DB102の新興医薬品に関する洞察と市場予測：2032年

DB102（エンザスタウリン）は、経口投与可能なファースト・イン・クラスの低分子セリン・スレオニンキナーゼ阻害剤であり、PKCβ、PI3K、AKT経路を阻害します。DB102はEli Lilly社が開発し、Denovo社が全世界での権利を取得しました。

Denovoは、DLBCLおよびGBM患者に期待される治療効果と有意に相関するバイオマーカーの同定を完了し、国際特許を出願しました。Denovoは2018年、極めて重要な第III相国際共同DLBCL臨床試験を開始しました。2018年、Denovoはスタンフォード大学から肺動脈性肺高血圧症（PAH）に対するDB102の使用権をライセンスしました。

現在、バイオマーカーDGM1（Denovo Genomic Marker 1）を有する新規診断の高リスク（IPI >=3）DLBCL患者を対象に、DB102のR-CHOPとの併用とR-CHOP単独との有効性を評価する第III相試験を実施中です。さらに、同社はこの第III相試験のトップラインデータを2022年までに発表する予定です。しかし、今のところこれに関する最新情報はありません。

当レポートでは、主要7ヶ国におけるDB102市場について調査し、市場の概要とともに、2024年～2032年の売上予測データ、競合情勢、および国別動向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 DLBCLにおけるDB102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 DB102市場評価

• DLBCLにおけるDB102の市場展望
• 主要7ヶ国分析
  • DLBCL向け主要7ヶ国におけるDB102の市場規模
• 国別の市場分析
  • 米国
  • ドイツ
  • 英国

第6章 SWOT分析

第7章 アナリストの見解

第8章 付録

• 参考文献
• レポート調査手法

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: DB102, Clinical Trial Description, 2023
• Table 2: DB102, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: DB102 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: DB102 Market Size in the US, in USD million (2019-2032)
• Table 7: DB102 Market Size in Germany, in USD million (2019-2032)
• Table 8: DB102 Market Size in France, in USD million (2019-2032)
• Table 9: DB102 Market Size in Italy, in USD million (2019-2032)
• Table 10: DB102 Market Size in Spain, in USD million (2019-2032)
• Table 11: DB102 Market Size in the UK, in USD million (2019-2032)
• Table 12: DB102 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: DB102 Market Size in the 7MM, USD million (2019-2032)
• Figure 2: DB102 Market Size in the United States, USD million (2019-2032)
• Figure 3: DB102 Market Size in Germany, USD million (2019-2032)
• Figure 4: DB102 Market Size in France, USD million (2019-2032)
• Figure 5: DB102 Market Size in Italy, USD million (2019-2032)
• Figure 6: DB102 Market Size in Spain, USD million (2019-2032)
• Figure 7: DB102 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: DB102 Market Size in Japan, USD million (2019-2032)

"DB102 Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about DB102 for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets. A detailed picture of the DB102 for DLBCL 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 DB102 for DLBCL. 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 DB102 market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.

Drug Summary:

DB102 (Enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that have been studied in more than 3,000 patients across a range of solid and hematological tumor types. Eli Lilly originally developed DB102 and for which Denovo has acquired worldwide rights.

Denovo has completed the biomarker identification, significantly correlated with the expected therapeutic effects on DLBCL and GBM patients, and has filed international patent applications. Denovo initiated a pivotal Phase III global DLBCL clinical trial in 2018. In 2018, Denovo licensed the rights to use DB102 for pulmonary arterial hypertension (PAH) from Stanford University.

Currently, the drug is in a Phase III trial evaluating the efficacy of DB102 in combination with R-CHOP vs. R-CHOP alone in newly diagnosed high-risk (IPI >=3) DLBCL patients with the biomarker DGM1 (Denovo Genomic Marker 1) (Denovo Biopharma, 2021a). Moreover, the company has also anticipated announcing the topline data of this Phase III trial by 2022. However, so far, there is no update regarding this.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the DB102 description, mechanism of action, dosage and administration, research and development activities in Diffuse Large B-cell lymphoma (DLBCL).
• Elaborated details on DB102 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the DB102 research and development activities in DLBCL across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around DB102.
• The report contains forecasted sales of DB102 for DLBCL till 2032.
• Comprehensive coverage of the late-stage emerging therapies for DLBCL.
• The report also features the SWOT analysis with analyst views for DB102 in DLBCL.

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.

DB102 Analytical Perspective by DelveInsight

In-depth DB102 Market Assessment

This report provides a detailed market assessment of DB102 for Diffuse Large B-cell lymphoma (DLBCL) 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 2024 to 2032.

DB102 Clinical Assessment

The report provides the clinical trials information of DB102 for DLBCL covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Diffuse Large B-cell lymphoma (DLBCL) 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 DB102 dominance.
• Other emerging products for DLBCL are expected to give tough market competition to DB102 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 DB102 in DLBCL.
• Our in-depth analysis of the forecasted sales data of DB102 from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the DB102 in DLBCL.

Key Questions:

• What is the product type, route of administration and mechanism of action of DB102?
• What is the clinical trial status of the study related to DB102 in Diffuse Large B-cell lymphoma (DLBCL) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the DB102 development?
• What are the key designations that have been granted to DB102 for DLBCL?
• What is the forecasted market scenario of DB102 for DLBCL?
• What are the forecasted sales of DB102 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 DB102 for DLBCL?
• Which are the late-stage emerging therapies under development for the treatment of DLBCL?

Table of Contents

1. Report Introduction

2. DB102 Overview in DLBCL

• 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. DB102 Market Assessment

• 5.1. Market Outlook of DB102 in DLBCL
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of DB102 in the 7MM for DLBCL
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of DB102 in the United States for DLBCL
  • 5.3.2. Market Size of DB102 in Germany for DLBCL
  • 5.3.3. Market Size of DB102 in France for DLBCL
  • 5.3.4. Market Size of DB102 in Italy for DLBCL
  • 5.3.5. Market Size of DB102 in Spain for DLBCL
  • 5.3.6. Market Size of DB102 in the United Kingdom for DLBCL
  • 5.3.7. Market Size of DB102 in Japan for DLBCL

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