본 보고서는 만성 특발성 두드러기에 대해 상세히 분석했으며, 과거 역학 및 예측, 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본의 만성 특발성 두드러기 시장 동향을 조사하여 전해드립니다.
본 보고서는 주요 7개국 만성 특발성 두드러기 시장 규모, 현재 치료법, 신약, 개별 치료법 시장 점유율, 2020년에서 2034년까지의 주요 7개국 만성 특발성 두드러기 시장 규모 현황 및 예측을 제공합니다. 또한, 만성 특발성 두드러기 치료 시장의 관행/알고리즘과 미충족 의료 수요를 포괄하여 최적의 기회를 발굴하고 시장 잠재력을 평가합니다.
두드러기는 혈관 부종을 동반하거나 동반하지 않는 흔하고 불균일 한 염증성 피부 질환입니다. 피부 비만 세포의 활성화와 탈과립, 히스타민 및 기타 매개체의 방출로 인해 감각 신경의 활성화, 혈관 확장, 혈장 삼출, 세포 동원을 유발하여 부종, 혈관 부종 또는 둘 다의 증상을 유발합니다. 두드러기는 6주 미만 또는 6주 이상 지속되는지 여부에 따라 급성 또는 만성으로 분류됩니다.
만성 두드러기는 6주 이상 지속되고 1년 이상 지속되는 자연발생적 또는 유발성 두드러기입니다. 만성 두드러기는 삶의 질에 영향을 미치고, 정신 질환의 동반 및 높은 의료 비용과 관련이 있으며, 종종 환자에게 큰 사회경제적 고통을 초래합니다. 원인을 알 수 없는 만성 자연적 두드러기와는 달리, 만성 유발성 두드러기는 증상과 징후를 유발하는 뚜렷한 아형 특이적 유발 요인이 있습니다.
진단은 신체 진찰과 병력을 바탕으로 이루어집니다. 기저 질환을 배제하거나 유발 요인을 확인하기 위해 혈액 검사, 알레르기 검사, 피부 생검 등의 추가 검사를 시행합니다. 갑상선 기능, 항갑상선 과산화효소 항체 및 항사이로글로불린 항체 선별 검사를 권장합니다. 자가 혈청 피부 검사(ASST) 양성, 호염기구 히스타민 유리 측정법(BHRA)을 통한 항 FCeRIa 항체 또는 항IgE 자가 항체 환자 혈청의 in vitro 검사도 권장됩니다.
질병 활동성(예: 두드러기 활동성 점수), 질병 조절(예: 두드러기 조절 검사), QOL에 미치는 영향(예: 만성 두드러기 QOL 지표)을 평가하기 위한 도구도 개발되어 있습니다. 치료 방침을 결정하고 경과를 관찰하는 데 도움을 주기 위해 기준선 평가를 시행해야 합니다.
만성 특발성 두드러기의 치료는 어려운 과제이며, 치료 목표는 질병 활동성 감소, 증상의 완전한 조절, 삶의 질 향상입니다. 현재 치료 방침은 증상을 완화하고 재발을 예방하는 것을 목표로 하고 있습니다. 치료 패턴은 1차 선택 치료부터 시작하여 단계적으로 더 높은 수준의 치료로 진행하는 것이 일반적입니다.
가이드라인은 2세대 H1-항히스타민제(세티리진, 로라타딘, 펙소페나딘)를 1차 선택 약물로 사용할 것을 권장하고 있습니다. 1세대 H1-항히스타민제는 항콜린 작용과 중추신경계 부작용으로 인해 더 이상 일상적인 사용이 권장되지 않지만, 여전히 임상에서 사용되고 있습니다. 표준 용량에 반응하지 않는 만성 특발성 두드러기 환자에게는 다음 단계의 치료로 2세대 H1 항히스타민제를 4배까지 증량하는 것이 권장되며, H2 항히스타민제는 종종 H1 항히스타민제와 병용하여 만성 특발성 두드러기의 증상 조절을 개선합니다.
졸레어(오말리주맙)는 인간 IgE에 선택적으로 결합하는 재조합 DNA 유래의 인간화 IgG1κ 단클론항체입니다. 오말리주맙은 항생제 젠타마이신을 함유할 수 있는 영양 배지에서 중국 햄스터 난소(CHO) 세포 현탁 배양에 의해 생산되지만, 최종 제품에서는 젠타마이신이 검출되지 않습니다. 오말리 주맙은 IgE와 결합하여 유리 IgE 수준을 감소시킵니다. 그 후, 세포의 IgE 수용체(FcεRI)의 발현이 감소합니다. 오말리주맙의 이러한 작용이 CIU 증상을 개선하는 메커니즘은 아직 밝혀지지 않았으며, 2018년 12월 유럽위원회(EC)는 만성 특발성 두드러기 환자가 치료제를 투여할 수 있도록 XOLAIR(오말리주맙) 자가투여용 프리필드 시린지(PFS)를 승인했습니다.
2018년 9월, 미국 FDA는 만성 자연적 두드러기 치료제로서 XOLAIR 75mg/0.5mL 및 150mg/1mL 1회용 프리필드 시린지 75mg/0.5mL 및 150mg/1mL를 승인했으며, 2017년 3월, PMDA는 만성 자연적 두드러기 치료제로서 새로운 효능-효과 및 용법-용량(150mg 및 75mg SC 주사제)을 승인했습니다. 2014년 3월, 미국 FDA와 EC는 12세 이상 환자 중 H1-항히스타민제 치료에도 불구하고 증상이 지속되는 만성 특발성 두드러기 치료제로 XOLAIR(오말리주맙)를 승인했습니다.
2024년 5월, EC는 XOLAIR의 바이오시밀러인 오말리주맙 바이오시밀러 OMLYCLO(CT-P39)를 승인했습니다.
만성 특발성 두드러기 신흥 치료제
레미부루티닙(LOU064)은 B세포, 미세아교세포 등 특정 면역세포의 염증 활성에 중요한 역할을 하는 브루톤형 티로신 키나아제(BTK) 효소를 강력하고 선택적으로 억제하는 경구용 치료제입니다. 레미부루티닙은 비만세포와 호염기구의 IgE 가교에 의해 유발되는 탈과립과 자연발생적 및 유발성 만성 두드러기 환자의 혈청 내 존재하는 인자에 의해 유발되는 활성화를 억제합니다.
레미부루티닙은 현재 H1-항히스타민제로 잘 조절되지 않는 만성 특발성 두드러기 환자를 대상으로 임상 3상 시험이 진행 중입니다. 레미부루티닙은 재발성 다발성 경화증, 땅콩 알레르기 등 다른 적응증에 대한 개발도 진행 중입니다.
최근 노바티스는 만성 특발성 두드러기 환자에서 레미부루티닙의 장기적인 효과와 안전성을 입증하는 새로운 데이터를 발표했습니다. 주요 임상 3상 시험인 REMIX-1과 REMIX-2에서 레미부루티닙 치료는 2세대 H1-항히스타민제 사용에도 증상이 지속되는 만성 특발성 두드러기 환자에서 조기에 유의미한 증상 개선 효과를 보였습니다. 또한, 회사는 레미부루티닙을 2025년에 승인 신청할 예정입니다. 해당 데이터는 유럽 알레르기 임상면역학회(EAACI) 2024에서 발표됐습니다.
테즈스피어(테제페맙[AMG 157])는 알레르기성 질환, 호산구성 질환, 호흡기 염증성 질환의 발병과 지속에 중요한 역할을 하는 상피세포 사이토카인인 흉선간질림프포에틴(TSLP)의 작용을 억제하는 최초의 동종요법 항체입니다. TSLP, IL-25, IL-33은 상피에서 서로 다른 트리거에 따라 방출되어 Th2 염증 반응을 시작하고 Th2 세포에서 T 세포의 분극을 매개하여 Th2 염증 반응을 시작하며, TSLP 억제 작용을 하는 인간 단클론항체로서 아스트라제네카가 암젠과 공동으로 개발하고 있습니다. 테세페르맙은 만성 특발성 두드러기 환자의 피부 병변을 예방 및 치료하는 것으로 보입니다.
이 약은 만성 특발성 두드러기 치료제로서 임상 II상 시험(INCEPTION 시험)을 완료하고 결과를 발표한 바 있으나, 이후 업데이트가 이루어지지 않고 있습니다. 또한, TEZSPIRE는 미국, EU, 일본 및 기타 국가에서 중증 천식 치료제로 승인되었습니다. 또한 미국에서는 12세 이상의 성인 및 소아 중증 천식 환자의 추가 유지요법으로 승인됐습니다. 또한 COPD, 코 폴립을 동반한 만성 비부비동염, 호산구성 식도염 등 다른 적응증에 대한 가능성도 검토되고 있습니다.
만성 특발성 두드러기는 피부에 두드러기나 부종이 반복적으로 나타나는 것이 특징인 만성질환입니다. 만성 특발성 두드러기는 6주 이상 증상이 지속되는 피부 알레르기 질환입니다. 진단은 신체검사와 병력을 바탕으로 이루어집니다. 기저질환을 배제하거나 유발 원인을 확인하기 위해 혈액검사, 알레르기 검사, 피부 생검 등의 추가 검사를 시행합니다. 만성 특발성 두드러기의 치료는 어렵고, 치료 목표는 질병 활동성 감소, 증상의 완전한 조절, 삶의 질 개선입니다. 현재 치료 방침은 증상을 완화하고 재발을 예방하는 것을 목표로 하고 있습니다. 치료 패턴은 일반적으로 단계적 접근을 포함하며, 1차 선택 치료부터 시작하여 필요에 따라 더 높은 수준의 선택으로 나아가는 것이 일반적입니다.
치료는 일반적으로 낮에는 비진정성 항히스타민제, 밤에는 진정성 항히스타민제로 시작하며, H2 항히스타민제는 만성 특발성 두드러기에서 더 나은 증상 조절을 위해 H1 항히스타민제와 병용하는 경우가 많으며, 소화불량이나 신맛을 호소하는 경우 H2 항히스타민제를 추가하기도 합니다. 추가하기도 합니다. 만성 특발성 두드러기에 가장 많이 사용되는 H2 항히스타민제는 라니티딘입니다. 그러나 라니티딘은 안전성 문제로 인해 많은 시장에서 철수하고 있다는 점에 유의해야 합니다.
그러나 많은 환자에서 증상이 조절되지 않고, 표준 용량의 H1-항히스타민제가 효과를 보이는 환자는 절반 이하입니다. 졸음과 같은 부작용은 감수성이 높은 사람에게 발생할 수 있으며, 용량을 증가시켰음에도 불구하고 치료 부담이 증가합니다.
Novartis와 Genentech의 XOLAIR는 H1-항히스타민제 치료에도 불구하고 증상이 지속되는 12세 이상의 만성 특발성 두드러기 환자를 위해 승인된 생물학적 제제입니다. 오말리주맙은 만성 특발성 두드러기 환자에서 부종과 혈관 부종의 발생을 예방하고, 삶의 질을 개선하며, 장기 치료에 적합하고, 치료 중단 후 재발을 효과적으로 치료합니다. 오말리주맙은 미국, 유럽, 일본에서 H1-항히스타민제 치료에도 불구하고 증상이 지속되는 만성 특발성 두드러기 치료제로 승인되었습니다.
그러나 오말리주맙을 투여해도 증상이 호전되지 않는 환자가 3분의 1에 육박하고 있어, SC 투여는 의료 인프라와 환자의 부담을 가중시킬 수 있습니다.
현재 만성 특발성 두드러기 치료제 시장은 주요 7개국의 일반적인 치료 패턴에 따라 일반적으로 사용되는 다양한 치료제로 세분화되어 있으며, 전체 처방 패턴에 약간의 차이가 있는 것으로 나타났습니다. 경구용 코르티코스테로이드, 처방 항히스타민제, 류코트리엔 수용체 길항제, 면역억제제, XOLAIR, 기타 등이 예측 모델에서 다루는 주요 약물입니다.
본 보고서는 주요 7개국 만성 특발성 두드러기 시장에 대해 조사했으며, 시장 개요, 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 미충족 의료 수요 등을 정리하여 전해드립니다.
DelveInsight's "Chronic Spontaneous Urticaria Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Chronic Spontaneous Urticaria, historical and forecasted epidemiology, as well as the Chronic Spontaneous Urticaria market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Chronic Spontaneous Urticaria Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM chronic spontaneous urticaria market size from 2020 to 2034. The report also covers Chronic Spontaneous Urticaria Treatment Market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Chronic Spontaneous Urticaria Treatment Market: Understanding and Algorithm
Urticaria is a common and heterogeneous inflammatory skin disorder with or without associated angioedema. It presents with wheals, angioedema, or both due to activation and degranulation of skin mast cells, followed by the release of histamine and other mediators leading to sensory nerve activation, vasodilatation, plasma extravasation, and cellular recruitment. It is classified as acute or chronic, depending on whether the onset of episodes lasts for less or >6 weeks, respectively.
Chronic urticaria is spontaneous or inducible, lasts >6 weeks, and persists for >1 year. It impacts the quality of life and is linked to psychiatric comorbidities and high healthcare costs, often causing huge socio-economic distress for the patients. In contrast to chronic spontaneous urticaria, where the cause is unknown, chronic inducible urticaria has definite and subtype-specific triggers that induce signs and symptoms.
Chronic Spontaneous Urticaria Diagnosis
The diagnosis is based on a physical examination and medical history. Additional tests are performed to rule out underlying causes or to identify triggers, such as blood tests, allergy tests, or skin biopsies. Screening tests for thyroid function and antithyroid peroxidase and antithyroglobulin antibodies are recommended. Positive autologous serum skin test (ASST) and in vitro testing of the patient's serum for the anti-FCeRIa or the anti-IgE autoantibodies by basophil histamine release assay (BHRA) is also recommended.
Some tools have been developed to assess disease activity (e.g., urticaria activity score), disease control (e.g., urticaria control test), and impacts on quality of life (e.g., chronic urticaria quality of life index). Baseline assessments should be performed to help guide treatment decisions and monitor progress.
Chronic Spontaneous Urticaria Treatment
Treating chronic spontaneous urticaria is challenging, and the therapeutic goal is a reduction in disease activity, complete symptom control, and improvement in QoL. The current treatment regime aims to alleviate symptoms and prevent their recurrence. The treatment pattern typically involves a stepwise approach, starting with first-line treatments and progressing to more advanced options.
The guidelines recommend using second-generation H1-antihistamines (cetirizine, loratadine, fexofenadine) as the first-line pharmacological treatment. Due to anticholinergic properties and the adverse effect profile on the central nervous system, the routine use of first-generation H1-antihistamines is no longer recommended, though they are still used in clinical practice. The up-dosing of second-generation H1-antihistamine up to fourfold in patients with chronic spontaneous urticaria unresponsive to a standard dose is further recommended as the next step in treatment. H2 antihistamines are often combined with H1 to achieve better symptom control in chronic spontaneous urticaria.
As the market is derived using a patient-based model, the Chronic Spontaneous Urticaria epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented total diagnosed prevalent cases of chronic urticaria, type-specific cases of chronic urticaria, total diagnosed prevalent cases of chronic spontaneous urticaria, age-specific cases of chronic spontaneous urticaria, gender-specific cases of chronic spontaneous urticaria, and severity-specific cases of chronic spontaneous urticaria in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the Chronic Spontaneous Urticaria therapeutics market report encloses a detailed analysis of Chronic Spontaneous Urticaria-marketed drugs and mid to late-stage (Phase III and Phase II) Chronic Spontaneous Urticaria pipeline drugs analysis. It also helps understand the Chronic Spontaneous Urticaria clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest Chronic Spontaneous Urticaria news and press releases.
Chronic Spontaneous Urticaria Marketed Drugs
XOLAIR (omalizumab) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human IgE. It is produced by a Chinese hamster ovary (CHO) cell suspension culture in a nutrient medium that may contain the antibiotic gentamicin; gentamicin is not detectable in the final product. Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. Also, the mechanism by which these effects of omalizumab result in an improvement of CIU symptoms is unknown. In December 2018, the European Commission (EC) approved XOLAIR (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with chronic spontaneous urticaria to administer their treatment.
In September 2018, the US FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for XOLAIR as an additional formulation for chronic spontaneous urticaria. In March 2017, the PMDA approved XOLAIR with a new additional indication and a new dosage (SC injection 150 mg and 75 mg) for treating chronic spontaneous urticaria. In March 2014, the US FDA and the EC approved XOLAIR (omalizumab) for treating chronic spontaneous urticaria for patients 12 years of age and older who remain symptomatic despite H1-antihistamine therapy.
In May 2024, the EC approved OMLYCLO (CT-P39), an omalizumab biosimilar referencing XOLAIR.
Chronic Spontaneous Urticaria Emerging Drugs
Remibrutinib (LOU064) is an oral treatment that potently and selectively inhibits Bruton's tyrosine kinase (BTK) enzyme, which plays a critical role in the inflammatory activity of certain immune cells such as B cells and microglia. Remibrutinib inhibits degranulation induced by IgE cross-linking in mast cells and basophils and the activation triggered by factors present in the sera of spontaneous and inducible chronic urticaria patients.
Remibrutinib is currently being tested in Phase III clinical studies for chronic spontaneous urticaria in patients inadequately controlled by H1-antihistamines. The drug is also being developed for other indications, including relapsing multiple sclerosis and peanut allergy.
Recently, Novartis announced new data that confirm the long-term efficacy and safety of remibrutinib in chronic spontaneous urticaria. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early in patients with chronic spontaneous urticaria who remained symptomatic despite second-generation H1-antihistamine use. Moreover, the company plans to plans to submit remibrutinib for regulatory approval in 2025. Data presented at European Academy of Allergy and Clinical Immunology (EAACI) 2024.
TEZSPIRE (tezepelumab [AMG 157]) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and airway inflammation diseases. TSLP, IL-25, and IL-33 are released following different triggers on epithelia and start the Th2 inflammatory response, mediating T-cell polarization in Th2 cells. Tezepelumab with its inhibitory action of TSLP appears to prevent and treat the lesional skin of patients with chronic spontaneous urticaria.
The drug has completed a Phase II (INCEPTION) trial and posted results for the treatment of chronic spontaneous urticarial with no further updates. Moreover, TEZSPIRE is approved for treating severe asthma in the US, EU, Japan, and other countries. TEZSPIRE is also approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 and older with severe asthma. Moreover the drug candidate is being investigated for other potential indications, including COPD, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.
Chronic Spontaneous Urticaria Drugs Market Insights
Chronic spontaneous urticaria is a chronic condition characterized by the recurrent appearance of hives or wheals on the skin. It is a disturbing allergic condition of the skin, where symptoms persist for more than 6 weeks. The diagnosis is based on a physical examination and medical history. Additional tests are performed to rule out underlying causes or to identify triggers, such as blood tests, allergy tests, or skin biopsies. Treating chronic spontaneous urticaria is challenging, and the therapeutic goal is a reduction in disease activity, complete symptom control, and improvement in QoL. The current treatment regime aims to alleviate symptoms and prevent their recurrence. The treatment pattern typically involves a stepwise approach, starting with first-line treatments and progressing to more advanced options if necessary.
Treatment is generally initiated with nonsedating antihistamines in the daytime and sedating antihistamines at night. H2 antihistamines are often combined with H1 to achieve better symptom control in chronic spontaneous urticaria and are added if individuals complain of indigestion or acidity. The most commonly used H2 antihistamine for chronic spontaneous urticaria is ranitidine. However, it is important to note that ranitidine has been withdrawn from many markets due to safety concerns.
Many patients, however, do not achieve symptom control, with only less than half of patients responding to H1-antihistamines at standard doses. Adverse effects such as somnolence can occur in susceptible individuals, increasing the treatment burden, despite increasing the dose.
Novartis and Genentech's XOLAIR is an approved biologic for chronic spontaneous urticaria patients age 12 years and older who remain symptomatic despite H1-antihistamine treatment. In chronic spontaneous urticaria, omalizumab prevents wheal and angioedema development, improves the quality of life, is suitable for long-term treatment, and effectively treats relapse after discontinuation. The drug is approved in the US, Europe, and Japan for treating chronic spontaneous urticaria who remain symptomatic despite H1-antihistamine treatment.
However, almost one-third of patients remain symptomatic despite omalizumab, and the SC administration route further burdens the healthcare infrastructure and patients.
The current Chronic Spontaneous Urticaria Drugs Market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. Oral corticosteroids, prescription antihistamines, leukotriene receptor antagonists, immunosuppressive agents, XOLAIR, and others are the major drugs covered in the forecast model.
This section focuses on the uptake rate of potential Chronic Spontaneous Urticaria drugs expected to be launched in the market during 2020-2034. For example, Novartis Pharmaceuticals' remibrutinib (LOU064), a BTK inhibitor, is expected to enter the US market by 2025 and is projected to have a slow uptake during the forecast period.
Chronic Spontaneous Urticaria Pipeline Development Activities
The Chronic Spontaneous Urticaria therapeutics market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key Chronic Spontaneous Urticaria Companies involved in developing targeted therapeutics.
Pipeline Development Activities
The Chronic Spontaneous Urticaria therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Chronic Spontaneous Urticaria.
KOL Views
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 chronic spontaneous urticaria evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, 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 University of Texas Health Science Center, Johns Hopkins University, Harvard Medical School, King's College in London, Fondation Fondamental in Creteil, and the University of Shizuoka were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or chronic spontaneous urticaria 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
According to our primary research analysis, though the current treatment guideline recommends the use of second-generation H1-antihistamines (cetirizine, loratadine, fexofenadine) as the first-line pharmacological treatment, followed by up-dosing in patients with chronic spontaneous urticaria unresponsive to a standard dose and omalizumab as a second-line adjunct therapy for chronic spontaneous urticaria unresponsive to second-generation H1-antihistamines, patients are not always treated according to formal guideline recommendations. Usage of sedating first-generation H1-antihistamines, IV immunoglobulin, and long-term oral corticosteroids as primary treatments are common, and the high cost of the only approved biologic, XOLAIR, further dampens its use, despite all the benefits. Further, almost one-third of patients remain symptomatic despite using omalizumab, and the SC administration route further burdens the healthcare infrastructure and patients. H2-antagonists and dapsone though not recommended, still have relevance as they are affordable in some restricted healthcare systems.
The current Chronic Spontaneous Urticaria Pipeline, though, mostly has adjuncts to treat refractory cases, they are still novel molecules like BTK inhibitors, interleukins inhibitors, and siglec-8-directed agonists, targeting novel pathways in chronic spontaneous urticaria that have shown significant improvements in UAS7 scores with improved safety profiles in early-stage trials. There is hope that the entry of these biologics and drugs will provide options based on patient-specific needs. Further, the competition will end the monopoly and hopefully improve the accessibility of biologics, which ensures more patient compliance than OTC therapies. However, there is still a need for personalized curative monotherapies that cure the disease rather than relieve the symptoms.
Chronic Spontaneous Urticaria Drugs Market: Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint 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.
Conjoint 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.
Chronic Spontaneous Urticaria Therapeutics Market Access and Reimbursement
The guidelines recommend second-generation H1-antihistamine as a first-line treatment for all types of urticaria. X of second-generation H1- antihistamine up to fourfold in patients with CU unresponsive to a standard dose is recommended as a second-line treatment before other treatments are considered. The guidelines further recommend the only approved monoclonal antibody, omalizumab, for treating patients with CU unresponsive to high-dose antihistamines. Cyclosporine is used off-label and is recommended only for patients with severe disease, refractory to any dose of antihistamine and omalizumab in combination.
XOLAIR Copay Program is specific for patients who have commercial health insurance. Patients under Medicare, Medicaid, or any federal or state-level program are not eligible. The patient is enrolled in the copay program, which means that after reaching the maximum program benefit, the patient would bear all out-of-pocket costs. The patient must pay USD 5/XOLAIR out-of-pocket expenses, and the company will cover the remaining USD 10,000/12-month period. There is no income limit to avail of this program.
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.
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.
Chronic Spontaneous Urticaria Therapeutics Market Report Scope
Chronic Spontaneous Urticaria Treatment Market Insights
Chronic Spontaneous Urticaria Epidemiology Insights
Current Chronic Spontaneous Urticaria Treatment Market Scenario, Marketed Drugs, and Emerging Therapies