Global Ophthalmology Drugs Market to 2023 – Angiogenesis Inhibitors in wAMD Set to Retain High Market Share, While Expansive Pipeline for Glaucoma Leads the Research Landscape

Ophthalmology is a broad therapy area that consists of almost 100 disorders associated with the eyes and visual system, including such diseases as glaucoma, age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR) and dry eye syndrome (DES). Many of these disorders are progressive, and if left untreated can lead to severe visual impairment or even blindness.

The patents protecting the three most commercially successful products, all marketed in wet AMD, are expected to expire in the coming years – Lucentis (ranibizumab) and Avastin (Bevacizumab) in 2018, and Eylea (aflibercept) in 2020. However, revenue from anticipated new approvals such as lampalizumab in dry AMD, Fovista (pegpleranib sodium) in wet AMD and brolucizumab in wet AMD and DME is expected to exceed the revenue lost following the patent expiry of current market leaders.

There is also significant interest in developing products for other indications; in 2017, Spark Therapeutics is expected to gain FDA approval in retinitis pigmentosa and Leber congenital amaurosis for its orphan drug, Voretigene Neparvovec, which if successful will be the first gene therapy approved for any genetic disease.

At the same time, a number of small and specialized ophthalmology companies such as Santen and Aerie are expected to enter the market, diversifying the landscape, which currently consists primarily of large biotech companies.

Scope

– The ophthalmology therapeutics market is forecast to reach $35 billion in 2023. What are the key market segments driving this growth?

– The pipeline contains over 800 products. What molecule types and molecular targets are in the pipeline? What are the commercial prospects of promising late-stage products?

– Despite specific drug classes such as angiogenesis inhibitors dominating the commercial landscape, there is a very high proportion of novel drug classes in the pipeline. Which drug classes account for the largest proportion of early-stage development, and how do clinical failure rates, clinical trial size and clinical trial duration differ by indication and molecular target?

– Although they are dominant in the market, large biotech companies are anticipated to lose market share to specialty ophthalmology companies, which are much more active in the pipeline. Which of the leading companies will have the highest market share by 2023? Which new companies will enter the market?

– What licensing and co-development deals have occurred within this therapy area since 2006?

Reasons to buy

- Understand the current clinical and commercial landscape through a comprehensive analysis of innovation in the ophthalmology therapeutics market, in the context of the overall pipeline and current market landscape. The report also includes analysis of the deals landscape, including both licensing deals and co-development deals. Key indications covered in detail include glaucoma, AMD, DME, DR and DES.

- Understand the current treatment landscape, with profiles of key marketed products and a focus on historical and forecast sales patterns, and an overview of each drug’s mechanism of action.

- Analyze the ophthalmology therapeutics pipeline through a comprehensive review, segmented by stage of development, molecule type and molecular target. This review also provides a detailed look at ophthalmology therapeutics clinical trials, to provide an insight into the risk associated with attempting to bring pipeline analgesics to market.

- Predict growth in market size, with in-depth market forecasting from 2016 to 2023. The forecast will provide an understanding of how epidemiology trends, new drug entries and new drug patent expirations will influence market value.

- Identify the key pipeline products, with a particular focus on those due to be brought to market in the near future, as well as sales forecasts for these products.

- Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from ophthalmology therapeutic products. In addition, analysis determines the primary factors that will drive market growth for the disease area’s key companies.

- Assess the licensing and co-development deal landscape for ophthalmology therapies.

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 6

2 Introduction 9

2.1 Therapy Area Introduction 9

2.1.1 Glaucoma 9

2.1.2 Age-Related Macular Degeneration 10

2.1.3 Diabetic Retinopathy 10

2.1.4 Diabetic Macular Edema 10

2.1.5 Dry Eye Syndrome 11

2.2 Symptoms 11

2.3 Diagnosis 13

2.4 Etiology and Pathophysiology 13

2.4.1 Etiology 13

2.4.2 Pathophysiology 15

2.5 Co-morbidities and Complications 18

2.6 Prognosis 19

2.6.1 Glaucoma 19

2.6.2 Age-Related Macular Degeneration 20

2.6.3 Diabetic Retinopathy and Diabetic Macular Edema 20

2.6.4 Dry Eye Syndrome 20

2.7 Epidemiology Patterns; Prevalence, Patient Segmentation, and Diagnostic and Treatment Usage Rates 21

2.7.1 Glaucoma 21

2.7.2 Age-Related Macular Degeneration 22

2.7.3 Diabetic Macular Edema 23

2.7.4 Diabetic Retinopathy 24

2.7.5 Dry Eye Syndrome 25

2.8 Treatment 26

3 Key Marketed Products 29

3.1 Overview 29

3.2 Lucentis (ranibizumab) 29

3.3 Eylea (aflibercept) 30

3.4 Avastin (bevacizumab) 32

3.5 Restasis (cyclosporine) 33

3.6 Alphagan (brimonidine tartrate) 35

3.7 Lumigan (bimatoprost) 36

3.8 Xalatan (latanoprost) 37

3.9 Conclusion 38

4 Pipeline Landscape Assessment 39

4.1 Overview 39

4.2 Pipeline Development Landscape 39

4.3 Molecular Targets in the Pipeline 41

4.4 Clinical Trials 43

4.4.1 Failure Rate 43

4.4.2 Clinical Trial Duration 47

4.4.3 Clinical Trial Size 51

4.4.4 Aggregate Clinical Program Size 54

4.4.5 Assessment of Key Pipeline Products 58

4.4.6 Conclusion 64

5 Multi-Scenario Market Forecast to 2023 65

5.1 Overall Market Size 65

5.2 Generic Penetration 69

5.2.1 Angiogenesis Inhibitors (VEGF/PlGF/PDGF Inhibitors) 70

5.2.2 Antihistamines (Histamine H1 Receptor) 71

5.2.3 Anti-inflammatory Agents (Glucocorticoid Receptor/IL-1 Receptor/Prostaglandin Receptor) 71

5.2.4 IOP Modulators (Prostaglandins, Beta Blockers and the Rho Kinase Signaling Pathway) 72

6 Company Analysis and Positioning 74

6.1 Revenue and Market Share Analysis by Company 75

6.1.1 Novartis - Can the Approval of Fovista and Brolucizumab Offset Revenue Lost Following Patent Expirations? 79

6.1.2 Regeneron - Will Regeneron be Able to Retain its Position in the Ophthalmology Market across the Forecast Period with Eylea Alone? 81

6.1.3 Roche - To What Extent Will Pipeline Product Approvals Offset the Patent Expiries of Lucentis and Avastin? 83

6.1.4 Bayer - Can Bayer Retain its Position in the Ophthalmology Market Given its Small Product Portfolio and Ophthalmology Pipeline? 85

6.1.5 Allergan - How Will Declining Revenue from Restasis Affect Allergan’s Overall Position within the Ophthalmology Therapy Area? 86

6.1.6 Shire - How Will Anticipated New Approvals Perform Across the Forecast Period? 87

6.1.7 Mallinckrodt - Will its Small Ophthalmology Portfolio and Limited Pipeline be Sufficient to Maintain the Position of Mallinckrodt in the Market? 88

6.1.8 Santen - Will Santen Continue to Rely on Ophthalmology Therapy Area for the Majority of its Company Revenue? 89

6.1.9 Aerie - Will Aerie be Able to Successfully Enter the Market with Two New Approvals? 91

6.2 Company Landscape 92

6.3 Marketed and Pipeline Portfolio Analysis 93

7 Strategic Consolidations 95

7.1 Licensing Deals 95

7.1.1 Deals by Region, Year and Value 95

7.1.2 Deals by Stage of Development and Value 97

7.1.3 Deals by Molecule Type, Mechanism of Action and Value 98

7.1.4 Table for Licensing Deals Valued Above $100m 100

7.2 Co-development Deals 106

7.2.1 Deals by Region, Year and Value 106

7.2.2 Deals by Stage of Development and Value 107

7.2.3 Deals by Molecule Type, Mechanism of Action and Value 108

7.2.4 Table for Co-development Deals Valued Above $100m 110

8 Appendix 113

8.1 References 113

8.2 Figures of All Clinical Stage Pipeline Products 121

8.3 Abbreviations 129

8.4 Disease List 130

8.5 Methodology 130

8.5.1 Coverage 130

8.5.2 Secondary Research 130

8.5.3 Market Size and Revenue Forecasts 131

8.5.4 Pipeline Analysis 131

8.5.5 Competitive Landscape 132

8.6 Contact Us 132

8.7 Disclaimer 132

List of Tables

1.1 List of Tables

Table 1: Ophthalmology Disease Therapeutics Market, Symptoms of Glaucoma, AMD, DME, DR and DES 12

Table 2: Ophthalmology Disease Therapeutics Market, Etiology of Glaucoma, AMD, DME, DR and DES 14

Table 3: Ophthalmology Disease Therapeutics Market, Complications associated with glaucoma, AMD, DR and DES 19

Table 4: Ophthalmology, Global, Epidemiology of Ophthalmologic Disorders, 2017 21

Table 5: Ophthalmology Disease Therapeutics Market, Treatment options available for glaucoma 27

Table 6: Ophthalmology Therapeutics Market, Global, Approved Indications for Lucentis, 2017 29

Table 7: Ophthalmology Therapeutics Market, Global, Approved Indications for Eylea, 2017 31

Table 8: Ophthalmology Therapeutics Market, Global, Off-label Indications for Avastin, 2016 32

Table 9: Ophthalmology Therapeutics Market, Global, Approved Indications for Restasis, 2017 34

Table 10: Ophthalmology Therapeutics Market, Global, Approved Indications for Alphagan, 2017 35

Table 11: Ophthalmology Therapeutics Market, Global, Approved Indications for Lumigan, 2017 36

Table 12: Ophthalmology Therapeutics Market, Global, Approved Indications for Xalatan, 2017 37

Table 13: Opthallmology, Global, Annual Revenue Forecast for Key Products ($bn), 2016-2023 66

Table 14: Ophthalmology Therapeutics Market, Global, Forecast Revenues by Company, 2016-2023 75

Table 15: Ophthalmology Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006-2017 100

Table 16: Ophthalmology Therapeutics Market, Global, Co-development Deals Valued Above $100m, 2006-2017 110

List of Figures

1.2 List of Figures

Figure 1: Ophthalmology, Seven Major Markets, Epidemiology Patterns for Glaucoma (millions), 2016-2023 22

Figure 2: Ophthalmology, Seven Major Markets, Epidemiology Patterns for Age-Related Macular Degeneration (millions), 2016-2023 23

Figure 3: Ophthalmology, Seven Major Markets, Epidemiology Patterns for Diabetic Macular Edema (millions), 2016-2023 24

Figure 4: Ophthalmology, Seven Major Markets, Epidemiology Patterns for Diabetic Retinopathy (millions), 2016-2023 25

Figure 5: Ophthalmology, Global, Epidemiology Patterns for Dry Eye Syndrome (millions), 2016-2023 26

Figure 6: Ophthalmology Therapeutics Market, Global, Annual Revenue for Lucentis ($bn), 2006-2023 30

Figure 7: Ophthalmology Therapeutics Market, Global, Annual Revenue for Eylea ($bn), 2011-2023 32

Figure 8: Ophthalmology Therapeutics Market, Global, Annual Revenue for Avastin ($bn), 2006-2023 33

Figure 9: Ophthalmology Therapeutics Market, Global, Annual Revenue for Restasis ($bn), 2006-2023 35

Figure 10: Ophthalmology Therapeutics Market, Global, Annual Revenue for Alphagan ($bn), 2006-2023 36

Figure 11: Ophthalmology Therapeutics Market, Global, Annual Revenue for Lumigan ($bn), 2006-2023 37

Figure 12: Ophthalmology Therapeutics Market, Global, Annual Revenue for Xalatan ($m), 2006-2023 38

Figure 13: Ophthalmology Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 39

Figure 14: Ophthalmology Therapeutics Market, Global, Pipeline for Ophthalmology by Stage of Development, Molecule Type and Program Type, 2017 40

Figure 15: Ophthalmology Therapeutics Market, Global, Pipeline for Key Ophthalmology Indications by Stage of Development, 2017 41

Figure 16: Ophthalmology Therapeutics Market, Pipeline by Mechanism of Action (%), 2017 42

Figure 17: Ophthalmology Therapeutics Market, Global, Pipeline for Key Ophthalmology Indications by Mechanism of Action, 2017 43

Figure 18: Ophthalmology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006-2017 44

Figure 19: Ophthalmology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2017 45

Figure 20: Ophthalmology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2017 46

Figure 21: Ophthalmology Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2017 47

Figure 22: Ophthalmology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2017 48

Figure 23: Ophthalmology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2017 49

Figure 24: Ophthalmology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2017 50

Figure 25: Ophthalmology Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2017 51

Figure 26: Ophthalmology Therapeutics Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2017 52

Figure 27: Ophthalmology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2017 52

Figure 28: Ophthalmology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2017 53

Figure 29: Ophthalmology Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2017 54

Figure 30: Ophthalmology Therapeutics Market, Global, Clinical Program Size by Stage of Development (months), 2006-2017 55

Figure 31: Ophthalmology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2017 56

Figure 32: Ophthalmology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2017 57

Figure 33: Ophthalmology Therapeutics Market, Global, Clinical Program Size by Stage of Development and Mechanism of Action (participants), 2006-2017 58

Figure 34: Ophthalmology, Global, Revenue Forecast for Lampalizumab ($m), 2018-2023 59

Figure 35: Ophthalmology, Global, Revenue Forecast for Fovista ($m), 2017-2023 60

Figure 36: Ophthalmology, Global, Revenue Forecast for Brolucizumab ($m), 2017-2023 61

Figure 37: Ophthalmology, Global, Revenue Forecast for Voretigene Neparvovec ($m), 2017-2023 62

Figure 38: Ophthalmology, Global, Revenue Forecast for Roclatan ($m), 2018-2023 63

Figure 39: Ophthalmology, Global, Revenue Forecast for Abicipar Pegol ($m), 2020-2023 64

Figure 40: Ophthalmology, Global, Market Size ($bn), 2016-2023 65

Figure 41: Ophthalmology, Global, Market Share of Key Products, 2016-2023 68

Figure 42: Ophthalmology, Global, Annual Revenue Forecast for Key Products ($m), 2016-2023 69

Figure 43: Ophthalmology, Global, Annual Revenue Forecast for Angiogenesis Inhibitors ($bn), 2016-2023 70

Figure 44: Ophthalmology, Global, Annual Revenue Forecast for Antihistamines ($m), 2016-2023 71

Figure 45: Ophthalmology, Global, Annual Revenue Forecast for Anti-inflammatories ($m), 2016-2023 72

Figure 46: Ophthalmology, Global, Annual Revenue Forecast for IOP-Lowering Drugs ($bn), 2016-2023 73

Figure 47: Ophthalmology Therapeutics Market, Global, Cluster by Growth and Market Share, 2016-2023 74

Figure 48: Ophthalmology Therapeutics Market, Global, Forecast Market Share by Company (%),2016-2023 77

Figure 49: Ophthalmology, Global, Companies by Compound Annual Growth Rate (%), 2016-2023 78

Figure 50: Ophthalmology, Global, Revenues by Product Type, 2014-2022 79

Figure 51: Ophthalmology, Global, Novartis Annual Revenue Forecast ($m), 2016-2023 80

Figure 52: Ophthalmology, Global, Regeneron Annual Revenue Forecast ($m), 2016-2023 82

Figure 53: Ophthalmology, Global, Roche Annual Revenue Forecast ($m), 2016-2023 84

Figure 54: Ophthalmology, Global, Bayer Annual Revenue Forecast ($m), 2016-2023 85

Figure 55: Ophthalmology, Global, Allergan Annual Revenue Forecast ($m), 2016-2023 87

Figure 56: Ophthalmology, Global, Shire Therapeutics Annual Revenue Forecast ($m), 2016-2023 88

Figure 57: Ophthalmology, Global, Mallinckrodt Therapeutics Annual Revenue Forecast ($m), 2016-2023 89

Figure 58: Ophthalmology, Global, Santen Therapeutics Annual Revenue Forecast ($m), 2016-2023 90

Figure 59: Ophthalmology, Global, Aerie Annual Revenue Forecast ($m), 2016-2023 91

Figure 60: Ophthalmology, Global, Companies by Type, 2017 92

Figure 61: Ophthalmology, Global, High-Activity and Late-Stage Pipeline Developers by Level of Ophthalmology Specialization, 2017 93

Figure 62: Ophthalmology, Global, Proportion of Total Company Revenue Attributed to Ophthalmology, 2016-2023 94

Figure 63: Ophthalmology, Global, Licensing Deals, 2006-2017 96

Figure 64: Ophthalmology Global, Licensing Deals by Indication and Value, 2006-2017 97

Figure 65: Ophthalmology, Global, Licensing Deals, 2006-2017 98

Figure 66: Ophthalmology, Global, Licensing Deals by Molecule Type and Mechanism of Action, 2006-2017 99

Figure 67: Ophthalmology, Global, Co-development Deals, 2006-2017 107

Figure 68: Ophthalmology, Global, Co-development Deals, 2006-2017 108

Figure 69: Ophthalmology, Global, Co-development Deals by Molecule Type and Mechanism of Action, 2006-2017 109

Figure 70: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 1 121

Figure 71: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 2 122

Figure 72: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 3 123

Figure 73: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 4 124

Figure 74: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 5 125

Figure 75: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 6 126

Figure 76: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 7 127

Figure 77: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 8 128

Figure 78: Ophthalmology, Global, Table of all Clinical Stage Pipeline Products, 2016 Part 9 129

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