Germany Age-Related Macular Degeneration Therapeutics Market Analysis

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

The Germany Age-Related Macular Degeneration (AMD) Therapeutics Market is at around US $395 Mn in 2022 and is projected to reach US $684 Mn in 2030, exhibiting a CAGR of 7.10% during the forecast period.

Age-related macular degeneration (AMD) is a progressive ocular condition that predominantly affects older individuals, potentially resulting in significant vision loss. It specifically impacts the macula, which is responsible for central vision, thereby complicating tasks such as reading. The condition manifests in two main forms, namely dry AMD and wet AMD. Symptoms encompass distorted vision, difficulty seeing clearly, and a gradual deterioration of eyesight. Dry AMD is more prevalent but progresses at a slower rate. Conversely, wet AMD, while less common, is more severe and is characterized by the abnormal growth of blood vessels beneath the macula. Treatment options encompass anti-VEGF therapy, utilizing medications such as Lucentis, Vabysmo, Avastin (developed by Genentech), and Eylea (produced by Regeneron Pharmaceuticals). Additionally, laser therapy and the intake of nutritional supplements like zinc and copper serve as preventive measures.

It is estimated that the prevalence of AMD is around 8.5% in the older age group in Germany, where approximately 35,000 new AMD cases are diagnosed every year. However, the aging population above the age of 65 that is susceptible to AMD is expected to increase by 25% until the year 2050. Thus, there is a direct correlation between prevalence and age. Consequently, the market is fuelled by significant factors such as the growth of the aging population and the subsequent rise in prevalence, increased diagnosis and awareness, and increased government spending expanding the therapeutics industry. However, the lack of specialist professionals and the economic constraints for approaches like gene therapy and laser surgery, which are implemented in response to demand, limit the market's potential.

The market leader in France is Roche, with Lucentis earning a market share of around 40%, which is closely followed by Novartis for both Lucentis and a low-cost alternative, Avastin, with a share of about 25% in the market.

Market Dynamics

Market Growth Drivers

Surge in prevalence of AMD: Estimates suggest that there is an overall prevalence of about 8.5% of AMD in Germany. Approximately 35,000 new cases of AMD are diagnosed every year, and the prevalence is expected to rise by around 20% until the year 2050. Germany is considered to have one of the eldest populations, and this demographic is particularly vulnerable to AMD, resulting in a larger pool of patients and enhanced market demand.

Increased awareness and diagnosis: Government initiatives such as the National Eye Health Program and targeted public health programs like “Visual Impairment in Age” raise awareness about specifically AMD in older population. This results in increased diagnosis of patients requiring treatment, contributing to market expansion.

Increased investment: Germany has rising economic growth coupled with a robust healthcare system. The German government, along with external agencies, are actively investing in research infrastructure and funding clinical trials by leading pharmaceutical giants that contribute to personalised and innovative therapeutics propelling the market.

Market Restraints

Lack of specialists: Owing to the increasing prevalence and focus on early diagnosis, Germany faces a shortage of human resources such as optometrists and ophthalmologists, especially in rural areas, which results in disparities across regions. Delayed diagnosis and treatment further hinder market growth.

Economic constraints: The typical approach to treating wet AMD, involving anti-VEGF injections, is associated with considerable expense and frequent administrations. The cost per dose of Lucentis solution is exceptionally high for patients, imposing a significant financial strain on both the healthcare system and individual patients, thereby restricting market penetration. While Germany has Social Health Insurance, coverage of advanced approaches such as gene therapy, is complex potentially hindering their widespread adoption.

Limited competition: Only a few selected therapeutic options are currently available to treat AMD as a result the market is dominated by a few top players which potentially restricts and digresses price competitions and innovation.

Notable Updates

December 2023, Vuity (brolucizumab) by AbbVie is the sole FDA-approved eye drop for the treatment of blurry vision in older individuals and has recently obtained approval in Germany. This expands the range of treatment options for wet AMD, offering longer dosing intervals in comparison to other medications.

Healthcare Policies and Regulatory Landscape

The regulatory framework for healthcare in Germany is shaped by both German and EU directives, standards, and safety regulations. Oversight of medical devices in Germany is carried out by the Federal Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), which enforces the Medical Devices Act and the Medical Devices Regulation, aligning with EU regulations. Germany's healthcare system is characterized by a decentralized decision-making structure involving the federal government, state laws, and regional associations of sickness funds. The Federal Joint Committee plays a key role in determining the services covered by sickness funds, relying on evidence from comparative effectiveness reviews and health assessments.

Companies seeking healthcare licensure in Germany must undergo a comprehensive registration process through the BfArM, facilitated by the electronic portal DIMDI. For new entrants into the German market, it is crucial to comprehend the regulatory environment and ensure compliance with applicable regulations.

Competitive Landscape

Key Players

• F. Hoffman-La-Roche Ltd
• Novartis AG
• Regeneron Pharmaceuticals
• Apellis Pharmaceuticals
• Neurotech Pharmaceuticals
• Bayer
• Pfizer Inc
• Genetech
• Kanghong Pharma
• Bausch Health Companies Inc