COPD market to reach $30.8 billion in 7MM by 2033: GlobalData

The chronic obstructive pulmonary disease (COPD) market in the seven major markets (7MM*) is set to grow from $11.5 billion in 2023 to $30.8 billion in 2033, driven by the launch of the first biologic for COPD, and other pioneering pipeline agents, forecasts GlobalData.

GlobalData’s latest report, “COPD in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033,”  reveals that the growth will be supported by approval from the FDA and EMA for Sanofi and Regeneron’s Dupixent (dupilumab), the first biologic approved for COPD.

Additionally, growth of the US COPD market can be attributed to the FDA’s approval of Verona Pharma’s Ohtuvayre (ensifentrine), a first-in-class dual phosphodiesterase (PDE)3 and PDE4 inhibitor, given via nebulisation to all severities of COPD patients. The COPD late-stage pipeline is abundant in other biologics with new mechanisms of action, further adding to the growth of the COPD market by 2033.

According to the report, inhaled corticosteroids (ICS), long-acting beta-2 agonists (LABA), and long-acting muscarinic antagonists (LAMA) will continue to remain the dominant treatment modality for COPD during the forecast period. This theme is observed in currently marketed products, with biologics and PDE inhibitors used as add-on maintenance therapies to supplement patients that continually exacerbate despite their standard of care (SOC) regimen.

Asiyah Nawab, Pharma Analyst at GlobalData, states, “Sanofi/Regeneron’s Dupixent has demonstrated great efficacy for patients that present with moderate-to-severe exacerbations with high blood eosinophils, while simultaneously administering their SOC. Clinical trial data and pooled analysis presented at the 2024 European Respiratory Society (ERS) congress have shown that Dupixent is able to reduce the annualised rate of exacerbations in COPD patients, as well as improve symptoms and the quality of life of patients.”

Key opinion leaders (KOLs) interviewed by GlobalData have emphasised that the data presented during Dupixent’s two Phase III clinical trials (BOREAS and NOTUS) show successful, consistent data, supporting its use for the exacerbating group, despite its high cost of therapy and limited subgroup of patients eligible for treatment. Other KOLs have communicated that Dupixent is to dominate the biologics market after receiving both EMA and FDA approval, filling a gap in the COPD market.

In addition to the entry of biologics for COPD exacerbators, the FDA approval of Verona Pharma’s Ohtuvayre in the US in June 2024 has also shown great efficacy as maintenance treatment for COPD patients, for all severities of COPD. This has been highlighted by two Phase III clinical trials, ENHANCE-1 and ENHANCE-2, which met their primary endpoints, and showed a reduction in exacerbations of 41 per cent over 24-weeks of treatment compared to placebo.

Nawab adds, “The entry of these newer therapies will be used as add-on maintenance treatment for COPD patients, supplementing the SOC. Of the marketed therapies and recent changes in the treatment regimen by the Global Initiative of Obstructive Lung Diseases (GOLD) committee for COPD, GlobalData predicts that there will be an increased uptake in the use of ICS/LABA/LAMA fixed-dose combinations, with GSK’s Trelegy Ellipta being a leading triple therapy over the forecast period, anticipated to accumulate total sales of $2.16 billion by 2033.”

The changes made by GOLD have communicated that ICS/LABA fixed-dose combinations should not be used, which has been reflected in the COPD report, highlighting a 1.4 per cent reduction in the CAGR for this therapy option over the 10-year forecast period.

Nawab concludes, “While the COPD market is projected to grow strongly in 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 observed by several pharmaceutical companies in the US.

“GSK’s Trelegy Ellipta is set to lose market exclusivity in the US in 2027 and in the 5EU (France, Germany, Italy, Spain, and UK) in 2029, leading to anticipated entry of generics. However, 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 are undoubtedly expected to be a driving force for market growth in the COPD space.”

*7MM: The US, France, Germany, Italy, Spain, the UK, and Japan