Asthma & COPD Medicine Manufacturing in European Union 2026: Industry Statistics & Trends

The Asthma & COPD Medicine Manufacturing industry in the European Union focuses on the research, development, and production of therapeutic preparations, such as bronchodilators and corticosteroid inhalers, used to treat chronic respiratory diseases. The sector operates under strict European Medicines Agency (EMA) oversight and is experiencing a shift toward advanced biologics and biosimilars to treat severe asthma phenotypes. Reflecting broader market resilience, Eurostat data indicates that the gross value added of the pharmaceutical manufacturing sector in key regional hubs like Greece reached €1.4 billion in 2023, while total pharmaceutical parallel trade across fragmented EU markets was

Industry snapshot

Key public data points

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What does the Asthma & COPD Medicine Manufacturing in European Union industry cover?

This industry comprises the manufacturing of pharmaceutical preparations and medical inhalation devices specifically designed for the management of asthma and Chronic Obstructive Pulmonary Disease (COPD). It encompasses the formulation of active pharmaceutical ingredients (APIs) into dry powder inhalers (DPIs), metered-dose inhalers (MDIs), and nebulizer solutions.

• •Classified under NACE Rev. 2 code 21.20 for the manufacture of pharmaceutical preparations.
• •Covers both small-molecule bronchodilators and advanced monoclonal antibodies targeting severe respiratory inflammation.
• •Includes the production of specialized delivery mechanisms, which require adherence to precise device-manufacturing tolerances.

Who operates in the industry and how is it structured?

The European Union's respiratory medicine manufacturing sector is highly capital-intensive and characterized by a mix of massive multinational conglomerates and specialized regional biopharmaceutical entities. Manufacturing facilities are strategically located across Western and Central Europe to exploit established clinical research ecosystems and integrated logistics networks.

• •According to EFPIA's 2026 report, Europe accounted for 23.7% of estimated global pharmaceutical sales in 2025.
• •Parallel trade within the EU internal market reached an ex-factory value of €7,331 million in 2024, altering domestic market shares.
• •Production requires deep integration between chemical synthesis plants and specialized medical device assembly lines.

What drives demand in the industry?

The primary catalyst for industry expansion is the rising prevalence of chronic respiratory conditions driven by an aging European population and environmental triggers such as urban air pollution. Additionally, updated clinical guidelines favoring early triple-therapy interventions for COPD are accelerating the transition toward high-value combination inhalers.

• •Respiratory diseases represent one of the leading chronic health burdens across all European Union member states.
• •Increased clinical adoption of targeted biologics for severe, uncontrolled asthma pushes demand for sterile injectable production.
• •National healthcare system reimbursement policies dictate production volumes and product access across member states.

Who are the notable companies in the industry?

Competition in the EU asthma and COPD sector is fierce, defined by intense R&D races to develop long-acting formulations and smart connected inhalers. Major market participants utilize extensive European manufacturing networks to secure supply chains against global disruptions.

• •GSK plc operates major respiratory manufacturing hubs in Europe, producing globally distributed inhaler lines.
• •Sanofi SA produces advanced biological therapies widely prescribed for severe asthma indications within the EU.
• •AstraZeneca PLC maintains deep European operations dedicated to small-molecule and biological respiratory therapeutics.
• •Chiesi Farmaceutici S.p.A., an Italy-headquartered multinational, specializes heavily in proprietary formulation technologies for respiratory diseases.

What are the recent trends and outlook?

The industry is pivoting rapidly toward environmental sustainability, focusing on the development of low-global-warming-potential (GWP) propellants for metered-dose inhalers. Concurrently, digitalization is shaping the pipeline as operators embed electronic adherence-tracking sensors directly into respiratory hardware.

• •Manufacturers are phasing out traditional fluorinated greenhouse gases in response to revised EU F-gas environmental regulations.
• •Biosimilar entry for legacy respiratory biologics is intensifying price competition and expanding patient access.
• •Data from IQVIA cited in 2026 highlights that the average market growth for the top five EU pharmaceutical markets stood at 8.4% during the 2020-2025 period.

How is the industry regulated?

Manufacturers face an exceptionally stringent regulatory matrix governed by the European Medicines Agency (EMA) and national competent authorities. Compliance demands rigorous adherence to Good Manufacturing Practices (GMP) alongside complex clinical trial authorizations to maintain market access.

• •All manufacturing facilities must achieve and hold EMA Good Manufacturing Practice (GMP) certification.
• •The implementation of the EU Clinical Trials Regulation (CTR) aims to harmonize multi-country trials, though EFPIA notes Europe's global trial share fell to 19% in 2023.
• •Combination products must simultaneously satisfy pharmaceutical regulations and the EU Medical Device Regulation (MDR).

Government, statistical and trade sources used for this Claight analysis.

• EFPIA The Pharmaceutical Industry in Figures 2026 ·
• European Medicines Agency (EMA) Regulatory Guidelines ·
• Eurostat Structural Business Statistics ·
• Foundation for Economic and Industrial Research (IOBE) Pharma Report 2025