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«GDHC191DFR / Published July 2013 Executive Summary Below table provides a summary of the key metrics for The strong late-stage pipeline is set to ...»

Cyclokat (Dry Eye Syndrome)

Forecast and Market Analysis to 2022

GDHC191DFR / Published July 2013

Executive Summary

Below table provides a summary of the key metrics for The strong late-stage pipeline is set to offer a strong

Cyclokat in the major pharmaceuticals markets. competition to Cyclokat.

Potential generic Restasis will prove detrimental to

Cyclokat: Key Metrics in the Major Pharmaceutical Markets, 2012 - 2022 Cyclokat uptake in the US, since they both have the 2022 Market Sales same active ingredient.

US $87.6m 5EU $518.0m Below figure illustrates Cyclokat sales during the forecast Total Global* $605.6m period.

Key events (2012-2022) Level of Impact Cyclokat launch in the US in 2016 ↑ Sales of Cyclokat by Region, 2022 Cyclokat launch in the 5EU in 2014 ↑↑ *For the purposes of this report, Global = US, France, Germany, Italy, Spain, UK 2022 14.5% Source: GlobalData Total: $605.6m NA: Not Applicable Sales of Cyclokat in the Global Dry Eye Syndrome US Market 5EU GlobalData expects Cyclokat to launch in the US

–  –  –

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.1.3 Classification

3.1.4 Prognosis

3.1.5 Quality of Life

3.2 Symptoms

4 Disease Management

4.1 Overview

4.1.1 Diagnosis Overview

4.1.2 Treatment Guidelines

4.1.3 Treatment Overview

5 Competitive Assessment

5.1 Overview

5.2 Strategic Competitor Assessment

6 Opportunity and Unmet Need

6.1 Overview

6.2 Diagnostic tests are not specific enough to identify subgroups of patients..................32

6.3 Frequent dosing and side effects limit compliance

6.4 Lack of physician and patient awareness

–  –  –

6.5 Trial design may be a factor in so few drugs being approved

6.6 Unmet Needs Gap Analysis

6.7 Comprehensive method for measuring dry eye signs and severity levels

6.8 Increase treatment rates among milder forms of the disease

7 Pipeline Assessment

7.1 Overview

7.2 Promising drugs in clinical development

8 Cyclokat

8.1 Overview

8.2 Efficacy

8.3 Safety

8.4 Dosing and Formulation

8.5 Potential Clinical Positioning

8.6 Potential Commercial Positioning

8.7 Pricing and Reimbursement

8.8 SWOT Analysis

8.9 Forecast

9 Appendix

9.1 Bibliography

9.2 Abbreviations

9.3 Methodology

9.4 Forecasting Methodology

9.4.1 Diagnosed DES patients

9.4.2 Percent Drug-treated Patients

9.4.3 General Pricing Assumptions

9.4.4 Individual Drug Assumptions

9.4.5 Generic Erosion

9.5 Physicians and Specialists Included in this Study

–  –  –

9.6 About the Authors

9.6.1 Author

9.6.2 Global Head of Healthcare

9.7 About GlobalData

9.8 Contact Us

9.9 Disclaimer

–  –  –

Table 1: Symptoms of Dry Eye Syndrome

Table 2: Treatment Guidelines for Dry Eye Syndrome

Table 3: Commonly Prescribed Drugs for Dry Eye Syndrome by Class in the Global Markets, 2012

Table 4: Leading Treatments for Dry Eye Syndrome, 2012

Table 5: Overall Unmet Needs – Current Level of Attainment

Table 6: Clinical Unmet Needs – Gap Analysis, 2012

Table 7: Dry Eye Syndrome – Phase Pipeline, 2012

Table 8: Comparison of Therapeutic Classes in Development for Dry Eye Syndrome, 2012........41 Table 9: Product Profile – Cyclokat

Table 10: Cyclokat SWOT Analysis, 2012

Table 11: Global Sales Forecasts ($m) for Cyclokat, 2012–2022

–  –  –

Figure 1: Dry Eye Syndrome – Disease Etiology

Figure 2: Tear Film in Normal Eye and Dry Eye

Figure 3: Sequence of Diagnostic Tests Used to Diagnose Dry Eye Syndrome

Figure 4: Delphi Panel Treatment Recommendations for Dysfunctional Tear Syndrome Without Lid Margin Disease, 2006

Figure 5: Delphi Panel Treatment Recommendations for Dysfunctional Tear Syndrome With Lid Margin Disease and Abnormal Tear Distribution, 2006

Figure 6: Treatment Recommendations for Dry Eye Syndrome from the Management and Therapy Subcommittee, Dry Eye Workshop, 2007

Figure 7: American Academy of Ophthalmology Preferred Practice Pattern for Dry Eye, 2011......25 Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in Dry Eye Syndrome, 2012– 2022

–  –  –

This report provides a thorough analysis of the current and future landscape of DES therapeutics.

For this report, the global coverage includes the seven major markets (7MM), US, UK, Germany, France, Italy, Spain, UK, and Japan, as well as the emerging markets of China and India. Artificial tears are the mainstay of therapy for the treatment of dry eye, regardless of severity of the disease, along with other pharmacologic treatment options, including Restasis (cyclosporine 0.05% ophthalmic emulsion), Diquas (diquafosol tetrasodium), and Mucosta (2% rebamipide ophthalmic suspension). The DES pipeline is strong, with 49 molecules in various phases of development.

More notably, the late-stage pipeline has three products with novel mechanisms of action to treat the inflammation associated with the disease.

Since the last GlobalData DES report, in addition to a consistently growing patient population as a result of aging baby boomers and lifestyle changes associated with increased industrialization, two new entrants have emerged in the DES market: Diquas and Mucosta. Both have been launched in Japan and are contributing significantly to the treatment paradigm and will continue to capture market share.

–  –  –

GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, Boston, London, India and Singapore.

–  –  –

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData.

© GlobalData.

This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Page 57 GDHC191DFR / Published JULY 2013

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