진플라바 신규 약제 인사이트와 시장 예측(2032년)

“"ZINPLAVA Drug Insight and Market Forecast - 2032" report provides comprehensive insights about ZINPLAVA for Clostridium Difficile Infection (CDI) in the seven major markets. A detailed picture of the ZINPLAVA for clostridium difficile infection in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the ZINPLAVA for clostridium difficile infection. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the ZINPLAVA market forecast analysis for clostridium difficile infection in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in clostridium difficile infection.

Drug Summary:

ZINPLAVA (bezlotoxumab), developed by Merck Sharp & Dohme LLC (MSD) is a human monoclonal antibody that binds to C. difficile Toxin B, indicated to reduce the recurrence of CDI in patients 18 years or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. In vitro studies in cell-based assays using Vero cells or Caco-2 cells suggest that the drug neutralizes the toxic effects of toxin B. ZINPLAVA is used in conjunction with antibacterial drug treatment of CDI.

The FDA approval of ZINPLAVA was based on two Phase III trials, MODIFY I and II. ZINPLAVA is not an antibacterial drug and is not indicated for the treatment of CDI (Merck, 2016a). In May 2022, Merck completed the Phase III trial (MODIFY III) for rCDI in children aged 1 to <18 years of age with a confirmed diagnosis of CDI.

Dosage and administration

The recommended dose of ZINPLAVA for CDI patients is a single dose of 10 mg/kg administered as an intravenous infusion over 60 min. The drug should be administered during antibacterial drug treatment for CDI.

Mechanism of action

ZINPLAVA is a human monoclonal IgG1/kappa antibody, which binds to the Toxin B of C. difficile, inhibits the binding of the toxin B to the colonocytes, and neutralizes the toxin. The drug binds to the two epitopes within the N-terminal half of the CROP domain of the toxin through its two Fab regions to block the carbohydrate-binding pockets of the toxin and prevents the toxin from binding to the host cells. However, it does not bind to C. difficile toxin A.

Scope of the Report:

The report provides insights into:

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

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.

ZINPLAVA Analytical Perspective by DelveInsight

In-depth ZINPLAVA Market Assessment

This report provides a detailed market assessment of ZINPLAVA for clostridium difficile infection in the seven major markets, 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.

ZINPLAVA Clinical Assessment

The report provides the clinical trials information of ZINPLAVA for clostridium difficile infection covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

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

Key Questions:

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

Table of Contents

1. Report Introduction

2. ZINPLAVA Overview in Clostridium difficile infection

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Regulatory Milestone
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. ZINPLAVA Market Assessment

• 5.1. Market Outlook of ZINPLAVA in Clostridium difficile infection
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of ZINPLAVA in the 7MM for Clostridium difficile infection
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of ZINPLAVA in the United States for Clostridium difficile infection
  • 5.3.2. Market Size of ZINPLAVA in Germany for Clostridium difficile infection
  • 5.3.3. Market Size of ZINPLAVA in France for Clostridium difficile infection
  • 5.3.4. Market Size of ZINPLAVA in Italy for Clostridium difficile infection
  • 5.3.5. Market Size of ZINPLAVA in Spain for Clostridium difficile infection
  • 5.3.6. Market Size of ZINPLAVA in the United Kingdom for Clostridium difficile infection
  • 5.3.7. Market Size of ZINPLAVA in Japan for Clostridium difficile infection

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options