BRII-835+BRII-179の市場規模、予測、新薬の考察（2032年）

薬剤のサマリー

BRII-836（VIR-2218）は、試験中のHBVを標的とする皮下投与のsiRNAであり、効果的な免疫反応を刺激し、HBVとHDVに対して直接的な抗ウイルス活性を有します。このsiRNAは、安定性を高め、オフターゲット活性を最小化するESC+（Enhanced Stabilization Chemistry Plus）技術を搭載した臨床初のsiRNAであり、潜在的に治療指数の向上をもたらす可能性があります。

また、BRII-179（VBI-2601）は、Pre-S1、Pre-S2、SのHBV表面抗原を発現し、B細胞とT細胞免疫の増強を誘導するように設計された、新しい組換えタンパク質ベースのHBV免疫療法候補薬です。Brii Bioは2018年12月にVBIワクチンからBRII-179（VBI-2601）のライセンスを受け、中国本土、中国香港、マカオ、台湾のライセンス地域におけるBRII-179（VBI-2601）の商業権を得ました。

いずれの薬剤もHBV患者における機序が証明されており、併用することで機能的治癒が期待できる可能性があります。この薬剤は、siRNA遺伝子サイレンシングにより免疫抑制性ウイルス抗原を除去し、免疫療法ワクチンにより宿主HBV特異的免疫を刺激し回復させるという、二重の作用機序を包含しています。

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）と中国市場におけるB型慢性肝炎向けBRII-835+BRII-179について調査分析し、作用機序、用法と用量、研究開発活動についての考察、収益の予測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 B型慢性肝炎におけるBRII-835+BRII-179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（上市済みの治療法）

第4章 競合情勢（後期の新治療法）

第5章 BRII-835+BRII-179市場の評価

• B型慢性肝炎におけるBRII-835+BRII-179の市場見通し
• 主要7市場と中国の分析
  • 主要7市場と中国におけるB型慢性肝炎向けBRII-835+BRII-179の市場規模
• 市場の分析：国別
  • 米国のB型慢性肝炎向けBRII-835+BRII-179の市場規模
  • ドイツのB型慢性肝炎向けBRII-835+BRII-179の市場規模
  • 英国のB型慢性肝炎向けBRII-835+BRII-179の市場規模
  • 中国のB型慢性肝炎向けBRII-835+BRII-179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: BRII-835 + BRII-179, Clinical Trial Description, 2023
• Table 2: BRII-835 + BRII-179, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Late-stage Emerging Therapies)
• Table 5: BRII-835 + BRII-179 Market Size in the 7MM and China, in USD million (2019-2032)
• Table 6: BRII-835 + BRII-179 Market Size in the US, in USD million (2019-2032)
• Table 7: BRII-835 + BRII-179 Market Size in Germany, in USD million (2019-2032)
• Table 8: BRII-835 + BRII-179 Market Size in France, in USD million (2019-2032)
• Table 9: BRII-835 + BRII-179 Market Size in Italy, in USD million (2019-2032)
• Table 10: BRII-835 + BRII-179 Market Size in Spain, in USD million (2019-2032)
• Table 11: BRII-835 + BRII-179 Market Size in the UK, in USD million (2019-2032)
• Table 12: BRII-835 + BRII-179 Market Size in Japan, in USD million (2019-2032)
• Table 13: BRII-835 + BRII-179 Market Size in China, in USD million (2019-2032)

List of Figures

• Figure 1: BRII-835 + BRII-179 Market Size in the 7MM and China, USD million (2019-2032)
• Figure 2: BRII-835 + BRII-179 Market Size in the United States, USD million (2019-2032)
• Figure 3: BRII-835 + BRII-179 Market Size in Germany, USD million (2019-2032)
• Figure 4: BRII-835 + BRII-179 Market Size in France, USD million (2019-2032)
• Figure 5: BRII-835 + BRII-179 Market Size in Italy, USD million (2019-2032)
• Figure 6: BRII-835 + BRII-179 Market Size in Spain, USD million (2019-2032)
• Figure 7: BRII-835 + BRII-179 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: BRII-835 + BRII-179 Market Size in Japan, USD million (2019-2032)
• Figure 9: BRII-835 + BRII-179 Market Size in China, USD million (2019-2032)

"BRII-835 + BRII-179 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about BRII-835 + BRII-179 for chronic hepatitis B in the seven major markets and China. A detailed picture of the BRII-835 + BRII-179 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 BRII-835 + BRII-179 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 BRII-835 + BRII-179 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:

BRII-836 (VIR-2218) is an investigational subcutaneously administered HBV-targeting siRNA that can stimulate an effective immune response and have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index.

Also, BRII-179 (VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens and is designed to induce enhanced B-cell and T-cell immunity. Brii Bio licensed BRII-179 (VBI-2601) from VBI Vaccines in December 2018, providing Brii Bio with commercial rights to BRII-179 (VBI-2601) in the licensed territories of Mainland China, China Hong Kong, Macau, and Taiwan.

Both agents have demonstrated proof of mechanism in HBV patients; a combination might be a potential functional cure. It encompasses dual mechanisms of action, removing immunosuppressive viral antigens by siRNA gene silencing followed by stimulating and restoring the host HBV-specific immunity with an immunotherapeutic vaccine.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the BRII-835 + BRII-179 description, mechanism of action, dosage and administration, research and development activities in chronic hepatitis B.
• Elaborated details on BRII-835 + BRII-179 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the BRII-835 + BRII-179 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 BRII-835 + BRII-179.
• The report contains forecasted sales of BRII-835 + BRII-179 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 BRII-835 + BRII-179 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.

BRII-835 + BRII-179 Analytical Perspective by DelveInsight

• In-depth BRII-835 + BRII-179 Market Assessment

This report provides a detailed market assessment of BRII-835 + BRII-179 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 2027 to 2032.

• BRII-835 + BRII-179 Clinical Assessment

The report provides the clinical trials information of BRII-835 + BRII-179 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 BRII-835 + BRII-179 dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to BRII-835 + BRII-179 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 BRII-835 + BRII-179 in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of BRII-835 + BRII-179 from 2027 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the BRII-835 + BRII-179 in chronic hepatitis B.

Key Questions:

• What is the product type, route of administration and mechanism of action of BRII-835 + BRII-179?
• What is the clinical trial status of the study related to BRII-835 + BRII-179 in chronic hepatitis B and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the BRII-835 + BRII-179 development?
• What are the key designations that have been granted to BRII-835 + BRII-179 for chronic hepatitis B?
• What is the forecasted market scenario of BRII-835 + BRII-179 for chronic hepatitis B?
• What are the forecasted sales of BRII-835 + BRII-179 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 BRII-835 + BRII-179 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. BRII-835 + BRII-179 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. BRII-835 + BRII-179 Market Assessment

• 5.1. Market Outlook of BRII-835 + BRII-179 in Chronic hepatitis B
• 5.2. 7MM and China Analysis
  • 5.2.1. Market Size of BRII-835 + BRII-179 in the 7MM and China for Chronic hepatitis B
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of BRII-835 + BRII-179 in the United States for Chronic hepatitis B
  • 5.3.2. Market Size of BRII-835 + BRII-179 in Germany for Chronic hepatitis B
  • 5.3.3. Market Size of BRII-835 + BRII-179 in France for Chronic hepatitis B
  • 5.3.4. Market Size of BRII-835 + BRII-179 in Italy for Chronic hepatitis B
  • 5.3.5. Market Size of BRII-835 + BRII-179 in Spain for Chronic hepatitis B
  • 5.3.6. Market Size of BRII-835 + BRII-179 in the United Kingdom for Chronic hepatitis B
  • 5.3.7. Market Size of BRII-835 + BRII-179 in Japan for Chronic hepatitis B
  • 5.3.8. Market Size of BRII-835 + BRII-179 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