Nerlynx - Drug Insight and Market Forecast - 2030

Overview
“Nerlynx - 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 Nerlynx 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
Neratinib, sold under the brand name Nerlynx, a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.
In February 2020, Puma Biotechnology announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

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

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.

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

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

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

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