The chronic obstructive pulmonary disease (COPD) market in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is set to grow from sales of $11.5bn in 2023 to $30.8bn in 2033. The recent approvals of Sanofi/Regeneron’s Dupixent for COPD (from the European Medicines Agency/EMA in July 2024 and the US Food and Drug Administration/FDA in September 2024) and the anticipated approval of COPD pipeline agents during the forecast period from 2023 to 2033 are expected to drive the growth of the COPD market in the 7MM.

A critical factor that has been targeted in recent years by companies within the COPD space that aim to heighten their chances of success upon entering the COPD market is the control of moderate-to-severe exacerbators, which has now been demonstrated by tapping into a new territory: biologics. Current marketed therapies on the COPD market such as triple therapies have aimed to reduce exacerbations in COPD patients and manage symptoms. However, many patients continue to exacerbate. Key opinion leaders (KOLs) interviewed by leading data and analytics company GlobalData noted that there have been issues involving compliance with the treatment regimen as the therapy is taken via inhalation several times per day. One way around this has been the recent EMA and FDA approvals of Dupixent, an interleukin (IL)-4 and IL-13-targeting monoclonal antibody, which has been shown to be able to successfully decrease exacerbations according to data presented in two Phase III clinical trials (BOREAS and NOTUS). KOLs have also emphasised that patient adherence to this therapy is higher due to its frequency of administration (every two weeks), compared to daily for inhalers. GlobalData forecasts Dupixent’s total sales for COPD to reach $6.57bn in the 7MM by 2033, according to GlobalData’s COPD in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033 report.

Looking ahead, the current late-stage pipeline products for COPD include many biologics, some of which have first-in-class mechanisms of action. AstraZeneca’s Fasenra and GSK’s Nucala, two biologics that are already marketed for asthma and other indications, are promising in the pipeline. KOLs have noted that biologics approved for asthma are promising as they also target type 2 inflammation, suggesting that the therapies will also be beneficial in COPD patients. The IL-33 pathway is also being explored in COPD, presenting with a first-in-class mechanism of action. Another biologic, Sanofi/Regeneron’s itepekimab, has clinical trial data showing its use in former smokers, a more defined subset of COPD patients. Itepekimab is still undergoing Phase III clinical trials for COPD, but is expected to acquire market share if approved.

Currently, COPD-marketed therapy leaders include GSK’s Trelegy Ellipta, which is anticipated to grow in sales to $2.16bn by 2033. This growth can be attributed to recent changes made in the COPD treatment regimen by the Global Initiative of Obstructive Lung Diseases (GOLD) committee. GlobalData forecasts that there will be an increased uptake in the use of triple therapy (inhaled corticosteroids [ICS], long-acting beta-2 agonists [LABA], and long-acting muscarinic antagonists [LAMA] fixed-dose combinations). The changes made by GOLD have communicated that ICS/LABA fixed-dose combinations should not be used, which has been reflected in GlobalData’s COPD report, highlighting a 1.4% reduction in the compound annual growth rate for this therapy option over the ten-year forecast period.

While the COPD market is projected to show strong growth during the forecast period, potential barriers to this growth include loss of exclusivity within the forecast period and the introduction of the $35 inhaler cap in the US that will be observed by several pharmaceutical companies in the US. GlobalData expects the anticipated launch of other late-stage pipeline agents - particularly biologics with lower frequencies of administration, new mechanisms of action, and new routes of administration - to be a driving force for market growth in the COPD space.