Global Allergy Diagnostics Market By Product (Assay Kits, Instruments, Consumables, Services) By Allergy Type (Food, Seasonal, Drug, Inhalant, Anaphylaxis/Contact Allergies, Others) By Test (In Vivo, In Vitro) By End User (Hospital, Diagnostic Laboratory, Academic and Research Institutes, Others) By Company, By Region, Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 6.58 Billion
CAGR (2026-2031)	11.99%
Fastest Growing Segment	Assay Kits
Largest Market	Asia Pacific
Market Size (2031)	USD 12.98 Billion

Market Overview

The Global Allergy Diagnostics Market will grow from USD 6.58 Billion in 2025 to USD 12.98 Billion by 2031 at a 11.99% CAGR. Allergy diagnostics encompass the medical assays, consumables, and instruments utilized to detect allergen-specific antibodies or cellular reactions, facilitating the clinical identification of hypersensitivities to environmental and food-based substances. The market’s expansion is primarily driven by the escalating global incidence of atopic diseases and the increasing clinical imperative for early detection to manage chronic conditions effectively. According to the Asthma and Allergy Foundation of America, in 2024, approximately 100 million individuals in the United States were reported to live with various allergic conditions, highlighting the critical necessity for robust diagnostic frameworks to address this growing health burden.

However, the market faces a substantial obstacle regarding the high acquisition and operational costs associated with automated diagnostic platforms. These financial barriers often restrict the widespread adoption of comprehensive testing panels within resource-limited healthcare settings and smaller laboratories, effectively impeding market penetration in developing economic regions where healthcare budgets are constrained.

Key Market Drivers

The escalating global prevalence of allergic diseases and comorbidities, intensified by environmental pollution and rapid urbanization, acts as a primary catalyst for the expansion of the allergy diagnostics market. As air quality deteriorates and pollen seasons lengthen due to climate change, the frequency of respiratory sensitizations has spiked, necessitating more frequent and accurate screening protocols. According to the Asthma and Allergy Foundation of America, March 2024, in the '2024 Allergy Capitals' report, approximately 25.7% of adults in the United States have a diagnosed seasonal allergy. This pervasive burden drives healthcare providers to adopt comprehensive diagnostic panels to differentiate between allergic rhinitis and other respiratory conditions, thereby increasing the utilization of immunoassay analyzers and consumable test kits in clinical settings.

Simultaneously, the market is being substantially propelled by the surge in the incidence of severe food allergies and dietary sensitivities, which demands precise risk assessment tools. The growing complexity of food-based hypersensitivities has shifted clinical focus toward component-resolved diagnostics to identify specific anaphylaxis-triggering proteins. According to the World Allergy Organization, March 2024, in the journal article 'The clinical burden of food allergies: Insights from the FARE Patient Registry', 46% of patients within the registry reported experiencing food-induced anaphylaxis, underscoring the critical need for advanced stratification. Furthermore, according to the Food Standards Agency, August 2024, in the 'Using NHS Data to Monitor Trends in the Occurrence of Severe, Food-Induced Allergic Reactions' report, hospital admissions for food-induced anaphylaxis in England increased to 4.02 admissions per 100,000 population, highlighting the urgent clinical imperative for robust diagnostic interventions.

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Key Market Challenges

The high acquisition and operational expenses associated with automated diagnostic platforms present a significant restraint on the expansion of the allergy diagnostics market. Small and medium-sized laboratories frequently lack the capital budget required to purchase these instruments or sustain the ongoing costs of consumables and maintenance. This financial barrier effectively restricts the adoption of comprehensive testing panels to large, well-funded medical centers, leaving smaller facilities and resource-limited regions underserved. Consequently, the market struggles to penetrate developing economic regions where healthcare expenditure is strictly monitored and prioritized.

According to the European Academy of Allergy and Clinical Immunology, in 2024, it was estimated that chronic allergic diseases affected approximately 150 million citizens across Europe. Despite this high prevalence and the corresponding need for diagnosis, the inability of smaller healthcare providers to afford automated systems creates a gap between clinical demand and testing availability. When diagnostic infrastructure is financially inaccessible to a large segment of the healthcare landscape, patient access to testing is reduced, directly limiting the potential volume of assays performed and impeding overall market growth.

Key Market Trends

The Integration of Artificial Intelligence (AI) and Machine Learning (ML) into diagnostic workflows is fundamentally reshaping allergy testing by automating the interpretation of complex immunological data. These advanced algorithms analyze patient history and sensitization patterns to predict allergen reactivity with higher precision than traditional manual assessments, significantly reducing administrative burdens on clinicians. According to the European Journal of Public Health, October 2024, in the 'AI-Enhanced Allergy Diagnostics' article, clinical trials involving approximately 300 patients demonstrated that AI-supported diagnostic methods saved an average of 40 minutes per patient for medical staff while maintaining high sensitivity. This technological shift addresses the bottleneck of 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 enable the simultaneous quantification of specific IgE antibodies against a vast array of allergens from a single serum sample. This evolution supports the widespread adoption of Component-Resolved Diagnostics (CRD), allowing practitioners to distinguish between genuine sensitization and cross-reactivity more effectively than single-plex assays. A notable advancement in this domain occurred when, according to AliveDx, July 2024, in the 'AliveDx Receives IVDR CE Mark' press release, the company secured regulatory approval for its proprietary microarray immunoassay designed to simultaneously detect over 30 distinct allergens, including both inhalant and food-based proteins. Such platforms are increasingly critical for developing personalized management plans for polysensitized individuals without requiring large blood volumes.

Segmental Insights

The Assay Kits segment is positioned to experience the fastest growth within the Global Allergy Diagnostics Market, primarily due to the rising prevalence of allergic diseases necessitating frequent testing. Unlike capital equipment, these consumables are required for every diagnostic procedure, ensuring a steady and recurring demand stream. The market expansion is further supported by the commercialization of validated testing panels authorized by regulatory entities such as the U.S. Food and Drug Administration. This regulatory oversight ensures test reliability, thereby encouraging healthcare providers to increase the utilization of these essential diagnostic tools.

Regional Insights

Asia Pacific currently stands as a leading region in the global allergy diagnostics market, driven by rapid economic development and a massive patient population. This regional dominance is primarily attributed to the escalating prevalence of allergic diseases resulting from intense urbanization and increasing environmental pollution. Governments and healthcare institutions are responding by expanding medical infrastructure and prioritizing disease management programs. Furthermore, rising disposable incomes in emerging economies have empowered a growing middle class to access professional testing services. These factors collectively position Asia Pacific as the central driver of demand and expansion within the global market.

Recent Developments

• In October 2025, bioMérieux acquired a stake in Allergen Alert, a startup focused on rapid food allergen detection, during a €3.6 million funding round. This strategic investment followed the startup's creation within bioMérieux’s own intrapreneurship program. Allergen Alert is developing a portable, connected solution designed to identify specific allergens and gluten in food products within minutes. The collaboration underscores bioMérieux’s commitment to food safety and innovation in diagnostic technologies. By supporting this venture, the company aims to provide individuals and professionals with reliable tools to manage food allergies and celiac disease more effectively in daily life.
• In September 2025, Siemens Healthineers expanded its 3gAllergy assay portfolio by introducing nine new component allergens on the IMMULITE 2000 XPi System. This product launch featured six specific components targeting peanut proteins, which are frequently linked to fatal anaphylaxis, as well as new tests for wheat and house dust mites. The Head of Immulite, Plasma Proteins, and Syva at Siemens Healthineers noted that these molecular-level insights would allow clinicians to distinguish between high-risk sensitizations and mild exposures. This advancement aims to support personalized patient care by reducing unnecessary dietary restrictions and improving the management of severe allergic reactions.
• In May 2025, Revvity, Inc. launched the IDS i20 analytical random access platform, a fully automated system developed by its subsidiary EUROIMMUN. This CE-marked and FDA-listed instrument was designed to consolidate specialty testing, including allergy diagnostics, onto a single, efficient device. The platform enables laboratories to process up to 20 analytes simultaneously across various disciplines such as autoimmunity, infection, and endocrinology. The company emphasized that this new solution offers superior reagent capacity and higher throughput compared to traditional manual methods, thereby streamlining workflows and enhancing the operational capabilities of clinical laboratories performing complex diagnostic assays.
• In October 2024, ALK announced that the U.S. Food and Drug Administration (FDA) had cleared its new AccuTest line of allergy skin testing devices and well trays. This regulatory approval encompassed the AccuTest-1, AccuTest-8, and AccuTest-10 applicators, alongside 48-well and 60-well allergen trays intended for diagnosing allergic conditions. The company highlighted that these devices were engineered with reduced tine lengths and diameters to enhance testing precision while minimizing patient discomfort. Furthermore, a study supporting the clearance demonstrated that the lower variability of these instruments could significantly increase the reliability of skin prick testing results for allergy practitioners and patients.

Key Market Players

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

By Product	By Allergy Type	By Test	By End User	By Region
Assay Kits Instruments Consumables Services	Food Seasonal Drug Inhalant Anaphylaxis/Contact Allergies Others	In Vivo In Vitro	Hospital Diagnostic Laboratory Academic and Research Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Allergy Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• 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
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE