PUBLISHER: DelveInsight | PRODUCT CODE: 1951021
PUBLISHER: DelveInsight | PRODUCT CODE: 1951021
Asthma Market and Epidemiology Analysis
Key Factors Driving the Asthma Market
DelveInsight's "Asthma Market Insights, Epidemiology, and Market Forecast - 2036" report delivers an in-depth understanding of asthma, historical and forecasted epidemiology, as well as the asthma therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The asthma market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM asthma market size from 2022 to 2036. The report also covers asthma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Asthma Disease Understanding
Asthma overview
Asthma is the world's most common long-term respiratory illness, characterized by inflammation of the airways, heightened bronchial sensitivity, and excessive mucus production. Exposure to triggers such as allergens, pollutants, or infections initiates a complex process involving inflammation and structural changes in the airways, leading to episodic airflow limitation. In its severe form, this airway narrowing becomes continuous and less responsive to standard therapies, contributing to frequent flare-ups, declining lung capacity, and potentially life-threatening episodes. Although asthma poses a major health burden, its biological mechanisms are still not fully understood, and widely applicable clinical biomarkers remain scarce.
Severe asthma is divided into Type 2 (T2) and non-Type 2 categories based on the dominant inflammatory pathways. T2 asthma, influenced by IgE, eosinophils, and cytokines such as IL-4 and IL-13, typically responds well to targeted biologic treatments. In contrast, non-T2 asthma often resists corticosteroid therapy and has fewer effective treatment options. Genetic factors (such as variants in ORMDL3 or TSLP) and environmental influences (including smoking, obesity, and infections) affect both susceptibility and therapeutic outcomes. Distinct forms-like aspirin-exacerbated respiratory disease and occupational asthma-have their own specific mechanisms, underscoring the disorder's diversity and complex origins.
Asthma diagnosis
Asthma is diagnosed by recognizing typical symptoms-such as wheezing, shortness of breath, and coughing-and demonstrating reversible airflow obstruction on spirometry. This usually appears as a low FEV1/FVC ratio that improves after bronchodilator administration (generally >=12% and >=200 mL increase in FEV1, per GINA). When spirometry results are normal but clinical suspicion remains high, bronchoprovocation tests like methacholine challenge can reveal airway hyperreactivity. Elevated FeNO levels (typically >40-50 ppb) further support the presence of Type 2 airway inflammation. Peak expiratory flow monitoring can show daily variability, though it cannot confirm asthma on its own. Other assessments-such as slow vital capacity, oxygen saturation, or imaging-may be useful in complicated or unusual presentations. Ultimately, asthma diagnosis is based on both clinical findings and objective measures of lung function, rather than any single test.
Asthma treatment
Asthma care follows a personalized, step-by-step strategy designed to control symptoms, prevent flare-ups, and preserve lung function. Initial treatment depends on how severe the symptoms are, with inhaled corticosteroids serving as the main therapy-often paired with formoterol for both daily control and rapid symptom relief. Therapy is adjusted up or down according to the patient's response, and short-acting B-agonists are used only when needed for quick relief.
For patients with severe or poorly controlled disease, biologic therapies tailored to specific inflammatory phenotypes (such as those targeting IgE, IL-5, IL-4Ra, or TSLP) help reduce type 2 inflammation. During acute attacks, immediate management includes inhaled bronchodilators, systemic corticosteroids, and supplemental oxygen, with magnesium sulfate and ipratropium added in more serious cases. If symptoms remain uncontrolled, non-invasive ventilation or intubation may be required. Ongoing follow-up focuses on optimizing treatment, ensuring proper inhaler technique, reducing triggers, and emphasizing coordinated, evidence-based care.
As the Asthma market is derived using a patient-based model, the asthma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented total diagnosed prevalent cases of asthma, age-specific cases of asthma, gender-specific cases of asthma, severity-specific cases of asthma and type-specific severity cases of asthma in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2022 to 2036.
Key Findings from Asthma Epidemiological Analyses and Forecast
Asthma Recent Developments
Asthma Drug Analysis
The drug chapter segment of the asthma report encloses a detailed analysis of asthma marketed drugs and mid to late-stage (Phase III and Phase II) Asthma pipeline drugs. It also helps understand the asthma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Asthma Marketed Drugs
DUPIXENT (dupilumab): Sanofi/Regeneron Pharmaceuticals
DUPIXENT, developed by Sanofi and Regeneron, is a biologic medication given subcutaneously using a prefilled syringe under clinical supervision. It is authorized as an add-on maintenance treatment for individuals aged 6 and older who have moderate-to-severe asthma characterized by an eosinophilic profile or who depend on oral corticosteroids. By inhibiting IL-4 and IL-13 signaling-central pathways in Type 2 inflammation-DUPIXENT provides a targeted and effective option for managing uncontrolled asthma.
In January 2022, the Committee for Medicinal Products for Human Use (CHMP) issued a favorable recommendation to broaden DUPIXENT (dupilumab)'s approval in the European Union. The opinion supported its use as an add-on maintenance therapy for children ages 6-11 with severe asthma driven by Type 2 inflammation-identified by elevated blood eosinophils and/or FeNO-who remain insufficiently controlled despite two maintenance treatments.
TEZSPIRE (tezepelumab): Amgen/AstraZeneca
Developed jointly by AstraZeneca and Amgen, Tezspire (tezepelumab) is a groundbreaking monoclonal antibody designed to inhibit TSLP-an epithelial cytokine that plays a central role in triggering and sustaining airway inflammation. By targeting this upstream regulator, Tezspire can influence multiple inflammatory pathways, helping manage allergic, eosinophilic, and other severe asthma types, including airway hyper-responsiveness. Its wide-reaching mechanism means it may be effective for patients regardless of biomarker profiles, making it a flexible treatment option for diverse severe asthma populations.
In February 2023, the U.S. Food and Drug Administration authorized Tezspire for at-home use through a prefilled, single-use auto-injector pen for individuals aged 12 and older with severe asthma.
FASENRA (benralizumab): AstraZeneca
FASENRA (benralizumab) is a monoclonal antibody created to bind the IL-5 receptor alpha on eosinophils, prompting natural killer cells to induce apoptosis and resulting in fast, almost complete depletion of eosinophils. It is AstraZeneca's first biologic therapy for respiratory conditions and is authorized as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan, and multiple other regions.
In April 2024, the US FDA extended its approval of FASENRA to include children aged 6-11 with severe eosinophilic asthma as an add-on maintenance therapy.
Asthma Emerging Drugs
Dexpramipexole: Areteia Therapeutics
Dexpramipexole is an orally administered small-molecule agent that powerfully reduces eosinophil levels and counters tissue sclerosis. It boosts mitochondrial performance, limits the generation of reactive oxygen species (ROS), and blocks apoptotic signaling, thereby helping cells withstand neurotoxic stress. Its protective effects arise from a blend of antioxidant, anti-apoptotic, and detoxification activities, together with increased expression of neurotrophic factors-making it a strong therapeutic prospect for inflammation-driven and neurodegenerative diseases.
Areteia Therapeutics has fully enrolled its first Phase III study, EXHALE-4, with initial results expected in Q3 2025. Two additional Phase III studies, EXHALE-2 and EXHALE-3, are still in progress, with findings projected by late 2026.
Depemokimab (GSK3511294): GlaxoSmithKline
Depemokimab, developed by GSK, is a humanized monoclonal antibody targeting IL-5 and formulated for subcutaneous administration. As the first ultra-long-acting, next-generation biologic, it is designed with improved IL-5 binding affinity and strong potency, allowing for dosing just twice per year. By inhibiting IL-5-a key cytokine responsible for eosinophil growth and survival-Depemokimab offers a promising therapeutic option for individuals with severe eosinophilic asthma.
In September 2024, GSK unveiled complete Phase III results from the SWIFT-1 and SWIFT-2 trials evaluating depemokimab in severe eosinophilic asthma at the European Respiratory Society International Congress, alongside a concurrent publication in the New England Journal of Medicine.
BREZTRI AEROSPHERE (BGF; PT-010): AstraZeneca
BREZTRI AEROSPHERE is a triple-therapy inhaler that combines budesonide (an ICS), glycopyrrolate (a LAMA), and formoterol fumarate (a LABA) using Aerosphere pMDI technology to improve delivery to the lungs. It is intended for individuals who require treatment beyond dual-agent options, providing better symptom management in obstructive airway conditions. Because LABA medications can increase certain risks when used alone in asthma, pairing them with an ICS-as done in BREZTRI-helps mitigate these concerns and offers a safer, more effective step-up therapy.
In May 2025, AstraZeneca announced that BREZTRI AEROSPHERE met all primary goals in its Phase III KALOS and LOGOS studies, confirming its effectiveness for patients whose asthma remains uncontrolled.
The company is also running additional Phase III trials to evaluate PT010's safety and efficacy in adults and adolescents with severe asthma that does not respond adequately to current standard treatments.
Asthma Drug Class Insights
Current pharmacologic strategies focus on symptom relief and exacerbation prevention, though they have limited influence on disease progression. Inhaled corticosteroids (ICS) remain the foundation of maintenance therapy and are commonly paired with long-acting beta-agonists (LABAs) in fixed-dose combinations like ENERZAIR BREEZHALER and TRIMBOW. For rapid relief, short-acting beta-agonists (SABAs) such as Albuterol are standard, and dual rescue options like AIRSUPRA (SABA + ICS) are emerging.
Other key classes include oral corticosteroids (OCS) for severe exacerbations, long-acting muscarinic antagonists (LAMAs) for add-on therapy, and biologics such as DUPIXENT (anti-IL-4Ra) for eosinophilic and allergic asthma. These biologics target IgE, IL-5, IL-5Ra, IL-4Ra, and TSLP, offering precision treatment for severe phenotypes.
Asthma is a widespread, long-lasting respiratory condition characterized by reversible airflow limitation and symptoms such as wheezing, shortness of breath, and coughing. It stems from chronic airway inflammation and structural changes, making a control-focused management strategy essential. Treatment aims to maintain long-term symptom stability, prevent flare-ups, and protect lung function through individualized, step-wise therapy and continuous patient follow-up.
Several next-generation asthma treatments are moving through late-stage clinical development, including dexpramipexole, depemokimab, and the triple-therapy inhaler BREZTRI AEROSPHERE. Dexpramipexole is expected to report top-line EXHALE-4 trial results in Q3 2025, with more studies underway. Depemokimab showed favorable Phase III outcomes in 2024, and BREZTRI AEROSPHERE achieved primary goals in two Phase III trials reported in May 2025. Collectively, these and other investigational therapies demonstrate a strong development pipeline aimed at treating a broader range of asthma phenotypes and addressing unmet needs in disease control.
Asthma Competitive Landscape
The asthma market is highly competitive and characterized by the presence of several global pharmaceutical companies offering a range of inhaled corticosteroids, long-acting bronchodilators, combination therapies, and biologics. Major players focus on expanding their portfolios through innovation in drug delivery systems, strategic alliances, mergers, and acquisitions, and lifecycle management of existing products to maintain market share. The landscape is also shaped by the launch of novel biologics targeting severe asthma phenotypes, increasing competition among established brands and emerging entrants.
Additionally, the growing availability of generics and biosimilars is putting pricing pressure on branded therapies, prompting companies to emphasize differentiation through efficacy, safety, and patient convenience. Overall, competition is driving therapeutic advancements and broader access to treatment options across major markets.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2022-2036. For example, GSK's depemokimab, a long-acting anti-IL-5 antibody, is currently under regulatory review, with potential US market entry expected in 2026, with medium-fast uptake during the forecast period.
Asthma Clinical Trial Activities
The Asthma pipeline report provides insights into different Asthma clinical trials within Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Asthma Pipeline Development Activities
The Asthma clinical trial analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for asthma.
Latest KOL Views on Asthma Market Report
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on asthma evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Johns Hopkins University School of Medicine, US University of Arizona, US, University of California San Francisco, US, Department of Pulmonology, University Hospital Munich, Germany, Hopital Cochin, Paris, University of Milan, Italy, Asthma Outcomes Research, University of Manchester, UK, and Kyoto University Respiratory Center, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or asthma market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View on Asthma Report
As per the KOLs from the US, We are seeing an alarming disconnect between asthma control and medication adherence. The SMART approach has shown considerable promise, yet patient understanding remains a key barrier. With 70-90% of inhaler users making at least one mistake, treatment efficacy is inevitably compromised. The challenge is not just the drugs-it is the delivery and the education. Unless we standardize patient training and leverage digital inhaler tracking, we will continue to see avoidable ER visits and hospitalizations.
According to KOLs from Germany, biologics like mepolizumab are reshaping the management of severe eosinophilic asthma. However, their use remains underutilized due to complex eligibility criteria and the absence of standardized biomarkers. BMZ thickness is emerging as a promising diagnostic marker that could aid in patient stratification for targeted therapies. Strengthening clinical infrastructure is crucial to effectively integrate these advances into routine practice.
According to KOLs from Japan, the country has seen success with the adoption of biologics, particularly for eosinophilic asthma. There is cautious optimism around inhaled JAK inhibitors like AZD4604, which offer targeted anti-inflammatory action in the lungs with reduced systemic exposure-an appealing option in Japan's safety-conscious healthcare system. However, real-world validation is essential before these therapies become mainstream. Without it, there is concern they may not deliver meaningful improvements in patient outcomes or quality of life.
Asthma Report Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Attribute Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Attribute analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Asthma Market Access and Reimbursement
NUCALA
AIRSUPRA
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Scope of the Asthma Market Report
Key Questions Answered in the Asthma Report:
Asthma Market Insights
Asthma Epidemiology Insights
Current Asthma Treatment Scenario, Marketed Drugs, and Emerging Therapies
Reasons to Buy Asthma Market Forecast Report