ベピロビルセン市場：市場規模、予測、新たな洞察-2032年

ベピロビルセン（GSK3228836）はIonis Pharmaceuticalsにより創製され、共同開発されました。ベピロビルセンは、GSKが2019年8月にIonis Pharmaceuticalsから導入したASO HBVプログラム資産の1つです。これは、B型肝炎ウイルスが感染した肝細胞（肝細胞）内で自己複製し、免疫系によるクリアランスを回避することで疾患の慢性化を促進するウイルス抗原（タンパク質）を作るために使用するRNAを特異的に認識するように設計された治験用アンチセンスオリゴヌクレオチド（ASO）です。ASOは肝臓の酵素を動員し、RNAを不活性型に消化して除去します。その後、RNAのレベルが低下すると、ウイルスと肝細胞によるウイルス抗原（HBsAg）の産生の両方が減少し、循環血液中のHBV DNAと抗原のレベルの低下によって測定することができます。ベピロビルセンにはさらに、Toll-like receptor 8（TLR8）を介して免疫応答を刺激する特性もあり、免疫系が循環血液からウイルスを持続的に除去するのを助ける可能性があります。

現在、活動性CHB患者を対象としたこの薬剤の第III相臨床試験（NCT05630820）および2つの第II相臨床試験（NCT04544956；NCT04676724）で評価中です。最近、第II相試験（NCT04449029）が終了しました。その結果、ベピロビルセンによる治療により、ヌクレオシド／ヌクレオチドアナログ（NA）療法を併用している患者およびNA療法を併用していない患者において、HBsAgおよびHBV DNAのクリアランスが持続することが示されました。

今後数年間で、B型慢性肝炎の市場シナリオは、世界中の広範な調査と医療支出の増加により変化します。各社は、病状を治療/改善するための新たなアプローチに焦点を当てた治療法を開発し、課題を評価し、ベピロビルセンの優位性に影響を与える可能性のある機会を模索しています。B型慢性肝炎に対する他の新興製品は、ベピロビルセンに対して厳しい市場競争を与えると予想され、近い将来、後発の新興治療薬が上市されれば、市場に大きな影響を与えるとみられています。

当レポートでは、主要7ヶ国および中国におけるB型慢性肝炎治療薬のベピロビルセン市場について調査し、市場の概要とともに、競合情勢、2032年までの市場規模予測、および国別市場分析などを提供しています。

目次

第1章 レポートのイントロダクション

第2章 慢性B型肝炎におけるベピロビルセンの概要

• 製品の詳細
• 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
• 製品プロファイル

第3章 競合情勢（上市済み治療法）

第4章 競合情勢（後期段階の新興治療法）

第5章 ベピロビルセン市場評価

• 慢性B型肝炎におけるベピロビルセン市場の見通し
• 主要7ヶ国と中国の分析
  • 主要7ヶ国と中国における慢性B型肝炎治療薬ベピロビルセンの市場規模
• 国別市場分析
  • 米国
  • ドイツ
  • 英国
  • 中国

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: Bepirovirsen, Clinical Trial Description, 2023
• Table 2: Bepirovirsen, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Late-stage Emerging Therapies)
• Table 5: Bepirovirsen Market Size in the 7MM and China, in USD million (2019-2032)
• Table 6: Bepirovirsen Market Size in the US, in USD million (2019-2032)
• Table 7: Bepirovirsen Market Size in Germany, in USD million (2019-2032)
• Table 8: Bepirovirsen Market Size in France, in USD million (2019-2032)
• Table 9: Bepirovirsen Market Size in Italy, in USD million (2019-2032)
• Table 10: Bepirovirsen Market Size in Spain, in USD million (2019-2032)
• Table 11: Bepirovirsen Market Size in the UK, in USD million (2019-2032)
• Table 12: Bepirovirsen Market Size in Japan, in USD million (2019-2032)
• Table 13: Bepirovirsen Market Size in China, in USD million (2019-2032)

List of Figures

• Figure 1: Bepirovirsen Market Size in the 7MM and China, USD million (2019-2032)
• Figure 2: Bepirovirsen Market Size in the United States, USD million (2019-2032)
• Figure 3: Bepirovirsen Market Size in Germany, USD million (2019-2032)
• Figure 4: Bepirovirsen Market Size in France, USD million (2019-2032)
• Figure 5: Bepirovirsen Market Size in Italy, USD million (2019-2032)
• Figure 6: Bepirovirsen Market Size in Spain, USD million (2019-2032)
• Figure 7: Bepirovirsen Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: Bepirovirsen Market Size in Japan, USD million (2019-2032)
• Figure 9: Bepirovirsen Market Size in China, USD million (2019-2032)

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

Bepirovirsen (GSK3228836) was discovered by and jointly developed with Ionis Pharmaceuticals. Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019. It is an investigational antisense oligonucleotide (ASO) designed to specifically recognize the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) that facilitate chronicity of the disease by helping to avoid clearance by the immune system. The ASO recruits the liver's enzymes to eliminate the RNA by digesting it to an inactive form. The subsequent reduction in the levels of the RNA results in a decrease in both the virus and the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the HBV DNA and antigen levels in the circulating blood. Bepirovirsen has the additional property of stimulating immune responses via toll-like receptor 8 (TLR8), which may help the immune system to achieve durable clearance of the virus from circulating blood.

Currently, it is being evaluated in Phase III (NCT05630820) and two Phase II (NCT04544956; NCT04676724) clinical trials for this drug in patients with active CHB. Recently, it has completed a Phase II (NCT04449029) study. The results showed that treatment with bepirovirsen resulted in sustained clearance of HBsAg and HBV DNA in patients on concurrent nucleoside/nucleotide analogs (NA) and patient not-on-NA therapy.

Scope of the Report:

The report provides insights into:

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

Bepirovirsen Analytical Perspective by DelveInsight

• In-depth Bepirovirsen Market Assessment

This report provides a detailed market assessment of bepirovirsen 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 2026 to 2032.

• Bepirovirsen Clinical Assessment

The report provides the clinical trials information of bepirovirsen 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 bepirovirsen dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to bepirovirsen 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 bepirovirsen in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of bepirovirsen from 2026 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the bepirovirsen in chronic hepatitis B.

Key Questions:

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

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. Bepirovirsen Market Assessment

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