수포성 각막병증 시장 - 시장 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• According to DelveInsight's estimates, in 2023, there were approximately 192 thousand diagnosed Bullous Keratopathy prevalent cases in the 7MM. Of these, the United States accounted for 41% of the cases, while Germany and Japan represented 13% and 9% of the cases, respectively.
• The bullous keratopathy market is set for steady growth, with a robust compound annual growth rate (CAGR) anticipated from 2024 to 2034. This expansion in the 7MM is driven by the introduction of innovative therapies such as TTHX1114 (NM141), EO2002, and CLS001, among others, along with an aging population, advancements in eye surgeries like cataract and glaucoma procedures, and the widespread use of intraocular lenses (IOLs).
• According to DelveInsight's analysis, the Bullous Keratopathy Drugs Market in the 7MM was valued at approximately USD 13.8 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 11.5%.
• Companies like Aurion Biotechnologies have been pioneers in the bullous keratopathy market with the launch of VYZNOVA (neltependocel) in Japan. Other companies are entering the space, leveraging orphan drug designations and seeking to expand market share through clinical trials and partnerships focused on new treatment modalities.
• In April 2024, Emmecell completed the final dose administration for the last patient in the US Phase I trial evaluating the safety and efficacy of EO2002 for corneal edema. A Phase III pivotal study is scheduled for the first quarter of 2025, positioning EO2002 as a potential breakthrough treatment in this space.
• Despite the approval of VYZNOVA (neltependocel) in Japan, a significant gap remains in non-surgical treatments for advanced corneal edema in the US and EU. Currently, patients have only two options: corneal transplantation or endothelial keratoplasty, both of which are complex and come with significant limitations and risks.
• Corneal edema's progression, leading to ongoing discomfort and vision loss, highlights the need for new treatments. Corneal transplantation, though effective, comes with risks like rejection and high costs, emphasizing the urgency for less invasive, innovative therapies.

DelveInsight's "Bullous Keratopathy Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of bullous keratopathy, historical and forecasted epidemiology, as well as the bullous keratopathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Bullous Keratopathy Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM bullous keratopathy market size from 2020 to 2034. The report also covers bullous keratopathy treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Bullous Keratopathy Treatment Market: Understanding and Algorithm

The term keratopathy comes from the root words Kera, meaning cornea, and pathy, meaning disease; therefore, keratopathy is the disease of the cornea with a vast array of underlying causes and mechanisms. Keratopathy can occur due to an eye condition or systemic conditions. There are several types of keratopathy, including bullous keratopathy. Bullous keratopathy is a pathological condition in which small vesicles, or bullae, formation occurs in the cornea due to endothelial dysfunction. Initially, there is endothelial trauma, followed by progressive stromal and epithelial edema. The epithelial edema results in the formation of bullae, hence the name bullous keratopathy.

Bullous keratopathy is also called pseudophakic bullous keratopathy (PBK) or pseudophakic corneal edema (PCE) in certain cases because it specifically occurs in individuals who have undergone cataract surgery and have had an IOL implanted in their eye. The main characterization is the formation of fluid-filled blisters or bullae on the cornea, which can cause pain, blurred vision, and other visual disturbances. This condition typically occurs due to damage to the corneal endothelium, the innermost layer of cells that maintains the cornea's clarity and controls fluid balance.

Bullous keratopathy diagnosis

Diagnosis of bullous keratopathy typically involves a comprehensive eye examination, including visual acuity testing, slit-lamp examination, and evaluation of corneal thickness and clarity. In some cases, additional tests such as corneal topography or specular microscopy are required to assess the severity and extent of corneal damage.

Bullous keratopathy Treatment

The treatment options for bullous keratopathy depend on the underlying cause and the severity of the condition. In the early stages, conservative measures to manage symptoms, such as lubricating eye drops, hyperosmotic agents, anti-glaucoma medications, steroids, ointments, or bandage contact lenses, are used to relieve pain and protect the cornea. The approval of allogeneic cell therapy in Japan may prove to be effective. However, if the condition progresses and significantly affects vision and quality of life, surgical intervention may be necessary.

Corneal transplantation, specifically endothelial keratoplasty (EK) procedures like Descemet's stripping automated endothelial keratoplasty (DSAEK) or Descemet's membrane endothelial keratoplasty (DMEK), is a common surgical option for bullous keratopathy. These procedures involve replacing the damaged corneal endothelium with healthy donor tissue to restore corneal clarity and improve visual function.

Bullous Keratopathy Epidemiology

As the market is derived using a patient-based model, the bullous keratopathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total cases of major etiologies of bullous keratopathy, total cases of bullous keratopathy in major etiologies, total diagnosed prevalent cases of bullous keratopathy , gender-specific diagnosed prevalent cases of bullous keratopathy, total cases of bullous keratopathy in corneal transplant/keratoplasty in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• According to DelveInsight's epidemiology model, the total number of diagnosed prevalent cases of bullous keratopathy was approximately 192 thousand among the 7MM in 2023. This number is expected to increase during the forecast period (2024-2034), driven by an aging population and an increased number of ocular surgeries.
• In the 7MM, the US accounted for approximately 41% of total diagnosed prevalent cases of bullous keratopathy while EU4 and the UK accounted for nearly 50% of cases and Japan accounted for approximately 9% of cases in 2023.
• In 2023, the US accounted for the highest number of diagnosed prevalent cases of bullous keratopathy among the 7MM, with approximately 79 thousand cases.
• Among the EU4 and the UK, Germany had the highest number of diagnosed prevalent cases of bullous keratopathy, with approximately 26 thousand cases in 2023, followed by France with nearly 22 thousand cases. On the other hand, Spain had the lowest number of cases, with approximately 14 thousand.
• Japan accounted for approximately 18 thousand diagnosed prevalent cases of bullous keratopathy in 2023 which is expected to change during the forecast period.
• Among the gender-specific diagnosed prevalent cases of bullous keratopathy, there were approximately 30 thousand male and 48 thousand female cases in the US in 2023.
• In the UK, there were approximately 39% male and 61% female cases of bullous keratopathy in 2023.
• In 2023, Japan accounted for approximately 7 thousand male and 10 thousand female cases of bullous keratopathy, which is expected to change during the forecast period.

Bullous Keratopathy Drug Chapters

The drug chapter segment of the Bullous Keratopathy therapeutics market report encloses a detailed analysis of bullous keratopathy-marketed drugs and mid to late-stage (Phase III and Phase II) Bullous Keratopathy pipeline drugs analysis. It also helps understand the bullous keratopathy clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest Bullous Keratopathy news and press releases.

Bullous Keratopathy Marketed Drugs

• VYZNOVA (neltependocel): Aurion Biotechnologies

VYZNOVA, developed by Aurion Biotechnologies, is a cell therapy indicated for treating bullous keratopathy of the cornea in Japan. VYZNOVA consists of allogeneic human corneal endothelial cells, referred to as "neltependocel", and Y-27632, a small molecule drug that inhibits Rho-associated, coiled-coil containing protein kinase. This combination facilitates the regeneration of fully differentiated corneal endothelial cells (CECs) outside the body. Donor corneal cells undergo a proprietary, multi-step process to create off-the-shelf allogeneic CECs. These cells are injected into the eye, where they form a healthy mono-layer and reduce corneal edema by removing excess fluid.

In March 2023, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved VYZNOVA to treat bullous keratopathy of the cornea.

Bullous Keratopathy Emerging Drugs

• TTHX1114 (NM141): Trefoil Therapeutics

TTHX1114 (NM141) is an engineered form of fibroblast growth factor-1 protein (FGF-1). The native FGF-1 is a potent stimulator of cell proliferation and migration and has cell-protective properties. The compound uniquely activates all seven forms of the FGF receptor, contributing to its potency; however, the naturally occurring FGF-1 molecule has an extremely short half-life. The engineered FGF-1, TTHX1114, is designed to increase the half-life of the FGF-1 molecule and stimulate the proliferation and migration of corneal endothelial cells.

TTHX1114 is intended to restore vision in patients with corneal endothelial diseases, including pseudophakic bullous keratopathy. It is being developed as an intracameral injection, which involves injecting a small amount of TTHX1114 into the anterior chamber of the eye (directly behind the cornea) using a very small needle.

In April 2023, Trefoil Therapeutics presented Phase II results for TTHX1114 in patients with Fuchs endothelial corneal dystrophy (FECD) undergoing Descemet's Stripping Only (DSO) in combination with cataract surgery at the Annual Association for Research in Vision and Ophthalmology (ARVO) Meeting.

• EO2002: Emmecell

EO2002 is a first-in-class, non-surgical, magnetic cell-based therapy that can modify disease, developed through an exclusive magnetic cell delivery (MCD) nanoparticle platform. The MCD platform facilitates the delivery, retention, and integration of cell therapies by leveraging magnetic nanoparticles to effectively localize and integrate cell therapies to the appropriate target tissue.

In April 2024, Emmecell completed the final dose administration for the last patient in the US randomized, double-masked, multi-center Phase I trial assessing the safety and efficacy of EO2002 for treating corneal edema. Topline results are expected in the second half of 2024, with a Phase III pivotal study planned for the first quarter of 2025.

Bullous Keratopathy Drugs Market Insights

The current Bullous Keratopathy treatment market landscape involves both pharmacological and surgical therapies. Medicinal interventions such as cell therapy, hypertonic saline drops and ointment (sodium chloride 5%), antibiotics, anti-inflammatories, antiglaucoma, lubricating drops, and other medications are used for symptomatic relief. However, medical management is only favorable in the early stages of the disease, and when it fails, surgery is considered.

Cornea transplant remains the gold standard of treatment for bullous keratopathy, which requires the replacement of damaged endothelium with a healthy endothelium from a donor to restore the normal structure and function of endothelial cells; however, visual recovery takes some time. The graft size is usually 7-7.5 mm to avoid complications of small and large grafts, such as astigmatism and secondary glaucoma.

Hydrophilic contact lenses are widely used to decrease pain associated with epithelial bullae; however, they do not reduce the amount of edema. The contact lenses can be used with 5% hypertonic saline to improve visual acuity by decreasing epithelial and stromal edema. Usually, the pain associated with PBK arises from the rupture of bullae with exposure of corneal nerves endings or swelling of epithelium leading to stretching of nerve endings, and the lenses alleviate pain as long as the lens remains in place by acting as an effective precorneal protective layer.

Bullous Keratopathy Market Outlook

The approval of the first allogenic cell therapy globally marked a significant advancement in the treatment of corneal endothelial disease. In March 2023, PMDA approved VYZNOVA for treating bullous keratopathy of the cornea. The therapy addresses the need for non-surgical intervention and overcomes the donor cornea shortage by treating more than 100 eyes with fully differentiated CECs from a single donor. Healthy cells from a donor cornea are cultured in a novel, multi-step, proprietary, and patented process that produces off-the-shelf, allogeneic, fully differentiated CEC. Further, the endothelial cells are administrated intracamerally, where a repopulation of cells into a healthy monolayer occurs. Removing fluid from the cornea starts leading to the reduction of corneal edema.

A 2015 study demonstrated an increased expression of several pro-inflammatory mediators at the protein level in the corneal epithelium in patients with pseudophakic corneal edema when treated with systemic L-cysteine.

Current Bullous Keratopathy treatment options have limitations. Symptomatic treatments are effective only in the early stages and do not address the root cause or offer a long-term solution. Corneal transplantation, while standard, carries risks like infection, donor cornea rejection, and the need for long-term immunosuppressants. Additionally, increased transplant demand worsens the global donor tissue shortage. Advancing research, refining corneal endothelial regeneration techniques, and developing new therapies are essential to overcoming these challenges and enhancing disease management.

• The current emerging pipeline of bullous keratopathy is scarce, with no late-stage product. However, assets in the early stage, including TTHX1114 (NM141) of Trefoil Therapeutics, Emmecell's EO2002, and Cellusion's CLS001, among others carry hope for the future
• The total Bullous Keratopathy Treatment Market Size in the 7MM was approximately USD 13.8 million in 2023 and is projected to increase during the forecast period (2024-2034).
• The Bullous Keratopathy Market Size in the US was approximately USD 7.8 million in 2023 and is anticipated to increase due to the launch of emerging therapies.
• The total Bullous Keratopathy Market Size of EU4 and the UK was calculated to be approximately USD 4.8 million in 2023, which was nearly 34% of the total market revenue for the 7MM.
• Among EU4 and the UK, Germany accounted for the highest Bullous Keratopathy Market with approximately USD 1.3 million in 2023, followed by France with approximately USD 1.1 million in the respective year, and Italy with nearly USD 0.9 million in 2023.
• In 2023, the total Bullous Keratopathy Market Size was approximately USD 1.2 million in Japan which is anticipated to increase during the forecast period (2024-2034).
• As per the estimates, among the therapies currently in use, the standard of care (such as hyperosmotic sodium chloride) held the largest Bullous Keratopathy Market Share, generating approximately USD 13.7 million in revenue in 2023 across the 7MM.

Bullous Keratopathy Drugs Uptake

This section focuses on the uptake rate of potential Bullous Keratopathy drugs expected to be launched in the market during 2020-2034.

Bullous Keratopathy Pipeline Development Activities

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

Pipeline Development Activities

The Bullous Keratopathy therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for bullous keratopathy.

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 our secondary research. Industry Experts contacted for insights on bullous keratopathy evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Texas Health Science Center, Illinois College of Optometry and Salus University in the US, Eberhard-Karls-University Tubingen in Germany, University of Manchester and the Manchester Royal Eye Hospital in the UK, and Juntendo University Shizuoka Hospital in Japan, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or bullous keratopathy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

As per the KOLs from the US, standardized guidelines are urgently required as there are no guidelines for an accurate diagnosis and management of bullous keratopathy. An understanding of the precipitating causes and the Etiopathogenesis will further help in framing a curative treatment regimen. As per the KOLs from the UK, despite significant advancements in treating corneal endothelial disease, including improvements from traditional endothelial keratoplasty to DSEK, DMEK grafts, and injectable endothelial treatments, corneal disease remains a major global cause of blindness.

As per the KOLs from Japan, bullous keratopathy most commonly develops following glaucoma surgery, although it can also occur after complicated cataract surgery and laser iridotomy. Additionally, old age is a significant risk factor, as endothelial cell count decreases with advancing age.

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 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. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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.

Bullous Keratopathy Therapeutics Market Access and Reimbursement

Although VYZNOVA is approved in Japan for treating bullous keratopathy, the US and EU markets crave licensed therapies. The current treatment relies on symptomatic management and surgical interventions. However, the costs associated with corneal transplantation, including pre-operative evaluations, surgical fees, postoperative care, and long-term medication use, pose financial burdens for patients. Hence, limiting access to treatment for individuals with limited financial resources or inadequate insurance coverage. Therefore, access to affordable treatments and interventions is a significant concern for individuals with bullous keratopathy. Developing cost-effective therapies and ensuring their availability to a broader population can reduce the burden on patients and healthcare systems.

Corneal transplant coverage

A corneal transplant is usually covered by private medical insurance and Medicare when deemed medically necessary. Out-of-pocket costs may include a specialty copay, a hospital copay, and coinsurance of 10-50% for the procedure up to the yearly out-of-pocket maximum allowance. Capital BlueCross considers corneal transplantation medically necessary for patients with bullous keratopathy. Similarly, Blue Cross Blue Shield of Massachusetts considers DSEK, DSAEK, DMEK, or DMAEK medically necessary to treat endothelial dysfunction, including bullous keratopathy.

PacificSource provides coverage for AMT, but prior authorization is required. PacificSource considers AMT or limbal stem cell transplantation for ocular surface reconstruction medically necessary when ALL following criteria are met:

1. Member has limbal deficiency (hypo function or total loss of stem cells) refractory to conventional treatment (e.g., topical lubricants, antibiotics, therapeutic contact lenses, and patching).

2. At least one of the following indications:

A. Reconstruction of the corneal surface, as indicated for one of the following conditions:

• Acute thermal/chemical burns
• Band keratopathy that failed conservative treatment
• Corneal ulceration (central or peripheral)
• Descemetocele or perforation
• Neurotropic keratitis
• Painful bullous keratopathy
• Partial or complete limbal stem cell deficiency (with stem cell grafting)
• Persistent epithelial defect that failed conservative treatment
• Reconstruction of the surface of the conjunctiva

B. Reconstruction of the surface of the conjunctiva, as indicated for one of the following conditions:

• Acute Stevens-Johnson syndrome
• Acute thermal/chemical burns
• Covering defects after removal of conjunctival lesions (conjunctival intraepithelial neoplasia, tumors, scars, or folds parallel to the edges of the eyelids)
• Bleb revisions
• Pterygium if there was insufficient conjunctiva for an autograft
• Scleral thinning
• Superior limbic keratoconjunctivitis that failed conjunctival resection
• Sympblepharon, fornix reconstruction

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

Bullous Keratopathy Therapeutics Market Report Scope

• The Bullous Keratopathy therapeutics market report covers a segment of key events, an executive summary, and a descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• 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 bullous keratopathy market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Bullous Keratopathy Therapeutics Market 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 bullous keratopathy drugs market.

Bullous Keratopathy Therapeutics Market Report Insights

• Patient-based Bullous Keratopathy Market Forecasting
• Therapeutic Approaches
• Bullous keratopathy Pipeline Drugs Analysis
• Bullous keratopathy Market Size and Trends
• Existing and Future Bullous Keratopathy Drugs Market Opportunity

Bullous Keratopathy Therapeutics Market Report Key Strengths

• 11 years Bullous Keratopathy Market Forecast
• The 7MM Coverage
• Bullous keratopathy Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Bullous Keratopathy Drugs Uptake
• Key Bullous Keratopathy Market Forecast Assumptions

Bullous Keratopathy Therapeutics Market Report Assessment

• Current Bullous Keratopathy Treatment Market Practices
• Bullous Keratopathy Unmet Needs
• Bullous Keratopathy Pipeline Drugs Analysis Profiles
• Bullous Keratopathy Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Bullous Keratopathy Therapeutics Market Insights

• What was the total Bullous Keratopathy Treatment Market Size, the Bullous Keratopathy Drugs Market Size by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will TTHX1114 (NM141) affect the treatment paradigm of bullous keratopathy?
• How will VYZNOVA (neltependocel) compete with other upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Bullous Keratopathy Epidemiology Insights

• What are the disease risks, burdens, and Bullous Keratopathy Unmet Needs? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to bullous keratopathy?
• What is the historical and forecasted bullous keratopathy patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent bullous keratopathy population during the forecast period (2024-2034)?
• What factors are contributing to the growth of bullous keratopathy cases?

Current Bullous Keratopathy Treatment Market Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the Bullous Keratopathy Treatment? What are the current clinical and treatment guidelines for treating bullous keratopathy?
• How many companies are developing therapies for the treatment of bullous keratopathy?
• How many emerging therapies are in the mid-stage and late stage of development for treating bullous keratopathy?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted Bullous Keratopathy Drugs Market?

Reasons to Buy:

• The Bullous Keratopathy therapeutics market report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the bullous keratopathy drugs market.
• Insights on patient burden/disease Bullous Keratopathy Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing Bullous Keratopathy drugs market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for bullous keratopathy, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives 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 Bullous Keratopathy drugs market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Bullous Keratopathy Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Bullous Keratopathy in 2020
• 3.2. Market Share (%) Distribution of Bullous Keratopathy in 2034

4. Methodology of Bullous Keratopathy Epidemiology and Market

5. Executive Summary of Bullous Keratopathy

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Corneal Conditions
• 7.3. Classification
  • 7.3.1. Keratopathy
  • 7.3.2. Bullous Keratopathy
• 7.4. Etiology
• 7.5. Signs and Symptoms
• 7.6. Risk Factors
• 7.7. Pathophysiology
• 7.8. Diagnosis
• 7.9. Treatment
  • 7.9.1. Therapeutic Approaches
  • 7.9.2. Corneal Transplantation

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1. Cases of Major Etiologies of Bullous Keratopathy
  • 9.2.2. Bullous Keratopathy Cases in Major Etiologies
  • 9.2.3. Gender-specific Cases of Bullous Keratopathy
  • 9.2.4. Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty
• 9.3. Total Cases of Bullous Keratopathy in the 7MM
• 9.4. The US
  • 9.4.1. Cases of Major Etiologies of Bullous Keratopathy in the US
  • 9.4.2. Bullous Keratopathy Cases in Major Etiologies in the US
  • 9.4.3. Total Bullous Keratopathy Cases in the US
  • 9.4.4. Gender-specific Cases of Bullous Keratopathy in the US
  • 9.4.5. Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in the US
• 9.5. EU4 and the UK
  • 9.5.1. Cases of Major Etiologies of Bullous Keratopathy in EU4 and the UK
  • 9.5.2. Bullous Keratopathy Cases in Major Etiologies in EU4 and the UK
  • 9.5.3. Total Bullous Keratopathy Cases in EU4 and the UK
  • 9.5.4. Gender-specific Cases of Bullous Keratopathy in EU4 and the UK
  • 9.5.5. Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Cases of Major Etiologies of Bullous Keratopathy in Japan
  • 9.6.2. Bullous Keratopathy Cases in Major Etiologies in Japan
  • 9.6.3. Total Bullous Keratopathy Cases in Japan
  • 9.6.4. Gender-specific Cases of Bullous Keratopathy in Japan
  • 9.6.5. Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in Japan

10. Marketed Drugs

• 10.1. VYZNOVA (neltependocel): Aurion Biotechnologies
  • 10.1.1. Drug Description
  • 10.1.2. Regulatory Milestones
  • 10.1.3. Other Development Activities
  • 10.1.4. Clinical Development
  • 10.1.5. Safety and Efficacy
  • 10.1.6. Product Profile

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. TTHX1114 (NM141): Trefoil Therapeutics
  • 11.2.1. Drug Description
  • 11.2.2. Other Developmental Activity
  • 11.2.3. Clinical Development
  • 11.2.4. Clinical Trials Information
  • 11.2.5. Safety and Efficacy
  • 11.2.6. Product Profile
  • 11.2.7. Analysts' Views
• 11.3. EO2002: Emmecell
  • 11.3.1. Drug Description
  • 11.3.2. Other Developmental Activity
  • 11.3.3. Clinical Development
  • 11.3.4. Clinical Trials Information
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Product Profile
  • 11.3.7. Analysts' Views
• 11.4. CLS001: Cellusion
  • 11.4.1. Drug Description
  • 11.4.2. Other Developmental Activity
  • 11.4.3. Clinical Development
  • 11.4.4. Clinical Trials Information
  • 11.4.5. Safety and Efficacy
  • 11.4.6. Product Profile
  • 11.4.7. Analysts' Views

12. Bullous keratopathy: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Total Market Size of Bullous Keratopathy in the 7MM
• 12.5. Total Market Size of Bullous Keratopathy by Therapies in the 7MM
• 12.6. Market Size of Bullous Keratopathy in the US
  • 12.6.1. Total Market Size of Bullous Keratopathy
  • 12.6.2. The Market Size of Bullous Keratopathy by Therapies
• 12.7. Market Size of Bullous Keratopathy in EU4 and the UK
  • 12.7.1. Total Market Size of Bullous Keratopathy
  • 12.7.2. The Market Size of Bullous Keratopathy by Therapies
• 12.8. Market Size of Bullous Keratopathy in Japan
  • 12.8.1. Total Market Size of Bullous Keratopathy
  • 12.8.2. The Market Size of Bullous Keratopathy by Therapies

13. Key Opinion Leaders' Views

14. SWOT

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight