Food Allergy - Market Insight, Epidemiology And Market Forecast - 2034

Key Highlights

The Food Allergen Labeling and Consumer Protection Act (FALCPA) require that food packaging identify any of the “Top 9” allergens—milk, eggs, peanuts, tree nuts, soy, wheat, fin fish, shellfish, and sesame—when present in a product. However, manufacturers are not obligated to disclose the use of highly refined oils derived from peanuts, tree nuts, or soy.

The high incidence of anaphylaxis and serious allergic reactions (SAR) among patients in the high-risk cohort underscores a significant unmet medical need. This is particularly concerning given the lack of approved preventive treatments for anaphylaxis in food allergy patients classified as high-risk.

Antihistamines, corticosteroids, and bronchodilators may also be used; however, it is essential to recognize that these medications do not treat anaphylaxis but rather serve as adjunctive therapies for managing anaphylaxis.

Epinephrine is the first-line medication for the treatment of anaphylaxis. Intramuscular (IM) or intravenous (IV) epinephrine should be administered, although the IM route is preferred, with injection placement in the lateral thigh. Intravenous administration is done in the inpatient setting with appropriate monitoring. Epinephrine administered via intranasal and sublingual routes is expected to change future epinephrine prescribing habits, as these options solve the issues of needle hesitancy, convenience, and bulkiness.

The current standard of care and effective management of food allergy involves avoiding the allergen and using an Adrenaline Auto-injector (AAI) in the event of an allergic reaction.

Currently, PALFORZIA (peanut allergen powder), XOLAIR (omalizumab), and NEFFY (epinephrine nasal spray) are the only approved medications offering important treatment options for patients with food allergies and healthcare providers. PALFORZIA is specifically approved for peanut allergy, while XOLAIR is approved for multiple allergens.

The evolving food allergy treatment landscape features clinical trials led by DBV Technologies (Viaskin [DBV712] Peanut Patch), Novartis (Remibrutinib), Aravax (PVX108), ALK-Abello (Sublingual Immunotherapy-Tablet), InnoUp Farma (INP20), Allergy Therapeutics (VLP Peanut), Intrommune Therapeutics (INT301), Regeneron Pharmaceuticals (Linvoseltamab + Dupilumab), RAPT Therapeutics (RPT904), and others.

In March 2025, DBV Technologies reached an understanding with the US Food and Drug Administration (FDA) based on written responses to its Type D Investigational New Drug (IND) meeting request. The FDA concurred with DBV’s proposal that safety exposure data from the VITESSE Phase III study of the Viaskin Peanut Patch in children aged 4–7 years would be sufficient to support BLA filing for this age group, thereby accelerating the anticipated timeline for BLA submission to the first half of 2026.

The FDA approved OMLYCLO (omalizumab-igec) in March 2025 as the first and only biosimilar interchangeable with XOLAIR for IgE-mediated food allergies, potentially increasing treatment accessibility and fostering greater market competition.

Due to PALFORZIA’s slow uptake and Viaskin Peanut’s favorable safety, efficacy, and ease of use, the patch is expected to become a leading noninvasive treatment after its anticipated early 2027 launch. The company had anticipated the Biologics License Application (BLA) submission for age group 4–7 is planned for the first half of 2026, with a submission for ages 1–3 to follow in the second half of the year.

DelveInsight's ‘Food Allergy – Market Insights, Epidemiology and Market Forecast – 2034’ report delivers an in-depth understanding of the food allergy, historical and forecasted epidemiology as well as the food allergy market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The food allergy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM food allergy market size from 2020 to 2034. The report also covers current food allergy treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

The United States

EU4 (Germany, France, Italy, and Spain) and the United Kingdom

Japan

Study Period: 2020–2034

Food Allergy Understanding and Treatment Algorithm

Food Allergy Overview

Food allergy is defined as an immune reaction to proteins in the food and can be Immunoglobulin (Ig) IgE-mediated or non-IgE-mediated. IgE-mediated food allergy is a worldwide health problem that affects millions of people and numerous aspects of a person’s life. Any food can cause an allergy, but overall, only a few foods account for the vast majority of allergies. This includes milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Allergic reactions can affect the skin, gastrointestinal, cardiovascular, and respiratory systems, with symptoms like hives, vomiting, coughing, wheezing, throat tightness, tongue swelling, weak pulse, dizziness, and in severe cases, life-threatening anaphylaxis. Multiple symptoms may occur simultaneously across different body systems. There is currently insufficient evidence to support a protective effect of the early introduction of allergenic foods other than peanut and egg. Although it is plausible that similar mechanisms of protection may be present for other foods, such as tree nuts, it is also possible that different “windows of opportunity” exist for different foods. One notable example is cow’s milk, with a recent RCT showing a reduction in cow’s milk allergy at age 6 months with daily cow’s milk formula ingestion from 1-month to 2 months of age compared with cow’s milk avoidance during this early life period.

Food Allergy Diagnosis

Patients with food allergies, especially those with asthma, a history of severe reactions, or allergies to peanuts, nuts, seeds, or seafood, should carry self-injectable epinephrine and have a written emergency plan. Diagnosis involves in vivo methods such as skin-prick tests and allergy blood tests, which measure allergen-specific IgE levels. Intradermal testing is not recommended due to its high risk of false positives and severe reactions, while Atopy Patch Tests (APTs) may be helpful in specific cases like eosinophilic esophagitis. The oral food challenge remains the gold standard for confirming food allergies. In vitro testing, including sIgE blood tests like RadioAllergoSorbent Test (RAST) and Fluorescence Enzyme ImmunoAssay (FEIA), is useful when skin tests are not feasible. The advanced AllerScan test improves accuracy by detecting IgE reactivity to specific allergenic epitopes for precise food and environmental allergy profiling.

The differential diagnosis of food allergy includes several conditions that may present with similar gastrointestinal or systemic symptoms. These include factitious disorder, esophagitis and esophageal motility disorders, giardiasis, gastroesophageal reflux disease (GERD), and irritable bowel syndrome (IBS). Other potential mimickers are bacterial or viral gastroenteritis, lactose intolerance, and rare conditions like Whipple disease. Careful clinical evaluation and appropriate testing are essential to distinguish true food allergies from these other disorders.

Further details are provided in the report.

Food Allergy Treatment

Food allergy treatment research focuses on immunotherapy and antibody-based therapies. Immunotherapy includes oral, sublingual, and epicutaneous methods to build tolerance by gradually exposing patients to allergens, with promising results especially for peanut allergies. Antibody treatments involve lab-made antibodies like tezepelumab (blocking immune signaling) and omalizumab (binding to IgE to prevent allergic reactions). The monoclonal antibody dupilumab targets IL-4Ra, reducing allergic inflammation and is FDA-approved for several allergic conditions. Researchers also explore anti-alarmin therapies targeting cytokines like TSLP, IL-25, and IL-33. Recently, the FDA approved XOLAIR (omalizumab) to reduce allergic reactions and anaphylaxis risk in children and adults with IgE-mediated food allergies after accidental exposure.

Further details related to treatment will be provided in the report…

Food Allergy Epidemiology

As the market is derived using a patient-based model, the food allergy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented total diagnosed prevalent cases of food allergy, allergen-specific diagnosed prevalent cases of food allergy, gender-specific diagnosed prevalent cases of food allergy, and severity-specific diagnosed prevalent cases of food allergy in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

The total number of diagnosed prevalent cases of food allergy in the 7MM ranges from approximately 60,276,500 in 2024.

Among the gender-specific contribution, male had the highest occurrence of cases from ~19,309,000 in 2024 in the US.

In EU4 and the UK, maximum cases of food allergy were in Spain with ~5,775,500, whereas the minimum number of cases were in France in 2024.

The total number of diagnosed prevalent cases of food allergy in Japan were ~2,669,600 in 2024.

In 2024, within the 7MM, on the basis of severity in adults, the number of food allergy cases was more in severe; 24,979,000 then mild to moderate. These numbers are expected to rise by 2034.

In 2024, shellfish allergy was the most common type of food allergy in the US with the highest number of cases; 8,549,100.

Food Allergy Drug Chapters

The drug chapter segment of the Food Allergy report encloses a detailed analysis of food allergy marketed drugs and late-stage (Phase III, Phase II/III, Phase II, Phase I/II, and Phase I) pipeline drugs. The marketed drugs segment encloses drugs such as XOLAIR (Roche and Novartis), NEFFY/EURNEFFY (ARS Pharmaceuticals, ALK-Abelló, and Alfresa Pharma), and PALFORZIA (Stallergenes Greer), among others. It also helps understand the food allergy clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

PALFORZIA (peanut allergen powder-dnfp): Stallergenes Greer

PALFORZIA is an oral immunotherapy treatment indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts for patients. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS.

PALFORZIA is the first, and only US FDA-approved OIT for the mitigation of allergic reactions, including anaphylaxis that may occur with accidental exposure to peanuts for patients ages 1–17 years. In February 2025, Stallergenes Greer launched PALFORZIA in the US to treat toddler patients, ages 1–3 years, with a confirmed diagnosis of peanut allergy.

In December 2020, the European Medicines Agency (EMA) approved PALFORZIA for treating peanut allergy in patients aged 4–17 and those who become adults during treatment, and in January 2025, the European Commission extended its indication to include toddlers aged 1–3 across all 27 EU member states and the three European Economic Area countries (Iceland, Liechtenstein, and Norway).

XOLAIR (omalizumab): Roche and Novartis

XOLAIR is an FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. XOLAIR is given as an injection under the skin, either by a healthcare provider or at home through self-injection (after initiating treatment in a healthcare setting). XOLAIR’s primary patents have expired, and the formulation patent will expire in the US in late 2025 (November 2025).

In February 2024, the FDA approved XOLAIR for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.

PALFORZIA

(peanut allergen powder-dnfp) Stallergenes Greer Oral Slowly reduces the immune system's robust anaphylactic response, allowing for greater tolerance to peanuts 2020

Emerging Drugs

Viaskin (DBV712) peanut patch: DBV Technologies

Viaskin Peanut is an Epicutaneous Immunotherapy (EPIT) that delivers small amounts of peanut protein through a wearable patch to induce desensitization. It is currently being investigated in the Phare III trial for the treatment of peanut allergy in young children.

In December 2024, DBV Technologies announced successful FDA communication outlining a clear regulatory pathway and formalized guidance for accelerated approval of the Viaskin Peanut Patch in toddlers aged 1–3 years.

PVX108: Aravax

PVX108 is an advanced immunotherapy designed to re-train the immune system by administering engineered peptides to precisely target T cells and reverse the course of allergic disease. Unlike most treatments available or under development for peanut allergy, PVX108 does not contain peanut proteins, which puts patients at significant risk of serious side effects, which leads to complex and burdensome dosing regimens.

As per the news released in October 2024, Aravax anticipates headline results of Phase II PVX108 for treating patients aged between 4 and 17 years with peanut allergy in H1 2026.

Drug Class Insights

Bruton's Tyrosine Kinase (BTK) inhibitors

BTK inhibitors target a crucial enzyme involved in the activation of immune cells like B cells, mast cells, and basophils that drive allergic reactions. By blocking BTK, these inhibitors prevent the signaling pathways that lead to the release of histamine and other inflammatory mediators responsible for allergy symptoms. This reduces the severity of immune responses to food allergens, helping to prevent or minimize reactions such as anaphylaxis. BTK inhibitors are being studied as a promising new treatment to improve safety and control in managing food allergies by directly modulating the underlying immune mechanisms.

Anti-IgE Therapy

Anti-IgE therapy works by targeting and neutralizing Immunoglobulin E (IgE), the antibody responsible for triggering allergic reactions. By binding to free IgE in the bloodstream, anti-IgE treatments prevent IgE from attaching to immune cells like mast cells and basophils. This stops these cells from releasing histamine and other chemicals that cause allergy symptoms, reducing the severity and frequency of allergic reactions.

Desensitization

Desensitization refers to the process of gradually exposing the immune system to increasing amounts of an allergen to shift the response from allergic to protective. Over time, this exposure retrains the immune system to tolerate the allergen without triggering a harmful reaction. Desensitization raises the threshold for allergic responses, lowering the risk of severe reactions such as anaphylaxis and improving patients’ quality of life.

Food Allergy Market Outlook

Currently, approved treatment options include immunotherapy, such as oral dose escalation of allergenic food proteins or a branded peanut allergen powder, and biologic therapy like XOLAIR, which is administered via subcutaneous injection. While desensitization-based food allergen-specific immunotherapies involving other modes of administration are in development, such as SLIT or EPIT, these are not yet approved or commercially available.

The food allergy treatment market is undergoing a significant transformation, driven by rising prevalence, increasing awareness, and advances in therapeutic approaches. Historically, management has relied heavily on strict allergen avoidance and emergency interventions, particularly the use of epinephrine autoinjectors such as EpiPen, Auvi-Q, and Adrenaclick. These interventions, though life-saving, do not address the underlying immune response and are primarily designed for acute management rather than long-term treatment.

Currently, the only approved medications providing significant treatment options for food allergy patients and healthcare providers are PALFORZIA (peanut allergen powder), XOLAIR (omalizumab), and NEFFY (epinephrine nasal spray). PALFORZIA is specifically approved to treat peanut allergy, whereas XOLAIR is approved for use with multiple allergens.

In addition to approved therapies, several key players are actively involved in the development of food allergy treatments, indicating strong momentum in the field. These include DBV Technologies (Viaskin), Novartis (Remibrutinib), Aravax (PVX108), ALK-Abelló (SLIT-tablet), Allergy Therapeutics (VLP Peanut), and RAPT Therapeutics (RPT904). This growing pipeline underscores the expanding therapeutic landscape and increasing efforts to address the unmet needs in food allergy management.

The food allergy treatment market is growing steadily, driven by the increasing use of biologics, improved diagnosis, and rising awareness. The US accounts for the largest market size of chronic food allergy, in comparison toEU4 and the UK (Germany, France, Italy, the UK, and Spain) and Japan.

Among the 7MM, the US accounted for the largest market size of food allergy. i.e., USD ~2,420 million in 2024.

Among EU4 and the UK, Spain accounted for the highest market size in 2024, while France occupied the lowest.

In 2024, among all the current therapies for food allergy, the highest revenue was generated by Epinephrine, i.e., nearly USD 1,420 million in the US.

By 2034, it is estimated that ANAPHYLM will secure the largest market size among the emerging therapies in the 7MM.

Key Updates

In March 2025, the US FDA approved NEFFY for the treatment of Type I allergic reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to <30 kgs (33 to <66 lbs). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in >35 years.

In March 2025, DBV Technologies reached an understanding with the US FDA based on written replies to its Type D IND meeting request. The FDA concurred with DBV’s proposal that safety exposure data from the VITESSE Phase III study of the Viaskin Peanut Patch in children aged 4–7 years would be sufficient to support BLA filing for this age group, thereby accelerating the anticipated timeline for BLA submission to the first half of 2026.

In January 2025, ARS Pharmaceuticals announced that the company has filed for approval of NEFFY 2 mg in Canada and the United Kingdom, where it will be marketed as EURNEFFY for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh =30 kg (66 lbs).

In January 2025, Regeneron Pharmaceuticals presented initial data from the first patient in the proof-of-concept study of linvoseltamab in combination with DUPIXENT for severe food allergy at the J.P. Morgan Healthcare Conference.

Further details will be provided in the report….

Food Allergy Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034. The analysis covers the food allergy market's uptake by drugs, patient uptake by therapy, and sales of each drug.

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034. The landscape of food allergy treatment has experienced a profound transformation with the uptake of novel medicines. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, professionals, and the entire healthcare community in their tireless pursuit of advancing care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Further details will be provided in the report….

Food Allergy Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, Phase I/II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities. The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for food allergy emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SME's opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the food allergy evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and Others.

DelveInsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as Johns Hopkins University, Stanford University, and King’s College London were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or food allergy market trends. This will support clients in potential upcoming novel treatments by identifying the overall market scenario and unmet needs.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats are identified in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies. These pointers are based on the analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint analysis evaluates multiple approved and emerging therapies based on relevant attributes, including safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The analyst evaluates multiple emerging therapies based on relevant attributes, including safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial’s primary and secondary outcome measures are evaluated.

Furthermore, the safety of the therapies is evaluated, with a focus on acceptability, tolerability, and adverse events, which provide a clear understanding of the side effects posed by the drug in the trials. Additionally, the scoring is based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The United States

PALFORZIA

PALFORZIA Support Program

This program helps answer the patients’ questions about

Accessing PALFORZIA

Insurance coverage

Financial assistance option

Co-pay Savings Program

Commercially insured patients who meet eligibility criteria may

Receive help with out-of-pocket costs for PALFORZIA.

Pay as little as USD 20 per month, with a maximum benefit of USD 6,200 per calendar year.

Patient Assistance Program (PAP)

Uninsured patients or patients whose insurance does not cover PALFORZIA may

Receive PALFORZIA at no cost if they meet specific eligibility and financial criteria.

Further detailed analysis will be provided in the report…

Scope of the Report

The report covers a segment of key events, an executive summary, and a descriptive overview of food allergy, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.

Comprehensive insights have been provided into the epidemiology segments and forecasts, as well as the future growth potential of the diagnosis rate and disease progression along treatment guidelines.

Additionally, an all-inclusive account of both current and emerging therapies, along with elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.

A detailed review of the food allergy market, including historical and forecasted market size, market share by therapy, detailed assumptions, and the rationale behind our approach, is included in the report, covering the 7MM drug outreach.

The report provides an edge in developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journeys, and treatment preferences, which help shape and drive the 7MM food allergy market.

Food Allergy Report Insights

Patient population

Therapeutic approaches

Food allergy pipeline analysis

Food allergy market size and trends

Existing and future market opportunity

Food Allergy Report Key Strengths

Ten-year forecast

7MM coverage

Food allergy epidemiology segmentation

Key cross competition

Highly analyzed market

Drug uptake

Food Allergy Report Assessment

Current treatment practices

Unmet needs

Pipeline product profiles

Market attractiveness

Qualitative analysis (SWOT and conjoint analysis)

FAQs

What was the food allergy market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like by 2034? What are the contributing factors for this growth?

What are the pricing variations among different geographies for approved therapies?

What can be the future treatment paradigm for food allergy?

What are the disease risks, burdens, and unmet needs of food allergy? What will be the growth opportunities across the 7MM concerning the patient population with food allergies?

Who is the major competitor of statins in the market, and how will the competitors affect their market share?

What are the current options for the treatment of food allergy? What are the current guidelines for treating food allergies in the US, Europe, and Japan?

What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?

Reasons to Buy

The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the food allergy market.

Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.

Understand the existing market opportunities in varying geographies and the growth potential over the coming years.

Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.

Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.

Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.

To understand KOLs’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.

Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy. Show more