United States Asthma and COPD Drug Market Outlook 2025 | Rapid Growth in Respiratory Therapeutics

According to DataM Intelligence has published a new research report on "Asthma and COPD Drug Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

United States: Recent Industry Developments
✅ October 2025: FDA approved a new biologic therapy targeting severe eosinophilic asthma, offering improved long-term symptom control.
✅ September 2025: Leading pharma companies expanded inhaled combination therapies to address rising COPD prevalence.
✅ August 2025: Digital inhalers integrated with AI-based monitoring platforms gained adoption to support patient adherence and early intervention.

Japan: Recent Industry Developments
✅ October 2025: Japanese manufacturers introduced next-generation inhalers designed for precise dosage delivery and reduced side effects.
✅ September 2025: Collaborations between hospitals and pharma innovators advanced the development of biologics for steroid-resistant asthma.
✅ August 2025: Increased investment in COPD-focused R&D supported the launch of long-acting bronchodilators tailored to aging population needs.

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Latest M & A

Merck announced its $10 billion acquisition of Verona Pharma, gaining Ohtuvayre (ensifentrine), a dual PDE3/PDE4 inhibitor and first novel inhaled COPD drug approved in over two decades.​

This deal is the second largest pharma M&A in 2025, signaling Merck's deepening commitment to respiratory and pulmonary markets and driving near- and long-term portfolio growth with Ohtuvayre

Top Industry Players:

AstraZeneca PLC, Boehringer Ingelheim GmbH, GlaxoSmithKline PLC, Novartis AG, Hoffmann-La Roche Ltd, Pfizer Inc., Grifols SA, Merck & Co. Inc., Sanofi SA and Sumitomo Dainippon Pharma Co. Ltd.

Recent FDA Approvals and Clinical Trial Updates

The FDA approved Ohtuvayre (ensifentrine) for COPD based on ENHANCE phase 3 trial data, showing efficacy both as monotherapy and add-on therapy for moderate-to-severe COPD patients.​

In May, GSK's Nucala (mepolizumab) received FDA approval as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype, based on the positive MATINEE and METREX phase III trials.​

Sanofi/Regeneron's Dupixent (dupilumab) was approved in September as the first add-on treatment for adults with COPD and an eosinophilic phenotype, representing a novel biologic option after landmark phase 3 studies.​

Benralizumab, already used in severe eosinophilic asthma, is progressing through clinical studies for rapidly treating asthma and COPD flare-ups-trials published in The Lancet show its potential for FDA approval as the first new therapy for exacerbations in 50 years.

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Key Segments:

By drug type: (Combination Drugs, Leukotriene antagonists, Inhaled corticosteroids, Anticholinergics, Short-acting beta-agonists, Long-acting beta-agonists, Others)

Regional Analysis for Market:

✅ North America - 38% share
(Largest market due to high prevalence, strong reimbursement, and leading pharma presence)

✅ Europe - 30% share
(Strong adoption of inhaled therapies & established healthcare infrastructure)

✅ Asia-Pacific - 24% share
(Fastest-growing region driven by rising pollution, smoking rates, and expanding access to treatment)

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Recently Introduced Drugs

Ohtuvayre (ensifentrine): Marketed by Verona Pharma (and now Merck), a new dual PDE3/PDE4 inhibitor for COPD maintenance therapy.​

Nucala (mepolizumab): GSK, newly approved for eosinophilic COPD, with proven efficacy in reducing exacerbations and improving outcomes.​

Dupixent (dupilumab): Sanofi/Regeneron, biologic for COPD and asthma, now expanded indication post-FDA approval.​

Benralizumab: AstraZeneca, trialed for use in acute exacerbations for asthma and COPD, awaiting further regulatory milestones.

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Other Noteworthy Developments

Chiesi dropped its asthma/COPD Phase III asset tanimilast after failing to meet endpoints, highlighting the high-risk nature of respiratory drug development.​

The global asthma and COPD drugs market is projected to reach $117.6 billion by 2034 at a 6% CAGR, indicating strong demand and continuous innovation.

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