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

The Global Allergy Diagnostics and Therapeutics Market is projected to expand from USD 36.33 Billion in 2025 to USD 57.62 Billion by 2031, reflecting a compound annual growth rate (CAGR) of 7.99%. This sector encompasses medical devices, assay kits, and pharmaceutical interventions designed to identify and manage hypersensitivity reactions to specific allergens. Market growth is primarily fueled by the increasing global prevalence of allergic conditions, such as allergic rhinitis and food allergies, which require distinct clinical management strategies. Additionally, rising urbanization and escalating pollution levels act as key drivers by intensifying exposure to environmental triggers, thereby widening the patient demographic in need of medical attention.

Despite these positive indicators, the market encounters significant obstacles due to the high costs associated with specific immunotherapy regimens and advanced diagnostic panels, which limit patient access in cost-sensitive developing nations. This financial hurdle is frequently exacerbated by insufficient reimbursement frameworks that slow the broad adoption of innovative treatments. Highlighting the magnitude of this public health challenge, the Asthma and Allergy Foundation of America reported in 2024 that allergic conditions impacted over 100 million individuals in the United States.

Market Drivers

The increasing adoption of immunotherapy and biologics serves as a major catalyst for market growth, marking a shift from symptomatic relief to disease-modifying strategies. Clinicians are frequently prescribing advanced treatments, such as oral and epicutaneous immunotherapy, which have proven highly effective in desensitizing patients to dangerous allergens. For example, the American College of Allergy, Asthma & Immunology revealed at its Annual Meeting in November 2025 that over 70% of toddlers treated with the Viaskin Peanut Patch achieved tolerance to specific peanut protein levels after three years. This clinical efficacy is driving commercial success, as evidenced by ALK-Abelló's November 2025 'Q3 2025 Outlook Update', which raised full-year revenue growth projections to 13-15% in local currencies due to higher patient volumes for immunotherapy products.

Concurrently, technological advancements in diagnostic methodologies are accelerating sector growth by improving the speed and accuracy of allergen detection. Innovations such as component-resolved diagnostics (CRD) and molecular diagnostics enable the precise identification of specific allergic proteins, thereby minimizing cross-reactivity issues common with traditional skin-prick tests. This evolution facilitates the demand for personalized management and precision medicine, allowing providers to identify sensitivities with granular detail. Demonstrating the economic significance of this segment, Thermo Fisher Scientific's '2024 Annual Report' from April 2025 noted that its Specialty Diagnostics business achieved $4.51 billion in revenue, underscoring the strong global investment in advanced diagnostic tools.

Market Challenges

The high costs associated with specific immunotherapy regimens and advanced diagnostic panels present a major restraint on the Global Allergy Diagnostics and Therapeutics Market. Although precision medicine is clinically necessary, the substantial financial requirements for long-term desensitization therapies and molecular diagnostic assays hinder market penetration, especially in price-sensitive economies. Consequently, healthcare providers and patients often resort to conventional symptomatic treatments, such as antihistamines, rather than pursuing curative interventions. This economic friction reduces the addressable patient population and retards the volume growth of novel therapeutics, thereby preventing the market from fully leveraging the rising global prevalence of allergies.

This financial obstacle is further compounded by inadequate reimbursement structures that frequently fail to offset the expenses of modern allergy management. When insurance providers restrict or deny coverage for component-resolved diagnostics or biologics, the resulting out-of-pocket costs become unmanageable for many patients. According to the European Academy of Allergy and Clinical Immunology, direct healthcare costs for allergic diseases in 2024 were estimated between €1,823 and €6,656 per patient annually. Such high per-capita expenses demonstrate why financial accessibility remains a critical bottleneck that directly limits revenue generation and obstructs the widespread adoption of advanced care solutions.

Market Trends

The emergence of wearable biosensors for real-time allergen detection is transforming preventative management by enabling consumers to identify dietary and environmental triggers outside clinical environments. Moving beyond reliance on product labeling, these portable devices employ electrochemical sensing or advanced molecular imprinted polymers to detect trace allergens in air and food, providing immediate assurance. The commercial potential of this innovation is highlighted by FoodBev Media's August 2024 report, 'Amulet secures $5.8m in Series A round to launch portable food allergen sensors', which notes that Amulet raised $5.8 million to scale technology allowing individuals to test for common allergens like gluten and peanuts on the go.

Additionally, the progression of microbiome-based therapeutic approaches signifies a shift toward treating the underlying dysbiosis responsible for allergic hypersensitivity, differing from traditional desensitization or symptomatic relief. This trend emphasizes live biotherapeutic products (LBPs) aimed at restoring gut microbial diversity to modulate immune responses and potentially halt the "atopic march" in early life. Illustrating significant investment in this area, BioSpace reported in March 2024, in the article 'Siolta Therapeutics Raises $12 Million in Series C Financing for Clinical Development', that the company secured $12 million to advance its lead candidate, STMC-103H, a defined-consortia biotherapeutic developed to prevent the onset of allergic diseases like food allergies and atopic dermatitis in newborns.

Key Players Profiled in the Allergy Diagnostics and Therapeutics Market

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

Report Scope

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

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

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Allergy Diagnostics and Therapeutics 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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