한글목차

VEMLIDY는 HBV 뉴클레오시드 유사체 역전사효소 억제제로, 성인 및 12세 이상의 보상성 간질환을 앓고 있는 소아 환자의 만성 B형 간염 바이러스 감염 치료에 적응증을 갖고 있습니다.

VEMLIDY는 새로운 테노포비르 표적 프로드러그로서 길리어드의 VIREAD(테노포비르 디소프록실 푸마르산염, TDF) 300mg과 유사한 항바이러스 효과를 나타내며, 용량은 길리어드의 VIREAD(테노포비르 디소프록실 푸마르산염, TDF) 300mg의 10분의 1 이하입니다. mg의 10분의 1 이하입니다. 제품 라벨에는 젖산증/지방증을 동반한 심각한 간 비대 및 치료 후 B형 간염의 심각한 급성 악화 위험에 대한 경고 문구가 포함되어 있습니다.

앞으로 몇 년동안 만성 B형 간염 시장 시나리오는 전 세계적으로 광범위한 조사와 의료비 지출 증가로 인해 변화할 것입니다. 각 회사는 질병을 치료/개선하기 위한 새로운 접근법에 초점을 맞춘 치료법을 개발하고, 과제를 평가하고, VEMLIDY의 우위에 영향을 미칠 수 있는 기회를 모색하고 있습니다. 만성 B형 간염을 대상으로 하는 다른 신흥 제품들이 베믈리디와 치열한 시장 경쟁을 벌일 것으로 예상되며, 가까운 시일 내에 후발 신약이 출시되면 시장에 큰 영향을 미칠 것으로 예상됩니다.

이 보고서는 주요 7개국과 중국의 만성 B형 간염 치료제 VEMLIDY 시장에 대해 조사했으며, 시장 개요, 경쟁 구도, 2032년까지 시장 규모 예측, 국가별 시장 분석 등의 정보를 전해드립니다.

목차

제1장 보고서 서론

제2장 만성 B형 간염 치료제 VEMLIDY 개요

• 제품 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 단계 신흥 치료법)

제5장 VEMLIDY 시장 평가

• 만성 B형 간염 치료제 VEMLIDY 시장 전망
• 주요 7개국과 중국 분석
  • 주요 7개국 및 중국의 만성 B형 간염 치료제 VEMLIDY 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국
  • 중국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight에 대해

제12장 보고서 구입 옵션

영문목차

"VEMLIDY Market Size, Forecast, and Market Insight - 2032" report provides comprehensive insights about VEMLIDY for chronic hepatitis B in the seven major markets and China. A detailed picture of the VEMLIDY 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 VEMLIDY 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 VEMLIDY 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:

VEMLIDY is a HBV nucleoside analog reverse transcriptase inhibitor and is indicated for treating chronic hepatitis B virus infection in adults and pediatric patients 12 years and older with compensated liver disease.

VEMLIDY is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's VIREAD (tenofovir disoproxil fumarate, TDF) 300 mg. It has a boxed warning on its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B.

• Dosage and administration

The recommended dosage of VEMLIDY in adults and pediatric patients aged 12 and older is one 25 mg tablet taken orally once daily with food.

• Mechanism of action

Tenofovir alafenamide is an antiviral drug against the hepatitis B virus; it is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analog). Tenofovir alafenamide is a lipophilic cell-permeate compound that enters primary hepatocytes by passive diffusion and hepatic uptake transporters OATP1B1 and OATP1B3. It is then converted to tenofovir through hydrolysis, primarily by carboxylesterase 1 (CES1) in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination.

Scope of the Report:

The report provides insights into:

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

VEMLIDY Analytical Perspective by DelveInsight

• In-depth VEMLIDY Market Assessment

This report provides a detailed market assessment of VEMLIDY 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.

• VEMLIDY Clinical Assessment

The report provides the clinical trials information of VEMLIDY 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 VEMLIDY dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to VEMLIDY 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 VEMLIDY in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of VEMLIDY from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the VEMLIDY in chronic hepatitis B.

Key Questions:

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

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