慢性特発性蕁麻疹 (CSU) 治療薬 - 市場考察、疫学、市場予測：2030年
Chronic Spontaneous Urticaria - Market Insights, Epidemiology, and Market Forecast - 2030
|慢性特発性蕁麻疹 (CSU) 治療薬 - 市場考察、疫学、市場予測：2030年|
発行: DelveInsight Business Research LLP
ページ情報: 英文 188 Pages
当レポートでは、慢性特発性蕁麻疹 (CSU) 治療薬について調査分析し、過去・将来の疫学、米国・欧州5ヶ国 (ドイツ、スペイン、イタリア、フランス、英国) ・日本の市場動向に焦点を当てて、現在の治療法、新薬、市場規模などについて、体系的な情報を提供しています。
DelveInsight's 'Chronic spontaneous urticaria (CSU) - Market Insights, Epidemiology, and Market Forecast-2030' report delivers an in-depth understanding of the Chronic spontaneous urticaria (CSU), historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The Chronic spontaneous urticaria (CSU) market report provides current treatment practices, emerging drugs and their market share of the individual therapies, current and forecasted Chronic spontaneous urticaria (CSU) symptoms market size from 2017 to 2030 segmented by seven major markets. The report also covers current Chronic spontaneous urticaria (CSU) symptoms treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2017-2030
Chronic spontaneous urticaria (CSU) Overview
Chronic urticaria is a debilitating disease that is characterized by itching and hives with or without angioedema, lasting for more than 6 weeks. Chronic urticaria might be triggered due to stimuli such as stroking or scratching the skin, exercise, emotional upset (cholinergic urticaria), cold, heat, pressure, sunlight (solar urticaria), contact with water or various chemicals (contact urticaria), or vibration. Urticaria induced, thus, is known as chronic induced urticaria (CIndU). However, more commonly chronic urticaria is endogenous and independent of any external causes. This urticaria is known as chronic spontaneous urticaria (CSU).
However, there are still few unmet needs in the understanding of disease etiology in cases where autoimmunity is ruled out. Quality of life is severely impacted in CSU patients due to unpredictability of attacks, fatigue caused by treatment side effects, and cosmetic disfigurement. Patients with CSU often exhibit psychiatric comorbidities. CSU also has a large direct and indirect economic impact due to increased healthcare cost because of continued medication to control symptoms, and frequent, often unanticipated healthcare visits.
Chronic spontaneous urticaria (CSU) Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the Chronic spontaneous urticaria (CSU) market for the treatment of the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The DelveInsight Chronic spontaneous urticaria (CSU) market report gives a thorough understanding of Chronic spontaneous urticaria (CSU) symptoms by including details such as disease definition, symptoms, causes, physiology, and diagnosis. It also provides Chronic spontaneous urticaria (CSU) symptoms of treatment algorithms and treatment guidelines for Chronic spontaneous urticaria (CSU) symptoms in the US, Europe, and Japan.
A potential diagnostic pitfall is the failure to consider a diagnosis of urticarial vasculitis in patients with lesions lasting longer than 24 h, in patients with lesions associated with pain more than with itching, and in patients with lesions resolving with pigmentary changes or scaling.
While in most cases, no diagnostic testing may be necessary, targeted laboratory testing based on clinical suspicion is appropriate. In most patients, the only screening tests that are recommended to be performed are a complete blood cell (CBC) count with differential, erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP), liver enzymes, and thyrotropin (TSH).
The FDA has approved XOLAIR by Roche/Novartis for Chronic spontaneous urticaria (CSU) .
The Chronic spontaneous urticaria (CSU) symptoms epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
The diagnosed prevalent cases of Chronic spontaneous urticaria (CSU) is increasing in 7MM during the study period, i.e., 2017-2030.
The disease epidemiology covered in the report provides historical as well as forecasted Chronic spontaneous urticaria (CSU) symptoms epidemiology segmented as the Total Prevalent cases of Chronic spontaneous urticaria (CSU), Gender-Specific cases of Chronic spontaneous urticaria (CSU), Age-Specific cases of Chronic spontaneous urticaria (CSU). The report includes the prevalent scenario of Chronic spontaneous urticaria (CSU) symptoms in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
The epidemiology segment also provides the Chronic spontaneous urticaria (CSU) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The total prevalent cases of Chronic spontaneous urticaria (CSU) associated in 7MM countries was 1,169,632 in 2017.
The drug chapter segment of the Chronic spontaneous urticaria (CSU) report encloses the detailed analysis of Chronic spontaneous urticaria (CSU) marketed drugs and early stage (Phase-I, II, III) pipeline drugs. It also helps to understand the Chronic spontaneous urticaria (CSU) 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.
Chronic spontaneous urticaria (CSU) Emerging Drug
Dupilumab (DUPIXENT) is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the 'Type I' receptor and both IL-4 and IL-13 signaling through the 'Type II' receptor. Multiple cell types that express IL-4Rα (e.g., mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation. Blocking IL4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE.
Ligelizumab: Novartis Pharmaceuticals
Ligelizumab (QGE031) is a new high-affinity humanized monoclonal anti-IgE antibody that has previously shown dose-dependent and time-dependent suppression of free IgE, basophil FcεRI, basophil surface IgE, and skin-prick test responses to an allergen that was superior in extent and duration to that observed with omalizumab and aims to become first-choice biologic after antihistamine therapy.
Products detail in the report…
The Chronic spontaneous urticaria (CSU) market outlook of the report helps to build the detailed comprehension of the historic, current and forecasted Chronic spontaneous urticaria (CSU) market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.
This segment gives a thorough detail of Chronic spontaneous urticaria (CSU) market trend of each marketed drug and early-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, Chronic spontaneous urticaria (CSU) market in 7MM is expected to grow in the study period 2017-2030.
In the United States, Joint Task Force on Practice Parameters (JTFPP) had released treatment guidelines for CSU in 2014 that recommended a stepwise management plan to help alleviate the symptoms of CSU. The first line of treatment includes monotherapy with a second-generation H1-antihistamine. If symptoms persist, a practitioner has one of several options for the 2nd line of treatment. The recommended steps include a four-fold increase in second-generation H1-antihistamine dose, the addition of an alternative second-generation H1- antihistamine, the addition of an H2-antihistamine, addition of a leukotriene receptor antagonist (LTRA), or addition of a first-generation H1-antihistamine. If the symptoms don't alleviate, the practitioner can prescribe a dose advancement of a potent antihistamine (i.e., doxepin or hydroxyzine). For those with recalcitrant disease, the organization recommends the use of Omalizumab, cyclosporine, or an alternative immunosuppressant.
Several drugs are currently in use for the treatment of chronic urticaria with evidence ranging from randomized, double-blind placebo-controlled clinical investigations to anecdotal case reports. It, therefore, becomes imperative to understand the mechanism of action of these drugs for any upcoming player in the industry.
This section includes a glimpse of the Chronic spontaneous urticaria (CSU) market in 7MM. The market size of Chronic spontaneous urticaria (CSU) in the seven major markets was found to be USD 1,073.3 million in 2017.
This section provides the total Chronic spontaneous urticaria (CSU) market size and market size by therapies in the United States.
The United States accounts for the largest market size of Chronic spontaneous urticaria (CSU) in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
The total Chronic spontaneous urticaria (CSU) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The total Chronic spontaneous urticaria (CSU) market Size and market Size by therapies in Japan are also mentioned.
This section focusses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017-2030. The analysis covers Chronic spontaneous urticaria (CSU) market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.
Chronic spontaneous urticaria (CSU) Pipeline Development Activities
The report provides insights into the therapeutic candidate in Phase I, II and III stage. It also analyses Chronic spontaneous urticaria (CSU) key players involved in developing targeted therapeutics.
Major players include Sanofi/Regenron, Novartis, AstraZeneca, and others.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing and patent details for Chronic spontaneous urticaria (CSU) emerging therapies.
Reimbursement Scenario in Chronic spontaneous urticaria (CSU)
Approaching reimbursement proactively can have a positive impact both during the early stages of product development and well after product launch. In the report, we take reimbursement into consideration 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.
Xolair (Omalizumab) is approved for the treatment of antihistamine-resistant chronic spontaneous urticaria (CSU) in over 80 countries around the world. It is licensed by the European Medicines Agency of the European Union and the Food and Drug Administration of the USA. However, if the healthcare systems do not provide reimbursement in the countries where it is licensed, its accessibility for treatment is precluded by its relatively high cost. An argument of the health authorities to keep it off reimbursement lists is that CU is not a fatal disease and the regulators in countries with limited financial resources do not attach to omalizumab enough weight to override the reimbursement threshold. However, the presence of angioedema imparts to CU a higher level of importance, as the general public perceives the condition as life-threatening. Although omalizumab provides an effective treatment for CU patients with angioedema, it is all too often not available to them because of the failure of health authorities to reimburse it.
Moreover, 93% of Xolair syringe cost is covered by Medicare part D and Medicare Advantage plan. The same program covers 100% of the cost of Xolair vial. It also covers costs under Part B (Medical Insurance), which helps cover the costs of outpatient care and services. If Xolair is administered during hospital admittance or while being cared for in a skilled nursing facility, Medicare Part A would be billed first, and patients who have a Medicare Advantage plan would also receive the same Part A and Part B coverage. Still, these MA enrollees may also have additional coverage
To keep up with current market trends, we take KOLs and SME's opinion working in Chronic spontaneous urticaria (CSU) domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Chronic spontaneous urticaria (CSU) market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the Chronic spontaneous urticaria (CSU) Market by using various Competitive Intelligence tools that includes - 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.
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
The EAACI/GA²LEN/EDF/WAO guideline