Dupilumab Emerging Drug Insight

“Dupilumab Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about Dupilumab for chronic spontaneous urticaria and bullous pemphigoid in seven major markets. A detailed picture of the dupilumab 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 dupilumab. 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 dupilumab market forecast analysis in 7MM, SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies.

Drug Summary

Dupilumab (DUPIXENT) is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the ‘Type I’ receptor and both IL-4 and IL-13 signaling through the ‘Type II’ receptor.

Multiple cell types that express IL-4Rα (e.g., mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation. Blocking IL4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE.

Dupixent is approved in the US to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid-dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled. In adolescents 12 years or older, it is recommended that Dupixent be administered by or under the supervision of an adult. In children younger than 12 years, Dupixent should be administered by a caregiver.

Dupilumab is a novel monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling and was previously found to be effective in atopic dermatitis and asthma. Considering that CSU and atopic diseases share many common features (e.g. key pathogenic role of mast cells and (Immunoglobulin E) IgE, itch is a dominant symptom, Th2 dominance), it is reasonable to expect that Dupilumab is beneficial in CSU.

The gold standard treatment of CSU consists of administration of antihistamines. In more than 50% of the patients, symptoms persist with standard dosing of antihistamines. In antihistamine-refractory patients with chronic spontaneous urticaria and bullous pemphigoid, the currently only licensed treatment is omalizumab, a monoclonal anti-IgE antibody.

In July 2021, Phase 3 trial met its primary endpoints and all key secondary endpoints at 24 weeks, showing Dupixent nearly doubled reduction in itch and urticaria activity scores.

Scope of the Report

The report provides insights into:

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

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’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.

Dupilumab Analytical Perspective by DelveInsight

• In-depth Dupilumab Market Assessment

This report provides a detailed market assessment of dupilumab for chronic spontaneous urticaria and bullous pemphigoid 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 2023 to 2032.

• Dupilumab Clinical Assessment

The report provides the clinical trials information of dupilumab for chronic spontaneous urticaria and bullous pemphigoid covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights 

• In the coming years, the market scenario for chronic spontaneous urticaria and bullous pemphigoid 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 dupilumab dominance.
• Other emerging products for chronic spontaneous urticaria and bullous pemphigoid are expected to give tough market competition to dupilumab 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 dupilumab in chronic spontaneous urticaria and bullous pemphigoid.
• Our in-depth analysis of the forecasted sales data of dupilumab from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the dupilumab in chronic spontaneous urticaria and bullous pemphigoid.

Key Questions

• What is the product type, route of administration and mechanism of action of dupilumab?
• What is the clinical trial status of the study related to dupilumab in chronic spontaneous urticaria and bullous pemphigoid and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the dupilumab development?
• What are the key designations that have been granted to dupilumab for chronic spontaneous urticaria and bullous pemphigoid?
• What is the forecasted market scenario of dupilumab for chronic spontaneous urticaria and bullous pemphigoid?
• What are the forecasted sales of dupilumab 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 dupilumab for chronic spontaneous urticaria and bullous pemphigoid?
• Which are the late-stage emerging therapies under development for the treatment of chronic spontaneous urticaria and bullous pemphigoid?