China Northeast Securities predicts that by 2030, the market size for basic artificial tears and new dry eye prescription drugs will each exceed 10 billion yuan.
Dry eye is a chronic ocular surface disease caused by various factors that significantly affects patients' quality of life and work efficiency. The global incidence of dry eye ranges from approximately 5.5% to 33.7%, with higher rates among Asians. In China, the incidence is about 21% to 30%, with a total of over 300 million patients, 40% of whom are moderate to severe cases requiring anti-inflammatory treatment. With the increase in digital device usage and an aging population, the rate of dry eye is expected to continue to rise. Concurrently, residents' awareness of eye disease diagnosis and treatment is gradually improving, offering promising expansion in the dry eye market.
Currently, ophthalmic-focused companies such as Xingqi Ophthalmic Medicine have taken the lead in this sector. Large pharmaceutical companies like Hengrui Pharmaceuticals and Qilu Pharmaceuticals, as well as specialized enterprises like Kanghong Pharmaceuticals and Muxing Pharmaceuticals, are also accelerating their efforts to enter the dry eye medication market.
The primary treatment for dry eye is artificial tears, which supplement the tear film and lubricate the ocular surface. Prescription drugs such as diquafosol sodium are gradually entering the OTC market. Domestically, Hengrui Pharmaceuticals' SHR8058 perfluorohexyloctane and Muxing Pharmaceuticals' varenicline tartrate nasal spray have submitted NDA applications.
For moderate to severe dry eye accompanied by inflammation, anti-inflammatory treatment is essential. Currently, the only approved anti-inflammatory medication for dry eye in China is Xingqi Ophthalmic Medicine's 0.05% cyclosporine eye drops, leaving market demand unmet. Anti-inflammatory drugs currently submitting NDA/ANDA include Hengrui Pharmaceuticals' SHR8028 anhydrous cyclosporine and Norfumed Pharmaceuticals' 0.05% cyclosporine eye drops.
For moderate to severe dry eye patients with corneal epithelial damage, biological agents promoting ocular surface repair are also necessary, including various growth factor eye drops, calf blood deproteinized extract eye preparations, and autologous serum eye drops.
Currently, domestic pharmaceutical companies are focusing on submitting NDA/ANDA applications for dry eye prescription drugs, heralding a new wave of upgrades in China's dry eye medication market.
The first upgrade in dry eye medication primarily concentrated on artificial tears and the promotion of prescription drugs such as diquafosol sodium and cyclosporine. The second upgrade includes the introduction and development of new dry eye medications, such as anhydrous cyclosporine, perfluorohexyloctane, and varenicline nasal spray, offering a broader range of treatment options for dry-eye patients.
Nevertheless, due to the complexity of dry eye symptoms, no single medication can meet the needs of all patients. The introduction of new drugs will further enrich treatment options and meet the demands of more patients.
Note that product development progress and commercialization may face risks.