Stargardt Disease Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The Fuchs Endothelial Corneal Dystrophy (FECD) market is projected to witness consistent growth throughout the forecast period (2023-2034). The market size of FECD in the 7MM is expected to increase, driven by the launch of emerging therapies.
• The analyst's analyst projects that among the Total Diagnosed Prevalent Cases of Fuchs Endothelial Corneal Dystrophy (FECD) in the 7MM approximately 35% of cases were from the US. As per our estimations, in 2022, the EU4 and the UK accounted for nearly 9.2 million diagnosed prevalent cases of FECD.
• In the 7MM, the market mainly consisted of Standard of care (Hyperosmotic sodium chloride, Steroids, etc.), which generated nearly USD 850 million in 2022.
• The total market size of the Fuchs Endothelial Corneal Dystrophy (FECD) treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments, namely, Ripasudil/K-321, TTHX1114/NM141, and others.

This report delivers an in-depth understanding of the FECD, historical and forecasted epidemiology and the FECD market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Fuchs Endothelial Corneal Dystrophy (FECD) market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM FECD market size from 2020 to 2034. The report also covers current FECD treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Fuchs Endothelial Corneal Dystrophy (FECD) Overview

Fuchs Endothelial Corneal Dystrophy (FECD) is a progressive hereditary disease affecting the cornea's endothelial layer. It is characterized by corneal edema, guttae formation, reduced visual acuity, and can lead to corneal blindness. FECD is more common in women, and its prevalence varies geographically in the 7MM. FECD is associated with genetic factors, with mutations in genes like COL8A2, SLC4A11, TCF4, and ZEB1 implicated in its development.

Fuchs Endothelial Corneal Dystrophy (FECD) Diagnosis

Diagnosis of FECD involves clinical examination, in vivo imaging, and laboratory examination of removed corneas. Currently, slit lamp examination, specular microscopy, corneal thickness measurement, and confocal microscopy are used to identify FECD. There is a huge unmet medical need to improve the sensitivity of testing in the early stages. Although various tools are developed to improve disease diagnosis at an early stage such as deep learning algorithms and techniques like Scheimpflug tomography and anterior segment optical coherence tomography (AS-OCT), there is still a need to improve the availability and accessibility of these image analysis tools for early detection, monitoring of disease progression, and customized therapeutic interventions.

Fuchs Endothelial Corneal Dystrophy (FECD) Treatment

Medical management of early FECD is limited to decreasing corneal edema with topical sodium chloride 5% drops, hypertonic saline drops, and solutions (ophtasyloxane) or ointments to shorten the morning edema and facilitate corneal dehydration. Phototherapeutic keratectomy, amniotic membrane transplants, anterior stromal puncture, and conjunctival flaps are also used to relieve painful symptoms, especially those associated with ruptured bullae in the later stages of the disease. Even cycloplegic, antibiotic ointment and patching are prescribed to treat ruptured corneal bullae. If a persistent or large epithelial defect is there, then bandage contact lenses are recommended.

However, these treatments do not have any curative effect because they do not act on the cause of the disease, which is the dysfunction of the endothelial layer. Frequency of usage has no effect; it only provides temporary relief and does not change the course of the disease; also, there is a stinging associated with these agents, which reduces acceptance.

Fuchs Endothelial Corneal Dystrophy (FECD) Epidemiology

As the market is derived using the patient-based model, the Fuchs Endothelial Corneal Dystrophy (FECD) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of FECD, Gender-specific Cases of FECD, Age-specific Cases of FECD, and Grade-specific Cases of FECD in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034.

• The analyst's analyst estimate that approximately 18.9 million Diagnosed Prevalent Cases of FECD were found in 2022 in the 7MM.
• The United States exhibited the highest diagnosed prevalent population of FECD, as compared to other 7MM countries. As per the analyst's estimations, the Total Diagnosed Prevalent Cases of FECD in the US was around 6.5 million in 2022 and is projected to increase during the forecast period owing to the increasing awareness among the prevalent population.
• According to This reported in Germany among the EU4 countries, while the least number of cases was found in Spain.
• The estimates show the Total Diagnosed Prevalent Cases of FECD in Japan was found to be around 3 million in 2022, which is estimated to decrease by 2034 because of the decreasing country population.
• The Gender-specific Cases of FECD in the 7MM were ~12.3 million for females and ~6.6 million for males in 2022 and are expected to increase within the forecast period (2023-2034). The increased prevalence in females is likely due to a combination of factors, including gender differences in behavior and neural development, and others.
• According to the analysis, the Age-specific Cases of FECD were categorized into 40-49, 50-59, 60-69, 70-79, and =80 years. The higher number of cases (~1.9 million) was accounted for by the 50-59 year age group in 2022 in the US.
• The Grade-specific Cases of FECD were categorized into Grade 1-3 and Grade 4-6. According to estimates, patients with Grade 1-3 FECD were higher (~6.8 million) than patients with Grade 4-6 FECD (~2.4 million) in the EU4 and the UK.

Fuchs Endothelial Corneal Dystrophy (FECD) Drug Chapters

The drug chapter segment of the FECD report encloses a detailed analysis of FECD marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands FECD clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

Ripasudil (K-321): Kowa Pharmaceuticals

Ripasudil (K-321), being developed by Kowa Pharmaceuticals, is a rho-kinase inhibitor that lowers intraocular pressure (IOP) by increasing conventional aqueous outflow. Rho-associated protein kinase (ROCK) is a protein that regulates the shape and movement of cells in several tissues, including the eye. This drug is the only Phase III product for FECD, besides having an early mover advantage, is the much-awaited therapy that is a nonsurgical alternate to address the complications due to corneal transplantation.

TTHX 1114: Trefoil Therapeutics

Trefoil Therapeutics’ nonsurgical therapy, TTHX 1114, an engineered FGF-1, is one of the best emerging therapies being developed for FECD. With a targeted intracameral injection route of administration, this cell proliferation stimulator has the ability to restore vision loss while reducing the risk of transplant failure. Its excellent Phase II results make it one of the most anticipated emerging therapies in the pipeline.

Fuchs Endothelial Corneal Dystrophy (FECD) Market Outlook

FECD has a diverse treatment classification associated with the disease landscape. The management of FECD primarily revolves around the utilization of hyperosmotic sodium chloride, steroids, and others as needed.

Standard of care (Hyperosmotic sodium chloride, Steroids, etc.) is the major revenue generator in the current treatment landscape.

The market for FECD is expected to experience positive growth with the approval of potential drugs like Ripasudil/K-321, TTHX1114/NM141, and others.

• The total market size of FECD in the 7MM reached approximately USD 850 million in 2022. Projections indicate a substantial growth during the forecast period.
• Out of the 7MM, the United States dominated the market in 2022, representing the largest share at nearly 46%.
• In 2022, EU4 and the UK captured an estimated USD 330 million, which is anticipated to increase at a substantial CAGR. Among the European countries, Germany covered the largest market share in 2022, followed by Italy, France, and the UK. Spain accounted for the least market in the same year.
• Japan alone represented approximately 16% of the total FECD market in 2022, projected to increase at a substantial CAGR during the study period.
• The total market size of the FECD treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments.

Fuchs Endothelial Corneal Dystrophy (FECD) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, TTHX1114/ NM141 in the US is expected to be launched by 2025.

Fuchs Endothelial Corneal Dystrophy (FECD) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for FECD emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on FECD evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Jules Stein Eye Institute/UCLA, Los Angeles, Fight for Sight, New York, Department of Pharmacology and Biochemistry, UT Southwestern Medical Center, Texas, Philadelphia Eye Associates and Wills Eye Hospital, Philadelphia, Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Moorfields Eye Hospital, London, Kyoto Prefectural University of Medicine, Kyoto, and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or FECD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Fuchs Endothelial Corneal Dystrophy (FECD), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Fuchs Endothelial Corneal Dystrophy (FECD) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Fuchs Endothelial Corneal Dystrophy (FECD) market.

Fuchs Endothelial Corneal Dystrophy (FECD) Report Insights

• Patient Population
• Therapeutic Approaches
• Fuchs Endothelial Corneal Dystrophy (FECD) Pipeline Analysis
• Fuchs Endothelial Corneal Dystrophy (FECD) Market Size and Trends
• Existing and Future Market Opportunity

Fuchs Endothelial Corneal Dystrophy (FECD) Report Key Strengths

• 12 years Forecast
• The 7MM Coverage
• Fuchs Endothelial Corneal Dystrophy (FECD) Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Fuchs Endothelial Corneal Dystrophy (FECD) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the Fuchs Endothelial Corneal Dystrophy (FECD) total market size, the market size by therapies, and market share (%) distribution in 2020, and how would it all look in 2034? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of Fuchs Endothelial Corneal Dystrophy (FECD)?
• What are the patents of emerging therapies for Fuchs Endothelial Corneal Dystrophy (FECD)?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Fuchs Endothelial Corneal Dystrophy (FECD)? What will be the growth opportunities across the 7MM concerning the patient population of Fuchs Endothelial Corneal Dystrophy (FECD)?
• What is the historical and forecasted Fuchs Endothelial Corneal Dystrophy (FECD) patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis?
• Which country is more prevalent for Fuchs Endothelial Corneal Dystrophy (FECD) and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Fuchs Endothelial Corneal Dystrophy (FECD)? What are the current guidelines for treating Fuchs Endothelial Corneal Dystrophy (FECD) in the US and Europe?
• How many companies are developing therapies for treating Fuchs Endothelial Corneal Dystrophy (FECD)?
• How many emerging therapies are in the mid-stage and late stage of development for treating Fuchs Endothelial Corneal Dystrophy (FECD)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Fuchs Endothelial Corneal Dystrophy (FECD)?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted markets of Fuchs Endothelial Corneal Dystrophy (FECD)?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Fuchs Endothelial Corneal Dystrophy (FECD) Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and ranking of potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Fuchs Endothelial Corneal Dystrophy (FECD) Epidemiology and Market Insight report for the 7MM covers the forecast period from 2023 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Fuchs Endothelial Corneal Dystrophy (FECD) market?

The Fuchs Endothelial Corneal Dystrophy (FECD) market is quite robust. The major layers are Kowa Pharmaceuticals, Trefoil Therapeutics, Alcon, and others which are currently developing drugs for the treatment of Fuchs Endothelial Corneal Dystrophy (FECD).

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Fuchs Endothelial Corneal Dystrophy (FECD) market?

The increase in diagnosed prevalent cases of Fuchs Endothelial Corneal Dystrophy (FECD) and the launch of emerging therapies are attributed to be the key drivers for increasing Fuchs Endothelial Corneal Dystrophy (FECD) market.

5. What is the expected impact of emerging therapies or advancements in Fuchs Endothelial Corneal Dystrophy (FECD) treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Fuchs Endothelial Corneal Dystrophy (FECD) treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Fuchs Endothelial Corneal Dystrophy (FECD) market.