特発性炎症性筋炎市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 2023年に特発性炎症性筋炎と診断された有病者は主要7ヶ国で約191,589人でした。このうち米国が48％、EU4ヶ国と英国が約38％、日本が14％を占めています。
• 特発性炎症性筋炎市場は急速な成長を遂げ、2024年から2034年までのCAGRは堅調に推移すると予測されています。この主要7ヶ国全体での拡大は、ダズキバート（PF 06823859）、エフガルチギモド、SAPHNELO（アニフロルマブ）、ブレポシチニブ、HIZENTRAなどの革新的な治療薬の上市により牽引されるでしょう。さらに、遺伝的素因、ウイルス感染、紫外線などの危険因子に煽られた有病率の上昇が、効果的な治療に対する需要をさらに押し上げると予想されます。
• 主要7ヶ国の特発性炎症性筋炎の市場規模は、2023年に約4億4,700万米ドルとなりました。同市場は、2024年から2034年までの予測期間において、この市場はCAGR 21.1％で成長すると予測されています。
• 特発性炎症性筋炎市場では、Octapharma、Pfizer、Mitsubishi Tanabe Pharmaが米国と欧州でオクタガム10%、日本でヴェノグロブリン-IH 5%のような承認された治療を提供し、市場をリードしています。
• コルチコステロイドや疾患修飾性抗リウマチ薬（DMARDs）のような特発性炎症性筋炎の現在の治療は、一部の患者には効果がなく、副作用を引き起こすことがあります。より少ない副作用で免疫調節異常に対処する、より標的を絞った治療法が切実に求められています。
• 当レポートは、特発性炎症性筋炎の詳細な理解、過去の疫学と予測、米国、EU4ヶ国（ドイツ、フランス、イタリア、スペイン）、英国、日本における特発性炎症性筋炎の市場動向をお届けします。
• また、現在の治療法、新薬、個々の治療法の市場シェア、2020年から2034年までの主要7ヶ国特発性炎症性筋炎市場規模の現状と予測を提供します。また、特発性炎症性筋炎の治療実践/アルゴリズムやアンメットメディカルニーズを網羅し、最良の機会を発掘し、市場の可能性を評価します。

筋炎は文字通り「筋肉の炎症」を意味し、筋組織の炎症を特徴とする多様な疾患群を指します。特発性炎症性筋炎（IIM）はこれらの疾患のサブセットであり、慢性的な筋炎症、筋力低下、場合によっては疼痛を特徴とします。

炎症性ミオパチーには、感染性筋炎、自己免疫性筋炎、薬剤性筋炎、特発性筋炎のほか、封入体筋炎や骨化性筋炎のような他の疾患と関連した筋炎など、根本的な原因によってさまざまな病型があります。IIMには、皮膚筋炎、多発性筋炎、重複性筋炎、散発性封入体筋炎（sIBM）、壊死性自己免疫性筋炎（NAM）などの疾患が含まれます。

まれではありますが、IIMは成人および小児の両方に罹患する可能性があり、患者は通常、亜急性から慢性の近位筋の筋力低下を呈し、椅子からの立ち上がり、階段の昇降、物の持ち上げ、髪をとかすなどの動作が困難になります。

筋力低下に加えて、筋炎の患者さんには他の様々な症状が現れることがあり、それが病気の主な症状であることもあります。炎症性関節炎、間質性肺疾患、皮疹などです。

ミオパチーの診断には、臨床検査、画像検査、集学的診察、組織学的検査、遺伝学的検査が必要です。免疫介在性壊死性ミオパチーや封入体筋炎の場合は、炎症の概念を再考する必要があります。

IIM治療の主な目標は、筋力を回復させ、炎症を抑制・除去し、他の臓器障害を予防することです。神経内科、リウマチ科、皮膚科、呼吸器科、理学療法、作業療法、言語療法など、集学的アプローチによる治療が理想的です。

現在、特発性炎症性筋炎の治療には、プレドニゾロンを含む副腎皮質ステロイド、オクタガム10％を含む免疫グロブリン、メトトレキサート、ミコフェノール酸、アザチオプリンなどの免疫抑制剤、リツキシマブ、アバタセプト、TNF阻害剤などの生物学的製剤が使用されています。

• 主要7ヶ国Mにおける特発性炎症性筋炎の総診断有病者数は、2023年には約19万1,589例であり、予測期間中（2020年～2034年）に増加すると予測されます。
• 2023年の特発性炎症性筋炎の診断有病者数は米国が約9万1,734例で最も多く、2034年までに増加すると予測されます。
• EU4ヶ国と英国の中では、2023年に特発性炎症性筋炎と診断された有病者数が最も多かったのはドイツで約2万1,781例、次いでフランスが約1万7,475例でした。一方、スペインは約6,235例で最も少なくなっています。
• 2023年に診断された特発性炎症性筋炎の有病者数は、日本が約2万6,094例で、2034年までに増加すると予想されています。
• 2023年、特発性炎症性筋炎のタイプ別診断有病者数のうち、米国は多発性筋炎で約3万649例、皮膚筋炎で3万8,517例、封入体筋炎で2万2,569例でした。
• 2023年、ドイツでは男性約8,712人、女性約1万3,069人が特発性炎症性筋炎と診断されました。
• 2023年、日本では、0～17歳、18～44歳、45～64歳、65歳以上の各年齢層で特発性炎症性筋炎と診断された有病者数は、それぞれ1,044人、7,959人、9,655人、7,437人でした。

オクタガム10%（免疫グロブリン静注［ヒト］）：Octapharma／Pfizer

オクタガム10％は、Octapharma Pharmazeutika Produktionsges社が製造し、Pfizer社が販売している、ヒト血漿由来の静注用免疫グロブリン（IgG）製剤です。2021年7月に米国FDAにより承認され、特に筋力と皮膚に影響を及ぼすまれな自己免疫疾患である成人皮膚筋炎の治療に適応されています。この薬剤は、罹患患者の筋機能を改善し、皮疹を軽減します。また、米国FDAから希少疾病用医薬品の指定を受けています。欧州では、オクタガム10%は成人の皮膚筋炎に対する免疫調節療法として2021年6月に承認され、ドイツでは2021年5月に国内承認されました。この薬は病院、輸液センター、または自宅で投与することができます。

VENOGLOBULIN-IH 5% IV（ヒト免疫グロブリンG）：Mitsubishi Tanabe Pharma

Mitsubishi Tanabe Pharmaが開発したVENOGLOBULIN-IHは、献血血漿由来のヒト免疫グロブリン製剤であり、ステロイドの効果が不十分な多発性筋炎または皮膚筋炎患者の筋力低下を改善する目的で開発されました。国内臨床試験において、治療後の筋力および日常活動スコアの有意な改善が確認されています。また、VENOGLOBULIN-IHの安全性プロファイルは既存の治療薬と同等であることが確認されました。日本では、多発性筋炎および皮膚筋炎の治療薬として希少疾病用医薬品の指定を受けています。VENOGLOBULIN-IHは、日本では2010年10月に、ステロイド療法が十分に奏効しないこれらの疾患の患者における筋力低下の治療薬として承認されました。本剤は静脈内投与されます。

ダズキバートPF-06823859（抗βインターフェロン）：Pfizer

ダズキバート（PF-06823859）は、中等症から重症の皮膚筋炎および多発性筋炎の治療薬として開発中の強力なヒト化IgG1Kモノクローナル抗体です。選択的インターフェロン（IFNB1）遮断薬として、自己免疫疾患に関連する免疫反応の主要なメディエーターであるIL-23サイトカインを標的として阻害します。ダズキバートは静脈内および皮下注射により投与され、これらの疾患における免疫活性を調節するようデザインされています。ダズキバートは、欧州医薬品庁（EMA）より、皮膚筋炎を適応症とするオーファンドラッグおよびプライムドラッグの指定を受けています。米国では、同じ適応症でオーファンドラッグとファストトラックの両方の指定を受けています。

現在、ダズキバートは皮膚筋炎と多発性筋炎を対象に第III相臨床試験中です。

エフガルチギモド：Argenx

エフガルチギモドは、新生児Fc受容体（FcRn）を標的とするファースト・イン・クラスの治験用抗体フラグメントです。本薬は、アンメット・メディカル・ニーズが高い、病原性免疫グロブリンG（IgG）およびIgG自己抗体を伴う重篤な自己免疫疾患の治療薬として検討されています。抗アセチルコリン受容体抗体陽性の成人患者を対象とした汎発性重症筋無力症（gMG）の治療薬として、米国、欧州、日本ですでにVYVGARTとして承認されているエフガルティギモドは、現在進行中のALKIVIA試験で評価されています。

このシームレスな第II/III相試験では、免疫介在性壊死性ミオパチー（IMNM）、抗シンテターゼ症候群（ASyS）、皮膚筋炎の3つの筋炎サブセットにおけるエフガルチギモドの可能性が検討されており、2024年後半に結果が出る予定です。

SAPHNELO（アニフロルマブ）：AstraZeneca

SAPHNELO（アニフロルマブ）は、I型IFN受容体のサブユニット1を標的とする完全ヒト型モノクローナル抗体で、I型インターフェロンの活性を効果的に阻害します。米国FDAより希少疾病用医薬品の指定を受けており、現在、皮膚筋炎の治療薬として第III相開発段階にあります。

特発性炎症性筋炎の治療では、第一選択薬として主にコルチコステロイドが使用され、十分な効果が得られない患者にはメトトレキサートやアザチオプリンなどの免疫抑制剤が併用されることが多いです。重症例や抵抗性例では免疫グロブリン静注（IVIG）が有効な場合があり、難治性例ではリツキシマブなどの生物学的製剤が考慮されます。

新しい治療薬としては、ダズキバート（PF 06823859）、エフガルチギモド、SAPHNELO（アニフロルマブ）、ブレポシチニブ、HIZENTRAなどがあります。

ダズキバート（PF-06823859）はヒト化IgG1Kモノクローナル抗体で、自己免疫反応における重要なメディエーターであるインターフェロン・ベータ1（IFNB1）を阻害します。

エフガルチギモドは、新生児FcRn受容体を標的として作用し、IgG抗体のリサイクルを阻害することで、自己免疫疾患における病原性IgGレベルの低下をもたらします。HIZENTRAは、免疫調節作用が期待される幅広いIgG抗体を投与し、病原体の中和や免疫反応の調節を助けるが、その正確な作用機序は不明です。どちらもIgG活性を調節することにより、皮膚筋炎のような自己免疫疾患に対処することを目的としています。

特発性炎症性筋炎は希少疾患に分類されてはいますが、近年認知度が高まっています。これは主に、診断技術の向上、ヘルスケア専門家の意識の向上、病態に対する理解の深まりによるものです。罹患率の上昇は、治療を求める患者をより多く特定することで、市場の成長を促進する可能性があります。炎症性筋炎の治療には通常、薬物療法と支持的介入が組み合わされ、主な目的は炎症を抑え、症状を管理し、筋機能を維持し、合併症を予防することです。

特発性炎症性筋炎の治療は、薬物療法、理学療法、支持療法を組み合わせた多面的なアプローチで進歩してきました。プレドニゾンやアクターゲルなどの高用量コルチコステロイドは、炎症と免疫反応をコントロールするための第一選択薬です。メトトレキサート、アザチオプリン、タクロリムスなどの免疫抑制剤は、コルチコステロイドの長期使用を減らすためにしばしば追加されます。

効果が不十分な場合は、リツキシマブなどの生物学的製剤で標的免疫抑制を行います。理学療法は筋力と機能の維持に不可欠であり、非ステロイド性抗炎症薬（NSAIDs）や日焼け防止などの支持療法は症状の管理に役立ちます。免疫グロブリン静注療法（IVIG）も治療の選択肢のひとつで、米国と欧州ではオクタガム10％が、日本ではベノグロブリン-IH5％が承認されています。重症の難治性症例に対しては、シクロホスファミドの静注療法が考慮されるが、重篤な副作用の可能性があるため、その使用は制限されています。治療計画は、疾患の重症度や個々の反応性に基づいて調整され、有効性と副作用の最小化のバランスを目指します。

特発性炎症性筋炎は、既存の治療法では十分な治療効果が得られないことが多いため、新しい治療法の必要性が高いです。革新的な薬剤開発は、患者により効果的な選択肢を提供する可能性があります。現在、dazukibart（PF 06823859）、efgartigimod、SAPHNELO（anifrolumab）、brepocitinib、HIZENTRA、empasiprubart、ulviprubart（ABC008）、daxdilimab、nipocalimab、GLPG3667、enpatoran（M5049）、froniglutide（PF1801）、CABA-201など、いくつかの有望な薬剤がパイプラインにあります。

• 主要7ヶ国における特発性炎症性筋炎の総市場規模は、2023年に約4億4,700万米ドルであり、予測期間中（2024～2034年）に拡大すると予測されます。
• 米国における特発性炎症性筋炎の市場規模は、2023年に約2億6,830万米ドルであり、新興治療薬の上市により増加が予測されます。
• EU4ヶ国と英国の合計市場規模は2023年に約1億6,100万米ドルと算出され、主要7ヶ国の総市場収益の約36%を占めました。
• EU4ヶ国と英国の中では、ドイツが2023年に約4,750万米ドルで最も高い市場規模を占め、次いでフランスが約3,810万米ドル、イタリアが約3,260万米ドルでした。
• 2023年の日本における特発性炎症性筋炎の総市場規模は約1,770万米ドルであり、予測期間中（2024～2034年）に拡大すると予測されます。
• 推計別と、現在使用されている治療法のうち、免疫グロブリン製剤が最大の市場シェアを占め、2023年には主要7ヶ国全体で約2億7,030万米ドルの売上を計上しました。

当レポートでは、主要7ヶ国における特発性炎症性筋炎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。

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 市場概要

• 2020年の特発性炎症性筋炎の市場シェア（％）分布
• 2034年の特発性炎症性筋炎の市場シェア（％）分布

第4章 疫学と市場予測の調査手法

第5章 エグゼクティブサマリー

第6章 主要な出来事

第7章 疾患の背景と概要

• イントロダクション
• 臨床症状
• 病因と危険因子
• 病態生理学
• 診断
• 治療

第8章 患者動向

第9章 疫学と患者人口

• 主な調査結果
• 前提と根拠：主要7ヶ国
• 主要7ヶ国における特発性炎症性筋炎の診断された有病症例の総数
• 米国
• EU4ヶ国と英国
• 日本

第10章 上市済み薬剤

• キークロス競合
• オクタガム10％（静脈内免疫グロブリン[ヒト]）：Octapharma/Pfizer
• ベノグロブリンIH 5% IV（ヒト免疫グロブリンG）：Mitsubishi Tanabe Pharma

第11章 新興薬剤

• キークロス競合
• Dazukibart PF-06823859（抗βインターフェロン）：Pfizer
• エフガルチギモド：アルゲンクス
• SAPHNELO（アニフロルマブ）：AstraZeneca
• ブレポシチニブ：Priovant Therapeutics/Pfizer
• ハイゼントラ：CSL Behring
  • アナリストの見解
• エンパシプルバート：Argenx
• ウルビプルバート（ABC008）：Abcuro, Inc.
  • その他の開発活動
  • 臨床試験情報
• ダクスディリマブ：Amgen
• ニポカリマブ：Janssen
• フロニグルチド（PF1801）：Immunoforge
• GLPG3667：Galapagos NV
• エンパトラン（M5049）：メルクKGaA（EMD Serono Research & Development Institute）
• CABA-201：Cabaletta Bio
• 臍帯内層幹細胞（ULSC）：Restem

第12章 特発性炎症性筋炎：市場分析

• 主な調査結果
• 主要な市場予測の前提条件
• 市場見通し
• 属性分析
• 主要7ヶ国における特発性炎症性筋炎の総市場規模
• 主要7ヶ国における特発性炎症性筋炎の治療法別市場規模
• 米国における特発性炎症性筋炎の総市場規模
• EU4ヶ国および英国における特発性炎症性筋炎の市場規模
• 日本における特発性炎症性筋炎の市場規模

第13章 主要オピニオンリーダーの見解

第14章 SWOT分析

第15章 アンメットニーズ

第16章 市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 日本

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of Epidemiology and Market (2020-2034)
• Table 2: Key Events for Idiopathic Inflammatory Myositis
• Table 3: Myositis Specific Antibodies And Disease Associations
• Table 4: Bohan and Peter Diagnostic Criteria for Polymyositis and Dermatomyositis
• Table 5: The European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile IIM
• Table 6: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the 7MM (2020-2034)
• Table 7: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Table 8: Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Table 9: Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Table 10: Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Table 11: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Table 12: Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Table 13: Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Table 14: Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Table 15: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Table 16: Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Table 17: Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Table 18: Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Table 19: Key Cross of Marketed Drugs
• Table 20: OCTAGAM 10%, Clinical Trials Description, 2024
• Table 21: VENOGLOBULIN-IH, Clinical Trials Description, 2024
• Table 22: Comparison of Emerging Drugs for Treatment
• Table 23: Dazukibart, Clinical Trials Description, 2024
• Table 24: Efgartigimod, Clinical Trials Description, 2024
• Table 25: Anifrolumab, Clinical Trials Description, 2024
• Table 26: Brepocitinib, Clinical Trials Description, 2024
• Table 27: HIZENTRA, Clinical Trials Description, 2024
• Table 28: Empasiprubart, Clinical Trials Description, 2024
• Table 29: Ulviprubart (ABC008), Clinical Trials Description, 2024
• Table 30: Daxdilimab, Clinical Trials Description, 2024
• Table 31: Nipocalimab, Clinical Trials Description, 2024
• Table 32: Froniglutide, Clinical Trials Description, 2024
• Table 33: GLPG3667, Clinical Trials Description, 2024
• Table 34: Enpatoran, Clinical Trials Description, 2024
• Table 35: CABA-201, Clinical Trials Description, 2024
• Table 36: Umbilical Cord Lining Stem Cells (ULSC), Clinical Trials Description, 2024
• Table 37: Key Market Forecast Assumptions for Brepocitinib
• Table 38: Key Market Forecast Assumptions for Efgartigimod
• Table 39: Key Market Forecast Assumptions for Dazukibart (PF-06823859)
• Table 40: Key Market Forecast Assumptions for HIZENTRA (IgPro20)
• Table 41: Key Market Forecast Assumptions for SAPHNELO (anifrolumab)
• Table 42: Total Market Size of Idiopathic Inflammatory Myositis in the 7MM, in USD Million (2020-2034)
• Table 43: Total Market Size of Idiopathic Inflammatory Myositis by Therapies in the 7MM, in USD Million (2020-2034)
• Table 44: Total Market Size of Idiopathic Inflammatory Myositis in the US, in USD Million (2020-2034)
• Table 45: Total Market Size of Idiopathic Inflammatory Myositis by Therapies in the US, in USD Million (2020-2034)
• Table 46: Total Market Size of Idiopathic Inflammatory Myositis in EU4 and the UK, in USD Million (2020-2034)
• Table 47: The Market Size of Idiopathic Inflammatory Myositis by Therapies in EU4 and the UK, in USD Million (2020-2034)
• Table 48: Total Market Size of Idiopathic Inflammatory Myositis in Japan, in USD Million (2020-2034)
• Table 49: Total Market Size of Idiopathic Inflammatory Myositis by Therapies in Japan, in USD Million (2020-2034)

List of Figures

• Figure 1: Typical Histopathological Changes in IIM Subgroups
• Figure 2: Diagnostic Algorithm To Diagnose IIM
• Figure 3: Current Treatment Algorithm for IIM
• Figure 4: Patient Journey
• Figure 5: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the 7MM (2020-2034)
• Figure 6: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Figure 7: Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Figure 8: Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Figure 9: Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US (2020-2034)
• Figure 10: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Figure 11: Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Figure 12: Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Figure 13: Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK (2020-2034)
• Figure 14: Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Figure 15: Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Figure 16: Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Figure 17: Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan (2020-2034)
• Figure 18: Total Market Size of Idiopathic Inflammatory Myositis in the 7MM, in USD Million (2020-2034)
• Figure 19: Total Market Size of Idiopathic Inflammatory Myositis by Therapies in the 7MM, in USD Million (2020-2034)
• Figure 20: Total Market Size of Idiopathic Inflammatory Myositis in the US, in USD Million (2020-2034)
• Figure 21: Total Market Size of Idiopathic Inflammatory Myositis by Therapies in the US, in USD Million (2020-2034)
• Figure 22: Total Market Size of Idiopathic Inflammatory Myositis in EU4 and the UK, in USD Million (2020-2034)
• Figure 23: Total Market Size of Idiopathic Inflammatory Myositis by Therapies in EU4 and the UK, in USD Million (2020-2034)
• Figure 24: Total Market Size of Idiopathic Inflammatory Myositis in Japan, in USD Million (2020-2034)
• Figure 25: Total Market Size of Idiopathic Inflammatory Myositis by Therapies in Japan, in USD Million (2020-2034)
• Figure 26: SWOT Analysis of Idiopathic Inflammatory Myositis
• Figure 27: Unmet Needs of Idiopathic Inflammatory Myositis
• Figure 28: HTA
• Figure 29: Reimbursement Process in Germany
• Figure 30: Reimbursement Process in France
• Figure 31: Reimbursement Process in Italy
• Figure 32: Reimbursement Process in Spain
• Figure 33: Reimbursement Process in the United Kingdom
• Figure 34: Reimbursement Process in Japan

Key Highlights:

• According to DelveInsight's estimates, in 2023, there were approximately 191,589 diagnosed prevalent cases of idiopathic inflammatory myositis in the 7MM. Of these, the United States accounted for 48% of the cases, while EU4 and the UK accounted for nearly 38% and Japan represented 14% of the cases, respectively.
• The idiopathic inflammatory myositis market is poised for rapid growth, with a strong compound annual growth rate (CAGR) projected from 2024 to 2034. This expansion across the 7MM will be driven by the launch of innovative therapies, including dazukibart (PF 06823859), efgartigimod, SAPHNELO (anifrolumab), brepocitinib, and HIZENTRA, among others. Additionally, the rising prevalence of cases, fueled by risk factors like genetic predisposition, viral infections, and UV radiation, is expected to further boost demand for effective treatments.
• According to DelveInsight's analysis, the idiopathic inflammatory myositis market in the 7MM was valued at approximately USD 447 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 21.1%.
• Octapharma, Pfizer, and Mitsubishi Tanabe Pharma have been leading players in the idiopathic inflammatory myositis market, offering approved treatments like OCTAGAM 10% in the US and EU, and VENOGLOBULIN-IH 5% in Japan.
• Current treatments for idiopathic inflammatory myositis, like corticosteroids and Disease-modifying Antirheumatic Drugs (DMARDs), can be ineffective for some patients and cause side effects. There is a critical need for more targeted therapies that address immune dysregulation with fewer adverse effects.
• DelveInsight's "Idiopathic Inflammatory Myositis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of idiopathic inflammatory myositis, historical and forecasted epidemiology, as well as the idiopathic inflammatory myositis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• The idiopathic inflammatory myositis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM idiopathic inflammatory myositis market size from 2020 to 2034. The report also covers idiopathic inflammatory myositis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Idiopathic Inflammatory Myositis Understanding and Treatment Algorithm

Idiopathic inflammatory myositis overview

Myositis, literally meaning "muscle inflammation," refers to a diverse group of diseases characterized by inflammation of striated muscle tissue. Idiopathic Inflammatory Myopathies (IIM) are a subset of these conditions, marked by chronic muscle inflammation, weakness, and, in some cases, pain.

Inflammatory myopathies can take various forms based on their underlying cause, including infectious, autoimmune, drug-induced, and idiopathic myositis, as well as myositis associated with other conditions like inclusion body myositis and myositis ossificans. IIM encompasses conditions such as dermatomyositis, polymyositis, overlap myositis, sporadic inclusion body myositis (sIBM), and Necrotizing Autoimmune Myopathy (NAM).

Though rare, IIM can affect both adults and children, with patients typically presenting with sub-acute to chronic proximal muscle weakness, making activities like rising from a chair, climbing stairs, lifting objects, or combing hair difficult.

In addition to muscle weakness, myositis patients may experience a variety of other symptoms, which can even be the primary manifestation of the disease for some individuals. These include inflammatory arthritis, interstitial lung disease, and skin rashes.

Idiopathic inflammatory myositis diagnosis

Diagnosing myopathies involves a laboratory evaluation, imaging studies, multidisciplinary consultations, histologic examination, and potentially genetic studies. In the cases of immune-mediated necrotizing myopathy and Inclusion body myositis, the concept of inflammation must be rethought.

Idiopathic inflammatory myositis treatment

The main goals of IIM therapy are to restore muscle strength, limit/eliminate inflammation, and prevent other organ damage. It is ideal if the treatment involves a multidisciplinary approach; neurology, rheumatology, dermatology, pulmonary, physical occupational, and speech therapy.

The current therapeutic landscape in idiopathic inflammatory myositis overall includes the use of corticosteroids, including prednisolone, immunoglobulins including OCTAGAM 10%, immunosuppressants like methotrexate, mycophenolate, azathioprine, and biologics, including rituximab, abatacept, and TNF inhibitors.

Idiopathic Inflammatory Myositis Epidemiology

As the market is derived using a patient-based model, the Idiopathic Inflammatory Myositis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of idiopathic inflammatory myositis, type-specific diagnosed prevalent cases of idiopathic inflammatory, gender-specific diagnosed prevalent cases of idiopathic inflammatory, and age-specific diagnosed prevalent cases of idiopathic inflammatory myositis 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 total diagnosed prevalent cases of idiopathic inflammatory myositis in the 7MM were approximately 191,589 cases in 2023, which are expected to increase during the forecast period (2020-2034).
• In 2023, the US accounted for the highest diagnosed prevalent cases of idiopathic inflammatory myositis with approximately 91,734 cases, which are expected to increase by 2034.
• Among EU4 and the UK, Germany had the highest diagnosed prevalent cases of idiopathic inflammatory myositis with nearly 21,781 cases in 2023, followed by France with around 17,475 cases. On the other hand, Spain accounted for the least with nearly 6,235 cases.
• In 2023, Japan accounted for approximately 26,094 diagnosed prevalent cases of idiopathic inflammatory myositis which are expected to increase by 2034.
• In 2023, among the type specific diagnosed prevalent cases of idiopathic inflammatory myositis, the US accounted for approximately 30,649 cases for polymyositis, 38,517 cases for dermatomyositis, and 22,569 cases for inclusion body myositis.
• In 2023, Germany had approximately 8,712 males and 13,069 females diagnosed with idiopathic inflammatory myositis.
• In 2023, the diagnosed prevalent cases of idiopathic inflammatory myositis across the age groups 0-17 years, 18-44 years, 45-64 years, and 65 years and older were approximately 1,044, 7,959, 9,655, and 7,437, respectively, in Japan.

Idiopathic Inflammatory Myositis Drug Chapters

The drug chapter segment of the idiopathic inflammatory myositis report encloses a detailed analysis of idiopathic inflammatory myositis-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the idiopathic inflammatory myositis 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.

Marketed Drugs

OCTAGAM 10% (Intravenous Immune Globulin [Human]): Octapharma/Pfizer

OCTAGAM 10%, manufactured by Octapharma Pharmazeutika Produktionsges and distributed by Pfizer, is an intravenous immunoglobulin (IgG) solution derived from human plasma. Approved by the US FDA in July 2021, it is specifically indicated for the treatment of adult dermatomyositis, a rare autoimmune condition affecting muscle strength and skin. This medication helps improve muscle function and reduce skin rashes in affected patients. It has also received orphan drug designation from the US FDA. In Europe, OCTAGAM 10% was granted approval in June 2021 as an immunomodulatory therapy for dermatomyositis in adults, with national approval in Germany following in May 2021. The medication can be administered in hospitals, infusion centers, or at home.

VENOGLOBULIN-IH 5% IV (Human Immunoglobulin G): Mitsubishi Tanabe Pharma

VENOGLOBULIN-IH, developed by Mitsubishi Tanabe Pharma, is a human immunoglobulin derived from donated plasma, designed to address muscle weakness in patients with polymyositis or dermatomyositis who exhibit insufficient response to steroids. Domestic clinical studies demonstrated significant improvements in muscle strength and daily activity scores in these patients following treatment. The safety profile of VENOGLOBULIN-IH was found to be comparable to that of existing therapies. It has received orphan drug designation in Japan for the treatment of polymyositis and dermatomyositis. VENOGLOBULIN-IH was approved in Japan in October 2010 for treating muscle weakness in patients with these conditions who do not respond adequately to steroid therapy. The medication is administered intravenously.

Emerging Drugs

Dazukibart PF-06823859 (anti-beta interferon): Pfizer

Dazukibart (PF-06823859) is a potent humanized IgG1K monoclonal antibody in development for the treatment of moderate to severe dermatomyositis and polymyositis. As a selective interferon (IFNB1) blocker, it targets and inhibits the IL-23 cytokine, a key mediator in the immune response associated with autoimmune diseases. Administered via intravenous and subcutaneous injection, Dazukibart is designed to modulate immune activity in these conditions. It has received orphan drug designation and prime drug designation from the European Medicines Agency (EMA) for dermatomyositis. In the US, it holds both orphan drug and fast-track designations for the same indication.

Currently, dazukibart is in Phase III clinical trial for dermatomyositis and polymyositis.

Efgartigimod: Argenx

Efgartigimod is a first-in-class investigational antibody fragment designed to target the neonatal Fc receptor (FcRn). It is being explored for the treatment of severe autoimmune diseases associated with pathogenic immunoglobulin G (IgG) and IgG autoantibodies, where significant unmet medical needs exist. Already approved as VYVGART in the US, Europe, and Japan for the treatment of generalized Myasthenia Gravis (gMG) in adult anti-acetylcholine receptor antibody-positive patients, efgartigimod is now being evaluated in the ongoing ALKIVIA trial.

This seamless Phase II/III study is investigating its potential across three myositis subsets-Immune-mediated Necrotizing Myopathy (IMNM), Antisynthetase Syndrome (ASyS), and dermatomyositis-with results expected in the second half of 2024.

SAPHNELO (Anifrolumab): AstraZeneca

SAPHNELO (anifrolumab) is a fully human monoclonal antibody that targets subunit 1 of the Type I IFN receptor, effectively inhibiting the activity of Type I interferons. The drug has received orphan drug designation from the US FDA and is currently in Phase III development for the treatment of dermatomyositis.

Drug Class Insights

Idiopathic inflammatory myositis treatment primarily involves corticosteroids as the first-line therapy, often combined with immunosuppressants like methotrexate or azathioprine for patients who do not respond adequately. In cases of severe or resistant disease, intravenous immunoglobulin (IVIG) may be beneficial, and biologics such as rituximab are considered for refractory cases.

Emerging therapies include dazukibart (PF 06823859), efgartigimod, SAPHNELO (anifrolumab), brepocitinib, and HIZENTRA, among others.

Dazukibart (PF-06823859) is a humanized IgG1K monoclonal antibody that blocks Interferon beta 1 (IFNB1), a key mediator in autoimmune responses.

Efgartigimod works by targeting the neonatal FcRn receptor, preventing the recycling of IgG antibodies, which leads to a reduction in pathogenic IgG levels in autoimmune diseases. HIZENTRA delivers a broad range of IgG antibodies with potential immunomodulatory effects, helping neutralize pathogens and modulate immune responses, though its exact mechanism of action is unclear. Both aim to address autoimmune conditions like dermatomyositis by modulating IgG activity.

Market Outlook

Idiopathic inflammatory myositis, though classified as a rare disease, has gained increasing recognition in recent years. This is largely due to improvements in diagnostic techniques, greater awareness among healthcare professionals, and a deeper understanding of the condition. The rising incidence could drive market growth by identifying more patients seeking treatment. Management of inflammatory myositis typically involves a combination of pharmacological therapies and supportive interventions, with the primary objectives being to reduce inflammation, manage symptoms, maintain muscle function, and prevent complications.

The treatment landscape for idiopathic inflammatory myositis has advanced with a multi-faceted approach, combining medications, physical therapy, and supportive care. High-dose corticosteroids, such as prednisone or ACTHAR GEL, are typically the first-line therapy to control inflammation and immune response. Immunosuppressive agents like methotrexate, azathioprine, and tacrolimus are frequently added to reduce long-term corticosteroid use.

In cases of inadequate response, biologics such as rituximab offer targeted immune suppression. Physical therapy remains essential for maintaining muscle strength and function, while supportive measures, including NSAIDs and sun protection, help manage symptoms. Intravenous Immunoglobulin (IVIG) therapy provides another treatment option, with OCTAGAM 10% approved in the US and Europe and VENOGLOBULIN-IH 5% available in Japan. For severe refractory cases, IV cyclophosphamide may be considered, though its use is limited due to potentially severe side effects. Treatment plans are tailored based on disease severity and individual response, aiming to balance efficacy with minimizing side effects.

There is a significant need for new treatments for idiopathic inflammatory myositis, as existing therapies often fall short of fully managing the condition. Innovative drug development could provide more effective options for patients. Several promising drugs are currently in the pipeline, including dazukibart (PF 06823859), efgartigimod, SAPHNELO (anifrolumab), brepocitinib, HIZENTRA, empasiprubart, ulviprubart (ABC008), daxdilimab, nipocalimab, GLPG3667, enpatoran (M5049), froniglutide (PF1801), and CABA-201, among others.

• The total market size of idiopathic inflammatory myositis in the 7MM was approximately USD 447.0 million in 2023 and is projected to increase during the forecast period (2024-2034).
• The market size for Idiopathic Inflammatory Myositis in the US was approximately USD 268.3 million in 2023 and is anticipated to increase due to the launch of emerging therapies.
• The total market size of EU4 and the UK was calculated to be approximately USD 161.0 million in 2023, which was nearly 36% of the total market revenue for the 7MM.
• Among EU4 and the UK, Germany accounted for the highest market with approximately USD 47.5 million in 2023, followed by France with approximately USD 38.1 million in the respective year, and Italy with nearly USD 32.6 million in 2023.
• In 2023, the total market size of idiopathic inflammatory myositis was approximately USD 17.7 million in Japan, which is anticipated to increase during the forecast period (2024-2034).
• As per the estimates, among the therapies currently in use, the immunoglobulins held the largest market share, generating approximately USD 270.3 million in revenue in 2023 across the 7MM.

Idiopathic Inflammatory Myositis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.

Idiopathic Inflammatory Myositis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for idiopathic inflammatory myositis.

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 idiopathic inflammatory myositis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and 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 David Geffen School of Medicine, the US, University Hospital Aachen, Germany, Institute of Molecular Medicine, Brescia, Italy, National Institute of Allergy and Infectious Disease, Spain, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, UK, and Jikei University School of Medicine, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or idiopathic inflammatory myositis 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

As per the KOLs from the US, assessing disease activity in inflammatory myositis is challenging due to the absence of validated biomarkers or objective measures. Reliable biomarkers, advanced imaging, and functional assessment tools would improve treatment decision-making and provide more accurate monitoring of treatment efficacy.

As per the KOLs from Germany, dermatomyositis and polymyositis share lymphocytic inflammation, but differ in lymphocyte involvement and distribution. Polymyositis features CD8+ T-cells attacking muscle fibers, leading to diffuse endomysial inflammation, without vasculopathy. In dermatomyositis, B cells and complement target small blood vessels, causing perivascular inflammation, muscle microinfarction, and perifascicular atrophy.

As per the KOLs from Japan, in biologic agents like rituximab are considered for refractory or severe cases of myositis, targeting specific immune cells involved in the disease in Japan. When myositis is linked to certain autoantibodies, Intravenous Immunoglobulin (IVIG) is administered to help regulate the immune response.

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.

Market Access and Reimbursement

Pfizer OCTAGAM Copay Program

Pfizer's OCTAGAM Copay Program offers eligible patients with commercial insurance the opportunity to pay as little as USD 0 for OCTAGAM 10%. The program, available through specialty infusion pharmacies, provides a maximum benefit of USD 12,500 per calendar year or the cost of the patient's copay over 12 months, whichever is less. Patients enrolled in state or federally-funded insurance programs are not eligible.

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.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of idiopathic inflammatory myositis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the idiopathic inflammatory myositis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM idiopathic inflammatory myositis market.

Idiopathic inflammatory myositis report insights

• Patient Population
• Therapeutic Approaches
• Idiopathic Inflammatory Myositis Pipeline Analysis
• Idiopathic Inflammatory Myositis Market Size and Trends
• Existing and Future Market Opportunity

Idiopathic Inflammatory Myositis report key strengths

• 11 years Forecast
• The 7MM Coverage
• Idiopathic Inflammatory Myositis Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Idiopathic Inflammatory Myositis report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of idiopathic inflammatory myositis, the market size of idiopathic inflammatory myositis by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will Dazukibart (PF-06823859) affect the treatment paradigm of idiopathic inflammatory myositis?
• How will OCTAGAM 10% compete with other upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of idiopathic inflammatory myositis? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Idiopathic Inflammatory Myositis?
• What is the historical and forecasted idiopathic inflammatory myositis patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent idiopathic inflammatory myositis population during the forecast period (2024-2034)?
• What factors are contributing to the growth of idiopathic inflammatory myositis cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of idiopathic inflammatory myositis? What are the current clinical and treatment guidelines for treating idiopathic inflammatory myositis?
• How many companies are developing therapies for the treatment of idiopathic inflammatory myositis?
• How many emerging therapies are in the mid-stage and late stage of development for treating idiopathic inflammatory myositis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of idiopathic inflammatory myositis?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the idiopathic inflammatory myositis market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for idiopathic inflammatory myositis, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Idiopathic Inflammatory Myositis in 2020
• 3.2. Market Share (%) Distribution of Idiopathic Inflammatory Myositis in 2034

4. Epidemiology and Market Forecast Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Clinical Manifestations
• 7.3. Etiology and Risk Factors
• 7.4. Pathophysiology
• 7.5. Diagnosis
  • 7.5.1. Differential Diagnosis
  • 7.5.2. Diagnostic Criteria
    • 7.5.2.1. Bohan and Peter's Diagnostic Criteria for Polymyositis and Dermatomyositis
  • 7.5.3. Diagnostic Algorithm
  • 7.5.4. Diagnostic Guidelines
    • 7.5.4.1. The European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile IIM: 2017
• 7.6. Treatment
  • 7.6.1. Treatment Algorithm
  • 7.6.2. Treatment Guidelines
    • 7.6.2.1. British Society for Rheumatology Guideline on Management of Pediatric, Adolescent, and Adult Patients with IIM

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
• 9.3. Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the 7MM
• 9.4. The US
  • 9.4.1. Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
  • 9.4.2. Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
  • 9.4.3. Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
  • 9.4.4. Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
• 9.5. EU4 and the UK
  • 9.5.1. Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
  • 9.5.2. Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
  • 9.5.3. Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
  • 9.5.4. Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan
  • 9.6.2. Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan
  • 9.6.3. Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan
  • 9.6.4. Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan

10. Marketed Drugs

• 10.1. Key Cross Competition
• 10.2. OCTAGAM 10% (Intravenous Immune Globulin [Human]): Octapharma/Pfizer
  • 10.2.1. Product Description
  • 10.2.2. Product Profile
  • 10.2.3. Regulatory Milestone
  • 10.2.4. Other Developmental Activities
  • 10.2.5. Clinical Trials Information
  • 10.2.6. Safety and Efficacy
• 10.3. VENOGLOBULIN-IH 5% IV (Human Immunoglobulin G): Mitsubishi Tanabe Pharma
  • 10.3.1. Product Description
  • 10.3.2. Product Profile
  • 10.3.3. Regulatory Milestone
  • 10.3.4. Other Developmental Activities
  • 10.3.5. Clinical Trials Information
  • 10.3.6. Safety and Efficacy

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. Dazukibart PF-06823859 (anti-beta interferon): Pfizer
  • 11.2.1. Drug Description
  • 11.2.2. Drug Profile
  • 11.2.3. Other Developmental Activities
  • 11.2.4. Clinical Trials Information
  • 11.2.5. Safety and Efficacy
  • 11.2.6. Analyst Views
• 11.3. Efgartigimod: Argenx
  • 11.3.1. Drug Description
  • 11.3.2. Drug Profile
  • 11.3.3. Clinical Trials Information
• 11.4. SAPHNELO (Anifrolumab): AstraZeneca
  • 11.4.1. Drug Description
  • 11.4.2. Drug Profile
  • 11.4.3. Other Developmental Activities
  • 11.4.4. Clinical Trials Information
  • 11.4.5. Analyst Views
• 11.5. Brepocitinib: Priovant Therapeutics/Pfizer
  • 11.5.1. Drug Description
  • 11.5.2. Drug Profile
  • 11.5.3. Other Developmental Activities
  • 11.5.4. Clinical Trials Information
  • 11.5.5. Safety and Efficacy
  • 11.5.6. Analyst Views
• 11.6. HIZENTRA: CSL Behring
  • 11.6.1. Drug Description
  • 11.6.2. Drug Profile
  • 11.6.3. Other Developmental Activities
  • 11.6.4. Clinical Trials Information
  • 11.6.5. Analysts' View
• 11.7. Empasiprubart: Argenx
  • 11.7.1. Drug Description
  • 11.7.2. Drug Profile
  • 11.7.3. Clinical Trials Information
• 11.8. Ulviprubart (ABC008): Abcuro, Inc.
  • 11.8.1. Drug Description
  • 11.8.2. Drug Profile
  • 11.8.3. Other Development Activities
  • 11.8.4. Clinical Trial Information
  • 11.8.5. Safety and Efficacy
  • 11.8.6. Analyst Views
• 11.9. Daxdilimab: Amgen
  • 11.9.1. Drug Description
  • 11.9.2. Drug Profile
  • 11.9.3. Other Developmental Activities
  • 11.9.4. Clinical Trials Information
• 11.10. Nipocalimab: Janssen
  • 11.10.1. Drug Description
  • 11.10.2. Drug Profile
  • 11.10.3. Other Development Activities
  • 11.10.4. Clinical Trials Information
• 11.11. Froniglutide (PF1801): Immunoforge
  • 11.11.1. Drug Description
  • 11.11.2. Drug Profile
  • 11.11.3. Other Developmental Activities
  • 11.11.4. Clinical Trials Information
• 11.12. GLPG3667: Galapagos NV
  • 11.12.1. Drug Description
  • 11.12.2. Drug Profile
  • 11.12.3. Clinical Trials Information
  • 11.12.4. Safety and Efficacy
• 11.13. Enpatoran (M5049): Merck KGaA (EMD Serono Research & Development Institute)
  • 11.13.1. Drug Description
  • 11.13.2. Drug Profile
  • 11.13.3. Clinical Trials Information
• 11.14. CABA-201: Cabaletta Bio
  • 11.14.1. Drug Description
  • 11.14.2. Drug Profile
  • 11.14.3. Other Developmental Activities
  • 11.14.4. Clinical Trials Information
  • 11.14.5. Safety and Efficacy
  • 11.14.6. Analyst Views
• 11.15. Umbilical Cord Lining Stem Cells (ULSC): Restem
  • 11.15.1. Drug Description
  • 11.15.2. Drug Profile
  • 11.15.3. Clinical Trials Information
  • 11.15.4. Safety and Efficacy

12. Idiopathic Inflammatory Myositis: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
  • 12.2.1. Cost Assumptions and Rebates
  • 12.2.2. Pricing Trends
  • 12.2.3. Analogue Assessment
  • 12.2.4. Launch Year and Therapy Uptake
• 12.3. Market Outlook
• 12.4. Attribute Analysis
• 12.5. Total Market Size of Idiopathic Inflammatory Myositis in the 7MM
• 12.6. Total Market Size of Idiopathic Inflammatory Myositis by Therapies in the 7MM
• 12.7. Total Market Size of Idiopathic Inflammatory Myositis in the US
  • 12.7.1. Total Market Size of Idiopathic Inflammatory Myositis
  • 12.7.2. The Market Size of Idiopathic Inflammatory Myositis by Therapies in the US
• 12.8. Market Size of Idiopathic Inflammatory Myositis in EU4 and the UK
  • 12.8.1. Total Market Size of Idiopathic Inflammatory Myositis in EU4 and the UK
  • 12.8.2. The Market Size of Idiopathic Inflammatory Myositis by Therapies in EU4 and the UK
• 12.9. Market Size of Idiopathic Inflammatory Myositis in Japan
  • 12.9.1. Total Market Size of Idiopathic Inflammatory Myositis in Japan
  • 12.9.2. The Market Size of Idiopathic Inflammatory Myositis by Therapies in Japan

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight