Dry Eye Disease Market Growth Projections 2024-2034: DelveInsight Analysis | Palatin Technologies, Novaliq, mc2 therapeutics

The Key Dry Eye Disease Companies in the market include - Palatin Technologies, Novaliq, mc2 therapeutics, and others.

The Dry Eye Disease market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Dry Eye Disease pipeline products will significantly revolutionize the Dry Eye Disease market dynamics.

DelveInsight's "Dry Eye Disease Market Insights, Epidemiology, and Market Forecast-2034 report offers an in-depth understanding of the Dry Eye Disease, historical and forecasted epidemiology as well as the Dry Eye Disease market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Dry Eye Disease market report covers emerging drugs, current treatment practices, market share of the individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates the current treatment practice/algorithm, market drivers & barriers, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

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Some of the key facts of the Dry Eye Disease Market Report:

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The Dry Eye Disease market size is anticipated to grow with a significant CAGR during the study period (2020-2034)

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In April 2025, The U.S. Food and Drug Administration (FDA) declined to approve Aldeyra Therapeutics' dry eye disease treatment, reproxalap, citing insufficient efficacy data. This marks the second rejection, following a similar outcome in 2023. The FDA recommends at least one additional trial to demonstrate the drug's effectiveness.

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In February 2025, Cambium Bio revealed that the FDA has approved the protocol for its Phase III clinical trials of Elate Ocular, aimed at treating moderate to severe dry eye disease.

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In January 2025, Stuart Therapeutics, Inc. (Stuart), a clinical-stage drug platform company focused on developing innovative treatments for ophthalmic conditions, has announced the completion of the final patient visit in its Phase III clinical trial of ST-100 (vezocolmitide), its lead therapeutic candidate for Dry Eye Disease.

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In December 2024, The FDA issued a nationwide recall of a specific single-use eye drop product. Alcon Laboratories voluntarily recalled one lot (Lot 10101) of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count, after a customer reported possible fungal contamination in a vial. This recall is limited to the identified lot only.

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In August 2024, Aldeyra Therapeutics, Inc. (Nasdaq: ALDX), a biotechnology company focused on discovering and developing innovative therapies for immune-mediated and metabolic diseases, today announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled clinical trial of 0.25% reproxalap ophthalmic solution. This investigational drug candidate aims to treat dry eye disease. Reproxalap showed statistical superiority to the vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), a symptom of dry eye disease accepted by the U.S. Food and Drug Administration (FDA).

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In January 2024, Alcon, headquartered in Switzerland, announced the success of its dry eye disease medication AR-15512 in meeting primary endpoints in two Phase III trials, namely COMET-2 and COMET-3. With encouraging results from these trials, the company intends to submit a new drug application (NDA) for AR-15512 to the US Food and Drug Administration (FDA) by mid-2024, as outlined in a press release dated January 9th.

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In January 2024, Stuart Therapeutics, a biopharmaceutical firm based in the United States, has initiated a Phase III clinical study for their drug candidate vezocolmitide (ST-100) targeting patients with dry eye disease. This randomized, placebo-controlled trial seeks to assess the effectiveness and safety of a single dose of the ophthalmic solution compared to a placebo. The trial is set to enroll 320 participants.

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In 2023, the United States held the largest market share for Dry Eye Disease among the 7MM, with an estimated value of around USD 2,739 million, and this figure is projected to grow further by 2034.

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In 2023, the UK had the largest market size for DED among EU countries, reaching USD 232 million, while Spain had the smallest market size, at approximately USD 80 million.

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The anticipated launch of new therapies, including RGN-259, Tavilermide (MIM-D3), and AR-15512, is expected to drive changes in the total market size of DED in the coming years.

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According to DelveInsight's assessment, the estimated total number of diagnosed prevalent cases of DED in the 7MM was approximately 54.7 million in 2023.

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In 2023, the United Kingdom had the highest number of diagnosed prevalent cases of DED among European countries, with around 6.1 million cases, followed by Germany with approximately 5 million. Spain, meanwhile, had the lowest prevalence, with 2.1 million cases.

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The US accounted for the highest percentage of diagnosed prevalent cases of DED among the 7MM countries, representing 41%, while Japan had the lowest, at 19%. This trend is expected to continue throughout the forecast period.

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In the US, gender-specific data showed around 9.4 million diagnosed prevalent cases of DED among males and approximately 13 million among females. Projections suggest that by 2034, the prevalence among females will continue to outpace that of males.

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In 2023, severity-specific data indicated that mild DED affected the largest group in the US, with around 11.2 million cases, while severe cases numbered 4.5 million. This trend, with mild cases outnumbering severe ones, is expected to persist throughout the forecast period.

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Key Dry Eye Disease Companies: Palatin Technologies, Novaliq, mc2 therapeutics, and others

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Key Dry Eye Disease Therapies: PL9643, NOV03, CyclASol, MC2-03, and others

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The Dry Eye Disease epidemiology based on gender analyzed that females are more affected by Dry Eye Disease than males

Dry Eye Disease Overview

Dry eye disease, also known as dry eye syndrome (DES) or keratoconjunctivitis sicca (KCS), is a common condition when eyes do not produce enough tears or the tears evaporate too quickly. As tears are essential to lubricate and nourish the eye, the condition leads to eyes drying out and becoming red, swollen, and irritated. Causes for Dry Eye Disease include decreased tear production, excessive tear evaporation, and abnormality in the production of mucus or lipids of the tear layer.

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Dry Eye Disease Market

The dynamics of the Dry Eye Disease market are anticipated to change in the coming years owing to the expected launch of emerging therapies and others during the forecasted period 2020-2034.

"Of the emerging therapies, MC2-03 (mc2 therapeutics), PL9643 (Palatin Technologies), and many other compelling treatments are expected to change the market scenario of Dry Eye Disease in the upcoming years."

Dry Eye Disease Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Dry Eye Disease Epidemiology Segmentation:

The Dry Eye Disease market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Total Prevalence of Dry Eye Disease

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Prevalent Cases of Dry Eye Disease by severity

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Gender-specific Prevalence of Dry Eye Disease

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Diagnosed Cases of Episodic and Chronic Dry Eye Disease

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Dry Eye Disease Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Dry Eye Disease market or expected to get launched during the study period. The analysis covers Dry Eye Disease market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Dry Eye Disease Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

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Dry Eye Disease Therapies and Key Companies

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PL9643: Palatin Technologies

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NOV03: Novaliq

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CyclASol: Novaliq

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MC2-03: mc2 therapeutics

Scope of the Dry Eye Disease Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Dry Eye Disease Companies: Palatin Technologies, Novaliq, mc2 therapeutics, and others

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Key Dry Eye Disease Therapies: PL9643, NOV03, CyclASol, MC2-03, and others

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Dry Eye Disease Therapeutic Assessment: Dry Eye Disease current marketed and Dry Eye Disease emerging therapies

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Dry Eye Disease Market Dynamics: Dry Eye Disease market drivers and Dry Eye Disease market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Dry Eye Disease Unmet Needs, KOL's views, Analyst's views, Dry Eye Disease Market Access and Reimbursement

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Table of Contents

1. Dry Eye Disease Market Report Introduction

2. Executive Summary for Dry Eye Disease

3. SWOT analysis of Dry Eye Disease

4. Dry Eye Disease Patient Share (%) Overview at a Glance

5. Dry Eye Disease Market Overview at a Glance

6. Dry Eye Disease Disease Background and Overview

7. Dry Eye Disease Epidemiology and Patient Population

8. Country-Specific Patient Population of Dry Eye Disease

9. Dry Eye Disease Current Treatment and Medical Practices

10. Dry Eye Disease Unmet Needs

11. Dry Eye Disease Emerging Therapies

12. Dry Eye Disease Market Outlook

13. Country-Wise Dry Eye Disease Market Analysis (2020-2034)

14. Dry Eye Disease Market Access and Reimbursement of Therapies

15. Dry Eye Disease Market Drivers

16. Dry Eye Disease Market Barriers

17. Dry Eye Disease Appendix

18. Dry Eye Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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