Immunoassay Market - By Technology (ELISA, CLIA, RIA), Product (Reagent & Kits, Analyzers/Instruments), Specimen (Blood, Saliva, Urine), Application (Oncology, Cardiology), End-use (Hospitals & Clinics, Diagnostic Labs) – Global Forecast, 2024 – 2032

Immunoassay Market Size

Immunoassay Market size was valued at USD 31.4 billion in 2023 and is estimated to grow at a CAGR of 5.3% between 2024 and 2032. Immunoassay is a laboratory technique used to detect and quantify specific molecules, such as proteins, hormones, or antibodies, in a biological sample. In this technique, the specificity of antigen-antibody interactions is leveraged for the identification and measurement of target substances.
 

It offers high sensitivity and specificity, allowing for the precise detection of specific analytes even at low concentrations. High market growth can be attributed to factors such as increasing prevalence of chronic conditions, advancements in immunoassay technologies, growing demand for point-of-care testing (which accounted for USD 38.5 billion in 2022), rising awareness and screening programs, growing aging population, and increased disease screening.
 

The increasing prevalence of chronic conditions is a significant driver for the market. For instance, according to the Centres of Disease Control and Prevention (CDC), in 2023, six in ten individuals have at least one chronic disease in the U.S. Immunoassay play a crucial role in the diagnosis, monitoring, and management of chronic conditions due to their ability to detect specific biomarkers associated with these diseases, thereby surging the market expansion.
 

Immunoassay Market Trends

Advancements in immunoassay technologies play a significant role as driver for the market as it influences various aspects of molecular diagnostics, research applications, accurate monitoring of diseases, and the overall healthcare landscape.
 

• For instance, according to a report of the National Library of Medicines, in 2023, single-molecule immunoassay technique can test 66 samples in 1 hour, making more efficient than conventional immunological detection techniques.
   
• Furthermore, advancements in immunoassay technologies have facilitated the integration of multiplexing capabilities, enabling the simultaneous detection of multiple biomarkers in a single test. Consequently, providing a comprehensive and efficient approach to assessing complex diseases, contributing to a more holistic understanding of patient health.
   
• Thus, the continuous evolution of new technologies by addressing key challenges, expanding application areas, boost the market size.
   

Immunoassay Market Analysis

Based on product, the global market is bifurcated into reagents & kits, and analyzers/instruments. The reagents & kits segment held the largest business share of 66.2% in 2023. The reagents & kits segment is classified into ELISA reagents & kits, ELISpot reagents & kits, rapid test reagents & kits, western blot reagents & kits, chemiluminescence immunoassay reagents & kits, immunofluorescence assay reagents & kits, and other reagents & kits. Similarly, analyzers/instruments are bifurcated into open ended systems and closed ended systems.
 

• Reagents and kits are essential components for conducting immunoassay procedures. Immunoassays rely on the interaction between antigens and antibodies, and reagents are critical for facilitating and detecting these interactions. Kits are often designed to include all the necessary components, streamlining the assay process.
   
• Further, new launch in the industry propels the demand for these reagents & kits. For instance, in 2022, Agilent Technologies, Inc. introduced Dako SARS-CoV-2 lgG linked immunosorbent assay in the U.S. Consequently, this product launch boosted the company’s sales.

Based on technology, the global immunoassay market is classified into enzyme-linked immunosorbent assay (ELISA), chemiluminescence immunoassay (CLIA), radioimmunoassay (RIA), immunofluorescence assay (IFA), western blotting, ELISpot, and other technologies. The ELISA segment held the largest market revenue of USD 14.9 billion in 2023.
 

• ELISA is a versatile immunoassay technique that can be adapted for the detection of various analytes, including proteins, antibodies, hormones, and antigens. Its versatility makes it suitable for a wide range of applications across different fields, including clinical diagnostics, research, and drug development.
   
• Further, increasing use of ELISA for various types of detection contributed to the growth of the technology. For instance, in 2021, the researchers of University of Central Florida developed a screening method using ELISA, making the test 300 times more sensitive at detecting carcinoembryonic antigen, a cancer biomarker. Therefore, increasing the utilizing of this technique.
   
• Additionally, ELISA can be used to detect and quantify a broad spectrum of biological molecules. This flexibility allows researchers and clinicians to use ELISA for diverse purposes, from measuring specific disease markers in clinical samples to assessing protein expression in research experiments, thereby escalating the segment progress.
   

Based on specimen, the immunoassay market is divided into blood, urine, saliva, and other specimens. The blood segment is projected to reach USD 21 billion by 2032.
 

• Blood is a rich source of biomarkers, including proteins, antibodies, hormones, and various other molecules. As, many diseases and health conditions manifest changes in the composition of blood, making it a valuable specimen for diagnostic testing using immunoassays.
   
• Additionally, advancements in the blood collection technique propels the market. For instance, in 2022, CSL received clearance from the U.S. FDA for the Rika Plasma Donation System developed by Cell Technologies and Terumo Blood. This approval accelerated the collection of plasma.
   
• Further, blood is routinely collected for clinical testing and clinical trials, making it a readily available specimen in healthcare settings.
   

Based on application, the immunoassay market is divided into infectious diseases, oncology, endocrinology, cardiology, autoimmune diseases, therapeutic drug monitoring, and other applications. The infectious diseases segment held the largest business share of 36.4% in 2023.
 

• Infectious diseases represent a significant global health concern. Outbreaks of infectious diseases, such as viral infections (e.g., influenza, hepatitis, HIV), bacterial infections (e.g., tuberculosis), and emerging infectious diseases (e.g., COVID-19), have driven the demand for immunoassay for early detection and monitoring.
   
• For instance, according to the World health Organization (WHO), in 2022, around 38.4 million people around the world were affected by HIV with around 1.5 million new cases being registered in 2021 alone.
   
• Additionally, immunoassay is widely employed for the detection of antibodies and antigens associated with sexually transmitted infections (STIs) such as syphilis and gonorrhea.
   

Based on end-use, the immunoassay market is classified into hospitals and clinics, diagnostic centres, research and academic laboratories, homecare settings, and other end-users. The hospitals and clinics segment held the largest market size of USD 9.8 billion in 2023.
 

• Hospitals and clinics serve as central locations for patient care, and immunoassay are integral to the diagnostic processes involved in patient management. Thus, these assays aid healthcare professionals in making informed decisions regarding treatment plans, medication adjustments, and overall patient care.
   
• Additionally, these settings are often involved in clinical research and trials, and immunoassays are vital for biomarker discovery, validation, and monitoring in these studies. Consequently, widespread use of immunoassay in research further strengthens their presence in hospital and clinics, thereby escalating the segment landscape.

In 2023, North America held a significant share of 40.6% in the immunoassay market. The region boasts of a highly advanced and well-established healthcare infrastructure. This infrastructure includes state-of-the-art clinical laboratories, medical research institutions, and a network of healthcare facilities that are well-equipped to adopt and implement advanced diagnostic technologies such as immunoassays.
 

• North America faces a significant burden of chronic diseases, such as diabetes, cardiovascular disorders, and cancer. As, immunoassays play a crucial role in the detection and monitoring of biomarkers associated with these conditions, thereby driving the growth.
   
• For instance, according to the National Institutes of Health, in 2022, nearly 25% of the geriatric population base suffers from cancer of which 30% are obese, creating an opportunity for local market players to boost their sales of immunoassay-based tests for cancer, cardiology, endocrinology, infectious diseases, and other diseases.
   

Immunoassay Market Share

The immunoassay industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products based on different technologies, global expansion, research and development, and diverse diagnostic modalities are among the key market strategy being adopted by players. Some of the leading industry players including Thermo Fisher Scientific Inc., Abbott Laboratories, QIAGEN, among others have a notable presence in the market.
 

Immunoassay Market Companies

Foremost players operating in the immunoassay industry are as mentioned below:

• Abbott Laboratories
• Agilent Technologies, Inc.
• Becton Dickinson and Company
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• F. Hoffmann-La Roche AG
• Hologic Inc.
• Luminex Corporation
• PerkinElmer, Inc.
• QIAGEN
• Sysmex Corporation
• Thermo Fisher Scientific Inc.
   

Immunoassay Industry News:

• In 2021, Abbott Laboratories COVID-19 Ag rapid test device received CE mark for asymptomatic diagnosis of the SARS-CoV-2 virus. It utilized the immunoassay technique using human nasal swab. Thus, this approval expanded the product portfolio of the company and helped to generate sales.
   
• In August 2023, Thermo Fisher Scientific launched the high-plex luminex assays for multi-omics. This provided complementary and highly correlative multiplex panels, enabling the measurement of gene expression and protein on a single platform, thus allowing for the analysis of both protein and gene expression from a single sample. Thus, this launch allowed the product diversification and growth of the company.
   

The immunoassay market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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Market, By Product

• Reagents & kits
  • ELISA reagents & kits   
  • ELISPOT reagents & kits   
  • Rapid test reagents & kits      
  • Western blot reagents & kits
  • Chemiluminescence immunoassay reagents & kits
  • Immunofluorescence assay reagents & kits
  • Other reagents & kits 
• Analyzers/Instruments
  • Open ended systems
  • Closed ended systems

Market, By Technology

• Enzyme-linked immunosorbent assay (ELISA)
• Chemiluminescence immunoassay (CLIA)
• Radioimmunoassay (RIA)
• Immunofluorescence assay (IFA)
• Western blotting
• ELISpot
• Other technologies

Market, By Specimen

• Blood
• Urine
• Saliva
• Other specimens

Market, By Application

• Infectious diseases
• Oncology
• Endocrinology
• Cardiology
• Autoimmune diseases
• Therapeutic drug monitoring
• Other applications    

Market, By End-use

• Hospitals and clinics
• Diagnostic centers
• Research and academic laboratories
• Homecare settings
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa