PUBLISHER: DelveInsight | PRODUCT CODE: 1083574
PUBLISHER: DelveInsight | PRODUCT CODE: 1083574
DelveInsight's, 'Severe Asthma - Market Insights, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of the Severe Asthma, historical and forecasted epidemiology as well as the Severe Asthma market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The Severe Asthma market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current and forecasted 7MM Severe Asthma market size from 2019 to 2032. The Report also covers current Severe Asthma treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2019-2032
Asthma is the most common chronic respiratory illness worldwide. It affects the airways in the lungs, which become inflamed and narrowed due to various triggers, making it harder for air to flow out. It is a complex activity between airway inflammation and airway remodeling that results in airway hyper-responsiveness (AHR), leading to variable and excessive airway narrowing.
It is a heterogeneous disease characterized by reversible bronchial obstruction with recurrent wheezing and airflow obstruction as its hallmark. Other features associated with asthma, such as epithelial sloughing, mucous hypersecretion, bronchial hyper-responsiveness, and mucosal edema, are variable and usually depend on the age of onset, associated comorbidities, laboratory abnormalities, and reversibility of airflow obstruction.
The characteristic symptoms of asthma include wheezing, shortness of breath, cough, a sensation of tightness in the chest, straining of neck and chest muscles, rapid breathing, and changes in heart rate. These symptoms typically worsen at night and after exposure to triggers, such as environmental allergens, upper respiratory tract infections, tobacco, cold air, and exercise.
NAEPP/EPR guidelines broadly classify asthma into intermittent or persistent. Persistent asthma is further sub-divided based on severity into mild, moderate, and severe.
NIH Guidelines for diagnosis and treatment of asthma characterize severe persistent asthma by symptoms that tend to be continual, cause limitations in physical activity, and are generally associated with frequent and severe exacerbations. Most individuals with severe asthma have frequent nighttime symptoms and persistent airflow obstruction with a forced expiratory volume (FEV1) of less than 60% predicted before treatment. Based on the response to treatment, severe asthma is further classified into type-2 inflammation and non-type-2 inflammation. Type-2 inflammation includes allergic asthma and eosinophilic asthma (or e-asthma) while non-type-2 inflammation includes non-eosinophilic asthma.
Most people with asthma can manage their symptoms well with the usual medicines like a preventer inhaler and a reliever inhaler, but severe asthma is difficult to control the disease.
Severe asthma may be defined not only by difficult-to-control airway disease symptoms but also by the severity of abnormalities and measurements of pulmonary function. Careful physiologic characterizations of patients with well-defined severe asthma are lacking, making diagnosis difficult. In most cases, diagnosis depends on the symptoms and the response to treatment already being administered.
However, to establish a diagnosis of asthma, the clinician determines whether episodic symptoms of airflow obstruction or airway hyperresponsiveness are present and whether airflow obstruction is at least partially reversible, measured by spirometry. Reversibility is determined by an increase in FEV1 of >200 mL and 12% from baseline measure after inhalation of short-acting b2-agonist (SABA) (Lommatzsch & Virchow, 2014).
Most asthma control medications focus on reducing airway inflammation and preventing the associated symptoms. The mainstay treatment for persistent asthma consists of inhaled corticosteroids. Quick-relief (reliever) or rescue medicines quickly ease symptoms that arise acutely Short-acting beta-agonists (SABAs) rapidly reduce airway bronchoconstriction and are recommended rescue medication for rapid symptom relief. Additional long-term controller medicines, such as long-acting beta 2 agonists (LABA), montelukast, or theophylline, are added if asthma is still uncontrolled. Oral corticosteroids can be added to treatment if patients are still experiencing symptoms and flare-ups. There are currently six approved monoclonal antibodies for add-on biological treatment of severe asthma. They include omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab for the treatment of severe asthma. At present, there is no approved therapy for severe non-eosinophilic asthma which is non-responsive to corticosteroid treatment also.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of asthma, severity-specific diagnosed prevalent cases of asthma, and type-specific diagnosed prevalent cases of severe asthma, the scenario of Severe Asthma in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.
The epidemiology segment also provides the Severe Asthma epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The drug chapter segment of the Severe Asthma report encloses the detailed analysis of Severe Asthma marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Severe Asthma clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.
Cinqair injection is a humanized interleukin-5 antagonist monoclonal antibody for add-on maintenance treatment of adult patients with severe asthma and with an eosinophilic phenotype, developed by Teva Pharmaceuticals. Cinqair is for intravenous infusion only. It is not to be administered as an intravenous push or bolus. The recommended dosage regimen is 3 mg/kg once every 4 weeks administered by intravenous infusion over 20-50 min.
Fasenra (benralizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection. Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with a dissociation constant of 11 pM, developed by AstraZeneca. The IL-5 receptor is expressed on the surface of eosinophils and basophils. Benralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
GSK3511294 (depemokimab), which GlaxoSmithKline is developing to treat severe eosinophilic asthma, is a humanized anti-interleukin (IL)-5 monoclonal antibody. As a new biological entity, it is engineered to ensure high affinity and long-acting suppression of IL-5 functions. IL-5 are cytokines responsible for the proliferation, activation, and survival of eosinophils, thus making them a proven treatment target for severe asthma patients with higher levels of eosinophils.Depemokimab with an extended half-life and improved IL-5 affinity compared to other approved therapies is the first biologic to be administered subcutaneously once every 26 weeks. Currently, GlaxoSmithKline is conducting multiple Phase III trials to assess the safety and efficacy of depemokimab for the treatment of severe eosinophilic asthma.
PT027, which AstraZeneca is developing in partnership with Avillion, is a fixed-dose combination of albuterol and budesonide. Albuterol, also known as salbutamol, is a short-acting beta2-agonist (SABA), while budesonide is an inhaled corticosteroid (ICS). It is a SABA/ICS fixed-dose rescue therapy for moderate to severe asthma being developed as a pressurized metered-dose inhaler (pMDI) using AstraZeneca's Aerosphere delivery technology. AstraZeneca has completed Phase III trials for PT027 and based on these results, the company plans to file for regulatory submission in the US in 2022
The treatment aims to reduce the symptom burden (i.e., good symptom control while maintaining normal activity levels) and minimize the risk of adverse events such as exacerbations, fixed airflow limitation, and treatment side effects. Guideline-based management of asthma focuses on disease severity and choosing the appropriate medical therapy to control symptoms and reduce the risk of exacerbations.
In patients with mild persistent disease, low-dose Inhaled corticosteroids (ICS) decreases the risk of severe exacerbations leading to hospitalization and improving asthma control. When low-dose ICS is ineffective in controlling the disease, a combination of low-dose ICS with long-acting beta-agonist (LABA) maintenance is the recommended first-choice treatment, plus as-needed short-acting beta-agonists (SABA). Alternatively, the combination of low-dose ICS/LABA (formoterol) is to be used as single maintenance and reliever treatment.
Severe asthmatics require higher doses of inhalers and often require medications (anticholinergics) that relax the muscles around the airways, making it easier to breathe. Long-term usage of combination inhaled controller medications may not be sufficient for treating severe asthmatics, and long-term use of oral steroids carries the risk of increased side effects.
Several new therapeutic options for severe asthma are currently being emerged. The key players include GlaxoSmithKline, AstraZeneca, Bond Avillion, Novartis, 4D pharma, Roche, Pieris Pharma, AstraZeneca, Biosion, and others.
This section provides the total Severe Asthma market size and market size by therapies in the United States.
The total Severe Asthma market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The total Severe Asthma market size and market size by therapies in Japan are provided.
This section focuses on the rate of uptake of the potential drugs recently launched in the Severe Asthma market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Severe Asthma market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, and the reasons behind the maximal use of new drugs and allow, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The report provides insights into different therapeutic candidates in phase II, and phase III stages and also analyzes key players involved in developing targeted therapeutics.
The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for Severe Asthma emerging therapies.
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
We perform competitively and market Intelligence analysis of the Severe Asthma market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.