TAVALISSEの薬剤に関する洞察と市場予測：2032年

フォスタマチニブ二ナトリウム（別名TAVALISSE；R-985788）は、Rigel pharmaceuticalsが開発した経口生物学的製剤で、持続性／慢性成人特発性血小板減少性紫斑病の治療薬として承認されています。この治療薬は、FcRをトリガーとするSyk依存的な貪食時の細胞骨格の再配列を阻害します。リゲル社によると、フォスタマチニブはSYKキナーゼを介してマクロファージとB細胞の両方でIgG受容体シグナル伝達を阻害するというユニークな作用機序を持つ。

TAVALISSEは米国とEUで慢性ITPの治療薬として承認されています。日本では製造販売承認申請中。

1回100mgを1日2回経口投与します。1ヵ月後、血小板数が50×109/L以上に増加していない場合は、150mgを1日2回に増量します。出血のリスクを軽減するために必要な血小板数50×109/L以上を達成・維持するためには、タバリスの最低用量を使用する必要があります。TAVALISSEは食事の有無にかかわらず服用できます。タバリスTAVALISSEの服用を忘れた場合、患者は次の用量を定時に服用するよう指示されるべきです。

フォスタマチニブは、脾チロシンキナーゼ（SYK）に対する活性が実証されたチロシンキナーゼ阻害剤です。フォスタマチニブの主要代謝物であるR406は、Fc活性化受容体およびB細胞受容体のシグナル伝達を阻害します。フォスタマチニブの代謝物R406は、抗体を介した血小板の破壊を抑制します。

当レポートでは、主要7ヶ国におけるTAVALISSE市場について調査し、市場の概要とともに、2023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 免疫性血小板減少症（ITP）に対するTAVALISSE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
• 規制上のマイルストーン
• その他の開発活動
• 製品概要

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 TAVALISSE市場評価

• ITPに対するTAVALISSEの市場展望
• 主要7ヶ国市場分析
  • 主要7ヶ国におけるITPに対するTAVALISSEの市場規模
• 国別市場分析
  • 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

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

List of Figures

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

“"TAVALISSE Drug Insight and Market Forecast - 2032" ” report provides comprehensive insights about TAVALISSE for immune thrombocytopenic purpura (ITP) in the seven major markets. A detailed picture of the TAVALISSE for ITP 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 TAVALISSE for ITP. 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 TAVALISSE market forecast analysis for ITP in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in ITP.

Drug Summary:

Fostamatinib disodium (also known as TAVALISSE; R-985788) is an orally-bioavailable investigational agent developed by Rigel pharmaceuticals and approved for treating patients suffering from persistent/chronic adult idiopathic thrombocytopenic purpura. The therapeutic candidate inhibits FcR-triggered, Syk-dependent cytoskeletal rearrangement during phagocytosis. As stated by Rigel Pharmaceuticals, fostamatinib has a unique mechanism of action, blocking IgG receptor signaling in both macrophages and B cells via SYK kinase.

TAVALISSE is approved in the US and the EU to treat chronic ITP. The company has submitted a new drug application for manufacturing and marketing approval in Japan.

Dosage

TAVALISSE is initiated at a dose of 100 mg taken orally twice daily. After a month, if the platelet count has not increased to at least 50 × 109/L, the dose should be increased to 150 mg twice daily. The lowest dose of TAVALISSE should be used to achieve and maintain a platelet count of at least 50 × 109/L as necessary to reduce the risk of bleeding. TAVALISSE may be taken with or without food. In the case of a missed dose of TAVALISSE, patients should be instructed to take their next dose at its regularly scheduled time.

Mechanism of action

Fostamatinib is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK). The major metabolite of fostamatinib, R406, inhibits signal transduction of Fc-activating receptors and B-cell receptors. The fostamatinib metabolite R406 reduces antibody-mediated destruction of platelets.

Scope of the Report:

The report provides insights into:

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

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.

TAVALISSE Analytical Perspective by DelveInsight

In-depth TAVALISSE Market Assessment

This report provides a detailed market assessment of TAVALISSE for immune thrombocytopenic purpura (ITP) 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 2023 to 2032.

TAVALISSE Clinical Assessment

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

Report Highlights:

• In the coming years, the market scenario for immune thrombocytopenic purpura (ITP) 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 TAVALISSE dominance.
• Other emerging products for ITP are expected to give tough market competition to TAVALISSE 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 TAVALISSE in ITP.
• Our in-depth analysis of the forecasted sales data of TAVALISSE from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the TAVALISSE in ITP.

Key Questions:

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

Table of Contents

1. Report Introduction

2. TAVALISSE Overview in ITP

• 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. Regulatory Milestone
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. TAVALISSE Market Assessment

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

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