XOLAIR Marketed Drug Insight and Market Forecast - 2032

“XOLAIR Marketed Drug Insight and Market Forecast - 2032” report provides comprehensive insights about XOLAIR for Chronic Spontaneous Urticaria in seven major markets. A detailed picture of the XOLAIR for Chronic Spontaneous Urticaria in 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019 -2032 is provided in this report along with a detailed description of the XOLAIR for Chronic Spontaneous Urticaria. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the XOLAIR market forecast analysis for Chronic Spontaneous Urticaria in 7MM, SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Chronic Spontaneous Urticaria.

Drug Summary

XOLAIR (omalizumab) is the only approved anti-IgE antibody indicated for moderate to severe persistent asthma in patients of 6 years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids, and chronic idiopathic urticaria in adults and adolescents of 12 years and older who remain symptomatic despite H1 antihistamine treatment.

Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE); the antibody has a molecular weight of approximately 149 kilo Daltons. XOLAIR is produced by a Chinese hamster ovary (CHO) cell suspension culture in a nutrient medium that may contain the antibiotic gentamicin; gentamicin is not detectable in the final product. Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. Also, the mechanism by which these effects of omalizumab result in an improvement of CIU symptoms is unknown.

Xolair is approved for the treatment of CSU in over 80 countries, including the European Union and chronic idiopathic urticaria (CIU), as it is known in the US and Canada. Xolair has over one million patient-years of exposure. Also, a liquid formulation of Xolair in prefilled syringes has been approved in the EU and more than 10 countries outside of the EU, including Canada, the US, and Australia. In the US, Novartis and Genentech worked together to develop and co-promote Xolair. Outside the US, Novartis markets Xolair and records all sales and related costs.

Dosage: 150 mg or 300 mg of XOLAIR is administered by subcutaneous injection every 4 weeks for the treatment of CIU. The dosing of XOLAIR in CIU patients is not dependent on serum IgE (free or total) level or body weight. XOLAIR injection is a clear to slightly opalescent and colorless-to-pale brownish-yellow solution available as 150 mg/mL in a single-dose prefilled syringe with a purple needle shield for CSU.

Administration: XOLAIR is available as a prefilled syringe and as a lyophilized powder in a vial for reconstitution. Both XOLAIR prefilled syringe and lyophilized powder should be administered by a healthcare professional. XOLAIR is administered by subcutaneous injection, which may take 5-10 s to administer. Also, more than one injection per site should not be administered.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the XOLAIR description, mechanism of action, dosage and administration, research and development activities in Chronic Spontaneous Urticaria.
• Elaborated details on XOLAIR regulatory milestones and other development activities have been provided in this report.
• The report also highlights the XOLAIR research and development activities in Chronic Spontaneous Urticaria across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around XOLAIR.
• The report contains forecasted sales of XOLAIR for Chronic Spontaneous Urticaria till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Chronic Spontaneous Urticaria.
• The report also features the SWOT analysis with analyst views for XOLAIR in Chronic Spontaneous Urticaria.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

XOLAIR Analytical Perspective

In-depth XOLAIR Market Assessment

This report provides a detailed market assessment of XOLAIR for Chronic Spontaneous Urticaria in seven major markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2022 to 2032.

XOLAIR Clinical Assessment

The report provides the clinical trials information of XOLAIR for Chronic Spontaneous Urticaria covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Chronic Spontaneous Urticaria is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence XOLAIR dominance.
• Other emerging products for Chronic Spontaneous Urticaria are expected to give tough market competition to XOLAIR and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of XOLAIR in Chronic Spontaneous Urticaria.
• The in-depth analysis of the forecasted sales data of XOLAIR from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the XOLAIR in Chronic Spontaneous Urticaria.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of XOLAIR?
• What is the clinical trial status of the study related to XOLAIR in Chronic Spontaneous Urticaria and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the XOLAIR development?
• What are the key designations that have been granted to XOLAIR for Chronic Spontaneous Urticaria?
• What is the forecasted market scenario of XOLAIR for Chronic Spontaneous Urticaria?
• What are the forecasted sales of XOLAIR in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to XOLAIR for Chronic Spontaneous Urticaria?
• Which are the late-stage emerging therapies under development for the treatment of Chronic Spontaneous Urticaria?

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