Severe Asthma Market Set for Robust Growth Through 2034, Driven by Breakthrough Biologics and Emerging Pipeline Therapies | DelveInsight
DelveInsight’s “Severe Asthma Market Insights, Epidemiology, and Market Forecast–2034” report delivers a comprehensive understanding of the severe asthma treatment market, historical and forecasted epidemiology, as well as market trends across the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The report comprehensively evaluates the current treatment landscape, emerging therapies, market share of individual treatments, and severe asthma market forecasts through 2034, providing crucial insights for stakeholders in the respiratory therapeutic area.
The severe asthma treatment market is projected to experience a significant upsurge at a substantial CAGR from nearly USD 7.8 billion in 2023. The US accounts for the largest severe asthma market size, representing around 70% of the total 7MM market size, primarily due to the high prevalence of the condition and elevated treatment costs. Among European countries, the United Kingdom demonstrated the highest market size with USD 430 million in 2023.
Download the Severe Asthma Market report to understand which factors drive the Pompe therapeutic market @ Severe Asthma Market Trends.
According to DelveInsight’s estimates, total diagnosed prevalent cases of asthma in the 7MM were found to be around 43 million cases in adults and about 11 million cases in the pediatric population in 2023, with these cases expected to rise significantly by 2034. In 2023, the aggregate number of reported diagnosed prevalent cases of severe asthma across the 7MM amounted to 5.1 million cases, representing approximately 9% of the total diagnosed asthma cases, with projections indicating a substantial increase by 2034.
Furthermore, the United States accounted for the highest number of severe asthma cases, totaling approximately 2 million cases in 2023, followed by Japan with a little less than 1 million cases. Among severity-specific diagnosed cases of asthma, intermittent asthma accounted for the largest number of cases, comprising approximately 25 million cases in the 7MM in 2023. In the US, there were approximately 1.2 million cases each of Type-2 inflammation and non-type-2 inflammation severe asthma.
The DelveInsight report further categorizes the severe asthma patient population based on type-specific inflammation patterns, distinguishing between type-2 and non-type-2 inflammation, which underscores the heterogeneity of the condition and necessitates tailored therapeutic approaches. This classification is essential for understanding treatment responses and is crucial for accurate epidemiological assessment and therapeutic targeting.
Discover evolving trends in the Severe Asthma patient pool forecasts @ Severe Asthma Epidemiology Analysis.
The DelveInsight report also analyses the current and emerging severe asthma treatment landscape. The approved biologics for severe asthma treatment include omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Among the approved biologics for severe asthma, DUPIXENT is expected to garner the highest market size by 2034 in the 7MM. The approved therapies in the US for severe asthma treatment include CINQAIR (reslizumab) by Teva Pharmaceutical Industries (TEVA), DUPIXENT (dupilumab) by Sanofi (SNY) and Regeneron (REGN), FASENRA (benralizumab) by AstraZeneca (AZN) and Kyowa Kirin (KYKOF), TEZSPIRE (tezepelumab) by AstraZeneca and Amgen (NASDAQ: AMGN), Nucala (mepolizumab) by GlaxoSmithKline (NYSE: GSK), and XOLAIR (omalizumab) by Novartis (NYSE: NVS) and Genentech (NYSE: DNA). Furthermore, at present, no approved therapy for severe non-eosinophilic asthma is non-responsive to corticosteroid treatment.
The severe asthma therapies pipeline demonstrates robust innovation, with several promising treatments in late-stage development. The potential drugs expected to launch in the forecasted period include Depemokimab/GSK3511294 and PT010, among others. GSK3511294 (depemokimab), developed by GlaxoSmithKline for severe eosinophilic asthma, is a humanized anti-interleukin (IL)-5 monoclonal antibody engineered to ensure high affinity and long-acting suppression of IL-5 functions. Notably, depemokimab is the first biologic to be administered subcutaneously once every 26 weeks, with GlaxoSmithKline currently conducting multiple Phase III trials to assess its safety and efficacy.
PT010, being developed by AstraZeneca, is a fixed-dose combination of micronized budesonide, glycopyrrolate, and formoterol fumarate for oral inhalation administered via pressurized metered-dose inhaler using Aerosphere delivery technology. AstraZeneca is conducting multiple Phase III trials to assess PT010’s safety and efficacy in adults and adolescents with severe asthma inadequately controlled with standard care.
For Depemokimab/GSK3511294, drug uptake is expected to be slow-medium with a probability-adjusted peak share of around 5.0%, with years to peak expected to be 7 years from launch in the US. Upcoming therapies such as GSK3511294 (Depemokimab) and PT010 have the potential to create a significant positive shift in the severe asthma market size.
In March 2025, GSK announced that the FDA accepted for review the Biologics License Application for depemokimab in two respiratory indications. The proposed indications include add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation, and treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). The PDUFA date is set for December 16, 2025. If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing.
In March 2025, the FDA has approved Celltrion’s OMLYCLO (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing Xolair, for use in treating moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria
Furthermore, in May 2025, AstraZeneca announced positive full results from the BATURA Phase IIIb trial, showing Airsupra demonstrated a 47% reduction in the risk of severe exacerbations in mild asthma compared with albuterol alone. The trial also showed a 63% reduction in mean annualized systemic corticosteroid use. Additionally, in April 2025, Sanofi shared preliminary Phase II results for amlitelimab in the TIDE-Asthma study, demonstrating compelling efficacy in heterogeneous inflammatory asthma. While the primary endpoint was not met at the highest dose, the study showed clinically meaningful reductions in asthma exacerbations at the medium dose and improvements in lung function and asthma control.
In January 2025, the FDA cleared Kinaset Therapeutics’ investigational new drug (IND) application for frevecitinib (KN-002), a novel inhaled dry powder therapeutic for patients with inadequately controlled asthma. These recent developments highlight the momentum in the severe asthma treatment landscape.
Discover more recent advancements in the Severe Asthma treatment landscape @ Severe Asthma Recent Developments.
Looking ahead, the severe asthma market is expected to witness continued innovation driven by enhanced understanding of disease mechanisms, improved diagnostic approaches, and personalized medicine approaches. The expected launch of potential therapies may increase market size in the coming years, assisted by an increase in the diagnosed prevalent population of severe asthma. It is believed that the severe asthma treatment market could change significantly by 2034 in the US with the launch of novel therapies offering better and broader efficacy, improved treatment duration, better dosages, and enhanced convenience.
DelveInsight’s analysis underscores that despite therapeutic advances, substantial opportunities remain for developing more effective, convenient, and affordable treatment options that can achieve optimal asthma control and improved quality of life for severe asthma patients worldwide. As research continues and diagnostic capabilities improve, the severe asthma market is positioned for remarkable expansion and therapeutic innovation through 2034.
Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary of Severe Asthma
4. Key Events
5. Epidemiology and Severe Asthma Market Forecast Methodology
6. Severe Asthma Market Overview at a Glance
7. Severe Asthma Background and Overview
8. Severe Asthma Treatment and Management
9. Severe Asthma Epidemiology and Patient Population in the 7MM
10. Severe Asthma Patient Journey
11. Severe Asthma Marketed Therapies
12. Severe Asthma Emerging Therapies
13. Severe Asthma: Seven Major Market Analysis
14. Severe Asthma Unmet Needs
15. SWOT Analysis
16. KOL Views
17. Market Access and Reimbursement
18. Appendix
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
Related Reports:
Severe Asthma Pipeline Insight
Severe Asthma Pipeline Insight provides comprehensive insights about the Severe Asthma pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Severe Asthma companies, including Areteia Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, Oneness Biotech, Biosion, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, and Lanier Biotherapeutics, among others.
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services
