Interleukin (IL-5) / Interleukin (IL-5R) Antagonists Drugs Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Interleukin 5 (IL5) is an interleukin produced by type-2 T helper cells and mast cells. Through binding to the interleukin-5 receptor, interleukin 5 stimulates B cell growth and increases immunoglobulin secretion - primarily IgA and it is also a key mediator in eosinophil activation. The mechanism of action (MOA) of the IL-5/ IL-5R receptor antagonists works by blocking the interaction between IL-5 and its receptor. By inhibiting this interaction, these drugs interfere with the signaling pathway that promotes eosinophil production, maturation, activation, and survival. This leads to a reduction in the number and activity of eosinophils in the body. IL-5/IL-5R antagonists act to downregulate eosinophil activity and provide therapeutic benefits in diseases characterized by excessive eosinophilic inflammation, such as eosinophilic asthma and eosinophilic esophagitis. IL-5/ IL-5R antagonist drugs can help alleviate symptoms, reduce exacerbations, and improve overall disease control. IL-5/ IL-5R antagonists are used to treat asthma, respiratory hypersensitivity, bronchial diseases, lung diseases, nose diseases, allergic rhinitis, brain diseases, common cold, gastroenteritis, autoimmune diseases, and lymphatic diseases. Increased incidence of respiratory tract infections and allergic rhinitis are the key drivers for the IL-5/ IL-5R market.

For instance, according to the Centers for Disease Control and Prevention 2021, around there were 4.6% of adults who have ever been diagnosed with COPD, emphysema, or chronic bronchitis. The introduction of newer products by market players may look for opportunities that greatly impact comprehensive research and development in IL-5/ IL-5R antagonists. For instance, GlaxoSmithKline launched Nucala (Mepolizumab) to treat chronic rhinosinusitis. Moreover, numerous market participants are developing innovative compounds to address the difficulties in therapy. For instance, GSK’s Depemokimab (GSK3511294) for the indication of asthma is under the various stages of clinical studies.

Key Market Developments:

• In September 2020, GlaxoSmithKline received an FDA grant for an expanded indication of its Nucala (Mepolizumab) for Hypereosinophilic Syndrome.
• In July 2021, GlaxoSmithKline received an FDA grant for an expanded indication of its Nucala (Mepolizumab) for chronic rhinosinusitis with nasal polyps.

Approved Drug Molecules and Brand Names for IL-5/ IL-5R Antagonists Drugs:

• Nucala (Mepolizumab)
• Cinqair (Reslizumab)
• Fasenra (Benralizumab)

Drugs under the Pipeline for IL-5/ IL-5R Antagonists Drugs:

• Orismilast Oral (LEO 32731)
• Depemokimab (GSK3511294)
• ASM8
• SHR-1703
• SSGJ-610
• BAT2606 (Mepolizumab Biosimilar)
• Mepolizumab Biosimilar
• Orismilast Topical (LEO 32731 Topical)
• Trabikibart (CSL311)

Clinical Activity and Developments of IL-5/ IL-5R Antagonists Drugs:

Till July 2023, there will be about 12 companies with over 15 compounds that focus on various forms of respiratory and hypersensitivity disorders. For these molecules, more than 270 clinical trials are being conducted, and most are in phase-2 and phase-3 clinical trials by players across the globe. For instance,

• In October 2019, AstraZeneca received the FDA for the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen) based on the data from the Phase III GRECO trial and the Phase I AMES trial.
• In May 2023, Innovent Biologics completed phase 1, a randomized, double-blind, placebo-controlled, multiple oral dose trial to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic of IBI353 (Orismilast) in healthy subjects.