The U.S. allergy and autoimmune disease diagnostics market, valued at USD 4.24 billion in 2024, is anticipated to expand at a CAGR of 8.5% from 2025 to 2034, with growth increasingly driven by segment-wise performance across product types, end-user applications, and technological platforms. The market can be segmented by product type into immunoassay analyzers, reagent kits, rapid tests, and software platforms, with reagent kits representing the largest and most established segment due to their recurring revenue model and widespread use in hospital laboratories and reference labs. Immunoassay platforms—particularly chemiluminescent immunoassays (CLIA) and enzyme-linked immunosorbent assays (ELISA)—dominate autoimmune testing, while molecular allergen component testing is gaining traction in allergy diagnostics for improved specificity and cross-reactivity assessment.
By end-user, hospital and clinical laboratories account for over 60% of total demand, driven by the need for high-throughput, automated testing in large health systems. Application-specific growth is evident in food allergy diagnostics, where component-resolved diagnostics (CRD) are enabling precision testing for peanut, milk, and egg allergies, reducing unnecessary dietary restrictions. The rise of personalized medicine and biologic therapies for autoimmune diseases is further expanding the need for companion diagnostics and disease activity monitoring. Segment-specific pricing reflects performance tiers, with basic ELISA kits priced between USD 100–300 per test panel, while advanced multiplex arrays and CLIA-based systems can exceed USD 1,000 per run. The integration of AI-driven interpretation tools, cloud-based data storage, and interoperability with electronic health records (EHRs) is enabling product differentiation and improving clinical decision-making.
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Product differentiation is emerging through assay sensitivity, multiplexing capability, and workflow integration. Leading manufacturers are investing in high-sensitivity assays for early disease detection, multi-analyte panels that reduce sample volume and turnaround time, and fully automated platforms that minimize manual intervention. Additionally, the development of point-of-care (POC) rapid tests for IgE and ANA is expanding access to diagnostics in primary care and urgent care settings.
Value chain optimization is a strategic imperative, as healthcare providers seek to reduce test turnaround time, improve diagnostic accuracy, and meet rising demand for traceable, auditable results. Leading players are investing in closed-system reagent cartridges, digital quality control, and remote monitoring to enhance reliability and compliance. Furthermore, the convergence of diagnostics with digital health platforms, AI-driven risk prediction, and teleconsultation is creating new opportunities for application-specific growth, particularly in chronic disease management and preventive care. As the industry evolves beyond standalone tests toward integrated diagnostic ecosystems, segment-wise performance will increasingly depend on innovation, interoperability, and alignment with evolving clinical and payer requirements.
Competitive Landscape:
- Thermo Fisher Scientific Inc.
- Siemens Healthineers AG
- Abbott Laboratories
- Roche Diagnostics (a division of F. Hoffmann-La Roche Ltd)
- Bio-Rad Laboratories, Inc.
- Euroimmun AG (a PerkinElmer company)
- QuidelOrtho Corporation
- WANTAI Biological Pharmacy Enterprise Co., Ltd. (U.S. operations)
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