“Difamilast Market Drug Insight and Market Forecast - 2032” report provides comprehensive insights about difamilast for Atopic Dermatitis (AD) in the seven major markets. A detailed picture of the difamilast for atopic dermatitis in the 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 difamilast for atopic dermatitis. 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 difamilast market forecast analysis for atopic dermatitis in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in atopic dermatitis.
Otsuka entered into a licensing agreement with Medimetriks in February 2016, which granted Medimetriks development, marketing, and manufacturing rights for the drug in the US. Under the terms of the deal, Medimetriks paid Otsuka USD 22 million upfront and additional milestones through NDA approval. Additionally, Medimetriks had funded and handled Phase III trials of the drug for AD in children and adults within the US. Medimetriks is anticipating the launch of the drug by 2023 in the US and has patent protection through 2033.
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Drug Summary
Discovered by Otsuka pharmaceuticals, difamilast (OPA-15406, MM36) is an investigational non-steroidal, topical, anti-inflammatory PDE4 inhibitor in development for the treatment of mild-to-moderate AD. It is believed to exert anti-inflammatory action by inhibiting the production of cytokines, and chemical mediators thought to cause the signs and symptoms of AD. In particular, MM36 exhibits highly selective inhibitory activity against PDE4 subtype B, which is an enzyme that may play a significant role in inflammation. The drug has been approved by the MHLW in Japan in 2021 under the brand name MOIZERTO.Otsuka entered into a licensing agreement with Medimetriks in February 2016, which granted Medimetriks development, marketing, and manufacturing rights for the drug in the US. Under the terms of the deal, Medimetriks paid Otsuka USD 22 million upfront and additional milestones through NDA approval. Additionally, Medimetriks had funded and handled Phase III trials of the drug for AD in children and adults within the US. Medimetriks is anticipating the launch of the drug by 2023 in the US and has patent protection through 2033.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the difamilast description, mechanism of action, dosage and administration, research and development activities in atopic dermatitis.
- Elaborated details on difamilast regulatory milestones and other development activities have been provided in this report.
- The report also highlights the difamilast research and development activities in atopic dermatitis across the United States, Europe and Japan.
- The report also covers the patents information with expiry timeline around difamilast.
- The report contains forecasted sales of for atopic dermatitis till 2032.
- Comprehensive coverage of the late-stage emerging therapies for atopic dermatitis.
- The report also features the SWOT analysis with analyst views for difamilast in atopic dermatitis.
Methodology
The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the research 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.Difamilast Analytical Perspective
In-depth Difamilast Market Assessment
This report provides a detailed market assessment of difamilast for atopic dermatitis in the 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.Difamilast Clinical Assessment
The report provides the clinical trials information of difamilast for atopic dermatitis covering trial interventions, trial conditions, trial status, start and completion dates.Report Highlights
- In the coming years, the market scenario for atopic dermatitis 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 difamilast dominance.
- Other emerging products for atopic dermatitis are expected to give tough market competition to difamilast 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 difamilast in atopic dermatitis.
- This in-depth analysis of the forecasted sales data of difamilast from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the difamilast in atopic dermatitis.
Key Questions Answered
- What is the product type, route of administration and mechanism of action of difamilast?
- What is the clinical trial status of the study related to difamilast in atopic dermatitis and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the difamilast development?
- What are the key designations that have been granted to difamilast for atopic dermatitis?
- What is the forecasted market scenario of difamilast for atopic dermatitis?
- What are the forecasted sales of difamilast 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 difamilast for atopic dermatitis?
- Which are the late-stage emerging therapies under development for the treatment of atopic dermatitis?
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Table of Contents
1. Report Introduction2. Difamilast Overview in Atopic Dermatitis
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical studies
2.2.2. Clinical trials information
2.2.3. Safety and efficacy
2.3. Regulatory milestones
2.4. Other Developmental Activities
2.5. Product Profile
3. Competitive Landscape (Marketed Therapies)
4. Competitive Landscape (Late-stage Emerging Therapies)
5. Difamilast Market Assessment
5.1. Market Outlook of Difamilast in Atopic Dermatitis
5.2. 7MM Market Analysis
5.2.1. Market size of difamilast in the 7MM for atopic dermatitis
5.3. Country-wise Market Analysis
5.3.1. Market size of difamilast in the United States for atopic dermatitis
5.3.2. Market size of difamilast in Germany for atopic dermatitis
5.3.3. Market size of difamilast in France for atopic dermatitis
5.3.4. Market size of difamilast in Italy for atopic dermatitis
5.3.5. Market size of difamilast in Spain for atopic dermatitis
5.3.6. Market size of difamilast in the United Kingdom for atopic dermatitis
5.3.7. Market size of difamilast in Japan for atopic dermatitis
6. SWOT Analysis
7. Analysts’ Views
8. Appendix
8.1. Bibliography
8.2. Report Methodology
9. Publisher Capabilities
10. Disclaimer
11. About the Publisher
12. Report Purchase Options
List of Tables
Table 1: Difamilast, Clinical Trial Description, 2022
Table 2: Difamilast, General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Emerging Therapies)
Table 5: Difamilast Market Size in the 7MM, in USD million (2019-2032)
Table 6: Difamilast Market Size in the US, in USD million (2019-2032)
Table 7: Difamilast Market Size in Germany, in USD million (2019-2032)
Table 8: Difamilast Market Size in France, in USD million (2019-2032)
Table 9: Difamilast Market Size in Italy, in USD million (2019-2032)
Table 10: Difamilast Market Size in Spain, in USD million (2019-2032)
Table 11: Difamilast Market Size in the UK, in USD million (2019-2032)
Table 12: Difamilast Market Size in Japan, in USD million (2019-2032)
List of Figures
Figure 1: Difamilast Market Size in the 7MM, USD million (2019-2032)
Figure 2: Difamilast Market Size in the United States, USD million (2019-2032)
Figure 3: Difamilast Market Size in Germany, USD million (2019-2032)
Figure 4: Difamilast Market Size in France, USD million (2019-2032)
Figure 5: Difamilast Market Size in Italy, USD million (2019-2032)
Figure 6: Difamilast Market Size in Spain, USD million (2019-2032)
Figure 7: Difamilast Market Size in the United Kingdom, USD million (2019-2032)
Figure 8: Difamilast Market Size in Japan, USD million (2019-2032)