シェーグレン症候群 - 世界市場の考察、疫学、市場予測（2034年）

主なハイライト

• シェーグレン症候群は、唾液腺と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によって引き起こされる自己免疫疾患です。
• 原発性シェーグレン症候群と続発性シェーグレン症候群に分類されます。原発性シェーグレン症候群（pSS）は、その他の自己免疫疾患がない場合に発症し、角結膜乾燥症（ドライアイ）と口腔乾燥症（ドライマウス）を特徴とし、シッカ症候群と総称されます。一方、続発性シェーグレン症候群では、関節リウマチや全身性エリテマトーデス（SLE）などの他の自己免疫疾患を合併します。
• ドライアイとドライマウスはSSのもっとも一般的な症状です。シェーグレン症候群では、免疫系は関節、甲状腺、腎臓、肝臓、肺、皮膚、神経などの他の身体部位も標的とします。その結果、関節痛、腫れ、皮膚の発疹、膣の乾燥などが生じます。また、皮膚、関節、筋肉、血液、肺、心臓、腎臓、神経などの他の臓器系にも影響を及ぼします。
• シェーグレン症候群の診断は、病歴、身体診察、特異的な眼、口腔の評価、血液検査、唾液腺の評価（生検と超音波検査）に基づいて行われます。
• 2023年、シェーグレン症候群と診断された患者数は主要7市場で約300万人であり、2034年までに増加する可能性が高いです。
• 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ー、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。
• ドライアイには通常、人工涙液を日中定期的に点眼するか、夜間にジェルを塗布します。患者がイースト菌感染症を発症した場合は、抗真菌療法が用いられます。加湿器や生理食塩水の鼻腔への注入は、鼻の乾燥を改善することがあります。胃酸を減少させる薬物（プロトンポンプ阻害薬やH2ブロッカーなど）は、酸逆流の症状を軽減する可能性があります。治療により乾燥が緩和されることもありますが、通常は乾燥が持続します。
• 腺外（全身）主要臓器系疾患に対する最初のアプローチは、経口/非経口コルチコステロイドです。さまざまなDMARDs（メトトレキサート、アザチオプリン）がステロイドを温存する薬剤として使用されているが、シェーグレンに対して特別に承認されているものはありません。ヒドロキシクロロキンは炎症性多発性関節炎の治療に推奨されます。B細胞の枯渇は、ある種の重度の膠原病外症状（血管炎）に関与している可能性があります。TNFα阻害薬はシェーグレン症候群に有効であるとは証明されていません。
• 予測期間に大きな変化をもたらす可能性のある薬剤は、lanalumab（VAY736）、CFZ533（iscalimab）、RSLV-132、Dazodalibep（VIB4920）、OXERVATE（cenegermin）、SOTYKTU（deucravacitinib）などです。
• 主要7市場のシェーグレン症候群の総市場規模では米国がもっとも大きく、2023年に市場全体の約62%を占めました。
• 主要7市場の新治療法の中でも、CFZ533（iscalimab）とVIB（4920年）（dazodalibep）は、シェーグレン症候群の市場規模に大きな影響を与える可能性が高いです。
• このように、この疾患と患者にはまだ複数のアンメットニーズが存在しており、効果的な対症療法と全身療法、患者の層別化、疾患活動性/重症度の予測、治療に対する反応性を示すバイオマーカーの同定に多大な努力が必要です。
• 結論として、シェーグレン症候群は未だ不治の病と考えられていますが、ここ数年でその分類と革新的な治療法が研究開発され、さらなる診断、評価、治療が進行中です。また、シェーグレン症候群を治療するさまざまな新薬がパイプラインにあります。

当レポートでは、シェーグレン症候群の主要7市場（米国、ドイツ、スペイン、イタリア、フランス、英国、日本）について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 シェーグレン症候群のエグゼクティブサマリー

第4章 シェーグレン症候群市場の概要

• 主要7市場のシェーグレン症候群の市場シェア分布：治療法別（2020年）
• 主要7市場のシェーグレン症候群の市場シェア分布：治療法別（2034年）

第5章 重要な出来事

第6章 疫学と市場予測の調査手法

第7章 疾患の背景と概要

• イントロダクション
• シェーグレン症候群の分類
• 兆候と症状
• 病因
• 発病機序
• 臨床症状
• シェーグレン症候群のバイオマーカー

第8章 シェーグレン症候群の診断

• 診断方法
• 鑑別診断
• 診断アルゴリズム

第9章 治療と管理

• 現在の治療法
• 治療アルゴリズム

第10章 診断と治療のガイドライン

• エビデンスに基づく医療の臨床実践ガイドライン（米国、EU、日本）
• シェーグレン症候群における肺疾患の評価と管理に関するコンセンサスガイドライン
• 局所/全身治療によるシェーグレン症候群の管理に関するEULARの推奨事項
• 英国リウマチ学会の成人原発性シェーグレン症候群の治療ガイドライン
• シェーグレン症候群の改訂AECG分類基準とACR分類基準の比較
• 米国のシェーグレン症候群の治療ガイドライン
• 原発性シェーグレン症候群の全身症状に対する治療の推奨事項

第11章 疫学と患者人口

• 主な調査結果
• 前提条件と根拠
• 主要7市場のシェーグレン症候群と診断された患者数
• 米国
• 欧州4ヶ国・英国
• 日本

第12章 ペイシェントジャーニー

第13章 上市済みの治療法

• 上市済みの治療法の主な競合
• SALAGEN (pilocarpine): ADVANZ Pharma
• EVOXAC (cevimeline): Daiichi Sankyo

第14章 新しい治療法

• 主な競合
• Dazodalibep: Amgen
• OXERVATE (cenegermin): Dompe Farmaceutici
• VAY736 (ianalumab): Novartis
• CFZ 533 (iscalimab): Novartis
• RSLV-132: Resolve Therapeutics
• SOTYKTU (deucravacitinib): Bristol Myers Squibb
• Nipocalimab: Johnson & Johnson

第15章 シェーグレン症候群：主要7市場の分析

• 主な調査結果
• 市場見通し
• コンジョイント分析
• 主な市場予測の前提条件
• 主要7市場のシェーグレン症候群の総市場規模
• 主要7市場のシェーグレン症候群の市場規模：治療法別
• 米国の市場規模
  • 米国のシェーグレン症候群の総市場規模
  • 米国のシェーグレン症候群の市場規模：治療法別
• 欧州4ヶ国・英国の市場規模
  • 欧州4ヶ国・英国のシェーグレン症候群の総市場規模
  • 欧州4ヶ国・英国のシェーグレン症候群の市場規模：治療法別
• 日本の市場規模
  • 日本のシェーグレン症候群の総市場規模
  • 日本のシェーグレン症候群の市場規模：治療法別

第16章 アンメットニーズ

第17章 SWOT分析

第18章 KOLの見解

第19章 市場参入と償還

• 米国
• 欧州4ヶ国・英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本

第20章 付録

第21章 DelveInsightのサービス内容

第22章 免責事項

第23章 DelveInsightについて

List of Tables

• Table 1: Summary of Sjogren's syndrome Market and Epidemiology (2020-2034)
• Table 2: American-European Consensus Group Criteria - Revised international Classification Criteria for Sjogren's syndrome
• Table 3: Revised Rules for Classification - American-European Consensus Group Criteria
• Table 4: ACR/EULAR Criteria
• Table 5: Selected Non-HLA Genes Implicated in Sjogren's syndrome
• Table 6: Biomarkers in Primary Sjogren's syndrome
• Table 7: Diagnostic Tests to Evaluate Sicca Symptoms in Patients with Sjogren's syndrome
• Table 8: Evaluation of Dry Eye
• Table 9: Currently Available Evidence-Based Medicine Clinical Practice Guidelines on Diagnosis and Management of Sjogren's syndrome
• Table 10: Recommendations for Evaluating Patients with Sjogren's syndrome
• Table 11: EULAR Recommendations for the Management of Sjogren's syndrome With Topical and Systemic Therapies
• Table 12: Comparison of the Revised AECG Classification Criteria and the ACR Classification Criteria for Sjogren's syndrome
• Table 13 : Oral Management Guidelines for Caries Prophylaxis
• Table 14: Guidelines for DMARDS use for Musculoskeletal Pain in Sjogren's syndrome
• Table 15: Guidelines for the Treatment of Fatigue in Sjogren's Disease
• Table 16: Guidelines for the use of Biological Medications in Sjogren's Disease
• Table 17: Diagnosed Prevalent Cases of Sjogren's syndrome in the 7MM, in Thousands (2020-2034)
• Table 18: Diagnosed Prevalent Cases of Sjogren's syndrome in the United States, in Thousands (2020-2034)
• Table 19: Type-specific Cases of Sjogren's syndrome in the United States, in Thousands (2020-2034)
• Table 20: Gender-specific Cases of Sjogren's syndrome in the United States, in Thousands (2020-2034)
• Table 21: Severity-specific of Sjogren's syndrome in the United States, in Thousands (2020-2034)
• Table 22: Antigen-specific Cases of Sjogren's syndrome in the United States, in Thousands (2020-2034)
• Table 23: Total Treated Cases of Sjogren's syndrome in the United States, in Thousands (2020-2034)
• Table 24: Diagnosed Prevalent Cases of Sjogren's syndrome in EU4 and the UK, in Thousands (2020-2034)
• Table 25: Type-specific Cases of Sjogren's syndrome in EU4 and the UK, in Thousands (2020-2034)
• Table 26: Gender-specific Cases of Sjogren's syndrome in EU4 and the UK, in Thousands (2020-2034)
• Table 27: Severity-specific Cases of Sjogren's syndrome in EU4 and the UK, in Thousands (2020-2034)
• Table 28: Antigen-specific Cases of Sjogren's syndrome in EU4 and the UK, in Thousands (2020-2034)
• Table 29: Treated Cases of Sjogren's syndrome in EU4 and the UK, in Thousands (2020-2034)
• Table 30: Diagnosed Prevalent Cases of Sjogren's syndrome in Japan, in Thousands (2020-2034)
• Table 31: Type-specific Cases of Sjogren's syndrome in Japan, in Thousands (2020-2034)
• Table 32: Gender-specific Cases of Sjogren's syndrome in Japan, in Thousands (2020-2034)
• Table 33: Severity-specific of Sjogren's syndrome in Japan, in Thousands (2020-2034)
• Table 34: Antigen-specific Cases of Sjogren's syndrome in Japan, in Thousands (2020-2034)
• Table 35: Total Treated Cases of Sjogren's syndrome in Japan, in Thousands (2020-2034)
• Table 36: Comparison of Marketed Drugs
• Table 37: EVOXAC (cevimeline), Clinical Trial Description, 2024
• Table 38: Comparison of Emerging drugs
• Table 39: Dazodalibep; Clinical Trial Description, 2024
• Table 40: OXERVATE (cenegermin); Clinical Trial Description, 2024
• Table 41: VAY736 (ianalumab); Clinical Trial Description, 2024
• Table 42: CFZ 533 (iscalimab); Clinical Trial Description, 2024
• Table 43: RSLV-132; Clinical Trial Description, 2024
• Table 44: SOTYKTU (deucravacitinib); Clinical Trial Description, 2024
• Table 45: Nipocalimab; Clinical Trial Description, 2024
• Table 46: Conjoint Analysis
• Table 47: Conjoint Analysis
• Table 48: Key Market Forecast Assumption of Sjogren's syndrome in the United States
• Table 49: Key Market Forecast Assumption of Sjogren's syndrome in EU4 and the UK
• Table 50: Key Market Forecast Assumption of Sjogren's syndrome in Japan
• Table 51: Total Market Size of Sjogren's syndrome in the 7MM, in USD million (2020-2034)
• Table 52: Market Size of Sjogren's syndrome by Therapies in the 7MM, in USD million (2020-2034)
• Table 53: Total Market Size of Sjogren's syndrome in the US, in USD million (2020-2034)
• Table 54: Market Size of Sjogren's syndrome by Therapies in the US, in USD million (2020-2034)
• Table 55: Total Market Size of Sjogren's syndrome in EU4 and the UK, in USD million (2020-2034)
• Table 56: Market Size of Sjogren's syndrome by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 57: Total Market Size of Sjogren's syndrome in Japan, in USD million (2020-2034)
• Table 58: Market Size of Sjogren's syndrome by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Understanding of Sjogren's syndrome
• Figure 2: Signs and Symptoms of Sjogren's syndrome
• Figure 3: The Pathogenesis of Autoimmune Epitelitis as a Potential Explanation for Sjogren's syndrome
• Figure 4: Interplay of Immune and Nonimmune Factors in the Pathophysiology of Sjogren's syndrome
• Figure 5: Diagnostic Algorithm for Sjogren's syndrome in Primary Care
• Figure 6: Algorithm of Glandular Function Assessment and Therapeutic Approach in Patients With Primary Sjogren Syndrome Presenting With Oral Dryness.
• Figure 7: Treatment Algorithm for Sjogren's syndrome
• Figure 8: Diagnosed Prevalent Cases of Sjogren's syndrome in the 7MM (2020-2034)
• Figure 9: Diagnosed Prevalent Cases of Sjogren's syndrome in the United States (2020-2034)
• Figure 10: Type-specific Cases of Sjogren's syndrome in the United States (2020-2034)
• Figure 11: Gender-specific Cases of Sjogren's syndrome in the United States (2020-2034)
• Figure 12: Severity-specific Cases of Sjogren's syndrome in the United States (2020-2034)
• Figure 13: Antigen-specific Cases of Sjogren's syndrome in the United States (2020-2034)
• Figure 14:Total Treated Cases of Sjogren's syndrome in the United States (2020-2034)
• Figure 15: Diagnosed Prevalent Cases of Sjogren's syndrome in EU4 and the UK (2020-2034)
• Figure 16: Type-specific Cases of Sjogren's syndrome in EU4 and the UK (2020-2034)
• Figure 17: Gender-specific Cases of Sjogren's syndrome in EU4 and the UK (2020-2034)
• Figure 18: Severity-specific Cases of Sjogren's syndrome in EU4 and the UK (2020-2034)
• Figure 19: Antigen-specific Cases of Sjogren's syndrome in EU4 and the UK (2020-2034)
• Figure 20: Treated Cases of Sjogren's syndrome in EU4 and the UK (2020-2034)
• Figure 21: Diagnosed Prevalent Cases of Sjogren's syndrome in Japan(2020-2034)
• Figure 22: Type-specific Cases of Sjogren's syndrome in Japan (2020-2034)
• Figure 23: Gender-specific Cases of Sjogren's syndrome in Japan (2020-2034)
• Figure 24: Severity-specific Cases of Sjogren's syndrome in Japan (2020-2034)
• Figure 25: Antigen-specific Cases of Sjogren's syndrome in Japan (2020-2034)
• Figure 26:Total Treated Cases of Sjogren's syndrome in Japan (2020-2034)
• Figure 27: Total Market Size of Sjogren's syndrome in the 7MM (2020-2034)
• Figure 28: Market Size of Sjogren's syndrome by Therapies in the 7MM (2020-2034)
• Figure 29: Total Market Size of Sjogren's syndrome in the US (2020-2034)
• Figure 30: Market Size of Sjogren's syndrome by Therapies in the US (2020-2034)
• Figure 31: Total Market Size of Sjogren's syndrome in EU4 and the UK (2020-2034)
• Figure 32: Market Size of Sjogren's syndrome by Therapies in EU4 and the UK (2020-2034)
• Figure 33: Total Market Size of Sjogren's syndrome in Japan (2020-2034)
• Figure 34: Market Size of Sjogren's syndrome by Therapies in Japan (2020-2034)
• Figure 35: Health Technology Assessment
• Figure 36: Reimbursement Process in Germany
• Figure 37: Reimbursement Process in France
• Figure 38: Reimbursement Process in Italy
• Figure 39: Reimbursement Process in Spain
• Figure 40: Reimbursement Process in the United Kingdom
• Figure 41: Reimbursement Process in Japan

Key Highlights:

• Sjogren's syndrome is an autoimmune disorder caused by the lymphocytic infiltration of exocrine glands resulting in glandular dysfunction, preferentially of the salivary and lacrimal glands.
• It can be classified into two types, i.e., primary Sjogren's syndrome and secondary Sjogren's syndrome. Primary Sjogren's syndrome (pSS) occurs in the absence of other autoimmune diseases and is characterized by keratoconjunctiva sicca (dry eyes) and xerostomia (dry mouth), collectively called the sicca syndrome. In contrast, secondary Sjogren's syndrome presents other autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus (SLE).
• Dry eyes and dry mouth are the most common symptoms of SS. In Sjogren's syndrome, the immune system also targets other body parts such as joints, thyroids, kidneys, liver, lungs, skin, and nerves. This results in joint pain, swelling, skin rashes, vaginal dryness, and others. It also affects other organ systems, which include skin, joints, muscles, blood, lungs, heart, kidneys, and nerves.
• The diagnosis of Sjogren's syndrome is made based on medical history, physical examination, specific ocular, oral evaluation, blood tests, and salivary gland assessment (biopsy and ultrasound).
• In 2023, the diagnosed prevalent cases of Sjogren's syndrome were approximately 3,000,000 cases in the 7MM, which is likely to rise by 2034.
• At present, there is no curing method for Sjogren's syndrome. Treatment focuses on relieving symptoms using artificial tears and saliva, sugar-free candy, and secretagogue drugs such as pilocarpine or cevimeline. General symptoms such as pain and fatigue are frequently treated with hydroxychloroquine. Specific extraglandular involvement may require immunosuppressive drugs.
• Dry eyes usually respond to artificial tears applied regularly during the day or to gels applied at night. If patients develop yeast infections, anti-fungal therapies may be used. Humidifiers and nasal saline irrigation may improve nasal dryness. Medications that reduce gastric acid (such as proton pump inhibitors and H2 blockers) may lessen symptoms of acid reflux. Treatments may help relieve some of the dryness, but usually, some dryness persists.
• The first approach to extra-glandular (systemic) major organ-system disease is oral/parenteral corticosteroids. Various DMARDs (methotrexate, azathioprine) have been successfully employed as steroid-sparing agents, although none is specifically approved for Sjogren. Hydroxychloroquine is recommended to treat inflammatory polyarthritis; B cell depletion may have a role in certain severe extra-glandular manifestations (vasculitis). TNF-alpha inhibitors have not proved effective for Sjogren's syndrome.
• The potential drugs that can mark a significant change in the forecast period include lanalumab (VAY736), CFZ533 (iscalimab), RSLV-132, Dazodalibep (VIB4920), OXERVATE (cenegermin), SOTYKTU (deucravacitinib), and others.
• In the total market size of Sjogren's syndrome in the 7MM, the United States accounted for the highest market size, i.e., around 62% of the market in 2023.
• Among all the emerging therapies, CFZ533 (iscalimab) and VIB4920 (dazodalibep) are likely to have a major influence on the market size of Sjogren's syndrome in the 7MM.
• Several unmet needs thus still exist for the disease and patients, and significant efforts should be placed to identify effective symptomatic and systemic therapies and biomarkers for stratifying patients, predicting disease activity/severity, and response to treatment.
• In conclusion, although it is still considered a non-curable disease, the classification and innovative methods of Sjogren's syndrome have been researched and developed over the past few years, and further diagnosis, assessment, and treatment are underway. Various potential novel medicines are in the pipeline to treat the disease.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the Sjogren's syndrome market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Sjogren's syndrome market.

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.

• In 2023, the total market size of Sjogren's syndrome was around USD 1,900 million, which is expected to increase by 2034 during the study period (2020-2034) in the 7MM.
• Among the 7MM, the United States accounted for the highest market size in 2023, whereas Japan accounted for the least market size.
• Among the EU4 and the UK, the UK had the largest market size for Sjogren's syndrome, while the lowest market was estimated to be covered by Spain in 2023.
• Germany accounted for approximately 9% of the total market size among the 7MM.
• Novartis and Amgen are key players in the market for Sjogren syndrome, and their drugs, CFZ533 (iscalimab) and VIB4920 (dazodalibep) are expected to generate the highest revenue in the 7MM by 2034.

Sjogren's Syndrome Drug Chapters

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.

Note: Detailed assessment will be provided in the final report of Sjogren's syndrome...

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.

Sjogren's Syndrome Market Outlook

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...

Sjogren's Syndrome Epidemiology

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.

• In the 7MM, nearly 1,500,000 diagnosed prevalent cases were observed in the year 2023, which is expected to increase during the forecast period (2024-2034).
• In the US, the highest number of antigen-specific cases accounted for auto-antibodies (+ve), followed by anti-Ro/SSA (+ve) and anti-La/SSB (+ve) in 2023.
• As per DelveInsight's analysis, a higher number of cases were observed for mild than moderate to severe, based on severity-specific cases of Sjogren's syndrome, throughout the 7MM.
• Among EU4 and the UK, the majority of Sjogren's syndrome cases were reported in females. The highest number of gender-specific cases was observed in the United Kingdom in 2023.
• In 2023, the US accounted for the highest number of treated cases, whereas Japan had the lowest number of treated cases. In Japan, there were around 54,000 treated cases of Sjogren's syndrome in 2023. These cases are likely to rise by 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.

Sjogren's Syndrome Report Insights

• Patient Population
• Therapeutic Approaches
• Sjogren's Syndrome Market Size and Trends
• Existing Market Opportunity

Sjogren's Syndrome Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Sjogren's Syndrome Epidemiology Segmentation
• Key Cross Competition

Sjogren's Syndrome Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Sjogren's syndrome management recommendations?
• Would research and development advances pave the way for future tests and therapies for Sjogren's syndrome?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Sjogren's syndrome?
• What kind of uptake will the new therapies witness in the coming years in Sjogren's syndrome patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Sjogren's syndrome

4. Sjogren's Syndrome Market Overview at a Glance

• 4.1. Market Share by Therapies (%) Distribution of Sjogren's syndrome in 2020 in the 7MM
• 4.2. Market Share by Therapies (%) Distribution of Sjogren's syndrome in 2034 in the 7MM

5. Key Events

6. Epidemiology and Market Forecast Methodology

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Classification of Sjogren's syndrome
• 7.3. Signs and Symptoms
• 7.4. Etiology
• 7.5. Pathogenesis
• 7.6. Clinical Manifestations
• 7.7. Biomarkers in Sjogren's syndrome

8. Diagnosis of Sjogren 's syndrome

• 8.1. Diagnostic Methods
• 8.2. Differential Diagnosis
• 8.3. Diagnostic Algorithm

9. Treatment and Management

• 9.1. Current Treatment Practices
• 9.2. Treatment Algorithm

10. Diagnosis and Treatment Guidelines

• 10.1. Evidence-based Medicine Clinical Practice Guidelines (US, EU, JP)
• 10.2. Consensus Guidelines for Evaluation and Management of Pulmonary Disease in Sjogren's
• 10.3. EULAR Recommendations for the Management of Sjogren's syndrome with Topical and Systemic Therapies
• 10.4. The British Society for Rheumatology guideline for the management of adults with primary Sjogren's syndrome
• 10.5. Comparison of the Revised AECG Classification criteria and the ACR Classification criteria for Sjogren's syndrome:
• 10.6. United States Treatment Guidelines for Sjogren's Disease
• 10.7. Treatment Recommendations for Systemic Manifestations of Primary Sjogren's syndrome

11. Epidemiology and Patient Population

• 11.1. Key Findings
• 11.2. Assumptions and Rationale
• 11.3. Diagnosed Prevalent Cases of Sjogren's syndrome in the 7MM
• 11.4. The United States
  • 11.4.1. Diagnosed Prevalent Cases of Sjogren's syndrome in the United States
  • 11.4.2. Type-specific Cases of Sjogren's syndrome in the United States
  • 11.4.3. Gender-specific Cases of Sjogren's syndrome in the United States
  • 11.4.4. Severity-specific Cases of Sjogren's syndrome in the United States
  • 11.4.5. Antigen-specific Cases of Sjogren's syndrome in the United States
  • 11.4.6. Total Treated Cases of Sjogren's syndrome in the United States
• 11.5. EU4 and the UK
  • 11.5.1. Diagnosed Prevalent Cases of Sjogren's syndrome in EU4 and the UK
  • 11.5.2. Type-specific Cases of Sjogren's syndrome in EU4 and the UK
  • 11.5.3. Gender-specific Cases of Sjogren's syndrome in EU4 and the UK
  • 11.5.4. Severity-specific Cases of Sjogren's syndrome in EU4 and the UK
  • 11.5.5. Antigen-specific Cases of Sjogren's syndrome in EU4 and the UK
  • 11.5.6. Total Treated Cases of Sjogren's syndrome in EU4 and the UK
• 11.6. Japan
  • 11.6.1. Diagnosed Prevalent Cases of Sjogren's syndrome in Japan
  • 11.6.2. Type-specific Cases of Sjogren's syndrome in Japan
  • 11.6.3. Gender-specific Cases of Sjogren's syndrome in Japan
  • 11.6.4. Severity-specific Cases of Sjogren's syndrome in Japan
  • 11.6.5. Antigen-specific Cases of Sjogren's syndrome in Japan
  • 11.6.6. Total Treated Cases of Sjogren's syndrome in Japan

12. Patient Journey

13. Marketed Therapies

• 13.1. Key Cross of Marketed Therapies
• 13.2. SALAGEN (pilocarpine): ADVANZ Pharma
  • 13.2.1. Product Description
  • 13.2.2. Regulatory Milestones
  • 13.2.3. Other Developmental Activity
  • 13.2.4. Safety and Efficacy
• 13.3. EVOXAC (cevimeline): Daiichi Sankyo
  • 13.3.1. Product Description
  • 13.3.2. Regulatory Milestones
  • 13.3.3. Other Developmental Activities
  • 13.3.4. Clinical Development
  • 13.3.5. Safety and Efficacy

14. Emerging Therapies

• 14.1. Key Cross Competition
• 14.2. Dazodalibep: Amgen
  • 14.2.1. Product Description
  • 14.2.2. Other Developmental Activities
  • 14.2.3. Clinical Development
  • 14.2.4. Clinical Trial Information
  • 14.2.5. Safety and Efficacy
• 14.3. OXERVATE (cenegermin): Dompe Farmaceutici
  • 14.3.1. Product Description
  • 14.3.2. Other Developmental Activities
  • 14.3.3. Clinical Development
  • 14.3.4. Clinical Trial Information
• 14.4. VAY736 (ianalumab): Novartis
  • 14.4.1. Product Description
  • 14.4.2. Other Developmental Activities
  • 14.4.3. Clinical Development
  • 14.4.4. Clinical Trial Information
  • 14.4.5. Safety and Efficacy
• 14.5. CFZ 533 (iscalimab): Novartis
  • 14.5.1. Product Description
  • 14.5.2. Clinical Development
  • 14.5.3. Clinical Trial Information
  • 14.5.4. Safety and Efficacy
• 14.6. RSLV-132: Resolve Therapeutics
  • 14.6.1. Product Description
  • 14.6.2. Clinical Development
  • 14.6.3. Clinical Trial Information
  • 14.6.4. Safety and Efficacy
• 14.7. SOTYKTU (deucravacitinib): Bristol Myers Squibb
  • 14.7.1. Product Description
  • 14.7.2. Other Developmental Activities
  • 14.7.3. Clinical Development
  • 14.7.4. Clinical Trial Information
• 14.8. Nipocalimab: Johnson & Johnson
  • 14.8.1. Product Description
  • 14.8.2. Clinical Development
  • 14.8.3. Clinical Trial Information
  • 14.8.4. Safety and Efficacy

15. Sjogren's Syndrome: Seven Major Market Analysis

• 15.1. Key Findings
• 15.2. Market Outlook
• 15.3. Conjoint Analysis
• 15.4. Key Market Forecast Assumptions
• 15.5. Total Market Size of Sjogren's syndrome in the 7MM
• 15.6. Market Size of Sjogren's syndrome by Therapies in the 7MM
• 15.7. The United States Market Size
  • 15.7.1. Total Market Size of Sjogren's syndrome in the United States
  • 15.7.2. Market Size of Sjogren's syndrome by Therapies in the United States
• 15.8. EU4 and the UK Market Size
  • 15.8.1. Total Market Size of Sjogren's syndrome in EU4 and the UK
  • 15.8.2. Market Size of Sjogren's syndrome by Therapies in EU4 and the UK
• 15.9. Japan Market Size
  • 15.9.1. Total Market Size of Sjogren's syndrome in Japan
  • 15.9.2. Market Size of Sjogren's syndrome by Therapies in Japan

16. Unmet Needs

17. SWOT Analysis

18. KOL Views

19. Market Access and Reimbursement

• 19.1. United States
  • 19.1.1. Centre for Medicare and Medicaid Services (CMS)
• 19.2. EU4 and the UK
  • 19.2.1. Germany
  • 19.2.2. France
  • 19.2.3. Italy
  • 19.2.4. Spain
  • 19.2.5. United Kingdom
• 19.3. Japan
  • 19.3.1. MHLW
  • 19.3.2. Reimbursement Scenario in Sjogren's syndrome

20. Appendix

• 20.1. Bibliography
• 20.2. Report Methodology

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight