The global Food Allergy Immunotherapy Market is projected to grow from USD 99.7 million in 2025 to USD 249.3 million by 2035, reflecting an incremental gain of USD 149.6 million and a compound annual growth rate (CAGR) of 8.1%. This expansion underscores a decade of accelerated innovation, regulatory approvals, and increasing patient adoption of novel allergy treatments.
Market Growth and Industry Momentum
Between 2025 and 2030, the market is expected to surge by USD 57.9 million, accounting for over 63% of decade growth, fueled by heightened awareness of food allergies, improved diagnostics, and integration of immunotherapy into clinical pathways. From 2030 to 2035, the market is set to add another USD 91.6 million, marking a phase of consolidation, product diversification, and broader patient access.
Key drivers include the growing prevalence of pediatric food allergies, expanding regulatory support, and demand for proactive, disease-modifying therapies that go beyond avoidance and emergency interventions.
Leading Products and Segment Performance
The market remains heavily dominated by PALFORZIA, the first FDA- and EMA-approved oral immunotherapy for peanut allergy, projected to hold 82.7% market share in 2025. PALFORZIA has set the benchmark for oral immunotherapy (OIT), offering structured desensitization programs that reduce the risk of severe allergic reactions.
Meanwhile, Genentech’s XOLAIR (omalizumab) is expected to capture 22% market share by the end of the decade, particularly in combination therapies designed to enhance the safety and efficacy of OIT.
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Among allergen types, peanut allergy treatments account for 84.5% of the market in 2025, reflecting both the high prevalence of peanut allergies and the severity of associated risks. Other allergens such as milk, eggs, and wheat are gaining clinical attention, with multiple pipeline therapies advancing through trials.
Regional Outlook and Global Expansion
North America and Europe remain the largest growth regions, supported by strong clinical adoption and favorable reimbursement structures.
- United States: Forecast CAGR of 7.5%, backed by early FDA approvals, high allergy prevalence among children, and strong parental demand.
- Europe: Expected CAGR of 9.1%, led by Germany (8.6%), UK (8.5%), and France (8.1%), where national healthcare systems are integrating early-stage immunotherapy trials.
- Asia Pacific: Emerging opportunities in China (6.0% CAGR) and India (6.1% CAGR), where pediatric allergy diagnosis is increasing and telehealth-enabled care models are gaining traction.
- Japan and South Korea are also advancing early-stage OIT programs, leveraging robust pediatric care infrastructure and digital health platforms.
Competitive Landscape
The market is highly consolidated, led by Stallergenes Greer (PALFORZIA) with nearly 79% global market share in 2025. The company benefits from deep clinical trial data, established pediatric allergy networks, and expanded regulatory approvals—including the recent European Commission authorization of PALFORZIA for children aged one to three years.
Genentech (Roche/Novartis) is positioning XOLAIR as a key adjunct therapy, with the FDA’s February 2024 approval expanding its use for food allergy management in patients as young as one year old. This approval signals growing confidence in biologic therapies as part of integrated allergy management.
Industry Trends Shaping the Next Decade
Several trends are expected to define the food allergy immunotherapy market between 2025 and 2035:
- Integration of Digital Health: Remote monitoring, adherence apps, and tele-allergy consults are improving patient safety and treatment adherence.
- Personalized Immunotherapy: Precision dosing models and real-world immunologic data are enhancing clinical outcomes.
- Shift Toward Pediatric Adoption: Earlier treatment approvals (ages 1–3) mark a pivotal shift in allergy prevention and long-term management.
- Expansion Beyond Peanuts: Increasing focus on egg, milk, and multi-allergen therapies is diversifying the pipeline.
- Globalization of Clinical Trials: Rising participation in Asia and Latin America reflects expanding recognition of food allergies as a global health concern.
Why the Market is Growing
Food allergies affect millions worldwide, with prevalence rising particularly in children. Traditional management—strict avoidance and emergency epinephrine—does not address the root cause or reduce long-term risk. Immunotherapies like OIT and biologics represent a proactive, disease-modifying approach, offering families greater safety and quality of life.
Moreover, advocacy-led awareness campaigns, school-based safety initiatives, and regulatory prioritization of allergy care are accelerating clinical acceptance and investment in the sector.
Outlook
With an expanding ecosystem of innovative therapies, digital health integration, and strong regulatory momentum, the Food Allergy Immunotherapy Market is positioned for robust growth through 2035. As PALFORZIA sets the commercial standard and biologics like XOLAIR gain traction, competition is expected to intensify, spurring continued R&D investment.
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