市場調査レポート
商品コード
1544154
シェーグレン症候群市場 - 市場の洞察、疫学、市場予測:2034年Sjogren's Syndrome - Market Insight, Epidemiology And Market Forecast - 2034 |
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シェーグレン症候群市場 - 市場の洞察、疫学、市場予測:2034年 |
出版日: 2024年08月01日
発行: DelveInsight
ページ情報: 英文 202 Pages
納期: 1~3営業日
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2023年、シェーグレン症候群の総市場規模は約19億米ドルであり、調査期間中(2020年~2034年)に主要7ヶ国で2034年までに増加すると予測されています。主要7ヶ国中、2023年の市場規模は米国が最も大きく、日本は最も小さいものでした。EU4ヶ国および英国の中で、シェーグレン症候群の市場規模が最も大きいのは英国であり、2023年の市場規模が最も小さいのはスペインと推定されています。ドイツは主要7ヶ国の中で市場規模全体の約9%を占めています。
シェーグレン症候群は、唾液腺および涙腺を中心とした腺機能障害をもたらす外分泌腺へのリンパ球浸潤別引き起こされる自己免疫疾患です。
シェーグレン症候群の診断は、病歴、身体診察、特異的な眼、口腔評価、血液検査、唾液腺評価(生検および超音波検査)に基づいて行われます。2023年、シェーグレン症候群の診断された有病者数は主要7ヶ国で約3,000,000例であり、2034年までに増加する可能性が高いとみられています。
現在のところ、シェーグレン症候群を治癒させる方法はありません。治療は、人工涙液や唾液、砂糖の入っていないキャンディ、ピロカルピンやセビメリンなどの分泌促進薬を用いて症状を和らげることに重点を置いています。疼痛や疲労などの一般症状には、ヒドロキシクロロキンがよく用いられます。特異的な膠細胞外病変に対しては、免疫抑制薬が必要となります。
主要7ヶ国におけるシェーグレン症候群の総市場規模では、米国が最も大きく、2023年の市場全体の約62%を占めています。 新たな治療薬の中でも、CFZ533(iscalimab)とVIB4920(dazodalibep)は、主要7ヶ国のシェーグレン症候群の市場規模に大きな影響を与えるとみられています。
当レポートでは、主要7ヶ国におけるシェーグレン症候群市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。
Report Summary
Market
Various key players are leading the treatment landscape of Sjogren's syndrome, such as Novartis, Amgen, Resolve Therapeutics, Bristol Myers Squibb, and others. The details of the country-wise and therapy-wise market size have been provided below.
The section dedicated to drugs in the Sjogren's syndrome report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to Sjogren's syndrome.
The drug chapters section provides valuable information on various aspects related to clinical trials of Sjogren's syndrome, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Sjogren's syndrome.
Marketed Therapies
SALAGEN (pilocarpine): ADVANZ Pharma
SALAGEN (pilocarpine) tablets are made from the naturally occurring alkaloid pilocarpine obtained from the leaflets of the South American shrub Pilocarpus jaborandi. Pilocarpine HCl is a cholinomimetic (cholinergic parasympathomimetic) agent capable of exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. SALAGEN indications include the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck and the treatment of symptoms of dry mouth in patients with Sjogren's syndrome.
EVOXAC (cevimeline): Daiichi Sankyo
EVOXAC (cevimeline) is a cholinergic agonist which binds to muscarinic receptors. Muscarinic agonists in enough dosage can increase the secretion of exocrine glands, such as salivary and sweat glands, and increase the tone of the smooth muscle in the gastrointestinal and urinary tracts. EVOXAC was developed by Daiichi Sankyo and is approved in the US, Europe, and Japan to treat patients with symptoms of dry mouth in patients with Sjogren's syndrome. In January 2022, Daiichi Sankyo entered into an agreement with Cosette Pharmaceuticals; Daiichi Sankyo divested, and Cosette acquired rights for manufacturing, commercialization, and certain other rights for EVOXAC (cevimeline HCL) in the US.
Emerging Therapies
CFZ 533 (iscalimab): Novartis
CFZ 533 (iscalimab) is a novel, fully human IGg1 anti-CD40 monoclonal antibody, preventing cluster of differentiation (CD40) pathway signaling and activation of CD40+ cell types. Currently, it is being evaluated in a Phase II clinical trial to treat patients with Sjogren's syndrome. Apart from this indication, the company is also developing this molecule to treat patients with generalized myasthenia gravis, grave disease, rheumatoid arthritis, lupus nephritis, and renal transplant rejection.
VIB4920 (dazodalibep): Amgen
Dazodalibep is a CD40 ligand antagonist that blocks T-cell interaction with CD40-expressing B cells, disrupting the overactivation of the CD40 ligand co-stimulatory pathway. Currently, Amgen is in the recruiting phase for its Phase III clinical development of dazodalibep, an investigational medicine for the treatment of Sjogren's syndrome. In November 2023, Amgen announced promising results from its Phase II study of dazodalibep for treating Sjogren's syndrome.
At present, the therapeutic market size of Sjogren's syndrome in the US is mainly accounted for by local therapies, systemic therapy, and biological therapies. The local therapies mainly include pilocarpine, cevimeline, topical fluoride, topical cyclosporine, autologous serum eye drops, and others. Systemic therapy mainly uses corticosteroids, hydroxychloroquine, and immunosuppressants. Methotrexate (MTX), Cyclosporine A, Azathioprine, Leflunomide, and Mycophenolic acid are also commonly used DMARDs. Biological therapy with rituximab is in extensive use in the US market. Along with this, TNF-alpha inhibitors, BAFF, and others are in development.
Drugs with a systemic effect, secretagogues, such as pilocarpine and cevimeline, are approved by the US FDA for the treatment of dry eyes and mouth in patients with Sjogren's syndrome. Both drugs are muscarinic receptor agonists and induce a transient increase in salivary and lacrimal gland outputs in patients with some residual functional glandular tissue. Common adverse effects of these drugs include sweating, flushing, the urgent need for urination, and gastrointestinal discomfort, which might limit their clinical application.
Despite all these available symptomatic treatments, Sjogren's disease (SS) is among the most difficult to evaluate and manage. Clinicians are frequently challenged to differentiate symptoms related to disease activity. Additionally, the presence of multiple comorbidities may influence the severity and further complicate the evaluation process. There is a vital need for developing SS-specific outcome measures that encompass the spectrum of organ system involvement and are sensitive to clinically meaningful change. Better staging to identify patients with early disease and the discovery of novel biomarkers and/or genetic profiling to define specific patient subsets should facilitate better patient selection for targeted therapies.
To meet the current demands of the patient pool and to counter the unmet needs of the therapeutic market, drug developers are gradually shifting their attention toward SS as a possible indication for new targeted therapies. Several companies are working robustly on many new therapies, such as RSLV-132 (Resolve Therapeutics), VAY736 (Novartis/MorphoSys), CFZ533 (Novartis), OXERVATE (Dompe Farmaceutici), VIB4920 (Amgen), and SOTYKTU (Bristol Myers Squibb). A mid-stage pipeline is crowded, with several potential therapies with the imminent attention of big pharmaceutical companies for this market space. These all are anticipated to enter Sjogren's syndrome market by 2030.
Further details are provided in the report...
Sjogren's Syndrome Disease Understanding and Treatment
Sjogren's Syndrome Overview
Sjogren's syndrome is a chronic autoimmune disease with a specific predisposition for causing inflammation of the exocrine glands, predominantly the salivary and lacrimal glands, including the nose, upper respiratory tract, and oropharynx and, in women, the vagina. In Sjogren's syndrome, the immune system inappropriately attacks various cells leading to activation of the various pathways, resulting in inflammation. The main consequence of this inflammation is the development of sicca symptoms due to damage to salivary and tear glands, such as dryness of the mucosal surfaces, principally in the mouth and eyes.
Five features of this disease, such as the development of sicca symptoms, systemic disease involvement, lymphocytic infiltration to exocrine glands, the presence of autoantibodies, and the increased risk of lymphoma in Sjogren's syndrome patients, characterized Sjogren's syndrome in the early years of its discovery. The autoimmune etiopathogenetic basis was confirmed in the 1960s, and the presence of the autoantibodies Sjogren's syndrome-related antigen A (SSA; also known as anti-Ro/SSA antibodies) and SSB (also known as anti-La/SSB antibodies), in addition to organ-specific lymphocyte infiltration (for example, focal lymphocytic sialadenitis (FLS) or inflammation of the salivary glands) became central for the pathobiology and diagnosis of this disease. Since then, knowledge of Sjogren's syndrome has progressed substantially.
Further details are provided in the report...
Sjogren's syndrome Diagnosis
Sjogren's syndrome is a multisystem disorder that is heterogeneous in its presentation, course, and outcome. There is still no single clinical, laboratory, pathological, or radiological feature that could serve as a gold standard for the diagnosis and/or classification of this syndrome. Labial salivary gland biopsy with a subsequent histopathological evaluation is currently in use.
The two main oral tests to evaluate salivary gland function are the measurement of salivary flow rates and salivary gland scintigraphy. The main ocular tests include Schirmer's tests and analysis of the corneal surface using dyes (fluorescein and lissamine green) that stain degenerated or dead cells (corneal staining).
Ultrasonography and MRI are mainly used to evaluate the most common complications of Sjogren's syndrome, such as infections and lymphoma.
Serologic and laboratory findings associated with Sjogren's syndrome include diffuse hypergammaglobulinemia, which is found in approximately most of the patients with the disease. Serum levels of C-reactive protein are usually normal in patients with Sjogren's syndrome, so increased levels indicate the presence of an infection. Raised serum levels of B2-microglobulin have been reported in one-third of patients with Sjogren's syndrome. Other laboratory abnormalities might suggest Sjogren's syndrome-related renal involvement (such as increased levels of creatinine, proteinuria, hypokalemia, and a urine pH of >5.5 despite severe academia) or associated liver disease (indicated by increased levels of transaminases or alkaline phosphatases).
Further details related to country-based variations are provided in the report...
Sjogren's Syndrome Treatment
There is no known cure for Sjogren's syndrome, nor is there a specific treatment to restore gland secretion. Unfortunately, irreparable glandular damage often occurs at the time of sicca development, and therefore return of glandular function is not anticipated. Treatment is aimed at slowing or preventing further glandular damage, alleviating symptoms of dryness, and considering immune modulation in the case of extra-glandular disease.
Hydroxychloroquine is used as a first-line treatment for general symptoms, including sicca, arthralgia, and musculoskeletal pain. Methotrexate can be used in cases in which hydroxychloroquine is ineffective. Glucocorticoids are commonly used for episodes of salivary gland swelling as well as for more severe manifestations, including severe cutaneous, pulmonary, renal, musculoskeletal, or neurological involvement. When longer-term immune modulation is indicated, DMARDs (mycophenolate mofetil, cyclosporine A, azathioprine) are commonly used to limit glucocorticoid toxicity. The use of biologicals such as rituximab is indicated for severe disease with proven organ damage that is resistant to non-biologic immunosuppressant drugs or when conventional therapies are insufficient. Rituximab should be considered as a treatment option for adults with pSS and any of the following manifestations: vasculitis, severe parotid swelling, inflammatory arthritis, pulmonary disease, or peripheral neuropathy, especially mononeuritis multiplex.
Drugs with a systemic effect like secretagogues, such as pilocarpine and cevimeline, can be used for the symptomatic management of dry mouth as they stimulate the salivary glands.
Ocular dryness is addressed by limiting tear loss (wearing glasses, avoiding dry or windy environments), avoiding medications that may precipitate decreased tear production, using interventions to increase tear production with medication (e.g., cyclosporine, immune suppression) or punctual plugs, and replacement with artificial tears and lubrication.
Further details related to treatment and management are provided in the report...
The Sjogren's syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by diagnosed prevalent cases, type-specific cases, gender-specific cases, severity-specific cases, antigen-specific cases, total treated cases of Sjogren's syndrome in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.
KOL Views
To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.
We have reached out to industry experts to gather insights on various aspects of Sjogren's syndrome, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.
Our team of analysts at DelveInsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the John Hopkins Medicine, Duke University, University of Pennsylvania, University of Munich, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Sjogren's syndrome market, which will assist our clients in analyzing the overall epidemiology and market scenario.
Qualitative Analysis
We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis 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 approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for Sjogren's syndrome, important primary and secondary endpoints are ESSDAI score, ESSPRI scores, FACIT-F score, Profile of Fatigue Score (ProF), etc. Based on these parameters, the overall efficacy is evaluated.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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, a final weightage score is decided based on which the emerging therapies are ranked.
Market Access and Reimbursement
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.