The Rise of Anaphylaxis in the United States
Anaphylaxis is a growing problem in the United States. With its widespread prevalence and increasing incidence, it is a serious, potentially fatal allergic reaction with a rapid onset that requires early intervention. The rate of occurrence of anaphylaxis in the general population is increasing, especially in people in their first 20 years of life. The lifetime prevalence of anaphylaxis is between 1.6% and 5.1% of the US population, based on the current 2023 US population; this would equate to 5-17 million persons at risk, although some estimates are as high as 49 million1. There was a 32% increase in the incidence of reported anaphylaxis when comparing 2004–2007 rates with 2008-2016.
Medications and stinging insects are the leading triggers in adults, while foods and stinging insects are the most common triggers in children and adolescents. Food allergy impacts 8%–11% of children and adults in the US, while adverse drug reactions affect up to 10% of the world’s population. Anaphylactic reactions are triggered most commonly by medications (35%), food (32%), insects (19%), latex (3.1%), and unknown causes (11%). Perhaps more staggering is that ER visits for anaphylactic food reactions grew 377% from 2007-162. Only half of patients who experienced an anaphylactic event have been prescribed epinephrine3, and the majority of patients have poor carry rates and refill rates4
The Unmet Need
The first Epinepherine Auto Injector was approved in 1987. Unfortunately, innovation has been limited until recently and the epinephrine market is primed to move from needle to nasal. Epinephrine Auto-injectors elicit concern, anxiety, and discomfort among children, caregivers, and adults, which results in barriers to use. The most common barriers are affordability, fear of administration, social stigma and embarrassment and portability.
55-60%4 of patients do not carry their epinephrine all of the time. Only 67% carry "most of the time"
Delay or Do Not Treat
Up to 50%5,6 patients delay treatment. 25-50%6 of patients do not administer. Needle delivery is main barrier
Do not have 2nd Device
Up to 30%7 of patients require a second injection. Majority of patients only carry 1 autoinjector
Treating anaphylaxis early is important, but patients often do not carry their epinephrine, do not administer, or delay use which increases the risk of a severe attack. Delaying timely epinephrine administration has been associated with poor outcomes and increased cost9-12. There are ~100,000 yearly ED visits due to anaphylaxis8. When epinephrine is administered prior to ED arrival, the likelihood of hospital admission is reduced significantly9. In fact, the mean total cost of an anaphylaxis related hospitalization is project to approach $24,000 in 201913