LSTA-12の市場規模、予測、新薬の考察（2032年）

薬剤のサマリー

LSTA-12（日本ではHonedra、CLBS12としても知られる）は、患肢の血流を改善することで、CLIやバージャー病の重篤な悪影響を予防する実験的な再生医療です。CD34+細胞療法であり、1回の治療で対象肢に20回、筋肉内注射することを意図しています。

CD34+細胞は、血管の発育や修復を促進する幹細胞を意図的に探して発見されました。人体のすべての組織は、時間の経過とともに細胞が入れ替わることでその機能を維持しています。CD34+細胞を投与することによって、新しい微小血管の発達と形成を促進し、それによって患部への血流を増加させます。現在までに発見された他のネイティブ細胞で、これと同じ能力を示したものはありません。

初期の臨床反応は、良好な治療効果と安全性プロファイルと一致しており、日本とその他の地域で既に発表されているCD34+細胞治療の臨床試験と一致しています。

Caladrius独自のCD34+細胞治療技術は、虚血によって引き起こされる疾患や状態に対処するよう設計された治療製品候補の開発につながっています。虚血は、健康な組織への酸素を含んだ血液の供給が制限されることで起こります。Caladriusは、冠動脈微小血管障害（CMD）、重症虚血肢（CLI）、糖尿病性腎臓病（DKD）、無選択性難治性無力狭心症（NORDA）などに限らない、基礎的な虚血傷害によって引き起こされる複数の病態が、CD34+細胞技術によって改善されうると考えています。

当レポートでは、日本における末梢動脈疾患（PAD）向けLSTA-12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 PADにおけるLSTA-12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 LSTA-12市場の評価

• PADにおけるLSTA-12の市場見通し
• 日本の分析
  • 日本のPAD向けLSTA-12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: LSTA-12, Clinical Trial Description, 2023
• Table 2: LSTA-12, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Late-stage Emerging Therapies)
• Table 5: LSTA-12 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: LSTA-12 Market Size in Japan, USD million (2019-2032)

"LSTA-12 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about LSTA-12 for Peripheral Artery Disease (PAD) in Japan. A detailed picture of the LSTA-12 for PAD in Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the LSTA-12 for PAD. 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 LSTA-12 market forecast analysis for PAD in Japan, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in PAD.

Drug Summary:

LSTA-12 (also known as Honedra and CLBS12 in Japan) is an experimental regenerative medicine to prevent the serious adverse consequences of CLI and Buerger's disease by improving blood flow in the affected limb. It is CD34+ cell therapy intended to administer by Intramuscular route, 20 injections in the target limb in a single treatment.

The CD34+ cell was discovered due to the deliberate search for a stem cell capable of stimulating blood vessels' development and/or repair. All tissues in the human body maintain their function by replacing cells over time. By administering CD34+ cells, the company promotes the development and formation of new microvasculature, thereby increasing blood flow to the impacted area. No other native cell discovered to date has demonstrated this same capability.

The initial clinical responses are consistent with a positive therapeutic effect and safety profile and with previously published clinical trials of CD34+ cell therapy in Japan and elsewhere.

Caladrius' proprietary CD34+ cell therapy technology has led to the development of therapeutic product candidates designed to address diseases and conditions caused by ischemia. Ischemia occurs when the supply of oxygenated blood to healthy tissue is restricted. Caladrius believes that several conditions caused by underlying ischemic injury can be improved through its CD34+ cell technology, including but not limited to coronary microvascular dysfunction (CMD), critical limb ischemia (CLI), diabetic kidney disease (DKD), and no-option refractory disabling angina (NORDA).

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the LSTA-12 description, mechanism of action, dosage and administration, research and development activities in Peripheral Artery Disease (PAD).
• Elaborated details on LSTA-12 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the LSTA-12 research and development activities in PAD across Japan.
• The report also covers the patents information with expiry timeline around LSTA-12.
• The report contains forecasted sales of LSTA-12 for PAD till 2032.
• Comprehensive coverage of the late-stage emerging therapies for PAD.
• The report also features the SWOT analysis with analyst views for LSTA-12 in PAD.

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.

LSTA-12 Analytical Perspective by DelveInsight

• In-depth LSTA-12 Market Assessment

This report provides a detailed market assessment of LSTA-12 for Peripheral Artery Disease (PAD) in Japan. This segment of the report provides forecasted sales data from 2025 to 2032.

• LSTA-12 Clinical Assessment

The report provides the clinical trials information of LSTA-12 for PAD covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Peripheral Artery Disease (PAD) 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 LSTA-12 dominance.
• Other emerging products for PAD are expected to give tough market competition to LSTA-12 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 LSTA-12 in PAD.
• Our in-depth analysis of the forecasted sales data of LSTA-12 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the LSTA-12 in PAD.

Key Questions:

• What is the product type, route of administration and mechanism of action of LSTA-12?
• What is the clinical trial status of the study related to LSTA-12 in Peripheral Artery Disease (PAD) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the LSTA-12 development?
• What are the key designations that have been granted to LSTA-12 for PAD?
• What is the forecasted market scenario of LSTA-12 for PAD?
• What are the forecasted sales of LSTA-12 in Japan?
• What are the other emerging products available and how are these giving competition to LSTA-12 for PAD?
• Which are the late-stage emerging therapies under development for the treatment of PAD?

Table of Contents

1. Report Introduction

2. LSTA-12 Overview in PAD

• 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. LSTA-12 Market Assessment

• 5.1. Market Outlook of LSTA-12 in PAD
• 5.2. Japan Analysis
  • 5.2.1. Market Size of LSTA-12 in Japan for PAD

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