Allergy Diagnostics and Therapeutics Market

The global Allergy Diagnostics and Therapeutics Market is valued at USD 36.32 Billion in 2024 and is projected to reach a value of USD 71.32 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 6.4% between 2025 and 2035.

The Allergy Diagnostics and Therapeutics market is driven by the increasing prevalence of allergy disorders among children and the elderly, the growing adoption of in vitro diagnostic (IVD) techniques, and improved access to diagnostic tools in developing countries within the Asia-Pacific region. The rising incidence of allergy disorders is caused by factors including changing lifestyles, increased pollution, bad habits like smoking, and fast urbanization. The introduction of innovative therapeutic medications, such as immunotherapy, is anticipated to address unmet patient demands and propel market expansion throughout the 2024-2032.

Key Highlights

• In 2024, by Type, Therapeutics segment dominated with the market share of 82.1%, owing to the rising prevalence of allergic conditions and the growing demand for effective treatment options such as immunotherapies and biologics
• By Allergen Type, Inhaled dominated the market in 2024 with significant market share of 50.1% due to the high incidence of respiratory allergies, such as allergic rhinitis and asthma, triggered by airborne allergens like pollen, dust mites, and mold
• In 2024, In vitro Test dominated the Test Type segment with 52.2% market share because of their accuracy, reliability, and ability to detect specific IgE antibodies to various allergens
• In 2024, North America led the market, capturing 37.1% market share due to the regions advanced healthcare infrastructure, high prevalence of allergic diseases, and substantial investments in research and development

Type Overview

By Type, the market is segmented into Diagnostics and Therapeutics. In 2024, the Therapeutics segment dominated the market with the largest share of 82.1%. Therapeutics addresses patients' major concerns by focusing on alleviating symptoms and allergy relief. Epinephrine category dominated under therapeutics due to its quick and potent actions in treating severe allergic reactions, like anaphylaxis. Epinephrine is a hormone that is found naturally that replicates the bodys fight-or-flight reaction, rapidly relieving symptoms including low blood pressure and respiratory distress. Its extensive record of usage, affordability, and accessibility all contribute to its market dominance. It is a vital and reliable tool for treating allergies in an emergency.

Allergen Type Overview

By Allergen Type, the market is segmented into Food, Inhaled, Drug and Other Allergens. In 2024, the Inhaled segment dominated the market with 50.1% market share. Inhaled allergies, the most prevalent type of allergy, are triggered by various airborne pollutants both indoors and outdoors. Seasonal inhalant allergies, commonly referred to as hay fever, are widespread, with outdoor allergens including pollen, mold spores, fungi, and dust, and indoor allergens comprising animal dander, dust mites, and fragrances. For instance, according to a study, the global prevalence of chronic obstructive pulmonary disorder (COPD) is anticipated to reach nearly 600 million cases worldwide by 2050. Furthermore, strategic initiatives by key market players, such as Oncologicas launch of Allergyfocus in June 2022—a comprehensive antibody allergy test detecting 99% of common global allergies—are expected to enhance the demand for advanced diagnostic devices.

Regional Overview

North America Dominated Sales with a 37.1% share in 2024. North America’s dominance is largely attributed to the regions advanced healthcare infrastructure, high awareness of allergic conditions, and significant investments in R&D. The prevalence of allergic diseases, such as asthma, allergic rhinitis, and food allergies, is notably high in North America, driving the demand for both diagnostic tools and therapeutic solutions. The regions growth is also fueled by the rising incidence of conditions like chronic obstructive pulmonary disease (COPD), emphysema, and chronic bronchitis. For instance, a December 2022 CDC update revealed that, 4.6% of adults had been diagnosed with COPD, emphysema, or chronic bronchitis, leading to 791,000 emergency department visits primarily due to COPD. The growing number of COPD cases is directly linked to an increased demand for allergy diagnostic devices, further boosting market growth.

The North American market is also being propelled by a surge in company activities and product approvals, which are expected to drive expansion during the forecast period. For instance, in August 2022, the FDA approved Thermo Fisher’s ImmunoCAP Specific IgE (sIgE) Allergen Components for wheat and sesame allergies for in vitro diagnostic use, enabling healthcare providers to identify these allergies in at-risk patients. Additionally, the collaboration between RxCap, Inc. and ZEPHYRx LLC in September 2022 to integrate remote monitoring platforms highlights the increasing focus on monitoring lung function in patients with serious pulmonary conditions.

U.S. Overview

The U.S. Allergy Diagnostics and Therapeutics market was valued at approximately USD 11.6 billion in 2024 and is projected to grow to around USD 23.67 billion by 2035, with a compound annual growth rate (CAGR) of 6.4% from 2025 to 2035. The markets substantial size is fueled by rising awareness and improved diagnostic tools, as well as the high prevalence of allergies and related conditions such food allergies, asthma, and allergic rhinitis. For instance, according to statistics published by the According to the World Health Organization (WHO) in January 2023, approximately 25% of children and 33% of adults in the U.S. experience seasonal allergies. Additionally, around 6% of both children and adults in the U.S. are affected by food allergies, with the prevalence being notably higher among Black, Asian, and Hispanic populations. The substantial expansion of the market is attributed to the presence of significant players in the industry as well as ongoing advances in therapeutic treatments and diagnostic technologies. This includes the development of novel treatment options like immunotherapy and improvements in molecular diagnostics, which are transforming the countrys approach to allergy management.

Top Trends

• Advancements in Molecular Diagnostics: The market is witnessing a significant shift towards molecular allergy diagnostics, which offer higher precision in identifying specific allergens.
• Growing Adoption of Immunotherapy: The ongoing research and development of novel immunotherapy products, including biologics, are driving the trend, offering patients more effective and targeted treatment options.
• Increased Focus on Food Allergy Diagnostics: The rising incidence of food allergies, particularly among children, has led to a growing focus on developing accurate and reliable food allergy diagnostics.
• Regulatory Support and Approvals: There is an increasing number of regulatory approvals for new allergy diagnostics and therapeutics, reflecting the ongoing innovation in the market.

Premium Insights

Track market trends LIVE & outsmart rivals with our Premium Data Intel Tool: Vantage Point

Market Dynamics

Rising prevalence of allergies drives the Allergy Diagnostics and Therapeutics market

The global prevalence of allergic diseases, including asthma, allergic rhinitis, and food allergies rising over the decade, driven by various factors such as environmental changes, urbanization, and lifestyle modifications. This rise in allergy diseases has been attributed to dietary changes, pollution, and increased exposure to allergens, especially in urban areas. To detect these allergies early and treat them successfully, there is a rising need for precise and reliable diagnostic instruments. The need for advanced tools for diagnosis that accurately detect certain allergens, including molecular allergy diagnostics and immunoassays, is growing due to the rise in allergic illnesses.

High costs of diagnostic tests and treatments hinder the market growth

Allergy diagnostic methods, like skin prick tests, particular IgE tests, and molecular diagnostics, frequently cost more since they need specialized tools and competent technicians. Furthermore, many patients do noy have health insurance so they are not be able to afford the expense of allergy therapies, such as immunotherapy, biologics, and customized medicine. In developing countries, where healthcare infrastructure may be less advanced, the affordability of these diagnostic and therapeutic options is a major concern, limiting access to effective allergy management. This cost barrier can lead to delayed diagnosis and treatment, exacerbating the burden of allergic diseases and potentially leading to more severe health outcomes.

Development of personalized allergy therapies offers significant opportunities for the development of tailored allergy treatments

The treatment plans for personalized allergy therapies are made according to each patients unique immunological response, genetic composition, and allergy profile. Healthcare practitioners can customize immunotherapy or biologic treatments to each patients unique needs by using data from genomics and proteomics, for instance, to identify individuals who are more likely to respond to specific medications. The development of such customized medicines improves treatment efficacy and lowers the possibility of side effects, making it a more appealing choice for patients as well as healthcare providers.

Competitive Landscape

The competitive landscape of the Allergy Diagnostics and Therapeutics market is marked by intense competition among key players who are focusing on strategic collaborations, licensing agreements, and product innovations to enhance their market presence. Companies like ALK, Thermo Fisher Scientific, Astria Therapeutics, and Aimmune Therapeutics are leading the market with FDA-approved treatments and advanced diagnostic tests, addressing a wide range of allergic conditions. These players are also expanding their product portfolios and geographic reach, aiming to meet the growing demand for effective allergy management solutions globally. The market is further driven by advancements in immunotherapy, personalized medicine, and the increasing prevalence of allergies, which is prompting continuous investment in research and development.

The key players in the global Allergy Diagnostics and Therapeutics market include - Thermo Fisher Scientific Inc. among others.

Recent Market Developments

Astria Therapeutics and Inchon’s Sciences Sign License Agreement for STAR-0310 Development

• In October 2023, Astria Therapeutics, Inc. entered into a license agreement with Inchon’s Sciences to advance the development of STAR-0310 from the OX40 portfolio. This collaboration aims to explore its potential for treating atopic dermatitis (AD) and other allergic and immunological disorders

FDA Expands ALKs ODACTRA Approval for Adolescent Allergy Treatment

• In January 2023, ALK secured FDA approval to expand the use of ODACTRA, a sublingual immunotherapy tablet, for treating house dust mite-induced allergic rhinitis in adolescents aged 12 to 17

Allergy Partners Collaborates with Aimmune Therapeutics to Provide PALFORZIA for Peanut Allergy Patients

• In October 2022, Allergy Partners joined forces with Aimmune Therapeutics to offer patients aged 4 to 17 direct access to PALFORZIA, an FDA-approved treatment for peanut allergies. This treatment will be available through Allergy Partners Therapeutics (APT) across their national network

Thermo Fisher Scientifics ImmunoCAP Blood Tests for Wheat and Sesame Allergies Gain FDA Approval

• In August 2022, Thermo Fisher Scientific received FDA approval for its ImmunoCAP blood tests, designed to identify allergies to wheat and sesame. These in vitro diagnostic tests can distinguish between wheat sensitization and grass cross-reactivity, potentially helping many patients avoid unnecessary dietary restrictions

The global Allergy Diagnostics and Therapeutics market can be categorized as Type, Allergen Type, Test Type and Region.