MGB-BP-3の新興薬剤に関する洞察と市場予測：2032年

MGB Biopharmaが開発中のMGB-BP-3は、クロストリジウムディフィシル関連疾患（CDAD）治療用の新規作用機序を有する強力な経口殺菌性抗生物質です。MGB-BP-3は迅速な殺菌作用を有し、クロストリジウムディフィシルが芽胞を形成する前に植物型で死滅させることができるため、初期治癒を達成し、疾患の再発を予防し、クロストリジウムディフィシル感染症の総負担を軽減することができます。さらに、MGB-BP-3はBI/NAP1/027株に対して強力な殺菌活性を有しており、この株は現在の治療法にほとんど耐性を示す最も病原性の強い株です。

良好な第II相データは、MGB-BP-3がCDIの高い治癒持続率を提供することを示しています。2021年1月、MGBバイオファーマは米国FDAとの第Ⅱ相終了（EOP2）会議が無事終了したことを発表しました。この会議で米国FDAは、同社の2つの前向き第III相試験のデザインと評価項目が適切であることを確認しました。この第III相試験では、約900人の患者を採用する予定であり、臨床効果の持続という重要な指標におけるバンコマイシンに対するMGB-BP-3の優越性を評価項目の1つに含める予定です。

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、MGB-BP-3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、MGB-BP-3に厳しい市場競合を与えることが予想され、近い将来、後発の新興治療薬の発売が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MGB-BP-3市場について調査し、市場の概要とともに、2028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MGB-BP-3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 MGB-BP-3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MGB-BP-3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MGB-BP-3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: MGB-BP-3, Clinical Trial Description, 2023
• Table 2: MGB-BP-3, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: MGB-BP-3 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: MGB-BP-3 Market Size in the US, in USD million (2019-2032)
• Table 7: MGB-BP-3 Market Size in Germany, in USD million (2019-2032)
• Table 8: MGB-BP-3 Market Size in France, in USD million (2019-2032)
• Table 9: MGB-BP-3 Market Size in Italy, in USD million (2019-2032)
• Table 10: MGB-BP-3 Market Size in Spain, in USD million (2019-2032)
• Table 11: MGB-BP-3 Market Size in the UK, in USD million (2019-2032)
• Table 12: MGB-BP-3 Market Size in Japan, in USD million (2019-2032)

List of Figures

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

“"MGB-BP-3 Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about MGB-BP-3 for clostridium difficile infection (CDI) in the seven major markets. A detailed picture of the MGB-BP-3 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 MGB-BP-3 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 MGB-BP-3 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:

MGB-BP-3, being developed by MGB Biopharma, is a potent oral bactericidal antibiotic with a novel mode of action for the treatment of Clostridium difficile-associated disease (CDAD). MGB-BP-3 has a fast bactericidal effect which can kill C. difficile in its vegetative form before it forms spores, thus achieving an initial cure and preventing the disease from recurring and reducing the total burden of C. difficile. Moreover, MGB-BP-3 has strong bactericidal activity against the BI/NAP1/027 strain, the most virulent strain that is largely resistant to current therapy.

The positive Phase II data showed that MGB-BP-3 provides high rates of sustained cure from CDI. In January 2021, MGB Biopharma announced the successful completion of its End-of-Phase II (EOP2) meeting with the US FDA. At the meeting, the US FDA confirmed that the design and the endpoints of the company's two prospective Phase III studies were appropriate. The Phase III studies, which are expected to recruit approximately 900 patients, will include the superiority of MGB-BP-3 against vancomycin in the critical measure of sustained clinical response as one of their endpoints.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the MGB-BP-3 description, mechanism of action, dosage and administration, research and development activities in clostridium difficile infection.
• Elaborated details on MGB-BP-3 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the MGB-BP-3 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 MGB-BP-3.
• The report contains forecasted sales of MGB-BP-3 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 MGB-BP-3 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.

MGB-BP-3 Analytical Perspective by DelveInsight

In-depth MGB-BP-3 Market Assessment

This report provides a detailed market assessment of MGB-BP-3 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 2028 to 2032.

MGB-BP-3 Clinical Assessment

The report provides the clinical trials information of MGB-BP-3 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 MGB-BP-3 dominance.
• Other emerging products for clostridium difficile infection are expected to give tough market competition to MGB-BP-3 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 MGB-BP-3 in clostridium difficile infection.
• Our in-depth analysis of the forecasted sales data of MGB-BP-3 from 2028 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the MGB-BP-3 in clostridium difficile infection.

Key Questions:

• What is the product type, route of administration and mechanism of action of MGB-BP-3?
• What is the clinical trial status of the study related to MGB-BP-3 in clostridium difficile infection and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the MGB-BP-3 development?
• What are the key designations that have been granted to MGB-BP-3 for clostridium difficile infection?
• What is the forecasted market scenario of MGB-BP-3 for clostridium difficile infection?
• What are the forecasted sales of MGB-BP-3 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 MGB-BP-3 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. MGB-BP-3 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. MGB-BP-3 Market Assessment

• 5.1. Market Outlook of MGB-BP-3 in Clostridium difficile infection
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of MGB-BP-3 in the 7MM for Clostridium difficile infection
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of MGB-BP-3 in the United States for Clostridium difficile infection
  • 5.3.2. Market Size of MGB-BP-3 in Germany for Clostridium difficile infection
  • 5.3.3. Market Size of MGB-BP-3 in France for Clostridium difficile infection
  • 5.3.4. Market Size of MGB-BP-3 in Italy for Clostridium difficile infection
  • 5.3.5. Market Size of MGB-BP-3 in Spain for Clostridium difficile infection
  • 5.3.6. Market Size of MGB-BP-3 in the United Kingdom for Clostridium difficile infection
  • 5.3.7. Market Size of MGB-BP-3 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