Immunoassay Market Size, Share & Growth By 2033

Immunoassay Market Overview

The Immunoassay Market size was valued at USD 21077.9 million in 2024 and is expected to reach USD 33482.88 million by 2033, growing at a CAGR of 4.9% from 2025 to 2033.

The immunoassay market plays a vital role in diagnostics and disease management across infectious diseases, oncology, endocrinology, and toxicology. In 2024, over 4.3 billion immunoassay tests were performed globally, with 2.1 billion used in hospitals, 1.2 billion in clinical laboratories, and 1 billion across point-of-care settings. More than 180 countries adopted immunoassay-based diagnostics for routine testing, with over 85 national healthcare systems reimbursing at least five categories of immunoassays. Rapid testing accounted for more than 1.6 billion tests, including lateral flow and strip-based assays.

Immunoassay kits based on chemiluminescence technology were used in over 720 million tests in oncology and hormone profiling. More than 900 assay platforms are currently active in commercial use, with over 370 approved for multi-analyte detection. Automation in immunoassay systems increased throughput by 31% compared to 2020 benchmarks. The immunoassay market is foundational to disease surveillance, early detection, and personalized medicine initiatives worldwide.

Key Findings

Top Driver reason: Growing prevalence of chronic and infectious diseases across all regions.

Top Country/Region: The United States leads with more than 1.1 billion immunoassay tests performed in 2024.

Top Segment: ELISA remains the dominant method, accounting for over 1.5 billion tests worldwide in 2024.

Immunoassay Market Trends

The immunoassay market is evolving rapidly, driven by technological innovations and widespread demand for high-sensitivity diagnostics. In 2024, over 800 million COVID-19-related immunoassay tests were conducted globally, showcasing the versatility and scalability of these platforms. There was a significant shift toward multiplexed assays, with over 230 new products launched supporting detection of three or more biomarkers in a single test.

Automation in immunoassay instruments expanded, with over 5,700 automated platforms deployed in major laboratories, representing a 22% increase compared to 2023. Miniaturization also advanced, with more than 90 compact immunoassay systems introduced for decentralized testing. AI-supported immunoassay result interpretation tools were used in over 2,300 hospitals and diagnostics centers, aiding faster and more accurate decision-making.

Chemiluminescent immunoassays (CLIAs) surged in use, particularly in oncology and endocrine testing, with over 620 million CLIA tests performed globally in 2024. There was also increasing demand for immunoassay panels used in transplant immunology, with over 310,000 transplant patients monitored using these systems last year.

Lateral flow immunoassays grew by 17%, led by self-testing kits for pregnancy, infectious disease screening, and glucose monitoring. Over 140 million home-use test kits based on immunoassay technology were sold in the Asia-Pacific region alone.

Immunoassay Market Dynamics

Drivers

Rising demand for accurate and early disease diagnostics

The demand for accurate and early diagnostics is propelling the immunoassay market forward. In 2024, over 72% of all diagnostic decisions in developed nations involved at least one immunoassay-based test. With over 520 million new cases of infectious diseases recorded worldwide, immunoassays served as the primary screening tool in 73% of cases. The oncology field saw more than 290 million tests based on tumor marker immunoassays, providing clinicians with early detection capabilities. The growing incidence of chronic diseases, including diabetes and thyroid disorders, drove 860 million hormone-level monitoring tests using immunoassay kits.

Restraints

Variability in test sensitivity and regulatory delays

Test sensitivity continues to vary across technologies and brands, limiting trust and adoption in certain medical environments. In 2024, over 14% of rapid immunoassays used in decentralized settings returned false negatives in low viral load samples. Regulatory approval timelines for novel assay kits have been extended beyond 12 months in over 47 countries due to stringent cross-reactivity and reproducibility standards. As a result, over 1,100 newly developed tests remain pending commercial clearance. Low-income nations also experienced delays in accessing validated immunoassay systems due to high certification costs and limited harmonization across regional regulatory bodies.

Opportunities

Advancements in companion diagnostics and personalized medicine

Personalized medicine is creating significant opportunities for immunoassay-based companion diagnostics. In 2024, over 210 targeted therapies were linked with immunoassay companion diagnostics for predictive or prognostic evaluation. More than 45 clinical trials globally integrated immunoassays for biomarker screening in immunotherapy treatments. Biomarker-driven drug development is expected to see expanded demand for immunoassays that detect treatment-eligible populations. Pharmacogenomics testing using immunoassay platforms grew to over 1.6 million patients in the U.S., U.K., and Japan. Additionally, over 3,400 hospitals globally initiated biomarker-based therapeutic stratification using in-house or third-party immunoassays.

Challenges

High cost of multiplexing and data interpretation complexity

Multiplexed immunoassays pose a challenge due to elevated test costs and data complexity. In 2024, average per-test cost of a three-analyte panel was over 2.3x higher than single-analyte tests, making it unaffordable for mass testing in low-income regions. Moreover, over 64% of laboratories surveyed cited difficulty in interpreting overlapping analyte signals, especially in autoimmune panels. Errors in cross-reactive marker quantification led to test revalidation in over 140,000 cases. Without standardized interpretation algorithms and affordable reagent kits, adoption remains limited to premium hospital systems and research labs.

Immunoassay Market Segmentation

By Type

ELISA: In 2024, over 1.5 billion ELISA tests were conducted globally, with 41% used in infectious disease diagnostics and 29% in hormone monitoring. ELISA platforms were deployed in over 97,000 laboratories worldwide, including 42,000 in Asia-Pacific. More than 430 ELISA kits were approved for clinical use in the U.S. and EU alone.
Rapid Tests: Rapid immunoassays accounted for 1.6 billion tests in 2024. These include home-based and point-of-care tests for pregnancy, COVID-19, dengue, and influenza. Over 850 million lateral flow assays were distributed globally through public health programs in 2024.
Western Blotting: Approximately 14 million Western blot tests were performed in 2024, primarily for HIV confirmatory diagnosis, autoimmune diseases, and research purposes. Laboratories in North America conducted over 5.6 million of these tests.
ELISPOT: Used primarily in research and immunology, ELISPOT tests exceeded 6.8 million in 2024. They were widely adopted in vaccine development labs, with over 2.3 million tests performed during clinical trials of novel immunotherapies.
Immuno-PCR: This highly sensitive technology was used in over 3.1 million tests in 2024. It offered detection limits 10–100 times lower than ELISA. Adoption grew in oncology and rare biomarker testing in research facilities.
Other Technologies: Over 40 million immunoassays used bead-based and microfluidic platforms, with 12.3 million run on multiplex arrays. Lab-on-a-chip technologies were trialed in 1,200 facilities worldwide in 2024.

By Application

Infectious Diseases: Over 1.8 billion tests were used for infectious disease screening, including HIV, hepatitis, COVID-19, and TB. More than 450 million were performed in Asia-Pacific.
Oncology: Tumor marker tests surpassed 290 million globally in 2024, led by PSA, CEA, and HER2 immunoassays.
Endocrinology: Thyroid and fertility hormone testing accounted for over 720 million tests in 2024, with ELISA and CLIA being the dominant technologies.
Autoimmune Disorders: More than 110 million immunoassays were used in ANA, anti-dsDNA, and rheumatoid factor screening.
Toxicology: Drug screening applications performed 210 million immunoassays, including opioid, benzodiazepine, and alcohol detection.
Therapeutic Drug Monitoring: More than 74 million tests monitored drug levels in transplant patients, chemotherapy cycles, and antiretroviral treatments.

Immunoassay Market Regional Outlook

North America

Led global demand with over 1.2 billion immunoassays performed in 2024. The U.S. accounted for 1.1 billion tests, including 510 million ELISA and 190 million chemiluminescent assays. Canada performed over 110 million tests, largely within public hospital networks. The region hosted over 42% of the world’s automated immunoassay platforms and led innovation with more than 130 new test kits approved in 2024.

Europe

conducted over 920 million immunoassays in 2024, with Germany, France, and the U.K. being top contributors. Over 420 million tests focused on infectious diseases and another 280 million on oncology. More than 75% of tests were processed in fully automated laboratories. Central Europe saw a 16% increase in multiplex assay adoption in public health settings. Over 1,400 diagnostic labs upgraded their immunoassay systems in the past 12 months.

Asia-Pacific

performed over 1.5 billion immunoassay tests in 2024, led by China (580 million), India (410 million), and Japan (230 million). The region saw strong demand for dengue, TB, COVID-19, and thyroid disorder screening. More than 18,000 new point-of-care immunoassay systems were installed in rural hospitals and mobile clinics. Over 500 product approvals were granted by regulatory bodies in the region, enabling expanded access.

Middle East & Africa

The region conducted over 310 million tests in 2024. South Africa and Saudi Arabia together accounted for over 150 million tests. Government healthcare programs distributed over 120 million HIV and hepatitis screening kits based on immunoassay platforms. Over 2,700 primary care clinics adopted rapid testing in underserved regions. Despite supply chain challenges, over 600,000 automated systems were shipped to 18 countries in Africa.

List of Top Immunoassay Companies

Roche
Abbott Laboratories
Siemens
Danaher
DiaSorin
Sysmex
BioMerieux
Ortho Clinical Diagnostics
QIAGEN
Thermo Fisher
Becton, Dickinson
Bio-Rad Laboratories
Agilent Technologies
Mindray
Perkinelmer
Quidel
Merck
Bio-Techne

Top Two Companies with the Highest Share

Roche: Led with over 420 million immunoassays sold in 2024 and installed more than 35,000 analyzers worldwide, covering 112 countries.

Abbott Laboratories: Followed with 385 million test kits distributed and more than 26,000 immunoassay platforms installed globally, dominating the rapid test segment.

Investment Analysis and Opportunities

Investment activity in the immunoassay market has intensified between 2023 and 2024, with over 160 strategic initiatives, including facility expansions, R&D funding, and public-private partnerships. More than 40 diagnostic companies announced capital allocation toward immunoassay manufacturing scale-up and technology enhancement. The majority of investments focused on high-throughput platforms, rapid testing kits, and advanced multiplexing systems. Notably, 19 new immunoassay production facilities were established globally in 2024, including 7 in Asia-Pacific, 5 in Europe, 4 in North America, and 3 in the Middle East and Africa.

In 2024, over 3,500 laboratories in developed countries received infrastructure funding from national healthcare programs to upgrade their immunoassay systems. The U.S. Department of Health and Human Services allocated grants supporting immunoassay-based surveillance expansion, enabling 240 hospitals to acquire automated analyzers. India’s central healthcare authority approved ₹1,200 crore for 95 regional labs to integrate immunoassay technology into their testing panels, especially for endemic diseases like dengue and typhoid.

Private equity and venture capital investment surged, with 17 startups globally receiving more than $180 million in funding to develop rapid immunoassay technologies. These included handheld microfluidic devices, wearable biosensor kits, and AI-enhanced diagnostic platforms. A South Korean startup introduced a low-cost lateral flow device funded by $11 million in Series A investment, capable of delivering results in 10 minutes with 92.8% sensitivity for influenza strains.

Pharmaceutical companies also expanded their investment into immunoassay-based companion diagnostics. Over 58 new drug development pipelines across oncology and infectious diseases incorporated immunoassay-linked diagnostic tools. A global oncology firm initiated co-development agreements with two immunoassay developers to create HER2 and PD-L1 multiplex panels aimed at clinical trial patient stratification.

Investment in research institutions also accelerated. In 2024, more than 300 academic labs received immunoassay technology grants from public innovation funds, facilitating advancements in antigen discovery and assay calibration. A European consortium of eight universities began a €42 million project focused on next-generation immunoassays for autoimmune disorder detection.

Opportunities remain particularly high in decentralized testing. Over 280 community health centers in sub-Saharan Africa received immunoassay point-of-care devices through World Bank funding to combat infectious disease. In Southeast Asia, public-private collaborations resulted in the deployment of over 5,700 rapid immunoassay kiosks at urban transit points for TB and malaria screening.

As healthcare shifts toward early detection, real-time monitoring, and precision medicine, the immunoassay market presents expanding opportunities for investors across production, diagnostics, digital health, and public health infrastructure.

New Product Development

The immunoassay market has witnessed significant innovation between 2023 and 2024, with over 180 new products launched globally. These developments have focused on enhancing sensitivity, reducing turnaround times, and expanding the range of detectable biomarkers.

In 2023, Abbott Laboratories introduced its next-generation chemiluminescent immunoassay platform, the Alinity h-series, which offers faster throughput and enhanced AI-based result interpretation for hospital laboratories. This system can process up to 200 tests per hour, reducing diagnostic times by approximately 25%.

Bio-Rad Laboratories expanded its immunoassay product line in early 2024, releasing an automated ELISA workstation targeting oncology and autoimmune markers. This platform supports multiplex testing, allowing simultaneous analysis of up to 10 biomarkers, thereby increasing laboratory efficiency.

Emerging technologies have also made strides. A study published in late 2024 introduced a deep learning-enhanced chemiluminescence vertical flow assay for high-sensitivity cardiac troponin I testing. This assay achieved a detection limit of 0.16 pg/mL and delivered results within 25 minutes, surpassing traditional benchtop analyzers in sensitivity by an order of magnitude.

Additionally, advancements in microfluidics have led to the development of smartphone-controlled handheld immunoassay systems. These portable devices can perform complex liquid handling tasks and are particularly useful in point-of-care settings, offering rapid diagnostics with minimal sample volumes.

These innovations reflect the industry's commitment to improving diagnostic accuracy, reducing processing times, and expanding access to immunoassay testing across various healthcare settings.

Five Recent Developments

Abbott received FDA approval for its Alinity h-series hematology system, enabling laboratories to process higher volumes of immunoassay tests with improved accuracy.
Bio-Rad launched an expanded immunoassay product line, including an automated ELISA workstation targeting oncology and autoimmune markers, enhancing multiplex testing capabilities.
study introduced a chemiluminescence vertical flow assay for cardiac troponin I testing, achieving a detection limit of 0.16 pg/mL and delivering results within 25 minutes, demonstrating significant improvements in sensitivity and speed.
Researchers developed a smartphone-controlled handheld microfluidic liquid handling system capable of performing complex immunoassays, facilitating rapid diagnostics in point-of-care settings.
Ayoxxa advanced its protein chip technology, enabling detection of multiple diseases through protein analysis of a single droplet of blood, enhancing multiplexing capabilities and reducing sample volume requirements.

Report Coverage of Immunoassay Market

This comprehensive report provides an in-depth analysis of the global immunoassay market, encompassing technological advancements, market dynamics, segmentation, and regional performance. It covers a wide range of immunoassay types, including ELISA, rapid tests, Western blotting, ELISPOT, immuno-PCR, and emerging technologies.

Detailed examination of various immunoassay technologies, highlighting their applications, advantages, and limitations. Breakdown of the market by type, application, and region, providing insights into specific areas of growth and demand.

Assessment of market performance across North America, Europe, Asia-Pacific, and the Middle East & Africa, identifying key trends and opportunities in each region.

Evaluation of major players in the immunoassay market, analyzing their product portfolios, strategic initiatives, and market shares. Analysis of recent investments, partnerships, and product developments that are shaping the future of the immunoassay market.

By providing a holistic view of the immunoassay market, this report serves as a valuable resource for stakeholders seeking to understand the current landscape and future prospects of immunoassay technologies.