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시장보고서
상품코드
2082938
건성 황반변성 : 시장 동향, 역학 및 시장 예측(2036년)Dry Age-related Macular Degeneration - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
주요 7개국 건성 연령 관련 황반변성(AMD) 시장 규모 및 전망
본 '건성 AMD 시장 보고서'에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, 건성 AMD 환자의 부담 추이, 수익 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료 도입률 분석을 평가하는 한편, 전 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 전망(과거 데이터 및 2022년-2036년 전망)을 제시하고 있습니다. 본 보고서는 건성 AMD 분야의 주요 미충족 의료 수요를 부각하고, 경쟁 구도 및 임상 환경을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
건성 AMD는 주로 60세 이상, 특히 85세 이상의 사람들에게 발병합니다. 전 세계 고령 인구의 급격한 증가는 환자 수의 직접적인 증가로 이어지고 있습니다.
건성 AMD는 이미 전체 AMD 사례의 약 85-90%를 차지하고 있으며, 시장 규모를 확대되고 있습니다. 지리적 위축(진행성 건성 AMD) 증가로 인해 치료 수요는 더욱 확대되고 있습니다.
광간섭 단층촬영(OCT)이나 안저 영상 진단과 같은 첨단 영상 진단 기술 덕분에 더욱 조기적이고 정확한 진단이 가능해지면서, 치료를 받는 환자 수가 증가하고 있습니다.
건성 노인성 황반변성(AMD)의 개요와 진단
건성 연령 관련 황반변성(AMD)은 주로 망막의 중심부이자 선명하고 세밀한 시력을 담당하는 황반에 영향을 미치는 만성적이고 진행성인 망막 질환입니다. 이는 노화성 황반변성 중 가장 흔한 형태입니다. 이 질환은 망막 아래에 '드루젠'이라 불리는 세포외 침착물이 축적되어 망막색소상피(RPE) 세포가 서서히 변성되는 것이 특징입니다. 시간이 지남에 따라 이는 중심 시력의 상실로 이어져, 독서, 운전, 얼굴 인식 등의 활동에 영향을 미칩니다. 병세가 진행된 단계에서는 돌이킬 수 없는 망막 세포 손실을 특징으로 하는 중증 형태인 ‘지리적 위축’으로 진행될 가능성이 있습니다. 위험 요인으로는 노화, 흡연, 유전적 소인, 심혈관 질환 등이 있습니다.
건성 AMD의 진단에는 종합적인 안과 검사와 첨단 영상 진단 기술이 활용됩니다. 안과 전문의는 일반적으로 동공 확장 검사를 통해 안저를 검사하여 드루젠이나 색소 변화를 확인합니다. OCT 등의 영상 진단법은 망막의 고해상도 단면 영상을 제공하여, 질환의 조기 발견 및 진행 상황의 경과 관찰을 가능하게 합니다. 또한, 안저 자가형광 검사나 플루오레세인 형광 안저 조영 검사도 망막의 건강 상태를 평가하고, 건성 AMD와 습성 AMD를 구별하기 위해 사용되기도 합니다. 진단 정확도를 높이고 조기 개입을 촉진하기 위해, 인공지능(AI)을 활용한 도구가 진단 워크플로우에 통합되는 사례가 늘고 있습니다.
현재 건성 노인성 황반변성(AMD)의 치료 현황
건성 AMD의 치료 옵션은 기존에 제한적이었으며, 주로 병변의 진행을 늦추는 데 중점을 두었고, 손상을 회복시키는 데는 중점을 두지 않았습니다. 질병 진행 위험을 줄이기 위해, 중간기에는 AREDS 연구의 배합(비타민 C, 비타민 E, 아연, 구리, 루테인, 제아잔틴)을 기반으로 한 영양 보충제 섭취가 일반적으로 권장됩니다. 최근에는 보체 억제제 등의 표적 치료제가 등장하면서, 지리적 위축에 대한 최초의 질환 수정 치료법이 제공되게 되었습니다. 저시력 보조기구나 생활 습관 개선(금연, 건강한 식습관 등)을 포함한 지지 요법은 여전히 치료에 있어 필수적인 요소입니다. 유전자 치료 및 재생 의학에 대한 지속적인 연구를 통해 치료의 전망이 더욱 크게 변화할 것으로 기대됩니다.
건성 연령 관련 황반변성(AMD)의 역학 분석 및 예측에 관한 주요 조사 결과
건성 연령 관련 황반변성(AMD)의 치료는 그동안 주로 영양 보충제(예: AREDS 제제), 생활 습관 개선, 그리고 질병의 진행을 늦추고 증상을 관리하기 위한 시각 보조 기구와 같은 대증 요법에 국한되어 왔습니다. 승인된 치료법으로는 아바신카프타드 페골(IZERVAY)과 페그세타코플란(SYFOVRE)이 있으며, 둘 다 보체 캐스케이드를 표적으로 합니다. 이러한 치료법은 지리적 위축의 진행을 늦춤으로써 기전에 기반한 치료로의 패러다임 전환을 나타내지만, 상실된 시력을 회복시킬 수는 없으며 정기적인 유리체 내 투여가 필요합니다.
건성 AMD 치료법 개발은 급속도로 진화하고 있으며, 보체 억제를 넘어선 새로운 생물학적 경로에 초점을 맞춘 치료법이 등장하고 있습니다. 틴라레반트(LBS-008)는 망막 내 유독한 비타민 A 대사 산물의 축적을 줄이도록 설계된 경구용 치료제로, 이를 통해 망막 변성의 주요 원인을 해결합니다. 마찬가지로, 길데우레티놀 아세테이트(ALK-001)는 비타민 A의 이량체화를 표적으로 하여 유해한 망막 침착물의 형성을 방지합니다. AVD-104는 당 면역 조절을 통해 염증을 완화하고 망막 세포를 보호합니다. 이러한 치료법들은 대사 경로나 염증 경로를 표적으로 하는 혁신적인 작용기전에 더해, 경구 투여 및 비침습적인 치료 옵션으로의 전환을 부각시키고 있습니다.
전반적으로, 승인된 보체 억제제와 다양한 표적 치료제 파이프라인의 등장은 건성 AMD에서 대증 요법에서 질병 수정 전략으로의 중요한 전환을 의미합니다. 임상시험 설계의 개선을 통해 2022년부터 2036년에 걸쳐 주요 7개국 시장 전반에서 혁신과 시장 확대가 촉진되어, 기존 제품 및 파이프라인 후보에 대해 큰 상업적 기회가 창출될 것으로 예측됩니다.
전반적으로, 건성 AMD 분야의 혁신은 보체 억제와 상호 보완적인 생물학적 경로에 작용하는 대사 및 망막 보호 전략의 결합을 통해 추진되고 있습니다. 이러한 치료법들이 임상 개발을 진행하며 주요 시장으로 확대됨에 따라, 치료 패러다임을 대증요법에서 지속적 질환 수정 치료로 전환하고, 오랫동안 충족되지 않았던 의료적 요구를 해결하며, 견실한 시장 성장을 뒷받침할 것으로 기대됩니다.
Dry Age-related Macular Degeneration (AMD) Market Size and Forecast in the 7MM
DelveInsight's 'Dry Age-related Macular Degeneration (AMD) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of dry AMD, historical and forecasted epidemiology, as well as the dry AMD market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Dry AMD market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates dry AMD 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 dry AMD 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 Dry Age-related Macular Degeneration (AMD) Market
Dry AMD predominantly affects people aged 60+ and especially 85+. The rapid growth of the elderly population globally is directly increasing the patient pool.
Dry AMD already accounts for ~85-90% of all AMD cases, amplifying market size. Growth in geographic atrophy (advanced dry AMD) further expands treatment demand.
Advanced imaging tools such as Optical Coherence Tomography (OCT) and Fundus imaging enable earlier and more accurate diagnosis, increasing the number of treated patients .
Dry Age-related Macular Degeneration (AMD) Overview and Diagnosis
Dry AMD is a chronic, progressive retinal disorder that primarily affects the macula, the central part of the retina responsible for sharp, detailed vision. It is the most common form of age-related macular degeneration. The condition is characterized by the accumulation of extracellular deposits called drusen beneath the retina and gradual degeneration of retinal pigment epithelium (RPE) cells. Over time, this leads to central vision loss, impacting activities such as reading, driving, and recognizing faces. Advanced stages may progress to geographic atrophy, a severe form marked by irreversible retinal cell loss. Risk factors include aging, smoking, genetic predisposition, and cardiovascular conditions.
Diagnosis of dry AMD relies on comprehensive ophthalmic evaluation and advanced imaging techniques. Eye care specialists typically use dilated fundus examination to identify drusen and pigmentary changes. Imaging modalities such as OCT provide high-resolution cross-sectional images of the retina, enabling early detection and monitoring of disease progression. Fundus autofluorescence and fluorescein angiography may also be used to assess retinal health and differentiate between dry and wet AMD. Increasingly, artificial intelligence-based tools are being integrated into diagnostic workflows to improve accuracy and facilitate earlier intervention.
Current Dry Age-related Macular Degeneration (AMD) Treatment Landscape
Treatment options for dry AMD have historically been limited, focusing mainly on slowing disease progression rather than reversing damage. Nutritional supplementation based on the AREDS Study formulation (vitamins C and E, zinc, copper, lutein, and zeaxanthin) is commonly recommended for intermediate stages to reduce progression risk. Recently, targeted therapies such as complement inhibitors have emerged, offering the first disease-modifying approaches for geographic atrophy. Supportive measures, including low-vision aids and lifestyle modifications (e.g., smoking cessation and healthy diet), remain essential components of care. Ongoing research into gene therapy and regenerative treatments is expected to further transform the therapeutic landscape.
Dry Age-related Macular Degeneration (AMD) Unmet Needs
The section "unmet needs of dry AMD" 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 Dry Age-related Macular Degeneration (AMD) Epidemiological Analysis and Forecast
Dry Age-related Macular Degeneration (AMD) Drug Analysis & Competitive Landscape
The dry AMD drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase III-II/III clinical trials and preclinical 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 dry AMD treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the dry AMD therapeutics market.
Approved Therapies for Dry Age-related Macular Degeneration (AMD)
Avacincaptad pegol (IZERVAY): Astellas Pharma and Iveric Bio
Avacincaptad pegol (IZERVAY) is a novel ophthalmic therapy developed by Iveric Bio and later commercialized under Astellas Pharma following its acquisition of Iveric Bio in 2023. It is an RNA aptamer-based drug designed for the treatment of geographic atrophy. The drug received US FDA approval in August 2023, marking a significant milestone as one of the first disease-modifying therapies targeting dry AMD progression. Avacincaptad pegol is administered as a monthly intravitreal injection into the affected eye. Its approval was based on Phase III trials (GATHER1 and GATHER2), which demonstrated a statistically significant reduction in the rate of geographic atrophy lesion growth compared with sham treatment.
Pegcetacoplan (SYFOVRE): Apellis Pharmaceuticals
Pegcetacoplan (SYFOVRE) is a first-in-class complement inhibitor approved for the treatment of geographic atrophy. It targets complement component C3, a central protein in the complement cascade. Administered via intravitreal injection either monthly or every other month, SYFOVRE demonstrated clinically meaningful reductions in GA lesion growth in Phase III (OAKS and DERBY) trials, with increasing efficacy observed over time. While it does not restore lost vision, it significantly slows disease progression.
Dry Age-related Macular Degeneration (AMD) Pipeline Analysis
Tinlarebant (LBS-008): Belite Bio
Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that contribute to disease progression in geographic atrophy. Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye.
Gildeuretinol acetate (ALK-001): Alkeus Pharmaceuticals
Oral gildeuretinol acetate (ALK-001) is a new molecular entity designed to reduce the dimerization of vitamin A without modulating the visual cycle. Gildeuretinol is being evaluated in clinical trials for the treatment of Stargardt disease and has been studied for geographic atrophy secondary to age-related macular degeneration.
Dry Age-related Macular Degeneration (AMD) Key Players, Market Leaders and Emerging Companies
Dry Age-related Macular Degeneration (AMD) Drug Updates
The treatment landscape for dry AMD has historically been limited to supportive care, primarily involving nutritional supplementation (e.g., AREDS formulations), lifestyle modifications, and visual aids to slow disease progression and manage symptoms. The approved therapies consist of Avacincaptad pegol (IZERVAY) and Pegcetacoplan (SYFOVRE), both targets the complement cascade. These therapies represent a paradigm shift toward mechanism-based treatment by slowing the progression of geographic atrophy, although they do not restore lost vision and require regular intravitreal administration.
The pipeline for dry AMD is rapidly evolving, with emerging therapies focusing on novel biological pathways beyond complement inhibition. Tinlarebant (LBS-008) is an oral therapy designed to reduce the accumulation of toxic vitamin A byproducts in the retina, thereby addressing a key driver of retinal degeneration. Similarly, Gildeuretinol acetate (ALK-001) targets vitamin A dimerization to prevent the formation of harmful retinal deposits. AVD-104 utilizes glycoimmune modulation to reduce inflammation and protect retinal cells. These therapies highlight a shift toward oral and less invasive treatment options, alongside innovative mechanisms targeting metabolic and inflammatory pathways.
Overall, the emergence of both approved complement inhibitors and a diverse pipeline of targeted therapies marks a significant transition from supportive care to disease-modifying strategies in dry AMD. Improved trial design is expected to drive innovation and market expansion across the 7MM from 2022 to 2036, yielding significant commercial opportunities for existing products and pipeline candidates.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Dry Age-related Macular Degeneration (AMD) (2022-2036 Forecast)
The dry AMD market (2022-2036 forecast) is increasingly transitioning toward mechanism-based therapies that target core disease pathways such as complement-mediated inflammation, retinal toxicity, and metabolic dysfunction. The market consists of small molecules and biologics.
Overall, innovation in dry AMD is being driven by a combination of complement inhibition and metabolic/retinal protection strategies acting on complementary biological pathways. As these therapies advance through clinical development and expand across major markets, they are expected to move the treatment paradigm beyond supportive care toward sustained disease modification, addressing longstanding unmet needs and supporting robust market growth.
Dry Age-related Macular Degeneration (AMD) 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 dry AMD 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.
During the forecast period, approved therapies such as IZERVAY and SYFOVRE are expected to witness increasing uptake as foundational treatments for geographic atrophy. Their adoption is primarily driven by their ability to slow disease progression through complement inhibition (C5 and C3 pathways, respectively).
Among emerging therapies, Tinlarebant (LBS-008) is expected to gain strong traction due to its oral administration and mechanism targeting vitamin A metabolism, offering a less invasive alternative with potential use in earlier-stage disease. Similarly, Gildeuretinol acetate (ALK-001) is projected to show promising uptake driven by its disease-modifying potential in reducing retinal toxicity. Overall uptake will depend on clinical efficacy, safety outcomes, and positioning alongside standard of care therapies.
Dry Age-related Macular Degeneration (AMD) Therapies Price Scenario & Trends
Pricing and analogue assessment of dry AMD 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.
Industry Experts and Physician Views for Dry Age-related Macular Degeneration (AMD)
To keep up with dry AMD 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 dry AMD 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 dry AMD, 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 Department of Ophthalmology at NYU Grossman School of Medicine, Saint John's Health Center, and Clinical Research at Sierra Eye Associates, etc. were contacted. Their opinion helps understand and validate current and emerging dry AMD therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in dry AMD.
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 dry AMD, 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 majorly 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