한글목차

Merck & Co와 Astellas Pharma가 생산하는 DIFICID(피닥소마이신)는 성인과 생후 6개월 이상 소아의 CDAD 치료에 사용되는 마크로리드계 항생제입니다. 클로스트리디움 디피실은 대장을 손상시켜 복통과 심한 설사를 유발하는 감염을 일으키는 세균입니다.

피닥소마이신(일명 OPT-80, PAR-101)은 새로운 항생제이며, 매크로사이클이라고 불리는 새로운 유형의 항균제의 첫 번째 대표 약물입니다. 주로 클로스트리디움 디피실 감염에 효과적이며 다른 그람 양성균에 대해서도 중간 정도의 활성을 보입니다. 이 약은 흡수가 잘 되지 않고 소화관 내에서 활성을 발휘하기 때문에 CDI(CDAD라고도 함)의 적응증 및 치료에 사용할 때 유리합니다.

DIFICID는 식사와 관계없이 경구 투여합니다. 성인의 경우 1회 200mg을 1일 2회, 10일간 경구 투여합니다. 체중 12.5kg 이상이고 정제를 삼킬 수 있는 소아 환자는 1회 디피시드정 200mg을 1일 2회, 10일간 경구투여합니다. 정제를 삼킬 수 없는 소아 환자에게는 DIFICID 경구 현탁액을 투여할 수 있습니다.

피닥소마이신의 구조는 불포화 18원 고리형 대환형 코어를 포함합니다. 댁티로스포란지움 아우란티아쿰(dactylosporangium aurantiacum) 균주에서 분리되었으며, 티아미신의 일종입니다. 피닥소마이신은 RNA 중합효소에 결합하여 박테리아의 단백질 합성을 억제합니다. 클로스트리디움 디피실 감염에 대한 살균 활성은 피닥소믹신은 6-10시간, 활성 대사 산물인 OP-1118은 3시간의 항균 후 효과가 지속됩니다.

앞으로 수년간 클로스트리듐 디피실 감염증 시장 시나리오는 세계에서 광범위한 조사와 의료비 지출 증가로 인해 변화할 것입니다. 각 회사는 질병을 치료/개선하기 위한 새로운 접근법에 초점을 맞춘 치료법을 개발하고, 과제를 평가하고, DIFICID의 우위에 영향을 미칠 수 있는 기회를 모색하고 있습니다. 클로스트리듐 디피실 감염에 대한 다른 신흥 제품들은 DIFICID에 치열한 시장 경쟁을 가져올 것으로 예상되며, 가까운 시일 내에 후발주자 신약이 출시될 경우 시장에 큰 영향을 미칠 것으로 예상됩니다.

주요 7개국의 DIFICID 시장에 대해 조사했으며, 시장의 개요와 2025-2032년 판매 예측 데이터, 경쟁 구도 및 국가별 동향 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 클로스트리듐 디피실 감염증에 대한 DIFICID의 개요

• 제품 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 규제상 마일스톤
• 기타 개발 활동
• 제품 개요

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신규 치료법)

제5장 어려운 시장 평가

• 클로스트리듐 디피실 감염증에 대한 DIFICID의 시장 전망
• 주요 7개국 시장 분석
  • 주요 7개국의 클로스트리듐 디피실 감염증에 대한 DIFICID의 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

“"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