Pulmonary Hypertension Associated with Interstitial Lung Disease Market to Reach New Growth Phase as Next-Generation Inhaled Therapies Advance | DelveInsight
(Albany, New York) – September 23, 2026 – The Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) market is entering an evolving phase of therapeutic development as increasing disease recognition, improvements in diagnostic practices, and the advancement of next-generation inhaled and oral therapies reshape the treatment landscape. According to DelveInsight’s latest report, “Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Market Insights, Epidemiology, and Market Forecast – 2036,” the 7MM PH-ILD market was valued at approximately USD 3 billion in 2025 and is projected to grow at a 3.9% CAGR from 2026 to 2036.
The report evaluates the PH-ILD market across the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan, providing historical and forecasted epidemiology, market size, treatment patterns, competitive intelligence, drug uptake, pricing, reimbursement, and pipeline analysis through 2036. In 2025, the United States represented the largest market at approximately USD 2.5 billion, while the EU4 and UK collectively accounted for approximately USD 500 million, and Japan represented approximately USD 300 million.
Key Takeaways
- The 7MM PH-ILD market was approximately USD 3 billion in 2025.
- The market is projected to expand at a 3.9% CAGR during 2026–2036.
- The United States PH-ILD market was approximately USD 2.5 billion in 2025.
- The EU4 and UK collectively represented approximately USD 500 million in 2025.
- Japan accounted for approximately USD 300 million in market value in 2025.
- The total diagnosed prevalent population of PH-ILD across the 7MM was nearly 182,000 cases in 2025.
- The United States accounted for approximately 83,000 diagnosed prevalent PH-ILD cases in 2025.
- EU4 and the UK together contributed approximately 70,000 diagnosed prevalent cases, while Japan accounted for approximately 29,000 cases.
- Current approved inhaled therapies include treprostinil (YUTREPIA) and treprostinil (TYVASO/TYVASO DPI/TREPROST).
- Emerging therapies include treprostinil liposomal (L606), treprostinil palmitil inhalation powder (TPIP), mosliciguat, and H1614 (HB-1614).
- The development landscape is increasingly focused on improving pulmonary delivery, dosing convenience, efficacy, and long-term disease management.
Keen to know more about the PH-ILD market and emerging therapies? Request a sample copy of DelveInsight’s Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Market Insights, Epidemiology, and Market Forecast – 2036 report:
Key Factors Driving the PH-ILD Market
Increasing Disease Recognition and Improved Diagnosis
One of the major factors supporting PH-ILD market expansion is increasing recognition of the disease and improvements in diagnostic practices. PH-ILD can be difficult to identify because its symptoms overlap substantially with those of underlying interstitial lung disease. Increasing clinical awareness and more systematic evaluation of patients with disproportionate worsening of breathlessness may improve identification of PH-ILD and expand the treatable patient population.
Growing Adoption of Targeted Inhaled Therapies
The treatment landscape has increasingly incorporated targeted inhaled therapies. Treprostinil (TYVASO/TYVASO DPI/TREPROST) has played a central role in PH-ILD management, while YUTREPIA provides a dry-powder formulation designed to deliver treprostinil directly to the lungs.
In May 2025, YUTREPIA received full FDA approval for improving exercise capacity in adults with PAH and PH-ILD. Its handheld, breath-actuated delivery system represents an additional administration option within the inhaled prostacyclin landscape.
Expansion of Next-Generation Inhaled Therapies
The PH-ILD pipeline is increasingly focused on formulations intended to improve drug delivery, dosing frequency, tolerability, and patient convenience. Treprostinil liposomal (L606) and treprostinil palmitil inhalation powder (TPIP) are late-stage candidates that could contribute to future market development.
L606 is designed as a liposomal formulation intended to provide sustained pulmonary release and more consistent exposure, while TPIP is being developed as a once-daily inhaled prostacyclin formulation.
Large Underlying ILD Patient Population
The broader ILD population represents an important pool of patients at risk of developing associated pulmonary hypertension. DelveInsight estimates that the diagnosed prevalent ILD population across the 7MM exceeded 1 million cases in 2025, compared with nearly 182,000 diagnosed prevalent PH-ILD cases.
Persistent Unmet Medical Need
Despite advances in targeted therapy, significant treatment gaps remain. Delayed diagnosis, overlapping clinical symptoms, reliance on invasive right heart catheterization for definitive diagnosis, limited noninvasive biomarkers, and the lack of standardized diagnostic pathways continue to create challenges for patients and healthcare providers.
Competitive Landscape
The current PH-ILD treatment landscape is primarily centered around inhaled treprostinil-based therapies.
Treprostinil (YUTREPIA) – Liquidia Corporation
YUTREPIA is a dry-powder inhalation formulation of treprostinil sodium. In May 2025, it received full FDA approval for improving exercise capacity in adults with PAH and PH-ILD.
The product uses Liquidia’s PRINT technology and a handheld breath-actuated inhaler designed for pulmonary delivery.
Treprostinil (TYVASO/TYVASO DPI/TREPROST) – United Therapeutics
Treprostinil inhalation products developed by United Therapeutics represent an established component of PH-ILD management. TYVASO and TYVASO DPI provide inhaled treprostinil delivery, while TREPROST has also expanded access in Japan following regulatory approval for a new indication in 2024.
Emerging Competitive Landscape
The future competitive landscape includes:
- Treprostinil liposomal (L606) – Pharmosa BioPharm/Liquidia Corporation
- Treprostinil Palmitil Inhalation Powder (TPIP) – Insmed
- Mosliciguat – Roivant Sciences/Pulmovant
- H1614 (HB-1614) – Halo Biosciences
These candidates target different aspects of pulmonary vascular disease and are being developed with an emphasis on improved delivery, dosing, and treatment outcomes.
Recent Developments in the PH-ILD Market
- May 2025: YUTREPIA received full FDA approval for improving exercise capacity in adults with PAH and PH-ILD.
- May 2025: Gossamer Bio reported completion of enrollment for the global Phase III PROSERA study evaluating seralutinib in patients with Functional Class II and III PAH.
- June 2025: Halo Biosciences reported publication of results from the Phase IIa SATURN study evaluating HB-1614 for PH-ILD.
- June 2025: Insmed reported positive topline results from its Phase IIb study of TPIP as a once-daily treatment for PAH.
- September 2024: TREPROST received approval in Japan for a new indication targeting adults at risk of disease progression.
- January 2025: Liquidia presented developments related to L606, highlighting twice-daily dosing, improved tolerability, and delivery through a next-generation breath-actuated handheld nebulizer.
What is Pulmonary Hypertension Associated with Interstitial Lung Disease?
Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) refers to pulmonary hypertension occurring in patients with interstitial lung diseases. ILD encompasses a broad range of pulmonary disorders involving inflammation, fibrosis, or scarring of the interstitial tissue surrounding the alveoli and blood vessels.
Chronic smoking and prolonged exposure to environmental or occupational toxins can contribute to lung injury, inflammation, and fibrosis, potentially increasing pulmonary artery pressure.
Diagnosis can be challenging because symptoms such as breathlessness may result from either ILD or pulmonary hypertension. When symptoms are disproportionate to the severity of underlying lung disease, further evaluation for PH may be warranted.
Noninvasive diagnostic tools include pulmonary function tests, six-minute walk distance (6MWD), echocardiography, chest X-rays, and CT scans. However, right heart catheterization (RHC) remains the most accurate and definitive method for diagnosing pulmonary hypertension.
Current Treatment Landscape
The current management of PH-ILD focuses on treating the underlying ILD, supporting oxygenation and exercise capacity, and using targeted pulmonary vasodilator therapy when appropriate.
Supplemental oxygen and pulmonary rehabilitation remain important components of supportive care. Targeted therapies include inhaled prostacyclin therapies designed to reduce pulmonary vascular resistance and improve exercise capacity.
The current approved PH-ILD-specific treatment landscape includes:
- Treprostinil (YUTREPIA) – Liquidia Corporation
- Treprostinil (TYVASO/TYVASO DPI/TREPROST) – United Therapeutics
DelveInsight notes that clinicians continue to prescribe PAH-approved therapies off-label for a substantial proportion of PH-ILD patients because of persistent therapeutic gaps.
Epidemiology
DelveInsight estimates that the total diagnosed prevalent population of PH-ILD across the 7MM was nearly 182,000 cases in 2025. The broader diagnosed prevalent ILD population exceeded 1 million cases during the same year.
The United States represented the largest PH-ILD patient population, with approximately 83,000 diagnosed prevalent cases in 2025. Male patients accounted for approximately 43,000 cases, compared with nearly 40,000 female cases.
Across the EU4 and the UK, approximately 70,000 PH-ILD diagnosed prevalent cases were reported in 2025. The United Kingdom represented the largest individual European segment with nearly 18,000 cases.
Japan accounted for approximately 29,000 diagnosed prevalent PH-ILD cases in 2025, representing a significant patient population within the Asia-Pacific market.
The epidemiological assessment covers:
- Diagnosed prevalent ILD cases
- Type-specific diagnosed prevalent ILD cases
- Type-specific diagnosed prevalent PH-ILD cases
- Total diagnosed prevalent PH-ILD cases
- Gender-specific diagnosed prevalent PH-ILD cases
Unmet Needs in PH-ILD
Diagnostic Challenges and Misdiagnosis
The overlap between ILD and pulmonary hypertension symptoms can delay recognition of PH-ILD. Patients may experience worsening breathlessness that is initially attributed solely to progression of ILD.
Need for Noninvasive Biomarkers
The continued reliance on invasive RHC for definitive diagnosis highlights the need for reliable noninvasive biomarkers and improved imaging technologies that can facilitate earlier identification.
Need for Diversified Therapies
Although inhaled treprostinil therapies have expanded treatment options, additional therapies with differentiated mechanisms, routes of administration, efficacy profiles, and dosing schedules remain necessary.
Administration Burden
Frequent inhaled dosing can create a daily treatment burden. Next-generation formulations such as L606 and TPIP are being developed partly to improve convenience and potentially reduce administration frequency.
Lack of Standardized Diagnostic Pathways
The absence of consistent diagnostic pathways can result in variability in disease recognition and management. Improved coordination among pulmonologists, cardiologists, and other specialists remains important for comprehensive PH-ILD care.
Scope of the PH-ILD Market Report
The DelveInsight report provides comprehensive market and epidemiological analysis across the 7MM, comprising the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan.
Study Period: 2022–2036 Historical Period: 2022–2025 Forecast Period: 2026–2036 Base Year: 2025 7MM Market Size in 2025: Approximately USD 3 billion Forecast CAGR: 3.9% 7MM Diagnosed Prevalent PH-ILD Cases in 2025: Nearly 182,000 Geographies: US, Germany, France, Italy, Spain, UK, and Japan Market Segmentation: Region/geography, drugs/therapies, and class of therapies
The report also assesses the addressable patient population, market drivers and barriers, pricing analogues, reimbursement, KOL insights, SWOT analysis, attribute analysis, unmet needs, competitive landscape, patient burden trends, therapy adoption and uptake, and peak patient share.
To Know More About the PH-ILD Market
Table of Contents
- Executive Summary
- PH-ILD Market Overview
- Disease Background and Overview
- Causes, Risk Factors, Signs and Symptoms
- Diagnosis and Disease Assessment
- Epidemiology and Patient Population
- Current Treatment Landscape
- Treatment Algorithm
- Approved/Marketed Therapies
- Emerging Therapies and Pipeline Analysis
- Competitive Landscape
- PH-ILD Market Size and Forecast
- Market Drivers and Barriers
- Drug Uptake and Patient Share Analysis
- Pricing and Reimbursement Analysis
- Key Opinion Leader Insights
- SWOT and Attribute Analysis
- Unmet Needs
- Recent Developments
- Company Profiles
- Market Access and Reimbursement
- Future Market Outlook
- DelveInsight Methodology and Forecast Approach
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in the life sciences and healthcare industries. Founded in 2014, the company provides comprehensive market intelligence, epidemiology, and insights across pharmaceuticals, biotechnology, medical devices, and emerging therapies. DelveInsight helps healthcare organizations make informed strategic decisions through data-driven research and industry expertise.
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