The chronic obstructive pulmonary disease (COPD) market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is forecast to grow from $11.6bn in 2023 to $30.2bn by 2033, representing a compound annual growth rate of 10%, according to leading data and analytics company GlobalData. This growth is primarily driven by the recent entry of biologics into the treatment landscape and an increasing focus on precision medicine.
A major catalyst in the COPD market has been the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals of Sanofi and Regeneron’s Dupixent, the first biologic therapy approved for COPD. Dupixent addresses a longstanding unmet need by targeting type 2 inflammation, which plays a role in a subset of moderate-to-severe patients. Pivotal Phase III trials (BOREAS and NOTUS) showed Dupixent, compared to placebo, reduced the number of annual exacerbations by as much as 30%, and improved lung function (forced expiratory volume in one second/FEV1) by 80ml. The therapy is positioned for GOLD E patients with type 2 inflammatory profiles: specifically, those with an eosinophilic count equal to or greater than 300 cells per microlitre.
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Another key biologic on the horizon is GSK’s Nucala. Already indicated to treat severe asthma, Nucala is anticipated to receive COPD approval in the third quarter of 2025, following its May 2025 Prescription Drug User Fee Act date. GlobalData expects approval of Nucala will further diversify the COPD treatment landscape, as key opinion leader (KOL) interviews have indicated confidence in Nucala to treat severe asthma, denoting a level of trust with this therapy.
Beyond biologics, traditional inhaler therapies continue to play a critical role in disease management. In particular, the triple therapies are expected to remain a cornerstone, with US sales projected to reach $2.7bn in 2033, accounting for 11.3% of the market. These therapies provide a foundation for symptom control and exacerbation reduction, particularly in broader patient populations.
Advances in biomarker development are also shaping the future of COPD care. Currently available biomarkers often lack specificity, making it difficult to differentiate between stable and acute disease states. The bioMARK study is attempting to overcome this by using interleukin 6 (IL-6)/IL-8 ratios and sputum microbiota shifts as 30-day predictors of exacerbations. Furthermore, the study has demonstrated that combining multiple biomarkers – such as IL-6, IL-8, and tissue inhibitor of metalloproteinase 1 from blood and urine samples – can achieve an area under the curve of 0.89 for predicting seven-day exacerbations, significantly improving predictive accuracy.
Biologics in late-stage development are further embracing a precision medicine approach, targeting biomarker-defined subgroups of COPD patients. For instance, Sanofi/Regeneron’s itepekimab, an anti-IL-33 biologic, is being studied specifically in former smokers with frequent exacerbations – a subset representing roughly 45% of severe COPD cases. Although itepekimab failed to demonstrate efficacy in the broader COPD population, it showed promise in former smokers, with a 30% reduction in exacerbations and a 110ml improvement in FEV1 in Phase II trials. If successful in Phase III, itepekimab could become the first therapy with a specific indication for former smokers.
Another emerging biologic is Roche’s astegolimab, an anti-ST2 monoclonal antibody currently in Phase III development. While its Phase IIa COPD-ST2OP trial yielded mixed results, with no statistically significant reduction in exacerbations, it did show improvement in patient-reported health status. Unlike AstraZeneca’s tozorakimab, which targets IL-33, astegolimab targets the ST2/IL-33 receptor itself, offering a potentially stronger, more sustained effect on type 2 inflammation. Roche may be well-positioned to differentiate astegolimab by highlighting its efficacy across both current and former smokers and aligning its launch strategy with smoking cessation programmes.
Despite the growth of the COPD market over the forecast period, potential barriers to growth remain. The introduction of a $35 inhaler cap by several US pharmaceutical companies is expected to impact revenue from traditional therapies. In addition, the upcoming loss of exclusivity for key branded products such as the triple therapies is likely to introduce generic erosion across the market.
