Overview
Inclisiran - Emerging Insight and Market Forecast - 2030 report by the publisher outlays comprehensive insights of the product indicated for the treatment of its approved condition. A detailed picture of the Inclisiran 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 cover 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.
Inclisiran, the first cholesterol-lowering therapy in the RNAi therapeutics class, is an investigational therapy under clinical development to evaluate its ability to lower low-density lipoprotein cholesterol (also known as LDL-C) through twice-yearly dosing. Inclisiran harnesses the body's natural process of RNA interference to specifically prevent production of the PCSK9 protein in the liver which enhances the liver's ability to remove LDL-C from the bloodstream, thereby lowering LDL-C levels. In phase II studies, inclisiran provided clinically significant LDL-C reductions greater than 50 percent in addition to the effects of statins and/or ezetimibe, and LDL-C reductions were sustained throughout the six-month dosing interval. The safety and efficacy of inclisiran were evaluated in the ORION-11 phase III study with positive results; Inclisiran is not yet approved for use by the FDA or any other regulatory authority. In February 2013 Alnylam granted global rights under a license and collaboration agreement to The Medicines Company to develop, manufacture, and commercialize inclisiran.
Scope of the report
The report provides insights into:
Methodology
The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher'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.
Inclisiran Analytical Perspective
In-depth Inclisiran Market Assessment
This report provides a detailed market assessment of Inclisiran 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.
Inclisiran Clinical Assessment
The report provides the clinical trials information of Inclisiran covering trial interventions, trial conditions, trial status, start and completion dates.
Report highlights
Key Questions Answered
Inclisiran - Emerging Insight and Market Forecast - 2030 report by the publisher outlays comprehensive insights of the product indicated for the treatment of its approved condition. A detailed picture of the Inclisiran 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 cover 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.
Inclisiran, the first cholesterol-lowering therapy in the RNAi therapeutics class, is an investigational therapy under clinical development to evaluate its ability to lower low-density lipoprotein cholesterol (also known as LDL-C) through twice-yearly dosing. Inclisiran harnesses the body's natural process of RNA interference to specifically prevent production of the PCSK9 protein in the liver which enhances the liver's ability to remove LDL-C from the bloodstream, thereby lowering LDL-C levels. In phase II studies, inclisiran provided clinically significant LDL-C reductions greater than 50 percent in addition to the effects of statins and/or ezetimibe, and LDL-C reductions were sustained throughout the six-month dosing interval. The safety and efficacy of inclisiran were evaluated in the ORION-11 phase III study with positive results; Inclisiran is not yet approved for use by the FDA or any other regulatory authority. In February 2013 Alnylam granted global rights under a license and collaboration agreement to The Medicines Company to develop, manufacture, and commercialize inclisiran.
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 patent's information with expiry timeline around Inclisiran.
- The report contains historical and forecasted sales for Inclisiran 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 Inclisiran.
Methodology
The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher'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.
Inclisiran Analytical Perspective
In-depth Inclisiran Market Assessment
This report provides a detailed market assessment of Inclisiran 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.
Inclisiran Clinical Assessment
The report provides the clinical trials information of Inclisiran covering trial interventions, trial conditions, trial status, start and completion dates.
Report highlights
- In the coming years, the market scenario for Inclisiran 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 Inclisiran 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 Inclisiran 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 Inclisiran.
- Our in-depth analysis of the sales data of Inclisiran from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Inclisiran in the market.
Key Questions Answered
- What is the prescribed dosage and strengths of Inclisiran are available in the market?
- What are the common adverse reactions or side effects of Inclisiran?
- What is the product type, route of administration and mechanism of action of Inclisiran?
- What are the chemical specifications of Inclisiran?
- How are the clinical trials diversified on the basis of the trial status?
- What is the history of Inclisiran, and what is its future?
- What are the marketed details of Inclisiran 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 Inclisiran and when these patents will get expire?
- What are the pros (benefits) and cons (disadvantages) of Inclisiran?
- In which countries Inclisiran got approval and when it gets launched?
- What are the clinical trials are currently ongoing for Inclisiran?
- How the safety and efficacy results determined the approval of Inclisiran?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Inclisiran development?
- What are the key designations that have been granted to Inclisiran?
- What is the historical and forecasted market scenario of Inclisiran?
- How is the market trend of Inclisiran 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 Inclisiran?
- Which are the late-stage emerging therapies under development for the treatment of the indicated condition?
Table of Contents
1. Product Overview
2. SWOT Analysis
3. Regulatory Milestones
4. Market Assessment
7. Appendix
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Alnylam Pharmaceuticals
- Novartis
- The Medicines Company