특발성 폐 섬유증(IPF) : 전략적 시장 분석과 파이프라인 전망(2025년)

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