Immunoassays Market Size to Hit USD 42.77 Billion by 2034

According to Nova One Advisor, the global immunoassays market size is calculated at USD 28.51 billion in 2025 and is expected to be worth around USD 42.77 billion by 2034, growing at a compound annual growth rate (CAGR) of 4.62% over the forecast period 2025 to 2034. A study published by Nova One Advisor a sister firm of Precedence Research.

Ottawa, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The global Immunoassays Market size is calculated at USD 27.25 billion in 2024, grew to USD 28.51 billion in 2025, and is projected to reach around USD 42.77 billion by 2034. The market is projected to expand at a CAGR of 4.62% between 2025 and 2034.

Immunoassays Market Key Takeaways

By region, North America held the largest share of the immunoassays market in 2024.
By region, Asia Pacific is expected to experience the fastest growth between 2025 and 2034.
By product, the reagents & kits segment led the market in 2024.
By product, the analysers segment is expected to expand at the highest CAGR over the projected timeframe.
By technology, the ELISA segment led the market in 2024.
By technology, the chemiluminescence immunoassay segment is expected to expand at the highest CAGR over the projection period.
By application, the infectious diseases segment led the market in 2024.
By end user, the hospitals & clinics segment led the market in 2024.
By specimen type, the blood segment led the market in 2024.

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What are immunoassays?

The global immunoassays market is growing due to the rising prevalence of infectious and chronic diseases and the increasing demand for early and precise diagnostics. Immunoassays are applied to measure molecules of biological interest based on the selectivity and specificity of antibody reagents generated. The immunoassay is a reliable and rapid technology for detecting a molecule that contains at least one antigenic moiety. Immunoassays rely on the inherent capability of an antibody to bind particular chemical groups on conformationally flexible antigens, like carbohydrates, or specific molecular conformations in the case of large, conformationally stiff molecules, such as proteins.

What are the Key Drivers in the Immunoassays Market?

Increasing prevalence of evolving diseases and resistance to antibiotics means the demand for immunoassays is significantly to increase further in the future as they meet the demand for rapid and cost-effective diagnosis. Immunoassays are not only important to the identification of infectious diseases, but also crucial to many non-communicable diseases. This technology mainly uses non-communicable diseases, which are cardiovascular diseases such as heart attacks and stroke, cancers, chronic respiratory diseases like chronic obstructive pulmonary disease and asthma and diabetes. Numerous immunoassay technologies are presently used to identify such diseases.

For Instance, In January 2025, SpinChip Diagnostics ASA, an innovative diagnostics company developing next generation Point of Care platforms for in vitro diagnostics, announced its agreement to be acquired by bioMérieux, a global leader in in vitro diagnostics. Under the agreement, bioMérieux will acquire 100% ownership of SpinChip for a Total Enterprise Value of NOK 1,624 million.

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Report Scope of Immunoassays Market

Report Attribute	Details
Market size value in 2025	USD 28.51 billion
Revenue forecast in 2034	USD 42.77 billion
Growth rate	CAGR of 4.16% from 2025 to 2034
Base year for estimation	2024
Historical data	2021 - 2024
Forecast period	2025 - 2034
Quantitative units	Revenue in USD million/billion and CAGR from 2025 to 2034
Report coverage	Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Segments covered	By Product, By Technology, By Application, By End User, By Specimen Type, By Region
Regional scope	North America; Europe; Asia Pacific; Latin America; MEA
Country scope	U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; India; China; Japan; Australia; South Korea; Thailand; Brazil; Argentina; Saudi Arabia; UAE; South Africa; Kuwait
Customization scope	Free report customization (equivalent up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope.

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Growth Drivers for the Indian Immunoassay Market

The Indian immunoassay market is poised for robust growth due to several key factors:

Technological Advancements:

CLEIA (Chemiluminescence Enzyme Immunoassay): This technology offers high sensitivity and specificity, making it highly effective for detecting low-abundance analytes. This is especially important for early-stage disease detection, such as cancers or rare conditions, driving demand in diagnostic settings.
AI and Machine Learning: Integration of AI helps in the interpretation of immunoassay results, improving diagnostic accuracy and reducing human error. This enhances clinical decision-making, enabling better patient outcomes.

Rising Disease Burden:

Non-communicable diseases (NCDs): The increasing prevalence of NCDs like diabetes and cancer is boosting the need for regular testing and monitoring, increasing the demand for immunoassay tests.
Infectious diseases: The prevalence of diseases like tuberculosis, hepatitis, and emerging infectious diseases further drives the demand for rapid, accurate diagnostic tests.

Expanding Healthcare Infrastructure:

Government initiatives like Ayushman Bharat are improving healthcare accessibility and affordability, particularly in rural regions, facilitating wider adoption of immunoassays.
Increased investment in diagnostic facilities and healthcare infrastructure encourages the use of advanced technologies such as CLEIA, offering better diagnostic tools for medical professionals.

Growing Health Awareness:

The rise in preventive healthcare and the emphasis on early disease detection are encouraging more individuals to seek regular check-ups, creating a sustained demand for immunoassay tests in clinics and hospitals.

Favorable Regulatory Environment:

Government policies supporting local manufacturing, like the Make in India initiative, are driving the growth of domestic production of diagnostic equipment. This not only makes advanced technologies more accessible but also reduces costs, making immunoassay tests more affordable and widespread.

Rise of Personalized Medicine:

Immunoassays play a crucial role in personalized medicine, where treatments are tailored to the individual based on their specific biomarkers. As personalized healthcare becomes more prevalent, immunoassays are integral in optimizing patient care and treatment efficacy.

Importance of Immunoassays in Indian Healthcare

Immunoassays are central to the evolving landscape of Indian healthcare due to their wide-ranging applications:

Early Disease Detection

Immunoassays allow for the early detection of diseases, enabling timely intervention and better patient outcomes.

Disease Monitoring

They are crucial in monitoring disease progression and evaluating the effectiveness of treatments, particularly for chronic diseases like diabetes and cancer.

Public Health Impact

Immunoassays are extensively used in large-scale public health programs for screening and monitoring infectious diseases, such as HIV and malaria.

Support for Research and Development

Immunoassays play a significant role in drug development and vaccine research, helping to accelerate innovation in the pharmaceutical industry.

Accuracy and Reliability

Technologies like CLEIA have raised the bar for diagnostic accuracy, reducing false positives and negatives, and increasing trust in diagnostics.

What are the Ongoing Trends in the Immunoassays Market?

In June 2025, Quanterix Corporation, a company fueling scientific discovery through ultrasensitive biomarker detection, announced that the HD-X Simoa Immunoassay Analyser has received Class 1 Medical Device registration by the Ministry of Food and Drug Safety (MFDS) in South Korea through its regional distribution partner, HS Biosystems.
In June 2025, Revvity, Inc. announced the launch of pHSense reagents, a powerful technology designed to advance internalisation studies in drug discovery. pHSense reagents are designed for high-throughput, plate-based workflows and intended for researchers studying G protein-coupled receptors (GPCRs) or antibody-drug conjugates (ADCs). They offer a scalable, accurate, and easy-to-implement solution for monitoring antibody, ADC, or receptor internalisation.
In July 2025, Spear Bio, a biotechnology company pioneering homogeneous ultrasensitive immunoassay technology, announced the commercial launch of its SPEAR UltraDetect immunoassay solution. It delivers unparalleled sensitivity, specificity, precision, and scalability for robust biomarker measurement. The initial launch includes four assays, targeting key neurology biomarkers: phosphorylated tau 231 (pTau231), phosphorylated tau 217 (pTau217), glial fibrillary acidic protein (GFAP), and neurofilament light (NfL).

What is the Emerging Challenge in the Immunoassays Market?

Immunoassays are extensively used for therapeutic drug monitoring of different immunosuppressants. A main limitation of these immunoassays is their significant cross-reactivity with numerous metabolites of these agents. Key challenges include non-specific protein binding, non-specific relations within the immunoassays, infrequent insufficient reproducibility, comparatively long assay times, and photobleaching, which limits the growth of the market.

By Regional Analysis

Why did North America Dominate the Market in 2024?

By capturing a major share, North America registered dominance in the market in 2024, as this region has widespread and sophisticated laboratory networks, advanced diagnostic technology, and a well-established healthcare diagnostics infrastructure. The growing rates of chronic conditions such as cancer and infectious diseases drive the demand for precise and effective analytical tools, where immunoassays play a significant role, which contributes to the growth of the market.

For Instance, In January 2025, bioMérieux acquired 100% ownership of SpinChip for a total enterprise value of €138m. The cash out will amount to approximately €111m since bioMérieux already owns 20% of the shares of SpinChip.

How did the Asia Pacific Grow Notably in the Market in 2024?

During 2025-2034, the Asia Pacific is anticipated to expand at a rapid CAGR in the immunoassays market as the growing pharmaceutical and biotechnology fields are rising research and development activities, which utilise immunoassays. A growing number of chronic and infectious diseases in the Asia Pacific drives the requirement for diagnostics. Government initiatives in countries like China, India, and Japan are foremost in healthcare infrastructure upgrades, increasing the adoption of diagnostic tools, which drives the growth of the market.

For Instance, In September 2025, Beckman Coulter introduces the automated BD-Tau assay for clinical research. The new test is available on the DxI 9000 and Access 2 Analysers, along with a range of neurodegenerative disease RUO assays.

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Segmental Insights

By Product Analysis

Which Product Led the Immunoassays Market in 2024?

The reagents and kits segment accounted for the dominating share of the market in 2024, as immunoassay reagents and kits have been used for decades to enable the generation of consistent and reproducible data with lower up-front optimisation. They used to identify proteins, nucleic acids, lipids or small molecule targets, as long as there are known antibodies that bind precisely to that target. Profitable kits and reagents undergo rigorous quality control (QC) and validation by dedicated manufacturers.

Whereas the analysers segment is predicted to register rapid expansion in the forecasting period, as immunoassay analysers with high throughput that are standard for large laboratories with high HbA1c volumes. Immunoassay analysers process a large number of samples in a limited period of time, lowering the turnaround time for outcomes. Immunoassay analysers with automation abilities rationalise workflows, making them crucial in healthcare and research settings.

By Technology Analysis

How did the ELISA segment dominate the market in 2024?

In 2024, the ELISA segment captured the biggest share of the immunoassays market, as ELISA has great sensitivity due to an enzyme as a reporting group. This is a small portion which could cause reactions for the production of the chromogenic reaction phenomenon. ELISA kits make it a more favoured biotechnical device for a broad range of applications. It is helpful for both the healthcare diagnosis of diagnostic conditions or diseases and scientific research. ELISA tests are eco-friendly and safe to the evasion of radioactive substances and major amounts of organic solvents.

Although the chemiluminescence immunoassay segment will expand fastest during 2025-2034, as the chemiluminescent immunoassay analyser removes the application of radioactive substances. It has exclusive properties of high sensitivity, speed, and high specificity, precision, specificity, and automation. Chemiluminescence immunoassay (CLIA) offers numerous potential advantages and has applications in healthcare bioanalysis, chemistry, and environmental analysis.

By Application Analysis

How did the infectious diseases dominate the Market in 2024?

The infectious diseases segment held the biggest share of the immunoassays market in 2024, as infectious disease immunoassays play a significant role in detecting and identifying various pathogens that pose a risk to human health. These assays utilise the body's immune response to identify the presence of specific antibodies or antigens related to infectious agents. The immune system produces antibodies in response to the presence of external substances, such as viruses, bacteria, or other pathogens.

By End-User Analysis

How did the hospitals & clinics dominate the Market in 2024?

The hospitals and clinics segment held the biggest share of the immunoassays market in 2024, as immunoassays are regularly applied for healthcare diagnostics, therapeutic drug monitoring, biopharmaceutical analysis, drug abuse challenging, ecological monitoring and food safety testing. In instrumental processes, extensive sample clean-up may be required to remove interferences, and this can often be the rate-determining step in residue analysis.

By Specimen Type Analysis

How did the blood dominate the Market in 2024?

The blood segment held the biggest share of the immunoassays market in 2024, as immunological analysis apparatus has greatly amplified the specificity and sensitivity of the analysis index, and significantly enhanced the accuracy and effectiveness of the test. This test has a high sensitivity and detects antigens at picogram levels.

Immunoassays Market Companies

Thermo Fisher Scientific – Thermo Fisher provides a comprehensive portfolio of immunoassay reagents, kits, and automated analyzers, supporting clinical diagnostics and research applications globally. The company invests heavily in R&D to introduce innovative immunoassay technologies that enhance sensitivity and throughput.
Roche Diagnostics – Roche is a leading player offering high-quality immunoassay instruments, reagents, and testing platforms for hospitals, laboratories, and pharmaceutical research. Its strong focus on automation and digital integration ensures accurate and efficient diagnostics, reinforcing its market dominance.
Abbott Laboratories – Abbott develops advanced immunoassay platforms, including point-of-care and laboratory-based solutions, for infectious diseases, oncology, and hormonal testing. The company emphasizes innovation, reliability, and rapid diagnostics, driving adoption across clinical and research settings.
Siemens Healthineers – Siemens provides a range of immunoassay analyzers, reagents, and diagnostic solutions with high throughput and accuracy. Its global presence and strong service network support widespread adoption in hospitals and laboratories.
Bio-Rad Laboratories – Bio-Rad specializes in immunoassay kits, reagents, and quality control solutions for clinical diagnostics and life sciences research. Its focus on high-quality and validated products enhances precision and reliability in diagnostic testing.
Beckman Coulter – Beckman Coulter offers immunoassay analyzers, reagents, and automation solutions for clinical laboratories and research institutions. The company supports efficiency and accuracy with scalable solutions and comprehensive after-sales services.
GE Healthcare – GE Healthcare provides immunoassay analyzers and reagents that integrate advanced imaging and diagnostic technologies. Its solutions focus on enhancing laboratory workflows and improving diagnostic outcomes worldwide.
DiaSorin S.p.A. – DiaSorin develops innovative immunoassay kits and analyzers for infectious diseases, oncology, and autoimmune disorders. Its strong R&D capabilities ensure high sensitivity and specificity, boosting its adoption in clinical diagnostics.

What are the Recent Developments in the Immunoassays Market?

In September 2025, Beckman Coulter Diagnostics, a Danaher company and a leader in global clinical diagnostics innovation, launched the industry's first fully automated Brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test. Access BD-Tau, along with Beckman Coulter Diagnostics' expanding portfolio of neurodegenerative disease RUO assays, is available for use on the groundbreaking DxI 9000 Immunoassay Analyser and Access 2 Analyser.
In September 2025, GE HealthCare enters an agreement to acquire icometrix; Beckman Coulter Diagnostics launches the industry's first fully automated brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test
In January 2025, SpinChip Diagnostics ASA, an innovative diagnostics company developing next-generation Point of Care platforms for in vitro diagnostics, announced its agreement to be acquired by bioMérieux, a global leader in in vitro diagnostics. Under the agreement, bioMérieux will acquire 100% ownership of SpinChip for a Total Enterprise Value of NOK 1,624 million.
In March 2025, Gentian Diagnostics announced the launch of the GCAL Calprotectin Immunoassay with Beckman Coulter Diagnostics to its clinical chemistry platforms. This collaboration illustrates our commitment to enhancing diagnostic efficiency for improved treatment decisions.

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Immunoassays Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Nova One Advisor has segmented the global immunoassays market

By Product

Reagents & Kits
Analyzers/Instruments
Software & Services

By Technology

ELISA
Rapid Tests
Chemiluminescence Immunoassay (CLIA)
Radioimmunoassay (RIA)
Fluorescence Immunoassay (FIA)

By Application

Infectious Diseases
Oncology
Cardiology
Autoimmune Disorders
Endocrinology & Hormonal Disorders
Toxicology & Drug Testing

By End User

Hospitals & Clinics
Diagnostic Laboratories
Research & Academic Institutes
Pharmaceutical & Biotechnology Companies

By Specimen Type

Blood
Urine
Saliva
Other Fluids

By Regional

North America
Europe
Asia Pacific
Latin America
Middle East & Africa

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