Peanut allergy (PA) is one of the most common food allergies that affect children in Western nations. It is diagnosed at early stages and often persists till adulthood in approximately 75%–80% of the cases. DelveInsight estimates that approximately 10,578,543 Peanut allergy prevalent cases were reported in 7MM (the US, EU5 (the UK, Italy, Spain, Germany and France) and Japan) out of which the US accounted for the highest prevalence with over 6 million cases.
Infamously, it has become the leading cause of food allergy-linked death due to anaphylaxis, the most severe and life-threatening allergic reaction in response to an allergen that may lead to impaired breathing, swelling in the throat, a sudden drop in blood pressure, pale skin, or blue lips, fainting and dizziness. Other non-fatal symptoms include indigestion, stomach cramps, vomiting, diarrhea, wheezing, and shortness of breath, cough, hives, tongue/lip swelling, or confusion.
Historically, the gold standard of the treatment for Peanut allergy constituted a strategic plan for peanut avoidance coupled with an adrenaline auto-injector (AAI) in case of contingencies. However, in 2017 the treatment paradigm in the Peanut allergy therapy market transformed to incorporate different treatment approaches and pharmacotherapies. After the results of the trial, Learning Early About Peanut allergy (LEAP), which demonstrated that children who are at greater risk of developing Peanut allergy when exposed to peanuts within the first 12 months are at a lower likelihood to have their allergy progressed to higher severity levels. The study revolutionized the therapy recommendations in the Peanut allergy therapy market. The present market consists of antihistamines, injectable epinephrine, steroids, and bronchodilators prescribed to patients with mild and moderate to severe cases of Peanut allergy for anaphylaxis management.
Allergen immunotherapy (AIT) that can be administered via oral, sublingual, epicutaneous, and subcutaneous routes comprises progressive administration of amounts of the allergen at the question to develop food desensitization. It further helps in increasing the reaction threshold with regular exposure to the allergen. Allergen immunotherapy targets achieving a long-term result and effectiveness even after desensitization allowing patients to introduce food without reactions, even after a period of discontinuation of the offending food. In 2019, the US FDA gave a green signal to the first-ever allergen immunotherapy, Palforzia, developed by Aimmune Therapeutics. It is an oral immunotherapy, approved for children and teens aged 4–17 with existing peanut allergies and available only through a Risk Evaluation and Mitigation Strategy (REMS) in the Peanut allergy therapeutics market.
Overall, the current Peanut allergy market consists of different formulations of immunotherapies, antihistamines, epinephrine, and other therapies such as self injectors with a total worth of USD 360.8 million in 2020 in the 7MM, with the USA accounting for more than 80% of the 7MM Peanut allergy market share. Epinephrine is considered the first-line medication for the treatment of anaphylaxis. Antihistamines, corticosteroids, and bronchodilators are also available; however, these medications address systemic symptoms and do not treat anaphylaxis; instead, they are adjunctive therapies for anaphylaxis management.
According to our KOLs, the OITs are a promising therapeutic option in the Peanut allergy market; however, they carry the chances of anaphylaxis during the buildup phase and/or maintenance and do not form a curative approach. The availability of these medications does not guarantee a sure shot cure, and immunotherapies take upto a year and always carry a risk of associated allergic reactions.
Further, there is no standard theory on which the treatment approach is based owing to a lack of clarity in etiology of Peanut allergy. Heterogeneity is observed among oral Immunotherapy trial results with different dosing regimens and endpoints, adding to conundrums by making it difficult to compare, interpret and finalize a standard of dosing.
Nevertheless, there are several products in the pipeline in different clinical stages of development by key players, including Nestle Health Sciences, DBV Technologies, Regeneron/Sanofi, Camallergy, and others, which are expected to get launched in the US Peanut allergy market in the near future. Viaskin Peanut (DBV Technologies), CA002 (Camallegry), and Dupixient (Sanofi and Regeneron), VE416, ADP101 (Alladapt Immunotherapeutics), INP20 (InnoUp Farma), and CNP-201 are some of the several Peanut allergy pipeline therapies expected to expand market size during the forecast period.
The growing Peanut allergy prevalence is a major factor giving maximum thrust to the growth of the Peanut allergy market. Besides, a rise in R&D aimed at having specific allergen immunotherapy (AIT) that can effectively help in reaching allergen desensitization with minimal risks of allergic reactions in less than usual time. Furthermore, the promising Peanut allergy pipeline landscape and inclination of pharma and biotech companies towards developing novel immunotherapies is substantially pushing the growth of the market size at a modest CAGR, estimated DelveInsight.
However, the pipeline therapies constituting immunotherapies/ biologics are expected to put a stress on the pockets of patients and their caretakers owing to their huge medical cost. The patients are always at risk of accidental exposure that may lead to an unpredictable and lifelong risk of severe reactions. As per the data from the study (Cannon, 2018), the total medical and healthcare cost for Peanut allergy was approximated to be USD 4184 per child, with USD 4.3 billion in direct medical costs. With only approved treatment in the market, the options to choose among the basket gets limited, leaving patients vulnerable even if it falls under health insurance under Medicaid, Managed Medicaid, TriCare, and Medicare and others. Anyhow, the unmet needs and prevailing gaps are witnessed as nothing short of opportunities to put on the table better, innovative and novel therapies to cure Peanut allergies, improve QOLs significantly and save on healthcare costs. Limited therapies and restricted RoAs expand elbow room for therapies that require lower doses of antigen, avoid allergen ingestion, and have fewer systemic side effects, thus, offering a lot of potential growth prospects in the Peanut allergy therapy market.