leqvio drug insight and market forecast

"LEQVIO Market Size, Forecast, and Drug Insight – 2032” report provides comprehensive insights about LEQVIO for PCSK9 Inhibitors (PCSK9i) in the 7MM. A detailed picture of the LEQVIO for PCSK9 Inhibitors in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan, for the study period 2019–2032 is provided in this report along with a detailed description of the LEQVIO for PCSK9 Inhibitors. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the LEQVIO market forecast, analysis for PCSK9 Inhibitors in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in PCSK9 Inhibitors.

Drug Summary

LEQVIO (inclisiran, KJX839) is the first and only small interfering RNA (siRNA) therapy developed by Novartis to reduce LDL-C levels via an RNA interference (RNAi) mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease (ASCVD), a deadly form of cardiovascular disease. With two doses a year and effective and sustained LDL-C reduction, LEQVIO works as a complement to statins. LEQVIO works differently from other therapies by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C, and clearing it from the bloodstream.

Inclisiran is a long-acting, synthetic siRNA directed against PCSK9, and it has been shown to significantly decrease hepatic production of PCSK9 and cause a marked reduction in LDL-C levels. It is conjugated to triantennary N-acetylgalactosamine carbohydrates and administered via subcutaneous injection. These carbohydrates bind to abundant liver-expressed asialoglycoprotein receptors, leading to the uptake of inclisiran specifically into the hepatocytes.

The siRNA molecules follow the natural pathway of RNA interference (RNAi) by binding intracellularly to the RNA-induced silencing complex (RISC), thus enabling it to cleave messenger RNA (mRNA) molecules specifically encoding PCSK9. siRNA can evade the radar of the mammalian interferon response and produce strong and specific gene silencing. More specifically, siRNA interferes with the expression of specific genes with complementary nucleotide sequences by affecting the degradation of mRNA post-transcription, thus preventing. The drug belongs to The Medicines Company, which is now a part of Novartis after the acquisition. Novartis has obtained global rights to develop, manufacture, and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. 

Dosage and administration

The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection: initially, again at three months, followed by every six months. Inclisiran can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor. To maintain LDL-C lowering, it is recommended that inclisiran is administered within two weeks after the last dose of a monoclonal antibody PCSK9 inhibitor.

Mechanism of action

Inclisiran is a cholesterol-lowering, double-stranded, small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilizes the RNA interference mechanism and directs the catalytic breakdown of mRNA for PCSK9. This increases LDL-C receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in circulation.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the LEQVIO description, mechanism of action, dosage and administration, research and development activities in PCSK9 Inhibitors.
• Elaborated details on LEQVIO regulatory milestones and other development activities have been provided in this report.
• The report also highlights the LEQVIO research and development activity in PCSK9 Inhibitors in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around LEQVIO.
• The report contains forecasted sales of LEQVIO for PCSK9 Inhibitors till 2032.
• Comprehensive coverage of the late-stage emerging therapies for PCSK9 Inhibitors.
• The report also features the SWOT analysis with analyst views for LEQVIO in PCSK9 Inhibitors.

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.

LEQVIO Analytical Perspective by DelveInsight

• In-depth LEQVIO Market Assessment

This report provides a detailed market assessment of LEQVIO in PCSK9 Inhibitors in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

• LEQVIO Clinical Assessment

The report provides the clinical trials information of LEQVIO in PCSK9 Inhibitors covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights  

• In the coming years, the market scenario for PCSK9 Inhibitors 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 LEQVIO dominance.
• Other emerging products for PCSK9 Inhibitors are expected to give tough market competition to LEQVIO 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 LEQVIO in PCSK9 Inhibitors.
• Our in-depth analysis of the forecasted sales data from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the LEQVIO in PCSK9 Inhibitors. 

Key Questions

• What is the product type, route of administration and mechanism of action of LEQVIO?
• What is the clinical trial status of the study related to LEQVIO in PCSK9 Inhibitors and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the LEQVIO development?
• What are the key designations that have been granted to LEQVIO for PCSK9 Inhibitors?
• What is the forecasted market scenario of LEQVIO for PCSK9 Inhibitors?
• What are the forecasted sales of LEQVIO 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 in PCSK9 Inhibitors and how are they giving competition to LEQVIO for PCSK9 Inhibitors?
• Which are the late-stage emerging therapies under development for the treatment of PCSK9 Inhibitors?