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시장보고서
상품코드
2082943
그레이브스 안병증 : 시장 인사이트, 역학 및 시장 예측(2036년)Graves Ophthalmopathy - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
본 ‘그레이브스 안병증 시장 보고서’에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, 그레이브스 안병증 환자의 부담 추이, 수익 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료 도입률 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서는 그레이브스 안병증의 주요 미충족 요구 사항을 부각시키고, 경쟁 환경 및 임상 상황을 분석하여 고부가가치 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
질병의 유병률 및 인지도 상승
그레이브스 안병증의 유병률 증가와 진단 기법의 발전으로 인해 환자층이 확대되고 있습니다. 또한, 임상의들 사이에서 이에 대한 인식이 높아짐에 따라 조기 발견 및 조기 치료로 이어지고 있습니다.
연구개발(R&D) 확대 및 전략적 제휴
로슈, 앰젠, 슬링 테라퓨틱스 등의 기업들은 혁신적인 투여 방법(피하 투여, 경구 투여) 및 신약 개발에 투자하고 있습니다.
그레이브스 안병증의 개요와 진단
그레이브스 안병증(갑상선 안증: TED라고도 함)은 그레이브스병에 수반되는 자가면역성 염증성 질환으로, 면역 매개성 안와 섬유아세포의 활성화로 인해 안외근 및 안와 지방의 비대가 발생합니다. 그 결과, 안구 돌출, 안검 후퇴, 안와 주위의 부종과 같은 특징적인 증상이 나타나며, 중증의 경우 시신경 압박을 유발합니다. 이 질환은 일반적으로 활동성 염증기를 거쳐 만성 섬유화기로 진행되며, 그 중증도는 경미한 불편감부터 시력을 위협하는 합병증에 이르기까지 다양합니다. 위험 요인으로는 흡연, 갑상선 기능 이상, 그리고 갑상선 자극 면역글로불린 수치 상승 등이 있습니다.
그레이브스 안병증의 진단은 주로 임상 소견에 근거하지만, 검사 소견 및 영상 소견을 통해 뒷받침됩니다. 환자에서는 일반적으로 눈의 자극감, 충혈, 복시, 진행성 안구 돌출이 나타납니다. 갑상선 기능 검사(TSH, 유리 T4, T3) 및 갑상선 항체 수치, 특히 TSH 수용체 항체의 측정은 기저에 있는 자가면역성 갑상선 질환을 확인하는 데 도움이 됩니다. 안와 CT나 MRI 등의 영상 검사는 안외근의 비대나 안와 조직으로의 확산 여부를 평가하고, 다른 안와 질환을 배제하기 위해 시행됩니다. 질환의 활동성과 중증도는 대부분의 경우 임상 활동성 점수(CAS)를 통해 평가되며, 이는 치료 방침을 결정하는 데 지침이 됩니다.
그레이브스 안병증의 현재 치료 현황
치료법은 질환의 중증도와 활동성에 따라 결정되며, 대증요법, 약물요법 및 외과적 접근법을 병행하여 시행됩니다. 경증의 경우, 윤활제 사용이나 금연 등 위험 요인을 관리함으로써 대처할 수 있지만, 중등도에서 중증의 활동성 질환에서는 대부분의 경우 면역억제요법이 필요하며, 일반적으로 메틸프레드니솔론 등의 정맥 내 코르티코스테로이드가 사용됩니다. 이 질환에 대해 유일하게 승인된 특이적 치료법은 앰젠(Amgen)사가 판매하는 'TEPEZZA'입니다. 이는 IGF-1 수용체를 표적으로 하며, 안구 돌출 및 복시의 완화에서 유의미한 효능이 입증되었습니다. 안와 감압술, 사시 수술, 눈꺼풀 수술 등의 외과적 시술은 일반적으로 비활동기이거나 시력을 위협하는 병태인 경우에 한해 시행됩니다.
그레이브스 안병증의 역학 분석 및 예측에 관한 주요 조사 결과
그레이브스 안병증의 치료 방식은 주로 지지 요법이나 수술에서 질환 수정 면역 요법으로 전환되고 있습니다. 기존의 치료법으로는 활동성 질환에 대해 메틸프레드니솔론 등의 고용량 정맥 내 코르티코스테로이드가 사용됩니다. 또한, 토시리주맙이나 리툭시맙 등 일부 적응증 외 사용 생물학적 제제가 난치성 환자에게 사용되고 있지만, 이들 약제는 TED(그레이브스 안병증)에 대해 특별히 승인된 것은 아닙니다.
암젠이 개발한 TED 최초의 표적 치료제인 테프로줌맙(TEPEZZA)의 승인으로 획기적인 진전이 이루어졌습니다. 이 약은 IGF-1R을 억제하여 안구 돌출 및 복시를 현저히 완화시킵니다. 파이프라인은 엘레그로버트와 같은 IGF-1R 항체, 사트랄리주맙과 같은 IL-6 억제제, 린시티닙과 같은 경구용 저분자 화합물 등 표적 치료제를 중심으로 확대되고 있습니다.
전반적으로, 표적 치료의 발전에 힘입어 2022년부터 2036년에 걸쳐 주요 7개국의 그레이브스 안병증 시장은 꾸준한 성장을 이룰 것으로 예상되며, 이는 이미 시판 중인 제품과 신약 파이프라인 모두에 큰 상업적 영향을 미칠 것으로 전망됩니다.
표적 면역요법은 시장 성장을 주도하는 핵심 혁신 동향을 정의하고 있습니다.
DelveInsight's 'Graves Ophthalmopathy - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Graves ophthalmopathy, historical and forecasted epidemiology, as well as the Graves ophthalmopathy market trends in the United States, EU4 (Germany, Spain, Italy, and France), and the United Kingdom, and Japan.
The Graves Ophthalmopathy market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates Graves' ophthalmopathy 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 Graves' ophthalmopathy 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 Graves Ophthalmopathy Market
Rising Disease Prevalence & Awareness
The increasing prevalence of Graves' ophthalmopathy and better diagnostic practices are expanding the patient pool, with improved awareness among clinicians, leading to earlier detection and treatment.
Increased R&D and Strategic Collaborations
Companies like Roche, Amgen, and Sling Therapeutics are investing in innovative delivery methods (subcutaneous, oral) and new drug development.
Graves Ophthalmopathy Overview and Diagnosis
Graves' ophthalmopathy, also known as Thyroid Eye Disease (TED), is an autoimmune inflammatory condition associated with Graves' disease in which immune-mediated activation of orbital fibroblasts leads to expansion of extraocular muscles and orbital fat. This results in characteristic features such as proptosis (eye bulging), eyelid retraction, periorbital edema, and, in severe cases, optic nerve compression. The disease typically follows an active inflammatory phase followed by a chronic fibrotic phase, and its severity can range from mild discomfort to vision-threatening complications. Risk factors include smoking, thyroid dysfunction, and high levels of thyroid-stimulating immunoglobulins.
Diagnosis of Graves' ophthalmopathy is primarily clinical, supported by laboratory and imaging findings. Patients commonly present with eye irritation, redness, diplopia, and progressive proptosis. Thyroid function tests (TSH, free T4, T3) and thyroid antibody levels, particularly TSH receptor antibodies, help confirm the underlying autoimmune thyroid disorder. Imaging studies such as CT or MRI of the orbits are used to assess enlargement of extraocular muscles and orbital tissue involvement, and to rule out other orbital pathologies. Disease activity and severity are often graded using clinical activity scores (CAS), which guide treatment decisions.
Current Graves Ophthalmopathy Treatment Landscape
Management depends on disease severity and activity, combining supportive, medical, and surgical approaches. Mild cases may be managed with lubricants and risk factor control, like smoking cessation, while moderate-to-severe active disease often requires immunosuppression, typically with intravenous corticosteroids such as Methylprednisolone. The only disease-specific approved therapy is TEPEZZA, marketed by Amgen, which targets the IGF-1 receptor and has shown significant efficacy in reducing proptosis and diplopia. Surgical interventions, including orbital decompression, strabismus surgery, or eyelid procedures, are typically reserved for the inactive phase or vision-threatening disease.
Graves' Ophthalmopathy Unmet Needs
The section "unmet needs of Graves' ophthalmopathy" 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 Graves Ophthalmopathy Epidemiological Analysis and Forecast
Graves Ophthalmopathy Drug Analysis & Competitive Landscape
The Graves' ophthalmopathy drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase III-I 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 graves ophthalmopathy treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the graves ophthalmopathy therapeutics market.
Approved Therapies for Graves Ophthalmopathy
Teprotumumab (TEPEZZA): Amgen
Teprotumumab, marketed as TEPEZZA, is an insulin-like growth factor-1 receptor (IGF-1R) inhibiting monoclonal antibody originally developed by Horizon Therapeutics and now part of Amgen following its 2023 acquisition. It is the first and only FDA-approved therapy specifically for TED, targeting the underlying autoimmune pathway rather than just symptoms. TEPEZZA has demonstrated strong efficacy in reducing proptosis and diplopia in clinical trials.
Graves Ophthalmopathy Pipeline Analysis
Elegrobart (VRDN-003): Viridian Therapeutics
Elegrobart is an investigational monoclonal antibody developed by Viridian Therapeutics for the treatment of TED. It targets and blocks the IGF-1R, a key pathway involved in the disease process. It is being developed as a potential best-in-class subcutaneous anti-IGF-1R therapy for self-administration at home using a low-volume autoinjector, with every-4-week or every-8-week dosing. The company, in its SEC filing, anticipated that Elegrobart is on track for a BLA submission anticipated in Q1 2027.
Linstinitb: Sling Therapeutics
Linsitinib is developed for TED that will ease the treatment burden for patients, caregivers, and physicians. Linsitinib is the first and only oral small-molecule therapy to establish statistical and clinical significance in TED. Linsitinib works by inhibiting the IGF-1R target, which is the only validated clinical target in TED and the only target for current FDA-approved therapies. Activation of the IGF-1R target leads to inflammation and proptosis seen in TED. Linsitinib has an established safety profile through treatment of more than 900 patients in fifteen clinical trials in multiple diseases.
Graves Ophthalmopathy Key Players, Market Leaders, and Emerging Companies
Graves Ophthalmopathy Drug Updates
The treatment landscape of Graves' ophthalmopathy has shifted from mainly supportive care and surgery toward disease-modifying immunotherapy. Conventional management includes high-dose intravenous corticosteroids such as Methylprednisolone for active disease. In addition, several off-label biologics, such as Tocilizumab and Rituximab, are used in refractory patients, although they are not specifically approved for TED.
A breakthrough came with the approval of Teprotumumab (TEPEZZA) by Amgen, the first targeted therapy for TED. It inhibits IGF-1R, leading to significant reductions in proptosis and diplopia. The pipeline is expanding with targeted approaches, including IGF-1R antibodies like elegrobart, IL-6 inhibitors such as satralizumab, and oral small molecules like linsitinib.
Overall, the advancements in targeted treatments are expected to drive steady growth in the 7MM Graves' Ophthalmopathy market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Graves Ophthalmopathy (2022-2036 Forecast)
The Graves' ophthalmopathy market comprises targeted immunotherapies, each targeting different aspects of Graves' ophthalmopathy.
Targeted Immunotherapy defines the core innovation landscape driving market growth.
Graves Ophthalmopathy 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 graves ophthalmopathy drug's uptake, performance at peak, factors affecting performance during the prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
The uptake of therapies in Graves' ophthalmopathy is expected to vary based on clinical positioning, mechanism of action, and stage of development. One approved therapy, TEPEZZA, is set to experience moderate but meaningful uptake. Its targeted IGF-1R inhibiting mechanism and demonstrated efficacy in reducing proptosis and diplopia support its use in active moderate-to-severe and refractory cases of Thyroid Eye Disease.
In contrast, pipeline candidates such as elegrobart (VRDN-003), satralizumab (RG6168), and linsitinib are likely to demonstrate progressive uptake upon approval, as these therapies are designed to improve upon existing treatment options by targeting key disease pathways such as IGF-1R signaling and IL-6-mediated inflammatory pathways.
Detailed insights into emerging therapies' drug uptake are included in the report
Graves Ophthalmopathy Therapies Price Scenario & Trends
Pricing and analogue assessment of Graves' ophthalmopathy 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 understanding of how pricing influences market access, adherence, and long-term uptake.
The recommended dosing regimen for TEPEZZA consists of an initial intravenous infusion of 10 mg/kg, followed by 20 mg/kg administered every three weeks for a total of seven additional infusions. The total treatment cost is approximately USD 350,000 for a 75 kg patient.
Industry Experts and Physician Views for Graves Ophthalmopathy
To keep up with Graves' ophthalmopathy 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 Graves' ophthalmopathy emerging 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 Graves' ophthalmopathy, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as the Institute for Genomic Sciences, Florida International University, and Essen University Hospital, etc. were contacted. Their opinion helps understand and validate current and emerging Graves' ophthalmopathy therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Graves ophthalmopathy.
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 Graves' ophthalmopathy, 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