角膜上皮幹細胞疲弊症（LSCD）市場：1次調査（KOLの洞察） - 市場インテリジェンス - 疫学と2034年までの市場予測

角膜上皮幹細胞疲弊症（LSCD）市場は、四肢組織移植のような組織ベースの技術によって大きく貢献しています。2034年までには、新規の新興治療薬の取り込みが、角膜上皮幹細胞疲弊症（LSCD）治療薬市場に劇的な変化をもたらす主要なブレークポイントとなるでしょう。調査対象国（米国、フランス、ドイツ、イタリア、スペイン、英国、日本）における角膜上皮幹細胞疲弊症（LSCD）の市場規模は、2020年～2034年の調査期間中に22.60%のCAGRで高成長を遂げ、2034年までに17億米ドルになると予測されています。

角膜上皮幹細胞疲弊症（LSCD）とは、角膜上皮幹細胞/前駆細胞の機能障害があり、角膜上皮の正常な恒常性を維持することができない臨床状態を指します。

これらの細胞は、いくつかの異なるプロセスによって損傷を受ける可能性があり、角膜辺縁幹細胞が失われると、角膜上皮細胞が結膜上皮細胞に置き換わり、角膜の正常な透明度が低下し、治癒障害、瘢痕化、視力低下を引き起こします。

上皮の不安定性はこの疾患の特徴であり、上皮が繰り返し破壊され、持続的な上皮欠損が形成されます。持続性上皮欠損の再発は、その下にある間質に影響を及ぼし、解決しない症例では瘢痕化や無菌性融解につながります。

当レポートでは、世界の角膜上皮幹細胞疲弊症（LSCD）市場について調査し、市場の現状とともに、疾患の概要と治療法、患者動向、および地域別の動向などを提供しています。

目次

第1章 エグゼクティブサマリー

第2章 角膜上皮幹細胞疲弊症（LSCD）疾患の背景

• 角膜上皮幹細胞疲弊症（LSCD）のイントロダクション
• 角膜上皮幹細胞疲弊症（LSCD）の段階
• 兆候と症状
• 角膜上皮幹細胞疲弊症（LSCD）の原因とリスク要因
• 角膜上皮幹細胞疲弊症（LSCD）の病態
• 角膜上皮幹細胞疲弊症（LSCD）の病因

第3章 角膜上皮幹細胞疲弊症（LSCD）の診断

• 角膜上皮幹細胞疲弊症（LSCD）の診断
• 角膜上皮幹細胞疲弊症（LSCD）診断アルゴリズム
• 輪部幹細胞欠損症の診断を確認するために使用される診断ツール

第4章 疫学と患者概要

• 主な調査結果
• 方法とデータソース
• 角膜上皮幹細胞疲弊症（LSCD）疫学とモデルパラメータの主要な情報源
  • 米国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
  • 日本

第5章 現在の治療法と医療実践

第6章 角膜上皮幹細胞疲弊症（LSCD）患者動向

第7章 米国、EU4、英国、日本でアンメットニーズ

第8章 上市済み治療法

• Holoclar（Chiesi Farmaceutici/Holostem Terapie Avanzate）
• Nepic（Japan Tissue Engineering）
• Ocural（Japan Tissue Engineering）
• Sakracy（Hirosaki Lifescience Innovation）

第9章 新たな治療法

• 主な調査結果
• パイプラインの概要
• 角膜上皮幹細胞疲弊症（LSCD）分野における注目すべき進展

第10章 角膜上皮幹細胞疲弊症（LSCD）の処方パターン

第11章 角膜上皮幹細胞疲弊症（LSCD）- 価格設定と償還

第12章 将来の治療パラダイム

第13章 現行および新規治療の年間コスト

第14章 角膜上皮幹細胞疲弊症（LSCD）における後期治療の戦略的検討

第15章 市場見通し

• 主な調査結果
• 概要
• 2034年までの国別市場予測

第16章 国別市場予測

• 米国
• ドイツ
• フランス
• イタリア
• スペイン
• 英国
• 日本

第17章 市場促進要因と抑制要因

第18章 付録

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