Significant Growth Anticipated in Seven Major Markets
The chronic obstructive pulmonary disease (COPD) market in the seven major markets (7MM) — which includes the US, France, Germany, Italy, Spain, the UK, and Japan — is expected to expand from $11.5 billion in sales in 2023 to an impressive $30.8 billion by 2033. This growth is fueled by recent approvals of new therapies and anticipated pipeline agents during the forecast period from 2023 to 2033.
Recent Approvals Driving Market Expansion
The approval of Dupixent, developed by Sanofi and Regeneron, for COPD by both the European Medicines Agency (EMA) in July 2024 and the US Food and Drug Administration (FDA) in September 2024 is a key factor in this market growth. The introduction of Dupixent and other new treatments is expected to significantly impact the COPD market.
Targeting Exacerbations with Biologics
In recent years, companies have focused on controlling moderate-to-severe exacerbations in COPD patients. Traditionally, therapies like triple therapies aimed to reduce exacerbations and manage symptoms. However, many patients still experience frequent exacerbations. Key opinion leaders (KOLs) from GlobalData have identified compliance issues with current treatment regimens, which require multiple daily inhalations.
Dupixent, an interleukin (IL)-4 and IL-13-targeting monoclonal antibody, has shown promise in reducing exacerbations. Data from two Phase III clinical trials, BOREAS and NOTUS, indicated its effectiveness. KOLs noted that adherence to Dupixent is higher due to its bi-weekly administration compared to daily inhalers. GlobalData projects that Dupixent’s total sales for COPD will reach $6.57 billion in the 7MM by 2033.
Promising Late-Stage Pipeline Products
Looking ahead, several late-stage pipeline products for COPD include biologics with innovative mechanisms of action. AstraZeneca’s Fasenra and GSK’s Nucala, both currently approved for asthma, show potential benefits for COPD patients due to their targeting of type 2 inflammation. Additionally, the IL-33 pathway is being explored, with a first-in-class mechanism of action.
Sanofi and Regeneron’s itepekimab is another promising biologic that has shown positive clinical trial data for former smokers, a specific subset of COPD patients. Itepekimab is currently in Phase III clinical trials and is expected to capture market share if approved.
Market Leaders and Future Trends
GSK’s Trelegy Ellipta leads the COPD therapy market, with projected sales of $2.16 billion by 2033. This anticipated growth follows recent updates in the COPD treatment guidelines by the Global Initiative of Obstructive Lung Diseases (GOLD). These updates suggest an increased use of triple therapy combinations, comprising inhaled corticosteroids (ICS), long-acting beta-2 agonists (LABA), and long-acting muscarinic antagonists (LAMA). Notably, GOLD recommends against using ICS/LABA fixed-dose combinations, contributing to a 1.4% decrease in the compound annual growth rate for this therapy over the next ten years.
Potential Challenges Ahead
Despite the promising growth projections for the COPD market, there are potential challenges, including the loss of exclusivity for some treatments and the implementation of a $35 inhaler cap in the US. Nevertheless, GlobalData anticipates that the launch of new late-stage pipeline agents—especially biologics with reduced administration frequency, novel mechanisms of action, and alternative routes of administration—will continue to drive market expansion in the COPD sector.
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