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1466818

세계의 신경영양성 각막염(NK) 시장 : 주요 조사(KOL 인사이트) - 시장 정보, 역학 및 시장 예측(-2034년)

Neurotrophic Keratitis (NK) | Primary Research (KOL´s Insight) | Market Intelligence | Epidemiology & Market Forecast-2034

발행일: | 리서치사: Mellalta Meets LLP | 페이지 정보: 영문 180 Pages | 배송안내 : 1-2일 (영업일 기준)

    
    
    


※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

신경영양성 각막염(NK, Neurotrophic Keratitis) 시장은 최초이자 유일하게 승인된 치료제인 Oxervate/cenegermin과 무방부제 인공 눈물, 연고 등과 같은 보조 치료제가 크게 기여하고 있습니다. 2034년까지 새로운 신흥 치료법의 도입은 신경영양성 각막염(NK) 치료제 시장에 급격한 변화를 가져오는 주요 분기점이 될 것입니다. 조사 대상 국가(미국, 프랑스, 독일, 이탈리아, 스페인, 영국, 일본)에 대한 신경영양각막염(NK) 시장 규모는 2020-2034년 조사기간 중에 CAGR 11%로 고성장을 이루고, 2034년까지 24억 달러에 달할 것으로 예측됩니다.

신경영양성 각막염은 신경 위축성 각막병증으로도 알려져 있으며 각막 민감도 감소와 각막 치유력 저하를 특징으로 하는 퇴행성 질환입니다. 이 질환은 각막을 손상되기 쉽게 만들고 반사 눈물샘을 감소시킵니다. 상피가 파괴되면 치유가 잘 되지 않아 궤양, 감염, 융해, 천공이 이차적으로 발생할 수 있습니다.

신경영양성 각막염 환자는 삼차 신경에 손상이 있습니다. 이로 인해 각막의 감각이 감소하거나 부족해지고, 각막 세포의 손상을 복구하고 생존을 보장하는 데 중요한 역할을 하는 물질의 생산이 감소합니다.

신경영양성 각막염(NK)의 진단은 어렵지만, 질병의 진행을 막기 위해서는 조기에 발견하는 것이 중요합니다. NK 치료의 주요 목표는 상피의 무결성을 유지하고 상피의 치유를 촉진하고 각막 장애의 진행을 예방하는 것입니다. 이러한 목표를 달성하기 위해서는 조기 진단, 중증도에 따른 치료 및 빈번한 모니터링이 중요합니다. NK의 치료는 안구 윤활을 위한 윤활 점안, 초감염을 예방하기 위한 국소 항생제, 치유를 촉진하고 상피의 무결성을 유지하기 위한 점안제나 젤 등 침습성이 낮은 약리학적 선택에서 시작하고 자연스러운 형태로 순차적으로 이루어지는 경우가 많습니다. 난치성 증상이나 진단 시 병세가 진행되는 경우에는 보다 침습적이고 비약리학적 치료가 필요합니다. 여기에는 치료용 콘택트렌즈, 양막 이식(AMT), 정립종 절제술(영구적 또는 일시적), 결막 플랩 등이 포함됩니다.

세계의 신경영양성 각막염(NK, Neurotrophic Keratitis) 시장에 대해 조사했으며, 시장 현재 상황/질병 개요 및 치료법/환자 동향/지역별 동향 등을 제공합니다.

목차

제1장 주요 요약

제2장 신경영양성 각막염(NK) 질환의 배경

  • 신경영양성 각막염(NK)의 소개
  • 신경영양성 각막염(NK)의 단계
  • 징후 및 증상
  • 신경영양성 각막염(NK)의 원인과 위험 요인
  • 신경영양성 각막염(NK)의 발병 기전

제3장 신경영양성 각막염(NK)의 진단

  • 신경영양성 각막염(NK)의 진단

제4장 역학 및 환자 집단

  • 주요 조사 결과
  • 방법 및 데이터 소스
    • 국가별 신경영양성 각막염(NK)의 유병률
    • 신경영양성 각막염(NK)의 국가별 이환율(단계별)
    • 신경영양성 각막염(NK)의 국가별 진단 및 치료 사례
  • 신경영양성 각막염(NK) 역학과 모델 매개 변수의 주요 정보원
    • 미국
    • 독일
    • 프랑스
    • 이탈리아
    • 스페인
    • 영국
    • 일본

제5장 현재의 치료법 및 의료 행위

  • 신경영양성 각막염(NK)의 치료 및 진료
  • 신경영양성 각막염(NK)의 각막 신경화
  • 신경영양성 각막염(NK)의 치료 권장 사항
  • 중재적 관리에 관한 전문가의 의견

제6장 신경영양성 각막염(NK) 환자 동향

제7장 미국, EU 4개국, 영국, 일본에서 미충족 요구

제8장 출시가 끝난 치료법

  • Oxervate/cenegermin(Dompe Farmaceutici)
  • Cacicol/ReGeneraTing Agents(Laboratoires Thea)

제9장 새로운 치료법

  • 주요 조사 결과
  • 파이프라인 개요
  • 신경영양성 각막염(NK) 부문에서 주목할 만한 진전

제10장 신경영양성 각막염(NK)의 처방 패턴

제11장 신경영양성 각막염(NK)-가격과 상환

  • 신경영양성 각막염(NK) 환자에서 자원 이용과 경제적 영향
  • Oxervate 가격 설정 및 상환

제12장 향후 치료 패러다임

  • 신경영양성 각막염(NK)경쟁 구도으로 예상되는 승인
  • 향후 치료 알고리즘과 경쟁의 포지셔닝
  • 새로운 치료법에 관한 주요 데이터 개요

제13장 현행 및 신규 치료의 연간 비용

제14장 신경영양성 각막염(NK)에서 후기 치료의 전략적 고려 사항

제15장 시장 전망

  • 주요 조사 결과
  • 개요
  • 국가별 시장 예측(-2034년)

제16장 국가별 시장 예측

  • 미국
  • 독일
  • 프랑스
  • 이탈리아
  • 스페인
  • 영국
  • 일본

제17장 시장 성장 촉진 및 억제요인

제18장 부록

LYJ

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
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