IgA Nephropathy Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• AMD is a leading cause of severe vision loss in people over age 60. Intermediate AMD is a more critical distinction clinically because it places the individual at risk for progression to more advanced AMD.
• Limited knowledge regarding pathophysiology, disease severity, and consequences is impeding the development of effective treatments for intermediate AMD.
• Detecting early biomarkers signaling the risk of progression from intermediate AMD to vision-threatening late stages is crucial for personalized management and timely intervention.
• Screening for AMD is generally not performed in the EU despite the potential benefits of early detection for high-risk groups. Additionally, the availability of AMD treatment in the EU can vary significantly based on geography. For instance, in Germany, the time to receive treatment is nearly twice as long for individuals from rural areas compared to metropolitan areas. In the UK, there can be a 40-fold difference depending on the patient's location within the country.
• No curative treatment exists for intermediate AMD, and only a limited number of trials are currently in progress. Detecting and treating AMD at an intermediate stage is crucial for preserving good and functional vision, preventing progression to irreversible vision loss in the late stages of the disease.
• Addressing the significant unmet need in treating Intermediate dry AMD, only candidates that stabilize mitochondria, such as Allegro's Risuteganib, have demonstrated improvements in best-corrected visual acuity (BCVA) in this patient population.
• AlphaRET 2RT (2RT is a rejuvenative retinal laser therapy that utilizes a nanosecond laser pulse and unique pixelated laser beam profile) stands as a prominent candidate for treating patients with iAMD at an earlier disease state, aiming to prevent late-stage progression. This marks a revolutionary shift from the current standard and presents substantial clinical and commercial potential.
• Adopting lifestyle changes like quitting smoking, managing blood pressure, and adopting a healthier diet has the potential to decrease the risk of disease progression.
• Payers are likely to show a high willingness to pay, considering the absence of approved therapies leading to a significant unmet need. The potential to prevent progression to wet AMD, associated with high treatment costs, further contributes to this willingness to pay.
• The ForeseeHome AMD Monitoring Program by Notal Vision introduces a new option for monitoring a patient's vision at home. This at-home monitoring, offered by ForeseeHome, addresses concerns about missing the conversion from intermediate AMD to neovascular AMD. By enabling frequent monitoring for at-risk patients, it increases the chances of early detection of conversion to neovascular AMD, ultimately reducing the risk of vision loss post-conversion.
• Currently, only two significant players, Novartis with Iptacopan and Allegro Ophthalmics with Risuteganib, are actively involved in the pipeline for intermediate AMD.
• Antioxidant vitamin and mineral supplementation, as per the Age-related Eye Disease Study (AREDS2), should be considered in patients with intermediate or advanced AMD. There is no evidence to support the use of these supplements for patients who have less than intermediate AMD and no evidence of any prophylactic value for family members without signs of AMD.
• In 2023, in the 7MM the total market size of intermediate AMD was ~USD 990 million.

This 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.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Intermediate AMD Disease Understanding and Treatment Algorithm

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.

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.

Intermediate AMD Epidemiology

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.

• Among the 7MM, the US accounted for the highest prevalent cases of intermediate AMD in 2023, with around 19,861,500 cases, these cases are expected to increase during the forecast period.
• Among EU4 and the UK, the total prevalent cases of intermediate AMD were maximum in Germany, while the lowest number of cases were in Spain in 2023.
• According to the estimates, in Japan, it is observed that intermediate AMD was most prevalent in the 65-84 years age group, accounting for over 45% of total cases in 2023.

Intermediate AMD Drug Chapters

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 avß3 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 a5ß1 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 Market Outlook

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.

Key Findings

• The total market size in the US for intermediate AMD was estimated to be ~USD 540 million in 2023, which is expected to grow during the forecast period (2024-2034).
• The total market size in EU4 and the UK for intermediate AMD was estimated to be nearly USD 320 million in 2023, which is expected to grow during the forecast period.
• In 2032, among the emerging therapies, the highest revenue was generated by Luminate (risuteganib), in Japan.

Intermediate AMD Drugs Uptake

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.

The 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.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of intermediate AMD, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of mid-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the intermediate AMD market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive intermediate AMD.

Intermediate AMD Report Insights

• Patient Population
• Therapeutic Approaches
• Intermediate AMD Pipeline Analysis
• Intermediate AMD Market Size and Trends
• Existing and Future Market Opportunity

Intermediate AMD Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Intermediate AMD Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Intermediate AMD Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Analyst Views)

FAQs

• What was the intermediate AMD market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
• What can be the future treatment paradigm for intermediate AMD?
• What are the disease risks, burdens, and unmet needs of intermediate AMD? What will be the growth opportunities across the 7MM concerning the patient population with intermediate AMD?
• What are the current options for the treatment of intermediate AMD? What are the current guidelines for treating intermediate AMD in the 7MM?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What is the patient share in Intermediate AMD?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving intermediate AMD.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis ranking of class-wise potential current and emerging therapies under the analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.