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(Albany, US), November 3, 2026 – DelveInsight’s ‘Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) – Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of PH-ILD, historical and forecasted epidemiology, as well as the pulmonary hypertension associated with interstitial lung disease market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

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Key Takeaways from the Pulmonary Hypertension associated with Interstitial Lung Disease Market Report

• In May 2025, Gossamer Bio finished enrolling Functional Class II and III PAH patients for its global Phase III PROSERA study of seralutinib.

• According to DelveInsight’s analysis, the PH-ILD market across the 7MM was valued at approximately USD 3 billion in 2025 and is projected to expand at a CAGR of 3.9% through 2036, driven by the anticipated entry of advanced therapies and improved clinical management.

• In 2025, the United States accounted for approximately 83,000 diagnosed prevalent cases of PH-ILD, the largest patient base in the 7MM and a key figure for anyone tracking the number of PH-ILD patients in the US, while EU4 and the UK contributed nearly 70,000 cases.

• The total diagnosed prevalent population of PH-ILD across the 7MM is estimated at nearly 182,000 as of 2025.

• The broader diagnosed prevalent population of ILD in the 7MM reached more than 1 million cases in 2025, underscoring the large pool of patients at risk within the interstitial lung disease market.

• Treprostinil (TYVASO/TYVASO DPI/TREPROST) generated over ~USD 1,100 million in the 7MM in 2025, reflecting the scale of the inhaled treprostinil market size within the current treatment landscape.

• The current standard of care includes approved inhaled therapies such as treprostinil (YUTREPIA) and treprostinil (TYVASO/TYVASO DPI/TREPROST), which focus on symptom management and improving quality of life (QoL).

• Significant treatment gaps persist due to delayed diagnosis, as overlapping symptoms with ILD often lead to misdiagnosis, and the reliance on invasive procedures like Right Heart Catheterization limits early detection.

• The leading Pulmonary Hypertension associated with Interstitial Lung Disease Companies include Liquidia Corporation, United Therapeutics, Pharmosa BioPharm, Halo Biosciences, Roivant Sciences/Pulmovant, Insmed, and others.

• Promising Pulmonary Hypertension associated with Interstitial Lung Disease Therapies include Treprostinil (YUTREPIA), Treprostinil (TYVASO/TYVASO DPI/TREPROST), Treprostinil liposomal (L606), Treprostinil Palmitil Inhalation Powder (TPIP), Mosliciguat, H1614 (HB-1614), and others.

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Pulmonary Hypertension associated with Interstitial Lung Disease Overview

PH-ILD refers to a wide range of lung conditions, many of which involve scarring or inflammation in the thin layer of tissue between the air sacs and nearby blood vessels. This delicate region, known as the interstitium, is just micrometers thick but plays a vital role by maintaining the structure of the alveoli and enabling smooth oxygen transfer into the bloodstream. Chronic smoking and long-term exposure to environmental or occupational toxins can damage the lung tissue, contributing to inflammation and fibrosis that elevate pulmonary artery pressure. Diagnosing PH-ILD requires a combination of noninvasive and invasive methods. If a patient with ILD shows unexplained worsening of breathlessness or has symptoms disproportionate to the extent of their lung disease, further evaluation for PH is recommended. Healthcare providers often rely on noninvasive tools such as pulmonary function tests, the 6MWD, echocardiography, and imaging such as chest X-rays or CT scans, while RHC remains the most accurate and conclusive method for a definitive diagnosis.

Pulmonary Hypertension associated with Interstitial Lung Disease Epidemiology Segmentation in the 7MM

• Diagnosed Prevalent Cases of ILD

• Type-specific Diagnosed Prevalent Cases of ILD

• Type-specific Diagnosed Prevalent Cases of PH-ILD

• Total Diagnosed Prevalent Cases of PH-ILD

• Gender-specific Diagnosed Prevalent Cases of PH-ILD

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Pulmonary Hypertension associated with Interstitial Lung Disease Epidemiology Key Findings

• As of 2025, the total diagnosed prevalent population of PH-ILD across the 7MM is estimated at nearly 182,000.

• The broader diagnosed prevalent population of ILD in the 7MM reached approximately more than 1 million cases in 2025.

• In 2025, the United States represented the largest share of the PH-ILD market, with nearly 83,000 diagnosed prevalent cases, supported by advanced diagnostic infrastructure and higher clinical awareness.

• In 2025, EU4 and the UK together contributed approximately 70,000 cases of PH-ILD, with the United Kingdom representing the largest individual European segment with nearly 18,000 diagnosed cases.

• Japan accounted for approximately 29,000 diagnosed prevalent cases of PH-ILD in 2025.

• Gender-specific analysis in the United States for 2025 shows a slightly higher prevalence in males, with approximately 43,000 cases, compared to nearly 40,000 cases in females.

Approved Therapies for Pulmonary Hypertension associated with Interstitial Lung Disease

• Treprostinil (YUTREPIA): Liquidia Corporation

YUTREPIA is a dry powder inhalation formulation of treprostinil sodium, a prostacyclin mimetic. It is delivered through a single-use, handheld inhaler, with each capsule containing treprostinil sodium blended with excipients L-leucine, polysorbate 80, sodium chloride, sodium citrate, and trehalose. In May 2025, YUTREPIA received full FDA approval for improving exercise capacity in adults with PAH and PH-ILD. As the first dry powder prostacyclin therapy enabled by Liquidia’s PRINT technology, YUTREPIA delivers uniform particles to the deep lung via a low-resistance, breath-actuated device, offering enhanced usability and potential adherence benefits.

• Treprostinil (TYVASO/TYVASO DPI/TREPROST): United Therapeutics

TYVASO inhalation solution and TYVASO DPI inhalation powder are prescription medicines used in adults to treat PAH (Group 1) and PH-ILD (Group 3). TYVASO was marketed in the US in 2022, and TREPROST received approval in Japan in 2024, including a new indication in September 2024 for adults at risk of disease progression.

Pulmonary Hypertension associated with Interstitial Lung Disease Pipeline Analysis

• Treprostinil liposomal (L606): Pharmosa BioPharm/Liquidia Corporation

L606 is a liposomal formulation of treprostinil, with liposome particle sizes ranging from 110–140 nm, suspended in a sodium citrate–bicarbonate buffer. It is engineered to enhance drug stability and prolong systemic circulation by protecting treprostinil from rapid degradation and clearance. The liposomal encapsulation enables sustained pulmonary release, allowing more consistent drug exposure and minimizing peaks and troughs that may lead to side effects. In January 2025, at the 43rd J.P. Morgan Healthcare Conference, Liquidia highlighted its twice-daily dosing, improved tolerability, and rapid delivery via a next-generation breath-actuated handheld nebulizer with smart technology. L606 is in Phase III for PH-ILD, with an anticipated US launch in 2030.

• Treprostinil Palmitil Inhalation Powder (TPIP): Insmed

TPIP is an oral inhalation prostacyclin agonist being developed for PH-ILD. In June 2025, Insmed reported positive topline results from its Phase IIb study of TPIP as a once-daily treatment for PAH.

• Mosliciguat: Roivant Sciences/Pulmovant

Mosliciguat is an inhaled guanylate cyclase stimulant currently in Phase II for PH-ILD.

• H1614 (HB-1614): Halo Biosciences

H1614 (HB-1614) is an oral hyaluronan-synthesis inhibitor in Phase II for PH-ILD. In June 2025, Halo Biosciences reported the publication of results from its Phase IIa SATURN study in Thorax, a pivotal milestone for the candidate.

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Pulmonary Hypertension associated with Interstitial Lung Disease Market Outlook

The market outlook for PH-ILD is evolving, driven by high unmet clinical need, increasing disease recognition, and the progressive nature of cardiopulmonary impairment associated with the condition. While no curative therapies currently exist, growing adoption of supportive care, oxygen therapy, and targeted pulmonary vasodilators, along with advancements in understanding disease pathophysiology, are expected to support market growth. Among the 7MM, the United States accounted for the largest market size, valued at approximately USD 2,500 million in 2025. EU4 and the UK combined represented a market size of approximately USD 500 million, driven by the increasing adoption of specialized inhaled therapies, while Japan accounted for approximately USD 300 million. The landscape is anchored by approved inhaled therapies like treprostinil (TYVASO/TYVASO DPI/TREPROST), which generated over ~USD 1,100 million in the 7MM in 2025, alongside the emergence of treprostinil (YUTREPIA). The transition toward next-generation therapies such as treprostinil liposomal (L606) and treprostinil palmitil (TPIP) represents a significant leap in precision delivery, aiming to optimize drug concentration in the lungs and improve long-term quality of life and functional outcomes for patients with severe PH-ILD phenotypes.

Pulmonary Hypertension associated with Interstitial Lung Disease Market Drivers

• Increasing recognition of the disease and improvement in diagnostic practices, enabling earlier identification and treatment initiation

• Expanding treatable patient pool, driving demand for both existing therapies and emerging pipeline treatments

• Advancements in diagnostic approaches, including noninvasive tools and confirmatory methods like Right Heart Catheterization

• Anticipated entry of next-generation inhaled and oral therapies

• Growing adoption of supportive care and targeted pulmonary vasodilators

Pulmonary Hypertension associated with Interstitial Lung Disease Market Barriers

• Delayed diagnosis, as overlapping symptoms with ILD often lead to misdiagnosis

• Reliance on invasive procedures like Right Heart Catheterization, which limits early detection

• Scarcity of specifically approved therapies, presenting a challenge in standardizing care

• Lack of standard diagnostic pathways, leaving PH-ILD patients at risk

• Off-label prescribing of PAH-approved medications for nearly half of PH-ILD patients due to persistent therapeutic gaps

Pulmonary Hypertension associated with Interstitial Lung Disease Treatment Landscape

The treatment of PH-ILD primarily focuses on managing the underlying lung disease, yet the scarcity of specifically approved therapies presents a significant challenge in standardizing care. Currently, the landscape is anchored by approved inhaled therapies such as treprostinil (YUTREPIA) and treprostinil (TYVASO/TYVASO DPI/TREPROST), which focus on symptom management and improving quality of life. Despite these options, many clinicians still report prescribing PAH-approved medications off-label for nearly half of their PH-ILD patients. The paradigm is shifting as late-stage pipeline assets like treprostinil liposomal (L606) and treprostinil palmitil inhalation powder (TPIP) advance, alongside emerging candidates such as mosliciguat, seralutinib, and H1614 (HB-1614). Key unmet needs include diagnostic challenges and risk of misdiagnosis, the need for noninvasive biomarker development, the critical need for diversified therapies, and expanding treprostinil routes to ease the daily burden.

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Scope of the Pulmonary Hypertension associated with Interstitial Lung Disease Market Report

• Coverage- 7MM

• Study Period- 2022–2036

• Forecast Period- 2026–2036

• Pulmonary Hypertension associated with Interstitial Lung Disease Companies- Liquidia Corporation, United Therapeutics, Pharmosa BioPharm, Halo Biosciences, Roivant Sciences/Pulmovant, Insmed, and others.

• Pulmonary Hypertension associated with Interstitial Lung Disease Therapies- Treprostinil (YUTREPIA), Treprostinil (TYVASO/TYVASO DPI/TREPROST), Treprostinil liposomal (L606), Treprostinil Palmitil Inhalation Powder (TPIP), H1614 (HB-1614), and others.

• Pulmonary Hypertension associated with Interstitial Lung Disease Market Dynamics: market drivers and market barriers

• Pulmonary Hypertension associated with Interstitial Lung Disease Competitive Intelligence Analysis: SWOT Analysis, Attribute Analysis

• Pulmonary Hypertension associated with Interstitial Lung Disease Unmet Needs, KOL Views, Reimbursement, Cost Assumptions and Pricing Analogues

Table of Contents

1. Key Insights

2. Report Introduction

3. Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Market Overview at a Glance

4. Executive Summary

5. Key Events

6. Disease Background and Overview: PH-ILD

7. Epidemiology and Market Methodology

8. Epidemiology and Patient Population

9. Patient Journey

10. Marketed Therapies

11. Emerging Drugs Profiles

12. PH-ILD: 7MM Market Analysis

13. Key Opinion Leaders’ Views

14. Unmet Needs

15. SWOT Analysis

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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