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Immunoassay Market


Global Immunoassay Market Global Industry Analysis and Forecast (2025-2033) by Product (Reagents & Kits, Analyzers/Instruments, and Software & Services), Application (Oncology, Therapeutic Drug Monitoring, Cardiology, Infectious Disease Testing, Endocrinology, Autoimmune Diseases, and Other Applications), Technology (Radioimmunoassay (RIA), Enzyme Immunoassays (EIA), Rapid Test, and Other Technologies), Specimen (Saliva, Blood, Urine, and Other Specimens), End-Use (Hospitals, Clinical Laboratories, Blood Banks, Academic Research Centers, Pharmaceutical and Biotech Companies, and Other End-Uses), and Region


August 2025

Healthcare

Pages: 138

ID: IMR2162

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Immunoassay Market Synopsis

 

The Global Immunoassay Market was valued at USD 33.4 billion in 2024 and is expected to grow from USD 35.6 billion in 2025 to USD 58.7 billion by 2033, reflecting a CAGR of 6.5% over the forecast period.

 

The market of immunoassays records continuous growth in its size which is conditioned by the growing impact of infectious diseases, chronic ailments, and the growing need in providing rapid, accurate, and cost-effective diagnostics. Widely used in clinical diagnostics, biotechnology, pharmaceutical research, and environmental testing, immunoassays, or biochemical tests to detect/quantify a specific antigen or antibody, are widely responsible for significant advances in clinical and biotechnological development since its inception. Improved sensitivity, specificity, and efficiency of immunoassays developed through technological improvement of automated platforms, high-throughput screening, chemiluminescence and fluorescence-based methods and technique integration have made it grow more area of application both at laboratory and point-of-care areas.

 

Immunoassay Market Overview

 

Key Takeaways of the Immunoassay Market

 

o   On the basis of Product, the Reagents & Kits segment is expected to lead the Immunoassay Market with the revenue share of 48.2% throughout the forecast period.

o   The Infectious Disease Testing, by Application, is projected to be the most significant shareholder of 24.6% of the Immunoassay Market through the projection period.

o   Enzyme immunoassays accounted for the largest market share of 40.1% in 2024, driven by their extensive use in personalized medicine, cancer diagnostics, cardiovascular disease testing, and infectious disease detection.

o   In terms of Specimen, the Blood category is forecasted to the biggest market share of 34.2% of Immunoassay Market throughout the forecast period.

o   The hospitals segment is projected to capture the highest market share of 31.1% in Immunoassay Market by the End-Use in the forecast period.

o   North America is expected to dominate the market over the forecast period with the revenue share of 37.1%.

 

Immunoassay Market Driver Analysis

 

Rising Prevalence of Chronic and Infectious Diseases

 

The increased cases of cancer, diabetes, and infections are a major contributor towards the need of precise diagnostics tests such as immunoassays. Since the burden of these conditions is constantly increasing all over the whole world, early detection and accurate monitoring were proven to be critical in terms of providing the proper treatment and further patient outcomes. The specificity and sensitivity of the Immunoassays are high revealing the biomarkers of the disease at an early stage and this aspect is critical because it aids in early intervention. As such, the detection of tumor markers with cancer diagnostics as well as tracking of insulin and other related biomarkers related to diabetes management are based on immunoassays.

 

Immunoassay Market Restraint Analysis

 

Cross-Reactivity and False Results

 

The risk of false positives or false negatives presented by limitations on assays is a serious threat to the validity of immunoassays. Inaccurate results of test may be due to factors like cross-reactivity between similar molecules, sample poor quality, and substances in the specimen interfering with test accuracy. False positives can cause unwarranted second rounds of examination, stress to the patient, and raise health expenditures, whereas false negatives can cause poor clinical outcomes as the patient might not get the diagnosis and treatment in time. Even with the current sensitivity and specificity in regard to the advancement in assay design and detection methods, these short comings display the need to constantly innovate, validate and integrate add-on testing modalities to achieve viable diagnostic outcomes.

 

Immunoassay Market Opportunity Analysis

 

Integration of Artificial Intelligence and Automation

 

Data analysis that supports and facilitates immunoassay testing is becoming as fast as it is accurate with the introduction of easily automated platforms and AI-based systems. Module intelligence will be able to handle large and complicated data suites, recognize obscure trends and mitigate the possibility of human error to misinterpret the findings resulting in more accurate diagnostics. Automated platforms facilitate the testing activity in the laboratory setting by decreasing person-power contribution, cutting down the turnaround time, and capable of high-throughput testing. The combination of these technologies will result in better use of resources, reproducibility, and enable the providers to make more accurate and rapid diagnosis.

 

Immunoassay Market Trend Analysis

 

Adoption of Chemiluminescence and Fluorescence-Based Assays

 

The trend is toward utilizing very sensitive and specific technologies both in clinical and research settings since it is more accurate and reliable biomarker detection can be achieved. Advanced technologies in clinical diagnostics allow detecting the diseases earlier, often making the treatment processes more effective and offering better results. Likewise, high sensitivities and specificities are critical in achieving accuracy in data generation, drug discovery, and validation of new biomarkers, in research environments. Chemiluminescence, fluorescence-based assay, and next-generation platforms are becoming popular technologies due to their ability to reduce the chances of a false read, deliver clear, repeatable data.

 

Immunoassay Market Segment Analysis

 

The Immunoassay Market is segmented on the basis of Product, Application, and Specimen.

By Product

 

o   Reagents & Kits

o   Rapid Tests Reagents & Kits

o   ELISA Reagents & Kits

o   Western Blot Reagents & Kits

o   ELISPOT Reagents & Kits

o   Other Reagents & Kits

o   Analyzers/Instruments

o   Open Ended Systems

o   Closed Ended Systems

o   Software & Services

 

By Application

 

o   Oncology

o   Therapeutic Drug Monitoring

o   Cardiology

o   Infectious Disease Testing

o   Endocrinology

o   Autoimmune Diseases

o   Other Applications

 

By Technology

 

o   Radioimmunoassay (RIA)

o   Enzyme Immunoassays (EIA)

o   Chemiluminescence Immunoassays (CLIA)

o   Fluorescence Immunoassays (FIA)

o   Rapid Test

o   Other Technologies

 

By Specimen

 

o   Saliva

o   Blood

o   Urine

o   Other Specimens

 

By End-Use

 

o   Hospitals

o   Clinical Laboratories

o   Blood Banks

o   Academic Research Centers

o   Pharmaceutical and Biotech Companies

o   Other End-Uses

 

By Region

 

o   North America (U.S., Canada, Mexico)

o   Eastern Europe (Bulgaria, The Czech Republic, Hungary, Poland, Romania, Rest of Eastern Europe)

o   Western Europe (Germany, UK, France, Netherlands, Italy, Russia, Spain, Rest of Western Europe)

o   Asia Pacific (China, India, Japan, South Korea, Malaysia, Thailand, Vietnam, The Philippines, Australia, New-Zealand, Rest of APAC)

o   Middle East & Africa (Turkey, Bahrain, Kuwait, Saudi Arabia, Qatar, UAE, Israel, South Africa)

o   South America (Brazil, Argentina, Rest of SA)

 

By Product, Reagents & Kits Segment is Expected to Dominate the Market During the Forecast Period

 

The reagents & kits segment is projected to lead the immunoassay market throughout the prediction period, due to their frequent application in many different types of diagnostic assays and research studies. They play a key role in carrying out immunoassays and their high consumption rate in clinical laboratories and hospitals among other research institutions make them possess market leadership. 

 

The remaining product segments include analyzers/ instruments and software and services. The segment of analyzers/instruments is an important one because their stock has only high levels, which are supported by the advancements of the automation and portability and the expansion of the throughput capacities, infusing high proportions of the speed and precision demanded by diagnostics.

 

By Application, the Infectious Disease Testing Segment is Expected to Held the Largest Share

 

The largest share of the immunoassay market is projected to be dominated by the Infectious Disease Testing segment through application during the forecast period. This pillars strength is explained by the growing number of cases of infectious diseases, e.g., HIV, hepatitis, influenza, tuberculosis, and new viral epidemics that necessitate fast, precise, and high-upscale diagnostic methods.

 

The other significant market segments are Oncology, Cardiology, Endocrinology, Autoimmune Disease Testing and Therapeutic Drug Monitoring among others. The Oncology segment is experiencing a steady growth because of an increase in the demand of detecting tumor markers and tailored approaches to treat the cancer. Endocrinology has an advantage because there is a need that requires hormone level monitoring, case in point in diabetes and thyroid diseases.

 

By Technology, the Enzyme Immunoassays (EIA) Segment is Expected to Held the Largest Share

 

With the help of technology, the Enzyme Immunoassays (EIA) segment is anticipated to control the biggest part of the total immunoassay market throughout the forecast years. The main factors are that EIA is extensively used both in clinical and research laboratories because of high sensitivity, high specificity, and a low cost-effectiveness. Enzyme immunoassays are widely applied in monitoring the presence of a wide variety of biomarkers that pertain to infectious diseases, cancer, cardiovascular disorders and hormonal imbalances.

 

Immunoassay Market By Technology By technology

 

The other active areas of technology are Radioimmunoassays (RIA), Fluorescence Immunoassays (FIA), Chemiluminescence Immunoassays (CLIA) and Rapid Test Immunoassays. The high sensitivity and its capacity to accommodate high throughput testing means CLIA is increasingly adopted also at the same time as the accuracy in identifying low abundant analytes is making FIA more popular.

 

By Specimen, the Smallholder & Commercial Farmers Segment is Expected to Held the Largest Share

 

The immunoassay market is projected to have the largest market share by specimen blood segment over the forecast period. The most popular specimen specimen type used in immunoassays is blood because it is highly reliable and is rich in biomarkers located in the serum or plasma, which are essential in the diagnosis of most conditions. Blood-based immunoassays give truly accurate, sensitive, and timely results whether dealing with infectious diseases, hormonal disorders, cancer indicators, or cardiovascular condition. It is additionally strengthened by the fact that blood collection has become routine in clinical practice and that blood samples can be used in many different immunoassay platforms.

 

By End-Use, the Agricultural Suppliers & Organic Stores Segment is Expected to Held the Largest Share

 

Among end-use, this segment Agricultural Suppliers & Organic Stores is projected to have the largest share of the immunoassay market by the end of the forecast period especially in food safety, veterinary diagnostics and environmental monitoring applications. These stores are important in supplying diagnostic kits as well as reagents to detect contaminants, pathogens, and residues in farm produce, livestock and the soil. As the sale of organic, residue-free food products continues to rise, the use of immunoassays becomes widespread to live up to the safety standards and organic certification demands.

 

Immunoassay Market Regional Insights

 

North America is Expected to Dominate the Market Over the Forecast period 

 

North America is projected to lead the immunoassay market during the forecast period due to favourable healthcare infrastructure, higher healthcare expenditure, and substantial acceptance of innovative diagnostic devices. The presence of big players in the market, strong research and development sector and the well-established regulatory environment that allows to develop new immunoassay products contributes to the success of the region. Besides, the market is further boosted by the high rate of chronic and infectious disease prevalence, increased personalized medicine demand, and the increased application of point-of-care testing.

 

Immunoassay Market By Region

 

Recent Development

 

In January 2025, Anbio Biotechnology, a pioneer in diagnostic innovation, introduced its Dry CLIA Solution ADL-1000 a cutting-edge technology engineered to deliver rapid, accurate, and cost-efficient diagnostic results. Tailored for diverse clinical environments, the ADL-1000 addresses the growing need for streamlined workflows and high-performance testing solutions.

 

Active Key Players in the Immunoassay Market

 

o   Siemens Healthineers

o   Abbott

o   Danaher Corporation (Beckman Coulter)

o   Quidel Corporation

o   bioMérieux SA

o   Sysmex Corporation

o   Bio-Rad Laboratories, Inc.

o   Ortho Clinical Diagnostics

o   F. Hoffmann-La Roche AG

o   Thermo Fisher Scientific, Inc.

o   Becton, Dickinson, and Company

o   Other Key Players

 

Global Immunoassay Market Scope

 

Global Immunoassay Market

Base Year:

2025

Forecast Period:

2025-2033

Historical Data:

2017 to 2024

Market Size in 2024:

USD 33.4 Billion

Market Size in 2025:

USD 35.6 Billion

Forecast Period 2025-33 CAGR:

6.5%

Market Size in 2033:

USD 58.7 Billion

Segments Covered:

By Product

·         Reagents & Kits

o   Rapid Tests Reagents & Kits

o   ELISA Reagents & Kits

o   Western Blot Reagents & Kits

o   ELISPOT Reagents & Kits

o   Other Reagents & Kits

·         Analyzers/Instruments

o   Open Ended Systems

o   Closed Ended Systems

·         Software & Services

By Application

·         Oncology

·         Therapeutic Drug Monitoring

·         Cardiology

·         Infectious Disease Testing

·         Endocrinology

·         Autoimmune Diseases

·         Other Applications

By Technology

·         Radioimmunoassay (RIA)

·         Enzyme Immunoassays (EIA)

o   Chemiluminescence Immunoassays (CLIA)

o   Fluorescence Immunoassays (FIA)

·         Rapid Test

·         Other Technologies

By Specimen

·         Saliva

·         Blood

·         Urine

·         Other Specimens

By End-Use

·         Hospitals

·         Clinical Laboratories

·         Blood Banks

·         Academic Research Centers

·         Pharmaceutical and Biotech Companies

·         Other End-Uses

By Region

·         North America (U.S., Canada, Mexico)

·         Eastern Europe (Bulgaria, The Czech Republic, Hungary, Poland, Romania, Rest of Eastern Europe)

·         Western Europe (Germany, UK, France, Netherlands, Italy, Russia, Spain, Rest of Western Europe)

·         Asia Pacific (China, India, Japan, South Korea, Malaysia, Thailand, Vietnam, The Philippines, Australia, New-Zealand, Rest of APAC)

·         Middle East & Africa (Turkey, Bahrain, Kuwait, Saudi Arabia, Qatar, UAE, Israel, South Africa)

·         South America (Brazil, Argentina, Rest of SA)

Key Market Drivers:

·         Rising Prevalence of Chronic and Infectious Diseases

 

Key Market Restraints:

·         Cross-Reactivity and False Results

 

Key Opportunities:

·         Integration of Artificial Intelligence and Automation

 

Companies Covered in the report:

·         Siemens Healthineers, Abbott, Danaher Corporation (Beckman Coulter), Quidel Corporation and Other Key Players. 

 


📘 Frequently Asked Questions

1. What would be the forecast period in the Immunoassay Market Research report?

Answer: The forecast period in the Immunoassay Market Research report is 2025-2033.

2. Who are the key players in the Immunoassay Market?

Answer: Siemens Healthineers, Abbott, Danaher Corporation (Beckman Coulter), Quidel Corporation and Other Key Players.

3. What are the segments of the Immunoassay Market?

Answer: The Immunoassay Market is segmented into Product, Application, Specimen, and Regions. By Product, the market is categorized into Reagents & Kits, Analyzers/Instruments, and Software & Services. By Application, the market is categorized into Oncology, Therapeutic Drug Monitoring, Cardiology, Infectious Disease Testing, Endocrinology, Autoimmune Diseases, and Other Applications. By Specimen, the market is categorized into Radioimmunoassay (RIA), Enzyme Immunoassays (EIA), Rapid Test, and Other Technologies. By Specimen, the market is categorized into Saliva, Blood, Urine, and Other Specimens. By End-Use, the market is categorized into Hospitals, Clinical Laboratories, Blood Banks, Academic Research Centers, Pharmaceutical and Biotech Companies, and Other End-Uses. By region, it is analyzed across North America (U.S.; Canada; Mexico), Eastern Europe (Bulgaria; The Czech Republic; Hungary; Poland; Romania; Rest of Eastern Europe), Western Europe (Germany; UK; France; Netherlands; Italy; Russia; Spain; Rest of Western Europe), Asia-Pacific (China; India; Japan; Southeast Asia, etc.), South America (Brazil; Argentina, etc.), Middle East & Africa (Saudi Arabia; South Africa, etc.).

4. What is the Immunoassay Market?

Answer: The major growth in the immunoassay market is because of the growing popularity of the accurate and efficient diagnostic tools in the healthcare, biotechnology, and pharmaceutical industries. The popularity of immunoassays lies in their ability to either detect or quantify a specific antigen or antibody, which greatly facilitates the diagnosis of infectious diseases, control of chronic conditions, and the control of therapeutic drugs.

5. How big is the Immunoassay Market?

Answer: The Global Immunoassay Market was valued at USD 33.4 billion in 2024 and is expected to grow from USD 35.6 billion in 2025 to USD 58.7 billion by 2033, reflecting a CAGR of 6.5% over the forecast period.

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