Allergies have the ability to appear suddenly without warning. In recent years, the incidence of cases has increased, especially those of a respiratory and food nature. Allergists point out that it will continue to grow. Not only will the number of patients increase, but also the value of this market for laboratories. Specifically, it will increase by almost 50% in the next five years to reach €29.030 billion, according to Mordor Intelligence. This fact will be the result of a greater burden of cases and investment in the development of new treatments.
Epidemiological studies show that between 10 and 40% of the population suffers from some type of allergy – respiratory, cutaneous or food, among others – worldwide. It is estimated that by 2050 close to half of the population will have allergies as a result of changes in the environment and lifestyle. In the case of respiratory allergies, “pollens are more reactive and resistant, which makes this type of condition increasingly prevalent,” explains Irene Diez, medical director of Faes Farma.
In Spain, between 25 and 30% of citizens are allergic. In 2023, pharmacies billed €246.1 million from the sale of allergy products, according to the consultancy Iqvia. Specifically, 7.3% more than the previous year (€229.3 million). In addition, in 2024 pharmacies have already generated €60.2 million.
The allergy business is a ship in which more and more companies are looking to board. There is a list of reasons why they see it as a business opportunity. The CEO and president of Inmunotek, Jose Luis Buiza, says that one of the reasons is that the number of individuals demanding to be diagnosed and treated is increasing. “It is important to consider that allergic diseases greatly affect the quality of life of those who suffer from them and can eventually lead to very serious or even fatal situations,” he says.
For Irene Diez, one of the reasons is that there are “significant unmet needs”. “We want therapies where compliance is best for the patient; more specific and advanced, especially in those cases of more severe allergies that require treatments with a much more specific target,” she explains.
Furthermore, while in Europe there has been progress in a progressively more specific, selective, and patient-tailored therapeutic arsenal, this has not been the case in other foreign countries. “They are very powerful businesses that are growing at an increasing rate because more diagnoses are being made and regions are entering the industrialization process, but there is still room for more modern treatments,” explains Irene Diez, medical director of Faes Farma.
On the other hand, researching in the field of allergies has its challenges. Buiza points out that depending on the type of clinical trial, the complexity and cost are different. A high percentage of patients are usually allergic to multiple allergens, so “it is difficult to recruit a sufficient number of suitable subjects and you have to resort to multinational trials where complexity and costs skyrocket,” he says. In addition, “the environmental concentration of the allergen under study may vary due to climatic reasons, introducing an element of uncertainty that cannot be controlled in advance,” he adds.
In the case of the development of antihistamines, Diez says that “acute rhinitis is a disease with many clinical manifestations, so there are times when it is very difficult to demonstrate efficacy and benefit in the different symptoms in studies.” The pathogenesis of the disease also affects. “There are many inflammatory or immunologic pathways involved. So you can treat one, but not all of them,” she states.
It takes an average of a decade to 15 years to research a new therapy. Currently, efforts are focused on understanding the mechanisms of allergic sensitization and improving the efficacy and safety of treatments.
On one hand, in the field of biological treatments with monoclonal antibodies, great progress has been made, especially in controlling severe conditions such as severe asthma or chronic urticaria. On the other hand, in allergen-specific immunotherapy, biomarkers are being developed to provide information about the progress of treatment and identify patients who benefit from it. “The latest innovations that have come to market are more focused on biological treatments. They are more selective treatments that not only improve the symptoms of diseases, but are aimed at specific targets within the immune system,” says Irene Diez.
Inmunotek manufactures allergen vaccines primarily for respiratory allergies and also specializes in in vivo diagnostics. They are currently researching food allergies, specifically nuts – such as peanuts – eggs, milk, and shellfish, among others. It is worth mentioning that these investigations are currently just “concept tests.” On the other hand, Faes Farma, which has second-generation oral antihistamines for allergic rhinoconjunctivitis and urticaria, has developed other formulations in recent years tailored to specific patient needs. For example, an antihistamine eye drop that is used once a day.
Diagnosis of Drug Allergy
The diagnosis of drug allergy accounts for 19% of the market (respiratory accounts for 42% and food for 29%) and has a value of €1 billion globally. However, in this area, the tools available “do not meet the needs due to a lack of diagnostic precision,” according to the Bioherent team, a start-up developing a new product to detect this type of allergy.
According to Bioherent, the difficulties in entering the allergy diagnostics market are mainly regulatory. “The main issue is the development of clinical trials. You have to go through all the regulatory phases in order to obtain CE marking,” they say. “It takes about 18 months from when you contact the notified body. Additionally, there is currently a backlog of records, and not all authorities are able to evaluate these types of devices,” they add.
There is currently an overdiagnosis of this type of allergies. For example, about 10% of the population reports a penicillin allergy, but the reality is that only 1% are allergic. “Due to the lack of techniques, there are no well-adapted procedures for desensitizing these patients to determine who is actually allergic and who is not. In the end, everyone is treated as allergic,” says the head of the Allergology Department at the Regional University Hospital in Málaga and the president of the European Association of Allergology and Clinical Immunology, María José Torres. Additionally, she points out that Spain is a leader in allergy diagnosis as it has a long tradition of allergists and is considered a medical specialty.
Bioherent and its new detection method
Bioherent was founded in the summer of 2021 as a spin-off from the University of Málaga. It was created as an initiative of two research groups from this university and one from the Biomedicine Institute of Málaga. They identified a gap in the market in diagnosing antibiotic allergies. “Currently, there is no way to diagnose a patient with an allergy to an antibiotic through in vitro tools. In vivo tests are conducted, such as a provocation test. This can lead to a misdiagnosis and poses a risk of anaphylactic shock,” explains the team from the start-up.
The technology from Bioherent comes from the field of telecommunications and is able to detect biomarkers in patient samples at ultra-sensitive levels through a blood analysis. “Initially, we focused on the diagnostic problem of amoxicillin allergy. We identified a biomarker, which is specific immunoglobulin to amoxicillin in patient serum samples. We are now in the prototype phase,” they explain. Furthermore, “we are currently working on the issue of drug allergy diagnosis in three areas: developing cartridges for beta-lactam allergy, detecting and monitoring biologicals used in cancer treatments, and detecting allergic hypersensitivity reactions that occur, for example, in preoperative anesthesia and with other types of drugs,” they point out.
By 2025, they expect to have the first two prototypes to take them to the laboratory and hospitals (Regional University Hospital of Málaga, University Hospital of Salamanca, and the Clinic of Barcelona) and start conducting tests in real environments.
