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시장보고서
상품코드
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당뇨병성 망막병증 : 시장 인사이트, 역학 및 시장 예측(2036년)Diabetic Retinopathy - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
본 당뇨병성 망막병증 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대해 종합적인 분석을 수행하고 있습니다. 또한, 당뇨병성 망막병증 환자의 부담 추이, 매출액 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가하는 한편, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제공합니다. 본 보고서는 당뇨병성 망막병증 분야에서 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 환경을 분석하여 고부가가치 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
당뇨병성 망막병증의 유병률 증가
세계적으로 당뇨병 환자가 증가하고, 선별 검사 프로그램이 개선되며, 당뇨병에 대한 인식이 높아지는 가운데, 당뇨병성 망막병증의 유병률은 꾸준히 증가하고 있습니다. 이러한 환자 수 증가는 향후 몇 년간 시장 성장을 크게 견인할 것으로 예측됩니다.
표적 치료 분야의 기회 확대
항-VEGF 생물학적 제제의 사용 확대와 장시간 작용형 약물, 유전자 치료, 신호 전달 경로를 표적으로 하는 치료법 등 새로운 치료법의 등장으로 인해 당뇨병성 망막병증의 치료 환경은 변화하고 있습니다. 이러한 혁신 기술은 치료 효과의 지속성 향상, 치료 부담 경감, 그리고 시기능 개선을 목표로 하며, 향후 질환 관리의 방식을 재구축할 것입니다.
당뇨병성 망막병증 개요
당뇨병성 망막병증은 만성적인 고혈당에 기인하는 당뇨병 관련 미세혈관 장애로, 망막 혈관의 진행성 손상을 유발하며, 진행된 단계에서는 시력을 손상시키고 실명에 이를 수 있는 비정상적인 신생혈관의 형성을 초래합니다. 이는 특히 선진국에서 노동 연령층 성인의 중증 시력 상실을 일으키는 가장 흔한 원인 중 하나입니다. 이 질환의 병태는 미세 동맥류, 경성 침착물, 당뇨병성 황반부종 등의 초기 비증식성 변화부터 신생혈관 형성을 특징으로 하는 증식기에 이르기까지 다양합니다. 당뇨병성 망막병증의 위험과 진행은 혈당 조절 불량, 고혈압, 이상지질혈증, 신장병, 비만 및 기타 전신적 요인과 밀접한 관련이 있습니다. 치료를 소홀히 하면 돌이킬 수 없는 망막 손상으로 이어질 수 있지만, 정기적인 안과 검진을 통한 조기 발견과 적시의 치료를 통해 시력 예후는 크게 개선됩니다. 전 세계적으로 당뇨병의 부담이 커지는 가운데, 당뇨병성 망막병증의 유병률이 크게 증가할 것으로 예상되며, 예방 관리와 질환 관리의 중요성이 강조되고 있습니다.
당뇨병성 망막병증의 진단
당뇨병성 망막병증의 평가는 병력 청취, 안과 검사 및 영상 진단을 통해 이루어집니다. 환자에게는 시력 저하나 변동, 날파리증, 시야 결손 등의 증상이 나타날 수 있으며, 혈당이나 혈압 관리가 제대로 이루어지지 않는 것이 주요 위험 요인이 됩니다. 안저 검사에서는 일반적으로 미세 동맥류, 출혈, 경성 삼출물, 면화양 반점, 황반 부종이 관찰되며, 진행된 단계에서는 신생혈관이 확인됩니다. 이 질환은 비증식기(경증에서 중증)와 증식기로 분류되며, 후자의 경우 비정상적인 혈관 증식이나 출혈로 인해 시력 상실의 위험이 높아집니다. 플루오레세인 형광 안저 조영술과 같은 진단 도구는 혈관 누출이나 허혈을 감지하는 데 도움이 되며, 광간섭 단층촬영(OCT)은 망막 두께와 황반 부종을 평가합니다. HbA1c는 혈당 조절 및 질환의 진행 상황을 모니터링하기 위한 중요한 지표로 계속해서 자리 잡고 있습니다.
당뇨병성 망막병증의 치료
당뇨병성 망막병증의 치료는 질환의 병기와 중증도에 따라 다르지만, 그 주된 목적은 진행을 늦추고 시력 상실을 예방하는 데 있습니다. 초기 비증식기에는 적극적인 치료가 반드시 필요한 것은 아니며, 정기적인 경과 관찰과 함께 혈당 수치와 혈압을 엄격하게 관리하는 데 중점을 둡니다. 진행기, 특히 증식성 당뇨병성 망막병증이나 당뇨병성 황반부종이 확인되는 경우에는 치료 개입이 필요하며, 신생혈관 형성 및 체액 축적을 억제하기 위해 라니비주맙, 아프리벨셉트, 파리시맙, 그리고 적응증 외 사용인 베바시주맙 등의 항VEGF 약물을 유리체 내 주사합니다. 그 밖의 치료법으로는 삼출이나 비정상적인 혈관 증식을 억제하기 위한 레이저 광응고술과, 유리체 출혈이나 망막 박리 등의 합병증에 대한 유리체 절제술 등이 있습니다. 이러한 치료법은 질환의 진행을 효과적으로 안정화시키거나 지연시킬 수는 있지만, 완치를 보장하는 것은 아닙니다. 따라서 정기적인 안과 검진을 통한 지속적인 경과 관찰이 여전히 필수적입니다.
당뇨병성 망막병증의 역학 분석 및 예측에 관한 주요 조사 결과
당뇨병성 망막병증의 현재 치료법은 주로 흔한 합병증인 황반부종에 대처하는 데 중점을 두고 있습니다. 기존에 사용되어 온 유리체 절제술, 광응고 요법, 코르티코스테로이드 등의 치료법은 시력 개선 가능성이 낮고, 심각한 합병증 발생률이 높다는 문제가 있습니다. 그러나 최근, 항VEGF제가 당뇨성 황반부종(DME) 관리에 있어 유망한 진전으로 등장했습니다. 이러한 약물은 많은 DME 환자의 예후를 크게 개선했으나, 특히 여러 차례 치료를 받은 환자의 경우 모든 사례에 효과가 있는 것은 아닙니다.
당뇨병성 망막병증에 대한 약물 치료는 망막 손상을 줄이고 질환의 진행을 늦추는 것을 목적으로 합니다. 항-VEGF 요법은 주요 치료법 중 하나로, 비정상적인 혈관의 증식 및 누출을 방지합니다. 덱사메타손, 플루오시놀론 아세토니드, 트리암시놀론 아세토니드 등의 코르티코스테로이드는 염증이나 황반의 부기를 완화하지만, 안압 상승이나 백내장 등의 부작용을 일으킬 가능성이 있습니다. 병세가 진행된 증례의 경우, 전망막 광응고술이나 외과적 시술이 시행됩니다. 비승인 용도로 자주 사용되는 ‘아바스틴’은 보험 적용 범위가 넓은 치료 옵션 중 하나입니다. 신경 보호제, 유전자 치료, 새로운 약물 전달 시스템 등의 새로운 치료법은 치료 성과 향상을 목표로 하고 있습니다. 맞춤형 의료와 지속적인 연구는 장기적인 치료 효과와 접근성 최적화에 중점을 두고 있습니다.
당뇨병성 망막병증에 대한 비약물적 치료에서는 생활 습관 개선 및 의학적 개입을 통한 예방과 관리가 중시되고 있습니다. 혈당 조절과 혈압 관리는 질병의 진행을 늦추며, 항산화 물질이 풍부한 식이요법은 망막 건강 유지에 도움이 됩니다. 규칙적인 운동은 혈액 순환을 개선하고, 당뇨병의 합병증을 완화합니다. 범망막 광응고술 등의 레이저 치료는 진행된 증례에서 시력 상실을 예방합니다. 유리체 절제술은 출혈이나 흉터 조직을 제거합니다. 원격의료는 조기 발견과 경과 관찰을 촉진합니다. 플라보노이드와 항산화 물질을 함유한 자연 요법은 당뇨병성 망막병증의 증상 완화에 유망한 것으로 여겨지고 있습니다. 시력 손상을 최소화하기 위해서는 환자 교육과 정기적인 안과 검진이 여전히 필수적입니다. 다직종 협력을 통한 접근 방식은 환자에게 효과적인 관리와 치료 성과 향상을 보장합니다.
DelveInsight's 'Diabetic Retinopathy - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of diabetic retinopathy, historical and forecasted epidemiology, as well as the diabetic retinopathy market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.
The diabetic retinopathy market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates diabetic retinopathy 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 diabetic retinopathy 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 Diabetic Retinopathy Market
Rising Prevalence of Diabetic Retinopathy
The prevalence of diabetic retinopathy is steadily increasing, driven by the global rise in diabetes, improved screening programs, and greater disease awareness. This expanding patient pool is expected to significantly drive market growth over the coming years.
Growing Opportunities in Targeted Therapies
The diabetic retinopathy landscape is evolving with increasing adoption of anti-VEGF biologics and the emergence of novel therapies, including longer-acting agents, gene therapies, and pathway-targeted treatments. These innovations aim to improve durability, reduce treatment burden, and deliver better visual outcomes, reshaping future disease management.
Diabetic Retinopathy Overview
Diabetic retinopathy is a diabetes-related microvascular disorder that results from chronic hyperglycemia, leading to progressive damage of retinal blood vessels and, in advanced stages, the formation of abnormal new vessels that can impair vision and cause blindness. It is one of the most common causes of severe vision loss among working-age adults, particularly in developed regions. The disease spectrum ranges from early non-proliferative changes such as microaneurysms, hard exudates, and diabetic macular edema to proliferative stages characterized by neovascularization. The risk and progression of diabetic retinopathy are strongly associated with poor glycemic control, hypertension, dyslipidemia, nephropathy, obesity, and other systemic factors. If left untreated, it can lead to irreversible retinal damage; however, early detection through regular eye examinations and timely intervention significantly improves visual outcomes. With the growing global burden of diabetes, the prevalence of diabetic retinopathy is expected to rise substantially, underscoring the importance of preventive care and disease management.
Diabetic Retinopathy Diagnosis
Diabetic retinopathy is assessed through clinical history, ocular examination, and imaging. Patients may present with decreased or fluctuating vision, floaters, or visual field defects, while poor glycemic and blood pressure control are key risk factors. Fundus examination typically reveals microaneurysms, hemorrhages, hard exudates, cotton-wool spots, macular edema, and, in advanced stages, neovascularization. The disease is classified into nonproliferative (mild to severe) and proliferative stages, with the latter associated with a higher risk of vision loss due to abnormal vessel growth and hemorrhage. Diagnostic tools such as fluorescein angiography help detect vascular leakage and ischemia, while optical coherence tomography evaluates retinal thickness and macular edema. HbA1c remains an essential marker for monitoring glycemic control and disease progression.
Diabetic Retinopathy Treatment
Treatment of Diabetic retinopathy depends on disease stage and severity, with the primary goal of slowing progression and preventing vision loss. In early nonproliferative stages, active treatment may not be required, and management focuses on strict glycemic and blood pressure control with regular monitoring. In advanced stages, particularly proliferative diabetic retinopathy or when diabetic macular edema is present, intervention is necessary and includes intravitreal anti-VEGF injections such as ranibizumab, aflibercept, faricimab, and off-label bevacizumab to reduce neovascularization and fluid accumulation. Additional options include laser photocoagulation to control leakage and abnormal vessel growth, and vitrectomy surgery for complications like vitreous hemorrhage or retinal detachment. Although these treatments can effectively stabilize or slow disease progression, they are not curative, and ongoing monitoring with periodic eye examinations remains essential.
Diabetic Retinopathy Unmet Needs
The section "unmet needs of Diabetic Retinopathy" 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.
Comprehensive unmet needs insights in Diabetic retinopathy and their strategic implications are provided in the full report.
Key Findings from Diabetic Retinopathy Epidemiological Analysis and Forecast
Diabetic Retinopathy Drug Chapters & Competitive Analysis
The diabetic retinopathy 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 diabetic retinopathy treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the diabetic retinopathy therapeutics market.
Approved Therapies for Diabetic Retinopathy
Ranibizumab (LUCENTIS): Genentech
LUCENTIS is a vascular endothelial growth factor (VEGF) inhibitor that blocks VEGF from inside the eye. It is administered by intravitreal injection into the eye once a month, typically every 28 days. In April 2017, Genentech announced that the US FDA approved LUCENTIS (ranibizumab injection) at a 0.3 mg dose for monthly administration to treat all forms of diabetic retinopathy.
Aflibercept (EYLEA): Ionis Pharmaceuticals and AstraZeneca
EYLEA was approved by the FDA for the treatment of diabetic retinopathy in 2019. This approval marked the first time a VEGF inhibitor was approved for all stages of diabetic retinopathy, including DME, to reduce the risk of blindness. EYLEA is the only VEGF inhibitor approved with two dosing options for DR, allowing doctors to customize treatment to their patients' needs. The recommended dose for EYLEA in diabetic retinopathy is 2 mg administered by intravitreal injection every 4 weeks for the first 5 injections, followed by once every 8 weeks thereafter.
Diabetic Retinopathy Pipeline Analysis
Tarcocimab tedromer (KSI-301): Kodiak Sciences
Tarcocimab tedromer is a novel anti-VEGF biologic built on a proprietary antibody biopolymer conjugate platform. Administered via intravitreal injection and is expected to inhibit VEGF for up to 6 months continuously. The unique properties of KSI-301 are intended to provide patients with long-term control of DME and improve visual results while reducing the burden of frequent anti-VEGF injections. In addition, KSI-301 is designed to prevent and reverse the progression of diabetic retinopathy with long-term efficacy and may reduce the risk of vision-threatening complications from diabetic retinopathy. The Phase III GLOW2 study is a critical, multi-center clinical trial employing a prospective, randomized, and double-masked design to assess the effectiveness and safety of tarcocimab tedromer in patients with diabetic retinopathy who have not previously undergone treatment.
ABBV-RGX-314: Regenxbio/AbbVie
ABBV-RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV AAV8 vector containing a gene encoding a monoclonal antibody fragment. The expressed protein is designed to neutralize VEGF activity, modifying the pathway for the formation of new leaky blood vessels and retinal fluid accumulation. It is currently in Phase II of clinical development for the treatment of diabetic retinopathy. The company is currently enrolling patients in ALTITUDE (NCT04567550), a Phase II trial for the treatment of diabetic retinopathy using suprachoroidal delivery of ABBV-RGX-314.
Diabetic Retinopathy Key Players, Market Leaders, and Emerging Companies
Diabetic Retinopathy Drug Updates
Current treatments for diabetic retinopathy are predominantly focused on addressing macular edema, a common complication. Traditional therapies like vitrectomy, photocoagulation, and corticosteroids, historically utilized, lack the potential for vision enhancement and are associated with significant complication rates. However, in recent years, anti-VEGF drugs have emerged as a promising advancement in managing diabetic macular edema (DME). While these drugs have substantially improved outcomes for many DME patients, they may not be effective for all cases, particularly in those who have undergone multiple treatments.
Pharmacological treatments for diabetic retinopathy aim to reduce retinal damage and slow disease progression. Anti-VEGF therapy is the primary approach, preventing abnormal blood vessel growth and leakage. Corticosteroids like dexamethasone, fluocinolone acetonide, and triamcinolone acetonide reduce inflammation and macular swelling but may cause side effects like increased intraocular pressure and cataracts. Pan-retinal photocoagulation and surgical interventions address advanced cases. AVASTIN, often used off-label, is a widely reimbursed option. Emerging therapies, including neuroprotective agents, gene therapy, and novel drug delivery systems, aim to improve outcomes. Personalized medicine and ongoing research focus on optimizing long-term treatment efficacy and accessibility.
Non-pharmacological approaches to diabetic retinopathy emphasize prevention and management through lifestyle and medical interventions. Glycemic control and blood pressure regulation slow disease progression, while dietary modifications rich in antioxidants support retinal health. Regular exercise improves circulation, reducing diabetes complications. Laser therapy, such as pan-retinal photocoagulation, prevents vision loss in advanced cases. Vitrectomy removes hemorrhages and scar tissue. Telemedicine enhances early detection and monitoring. Natural remedies, including flavonoids and antioxidants, show promise in mitigating diabetic retinopathy. Patient education and routine eye screenings remain crucial for minimizing vision impairment. A multidisciplinary approach ensures effective management and improved outcomes for affected individuals.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Diabetic Retinopathy (2022-2036 Forecast)
The diabetic retinopathy market comprises Recombinant fusion protein, alongside monoclonal antibodies, each addressing stabilization or clearance pathways driving disease progression.
Diabetic Retinopathy 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 diabetic retinopathy market's uptake by drugs, patient uptake by therapy, and sales of each drug.
Diabetic Retinopathy Therapies Price Scenario & Trends
Pricing and analogue assessment of diabetic retinopathy 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.
Further details are provided in the final report....
Industry Experts and Physician Views for Diabetic Retinopathy
To keep up with diabetic retinopathy 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 diabetic retinopathy 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 diabetic retinopathy, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of North Carolina at Chapel Hill, the Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging diabetic retinopathy therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in diabetic retinopathy.
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 Diabetic retinopathy, 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.
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