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

Forecast Period	2027-2031
Market Size (2025)	USD 36.33 Billion
CAGR (2026-2031)	7.99%
Fastest Growing Segment	Diagnostics
Largest Market	North America
Market Size (2031)	USD 57.62 Billion

Market Overview

The Global Allergy Diagnostics and Therapeutics Market will grow from USD 36.33 Billion in 2025 to USD 57.62 Billion by 2031 at a 7.99% CAGR. Allergy diagnostics and therapeutics encompass the medical devices, assay kits, and pharmaceutical interventions utilized to identify and treat hypersensitivity reactions to specific allergens. The market trajectory is primarily supported by the rising prevalence of allergic conditions globally, including allergic rhinitis and food allergies, which necessitates distinct clinical management strategies. Furthermore, increasing urbanization and elevated pollution levels serve as fundamental drivers by intensifying widespread exposure to environmental triggers, thereby expanding the patient base requiring medical intervention.

Despite these strong growth indicators, the market faces a significant impediment regarding the high cost of specific immunotherapy regimens and advanced diagnostic panels, which restricts patient access in price-sensitive developing economies. This financial barrier is often compounded by inadequate reimbursement structures that delay the widespread adoption of novel treatments. Underscoring the scale of this public health issue, according to the Asthma and Allergy Foundation of America, in 2024, allergic conditions affected over 100 million people in the United States.

Key Market Drivers

The Growing Adoption of Immunotherapy and Biologics is a primary engine for market expansion, driven by a significant paradigm shift from symptom management to disease modification strategies. Clinicians are increasingly prescribing novel treatments, such as oral and epicutaneous immunotherapy, which have demonstrated substantial efficacy in desensitizing patients to life-threatening allergens. For instance, according to the American College of Allergy, Asthma & Immunology, November 2025, in findings presented at its Annual Meeting, over 70% of toddlers treated with the Viaskin Peanut Patch were able to tolerate a specific amount of peanut protein after three years of therapy. This clinical success is directly translating into commercial momentum for key industry stakeholders who are scaling operations to meet global demand. Underscoring this trend, according to ALK-Abelló, November 2025, in the 'Q3 2025 Outlook Update', the company upgraded its full-year revenue growth projection to 13-15% in local currencies, explicitly attributing this surge to higher patient volumes for its allergy immunotherapy products.

Technological Advancements in Diagnostic Methodologies are further propelling the sector by enhancing the accuracy and speed of allergen detection. Innovations in molecular diagnostics and component-resolved diagnostics (CRD) allow for the precise identification of specific allergic proteins, significantly reducing cross-reactivity issues associated with traditional skin-prick tests. This technological evolution supports the rising demand for personalized management plans and precision medicine, as healthcare providers utilize sophisticated tools to pinpoint sensitivities with greater granular detail. Reflecting the substantial economic scale of this segment, according to Thermo Fisher Scientific, April 2025, in the '2024 Annual Report', the company's Specialty Diagnostics business generated revenue of $4.51 billion, highlighting the robust global expenditure on advanced diagnostic assays and instruments.

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Key Market Challenges

The prohibitive cost associated with specific immunotherapy regimens and advanced diagnostic panels acts as a substantial restraint on the expansion of the Global Allergy Diagnostics and Therapeutics Market. While the clinical necessity for precision medicine is evident, the significant financial burden of long-term desensitization therapies and molecular diagnostic assays restricts market penetration, particularly in price-sensitive economies. High direct costs frequently compel healthcare providers and patients to opt for conventional symptomatic treatments, such as antihistamines, rather than curative interventions. This economic friction limits the addressable patient pool and slows the volume growth of novel therapeutics, effectively preventing the market from capitalizing on the rising global prevalence of allergies.

This financial barrier is further intensified by inadequate reimbursement frameworks that often fail to cover the full expense of modern allergy management. When insurance providers deny or limit coverage for biologics or component-resolved diagnostics, the resulting out-of-pocket expenditure becomes unsustainable for many patients. According to the European Academy of Allergy and Clinical Immunology, in 2024, the direct healthcare costs for allergic diseases were estimated to range between €1,823 and €6,656 per patient per year. Such substantial per-capita costs illustrate why financial accessibility remains a critical bottleneck that directly impedes revenue generation and hampers the widespread adoption of advanced allergy care solutions.

Key Market Trends

The Development of Wearable Biosensors for Real-Time Allergen Detection is fundamentally altering the landscape of preventative management by empowering consumers to identify environmental and dietary triggers outside of clinical settings. Unlike traditional avoidance strategies that rely strictly on product labeling, these portable devices utilize advanced molecular imprinted polymers or electrochemical sensing to detect trace allergens in food and air, addressing the critical need for immediate assurance. Validating the commercial viability of this consumer-centric innovation, according to FoodBev Media, August 2024, in the 'Amulet secures $5.8m in Series A round to launch portable food allergen sensors' article, Amulet raised $5.8 million to scale its portable detection technology, which allows individuals to test for common allergens like peanuts and gluten on the go.

The Advancement of Microbiome-Based Therapeutic Approaches represents a shift toward addressing the underlying dysbiosis that drives allergic hypersensitivity, distinct from the mechanism of conventional desensitization or symptomatic relief. This trend focuses on live biotherapeutic products (LBPs) that restore gut microbial diversity to modulate immune responses and potentially arrest the "atopic march" in early life. Highlighting the significant investment activity in this novel modality, according to BioSpace, March 2024, in the article 'Siolta Therapeutics Raises $12 Million in Series C Financing for Clinical Development', the company secured $12 million to advance its lead candidate, STMC-103H, a defined-consortia biotherapeutic designed to prevent the onset of allergic diseases such as atopic dermatitis and food allergies in newborns.

Segmental Insights

The diagnostics segment is projected to witness the most rapid expansion within the Global Allergy Diagnostics and Therapeutics Market due to the escalating global burden of allergic diseases. This growth is primarily driven by an increased clinical emphasis on early intervention and precise allergen identification to mitigate severe health risks. Moreover, regulatory support from entities like the U.S. Food and Drug Administration for novel in-vitro screening tools has facilitated broader market access and adoption. Consequently, healthcare providers are prioritizing comprehensive testing protocols over symptomatic treatment alone, thereby accelerating demand within this sector.

Regional Insights

North America leads the Global Allergy Diagnostics and Therapeutics Market, driven by the rising incidence of allergic conditions and a strong emphasis on early clinical intervention. The region benefits from established healthcare infrastructure that supports widespread testing and treatment adoption. Furthermore, the presence of key industry manufacturers combined with clear regulatory pathways defined by the U.S. Food and Drug Administration (FDA) accelerates the approval of new products. Comprehensive insurance coverage and favorable reimbursement policies also play a critical role in expanding patient access to essential allergy care services across the region.

Recent Developments

• In November 2024, Allergy Therapeutics submitted a Marketing Authorisation Application (MAA) to the Paul Ehrlich Institut in Germany for its investigational short-course subcutaneous immunotherapy, Grass MATA MPL. This regulatory submission was supported by data from the pivotal Phase III G306 clinical trial, which had previously demonstrated a statistically significant improvement in combined symptom and medication scores for patients treated with the therapy compared to a placebo. The company advanced this application under Germany's Therapy Allergen Ordinance, marking a critical step in bringing its novel treatment for grass pollen-induced allergic rhinoconjunctivitis to the European market.
• In September 2024, Mitsubishi Gas Chemical Company announced a strategic partnership with Alerje, a health technology firm focused on emergency medicine and food allergy management. The collaboration was formed to co-develop and distribute personalized allergy care solutions, effectively merging Mitsubishi Gas Chemical's capabilities in life sciences with Alerje's digital health platforms. A primary goal of this alliance was to introduce advanced allergy diagnostic technologies to the United States market. The companies aimed to enhance the quality of life for patients by integrating better diagnostic tools with comprehensive management systems for severe allergies.
• In August 2024, ARS Pharmaceuticals received FDA approval for neffy, an epinephrine nasal spray intended for the emergency treatment of Type I allergic reactions, including anaphylaxis. This approval represented a significant breakthrough in the allergy therapeutics market as the first needle-free epinephrine product available for patients and caregivers, addressing barriers often associated with injectable treatments. The product was cleared for use in adults and children weighing at least 30 kilograms. Following the authorization, the company initiated commercialization efforts to ensure the nasal spray was accessible through pharmacies and patient support programs across the United States.
• In February 2024, the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) injection for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods. This regulatory milestone established Xolair as the first and only medication approved for IgE-mediated food allergy in adults and pediatric patients aged one year and older. Developed by Genentech and Novartis, the treatment was designed to mitigate the risk of reactions to multiple food allergens, such as peanuts, milk, and eggs, primarily for patients who continued to practice strict food avoidance.

Key Market Players

• Thermo Fisher Scientific, Inc.
• R-Biopharm AG
• DASIT Group SPA
• AGILUS DIAGNOSTICS LTD.
• AESKU.GROUP GmbH
• bioMérieux SA
• Siemens Healthineers AG
• STALLERGENES GREER International AG
• HYCOR Biomedical, LLC
• Minaris Medical America, Inc.

By Type	By Allergen Type	By Test Type	By Region
Diagnostics Therapeutics	Food Inhaled Drug Other Allergens	vivo Test vitro Test	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Allergy Diagnostics and Therapeutics Market, By Type:

• Diagnostics
• Therapeutics

• Allergy Diagnostics and Therapeutics Market, By Allergen Type:

• Food
• Inhaled
• Drug
• Other Allergens

• Allergy Diagnostics and Therapeutics Market, By Test Type:

• vivo Test
• vitro Test

• Allergy Diagnostics and Therapeutics 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