U.S. Allergy And Autoimmune Disease Diagnostics Market to Observe Strong Development by 2033: Grand View Research Inc.

 Market Size & Trends

The U.S. allergy and autoimmune disease diagnostics market size was estimated at USD 4.03 billion in 2024 and is projected to reach USD 8.40 billion by 2033, growing at a CAGR of 8.67% from 2025 to 2033. The market is primarily driven by the rising incidence of allergic and autoimmune disorders, increasing patient awareness, and improved access to specialized diagnostic testing. Allergy diagnostics are widely used to identify specific IgE-mediated reactions, while autoimmune disease diagnostics support early detection and differentiation of complex conditions such as rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis.

In addition, the growing volume of diagnostic testing for allergy and autoimmune conditions has prompted significant improvements in sample handling, assay throughput, and data reporting. These enhancements support more efficient laboratory operations and expand access to specialized tests. Laboratories are increasingly adopting automation and integrated platforms to manage rising demand, streamline workflows, and maintain accuracy in high-complexity testing.

Digitized reporting systems and connectivity with electronic health records further improve coordination between diagnostic teams and clinicians. These tools reduce turnaround times and support timely clinical decision-making in managing chronic allergic and autoimmune conditions.

The U.S. market is experiencing continuous innovation, driven by research-focused developments and a shift toward more targeted diagnostic solutions. In April 2025, Beckman Coulter Life Sciences introduced its Next-Generation Basophil Activation Test (BAT) to support allergy research. Although designed for research use only, the test reflects a growing emphasis on functional assays that offer deeper insights into immune cell behavior and allergic triggers.

In a related development, WellTheory launched an enterprise solution in October 2023 to address autoimmune care through employer and payer networks. This platform focuses on structured, lifestyle-based management of autoimmune symptoms, underscoring a broader market trend toward integrating diagnostics with ongoing patient support. These efforts reflect how diagnostics are increasingly paired with care delivery models to improve long-term outcomes for individuals with chronic immune conditions.

The U.S. market is evolving toward more specialized, data-driven approaches that align diagnostics with personalized care. As testing technologies become more sophisticated and accessible, the market is expected to benefit from stronger clinical integration, improved patient engagement, and broader adoption across traditional healthcare settings and emerging care platforms.

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Key Trends Shaping the U.S. Allergy & Autoimmune Disease Diagnostics Market

• Shift Toward Precision Diagnostics:

There is a growing demand for diagnostic tools that provide more accurate, personalized insights into allergic and autoimmune conditions. Biomarker-based assays and multiplex platforms enable earlier detection and more specific differentiation between overlapping immune disorders.

• Integration of Automation and High-Throughput Systems:

Laboratories are increasingly adopting automated analyzers and integrated workflow solutions to improve efficiency and scale testing capacity. This trend supports faster turnaround times and reduces manual errors in complex immunological testing.

• Progress in Sample Collection and Remote Access Tools:

Laboratories and diagnostic developers are improving sample collection methods to support remote allergy and autoimmune testing access. Dried blood spot (DBS) sampling and mail-in collection kits are gaining traction for preliminary screening and longitudinal disease monitoring. These approaches support patient-centric care and increase access in underserved or non-urban areas.

• Growing Use of Digital Health Platforms:

Diagnostic insights are being increasingly integrated into digital care models. Platforms that combine diagnostic results with patient-reported outcomes and care coordination tools are gaining traction in autoimmune disease management.

• Research-Focused Innovation in Functional Assays:

Ongoing research is driving the development of novel functional diagnostics, such as basophil activation tests (BAT) and T-cell response assays. These tools aim to provide more clinically relevant insights into immune activity and hypersensitivity mechanisms.

Key U.S. Allergy And Autoimmune Disease Diagnostics Company Insights

Some key players in the market focus on innovation, expanding their test offerings, and improving accuracy to stay competitive. These companies are working toward regulatory approvals like FDA clearance to meet standards and increase market access.

They also invest in biomarker research, digital diagnostic tools, and partnerships to support new product development. These efforts aim to boost the use of their tests in both clinical settings and decentralized care environments, such as home testing and outpatient services.

Key U.S. Allergy And Autoimmune Disease Diagnostics Companies:

• Thermo Fisher Scientific, Inc.
• HYCOR Biomedical
• EUROIMMUN Medizinische Labordiagnostika AG (PerkinElmer, Inc.)
• Omega Diagnostics Group PLC
• Lincoln Diagnostics, Inc.
• GROUP GmbH
• Minaris Medical America, Inc.
• HOB Biotech Group Corp., Ltd.
• DASIT Group SPA
• R-Biopharm AG
• bioMérieux
• Siemens Healthcare GmbH
• Hoffmann-La Roche Ltd
• Abbott
• Beckman Coulter, Inc.
• Danaher Corporation
• Quest Diagnostics
• Nova Diagnostics Pte Ltd.

Recent Developments

• In April 2025, U.S.-based Beckman Coulter Life Sciences announced the launch of its Next-Generation BAT to support allergy diagnostics. Designed for research use only, the test offers a safer, non-invasive alternative to traditional oral food challenges by detecting allergen-induced basophil activation through a simple blood draw. This development highlights the growing focus on functional immunoassays in the U.S., supporting improved understanding of allergic responses and paving the way for more precise diagnostic tools in clinical settings.
• In April 2025, AliveDx submitted a U.S. FDA 510(k) premarket notification for its MosaiQ AiPlex CTDplus multiplex microarray assay, specifically targeting autoimmune connective tissue diseases, such as SLE, RA, systemic sclerosis, Sjögren’s syndrome, and idiopathic inflammatory myopathies. The assay detects up to 1,275 biomarkers per hour and had already earned CE-IVDR certification earlier that year. This submission represents a next-generation, high-throughput tool for more efficient and accurate autoimmune disease diagnosis in U.S. clinical labs.
• In January 2025, Werfen received FDA 510(k) clearance for its Aptiva APS IgG and IgM reagents, a diagnostic tool designed for detecting antiphospholipid syndrome (APS). Leveraging advanced PMAT (particle-based multi-analyte technology), these reagents allow semi-quantitative detection of anti-cardiolipin and anti-β₂ glycoprotein I antibodies. The system delivers up to 960 test results per eight-hour shift with minimal manual input, marking a significant expansion of the U.S. autoimmune diagnostic reagent offerings.

About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.