The peanut allergy treatment market is experiencing unprecedented growth momentum, with DelveInsight projecting a robust 16% compound annual growth rate through 2034. This expansion is fueled by the current usage of epinephrine, anticipated adoption of XOLAIR in adult patients, PALFORZIA's extension to toddler populations, and the expected market entry of innovative therapies like Viaskin Peanut patches.
According to DelveInsight's comprehensive market analysis, the peanut allergy market reached USD 400 million across seven major markets in 2024, with approximately 9.8 million diagnosed prevalent cases. However, significant treatment gaps persist, with only about 50% of the estimated 5.1 million affected individuals in the United States receiving appropriate therapy.
Current Treatment Landscape Shows Mixed Adoption
The treatment landscape currently features two approved therapies with varying market penetration. PALFORZIA, the oral immunotherapy option, has experienced limited uptake due to modest clinical benefits compared to standard peanut avoidance strategies, with minimal demonstrated impact on reducing allergic reactions. Following PALFORZIA's initial approval, Roche and Novartis' XOLAIR received FDA approval in early 2024, expanding treatment options for food allergies, including peanut allergy.
While XOLAIR presents a potentially lucrative option for adult patients with minimal needle phobia, its high annual cost ranging from USD 30,000 to USD 60,000 poses significant barriers to affordability and patient access, potentially limiting broader adoption across the patient population.
In February 2025, Stallergenes Greer announced the US launch of PALFORZIA for toddler patients aged 1-3 years with confirmed peanut allergy diagnoses. The FDA had approved this expanded indication in July 2024 based on data from the Phase III POSEIDON study published in the New England Journal of Medicine Evidence in 2023. The European Commission followed suit in January 2025, approving the indication extension across all 27 European member states and three European Economic Area states.
Pipeline Therapies Promise Market Transformation
The most promising development in the pipeline is DBV Technologies' Viaskin Peanut patch, an epicutaneous immunotherapy that delivers trace amounts of peanut protein through skin application to promote desensitization. This non-invasive approach has received both Fast Track and Breakthrough Therapy Designations from the FDA, positioning it as a potentially game-changing treatment option.
DBV Technologies expects to share top-line data from the VITESSE Phase III trial (NCT05741476) involving peanut-allergic children aged 4-7 years in Q4 2025. In March 2025, the company reached a crucial regulatory milestone when the FDA agreed that safety exposure data from the VITESSE trial would be sufficient to support a Biologics License Application for the 4-7 age group, accelerating the anticipated BLA submission timeline to the first half of 2026.
The company has also secured substantial financing, announcing up to USD 306.9 million in funding in March 2025, comprising USD 125.5 million in immediate gross proceeds and up to an additional USD 181.4 million contingent upon warrant exercises. A separate BLA for children aged 1-3 is planned for the second half of 2026, pending successful outcomes from the COMFORT Toddlers Study.
DelveInsight's analysis projects that by 2034, Viaskin is expected to generate the highest revenue among all therapies in the seven major markets. This projection reflects the strong demand for desensitization treatments, with approximately 70% of treated patients choosing this approach, creating clear opportunities for safer, easier alternatives like Viaskin to improve adoption and long-term protection.
Diverse Pipeline Addresses Unmet Medical Needs
Beyond Viaskin, several other innovative therapies are advancing through clinical development. Aravax's PVX108 represents a next-generation immunotherapy utilizing engineered peptides to specifically engage T cells and retrain the immune system to reverse allergic responses. The therapy is currently in Phase II clinical trials for children and adolescents with peanut allergies, with patient enrollment completed in October 2024.
Novartis is developing Remibrutinib, an oral, highly selective, covalent Bruton's Tyrosine Kinase inhibitor currently in Phase II trials for adults with peanut allergy. This represents a significant opportunity in the adult market, which remains largely untapped with XOLAIR as the sole approved treatment and only Remibrutinib under evaluation for the 18-55 age group.
ALK-Abello reported positive interim results in December 2024 from its Phase I/II ALLIANCE clinical trial for an investigational sublingual immunotherapy tablet for peanut allergy treatment. Additional pipeline candidates include InnoUp Farma's INP20 and Intrommune Therapeutics' INT301, along with combination approaches involving Regeneron Pharmaceuticals' Linvoseltamab and Dupilumab.
Market Dynamics Reflect Growing Investment
The peanut allergy treatment space is witnessing increasing investment and partnerships, accelerating the development of novel therapies. In November 2024, Aravax established a UK subsidiary at Oxford Science Park, marking a strategic step in its global expansion in food allergy treatment. The FDA also approved OMLYCLO (omalizumab-igec) in March 2025 as the first interchangeable biosimilar for XOLAIR, potentially improving access through competitive pricing.
According to DelveInsight's epidemiological analysis, mild-to-moderate peanut allergy cases contributed the majority of diagnoses in 2024 within the seven major markets, with trend estimates suggesting consistent growth during the 2020-2034 study period. The comprehensive pipeline includes over 15 prominent pharmaceutical and biotechnology companies actively engaged in therapy development, with DBV Technologies positioned as the frontrunner with its candidates in the most advanced preregistration phase.
The market transformation reflects a shift from traditional allergen avoidance strategies toward active desensitization approaches. Recent clinical guidelines now recommend early introduction of peanut-containing foods between 4-6 months of age, even for high-risk infants, representing a significant departure from previous strict avoidance practices. This proactive approach has demonstrated substantial reduction in peanut allergy development risk, supporting the growing emphasis on intervention-based treatment strategies.
