ハイゼントラの新興薬剤に関する洞察と市場予測：2032年

ハイゼントラは、無菌、無色透明、淡黄色、淡褐色のSC注射用正常ヒト免疫グロブリン溶液です。20％溶液で、純度98％以上の免疫グロブリンG（IgG）を20g/100mL含有します。IgGの90％以上は単量体および二量体、凝集体（2％以下、通常は0.1％以下）から構成されています。IgGサブクラスの分布は正常ヒト血漿と類似しています（概算値：IgG1 69％、IgG2 26％、IgG3 3％、IgG4 2％）。本製品は、生理的非必須アミノ酸であるプロリンを安定化剤として250mmol/L含有しており、ポリソルベート80およびナトリウムも微量含有しています。ハイゼントラには糖質安定剤（スクロース、マルトースなど）と保存料は含まれていません。

現在、成人DM患者を対象とした第III相臨床試験（RECLAIIM）が進行中であり、2027年11月までに完了する予定です。

当レポートでは、主要7ヶ国におけるハイゼントラ市場について調査し、市場の概要とともに、2025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 皮膚筋炎におけるハイゼントラの概要

• 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
• 製品概要

第3章 競合情勢（後期段階の新興治療法）

第4章 ハイゼントラ市場評価

• 皮膚筋炎に対すハイゼントラの市場展望
• 主要7ヶ国市場分析
  • 主要7ヶ国における皮膚筋炎に対するハイゼントラの市場規模
• 国別市場分析
  • 米国
  • ドイツ
  • 英国

第5章 SWOT分析

第6章 アナリストの見解

第7章 付録

• 参考文献
• レポート調査手法

第8章 DelveInsightのサービス内容

第9章 免責事項

第10章 DelveInsightについて

第11章 レポート購入オプション

List of Tables

• Table 1: HIZENTRA, Clinical Trial Description, 2023
• Table 2: HIZENTRA, General Description
• Table 3: Competitive Landscape (Emerging Therapies)
• Table 4: HIZENTRA Market Size in the 7MM, in USD million (2019-2032)
• Table 5: HIZENTRA Market Size in the US, in USD million (2019-2032)
• Table 6: HIZENTRA Market Size in Germany, in USD million (2019-2032)
• Table 7: HIZENTRA Market Size in France, in USD million (2019-2032)
• Table 8: HIZENTRA Market Size in Italy, in USD million (2019-2032)
• Table 9: HIZENTRA Market Size in Spain, in USD million (2019-2032)
• Table 10: HIZENTRA Market Size in the UK, in USD million (2019-2032)
• Table 11: HIZENTRA Market Size in Japan, in USD million (2019-2032)

List of Figures

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

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

Drug Summary:

HIZENTRA is a sterile, clear, colorless, pale-yellow, light-brown solution of normal human immunoglobulin for SC injection. It is a 20% solution containing 20 g/100 mL of total human plasma protein with a purity of at least 98% immunoglobulin G (IgG). More than 90% of the IgG consists of monomers and, dimers, aggregates (≤2%, typically below 0.1%). The distribution of the IgG subclasses is similar to that of normal human plasma (approximate values: 69% IgG1, 26% IgG2, 3% IgG3, 2% IgG4). The product contains 250 mmol/L of proline as a stabilizer, a physiological nonessential amino acid; the product also contains trace amounts of polysorbate 80 and sodium. HIZENTRA contains no carbohydrate stabilizer (e.g., sucrose, maltose) and no preservative.

Currently, the molecule is under investigation in a Phase III (RECLAIIM) clinical trial for adult patients with DM, anticipated to be completed by November 2027.

Scope of the Report:

The report provides insights into:

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

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.

HIZENTRA Analytical Perspective by DelveInsight

In-depth HIZENTRA Market Assessment

This report provides a detailed market assessment of HIZENTRA for dermatomyositis 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 2025 to 2032.

HIZENTRA Clinical Assessment

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

Report Highlights:

• In the coming years, the market scenario for dermatomyositis 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 HIZENTRA dominance.
• Other emerging products for dermatomyositis are expected to give tough market competition to HIZENTRA 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 HIZENTRA in dermatomyositis.
• Our in-depth analysis of the forecasted sales data of HIZENTRA from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the HIZENTRA in dermatomyositis.

Key Questions:

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

Table of Contents

1. Report Introduction

2. HIZENTRA Overview in Dermatomyositis

• 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 (Late-stage Emerging Therapies)

4. HIZENTRA Market Assessment

• 4.1. Market Outlook of HIZENTRA in dermatomyositis
• 4.2. 7MM Analysis
  • 4.2.1. Market Size of HIZENTRA in the 7MM for dermatomyositis
• 4.3. Country-wise Market Analysis
  • 4.3.1. Market Size of HIZENTRA in the United States for dermatomyositis
  • 4.3.2. Market Size of HIZENTRA in Germany for dermatomyositis
  • 4.3.3. Market Size of HIZENTRA in France for dermatomyositis
  • 4.3.4. Market Size of HIZENTRA in Italy for dermatomyositis
  • 4.3.5. Market Size of HIZENTRA in Spain for dermatomyositis
  • 4.3.6. Market Size of HIZENTRA in the United Kingdom for dermatomyositis
  • 4.3.7. Market Size of HIZENTRA in Japan for dermatomyositis

5. SWOT Analysis

6. Analysts' Views

7. Appendix

• 7.1. Bibliography
• 7.2. Report Methodology

8. DelveInsight Capabilities

9. Disclaimer

10. About DelveInsight

11. Report Purchase Options