IgE (Immunoglobulin E) Market Assessment and Forecast – Competition Landscape, Commercial, and Pipeline Analysis, 2023-2029

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IgE (Immunoglobulin E) is a type of antibody found in the immune system. Its main function is to mediate allergic reactions and defend against parasitic infections. IgE binds to allergens, such as pollen or food proteins, triggering an immune response. This response involves the release of chemical mediators, such as histamine, which cause the symptoms associated with allergies, such as itching, swelling, and inflammation. IgE is primarily involved in allergic diseases, including allergic rhinitis (hay fever), asthma, allergic conjunctivitis, and food allergies. The growth drivers of the IgE stimulator market are the increasing prevalence of allergic diseases worldwide, leading to a greater need for effective treatments, and advancements in biotechnology and immunotherapy that have resulted in the development of novel IgE-targeted therapies. Additionally, the growing awareness and understanding of the role of IgE in allergic reactions and the potential for personalized medicine approaches contribute to the market's growth.

According to the National Institute of Health, chronic obstructive pulmonary disease has a worldwide prevalence of 10.1% in people aged 40 years or older. Companies such as Roche, Novartis, LEOPharma, Mabpharm Limited, Regeneron, United BioPharma, Kashiv Biosciences, Synermore, Helixmith, SBI Biotech, Nestle, Aurobindo, Celltrion currently cater to asthma and obstructive pulmonary disease segment. Moreover, many companies are coming up with new molecules in this space. For instance, Roche is currently conducting a clinical trial of the drug HAE 1 (PRO 98498) for the treatment of asthma and respiratory hypersensitivity.

Key Developments

  • In Feb 2023, Genentech/Novartis launched Omalizumab for nasal polyps (adjunctive treatment) in the Netherlands, Portugal, Poland, Spain, Sweden, Belgium, Austria, Czech Republic, Denmark, Finland, Italy, France, Ireland, Hungary, Greece, Germany, Norway.
  • In May 2023, Kashiv BioSciences, LLC started a Phase 3 study to compare the efficacy, safety, and immunogenicity of ADL-018 150 mg and 300 mg with US-Licensed Xolair® 150 mg and 300 mg in patients with chronic idiopathic urticaria (CIU) who remained symptomatic despite treatment with approved doses of H1 antihistamines.
  • In December 2020, Xolair gains an FDA nod for adults with nasal polyps.

Approved IgE molecules

  • Xolair(Omalizumab)-Genentech, Novartis

IgE Pipeline Molecules

  • Ligelizumab (QGE031)-Novartis
  • FB825-LEOPharma
  • CMAB007(Omalizumabbiosimilar)-Mabpharmlimited
  • REGN1908-1909-Regeneron
  • UB-221-UnitedBioPharma
  • ADL-018(Omalizumabbiosimilar)-KashivBiosci
  • SYN-008(Omalizumabbiosimilar)-Synermore
  • Actinidiaargutaextract(PG102)-Helixmith,SBIBiotech
  • AIMab7195-Nestle
  • BP11(Omalizumabbiosimilar)-Aurobindo
  • CT-P39(Omalizumabbiosimilar)-Celltrion
  • GI-301-GIInnovation, YuhanCorp
  • Genolair((Omalizumabbiosimilar)-Generium
  • RP01-Resistentia
  • AVT23((Omalizumabbiosimilar)-Alvotech,AdvanzPharma
  • HAE1(PRO98498)-Roche
  • HS632(Omalizumabbiosimilar)-ZhejiangHisun
  • JYB1904-Jemincare
  • MEDI4212-AstraZeneca
  • TEV-45779(Omalizumabbiosimilar)-Teva
  • Zerafil(Omalizumabbiosimilar)-CinnaGen

Clinical Activity and Development of IgE

 In the IgE space, more than 15 companies are focusing on approximately 109 disease indications and right now about 48 clinical trials are being conducted in this category of drugs. For instance,

  • In February 2023, Novartis presented results assessing the efficacy and safety of Ligelizumab from PEARL-1 and PEARL-2 studies at the 2023 Annual Meeting of the American Academy of Allergy, Asthma, and Immunology.
  • In July 2022, according to the European Clinical Trials Database record, the study of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents has been completed.

    Product Name

    Total Studies

    Ligelizumab (QGE031)

    22

    FB825

    5

    CMAB007(omalizumabbiosimilar)

    4

    REGN1908-1909

    4

    UB-221

    4

    ADL-018(omalizumabbiosimilar)

    3

    SYN-008(omalizumabbiosimilar)

    3

    actinidiaargutaextract(PG102)

    3

    AIMab7195

    2

    BP11(omalizumabbiosimilar)

    2

    CT-P39(omalizumabbiosimilar)

    2

    GI-301

    2

    Genolair(omalizumabbiosimilar)

    2

    RP01

    2

    AVT23(omalizumabbiosimilar)

    1

    HAE1(PRO98498)

    1

Target Indication Analysis of IgE (Immunoglobulin E)

The IgEs are primarily used to treat asthma, hypersensitivity, and lung diseases. IgEs also help to prevent dermatitis. For instance, Xolair is one drug by Novartis that is used to decrease the incidence of dermatitis in adult patients. In the treatment of obstructive lung disease, inflammation, urticaria, and bronchial disease IgE Xolair is used widely. Through research and development, the indications in which IgEs can be used are getting expanded. Trials of Xolair are being conducted for the treatment of diseases like esophagitis, dyspnea, polyps, and gastroenteritis.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Frequently Asked Questions

The approved molecule of IgEs is Omalizumab (Xolair) by Novartis and in the United States Novartis Pharmaceutical Corporation and Genentech collaborated to work together for the development and promotion of the drug (Xolair).

The growth drivers of the IgE stimulator market are the increasing prevalence of allergic diseases worldwide, leading to a greater need for effective treatments, and advancements in biotechnology and immunotherapy that have resulted in the development of novel IgE-targeted therapies.

The major players in this space are Roche, Novartis, LEOPharma, Mabpharm Limited, Regeneron, United BioPharma, Kashiv Biosciences, Synermore, Helixmith, SBI Biotech, Nestle, Aurobindo, and Celltrion.

The key restraints of the IgE stimulator market include the complexity and variability of allergic diseases, which make it challenging to develop universally effective treatments, and the potential for adverse effects associated with IgE-targeted therapies. Additionally, the high cost of research and development, as well as the regulatory requirements for approval of new therapies, can pose barriers to market entry for IgE stimulators.

  • Roche,
  • Novartis
  • LEOPharma
  • MabpharmLimited
  • Regeneron
  • UnitedBioPharma
  • Kashiv Bioscience
  • Synermore
  • Helixmith
  • Nestle
  • Aurobindo
  • Celltrion
  • GI Innovation
  • Generium
  • Resistentia
  • Alvotech
  • AdvanzPharma
  • ZhejiangHisun
  • Jemincare
  • AstraZeneca
  • Teva
  • CinnaGen

Adjacent Markets