US Age-Related Macular Degeneration Therapeutics Market Analysis

US Age-Related Macular Degeneration Therapeutics Market Analysis: Executive Summary

The US Age-Related Macular Degeneration (AMD) Therapeutics Market is at around US $4.53 Bn in 2022 and is projected to reach US $7.73 Bn in 2030, exhibiting a CAGR of 6.9% during the forecast period.

Age-related macular degeneration (AMD) is an eye condition that affects the macula, the centre of the retina, and can cause central vision loss. AMD is classified into two types, which are dry and wet. The most frequent is dry AMD, which can progress to wet AMD and involves the formation of aberrant blood vessels beneath the retina. Blurred or fuzzy vision, difficulty recognizing familiar faces, straight lines that appear wavy, and a dark, empty area or blind spot in the center of vision are all symptoms of AMD. While there is no cure for AMD, there are therapeutic options that may prevent or reduce the disease's progression. Nutritional supplements, vision rehabilitation programs, and low-vision equipment, among other options such as anti-VEGF therapies including Lucentis, Vabysmo, Avastin manufactured by Genetech, Eylea by Regeneron Pharmaceuticals, and laser therapy, are the main therapies available.

It is estimated that currently 19.8 million Americans are living with AMD, accounting for a prevalence rate of about 12% for the age group 40 years and older. This prevalence is directly proportional to the age of the population. The market is therefore driven by major factors like an increase in the aging population and the subsequent increase in prevalence, rapid products in pipelines such as stem cell therapy, increased government initiatives, and consumer knowledge of the therapeutics industry. However, the market's potential is constrained by factors like treatment inaccessibility and the high cost of treatments like gene therapy and laser surgery that are implemented in response to demand.

The market leader in the US is Regeneron Pharmaceuticals with Eylea, which is an anti-VEGF treatment for wet AMD and earns a revenue of more than US $5 Bn annually. Regeneron is closely followed by its close competitor, Novartis.

Market Dynamics

Market Growth Drivers

Rise in the prevalence of AMD: AMD is the primary cause of vision loss in the aging population, affecting nearly 19.8 million Americans aged 40 years and older, corresponding to a prevalence rate of around 12%. This prevalence is directly proportional to age, with a prevalence of 9.95 to 19.5% observed for early stages and up to 4% for late-stage AMD. These numbers are expected to increase in the forecasted period, which will drive market growth.

Technological advancements: Progress in gene therapy, stem cell therapy, and novel drug delivery systems like nanotechnology is leading to hopeful and promising treatment alternatives for AMD. These advancements present the possibility of new entrants in the market for enhanced effectiveness of innovative therapies, which contributes to the expansion of the market.

Government initiatives: The healthcare system in the US ensures access to treatments for AMD, which potentially stimulates growth in the market. The US government is investing heavily in research initiatives such as autologous stem cell transplants that introduce new drugs in the pipeline. Groups such as the Bright Focus Foundation encourage timely treatment initiation and comprehensive disease management. These initiatives attempt to identify more people in need of treatment, potentially increasing market demand.

Market Restraints

High cost of treatments: The primary treatment for wet AMD, anti-VEGF injections, is expensive. The cost of 0.5 ml of Lucentis solution is around US $1200 for cash-paying patients. This presents a considerable monetary burden for both patients and the healthcare system. Moreover, insurance does not cover these costs, resulting in an economic barrier for patients.

Limited accessibility: There are currently no FDA-approved therapies for dry AMD, the most frequent form, leaving a significant unmet medical need. Medicare, the principal payer for the majority of US seniors, imposes strict coverage requirements and treatment frequency limits for AMD medicines. This causes manufacturers uncertainty and may limit patient access, restricting market growth.

Treatment limitations: Patients experience inconvenience when receiving anti-VEGF injections on a regular basis, whether monthly or every other month. As a result, treatment noncompliance reduces treatment effectiveness. Furthermore, some patients experience adverse reactions from the medication, which further impairs their adherence to the treatment, limiting market growth

Notable Recent Updates

August 2022, Pegcetacoplan (APL-2) by Apellis Pharmaceuticals and Zimura (avacincaptad pegol) by Iveric Bio, two drugs that target the complement system, showed favorable outcomes in late-stage research. Potential approval could be a game changer for people suffering from dry AMD.

July 2020, the drug Abicipar pegol by AbbVie, which acts as an anti-VEGF molecule for wet AMD, was rejected by the US FDA owing to the side effects of intraocular inflammation.

Healthcare Policies and Regulatory Landscape

The healthcare policy and regulatory landscape in the United States is complex and involves oversight by various governmental bodies. The Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Department of Health and Human Services (HHS) are the primary regulatory authorities.

The FDA is responsible for ensuring the safety and effectiveness of pharmaceuticals, medical devices, and other healthcare products by granting approval before their licensure. This process involves stages like pre-clinical research, clinical trials, FDA submission and approval, post-approval surveillance, and reimbursement and coverage.

The governing bodies and their procedures significantly shape the framework of healthcare policy and regulation in the US

Competitive Landscape

Key Players

• Regeneron Pharmaceuticals
• Novartis AG
• F. Hoffman-La-Roche Ltd
• Apellis Pharmaceuticals
• AbbVie
• Bayer
• Genetech
• Outlook Therapeutics
• Senti Biosciences
• Bausch Health Companies, Inc