IL-13 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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IL-13 is a cytokine (protein) secreted by many cells in the body, like CD4 cells, T helper cells, NK cells, mast cells, basophils, eosinophils, and others. It has a significant role in synthesizing IgE antibodies, airway hyperresponsiveness, mucus hypersecretion, and others. It is a mediator of allergic response and inflammation hence active in asthmatic patients. IL-13 also induces the secretion of chemokines that are required to recruit allergic effector cells to the lung. IL-13 Inhibitors are a class of drugs that inhibit IL-13 production and prevent allergic responses like asthma, dermatitis, atopic dermatitis, and others, as IL-13 is highly active in mediating allergic reactions in the body. Companies are trying to find new and novel molecules to prevent and cure these diseases. The development and launch of newer products by the market players will significantly enhance the revenue of the IL-13 Inhibitors market over the forecast years. For instance, according to a research article, the prevalence of Prurigo nodularis (PN) in 2020 in the USA was estimated to be 72 per 100,000 adult people. Companies are trying to develop new molecules to target these indications, and many of them are being evaluated in clinical trials. For instance, Dupixent (dupilumab) is approved in the USA and Europe for treating Atopic Dermatitis (AD).

Several of these inhibitors are on the market, while many are in ongoing clinical trials. 23 companies have various products in their pipelines, with 21 products in various stages of clinical trials. 1 product is in Phase 4, 3 products are in Phase 3, 10 products are in Phase 2, and 6 products are in Phase 1 of the clinical trials.

Key Developments of IL-13 Inhibitors

  • In January 2023, Dupixent (dupilumab) became the 1st drug to be approved by the European Commission (EC) for the treatment of adults and adolescents with Eosinophilic Esophagitis in Europe.
  • In December 2022, Dupixent (dupilumab) became the 1st drug to be approved by the European Commission for the treatment of adult patients with moderate to severe Prurigo Nodularis who are candidates for systemic therapy in Europe
  • In May 2022, Dupixent (dupilumab) was approved by the FDA for the treatment of patients with Eosinophilic Esophagitis.
  • In December 2021, FDA approved Adbry (Tralokinumab-ldrm) – the 1st IL-13 Inhibitor for adults with moderate to severe Atopic Dermatitis (AD).
  • In September 2020, Dupixent (dupilumab) was granted Breakthrough designation by the FDA for treating patients with Eosinophilic Esophagitis.
  • In December 2019, Eli Lilly’s drug Lebrikizumab received fast-track designation from the FDA for treating Atopic Dermatitis (AD), which is currently in Phase 3 of the clinical trials for the same indication.
  • In March 2017, Dupixent (dupilumab) was approved by the FDA for the treatment of patients with Atopic Dermatitis (AD).

Approved Molecules

  • Dupixent (Dupilumab)
  • Adbry (Tralokinumab-Ldrm)

Drugs in Pipeline

  • Cm310
  • Cendakimab (Cc-93538)
  • Deuterated S-Lisofylline (Pcs499)
  • Aerovant (Pitrakinra)
  • 611
  • Ar100
  • Gsk679586
  • Manfidokimab (Ak120)
  • Romilkimab (Sar156597)
  • Air645
  • Amg 317
  • Bits7201a
  • Gsk2434735
  • Pf-07264660
  • Pf-07275315
  • Qax-567
  • R256
  • Sar443765
  • Abrezekimab (Vr942)
  • Hypochlorous Acid (Pr022)

Clinical Activity and Developments of IL-13 Inhibitors

As of June 2023, 23 companies have approximately 21 products for 85 diseases. For these diseases more than 130 trials are being conducted by the players globally. For instance,

  • In December 2022, the University of California completed a Phase 1 clinical study to evaluate the impact of Dupilumab on the quality of life in moderate to severe Atopic Dermatitis patients.
  • In May 2023, Sanofi completed a Phase 3 clinical study to assess the efficacy, safety, and tolerability of dupilumab in patients with moderate to severe COPD with Type 2 inflammation.
  • In September 2023, completed a Phase 3 clinical study on the efficacy and safety of Tralokinumab in combination with topical corticosteroids          in subjects with severe Atopic dermatitis (AD)
  • In January 2023, Almirall, S.A. completed a Phase 3 clinical study to Assess the efficacy and safety of Lebrikizumab in combination with topical corticosteroids in patients with moderate to severe AD to whom cyclosporin was not advisable/ ineffective.

Molecule name

Number of studies

Dupixent (Dupilumab)

141

CM310

18

Cendakimab (CC-93538)

12

AR100

3

Aerovant (Pitrakinra)

5

 

Target Indication Analysis of IL-13 Inhibitors

Dupixent was approved by the FDA for the treatment of Atopic Dermatitis (AD), Eosinophilic Esophagitis, Asthma, Eczema, Dermatitis, and others, while Adbry (Tralokinumab-ldrm) is approved for the treatment of AD. Other indications for which IL-13 Inhibitors can be used are Asthma, Respiratory Hypersensitivity, Dermatitis, and others. According to the Asthma and Allergy Foundation of America (AAFA), in 2022, about 26 million people in the USA have asthma, of which 21 million are above the age of 18 while 4.8 million are children below the age of 18. Also, according to AAFA, in 2019 USA had a prevalence of AD of 7.3%. Therefore, there is an excellent opportunity for companies in the IL-13 Inhibitors market.

Frequently Asked Questions

Dupixent (Dupilumab) and Adbry (Tralokinumab-ldrm) are approved by the FDA while Lebrikizumab has received Fast-Track designation from the FDA.

These are being used in various indications like Asthma, Allergic reactions, Atopic Dermatitis, Eosinophilic Esophagitis and others.

Sanofi, Regeneron Pharmaceuticals Ltd., Keymed Biosciences Inc., AbbVie Inc. and BMS are some of the major market players for IL-13 Inhibitors.

Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and changing lifestyles leading to respiratory and skin diseases are the key opportunities for IL-13 Inhibitors in the market.

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  • Sanofi (France)
  • Regeneron Pharmaceuticals Ltd. (USA)
  • Keymed Biosciences Inc. (China)
  • AbbVie Inc. (USA)
  • BMS (USA)
  • Processa Pharmaceuticals Inc. (USA)
  • Aerovance (USA)
  • 3SBio Group (China)
  • ARJIL Pharmaceuticals (China)
  • GSK plc (UK)
  • Akeso Biopharma Co., Ltd. (China)
  • Ionis Pharmaceuticals Inc. (USA)
  • Amgen Inc. (USA)
  • Hoffmann-La Roche Ltd. (Switzerland)
  • Pfizer (USA)
  • Novartis AG (Switzerland)
  • AstraZeneca (USA)
  • Vectura Group Ltd. (UK)
  • UCB (Belgium)

ESSA Pharma (Canada)

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