NTCD-M3の新興薬剤に関する洞察と市場予測：2032年

NTCD-M3（クロストリジオイデスディフィシル菌の非毒素原性株-M3株）は、以前はVP 20621として知られており、rCDIの予防を目的としてDestiny Pharma社によって開発されています。NTCD-M3芽胞の経口製剤です。

クロストリジオイデスディフィシル菌NTCD-M3は、クロストリジオイデスディフィシル毒素を発現する遺伝子を持たない天然由来の非毒素原性クロストリジオイデスディフィシル菌株です。NTCD-M3は症状を引き起こすことなく一時的にヒトの腸内に定着し、治療後数週間で腸内細菌叢は正常に戻ります。従って、NTCD-M3は安全なグランドカバーとして機能し、抗生物質治療後にクロストリジオイデスディフィシルの毒性株が大腸内で増殖するのを防ぎます。

NTCD-M3の第IIb相試験はShireによって終了し、その結果は統計的に有意であり、有効性が確認されました。Destiny Pharmaは2023年半ばまでに第III相試験を開始する予定であり、その試験デザインは2020年7月に米国FDAによって承認されています。

Destiny Pharmaは、計画されている第III相臨床試験とその後の商業化に共同出資するための提携協議も行っています。また、提案されている第III相臨床試験デザインについて、EMAから前向きな科学的助言を得ています。

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することが予想されます。各社は、病態を治療／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、NTCD-M3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がNTCD-M3と厳しい市場競争を繰り広げることが予想され、近い将来、後発の新興治療薬が上市されれば、市場に大きな影響を与えるでしょう。

当レポートでは、主要7ヶ国におけるNTCD-M3市場について調査し、市場の概要とともに、2027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NTCD-M3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
• 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 NTCD-M3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NTCD-M3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NTCD-M3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: NTCD-M3, Clinical Trial Description, 2023
• Table 2: NTCD-M3, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: NTCD-M3 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: NTCD-M3 Market Size in the US, in USD million (2019-2032)
• Table 7: NTCD-M3 Market Size in Germany, in USD million (2019-2032)
• Table 8: NTCD-M3 Market Size in France, in USD million (2019-2032)
• Table 9: NTCD-M3 Market Size in Italy, in USD million (2019-2032)
• Table 10: NTCD-M3 Market Size in Spain, in USD million (2019-2032)
• Table 11: NTCD-M3 Market Size in the UK, in USD million (2019-2032)
• Table 12: NTCD-M3 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: NTCD-M3 Market Size in the 7MM, USD million (2019-2032)
• Figure 2: NTCD-M3 Market Size in the United States, USD million (2019-2032)
• Figure 3: NTCD-M3 Market Size in Germany, USD million (2019-2032)
• Figure 4: NTCD-M3 Market Size in France, USD million (2019-2032)
• Figure 5: NTCD-M3 Market Size in Italy, USD million (2019-2032)
• Figure 6: NTCD-M3 Market Size in Spain, USD million (2019-2032)
• Figure 7: NTCD-M3 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: NTCD-M3 Market Size in Japan, USD million (2019-2032)

“"NTCD-M3 Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about NTCD-M3 for clostridium difficile infection (CDI) in the seven major markets. A detailed picture of the NTCD-M3 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 NTCD-M3 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 NTCD-M3 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:

NTCD-M3 (a non-toxigenic strain of C. difficile bacteria- strain M3), previously known as VP 20621, is being developed by Destiny Pharma for the prevention of rCDI. It is an oral formulation of NTCD-M3 spores.

C. difficile NTCD-M3 is a naturally occurring non-toxigenic strain of C. difficile bacteria, which lacks the genes that can express C. difficile toxins. NTCD-M3 temporarily colonizes the human gut without causing any symptoms and the gut microbiome returns to normal a few weeks after treatment. Therefore, it acts as a safe ground cover and prevents the toxic strains of C. difficile from proliferating in the colon after antibiotic treatment.

Phase IIb trials for NTCD-M3 were completed by the Shire and the results were statistically significant confirming efficacy. Destiny Pharma plans to start the Phase III trial by mid of 2023, the design for which was approved by the US FDA in July 2020.

Destiny Pharma is also conducting partnership discussions to co-fund the planned Phase III clinical studies and the subsequent commercialization. It has also received positive scientific advice from EMA on the proposed Phase III study design.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the NTCD-M3 description, mechanism of action, dosage and administration, research and development activities in clostridium difficile infection.
• Elaborated details on NTCD-M3 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the NTCD-M3 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 NTCD-M3.
• The report contains forecasted sales of NTCD-M3 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 NTCD-M3 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.

NTCD-M3 Analytical Perspective by DelveInsight

In-depth NTCD-M3 Market Assessment

This report provides a detailed market assessment of NTCD-M3 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 2027 to 2032.

NTCD-M3 Clinical Assessment

The report provides the clinical trials information of NTCD-M3 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 NTCD-M3 dominance.
• Other emerging products for clostridium difficile infection are expected to give tough market competition to NTCD-M3 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 NTCD-M3 in clostridium difficile infection.
• Our in-depth analysis of the forecasted sales data of NTCD-M3 from 2027 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the NTCD-M3 in clostridium difficile infection.

Key Questions:

• What is the product type, route of administration and mechanism of action of NTCD-M3?
• What is the clinical trial status of the study related to NTCD-M3 in clostridium difficile infection and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the NTCD-M3 development?
• What are the key designations that have been granted to NTCD-M3 for clostridium difficile infection?
• What is the forecasted market scenario of NTCD-M3 for clostridium difficile infection?
• What are the forecasted sales of NTCD-M3 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 NTCD-M3 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. NTCD-M3 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. Other Developmental Activities
• 2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. NTCD-M3 Market Assessment

• 5.1. Market Outlook of NTCD-M3 in Clostridium difficile infection
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of NTCD-M3 in the 7MM for Clostridium difficile infection
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of NTCD-M3 in the United States for Clostridium difficile infection
  • 5.3.2. Market Size of NTCD-M3 in Germany for Clostridium difficile infection
  • 5.3.3. Market Size of NTCD-M3 in France for Clostridium difficile infection
  • 5.3.4. Market Size of NTCD-M3 in Italy for Clostridium difficile infection
  • 5.3.5. Market Size of NTCD-M3 in Spain for Clostridium difficile infection
  • 5.3.6. Market Size of NTCD-M3 in the United Kingdom for Clostridium difficile infection
  • 5.3.7. Market Size of NTCD-M3 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