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류마티스성 다발근통 : 시장 인사이트, 역학 및 예측(2036년)

Polymyalgia Rheumatica - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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류마티스성 다발근통에 대한 인사이트 및 동향

  • 류마티스성 다발근통은 주로 50세 이상의 성인에게 발병하는 노화 관련 염증성 류마티스 질환으로, 근위부 근골격계의 통증과 뻣뻣함, 적침(ESR) 및 C-반응성 단백질(CRP)의 상승을 특징으로 하며, 거대세포성 동맥염과 임상적으로 중요한 중복 증상이 나타나는 점 때문에 고령자의 유병률에 크게 기여하고 있습니다.
  • 이 질환은 IL-6를 매개로 한 염증 신호 전달이 중심적인 역할을 하는 면역 조절 이상에 의해 유발되며, T세포의 균형 이상(조절 T세포의 감소, Th17 활성 증가) 및 질환 특이적 자가항체의 결여도 관찰되며, 이러한 소견들은 사이토카인 주도형 염증성 병태를 뒷받침하고 있습니다.
  • 치료 체계는 여전히 코르티코스테로이드에 대한 의존도가 높은 편이며, 글루코코르티코이드(프레드니손/프레드니솔론)는 증상을 신속하게 완화시켜 주지만, 감량 기간 중 높은 재발률과 심각한 장기 독성이라는 한계가 있어 스테로이드 절약 요법에 대한 수요가 증가하고 있습니다.
  • 승인된 치료법 중, 사릴마브(KEVZARA)는 류마티스성 다발근통에 대해 FDA가 승인한 최초이자 유일한 생물학적 제제로, 코르티코스테로이드에 대한 반응이 불충분한 환자나, 코르티코스테로이드 용량을 줄일 수 없는 환자에서 IL-6 수용체 억제가 효과적인 스테로이드 절약 기전임을 입증하고 있습니다.
  • 개발 중인 파이프라인은 IL-6를 표적으로 하는 것에 그치지 않고, 섹티누맙(COSENTYX)은 IL-17A 억제를 통해 류마티스성 다발근통에서 제3상 임상시험에서 양호한 결과를 보여주고 있어, 사이토카인을 표적으로 하는 치료 전략의 다양화가 시사되고 있습니다.
  • 11β-HSD1 억제제인 크로프트리벤(SPI-62)과 같은 새로운 접근법은 세포 내 글루코코르티코이드의 활성화를 억제하는 것을 목적으로 하며, 질환을 효과적으로 관리하는 동시에 장기 스테로이드 요법의 위험-이익 프로파일을 개선하는 것을 목표로 하고 있습니다.
  • 작용기전에 관한 진전이 있음에도 불구하고, 이 분야는 여전히 시장이 고도로 집중되어 있으며, 보급률은 낮은 상황입니다. 승인된 치료법과 후기 임상시험 단계에 있는 치료법이 제한적이기 때문에 치료의 주축으로서 코르티코스테로이드에 대한 의존이 계속되고 있습니다.
  • 고령화, 진단 기술의 발전, 치료 기간의 장기화를 배경으로 시장은 점차 확대될 것으로 예측됩니다. 이러한 성장은 지속적인 관해와 안전성 향상을 실현할 수 있는 스테로이드 절약형 생물학적 제제나 스테로이드 조절 요법의 도입에 점점 더 의존하게 될 것입니다.

류마티스성 다발근통 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 류마티스성 다발근통 환자의 부담 동향, 매출액 및 시장 점유율 동향, 정점 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가함과 동시에, 전 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 전망(과거 데이터 및 2022-2036년 전망)을 제시하고 있습니다. 본 보고서는 류마티스성 다발근통 분야의 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 현황을 분석하여 고부가가치 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

류마티스성 다발근통 시장을 주도하는 주요 요인

고령화에 따른 질병 부담 증가

류마티스성 다발근통은 주로 50세 이상의 환자에게 발병하며, 나이가 들수록 발병률이 크게 증가합니다. 고령 인구의 지속적인 증가로 인해, 진단을 받는 환자 수가 늘어나고 치료 수요가 확대될 것으로 예측됩니다.

장기간에 걸친 코르티코스테로이드의 독성 및 재발 위험으로 인한 높은 미충족 의료 수요

코르티코스테로이드는 여전히 류마티스성 다발근통의 표준 치료법이지만, 장기간 치료 시 심각한 부작용이 따르고, 투여량을 서서히 줄이는 과정에서 재발이 빈번하게 나타나기 때문에 효과적인 스테로이드 절약 요법에 대한 수요가 크게 증가하고 있습니다.

코르티코스테로이드 이외의 표적 치료의 확대

KEVZARA의 승인 및 기타 표적 면역 조절 요법의 발전으로 인해 류마티스성 다발근통의 치료 환경이 혁신을 이루고 있으며, 스테로이드 절약 요법의 도입 확대와 장기적인 질환 관리의 개선이 촉진되고 있습니다.

류마티스성 다발근통의 이해와 치료 알고리즘

류마티스성 다발근통의 개요

류마티스성 다발근통은 주로 50세 이상의 성인에게 발병하는 만성 염증성 류마티스 질환으로, 양쪽 어깨와 고관절의 통증, 오래 지속되는 아침 경직, 전신성 염증을 특징으로 합니다. 이 질환은 운동 기능이나 삶의 질을 현저히 저하시킬 가능성이 있으며, 거대세포성 동맥염과 빈번하게 연관되어 있어, 두 질환에 공통적으로 나타나는 염증성 질환의 스펙트럼을 반영하고 있습니다. 고령자에서 높은 유병률, 재발 위험, 그리고 장기간에 걸친 코르티코스테로이드 치료에 대한 의존성으로 인해 류마티스성 다발근통은 큰 임상적 부담이 되고 있습니다.

류마티스성 다발근통의 진단

류마티스성 다발근통의 진단은 주로 임상적이며, 특징적인 증상, 염증 지표의 상승, 그리고 다른 질환의 배제를 바탕으로 이루어집니다. 환자는 일반적으로 양쪽 어깨 통증, 아침에 나타나는 뻣뻣함, 그리고 적혈구 침강 속도(ESR) 및/또는 C-반응성 단백질(CRP) 수치의 상승을 보입니다. 2012년 EULAR/ACR 분류 기준은 이 질환의 분류를 뒷받침하는 것으로, 50세 이상, 양측 어깨 통증, 그리고 염증 지표의 이상을 주요 구성 요소로 포함하고 있습니다. 초음파 검사, MRI, PET/CT 등의 영상 진단법은 특히 비정형적인 증례에서 특징적인 염증성 변화를 파악하고 진단의 정확도를 높이기 위해 사용되기도 합니다.

류마티스성 다발근통의 치료

류마티스성 다발근통의 치료는 염증 억제, 증상 완화, 그리고 질환 재발 예방을 중심으로 진행됩니다. 글루코코르티코이드(프레드니손/프레드니솔론)는 여전히 1차 치료제로 사용되며, 일반적으로 증상을 빠르게 호전시킨 후 서서히 용량을 줄여 나갑니다. 그러나 잦은 재발이나 장기간 코르티코스테로이드 사용에 따른 부작용으로 인해, 스테로이드 사용을 최소화하는 치료법이 필요하고 있습니다.

재발이 반복되는 환자나 코르티코스테로이드에 대한 반응이 불충분한 환자의 경우, IL-6 수용체 억제제인 '케브자라(KEVZARA)'가 류마티스성 다발근통에 대해 FDA가 승인한 유일한 표적 치료제입니다. 특정 증례에서는 코르티코스테로이드 투여량을 줄이고, 장기적인 질환 관리를 돕기 위해 메토트렉세이트를 보조 요법으로 사용하는 경우가 있습니다.

류마티스성 다발근통의 역학

류마티스성 다발근통의 역학 분석 및 예측에 관한 주요 조사 결과

  • 류마티스성 다발근통은 주로 고령자에게서 나타나는 질환으로, 50세 이후부터 발병률이 급격히 상승하며, 발병 정점은 보통 70-80세이지만, 50세 미만에서는 드물며, 고령화 사회와 밀접한 관련이 있는 것으로 확인되었습니다.
  • 70-80세 연령대에서 가장 높은 질병 부담이 나타나며, 고령층에서는 발병률과 유병률 모두 현저히 증가하고 있습니다.
  • 여성의 발병률은 남성보다 높으며, 여성 대 남성의 비율은 보통 2 : 1에서 3 : 1 사이입니다.
  • 지역별 차이가 뚜렷하며, 남유럽에 비해 북유럽 및 스칸디나비아 국가들의 인구에서 발병률이 현저히 높은 것으로 나타나, 유전적 및 환경적 취약 요인이 관여하고 있음을 시사하고 있습니다.

류마티스성 다발근통 시장 전망

류마티스성 다발근통 시장은 비교적 소규모이긴 하지만 성장을 지속하고 있는 염증성 질환 부문으로, 인구 고령화와 50세 이상 성인층에서 이 질환에 대한 인지도 제고에 힘입어 성장하고 있습니다. 치료는 여전히 전신 코르티코스테로이드에 크게 의존하고 있으며, 이러한 약물은 증상을 신속하게 완화시켜 주지만, 감량 기간 중 빈번한 재발은 물론 골다공증, 당뇨병, 심혈관계 합병증 등 심각한 장기적 부작용을 동반합니다. 그 결과, 안전성을 높이는 동시에 지속적인 관해를 유지할 수 있는 효과적인 스테로이드 절약 요법 및 질환 수정 요법에 대한 미충족 의료 수요가 극도로 높아지고 있습니다.

치료 양상은 표적형 생물학적 제제의 도입에 따라 변화하기 시작하고 있습니다. 그 선구자가 바로 류마티스성 다발근통 치료제로 최초로 승인된 생물학적 제제 'KEVZARA'이며, 이를 통해 IL-6 억제가 효과적인 치료 전략임이 입증되었습니다. 이러한 획기적인 진전에도 불구하고, 시장 상황은 여전히 침체되어 있으며, 고도의 치료 옵션은 제한적이어서 1차 치료법으로 코르티코스테로이드에 대한 의존이 계속되고 있습니다. 개발 파이프라인은 비교적 적지만 활발하게 진행되고 있으며, COSENTYX와 같은 약물은 3상 임상시험에서 양호한 결과를 보여, 사이토카인을 표적으로 하는 기전의 추가 확대를 뒷받침하고 있습니다. 한편, 11β-HSD1 억제(예 : 크로프트리벤)와 같은 새로운 접근법은 글루코코르티코이드와 관련된 독성을 줄이는 것을 목표로 하고 있습니다.

표적 치료의 적용 확대에 따라, 류마티스성 다발근통에서 스테로이드 절약 요법의 상업적 및 임상적 유효성이 입증되고 있습니다. 앞으로 시장에서는 지속적인 질환 관리, 코르티코스테로이드 노출 감소, 재발 관리 개선을 가져오는 생물학적 제제 및 신흥 표적 치료제가 점점 더 지지를 받을 것으로 예상되며, 이러한 치료법들은 기존의 장기 스테로이드 요법을 대체하며 시장 점유율을 확대해 나갈 것으로 보입니다.

  • 추산에 따르면, 2025년에는 주요 7개국(주요 7개 시장) 중 미국이 류마티스성 다발근통 시장에서 가장 큰 규모를 차지했습니다.
  • 류마티스성 다발근통의 지역별 시장 동향을 살펴보면, 매출액 면에서는 미국이 1위를 차지하고 있는 반면, 일본과 유럽에서는 유병률 상승, 진단 기술의 발전, 그리고 첨단 치료법의 도입 확대에 힘입어 꾸준한 성장세를 보이고 있습니다.
  • IL-6 수용체 억제제 : KEVZARA는 IL-6 수용체의 신호 전달을 억제하고 전신성 염증 반응을 완화함으로써, 류마티스성 다발근통에서 스테로이드 사용을 줄이는 표적 치료를 가능하게 합니다.
  • IL-17A 억제제인 COSENTYX는 IL-17A를 매개로 하는 염증 신호 전달을 억제하여 질환 관리 개선을 목표로 연구가 진행되고 있는 새로운 사이토카인 표적 기전을 구현하고 있습니다.
  • 11β-HSD1 억제제인 크로프트리벤은 코르티손이 코르티솔로 전환되는 과정을 억제함으로써 세포 내 코르티솔의 활성화를 억제하고, 글루코코르티코이드의 독성을 경감시키기 위한 새로운 국소적 스테로이드 절약 전략을 제공합니다.

자주 묻는 질문

  • 류마티스성 다발근통은 어떤 질환인가요?
  • 류마티스성 다발근통의 주요 치료법은 무엇인가요?
  • 류마티스성 다발근통 시장의 성장 요인은 무엇인가요?
  • 류마티스성 다발근통의 진단 방법은 무엇인가요?
  • 류마티스성 다발근통 시장의 미래 전망은 어떻게 되나요?
  • 류마티스성 다발근통의 역학적 특성은 무엇인가요?
  • 류마티스성 다발근통 시장에서 주요 기업은 어디인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 류마티스성 다발근통 : 주요 요약

제4장 주요 이벤트

제5장 류마티스성 다발근통 : 역학 및 예측 조사 방법

제6장 류마티스성 다발근통 : 시장 개요

제7장 류마티스성 다발근통 : 질환 배경 및 개요

제8장 류마티스성 다발근통 : 치료

제9장 류마티스성 다발근통 : 역학 및 환자 인구

제10장 류마티스성 다발근통 : 환자 경과

제11장 류마티스성 다발근통 : 시판 치료제

제12장 류마티스성 다발근통 : 신흥 치료법

제13장 류마티스성 다발근통 : 주요 7개국 분석

제14장 류마티스성 다발근통 : 미충족 수요

제15장 류마티스성 다발근통 : SWOT 분석

제16장 류마티스성 다발근통 : KOL(Key Opinion Leader)의 견해

제17장 시장 참여 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

KTH 26.07.24

Polymyalgia Rheumatica Insights and Trends

  • Polymyalgia rheumatica is an age-associated inflammatory rheumatic condition predominantly affecting adults above 50 years, characterized by proximal musculoskeletal pain and stiffness, elevated ESR and CRP, and a clinically important overlap with giant cell arteritis, contributing significantly to morbidity in elderly populations.
  • The disease is driven by immune dysregulation with a central role of IL-6-mediated inflammatory signaling, along with T-cell imbalance (decreased regulatory T cells, increased Th17 activity) and absence of disease-specific autoantibodies, supporting a cytokine-driven inflammatory pathology.
  • The treatment paradigm remains highly corticosteroid-dependent, with glucocorticoids (prednisone/prednisolone) providing rapid symptom relief but limited by high relapse rates during tapering and significant long-term toxicity, driving demand for steroid-sparing strategies.
  • Among approved therapies, sarilumab (KEVZARA) is the first and only FDA-approved biologic for polymyalgia rheumatica, validating IL-6 receptor inhibition as an effective steroid-sparing mechanism in patients with inadequate response or inability to taper corticosteroids.
  • The emerging pipeline extends beyond IL-6 targeting, with secukinumab (COSENTYX) showing positive Phase III results in polymyalgia rheumatica through IL-17A inhibition, indicating diversification of cytokine-targeted strategies.
  • Novel approaches such as clofutriben (SPI-62), an 11B-HSD1 inhibitor, aim to reduce intracellular glucocorticoid activation, improving the benefit-risk profile of long-term steroid therapy while maintaining disease control.
  • Despite mechanistic advances, the landscape remains highly concentrated and under-penetrated, with a limited number of approved and late-stage therapies, leading to continued reliance on corticosteroids as the backbone of treatment.
  • The market is expected to evolve gradually, driven by aging populations, improved diagnosis, and longer treatment duration, with growth increasingly dependent on the adoption of steroid-sparing biologics and steroid-modulating therapies capable of achieving durable remission and improved safety outcomes.

DelveInsight's 'Polymyalgia Rheumatica- Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Polymyalgia Rheumatica, historical and forecasted epidemiology, as well as the Polymyalgia Rheumatica market trends in the United States, EU4 (Germany, Spain, Italy, and France), and the United Kingdom, and Japan.

The Polymyalgia Rheumatica market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates polymyalgia rheumatica patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in polymyalgia rheumatica and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Polymyalgia Rheumatica Market

Increasing disease burden in the aging population

Polymyalgia rheumatica primarily affects individuals aged 50 years and older, with incidence increasing substantially with advancing age. The continued growth of the elderly population is expected to expand the diagnosed patient pool and drive treatment demand.

High unmet need due to long-term corticosteroid toxicity and relapse risk

Although corticosteroids remain the standard of care for polymyalgia rheumatica, prolonged treatment is associated with significant adverse effects and frequent disease relapses during dose tapering, creating a strong need for effective steroid-sparing therapies.

Expansion of targeted therapies beyond corticosteroids

The approval of KEVZARA and the advancement of additional targeted immunomodulatory therapies are transforming the polymyalgia rheumatica treatment landscape, supporting greater adoption of steroid-sparing approaches and improved long-term disease management.

Polymyalgia Rheumatica Understanding and Treatment Algorithm

Polymyalgia Rheumatica Overview

Polymyalgia rheumatica is a chronic inflammatory rheumatic disorder that primarily affects adults aged 50 years and older and is characterized by bilateral shoulder and hip pain, prolonged morning stiffness, and systemic inflammation. The condition can significantly impair mobility and quality of life and is frequently associated with giant cell arteritis, reflecting a shared inflammatory disease spectrum. Owing to its prevalence in older adults, risk of relapse, and dependence on long-term corticosteroid therapy, polymyalgia rheumatica represents a significant clinical burden.

Polymyalgia Rheumatica Diagnosis

The diagnosis of polymyalgia rheumatica is primarily clinical and is based on characteristic symptoms, elevated inflammatory markers, and exclusion of alternative conditions. Patients typically present with bilateral shoulder pain, morning stiffness, and elevated erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) levels. The 2012 EULAR/ACR classification criteria support disease classification and incorporate age >=50 years, bilateral shoulder aching, and abnormal inflammatory markers as key components. Imaging modalities such as ultrasound, MRI, and PET/CT may be used to identify characteristic inflammatory changes and improve diagnostic confidence, particularly in atypical cases.

Polymyalgia Rheumatica Treatment

The treatment of polymyalgia rheumatica is centered on controlling inflammation, relieving symptoms, and preventing disease relapse. Glucocorticoids (prednisone/prednisolone) remain the first-line standard of care and typically provide rapid symptom improvement, followed by gradual dose tapering. However, frequent relapses and the adverse effects associated with long-term corticosteroid use have created a need for steroid-sparing therapies.

For patients with relapsing disease or inadequate response to corticosteroids, KEVZARA, an IL-6 receptor inhibitor, is the only FDA-approved targeted therapy for polymyalgia rheumatica. In selected cases, methotrexate may be used as adjunctive therapy to reduce corticosteroid exposure and support long-term disease management.

Polymyalgia Rheumatica Unmet Needs

The section "Unmet Needs of Polymyalgia Rheumatica" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Limited steroid-sparing treatment options beyond IL-6 inhibition

2. High rates of relapse and prolonged corticosteroid dependence

3. Lack of validated biomarkers for diagnosis, prognosis, and treatment monitoring

4. Challenges in differentiating polymyalgia rheumatica from mimicking conditions, and others.....

Polymyalgia Rheumatica Epidemiology

Key Findings from Polymyalgia Rheumatica Epidemiological Analysis and Forecast

  • Polymyalgia rheumatica is predominantly a disease of older adults, with incidence increasing sharply after 50 years of age and peak onset typically between 70-80 years, while being rare below 50 years, confirming its strong association with ageing populations.
  • The highest disease burden is observed in individuals aged 70-80 years, with both incidence and prevalence rising significantly in older populations.
  • Women are affected more frequently than men, with female-to-male ratios typically ranging from 2:1 to 3:1.
  • There is strong geographic variability, with significantly higher incidence in Northern European and Scandinavian populations compared to Southern Europe, suggesting a role of genetic and environmental susceptibility factors.

Polymyalgia Rheumatica Drug Analysis & Competitive Landscape

The Polymyalgia Rheumatica drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the polymyalgia rheumatica treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the polymyalgia rheumatica therapeutics market.

Approved Therapies for Polymyalgia Rheumatica

Sarilumab (KEVZARA): Regeneron

KEVZARA is a human monoclonal antibody targeting the IL-6 receptor, approved by the US FDA in February 2023 as the first and only biologic therapy for polymyalgia rheumatica in adults with an inadequate response to corticosteroids or inability to successfully taper treatment. The approval was supported by the pivotal Phase III SAPHYR trial, which demonstrated significantly higher sustained remission rates with KEVZARA plus a 14-week corticosteroid taper versus placebo plus a 52-week taper. By validating IL-6 inhibition as a targeted treatment approach, KEVZARA established a differentiated steroid-sparing therapy in a disease historically dependent on long-term corticosteroid use. Reflecting its growing commercial uptake, KEVZARA demonstrated strong year-over-year sales growth in 2025, reinforcing its importance within the evolving polymyalgia rheumatica treatment landscape.

Polymyalgia Rheumatica Pipeline Analysis

Clofutriben (SPI-62): Sparrow Pharmaceuticals

Clofutriben is an oral, selective 11B-HSD1 inhibitor developed by Sparrow Pharmaceuticals that reduces intracellular cortisol activation by blocking the conversion of cortisone to cortisol in peripheral tissues. Designed as a steroid-sparing therapy, it is being evaluated in polymyalgia rheumatica and other corticosteroid-dependent conditions to reduce steroid-related toxicity while maintaining disease control.

Secukinumab (COSENTYX): Novartis

COSENTYX is an IgG1 monoclonal antibody developed by Novartis that inhibits IL-17A, a key driver of inflammatory immune responses. Administered via subcutaneous injection, it is an established therapy across multiple autoimmune diseases and is being explored in polymyalgia rheumatica as a pipeline asset to reduce corticosteroid dependence and improve steroid-sparing disease control.

Polymyalgia Rheumatica Key Players, Market Leaders, and Emerging Companies

  • Novartis
  • Sparrow Pharmaceuticals
  • Regeneron, and others

Polymyalgia Rheumatica Drug Updates

  • In October 2025, Novartis announced that COSENTYX met the primary endpoint and all secondary endpoints in the Phase III REPLENISH trial in adults with polymyalgia rheumatica.
  • In October 2025, Novartis announced that the results would be presented at a medical congress and submitted to health authorities in the first half of 2026.

Polymyalgia Rheumatica Market Outlook

The polymyalgia rheumatica market is a relatively small but evolving inflammatory disease segment, driven by population aging and increasing recognition of the disease in adults aged >=50 years. Treatment remains largely dependent on systemic corticosteroids, which provide rapid symptom relief but are associated with frequent relapses during tapering and substantial long-term toxicities, including osteoporosis, diabetes, and cardiovascular complications. As a result, there is a significant unmet need for effective steroid-sparing and disease-modifying therapies that can maintain durable remission with improved safety.

The treatment landscape is beginning to shift with the introduction of targeted biologics, led by KEVZARA, the first approved biologic for polymyalgia rheumatica, which has validated IL-6 inhibition as an effective therapeutic strategy. Despite this milestone, the market remains underpenetrated, with limited advanced treatment options and continued reliance on corticosteroids as first-line therapy. The pipeline is relatively sparse but active, with agents such as COSENTYX showing positive Phase III results and supporting expansion into additional cytokine-targeted mechanisms, while novel approaches such as 11B-HSD1 inhibition (e.g., clofutriben) aim to reduce glucocorticoid-related toxicity.

Growing adoption of targeted therapies has reinforced the commercial and clinical viability of steroid-sparing treatment strategies in polymyalgia rheumatica. Looking ahead, the market is expected to increasingly favor biologics and emerging targeted agents that provide sustained disease control, lower corticosteroid exposure, and improved relapse management, positioning them to gain share over traditional long-term steroid-based regimens.

  • According to estimates, the United States accounted for the largest polymyalgia rheumatica market among the 7MM in 2025.
  • Regional market dynamics for polymyalgia rheumatica show the United States leading in revenue, while Japan and Europe demonstrate steady growth, driven by rising prevalence, improved diagnostics, and increasing adoption of advanced therapies.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Polymyalgia Rheumatica (2022-2036 Forecast)

The polymyalgia rheumatica treatment landscape is driven by cytokine-mediated inflammation and glucocorticoid-dependent immune suppression, with an increasing shift toward targeted biologics, including IL-6 and IL-17A inhibitors, as well as other steroid-sparing therapeutic approaches.

  • IL-6 Receptor Inhibitors: KEVZARA blocks IL-6 receptor signaling, reducing systemic inflammatory response and enabling a targeted steroid-sparing treatment approach in polymyalgia rheumatica.
  • IL-17A Inhibitors: COSENTYX inhibits IL-17A-mediated inflammatory signaling, representing an emerging cytokine-targeted mechanism under investigation for improved disease control.
  • 11B-HSD1 Inhibitors: Clofutriben reduces intracellular cortisol activation by blocking cortisone-to-cortisol conversion, offering a novel local steroid-sparing strategy to reduce glucocorticoid toxicity.

Polymyalgia Rheumatica Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the Polymyalgia Rheumatica drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The polymyalgia rheumatica treatment landscape is largely driven by glucocorticoids (prednisone/prednisolone), which remain first-line therapy due to rapid and robust symptom control. However, long-term use is limited by relapse during tapering and significant cumulative toxicity (osteoporosis, diabetes, cardiovascular risk), creating sustained demand for steroid-sparing options.

KEVZARA is the only FDA-approved biologic, targeting IL-6 receptor signaling and enabling reduced steroid dependence in select relapsing or steroid-taper-intolerant patients, with expected gradual, niche uptake rather than broad use. The pipeline is expanding but remains early. COSENTYX has demonstrated positive Phase III results in polymyalgia rheumatica via IL-17A inhibition but remains unapproved, while clofutriben offers a novel 11B-HSD1-mediated steroid-modulating approach aimed at reducing glucocorticoid toxicity as an adjunct strategy.

Overall, the market remains highly corticosteroid-dependent and concentrated, with limited approved alternatives and gradual movement toward mechanism-based therapies (IL-6, IL-17, steroid metabolism modulation). However, uptake of newer agents is expected to be slow and selective, constrained by clinical practice familiarity and limited late-stage pipeline depth, resulting in a gradual shift toward a steroid-sparing, multi-mechanistic treatment paradigm rather than full replacement of corticosteroids.

Detailed insights of emerging therapies' drug uptake is included in the report.

Market Access and Reimbursement of Polymyalgia Rheumatica

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.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report....

Polymyalgia Rheumatica Therapies Price Scenario & Trends

Pricing and analogue assessment of polymyalgia rheumatica therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.

Further details are provided in the final report....

Industry Experts and Physician Views for Polymyalgia Rheumatica

To keep up with polymyalgia rheumatica market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the emerging polymyalgia rheumatica therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in polymyalgia rheumatica, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at the country level. Centers such as the University of Tennessee, United States, and the Institute for General Practice and Interprofessional Care, University Hospital Tubingen, Germany, Asahikawa Medical University Hospital, Japan, etc., were contacted. Their opinion helps understand and validate current and emerging polymyalgia rheumatica therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Polymyalgia Rheumatica.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Polymyalgia Rheumatica, 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.

Conjoint analysis analyzes 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.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, 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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of Polymyalgia Rheumatica, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the polymyalgia rheumatica 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 in shaping and driving the 7MM polymyalgia rheumatica market.

Report Insights

  • Polymyalgia Rheumatica Patient Population Forecast
  • Polymyalgia Rheumatica Therapeutics Market Size
  • Polymyalgia Rheumatica Pipeline Analysis
  • Polymyalgia Rheumatica Market Size and Trends
  • Polymyalgia Rheumatica Market Opportunity (Current and Forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-Enabled Market Research Report
  • 11-Year Forecast
  • Polymyalgia Rheumatica Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Polymyalgia Rheumatica Treatment Addressable Market (TAM)
  • Polymyalgia Rheumatica Competitive Landscape
  • Polymyalgia Rheumatica Major Companies Insights
  • Polymyalgia Rheumatica Price Trends and Analogue Assessment
  • Polymyalgia Rheumatica Therapies Drug Adoption/Uptake
  • Polymyalgia Rheumatica Therapies Peak Patient Share Analysis

Report Assessment

  • Polymyalgia Rheumatica Current Treatment Practices
  • Polymyalgia Rheumatica Unmet Needs
  • Polymyalgia Rheumatica in Clinical Development Analysis
  • Polymyalgia Rheumatica Emerging Drugs Product Profiles
  • Polymyalgia Rheumatica Market Attractiveness
  • Polymyalgia Rheumatica Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Polymyalgia Rheumatica market size, the market size by therapies, the market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of Polymyalgia Rheumatica?
  • What are the disease risks, burdens, and unmet needs of Polymyalgia Rheumatica? What will be the growth opportunities across the 7MM concerning the patient population with Polymyalgia Rheumatica?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of Polymyalgia Rheumatica? What are the current guidelines for treating Polymyalgia Rheumatica in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Polymyalgia Rheumatica market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, 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.
  • Identifying strong upcoming 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.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarizes and simplifies complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Polymyalgia Rheumatica

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Forecast Methodology of Polymyalgia Rheumatica

6. Polymyalgia Rheumatica Market Overview at a Glance

  • 6.1. Market Share (%) Distribution of Polymyalgia Rheumatica in 2025
  • 6.2. Market Share (%) Distribution of Polymyalgia Rheumatica in 2036

7. Disease Background and Overview of Polymyalgia Rheumatica

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Pathophysiology
  • 7.4. Symptoms
  • 7.5. Risk Factor
  • 7.6. Diagnosis

8. Treatment of Polymyalgia Rheumatica

  • 8.1. Guidelines for Management of Polymyalgia Rheumatica

9. Epidemiology and Patient Population of Polymyalgia Rheumatica

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale: The 7MM
    • 9.2.1. Total Prevalent Cases of Polymyalgia Rheumatica
    • 9.2.2. Total Diagnosed Prevalent Cases of Polymyalgia Rheumatica
  • 9.3. The United States
    • 9.3.1. Polymyalgia Rheumatica Prevalent cases in the United States
    • 9.3.2. Polymyalgia Rheumatica Diagnosed Prevalent cases in the United States
    • 9.3.3. Polymyalgia Rheumatica Gender-specific Diagnosed Prevalent Cases in the United States
    • 9.3.4. Polymyalgia Rheumatica Treated Cases in the United States
  • 9.4. EU4 and the UK
    • 9.4.1. Polymyalgia Rheumatica Prevalent cases in EU4 and the UK
    • 9.4.2. Polymyalgia Rheumatica Diagnosed Prevalent cases in EU4 and the UK
    • 9.4.3. Polymyalgia Rheumatica Gender-specific Diagnosed Prevalent Cases in EU4 and the UK
    • 9.4.4. Polymyalgia Rheumatica Treated Cases in EU4 and the UK
  • 9.5. Japan
    • 9.5.1. Polymyalgia Rheumatica Prevalent cases in Japan
    • 9.5.2. Polymyalgia Rheumatica Diagnosed Prevalent cases in Japan
    • 9.5.3. Polymyalgia Rheumatica Gender-specific Diagnosed Prevalent Cases in Japan
    • 9.5.4. Polymyalgia Rheumatica Treated Cases in Japan

10. Patient Journey of Polymyalgia Rheumatica

11. Marketed Therapies of Polymyalgia Rheumatica

  • 11.1. Marketed Competitive Landscape of Polymyalgia Rheumatica
  • 11.2. Sarilumab (KEVZARA): Regeneron
    • 11.2.1. Product Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Development Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Analyst's Views

12. Emerging Therapies of Polymyalgia Rheumatica

  • 12.1. Emerging Competitive Landscape of Polymyalgia Rheumatica
  • 12.2. Secukinumab (COSENTYX): Novartis
    • 12.2.1. Product Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
    • 12.2.4. Safety and Efficacy
    • 12.2.5. Analyst's Views
  • 12.3. Clofutriben (SPI-62): Sparrow Pharmaceuticals
    • 12.3.1. Product Description
    • 12.3.2. Other Developmental Activities
    • 12.3.3. Clinical Development
    • 12.3.4. Safety and Efficacy
    • 12.3.5. Analyst's Views

13. Polymyalgia Rheumatica: 7MM Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook
  • 13.3. Conjoint Analysis
  • 13.4. Key Market Forecast Assumptions
    • 13.4.1. Cost Assumptions and Rebate
    • 13.4.2. Pricing Trends
    • 13.4.3. Analogue Assessment
    • 13.4.4. Launch Year and Therapy Uptake
  • 13.5. Total Market Size of Polymyalgia Rheumatica in the 7MM
  • 13.6. The United States
    • 13.6.1. Total Market Size of Polymyalgia Rheumatica in the United States
    • 13.6.2. Market Size of Polymyalgia Rheumatica by Therapies in the United States
  • 13.7. EU4 and the UK
    • 13.7.1. Total Market Size of Polymyalgia Rheumatica in EU4 and the UK
    • 13.7.2. Market Size of Polymyalgia Rheumatica by Therapies in EU4 and the UK
  • 13.8. Japan
    • 13.8.1. Total Market Size of Polymyalgia Rheumatica in Japan
    • 13.8.2. Market Size of Polymyalgia Rheumatica by Therapies in Japan

14. Unmet Needs of Polymyalgia Rheumatica

15. SWOT Analysis of Polymyalgia Rheumatica

16. KOL Views of Polymyalgia Rheumatica

17. Market Access and Reimbursement

  • 17.1. United States
    • 17.1.1. Centre for Medicare & Medicaid Services (CMS)
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. United Kingdom
  • 17.3. Japan
  • 17.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Polymyalgia Rheumatica: Market Access and Reimbursement

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

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