Sanofi's Dupixent: Regulatory Momentum in the EU Drives Market Expansion and Competitive Edge in Biologics

Sanofi and Regeneron's Dupixent (dupilumab) is poised for a transformative phase in the European Union (EU) biologics market, driven by recent regulatory approvals and a robust pipeline expansion. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in September 2025 for Dupixent's use in treating chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and above who have inadequate responses to standard therapies Press Release: Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion^[1]. This marks the first new targeted therapy for CSU in over a decade in the EU, a market segment with a prevalence of 0.92% in the EU5 (France, Germany, Italy, Spain, and the UK) Prevalence, treatment and burden of chronic spontaneous urticaria in five European countries^[2].

The regulatory momentum extends to chronic obstructive pulmonary disease (COPD), where Dupixent received EU approval in July 2024 for patients with eosinophilic COPD uncontrolled by standard therapies EU Makes First-in-World Approval of Dupixent as …^[3]. Clinical trials demonstrated a 30–34% reduction in moderate-to-severe exacerbations over one year compared to placebo EU Makes First-in-World Approval of Dupixent as …^[3]. These approvals, combined with existing indications for atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP), position Dupixent as a versatile biologic targeting type 2 inflammation pathways.

Competitive Positioning: Dupixent's Edge in a Crowded Market

Dupixent's mechanism of action—blocking interleukin-4 (IL-4) and interleukin-13 (IL-13)—has been central to its dominance in atopic dermatitis, where it holds a 73.30% market share in 2024 Dupixent Market Size, Share & Growth | Industry Report 2033^[4]. In asthma, real-world data from the EU-ADVANTAGE study (2025) showed Dupixent reduced exacerbation risks by 22% compared to omalizumab (Xolair) and 35% compared to benralizumab (Fasenra) Real-world comparative effectiveness of biologic therapies in severe asthma^[5]. For CSU, Dupixent faces competition from Xolair, but its unique IL-4/IL-13 inhibition offers a differentiated profile, particularly for patients unresponsive to anti-IgE therapies Chronic Urticaria Competitive Landscape Assessment 2024^[6].

The COPD market, though nascent for biologics, is expected to see Dupixent dominate due to its first-mover advantage. Analysts project COPD-related sales could exceed €6.5 billion by 2033 in the 7MM (seven major markets) Sanofi/Regeneron’s Dupixent set to dominate COPD biologics market share following FDA approval, says GlobalData^[7]. This is supported by the EU's growing prevalence of COPD, which affects 36 million people and costs €38.6 billion annually in direct healthcare expenses Press Release: EFA calls for urgent European action on lung health …^[8].

Market Expansion: Prevalence and Financial Projections

The EU's chronic inflammatory disease burden provides a fertile ground for Dupixent's growth. Asthma prevalence in the EU5 was 6.7% in 2018, with the UK at 10.4% Prevalence and burden of asthma in five European countries: a ...^[9]. COPD, responsible for 80% of chronic respiratory disease (CRD) deaths in the WHO European Region, is projected to rise by 23% globally by 2050 Chronic respiratory diseases in the WHO European Region^[10]. For CSU, the 0.92% EU5 prevalence translates to approximately 4.6 million patients, many of whom remain inadequately treated Prevalence, treatment and burden of chronic spontaneous urticaria in five European countries^[2].

Financially, the EU Dupixent market is forecasted to grow at a compound annual growth rate (CAGR) of 14.2%, expanding from €6.72 billion in 2025 to €14.85 billion by 2031 Europe Dupixent Market Size, Share, Trends and Forecasts 2031^[11]. This growth is fueled by expanding pediatric indications, favorable reimbursement policies, and Sanofi's strategic collaborations with EU healthcare providers to enhance distribution and physician education Dupixent Market Report 2025 - Dupixent Market^[12].

Risks and Mitigants

While biosimilars may emerge post-patent expiry, Dupixent's entrenched patient base, clinical efficacy, and early adoption as a biologic therapy in Europe mitigate competitive threats Europe Dupixent Market Size, Share, Trends and Forecasts 2031^[13]. Additionally, Sanofi's pipeline, including IRAK4 degrader SAR444656 and anti-OX40L antibody amlitelimab, signals a commitment to maintaining its leadership in type 2 inflammation Sanofi to increase competition in atopic dermatitis market after Dupixent’s success, says GlobalData^[14].

Conclusion

Sanofi's regulatory progress for Dupixent in the EU underscores its potential to redefine market dynamics in biologics. With approvals for CSU and COPD, a strong competitive edge in asthma and atopic dermatitis, and a growing patient pool, Dupixent is well-positioned to outpace rivals and deliver sustained revenue growth. For investors, the drug's expanding indications and robust clinical data represent a compelling case for long-term value creation.