Fuchs Endothelial Corneal Dystrophy (FECD) - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight's 'Fuchs Endothelial Corneal Dystrophy - Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of the Fuchs Endothelial Corneal Dystrophy, historical and forecasted epidemiology as well as the Fuchs Endothelial Corneal Dystrophy market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Fuchs Endothelial Corneal Dystrophy market report provides current treatment practices, emerging drugs, market share of individual therapies, and the current and forecasted 7MM Fuchs Endothelial Corneal Dystrophy market size from 2019 to 2032. The Report also covers current Fuchs Endothelial Corneal Dystrophy treatment practice, SWOT analysis, reimbursement, market access, 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, Spain) and the United Kingdom
• Japan

Study Period: 2019-2032.

Fuchs Endothelial Corneal Dystrophy Understanding and Treatment Algorithm

Fuchs Endothelial Corneal Dystrophy Overview

Fuchs Endothelial Corneal Dystrophy is a non-inflammatory, sporadic, or autosomal-dominant dystrophy involving the endothelial layer of the cornea. Fuchs' dystrophy swells the cornea, causing glare, halo, and reduced visual acuity. The damage to the cornea in Fuchs' endothelial dystrophy can be severe, causing corneal blindness.

Fuchs Endothelial Corneal Dystrophy is characterized by an asymmetrical, bilateral, slowly progressive edema of the cornea in elderly patients. When inherited, the transmission is autosomal dominant. The corneal endothelium is a monolayer of cells that acts as the major pump for the deturgescence of the cornea and ensures clarity. The normal attrition rate of endothelial cells is 0.6% per year; the rate is accelerated in Fuchs Endothelial Corneal Dystrophy.

The root cause of the condition is a slowly progressive form of guttate lesions between the corneal endothelium and the Descemet membrane. These wartlike, anvil-shaped, or mushroom-shaped excrescences are abnormal elaborations of basement membrane and fibrillar collagen by distressed or dystrophic endothelial cells. As the lesions enlarge, the covering endothelial cells become stretched, eventually falling off.

Fuchs Endothelial Corneal Dystrophy is a condition that causes vision problems; the first symptom of this condition is a typically blurred vision in the morning which usually clears during the day. Over time, affected individuals lose the ability to see details (visual acuity). People with FECD also become sensitive to bright lights.

Fuchs Endothelial Corneal Dystrophy explicitly affects the front surface of the eye, called the cornea. Deposits called guttae, detectable during an eye exam, form in the cornea's middle and eventually spread throughout the cornea. These guttae contribute to cell death within the cornea, worsening vision problems. Tiny blisters may develop on the cornea, which can burst and cause eye pain.

The signs and symptoms of Fuchs Endothelial Corneal Dystrophy usually appear in a person's 40s or 50s. A scarce early-onset variant of this condition affects vision in a person's 20s. This dystrophy usually affects both eyes and can gradually worsen vision. Typically, the disease starts in the 30s and 40s, but many people with FECD do not develop symptoms until they reach their 50s or 60s.

Fuchs Endothelial Corneal Dystrophy Diagnosis

Corneal dystrophy may be found incidentally during a routine eye examination. Diagnosis may be confirmed by a thorough clinical evaluation, a detailed patient history, and a variety of tests, such as a slit-lamp examination, in which a special microscope (slit lamp) allows a physician to view the eye through high magnification. Some specific corneal dystrophies can be diagnosed with molecular genetic tests even before symptoms develop.

When corneal tissue is excised, it should be examined by light microscopy and transmission electron microscopy (TEM), as this can establish the precise diagnosis of many corneal dystrophies. For those dystrophies in which the mutant genes have been identified, molecular genetic analyses of the suspected gene can provide an accurate diagnosis.

The diagnosis of Fuchs Endothelial Corneal Dystrophy is clinical; however, some diagnostic tests can be helpful. Pachymetry, or measurement of the central corneal thickness, helps follow a patient with Fuchs Endothelial Corneal Dystrophy. Endothelial cell counts can also be helpful when counseling patients on how quickly their dystrophy may progress and how safe any other intra-ocular surgery might be. Specular microscopy is used to visualize the endothelium which can corroborate the typical endothelial changes associated with this dystrophy.

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Fuchs Endothelial Corneal Dystrophy Treatment

Medical treatments such as hyperosmotic saline drops or ointment can facilitate corneal dehydration. For symptomatic blurry vision in the mornings, some patients find it useful to use a hairdryer to place warm, dry air gently onto the cornea. Other supportive treatments and surgical procedures such as phototherapeutic keratectomy, amniotic membrane transplants, anterior stromal puncture, and conjunctival flaps can relieve painful symptoms, especially those associated with ruptured bullae in the later stages of the disease.

Several surgical procedures have shown utility in Fuchs Endothelial Corneal Dystrophy. Penetrating keratoplasty (PK), Descemet's stripping automated endothelial keratoplasty (DSAEK), and Descemet's membrane endothelial keratoplasty (DMEK) are the definitive treatments to restore vision. DSAEK is currently the most common treatment for endothelial cell dysfunction and results in better visual outcomes than PK and minimal changes in astigmatism and spherical equivalent. DMEK involves transplantation of only the endothelial layer and Descemet's membrane, and it provides the most rapid visual rehabilitation of all of the keratoplasty techniques; PLK and DLEK are used less often and are associated with a thick graft-host stromal interface.

Combined cataract/ intraocular lens (IOL) and Endothelial keratoplasty (EK) surgery are recommended in patients with moderate Fuchs Endothelial Corneal Dystrophy and visually significant cataracts. Patients with moderate Fuchs Endothelial Corneal Dystrophy, clear lens, and a shallow anterior chamber also should consider undergoing combined surgery, given the increased risk of postoperative cataract formation. A combined surgical approach may be more convenient and cost-effective than performing separate EK and cataract procedures.

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Fuchs Endothelial Corneal Dystrophy Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Fuchs Endothelial Corneal Dystrophy, Gender-specific Cases of Fuchs Endothelial Corneal Dystrophy, Age-specific Cases of Fuchs Endothelial Corneal Dystrophy, and Grade-specific Cases of Fuchs Endothelial Corneal Dystrophy scenario of Fuchs Endothelial Corneal Dystrophy in the 7MM covering the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

Key Findings

• According to DelveInsight estimates, in 2021, the total diagnosed prevalent cases of Fuchs Endothelial Corneal Dystrophy were estimated to be approximately 18,813,111 in the 7MM. These cases are expected to increase by 2032 at a CAGR of 0.6% during the study period (2019-2032).
• Among the 7MM, the United States accounted for nearly 34% of the total diagnosed prevalent cases of Fuchs Endothelial Corneal Dystrophy in the 7MM in the year 2021, which are expected to increase further by 2032.
• As per DelveInsight analysis, in EU4 and the United Kingdom, Germany had the highest total diagnosed prevalent cases of Fuchs Endothelial Corneal Dystrophy with approximately 2,448,548 in 2021, while Spain had the lowest diagnosed prevalent population of Fuchs Endothelial Corneal Dystrophy with 1,390,771 cases in 2021.
• In 2021, the diagnosed prevalent population of Fuchs Endothelial Corneal Dystrophy in Japan was found to be 3,166,886 cases, which is expected to change during the study period of 2019-2032.
• According to estimates based on DelveInsight's epidemiology model for Fuchs Endothelial Corneal Dystrophy, the gender distribution of the disease suggests a female predominance across the 7MM, with 2,504,351 male and 3,961,988 female cases in the US in 2021.
• In 2021, approximately 30.1% of the Fuchs Endothelial Corneal Dystrophy cases were for the 50-59 age group, followed by 23.7% in the 60-69 age group in the US.

Fuchs Endothelial Corneal Dystrophy Epidemiology

The epidemiology segment also provides the Fuchs Endothelial Corneal Dystrophy epidemiology data and findings across the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

Fuchs Endothelial Corneal Dystrophy Drug Chapters

The drug chapter segment of the Fuchs Endothelial Corneal Dystrophy report encloses a detailed analysis of Fuchs Endothelial Corneal Dystrophy marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Fuchs Endothelial Corneal Dystrophy clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.

Fuchs Endothelial Corneal Dystrophy Emerging Drugs

The potential drugs that are expected to launch in the forecasted period include ripasudil (K-321) (Kowa Pharmaceuticals), TTHX 1114 (Trefoil Therapeutics), netarsudil (Alcon), and others.

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. Based on the Phase II study investigating the safety and efficacy of K-321 in patients with FECD following descemetorhexis, Kowa Pharmaceuticals has initiated a Phase III trial in the US for FECD.

Products detail in the report…

TTHX 1114: Trefoil Therapeutics

TTHX 1114, developed by Trefoil Therapeutics, is a proprietary engineered fibroblast growth factor-1 [FGF-1 (eFGF-1)] variant designed to protect corneal endothelial cells from stress and injury and restore vision loss by stimulating cell proliferation and migration. Trefoil Therapeutics recently announced positive Phase II (STORM) trial results for TTHX1114 showing corneal regeneration and vision recovery following DSO surgery. It is also conducting an additional Phase II for TTHX1114 to evaluate its safety and observe the potential benefit of TTHX1114 delivered via intracameral injection.

Products detail in the report…

Netarsudil: Alcon

Netarsudil, being developed by Aerie Pharmaceuticals (acquired by Alcon), is an ophthalmic solution for treating corneal edema due to Fuchs Endothelial Corneal Dystrophy. It acts as a Rho kinase inhibitor thereby reducing intraocular pressure (IOP) by increasing the outflow of aqueous humor through the trabecular meshwork route. However, the exact mechanism is unknown. Aerie Pharmaceuticals completed a Phase II study that evaluated the safety and efficacy of netarsudil ophthalmic solution in patients with corneal edema due to Fuchs Endothelial Corneal Dystrophy and presented the results for the same at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in 2022. However, a further update on drug development is awaited.

Products detailed in the report

List of products to be continued in the report…

Fuchs Endothelial Corneal Dystrophy Market Outlook

Medical management of early Fuchs Endothelial Corneal Dystrophy 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.

A decade ago, when the only available transplantation option for Fuchs Endothelial Corneal Dystrophy was PK, the threshold for surgical intervention was high, and patients were conservatively followed until they developed advanced disease. PLK, also called DLEK, replaced the host's posterior lamina, DM, and endothelium with a donor button through a sclerocorneal incision.

Recent developments are being done to regenerate corneal endothelium directly by injecting cultured corneal endothelial cells into the anterior chamber without a carrier. However, animal experiments have revealed that an insufficient number of the injected cells adhere to the cornea's backside, so a corneal endothelium fails to regenerate in vivo. Studies have shown that cell adhesion is inhibited by the activation of Rho/ROCK signaling, and conversely, inhibition of this signaling pathway by ROCK inhibitor enhances cell adhesion. Thus coinjection of cultured corneal endothelial cells and a ROCK inhibitor regenerates the corneal endothelium and restores a transparent cornea in human subjects. Though further clinical data are necessary, cell-based therapy appears to be a potential future treatment for corneal endothelial decompensation diseases, including Fuchs Endothelial Corneal Dystrophy.

Therefore though corneal transplantations using donor corneas continue to remain the standard treatment, new therapeutic options, such as cell augmentation therapies along with magnetic cell-based therapy and the use of pharmaceutical agents like Rho kinase inhibitor, TGF-B inhibitor, N-acetylcysteine, oxotremorine, etc., and gene therapies using adenovirus vector therapy, Antisense, and CRISPR approaches are being developed that will provide less invasive and more effective therapies, along with reversing, the degeneration of endothelial cells for the treatment of Fuchs Endothelial Corneal Dystrophy.

According to DelveInsight, the overall dynamics of the Fuchs Endothelial Corneal Dystrophy market is anticipated to change in the coming years owing to the expected launch of emerging therapies.

Key Findings

• The market size of Fuchs Endothelial Corneal Dystrophy in the seven major markets was approximately USD 846.1 million in 2021, which is further expected to increase by 2032.
• The market size in the 7MM will increase at a CAGR of 8.6% due to increasing awareness of the disease.
• Among the 7MM countries, the US accounted for the highest market size of Fuchs Endothelial Corneal Dystrophy with USD 385.6 million in 2021 which is likely to increase by 2032.
• Among EU4 and the United Kingdom, Germany accounted for USD 87.6 million in 2021, followed by Italy with USD 66.6 million in the respective year, while Spain accounted for the lowest market with USD 49.8 million in 2021.
• Japan accounted for USD 132.2 million in 2021, which is expected to increase by 2032.

The United States Market Outlook

This section provides the total Fuchs Endothelial Corneal Dystrophy market size and market size by therapies (therapeutic and prophylactic) in the United States.

EU4 and the United Kingdom Market Outlook

The total Fuchs Endothelial Corneal Dystrophy market size and market size by therapies (therapeutic and prophylactic) in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Fuchs Endothelial Corneal Dystrophy market size and market size by therapies (therapeutic and prophylactic) in Japan are provided.

Fuchs Endothelial Corneal Dystrophy Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Fuchs Endothelial Corneal Dystrophy market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Fuchs Endothelial Corneal Dystrophy market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and the reasons behind the maximal use of new drugs and allows, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Fuchs Endothelial Corneal Dystrophy Development Activities

The report provides insights into different therapeutic candidates in the phase II, and phase III stages and also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for Fuchs Endothelial Corneal Dystrophy emerging therapies.

Reimbursement Scenario in Fuchs Endothelial Corneal Dystrophy

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Fuchs Endothelial Corneal Dystrophy market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report:

• The report covers a descriptive overview of Fuchs Endothelial Corneal Dystrophy, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Fuchs Endothelial Corneal Dystrophy epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Fuchs Endothelial Corneal Dystrophy is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Fuchs Endothelial Corneal Dystrophy market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Fuchs Endothelial Corneal Dystrophy market.

Report Highlights:

• The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the Fuchs Endothelial Corneal Dystrophy market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Fuchs Endothelial Corneal Dystrophy R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Fuchs Endothelial Corneal Dystrophy. The launch of emerging therapies (therapeutic and prophylactic) will significantly impact the Fuchs Endothelial Corneal Dystrophy market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Fuchs Endothelial Corneal Dystrophy Report Insights

• Patient Population
• Therapeutic Approaches
• Fuchs Endothelial Corneal Dystrophy Pipeline Analysis
• Fuchs Endothelial Corneal Dystrophy Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies (therapeutic and prophylactic)

Fuchs Endothelial Corneal Dystrophy Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Fuchs Endothelial Corneal Dystrophy Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Fuchs Endothelial Corneal Dystrophy Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• SWOT analysis

Key Questions

Market Insights:

• What was the Fuchs Endothelial Corneal Dystrophy market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Fuchs Endothelial Corneal Dystrophy total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Fuchs Endothelial Corneal Dystrophy market size during the forecast period (2022-2032)?
• At what CAGR, the Fuchs Endothelial Corneal Dystrophy market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Fuchs Endothelial Corneal Dystrophy market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Fuchs Endothelial Corneal Dystrophy market growth till 2032 and what will be the resultant market size in the year 2032?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of Fuchs Endothelial Corneal Dystrophy?
• What is the historical Fuchs Endothelial Corneal Dystrophy patient pool in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What would be the forecasted patient pool of Fuchs Endothelial Corneal Dystrophy at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Fuchs Endothelial Corneal Dystrophy?
• Out of the above-mentioned countries, which country would have the highest incidence population of Fuchs Endothelial Corneal Dystrophy during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Fuchs Endothelial Corneal Dystrophy along with the approved therapy?
• What are the current treatment guidelines for the treatment of Fuchs Endothelial Corneal Dystrophy in the US and Europe?
• What are the Fuchs Endothelial Corneal Dystrophy marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for the treatment of Fuchs Endothelial Corneal Dystrophy?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Fuchs Endothelial Corneal Dystrophy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Fuchs Endothelial Corneal Dystrophy therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Fuchs Endothelial Corneal Dystrophy and their status?
• What are the key designations that have been granted for the emerging therapies for Fuchs Endothelial Corneal Dystrophy?
• What is the 7MM historical and forecasted market for Fuchs Endothelial Corneal Dystrophy?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving Fuchs Endothelial Corneal Dystrophy.
• To understand the future market competition in the Fuchs Endothelial Corneal Dystrophy market.
• Organize sales and marketing efforts by identifying the best opportunities for Fuchs Endothelial Corneal Dystrophy in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Fuchs Endothelial Corneal Dystrophy market.
• To understand the future market competition in the Fuchs Endothelial Corneal Dystrophy market.