Orkambi - Drug Insight and Market Forecast - 2030

Overview
“ Orkambi - 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 Orkambi 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.

Drug Summary
ORKAMBI is a combination of lumacaftor, which is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del CFTR protein, and ivacaftor, which is designed to enhance the function of the CFTR protein once it reaches the cell surface.
In August 2018, Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved ORKAMBI (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF in this population.

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 Orkambi.
• The report contains historical and forecasted sales for Orkambi 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 Orkambi.

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.
Orkambi Analytical Perspective by DelveInsight
• In-depth Orkambi Market Assessment
This report provides a detailed market assessment of Orkambi 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.

• Orkambi Clinical Assessment
The report provides the clinical trials information of Orkambi covering trial interventions, trial conditions, trial status, start and completion dates.

Report highlights
• In the coming years, the market scenario for Orkambi 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 Orkambi 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 Orkambi 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 Orkambi.
• Our in-depth analysis of the sales data of Orkambi from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Orkambi in the market.

Key Questions
• What is the prescribed dosage and strengths of Orkambi are available in the market?
• What are the common adverse reactions or side effects of Orkambi?
• What is the product type, route of administration and mechanism of action of Orkambi?
• What are the chemical specifications of Orkambi?
• How are the clinical trials diversified on the basis of the trial status?
• What is the history of Orkambi, and what is its future?
• What are the marketed details of Orkambi 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 Orkambi and when these patents will get expire?
• What are the pros (benefits) and cons (disadvantages) of Orkambi?
• In which countries Orkambi got approval and when it gets launched?
• What are the clinical trials are currently ongoing for Orkambi?
• How the safety and efficacy results determined the approval of Orkambi?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Orkambi development?
• What are the key designations that have been granted to Orkambi?
• What is the historical and forecasted market scenario of Orkambi?
• How is the market trend of Orkambi 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 Orkambi?
• Which are the late-stage emerging therapies under development for the treatment of the indicated condition?