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
- 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. - 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. - 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. - 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. - 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
- 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. - 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. - 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. - 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. - 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
- 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. - By
Technology - 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. - By
End-User - 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. - By
Disease Indication - 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. - By
Region within the U.S. - 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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