“Tadekinig Alfa- Emerging Insight and Market Forecast – 2030” report provides comprehensive insights about an investigational product for Hemophagocytic Lymphohistiocytosis (HLH): Primary HLH, Secondary HLH, and Adult-onset Still’s Disease (AoSD) in Seven Major Markets. A detailed picture of the Tadekinig Alfa in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2018–2030 is provided in this report along with a detailed description of the product. The product details cover the mechanism of action, dosage and administration, route of synthesis, and Research and development activity including regulatory milestones, and other development activities. Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies.
Overview Tadekinig alfa, is a recombinant Interleukin-18 Binding Protein (r-hIL-18BP) which is being developed by AB2 Bio for diseases like Primary HLH, Secondary HLH, and AoSD. It binds with high affinity to IL-18, a major inflammatory mediator. This drug is administered subcutaneously and is often known as IL-18BP. In healthy people, both IL-18BP and IL-18 are present, with a surplus of IL-18BP keeping levels of free IL-18 low. But, in the case of patients with certain inflammatory diseases, the IL-18/IL-18BP balance is disturbed, which results in high levels of free and active IL-18, consequently leading to pathological inflammation. AB2 Bio aims to develop a drug that will not simply treat the symptoms but also target the fundamental causes of inflammation-based diseases.
Scope of the report The report provides insights into:
• A comprehensive product overview including the product description, mechanism of action, dosage and administration, Research and Development activity.
• Elaborated details on regulatory milestones and other development activities have been provided in this report.
• The report also highlights the drug research and development activity details across the United States, Europe, and Japan.
• The report also covers the patent information with an expiry timeline around Tadekinig Alfa.
• The report contains forecasted sales for Tadekinig Alfa till 2030.
• Comprehensive coverage of the late-stage emerging therapies for HLH and AoSD.
• The report also features the SWOT analysis with analyst insights and key findings of Tadekinig Alfa.
Methodology The report is built using data and information sourced primarily from internal databases, primary and secondary research, and in-house analysis ’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.
Tadekinig Alfa Analytical Perspective
• In-depth Tadekinig Alfa Market Assessment
This report provides a detailed market assessment of Tadekinig Alfa in the 7MM, covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan. This segment of the report provides forecasted sales data.
In this market assessment, only HLH was considered for forecasting purposes. HLH is a rare and life-threatening condition that majorly affects children. There are two major subtypes of HLH—primary HLH and secondary HLH. It is worth noting that, no development has been reported after the publication of results in 2018 (Gabay et al., 2018) for AoSD. A lack of late-stage evidence on safety and effectiveness and also the lack of visibility on company strategy makes it difficult to predict its potential aspects in AoSD, therefore the therapy was not considered for the forecast in AoSD. There are high expectations for Tadekinig alfa to do well in the HLH treatment space. Once approved, this drug will likely enjoy incentives provided by the orphan drug act, i.e., market exclusivity for several years since this drug is designated as an orphan in the United States and Europe. Analysts estimate that Tadekinig alfa will cover a decent market in upcoming years even after the fact that it is targeting a rare patient pool.
“Among the 7MM, Tadekinig alfa is projected to generate the highest revenue in the United States and Germany in 2030. Additionally, Germany is anticipated contribute the highest among (~25%) the EU-5 countries in 2030. Japan is expected to contribute around 4% to the total market size of Tadekinig Alfa in the 7MM in 2030”
• Tadekinig Alfa Clinical Assessment
This drug is mainly focusing on NLRC4 Mutation and XIAP Deficiency in HLH. Excellent safety and tolerability of Tadekinig alfa have been demonstrated in human subjects in Phase I/Ib clinical trials and a Phase II trial. Early signs of efficacy of Tadekinig alfa have been shown in a Phase II trial in patients suffering from refractory AoSD and also in single cases of therapeutic use in NLRC4-MAS, XIAP. The only approved therapy for HLH in the United States, Gamifant is approved for intravenous (IV) use. Conversely, the Route of administration (RoA) of Tadekinig alfa is subcutaneous. This will lead to better patient uptake as SC administration enables the self-administration of patients in-home or hospital care settings.
Report highlights • In the coming years, the market scenario for HLH 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 and academics are working to assess challenges and seek opportunities that could influence Tadekinig AlfA dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Other emerging products for HLH and AoSD are giving market competition to Tadekinig Alfa and the launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, development activities, and some key findings provide the current development scenario of Tadekinig Alfa.
• Our in-depth analysis of the forecasted sales data of Tadekinig Alfa from 2021 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Tadekinig Alfa.
Key Questions • Which company is developing Tadekinig Alfa along with the phase of the clinical study?
• What is the technology utilized in the development of Tadekinig Alfa?
• What are the product type, route of administration, and mechanism of action of Tadekinig Alfa?
• What is the clinical trial status of the study and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing, and other activities related to the Tadekinig Alfa development?
• What are the key designations that have been granted to Tadekinig Alfa?
• What is the forecasted market scenario of Tadekinig Alfa?
• What is the history of Tadekinig Alfa and what is its future?
• What are the forecasted sales of Tadekinig Alfa 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 these are giving competition to Tadekinig Alfa?
• Which are the late-stage emerging therapies under development for the treatment of the HLH?
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