한글목차

가장 활성도가 높은 세포를 선별하고 성분(적혈구, 혈소판 등)을 제거하여 세포의 치료 활성을 감소시킬 수 있는 천연 조직 추출물 유래 다세포 치료제(MCT)입니다. 익사카는 MCT 제품인 REX-001을 선도하고 있습니다. 이 제품은 CLTI 치료를 위해 환자의 골수에서 채취한 세포를 사용하는 확립된 생물학에 기반한 복합 다세포 제품입니다. 이 제품은 백혈구가 농축된 자가 골수 유래 세포 현탁액입니다. 전구세포와 면역세포(림프구, 단핵구, 과립구)의 조합으로 구성되어 있습니다.

CLTI의 임상적 진행으로 이어지는 복잡한 질병 과정(플라크 침착, 염증, 허혈, 혈관 변성, 궤양 형성)에 대응하도록 설계되었습니다. 중증 허혈성 사지(CLI)는 만성 질환이며 가장 심각한 형태의 말초 동맥 질환(PAD)입니다.

REX-001은 여러 면역세포와 전구세포를 하지의 질환 혈관에 직접 전달하는 환자맞춤형 세포면역치료제로 개발되고 있습니다. 현재 PAD 및 기타 적응증에 대해 여러 기관에서 임상 3상 시험을 진행 중입니다.

REX-001을 국소 투여하면 유익한 면역 조절 세포(성장인자 및 사이토카인)가 증가합니다. 이 세포는 말초혈액에 극미량만 존재하며, 질병 환자에서는 더욱 감소합니다.

앞으로 몇 년동안 말초동맥질환(PAD) 시장 시나리오는 전 세계적으로 광범위한 조사와 의료비 지출 증가로 인해 변화할 것입니다. 각 업체들은 질환을 치료/개선하기 위한 새로운 접근법에 초점을 맞춘 치료법을 개발하고, 과제를 평가하고, REX-001의 우위에 영향을 미칠 수 있는 기회를 모색하고 있으며, PAD에 대한 다른 신흥 제품들이 REX-001과 치열한 시장 경쟁을 벌일 것으로 예상되며, 가까운 시일 내에 후발주자 출시될 경우 시장에 큰 영향을 미칠 것으로 예상됩니다.

본 보고서는 주요 7개국의 말초동맥질환(PAD) 치료제 REX-001 시장에 대해 조사했으며, 시장 개요와 함께 경쟁 구도, 2032년까지 시장 규모 예측, 국가별 시장 분석 등의 정보를 전해드립니다.

목차

제1장 보고서 서론

제2장 PAD 치료제 REX-001개요

• 제품 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 기타 개발 활동
• 제품 개요

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신흥 치료법)

제5장 REX-001 시장 평가

• PAD 치료제 REX-001 시장 전망
• 주요 7개국 분석
  • 주요 7개국의 PAD REX-001 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight에 대해

제12장 보고서 구입 옵션

영문목차

"REX-001 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about REX-001 for Peripheral Artery Disease (PAD) in the seven major markets. A detailed picture of the REX-001 for PAD 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 REX-001 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 REX-001 market forecast analysis for PAD in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in PAD.

Drug Summary:

Multi-cell therapies (MCTs) derived from natural tissue extracts selected for the most active cells, removing components (such as red blood cells and platelets), potentially reducing the cells' therapeutic activity. Ixaka Ltd leads MCT product REX-001, a composite multi-cell product that builds on the established biology of using cells from a patient's bone marrow to treat CLTI. The product is an autologous bone-marrow-derived cell suspension enriched for white blood cells. It consists of a combination of progenitor cells and immune cells (lymphocytes, monocytes, granulocytes).

It is designed to address the complex disease processes (plaque deposition, inflammation, ischemia, vessel degeneration, ulcer formation) that lead to the clinical progression of CLTI. Critical limb ischemia (CLI) is a chronic condition and the most serious form of peripheral arterial disease (PAD).

REX-001 is being developed as patient-specific cellular immunotherapy that delivers multiple immune and progenitor cells directly to the diseased vessels of the lower leg. Currently, it is in a multi-site Phase III clinical trial to treat PAD and other indications.

Local administration of REX-001 boosts the beneficial immune-modulating cells (growth factors and cytokines), which are only present at very low levels in the peripheral blood and are further depleted in diseased patients.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the REX-001 description, mechanism of action, dosage and administration, research and development activities in Peripheral Artery Disease (PAD).
• Elaborated details on REX-001 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the REX-001 research and development activities in PAD across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around REX-001.
• The report contains forecasted sales of REX-001 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 REX-001 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.

REX-001 Analytical Perspective by DelveInsight

• In-depth REX-001 Market Assessment

This report provides a detailed market assessment of REX-001 for Peripheral Artery Disease (PAD) 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.

• REX-001 Clinical Assessment

The report provides the clinical trials information of REX-001 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 REX-001 dominance.
• Other emerging products for PAD are expected to give tough market competition to REX-001 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 REX-001 in PAD.
• Our in-depth analysis of the forecasted sales data of REX-001 from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the REX-001 in PAD.

Key Questions:

• What is the product type, route of administration and mechanism of action of REX-001?
• What is the clinical trial status of the study related to REX-001 in Peripheral Artery Disease (PAD) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the REX-001 development?
• What are the key designations that have been granted to REX-001 for PAD?
• What is the forecasted market scenario of REX-001 for PAD?
• What are the forecasted sales of REX-001 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 REX-001 for PAD?
• Which are the late-stage emerging therapies under development for the treatment of PAD?

Table of Contents

1. Report Introduction

2. REX-001 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. REX-001 Market Assessment

• 5.1. Market Outlook of REX-001 in PAD
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of REX-001 in the 7MM for PAD
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of REX-001 in the United States for PAD
  • 5.3.2. Market Size of REX-001 in Germany for PAD
  • 5.3.3. Market Size of REX-001 in France for PAD
  • 5.3.4. Market Size of REX-001 in Italy for PAD
  • 5.3.5. Market Size of REX-001 in Spain for PAD
  • 5.3.6. Market Size of REX-001 in the United Kingdom for PAD
  • 5.3.7. Market Size of REX-001 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