DRY EYE DISEASE MARKET ANALYSIS

Market Size and Trends

The dry eye disease market is estimated to be valued at USD 7.33 Bn in 2024 and is expected to reach USD 13.26 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 8.8% from 2024 to 2031.

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The dry eye disease market is expected to witness steady growth during the forecast period. This growth is attributed to rising geriatric population worldwide who are more prone to developing dry eye disease. Additionally, the increasing prevalence of chronic diseases, such as diabetes, which can cause tear deficiency is also contributing to the growth of the market. With growing awareness about disease diagnosis and treatment options, there is higher demand for prescription and over-the-counter medications to manage the symptoms of dry eyes. Furthermore, technological advancements in incorporating artificial tears, punctum plugs, and other medical devices for dry eye treatment is expected to provide new opportunities for market players over the next few years.

Increasing product launches and approvals for dry eye disease treatment

The increasing number of product approvals and launches for dry eye disease treatment over the past couple of years has provided a significant boost to the dry eye disease market. With the disease affecting a substantial portion of the global population, especially with rising screen time and digital device usage, the demand for effective treatment options has grown exponentially. Several biotechnology and pharmaceutical companies have responded to this demand by investing heavily in research and developing new drugs and therapies. For instance, in February 2023, Aldeyra Therapeutics, Inc., a company discovering and developing innovative therapies designed to treat immune-mediated diseases, announced that the U.S. Food and Drug Administration (FDA) had accepted the New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease.

Market Concentration and Competitive Landscape

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People who frequently use computer or screens are also at high risk of developing dry eyes, as using screens for a long period can lead to reduced blinking and tear production. Digital device usage has increased significantly in recent years among all age groups, due to extensive use for social and professional purposes. Blue light emitted by digital screens is associated with symptoms of dry eye syndrome. Exposure to blue light (range of 400–500 nm) can be harmful to the retina. Longer duration and less intense light exposure can also induce photochemical damage in the eyes. Furthermore, lack of sleep and excessive stress can play a crucial role in the onset of dry eye syndrome due to oily tear gland dysfunction. According to the data provided by SleepFoundation.org, a foundation providing information about sleep and promoting overall wellness, in May 2023, more than one-third of U.S. adults sleep less than seven hours per night, on average. According to the same source, 50 million to 70 million people in the U.S. have ongoing sleep disorders.

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Poor accessibility to eye care services in low- and middle-income countries and the restriction of existing treatment modalities to primary care practitioners are some of the reasons hampering market growth. For instance, according to an article published by The Lancet, a weekly peer-reviewed general medical journal, in February 2021, multiple obstacles need to be overcome to achieve universal coverage for eye health. Important issues include complex barriers to availability and access to quality services, cost, major shortages, and maldistribution of well-trained personnel, and lack of suitable, well-maintained equipment and consumables.

Market Opportunities – Increasing initiatives to create awareness about dry eye disease

Increasing efforts by key players and non-profit eye health organizations to increase awareness about dry eye disease among people is expected to drive the market growth over the forecast period. For instance, in July 2022, Prevent Blindness, a non-profit eye health organization of the U.S., declared July as Dry Eye Awareness Month to provide free resources to providers and the public on dry eyes, including fact sheets and shareable social media graphics available in English and Spanish, and a dedicated web page.

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The product type segment includes cyclosporine, corticosteroids, lifitegrast, ocular lubricant, punctal plugs, and others. The cyclosporine segment is estimated to hold 37.3% share of the market in 2024. Ophthalmic cyclosporine is used to increase tear production in people suffering from dry eye disease. Cyclosporine is an immunomodulator and functions by decreasing swelling in the eye to allow tear production. Cyclosporine is available in solution (liquid) and emulsion forms to treat dry eye syndrome. Increasing product launches by key players in the market is expected to drive the segment growth over the forecast period. For instance, in February 2022, Viatris Inc., a U.S.-based pharmaceutical and healthcare corporation, announced that its subsidiary, Mylan Pharmaceuticals Inc., received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion 0.05%, the first generic version of Allergan's Restasis.

Insights, By Formulation Type: Formulation flexibility drives the dominance of liquid

The formulation type segment includes liquid, gel, ointment, and others. The liquid subsegment is expected to have 56.8% of the market share in 2024. Liquid formulations are most widely utilized to treat dry eye disease symptoms attributed to its ease of application. There are several liquid formulations available in the market such as Restasis, Cequa, Xiidra, and Eysuvis. Most of the formulations contain cyclosporine as an active ingredient (Restasis, Cequa) while some have lifitegrast (Xiidra), and corticosteroid (Eysuvis) as an active ingredient. Rise in the number of clinical trials being undertaken by several clinical stage companies is anticipated to drive the liquid segment growth. For instance, in June 2022, RegeneRx Biopharmaceuticals Inc., a clinical-stage drug development company, announced that its U.S. joint venture (JV) partner and licensee, HLB Therapeutics (HLBT) plans to expand its ophthalmic clinical development programme with RGN-259 in two indications: neurotrophic keratopathy & dry eye disease. RGN-259 is a Tβ4-based sterile, preservative-free eye drop based on. Visomitin (SkQ1 as active ingredient) and AZR-MD-001 (SeS2 as active ingredients) are some other liquid formulations under clinical trials.

Insights, By Distribution Channel: Convenience and ease of access drives retail pharmacies growth

The distribution channel segment includes hospital pharmacies, retail pharmacies, supermarket/hypermarket, other stores, and online pharmacies. The retail pharmacies subsegment is expected to have 49.6% of the market share in 2024. Being located within communities, retail pharmacies offer patients easy geographic access without needing an appointment or visit to an ophthalmologist. This proximity and walk-in availability make retail pharmacies very convenient for treatment and refill requirements. In addition, major retail pharmacy chains have dedicated ocular departments staffed with optometrists and well-trained pharmacists who are able to appropriately counsel patients about their dry eye conditions and medications. Increasing expansion and launches of retail drug chains is expected to drive the segment growth over the forecast period. For instance, in February 2023, Aster Pharmacy, a division of Aster DM Healthcare, a modern-day healthcare ed-tech company announced the opening of its 250th pharmacy in Elamakkara, India. Aster Pharmacy which is a subsidiary of Alfaone Retail Pharmacies, a private limited company, announced the inauguration of its 200th location in September 2022. Aster Pharmacy has 507 pharmacies across the U.A.E., Saudi Arabia, Oman, Qatar, Bahrain, Jordan, India, and Bangladesh.

Regional Insights

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North America remains the dominant region in the global dry eye disease market and is anticipated to hold 69.8% of the market share in 2024. With high consumer awareness regarding eye health issues, many patients in the U.S. and Canada seek early diagnosis and treatment for dry eye symptoms. This has created a strong demand for various dry eye drugs and devices in the healthcare setting. Increasing number of research studies coupled with growing prevalence of dry eye diseases are the major factors anticipated to drive the growth of the market in this region over the forecasted period. For instance, in January 2021,

Surface Ophthalmics, a pharmaceutical firm dedicated to pioneering treatments for ocular conditions, has revealed that the initial participant in its Phase II clinical study for its experimental product SURF-100 (a combination of mycophenolate sodium and betamethasone sodium phosphate in Klarity vehicle) aimed at addressing chronic dry eye disease has been administered.

The Asia Pacific region, especially China and India, is emerging as the fastest growing market for dry eye disease. Growing industrialization and extensive time spent in front of digital screens have significantly contributed to increased screen time and dry eye cases in Asian countries in recent years. Moreover, the geriatric population in major Asian economies is rising rapidly, adding to the risk of age-related dry eye conditions. Regulatory approvals for clinical trials of novel drugs for the treatment of dry eye disease is anticipated to drive the growth of the market in the Asia Pacific region over the analysis period. For instance, in April, 2023, BRIM Biotechnology Inc., a clinical-stage company, announced that BRM421 for the treatment of dry eye disease, licensed to Grand Pharmaceutical Group Limited, a pharmaceutical company, for the China province, had been approved by the China National Medical Products Administration (NMPA) to conduct Phase 2 clinical trials.

Market Report Scope

Key Developments

• On January 11, 2024, Harrow, a leading U.S. eyecare pharmaceutical company, announced that VEVYE (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed prescription drug based on a “water‑free” semifluorinated alkane eyedrop technology, is now available in the U.S. – and includes a 100% Money‑Back Guarantee program. VEVYE, given in a 10 microliter drop, is the first and only cyclosporine-based medicine approved to treat both signs and symptoms of dry eye disease (DED).
• On January 9, 2024, Alcon, the world's leading eye care company dedicated to helping people see brilliantly, announced positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) assessing the efficacy and safety of AR-15512, a candidate treatment for dry eye disease (DED).
• In June 2023, Novaliq GmbH, a biopharmaceutical company, stated that the U.S. Food and Drug Administration (FDA) has approved VEVYE (cyclosporine ophthalmic solution) 0.1% for the treatment of dry eye symptoms. VEVYE (development name CyclASol) is the first and only cyclosporine solution approved to treat the signs and symptoms of dry eye disease, with efficacy established after 4 weeks of treatment.
• In May 2023, ENTOD Pharmaceuticals, a research-based pharmaceutical company, announced the launch of CYCLOTEARS eye drops for patients with Inflammatory Dry Eye Disease (DED) in India and for its various global markets. CYCLOTEARS eye drops would be the world's first dry eye treatment method to utilize the company's patented self-emulsifying drug delivery system (SEDDS) technology.

*Definition: The dry eye disease market involves products that aid in diagnosing and treating dry eye disease, a condition where a person does not produce enough tears or their tears do not have the correct properties to lubricate and nourish the eyes. Products in this market include artificial tear eye drops that lubricate dry eyes, cyclosporine eye drops that reduce inflammation, tear duct plugs that prevent tear drainage, ointments and gels to lubricate eyes overnight, devices like humidifiers and heat masks that add moisture to the eyes.

Market Segmentation

•  Product Type Insights (Revenue, USD BN, 2019 - 2031)
  • Cyclosporine
  • Corticosteroids
  • Lifitegrast
  • Ocular Lubricant
  • Punctal Plugs
  • Others
•  Formulation Type Insights (Revenue, USD BN, 2019 - 2031)
  • Liquid
  • Gel
  • Ointment
  • Others
•  Distribution Channel Insights (Revenue, USD BN, 2019 - 2031)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Supermarket/Hypermarket
  • Other Stores
  • Online Pharmacies
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Novartis AG
  • Alcon Inc.
  • I-MED Pharma Inc
  • Sun Pharmaceutical Industries Ltd.
  • Novaliq GmbH
  • Cipla Inc.
  • AbbVie Inc.
  • Lupin
  • Otsuka Holdings Co., Ltd.
  • Santen Pharmaceutical Co., Ltd
  • Cambium Medical Technologies
  • Viatris Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Bausch & Lomb Incorporated
  • Abbott
  • Adrif Vision
  • Grevis Pharmaceuticals Pvt. Ltd.
  • AFT Pharmaceuticals
  • URSAPHARM Arzneimittel GmbH
  • Altacor