Japan Age-Related Macular Degeneration Therapeutics Market Analysis

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

The Japan Age-Related Macular Degeneration (AMD) Therapeutics Market is at around US $0.67 Bn in 2022 and is projected to reach US $1.37 Bn in 2030, exhibiting a CAGR of 9.40% during the forecast period.

Age-related macular degeneration (AMD) is a progressive eye condition primarily impacting older individuals, potentially resulting in significant vision impairment. It affects the macula, which is responsible for central vision, making activities like reading challenging. Risk factors encompass diabetes, smoking, lifestyle changes, and others. AMD presents in two main forms: dry AMD and wet AMD. Symptoms involve distorted vision, difficulty seeing clearly, and a gradual decline in vision. Dry AMD is more prevalent but advances more slowly. On the other hand, wet AMD, though less common, is more severe and characterized by abnormal blood vessel growth beneath the macula. Treatment options include anti-VEGF therapy using medications such as Lucentis, Vabysmo, Avastin from Genentech, and Eylea from Regeneron Pharmaceuticals. Additionally, treatment may involve laser therapy and nutritional supplements like zinc and copper.

It is estimated that the prevalence of early-stage AMD is around 22.3% and approximately 10-15% of individuals aged 65 and above in Japan experience AMD. The market is therefore driven by major factors like an increase in the aging population and the subsequent increase in prevalence, evolving healthcare infrastructure, and technological advancements in the therapeutics industry. However, limited treatment options and market accessibility are a few factors that limit the market's potential.

The market is currently being dominated by Regeneron Pharmaceuticals with Eylea, which is an approved anti-VEGF drug for wet AMD. It is closely followed by Novartis, which captures a significant market share with Beovu, which is another drug in the same category.

Market Dynamics

Market Growth Drivers

Surge in the prevalence of AMD: Japan has one of the highest proportions of elderly populations globally, with more than 28% of individuals aged 65 and older. This demographic trend directly leads to a higher incidence of AMD, a significant contributor to vision impairment in older adults. Research indicates that approximately 10–15% of individuals aged 65 and above in Japan experience AMD, and wet AMD constitutes about 10–20% of these cases. The prevalence of early-stage AMD is expected to be around 22.3%, and it is steadily increasing in this demographic, which intensifies the need for efficient treatments.

Enhanced healthcare system: Japan possesses an advanced healthcare system characterized by extensive accessibility to diagnostic instruments like OTC and ophthalmologists. This setup facilitates the early identification and treatment of AMD patients, allowing market expansion

Technological advancements: Japan stands at the forefront of medical technology, driving the adoption of cutting-edge diagnostic tools and potentially paving the way for future advancements in AMD therapies, such as gene therapy and stem cell transplantations. The increasing investment in AMD therapeutics is evolving, resulting in more drugs in pipeline development entering the Japanese market.

Market Restraints

Market accessibility: Although Universal Health Insurance (UHI) encompasses a significant portion of the expenses associated with AMD treatment, certain limitations persist. Out-of-pocket costs still pose a barrier for specific patients, and the details of coverage for newer medications may take time to develop. This constraint impedes accessibility for many patients relying on the program, leading to uneven access based on their insurance status.

Treatment limitations: Currently, there are no approved medications for dry AMD, the more common form, creating a significant unmet demand. This limitation significantly impedes market expansion. Although anti-VEGF therapies demonstrate effectiveness for wet AMD, each dose of Lucentis is more than 1 million yen. This presents significant affordability challenges for both patients and the healthcare system.

Notable updates

March 2022, Chugai Pharmaceutical Co., Ltd. revealed that it has received regulatory approval today from the Ministry of Health, Labour and Welfare (MHLW) for Vabysmo® for Intravitreal Injection.

Healthcare Policies and Regulatory Landscape

Japan's healthcare policy and regulatory structure encompass various critical authorities and agencies. The primary entity responsible for healthcare regulations and licensing in Japan is the Ministry of Health, Labour, and Welfare (MHLW). The MHLW establishes the foundations and fundamental laws for the national health policy, which local governments implement. Additionally, the MHLW acts as a crucial regulatory body for the Medical and Medical Practitioners Law, overseeing various healthcare aspects, including licensing medical practitioners and regulating medical devices.

Obtaining a license for healthcare products in Japan requires adherence to regulations set by the MHLW and local governments. These entities supervise and oversee healthcare services, including the approval and monitoring of medical and healthcare products. To secure registration and marketing authorization for pharmaceuticals and medical devices, companies must receive approval from the MHRA. This process involves submitting technical and scientific data to validate the product's safety, quality, and effectiveness.

Japan's healthcare policy and regulatory framework involve numerous authorities and agencies, with the MHLW playing a pivotal role in healthcare product regulation. Both the public and private healthcare sectors in the country present diverse opportunities for companies operating within the healthcare industry.

Competitive Landscape

Key Players

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