Emerging therapies for Acute Respiratory Distress Syndrome (ARDS), including Sabizabulin (Veru-111), ExoFlo (DB-001), and others, are anticipated to drive significant growth in the ARDS market in the coming years.
DelveInsight has introduced its latest report, “Acute Respiratory Distress Syndrome – Market Insights, Epidemiology, and Market Forecast 2034”, providing comprehensive insights into ARDS, covering historical and projected epidemiology, as well as market dynamics across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
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During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:
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In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).
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In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.
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In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).
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In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.
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In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.
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In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER™ program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.
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In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.
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In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.
Some of the key facts of the Acute Respiratory Distress Syndrome Market Report:
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In 2023, the United States dominated the Acute Respiratory Distress Syndrome (ARDS) market within the seven major markets (7MM), with an estimated valuation of USD 1,643 million, and is expected to grow at a CAGR of 3.6%. The country also reported around 591,000 new ARDS cases—the highest among the 7MM—accounting for approximately 62% of the total incidence. By comparison, the EU4 and the UK represented nearly 34% of cases, while Japan contributed close to 4%.
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Current ARDS management relies largely on neuromuscular blocking agents, inhaled vasodilators, corticosteroids, and other supportive measures. Among these, inhaled vasodilators held the largest share in 2023, valued at about USD 1,063 million across the 7MM.
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Recent developments are reshaping the therapeutic landscape. In August 2024, MediciNova secured a Notice of Allowance from the U.S. Patent and Trademark Office for MN-166 (ibudilast) targeting post-COVID conditions. Similarly, in December 2024, PIF Partners received FDA Rare Pediatric Disease Designation for 101-PGC-005 (‘005), a CD206+ macrophage-targeting dexamethasone prodrug, which is also under Phase 3 evaluation in India for COVID-19-related ARDS.
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Market growth is being fueled by the rising prevalence of respiratory disorders, technological advancements in mechanical ventilation, expanding healthcare investments, and progress in targeted biologics. The ARDS market is projected to expand further during the forecast period, driven by the launch of novel therapies such as Sabizabulin (VERU-111), ExoFlo (DB-001), Invimestrocel, and Ibudilast.
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Key companies actively engaged in advancing the ARDS treatment landscape include Veru Inc., Direct Biologics, Athersys, Healios, MediciNova, and others. Leading investigational therapies—Sabizabulin, ExoFlo, and additional pipeline candidates—are expected to strengthen treatment options and enhance market growth over the coming years.
Acute Respiratory Distress Syndrome Overview
Acute Respiratory Distress Syndrome (ARDS) is categorized into three severity stages based on the PaO₂/FiO₂ ratio, which serves as a critical parameter for treatment decisions:
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Mild: 200–300 mmHg
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Moderate: 100–200 mmHg
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Severe:
The condition may evolve gradually over several days or emerge abruptly. The earliest and most frequent symptom is shortness of breath, followed by hypoxemia, rapid breathing, and abnormal lung sounds—such as bubbling, clicking, or rattling—identified during auscultation.
Patients typically present with severe dyspnea, tachypnea, and oxygen deficiency, often accompanied by cough, fatigue, and generalized respiratory distress. ARDS is usually precipitated by acute conditions such as pneumonia, sepsis, trauma, aspiration of stomach contents, or exposure to harmful substances.
Risk factors that heighten susceptibility include advanced age, chronic pulmonary diseases, obesity, and states of immunosuppression, all of which can complicate treatment and hinder recovery.
At the pathophysiological level, ARDS is characterized by damage to the alveolar–capillary barrier, leading to increased vascular permeability and fluid accumulation within the alveoli. This cascade results in alveolar collapse (atelectasis), reduced lung compliance, and severe hypoxemia. The associated inflammatory response further aggravates lung injury, contributing to the complexity and severity of the syndrome.
Acute Respiratory Distress Syndrome Market Outlook
Acute Respiratory Distress Syndrome (ARDS) is a severe, life-threatening form of respiratory failure that can result from pulmonary conditions such as pneumonia or aspiration, as well as systemic insults like sepsis, trauma, or pancreatitis. These triggers lead to non-cardiogenic pulmonary edema caused by widespread inflammatory damage to the alveolar–capillary barrier, reduced lung compliance, and loss of functional lung tissue.
Clinically, ARDS is characterized by hypoxemia, bilateral chest X-ray opacities, increased venous admixture, and elevated dead space. Histologically, it is marked by diffuse alveolar damage.
Management remains largely supportive, with mechanical ventilation as the cornerstone, supplemented by oxygen therapy, prone positioning, neuromuscular blockade, fluid management, and Positive End-Expiratory Pressure (PEEP), alongside treatment of the underlying cause. Patients are also at increased risk of secondary infections, often requiring antibiotics and additional supportive measures such as IV fluids and nutrition.
Key pathological features include alveolar flooding and pulmonary edema. Research indicates that β2-agonists may aid fluid clearance via sodium transport activation, while Keratinocyte Growth Factor (KGF) shows potential in enhancing alveolar epithelial repair, making it a promising candidate for future therapy.
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Acute Respiratory Distress Syndrome Emerging Drugs
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Sabizabulin (Veru-111): Veru
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ExoFlo (DB-001): Direct Biologics
Scope of the Acute Respiratory Distress Syndrome Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Acute Respiratory Distress Syndrome Companies: Veru Inc., Direct Biologics, Athersys, Healios, MediciNova, and others
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Acute Respiratory Distress Syndrome Therapies: Sabizabulin (Veru-111), ExoFlo (DB-001), and others.
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Acute Respiratory Distress Syndrome Therapeutic Assessment: Acute Respiratory Distress Syndrome current marketed and Acute Respiratory Distress Syndrome emerging therapies
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Acute Respiratory Distress Syndrome Market Dynamics: Acute Respiratory Distress Syndrome market drivers and Acute Respiratory Distress Syndrome market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
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Acute Respiratory Distress Syndrome Unmet Needs, KOL's views, Analyst's views, Acute Respiratory Distress Syndrome Market Access and Reimbursement
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Key benefits of the Acute Respiratory Distress Syndrome Market Report:
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The Acute Respiratory Distress Syndrome market report covers a descriptive overview and comprehensive insight of the Acute Respiratory Distress Syndrome Epidemiology and Acute Respiratory Distress Syndrome market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Acute Respiratory Distress Syndrome market report provides insights into the current and emerging therapies.
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The Acute Respiratory Distress Syndrome market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Acute Respiratory Distress Syndrome market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Acute Respiratory Distress Syndrome market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Acute Respiratory Distress Syndrome Patient Share (%) Overview at a Glance
5. Acute Respiratory Distress Syndrome Market Overview at a Glance
6. Acute Respiratory Distress Syndrome Disease Background and Overview
7. Acute Respiratory Distress Syndrome Epidemiology and Patient Population
8. Country-Specific Patient Population of Acute Respiratory Distress Syndrome
9. Acute Respiratory Distress Syndrome Current Treatment and Medical Practices
10. Unmet Needs
11. Acute Respiratory Distress Syndrome Emerging Therapies
12. Acute Respiratory Distress Syndrome Market Outlook
13. Country-Wise Acute Respiratory Distress Syndrome Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Acute Respiratory Distress Syndrome Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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