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Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers

2014-2024

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Contents

1. Executive Summary

1.1 Leading Ophthalmic Drug Manufacturers: Overview of Findings

1.2 Chapter Breakdown

1.3 Research and Analysis Methods

1.4 Scope of this Report

1.5 Drugs Considered for this Report

1.6 Glossary of Terms in this Report

2. Introduction to the Ophthalmic Drugs Market

2.1 The Eye: An Overview of Its Structure and Function

2.2 The Global Burden of Eye Disease

2.3 Ophthalmic Drugs: Market Segmentation

2.4 Glaucoma: the ‘Silent Thief of Sight’

2.4.1 A Classification of Glaucoma

2.4.1.1 Primary Open-Angle Glaucoma

2.4.1.2 Acute Angle-Closure Glaucoma

2.4.1.3 Congenital Glaucoma

2.4.1.4 Secondary Glaucoma

2.4.1.5 Normal-Tension Glaucoma

2.4.1.6 Ocular Hypertension

2.4.2 Risk Factors for Glaucoma

2.4.3 Diagnosis of Glaucoma

2.4.4 Drug Treatment of Glaucoma

1. Executive Summary

2. Introduction to the Ophthalmic Drugs Market

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Contents 2.4.5 Laser Treatment and Surgery for Glaucoma

2.5 Age-Related Macular Degeneration (AMD)

2.5.1 Dry (non-exudative) AMD

2.5.2 Wet (exudative) AMD

2.5.3 Risk Factors for AMD

2.5.4 Diagnosis of AMD

2.5.5 Treatment of AMD

2.6 Diabetic Retinopathy (DR)

2.6.1 Diagnosis of Diabetic Retinopathy

2.6.2 Treatment of Diabetic Retinopathy

2.7 Ocular Allergy and Allergic Conjunctivitis

2.7.1 Diagnosis of Ocular Allergy

2.7.2 Treatment of Ocular Allergy

2.8 Ocular Inflammatory Disease

2.8.1 Treatment of Ocular Inflammatory Disease

2.9 Eye Infections

2.9.1 Treatment of Eye Infections

2.10 Dry Eye Syndrome

2.10.1 Treatment of Dry Eye Syndrome

3. Ophthalmic Drugs: World Market 2014-2024

3.1 The World Ophthalmic Drugs Market in 2012 and 2013

3.2 World Ophthalmic Drugs Market: Sales Forecast 2014-2024

3.3 Leading Ophthalmic Drugs

3. Ophthalmic Drugs: World Market 2014-2024

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Contents 3.4 Leading Companies in the Ophthalmic Drugs Market

3.4.1 Top 25 Ophthalmic Drug Manufacturers 2014-2024

3.5 Ophthalmic Drugs Market Segments: Sales Forecasts 2014-2024

3.5.1 Glaucoma Drugs Market: Sales Forecast 2014-2024

3.5.2 Retinal Disorders Drugs Market: Sales Forecast 2014-2024

3.5.3 Allergic, Inflammatory and Infective Drugs Market: Sales Forecast 2014-2024

3.5.4 Dry Eye Drugs Market: Sales Forecast 2014-2024

3.6 Changing Market Shares by Segment 2014-2024

3.7 World Ophthalmic Drugs Market: Drivers and Restraints

4. Leading US Ophthalmic Drug Manufacturers in 2012 and 2013

4.1 Allergan

4.1.1 Allergan: Ophthalmic Product Portfolio

4.1.1.1 Restasis: Sales Forecast 2014-2024

4.1.1.2 Lumigan and Ganfort: Sales Forecast 2014-2024

4.1.1.3 Refresh Brand Products: Sales Forecast 2014-2024

4.1.1.4 Alphagan/Alphagan P and Combigan: Sales Forecast 2014-2024

4.1.1.5 Acular: Sales Forecast 2014-2024

4.1.2 Allergan: Ophthalmic Product Pipeline

4.1.2.1 Ozurdex (Dexamethasone Intravitreal Implant): The First Drug Therapy for

Diabetic Macular Oedema

4.1.2.2 Novadur (Intravitreal Brimonidine Implant)

4.1.2.3 AGN 208397 (Beclomethasone Intravitreal Injection)

4.1.2.4 Anti-VEGF DARPins (VEGF Inhibitors)

4. Leading US Ophthalmic Drug Manufacturers in 2012 and 2013

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Contents 4.1.3 Allergan: Ophthalmic Revenue Forecast 2014-2024

4.1.4 Allergan: SWOT Analysis

4.2 Merck

4.2.1 Merck: Ophthalmic Product Portfolio

4.2.1.1 Trusopt: Sales Forecast 2014-2024

4.2.1.2 Zioptan: Sales Forecast 2014-2024

4.2.1.3 AzaSite (azithromycin)

4.2.2 Merck: Ophthalmic Product Pipeline

4.2.3 Merck: Revenue Forecast 2014-2024

4.2.4 Merck: Drivers and Restraints

4.3 Pfizer

4.3.1 Pfizer: Ophthalmic Product Portfolio

4.3.1.1 Xalatan/Xalacom: Sales Forecast 2014-2024

4.3.1.2 Macugen (Valeant/Pfizer)

4.3.2 Pfizer: Ophthalmic Product Pipeline

4.3.3 Pfizer: Revenue Forecast 2014-2024

4.3.4 Pfizer: SWOT Analysis

4.4 Regeneron

4.4.1 Regeneron: Ophthalmic Product Portfolio

4.4.1.1 Eylea: US Sales Forecast 2014-2024

4.4.2 Regeneron: Ophthalmic Product Pipeline

4.4.3 Regeneron: Revenue Forecast 2014-2024

4.4.4 FDA Approves Zaltrap (aflibercept)

4.4.5 Eylea/Zaltrap and the Davis-Smyth Patent Agreements

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Contents 4.4.6 Regeneron: SWOT Analysis

5. Leading European Ophthalmic Drug Manufacturers in 2012 and 2013

5.1 Novartis (including Alcon)

5.1.1 Novartis: Ophthalmic Product Portfolio

5.1.1.1 Lucentis (ranibizumab)

5.1.1.2 Lucentis: Non-US Sales Forecast 2014-2024

5.1.1.3 Travatan/Travatan Z and DuoTrav: Sales Forecast 2014-2024

5.1.1.4 Vigamox: Sales Forecast 2014-2024

5.1.1.5 Azopt: Sales Forecast 2014-2024

5.1.1.6 Jetrea: Non-US Sales Forecast 2014-2024

5.1.2 Novartis: Ophthalmic Product Pipeline

5.1.2.1 Lucentis (ranibizumab) For Myopic Choroidal Neovascularisation

5.1.2.2 Finafloxacin (MerLion Pharmaceuticals/Novartis)

5.1.2.3 AKB-9778 (Aerpio Therapeutics)

5.1.2.4 AL-78898A (Complement Factor Inhibitor, Alcon)

5.1.3 Novartis: Revenue Forecast 2014-2024

5.1.4 Novartis: SWOT Analysis

5.2 Roche

5.2.1 Roche: Ophthalmic Product Portfolio

5.2.1.1 Lucentis: US Sales Forecast 2014-2024

5.2.1.2 Avastin: Sales Forecast 2014-2024

5.2.2 Roche: Ophthalmic Product Pipeline

5.2.2.1 Lampalizumab (RG7417)

5. Leading European Ophthalmic Drug Manufacturers in 2012 and 2013

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Contents 5.2.3 Roche: Revenue Forecast 2014-2024

5.2.4 Roche: SWOT Analysis

6. Leading Asia-Pacific and Other Ophthalmic Drug Manufacturers in

2012 and 2013

6.1 Santen

6.1.1 Santen: Ophthalmic Product Portfolio

6.1.1.1 Eylea: Japan Sales Forecast 2014-2024

6.1.1.2 Hyalein: Sales Forecast 2014-2024

6.1.1.3 Cosopt: Japan Sales Forecast 2014-2024

6.1.1.4 Tapros/Taflotan: Sales Forecast 2014-2024

6.1.1.5 Diquas: Sales Forecast 2014-2024

6.1.1.6 Cravit and Tarivid: Sales Forecast 2014-2024

6.1.2 Santen: Ophthalmic Product Pipeline

6.1.3 Santen: Revenue Forecast 2014-2024

6.1.4 Santen Acquires Novagali Pharma

6.1.5 Santen: SWOT Analysis

6.2 Senju

6.2.1 Senju: Ophthalmic Product Portfolio

6.2.2 Senju: Ophthalmic Product Pipeline

6.2.2.1 Y-39983 (SNJ-1656)

6.2.2.2 Difluprednate (SJE-2079)

6.2.3 Senju: Revenue Forecast 2014-2024

6.2.4 Senju: SWOT Analysis

6.3 Valeant

6. Leading Asia-Pacific and Other Ophthalmic Drug Manufacturers in

2012 and 2013

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Contents 6.3.1 Valeant’s Acquisition of Bausch and Lomb: Aggressive Expansion?

6.3.2 Bausch and Lomb Had Acquired ISTA Pharmaceuticals

6.3.3 Valeant: Ophthalmic Product Portfolio

6.3.3.1 Macugen (Valeant/Pfizer): A Drug in Decline

6.3.4 Valeant: Ophthalmic Product Pipeline

6.3.4.1 Latanoprostene Bunod (BOL-303259-X)

6.4.3.2 Mapracorat (BOL-303242-X)

6.3.5 Valeant: Revenue Forecast 2014-2024

6.3.6 Valeant: SWOT Analysis

7. Emerging Ophthalmic Drug Manufacturers in 2012 and 2013

7.1 Pipeline and Other Companies, 2012-2013

7.2 Notable Terminated Drug Candidates

7.3 Abbott: Fenofibrate Approved in Australia for Diabetic Retinopathy

7.4 Acucela

7.5 Aerie Pharmaceuticals

7.6 Aerpio Therapeutics: Developing AKB-9778

7.7 Akorn

7.7.1 Cosopt/Cosopt PF: Sales Forecast 2014-2024

7.7.2 AzaSite: Sales Forecast 2014-2024

7.8 Alimera Sciences

7.8.1 Iluvien: Will It Gain FDA Approval?

7.8.2 NADPH Oxidase Inhibitors Offer Potential for Dry AMD

7.9 Altheos

7. Emerging Ophthalmic Drug Manufacturers in 2012 and 2013

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Contents 7.10 Amakem

7.11 Ampio Pharmaceuticals

7.12 Bayer

7.12.1 Eylea: non-US Sales Forecast 2014-2024

7.13 BioDiem

7.13.1 BDM-E: A High-Value Divestment?

7.14 Can-Fite BioPharma/OphthaliX

7.15 Chengdu Kanghong Pharmaceutical: Still Developing Conbercept?

7.16 Colby Pharmaceutical

7.16.1 CPC-551: A Potential Treatment for Geographic Atrophy in Dry AMD

7.17 Eleven Biotherapeutics

7.18 EyeGate Pharmaceuticals

7.19 Gene Signal

7.19.1 Aganirsen: Preventing Corneal Graft Rejection

7.19.2 GSK

7.19.3 Darapladib for Diabetic Macular Oedema

7.20 Icon Bioscience

7.21 Lpath

7.21.1 iSONEP: Antibodies Against Bioactive Lipids

7.22 MacuCLEAR

7.22.1 MC-1101: a Potential Therapy for Dry AMD

7.23 Neurotech

7.23.1 Renexus (NT-501) for Dry AMD

7.24 Omeros

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Contents 7.25 Ophthotech

7.25.1 Fovista: A Strong Competitor for the AMD Market

7.25.2 ARC1905: Complement C5 Inhibitor

7.25.3 Has Volociximab Been Terminated?

7.26 Otsuka Pharmaceutical

7.27 OXiGENE: Developing Zybrestat for Wet AMD

7.28 RXi Pharmaceuticals: Will Bevasiranib Resume Development?

7.29 Shire

7.29.1 Jerini Ophthalmic’s JSM6427 and JPE-1375 Terminated?

7.29.2 Lifitegrast (SHP606) for Dry Eye

7.29.3 Premiplex (SHP607): Preventing Retinopathy of Prematurity

7.30 Sirnaomics: Acurita (STP601) Still in Preclinical Development?

7.31 ThromboGenics

7.31.1 Jetrea (ocriplasmin)

7.31.1.1 Jetrea: US Sales Forecast 2014-2024

7.31.2 TB-403: Anti-Placental Growth Factor

8. Qualitative Analysis of the Ophthalmic Drugs Market 2014-2024

8.1 Porter’s Five Forces Analysis of the Ophthalmic Drugs Market

8.1.1 Rivalry Among Competitors [Medium]

8.1.2 Threat of New Entrants [Low]

8.1.3 Power of Suppliers [Low]

8.1.4 Power of Buyers [Medium]

8.1.5 Threat of Substitutes [Medium]

8. Qualitative Analysis of the Ophthalmic Drugs Market 2014-2024

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Contents

9. Research Interviews

9.1 Interview with Professor David T. Shima, PhD, Institute of Ophthalmology, University

College London, UK

9.1.1 On the Role of VEGF in Retinal Disorders

9.1.2 On Candidate Molecule E10030

9.1.3 On Candidate Molecule JSM 6427

9.1.4 On New Sustained Release Formulations

9.1.5 On Delta-Notch Signalling

9.1.6 Potential Clinical Crossovers Between Ophthalmology and Oncology

9.1.7 Commercial and Clinical Possibilities in the Ophthalmology Market

9.1.8 On the Possibilities of Research into the Endothelial Fenestra

9.2 Expert Interview 2: Authority from a Company in the Industry (Views Provided

Anonymously)

9.2.1 Key Unmet Needs

9.2.2 Challenges Facing the Ophthalmic Sector

9.2.3 On Current Ophthalmic Treatments and Their Effectiveness

9.2.4 On Opportunities in the Ophthalmic Sector

9.3 Interview with Sean Ainsworth, CEO and Founder of RetroSense Therapeutics, Ann Arbor,

Michigan, USA

9.3.1 The Optogenetic Approach to Vision Restoration

9.3.2 Choosing Disease Targets and Delivery Vectors

9.3.3 The Regulatory Picture

9.3.4 Gene Therapies in AMD and Other Ophthalmic Therapeutic Areas

9. Research Interviews

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Contents 9.3.5 The Next Ten Years for Gene Therapy

9.4 Interview with Philip G. Ralston, Jr., CEO of MacuCLEAR, Plano, Texas, USA

9.4.1 MC-1101: Identifying and Treating Chiou Syndrome

9.4.2 Preventing Dry AMD Progression

9.4.3 Treating the Root Cause of Dry AMD

9.4.4 Phase 3: Endpoints and Prospects for MC-1101

9.5 Interview with Dr Michael Stewart, Associate Professor, Mayo Clinic, Jacksonville, Florida,

USA

9.5.1 The Impact of Eylea

9.5.2 The Comparative Dosing Schedules of Eylea and Lucentis

9.5.3 Patient Transitioning to Eylea: Salvage Switching

9.5.4 Avastin after the CATT Study

9.5.5 Prospects for Eylea in Other Indications and Combinations

9.5.6 Future Possibilities in Wet AMD Treatment

10. Conclusions

10.1 Ophthalmic Pharmaceuticals: A Growing Niche Market

10.2 The World Ophthalmic Drugs Market in 2012 and 2013

10.2.1 Leading Ophthalmic Drugs Market Segments

10.2.2 Leading Ophthalmic Drugs

10.2.3 Leading Ophthalmic Drug Manufacturers

10.3 World Ophthalmic Drugs Market Forecast 2014-2024

10.4 The Future of the Ophthalmic Drugs Market?

10.4.1 Increasing Revenue Concentration among Specialist Companies

10.4.2 The Rise of Generics

10. Conclusions

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Contents 10.4.3 Small Companies Can Have a Big Impact

10.4.4 What Will Succeed in the Ophthalmic Drugs Market?

Table 1.1 Currency Exchange Rates, 2012

Table 2.1 ICD-10 Classification of Visual Impairment, 2010

Table 2.2 Drug Treatments for Glaucoma, 2013

Table 2.3 Drug Treatments for AMD, 2013

Table 2.4 Drug Treatments for Ocular Allergy, 2013

Table 2.5 Drug Treatments for Ocular Inflammatory Disease, 2013

Table 2.6 Selected Drug Treatments for Eye Infections, 2013

Table 3.1 World Ophthalmic Drugs Market: Revenue ($m) and Market Share (%) by Segment,

2012-2013

Table 3.2 World Ophthalmic Drugs Market Forecast: Revenue ($m), AGR (%), CAGR (%), 2012-

2024

Table 3.3 Top 10 Ophthalmic Drugs: Revenue ($m), 2012-2013

Table 3.4 Top 10 Ophthalmic Drug Manufacturers: Net Revenue ($m), Ophthalmic Drugs

Revenue ($m), Market Share (%), 2012-2013

Table 3.5 Top 25 Ophthalmic Drug Manufacturers: Ophthalmic Drugs Revenue ($m), Leading

Pipeline Products, 2013

Table 3.6 World Ophthalmic Drugs Market Forecast: Revenues ($m), AGR (%), CAGR (%) by

Segment, 2012-2018

Table 3.7 World Ophthalmic Drugs Market Forecast: Revenues ($m), AGR (%), CAGR (%) by

Segment, 2018-2024

Table 3.8 Glaucoma Drugs Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2024

List of Tables

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Contents Table 3.9 Retinal Disorders Drugs Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-

2024

Table 3.10 Allergic, Inflammatory and Infective Drugs Market Forecast: Revenues ($m), AGR

(%), CAGR (%), 2012-2024

Table 3.11 Dry Eye Drugs Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2024

Table 3.12 Market Shares (%) of the Ophthalmic Drugs Market by Segment, 2012, 2018 and

2024

Table 4.1 Allergan: Overview, 2012-2013

Table 4.2 Allergan: Ophthalmic Drug Products, 2013

Table 4.3 Allergan: Restasis Revenue ($m), AGR (%), CAGR(%), 2002-2012

Table 4.4 Allergan: Restasis Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.5 Allergan: Lumigan Revenue ($m), AGR (%), CAGR(%), 2000-2012

Table 4.6 Allergan: Lumigan and Ganfort Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.7 Allergan: Refresh Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.8 Allergan: Alphagan/Alphagan P and Combigan Revenue ($m), AGR (%), CAGR(%),

2012-2024

Table 4.9 Allergan: Acular Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.10 Allergan: Revenues ($m) and Revenue Shares (%) by Region, 2012

Table 4.11 Allergan: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.12 Allergan: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 4.13 Merck: Overview, 2012-2013

Table 4.14 Merck: Trusopt Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.15 Merck: Zioptan Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.16 Merck: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.17 Pfizer: Overview, 2012-2013

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Contents Table 4.18 Pfizer: Xalatan/Xalacom Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.19 Pfizer: Macugen Revenue ($m), AGR (%), CAGR(%), 2004-2012

Table 4.20 Pfizer: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.21 Pfizer: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 4.22 Regeneron: Overview, 2012-2013

Table 4.23 Regeneron: Eylea Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.24 Regeneron: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 4.25 Regeneron: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 5.1 Novartis: Overview, 2012-2013

Table 5.2 Novartis: Lucentis Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.3 Novartis: Travatan/Travatan Z and DuoTrav Revenue ($m), AGR (%), CAGR(%), 2012-

2024

Table 5.4 Novartis: Vigamox Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.5 Novartis: Azopt Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.6 Novartis: Jetrea Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.7 Novartis: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.8 Novartis: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 5.9 Roche: Overview, 2012-2013

Table 5.10 Roche: Lucentis Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.11 Roche: Avastin Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.12 Roche: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 5.13 Roche: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 6.1 Santen: Overview, 2012-2013

Table 6.2 Santen: Revenue ($m) and Revenue Share (%) by Segment, 2012-2013

Table 6.3 Santen: Eylea Revenue ($m), AGR (%), CAGR(%), 2012-2024

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Contents Table 6.4 Santen: Hyalein Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.5 Santen: Cosopt Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.6 Santen: Tapros/Taflotan Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.7 Santen: Diquas Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.8 Santen: Cravit and Tarivid Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.9 Santen: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.10 Santen: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 6.11 Senju: Overview, 2012-2013

Table 6.12 Senju: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.13 Senju: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 6.14 Valeant: Overview, 2012-2013

Table 6.15 Valeant: Selected Products Revenue ($m), 2010-2012

Table 6.16 Valeant: Ophthalmic Drugs Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 6.17 Valeant: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Table 7.1 Akorn: Cosopt and Cosopt PF Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 7.2 Akorn: AzaSite Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 7.3 Bayer: Eylea Revenue ($m), AGR (%), CAGR(%), 2012-2024

Table 7.4 ThromboGenics: Jetrea Revenue ($m), AGR (%), CAGR(%), 2012-2024

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Contents

Figure 2.1 Structure of the Human Eye

Figure 2.2 Estimated Global Prevalence of Visual Impairment (millions of people), 2012

Figure 2.3 Global Causes of Visual Impairment (% of cases), 2012

Figure 2.4 Classification of Glaucoma, 2013

Figure 3.1 World Ophthalmic Drugs Market: Market Share (%) by Segment, 2012

Figure 3.2 World Ophthalmic Drugs Market: Market Share (%) by Segment, 2013

Figure 3.3 World Ophthalmic Drugs Market Forecast: Revenue ($m), 2012-2024

Figure 3.4 Top 10 Ophthalmic Drug Manufacturers: Market Share (%), 2013

Figure 3.5 Glaucoma Drugs Market Forecast: Revenues ($m), 2012-2024

Figure 3.6 Retinal Disorders Drugs Market Forecast: Revenues ($m), 2012-2024

Figure 3.7 Allergic, Inflammatory and Infective Drugs Market Forecast: Revenues ($m), 2012-

2024

Figure 3.8 Dry Eye Drugs Market Forecast: Revenues ($m), 2012-2024

Figure 3.9 World Ophthalmic Drugs Market: Market Shares (%) by Segment, 2018

Figure 3.10 World Ophthalmic Drugs Market: Market Shares (%) by Segment, 2024

Figure 3.11 World Ophthalmic Drugs Market: Drivers and Restraints, 2014-2024

Figure 4.1 Allergan: Restasis Revenue ($m), 2002-2012

Figure 4.2 Allergan: Restasis Revenue ($m), 2012-2024

Figure 4.3 Allergan: Lumigan Revenue ($m), 2000-2012

Figure 4.4 Allergan: Lumigan and Ganfort Revenue ($m), 2012-2024

Figure 4.5 Allergan: Refresh Revenue ($m), 2012-2024

Figure 4.6 Allergan: Alphagan/Alphagan P and Combigan Revenue ($m), 2012-2024

List of Figures

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Contents Figure 4.7 Allergan: Acular Revenue ($m), 2012-2024

Figure 4.8 Allergan: Revenue Shares (%) by Region, 2012

Figure 4.9 Allergan: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 4.10 Allergan: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 4.11 Merck: Trusopt Revenue ($m), 2012-2024

Figure 4.12 Merck: Zioptan Revenue ($m), 2012-2024

Figure 4.13 Merck: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 4.14 Merck: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 4.15 Merck: Drivers and Restraints, 2014-2024

Figure 4.16 Pfizer: Xalatan/Xalacom Revenue ($m), 2012-2024

Figure 4.17 Pfizer: Macugen Revenue ($m), 2004-2012

Figure 4.18 Pfizer: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 4.19 Pfizer: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 4.20 Regeneron: Eylea Revenue ($m), 2012-2024

Figure 4.21 Regeneron: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 4.22 Regeneron: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 5.1 Novartis: Lucentis Revenue ($m), 2012-2024

Figure 5.2 Novartis: Travatan/Travatan Z and DuoTrav Revenue ($m), 2012-2024

Figure 5.3 Novartis: Vigamox Revenue ($m), 2012-2024

Figure 5.4 Novartis: Azopt Revenue ($m), 2012-2024

Figure 5.5 Novartis: Jetrea Revenue ($m), 2012-2024

Figure 5.6 Novartis: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 5.7 Novartis: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 5.8 Roche: Lucentis Revenue ($m), 2012-2024

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Contents Figure 5.9 Roche: Avastin Revenue ($m), 2012-2024

Figure 5.10 Roche: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 5.11 Roche: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 6.1 Santen: Ophthalmic Drugs Revenue ($m) by Segment, 2012

Figure 6.2 Santen: Eylea Revenue ($m), 2012-2024

Figure 6.3 Santen: Hyalein Revenue ($m), 2012-2024

Figure 6.4 Santen: Cosopt Revenue ($m), 2012-2024

Figure 6.5 Santen: Tapros/Taflotan Revenue ($m), 2012-2024

Figure 6.6 Santen: Diquas Revenue ($m), 2012-2024

Figure 6.7 Santen: Cravit and Tarivid Revenue ($m), 2012-2024

Figure 6.8 Santen: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 6.9 Santen: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 6.10 Senju: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 6.11 Senju: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 6.12 Valeant: Ophthalmic Drugs Revenue ($m), 2012-2024

Figure 6.13 Valeant: Ophthalmic Drugs Market Share (%), 2012-2024

Figure 7.1 Akorn: Cosopt and Cosopt PF Revenue ($m), 2012-2024

Figure 7.2 Akorn: AzaSite Revenue ($m), 2012-2024

Figure 7.3 Alimera Sciences: Ophthalmic Drug Pipeline Progress, 2013

Figure 7.4 Bayer: Eylea Revenue ($m), 2012-2024

Figure 7.5 Gene Signal: Ophthalmic Drug Pipeline Progress, 2013

Figure 7.6 Neurotech: Ophthalmic Drug Pipeline Progress, 2013

Figure 7.7 Ophthotech: Ophthalmic Drug Pipeline Progress, 2013

Figure 7.8 Shire: Ophthalmic Drug Pipeline Progress, 2013

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Contents Figure 7.9 ThromboGenics: Jetrea Revenue ($m), 2012-2024

Figure 8.1 Porter’s Five Forces Analysis of the Ophthalmic Drugs Market, 2014-2024

Figure 10.1 World Ophthalmic Drugs Market: Revenues ($m) by Segment, 2013

Figure 10.2 World Ophthalmic Drugs Market: Revenues ($bn), 2012-2024

Figure 10.3 Leading Ophthalmic Drugs Manufactuters: Revenues ($m), 2012-2024

Abbott Laboratories (Abbott)

Abbvie

Acucela

Advanced Vision Research (acquired by Akorn)

Aerie Pharmaceuticals

Aerpio Therapeutics

Akorn Pharmaceuticals

Alcon (subsidiary of Novartis)

Alimera Sciences

Allergan

Allergro Ophthalmics

Altheos

Amakem

Ampio Pharma

Asahi Glass

AstraZeneca

Aton Pharma (acquired by Valeant)

Companies Listed

www.visiongain.com

Contents Banyu Pharmaceutical (part of Merck)

Bausch and Lomb (subsidiary of Valeant)

Bayer

Bayer Yakuhin (Japanese subsidiary of Bayer)

BioDiem

Biogen Idec

BioInvent International

Biovail Corporation (part of Valeant)

Bristol-Myers Squibb

Can-Fite BioPharma

Chengdu Kanghong Pharmaceutical

Chiron Corportation (part of Novartis)

Chugai Pharmaceutical (part of Roche)

CIBA VISION (part of Novartis)

Ciba-Geigy (part of Novartis)

Colby Pharmaceutical Company (Colby)

CoMentis

Daiichi Sankyo

Eleven Biotherapeutics

Eli Lilly and Company (Lilly)

EyeGate Pharmaceuticals

Eyetech Inc. / Eyetech Pharmaceuticals (acquired by Valeant)

Fougera Pharmaceuticals (acquired by Novartis)

Gene Signal

www.visiongain.com

Contents Genentech (subsidiary of Roche)

Genzyme (subsidiary of Sanofi)

Gilead Sciences

GSK

ICN Pharmaceuticals (original Valeant company)

Icon Bioscience

Inamed Corporation (subsidiary of Allergan)

InSite Vision

Inspire Pharmaceuticals (acquired by Merck)

ISTA Pharmaceuticals (part of Valeant)

Jerini AG

Jerini Ophthalmic (part of Jerini AG)

Johnson & Johnson

Kestrel Ophthalmics

Kyorin Pharmaceutical

Kyowa Hakko Kirin

LEO Pharma

Lpath

MacuCLEAR

MacuSIGHT, Inc.

MAP Pharmaceuticals (acquired by Allergan)

Meda

Medicis Corporation (acquired by Valeant)

Merck & Co. (Merck)

www.visiongain.com

Contents MerLion Pharmaceuticals

MSD K.K. (part of Merck)

Mylan Pharmaceuticals

Mystic Pharmaceuticals

Neurotech

NicOx

Nippon Boehringer Ingelheim (subsidiary of Boehringer Ingelheim)

NovaBay Pharmaceuticals

Novagali Pharma (acquired by Santen)

Novartis

Novo (subsidiary of Novo Nordisk)

Novo Nordisk

Oakwood Laboratories

OcuSciences

Omeros

Onyx Pharmaceuticals

OphthaliX (part-owned by Can-Fite BioPharma)

Ophthotech

OPKO Health

Ora

OSI Pharmaceuticals

Othera Pharmaceuticals (acquired by Colby)

Otsuka Pharmaceutical

Oxford BioMedica

www.visiongain.com

Contents OXiGENE

Parke-Davis (subsidiary of Pfizer)

PDL BioPharma

Pfizer

Pharmacia (acquired by Pfizer)

Potentia Pharmaceuticals

Premacure

Procter & Gamble

pSivida

Quark Pharmaceuticals

Reckitt Benckiser

Regeneron

RetroSense Therapeutics

ReVision Therapeutics

Roche

RXi Pharmaceuticals

Sandoz (part of Novartis)

Sanofi

Santen Pharmaceutical Co. (Santen)

SARcode Bioscience

Schering-Plough (part of Merck)

Senju

Senju Pharmaceuticals Science & Technology (Beijing) Co., Ltd. (subsidiary of Senju)

Senju USA Inc. (subsidiary of Senju)

www.visiongain.com

Contents Shire

Sirion Therapeutics

Sirna Therapeutics

Sirnaomics

SkinMedica (subsidiary of Allergan)

Spark Therapeutics

Symphony ViDA

Takeda Pharmaceutical

Teva

The Patent Board

ThromboGenics

Upjohn (acquired by Pfizer through Pharmacia)

Valeant Pharmaceuticals

Ventana Medical Systems (acquired by Roche)

Warburg Pincus LLC

Warner-Lambert (acquired by Pfizer)

Watson Pharmaceuticals

Wyeth Pharmaceuticals (part of Pfizer)

www.visiongain.com

Contents

A*STAR Institute for Infocomm Research (Singapore)

American Academy of Ophthalmology (AAO)

American Diabetes Association

American Society of Retina Specialists (ASRS)

Association for Research in Vision and Ophthalmology (ARVO)

Council of Europe

Emory University

European Medicines Agency (EMA)

Foundation Fighting Blindness (FFB) (US)

Health Canada

Institute of Experimental Medicine (Russia)

Institute of Ocular Pharmacology, Texas A&M (US)

Institute of Ophthalmology, University College London (UK)

Intellectual Property Appellate Board (India)

International Diabetes Federation

Internet Archive

Japan Patent Office (JPO)

Mayo Clinic

Ministry of Health, Labour and Welfare (MHLW) (Japan)

Monash University

National Eye Institute (NEI) (US)

National Health Service (NHS) (UK)

National Institute for Health and Care Excellence (NICE) (UK)

Other Organisations Mentioned in This Report

www.visiongain.com

Contents NHS Scotland

Novartis Institutes for BioMedical Research (NIBR) (part of Novartis)

Novartis Venture Funds (NVF) (part of Novartis)

Ophthalmology External Research Unit (part of Pfizer)

Ophthrisi (GSK research unit)

Rinat (Pfizer research unit)

Texas Emerging Technology Fund

Therapeutic Goods Administration (TGA) (Australia)

Tokyo University of Science

United States Food and Drug Administration (FDA)

University of Florida

University of Kentucky

University of Melbourne

University of Michigan

US Preventive Services Task Force (USPSTF)

US Securities and Exchange Commission (SEC)

World Health Organization (WHO)

www.visiongain.com Page 84

Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2014-2024

4.1.1.5 Acular: Sales Forecast 2014-2024

Acular (ketorolac tromethamine, Allergan) is a topical NSAID eyedrop solution, indicated in the

relief of ocular itching due to seasonal allergic conjunctivitis and post-operative ocular

inflammation. First launched in the Netherlands and Canada in 1992, it is now available in several

other countries worldwide, including the UK, Germany and the US. New forms, Acular PF and

Acular LS, have since received FDA approval and are also available in the US market.

Visiongain estimates that sales of Acular had declined to $60m in 2012. We predict that sales will

continue to decline further, reaching $33m in 2018 for a CAGR of -9.3% over 2012-2018. The US

patent for ketorolac tromethamine expired in the fourth quarter of 2009 and generic versions of

Acular are available. Sales will continue to fall from 2018 to 2024, reaching $26m in 2024 (Table

4.9 and Figure 4.7). This represents a CAGR of -4.2% over 2018-2024 and an overall CAGR of

-6.8% over 2012-2024.

Table 4.9 Allergan: Acular Revenue ($m), AGR (%), CAGR(%), 2012-2024

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024Acular ($m) 60 54 48 44 39 36 33 31 30 28 27 26 26Annual Growth Rate (%) -10.0 -10.0 -10.0 -10.0 -8.0 -8.0 -6.0 -5.0 -5.0 -3.0 -3.0 -3.0CAGR (%, 2012-2018 and 2018-2024)

-9.3 -4.2

CAGR (%, 2012-2024) -6.8

Figure 4.7 Allergan: Acular Revenue ($m), 2012-2024

60 54

48 44

39 36 33 31 30 28 27 26 26

0

10

20

30

40

50

60

70

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

Rev

enue

($m

)

Year

Source: visiongain 2013

Source: visiongain 2013

www.visiongain.com Page 99

Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2014-2024 • Warner-Lambert, acquired in 2000 for around $90bn. Warner-Lambert itself had become a

major pharmaceutical player through mergers and acquisitions, having joined with Parke-

Davis during the 1970s.

• Pharmacia and its subsidiary Upjohn, acquired in April 2003 for $60bn.

• Wyeth Pharmaceuticals, acquired in January 2009 for $68bn. This acquisition gave Pfizer

access to additional ophthalmic products.

The company is perhaps best known for its blockbuster drug Lipitor (atorvastatin), which lost patent

protection in November 2011. In July 2011, Pfizer announced that it intended to focus on its core

pharmaceutical business in the future and planned to divest its animal health and nutrition

divisions. In April 2012, Nestlé acquired the company’s infant nutrition business and in January

2013, Pfizer’s Animal Health business became a separate company called Zoetis. Table 4.17

presents an overview of Pfizer.

Table 4.17 Pfizer: Overview, 2012-2013

Ranking in 2013 (2012) 7 (7)Company Pfizer, Inc.Notable Subsidiaries Wyeth (2009)

Business Areas Pharmaceuticals, nutritionals, vaccines, consumer health

Established 1849Headquarters New York City, New York, USFY 2012 Revenue ($m) 58,896FY2012 Ophthalmic Drugs Revenue ($m) 812

Leading Ophthalmic Drugs Xalatan/Xalacom, Macugen

Market Share, 2012 (%) 4.5Market Share, 2024 (%) 0.7

4.3.1 Pfizer: Ophthalmic Product Portfolio

Pfizer currently markets three ophthalmic products: Xalatan (latanoprost) and Xalacom

(latanoprost/timolol) for glaucoma and Macugen (pegaptanib) for wet AMD. Both Xalatan/Xalacom

and Macugen face generic competition. Generic latanoprost was launched in Japan in May 2010

and launches in other major markets followed. Xalatan lost exclusivity in the US in March 2011 and

the company lost exclusivity for Xalatan and Xalacom in 15 major European markets in January

2012.

Source: Company reports; visiongain 2013

www.visiongain.com Page 154

Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2014-2024 Table 6.10 Santen: Ophthalmic Drugs Market SWOT Analysis, 2012-2024

Strengths WeaknessesStrong ophthalmic pipeline covering all major segments of the ophthalmic drugs market

Vulnerable to generic competition for several products such as Hyalein and Cravit

Strong presence in Asia-Pacific markets, especially Japan where it is market leader

Limited presence in the US and Europe

Opportunities Threats

Expansion into US and European markets Competition in domestic and international markets

Greater penetration into the Chinese market Failure of pipeline candidates in clinical trials

Santen has a well established history in the manufacture of ophthalmic drugs that dates back to

over 120 years in the market. It remains the market leader in Japan in 2013. Santen has focused

much of its marketing activity for ophthalmics on the domestic market and has entered co-

promotion agreements for some of its products in other markets. In 2010, for example, Santen

entered into a co-promotion agreement with Banyu Pharmaceutical Co., Ltd. (currently MSD K.K.)

regarding the glaucoma and ocular hypertension treatment Cosopt Combination Ophthalmic

Solution. A number of pipeline products are also being developed in collaboration with partners in

the US and elsewhere.

The company has continued to grow and develop especially in the Asian markets with strong

penetration throughout Asia including Korea and Hong Kong. Santen already enjoys a leading

position in China’s prescription ophthalmic pharmaceutical market where the company began

direct marketing its products in 2009 to further enhance its presence in that market. Moreover,

Santen has also filed an application for manufacturing and marketing approval in China and has

completed construction of a production plant in Suzhou, China.

The company has a global vision and aims to become an international player in this sector. To

make this happen, Santen will need to improve its presence in the US and European markets. In

Europe, the acquisition of Novagali Pharma (now Santen S.A.S.) has helped to achieve this as well

as bringing one marketed product and four pipeline candidates to the company. In the US, it was

reported that in March 2013 Santen made substantial changes to the management structure of its

US subsidiary, Santen Inc, supporting the idea that Santen is increasingly focusing on business

activities in the US market.

Santen’s pipeline is very strong compared to many of the industry leaders discussed in this report,

with candidates in all major segments of the ophthalmic drugs market. Particularly notable,

perhaps, are the recent launches of Diquas in Japan and South Korea, considering that Allergan’s

Source: visiongain 2013