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PharmaPoint: Glaucoma-Global Drug Forecast Market Analysis to 2023

PharmaPoint: Glaucoma-Global Drug Forecast Market Analysis to 2023


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Executive Summary

PharmaPoint: Glaucoma-Global Drug Forecast and Market Analysis to 2023

Glaucoma is a leading cause of preventable blindness globally. This chronic progressive optic neuropathy causes irreversible vision loss through damage to the optic nerve. There are currently no treatments that can directly prevent this damage, and all commercially available glaucoma therapies focus on lowering elevated intraocular pressure (IOP), a known risk factor for glaucoma development and progression. The launch of fixed-dose combination (FDC) products, which combine drugs from these various classes, will continue to be a source of significant growth in this market. The glaucoma market is about to enter a phase of new growth with the arrival of first-in-class drugs, such as Aerie's Rhopressa, Bausch & Lomb's Vesneo (latanoprost bunod), and Inotek's trabodenoson into the 7MM during the forecast period, which will generate additional growth in the global glaucoma market.

Highlights

Key Questions Answered

The glaucoma market has been dominated by prostaglandin analogue (PGA) drugs in the last decade. New classes of drugs are anticipated the reach the market within the forecast period. How will these change the position the PGA drugs hold during the forecast period? Will these drugs maintain their market dominance in 2023?

The current late stage glaucoma pipeline is varied, with first-in-class drugs in development with innovative modes of action. Which of these will have the biggest impact on the market? What strategies are developers undertaking to penetrate this crowded and highly generic market? Will these fulfil any unmet needs?

Population aging is occurring in almost all countries worldwide, particularly in the 7MM. This is expected to have a significant impact on the prevalence of age-related diseases such as glaucoma. How will epidemiological changes impact the growth of the future market?

Key Findings

The main driver of growth in the glaucoma market will be the introduction of first-in-class drugs over the forecast period. The launch of three first-in-class therapies will grow this market. New fixed-dose drugs entering the 7MM will also act as a stimulant for growth.

The biggest barrier for growth in the glaucoma market will be the increasing use of generic latanoprost across the 7MM. The low cost of this therapy will increase the pressure on new drugs hoping to enter these markets to show drug cost-effectivness. This is likely to have a negative impact on these markets, as regulatory bodies are adopting stricter criterial for new drug approvals and reimbursement listing.

The largest unmet needs mainly reflect the notorious problem of poor patient adherence to therapy. Simplifying dosing regimens is an important consideration for companies developing drugs to treat these patients.

Scope

Overview of glaucoma, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized Glaucoma market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the glaucoma therapeutics market.

Pipeline analysis: focus on the eight late-stage pipeline glaucoma drugs discussing emerging trends as well as overview of earlier phase drugs.

Analysis of the current and future market competition in the global glaucoma 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

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. Additionally a list of acquisition targets included in the pipeline product company list.

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 global glaucoma therapeutics market in 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.

Track drug sales in the global glaucoma therapeutics market from 2013-2023.

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

1 Table of Contents

1 Table of Contents 10

1.1 List of Tables 16

1.2 List of Figures 20

2 Introduction 22

2.1 Catalyst 22

2.2 Related Reports 23

3 Disease Overview 24

3.1 Etiology and Pathophysiology 26

3.1.1 Etiology 26

3.1.2 Pathophysiology 29

3.2 Classification 32

3.3 Symptoms 33

3.4 Diagnosis 34

4 Epidemiology 39

4.1 Disease Background 39

4.2 Risk Factors and Comorbidities 41

4.3 Global Trends 42

4.3.1 US 43

4.3.2 5EU 44

4.3.3 Japan 45

4.4 Forecast Methodology 46

4.4.1 Sources Used 49

4.4.2 Forecast Assumptions and Methods 52

4.4.3 Sources Not Used 58

4.5 Epidemiological Forecast for Glaucoma (2013-2023) 59

4.5.1 Total Prevalent Cases of Glaucoma 59

4.5.2 Age-Specific Total Prevalent Cases of Glaucoma 60

4.5.3 Sex-Specific Total Prevalent Cases of Glaucoma 62

4.5.4 Age-Standardized Total Prevalence of Glaucoma 64

4.5.5 Total Prevalent Cases of Glaucoma, by Clinical Type 65

4.5.6 Total Prevalent Cases of NTG 67

4.5.7 Diagnosed Prevalent Cases of POAG and PACG 69

4.6 Discussion 72

4.6.1 Epidemiological Forecast Insight 72

4.6.2 Limitations of the Analysis 73

4.6.3 Strengths of the Analysis 74

5 Disease Management 75

5.1 Diagnosis and Treatment Overview 75

5.1.1 Diagnosis 75

5.1.2 Treatment Guidelines 76

5.1.3 Leading Prescribed Drugs 78

5.1.4 Clinical Practice 78

5.2 US 81

5.3 5EU 85

5.4 Japan 90

6 Competitive Assessment 94

6.1 Overview 94

6.2 Product Profiles-Main Brands and Drug Classes 96

6.2.1 Xalatan (latanoprost) 96

6.2.2 Lumigan (bimatoprost) 102

6.2.3 Travatan (travoprost) 106

6.2.4 Tapros (tafluprost) 110

6.2.5 Beta Blockers 117

6.2.6 Carbonic Anhydrase Inhibitors 122

6.2.7 Alpha-Adrenergic Agonists 126

6.2.8 Simbrinza (brinzolamide + brimonidine) 129

6.2.9 Glanatec (ripasudil hydrochloride hydrate) 132

7 Unmet Need and Opportunity 138

7.1 Overview 138

7.2 Simplified Dosing Regimen 142

7.2.1 Unmet Need 142

7.2.2 Gap Analysis 143

7.2.3 Opportunity 146

7.3 Reminder Systems 147

7.3.1 Unmet Need 147

7.3.2 Gap Analysis 147

7.3.3 Opportunity 148

7.4 Long-Acting Therapy 149

7.4.1 Unmet Need 149

7.4.2 Gap Analysis 150

7.4.3 Opportunity 151

7.5 New Classes of IOP-Lowering Drugs 153

7.5.1 Unmet Need 153

7.5.2 Gap Analysis 155

7.5.3 Opportunity 156

7.6 Neuroprotective Drugs 157

7.6.1 Unmet Need 157

7.6.2 Gap Analysis 159

7.6.3 Opportunity 161

7.7 Improved Diagnosis and Monitoring 162

7.7.1 Unmet Need 162

7.7.2 Gap Analysis 163

7.7.3 Opportunity 164

8 Pipeline Assessment 165

8.1 Overview 165

8.2 Clinical Trials 165

8.2.1 Clinical Trial Mapping 165

8.2.2 Clinical Trial Design 166

8.3 Promising Drugs in Clinical Development 167

8.3.1 Rhopressa 169

8.3.2 Roclatan 181

8.3.3 Vesneo 189

8.3.4 Bimatoprost SR 198

8.3.5 Trabodenoson 206

8.3.6 OPC-1085EL 214

8.3.7 DE-117 218

8.3.8 OXT-TP 221

8.4 Promising Drugs in Early-Stage Development 223

8.4.1 ROCK Inhibitor AMA-0076 223

8.4.2 Sustained-Release PGA Products 224

8.5 Other Drugs in Development 227

9 Current and Future Players 228

9.1 Overview 228

9.2 Trends in Corporate Strategy 230

9.3 Company Profiles 231

9.3.1 Pfizer 231

9.3.2 Alcon 232

9.3.3 Allergan 234

9.3.4 Santen 235

9.3.5 Aerie Pharmaceuticals 237

9.3.6 Inotek Pharmaceuticals 239

9.3.7 Bausch & Lomb 240

9.3.8 Kowa Company 241

9.3.9 Otsuka Pharmaceutical 242

10 Market Outlook 244

10.1 Global Markets 244

10.1.1 Forecast 244

10.1.2 Drivers and Barriers-Global Issues 250

10.2 US 250

10.2.1 Forecast 250

10.2.2 Key Events 255

10.2.3 Drivers and Barriers 255

10.3 5EU 256

10.3.1 Forecast 256

10.3.2 Key Events 262

10.3.3 Drivers and Barriers 263

10.4 Japan 263

10.4.1 Forecast 263

10.4.2 Key Events 267

10.4.3 Drivers and Barriers 268

11 Appendix 269

11.1 Bibliography 269

11.2 Abbreviations 310

11.3 Methodology 315

11.4 Forecasting Methodology 315

11.4.1 Percent Drug-Treated Patients 315

11.4.2 Drugs Included in Each Therapeutic Class 316

11.4.3 Launch and Patent Expiry Dates 317

11.4.4 General Pricing Assumptions 317

11.4.5 Individual Drug Assumptions 318

11.4.6 Pricing of Pipeline Agents 327

11.5 Primary Research-KOLs Interviewed for this Report 327

11.6 Primary Research-High-prescriber Survey 329

11.7 About the Authors 330

11.7.1 Analyst 330

11.7.2 Therapy Area Director 330

11.7.3 Epidemiologist 331

11.7.4 Global Head of Healthcare 331

11.8 About GlobalData 332

11.9 Disclaimer 332

1.2 List of Figures

Figure 1: Open and Closed Iridocorneal Angles 25

Figure 2: The Aqueous Humor Cycle 28

Figure 3: Optic Nerve Damage-Cupping 30

Figure 4: Comparison of Healthy and Glaucomous Optic Nerves 38

Figure 5: 7MM, Total Prevalent Cases of Glaucoma, Ages ?40 Years, Both Sexes, N, 2013-2023 60

Figure 6: 7MM, Total Prevalent Cases of Glaucoma, by Age, Both Sexes, N, 2013-2023 62

Figure 7: 7MM, Total Prevalent Cases of Glaucoma, by Sex, Ages ?40 Years, N, 2013 64

Figure 8: 7MM, Age-Standardized Total Prevalence of Glaucoma, by Sex, Ages ?40 Years, %, 2013 65

Figure 9: 7MM, Total Prevalent Cases of Glaucoma, by Clinical Type, Ages ?40 Years, N, 2013 67

Figure 10: 7MM, Total Prevalent Cases of NTG, Ages ?40 Years, Both Sexes, N, 2013-2023 68

Figure 11: 7MM, Diagnosed Prevalent Cases of POAG, Ages ?40 Years, Both Sexes, N, 2013-2023 70

Figure 12: 7MM, Diagnosed Prevalent Cases of PACG, Ages ?40 Years, Both Sexes, N, 2013-2023 71

Figure 13: Glaucoma Clinical Treatment Flowchart 80

Figure 14: Glaucoma-Number of Phase II and III/IIb Clinical Trials in Various Drug Classes in the 7MM 166

Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in Glaucoma, 2013-2023 169

Figure 16: Rhopressa's Development in Glaucoma 177

Figure 17: Clinical and Commercial Positioning of Rhopressa 179

Figure 18: Roclatan's Development in Glaucoma 186

Figure 19: Clinical and Commercial Positioning of Roclatan 187

Figure 20: Vesneo Development in Glaucoma 194

Figure 21: Clinical and Commercial Positioning of Vesneo 196

Figure 22: Clinical and Commercial Positioning of Bimatoprost SR 204

Figure 23: Trabodenoson's Development in Glaucoma 210

Figure 24: Clinical and Commercial Positioning of Trabodenosen 212

Figure 25: OPC-1085EL's Development in Glaucoma 216

Figure 26: Clinical and Commercial Positioning of OPC-1085EL 217

Figure 27: DE-117's Development in Glaucoma 220

Figure 28: Global Sales of Branded Products for Glaucoma by Company, 2013-2023 229

Figure 29: Company Portfolio Gap Analysis in Glaucoma, 2013-2023 230

Figure 30: Global Sales for Glaucoma by Region, 2013-2023 247

Figure 31: Drug Sales by Class for Glaucoma, 2013 and 2023 248

Figure 32: Global Drug Sales by Class for Glaucoma, 2013-2023 249

Figure 33: Drug Sales by Class for Glaucoma in the US, 2013-2023 254

Figure 34: Drug Sales by Class for Glaucoma in the 5EU, 2013-2023 260

Figure 35: Drug Sales by Country for Glaucoma in the 5EU, 2013-2023 261

Figure 36: Drug Sales by Class for Glaucoma in Japan, 2013-2023 266

1.1 List of Tables

Table 1: Symptoms of Glaucoma 34

Table 2: Diagnostic Tests for Glaucoma. 34

Table 3: Types of Glaucoma 40

Table 4: Risk Factors and Comorbidities for Glaucoma 42

Table 5: 7MM, Sources of Glaucoma Total Prevalence Data Used in the Epidemiology Forecast 47

Table 6: 7MM, Sources of Epidemiological Data Used to Forecast the Total Prevalent Cases of Glaucoma Segmented by Clinical Types 48

Table 7: 7MM, Sources Not Used in the Epidemiological Analysis of Glaucoma 58

Table 8: 7MM, Total Prevalent Cases of Glaucoma, Ages ?40 Years, Both Sexes, N, 2013-2023 59

Table 9: 7MM, Total Prevalent Cases of Glaucoma, by Age, Both Sexes, N (Row %), 2013 61

Table 10: 7MM, Total Prevalent Cases of Glaucoma, by Sex, Ages ?40 Years, N (Row %), 2013 63

Table 11: 7MM, Total Prevalent Cases of Glaucoma, by Clinical Type, Ages ?40 Years, N (Row %), 2013 66

Table 12: 7MM, Total Prevalent Cases of NTG, Ages ?40 Years, Both Sexes, N, 2013-2023 68

Table 13: 7MM, Diagnosed Prevalent Cases of POAG, Ages ?40 Years, Both Sexes, N, 2013-2023 69

Table 14: 7MM, Diagnosed Prevalent Cases of PACG, Ages ?40 Years, Both Sexes, N, 2013-2023 71

Table 15: National and International Treatment Guidelines for Glaucoma 77

Table 16: Most Prescribed Drugs for Glaucoma in the Global Markets, 2013 78

Table 17: Country Profile-US 84

Table 18: Country Profile-5EU 89

Table 19: Country Profile-Japan 93

Table 20: Leading Treatments for Glaucoma, 2013 95

Table 21: Product Profile-Xalatan 99

Table 22: Xalatan SWOT Analysis, 2014 100

Table 23: Global Sales Forecast (USD m) for Xalatan, 2013-2023 101

Table 24: Global Sales Forecast (USD m) for Generic Latanoprost, 2013-2023 101

Table 25: Product Profile-Lumigan 104

Table 26: Lumigan SWOT Analysis, 2014 105

Table 27: Global Sales Forecast (USD m) for Lumigan, 2013-2023 106

Table 28: Product Profile-Travatan 108

Table 29: Travatan SWOT Analysis, 2014 109

Table 30: Global Sales Forecast (USD m) for Travatan/Travatan Z, 2013-2023 110

Table 31: Global Overview of Tafluprost 110

Table 32: Product Profile-Tapros Franchise 113

Table 33: Tafluprost Adverse Events 115

Table 34: Tafluprost SWOT Analysis, 2014 115

Table 35: Global Sales Forecast (USD m) for the Tapros Franchise, 2013-2023 116

Table 36: Beta Blockers Available in the 7MM 119

Table 37: Global Sales Forecast (USD m) for Beta Blocker Drugs, 2013-2023 122

Table 38: Carbonic Anhydrase Inhibitors Available in the 7MM 123

Table 39: Global Sales Forecast (USD m) for Carbonic Anhydrase Inhibitor Drugs, 2013-2023 126

Table 40: Alpha-Adrenergic Agonists available in the 7MM 127

Table 41: Global Sales Forecast (USD m) for Alpha-Adrenergic Agonist Drugs, 2013-2023 129

Table 42: Product Profile-Simbrinza 130

Table 43: Simbrinza SWOT Analysis, 2014 131

Table 44: Global Sales Forecast (USD m) for Simbrinza, 2013-2023 132

Table 45: Product Profile-Glanatec 135

Table 46: Glanatec SWOT Analysis, 2014 137

Table 47: Global Sales Forecast (USD m) for Glanatec, 2013-2023 137

Table 48: Unmet Needs and Opportunities in Glaucoma 141

Table 49: Promising Drugs in Clinical Development for Glaucoma 167

Table 50: Comparison of Drugs in Development for Glaucoma, 2014 168

Table 51: Product Profile-Rhopressa 177

Table 52: SWOT Analysis-Rhopressa, 2014 180

Table 53: Global Sales Forecasts (USD m) for Rhopressa, 2013-2023 181

Table 54: Product Profile-Roclatan 185

Table 55: SWOT Analysis-Roclatan, 2014 188

Table 56: Global Sales Forecasts (USD m) for Roclatan, 2013-2023 189

Table 57: Product Profile-Vesneo 194

Table 58: SWOT Analysis-Vesneo, 2014 197

Table 59: Global Sales Forecasts (USD m) for Vesneo, 2013-2023 198

Table 60: Product Profile-Bimatoprost SR 203

Table 61: SWOT Analysis-Bimatoprost SR, 2014 205

Table 62: Global Sales Forecasts (USD m) for Bimatoprost SR, 2013-2023 206

Table 63: Product Profile-Trabodenosen 210

Table 64: SWOT Analysis-Trabodenoson, 2014 213

Table 65: Global Sales Forecasts (USD m) for Trabodenosen, 2013-2023 214

Table 66: Product Profile-OPC-1085EL 215

Table 67: SWOT Analysis-OPC-1085EL, 2014 217

Table 68: Global Sales Forecasts (USD m) for OPC-1085EL, 2013-2023 218

Table 69: Product Profile-DE-117 220

Table 70: SWOT Analysis-DE-117, 2014 221

Table 71: Product Profile-OXT-TP 222

Table 72: SWOT Analysis-OTX-TP, 2014 223

Table 73: Drugs in Development, 2014 227

Table 74: Key Companies in the Glaucoma Market in the 7MM, 2014 228

Table 75: Pfizer's Glaucoma Portfolio Assessment, 2014 232

Table 76: Alcon's Glaucoma Portfolio Assessment, 2014 233

Table 77: Allergan's Glaucoma Portfolio Assessment, 2014 235

Table 78: Santen's Glaucoma Portfolio Assessment, 2014 237

Table 79: Aerie's Glaucoma Portfolio Assessment, 2014 238

Table 80: Inotek's Glaucoma Portfolio Assessment, 2014 240

Table 81: Baush & Lomb/Valeant's Glaucoma Portfolio Assessment, 2014 241

Table 82: Kowa's Glaucoma Portfolio Assessment, 2014 242

Table 83: Otsuka's Glaucoma Portfolio Assessment, 2014 243

Table 84: Global Sales Forecast (USD m) for Glaucoma, 2013-2023 246

Table 85: Glaucoma Market-Drivers and Barriers, 2013-2023 250

Table 86: US Sales Forecast (USD m) for Glaucoma, 2013-2023 253

Table 87: Key Events Impacting Sales for Glaucoma in the US, 2013-2023 255

Table 88: Glaucoma Market-Drivers and Barriers in the US, 2013-2023 255

Table 89: 5EU Sales Forecast (USD m) for Glaucoma, 2013-2023 259

Table 90 Key Events Impacting Sales for Glaucoma in the 5EU, 2013-2023 262

Table 91: Glaucoma Market-Drivers and Barriers in the 5EU, 2013-2023 263

Table 92: Japan Sales Forecast (USD m) for Glaucoma, 2013-2023 265

Table 93: Key Events Impacting Sales for Glaucoma in Japan, 2013-2023 267

Table 94: Glaucoma Market-Drivers and Barriers in Japan, 2013-2023 268

Table 95: Key Launch Dates 317

Table 96: Key Patent Expiries 317

Table 97: Surveyed High-Prescribing Physicians (Non-KOLs), by Country 329

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