Summary

Overview
Global Limbal Stem Cells Deficiency Market reached US$ XX billion in 2022 and is expected to reach US$ XX million by 2030 growing at a CAGR of XX% during the forecast period 2023-2030.
Limbal stem cell deficiency (LSCD) is a condition that occurs when there is dysfunction or damage to the limbal stem cells in the eye. Limbal stem cells play a crucial role in maintaining the health and integrity of the cornea. These stem cells are responsible for regenerating the corneal epithelium which is the outermost layer of the cornea.
The corneal epithelium cannot regenerate or heal itself if these stem cells are gone. This leads to corneal conjunctivalization and neovascularization, corneal scarring, chronic inflammation, epithelium breakdown, and persistent epithelial abnormalities.
Market Dynamics
The increasing burden of corneal blindness
The increasing burden of corneal blindness acts as a significant driver for market growth. Corneal blindness refers to a group of eye disorders that change the corneal transparency, causing corneal scarring and blindness. Over 6 million people worldwide are affected by corneal blindness, and limbal stem cell deficiency is one of the main causes.
For instance, according to the World Health Organization, 1.9 million people have corneal blindness due to the opacification of the cornea, which accounts for about 5% of the total patients who have blindness. Also, It is currently estimated that, globally, there are about 1.3 million people blind from the disease and a further 8.2 million have trichiasis.
Additionally, according to the American Academy of Opthalmology 2023, due to corneal opacities, it is estimated that 5.5 million people over 40 have bilateral vision loss worse than 20/60. It is predicted that 6.2 million more people are blind in one eye.
Furthermore, significant growth drivers such as the growing awareness of limbal stem cell deficiency, and increasing clinical trials for treatment therapies are expected to drive the market in the forecast period.
Complications associated with the treatment
The pain, blurred vision, and recurring epithelial erosions that increase the risk of infection and vision loss are all symptoms of untreated limbal stem cell deficiency (LSCD). Infectious keratitis is a common complication. In late stages, superficial and deep vascularization, persistent epithelial defects leading to ulceration, melting and perforation, fibrovascular pannus, scarring, keratinization, and calcification can occur.
Segment Analysis
The global limbal stem cell deficiency market is segmented based on type, treatment, end user and region.
The surgical segment accounted for approximately 56.7% of the market share
Treatments for limbal stem cell deficiency can include corneal transplant and limbal graft, which promote the regrowth of corneal tissue. Unilateral partial LSCD has been treated by repeated removal of the conjunctival epithelium from the corneal surface in the form of sequential sectoral conjunctival epitheliectomy (SSCE). The surgical segment is expected to hold the largest market share over the period forecast.
For instance, according to Clinicaltrials.gov, on October 26, 2022, the S.N. Fyodorov Eye Microsurgery State Institution conducted a clinical trial on Labial Mucosal Epithelium Grafting for Corneal Limbus Substitution. The purpose of the study is to evaluate the feasibility of the novel surgical intervention in clinical use. The expected study completion date is December 2025.
Additionally, on January 23, 2023, CHU de Quebec-Universite Laval conducted a clinical trial for Autologous Cultured Corneal Epithelium (CECA) for the treatment of Limbal Stem Cell Deficiency. The expected trial completion date is December 2025.
Geographical Analysis
North America is expected to hold a significant position in the global limbal stem cell deficiency market share
North America has maintained a significant market proportion due to factors such as the rising drug approval, and increasing healthcare expenditure, this trend is anticipated to continue throughout the forecast period.
For instance, in April 2022, The Food and Drug Administration (FDA) granted Fast Track designation to KPI-012 for the treatment of persistent corneal epithelial defect. KPI-012 is a topically dosed ophthalmic therapy designed using the human mesenchymal stem cell secretome (MSC-S) platform. KPI-012 contains human-derived biofactors to correct the impaired corneal healing.
COVID-19 Impact Analysis
The COVID-19 pandemic has had a significant impact on the global limbal stem cell deficiency market. The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular diagnoses, treatments, drug launches, and consultations worldwide. With the outbreak of the pandemic, many pharmaceutical or medical device manufacturing units faced labor shortages and were unable to travel to work due to lockdown restrictions. Therefore, owing to the above factors, the limbal stem cell deficiency market is expected to be moderately affected over the forecast period.
Market Segmentation
By Type
• Congenital LSCD
• Acquired LSCD
By Treatment
• Surgical
o Sequential sector conjunctival epitheliectomy (SSCE)
o Conjunctival limbal autograft (CLAU)
o Kerato-limbal allograft (KLAL)
o Simple limbal epithelial transplantation (SLET)
o Cultivated limbal epithelial transplant (CLET)
• Non-surgical
o Corticosteroid Eye drops
o Therapeutic soft contact lens
o Eye lubrication
o Autologous serum drops
By End User
• Hospitals
• Specialty Clinics
• Others
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Competitive Landscape
The major global players in the market include Chiesi USA Inc., Holostem Terapie Avanzate S.r.l., Kala Pharmaceuticals, Sandoz Group AG, Xenon Pharmaceuticals Inc., Bausch + Lomb Corp, Rayner Group, AdvaCare Pharma, Eyeris Vision Care Pvt. Ltd., Abbvie Inc. among others.
Key Developments
• In April 2023, Combangio, Inc., a subsidiary of Kala Pharmaceuticals, was awarded $15 Million by the California Institute for Regenerative Medicine to support the ongoing KPI-012 Program for the treatment of the persistent corneal epithelial defect.
Why Purchase the Report?
• To visualize the global limbal stem cell deficiency market segmentation based on type, treatment, end user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of limbal stem cell deficiency market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global limbal stem cells deficiency market report would provide approximately 61 tables, 63 figures, and 185 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Type
3.2. Snippet by Treatment
3.3. Snippet by End User
3.4. Snippet by Region
4. Market Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. The increasing burden of corneal blindness
4.1.1.2. XX
4.1.2. Restraints
4.1.2.1. Complications associated with the treatment
4.1.2.2. XX
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. DMI Opinion
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID
6.1.2. Scenario During COVID
6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion
7. By Type
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
7.1.2. Market Attractiveness Index, By Type
7.2. Congenital LSCD*
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Acquired LSCD
8. By Treatment
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
8.1.2. Market Attractiveness Index, By Treatment
8.2. Surgical*
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.2.3. Sequential sector conjunctival epitheliectomy (SSCE)
8.2.4. Conjunctival limbal autograft (CLAU)
8.2.5. Kerato-limbal allograft (KLAL)
8.2.6. Simple limbal epithelial transplantation (SLET)
8.2.7. Cultivated limbal epithelial transplant (CLET)
8.3. Non-surgical
8.3.1. Corticosteroid Eye drops
8.3.2. Therapeutic soft contact lens
8.3.3. Eye lubrication
8.3.4. Autologous serum drops
9. By End User
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
9.1.2. Market Attractiveness Index, By End User
9.2. Hospitals*
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Specialty Clinics
9.4. Others
10. By Region
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
10.1.2. Market Attractiveness Index, By Region
10.2. North America
10.2.1. Introduction
10.2.2. Key Region-Specific Dynamics
10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.2.6.1. U.S.
10.2.6.2. Canada
10.2.6.3. Mexico
10.3. Europe
10.3.1. Introduction
10.3.2. Key Region-Specific Dynamics
10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.3.6.1. Germany
10.3.6.2. UK
10.3.6.3. France
10.3.6.4. Italy
10.3.6.5. Spain
10.3.6.6. Rest of Europe
10.4. South America
10.4.1. Introduction
10.4.2. Key Region-Specific Dynamics
10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.4.6.1. Brazil
10.4.6.2. Argentina
10.4.6.3. Rest of South America
10.5. Asia-Pacific
10.5.1. Introduction
10.5.2. Key Region-Specific Dynamics
10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.5.6.1. China
10.5.6.2. India
10.5.6.3. Japan
10.5.6.4. Australia
10.5.6.5. Rest of Asia-Pacific
10.6. Middle East and Africa
10.6.1. Introduction
10.6.2. Key Region-Specific Dynamics
10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
11. Competitive Landscape
11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis
12. Company Profiles
12.1. Chiesi USA Inc.
12.1.1. Company Overview
12.1.2. Product Portfolio and Description
12.1.3. Financial Overview
12.1.4. Key Developments
12.2. Holostem Terapie Avanzate S.r.l.
12.3. Kala Pharmaceuticals
12.4. Sandoz Group AG
12.5. Xenon Pharmaceuticals Inc
12.6. Bausch + Lomb Corp
12.7. Rayner Group
12.8. AdvaCare Pharma
12.9. Eyeris Vision Care Pvt. Ltd.
12.10. Abbvie Inc.
LIST NOT EXHAUSTIVE
13. Appendix
13.1. About Us and Services
13.2. Contact Us