시장보고서
상품코드
2026037

에프조피티모드 : 판매 예측 및 시장 규모(2034년)

Efzofitimod Sales Forecast, and Market Size Analysis - 2034

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 30 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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한글목차
영문목차

에프조피티모드의 성장을 이끄는 주요 요인

1. Neuropilin-2(NRP2)를 타겟으로 하는 퍼스트 인 클래스 작용기전

에프조피티모드는 유육종증과 같은 염증성 질환에서 활성화된 면역세포에서 발현이 증가하는 수용체인 NRP2에 선택적으로 결합하는 퍼스트 인 클래스 면역조절제입니다.

  • 이 약은 자연면역 및 획득면역반응, 특히 대식세포에 의한 염증을 조절합니다.
  • 코르티코스테로이드와 달리 광범위한 면역억제가 아닌 질병의 근본적인 생물학적 메커니즘에 작용합니다.
  • 이러한 명확한 차별화는 프리미엄 포지셔닝과 스테로이드 내성 환자에서의 채택 가능성을 뒷받침합니다.
  • 다발성 간질성 폐질환(ILD)에서의 플랫폼으로서의 잠재력은 장기적인 가치를 높이고 있습니다.

2. 폐 유육종증에 대한 높은 미충족 수요

  • 폐 유육종증은 만성 육아종성 질환으로, 승인된 치료법이 제한적입니다. 독성 우려에도 불구하고 코르티코스테로이드는 여전히 표준 치료법으로 사용되고 있습니다.
  • 스테로이드의 장기 사용은 심각한 부작용을 동반하기 때문에 스테로이드 절약 요법에 대한 수요가 증가하고 있습니다.
  • 만약 승인된다면, 수십 년 만에 처음으로 미충족 수요를 충족시키는 새로운 치료법 중 하나가 될 수 있습니다.
  • 전문 호흡기 센터에서 빠른 보급을 촉진합니다.

3. 상업적 잠재력을 뒷받침하는 대규모 세계 임상 3상 시험 프로그램

  • EFZO-FIT 임상 3상은 9개국 85개 기관에서 268명의 환자를 등록하여 유육종증 관련 중재연구로는 역대 최대 규모로 진행되었습니다.
  • 전 세계 임상적 관심과 확장성 입증
  • 출시 전부터 의사의 인지도를 높이고 KOL의 참여를 강화합니다.

4. 주요 평가항목 미달에도 불구하고 유망한 부차적 임상결과를 보임.

  • 임상 3상 결과(2025년)는 다음과 같습니다:
  • 스테로이드 금단현상 : 52.6%(위약 40.2% 대비)
  • KSQ-Lung QOL 점수에서 유의미한 개선이 확인되었습니다(p=0.0479).
  • 이 약은 우수한 내약성과 일관된 안전성 프로파일을 보였습니다.

5. 다발성 간질성 폐질환(ILD)에 대한 적응증 확대 가능성

  • 작용 기전상 유육종증 이외의 질환에 대한 적용도 시사하고 있으며, 다음과 같은 질환에 적용될 수 있습니다:
  • 전신성 강피증 관련 간질성 폐질환(SSc-ILD)(진행 중인 연구)
  • 초기 단계의 데이터는 다른 섬유화 및 염증성 질환에서도 생물학적 및 임상적 효능을 시사하고 있습니다(기업공시정보).
  • 단일 자산인 의약품에서 플랫폼 자산으로 전환
  • 유육종증을 넘어 총 주소 지정 가능 시장(TAM)을 대폭 확대

에프조피티모드의 최근 동향

2023년 2월, aTyr Pharma는 제휴사인 Kyorin Pharmaceutical Co., Ltd.(Kyorin)이 일본에서 주요 ILD의 일종인 폐 유육종증 환자를 대상으로 주력 치료제 후보물질인 에프조피티모드의 유효성과 안전성을 평가하는 임상 3상 'EFZO-FIT(TM)' EFZO-FIT(TM) 임상 3상 시험에서 첫 환자 투약을 시작했다고 발표했습니다. 이 성과에 따라 aTyr와 Kyorin의 제휴 및 라이선스 계약에 따라 Kyorin은 aTyr에 1,000만 달러의 마일스톤을 지급하게 되었습니다.

이 보고서는 주요 7개국(미국, EU4(독일, 프랑스, 이탈리아, 스페인) 영국, 일본)의 에프조피티모드의 동향을 조사하고 폐 유육종증, COVID-19 폐렴, 간질성 폐질환, 류마티스 관절염 등 잠재적 적응증에 대한 종합적인 인사이트를 제공합니다. 이 보고서는 2020-2034년 에프조피티모드의 기존 사용 현황, 예상 시장 진입, 잠재적 적응증에 대한 실적에 대한 상세한 분석과 함께 잠재적 적응증에 대한 에프조피티모드의 상세한 설명을 제공합니다. 또한, 에프조피티모드의 매출 예측, 작용기전(MoA), 용량 및 투여방법, 규제 마일스톤을 포함한 연구개발, 기타 개발 활동, 향후 시장 평가, SWOT 분석, 애널리스트 견해, 경쟁 개요, 각 적응증별 다른 신흥 치료법 개요, 시장을 주도하는 요인에 대해 분석합니다.

자주 묻는 질문

  • 에프조피티모드의 주요 작용 기전은 무엇인가요?
  • 폐 유육종증에 대한 에프조피티모드의 시장 잠재력은 어떻게 되나요?
  • 에프조피티모드의 상업적 잠재력을 뒷받침하는 임상 시험은 무엇인가요?
  • 에프조피티모드의 임상 3상 결과는 어떤가요?
  • 에프조피티모드의 적응증 확대 가능성은 어떻게 되나요?
  • 에프조피티모드의 최근 동향은 무엇인가요?

목차

제1장 보고서 개요

제2장 에프조피티모드 개요 : 폐 사르코이드증, COVID-19 폐렴, 간질성 폐질환, 류마티스 관절염 등의 잠재적 적응증

제3장 에프조피티모드 : 경쟁 구도(출시된 치료제)

제4장 에프조피티모드 : 경쟁 구도(후기 개발 단계 치료제)

제5장 에프조피티모드 : 시장 평가

제6장 에프조피티모드 : SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 보고서 구입 옵션

KSM 26.05.19

Key Factors Driving Efzofitimod Growth

1. First-in-Class Mechanism Targeting Neuropilin-2 (NRP2)

Efzofitimod is a first-in-class immunomodulator that selectively binds to neuropilin-2 (NRP2), a receptor upregulated on activated immune cells in inflammatory diseases like sarcoidosis.

  • It modulates innate and adaptive immune responses, particularly macrophage-driven inflammation.
  • Unlike corticosteroids, it targets underlying disease biology rather than broad immunosuppression.
  • Strong differentiation supports premium positioning and potential adoption in steroid-refractory patients
  • Platform potential across multiple ILDs increases long-term value

2. High Unmet Need in Pulmonary Sarcoidosis

  • Pulmonary sarcoidosis is a chronic granulomatous disease with limited approved therapies, where corticosteroids remain the standard of care despite toxicity concerns.
  • Long-term steroid use is associated with significant adverse effects, creating demand for steroid-sparing agents.
  • If approved, efzofitimod could become one of the first novel therapies in decades, addressing a clear unmet need
  • Drives rapid uptake in specialist pulmonary centers

3. Large, Global Phase III Program Validating Commercial Potential

  • The EFZO-FIT Phase III trial enrolled 268 patients across 85 sites in 9 countries, the largest interventional sarcoidosis study conducted.
  • Demonstrates global clinical interest and scalability
  • Builds strong physician awareness and KOL engagement pre-launch

4. Encouraging Secondary Clinical Outcomes Despite Primary Endpoint Miss

  • Phase III results (2025) showed:
  • 52.6% steroid withdrawal vs 40.2% placebo
  • Significant improvement in KSQ-Lung quality-of-life score (p=0.0479)
  • Drug was well tolerated with consistent safety profile

5. Expansion Potential into Multiple Interstitial Lung Diseases (ILDs)

  • Mechanism suggests applicability beyond sarcoidosis, including:
  • Systemic sclerosis-associated ILD (SSc-ILD) (ongoing studies)
  • Early-stage data indicate biological and clinical activity in additional fibrotic/inflammatory diseases (company disclosures).
  • Transforms efzofitimod from a single-asset drug to a platform asset
  • Expands total addressable market significantly beyond sarcoidosis

Efzofitimod Recent Developments

In February 2023, aTyr Pharma announced that its partner Kyorin Pharmaceutical Co., Ltd. (Kyorin), a wholly owned subsidiary of Kyorin Holdings, Inc., dosed the first patient in Japan in EFZO-FIT(TM), a global pivotal Phase III study to evaluate the efficacy and safety of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). This achievement has triggered a $10 million milestone payment by Kyorin to aTyr pursuant to a collaboration and license agreement between the Company and Kyorin.

"Efzofitimod Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Efzofitimod for potential indication like Pulmonary sarcoidosis, COVID-19 pneumonia, Interstitial lung diseases and Rheumatoid arthritis in the 7MM. A detailed picture of Efzofitimod's existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the Efzofitimod for potential indications. The Efzofitimod market report provides insights about Efzofitimod's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Efzofitimod performance, future market assessments inclusive of the Efzofitimod market forecast analysis for potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Efzofitimod sales forecasts, along with factors driving its market.

Efzofitimod Drug Summary

Efzofitimod is an investigational, first-in-class immunomodulatory biologic derived from a splice variant of histidyl-tRNA synthetase, being developed primarily for the treatment of interstitial lung diseases, particularly pulmonary sarcoidosis. It selectively binds to neuropilin-2 (NRP2), a receptor expressed on activated immune cells, thereby modulating inflammatory pathways and reducing granulomatous inflammation without broadly suppressing the immune system. Administered via intravenous infusion, efzofitimod has demonstrated promising results in early-phase clinical trials, including improvements in lung function and reductions in corticosteroid use among sarcoidosis patients, supporting its potential as a steroid-sparing therapy. The drug has generally shown a favorable safety and tolerability profile, though it remains under clinical investigation and has not yet received regulatory approval. The report provides Efzofitimod's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Efzofitimod Market Report

The report provides insights into:

  • A comprehensive product overview including the Efzofitimod MoA, description, dosage and administration, research and development activities in potential indication like Pulmonary sarcoidosis, COVID-19 pneumonia, Interstitial lung diseases and Rheumatoid arthritis.
  • Elaborated details on Efzofitimod regulatory milestones and other development activities have been provided in Efzofitimod market report.
  • The report also highlights Efzofitimod's cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
  • The Efzofitimod market report also covers the patents information, generic entry and impact on cost cut.
  • The Efzofitimod market report contains current and forecasted Efzofitimod sales for potential indications till 2034.
  • Comprehensive coverage of the late-stage emerging therapies for respective indications.
  • The Efzofitimod market report also features the SWOT analysis with analyst views for Efzofitimod in potential indications.

Methodology:

The Efzofitimod market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Efzofitimod Analytical Perspective by DelveInsight

  • In-depth Efzofitimod Market Assessment

This Efzofitimod sales market forecast report provides a detailed market assessment of Efzofitimod for potential indication like Pulmonary sarcoidosis, COVID-19 pneumonia, Interstitial lung diseases and Rheumatoid arthritis in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Efzofitimod sales data uptil 2034.

  • Efzofitimod Clinical Assessment

The Efzofitimod market report provides the clinical trials information of Efzofitimod for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Efzofitimod Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Efzofitimod Market Potential & Revenue Forecast

  • Projected market size for the Efzofitimod and its key indications
  • Estimated Efzofitimod sales potential (Efzofitimod peak sales forecasts)
  • Efzofitimod Pricing strategies and reimbursement landscape

Efzofitimod Competitive Intelligence

  • Number of competing drugs in development (pipeline analysis)
  • Efzofitimod Market positioning compared to existing treatments
  • Efzofitimod Strengths & weaknesses relative to competitors

Efzofitimod Regulatory & Commercial Milestones

  • Efzofitimod Key regulatory approvals & expected launch timelines
  • Commercial partnerships, licensing deals, and M&A activity

Efzofitimod Clinical Differentiation

  • Efzofitimod Efficacy & safety advantages over existing drugs
  • Efzofitimod Unique selling points

Efzofitimod Market Report Highlights

  • In the coming years, the Efzofitimod market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
  • The Efzofitimod companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Efzofitimod's dominance.
  • Other emerging products for Pulmonary sarcoidosis, COVID-19 pneumonia, Interstitial lung diseases and Rheumatoid arthritis are expected to give tough market competition to Efzofitimod and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Efzofitimod in potential indications.
  • Analyse Efzofitimod cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
  • Our in-depth analysis of the forecasted Efzofitimod sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Efzofitimod in potential indications.

Key Questions:

  • What is the class of therapy, route of administration and mechanism of action of Efzofitimod? How strong is Efzofitimod's clinical and commercial performance?
  • What is Efzofitimod's clinical trial status in each individual indications such as Pulmonary sarcoidosis, COVID-19 pneumonia, Interstitial lung diseases and Rheumatoid arthritis and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Efzofitimod Manufacturers?
  • What are the key designations that have been granted to Efzofitimod for potential indications? How are they going to impact Efzofitimod's penetration in various geographies?
  • What is the current and forecasted Efzofitimod market scenario for potential indications? What are the key assumptions behind the forecast?
  • What are the current and forecasted sales of Efzofitimod in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
  • What are the other emerging products available and how are these giving competition to Efzofitimod for potential indications?
  • Which are the late-stage emerging therapies under development for the treatment of potential indications?
  • How cost-effective is Efzofitimod? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Efzofitimod Overview in potential indication like Pulmonary sarcoidosis, COVID-19 pneumonia, Interstitial lung diseases and Rheumatoid arthritis

  • 2.1. Product Detail
  • 2.2. Efzofitimod Clinical Development
    • 2.2.1. Efzofitimod Clinical studies
    • 2.2.2. Efzofitimod Clinical trials information
    • 2.2.3. Safety and efficacy
  • 2.3. Other Developmental Activities
  • 2.4. Product Profile

3. Efzofitimod Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Efzofitimod Therapies)

5. Efzofitimod Market Assessment

  • 5.1. Efzofitimod Market Outlook in potential indications
  • 5.2. 7MM Analysis
    • 5.2.1. Efzofitimod Market Size in the 7MM for potential indications
  • 5.3. Country-wise Market Analysis
    • 5.3.1. Efzofitimod Market Size in the United States for potential indications
    • 5.3.2. Efzofitimod Market Size in Germany for potential indications
    • 5.3.3. Efzofitimod Market Size in France for potential indications
    • 5.3.4. Efzofitimod Market Size in Italy for potential indications
    • 5.3.5. Efzofitimod Market Size in Spain for potential indications
    • 5.3.6. Efzofitimod Market Size in the United Kingdom for potential indications
    • 5.3.7. Efzofitimod Market Size in Japan for potential indications

6. Efzofitimod SWOT Analysis

7. Analysts' Views

8. Appendix

  • 8.1. Bibliography
  • 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options

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