“ Kalydeco - Drug Insight and Market Forecast - 2030” report by DelveInsight outlays comprehensive insights of the product indicated for the treatment of its approved condition. A detailed picture of the Kalydeco in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2017 - 2030 is provided in this report along with a detailed description of the product. The product details covers mechanism of action, dosage and administration, route of synthesis, and pharmacological studies, including product marketed details, regulatory milestones, and other development activities. Further, it also consists of market assessments inclusive of the market forecast, SWOT analysis, and detailed analyst views. It further highlights the market competitors, late-stage emerging therapies, and patent details in the global space.
KALYDECO (ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 4 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if KALYDECO is safe and effective in children under 4 months of age.
In September 2020, Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved KALYDECO (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data. KALYDECO is already approved in the U.S. and EU for the treatment of CF in patients ages six months and older.
Scope of the report
The report provides insights into:
• A comprehensive product overview including the product description, mechanism of action, dosage and administration, route of synthesis, pharmacological studies (pharmacodynamics and pharmacokinetics) and adverse reactions.
• Elaborated details on regulatory milestones and other development activities have been provided in this report.
• The report also highlights the drug marketed details across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around Kalydeco.
• The report contains historical and forecasted sales for Kalydeco till 2030.
• Comprehensive coverage of the late-stage emerging therapies (Phase III) in the space with a brief snapshot of the details.
• The report also features the SWOT analysis with analyst insights and key findings of Kalydeco.
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.
Kalydeco Analytical Perspective by DelveInsight
• In-depth Kalydeco Market Assessment
This report provides a detailed market assessment of Kalydeco 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 historical and forecasted sales data from 2017 to 2030.
• Kalydeco Clinical Assessment
The report provides the clinical trials information of Kalydeco covering trial interventions, trial conditions, trial status, start and completion dates.
• In the coming years, the market scenario for Kalydeco is set to change due to the extensive research in the treatment of the indicated condition 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 Kalydeco dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Other approved products for the disease are giving market competition to Kalydeco and 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 market scenario of Kalydeco.
• Our in-depth analysis of the sales data of Kalydeco from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Kalydeco in the market.
• What is the prescribed dosage and strengths of Kalydeco are available in the market?
• What are the common adverse reactions or side effects of Kalydeco?
• What is the product type, route of administration and mechanism of action of Kalydeco?
• What are the chemical specifications of Kalydeco?
• How are the clinical trials diversified on the basis of the trial status?
• What is the history of Kalydeco, and what is its future?
• What are the marketed details of Kalydeco in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• How many patents have been granted to Kalydeco and when these patents will get expire?
• What are the pros (benefits) and cons (disadvantages) of Kalydeco?
• In which countries Kalydeco got approval and when it gets launched?
• What are the clinical trials are currently ongoing for Kalydeco?
• How the safety and efficacy results determined the approval of Kalydeco?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Kalydeco development?
• What are the key designations that have been granted to Kalydeco?
• What is the historical and forecasted market scenario of Kalydeco?
• How is the market trend of Kalydeco is different in the Seven Major Markets (the United States, EU5 [Germany, France, Italy, Spain, and the United Kingdom], and Japan)?
• What are the other approved products available and how these are giving competition to Kalydeco?
• Which are the late-stage emerging therapies under development for the treatment of the indicated condition?