Pediatric Allergy Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Allergen (Food, Inhaled Drug, Other Allergens), By Product (Instruments, Services), By Test (In vivo Test, In vitro Test), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.53 Billion
CAGR (2026-2031)	10.99%
Fastest Growing Segment	Food
Largest Market	North America
Market Size (2031)	USD 4.73 Billion

Market Overview

The Global Pediatric Allergy Diagnostics Market will grow from USD 2.53 Billion in 2025 to USD 4.73 Billion by 2031 at a 10.99% CAGR. Pediatric allergy diagnostics encompass medical assays and clinical procedures, such as skin prick testing, specific IgE blood analysis, and oral food challenges, designed to identify allergic sensitivities in infants and adolescents. The market is primarily propelled by the escalating global prevalence of pediatric allergic conditions, particularly food allergies and asthma, which necessitates early and accurate detection to prevent severe health outcomes. Additionally, increasing environmental pollution and changing dietary habits are contributing to the rising incidence of atopic diseases, further fueling the demand for effective testing mechanisms. According to Food Allergy Research & Education, in 2024, patient registry data indicated that 46% of individuals with food allergies experienced anaphylaxis, underscoring the urgent need for reliable diagnostic interventions to manage this growing clinical burden.

However, a significant impediment to market expansion is the high cost associated with advanced diagnostic instrumentation, which limits accessibility in resource-constrained regions. The substantial financial investment required for specialized testing platforms, coupled with a shortage of trained pediatric allergists in developing economies, restricts the widespread adoption of these essential healthcare solutions and creates a distinct barrier to global market penetration.

Key Market Drivers

The rising global incidence of pediatric allergic conditions serves as the primary catalyst for the pediatric allergy diagnostics market, necessitating robust testing frameworks to manage increasing clinical caseloads. This surge is particularly evident in food allergies and respiratory conditions, where early identification is critical to mitigate life-threatening anaphylactic events and chronic health issues. As prevalence rates climb, healthcare systems are prioritizing accurate screening tools to differentiate between genuine allergies and sensitivities. According to the Asthma and Allergy Foundation of America, April 2025, in the 'Allergy Facts and Figures' update, approximately 4 million U.S. children, representing 5.8% of the pediatric population, have been diagnosed with food allergies. This demographic shift compels the market to expand its diagnostic capacities, ensuring that vulnerable pediatric populations receive timely and precise interventions.

Simultaneously, the market is being reshaped by the adoption of advanced component-resolved diagnostic (CRD) technologies and automated laboratory solutions, which offer superior precision compared to traditional whole-allergen extracts. These innovations enable clinicians to identify specific allergenic protein components, significantly reducing false positives and allowing for targeted immunotherapy. According to Revvity, Inc., May 2025, in a press release regarding the launch of its IDS i20 platform, the company introduced a fully automated system capable of running 20 analytes across diagnostic specialties, including allergy, to streamline laboratory workflows. This technological evolution is supported by substantial industry investment. For instance, according to Thermo Fisher Scientific, October 2025, in their 'Third Quarter 2025 Results', the company reported a revenue increase of 5% to $11.12 billion, highlighting the sustained economic momentum enabling the widespread deployment of such diagnostic instruments.

Download Free Sample Report

Key Market Challenges

The high cost associated with advanced diagnostic instrumentation constitutes a formidable barrier to the expansion of the global pediatric allergy diagnostics market. This financial burden significantly limits the adoption of necessary testing platforms in resource-constrained regions and developing economies, where healthcare budgets are often tight. Consequently, medical facilities in these areas are unable to procure the specialized equipment required for precise specific IgE blood analysis or oral food challenges. This lack of accessibility prevents the market from penetrating large, high-population demographics that are increasingly susceptible to atopic diseases, thereby stifling potential revenue streams and stalling global growth.

The shortage of accessible, high-quality diagnostics resulting from these financial and workforce constraints leads to a substantial gap in patient care and market efficiency. When advanced tools are unaffordable or unavailable, healthcare providers must rely on less accurate methods, leading to poor clinical outcomes that further deter investment in the sector. According to the European Academy of Allergy and Clinical Immunology, in 2024, approximately 45% of allergy patients in the European Union were likely to be misdiagnosed, highlighting the critical inability of the current market infrastructure to effectively reach and assess patients due to these prevailing access barriers.

Key Market Trends

The integration of artificial intelligence for precision diagnosis is rapidly transforming the Global Pediatric Allergy Diagnostics Market by standardizing the interpretation of clinical assessments and optimizing workflow efficiency. Unlike traditional manual readings of skin prick tests, which are subject to inter-observer variability, emerging AI-driven algorithms enable automated, objective analysis of wheal reactions, enhancing diagnostic consistency across pediatric populations. This technological integration directly addresses clinical bottlenecks by streamlining the evaluation process, allowing healthcare providers to manage higher patient volumes effectively. According to the European Journal of Public Health, October 2024, in the article 'AI-Enhanced Allergy Diagnostics', clinical trials involving approximately 300 patients demonstrated that AI-supported diagnostics reduced the time required for allergists by an average of 40 minutes per patient, significantly mitigating workforce constraints in allergy clinics.

Simultaneously, the market is witnessing a significant technological shift towards in vitro diagnostic modalities designed to replace high-risk in vivo procedures like oral food challenges. Novel functional assays are emerging that mimic allergic reactions in a controlled laboratory environment, offering a safer alternative for diagnosing complex food sensitivities in infants and children without the risk of inducing anaphylaxis. These advanced in vitro methods provide superior diagnostic performance compared to standard IgE testing by measuring actual cellular responses to specific allergens. According to the University of Bern, October 2024, in a press release regarding the 'Hoxb8 mast cell activation test', researchers developed a new in vitro diagnostic method that achieved a diagnostic accuracy of 95% in pediatric peanut allergy cases, surpassing the reliability of conventional skin and blood tests.

Segmental Insights

The food allergen segment is currently establishing itself as the fastest-growing category within the global pediatric allergy diagnostics market, driven by the escalating prevalence of hypersensitivities to common dietary staples such as cow’s milk, eggs, and peanuts among infants. This expansion is significantly supported by updated clinical guidelines from health authorities like the Centers for Disease Control and Prevention, which advocate for accurate early screening to prevent severe anaphylactic reactions. Consequently, the increased adoption of specific testing methods to ensure safe dietary management is consistently fueling the rapid development of this market segment.

Regional Insights

North America holds the leading position in the Global Pediatric Allergy Diagnostics Market, primarily driven by the increasing incidence of pediatric allergies and asthma. The region benefits from established healthcare infrastructure that facilitates early disease detection and management. Additionally, the strong presence of key industry players in the United States accelerates the availability of diagnostic solutions. Regulatory support from the U.S. Food and Drug Administration (FDA) for product approvals further strengthens market growth. Comprehensive reimbursement frameworks also play a critical role in ensuring widespread access to allergy testing services for children.

Recent Developments

• In September 2025, Siemens Healthineers expanded its 3gAllergy assay menu by launching nine new component allergens on the IMMULITE 2000 XPi System. This product update included six specific components for peanut allergy testing, designed to help clinicians distinguish between high-risk sensitizations and benign exposures. The launch also introduced components for wheat and house dust mites. By providing component-level insights, the company aims to enable more personalized management strategies for allergy sufferers, potentially reducing unnecessary dietary restrictions and improving the quality of life for patients with severe allergic sensitivities.
• In November 2024, Reacta Healthcare announced the successful completion of a pediatric allergy diagnostics project valued at approximately £1 million. This initiative, substantially funded by Innovate UK, focused on developing pharmaceutical-grade oral food challenge meals specifically tailored for children as young as six months. The company formulated challenge doses for peanut, milk, and egg allergies that incorporate unique texturizers and flavors suitable for infants. These new diagnostic tools aim to improve the safety and accuracy of food allergy detection in the pediatric population, addressing the rising prevalence of such conditions in young children.
• In October 2024, ALK-Abelló announced the launch of its new AllerTest line of allergy skin testing devices following clearance from the U.S. Food and Drug Administration. The new portfolio includes the AllerTest-1 single skin prick device as well as multi-head applicators, specifically the AllerTest-8 and AllerTest-10, designed to improve testing efficiency. These devices feature smaller tine lengths to ensure accuracy while minimizing patient discomfort, a critical factor in pediatric allergy diagnosis. The release also included compatible allergen well trays, strengthening the company’s position in the point-of-care allergy diagnostics market.
• In April 2024, Thermo Fisher Scientific introduced a new set of ImmunoCAP Specific IgE Allergen Components to enhance the precision of allergy diagnostics. This launch was designed to facilitate better differentiation between primary allergies and cross-reactions in patients. The expanded portfolio allows clinicians to identify the specific proteins causing sensitization, which is particularly valuable in complex cases involving pediatric patients. By offering a more granular analysis of allergic triggers, the company aims to support healthcare providers in making more informed decisions regarding immunotherapy and avoidance strategies for individuals with respiratory and food allergies.

Key Market Players

• bioMérieux SA
• Thermo Fisher Scientific, Inc
• Stallergenes Greer
• Minaris Medical America Inc.
• Siemens Healthineers AG
• Cambridge Nutritional Sciences Plc(Omega Diagnostics Ltd)
• R-Biopharm AESKU.GROUP GmbH & Co. KG
• EUROIMMUN Medizinische Labordiagnostika AG
• HYCOR Biomedical
• Lincoln Diagnostics, Inc.

By Allergen	By Product	By Test	By Region
Food Inhaled Drug Other Allergens	Instruments Services	In vivo Test In vitro Test	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Pediatric Allergy Diagnostics Market, By Allergen:

• Food
• Inhaled Drug
• Other Allergens

• Pediatric Allergy Diagnostics Market, By Product:

• Instruments
• Services

• Pediatric Allergy Diagnostics Market, By Test:

• In vivo Test
• In vitro Test

• Pediatric 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