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市場調査レポート
商品コード
1425960
中等度の加齢黄斑変性市場 - 市場の洞察、疫学、市場予測:2034年Intermediate AMD - Market Insights, Epidemiology, and Market Forecast - 2034 |
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中等度の加齢黄斑変性市場 - 市場の洞察、疫学、市場予測:2034年 |
出版日: 2024年02月01日
発行: DelveInsight
ページ情報: 英文 119 Pages
納期: 1~3営業日
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加齢黄斑変性(AMD)は60歳以上の視力低下の主な原因です。中等度AMDは、より進行したAMDに進行するリスクがあるため、臨床的にはより重要な区別です。病態生理、重症度、結果に関する知識が乏しいため、中等度AMDに対する効果的な治療法の開発が妨げられています。
中等度AMDから視力を脅かす後期AMDへの進行リスクを示すバイオマーカーを早期に検出することは、個人に合わせた管理と時宜を得た介入を行う上で極めて重要です。高リスク群に対する早期発見の潜在的利益にもかかわらず、EUでは一般にAMDのスクリーニングは行われていません。さらに、EUでAMD治療が受けられるかどうかは地域によって大きく異なります。例えば、ドイツでは、地方出身者が治療を受けるまでの期間は、大都市圏に比べ2倍近くかかります。英国では、患者の居住地によって40倍の差があります。
中等度AMDに対する根治的な治療法は存在せず、現在進行中の試験も限られています。AMDを中間段階で発見し治療することは、良好で機能的な視力を維持し、疾患末期の不可逆的な視力低下への進行を防ぐために極めて重要です。
2023年、主要7ヶ国における中等度のAMDの総市場規模は9億9,000万米ドルとなりました。米国における中等度のAMDの市場規模は、2023年に5億4,000万米ドルと推定され、予測期間中(2024年~2034年)に拡大が見込まれます。EU4ヶ国および英国における中等度のAMDの市場規模は、2023年に約3億2,000万米ドルと推定され、予測期間中の成長が期待されます。2032年、新興治療薬の中で最も収益が高かったのは、日本のルミネート(リステガニブ)でした。
主要7ヶ国Mの中で、2023年に中等度のAMDの有病率が最も高かったのは米国で、約1,986万1,500症例であり、これらの症例は予測期間中に増加すると予想されます。EU4ヶ国と英国では、2023年の中等度のAMD有病者数はドイツが最大で、スペインが最少でした。日本では、中等度のAMDは65~84歳の年齢層で最も多く、2023年には総症例の45%以上を占めています。
当レポートでは、主要7ヶ国における中等度のAMD市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。
DelveInsight's " Intermediate AMD - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of intermediate AMD, historical and forecasted epidemiology as well as the intermediate AMD market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The intermediate AMD market report provides current treatment practices, emerging drugs, intermediate AMD market share of the individual therapies, and current and forecasted intermediate AMD market size from 2020 to 2034, segmented by seven major markets. The report also covers current intermediate AMD treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Study Period: 2020-2034
Intermediate AMD Overview
Intermediate AMD represents a critical stage in the progression of this eye condition. Often asymptomatic or displaying minimal symptoms, individuals may experience distorted vision or central visual field loss. Notably, a heightened risk of progression to advanced AMD exists at this stage. Current standard care involves monitoring for changes in visual function and using tools like the Amsler grid. Despite limited available treatments, research explores innovative therapies, including risuteganib. Early detection and management are pivotal in preventing irreversible vision loss, making ongoing research crucial for addressing the challenges of intermediate AMD.
Intermediate AMD Diagnosis
Diagnosing Intermediate AMD involves identifying specific features like multiple medium drusen, at least one large druse, and non-center involving geographic atrophy. This stage may manifest mild visual changes, such as metamorphopsia or reduced visual acuity. Ophthalmologists use tools like the Amsler grid and conduct regular eye examinations for effective monitoring. As the intermediate stage poses a significant risk of progression to advanced AMD, accurate and timely diagnosis is crucial for implementing appropriate management strategies and preserving visual function. Diagnostic tests include visual acuity, dilated eye exams, Amsler grid, fluorescein angiography, and optical coherence tomography, contributing to accurate diagnosis and ongoing monitoring for timely interventions.
Further details related to diagnosis will be provided in the report…
Intermediate AMD Treatment
Treatmnet of Intermediate AMD emphasizes lifestyle adjustments, dietary modifications, and smoking cessation to potentially impede disease progression. Routine eye monitoring, employing tools such as the Amsler grid and comprehensive eye exams, plays a vital role. Standard care may include nutritional supplementation, drawing insights from studies like AREDS and AREDS2. Given the intermediate stage's risk of advancing to severe AMD, timely interventions are crucial for safeguarding visual function. While specific medical treatments for intermediate AMD are currently limited, ongoing research and clinical trials are actively seeking effective therapies for this disease phase.
Further details related to treatment will be provided in the report…..
The intermediate AMD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of intermediate AMD, diagnosed prevalent cases of intermediate AMD, and age-specific cases of intermediate AMD in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the intermediate AMD report encloses a detailed analysis of the mid-stage (Phase II/III and Phase II) pipeline drug. The current key players for emerging drugs and their respective drug candidates include Novartis (Iptacopan), Allegro Ophthalmics (Risuteganib). The drug chapter also helps understand the intermediate AMD clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.
Emerging Drugs
Iptacopan (LNP023): Novartis
Novartis Pharmaceuticals is developing Iptacopan, an oral small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, FB inhibitor LNP023 binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as intermediate age-related macular degeneration (iAMD), C3 glomerulopathy (C3G), paroxysmal nocturnal hemoglobinuria (PNH), etc. Recently, in December 2023, the US FDA approved FABHALTA (ipatocan) as the first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). Currently, the company is investigating iptacopan in the Phase II trial (NCT05230537) for the treatment of patients with early and intermediate age-related macular degeneration.
Risuteganib (ALG-1001): Allegro Ophthalmics
Allegro Ophthalmics is developing risuteganib (also known as ALG-1001), a breakthrough integrin-regulating therapy for ocular health that reduces mitochondrial dysfunction involved in intermediate dry AMD. By targeting multiple pathways, risuteganib helps reduce the cellular burden of oxidative stress and restores retinal homeostasis. Research suggests that risuteganib interferes with integrin functions that have been implicated in retinal diseases, giving it the potential for a broad-spectrum effect on different pathways of oxidative stress. Currently, the company has received the US FDA agreement under Special Protocol Assessment (SPA) for Phase IIb/III clinical trial of risuteganib for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD). Moreover, the overall protocol design of Phase IIb/III dry AMD clinical trial was finalized by the US FDA
Drug Class Insight
Integrin Inhibitor
Integrin inhibitor have been effective in several preclinical models, and promising results have been reported thus far from clinical trials. Indeed, most of the current avB3 clinical investigations centre on treating eye diseases (age-related macular degeneration (AMD) using topically dosed or intravitreally injected small molecules and peptides, although these molecules also inhibit other av integrins and/or a5B1 to varying degrees. The molecules that have progressed the furthest in the clinic are risuteganib (Luminate, Allegro Ophthalmics). It is a small peptide integrin regulator protecting cells of the human RPE against dysfunction related to oxidative stress. With age, decreased mitochondrial oxidative phosphorylation increases the generation of reactive oxygen species and decreased metabolic activity, thus negatively affecting cellular bioenergetics and mitochondrial functioning. It is also known that RPE mitochondrial dysfunction contributes to the oxidative stress causing AMD.
Intermediate AMD often presents with minimal symptoms, typically involving distorted vision or central visual field loss. Notably, rod recovery time after a bright flash is considerably more prolonged in AMD eyes, especially in the presence of reticular pseudodrusen. The therapeutic landscape of intermediate AMD is devoid of any approved treatment, and to manage this indication, there is a substantial unmet need for therapy to slow its worsening. The pathophysiology of dry AMD is poorly understood. However, there are chances of failure to reach the primary outcomes that might be linked to the advanced stage of the disease rather than a lack of action on appropriate targets. The lack of standardization and validation of related clinical trial endpoints remains an issue. Various composite measures have been used, but there is no gold standard. Composite endpoints and combined outcome measures are being increasingly used in longitudinal and interventional studies. There is no consensus on the best approach to implement combined endpoints in clinical trials on intermediate AMD, and further analysis is needed in this area as well. Current tests do not detect all of the sight problems experienced by people with earlier stages of the disease (e.g., iAMD). Furthermore, there is currently no way to identify which patients with iAMD are at greatest risk of progressing toward advanced AMD. Only few key players are active in the pipeline such as Novartis and Allegro Ophthalmics for the treatment of intermediate AMD.
Nutritional supplementation was predominantly initiated upon confirming a diagnosis of early or intermediate AMD, with a notable minority commencing after the onset of anti-VEGF therapy. Poor compliance, largely attributed to cost concerns, was frequently observed, especially in patients with early-stage disease. Refusal of nutritional supplementation was relatively uncommon. Ophthalmologists demonstrated a pragmatic outlook on the anticipated effects of supplements, with the primary expectation being the slowing of progression in the early stages of the disease. More than half anticipated a deceleration of progression even in the geographic atrophy stage. However, the expectation of halting progression during the later stages of the disease was notably lower.
Early detection and effective treatment of AMD at an intermediate stage would preserve good and functional vision because it would prevent the progression to the late stages of the disease, which are associated with profound and mostly irreversible vision loss.
Detailed market assessment will be provided in the final report.
Key Findings
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034. The landscape of intermediate AMD treatment has experienced a transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of retinal physicians, ophthalmologists, professionals, and the entire healthcare community in their tireless pursuit of advancing eye care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.
Intermediate AMD Pipeline Development Activities
The report provides insights into therapeutic candidates in Phase II/III, Phase II. It also analyzes key players involved in developing targeted therapeutics. Companies like Novartis and Allegro Ophthalmics actively engage in mid stage research and development efforts for intermediate AMD. The pipeline of intermediate AMDpossesses few potential drugs. However, there is a positive outlook for the therapeutics market, with expectations of growth during the forecast period (2024-2034).
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for intermediate AMD emerging therapy.
KOL- Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the intermediate AMD evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Retinal Specialist, ophthalmologist, eye specialist, and others.
DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the Institute for Saint John's Health Center in California, Byers Eye Institute, McPherson Eye Research Institute, Department of Ophthalmology, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or intermediate AMD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, 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. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Market Access and Reimbursement
Federal officials have approved the ForeseeHome reading center as an "independent diagnostic testing facility" covered by Medicare. The patient's Medicare copay for the service is about USD 15 a month, with no patient costs for the equipment and setup. There is also no cost to the prescribing clinician, and the device is shipped directly to the patient's home. With ForeseeHome conducting visual field tests through remote monitoring, there is no physician billing component for that specific home test. The remote monitoring system handles the billing directly with the insurance carrier for this single test. The economic benefit for the practice, in addition to the clinical advantages, lies in the ability to elevate the level of evaluation and management (E&M) code. This can be achieved through factors such as the time spent on the test or the complexity of the data being reviewed, providing an additional economic incentive for the practice.
In January 2020, the American Medical Association (AMA) established three new Current Procedural Terminology (CPT) Category III codes (0604T, 0605T, 0606T) to report patient-initiated remote retinal optical coherence tomography (OCT) scans performed by Notal Vision's home-based OCT technology. The new CPT codes allow for billing for the initial device provision, setup, and patient education on the use of the home OCT, as well as a means for the company's Notal Vision Diagnostic Clinic to provide technical support, data analyses, and reports to physicians and patients who can benefit from this technology. Prescribing physicians or other qualified healthcare professionals will be able to bill for reviewing, interpreting, and reporting data analyses every 30 days.
Detailed market access and reimbursement assessment will be provided in the final report.
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