U.S. Allergy Diagnostics & Therapeutics Market (2025 - 2030)

Market Size & Trends

The U.S. allergy diagnostics & therapeutics market size was valued at USD 10.86 billion in 2024 and is projected to grow at a CAGR of 6.8% from 2025 to 2030. The market is driven by the increasing prevalence of allergies among the population, and environmental factors such as increased pollution and lifestyle changes boost the demand for advanced solutions. The U.S. allergy diagnostics & therapeutics industry has witnessed a shift toward precision diagnostics. This evolution is fueled by groundbreaking innovations in molecular allergology and the widespread adoption of digital health tools.

Companies are actively expanding their allergy test portfolios, focusing on multiplex assays that enable the simultaneous detection of numerous allergens from a single patient sample. Furthermore, these diagnostic platforms are increasingly designed for seamless integration with Electronic Health Records (EHRs), a critical advancement that facilitates comprehensive patient data management and enhances clinical decision-making.

The industry is characterized by a high degree of innovation driven by ongoing research, technological advancements, and the development of more effective diagnostics and treatment options. In April 2025, Beckman Coulter Life Sciences announced the launch of its Next-Generation Basophil Activation Test (BAT). It is only for research purposes to expedite and improve allergy research.

The U.S. allergy diagnostics & therapeutics industry is also characterized by many new launches, strategic collaborations, and acquisitions among key players, emphasizing enhancing diagnostic accuracy and therapeutic efficacy. In January 2024, Inimmune Corporation and Intrommune Therapeutics announced a strategic partnership to develop a groundbreaking oral mucosal immunotherapy for peanut allergy.

Type Insights

The therapeutics segment accounted for the largest share, 81.3%, in 2024. Therapeutics aim to alleviate symptoms and provide relief from allergies, addressing patients' core concerns. The increasing prevalence of allergies drive the market growth. According to a CDC report, in 2021, 25.7% of adults in the U.S. were affected by seasonal allergies, while 6.2% reported food allergies.

The diagnostics segment is anticipated to witness the fastest CAGR of 10.16%over the forecast period due to demand for early detection and diagnosis of allergies, which is critical for effective management and treatment.In October 2024, ALK launched FDA-approved allergy skin testing devices and allergen trays in the U.S., featuring innovative, ergonomic designs for increased accuracy, patient comfort, and contamination prevention, enhancing allergy diagnosis and clinical efficiency.

Allergen Type Insights

The inhaled segment dominated the market in 2024. The U.S. has a significant prevalence of respiratory allergies, driving the segment growth. According to the Allergy & Asthma Network, in the U.S., two-thirds of asthma patients have environmental allergies due to poor air quality. In this population, boys (11%) are more prone to respiratory allergies than girls.

The food segment is anticipated to grow at the fastest CAGR over the forecast years. According to an IFIC study, in April 2025, food allergies affect 6.2% of adults and 5.8% of children in the U.S., with over half of Americans (53%) impacted by allergies, intolerances, or sensitivities, emphasizing the need for clear labeling and safety measures.

Test Type Insights

The in vitro segment held the largest market share of the U.S. allergy diagnostics & therapeutics industry in 2024. This test is utilized for identifying allergen-specific immunoglobulin E. (IgE). Serum IgE has a higher positive predictive value and better specificity for detecting aeroallergen (pollen & insect) sensitization. These factors can significantly impact allergy diagnostics market penetration during the forecast period.

The in vivo test segment is estimated to grow at a lucrative CAGR over the forecast period. This can be attributed to speed, cost-effectiveness, and clinical reliability of in-vivo test . These tests are widely adopted in outpatient and point-of-care settings, where immediate results and workflow efficiency are critical.

Key U.S. Allergy Diagnostics & Therapeutics Company Insights

Some of the key players in the U.S. allergy diagnostics & therapeutics industry include Thermo Fisher Scientific Inc.; Stallergenes Greer; and HYCOR Biomedical. Key players are involved in strategic initiatives such as new product launches, collaborations, and acquisitions to enhance their market shares.

• Thermo Fisher Scientific is a major life sciences company focused on improving health, environmental safety, and public welfare. It offers both cutting-edge technologies and pharmaceutical services.

• Stallergenes Greer is a biopharmaceutical company specializing in Allergen Immunotherapy (AIT) for respiratory and food allergies. The company offers innovative, safe, and effective diagnostic tools and treatments, including subcutaneous, sublingual, and oral immunotherapies.

Recent Developments

• In February 2025, Stallergenes Greer announced the U.S. launch of Palforzia for children aged 1 to 3 years with peanut allergy. This FDA-approved oral immunotherapy offers early intervention, aiming to reduce allergic reactions and improve the quality of life for pediatric patients.

• In February 2024, the FDA approved Xolair (omalizumab) in the U.S. for reducing allergic reactions to multiple foods in adults and children aged 1 and over.

• In May 2023, Thermo Fisher Scientific expanded access to ImmunoCAP allergy testing across the U.S. by partnering with Kroger Health. These tests are now available at Kroger’s Little Clinic locations.

U.S. Allergy Diagnostics & Therapeutics Market