacteria, viruses, and viral subtypes causing respiratory tract infections.
• December 2022- BioMérieux announced CE-marked the VIDAS® KUBE™, the next generation automated immunoassay system in the VIDAS® immunoassay portfolio. This innovation benefits clinical labs and food industries by providing fast and reliable results. VIDAS® has transformed the field of immunoassays, offering universal access to simple, automated technology. Currently used in over 160 countries by 25,000 laboratories, it features a single-test concept in an all-in-one kit. VIDAS® is one of the most widely used immunoassay systems in clinical laboratories worldwide.

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