The U.S. immunoassay market size was valued at USD 10,630 million in 2024 and is expected to hit around USD 14,150 million by 2034 with a CAGR of 2.9% from 2025 to 2034. the advances and investments in the medical sector, government initiatives, and demand for research laboratories have driven market growth.
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U.S. Immunoassay Market Key Takeaways:
· Based on Product, the reagents and kits led the market with the largest revenue share of 66.12% in 2024 and is expected to grow at the fastest CAGR over the forecast period.
· The software and services segment is expected to grow at a significant CAGR during the forecast period.
· Based on technology, the enzyme immunoassays (EIA) segment led the market with the largest revenue share of 64.19% in 2024 and is expected to grow at a significant CAGR over the forecast period.
· The increased research activities are anticipated to offer lucrative opportunities during the forecast period.
· Based on application, the infectious diseases testing segment led the market with the largest revenue share of 30.55% in 2024.
· The oncology segment is expected to grow at the fastest CAGR over the forecast period.
· Based on end-use, the hospital segment led the market with the largest revenue share of 34.01% in 2024.
· The clinical laboratories sector is expected to register at the fastest CAGR during the forecast period.
· Based on specimen, the blood segment led the market with the largest revenue share of 44.19% in 2024
· The urine specimen segment is expected to register at the fastest CAGR during the forecast period.
The expanding role of biochemical tests in material science applications drives market growth, particularly in designing and optimizing materials. The trend of drug repurposing, where existing drugs are explored for new therapeutic indications and measured potential side effects, boosts the need for sophisticated drug development approaches. The shift towards personalized medicine drives the demand for tailored drug design, creating opportunities for clinical diagnostics solutions. Biochemical tools play a crucial role in predicting and assessing the toxicity of chemical compounds, supporting advancements in toxicology studies. Growing collaboration among research institutions and pharmaceutical companies amplifies the utilization of biochemical tools, contributing to market growth. The agriculture sector's increasing focus on chemical research for crop protection and enhancement fuels the growth of eco-friendly applications. The preference for open-source immunoassay platforms increases, fostering community-driven development and accessibility.
The expansion of the biotechnology industry further propels the demand for these diagnostic tools in areas like genomics and proteomics. Stricter regulatory requirements in pharmaceutical and chemical industries drive the adoption of biochemical tools for compliance and documentation. International collaborations and the globalization of research initiatives contribute to their widespread adoption. The increasing focus on rare diseases prompts the use of these tests in identifying potential treatments and accelerating drug development. Rising investments and funding in chemical and pharmaceutical research provide the financial support necessary for developing and adopting innovative immunoassay technologies.
The integration of AI in the U.S. immunoassay market increases focus on drug development and discovery, which is a crucial driver for the growing demand for advanced immunoassay tools. As researchers seek to innovate and expedite the process of drug design, the importance of sophisticated computational methodologies has never been clearer. Recent breakthroughs in computational technologies significantly enhance the efficiency and functionality of biochemical tools, thereby promoting the expansion of this market. Moreover, the incorporation of big data analytics within the immunoassay market is revolutionizing the way researchers handle and interpret vast amounts of data. This capability allows for more thorough research processes, enabling scientists to uncover insights that were previously elusive due to data constraints. The integration of large-scale datasets facilitates a more nuanced understanding of chemical interactions and properties, which is essential for the advancement of drug development.
Simultaneously, the field of computational chemistry is experiencing a surge in popularity, further contributing to the demand for robust biochemical tools. As the discipline evolves, there is an increasing need for sophisticated data analysis and modeling techniques that can support complex chemical phenomena. As the landscape of drug discovery becomes increasingly competitive, the capacity to leverage these advanced technologies will be pivotal in achieving success. Overall, the interplay of these factors propels the ongoing growth and innovation within the field of immunoassay.
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Report Attribute |
Details |
Market size value in 2025 |
USD 10,940 million |
Revenue forecast in 2034 |
USD 14,150 million |
Growth rate |
CAGR of 2.9% from 2024 to 2034 |
Base year for estimation |
2024 |
Historical data |
2019 - 2023 |
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 |
Product, technology, application, end-use, specimen. |
Key companies profiled |
F. Hoffmann-La Roche AG; Abbott Laboratories; Siemens Healthineers; Danaher Corporation; Thermo Fisher Scientific; Bio-Rad Laboratories; Sysmex Corporation; DiaSorin; Agilent Technologies. |
Annual Subscription |
U.S. Immunoassay Market Trends
• Demand for diagnostic tests- CLIA diagnostic tests play a crucial role in detecting patients suffering from cancer and diabetes. The growing global population, coupled with an increase in chronic diseases, is significantly driving up the demand for these essential diagnostic tools. In response to this heightened demand, ongoing research and development in CLIA technology is fostering the innovation of new products with enhanced performance and efficiency.
• Incorporation of Technological advancements- The integration of technologies such as CLEIA, Enzyme-Linked Immunosorbent Assay (ELISA), and Radioimmunoassay (RIA) with conventional drug development, particularly in areas such as chronic disease and veterinary diagnostics presents a promising avenue for development. This holistic approach can enhance patient comfort, reduce reliance on pharmaceuticals, and improve drug development. Continued research and development aimed at scientifically validating the efficacy and safety of biochemical tests can also play a crucial role in addressing existing concernsU.S. Immunoassay Market Report Scope
U.S. Immunoassay – Industry Concentration & Characteristics
The market growth stage is low, and the pace is accelerating. The U.S. market is characterized by a high degree of innovation driven by technological advancements, increasing demand for personalized medicine, and the need for more sensitive and specific diagnostic tools. Immunoassays are increasingly being integrated with digital health technologies such as artificial intelligence and data analytics to enhance diagnostic accuracy and predictive capabilities.
The immunoassay market is also characterized by a high level of merger and acquisition (M&A) activity by the market players. This can be attributed to various factors, including the increasing competition and the need for companies to expand their product portfolios and market presence. In addition, the rapid pace of technological advancements in immunoassay technologies has led players to seek opportunities for strategic partnerships or acquisitions to access new technologies or enhance their existing product offerings. In January 2024, Roche declared that it had finalized a deal to acquire LumiraDx’s point of care (POC) technology. The acquisition offers them a broad range of clinical chemistry and immunoassay.
The market is also subject to increasing regulatory scrutiny to ensure that only safe and effective medical devices reach patients while maintaining quality standards and reimbursement policies within the healthcare system. The primary regulatory bodies overseeing the U.S. market are the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).
The market has high product expansion due to technological advancements, partnerships, and collaborations by market players. For instance, in July 2023, Beckman Coulter unveiled the DxI 9000 Access Immunoassay Analyzer, in response to clinical laboratory needs for speed, dependability, reliability, quality, and menu expansion, The DxI 9000 Analyzer has demonstrated the ability to create tests that are more sensitive and pertinent to clinical settings.
The U.S. market is characterized by a moderate level of regional expansion. Market players are adopting geographical expansion strategies to capitalize on this growth and increase their market share.
Segment Insights
Product Insights
The reagents and kits segment dominated the U.S. immunoassay market. Integration of AI in developing kits has enhanced the diagnosis and monitoring of respiratory diseases as it will protect medical professionals and patients from infecting each other during check-up sessions.
The software and services segment is the fastest-growing segment in the immunoassay market. The rising popularity of software solutions is particularly evident among biochemical tests. Moreover, they facilitate real-time collaboration, enabling faster security software and Laboratory Information System (LIS) times, which are crucial for the transfer of data. These innovations enable organizations to enhance efficiency and accuracy while diminishing the risks associated with drug development. As many companies emphasize large-scale collaboration to navigate ongoing industry changes, these technological advancements open up promising growth opportunities for key market players.
Technology Insights
The enzyme immunoassays segment dominated the U.S. immunoassay market and is also expected to be the fastest-growing segment. This specific method uses an enzyme bound to an antigen or antibody that identifies and measures substances. The test method provides information about diseases that can be tackled with proper treatment. The tests such as enzyme-linked immunosorbent assay (ELISA) and enzyme multiplied immunoassay technique (EMIT) are used to detect antibodies and antigens by forming an enzyme-triggered color change in the provided sample.
Application Insights
In the U.S. immunoassay market, the infectious diseases testing segment emerged as the dominant force, capturing the largest revenue share. This trend is largely driven by the alarming rise in the incidence of various infectious diseases, including HIV, hepatitis, influenza, and COVID-19. As healthcare providers seek efficient and timely methods for early detection and ongoing monitoring of these conditions, the demand for immunoassays has surged significantly.
The oncology segment is the fastest-growing segment in the U.S. immunoassay market, primarily driven by the increasing incidence of cancer across key geographical regions. This rise in prevalence highlights the urgent need for more effective diagnostics, which are essential for the development and assessment of innovative diagnostic and therapeutic strategies aimed at combating cancer effectively.
End-use Insights
The hospital segment dominated the U.S. immunoassay market since the hospitals provide diagnostic tests and treatment to patients. The routine check-ups and integration of technology have enhanced and improved hospital services. The patients are monitored through VR tools, and their medications are updated using AI-driven data. Hospitals offer an extensive array of services that encompass everything from accurate diagnosis to comprehensive treatment options. Equipped with advanced medical instruments and cutting-edge technology, these facilities ensure that patients receive the highest standard of care. The combination of skilled healthcare professionals and specialized equipment makes hospitals a top choice for individuals seeking medical attention and support during their health journeys.
The clinical laboratories segment is the fastest-growing segment in the U.S. immunoassay market. The segment dominates due to increasing requirements for investigating drugs. The major factors that drive the clinical laboratories segment in the pharmaceutical sector are product protocols and supply chain management. In the pharmaceutical segment, the safety of biochemical tools is most important. They also have permission to collect data on drug development for research and purposes, and they analyze test performance.
Specimen Insights
When examining the specimen types used in immunoassays, blood samples accounted for the highest revenue share in the market. This is attributed to ongoing technological advancements in blood testing methods, coupled with a growing incidence of various illnesses that necessitate comprehensive blood analyses. These advancements have not only improved accuracy and efficiency but also expanded the range of diseases that can be diagnosed through blood testing, further propelling growth in this segment.
In contrast, the urine specimen segment is anticipated to experience the most rapid growth over the forecast period. This increase is driven by the rising prevalence of chronic diseases, such as diabetes and cardiovascular disorders, as well as infectious illnesses. Regular monitoring of biomarkers in urine is becoming increasingly essential in managing these conditions, further intensifying demand for urinary immunoassays. As a result, the urine segment is well-positioned for significant expansion as healthcare providers prioritize patient monitoring and management through diverse bodily fluid analysis.
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Related Report
Some of the prominent players in the U.S. Immunoassay market include:
- F. Hoffmann-La Roche AG
- Abbott Laboratories
- Siemens Healthineers
- Danaher Corporation
- Thermo Fisher Scientific
- Bio-Rad Laboratories
- Sysmex Corporation
- DiaSorin
- Agilent Technologies
Recent Developments
• In June 2023, Fapon launched its recent chemiluminescence immunoassay system, Shine i8000/9000, at the American Association of Clinical Chemistry (AACC) Clinical Lab Expo and Meeting 2023.
• In July 2024, Fujirebio launched a Fully Automated Lumipulse® G GFAP Assay system. The system will be used for research use only and will be available in the United States, Japan, and Europe.
• In October 2023, Lucent Diagnostics announced the addition of the highly accurate p-Tau 217 blood test for Alzheimer's disease, named LucentAD p-Tau 217, to its expanding LucentAD product line. This lab-developed test represents a significant advancement in the use of scalable immunoassay-based blood biomarker tests for evaluating amyloid pathology in patients presenting with memory problem
• In July 2023, VerséaOphthalmics, LLC launched its T-POC TOTAL IgE Immunoassay, a point-of-care test that is based on tears for the detection and treatment of diseases of the ocular surface
• In May 2023, Beckman Coulter Diagnostics announced the global launch of the DxI 9000 Access Immunoassay Analyzer, designed to address demands for quality, reliability, speed, reproducibility, and menu expansion.
Segments Covered in the Report
By Product
• Reagents & Kits
o ELISA Reagents & Kits
o Rapid Test Reagent & Kits
o ELISpot Reagents & Kits
o Western Blot Reagents & Kits
o Other Reagents & Kits
• Analyzer
o By Type
o Open-ended System
o Closed-Ended System
o By Purchased Mode
o Rental Purchased
o Outright Purchased
• Software and Services
By Technology
• ELISA
o By generation
o Third generation & Above
o Second-generation & Below
• Rapid Tests
• ELISpot
• Western Blotting
• Radioimmunoassay
• Other technologies
By Specimen
• Blood
• Saliva
• Urine
• Other Specimen
By Application
• Infectious diseases
• Endocrinology
• Oncology
• Bone and mineral disorders
• Cardiology
• Blood screening
• Autoimmune Disorders
• Allergy Diagnostics
• Toxicology
• Newborn Screening
• Other Application
By End-User
• Hospitals & Clinics
• Clinical Laboratories
• Pharmaceutical & Biotechnology Companies And Cro
• Blood Banks
• Research & Academic Laboratories
• Home Care Setting
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