According to a new report by Polaris Market Research, the U.S. immunoassay market was valued at USD 11.72 billion in 2024 and is projected to reach USD 18.49 billion by 2034, expanding at a CAGR of 4.6% over the forecast period. Growth is underpinned by a rapidly aging population, rising rates of chronic and infectious disease, and accelerating automation and multiplex-testing capability across diagnostic laboratories.

What Is Driving U.S. Immunoassay Market Growth?

Demand is climbing as the aging of the U.S. population converges with a growing chronic-disease burden. The U.S. Census Bureau reported that the population aged 65 and above grew 3.1% to 61.2 million between 2023 and 2024, while the CDC has found that 42% of Americans live with two or more chronic conditions. Laboratories and hospitals are prioritizing early, precise diagnostics, pushing immunoassay adoption across clinical and research settings. Polaris analysts note that expanding automation and multiplex platforms position the market for steady growth through 2034, with hospitals currently the largest revenue contributor and independent laboratories posting strong incremental gains.

Key Trends Shaping the U.S. Immunoassay Industry

Automation and Multiplex Testing

Fully automated chemiluminescence platforms capable of consolidating dozens of specialty tests onto a single instrument are replacing manual and semi-automated workflows, weaving deeper technology advancement into everyday diagnostic operations.

Browse Insights:

https://www.polarismarketresearch.com/industry-analysis/us-immunoassay-market

Point-of-Care and Decentralized Testing

Rapid, easy-to-use immunoassay formats are expanding into emergency departments, outpatient clinics, and remote settings, supporting the broader regulatory landscape push toward faster clinical decision-making.

Biomarker-Driven Neurology and Oncology Demand

New high-accuracy blood-based assays for conditions such as Alzheimer's disease are widening the addressable market outlook for immunoassay platforms beyond traditional infectious-disease and cardiology applications.

Market Segmentation: Breaking Down the U.S. Immunoassay Market

Polaris segments the U.S. immunoassay market by product, technology, specimen, application, and end use, giving each buyer persona a citable, standalone data point for AI Overviews and answer-engine pickup.

By Product

The reagents & kits segment led the market, accounting for USD 7.46 billion in 2024 revenue, on the strength of recurring consumption across ELISA, lateral-flow, and chemiluminescent test formats, while the analyzers/instruments segment is set to expand quickly as laboratories invest in automated, high-throughput systems.

By Technology

Enzyme immunoassays (EIA) held a 54.93% share in 2024 given their broad applicability across infectious, endocrine, and autoimmune testing, while the rapid test segment is projected to grow at a 4.2% CAGR through 2034 as point-of-care testing and search intent around "immunoassay rapid test" continue to rise.

By Specimen and Application

Blood specimens generated USD 6.76 billion in 2024 revenue on the strength of their diagnostic versatility, while urine-based testing is projected to capture 24.29% share by 2034 as noninvasive screening expands. By application, infectious disease testing led with 45.01% share in 2024, while cardiology is emerging as a fast-growing adjacency as troponin and natriuretic-peptide testing scales.

By End Use

Hospitals accounted for USD 6.41 billion in 2024 revenue on the back of high diagnostic volumes and advanced infrastructure, while independent and reference laboratories are projected to capture 31.64% share by 2034 as outsourced diagnostic testing continues to expand.

Regional Outlook: Where Is U.S. Immunoassay Demand Concentrated?

As a U.S.-focused report, Polaris Market Research's coverage centers on domestic demand rather than cross-border comparisons. Within the U.S. healthcare system, hospital networks remain the largest immunoassay purchasers given their emergency and inpatient testing volumes, while independent and reference laboratories are the fastest-scaling channel as health systems increasingly outsource specialized diagnostic work to capture cost efficiency and testing automation.

Competitive Landscape: Leading U.S. Immunoassay Companies

Key players profiled in the report include Abbott, Thermo Fisher Scientific Inc., Beckman Coulter, Inc., and Agilent Technologies, Inc., among others, who are focusing on automation and high-throughput platform launches to strengthen market position across the reagents & kits and hospital segments outlined above. Recent moves include Beckman Coulter's FDA-cleared DxC 500i integrated analyzer and Fujirebio's Lumipulse G GFAP assay launch, both aimed at deepening share across U.S. hospital and laboratory networks.

Why It Matters for Buyers Evaluating Diagnostic Market Entry

For stakeholders researching the U.S. diagnostics landscape, this report benchmarks U.S immunoassay market share, segment-level pricing, and forecast data — by product, technology, specimen, application, and end use — to support sourcing, investment, and go-to-market decisions.0020It is built for procurement teams comparing suppliers, investors sizing entry points, and strategy teams tracking neurology and oncology biomarker testing as a growth adjacency.

About Polaris Market Research

Polaris Market Research is a B2B syndicated market research and consulting firm offering 5,000+ published reports across 20+ industry verticals, delivering data-backed insights to help businesses make informed decisions.

More Trending Latest Reports By Polaris Market Research:

Meteorological Devices Market

Cold Pain Therapy Market

Autoimmune Disease Diagnostics Market

How Mobile Payments Offer Greater Convenience in Financial Transactions?

Cold Pain Therapy Market

Cellular IoT Module Shipments Market

Blank Apparel Market

Industrial Lubricants Market

Analytical Instrumentation Market