Dry Eye Disease - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• In 2023, the market size of Dry eye disease (DED) was highest in the US among the 7MM, accounting for approximately USD 2.73 billion which is further expected to increase by 2034.
• In 2023, the total diagnosed prevalence of Dry eye disease (DED) was highest in the US among the 7MM, accounting for nearly 22.47 million cases which is further expected to increase by 2034.
• In Japan, in 2023, ~2,341 thousand males and ~ 8.29 million females were affected with Dry eye disease (DED). estimates that these numbers might increase by 2034.
• In 2023, the UK reported ~2,811 thousand mild, ~1,345 thousand moderate, and ~1,956 thousand severe cases of DED. Analysis by experts indicates that the overall severity-specific cases of DED are expected to rise in the coming years.
• The current market of Dry eye disease (DED) includes marketed therapies like VEVYE (cyclosporine ophthalmic solution),TYRVAYA, EYSUVIS (loteprednol etabonate ophthalmic suspension), CEQUA (cyclosporine ophthalmic solution), off label therapies, and eye droplets, making up a market size of USD 3.75 billion in the 7MM in 2023. The market size is expected to increase with the projected launch of emerging therapies during the forecast period (2024-2034).

This report delivers an in-depth understanding of the DED, historical and forecasted epidemiology as well as the DED market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Dry eye disease (DED) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM DED market size from 2020 to 2034. The Report also covers current DED treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Dry Eye Disease (DED) Overview

DED, which is also known as dry eye disease or keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface due to a loss of homeostasis of the tear film. It often results in ocular symptoms and visual disturbance due to underlying tear film instability, ocular surface inflammation and damage, and neurosensory abnormalities.

The most common cause of DED is hormonal changes which lead to poor functioning of the tear glands and reduced secretion of tears.

Dry Eye Disease (DED) Diagnosis

Diagnosing DED involves a comprehensive eye examination, including an assessment of symptoms, tear production, and eye surface health. Various diagnostic tests may be used, such as the Schirmer's test to measure tear production, tear breakup time to assess tear film stability, and ocular surface staining with dyes to detect damage. Additionally, a thorough medical history and evaluation of contributing factors like medications or environmental conditions are essential for an accurate diagnosis.

Despite advancements in DED diagnosis, significant unmet needs still persist. Many patients experience delays due to lack of standardized diagnostic criteria and reliance on subjective symptoms. Enhanced diagnostic tools and more precise, objective measures are crucial to improve early detection, accurately gauge disease severity, and tailor effective treatment strategies, ultimately reducing patient discomfort and healthcare burden.

Dry Eye Disease (DED) Treatment

Treatments for dry eyes focus on restoring or maintaining the natural tear levels to alleviate dryness and discomfort while preserving overall eye health. Although dry eyes can be a chronic issue, an optometrist can prescribe therapies to ensure comfort, sustain eye health, and prevent potential vision problems.

The management of DED often involve using over-the-counter artificial tears and prescription eye drops, such as RESTASIS or XIIDRA. Recently several nasal sprays like TYRVAYA are also in the market to provide alternative relief to the patients. Procedures like LipiFlow can enhance tear quality. Lifestyle modifications, including the use of humidifiers and omega-3 fatty acid supplements, are also suggested. For severe cases, punctal plugs or scleral contact lenses may be needed to retain moisture and reduce discomfort. Additionally personalized treatment plans can be discussed with an eye care professional as well.

Dry Eye Disease (DED) Epidemiology

As the market is derived using a patient-based model, the DED epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Total Diagnosed Prevalent Cases of DED, Gender-specific Diagnosed Prevalent Cases of DED, Age-specific Diagnosed Prevalent Cases of DED, and Severity-specific Diagnosed Prevalent Cases of DED in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• In the assessment, the estimated total diagnosed prevalent cases of DED in the 7MM were nearly 54.69 million in 2023.
• Among the European countries, the United Kingdom had the highest diagnosed prevalent cases of DED with ~6,112 thousand cases, followed by Germany, which had diagnosed prevalent population of ~5,004 thousand in 2023. On the other hand, Spain had the lowest prevalent population (2,064 thousand cases).
• The US reported the highest number of total diagnosed prevalent cases of DED among the 7MM countries with 41% whereas Japan reported the least cases (19%). This trend is anticipated to be followed during the forecast period as well.
• In the US, gender-specific diagnosed prevalent cases of DED revealed ~9,439 thousand cases among males and approximately ~13,035 thousand cases among females. Projections indicate that by 2034, the prevalence among females will surpass that of males.
• Severity-specific data from 2023 reported that mild DED affects the largest group in the US, with approximately 11.23 million cases, while severe cases totaled 4.49 million. It is projected that this trend, with a higher prevalence of mild cases compared to severe ones, will continue throughout the forecast period.
• The analysis shows that the UK reported the highest number of DED cases in individuals aged 50 and older, with ~4,889 thousand cases. This was followed by ~691 thousand cases in the 40-49 age group and ~532 thousand cases in the 18-39 age group. Projections indicate that the UK is expected to continue leading in these figures by 2034.

Dry Eye Disease (DED) Drug Chapters

The drug chapter segment of the DED report encloses a detailed analysis of DED off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the DED clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

CEQUA (cyclosporine ophthalmic solution) 0.09%: Sun Pharma

CEQUA (cyclosporine ophthalmic solution) 0.09% is a clear, sterile solution used to enhance tear production in patients with dry eye disease (keratoconjunctivitis sicca). The recommended dosage is one drop in each eye twice daily, with the vial discarded after use. Cyclosporine, a calcineurin inhibitor, functions as a partial immunomodulator, though its precise mechanism in this topical form remains undefined. Approved by the US FDA in August 2018, CEQUA represents a targeted approach to managing tear production issues associated with ocular inflammation.

TYRVAYA (varenicline solution): Oyster Point Pharma

Varenicline, a nicotinic acetylcholine receptor agonist, received US FDA approval in October 2021 for its use as TYRVAYA, a preservative-free nasal spray designed to treat DED. This new formulation offers an innovative method for managing the symptoms associated with dry eye disease. Administered as one spray in each nostril twice daily, TYRVAYA requires priming with seven actuations before the first use and re-priming with one actuation if not used for over five days. The efficacy of TYRVAYA is attributed to varenicline's interaction with specific nicotinic acetylcholine receptor subtypes, which activates the trigeminal parasympathetic pathway, enhancing basal tear production. While varenicline's binding to various neuronal nicotinic receptors is well-documented, the precise mechanism of action remains under investigation.

Emerging Drugs

Reproxalap: Aldeyra Therapeutics, Inc.

Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis. Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which is elevated in ocular and systemic inflammatory disease. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. In October 2023, Aldeyra Therapeutics, Inc. entered an exclusive option agreement with AbbVie Inc.

Tivanisiran (SYL1001): Sylentis, S.A./PharmaMar

Tivanisiran (SYL1001) is a small interfering RNA (siRNA) that is administered in solution as eye drops. This siRNA inhibits the synthesis of transient receptor potential vanilloid-1, also known as TRPV1. TRPV1 is directly involved in the pathophysiology of dry eye disease as it has a dual function on the ocular surface. It acts in the detection, transmission, and regulation of the sensation of pain in the eye, as well as in the mediation of innate inflammatory response, mechanisms whose regulation is key for the treatment and prevention of DED. In December 2023, Sylentis, a PharmaMar Group company, reported that the FYDES (Phase III) study evaluating the safety of tivanisiran in patients with dry eye disease successfully met its primary endpoint.

Tavilermide (MIM-D3): Mimetogen

Tavilermide is a cyclic peptidomimetic drug that mimics nerve growth factor (NGF) and acts as a partial TrkA receptor agonist, enhancing NGF's effects crucial for ocular surface health. Unlike other dry eye therapies, it addresses multiple mechanisms of dry eye disease by promoting protein secretion from conjunctival glands, maintaining ocular lubrication. Tavilermide, a preservative-free sterile ophthalmic solution, has shown consistent safety and efficacy in Phase II and III trials and is currently under Phase III evaluation.

AR-15512: Alcon/Aerie Pharmaceuticals

AR-15512, a novel topical agonist targeting the transient receptor potential melastatin 8 (TRPM8), is a pioneering treatment for dry eye disease symptoms. Scheduled for a New Drug Application filing with the FDA by mid-2024, AR-15512 works by activating TRPM8, a cold-sensing receptor found in the cornea and eyelid, which may alleviate dry eye symptoms. The drug is currently undergoing Phase III clinical trials.

Additionally The Phase III COMET trials of AR-15512, a pioneering topical TRPM8 agonist for dry eye disease, demonstrated significant positive outcomes. Both pivotal studies, COMET-2 and COMET-3, met their primary efficacy and safety endpoints, highlighting AR-15512's potential as an effective treatment for managing dry eye disease symptoms.

RP101: Redwood Pharma AB

RP101, a novel topical treatment for postmenopausal women with chronic, moderate-to-severe DED, represents a significant advancement as a hormonal therapy. The formulation aims to restore local estrogen levels in the eye, enhancing tear film production and addressing specific biological mechanisms underlying DED. With a convenient dosing regimen of one or two applications per day, RP101 has shown robust safety and efficacy in a European Phase II trial, reinforcing positive outcomes observed in previous US Phase II studies.

However according to the Redwood Pharma’s recent news report, the company is facing financial challenges and plans to expedite the sale of their assets including RP101 through an accelerated auction. The company has struggled to secure funding for the final stages of product market introduction in the current financial environment and are actively seeking buyers to acquire these assets and advance the development and commercialization of its ophthalmic product portfolio.

Dry Eye Disease (DED) Market Outlook

Dry eye disease (DED), or keratoconjunctivitis sicca, represents a significant market opportunity due to its widespread impact and diverse treatment landscape. The market is driven by the need for effective management solutions addressing tear film imbalance, which causes discomfort and potential complications.

Current treatment options include over-the-counter artificial tears and prescription medications like CEQUA and EYSUVIS. Advanced therapies, such as LipiFlow, are used to enhance tear quality, while lifestyle modifications and supplements like omega-3 fatty acids also play a role. Severe cases may require specialized interventions like punctal plugs or scleral contact lenses. With a growing focus on advanced treatment options, the market for DED is expanding, highlighting opportunities for innovation and investment in new therapies and technologies.

The DED market is poised for transformation with the anticipated introduction of therapies like RGN-259, Tavilermide (MIM-D3), AR-15512, and others. The approval of these therapies could significantly impact market dynamics, although their success rates remain uncertain.

• The United States accounted for the highest market size of DED approximately 73% of the total market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• Among the EU countries, the UK had the highest market size with USD 232 million in 2023, while Spain had the lowest market size for DED with USD ~80 million in 2023.
• With the expected launch of upcoming therapies, such as RGN-259, Tavilermide (MIM-D3), and AR-15512, among others, the total market size of DED is expected to show change in the upcoming years.

Dry Eye Disease (DED) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, PL9643 in the US is expected to be launched by 2025 with a peak share of 1.0%. Tavilermide (MIM-D3) is anticipated to take 8 years to peak with a slow medium uptake.

Dry Eye Disease (DED) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for DED emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Dry Eye Disease (DED) evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Harvard Medical School, Boston, Massachusetts, US University of Pikeville, Kentucky College of Optometry, Pikeville, Kentucky, US; Magdeburg-Stendal University of Applied Sciences, Stendal, Sachsen-Anhalt, Germany; Department of Ophthalmology, Dijon University Hospital, Dijon, France; University of Milan, Milan, Italy; Optometry and Vision Science, Aston University, Birmingham, UK and Ryogoku Eye Clinic, Tokyo, Japan; and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or DED market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Dry Eye Disease, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Dry Eye Disease (DED) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Dry Eye Disease (DED) market.

Dry Eye Disease (DED) Report Insights

• Patient Population
• Therapeutic Approaches
• Dry Eye Disease (DED) Pipeline Analysis
• Dry Eye Disease (DED) Market Size and Trends
• Existing and Future Market Opportunity

Dry Eye Disease (DED) Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Dry Eye Disease (DED) Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Dry Eye Disease (DED) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the Dry Eye Disease (DED) market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Dry Eye Disease (DED) total market size as well as market size by therapies across the 7MM during the forecast period (2024-2034)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Dry Eye Disease (DED) market size during the forecast period (2024-2034)?
• At what CAGR, the Dry Eye Disease (DED) market is expected to grow at the 7MM level during the forecast period (2024-2034)?
• What would be the Dry Eye Disease (DED) market outlook across the 7MM during the forecast period (2024-2034)?
• What would be the DED market growth till 2034 and what will be the resultant market size in the year 2034?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What is the disease risk, burden, and unmet needs of DED?
• What is the historical Dry Eye Disease (DED) patient population in the United States, EU4 (Germany, France, Italy, Spain) and the UK, and Japan?
• What would be the forecasted patient population of Dry Eye Disease (DED) at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Dry Eye Disease?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Dry Eye Disease (DED) during the forecast period (2024-2034)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2024-2034)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Dry Eye Disease (DED) along with the approved therapy?
• What are the current treatment guidelines for the treatment of Dry Eye Disease (DED) in the US, Europe, And Japan?
• What are the Dry Eye Disease (DED) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Dry Eye Disease?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Dry Eye Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Dry Eye Disease (DED) therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Dry Eye Disease (DED) and their status?
• What are the key designations that have been granted for the emerging therapies for Dry Eye Disease?
• What are the 7MM historical and forecasted market of Dry Eye Disease?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Dry Eye Disease (DED) Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Dry Eye Disease (DED) Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Dry Eye Disease (DED) market?

The Dry Eye Disease (DED) market is quite robust. The major layers are Mitotech, SA/ORA, Inc., Mimetogen, Aldeyra Therapeutics, Inc., BRIM Biotechnology, Inc., and others which are currently developing drugs for the treatment of DED.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Dry Eye Disease (DED) market?

The increase in diagnosed prevalent cases of Dry Eye Disease (DED) and the launch of emerging therapies are attributed to be the key drivers for increasing the DED market.

5. What is the expected impact of emerging therapies or advancements in Dry Eye Disease (DED) treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the DED treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Dry Eye Disease (DED) market.