Chronic Obstructive Pulmonary Disease (COPD) Biologics Market Size & Industry Outlook
The global chronic obstructive pulmonary disease (COPD) biologics market size reached US$ 604.70 million in 2024 is expected to reach US$ 1,678.90 million by 2033, growing at a CAGR of 12.1% during the forecast period 2025-2033. The global chronic obstructive pulmonary disease (COPD) biologics Market is experiencing significant growth due to rising COPD prevalence, precision medicine advancements, and recent regulatory approvals. Dupixent, the first biologic for COPD in the U.S. and Europe, has set an example, while in May 2025, GSK plc announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance therapy for adults with COPD who remain inadequately controlled and have an eosinophilic phenotype. Also, the aging population, high smoking history, and better diagnostic testing are driving biologic adoption in G7 countries.
The U.S. leads due to robust approvals and payer support, while Europe is witnessing momentum with early adoption in Germany due to strong government support, faster drug approvals, and broad insurance coverage. The high COPD burden from aging, smoking, and pollution, along with active clinical trials and advanced healthcare systems, further drive early uptake and make the region a leader in introducing these therapies. The market is shifting from traditional inhaled therapies to biologics with disease-modifying potential, positioning it as a transformative driver of COPD management over the next decade.
Key Highlights
- North America dominates the chronic obstructive pulmonary disease (COPD) biologics market with the largest revenue share of 43.5% in 2024.
- The Asia Pacific is the fastest-growing region and is expected to grow at the fastest CAGR of 8.1% over the forecast period.
- Based on drug class, Dupilumab segment led the market with the largest revenue share of 54.1% in 2024.
- The major market players in the Chronic Obstructive Pulmonary Disease (COPD) Biologics market includes Sanofi / Regeneron Pharmaceuticals Inc & GlaxoSmithKline.
Market Dynamics
Drivers: Increasing Prevalence of COPD is significantly driving the Chronic Obstructive Pulmonary Disease (COPD) Biologics market growth
The global biologics market is driven by the increasing prevalence of chronic obstructive pulmonary disease (COPD), driven by factors like smoking, air pollution, and occupational exposures. This growing patient population, especially those with moderate-to-severe COPD, drives demand for targeted therapies.
With rising COPD cases in G7 countries are driving demand for effective treatments, accelerating the adoption of biologics like Dupilumab and Mepolizumab, and fueling market growth.
For instance, according to the British Lung Foundation, COPD is the second most common lung disease in the UK, affecting 1.2 billion people and costing £1.8 Million annually. COPD is the fourth and fifth most common cause of death for men and women, with the UK having the third highest mortality rate in Europe and the 12th highest worldwide.
Additionally, as of 2024, chronic obstructive pulmonary disease (COPD) remains a significant health concern in Germany. Around 5.8% of adults aged 18 years and older report living with COPD, with similar rates in men and women. Prevalence rises sharply with age, affecting about 8.5% of people aged 45 years or older.
Moreover, according to the Japanese Ministry of Health, Labour and Welfare (MHLW) in Japan, estimates of COPD prevalence vary widely, with official data suggesting 0.2%–0.4% of the population, while the NICE study reported 8.6% among adults aged 40 and above. The study also highlighted a low diagnosis rate, with only 9.4% of those with airflow obstruction formally diagnosed. Similarly, in France, the prevalence of chronic obstructive pulmonary disease (COPD) is estimated at 2.6 million and is projected to rise to 2.8 million by 2025.
Restraints: High Treatment Cost of Biologics are hampering the growth of the Chronic Obstructive Pulmonary Disease (COPD) Biologics market
High treatment costs for biologics present a major challenge in the global COPD biologics market. Complex, resource-intensive R&D and specialised sterile manufacturing drive high list prices, while limited competition and slow uptake of biosimilars keep costs elevated. These prices strain payer budgets and restrict reimbursement, leaving many patients without access or requiring restrictive step-therapy and prior-authorization policies. As a result, adoption remains concentrated in well-funded healthcare systems and among a narrow patient segment, slowing overall market penetration and limiting the public-health impact of these advanced therapies.
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Chronic Obstructive Pulmonary Disease (COPD) Biologics Market, Segment Analysis
The global chronic obstructive pulmonary disease (COPD) biologics market is segmented based on drug class, route of administration, distribution channel, and region.
Drug Class: The Dupilumab from Drug Class segment to dominate the Chronic Obstructive Pulmonary Disease (COPD) Biologics market with a 54.1% share in 2024
Dupilumab is a biologic therapy for COPD patients with type 2 inflammation, especially those with elevated blood eosinophil counts. Clinical trials show that when combined with standard inhaled therapy, Dupilumab can reduce exacerbations by 30-34%, improve lung function by 134 mL in forced expiratory volume (FEV), and improve patients' quality of life by reducing breathlessness and increasing physical activity.
The Dupilumab segment in COPD biologics is driven by the need for more effective and targeted treatments for patients with severe or uncontrolled disease. Key factors include the ability of the therapy to reduce exacerbations, improve lung function, and enhance quality of life.
Additionally, drug launches, FDA approvals, growing awareness of personalized medicine, advances in diagnostic testing to identify suitable patients, and increasing patient and physician acceptance of biologic therapies also support its adoption.
For instance, in June 2025, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP).
Furthermore, In FY 2024, Dupixent achieved global sales of €13,072 million, up 23.1%, driven by strong demand across indications such as atopic dermatitis, asthma, and COPD, with notable growth in the U.S., Europe, and Japan. The launch in COPD and expansion across multiple regions are expected to further support market growth by increasing patient access and broadening the therapy’s adoption.
Distribution Channel: The hospital pharmacies is estimated to have a 54.1% of the Chronic Obstructive Pulmonary Disease (COPD) Biologics market share in 2024
Hospital pharmacies play a pivotal role in the global COPD biologics market by acting as the primary channel for procurement, storage, and administration of these high-value therapies. They ensure proper cold-chain management, inventory control, and compliance with regulatory standards, which are critical for biologic stability and safety. Hospital pharmacists also collaborate with pulmonologists and care teams to guide dosing, monitor adverse reactions, and manage reimbursement paperwork or prior authorizations. By serving as the central hub for both clinical oversight and logistical support, hospital pharmacies help streamline patient access to COPD biologics and improve adherence to prescribed treatment regimens.
Geographical Analysis
North America dominates the global Chronic Obstructive Pulmonary Disease (COPD) Biologics market with a 43.5% in 2024
North America is a significant contributor to the growth of the global market for biologic treatments for chronic obstructive pulmonary disease (COPD). The region experiences a high prevalence of COPD, particularly among older adults, which creates a substantial patient population in need of effective therapies. Moreover, awareness campaigns, favorable regulatory policies, and insurance coverage further support the adoption of these advanced therapies, making them more accessible to patients.
For instance, in July 2025, the American Lung Association is rolling out a new initiative aimed at supporting and empowering individuals living with chronic obstructive pulmonary disease (COPD), particularly in rural and underserved communities across the U.S. An estimated 16 million Americans are affected by COPD, a chronic and progressive lung condition that restricts airflow and makes breathing difficult.
For instance, in September 2024, the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance therapy for adults with chronic obstructive pulmonary disease (COPD) who remain inadequately controlled and have an eosinophilic phenotype. This approval makes Dupixent the first biologic treatment in the U.S. for this specific patient population.
Thus, North America is expected to remain a leading force in advancing COPD biologics, driving both patient outcomes and market growth through continuous innovation and accessibility.
Europe is the second region after North America which is expected to dominate the global Chronic Obstructive Pulmonary Disease (COPD) Biologics market with a 34.5% in 2024
Europe is witnessing steady growth in the COPD biologics market due to a rising burden of chronic respiratory diseases, increasing awareness of advanced treatment options, and supportive healthcare policies. The European Medicines Agency’s centralized approval process enables faster market entry for biologics, while pan-European disease management programs improve early diagnosis and referral rates. Combined with expanding specialist networks and a focus on value-based care, these factors are fostering higher adoption of biologics across major European countries. Germany’s strong healthcare infrastructure, high per-capita spending, and well-established reimbursement system drive uptake of advanced biologics for COPD. The presence of leading pharmaceutical manufacturers, robust clinical trial activity, and rapid guideline updates also accelerate physician adoption and patient access.
The Asia Pacific region is the fastest-growing region in the global Chronic Obstructive Pulmonary Disease (COPD) Biologics market, with a CAGR of 8.1% in 2024
In Asia-Pacific, the market is propelled by a large and growing COPD patient pool, expanding healthcare coverage in emerging economies, and increased investments in healthcare infrastructure. Rising air pollution and smoking rates are also increasing disease incidence, thereby creating demand for more effective biologics.
Japan’s market is driven by its rapidly aging population, high COPD diagnosis rates, and government initiatives to support innovative therapies through expedited approval processes. Strong domestic pharmaceutical R&D capabilities and favorable pricing negotiations with public insurers further support biologic adoption.
Competitive Landscape
Top companies in the Chronic Obstructive Pulmonary Disease (COPD) Biologics market include Sanofi/Regeneron pharmaceuticals Inc, GSK and among others.
Sanofi and Regeneron Pharmaceuticals Inc. play a key role in the global COPD biologics market through their joint development and commercialization of innovative monoclonal antibody therapies targeting inflammatory pathways implicated in chronic airway disease. Leveraging their experience with successful respiratory and immunology products, the companies bring strong R&D capabilities, large-scale clinical programs, and global commercialization networks that accelerate market penetration. Their collaboration also emphasizes patient-support services and real-world evidence generation to strengthen payer confidence and broaden access, positioning them as major drivers of innovation and adoption in the COPD biologics space.
Market Scope
| Metrics | Details | |
| CAGR | 12.1% | |
| Market Size Available for Years | 2022-2033 | |
| Estimation Forecast Period | 2025-2033 | |
| Revenue Units | Value (US$ Mn) | |
| Segments Covered | Drug Class | Dupilumab, Mepolizumab |
| Route of Administration | Subcutaneous | |
| Distribution Channel | Hospital Pharmacies, Specialty Pharmacies | |
| Regions Covered | North America, Europe, Asia-Pacific, South America and the Middle East & Africa | |
The global Chronic Obstructive Pulmonary Disease (COPD) Biologics market report delivers a detailed analysis with 62 key tables, more than 57 visually impactful figures, and 159 pages of expert insights, providing a complete view of the market landscape.
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