水疱性角膜症市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 2023年に主要7ヶ国で診断された水疱性角化症の有病患者数は約19万2,000人でした。このうち米国が41%を占め、ドイツが13%、日本が9%でした。
• 水疱性角膜症市場は着実に成長し、2024年から2034年までのCAGRは堅調に推移すると予想されます。この主要7ヶ国の拡大は、高齢化、白内障や緑内障手術などの眼科手術の進歩、眼内レンズ（IOL）の普及に加え、TTHX1114（NM141）、EO2002、CLS001などの革新的な治療法の導入が原動力となっています。
• 主要7ヶ国の水疱性角膜症治療薬の市場規模は2023年に約1,380万米ドルとなりました。同市場は、2024年から2034年までの予測期間において、CAGR 11.5％で成長すると予測されています。
• Aurion Biotechnologiesのような企業は、日本でVYZNOVA（ネルテペンドセル）を発売し、水疱性角膜症市場のパイオニアとなっています。他の企業もこの分野に参入しており、希少疾病用医薬品の指定を活用し、新たな治療法に焦点を当てた臨床試験や提携を通じて市場シェアの拡大を図っています。
• Emmecellは2024年4月、角膜浮腫に対するEO2002の安全性と有効性を評価する米国第I相試験において、最後の患者への最終投与を完了しました。第III相臨床試験は2025年第1四半期に予定されており、EO2002はこの分野における画期的な治療薬となる可能性があります。
• 日本ではVYZNOVA（ネルテペンドセル）が承認されたにもかかわらず、米国および欧州では進行した角膜浮腫に対する非外科的治療には大きな隔たりが残っています。現在のところ、患者には角膜移植術か角膜内皮移植術の2つの選択肢しかないが、いずれも複雑で大きな限界とリスクを伴います。
• 角膜浮腫の進行は、継続的な不快感と視力低下につながるため、新たな治療の必要性が浮き彫りになっています。角膜移植は効果的ではあるが、拒絶反応などのリスクと高額な費用が伴うため、侵襲の少ない革新的な治療法の緊急性が強調されています。

当レポートは、水疱性角膜症の詳細、過去の疫学と予測、米国、EU4ヶ国（ドイツ、フランス、イタリア、スペイン）、英国、日本の水疱性角膜症市場動向をお届けします。

現在の治療法、新薬、個々の治療法の市場シェア、2020年から2034年までの主要7ヶ国の水疱性角化症市場規模の現状と予測を提供します。また、水疱性角化症治療の市場慣行/アルゴリズム、アンメットメディカルニーズも網羅し、最良の治療機会を発掘し、市場の可能性を評価します。

角膜症という用語は、角膜を意味するKeraと病気を意味するpathyという語源に由来します。角膜症は、眼疾患または全身疾患によって発症します。角膜症には、水疱性角膜症を含むいくつかのタイプがあります。水疱性角膜症は、内皮機能障害により角膜に小水疱または水疱が形成される病的状態です。最初に内皮の外傷があり、次いで間質と上皮の浮腫が進行します。上皮の浮腫は水疱の形成をもたらし、これが水疱性角膜症という名前の由来です。

水疱性角膜症は、白内障手術を受けて眼内レンズを挿入した人に特に起こるため、場合によっては偽水疱性角膜症（PBK）または偽水疱性角膜浮腫（PCE）とも呼ばれます。主な特徴は、角膜上に液体を含んだ水疱または水疱が形成されることで、痛み、かすみ目、その他の視覚障害を引き起こす可能性があります。この症状は通常、角膜の透明性を維持し、体液バランスを制御する細胞の最内層である角膜内皮の損傷によって起こります。

水疱性角膜症の診断には通常、視力検査、細隙灯検査、角膜の厚みと透明度の評価など、総合的な眼科検査が行われます。場合によっては、角膜トポグラフィーや鏡面顕微鏡検査などの追加検査が角膜障害の重症度や程度を評価するために必要となります。

水疱性角膜症の治療法は、根本的な原因や重症度によって異なります。初期段階では、痛みを和らげ角膜を保護するために、潤滑点眼薬、高浸透圧薬、抗緑内障薬、ステロイド、軟膏、包帯コンタクトレンズなどの症状を管理する保存的手段が用いられます。日本で承認された同種細胞療法が有効であることが証明されるかもしれません。しかし、病状が進行し、視力や生活の質に大きな影響を及ぼす場合には、外科的治療が必要となります。

角膜移植、特にデスメ膜剥離自動内皮角膜移植術（DSAEK）やデスメ膜内皮角膜移植術（DMEK）のような内皮角膜移植術（EK）は、水疱性角膜症に対する一般的な外科的選択肢です。これらの手術では、損傷した角膜内皮を健康なドナー組織で置換することで、角膜の透明性を回復し、視機能を改善します。

• 2023年に主要7ヶ国で診断された水疱性角膜症の有病者総数は約19万2,000人でした。この数は、高齢化と眼科手術の増加により、予測期間中（2024～2034年）に増加すると予想されます。
• 主要7ヶ国では、米国が水疱性角膜症の診断有病者総数の約41%を占め、EU4ヶ国と英国が約50%、日本が約9%でした（2023年）。
• 2023年、米国は主要7ヶ国の中で水疱性角化症の診断有病者数が最も多く、約7万9,000例でした。
• EU4ヶ国と英国の中で、2023年に水疱性角化症の有病者と診断された症例数が最も多かったのはドイツで約2万6,000症例、次いでフランスで約2万2,000症例でした。一方、最も症例数が少なかったのはスペインで約1万4,000例でした。
• 日本は、2023年の水疱性角膜症の診断有病者数が約1万8,000人であり、予測期間中に変化することが予想されます。
• 2023年の米国における水疱性角膜症の診断された有病者の性別では、男性が約3万人、女性が約4万8,000人でした。
• 英国では、2023年に水疱性角化症の男性症例は約39%、女性症例は約61%でした。
• 2023年、日本では水疱性角化症の男性症例が約7,000人、女性症例が約1万人であったが、予測期間中に変化することが予想されます。

水疱性角膜症治療薬

• VYZNOVA（ネルテペンドセル）：Aurion Biotechnologies

Aurion Biotechnologiesが開発したVYZNOVAは、日本では角膜水疱症に適応を持つ細胞治療薬です。VYZNOVAは、「ネルテペンドセル」と呼ばれる同種ヒト角膜内皮細胞と、Rho関連コイルドコイル含有プロテインキナーゼを阻害する低分子薬剤Y-27632から構成されます。この組み合わせにより、体外で完全に分化した角膜内皮細胞（CEC）の再生が容易になります。ドナーの角膜細胞は、独自の多段階プロセスを経て、既製の同種CECが作られます。これらの細胞は眼球に注入され、そこで健康な単層膜を形成し、余分な液体を除去することで角膜浮腫を軽減します。

2023年3月、日本の独立行政法人医薬品医療機器総合機構（PMDA）は、角膜水疱症の治療薬としてVYZNOVAを承認しました。

水疱性角膜症の新薬

• TTHX1114（nm141）：Trefoil Therapeutics

TTHX1114（NM141）は、線維芽細胞増殖因子-1タンパク質（FGF-1）の遺伝子組換え型です。本来のFGF-1は、細胞増殖と遊走の強力な刺激因子であり、細胞保護作用を有します。この化合物は、FGFレセプターの7つの形態すべてを独自に活性化し、その効力の一因となっています。しかし、天然に存在するFGF-1分子は半減期が極めて短いです。人工FGF-1であるTTHX1114は、FGF-1分子の半減期を延ばし、角膜内皮細胞の増殖と移動を刺激するように設計されています。

TTHX1114は、偽水疱性角膜症などの角膜内皮疾患患者の視力回復を目的としています。TTHX1114は、ごく細い針を用いて少量のTTHX1114を前眼房（角膜の真後ろ）に注入する腔内注射薬として開発されています。

2023年4月、Trefoil Therapeuticsは、白内障手術と併用してデスメ膜剥離術（DSO）を受けるフックス内皮角膜ジストロフィー（FECD）患者を対象としたTTHX1114の第II相試験結果をARVO（Association for Research in Vision and Ophthalmology）年次総会で発表しました。

• EO2002：Emmecell

EO2002は、独自の磁気細胞デリバリー（MCD）ナノ粒子プラットフォームによって開発された、疾患を修飾することができる、ファースト・イン・クラスの非外科的磁気細胞ベースの治療法です。MCDプラットフォームは、磁性ナノ粒子を活用し、細胞療法を適切な標的組織に効果的に局在させ、統合することで、細胞療法の送達、保持、統合を容易にします。

2024年4月、Emmecellは角膜浮腫に対するEO2002の安全性と有効性を評価する米国無作為化二重マスク多施設共同第I相試験において、最後の患者への最終投与投与を完了しました。トップライン結果は2024年後半に、第III相ピボタル試験は2025年第1四半期に予定されています。

現在の水疱性角膜症治療市場には、薬理療法と外科療法の両方が存在します。細胞療法、高張食塩水の点眼や軟膏（塩化ナトリウム5％）、抗生物質、抗炎症薬、抗緑内障薬、潤滑点眼薬などの薬物療法が症状緩和のために使用されます。しかし、内科的治療が良好なのは病気の初期段階だけであり、失敗した場合には手術が考慮されます。

角膜移植は依然として水疱性角膜症の治療のゴールドスタンダードであり、内皮細胞の正常な構造と機能を回復させるために、損傷した内皮をドナーからの健康な内皮と置き換える必要がある；しかし、視力回復には時間がかかります。移植片の大きさは、乱視や続発性緑内障など、移植片の大小による合併症を避けるため、通常7～7.5mmです。

親水性コンタクトレンズは、上皮水疱に伴う痛みを軽減するために広く使用されているが、浮腫の量を減らすことはできないです。コンタクトレンズは5％高張食塩水と併用することで、上皮および間質の浮腫を減少させ、視力を改善することができます。通常、PBKに伴う痛みは、角膜神経終末の露出を伴う水疱の破裂、または神経終末の伸張につながる上皮の腫脹に起因しており、レンズが効果的な角膜前保護層として機能することにより、レンズが所定の位置にある限り、痛みは緩和されます。

世界初の同種細胞治療が承認されたことは、角膜内皮疾患の治療に大きな進歩をもたらしました。2023年3月、PMDAはVYZNOVAを角膜水疱性角膜症の治療薬として承認しました。この治療法は、非外科的介入の必要性に対処し、1人のドナーから完全に分化したCECで100眼以上を治療することにより、ドナー角膜不足を克服します。ドナー角膜から採取された健康な細胞は、新規の、多段階の、独自の、特許取得済みのプロセスで培養され、既製品の同種完全分化CECが作製されます。さらに、内皮細胞は角膜内に投与され、そこで健康な単層への細胞の再増殖が起こる。角膜から体液を除去することで、角膜浮腫の軽減につながります。

2015年の研究では、L-システインを全身投与した場合、仮性角膜浮腫患者の角膜上皮において、いくつかの炎症性メディエーターの発現がタンパク質レベルで増加することが示されました。

現在の水疱性角膜症の治療法には限界があります。対症療法は初期の段階でのみ有効であり、根本的な原因に対処するものではなく、長期的な解決策を提供するものでもありません。角膜移植は標準的ではありますが、感染症、ドナー角膜の拒絶反応、長期の免疫抑制剤の必要性などのリスクを伴います。さらに、移植需要の増加は、世界のドナー組織不足を悪化させています。研究を進め、角膜内皮再生技術を洗練させ、新しい治療法を開発することは、これらの課題を克服し、疾患管理を強化するために不可欠です。

• 現在の水疱性角膜症の新興パイプラインは乏しく、後期段階の製品はありません。しかし、Trefoil TherapeuticsのTTHX1114（NM141）、EmmecellのEO2002、CellusionのCLS001など、初期段階の資産は将来への希望を運んでいます。
• 主要7ヶ国の水疱性角膜症治療市場規模合計は、2023年に約1,380万米ドルであり、予測期間中（2024年～2034年）に拡大すると予測されます。
• 米国における水疱性角化症の市場規模は、2023年に約780万米ドルであり、新たな治療法の発売により増加が予測されます。
• EU4ヶ国と英国の水疱性角化症市場規模は、2023年に約480万米ドルと算出され、主要7ヶ国の総市場収益の約34%を占めました。
• EU4ヶ国と英国の中では、ドイツが2023年に約130万米ドルで最も高い水疱性角化症市場を占め、次いでフランスが同約110万米ドル、イタリアが約90万米ドルでした。
• 2023年の日本における水疱性角化症市場規模は約120万米ドルであり、予測期間（2024-2034年）中に拡大すると予測されます。
• 推計によると、現在使用されている治療法のうち、標準治療（高浸透圧塩化ナトリウムなど）が最大の水疱性角化症市場シェアを占め、2023年には主要7ヶ国全体で約1,370万米ドルの収益を生み出しました。

当レポートでは、主要7ヶ国における水疱性角膜症市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 水疱性角膜症市場概要

• 2020年の水疱性角膜症の市場シェア（％）分布
• 2034年の水疱性角膜症の市場シェア（％）分布

第4章 水疱性角膜症の疫学と市場の調査手法

第5章 水疱性角膜症のエグゼクティブサマリー

第6章 主要な出来事

第7章 疾患の背景と概要

• イントロダクション
• 角膜の状態
• 分類
  • 角膜症
  • 水疱性角膜症
• 病因
• 兆候と症状
• リスク要因
• 病態生理学
• 診断
• 治療
  • 治療アプローチ
  • 角膜移植

第8章 患者動向

第9章 疫学と患者人口

• 主な調査結果
• 前提と根拠：主要7ヶ国
• 主要7ヶ国における水疱性角膜症の総症例数
• 米国
• EU4ヶ国と英国
• 日本

第10章 上市済み薬剤

• VYZNOVA（ネルテペンドセル）：Aurion Biotechnologies

第11章 新興薬剤

• キークロス競合
• TTHX1114（NM141）：Trefoil Therapeutics
• EO2002：Emmecell
• CLS001：Cellusion

第12章 水疱性角膜症：市場分析

• 主な調査結果
• 主要な市場予測の前提条件
• 市場見通し
• 主要7ヶ国における水疱性角膜症の総市場規模
• 主要7ヶ国における水疱性角膜症の治療法別市場規模
• 米国における水疱性角膜症の市場規模
• EU4ヶ国と英国における水疱性角膜症の市場規模
• 日本における水疱性角膜症の市場規模

第13章 主要オピニオンリーダーの見解

第14章 SWOT

第15章 アンメットニーズ

第16章 市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 日本

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of Market and Epidemiology (2020-2034)
• Table 2: Key Events for Bullous Keratopathy
• Table 3: Total Cases of Bullous Keratopathy in the 7MM (2020-2034)
• Table 4: Cases of Major Etiologies of Bullous Keratopathy in the US (2020-2034)
• Table 5: Bullous Keratopathy Cases in Major Etiologies in the US (2020-2034)
• Table 6: Total Bullous Keratopathy Cases in the US (2020-2034)
• Table 7: Gender-specific Cases of Bullous Keratopathy in the US (2020-2034)
• Table 8: Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in the US (2020-2034)
• Table 9: Cases of Major Etiologies of Bullous Keratopathy in EU4 and the UK (2020-2034)
• Table 10: Bullous Keratopathy Cases in Major Etiologies in EU4 and the UK (2020-2034)
• Table 11: Total Bullous Keratopathy Cases in EU4 and the UK (2020-2034)
• Table 12: Gender-specific Cases of Bullous Keratopathy in EU4 and the UK (2020-2034)
• Table 13: Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in EU4 and the UK (2020-2034)
• Table 14: Cases of Major Etiologies of Bullous Keratopathy in Japan (2020-2034)
• Table 15: Bullous Keratopathy Cases in Major Etiologies in Japan (2020-2034)
• Table 16: Total Bullous Keratopathy Cases in Japan (2020-2034)
• Table 17: Gender-specific Cases of Bullous Keratopathy in Japan (2020-2034)
• Table 18: Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in Japan (2020-2034)
• Table 19: Comparison of Emerging Drugs for Treatment
• Table 20: TTHX1114 (NM141), Clinical Trial Description, 2023
• Table 21: EO2002, Clinical Trial Description, 2023
• Table 22: CLS001, Clinical Trial Description, 2023
• Table 23: Key Market Forecast Assumptions for VYZNOVA (neltependocel)
• Table 24: Total Market Size of Bullous Keratopathy in the 7MM, in USD million (2020-2034)
• Table 25: Total Market Size of Bullous Keratopathy by Therapies in the 7MM, in USD million (2020-2034)
• Table 26: Total Market Size of Bullous Keratopathy in the US, in USD million (2020-2034)
• Table 27: The Market Size of Bullous Keratopathy by Therapies in the US, in USD million (2020-2034)
• Table 28: Total Market Size of Bullous Keratopathy in EU4 and the UK, in USD million (2020-2034)
• Table 29: The Market Size of Bullous Keratopathy by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 30: Total Market Size of Bullous Keratopathy in Japan, in USD million (2020-2034)
• Table 31: The Market Size of Bullous Keratopathy by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Layers of Cornea
• Figure 2: Common Corneal Conditions That Require a Transplant
• Figure 3: Types of Keratopathy
• Figure 4: Etiology of PBK
• Figure 5: Symptoms of Bullous Keratopathy
• Figure 6: Difference Between a Healthy Cornea and a Bullous Keratopathic Cornea
• Figure 7: Overview of Bullous Keratopathy
• Figure 8: Patient Journey of Bullous Keratopathy
• Figure 9: Total Cases of Bullous Keratopathy in the 7MM (2020-2034)
• Figure 10: Cases of Major Etiologies of Bullous Keratopathy in the US (2020-2034)
• Figure 11: Bullous Keratopathy Cases in Major Etiologies in the US (2020-2034)
• Figure 12: Total Bullous Keratopathy Cases in the US (2020-2034)
• Figure 13: Gender-specific Cases of Bullous Keratopathy in the US (2020-2034)
• Figure 14: Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in the US (2020-2034)
• Figure 15: Cases of Major Etiologies of Bullous Keratopathy in EU4 and the UK (2020-2034)
• Figure 16: Bullous Keratopathy Cases in Major Etiologies in EU4 and the UK (2020-2034)
• Figure 17: Total Bullous Keratopathy Cases in EU4 and the UK (2020-2034)
• Figure 18: Gender-specific Cases of Bullous Keratopathy in EU4 and the UK (2020-2034)
• Figure 19: Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in EU4 and the UK (2020-2034)
• Figure 20: Cases of Major Etiologies of Bullous Keratopathy in Japan (2020-2034)
• Figure 21: Bullous Keratopathy Cases in Major Etiologies in Japan (2020-2034)
• Figure 22: Total Bullous Keratopathy Cases in Japan (2020-2034)
• Figure 23: Gender-specific Cases of Bullous Keratopathy in Japan (2020-2034)
• Figure 24: Bullous Keratopathy Cases in Corneal Transplant/Keratoplasty in Japan (2020-2034)
• Figure 25: Total Market Size of Bullous Keratopathy in the 7MM, in USD million (2020-2034)
• Figure 26: Total Market Size of Bullous Keratopathy by Therapies in the 7MM, in USD million (2020-2034)
• Figure 27: Total Market Size of Bullous Keratopathy in the US, in USD million (2020-2034)
• Figure 28: The Market Size of Bullous Keratopathy by Therapies in the US, in USD million (2020-2034)
• Figure 29: Total Market Size of Bullous Keratopathy in EU4 and the UK, in USD million (2020-2034)
• Figure 30: The Market Size of Bullous Keratopathy by Therapies in EU4 and the UK, in USD million (2020-2034)
• Figure 31: Total Market Size of Bullous Keratopathy in Japan, in USD million (2020-2034)
• Figure 32: The Market Size of Bullous Keratopathy by Therapies in Japan, in USD million (2020-2034)
• Figure 33: SWOT Analysis of Bullous Keratopathy
• Figure 34: Unmet Needs
• Figure 35: Health Technology Assessment
• Figure 36: Reimbursement Process in Germany
• Figure 37: Reimbursement Process in France
• Figure 38: Reimbursement Process in Italy
• Figure 39: Reimbursement Process in Spain
• Figure 40: Reimbursement Process in the United Kingdom
• Figure 41: Reimbursement Process in Japan

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