DIFICIDの薬剤に関する洞察と市場予測：2032年

Merck & CoとAstellas Pharmaが製造するDIFICID（フィダキソマイシン）は、成人および生後6カ月以上の小児のCDAD治療に使用されるマクロライド系抗生物質です。クロストリジオイデスディフィシルは、大腸を損傷し、腹痛や激しい下痢を引き起こす感染症を引き起こす細菌です。

フィダキソマイシン（別名OPT-80、PAR-101）は新規の抗生物質で、マクロサイクルと呼ばれる新しいクラスの抗菌薬の最初の代表薬です。主にクロストリジオイデスディフィシル感染症に有効で、その他のグラム陽性菌に対しても中程度の活性を示します。本剤は吸収が悪く、消化管内でその活性を発揮するため、CDI（CDADとも呼ばれる）の適応および治療に使用する場合に有利です。

DIFICIDは、食事の有無にかかわらず経口投与されます。成人には1回200mgを1日2回、10日間経口投与します。体重12.5kg以上で錠剤を嚥下できる小児患者には、1回DIFICID錠200mgを1日2回、10日間経口投与します。錠剤を嚥下できない小児患者には、DIFICID経口懸濁液を投与することができます。

フィダキソミシンの構造は、不飽和の18員環大環状コアを含みます。ダクチロスポランギウムアウランティアカム（dactylosporangium aurantiacum）菌の菌株から単離され、チアクミシンの仲間です。フィダキソミシンはRNAポリメラーゼに結合することにより細菌のタンパク質合成を阻害します。クロストリジオイデスディフィシル感染症に対する殺菌活性は、fidaxomicinでは6～10時間、活性代謝物であるOP-1118では3時間の抗菌後効果が続きます。

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、DIFICID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、DIFICIDに厳しい市場競争をもたらすと予想され、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DIFICID市場について調査し、市場の概要とともに、2025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DIFICID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 困難な市場評価

• クロストリジウムディフィシル感染症に対するDIFICID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DIFICID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: DIFICID, Clinical Trial Description, 2023
• Table 2: DIFICID, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: DIFICID Market Size in the 7MM, in USD million (2019-2032)
• Table 6: DIFICID Market Size in the US, in USD million (2019-2032)
• Table 7: DIFICID Market Size in Germany, in USD million (2019-2032)
• Table 8: DIFICID Market Size in France, in USD million (2019-2032)
• Table 9: DIFICID Market Size in Italy, in USD million (2019-2032)
• Table 10: DIFICID Market Size in Spain, in USD million (2019-2032)
• Table 11: DIFICID Market Size in the UK, in USD million (2019-2032)
• Table 12: DIFICID Market Size in Japan, in USD million (2019-2032)

List of Figures

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

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

DIFICID (fidaxomicin), manufactured by Merck & Co and Astellas Pharma, is a macrolide antibiotic used to treat CDAD in adults and children 6 months of age or older. C. difficile is a bacterium that can cause an infection that can damage the colon and cause stomach pain and severe diarrhea.

Fidaxomicin (also known as OPT-80 and PAR-101) is a novel antibiotic agent, and the first representative of a new class of antibacterials called macrocycles. It has a narrow-spectrum antibacterial profile mainly directed against C. difficile and exerts moderate activity against some other gram-positive species. The drug product is poorly absorbed and exerts its activity in the gastrointestinal (GI) tract, which is an advantage when used in the applied indication and treatment of CDI (also known as CDAD).

Dosage and administration

DIFICID is administered orally with or without food. The recommended dosage for adults is one 200 mg DIFICID tablet orally twice daily for 10 days. For pediatric patients weighing at least 12.5 kg and can swallow tablets, the recommended dosage is one 200 mg DIFICID tablet orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension.

The structure of fidaxomicin includes an unsaturated 18-membered macrocyclic core. It is isolated from a strain of the bacterium dactylosporangium aurantiacum and is a member of the tiacumicin family. Fidaxomicin inhibits bacterial protein synthesis by binding to RNA polymerase. The bactericidal activity against C. difficile is followed by a post-antibiotic effect of 6-10 h for fidaxomicin and 3 h with OP-1118, its active metabolite.

Scope of the Report:

The report provides insights into:

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

DIFICID Analytical Perspective by DelveInsight

In-depth DIFICID Market Assessment

This report provides a detailed market assessment of DIFICID 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 2025 to 2032.

DIFICID Clinical Assessment

The report provides the clinical trials information of DIFICID 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 DIFICID dominance.
• Other emerging products for clostridium difficile infection are expected to give tough market competition to DIFICID 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 DIFICID in clostridium difficile infection.
• Our in-depth analysis of the forecasted sales data of DIFICID from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the DIFICID in clostridium difficile infection.

Key Questions:

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

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