角膜浮腫 - 市場考察、疫学、市場予測（2034年）

主なハイライト

• 角膜浮腫市場は、予測期間（2023年～2034年）を通して安定した成長が見込まれます。米国の角膜浮腫の市場規模は、新治療法の発売により拡大が見込まれます。
• 米国の角膜浮腫と診断された患者の総数は2022年に約1,149,967人であり、これらの患者は予測期間中（2023年～2034年）にさらに増加すると予測されます。
• 米国では、市場は主に副腎皮質ステロイド薬と非ステロイド性抗炎症薬（NSAIDs）などで構成され、2022年の市場規模は4億8,900万米ドル近くに上っています。
• 角膜浮腫治療市場の総市場規模は、EO2002などの新しく効果的な治療法の登場により、予測期間に成長が見込まれます。

角膜浮腫市場の見通し

角膜浮腫の現在の治療法には、根本的な原因や重症度に基づいた専用の戦略が含まれます。初期管理には、炎症を抑え、角膜から余分な液体を取り除くために、高張食塩水や局所ステロイドの使用が含まれることが多いです。経口または外用の炭酸脱水酵素阻害薬などの高浸透圧薬も使用されます。バンデージコンタクトレンズは、角膜表面を滑らかにし、視力を向上させることで症状を緩和することができます。角膜内皮がひどく傷ついている場合は、デスメ膜剥離内皮角膜移植術（DSEK）やデスメ膜内皮角膜移植術（DMEK）などの角膜移植などの外科的介入が考慮されます。選択的レーザー線維柱帯形成術（SLT）のようなレーザー治療は、続発性緑内障を伴う症例に利用できます。さらに、浮腫の原因となる基礎疾患への対処や、潤滑のための人工涙液の使用も包括的な治療計画の一部となりえます。TTHX1114やsirolimusのような治験薬に見られるように、革新的な治療法を模索する継続的な研究により、角膜浮腫を管理する選択肢は将来的に拡大する可能性があります。

角膜浮腫市場は、EO2002、TTHX1114などのような潜在的な薬剤の承認により、プラス成長が予測されます。

• 米国の角膜浮腫の総市場規模は、2022年に約4億8,900万米ドルに達しました。予測期間に大幅な成長が見込まれます。

当レポートでは、米国の角膜浮腫市場について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 角膜浮腫市場の概要

• 角膜浮腫の市場シェア分布：治療法別（2020年）
• 角膜浮腫の市場シェア分布：治療法別（2034年）

第4章 角膜浮腫の疫学と市場調査手法

第5章 角膜浮腫のエグゼクティブサマリー

第6章 主な出来事

第7章 角膜浮腫：疾患の背景と概要

• イントロダクション
• 病因
• 病態生理学
• 診断
  • 鑑別診断
  • 診断アルゴリズム
  • 診断ガイドライン
• 管理
  • 治療アルゴリズム
  • 治療ガイドライン

第8章 疫学と患者数

• 主な調査結果
• 前提条件と根拠
• 米国
  • 米国の角膜浮腫と診断された患者の総数
  • 米国の病因特異的な角膜浮腫と診断された患者数

第9章 ペイシェントジャーニー

第10章 新薬

• 主な競合
• EO2002: Emmetrope Ophthalmics LLC ("Emmecell")
• TTHX1114: Trefoil Therapeutics
• GLANATEC (ripasudil/K-321): D. Western Therapeutics Institute (DWTI)/Kowa Ltd.
• STN1010904 (sirolimus)/AE001: Santen Pharmaceutical/Actual Eyes

第11章 角膜浮腫：市場の分析

• 主な調査結果
• 市場見通し
• コンジョイント分析
• 主な市場予測の前提条件
• 米国の角膜浮腫の総市場規模
• 米国の角膜浮腫の市場規模：治療法別

第12章 KOLの見解

第13章 SWOT分析

第14章 アンメットニーズ

第15章 市場参入と償還

• 米国
  • メディケア・メディケイドサービスセンター（CMS）

第16章 付録

第17章 DelveInsightのサービス内容

第18章 免責事項

List of Tables

• Table 1: Summary of Corneal Edema Market and Epidemiology (2023-2034)
• Table 2: Key Events
• Table 3: Total Diagnosed Prevalent Cases of Corneal Edema in the US, in 000's (2020-2034)
• Table 4: Etiology-specific Diagnosed Prevalent Cases of Corneal Edema in the US in 000's (2020-2034)
• Table 5: Comparison of Emerging Drugs
• Table 6: EO2002, Clinical Trial Description, 2024
• Table 7: TTHX1114, Clinical Trial Description, 2024
• Table 8: Ripasudil (K-321), Clinical Trial Description, 2024
• Table 9: STN1010904 (sirolimus)/AE001, Clinical Trial Description, 2024
• Table 10: Key Market Forecast Assumptions for EO2002
• Table 11: Key Market Forecast Assumptions for TTHX1114
• Table 12: Market Size of Corneal Edema in the United States, in USD million (2020-2034)
• Table 13: Market Size by Therapies of Corneal Edema in the US, in USD million (2020-2034)

List of Figures

• Figure 1: Etiology of Corneal Edema
• Figure 2: Diagnostic Algorithm of Corneal Edema
• Figure 3: Treatment Algorithm of Corneal Edema
• Figure 4: Total Diagnosed Prevalent Cases of Corneal Edema in the US in 000's (2020-2034)
• Figure 5: Etiology-specific Diagnosed Prevalent Cases of Corneal Edema in the US in 000's (2020-2034)
• Figure 6: Patient Journey of Corneal Edema
• Figure 7: Total Market Size of Corneal Edema in the United States (2020-2034)
• Figure 8: Market Size of Corneal Edema by Therapies in the US (2020-2034)
• Figure 9: Unmet Needs
• Figure 10: Health Technology Assessment

Key Highlights:

• The Corneal Edema market is projected to witness consistent growth throughout the forecast period (2023-2034). The market size of Corneal Edema in the US is expected to increase, driven by the launch of emerging therapies.
• DelveInsight's analyst projects that the total diagnosed prevalent cases of Corneal Edema in US were approximately 1,149,967 cases in 2022 and these cases are further expected to increase during the forecasted period (2023-2034).
• In the US, the market mainly consisted of Corticosteroids and Non-steroidal anti-inflammatory drugs (NSAIDs), and others, which generated nearly USD 489 million in 2022.
• The total market size of the Corneal Edema treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments, namely EO2002, and others.

DelveInsight's "Corneal Edema- Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the corneal edema, historical and forecasted epidemiology and the corneal edema market trends in the United States.

The Corneal Edema market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted United States Corneal Edema market size from 2020 to 2034. The report also covers current Corneal Edema 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

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Corneal Edema Overview

Corneal edema is characterized by the swelling of the cornea, the transparent, dome-shaped outer layer of the eye that shields the iris and pupil. The cornea is pivotal in directing light onto the retina to facilitate clear vision. The occurrence of corneal edema arises from an excess accumulation of fluid within the cornea, resulting in a blurred or cloudy visual appearance.

Corneal edema can manifest due to diverse factors, each contributing to the accumulation of excessive fluid within the cornea and resulting in a cloudy or hazy visual appearance. One prevalent cause is endothelial dysfunction, characterized by impairment in the cells lining the inner surface of the cornea, known as the endothelium. Conditions like Fuchs' dystrophy or damage from intraocular surgery can compromise the regulatory function of endothelial cells, leading to edema. Trauma or direct injury to the eye can also trigger corneal swelling. Inflammatory conditions, such as uveitis, exacerbate corneal edema by inducing inflammation within the eye.

Corneal edema presents with distinctive symptoms that affect both vision and overall eye comfort. A key symptom is the occurrence of blurred or hazy vision, a consequence of light scattering due to the buildup of fluid in the cornea. Individuals affected by corneal edema often encounter a significant reduction in visual acuity, leading to difficulties in perceiving fine details clearly. Another prevalent symptom is sensitivity to light, referred to as photophobia.

Corneal Edema Diagnosis

The diagnosis of corneal edema involves a comprehensive eye examination conducted by an ophthalmologist. Clinical evaluation typically includes a thorough assessment of the patient's medical history, symptoms, and any relevant contributing factors. Specialized tests, such as corneal topography or pachymetry, may be employed to measure corneal thickness and assess the extent of edema. Slit-lamp biomicroscopy allows for a detailed examination of the cornea, enabling the clinician to observe any signs of swelling, cloudiness, or changes in endothelial cell density. Additionally, visual acuity tests help quantify the impact of corneal edema on the patient's vision.

Corneal Edema Treatment

The treatment of corneal edema is tailored to address its underlying cause. In cases where endothelial dysfunction is a contributing factor, therapies may include hypertonic saline solutions to draw excess fluid from the cornea or the use of hyperosmotic agents for reducing swelling. Lubricating eye drops, often in the form of artificial tears, can provide relief from discomfort and dryness associated with corneal edema. In more severe instances, surgical interventions such as corneal transplantation may be considered to replace damaged tissue.

Corneal Edema Epidemiology

As the market is derived using the patient-based model, the Corneal Edema epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Etiology-specific Diagnosed Prevalent Cases of Corneal Edema, and Total Diagnosed Prevalent Cases of Corneal Edema covering the United States from 2020 to 2034.

As per DelveInsight's estimations, the total diagnosed prevalent cases of Corneal Edema in the United States were approximately 1,149,967 in 2022 and are projected to increase during the forecast period.

Corneal Edema Drug Chapters

The drug chapter segment of the Corneal Edema report encloses a detailed analysis of corneal edema marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands Corneal Edema 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

EO2002: Emmetrope Ophthalmics LLC

EO2002, developed by Emmecell, is a pioneering non-surgical magnetic cell-based therapy designed to modify diseases, particularly addressing corneal edema secondary to corneal endothelial dysfunction. This innovative therapy utilizes the exclusive Magnetic Cell Delivery (MCD) nanoparticle platform, allowing for easier access to treatment before the onset of disability and pain. EO2002 has the potential to prevent or delay the need for more invasive procedures like corneal transplantation. Currently, in Phase I evaluation (EMME-01 study), it aims to assess safety and tolerability in eyes qualifying for full-thickness corneal transplantation or endothelial keratoplasty.

TTHX1114: Trefoil Therapeutics

TTHX1114 is an investigational-engineered variant of the naturally occurring molecule fibroblast growth factor-1 (FGF1), which stimulates corneal endothelial and epithelial cell proliferation and migration as well as protects these cells from stress and injury. Trefoil is conducting clinical trials for TTHX1114 as an intracameral injection in patients susceptible to corneal edema due to endothelial damage, including Fuchs endothelial corneal dystrophy (FECD) and other corneal endothelial dystrophies (CED) and patients with other risk factors undergoing ocular surgeries. The drug is aimed at protecting and regenerating corneal endothelial cells lost due to disease and thereby improving vision.

Note: Detailed emerging therapies assessment will be provided in the final report of Corneal Edema

Corneal Edema Market Outlook

The current treatment approach for corneal edema involves a tailored strategy based on the underlying cause and severity of the condition. Initial management often includes the use of hypertonic saline solutions and topical steroids to reduce inflammation and draw out excess fluid from the cornea. Hyperosmotic agents, such as oral or topical carbonic anhydrase inhibitors, may also be employed. Bandage contact lenses can provide relief by creating a smoother corneal surface, improving vision. In cases where the corneal endothelium is severely compromised, surgical interventions like corneal transplantation, including Descemet's Stripping Endothelial Keratoplasty (DSEK) or Descemet's Membrane Endothelial Keratoplasty (DMEK), may be considered. Laser procedures, such as Selective Laser Trabeculoplasty (SLT), could be utilized in cases associated with secondary glaucoma. Additionally, addressing the underlying conditions contributing to edema and the use of artificial tears for lubrication may be part of the comprehensive treatment plan. The approach is dynamic, with ongoing research exploring innovative therapies, as seen in investigational drugs like TTHX1114 and sirolimus, potentially expanding the options for managing corneal edema in the future.

The market for Corneal Edema is expected to experience positive growth with the approval of potential drugs like EO2002, TTHX1114 and others.

• The Corneal Edema market's total size in the US reached approximately USD 489 million in 2022. Projections indicate a substantial growth during the forecast period.

Corneal Edema Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, EO2002 in the US is expected to be launched by 2028.

Further detailed analysis of emerging therapies drug uptake in the report…

Corneal Edema 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 Corneal Edema 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 Corneal Edema evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from University of Utah Hospital, the US, Department of Ophthalmology, Columbia University, New York, US, Department of Ophthalmology, Icahn School of Medicine at Mount Sinai, New York, Departments of Cornea and External Diseases, Scripps Clinic Torrey Pines, La Jolla, California and others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the US. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or corneal edema 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 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 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 Corneal Edema, 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 Corneal Edema market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the US 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 US Corneal Edema market.

Corneal Edema Report Insights

• Patient Population
• Therapeutic Approaches
• Corneal Edema Pipeline Analysis
• Corneal Edema Market Size and Trends
• Existing and Future Market Opportunity

Corneal Edema Report Key Strengths

• 12 years Forecast
• The United States Coverage
• Corneal Edema Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Corneal Edema 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 Corneal Edema 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 Corneal Edema?
• What are the patents of emerging therapies for Corneal Edema?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for 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 Corneal Edema? What will be the growth opportunities in the United States concerning the patient population of Corneal Edema?
• What is the historical and forecasted Corneal Edema patient pool in the United States?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Corneal Edema? What are the current guidelines for treating Corneal Edema in the US?
• How many companies are developing therapies for treating Corneal Edema?
• How many emerging therapies are in the mid-stage and late stage of development for treating Corneal Edema?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What is the US historical and forecasted market of Corneal Edema?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Corneal Edema 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.
• 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 Corneal Edema Epidemiology and Market Insight report for the United States 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 Corneal Edema market?

• The Corneal Edema emerging market has many drugs. The major key players developing therapies for Corneal Edema are Emmecell, Trefoil Therapeutics, Santen Pharmaceutical, and others.

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 prevalent cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Corneal Edema market?

• The increase in diagnosed prevalent cases of Corneal Edema and the launch of emerging therapies are attributed to be the key drivers for increasing Corneal Edema market.

5. What is the expected impact of emerging therapies or advancements in Corneal Edema treatment on the market?

• Introducing new therapies, advancements in disease understanding and diagnostic techniques, and innovations in treatment approaches can significantly affect the Corneal Edema treatment market. Market forecast reports might 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 Corneal Edema market.

Table of Contents

1. Key Insights

2. Report Introduction

3. Corneal Edema Market Overview at a Glance

• 3.1. Market Share (%) Distribution by Therapies of Corneal Edema in 2020
• 3.2. Market Share (%) Distribution by Therapies of Corneal Edema in 2034

4. Epidemiology and Market Methodology of Corneal Edema

5. Executive Summary of Corneal Edema

6. Key Events

7. Corneal Edema: Disease Background and Overview

• 7.1. Introduction
• 7.2. Etiology
• 7.3. Pathophysiology
• 7.4. Diagnosis
  • 7.4.1. Differential Diagnosis
  • 7.4.2. Diagnostic Algorithm
  • 7.4.3. Diagnostic Guidelines
    • 7.4.3.1. American Academy of Ophthalmology (AAO) 2018 Guideline for Corneal Edema and Opacification Preferred Practice Pattern
• 7.5. Management
  • 7.5.1. Treatment Algorithm
  • 7.5.2. Treatment Guidelines
    • 7.5.2.1. AAO 2018 Guideline for Corneal Edema and Opacification Preferred Practice Pattern

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale
  • 8.2.1. Etiology-specific Diagnosed Prevalent Cases of Corneal Edema
• 8.3. The United States
  • 8.3.1. Total Diagnosed Prevalent Cases of Corneal Edema in the US
  • 8.3.2. Etiology-specific Diagnosed Prevalent Cases of Corneal Edema in the US

9. Patient Journey

10. Emerging Drugs

• 10.1. Key Cross Competition
• 10.2. EO2002: Emmetrope Ophthalmics LLC ("Emmecell")
  • 10.2.1. Product Description
  • 10.2.2. Other Development Activities
  • 10.2.3. Clinical Development
  • 10.2.4. Clinical Trial Information
  • 10.2.5. Safety and Efficacy
  • 10.2.6. Product Profile
  • 10.2.7. Analysts' Views
• 10.3. TTHX1114: Trefoil Therapeutics
  • 10.3.1. Product Description
  • 10.3.2. Other Developmental Activities
  • 10.3.3. Clinical Development
  • 10.3.4. Clinical Trials Information
  • 10.3.5. Safety and Efficacy
  • 10.3.6. Product Profile
  • 10.3.7. Analyst Views
• 10.4. GLANATEC (ripasudil/K-321): D. Western Therapeutics Institute (DWTI)/Kowa Ltd.
  • 10.4.1. Product Description
  • 10.4.2. Other Development Activities
  • 10.4.3. Clinical Development
  • 10.4.4. Clinical Trial Information
  • 10.4.5. Product Profile
  • 10.4.6. Analysts' Views
• 10.5. STN1010904 (sirolimus)/AE001: Santen Pharmaceutical/ Actual Eyes
  • 10.5.1. Product Description
  • 10.5.2. Other Developmental Activities
  • 10.5.3. Clinical Development
  • 10.5.4. Clinical Trials Information
  • 10.5.5. Product Profile
  • 10.5.6. Analyst Views

11. Corneal Edema: Market Analysis

• 11.1. Key Findings
• 11.2. Market Outlook
• 11.3. Conjoint Analysis
• 11.4. Key Market Forecast Assumptions
• 11.5. Total Market Size of Corneal Edema in the US
• 11.6. Market Size of Corneal Edema by Therapies in the US

12. Key Opinion Leaders' Views

13. SWOT Analysis

14. Unmet Needs

15. Market Access and Reimbursement

• 15.1. The United States
  • 15.1.1. Center for Medicare and Medicaid Services (CMS)

16. Appendix

• 16.1. Bibliography
• 16.2. Acronyms and Abbreviations
• 16.3. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer