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시장보고서
상품코드
2082976
류마티스성 다발근통 : 시장 인사이트, 역학 및 예측(2036년)Polymyalgia Rheumatica - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
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.
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 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 분석 및 예측에 관한 주요 조사 결과
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.
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 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.
Key Findings from Polymyalgia Rheumatica Epidemiological Analysis and Forecast
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
Polymyalgia Rheumatica Drug Updates
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.
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.
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.
Market Insights