The U.S. allergy diagnostics and therapeutics market size was calculated at USD 10.88 billion in 2024 with projections indicating a rise from USD 11.63 billion in 2025 to approximately USD 21.20 billion by 2034, expanding at a CAGR of 6.9% from 2025 to 2034, a study published by Vision Research Reports.
The demand for personalized medicines with leverage of genetic testing and biomarker analysis has increased, driving the U.S. allergy diagnostics and therapeutics market.
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U.S. Allergy Diagnostics and Therapeutics Market Insights:
• By type, the therapeutics segment held the major market revenue of 82% in 2024.
• By type, the diagnostics segment is anticipated to grow at the notable CAGR of 10.17% between 2025 and 2034.
• By allergen type, the inhaled segment accounted for the major market share in 2024.
• By allergen type, the food segment will grow at a CAGR between 2025 and 2034.
• By test type, the in vitro segment contributed 55% of market revenue in 2024.
• By test type, the in vivo segment is expected to expand at a significant compound annual growth rate (CAGR) between 2025 and 2034.
U.S. Allergy Diagnostics and Therapeutics Market Market Overview & Industry Potential
The U.S. allergy diagnostic and therapeutic market is experiencing significant growth due to the expansion of the healthcare industry and an increased prevalence of allergies. The US has witnessed extreme growth in allergic reactions, including inhaled and food allergies. The growing innovations in early diagnosis technologies and advancements in both diagnostics and therapeutics are fostering the growth. Additionally, the growing adoption of precision diagnostics and digital health tools, as well as regulatory approval for novel innovations, are contributing to the market growth.
The U.S. healthcare has surged in the adoption of novel therapies and tools. The rising use of innovative technologies like electro-acupuncture and VEGA is enhancing measures of the body’s electromagnetic conductivity. Additionally, ongoing studies and their exploration in the use of anti-IgE therapies like omalizumab and Tezepelumab for minimizing nasal polyp severity in chronic rhinosinusitis are bringing significant innovations to the market.
What are the Major Trends of the U.S. Allergy Diagnostics and Therapeutics Market?
• Developments of Biologic Therapies: The growing innovations in the development of biologic therapeutics, like monoclonal antibodies targeting specific immune pathways for allergic responses, to enhancing the effectiveness of treatments for several allergies.
• Adoption of Digital Health Tools: The adoption of digital health tools has increased in U.S. healthcare to provide precision diagnostics, remote monitoring, and personalized medicines. The demand for digital tools integrated with EHRs has increased to enhance patient data management and decision-making capabilities.
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Which are the Major Growth factors of the U.S. Allergy Diagnostics and Therapeutics Market?
• Prevalence of Allergies: The U.S. is experiencing rapid growth in allergic prevalence, including asthma, allergic rhinitis, and atopic dermatitis, driving demand for novel and innovative diagnostics and therapeutics.
• Advancements in Diagnostic Technologies: The growing focus on diagnostic technology advancements like allergen microarrays, molecular diagnostics, and advanced immunoassays to improve diagnostic accuracy and efficiency, contributing to the market growth.
How is AI Benefiting the U.S. Allergy Diagnostics and Therapeutics Market?
AI is transforming the U.S. allergy diagnostics and therapeutics market, driven by extreme adoption of AI technology in the U.S. healthcare infrastructure. AI has proven its significant role in enhancing areas like diagnostic accuracy, personalized treatment strategies, and overall patient outcomes. AI enables extreme quality, high speed, early detection, and intervention. The real-time decision support provided by AI is shifting allergy diagnostics and therapeutics toward high success rates.
Pipelines in U.S. Allergy Diagnostics and Therapeutics:
|
Company |
Innovations |
Source |
|
Celldex Therapeutics, Inc. |
Showcased data for barzolvolimb to enhance angioedema at 52 weeks in the company's Phase 2 clinical trial in chronic spontaneous urticaria. |
|
|
Aquestive Therapeutics |
Showcased results from its pediatric study of Anaphylm sublingual film, demonstrating a consistent pharmacokinetic profile in children aged 7-17 years. The Anaphylm, including anaphylaxis, is expected to have its potential in early 2026. |
https://www.hcplive.com/view/allergy-month-in-review-april-2025
|
|
Stallergenes Greer |
Launched Palforzia for children aged 1 to 3years with a confirmed diagnosis of peanut allergy. This drug is the first and only oral immunotherapy FDA-approved designed to mitigate allergic reactions. |
|
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What are the Limitations & Challenges to the U.S. Allergy Diagnostics and Therapeutics Market?
• Limited Access to Testing and Specialist Care: Factors like high cost, regulatory challenges, limited treatment options, and reimbursement policies are hampering allergists’ access to advanced diagnostics and therapeutic solutions, leading to delays or prevention in proper care.
• High Cost: The high cost associated with development and manufacturing is making allergies more costly. Research and development accounting overall cost addition to allergy-associated diagnostics and therapeutics.
U.S. Allergy Diagnostics and Therapeutics Market Report Coverage
|
Report Attribute |
Key Statistics |
|
Market Size in 2025 |
USD 11.63 Billion |
|
Market Size in 2026 |
USD 12.43 Billion |
|
Market Size in 2030 |
USD 16.24 Billion |
|
Market Size in 2032 |
USD 18.55 Billion |
|
Market Size by 2034 |
USD 21.20 Billion |
|
Growth rate from 2025 to 2034 |
CAGR of 6.9% |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
Type, Allergen Type and Test Type |
|
Companies Covered |
Thermo Fisher Scientific Inc., Danaher Corporation (Beckman Coulter), Siemens Healthineers AG, bioMérieux SA, Omega Diagnostics Group PLC, Stallergenes Greer, Bio-Rad Laboratories, Inc., Astellas Pharma Inc., DBV Technologies,ALK-Abelló A/S |
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U.S. Allergy Diagnostics and Therapeutics Market Segment Analysis
Which Type Segment Dominated the U.S. Allergy Diagnostics and Therapeutics Market in 2024?
In 2024, the therapeutics segment dominated the market due to the increased prevalence of allergies and rising adoption of personalized medicines. The strong focus on treating allergies and providing relief is contributing to innovations and the development of novel therapeutics. Allergy therapeutics include antihistamines, decongestants, corticosteroids, mast cell stabilizers, leukotriene inhibitors, nasal anti-cholinergics, immunomodulators, epinephrine, and immunotherapies. Immunotherapy is the dominant sub-segment, driven by increasing emphasis on offering long-term relief. The ongoing developments of novel drugs, biologics, and targeted treatments are driving access to specialized treatment solutions.
The diagnostics segment is expected to grow fastest over the forecast period, driven by increased demand for early and accurate detection of allergies. The prevalence of allergies has increased in the U.S., and so has increased awareness about the importance of allergy testing. Advancements in diagnostics like skin prick tests, molecular diagnostics, and blood tests to detect specific allergen reactions are contributing to the segment's growth. Additionally, the introduction of novel diagnostic technologies like multiplex testing to enhance high-speed, reliable, and specialized results is gaining popularity in the U.S. market.
What Made Inhaled Allergy Type Lead the U.S. Allergy Diagnostics and Therapeutics Market in 2024?
The inhaled segment led the market in 2024, due to the increased prevalence of respiratory allergies like asthma and allergic rhinitis. The rising industrialization, air pollution, and continuous climate change are contributing to this growth. Allergen immunotherapy, like sublingual and subcutaneous options, is highly preferred for the respiratory allergies in the U.S. The major key market players like Thermo Fisher Scientific Inc. and Stallergenes Greer are driving continuous innovations and developments of novel and innovative diagnostics and therapeutics for inhaled allergies.
The food segment is the second-largest segment, leading the market, driven by high food allergies in the U.S. Food allergies are the major concern in the U.S, affecting children and adults. Food allergies have the potential to lead to severe reactions like life-threatening anaphylaxis, driving the need for accurate diagnosis and management solutions. The prevalence has increased the demand for accurate diagnostics and effective treatments. The awareness about food allergies and their symptoms is increasing among patients and healthcare providers, leading to a boost in the demand for innovative diagnostics and therapeutics.
How In Vitro Test Type Dominates the U.S. Allergy Diagnostics and Therapeutics Market?
The in vitro segment dominated the market in 2024, due to increased demand for precision diagnostics and personalized medicine approaches. The in vitro tests are suitable for patients with severe allergies and growing demand for personalized medicines. The in vitro test involves an IgE blood test, enzyme-linked immunosorbent assays (ELISA), and molecular diagnostics like polymerase chain reaction (PCR). The IgE blood test is leading the U.S. market due to its high ability to detect allergens, and allows targeted treatment plans. With growing innovations in this test, the segment is expected to witness more advancements like enhanced sensitivity and specificity.
The in vivo segment is expected to grow fastest over the forecast period, driven by increased demand for quick and more effective treatments. In vivo tests include, skin prick test, the intradermal test, and the patch test. The skin prick test and the intradermal tests are widely used in vivo tests for their speed, clinical efficacy, and cost-effectiveness. These tests are suitable for outpatient and point-of-care settings. The rising preference for blood tests, particularly in adult and aging populations, for rapid diagnostic results, is contributing to the growing adoption of in vivo tests.
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Which are the Key Players in the U.S. Allergy Diagnostics and Therapeutics Market?
• Danaher Corporation
• Thermo Fisher Scientific Inc.
• Omega Diagnostics group PLC
• bioMérieux SA
• siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Astellas Pharma Inc.
• DBV Technologies
• Stallergenes Greer
• ALK-Abello A/S
What are the Recent Developments in the U.S. Allergy Diagnostics and Therapeutics Market?
• In June 2025, AHN Medicine Institute, AHN Center for Asthma, Allergy, and Eosinophilic Lung Disease will launch today’s news advanced allergy and a stomach clinic in North Fayette, Pennsylvania. (Source: https://www.hcplive.com)
• In April 2025, Aquestive Therapeutics showcased its positive topline results from its pediatric study evaluating Anaphylm sublingual film for patients aged 7 to 17 years. The study involved children weighing over 30 kg with an allergic reaction history. (Source: https://www.contemporarypediatrics.com)
U.S. Allergy Diagnostics and Therapeutics Market Segment Covered in the Report
By Type
• Diagnostics
• Instruments
• Consumables
• Services
- Therapeutics
• Antihistamines
• Decongestants
• Corticosteroids
• Mast Cell Stabilizers
• Leukotriene Inhibitors
• Nasal Anti-Cholinergic
• Immuno-modulators
• Epinephrine
• Immunotherapy
By Allergen Type
• Food
• Dairy Products
• Poultry Product
• Tree nuts
• Peanuts
• Shellfish
• Wheat
• Soys
• Other Food Allergens
• Inhaled
• Drug
• Other Allergens
By Test Type
• In vivo test
• Skin Prick Test
• Intradermal Test
• Patch Test
• In vitro test
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