Allergy Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Allergy Diagnostics Market is projected to expand from USD 6.58 Billion in 2025 to USD 12.98 Billion by 2031, achieving a CAGR of 11.99%. This sector involves the medical instruments, consumables, and assays used to identify allergen-specific antibodies or cellular responses, enabling the clinical diagnosis of hypersensitivities to environmental and food-based triggers. Market growth is primarily fueled by the rising global incidence of atopic diseases and the clinical necessity for early detection to manage chronic conditions effectively. As reported by the Asthma and Allergy Foundation of America in 2024, approximately 100 million individuals in the United States live with various allergic conditions, underscoring the critical need for reliable diagnostic frameworks to address this expanding health burden.

However, the market encounters significant hurdles due to the high acquisition and operational costs associated with automated diagnostic platforms. These financial constraints frequently limit the adoption of comprehensive testing panels in smaller laboratories and resource-limited healthcare settings. Consequently, high costs impede market penetration in developing economic regions where healthcare budgets are tight, effectively restricting the widespread availability of these essential diagnostic tools.

Market Drivers

The rising global prevalence of allergic diseases and comorbidities, exacerbated by rapid urbanization and environmental pollution, serves as a primary catalyst for the growth of the allergy diagnostics market. As climate change degrades air quality and prolongs pollen seasons, the frequency of respiratory sensitizations has increased, creating a demand for more frequent and precise screening protocols. According to the March 2024 '2024 Allergy Capitals' report by the Asthma and Allergy Foundation of America, approximately 25.7% of adults in the United States have a diagnosed seasonal allergy. This widespread burden compels healthcare providers to utilize comprehensive diagnostic panels to distinguish allergic rhinitis from other respiratory conditions, thereby boosting the deployment of immunoassay analyzers and consumable kits in clinical settings.

Simultaneously, the market is significantly propelled by the surging incidence of severe food allergies and dietary sensitivities, which necessitate accurate risk assessment tools. The complexity of food-based hypersensitivities has shifted clinical focus toward component-resolved diagnostics to pinpoint specific proteins that trigger anaphylaxis. In the 'The clinical burden of food allergies' article published by the World Allergy Organization in March 2024, 46% of patients in the FARE Patient Registry reported experiencing food-induced anaphylaxis, highlighting the need for advanced stratification. Furthermore, the Food Standards Agency's August 2024 report noted that hospital admissions for food-induced anaphylaxis in England rose to 4.02 per 100,000 people, reinforcing the urgent clinical imperative for robust diagnostic interventions.

Market Challenges

The substantial acquisition and operational expenses tied to automated diagnostic platforms pose a major restraint on the expansion of the allergy diagnostics market. Small and medium-sized laboratories often lack the capital budget necessary to purchase these instruments or support the recurring costs of consumables and maintenance. This financial barrier effectively restricts the use of comprehensive testing panels to well-funded medical centers, leaving smaller facilities and resource-constrained regions underserved. Consequently, the market struggles to penetrate developing economic regions where healthcare spending is strictly monitored and prioritized.

According to the European Academy of Allergy and Clinical Immunology, approximately 150 million citizens across Europe were estimated to suffer from chronic allergic diseases in 2024. Despite this high prevalence and the associated need for diagnosis, the inability of smaller healthcare providers to afford automated systems creates a disparity between clinical demand and testing availability. When diagnostic infrastructure is financially inaccessible to a large segment of the healthcare landscape, patient access is reduced, which directly limits the volume of assays performed and impedes overall market growth.

Market Trends

The integration of Artificial Intelligence (AI) and Machine Learning (ML) into diagnostic workflows is fundamentally transforming allergy testing by automating the interpretation of complex immunological data. These advanced algorithms analyze patient history and sensitization patterns to predict allergen reactivity with greater precision than traditional manual assessments, significantly lowering administrative burdens on clinicians. As detailed in the 'AI-Enhanced Allergy Diagnostics' article within the European Journal of Public Health in October 2024, clinical trials involving around 300 patients showed that AI-supported methods saved medical staff an average of 40 minutes per patient while maintaining high sensitivity. This technological shift addresses specialist shortages by streamlining the stratification of high-risk patients and optimizing clinical decision-making.

Concurrently, the market is witnessing a decisive shift toward Multiplex Immunoassay and Microarray Platforms, which allow for the simultaneous quantification of specific IgE antibodies against a vast array of allergens from a single serum sample. This evolution supports the broader adoption of Component-Resolved Diagnostics (CRD), enabling practitioners to differentiate between genuine sensitization and cross-reactivity more effectively than single-plex assays. A significant advancement in this area was highlighted by AliveDx in a July 2024 press release, announcing regulatory approval for its proprietary microarray immunoassay designed to detect over 30 distinct allergens, including both food and inhalant proteins. Such platforms are increasingly critical for developing personalized management plans for polysensitized individuals without requiring large blood volumes.

Key Players Profiled in the Allergy Diagnostics Market

• Thermo Fisher Scientific Inc.
• Siemens Healthineers AG
• Abbott Laboratories
• Danaher Corporation
• Hologic, Inc.
• BioMerieux SA
• F. Hoffmann-La Roche AG
• Laboratory Corporation of America Holdings
• Allergy Therapeutics PLC
• Indoor Biotechnologies, Inc.

Report Scope

In this report, the Global Allergy Diagnostics Market has been segmented into the following categories:

Allergy Diagnostics Market, by Product:

• Assay Kits
• Instruments
• Consumables
• Services

Allergy Diagnostics Market, by Allergy Type:

• Food
• Seasonal
• Drug
• Inhalant
• Anaphylaxis/Contact Allergies
• Others

Allergy Diagnostics Market, by Test:

• In Vivo
• In Vitro

Allergy Diagnostics Market, by End User:

• Hospital
• Diagnostic Laboratory
• Academic and Research Institutes
• Others

Allergy Diagnostics Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Allergy Diagnostics Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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