U.S. allergy and autoimmune disease diagnostics market size and share is currently valued at USD 4.24 billion in 2024 and is anticipated to generate an estimated USD 9.56 billion by 2034, according to the latest study by Polaris Market Research. Besides, the report notes that the market exhibits a robust 8.5% Compound Annual Growth Rate (CAGR) over the forecasted timeframe, 2025 - 2034

Market’s Growth Drivers

1. Rising Prevalence of Allergies and Autoimmune Diseases
   The increasing incidence of chronic allergies and autoimmune disorders in the U.S. population is a key driver of market growth. Factors such as environmental pollution, changes in diet, lifestyle alterations, and genetic predisposition have contributed to higher rates of immune system dysregulation. This trend underscores the demand for accurate, reliable, and timely diagnostic solutions.
2. Advancements in Diagnostic Technologies
   Technological innovations in molecular diagnostics, multiplex immunoassays, and high-throughput screening methods have enhanced the ability to detect multiple allergens or autoimmune markers in a single test. Automation and AI-powered analytics have further improved test accuracy, speed, and efficiency, making diagnostics more accessible to healthcare providers and patients.
3. Increasing Adoption of Personalized Medicine
   Personalized medicine is gaining traction in the U.S., emphasizing tailored treatment plans based on individual genetic, immunological, and biochemical profiles. Diagnostic solutions that identify specific allergens or immune markers play a pivotal role in this approach, enabling clinicians to design individualized treatment regimens and monitor patient responses.
4. Awareness and Preventive Healthcare Initiatives
   Public awareness campaigns and preventive healthcare programs are encouraging early screening and diagnosis of allergic and autoimmune conditions. Early detection reduces the risk of disease progression, lowers hospitalization rates, and improves quality of life, driving demand for diagnostic testing services.
5. Integration of Digital Health and Remote Monitoring
   Digital health platforms, telemedicine, and wearable devices have enabled remote monitoring of patients with allergies and autoimmune disorders. These technologies allow continuous tracking of symptoms and immune responses, enhancing diagnostic accuracy and supporting proactive disease management.

Key Trends

1. Emergence of Multiplex Testing Platforms
   Multiplex diagnostic platforms capable of detecting multiple allergens or autoimmune markers simultaneously are gaining popularity. These platforms reduce testing time, minimize patient discomfort, and provide comprehensive diagnostic insights, facilitating faster clinical decision-making.
2. Shift Toward Biomarker-Based Diagnostics
   The identification of disease-specific biomarkers has revolutionized autoimmune disease diagnostics. Biomarkers enable precise disease detection, differentiation between similar conditions, and monitoring of treatment efficacy, thereby supporting personalized therapeutic interventions.
3. Adoption of Point-of-Care Testing (POCT)
   Point-of-care testing is increasingly utilized for allergy and autoimmune diagnostics, offering rapid results and immediate clinical guidance. POCT is particularly valuable in emergency settings, primary care clinics, and remote locations, expanding access to diagnostic services and reducing delays in treatment initiation.
4. Integration with Artificial Intelligence and Data Analytics
   AI and advanced analytics are being integrated into diagnostic platforms to enhance predictive accuracy, identify novel patterns, and streamline laboratory workflows. These technologies support earlier detection, risk stratification, and personalized treatment planning, driving clinical adoption and market growth.
5. Rising Focus on Pediatric and Geriatric Populations
   Allergies and autoimmune diseases affect both children and older adults differently, necessitating specialized diagnostic approaches. The development of age-specific tests and guidelines has contributed to the expansion of the market, addressing unmet needs in vulnerable populations.

Research Scope

The research scope of the U.S. allergy and autoimmune disease diagnostics market encompasses the analysis of diagnostic methods, emerging technologies, disease epidemiology, and healthcare infrastructure. Research focuses on market trends, growth drivers, and barriers, as well as competitive strategies adopted by key players.

Studies examine the clinical utility, accuracy, and adoption rates of various diagnostic platforms, including in vitro assays, molecular diagnostics, and POCT solutions. In addition, research evaluates reimbursement policies, regulatory frameworks, and patient access to advanced diagnostic technologies.

The scope also includes insights into collaborative initiatives between diagnostic companies, healthcare providers, and research institutions aimed at advancing innovation, improving patient outcomes, and expanding diagnostic capabilities. Furthermore, regional analysis highlights variations in adoption rates, healthcare access, and disease prevalence across the U.S.

Major Key Players:

• Abbott Laboratories
• Bio-Rad Laboratories
• bioMérieux SA
• EUROIMMUN Medizinische Labordiagnostika AG (Revvity, Inc.)
• Grifols S.A.
• Quest Diagnostics
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc.
• Trinity Biotech plc
• Werfen

𝐄𝐱𝐩𝐥𝐨𝐫𝐞 𝐓𝐡𝐞 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐑𝐞𝐩𝐨𝐫𝐭 𝐇𝐞𝐫𝐞: https://www.polarismarketresearch.com/industry-analysis/us-allergy-and-autoimmune-disease-diagnostics-market

Market Segmentation

1. By Diagnostic Type

• Allergy Diagnostics: Skin prick tests, serum-specific IgE tests, component-resolved diagnostics, and molecular allergen panels.
• Autoimmune Disease Diagnostics: Enzyme-linked immunosorbent assays (ELISA), immunofluorescence assays, multiplex immunoassays, PCR-based tests, and biomarker-based diagnostics.

• In Vitro Diagnostics (IVD): Laboratory-based tests for allergen detection and autoimmune disease markers.
• Point-of-Care Testing (POCT): Rapid tests providing immediate results for clinical decision-making.
• Molecular Diagnostics: Advanced genetic and biomarker-based platforms for precise disease detection.

• Hospitals and Clinics: Major providers of diagnostic services, leveraging laboratory and POCT solutions.
• Diagnostic Laboratories: Independent laboratories offering specialized tests and high-throughput platforms.
• Research and Academic Institutions: Conduct clinical trials, disease mapping, and biomarker discovery.
• Home-Based Testing: Emerging segment focusing on at-home diagnostic kits for allergies and autoimmune conditions.

• Allergic Conditions: Food allergies, respiratory allergies, skin allergies, drug allergies, and environmental allergies.
• Autoimmune Diseases: Rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, type 1 diabetes, psoriasis, and inflammatory bowel disease.

• East Coast: Concentration of leading diagnostic companies, research institutions, and clinical trials.
• West Coast: Focus on technological innovation and adoption of digital diagnostics.
• Midwest: High adoption in hospital networks and diagnostic laboratories.
• Southern States: Increasing penetration of home-based and POCT solutions.

Conclusion

The U.S. allergy and autoimmune disease diagnostics market is poised for robust growth, driven by rising disease prevalence, technological advancements, and increasing adoption of personalized medicine. Multiplex testing platforms, biomarker-based diagnostics, and point-of-care solutions are transforming clinical workflows and enabling faster, more accurate detection of allergies and autoimmune disorders.

Digital health integration, AI-driven analytics, and patient-centered approaches are further enhancing the diagnostic landscape, allowing healthcare providers to deliver targeted, timely, and effective care. With increasing awareness, regulatory support, and investment in research and innovation, the U.S. allergy and autoimmune disease diagnostics market is well-positioned to address unmet clinical needs, improve patient outcomes, and drive the next generation of precision healthcare.

As the market evolves, continued collaboration among diagnostic companies, healthcare providers, research institutions, and patient advocacy groups will be essential in expanding access, optimizing treatment strategies, and fostering innovation in allergy and autoimmune disease management.

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