HTD1801の市場規模、予測、新薬の考察（2032年）

薬剤のサマリー

HTD1801（ベルベリンウルソデオキシコール酸塩またはBUDCA）は、ベルベリンとウルソデオキシコール酸のイオン性塩であり、NASHとその合併症の一部に対して1回の治療で併用療法の可能性を提供する分子体です。BUDCAは、脂肪性肝疾患およびNASHと推定される患者において、幅広い代謝活性を有する単一分子です。経口投与が可能で、比較的忍容性が高いです。

フェーズIIランダム化比較試験のデータは、糖尿病とその他のメタボリックシンドロームの特徴を有する患者におけるNASHの治療薬としてのBUDCAのさらなる開発を支持するものであり、今後の試験において肝脂肪量（LFC）の減少が病理組織学的改善と相関することが予測されます。

当レポートでは、主要7市場（米国、ドイツ、フランス、イタリア、スペイン、英国、日本）における非アルコール性脂肪性肝炎（NASH）向けHTD1801について調査分析し、市場規模の予測や、作用機序、用法と用量、研究開発活動などの情報を提供しています。

目次

第1章 レポートのイントロダクション

第2章 非アルコール性脂肪肝炎（NASH）におけるHTD1801の概要

• 製品詳細
• 臨床開発
  • 臨床研究
  • 臨床試験情報
  • 安全性と有効性
• その他の開発活動
• 製品のプロファイル

第3章 競合情勢（上市済みの治療法）

第4章 競合情勢（後期段階の新治療法）

第5章 HTD1801市場の評価

• 非アルコール性脂肪肝炎（NASH）におけるHTD1801の市場見通し
• 主要7市場の分析
  • 主要7市場の非アルコール性脂肪肝炎（NASH）向けHTD1801の市場規模
• 市場の分析：国別
  • 米国の非アルコール性脂肪肝炎（NASH）向けHTD1801の市場規模
  • ドイツの非アルコール性脂肪肝炎（NASH）向けHTD1801の市場規模
  • 英国の非アルコール性脂肪肝炎（NASH）向けHTD1801の市場規模

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: HTD1801, Clinical Trial Description, 2023
• Table 2: HTD1801, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: HTD1801 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: HTD1801 Market Size in the US, in USD million (2019-2032)
• Table 7: HTD1801 Market Size in Germany, in USD million (2019-2032)
• Table 8: HTD1801 Market Size in France, in USD million (2019-2032)
• Table 9: HTD1801 Market Size in Italy, in USD million (2019-2032)
• Table 10: HTD1801 Market Size in Spain, in USD million (2019-2032)
• Table 11: HTD1801 Market Size in the UK, in USD million (2019-2032)
• Table 12: HTD1801 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: HTD1801 Market Size in the 7MM, USD million (2019-2032)
• Figure 2: HTD1801 Market Size in the United States, USD million (2019-2032)
• Figure 3: HTD1801 Market Size in Germany, USD million (2019-2032)
• Figure 4: HTD1801 Market Size in France, USD million (2019-2032)
• Figure 5: HTD1801 Market Size in Italy, USD million (2019-2032)
• Figure 6: HTD1801 Market Size in Spain, USD million (2019-2032)
• Figure 7: HTD1801 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: HTD1801 Market Size in Japan, USD million (2019-2032)

"HTD1801 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about HTD1801 for Non-alcoholic Steatohepatitis (NASH) in the seven major markets. A detailed picture of the HTD1801 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 HTD1801 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 HTD1801 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:

HTD1801 (berberine ursodeoxycholate or BUDCA) is an ionic salt of berberine and ursodeoxycholic acid, representing a molecular entity that offers the possibility of combination therapy for NASH and some of its comorbidities in a single treatment. BUDCA is a single molecule with a broad spectrum of metabolic activity in patients with fatty liver disease and presumed NASH. It is orally administered and relatively well tolerated.

The data from the Phase II randomized controlled trial support further development of BUDCA as a treatment for NASH in patients with diabetes and other features of the metabolic syndrome, and it is anticipated that the reduction in liver fat content (LFC) will correlate with histopathologic improvement in future studies.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the HTD1801 description, mechanism of action, dosage and administration, research and development activities in Non-alcoholic Steatohepatitis (NASH).
• Elaborated details on HTD1801 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the HTD1801 research and development activities in NASH across the United States, Europe, and Japan.
• The report also covers the patents information with expiry timeline around HTD1801.
• The report contains forecasted sales of HTD1801 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 HTD1801 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.

HTD1801 Analytical Perspective by DelveInsight

• In-depth HTD1801 Market Assessment

This report provides a detailed market assessment of HTD1801 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 2029 to 2032.

• HTD1801 Clinical Assessment

The report provides the clinical trials information of HTD1801 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 HTD1801 dominance.
• Other emerging products for NASH are expected to give tough market competition to HTD1801 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 HTD1801 in NASH.
• Our in-depth analysis of the forecasted sales data of HTD1801 from 2029 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the HTD1801 in NASH.

Key Questions:

• What is the product type, route of administration and mechanism of action of HTD1801?
• What is the clinical trial status of the study related to HTD1801 in Non-alcoholic Steatohepatitis (NASH) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the HTD1801 development?
• What are the key designations that have been granted to HTD1801 for NASH?
• What is the forecasted market scenario of HTD1801 for NASH?
• What are the forecasted sales of HTD1801 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 HTD1801 for NASH?
• Which are the late-stage emerging therapies under development for the treatment of NASH?

Table of Contents

1. Report Introduction

2. HTD1801 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. HTD1801 Market Assessment

• 5.1. Market Outlook of HTD1801 in Non-alcoholic Steatohepatitis (NASH)
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of HTD1801 in the 7MM for Non-alcoholic Steatohepatitis (NASH)
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of HTD1801 in the United States for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.2. Market Size of HTD1801 in Germany for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.3. Market Size of HTD1801 in France for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.4. Market Size of HTD1801 in Italy for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.5. Market Size of HTD1801 in Spain for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.6. Market Size of HTD1801 in the United Kingdom for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.7. Market Size of HTD1801 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