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市场调查报告书
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1866179

特发性肺纤维化：策略市场分析及研发管线展望（2025）

Idiopathic Pulmonary Fibrosis: Strategic Market Insights & Pipeline Outlook - 2025
出版日期: | 出版商: Mellalta Meets LLP | 英文 100 Pages | 商品交期: 7-10个工作天内

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简介目录

特发性肺纤维化：市场格局与策略展望（2025）

特发性肺纤维化 (IPF) 仍然是呼吸医学领域最具挑战性的疾病之一。儘管已有 Esbret®（吡非尼酮）和 Ofev®（尼达尼布）等核准疗法，但患者仍面临肺功能持续下降和存活期有限的问题，通常确诊后仅能存活三至五年。

受盛行率上升、公众意识提高、早期检测技术进步以及持续投资的推动，免疫检查点抑制剂市场预计在 2025 年将达到 450 亿美元，并在 2030 年达到 80 亿美元。

疾病机转：复杂的纤维化级联反应

特发性肺纤维化 (IPF) 是一种慢性进行性肺部疾病，其特征是肺组织过度疤痕化（纤维化），促使不可逆的肺功能丧失。此疾病是由肺泡上皮细胞反覆微损伤引起的，导致异常的伤口癒合、纤维母细胞活化和细胞外基质沉积。

关键的分子推动因素包括 TGF-β、PDGF、FGF 和 CTGF 讯号通路，这些讯号通路会持续加剧纤维化。这些通路的多样性使得 "一刀切" 的治疗方法无效，因此需要采用标靶的多通路治疗方法，不仅可以改善症状，还可以改变疾病本身的生物学特性。

市场趋势：临床疗效的争夺

特发性肺纤维化 (IPF) 的全球盛行率为每 10 万人 13-20 例。尼达尼布和吡非尼酮的全球年销售额合计超过 40 亿美元。疗效更佳或安全性显着提高的新型药物有望迅速普及，并有可能成为重磅炸弹级药物。

IPF 药物研发管线目前包含约 62 个在研候选药物。主要参与者包括：

  • 勃林格殷格翰－将产品线从 Ofev® 扩展到联合疗法和早期纤维化领域。
  • FibroGen、Pliant Therapeutics 和 Galecto——推进靶向整合素、LOXL2 和半乳糖凝集素-3 的下一代口服药物的研发。
  • United Therapeutics 和 Avalyn Pharma－探索吸入或局部给药机制。
  • PureTech 和 BridgeBio—拓展再生医学和分子标靶疗法领域。

临床开发趋势

  • Nelandilast (JASCAYD)：由勃林格殷格翰开发的 Nelandilast 于 2025 年 10 月获得 FDA 批准，成为 10 年来首个用于治疗特发性肺纤维化 (IPF) 的新药。
  • Deupirfenidone：PureTech 的口服抗纤维化药物在一项 IIb 期研究 (ELEVATE IPF) 中显示出在 26 週内稳定肺功能的潜力，且具有良好的安全性和耐受性。 经与FDA讨论，该公司计划于2025年底前启动III期临床试验。

儘管取得了一些进展，但近期pamrevlumab和bexotegrast的III期临床试验失败凸显了改进试验终点和更深入了解治疗对肺功能影响的必要性。该领域正在透过适应性试验设计（例如REMAP-ILD平台）以及更加重视联合疗法和个人化治疗方案来应对这些挑战。吡非尼酮专利将于2021年到期，这也促进了创新，支持扩大用药范围和下一代药物的研发。

为了应对疾病的异质性，治疗方向正转向同时针对抗发炎和抗纤维化机制的联合疗法。基于生物标记的检测和数位化终点也正在成为更快、更精准的临床评估工具。

市场与研发管线洞察 - 2025 年报告重点

Mellalta Meets 的 "特发性肺纤维化 - 研发管线展望 (2025)" 报告对市场机会和竞争格局进行了详区隔析。

重点领域包括：

  • 竞争分析 - 公司和产品区隔（从发现到 III 期临床试验）
  • 在研药物概况 - 研发阶段、介入类型和临床试验
  • 临床研发趋势 - 区域试验状态、疗效评估与安全性考量
  • 商业和投资趋势 - 授权协议、融资和合作关係
  • 策略机会 - 市场推动因素、挑战与展望
  • 近期发展与未来计划

目录

第一章：报告概述

第二章：概述

  • 特发性肺纤维化
  • 特发性肺纤维化的病理生理学肺纤维化
  • 特发性肺纤维化：治疗模式的转变
  • 未满足的需求

第三章 特发性肺纤维化研发管线分析

  • 概述
  • 依适应症/阶段划分的资产
  • 依研发阶段划分的在研产品
  • 特发性肺纤维化竞争格局
  • 依公司和研发阶段划分的在研产品
  • 特发性肺纤维化临床和监管时间表

第四章：特发性肺纤维化的收购、授权与合作协议

  • 特发性肺纤维化的收购、授权和交易价值
  • 特发性肺纤维化收购和授权（依交易类型和阶段划分的总价值）
  • 有前景的在研技术

第五章：特发性肺纤维化研发管线概览

  • 概述
  • 后期资产比较表
  • 特发性肺纤维化研发管线药物概况
    • BI 1015550（勃林格殷格翰）
    • BMS-986278（百时美施贵宝）
    • HEC585（阳光湖製药股份有限公司）
    • 吸入型曲前列尼尔（合併治疗公司）
    • 吡非尼酮（PureTech）
    • MTX-463（Mediar）治疗学）
    • 其他

第六章：特发性肺纤维化的未来展望

第七章：SWOT分析

第八章：附录

简介目录

Idiopathic Pulmonary Fibrosis: Market Landscape & Strategic Outlook - 2025

Idiopathic Pulmonary Fibrosis (IPF) remains one of the toughest challenges in respiratory medicine. Even with approved drugs like Esbriet(R) (pirfenidone) and Ofev(R) (nintedanib), patients still face a steady decline in lung function and limited survival-usually only three to five years after diagnosis.

The immune checkpoint inhibitors market is currently valued at $45 billion in 2025, projected to reach $8 billion by 2030, due to the rising prevalence, increased awareness and early detection, and continued investment.

Mechanism of Disease: A Complex Fibrotic Cascade

Idiopathic Pulmonary Fibrosis is a chronic, progressive lung disease characterized by excessive scarring (fibrosis) of lung tissue, leading to irreversible loss of function. The condition results from repeated micro-injury to alveolar epithelial cells, triggering abnormal wound healing, fibroblast activation, and extracellular matrix deposition.

Key molecular drivers include TGF-B, PDGF, FGF, and CTGF signaling, which perpetuate fibrosis. The heterogeneity of these pathways has made "one-size-fits-all" therapies ineffective-highlighting the need for targeted, multi-pathway approaches that can modify disease biology, not just symptoms.

The Market: A Race for Clinical Validation

IPF has a prevalence of 13 to 20 per 100,000 people worldwide. The combined global sales of nintedanib and pirfenidone exceed $4 billion annually. Any new agent demonstrating superior efficacy or a significantly better safety profile can expect rapid adoption and blockbuster potential.

IPF pipeline includes approximately 62 active assets in development. Key players include:

  • Boehringer Ingelheim - expanding beyond Ofev into combination and earlier-stage fibrosis.
  • FibroGen, Pliant Therapeutics, and Galecto - advancing next-gen oral agents targeting integrins, LOXL2, and galectin-3.
  • United Therapeutics, Avalyn Pharma- exploring inhaled or localized delivery mechanisms.
  • PureTech, and BridgeBio - pushing into regenerative and molecularly targeted therapies.

Clinical Development Trends

  • Nerandomilast (JASCAYD): Developed by Boehringer Ingelheim, nerandomilast received FDA approval in October 2025 as the first new treatment for IPF in over a decade.
  • Deupirfenidone: PureTech's oral antifibrotic showed potential to stabilize lung function over 26 weeks in a Phase 2b trial (ELEVATE IPF), with favorable safety and tolerability. The company plans to initiate a Phase 3 trial by the end of 2025 following FDA discussions.

Despite progress, recent Phase III failures of pamrevlumab and bexotegrast highlight the need for better trial endpoints and deeper understanding of therapeutic impact on lung function. The field is responding with adaptive trial designs, such as the REMAP-ILD platform, and increased focus on combination therapies and personalized treatment approaches. The expiration of pirfenidone's patent in 2021 has also spurred innovation, broadening access and encouraging development of next-generation agents.

The trend is shifting toward combination approaches, where anti-inflammatory and anti-fibrotic mechanisms are co-targeted to address disease heterogeneity. Biomarker-driven trials and digital endpoints are also emerging as enablers for faster and more precise clinical evaluation.

Market & Pipeline Insights: 2025 Report Highlights

The Idiopathic Pulmonary Fibrosis - Pipeline Analytics 2025 Report by Mellalta Meets provides an in-depth analysis of the market opportunity and competitive landscape.

Key coverage areas include:

  • Competitive Analysis - Breakdown of Companies and Products (Discovery to phase III)
  • Pipeline Drug Profiles - Stages of development, intervention types, clinical trials
  • Clinical Developments - Trials by region, efficacy outcomes, safety considerations
  • Business & Investment Trends - Licensing agreements, funding, and collaborations
  • Strategic Opportunities - Market drivers, challenges, and future outlook
  • Recent and upcoming events

Table of Content

1. REPORT OVERVIEW

2. OVERVIEW

  • 2.1. Idiopathic Pulmonary Fibrosis
  • 2.2. Pathophysiology of Idiopathic Pulmonary Fibrosis
  • 2.3. Idiopathic Pulmonary Fibrosis: Shift in Treatment Paradigm
  • 2.4. Unmet needs

3. IDIOPATHIC PULMONARY FIBROSIS PIPELINE ANALYSIS

  • 3.1. Overview
  • 3.2. Assets by Indication/Phase
  • 3.3. Pipeline Products by Stage of Development
  • 3.4. Idiopathic Pulmonary Fibrosis Competitive Landscape
  • 3.5. Pipeline Products by Company and Phases
  • 3.6. Idiopathic Pulmonary Fibrosis Clinical & Regulatory Timelines

4. IDIOPATHIC PULMONARY FIBROSIS ACQUISITIONS, LICENSING AND COLLABORATION DEALS

  • 4.1. Idiopathic Pulmonary Fibrosis Acquisitions, Licensing and Deal values
  • 4.2. Idiopathic Pulmonary Fibrosis Acquisitions, Licensing by Transaction type and total amount size by Phases
  • 4.3. Promising Technologies Under development

5. Idiopathic Pulmonary Fibrosis PIPELINE LANDSCAPE

  • 5.1. Profile at Glance
  • 5.2. Late-Stage Assets Comparisons At-a-glance
  • 5.3. Idiopathic Pulmonary Fibrosis Pipeline Drug Profiles
    • 5.3.1. BI 1015550 (Boehringer Ingelheim)
      • 5.3.1.1. Product Profile & Description
      • 5.3.1.2. Collaborations
      • 5.3.1.3. Other Developments
      • 5.3.1.4. Clinical Trials
    • 5.3.2. BMS-986278 (Bristol-Myers Squibb)
      • 5.3.2.1. Product Profile & Description
      • 5.3.2.2. Collaborations
      • 5.3.2.3. Other Developments
      • 5.3.2.4. Clinical Trials
    • 5.3.3. HEC585 (Sunshine Lake Pharma Co., Ltd.)
      • 5.3.3.1. Product Profile & Description
      • 5.3.3.2. Collaborations
      • 5.3.3.3. Other Developments
      • 5.3.3.4. Clinical Trials
    • 5.3.4. Inhaled Treprostinil (United Therapeutics)
      • 5.3.4.1. Product Profile & Description
      • 5.3.4.2. Collaborations
      • 5.3.4.3. Other Developments
    • 5.3.5. Pirfenidone (PureTech)
      • 5.3.5.1. Product Profile & Description
      • 5.3.5.2. Collaborations
      • 5.3.5.3. Other Developments
    • 5.3.6. MTX-463 (Mediar Therapeutics)
      • 5.3.6.1. Product Profile & Description
      • 5.3.6.2. Collaborations
      • 5.3.6.3. Other Developments
    • 5.3.7. Others...

6. IDIOPATHIC PULMONARY FIBROSIS FUTURE PROSPECTS

7. SWOT ANALYSIS

8. APPENDIX