Product Code: DIDM0034
"Casimersen - Emerging 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 Casimersen 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.
Casimersen uses Sarepta's proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 45 of the DMD gene. Casimersen is designed to bind to exon 45 of dystrophin pre-mRNA, resulting in exclusion, or "skipping," of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 45 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. In June 2020, Sarepta Therapeutics has completed the submission of the casimersen (SRP-4045) New Drug Application (NDA) for the treatment of Duchenne muscular dystrophy (DMD) in patients who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.The completion of the rolling submission includes data from the casimersen arm of the ESSENCE study (also known as study 4045-301), a global, randomized, double-blind, placebo-controlled Phase 3 study evaluating efficacy and safety in patients amenable to skipping exons 45 and 53. An interim analysis from ESSENCE demonstrated a statistically significant increase in dystrophin production as measured by western blot* in patients who received casimersen compared to baseline and placebo. The study is ongoing and remains blinded to collect additional efficacy and safety data. If the casimersen NDA is accepted and granted accelerated approval, the completed ESSENCE study will serve as a post-marketing confirmatory study.
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 Casimersen.
- The report contains historical and forecasted sales for Casimersen 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 Casimersen.
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.
Casimersen Analytical Perspective by DelveInsight
- In-depth Casimersen Market Assessment
This report provides a detailed market assessment of Casimersen 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.
- Casimersen Clinical Assessment
The report provides the clinical trials information of Casimersen covering trial interventions, trial conditions, trial status, start and completion dates.
- In the coming years, the market scenario for Casimersen 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 Casimersen 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 Casimersen 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 Casimersen.
- Our in-depth analysis of the sales data of Casimersen from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Casimersen in the market.
- What is the prescribed dosage and strengths of Casimersen are available in the market?
- What are the common adverse reactions or side effects of Casimersen?
- What is the product type, route of administration and mechanism of action of Casimersen?
- What are the chemical specifications of Casimersen?
- How are the clinical trials diversified on the basis of the trial status?
- What is the history of Casimersen, and what is its future?
- What are the marketed details of Casimersen 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 Casimersen and when these patents will get expire?
- What are the pros (benefits) and cons (disadvantages) of Casimersen?
- In which countries Casimersen got approval and when it gets launched?
- What are the clinical trials are currently ongoing for Casimersen?
- How the safety and efficacy results determined the approval of Casimersen?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Casimersen development?
- What are the key designations that have been granted to Casimersen?
- What is the historical and forecasted market scenario of Casimersen?
- How is the market trend of Casimersen 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 Casimersen?
- Which are the late-stage emerging therapies under development for the treatment of the indicated condition?
Table of Contents
1. Product Overview
- 1.1. Indication
- 1.2. Mechanism of Action
- 1.3. Dosage and Administration
- 1.4.1 Dosage Forms and Strengths
- 1.4. Route of Synthesis
- 1.5. Pharmacology
- 1.4.2 Pharmacodynamics
- 1.4.3 Pharmacokinetics
- 1.6. Adverse Reactions
- 1.7. Product Snapshot
- 1.8. Development Milestones of Casimersen
- 1.9. Marketed Details
- 1.4.4 United States
- 1.4.5 Europe
- 1.4.6 Japan
- 1.10. Patent Details
2. SWOT Analysis
3. Regulatory Milestones
- 3.1. Approvals
- 3.2. Research and Development
- 3.3. Clinical Trials Information
- 3.4. Safety and Efficacy
- 3.5. Product Developmental Activities
4. Market Assessment
- 4.1. 7MM Market Analysis
- 4.2. United States
- 4.3. Europe
- 4.4. Japan
- 4.5. Key Findings
5. Market Competitors
6. Emerging Therapies
- 7.1. Report Purchase Options
List of Tables
- Table 1 Casimersen, Description
- Table 2 Casimersen, Trial Diversification
- Table 3 Casimersen, Marketed Details United States
- Table 4 Casimersen, Marketed Details Europe
- Table 5 Casimersen, Marketed Details Japan
- Table 6 Patent Details: Casimersen
- Table 7 Casimersen, Clinical Trial Description, 2020
- Table 8 Safety and Efficacy Results for Casimersen
- Table 9 Casimersen, 7MM Market Size from 2017 to 2030 (in Million USD)
- Table 10 Casimersen, US Market Size from 2017 to 2030 (in Million USD)
- Table 11 Casimersen, EU Market Size from 2017 to 2030 (in Million USD)
- Table 12 Casimersen, EU5 Market Size from 2017 to 2030 (in Millions USD)
- Table 13 Casimersen, Japan Market Size from 2017 to 2030 (in Million USD)
- Table 14 Market Competitors
- Table 15 Emerging Therapies
List of Figures
- Figure 1 The Development Timeline of Casimersen
- Figure 2 Patent Details, Casimersen
- Figure 3 Casimersen, 7MM Market Size from 2017 to 2030 (in Million USD)
- Figure 4 Casimersen, US Market Size from 2017 to 2030 (in Millions USD)
- Figure 5 Casimersen, EU Market Size from 2017 to 2030 (in Millions USD)
- Figure 6 Casimersen, EU5 Market Size from 2017 to 2030 (in Millions USD)
- Figure 7 Casimersen, Japan Market Size from 2017 to 2030 (in Millions USD)