한글목차

약제 요약

엔테카비르는 강력하고 선택적인 B형 간염 바이러스 복제 억제제이며, HBe 항원 양성 및 HBe 항원 음성인 라미부딘 미치료 만성 B형 간염(CHB) 환자에서 매일 0.5mg의 ETV 투여는 라미부딘(LAM)과 비교하여 더 강력한 바이러스 억제, 더 높은 생화학적 완화율, 개선된 간 조직 영상과 관련이 있습니다. 3년간의 ETV 치료 후 대부분의 환자(94%)는 민감한 PCR 분석에서 검출되지 않는 혈청 HBV DNA 수준에 도달 할 수 있으며, LAM 내성 HBV 변이체를 가진 환자의 ETV 치료에는 하루 1mg의 고용량이 필요합니다. 그러나 3년후 강력한 HBV 억제율은 40%에 불과하고 유전자형 HBV 내성의 누적 비율은 1년차 6%에서 3년차에는 30% 이상으로 증가하며 ETV에 의한 HBV 내성은 라미부딘 미치료 환자에서 드물며 치료 3년후 내성률은 1% 미만인 것으로보고되었습니다. 결론적으로, ETV는 내성에 대한 유전적 장벽이 높은 매우 강력한 항HBV 약물로, 라미부딘 미치료 CHB 환자에서 매우 효과적이며 장기적인 치료에 가장 유망하지만, LAM 내성 HBV 변이체를 보유한 CHB 환자에게는 적합하지 않습니다.

주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)의 B형 만성 간염용 엔테카비르에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 B형 만성 간염에서의 엔테카비르 개요

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

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 신치료법)

제5장 엔테카비르 시장 평가

• B형 만성 간염에서 엔테카비르의 시장 전망
• 주요 7 시장과 중국 분석
  • 주요 7 시장과 중국의 B형 만성 간염용 엔테카비르의 시장 규모
• 시장 분석 : 국가별
  • 미국의 B형 만성 간염용 엔테카비르의 시장 규모
  • 독일의 B형 만성 간염용 엔테카비르의 시장 규모
  • 영국의 B형 만성 간염용 엔테카비르의 시장 규모
  • 중국의 B형 만성 간염용 엔테카비르의 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"Entecavir Market Size, Forecast, and Market Insight - 2032" report provides comprehensive insights about entecavir for chronic hepatitis B in the seven major markets and China. A detailed picture of the entecavir for chronic hepatitis B in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China for the study period 2019 -2032 is provided in this report along with a detailed description of the entecavir for chronic hepatitis B. 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 entecavir market forecast analysis for chronic hepatitis B in the 7MM and China, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in chronic hepatitis B.

Drug Summary:

Entecavir is a potent and selective inhibitor of hepatitis B virus replication. In HBeAg-positive and HBeAg-negative lamivudine-naive patients with chronic hepatitis B (CHB), treatment with ETV at a dose of 0.5 mg daily is associated with a more potent viral suppression, a higher rate of biochemical remission and a greater improvement of liver histology compared to Lamivudine (LAM). After 3 years of ETV treatment, the majority of patients (94%) may achieve serum HBV DNA levels undetectable by sensitive PCR assays. ETV treatment of patients with LAM-resistant HBV mutants requires a higher daily dose of 1 mg yet, potent HBV suppression at 3 years is achieved only in 40% of them while the cumulative rate of genotypic HBV resistance increases from 6% in the first year to >30% in year 3. ETV resistance of HBV is rare in lamivudine-naive patients with a reported rate of <1% after three years of treatment. In conclusion, ETV is a very potent anti-HBV drug with a high genetic barrier to resistance, highly effective in lamivudine-naive CHB patients and most promising for their long-term treatment but not very suitable for CHB patients harboring LAM-resistant HBV mutants.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the entecavir description, mechanism of action, dosage and administration, research and development activities in chronic hepatitis B.
• Elaborated details on entecavir regulatory milestones and other development activities have been provided in this report.
• The report also highlights the entecavir research and development activities in chronic hepatitis B across the United States, Europe, Japan, and China.
• The report also covers the patents information with expiry timeline around entecavir.
• The report contains forecasted sales of entecavir for chronic hepatitis B till 2032.
• Comprehensive coverage of the late-stage emerging therapies for chronic hepatitis B.
• The report also features the SWOT analysis with analyst views for entecavir in chronic hepatitis B.

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.

Entecavir Analytical Perspective by DelveInsight

• In-depth Entecavir Market Assessment

This report provides a detailed market assessment of entecavir for chronic hepatitis B in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China. This segment of the report provides forecasted sales data from 2024 to 2032.

• Entecavir Clinical Assessment

The report provides the clinical trials information of entecavir for chronic hepatitis B covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for chronic hepatitis B 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 entecavir dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to entecavir 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 entecavir in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of entecavir from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the entecavir in chronic hepatitis B.

Key Questions:

• What is the product type, route of administration and mechanism of action of entecavir?
• What is the clinical trial status of the study related to entecavir in chronic hepatitis B and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the entecavir development?
• What are the key designations that have been granted to entecavir for chronic hepatitis B?
• What is the forecasted market scenario of entecavir for chronic hepatitis B?
• What are the forecasted sales of entecavir in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China?
• What are the other emerging products available and how are these giving competition to entecavir for chronic hepatitis B?
• Which are the late-stage emerging therapies under development for the treatment of chronic hepatitis B?

Table of Contents

1. Report Introduction

2. Entecavir Overview in Chronic hepatitis B

• 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 Milestones
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. Entecavir Market Assessment

• 5.1. Market Outlook of Entecavir in Chronic hepatitis B
• 5.2. 7MM and China Analysis
  • 5.2.1. Market Size of Entecavir in the 7MM and China for Chronic hepatitis B
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of Entecavir in the United States for Chronic hepatitis B
  • 5.3.2. Market Size of Entecavir in Germany for Chronic hepatitis B
  • 5.3.3. Market Size of Entecavir in France for Chronic hepatitis B
  • 5.3.4. Market Size of Entecavir in Italy for Chronic hepatitis B
  • 5.3.5. Market Size of Entecavir in Spain for Chronic hepatitis B
  • 5.3.6. Market Size of Entecavir in the United Kingdom for Chronic hepatitis B
  • 5.3.7. Market Size of Entecavir in Japan for Chronic hepatitis B
  • 5.3.8. Market Size of Entecavir in China for Chronic hepatitis B

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