Dry Eye Syndrome: Global Drug Forecast and Market Analysis to 2026

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Dry Eye Syndrome (DES) is a multifactorial disease of the tears and ocular surface that causes ocular discomfort, visual disturbances, and tear film instability, which can potentially damage the ocular surface. With a rapidly accelerating worldwide prevalence and the limited treatment options available, there is a growing pressure for new therapies and curative treatment for DES patients. Significant efforts are being made to develop a new treatment for DES, as current pharmacologic management is known to only provide temporary symptomatic relief.
GlobalData estimates the 2016 sales for DES at approximately $2.2B across the 8MM covered in this report.
The DES pipeline activity comprises 10 active Phase III (or Phase II/III) pipeline agents with novel mechanisms of action as well as cyclosporines with improved clinical profiles. Additionally, six of these late-stage pipeline drugs are expected to be first-in-class therapies. The most notable pipeline drugs include RegeneRx’s thymosin beta-4 product RGN-259, Aldeyra’s reproxalap which acts as an “aldehyde trap”, and Sylentis’ TRPV1 inhibitor tivanisiran. Other late-phase novel drugs include Mitotech’s mitochondrial antioxidant product visomitin, Kala Pharmaceuticals’ corticosteroid KPI-121, and Novartis’ and Dompe’s recombinant human lubricin protein ECF-843. GlobalData expects these new drugs will expand the DES treatment options and contribute to overall market growth. Nevertheless, considerable opportunities remain within this severely underserved DES market.
Key Questions Answered
What are the key unmet needs clinically and in research? What do KOLs identify as the key unmet needs? Will the products in the DES pipeline fill these unmet needs?
When are the pipeline products expected to launch? What are the key features of the products in the pipeline?
What are the threats for drugs currently on the market? How will the new pipeline products be incorporated into the current treatment algorithm?
What are the key hurdles for manufacturers entering the DES market?

Scope

Overview of DES: including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized DES market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including mild DES, moderate DES, and severe DES), forecast from 2016 to 2026.

Key topics covered: strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DES therapeutics market

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for DES therapy. The most promising candidate in Phase III (and Phase II/III) development is profiled.

Analysis of the current and future market competition in the global DES therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global DES therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global DES therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Akorn
Alcon
Aldeyra
Allergan
Altacor
Apotex
Argentum Pharmaceuticals
Aspire
Auven Therapeutics
Bausch & Lomb
Chongqing Santen Kerui Pharmaceutical
Dompe
Famy Care Limited
G-TreeBNT
Greenstone
Intrexon Corporation
Kaken
Kala Pharmaceuticals
Kyorin
Laboratoires Thea
Lee’s Pharmaceutical
Lubris Biopharma
Magenta
MC2 Therapeutics
Mitotech
Mylan
Moorfield Pharmaceuticals
Nippon
Nissiin
Novaliq
Novartis
Otsuka
Parion Sciences
Pfizer
Pfizer’s InnoPharma
PharmaMar
Rayner
RegeneRx
Santen
Scope Ophthalmics
Seikagaku
Senju
Shire
Sun Pharmaceutical
Sylentis
Thea
Toa
Twi Pharmaceuticals
United Laboratories
Ursapharm
Wakamoto
Wockhardt

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 DES: Executive Summary

2.1 DES Therapeutics Market Will Grow to $5.6B by 2026

2.2 DES Is a High Risk Indication for Drug Development

2.3 While New Therapeutics Enter the DES Market, Unmet Needs Persist

2.4 Significant Opportunities Remain Within the DES Market to Fulfill Unmet Needs

2.5 Newly Approved Therapeutics Will Improve Treatment Options for DES Patients

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Disease Classification

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods – Population

5.4.3 Forecast Assumptions and Methods – Total and Diagnosed Prevalent Cases of DES

5.4.4 Forecast Assumptions and Methods – Total and Diagnosed Prevalent Cases of DES by Severity

5.5 Epidemiological Forecast for DES (2016–2026)

5.5.1 Total Prevalent Cases of DES

5.5.2 Age-Specific Total Prevalent Cases of DES

5.5.3 Sex-Specific Total Prevalent Cases of DES

5.5.4 Total Prevalent Cases of DES by Severity

5.5.5 Diagnosed Prevalent Cases of DES

5.5.6 Diagnosed Prevalent Cases of DES by Severity

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.1.1 Diagnosis

6.1.2 Treatment Guidelines

6.1.3 Clinical Practice

6.2 US

6.3 5EU

6.4 Japan

6.5 China

7 Competitive Assessment

7.1 Overview

7.2 Marketed Therapies and Artificial Tears for DES

7.3 Other Therapies

7.3.1 Autologous Serum

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 New Therapies for DES

8.3 Better Diagnostic Tools

8.4 Appropriate Clinical Trial Design

8.5 Simplified Dosing

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.3 Promising Drugs in Early-Stage Development

9.3.1 Lacripep

9.3.2 Voclosporin (LX-214)

9.3.3 SHP-659

9.3.4 Dextenza (OTX-DP)

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Allergan

10.4 Santen

10.5 Shire

10.6 RegeneRx

10.7 Aldeyra

10.8 Sylentis

10.9 Sun Pharmaceutical

10.10 Novartis

10.11 Dompe

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

11.5 China

11.5.1 Forecast

11.5.2 Key Events

11.5.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – Key Opinion Leaders Interviewed for This Report

12.4.1 Key Opinion Leaders

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

Table

Table 1: DES: Key Metrics in the 8MM

Table 2: Risk Factors and Comorbid Conditions Associated with DES

Table 3: Diagnostic Tests for DES

Table 4: Popular Validated Questionnaires for DES

Table 5: Treatment Guidelines for DES

Table 6: Country Profile – US

Table 7: Country Profile – 5EU

Table 8: Country Profile – Japan

Table 9: Country Profile – China

Table 10: Leading Treatments for DES, 2018

Table 11: Comparison of Therapeutic Classes in Development for DES, 2016–2026

Table 12: Key Companies in the DES Market in the 8MM, 2017

Table 13: Allergan’s DES Portfolio Assessment, 2018

Table 14: Santen’s DES Portfolio Assessment, 2018

Table 15: Shire’s DES Portfolio Assessment, 2018

Table 16: RegeneRx’s DES Portfolio Assessment, 2018

Table 17: Aldeyra’s DES Portfolio Assessment, 2018

Table 18: Sylentis’ DES Portfolio Assessment, 2018

Table 19: Sun Pharma’s DES Portfolio Assessment, 2018

Table 20: Novartis’ DES Portfolio Assessment, 2018

Table 21: Dompe’s DES Portfolio Assessment, 2018

Table 22: DES Market – Global Drivers and Barriers, 2016–2026

Table 23: Key Events Impacting Sales for DES in the US, 2016–2026

Table 24: DES Market – Drivers and Barriers in the US, 2016–2026

Table 25: Key Events Impacting Sales for DES in the 5EU, 2016–2026

Table 26: DES Market – Drivers and Barriers in the 5EU, 2016–2026

Table 27: Key Events Impacting Sales for DES in Japan, 2016–2026

Table 28: DES Market – Global Drivers and Barriers in Japan, 2016–2026

Table 29: Key Events Impacting Sales for DES in China, 2016–2026

Table 30: DES Market – Global Drivers and Barriers in China, 2016–2026

Table 31: Key Historical and Projected Launch Dates for DES

Table 32: Key Historical and Projected Patent Expiry Dates for DES

Table 33: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global Sales Forecast by Country for DES in 2016 and 2026

Figure 2: Analysis of the Company Portfolio Gap in DES During the Forecast Period

Figure 3: Vicious Circle of DES

Figure 4: Tear Film Structure

Figure 5: Classification of DES

Figure 6: 8MM, Age-Standardized Total Prevalence of DES (%), Both Sexes, Ages ≥20 Years, 2016

Figure 7: 8MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of DES

Figure 8: 8MM, Total Prevalent Cases of DES, Both Sexes, Ages ≥20 Years, N, 2016

Figure 9: 8MM, Age-Specific Total Prevalent Cases of DES, Both Sexes, Ages ≥20 Years, N, 2016

Figure 10: 8MM, Sex-Specific Total Prevalent Cases of DES, Both Sexes, Ages ≥20 Years, N, 2016

Figure 11: 8MM, Diagnosed Prevalent Cases of DES, Both Sexes, Ages ≥20 Years, N, 2016

Figure 12: Unmet Needs and Opportunities in DES

Figure 13: Bullseye Diagram of Products in Clinical Development for DES, 2016

Figure 14: Key Phase IIb/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for DES in the 8MM During the Forecast Period

Figure 15: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of DES During the Forecast Period

Figure 16: Analysis of the Company Portfolio Gap in DES During the Forecast Period

Figure 17: Global (8MM) Sales Forecast by Country for DES in 2016 and 2026

Figure 18: Sales Forecast by Class for DES in the US in 2016 and 2026

Figure 19: Sales Forecast by Class for DES in the 5EU in 2016 and 2026

Figure 20: Sales Forecast by Class for DES in Japan in 2016 and 2026

Figure 21: Sales Forecast by Class for DES in China in 2016 and 2026

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