한글목차

에플루시페르민(EFX)(이전 AKR-001)은 아케로의 NASH에 대한 주요 제품 후보입니다. 생물학적 활성 프로파일을 모방하기 위해 설계된 분화형 Fc-FGF21 융합 단백질입니다. EFX는 편리한 주 1회 SC 투여가 가능하도록 설계되었습니다. 그렇다면 NASH 치료제로 동급 최고의 약이 될 수 있습니다.

EFX는 현재 생검에서 NASH가 확인된 환자를 대상으로 한 2개의 임상 제IIb상 시험(F2-F3 섬유화를 가진 간경변 전 환자를 대상으로 한 HARMONY 시험 및 F4 섬유화를 간경변 환자를 대상으로 한 SYMMETRY 시험)에서 평가되고 있습니다.

본 보고서는 주요 7개국의 에플루시페르민 시장에 대해 조사했으며,, 시장 개요와 함께 경쟁 구도, 2032년까지 시장 규모 예측, 국가별 시장 분석 등을 제공합니다.

목차

제1장 보고서 소개

제2장 비알코올성 지방간염(NASH)에서의 에플루시페르민의 개요

• 제품 상세
• 임상 개발
• 기타 개발 활동
• 제품 프로파일

제3장 경쟁 구도(출시된 치료법

제4장 경쟁 구도(후기 단계의 신흥 치료법

제5장 에플루시페르민 시장 평가

• 비알코올성 지방간염(NASH)에서의 에플루시페르민 시장 전망
• 주요 7개국 분석
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 정보

제12장 보고서 구매 옵션

영문목차

"Efruxifermin Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about Efruxifermin for Non-alcoholic Steatohepatitis (NASH) in the seven major markets. A detailed picture of the Efruxifermin for NASH 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 Efruxifermin for NASH. 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 Efruxifermin market forecast analysis for NASH in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in NASH.

Drug Summary:

Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. It is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly SC dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treating NASH.

EFX is currently being evaluated in two Phase IIb clinical trials in patients with biopsy-confirmed NASH: the HARMONY study in pre-cirrhotic patients with F2-F3 fibrosis and the SYMMETRY study in cirrhotic patients with compensated F4 fibrosis. Results of the main study in patients with compensated cirrhosis due to NASH (F4) expected in fourth quarter of 2023.

Scope of the Report:

The report provides insights into:

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

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.

Efruxifermin Analytical Perspective by DelveInsight

• In-depth Efruxifermin Market Assessment

This report provides a detailed market assessment of Efruxifermin for Non-alcoholic Steatohepatitis (NASH) 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 2027 to 2032.

• Efruxifermin Clinical Assessment

The report provides the clinical trials information of Efruxifermin for Non-alcoholic Steatohepatitis (NASH) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Non-alcoholic Steatohepatitis (NASH) 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 Efruxifermin dominance.
• Other emerging products for NASH are expected to give tough market competition to Efruxifermin 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 Efruxifermin in NASH.
• Our in-depth analysis of the forecasted sales data of Efruxifermin from 2027 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Efruxifermin in NASH.

Key Questions:

• What is the product type, route of administration and mechanism of action of Efruxifermin?
• What is the clinical trial status of the study related to Efruxifermin in Non-alcoholic Steatohepatitis (NASH) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Efruxifermin development?
• What are the key designations that have been granted to Efruxifermin for NASH?
• What is the forecasted market scenario of Efruxifermin for NASH?
• What are the forecasted sales of Efruxifermin 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 Efruxifermin for NASH?
• Which are the late-stage emerging therapies under development for the treatment of NASH?

Table of Contents

1. Report Introduction

2. Efruxifermin Overview in Non-alcoholic Steatohepatitis (NASH)

• 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. Efruxifermin Market Assessment

• 5.1. Market Outlook of Efruxifermin in Non-alcoholic Steatohepatitis (NASH)
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of Efruxifermin in the 7MM for Non-alcoholic Steatohepatitis (NASH)
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of Efruxifermin in the United States for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.2. Market Size of Efruxifermin in Germany for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.3. Market Size of Efruxifermin in France for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.4. Market Size of Efruxifermin in Italy for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.5. Market Size of Efruxifermin in Spain for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.6. Market Size of Efruxifermin in the United Kingdom for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.7. Market Size of Efruxifermin in Japan for Non-alcoholic Steatohepatitis (NASH)

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