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市場調查報告書
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1466818

神經營養性角膜炎 (NK) 市場：初步研究（KOL 見解）- 市場情報 - 流行病學和 2034 年市場預測

Neurotrophic Keratitis (NK) | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2034
出版日期: | 出版商: Mellalta Meets LLP | 英文 180 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

神經營養性角膜炎 (NK) 市場主要受到支持性治療的推動，例如 Oxervate/cenegermin（第一個也是唯一一個獲得批准的治療方法）以及不含防腐劑的人工淚液和軟膏。 到 2034 年，新興療法的採用將成為一個重大轉折點，將為神經營養性角膜炎 (NK) 療法市場帶來巨大變化。 調查國家（美國、法國、德國、義大利、西班牙、英國、日本）的神經營養性角膜炎（NK）市場規模在2020-2034年的調查期間以11%的複合年增長率增長，預計將達到2.4美元。

神經營養性角膜炎，又稱神經營養性角膜病，是一種以角膜敏感性下降和角膜癒合不良為特徵的退化性疾病。 這種疾病使角膜更容易受傷並減少反射性流淚。 上皮破壞可導致潰瘍、感染、融化以及因癒合不良而導致的繼發性穿孔。

神經營養性角膜炎患者的三叉神經受損。 結果，角膜感覺減弱或消失，並且在修復損傷和角膜細胞存活中起重要作用的物質的產生減少。

神經營養性角膜炎 (NK) 的診斷很困難，但早期發現對於預防疾病進展很重要。 NK 治療的主要目標是維持上皮完整性、促進上皮癒合並防止角膜損傷進展。 早期診斷、針對嚴重程度的治療和頻繁監測是實現這些目標的關鍵。 NK 的治療包括侵入性較小的藥物治療，包括用於眼部潤滑的潤滑眼藥水、用於防止重複感染的局部抗生素以及用於促進癒合和維持上皮完整性的滴眼劑和凝膠。它從選擇開始，並且通常以自然方式依次發生。 難治性病例或診斷時已處於晚期疾病的病例需要更具侵入性的非藥物治療。 這些包括治療性隱形眼鏡、羊膜移植 (AMT)、霰粒腫切除術（永久或臨時）、結膜瓣等。

本報告調查了全球神經營養性角膜炎 (NK) 市場，並提供了市場現狀、疾病概述和治療、患者趨勢和區域趨勢。

目錄

第 1 章執行摘要

第2章神經營養性角膜炎（NK）疾病的背景

  • 神經營養性角膜炎 (NK) 簡介
  • 神經營養性角膜炎 (NK) 期
  • 徵兆和症狀
  • 神經營養性角膜炎（NK）的病因與危險因子
  • 神經營養性角膜炎（NK）的病因

第3章神經營養性角膜炎（NK）的診斷

  • 神經營養性角膜炎（NK）的診斷

第 4 章流行病學與病患群體

  • 主要發現
  • 方法與資料來源
    • 各國神經營養性角膜炎 (NK) 的盛行率
    • 特定國家神經營養性角膜炎 (NK) 的盛行率（按階段）
    • 神經營養性角膜炎（NK）各國診治案例
  • 神經營養性角膜炎（NK）流行病學和模型參數的主要來源
    • 美國
    • 德國
    • 法國
    • 義大利
    • 西班牙
    • 英國
    • 日本

第 5 章目前的治療方法與醫療實務

  • 神經營養性角膜炎（NK）的治療與治療
  • 神經營養性角膜炎 (NK) 中的角膜神經化
  • 神經營養性角膜炎 (NK) 的治療建議
  • 專家對介入管理的意見

第 6 章神經營養性角膜炎 (NK) 病患趨勢

第 7 章美國、四個歐盟國家、英國和日本未滿足的需求

第 8 章市售治療

  • Oxyrubate/Cenegermine (Dompe Farmaceutici)
  • Cacicol/Regenerant（Thea 實驗室）

第9章新的治療方法

  • 主要發現
  • 管道概覽
  • 神經營養性角膜炎 (NK) 領域的顯著進展

第10章神經營養性角膜炎（NK）的處方模式

第 11 章神經營養性角膜炎 (NK) - 定價與報銷

  • 神經營養性角膜炎 (NK) 患者的資源利用和經濟影響
  • Oxervate 定價與兌換

第12章未來治療典範

  • 神經營養性角膜炎 (NK) 的競爭格局和預期獲批
  • 未來的治療演算法與競爭定位
  • 新療法關鍵數據摘要

第 13 章當前和新治療方法的年度費用

第 14 章神經營養性角膜炎 (NK) 晚期治療的策略考量

第15章市場展望

  • 主要發現
  • 摘要
  • 2034 年之前按國家劃分的市場預測

第 16 章按國家劃分的市場預測

  • 美國
  • 德國
  • 法國
  • 義大利
  • 西班牙
  • 英國
  • 日本

第17章市場促進與約束因素

第18章附錄

簡介目錄

The Neurotrophic Keratitis (NK) market is hugely contributed by the first and only approved therapy Oxervate/cenegermin and supportive treatments like preservative-free artificial tears, ointments and more. By 2034, the uptake of novel emerging therapies will serve as a major breakpoint to get a drastic change in the Neurotrophic Keratitis (NK) therapeutics market. The sales of the emerging therapies for the treatment Neurotrophic Keratitis (NK) in the study countries (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) will experience high growth over the 2020-2034 study period, with 11% CAGR.

"One of the major obstacles in treating neurotrophic keratitis is once there is damage to the corneal nerves, there is impairment of those vital functions, which creates a significant disruption to the ocular surface. Most of these treatments are supportive and only stabilize the surface."

Neurotrophic keratitis, also known as neurotrophic keratopathy, is a degenerative disease characterized by decreased corneal sensitivity and poor corneal healing. This disorder leaves the cornea susceptible to injury and decreases reflex tearing. Epithelial breakdown can lead to ulceration, infection, melting, and perforation secondary to poor healing.

Patients with neurotrophic keratitis have damage to the trigeminal nerve. This results in reduced or lack of sensation in the cornea, and reduced production of the substances that play a vital role in repairing damage and ensuring survival of cornea cells.

Neurotrophic keratitis (NK) can be challenging to diagnose, but it is crucial to identify it early to prevent disease progression. The primary goals of treatment for NK are to preserve epithelial integrity, promote epithelial healing, and prevent the progression of corneal damage. Early diagnosis, severity-based treatment, and frequent monitoring are crucial for achieving these goals. The treatment of NK is often sequential in nature, starting with less invasive pharmacological options such as lubricant eye drops for eye lubrication, topical antibiotics to prevent super-infections, and eye drops or gels to promote healing and preserve epithelial integrity. In refractory cases or those with advanced disease at diagnosis, more invasive, non-pharmacological treatment alternatives may be required. These can include therapeutic contact lenses, amniotic membrane transplantation (AMT), tarsorrhaphy (permanent or temporary), or conjunctival flap.

Mellalta's Neurotrophic Keratitis (NK) Report- Market Summary

Market Size 2034: $2.4 billion

CAGR%: 11%

Key Market Players: RegeneRx Biopharmaceuticals/ReGenTree/HLB Therapeutics; BRIM Biotechnology; Recordati; Claris Biotherapeutics; Neuroptika

Forecast Period: 2020-2034

Countries Covered: US, France, Germany, Italy, Spain, UK, China, and Japan.

Current SOC: Nerve Growth Factor; Preservative free antibiotics; Artificial eye drops; Ointments; Surgical Interventions

Future SOC: NGF; HGF; Regenerative therapies

Key Unmet Need: Lack of restorative treatments for neurotrophic keratitis and early diagnosis; Variability in Clinical Practice

Key Insights: Approval of Cenegermin /Oxervate (Dompe) changed the treatment landscape by targeting underlying pathology with upto 72% patient achieving complete corneal healing at 8 weeks.

Provider-Patient (PPP) Perspective: Cost-effectiveness of treatment; Better Diagnostic Identification; Access to appropriate treatments and improved options

Mellalta's Neurotrophic Keratitis (NK) Report - Epidemiology

The total prevalent cases of Neurotrophic Keratitis (NK) in the G7 countries are anticipated to increase by a significant number of cases by 2034 for the study period (2020-2034). As per estimates, the United States will present with the highest prevalence of Neurotrophic Keratitis (NK) cases in 2034. Among the EU5, Germany had the highest Neurotrophic Keratitis (NK) cases, followed by France, Italy, Spain, and UK. Japan is reported to have the highest number of treated cases after the United States, Germany, France, and Italy.

Mellalta's Neurotrophic Keratitis (NK) Report - Current Market Size & Forecast Trends

The Neurotrophic Keratitis (NK) therapeutics market is expected to experience high growth throughout our study period (i.e., 2020 to 2034) with a CAGR of 11%. The United States captured the highest market share as compared to the European 5 countries and Japan.

The current standard of care is limited to therapies such as Artificial Tears, Autologous Serum Drops (SED), Corneal Neurotization/PK, and Amniotic Membrane Transplantation (AMT). Initial interventions advocate the cessation of corneal-sensitivity-reducing therapies, favoring instead preservative-free artificial tears and lubricant ointments. While the efficacy of topical corticosteroids in NK is debated due to potential adverse effects, emerging heparin sulfate biomimetic matrix regenerating agents offer promising prospects, demonstrating remarkable corneal healing and antiviral properties. The focus shifts to averting corneal ulcer development and promoting epithelial repair in NK Stage 2 and reduce corneal stromal scarring and prevent possible perforations in NK Stage 3.

Cenegermin, containing recombinant human nerve growth factor (rhNGF), marks a breakthrough, becoming the first FDA-approved drug for NK treatment in 2018. Clinical trials reveal its efficacy in promoting corneal healing, with patients exhibiting significant improvement compared to vehicle-treated counterparts. Moreover, its favorable safety profile underscores its potential as a cornerstone therapy. Apart from promoting corneal epithelial wound healing, cenegermin 20 µg/ml shows significant improvement in corneal sensitivity and in visual acuity with minor side effects. Moreover, findings suggest that cenegermin 20 µg/ml is also effective in pediatric patients.

In the 2024-2034 forecast period, there will be tremendous growth and shift in therapeutic market with the launch of novel emerging therapies like Timbetasin/RGN-259 (RegeneRx Biopharmaceuticals/ReGenTree/HLB Therapeutics), BRM424 (BRIM Biotechnology), REC 0/0559 (Recordati), CSB-001 (Claris Biotherapeutics), and NRO-1 (Neuroptika). The emerging therapies will likely compete with and replace existing treatments, reflecting a dynamic shift towards more advanced therapeutic options in the Neurotrophic Keratitis space and more.

Questions Answered

What is the size of clinically and commercially relevant drug-treatable Neurotrophic Keratitis (NK) populations, and how will drug-treatment rates change over time?

Potential challenges and opportunities in implementing approved therapy for Neurotrophic Keratitis (NK).

What are the most promising agents in the pipeline, and how will they shape the future of this therapy market?

What key drivers and constraints will affect the Neurotrophic Keratitis (NK) therapy market over the forecast period?

Report Highlights

Neurotrophic Keratitis (NK) - Current Market Trends

Neurotrophic Keratitis (NK) - Current & Forecasted Cases across the G7 Countries

Neurotrophic Keratitis (NK) - Market Opportunities and Sales Potential for Agents

Neurotrophic Keratitis (NK) - Patient-based Market Forecast to 2034

Neurotrophic Keratitis (NK) - Untapped Business Opportunities

Neurotrophic Keratitis (NK) - Product Positioning Vis-a-vis Competitors' Products

Neurotrophic Keratitis (NK) - KOLs Insight

Table of Content

1.Executive Summary

  • 1.1.Key Findings
  • 1.2.Key Market Challenges and Opportunities
  • 1.3.What Do the Experts Say?

2.Neurotrophic Keratitis (NK) Disease Background

  • 2.1.Neurotrophic Keratitis (NK) Introduction
  • 2.2.Stages of Neurotrophic Keratitis (NK)
  • 2.3.Sign & Symptoms
  • 2.4.Causes and Risk factors of Neurotrophic Keratitis (NK)
  • 2.5.Pathogenesis of Neurotrophic Keratitis (NK)

3.Neurotrophic Keratitis (NK) Diagnosis

  • 3.1.Diagnosis of Neurotrophic Keratitis (NK)

4.Epidemiology and Patient Populations

  • 4.1.Key Findings
  • 4.2.Methods and data Sources
    • 4.2.1.Country Specific Prevalent cases of Neurotrophic Keratitis (NK)
    • 4.2.2.Country Specific Prevalent cases of Neurotrophic Keratitis (NK) by Stages
    • 4.2.3.Country Specific Diagnosed and Treated cases of Neurotrophic Keratitis (NK)
  • 4.3.Key Sources for Neurotrophic Keratitis (NK) Epidemiology and Model Parameters
    • 4.3.1.United States
      • 4.3.1.1.United States Prevalent cases of Neurotrophic Keratitis (NK)
      • 4.3.1.2.United States Prevalent cases of Neurotrophic Keratitis (NK) by Stages
      • 4.3.1.3.United States Diagnosed and Treated cases of Neurotrophic Keratitis (NK)
    • 4.3.2.Germany
      • 4.3.2.1.Germany Prevalent cases of Neurotrophic Keratitis (NK)
      • 4.3.2.2.Germany Prevalent cases of Neurotrophic Keratitis (NK) by Stages
      • 4.3.2.3.Germany Diagnosed and Treated cases of Neurotrophic Keratitis (NK)
    • 4.3.3.France
      • 4.3.3.1.France Prevalent cases of Neurotrophic Keratitis (NK)
      • 4.3.3.2.France Prevalent cases of Neurotrophic Keratitis (NK) by Stages
      • 4.3.3.3.France Diagnosed and Treated cases of Neurotrophic Keratitis (NK)
    • 4.3.4.Italy
      • 4.3.4.1.Italy Prevalent cases of Neurotrophic Keratitis (NK)
      • 4.3.4.2.Italy Prevalent cases of Neurotrophic Keratitis (NK) by Stages
      • 4.3.4.3.Italy Diagnosed and Treated cases of Neurotrophic Keratitis (NK)
    • 4.3.5.Spain
      • 4.3.5.1.Spain Prevalent cases of Neurotrophic Keratitis (NK)
      • 4.3.5.2.Spain Prevalent cases of Neurotrophic Keratitis (NK) by Stages
      • 4.3.5.3.Spain Diagnosed and Treated cases of Neurotrophic Keratitis (NK)
    • 4.3.6.United Kingdom
      • 4.3.6.1.United Kingdom Prevalent cases of Neurotrophic Keratitis (NK)
      • 4.3.6.2.United Kingdom Prevalent cases of Neurotrophic Keratitis (NK) by Stages
      • 4.3.6.3.United Kingdom Diagnosed and Treated cases of Neurotrophic Keratitis (NK)
    • 4.3.7.Japan
      • 4.3.7.1.Japan Prevalent cases of Neurotrophic Keratitis (NK)
      • 4.3.7.2.Japan Prevalent cases of Neurotrophic Keratitis (NK) by Stages
      • 4.3.7.3.Japan Diagnosed and Treated cases of Neurotrophic Keratitis (NK)

5.Current Therapies and Medical Practice

  • 5.1.Treatment and Medical Practices of Neurotrophic Keratitis (NK)
  • 5.2.Corneal Neurotization in Neurotrophic Keratitis (NK)
  • 5.3.Treatment Recommendations for Neurotrophic Keratitis (NK)
  • 5.4.Expert Opinions on Interventional Management

6.Patient Journey in Neurotrophic Keratitis (NK)

  • 6.1.Referral Routes
  • 6.2.Diagnosis and Treatment Evaluation
  • 6.3.Treatment Choice

7.Unmet Needs in US, EU4, UK, and JP

8.Marketed Therapies Chapters

  • 8.1.Oxervate/cenegermin (Dompe Farmaceutici)
    • 8.1.1.Product Profile
    • 8.1.2.Clinical Development
    • 8.1.3.Market & Sales Opportunity Forecasted to 2034
  • 8.2.Cacicol/ReGeneraTing Agents (Laboratoires Thea)
    • 8.2.1.Product Profile
    • 8.2.2.Clinical Development
    • 8.2.3.Market & Sales Opportunity Forecasted to 2034

9.Emerging Therapies

  • 9.1.Key Findings
  • 9.2.Pipeline Overview
  • 9.3.Notable Developments in the Neurotrophic Keratitis (NK) space
    • 9.3.1.Product Analysis
      • 9.3.1.1.Timbetasin/RGN-259 (RegeneRx Biopharmaceuticals/ReGenTree/HLB Therapeutics)
        • 9.3.1.1.1.Product Profile
        • 9.3.1.1.2.Clinical Development
        • 9.3.1.1.3.Market & Sales Opportunity Forecasted to 2034
      • 9.3.1.2.BRM424 (BRIM Biotechnology)
        • 9.3.1.2.1.Product Profile
        • 9.3.1.2.2.Clinical Development
        • 9.3.1.2.3.Market & Sales Opportunity Forecasted to 2034
      • 9.3.1.3.REC 0/0559 (Recordati)
        • 9.3.1.3.1.Product Profile
        • 9.3.1.3.2.Clinical Development
        • 9.3.1.3.3.Market & Sales Opportunity Forecasted to 2034
      • 9.3.1.4.Varenicline (Oyster Point Pharma)
        • 9.3.1.4.1.Product Profile
        • 9.3.1.4.2.Clinical Development
        • 9.3.1.4.3.Market & Sales Opportunity Forecasted to 2034
      • 9.3.1.5.CSB-001 (Claris Biotherapeutics)
        • 9.3.1.5.1.Product Profile
        • 9.3.1.5.2.Clinical Development
        • 9.3.1.5.3.Market & Sales Opportunity Forecasted to 2034
      • 9.3.1.6.NRO-1 (Neuroptika)
        • 9.3.1.6.1.Product Profile
        • 9.3.1.6.2.Clinical Development
      • 9.3.1.7.AP-001 (Anida Pharma)
        • 9.3.1.7.1.Product Profile
      • 9.3.1.8.OCS-05 (Oculis)
        • 9.3.1.8.1.Product Profile
      • 9.3.1.9.Undisclosed (Stuart Therapeutics)
        • 9.3.1.9.1.Product Profile
      • 9.3.1.10.MR-146 (Viatris)
        • 9.3.1.10.1.Product Profile
      • 9.3.1.11.Kuragenx (Pandorum Technologies)
        • 9.3.1.11.1.Product Profile
      • 9.3.1.12.Not Exhaustive list (more drugs are covered..)

10.Prescription Pattern in Neurotrophic Keratitis (NK)

  • 10.1.Treatment pattern of Neurotrophic Keratitis (NK) in the United States
  • 10.2.Treatment Efficacy and Utilization Patterns in patients with Neurotrophic Keratitis (NK) in France
  • 10.3.Treatment Approaches in patients with Neurotrophic Keratitis (NK) in Italy

11.Neurotrophic Keratitis (NK) - Pricing & Reimbursement

  • 11.1.Resource Utilization and Economic Impact in patients with Neurotrophic Keratitis (NK)
  • 11.2.Oxervate Pricing and Reimbursement

12.Future Treatment Paradigm

  • 12.1.Neurotrophic Keratitis (NK) Competitor Landscape and Approvals Anticipated
  • 12.2.Future Treatment Algorithms and Competitor Positioning
  • 12.3.Key Data Summary for Emerging Treatment

13.Annual Cost of Current & Emerging Treatment

14.Late Phase Therapies Strategic Considerations in Neurotrophic Keratitis (NK)

15.Market Outlook

  • 15.1.Key Findings
  • 15.2.Overview
  • 15.3.Country Specific Market Forecast to 2034
    • 15.3.1.Country Specific Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 15.3.2.Country Specific Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)

16.Market Forecast by Country

  • 16.1.United States
    • 16.1.1.United States Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 16.1.2.United States Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)
  • 16.2.Germany
    • 16.2.1.Germany Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 16.2.2.Germany Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)
  • 16.3.France
    • 16.3.1.France Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 16.3.2.France Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)
  • 16.4.Italy
    • 16.4.1.Italy Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 16.4.2.Italy Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)
  • 16.5.Spain
    • 16.5.1.Spain Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 16.5.2.Spain Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)
  • 16.6.United Kingdom
    • 16.6.1.United Kingdom Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 16.6.2.United Kingdom Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)
  • 16.7.Japan
    • 16.7.1.Japan Market for Neurotrophic Keratitis (NK) 2019-2034 (USD Million)
    • 16.7.2.Japan Market for Neurotrophic Keratitis (NK) by Therapies 2019-2034 (USD Million)

17.Market Drivers and Constraints

    • 17.1.1.What Factors Are Driving the Market for Neurotrophic Keratitis (NK)?
    • 17.1.2.What Factors Are Constraining the Market for Neurotrophic Keratitis (NK)?

18.Appendix

  • 18.1.Methodology