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市場調查報告書
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1866179

特發性肺纖維化：策略市場分析及研發管線展望（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個工作天內

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簡介目錄

特發性肺纖維化：市場格局與策略展望（2025）

特發性肺纖維化 (IPF) 仍然是呼吸醫學領域最具挑戰性的疾病之一。儘管已有 Esbret®（吡非尼酮）和 Ofev®（尼達尼布）等核准療法，但患者仍面臨肺功能持續下降和存活期有限的問題，通常確診後僅能存活三至五年。

受盛行率上升、公眾意識提高、早期檢測技術進步以及持續投資的推動，免疫檢查點抑制劑市場預計在 2025 年將達到 450 億美元，並在 2030 年達到 80 億美元。

疾病機轉：複雜的纖維化級聯反應

特發性肺纖維化 (IPF) 是一種慢性進行性肺部疾病，其特徵是肺組織過度疤痕化（纖維化），促使不可逆的肺功能喪失。此疾病是由肺泡上皮細胞反覆微損傷引起的，導致異常的傷口癒合、纖維母細胞活化和細胞外基質沉積。

關鍵的分子推動因素包括 TGF-β、PDGF、FGF 和 CTGF 訊號通路，這些訊號通路會持續加劇纖維化。這些通路的多樣性使得 "一刀切" 的治療方法無效，因此需要採用標靶的多通路治療方法，不僅可以改善症狀，還可以改變疾病本身的生物學特性。

市場趨勢：臨床療效的爭奪

特發性肺纖維化 (IPF) 的全球盛行率為每 10 萬人 13-20 例。尼達尼布和吡非尼酮的全球年銷售額合計超過 40 億美元。療效更佳或安全性顯著提高的新型藥物有望迅速普及，並有可能成為重磅炸彈級藥物。

IPF 藥物研發管線目前包含約 62 個在研候選藥物。主要參與者包括：

  • 勃林格殷格翰－將產品線從 Ofev® 擴展到聯合療法和早期纖維化領域。
  • FibroGen、Pliant Therapeutics 和 Galecto——推進靶向整合素、LOXL2 和半乳糖凝集素-3 的下一代口服藥物的研發。
  • United Therapeutics 和 Avalyn Pharma－探索吸入或局部給藥機制。
  • PureTech 和 BridgeBio—拓展再生醫學和分子標靶療法領域。

臨床開發趨勢

  • Nelandilast (JASCAYD)：由勃林格殷格翰開發的 Nelandilast 於 2025 年 10 月獲得 FDA 批准，成為 10 年來首個用於治療特發性肺纖維化 (IPF) 的新藥。
  • Deupirfenidone：PureTech 的口服抗纖維化藥物在一項 IIb 期研究 (ELEVATE IPF) 中顯示出在 26 週內穩定肺功能的潛力，且具有良好的安全性和耐受性。 經與FDA討論，該公司計劃於2025年底前啟動III期臨床試驗。

儘管取得了一些進展，但近期pamrevlumab和bexotegrast的III期臨床試驗失敗凸顯了改進試驗終點和更深入了解治療對肺功能影響的必要性。該領域正在透過適應性試驗設計（例如REMAP-ILD平台）以及更加重視聯合療法和個人化治療方案來應對這些挑戰。吡非尼酮專利將於2021年到期，這也促進了創新，支持擴大用藥範圍和下一代藥物的研發。

為了應對疾病的異質性，治療方向正轉向同時針對抗發炎和抗纖維化機制的聯合療法。基於生物標記的檢測和數位化終點也正在成為更快、更精準的臨床評估工具。

市場與研發管線洞察 - 2025 年報告重點

Mellalta Meets 的 "特發性肺纖維化 - 研發管線展望 (2025)" 報告對市場機會和競爭格局進行了詳區隔析。

重點領域包括：

  • 競爭分析 - 公司和產品區隔（從發現到 III 期臨床試驗）
  • 在研藥物概況 - 研發階段、介入類型和臨床試驗
  • 臨床研發趨勢 - 區域試驗狀態、療效評估與安全性考量
  • 商業和投資趨勢 - 授權協議、融資和合作關係
  • 策略機會 - 市場推動因素、挑戰與展望
  • 近期發展與未來計劃

目錄

第一章：報告概述

第二章：概述

  • 特發性肺纖維化
  • 特發性肺纖維化的病理生理學肺纖維化
  • 特發性肺纖維化：治療模式的轉變
  • 未滿足的需求

第三章 特發性肺纖維化研發管線分析

  • 概述
  • 依適應症/階段劃分的資產
  • 依研發階段劃分的在研產品
  • 特發性肺纖維化競爭格局
  • 依公司和研發階段劃分的在研產品
  • 特發性肺纖維化臨床和監管時間表

第四章：特發性肺纖維化的收購、授權與合作協議

  • 特發性肺纖維化的收購、授權和交易價值
  • 特發性肺纖維化收購和授權（依交易類型和階段劃分的總價值）
  • 有前景的在研技術

第五章：特發性肺纖維化研發管線概覽

  • 概述
  • 後期資產比較表
  • 特發性肺纖維化研發管線藥物概況
    • BI 1015550（勃林格殷格翰）
    • BMS-986278（百時美施貴寶）
    • HEC585（陽光湖製藥股份有限公司）
    • 吸入型曲前列尼爾（合併治療公司）
    • 吡非尼酮（PureTech）
    • MTX-463（Mediar）治療學）
    • 其他

第六章：特發性肺纖維化的未來展望

第七章：SWOT分析

第八章：附錄

簡介目錄

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