Summary
Glaucoma is the leading cause of irreversible vision loss, worldwide. The term glaucoma includes many different diseases, which are associated with differing risk factors, symptoms, treatment, and prognosis. All forms of glaucoma are characterized by the loss of the retinal ganglion cells and their axons that make up the optic nerve, which results in a cupping of the optic nerve head. This leads to optic nerve damage and visual field loss. Raised intraocular pressure (IOP) is the primary risk factor for glaucoma, and progression of disease will normally stop if the IOP is lowered by 30-50%. Consequently, treatment options for glaucoma are developed around lowering the IOP. Although it is possible to slow the progression of glaucoma using current treatment options, it is not possible to reverse vision loss that has resulted from the disease.
Most drugs prescribed for glaucoma can be placed into one of four drug classes. Prostaglandin analogues (PGAs) are generally used as a first-line treatment, with beta blockers (BBs), alpha adrenergic receptor agonists (AAs), and carbonic anhydrase inhibitors (CAIs) also frequently used, albeit generally as second-line therapies in combination with PGAs. Certain combinations of available drugs are marketed as part of fixed-dose combination (FDC) therapies. Cholinergic agonists, also known as miotics, can also be used for the treatment of glaucoma, although they are much less commonly prescribed compared with PGAs, BBs, AAs, and CAIs.
Scope
- Overview of glaucoma, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
- Topline Glaucoma market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting glaucoma therapeutics sales in the 7MM.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- Analysis of the current and future market competition in the global CDI therapeutics and prophylactics 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 glaucoma therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the glaucoma therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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.
Companies Mentioned
Allergan
Alcon (Novartis)
Santen
Pfizer
Otsuka
Valeant
Aerie Pharmaceuticals
Ocular Therapeutix
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 11
2 Executive Summary 12
2.1 Solid Growth Is Projected for the Glaucoma Market between 2016 and 2026 13
2.2 The Development of Drugs with Novel MOAs Marks a Shift in Glaucoma Corporate Strategy 15
2.3 Some Unmet Need Remains for Glaucoma, In Particular Improving Patient Compliance 16
2.4 Opportunities Remain for Products that Further Address Unmet Needs in the Glaucoma Market 17
2.5 Late-Stage Pipeline Drugs Entering the Glaucoma Market Are Poised to Drive Growth 18
2.6 What Do Physicians Think? 20
3 Introduction 22
3.1 Catalyst 22
3.2 Related Reports 23
3.3 Upcoming Related Reports 23
4 Disease Overview 24
4.1 Introduction 24
4.2 Etiology and Pathophysiology 25
4.2.1 Etiology 25
4.2.2 Pathophysiology 28
4.3 Classification 32
4.4 Symptoms 34
4.5 Prognosis and Quality of Life 35
5 Epidemiology 36
5.1 Disease Background 36
5.2 Risk Factors and Comorbidities 37
5.3 Global and Historical Trends 37
5.4 Forecast Methodology 40
5.4.1 Sources 40
5.4.2 Forecast Assumptions and Methods 44
5.4.3 Total Prevalent Cases of POAG 44
5.4.4 Total Prevalent Cases of PACG 46
5.4.5 Total Prevalent Cases of NTG and PPG 48
5.4.6 Total Prevalent Cases of SG 49
5.4.7 Diagnosed Prevalent Cases 50
5.4.8 Diagnosed Incident Cases of Acute PACG 51
5.5 Epidemiological Forecast for Glaucoma (2016-2026) 52
5.5.1 Total Prevalent Cases of POAG 52
5.5.2 Age-Specific Total Prevalent Cases of POAG 53
5.5.3 Sex-Specific Total Prevalent Cases of POAG 54
5.5.4 Diagnosed Prevalent Cases of POAG 55
5.5.5 Total Prevalent Cases of PACG 56
5.5.6 Age-Specific Total Prevalent Cases of PACG 57
5.5.7 Sex-Specific Total Prevalent Cases of PACG 58
5.5.8 Diagnosed Prevalent Cases of PACG 59
5.5.9 Total Prevalent Cases of NTG 60
5.5.10 Diagnosed Prevalent Cases of NTG 61
5.5.11 Total Prevalent Cases of PPG 62
5.5.12 Diagnosed Prevalent Cases of PPG 63
5.5.13 Total Prevalent Cases of SG 64
5.5.14 Diagnosed Prevalent Cases of SG 65
5.5.15 Diagnosed Incident Cases of Acute PACG 66
5.6 Discussion 67
5.6.1 Epidemiological Forecast Insight 67
5.6.2 Limitations of the Analysis 67
5.6.3 Strengths of the Analysis 68
6 Disease Management 69
6.1 Diagnosis Overview 69
6.2 Treatment Overview 72
6.2.1 Treatment Guidelines 74
6.2.2 Leading Prescribed Drugs 75
6.2.3 Clinical Practice 75
6.3 US 77
6.4 5EU 79
6.5 Japan 81
7 Competitive Assessment 84
7.1 Overview 84
7.2 Product Profiles - Major Brands, Prostaglandin Analogues 84
7.2.1 Xalatan (latanoprost) 85
7.2.2 Lumigan (bimatoprost) 90
7.2.3 Travatan (travoprost) 96
7.2.4 Tapros (tafluprost) 99
7.2.5 Vyzulta (latanoprostene bunod) 104
7.3 Product Profiles, Fixed-Dose Combination Therapies 110
7.3.1 Overview 110
7.3.2 Efficacy 114
7.3.3 Safety 115
7.3.4 Forecast 115
7.4 Product Profiles, Beta Blockers (numerous brands) 115
7.4.1 Overview 115
7.4.2 Efficacy 118
7.4.3 Safety 118
7.4.4 Forecast 119
7.5 Product Profiles, Alpha-Adrenergic Agonists (numerous brands) 119
7.5.1 Overview 119
7.5.2 Efficacy 121
7.5.3 Safety 121
7.5.4 Forecast 121
7.6 Product Profiles, Carbonic Anhydrase Inhibitors (numerous brands) 122
7.6.1 Overview 122
7.6.2 Efficacy 123
7.6.3 Safety 124
7.6.4 Forecast 125
7.7 Product Profiles, Cholinergic Agonists (Miotics) (numerous brands) 125
7.7.1 Overview 125
7.7.2 Efficacy 126
7.7.3 Safety 127
7.7.4 Forecast 127
7.8 Product Profiles - Major Brands, Rho Kinase Inhibitors 127
7.8.1 Glanatec (ripasudil) 127
8 Unmet Needs and Opportunity Assessment 132
8.1 Overview 132
8.2 Improved Patient Compliance 134
8.2.1 Unmet Need 134
8.2.2 Gap Analysis 135
8.2.3 Opportunity 136
8.3 Treatment Options with Greater IOP-Lowering Ability 139
8.3.1 Unmet Need 139
8.3.2 Gap Analysis 140
8.3.3 Opportunity 141
8.4 Neuroprotective Drugs 142
8.4.1 Unmet Need 142
8.4.2 Gap Analysis 143
8.4.3 Opportunity 144
8.5 Improved Diagnosis and Monitoring 145
8.5.1 Unmet Need 145
8.5.2 Gap Analysis 146
8.5.3 Opportunity 146
9 Pipeline Assessment 148
9.1 Overview 148
9.2 Clinical Trial Mapping 150
9.2.1 Clinical Trials by Class, Development Phase and Region 150
9.3 Promising Drugs in Clinical Development 151
9.3.1 Rhopressa (netarsudil mesylate) 154
9.3.2 Roclatan (netarsudil mesylate + latanoprost) 161
9.3.3 Bimatoprost SR 167
9.3.4 OTX-TP 172
9.3.5 DE-117 177
9.3.6 SJP-0135 181
9.4 Promising Drugs in Early-Stage Development 184
9.4.1 ENV-515 184
9.4.2 Latanoprost SR Products 185
9.5 Other Drugs in Development 187
10 Current and Future Players 188
10.1 Overview 188
10.2 Trends in Corporate Strategy 191
10.3 Company Profiles 193
10.3.1 Allergan 193
10.3.2 Alcon (Novartis) 194
10.3.3 Santen 195
10.3.4 Pfizer 197
10.3.5 Otsuka 198
10.3.6 Valeant 199
10.3.7 Aerie Pharmaceuticals 200
10.3.8 Ocular Therapeutix 201
11 Market Outlook 203
11.1 Global Markets 203
11.1.1 Forecast 203
11.1.2 Drivers and Barriers - Global Issues 207
11.2 US 207
11.2.1 Forecast 207
11.2.2 Key Events 210
11.2.3 Drivers and Barriers 211
11.3 5EU 211
11.3.1 Forecast 211
11.3.2 Key Events 214
11.3.3 Drivers and Barriers 215
11.4 Japan 215
11.4.1 Forecast 215
11.4.2 Key Events 218
11.4.3 Drivers and Barriers 219
12 Appendix 220
12.1 Bibliography 220
12.2 Abbreviations 246
12.3 Methodology 249
12.3.1 Forecasting Methodology 249
12.3.2 Diagnosed Patients 249
12.3.3 Percent Drug-Treated Patients 250
12.3.4 Drugs Included in Each Therapeutic Class 250
12.3.5 Launch and Patent Expiry Dates 251
12.3.6 General Pricing Assumptions 252
12.3.7 Individual Drug Assumptions 253
12.3.8 Generic Erosion 268
12.3.9 Pricing of Pipeline Agents 268
12.4 Primary Research - KOLs Interviewed for This Report 270
12.5 Primary Research - Payers Interviewed for This Report 273
12.6 Primary Research - Prescriber Survey 274
12.7 About the Authors 275
12.7.1 Analysts 275
12.7.2 Therapy Area Director 275
12.7.3 Epidemiologist 276
12.7.4 Managing Epidemiologists 276
12.7.5 Global Director of Therapy Analysis and Epidemiology 277
12.7.6 Global Head of Healthcare 278
12.8 About GlobalData 279
12.9 Contact Us 279
12.10 Disclaimer 280
1.1 List of Tables
Table 1: Glaucoma: Key Metrics in the 7MM 12
Table 2: Symptoms of Glaucoma 35
Table 3: Risk Factors and Comorbidities for Glaucoma 37
Table 4: 7MM, Total Prevalent Cases of POAG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 52
Table 5: 7MM, Diagnosed Prevalent Cases of POAG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 55
Table 6: 7MM, Total Prevalent Cases of PACG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 56
Table 7: 7MM, Diagnosed Prevalent Cases of PACG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 59
Table 8: 7MM, Total Prevalent Cases of NTG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 60
Table 9: 7MM, Diagnosed Prevalent Cases of NTG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 61
Table 10: 7MM, Total Prevalent Cases of PPG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 62
Table 11: 7MM, Diagnosed Prevalent Cases of PPG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 63
Table 12: 7MM, Total Prevalent Cases of SG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 64
Table 13: 7MM, Diagnosed Prevalent Cases of SG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 65
Table 14: 7MM, Diagnosed Incident Cases of Acute PACG, Both Sexes, Ages ≥40 Years, N, Selected Years 2016-2026 66
Table 15: Diagnostic Tests for Glaucoma 69
Table 16: Drug Classes Used to Treat Glaucoma 73
Table 17: Treatment Guidelines for Glaucoma 74
Table 18: Most-Prescribed Drugs for Glaucoma by Class in the 7MM, 2016 75
Table 19: Country Profile - US 79
Table 20: Country Profile - 5EU 81
Table 21: Country Profile - Japan 83
Table 22: Product Profile - Xalatan 87
Table 23: Observed Clinical Efficacy of Xalatan in a Phase IV Trial 87
Table 24: Number of Treatment-Related AEs in a Phase IV Trial for Xalatan 88
Table 25: Xalatan SWOT Analysis, 2017 89
Table 26: Product Profile - Lumigan 92
Table 27: Results from a Phase IV Clinical Trial Comparing the Change in IOP After One Year In Patients Taking Lumigan, Xalatan, or Travatan 92
Table 28: Comparison of Results from Two Phase IV Clinical Trials Assessing the Change in IOP In Patients Who Receive One of Two Doses Of Lumigan 93
Table 29: Comparison of Reported AEs from Patients Receiving Lumigan 0.01% and Lumigan 0.03% 94
Table 30: Lumigan SWOT Analysis, 2017 95
Table 31: Product Profile - Travatan 97
Table 32: Travatan SWOT Analysis, 2017 98
Table 33: Product Profile - Tapros 101
Table 34: Reduction in IOP Observed in a Phase IV Trial Comparing Tapros and Xalatan 102
Table 35: Tapros AEs 102
Table 36: Tapros SWOT Analysis, 2017 103
Table 37: Product Profile - Vyzulta 106
Table 38: Observed Clinical Efficacy of Vyzulta in Two Phase III Trials 107
Table 39: Safety Profile of Vyzulta Observed in the LUNAR Phase III Trial 108
Table 40: Vyzulta SWOT Analysis, 2017 109
Table 41: FDCs Available in the 7MM 114
Table 42: Beta Blockers Available in the 7MM 116
Table 43: AA Monotherapies Available in the 7MM 120
Table 44: CAIs Available in the 7MM 122
Table 45: Results from a Phase III Clinical Trial Comparing the Change in IOP in Glaucoma Patients After Administration of Azopt, Trusopt, or Timolol 124
Table 46: Frequently Reported AEs During a Phase III Clinical Trial Comparing Azopt, Trusopt, and Timolol 125
Table 47: Cholinergic Agonists Available in the 7MM 126
Table 48: Product Profile - Glanatec 129
Table 49: Results from Two Phase III Clinical Trials Comparing the Change in IOP When Glanatec Is Used Adjunctively with Timolol or Xalatan 130
Table 50: Frequently Reported AEs During Two Phase III Clinical Trials Assessing the Safety and Efficacy of Glanatec When Used Adjunctively with Timolol or Xalatan 130
Table 51: Glanatec SWOT Analysis, 2017 131
Table 52: Promising Products in Late-Stage Clinical Development for Treatment of Glaucoma 152
Table 53: Product Profile - Rhopressa 157
Table 54: Most Frequently Observed AEs for Rhopressa and Timolol in Rocket-4 Phase III Trial 158
Table 55: Rhopressa SWOT Analysis, 2017 160
Table 56: Product Profile - Roclatan 163
Table 57: Mean Diurnal IOP Change over 90 days of Treatment with Roclatan Compared With Latanoprost and Rhopressa 164
Table 58: Common AEs Observed in the Mercury-1 and Mercury-2 Phase III Trials 164
Table 59: Roclatan SWOT Analysis, 2017 166
Table 60: Product Profile - Bimatoprost SR 169
Table 61: Data Presented from a Phase II Trial Comparing the Efficacy of Bimatoprost SR with Topical Bimatoprost 0.3% 169
Table 62: Bimatoprost SR SWOT Analysis, 2017 171
Table 63: Product Profile - OTX-TP 173
Table 64: Reduction in Diurnal IOP from Baseline Following Treatment with OTX-TP and Timolol 174
Table 65: OTX-TP SWOT Analysis, 2017 176
Table 66: Product Profile - DE-117 178
Table 67: AEs Reported in the Different Arms of Phase II Clinical Trials of DE-117 179
Table 68: DE-117 SWOT Analysis, 2017 181
Table 69: Product Profile - SJP-0135 182
Table 70: SJP-0135 SWOT Analysis, 2017 184
Table 71: Developmental Phase II Latanoprost SR Products for the Treatment of Glaucoma 186
Table 72: Drugs in Development for Glaucoma, 2017 187
Table 73: Key Companies in the Glaucoma Market in the 7MM, 2017 189
Table 74: Allergan’s Glaucoma Portfolio Assessment, 2017 194
Table 75: Alcon’s Glaucoma Portfolio Assessment, 2017 195
Table 76: Santen’s Glaucoma Portfolio Assessment, 2017 197
Table 77: Pfizer’s Glaucoma Portfolio Assessment, 2017 198
Table 78: Otsuka’s Glaucoma Portfolio Assessment, 2017 199
Table 79: Valeant’s Glaucoma Portfolio Assessment, 2017 200
Table 80: Aerie Pharmaceuticals’ Glaucoma Portfolio Assessment, 2017 201
Table 81: Ocular Therapeutics’ Glaucoma Portfolio Assessment, 2017 202
Table 82: Global Sales Forecast ($M) for Glaucoma by Product, 2016-2026 204
Table 83: Glaucoma Market - Global Drivers and Barriers, 2016-2026 207
Table 84: Key Events Impacting Sales for Glaucoma in the US, 2016-2026 210
Table 85: Glaucoma Market - Drivers and Barriers in the US, 2016-2026 211
Table 86: Key Events Impacting Sales for Glaucoma in the 5EU, 2016-2026 214
Table 87: Glaucoma Market - Drivers and Barriers in the 5EU, 2016-2026 215
Table 88: Key Events Impacting Sales for Glaucoma in Japan, 2016-2026 218
Table 89: Glaucoma Market - Drivers and Barriers in Japan, 2016-2026 219
Table 90: Sources Used For Diagnosed Glaucoma Incidence and Segmentation in the 7MM 250
Table 91: Projected Launch Dates for Glaucoma 251
Table 92: Key Historical and Projected Patent Expiry Dates for Glaucoma 252
Table 93: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 274
1.2 List of Figures
Figure 1: Global Sales Forecast by Country for Glaucoma in 2016 and 2026 14
Figure 2: Analysis of the Company Portfolio Gap in Glaucoma During the Forecast Period 16
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Glaucoma During the Forecast Period 19
Figure 4: The Flow of AqH in an Eye with OAG and ACG 26
Figure 5: The Different Causes of Secondary Glaucoma 27
Figure 6: The Aqueous Humor Cycle 29
Figure 7: Nerve Damage - Cupping 30
Figure 8: Different Classifications of Glaucoma 33
Figure 9: 7MM, Age-Standardized Total Prevalence of POAG, Men and Women, Ages ≥40 Years, 2016 38
Figure 10: 7MM, Age-Standardized Total Prevalence of PACG, Men and Women, Ages ≥40 Years, 2016 39
Figure 11: 7MM, Sources Used to Forecast Total Prevalent Cases of POAG 40
Figure 12: 7MM, Sources Used to Forecast Total Prevalent Cases of PACG 41
Figure 13: 7MM, Sources Used to Forecast Total Prevalent Cases of NTG 42
Figure 14: 7MM, Sources Used to Forecast Total Prevalent Cases of PPG 42
Figure 15: 7MM, Sources Used to Forecast Total Prevalent Cases of SG 43
Figure 16: 7MM, Sources Used to Forecast Diagnosed Incident Cases of Acute PACG 43
Figure 17: 7MM, Age-Specific Total Prevalent Cases of POAG, Both Sexes, Ages ≥40 Years, N, 2016 53
Figure 18: 7MM, Sex-Specific Total Prevalent Cases of POAG, Both Sexes, Ages ≥40 Years, N, 2016 54
Figure 19: 7MM, Age-Specific Total Prevalent Cases of PACG, Both Sexes, Ages ≥40 Years, N, 2016 57
Figure 20: 7MM, Sex-Specific Total Prevalent Cases of PACG, Both Sexes, Ages ≥40 Years, N, 2016 58
Figure 21: Glaucoma Clinical Treatment Flowchart 77
Figure 22: Drug Launch and Patent Expiration Timelines of PGAs for Glaucoma in the 7MM 85
Figure 23: Drug Launch and Patent Expiration Timelines of FDCs for Glaucoma in the 7MM 111
Figure 24: Unmet Need and Opportunity in Glaucoma, 2017 133
Figure 25: Bullseye Diagram of Products in Clinical Development for Glaucoma, 2017 149
Figure 26: Number of Ongoing Phase I-III Clinical Trials in Various Drug Classes for Glaucoma in the 7MM as of September 2017 150
Figure 27: Regional Shares of Ongoing Glaucoma Clinical Trials in the 7MM 151
Figure 28: Key Phase III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for Glaucoma in the 7MM During the Forecast Period 153
Figure 29: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Glaucoma During the Forecast Period 154
Figure 30: Clinical and Commercial Positioning of Rhopressa 159
Figure 31: Clinical and Commercial Positioning of Roclatan 165
Figure 32: Clinical and Commercial Positioning of Bimatoprost SR 170
Figure 33: Clinical and Commercial Positioning of OTX-TP 175
Figure 34: Clinical and Commercial Positioning of DE-117 180
Figure 35: Clinical and Commercial Positioning of SJP-0135 183
Figure 36: Global Sales of Branded Products for Glaucoma by Company in 2016 and 2026 190
Figure 37: Analysis of the Company Portfolio Gap in Glaucoma During the Forecast Period 191
Figure 38: Global (7MM) Sales Forecast by Country for Glaucoma in 2016 and 2026 206
Figure 39: Sales Forecast by Class for Glaucoma in the US in 2016 and 2026 209
Figure 40: Sales Forecast by Class for Glaucoma in the 5EU in 2016 and 2026 213
Figure 41: Sales Forecast by Class for Glaucoma in Japan in 2016 and 2026 217
