세계의 각막 윤부 줄기세포 결핍증(LSCD) 시장 : 주요 조사(KOL 인사이트) - 시장 정보, 역학 및 시장 예측(-2034년)

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