The chronic obstructive pulmonary disease (COPD) market across the seven major markets (7MM), is projected to grow from $11.6 billion in 2023 to $30.2 billion in 2033, representing a compound annual growth rate (CAGR) of 10%, driven by the entry of biologics into the treatment landscape and the continued integration of precision medicine approaches, forecasts GlobalData, a leading data and analytics company.
GlobalData’s latest report, “COPD in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033 – Update,” reveals that the market is being transformed by the approval of novel therapies targeting biomarker-defined patient subgroups.
The FDA and EMA approvals of Sanofi and Regeneron’s Dupixent (dupilumab), the first biologic therapy for COPD, have catalyzed this shift. Dupixent, targeting type 2 inflammation, has demonstrated a 30% reduction in annual exacerbations and an 80mL improvement in lung function, positioning it for patients with eosinophilic counts ≥300 cells/μL in GOLD E classification.
Asiyah Nawab, Healthcare Analyst at GlobalData, comments: “The approval of Dupixent represents a pivotal moment in the COPD treatment paradigm. For the first time, patients with specific inflammatory profiles are being matched to targeted therapy, improving outcomes beyond the capabilities of standard inhaler-based regimens.”
GSK’s Nucala (mepolizumab), currently approved for severe asthma, is expected to receive a COPD indication following its May 2025 PDUFA date. The key opinion leaders (KOLs) interviewed by GlobalData have expressed confidence in the biologic’s efficacy profile, citing positive experiences in asthma as a strong foundation for success in COPD.
Inhaled therapies remain foundational to COPD management. Triple therapy inhalers are expected to generate $2.7 billion in US sales by 2033, accounting for 11.3% of the total COPD market. These therapies continue to provide symptom relief and reduce exacerbations across broad patient populations.
Nawab continues: “While biologics are reshaping the landscape, inhaled therapies continue to be indispensable in daily COPD management. The evolving treatment algorithm increasingly reflects a layered approach—where precision medicine is used to augment standard of care.”
Innovation in biomarker development is further supporting the precision medicine movement. The bioMARK study has demonstrated that a combination of blood and urine biomarkers, such as IL-6, IL-8, and TIMP-1, can accurately predict seven-day exacerbation risk with an AUC of 0.89. This level of specificity holds promise in addressing current diagnostic gaps, particularly in distinguishing stable from acute disease states.
Several biologics in the late-stage development are targeting defined subgroups. Sanofi/Regeneron’s itepekimab, an anti-IL-33 agent, showed a 30% reduction in exacerbations and 110mL improvement in FEV1 among former smokers in Phase II studies, despite failing in the general COPD population. If Phase III trials are successful, itepekimab could become the first therapy with an indication specifically for former smokers.
Roche’s astegolimab, an anti-ST2 monoclonal antibody, is also in Phase III trials following its COPD-ST2OP Phase IIa study. While exacerbation reduction was not statistically significant, the therapy demonstrated improvements in patient-reported health status. By targeting the ST2/IL-33 receptor, astegolimab may offer a more sustained impact on type 2 inflammation and provide a differentiated option for both current and former smokers.
Despite the projected growth, market headwinds remain. The $35 inhaler cap adopted by several US pharmaceutical companies is expected to curb revenue growth from traditional therapies. Additionally, key branded therapies, including triple therapy inhalers, are anticipated to face generic competition as they lose market exclusivity over the forecast period.
Nawab concludes: “Biologics and biomarker-driven therapies are poised to redefine COPD treatment. However, manufacturers must navigate a complex landscape marked by pricing pressures, generic erosion, and evolving treatment guidelines to sustain long-term growth.”
