According to a new research report “Allergy Immunotherapy — Pipeline Analysis, Epidemiology, and Drug Forecasting” published by Pharma Proff, allergy immunotherapy currently exhibits a proliferating with 31 drug candidates (including marketed therapies).
Allergic diseases occur as a result of reaction of the body’s immune system with certain foreign substances, known as allergens, such as house dust mites (HDM), some food products (peanut, egg, milk and shellfish), pollen (grass, ragweed, and birch), and insect bites and stings (bee venom). The most common allergic conditions that may occur due to contact with these allergens, include allergic rhinitis, allergic conjunctivitis, allergic asthma, and skin allergy.
Allergic diseases are common, usually start in childhood or puberty, and generally exist throughout the lifetime of an individual. As evident from statistics by various organizations and literature surveys, the prevalence of allergic diseases has observed an increasing trend over the period of time.
Allergic Diseases Epidemiology Insights
As per the Pharma Proff estimation, in 2018, more than 315 million individuals were suffered from one of the allergic diseases in seven major markets (7MM), which include the U.S., Japan, and EU5 (Germany, France, the U.K., Italy, and Spain). Among these, the U.S. witnessed the highest prevalent population of allergic diseases, with around 45% of total allergic cases; while, Spain witnessed with the least number of the cases, in 2018. Accurate diagnosis of triggering or causative allergens is essential for appropriate advice for avoidance and environmental control measures.
Allergy Immunotherapy Marketed Therapies
A treatment known as allergen-specific immunotherapy reduces the sensitivity to some allergens in the long term. The individual is provided at regular intervals by either injecting the allergen in the form of different formulations into the skin (subcutaneous) or placing it under the tongue (sublingual). The current scenario reveals that this treatment approach is mainly administered for allergies caused by pollen, HDM, and insect venom.
The allergy immunotherapy market is primarily dominated by three key players, namely, Allergy Therapeutics PLC, ALK-Abelló A/S, and Stallergenes Greer Ltd. The marketed products that are widely prescribed for the treatment of allergic diseases are SLITone, AVANZ, Alutard SQ, STALORAL, Oralair, Venomil, Cedarcure, Pollinex, Actair, Oralvac, GRAZAX, Ragwitek, ITULAZAX, Alustal, Phostal, and Acarovac Plus.
Allergy Immunotherapy Pipeline Insights
As of December 2019, the allergy immunotherapy pipeline comprised 15 therapies in different clinical stages of development. A list of major players in the market has increased over the years. Some of these players involved in the development of immunotherapies for allergic diseases are Aimmune Therapeutics Inc., DBV Technologies S.A., Genentech Inc., ASIT biotech SA, Inmunotek SL, Anergis S.A., Biomay AG, and Regeneron Pharmaceuticals Inc.
Immunotherapy is mainly categorized into two types, namely, subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). Between the two, SLIT has been identified to play a major role in driving the market. In addition, two more types of immunotherapy – epicutaneous (EPIT) and oral (OIT) – are expected to enter the market shortly, thereby creating a positive impact on the market growth.
Additionally, the allergy immunotherapy market is categorized on the basis of the course of treatment into short-course and long-course. Several literatures suggest that immunotherapies that require administration of more than 2 years are considered as long-course, while those acted upon for ≤2 years are short-course. Pharma Proff suggests that short-course allergen-specific immunotherapies are preferred and prescribed more, thereby increasing the compliance rate among patients, and hence account for more than 50% of the total market size.
Addressing High Unmet Need for Clinical Trials Shall Accelerate the Allergy Immunotherapy Market
One unmet medical need that requires clarification in allergy immunotherapy trials is the method to measure the magnitude of clinical efficacy; for instance, effect sizes or a minimal clinically important difference (MCID). MCID is the smallest change in an outcome identified as important by patients. Contrary to pharmacotherapy trials, the allergy immunotherapy trails allow patients to use rescue drugs, making it impossible to consider the placebo group as “medication free”. The only setting where patients do not use rescue medications is the environmental exposure chambers, however, these studies are not acknowledged as phase III trials. Addressing these difficulties may provide novel ways to reduce heterogeneity in allergy immunotherapy clinical trials. Further, these changes would allow the broader, more effective use of immunotherapy in patients with allergic respiratory diseases.
Positive Clinical Trial Results Are Expected to Drive Allergy Immunotherapy Pipeline Advancements
Positive clinical results of various immunotherapies, which are undergoing clinical trials, are supporting the development of allergy immunotherapy-based drugs. For instance, results of phase II study of AllerT (Anergis S.A.), an allergy immunotherapy pipeline drug, have shown improvement in quality of life in patients with birch pollen allergy. The results were published in The Journal of Allergy and Clinical Immunology. Similarly, results of phase II study of BM32 (Biomay AG) have showed improvement regarding symptom medication in patients with grass pollen allergy.
Further, due to positive results of ongoing clinical trials, mid-to-small-sized companies are seeking funding collaborations with big pharma giants for the drug development. For instance, in December 2018, Vedanta Biosciences Inc. raised $27 million in a Series C financing with participation from strategic and institutional investors, including Bristol-Myers Squibb Company and Melinda Gates Foundation. A part of the financing will be used to advance Vedanta Biosciences’ pipeline of microbiome-derived product candidates, including VE416 for food allergy.
Increasing Approval of Designations Is Expected to Accelerate the Growth of Allergy Immunotherapy Pipeline
In August 2018, the United States Food and Drug Administration (USFDA) has granted Breakthrough Therapy designation to Xolair for the prevention of severe allergic reactions through accidental exposure to one or more foods in patients with allergies. The designation was granted on the basis of data from seven clinical studies over the last decade assessing the efficacy and safety of Xolair against a range of food allergens, including peanut, milk, and egg.
In September 2016, another therapy in the late-stage of clinical development that is Viaskin by DBV Technologies S.A. received Fast Track designation from the USFDA for the treatment of pediatric patients aged two years and older with immunoglobulin E (IgE)-mediated cow’s milk protein allergy. In addition, the drug was previously given Breakthrough Therapy designation, in April 2015, for peanut allergy in children.
Browse report overview with detailed TOC on "Allergy Immunotherapy—Pipeline Analysis, Epidemiology, and Drug Forecasting" at:https://www.pharmaproff.com/report/allergy-immunotherapy
In June 2015, Palforzia (AR101), an oral immunotherapy product by Aimmune Therapeutics Inc., was granted Breakthrough Therapy designation, by the USFDA, for the treatment of peanut allergy in children and adolescents aged 4–17 years. In September 2014, the drug was also provided Fast Track designation for peanut allergy.
Allergic Diseases Epidemiology Analysis
Allergy Immunotherapy Market Analysis
The report comprises detailed pipeline analysis of immunotherapies being developed for the treatment of allergic diseases. Comprehensive insights on the pipeline products have been provided, with special focus on strategic developments of key players, market estimation, attribute analysis, epidemiology, information on drug licensing, designations, financing and grants, technological advancements, patents, and upcoming conferences. In addition, the report highlights the winning strategies of companies involved in the allergy immunotherapy development. Detailed regulatory approval procedures in the U.S., Europe, and Japan are also provided in the report. Furthermore, the report contains competitive analysis and extensive information on monotherapies, combination therapies, targets and mechanisms of action, and drug origin with respect to allergy immunotherapy.