ジーンプラバの新興薬剤に関する洞察と市場予測：2032年

Merck Sharp &Dohme LLC（MSD）が開発したジーンプラバ（ベズロトクスマブ）は、クロストリジウムディフィシル、トキシンBに結合するヒトモノクローナル抗体で、CDIの抗菌薬治療を受けておりCDI再発リスクが高い18歳以上の患者におけるCDIの再発抑制を適応としています。Vero細胞またはCaco-2細胞を用いた細胞ベースのアッセイにおけるin vitro試験では、本剤がトキシンBの毒性作用を中和することが示唆されています。

FDAによるジーンプラバの承認は2つの第III相試験、MODIFY IとIIに基づいています。ジーンプラバは抗菌薬ではなく、CDIの治療には適応されません。2022年5月、MerckはCDIと確定診断された1歳以上18歳未満の小児を対象としたrCDIの第III相試験（MODIFY III）を終了しました。

ジーンプラバはヒト型モノクローナルIgG1/κ抗体であり、クロストリジウムディフィシル、トキシンBに結合し、大腸細胞へのトキシンBの結合を阻害し、トキシンを中和します。この薬剤は、2つのFab領域を介して毒素のCROPドメインのN末端半分にある2つのエピトープに結合し、毒素の糖鎖結合ポケットをブロックし、毒素が宿主細胞に結合するのを阻止します。ただし、クロストリジウムディフィシル、トキシンAには結合しません。

今後数年間で、クロストリジウムディフィシル感染症の市場シナリオは、世界中の広範な研究と医療支出の増加により変化します。各社は、病状を治療／改善するための新たなアプローチに焦点を当てた治療法を開発し、課題を評価し、ジーンプラバの優位性に影響を与える可能性のある機会を模索しています。クロストリジウムディフィシル感染症に対する他の新興製品は、ジーンプラバに厳しい市場競争を与えると予想され、近い将来、後発の新興治療薬が発売されれば、市場に大きな影響を与えるとみられています。

当レポートでは、主要7ヶ国におけるジーンプラバ市場について調査し、市場の概要とともに、2023年～2032年の売上予測データ、競合情勢、および国別動向などを提供しています。

目次

第1章 レポートのイントロダクション

第2章 クロストリジウムディフィシル感染症に対するジーンプラバの概要

• 製品の詳細
• 臨床開発
  • 臨床研究
  • 臨床試験情報
  • 安全性と有効性
• 規制上のマイルストーン
• その他の開発活動
• 製品概要

第3章 競合情勢（上市済み治療法）

第4章 競合情勢（後期段階の新興治療法）

第5章 ジーンプラバ市場評価

• クロストリジウムディフィシル感染症に対するジーンプラバの市場展望
• 主要7ヶ国市場分析
  • 主要7ヶ国におけるクロストリジウムディフィシル感染症に対するジーンプラバの市場規模
• 国別市場分析
  • 米国
  • ドイツ
  • 英国

第6章 SWOT分析

第7章 アナリストの見解

第8章 付録

第9章 DelveInsightのサービス内容

第10章 免責事項

第11章 DelveInsightについて

第12章 レポート購入オプション

List of Tables

• Table 1: ZINPLAVA, Clinical Trial Description, 2023
• Table 2: ZINPLAVA, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: ZINPLAVA Market Size in the 7MM, in USD million (2019-2032)
• Table 6: ZINPLAVA Market Size in the US, in USD million (2019-2032)
• Table 7: ZINPLAVA Market Size in Germany, in USD million (2019-2032)
• Table 8: ZINPLAVA Market Size in France, in USD million (2019-2032)
• Table 9: ZINPLAVA Market Size in Italy, in USD million (2019-2032)
• Table 10: ZINPLAVA Market Size in Spain, in USD million (2019-2032)
• Table 11: ZINPLAVA Market Size in the UK, in USD million (2019-2032)
• Table 12: ZINPLAVA Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: ZINPLAVA Market Size in the 7MM, USD million (2019-2032)
• Figure 2: ZINPLAVA Market Size in the United States, USD million (2019-2032)
• Figure 3: ZINPLAVA Market Size in Germany, USD million (2019-2032)
• Figure 4: ZINPLAVA Market Size in France, USD million (2019-2032)
• Figure 5: ZINPLAVA Market Size in Italy, USD million (2019-2032)
• Figure 6: ZINPLAVA Market Size in Spain, USD million (2019-2032)
• Figure 7: ZINPLAVA Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: ZINPLAVA Market Size in Japan, USD million (2019-2032)

“"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