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