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한글목차
주요 하이라이트
2023년 특발성 염증성 근염 진단을 받은 유병자는 주요 7개국에서 약 191,589명이었습니다. 이 중 미국이 48%, EU 4개국과 영국이 약 38%, 일본이 14%를 차지합니다.
특발성 염증성 근염 시장은 빠르게 성장하고 있으며, 2024년부터 2034년까지 연평균 성장률(CAGR)이 견조할 것으로 예상됩니다. 주요 7개국에서 다주키바트(PF 06823859), 에프가티기모도, SAPHNELO(애니플로맙), 브레포시티닙, 하이젠트라(HIZENTRA)와 같은 혁신적인 치료제의 출시로 인해 시장이 확대될 것으로 예상됩니다. 또한, 유전적 소인, 바이러스 감염, 자외선 등의 위험 요인으로 인한 유병률 증가는 효과적인 치료에 대한 수요를 더욱 증가시킬 것으로 예상됩니다.
주요 7개국 특발성 염증성 근염 시장 규모는 2023년 약 4억 4,700만 달러에 달했습니다. 이 시장은 2024년부터 2034년까지 예측 기간 동안 연평균 21.1%의 CAGR로 성장할 것으로 예상됩니다.
특발성 염증성 근염 시장에서는 Octapharma, Pfizer, Mitsubishi Tanabe Pharma가 미국과 유럽에서 Octagam 10%, 일본에서 Venoglobulin-IH 5%와 같은 승인된 치료제를 제공하며 시장을 선도하고 있습니다.
코르티코스테로이드나 질병조절 항류마티스제제(DMARDs)와 같은 특발성 염증성 근염의 현재 치료법은 일부 환자에게는 효과가 없고 부작용을 유발할 수 있습니다. 부작용이 적고 면역 조절 이상을 다루는 보다 표적화된 치료법이 절실히 요구되고 있습니다.
본 보고서는 특발성 염증성 근염에 대한 상세한 이해, 과거 역학 및 예측, 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본의 특발성 염증성 근염 시장 동향을 전해드립니다.
현재 치료법, 신약, 개별 치료법의 시장 점유율, 2020년에서 2034년까지 주요 7개국 특발성 염증성 근염 시장 규모 현황과 예측을 제공합니다. 또한 특발성 염증성 근염의 치료 관행/알고리즘과 미충족 의료 수요를 포괄하여 최적의 기회를 발굴하고 시장 잠재력을 평가합니다.
근염은 말 그대로 '근육의 염증'을 의미하며, 근육 조직의 염증을 특징으로 하는 다양한 질환군을 말합니다. 특발성 염증성 근염(IIM)은 이러한 질환의 하위 집합으로, 만성적인 근염증, 근력 약화, 경우에 따라서는 통증을 특징으로 합니다.
염증성 근병증은 감염성 근염, 자가면역성 근염, 약물성 근염, 특발성 근염, 봉입체 근염, 골화 근염과 같은 다른 질환과 관련된 근염 등 근본적인 원인에 따라 다양한 병형이 있으며, IIM에는 피부 근염, 다발성 근염, 중복성 근염, 산발성 봉입체 근염(sIBM), 괴사성 자가면역성 근염(NAM) 등의 질환이 포함됩니다. 괴사성 자가면역성 근염(NAM) 등의 질환이 포함됩니다.
드물지만 IIM은 성인과 소아 모두에서 발생할 수 있으며, 환자는 보통 아급성에서 만성적인 근위근의 근력 저하를 보이며, 의자에서 일어나기, 계단 오르기, 물건 들기, 머리 빗기 등의 동작에 어려움을 겪습니다.
근력 약화 외에도 근염 환자는 다양한 다른 증상이 나타날 수 있으며, 이는 질병의 주요 증상일 수도 있습니다. 염증성 관절염, 간질성 폐질환, 피부 발진 등입니다.
근병증의 진단을 위해서는 임상 검사, 영상 검사, 다학제적 검사, 조직학적 검사, 유전학적 검사가 필요합니다. 면역 매개성 괴사성 근병증이나 봉입체 근염의 경우 염증의 개념을 다시 생각해야 합니다.
IIM 치료의 주요 목표는 근력 회복, 염증 억제 및 제거, 다른 장기 장애를 예방하는 것입니다. 신경과, 류마티스내과, 피부과, 호흡기내과, 물리치료, 작업치료, 언어치료 등 다학제적 접근을 통한 치료가 이상적입니다.
현재 특발성 염증성 근염의 치료에는 프레드니솔론을 포함한 부신피질 스테로이드, 옥타검 10%를 포함한 면역글로불린, 메토트렉세이트, 미코페놀산, 아자티오프린 등의 면역 억제제, 리툭시맙, 아바타셉트, TNF 억제제 등의 생물학적 제제가 사용되고 있습니다.
주요 7개국 M의 특발성 염증성 근염 총 진단 유병자 수는 2023년 약 19만 1,589명이며, 예측 기간(2020-2034년) 동안 증가할 것으로 예측됩니다.
2023년 특발성 염증성 근염 진단 유병자 수는 미국이 약 9만 1,734명으로 가장 많았으며, 2034년까지 증가할 것으로 예측됩니다.
EU 4개국과 영국에서 2023년 특발성 염증성 근염 진단을 받은 유병자 수는 독일이 약 2만 1,781명으로 가장 많았고, 프랑스가 약 1만 7,475명으로 그 뒤를 이었습니다. 반면 스페인은 약 6,235명으로 가장 적었습니다.
2023년에 진단된 특발성 염증성 근염 유병자 수는 일본이 약 2만 6,094명으로 2034년까지 증가할 것으로 예상됩니다.
2023년 특발성 염증성 근염의 유형별 진단 유병자 수 중 미국은 다발성 근염이 약 3만 649명, 피부 근염이 3만 8,517명, 봉입체 근염이 2만 2,569명이었습니다.
2023년 독일에서는 남성 약 8,712명, 여성 약 1만 3,069명이 특발성 염증성 근염 진단을 받았습니다.
2023년 일본에서는 0-17세, 18-44세, 45-64세, 65세 이상 연령대에서 특발성 염증성 근염으로 진단받은 유병자 수는 각각 1,044명, 7,959명, 9,655명, 7,437명, 7,437명이었습니다.
옥타검 10%(면역글로불린 정맥주사[인간]) : Octapharma/Pfizer
옥타검 10%는 Octapharma Pharmazeutika Produktionsges가 제조하고 Pfizer가 판매하는 인간 혈장 유래 정맥주사용 면역글로불린(IgG) 제제로, 2021년 7월 미국 FDA의 승인을 받았으며, 특히 근육과 피부에 영향을 미치는 근육과 피부에 영향을 미치는 희귀 자가면역질환인 성인 피부근육염 치료에 적응증을 획득했습니다. 이 약은 환자의 근육 기능을 개선하고 피부 발진을 완화합니다. 또한, 미국 FDA로부터 희귀의약품으로 지정되었습니다. 유럽에서 옥타검 10%는 2021년 6월 성인 피부근육염에 대한 면역조절요법으로 승인되었으며, 독일에서는 2021년 5월에 국내 승인을 받았습니다. 이 약은 병원, 수액센터 또는 가정에서 투여할 수 있습니다.
Mitsubishi Tanabe Pharma가 개발한 VENOGLOBULIN-IH는 헌혈혈장 유래 인간 면역글로불린 제제로, 스테로이드 효과가 불충분한 다발성 근염 또는 피부근염 환자의 근력저하를 개선할 목적으로 개발되었습니다. 국내 임상시험에서 치료 후 근력 및 일상생활 활동 점수가 유의하게 개선된 것으로 확인되었습니다. 또한, VENOGLOBULIN-IH의 안전성 프로파일은 기존 치료제와 동등한 것으로 확인되었습니다. 일본에서는 다발성 근염 및 피부근염 치료제로 희귀의약품으로 지정되어 있으며, 2010년 10월 일본에서 스테로이드 요법에 충분히 반응하지 않는 다발성 근염 및 피부근염 환자의 근력저하 치료제로 승인 받았습니다. 이 약은 정맥으로 투여합니다.
다즈키바르트 PF-06823859(항β 인터페론) : Pfizer
다주키바트(PF-06823859)는 중등도에서 중증의 피부근염 및 다발성 근염 치료제로 개발 중인 강력한 인간화 IgG1K 단클론항체입니다. 선택적 인터페론(IFNB1) 차단제로서 자가면역질환과 관련된 면역반응의 주요 매개체인 IL-23 사이토카인을 표적으로 억제합니다. 다주키바트는 정맥 및 피하 주사로 투여되며, 이러한 질환에서 면역 활성을 조절하도록 설계되었습니다. 다주키바트는 유럽의약품청(EMA)으로부터 피부근육염을 적응증으로 하는 희귀의약품 및 필수의약품으로 지정되었습니다. 미국에서는 같은 적응증에 대해 희귀의약품과 패스트트랙 지정을 받았습니다.
현재 다즈키바트는 피부근염과 다발성 근염을 대상으로 임상 3상 시험이 진행 중입니다.
에프갈티기모도 : Argenx
에프가르티기모드는 신생아 Fc 수용체(FcRn)를 표적으로 하는 최초의 임상시험용 항체 단편입니다. 이 약은 미충족 의료 수요가 높은 병원성 면역글로불린 G(IgG) 및 IgG 자가항체를 동반한 중증 자가면역질환의 치료제로 검토되고 있습니다. 항아세틸콜린 수용체 항체 양성 성인 환자를 대상으로 한 범발성 중증근무력증(gMG) 치료제로 미국, 유럽, 일본에서 이미 VYVGART로 승인된 에프가르티기모드는 현재 진행 중인 ALKIVIA 임상에서 평가되고 있습니다.
면역 매개성 괴사성 근병증(IMNM), 항신테아제 증후군(ASyS), 피부근염의 세 가지 근염 하위군에서 에프가르티기모드의 가능성을 검토하는 원활한 임상 II/III상 시험은 2024년 하반기에 결과를 발표할 예정입니다.
SAPHNELO(애니플로맙) : 아스트라제네카
SAPHNELO(애니플로맙)는 I형 IFN 수용체 서브유닛1을 표적으로 하는 완전 인간형 단클론항체로 I형 인터페론의 활성을 효과적으로 억제합니다. 미국 FDA로부터 희귀의약품으로 지정되었으며, 현재 피부근육염 치료제로 임상 3상 개발 단계에 있습니다.
특발성 염증성 근염의 치료는 주로 코르티코스테로이드가 1차 선택 약제로 사용되며, 충분한 효과를 얻지 못하는 환자에게는 메토트렉세이트나 아자티오프린과 같은 면역억제제를 병용하는 경우가 많습니다. 중증이나 저항성 환자에서는 면역글로불린 정맥주사(IVIG)가 효과적일 수 있으며, 난치성 환자에서는 리툭시맙과 같은 생물학적 제제를 고려합니다.
새로운 치료제로는 다주키바트(PF 06823859), 에프가티기모도, SAPHNELO(애니플로맙), 브레포시티닙, HIZENTRA 등이 있습니다.
에프가르티기모드는 신생아 FcRn 수용체를 표적으로 작용하여 IgG 항체의 재활용을 억제함으로써 자가면역질환에서 병원성 IgG 수치를 감소시키며, HIZENTRA는 면역조절 작용이 기대되는 광범위한 IgG 항체를 투여하여 병원체 중화 및 면역반응 조절에 도움을 주지만, 정확한 작용기전은 밝혀지지 않았습니다. 면역반응의 조절을 돕지만, 그 정확한 작용 기전은 밝혀지지 않았습니다. 둘 다 IgG 활성을 조절하여 피부근육염과 같은 자가면역질환을 치료하는 것을 목표로 하고 있습니다.
특발성 염증성 근염은 희귀질환으로 분류되지만, 최근 들어 인지도가 높아지고 있습니다. 이는 주로 진단 기술 향상, 의료 전문가들의 인식 개선, 병태생리에 대한 이해도가 높아졌기 때문입니다. 유병률의 증가는 더 많은 환자들이 치료를 받기 위해 더 많은 환자를 식별함으로써 시장 성장을 촉진할 수 있습니다. 염증성 근염의 치료는 일반적으로 약물 치료와 지지적 개입을 결합하여 염증을 억제하고 증상을 관리하며 근육 기능을 유지하고 합병증을 예방하는 것이 주요 목표입니다.
특발성 염증성 근염의 치료는 약물 치료, 물리치료, 지지요법 등 다각적인 접근을 통해 발전해 왔습니다. 프레드니손이나 액토겔과 같은 고용량 코르티코스테로이드는 염증과 면역반응을 조절하기 위한 1차 선택약물입니다. 메토트렉세이트, 아자티오프린, 타크로리무스 등의 면역억제제는 코르티코스테로이드의 장기 사용을 줄이기 위해 종종 추가됩니다.
효과가 불충분한 경우, 리툭시맙과 같은 생물학적 제제로 표적 면역억제를 시행합니다. 물리치료는 근력과 기능 유지에 필수적이며, 비스테로이드성 항염증제(NSAIDs)와 자외선 차단과 같은 지지요법은 증상 관리에 도움이 됩니다. 면역글로불린 정맥주사 요법(IVIG)도 치료 옵션 중 하나이며, 미국과 유럽에서는 옥타검 10%가, 일본에서는 베노글로불린-IH 5%가 승인되었습니다. 중증 난치성 환자의 경우, 시클로포스파미드 정맥주사 요법이 고려되지만, 심각한 부작용의 가능성으로 인해 사용이 제한되어 있습니다. 치료 계획은 질병의 중증도 및 개인별 반응성에 따라 조정되며, 효과와 부작용 최소화의 균형을 목표로 합니다.
특발성 염증성 근염은 기존 치료법으로 충분한 치료 효과를 얻지 못하는 경우가 많기 때문에 새로운 치료법의 필요성이 높습니다. 혁신적인 약물 개발은 환자들에게 보다 효과적인 치료 옵션을 제공할 수 있습니다. 현재 dazukibart(PF 06823859), efgartigimod, SAPHNELO(anifrolumab), brepocitinib, HIZENTRA, empasiprubart, ulviprubart(ABC008), daxdilimab, nipocalimab, nipocalimab, nipocalimab, dazukibart(PF 06823859), efgartigimod, SAPHNELO(anifrolumab) nipocalimab,GLPG3667,enpatoran(M5049),froniglutide(PF1801),CABA-201 등 몇 가지 유망한 약물이 파이프라인에 있습니다.
주요 7개국 특발성 염증성 근염의 총 시장 규모는 2023년 약 4억 4,700만 달러로 예측 기간(2024-2034년) 동안 확대될 것으로 예상됩니다.
미국의 특발성 염증성 근염 시장 규모는 2023년 약 2억 6,830만 달러로, 새로운 치료제의 출시로 인해 증가할 것으로 예상됩니다.
EU 4개국과 영국의 총 시장 규모는 2023년 약 1억 6,100만 달러로 주요 7개국 총 시장 수익의 약 36%를 차지했습니다.
EU 4개국과 영국 중에서는 독일이 2023년 약 4,750만 달러로 가장 높은 시장 규모를 차지했고, 프랑스가 약 3,810만 달러, 이탈리아가 약 3,260만 달러로 그 뒤를 이었습니다.
2023년 일본의 특발성 염증성 근염의 총 시장 규모는 약 1,770만 달러로 예측 기간(2024-2034년) 동안 확대될 것으로 예상됩니다.
현재 사용되고 있는 치료제 중 면역글로불린 제제가 가장 큰 시장 점유율을 차지하고 있으며, 2023년 주요 7개국 전체에서 약 2억 7,030만 달러의 매출을 기록할 것으로 추정됩니다.
본 보고서는 주요 7개국 특발성 염증성 근염 시장에 대해 조사했으며, 시장 개요, 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 미충족 의료 수요 등을 조사하여 전해드립니다.
Enpatoran(M5049) : Merck KGaA(EMD Serono Research & Development Institute)
CABA-201 : Cabaletta Bio
Umbilical Cord Lining Stem Cells(ULSC) : Restem
제12장 특발성 염증성 근염 : 시장 분석
주요 조사 결과
주요 시장 예측 가정
시장 전망
속성 분석
주요 7개국의 특발성 염증성 근염 전체 시장 규모
주요 7개국의 특발성 염증성 근염 치료법별 시장 규모
미국의 특발성 염증성 근염 전체 시장 규모
EU 4개국 및 영국의 특발성 염증성 근염 시장 규모
일본의 특발성 염증성 근염 시장 규모
제13장 주요 오피니언 리더의 견해
제14장 SWOT 분석
제15장 미충족 수요
제16장 시장 접근과 상환
미국
EU 4개국과 영국
일본
제17장 부록
제18장 DelveInsight의 서비스 내용
제19장 면책사항
제20장 DelveInsight 소개
ksm
영문 목차
영문목차
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.
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.
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.
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
