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市場調查報告書
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1466820

角膜上皮幹細胞去除 (LSCD) 市場：初步研究 (KOL Insights) - 市場情報 - 流行病學和 2034 年市場預測

Limbal Stem Cell Deficiency (LSCD) | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2034
出版日期: | 出版商: Mellalta Meets LLP | 英文 156 Pages | 訂單完成後即時交付

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簡介目錄

角膜上皮幹細胞移除（LSCD）市場主要由基於組織的技術（例如肢體組織移植）貢獻。 到 2034 年，新興療法的採用將成為一個重大轉折點，將為角膜上皮幹細胞耗竭疾病 (LSCD) 藥物市場帶來巨大變化。 調查國家（美國、法國、德國、義大利、西班牙、英國和日本）角膜上皮幹細胞耗竭疾病（LSCD）的市場規模預計從2020年起的調查期間將以22.60%的複合年增長率增長到2034年。預計到2034年將達到17億美元。

角膜上皮幹細胞耗竭症（LSCD）是指角膜上皮幹細胞/祖細胞功能障礙，無法維持角膜上皮正常穩態的臨床病症。

這些細胞可能會因多種不同的過程而受損，當角膜緣幹細胞流失時，角膜上皮細胞會被結膜上皮細胞取代，從而降低角膜的正常透明度，導致癒合受損、疤痕形成和視力喪失。

上皮不穩定是這種疾病的標誌，上皮反覆遭到破壞並形成持續性上皮缺陷。 持續性上皮缺陷的復發會影響下面的基質，在未解決的病例中導致疤痕和無菌融化。

本報告調查了全球角膜上皮幹細胞耗竭疾病 (LSCD) 市場，並提供了市場現狀、疾病概述和治療、患者趨勢和區域趨勢。

目錄

第 1 章執行摘要

第2章角膜上皮幹細胞耗竭病（LSCD）疾病的背景

  • 角膜上皮幹細胞耗竭病 (LSCD) 簡介
  • 角膜上皮幹細胞耗竭病 (LSCD) 的各個階段
  • 徵兆和症狀
  • 角膜上皮幹細胞耗竭症（LSCD）的病因與危險因子
  • 角膜上皮幹細胞耗竭病（LSCD）的病理學
  • 角膜上皮幹細胞耗竭病（LSCD）的病因學

第3章角膜上皮幹細胞耗竭症（LSCD）的診斷

  • 角膜上皮幹細胞耗竭症（LSCD）的診斷
  • 角膜上皮幹細胞耗竭病 (LSCD) 診斷演算法
  • 用於確認角膜緣幹細胞缺陷診斷的診斷工具

第 4 章流行病學與病患概述

  • 主要發現
  • 方法與資料來源
  • 角膜上皮幹細胞耗竭病（LSCD）流行病學和模型參數的主要來源
    • 美國
    • 德國
    • 法國
    • 義大利
    • 西班牙
    • 英國
    • 日本

第 5 章目前的治療方法與醫療實務

第 6 章角膜上皮幹細胞耗竭病 (LSCD) 患者趨勢

第 7 章美國、歐盟 4 國、英國和日本未滿足的需求

第 8 章市售治療

  • Holoclar（Chiesi Farmaceutici/Holostem Terapie Avanzate）
  • Nepic（日本組織工程）
  • Ocural（日本組織工程學）
  • Sakracy（弘前生命科學創新）

第9章新的治療方法

  • 主要發現
  • 管道概覽
  • 角膜上皮幹細胞耗竭（LSCD）領域取得顯著進展

第10章角膜上皮幹細胞耗竭病（LSCD）的處方模式

第 11 章角膜上皮幹細胞耗竭病 (LSCD) - 定價與報銷

第12章未來治療典範

第 13 章當前和新治療方法的年度費用

第14章角膜上皮幹細胞耗竭性疾病（LSCD）後期治療的策略思考

第15章市場展望

  • 主要發現
  • 摘要
  • 2034 年之前按國家劃分的市場預測

第 16 章按國家劃分的市場預測

  • 美國
  • 德國
  • 法國
  • 義大利
  • 西班牙
  • 英國
  • 日本

第17章市場促進與約束因素

第18章附錄

簡介目錄

The Limbal Stem Cell Deficiency (LSCD) market is hugely contributed by tissue-based techniques like limbal tissue transplantation. By 2034, the uptake of novel emerging therapies will serve as a major breakpoint to get a drastic change in the Limbal Stem Cell Deficiency (LSCD) therapeutics market. The sales of the emerging therapies for the treatment Limbal Stem Cell Deficiency (LSCD) in the study countries (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) will experience high growth over the 2020-2034 study period, adding a value estimated at a total market of $1.7 Billion by 2034.

"Experts believes that the advent of alternative stem cell sources like MSCs and iPSCs heralds a significant shift toward personalized and regenerative therapies in the LSCD market."

Limbal stem cell deficiency (LSCD) describes the clinical condition when there is dysfunction of the corneal epithelial stem/progenitor cells and the inability to sustain the normal homeostasis of the corneal epithelium.

These cells can be damaged by several different processes and the loss of limbal stem cells results in the replacement of corneal epithelial cells with conjunctival epithelial cells, decreasing the normal clarity of the cornea and leading to impaired healing, scarring and vision loss.

Epithelial instability is a hallmark of the disease process, which can lead to repeated breakdown of the epithelium and the formation of persistent epithelial defects. Recurrent episodes of persistent epithelial defects can affect the underlying stroma, leading to scarring or sterile melts in non-resolving cases.

Mellalta's Limbal Stem Cell Deficiency (LSCD) Report- Market Summary

Market Size 2034: $1.7 billion

CAGR%: 22.60%

Key Market Players: KALA BIO; Claris Biotherapeutics

Forecast Period: 2020-2034

Countries Covered: US, France, Germany, Italy, Spain, UK, China, and Japan.

Current SOC: Limbal tissue transplantation

Future SOC: Hepatocyte Growth Factor (HGF)

Key Unmet Need: Geographical Limitations in Treatment Availability; Conventional Therapies Offer Only Temporary Solutions

Key Insights: Regulatory Challenges have been significant in the advancement of stem cell therapies for LSCD

Provider-Patient (PPP) Perspective: Cost-effectiveness of treatment; Better Diagnostic Identification; Access to appropriate treatments and improved options

Mellalta's Limbal Stem Cell Deficiency (LSCD) Report - Epidemiology

The total prevalent cases of Limbal Stem Cell Deficiency (LSCD) in the G7 countries are anticipated to increase by a significant number of cases by 2034 for the study period (2020-2034). In the United States, the number of individuals living with LSCD is expected to rise to 74,191 by 2034, following a CAGR of 0.8%. As per estimates, the United States will present with the highest prevalence of Limbal Stem Cell Deficiency (LSCD) cases in 2034. Among the EU5, Germany had the highest Limbal Stem Cell Deficiency (LSCD) cases, followed by the UK, France, Italy, and Spain. Japan is reported to have the highest number of treated cases after the United States.

Mellalta's Limbal Stem Cell Deficiency (LSCD) Report - Current Market Size & Forecast Trends

The Limbal Stem Cell Deficiency (LSCD) therapeutics market is expected to experience high growth throughout our study period (i.e., 2020 to 2034) to USD 1.7 billion. The United States captured the highest market share as compared to the European 5 countries and Japan.

The current standard of care is limited to tissue-based techniques such as limbal tissue transplantation to address LSCD. However, this traditional approach has several disadvantages. Firstly, it requires a substantial amount of healthy limbal tissue, which poses a risk of causing iatrogenic LSCD in the donor eye. Secondly, when the donor limbal tissue is from a living related or cadaveric donor, potent immunosuppression is required to prevent rejection and subsequent failure of the transplanted tissue. This poses challenges for patients, as lifelong immunosuppression can lead to potential risks such as infection or malignancy and may deter some patients from undergoing the procedure.

In the evolving landscape of LSCD management, stem cell-based therapies have emerged as frontrunners, revolutionizing treatment paradigms. Spearheaded by pioneering products like Holoclar, Nepic, Ocural, and Sakracy, these innovative treatments offer new hope to patients suffering from severe ocular surface disorders. Stem cell therapies, by harnessing the regenerative power of limbal epithelial cells, signify a paradigm shift from conventional treatments, offering a sustainable solution to the challenges of LSCD.

In the 2024-2034 forecast period, the market is set to undergo transformative growth with the anticipated entry of new therapies like KPI012 (KALA BIO) and CSB-001 (Claris Biotherapeutics) and others. The emerging therapies will likely replace existing treatments, reflecting a dynamic shift towards more advanced therapeutic options in the LSCD space and more.

Questions Answered

What is the size of clinically and commercially relevant drug-treatable Limbal Stem Cell Deficiency (LSCD) populations, and how will drug-treatment rates change over time?

Potential challenges and opportunities in implementing approved therapy for Limbal Stem Cell Deficiency (LSCD).

What are the most promising agents in the pipeline, and how will they shape the future of this therapy market?

What key drivers and constraints will affect the Limbal Stem Cell Deficiency (LSCD) therapy market over the forecast period?

Report Highlights

Limbal Stem Cell Deficiency (LSCD) - Current Market Trends

Limbal Stem Cell Deficiency (LSCD) - Current & Forecasted Cases across the G7 Countries

Limbal Stem Cell Deficiency (LSCD) - Market Opportunities and Sales Potential for Agents

Limbal Stem Cell Deficiency (LSCD) - Patient-based Market Forecast to 2034

Limbal Stem Cell Deficiency (LSCD) - Untapped Business Opportunities

Limbal Stem Cell Deficiency (LSCD) - Product Positioning Vis-a-vis Competitors' Products

Limbal Stem Cell Deficiency (LSCD) - KOLs Insight

Table of Content

1.Executive Summary

  • 1.1.Key Findings
  • 1.2.Key Market Challenges and Opportunities
  • 1.3.What Do the Experts Say?

2.Limbal Stem Cell Deficiency (LSCD) Disease Background

  • 2.1.Limbal Stem Cell Deficiency (LSCD) Introduction
  • 2.2.Stages of Limbal Stem Cell Deficiency (LSCD)
  • 2.3.Sign & Symptoms
  • 2.4.Causes and Risk factors of Limbal Stem Cell Deficiency (LSCD)
  • 2.5.Pathogenesis of Limbal Stem Cell Deficiency (LSCD)
  • 2.6.Etiology of limbal stem cell deficiency (LSCD)

3.Limbal Stem Cell Deficiency (LSCD) Diagnosis

  • 3.1.Diagnosis of Limbal Stem Cell Deficiency (LSCD)
  • 3.2.Limbal Stem Cell Deficiency (LSCD) Diagnostic Algorithm
  • 3.3.Diagnostic Tools used to confirm the diagnosis of Limbal Stem Cell Deficiency

4.Epidemiology and Patient Populations

  • 4.1.Key Findings
  • 4.2.Methods and data Sources
    • 4.2.1.Country Specific Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
    • 4.2.2.Country Specific Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
    • 4.2.3.Country Specific Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)
  • 4.3.Key Sources for Limbal Stem Cell Deficiency (LSCD) Epidemiology and Model Parameters
    • 4.3.1.United States
      • 4.3.1.1.United States Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
      • 4.3.1.2.United States Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
      • 4.3.1.3.United States Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)
    • 4.3.2.Germany
      • 4.3.2.1.Germany Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
      • 4.3.2.2.Germany Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
      • 4.3.2.3.Germany Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)
    • 4.3.3.France
      • 4.3.3.1.France Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
      • 4.3.3.2.France Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
      • 4.3.3.3.France Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)
    • 4.3.4.Italy
      • 4.3.4.1.Italy Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
      • 4.3.4.2.Italy Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
      • 4.3.4.3.Italy Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)
    • 4.3.5.Spain
      • 4.3.5.1.Spain Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
      • 4.3.5.2.Spain Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
      • 4.3.5.3.Spain Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)
    • 4.3.6.United Kingdom
      • 4.3.6.1.United Kingdom Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
      • 4.3.6.2.United Kingdom Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
      • 4.3.6.3.United Kingdom Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)
    • 4.3.7.Japan
      • 4.3.7.1.Japan Prevalent cases of Limbal Stem Cell Deficiency (LSCD)
      • 4.3.7.2.Japan Prevalent cases of Limbal Stem Cell Deficiency (LSCD) by Stages
      • 4.3.7.3.Japan Diagnosed and Treated cases of Limbal Stem Cell Deficiency (LSCD)

5.Current Therapies and Medical Practice

  • 5.1.Treatment and Medical Practices of Limbal Stem Cell Deficiency (LSCD)
  • 5.2.Stem Cell Based Therapies in LSCD
  • 5.3.Strategic Product Positioning in the Limbal Stem Cell Deficiency (LSCD) Treatment Landscape: A 10-Year Outlook
  • 5.4.Expert Opinions on Interventional Management

6.Patient Journey in Limbal Stem Cell Deficiency (LSCD)

  • 6.1.Referral Routes
  • 6.2.Diagnosis Evaluation
  • 6.3.Treatment Evaluation
  • 6.4.Factors influencing choice of treatment modality for CLET.

7.Unmet Needs in US, EU4, UK, and JP

8.Marketed Therapies Chapters

  • 8.1.Holoclar (Chiesi Farmaceutici/Holostem Terapie Avanzate)
    • 8.1.1.Product Profile
    • 8.1.2.Clinical Development
    • 8.1.3.Market & Sales Opportunity Forecasted to 2034
  • 8.2.Nepic (Japan Tissue Engineering)
    • 8.2.1.Product Profile
    • 8.2.2.Clinical Development
    • 8.2.3.Market & Sales Opportunity Forecasted to 2034
  • 8.3.Ocural (Japan Tissue Engineering)
    • 8.3.1.Product Profile
    • 8.3.2.Clinical Development
    • 8.3.3.Market & Sales Opportunity Forecasted to 2034
  • 8.4.Sakracy (Hirosaki Lifescience Innovation)
    • 8.4.1.Product Profile
    • 8.4.2.Clinical Development
    • 8.4.3.Market & Sales Opportunity Forecasted to 2034

9.Emerging Therapies

  • 9.1.Key Findings
  • 9.2.Pipeline Overview
  • 9.3.Notable Developments in the Limbal Stem Cell Deficiency (LSCD) space
    • 9.3.1.Product Analysis
      • 9.3.1.1.KPI-012 (KALA BIO)
        • 9.3.1.1.1.Product Profile
        • 9.3.1.1.2.Clinical Development
        • 9.3.1.1.3.Market & Sales Opportunity Forecasted to 2034
      • 9.3.1.2.CSB-001 (Claris Biotherapeutics)
        • 9.3.1.2.1.Product Profile
        • 9.3.1.2.2.Clinical Development
        • 9.3.1.2.3.Market & Sales Opportunity Forecasted to 2034
      • 9.3.1.3.Not Exhaustive list (more drugs are covered..)

10.Prescription Pattern in Limbal Stem Cell Deficiency (LSCD)

11.Limbal Stem Cell Deficiency (LSCD) - Pricing & Reimbursement

  • 11.1.Holoclar Pricing and Reimbursement
  • 11.2.Nepic Pricing and Reimbursement
  • 11.3.Ocural Pricing and Reimbursement
  • 11.4.Sakracy Pricing and Reimbursement

12.Future Treatment Paradigm

  • 12.1.Limbal Stem Cell Deficiency (LSCD) Competitor Landscape and Approvals Anticipated
  • 12.2.Future Treatment Algorithms and Competitor Positioning
  • 12.3.Key Data Summary for Emerging Treatment

13.Annual Cost of Current & Emerging Treatment

14.Late Phase Therapies Strategic Considerations in Limbal Stem Cell Deficiency (LSCD)

15.Market Outlook

  • 15.1.Key Findings
  • 15.2.Overview
  • 15.3.Country Specific Market Forecast to 2034
    • 15.3.1.Country Specific Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 15.3.2.Country Specific Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)

16.Market Forecast by Country

  • 16.1.United States
    • 16.1.1.United States Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 16.1.2.United States Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)
  • 16.2.Germany
    • 16.2.1.Germany Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 16.2.2.Germany Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)
  • 16.3.France
    • 16.3.1.France Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 16.3.2.France Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)
  • 16.4.Italy
    • 16.4.1.Italy Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 16.4.2.Italy Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)
  • 16.5.Spain
    • 16.5.1.Spain Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 16.5.2.Spain Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)
  • 16.6.United Kingdom
    • 16.6.1.United Kingdom Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 16.6.2.United Kingdom Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)
  • 16.7.Japan
    • 16.7.1.Japan Market for Limbal Stem Cell Deficiency (LSCD) 2019-2034 (USD Million)
    • 16.7.2.Japan Market for Limbal Stem Cell Deficiency (LSCD) by Therapies 2019-2034 (USD Million)

17.Market Drivers and Constraints

    • 17.1.1.What Factors Are Driving the Market for Limbal Stem Cell Deficiency (LSCD)?
    • 17.1.2.What Factors Are Constraining the Market for Limbal Stem Cell Deficiency (LSCD)?

18.Appendix

  • 18.1.Methodology