Report Title:
PharmaPoint: Macular Edema - Global Drug Forecast and Market Analysis to 2026 Published On: November 2017
Category: Life Sciences
Pages: 258
Report Overview: PharmaPoint: Macular Edema Global Drug Forecast and Market Analysis to 2026 Summary Macular Edema ME is a condition characterized by the thickening and swelling edema of the macula, which is the area of the retina that is responsible for central vision. The occurrence of ME is highly frequent in diabetics and usually manifests itself as DME, a complication of diabetic retinopathy, and is the most common cause of vision loss in patients affected by diabetes mellitus. In addition the risk for ME is also higher in patients with retinal vein occlusion, a common condition in the elderly, which consists of two types: branch retinal vein occlusion BRVO and central retinal vein occlusion CRVO. The current standard of care for macular edema focuses around the use of antiVEGF therapies which are administered as intravitreal injections. There are currently two approved antiVEGF therapies on the market for the treatment of both DME and MERVO, Roche/Novartis Lucentis and Regeneron/Bayers Eylea. Roches oncology antiVEGF is also used offlabel in many markets. Although antiVEGF therapies represent an effective treatment for ME, many patients do not show an adequate response to such therapy. In the case of these patients, they are often moved onto secondline treatment with corticosteroids. Over the next ten years, GlobalData forecasts four novel therapies to enter the ME market: CLSTA, Abicipar pegol, Luminate and Optina. GlobalData estimates that drug sales for ME in 2016 were approximately $3.7 billion across the seven major markets covered in this report. Over the 10year forecast period, the market is expected to grow to $7.0 billion at a CAGR of 6.7%. This growth will be driven by increased uptake of market leading therapy, Eylea, increased prevalence of diabetes and improved diagnosis and treatment rates. The launch of pipeline therapies will also be a driver of growth, with Allegro’s Luminate and Allergan’s Abicipar pegol forecast to be the highest selling pipeline agents in 2026. Scope Overview of macular edema, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management. Annualized macular edema therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments DME, MEBRVO and MECRVO forecast from 2016 to 2026. Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the macular edema therapeutics market Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for macular edema therapy. The most promising candidates in Phase III development are
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profiled. Analysis of the current and future market competition in the global macular edema 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 The report will enable you to Develop and design your inlicensing and outlicensing 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 macular edema therapeutics market. Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global macular edema therapeutics market in the 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 counterstrategies 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.
Table of Contents: 1 Table of Contents 1 Table of Contents 2 1.1 List of Tables 6 1.2 List of Figures 8 2 Executive Summary 10 2.1 Significant Growth Expected in the ME Market from 2016 to 2026 11 2.2 Eylea Will Dominate the ME Market Through to 2025 12 2.3 Future Players Are Unlikely to Rival the Might of Regeneron 14 2.4 Despite the Availability of AntiVEGFs, Unmet Needs Remain 15 2.5 LateStage Pipeline Therapies Will Be a Driver of Growth, Especially in the US 16 2.6 What Do Physicians think? 17 3 Introduction 20 3.1 Catalyst 20 3.2 Upcoming Related Reports 20 4 Disease Overview 21 4.1 Etiology and Pathophysiology 22 4.1.1 DME 22 4.1.2 MERVO 25 4.2 Classification 28 4.2.1 DME 28 4.2.2 MERVO 28 4.3 Symptoms and Diagnosis 29 4.3.1 DME 29 4.3.2 MERVO 29
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5 Epidemiology 31 5.1 Disease Background 31 5.2 Risk Factors and Comorbidities 32 5.3 Global and Historical Trends 32 5.4 Forecast Methodology 33 5.4.1 Sources 33 5.4.2 Forecast Assumptions and Methods 38 5.5 Epidemiological Forecast for Macular Edema 20162026 48 5.5.1 Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population 48 5.5.2 AgeSpecific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population 49 5.5.3 SexSpecific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population 50 5.5.4 Diagnosed Prevalent Cases of Clinically Significant DME Among the Diagnosed the DME Population 51 5.5.5 Total Prevalent Cases of ME following BRVO 52 5.5.6 AgeSpecific Total Prevalent Cases of ME Following BRVO 53 5.5.7 SexSpecific Total Prevalent Cases of ME Following BRVO 54 5.5.8 Total Prevalent Cases of ME Following CRVO 55 5.5.9 AgeSpecific Total Prevalent Cases of ME Following CRVO 56 5.5.10 SexSpecific Total Prevalent Cases of ME Following CRVO 56 5.6 Discussion 57 5.6.1 Epidemiological Forecast Insight 57 5.6.2 Limitations of Analysis 58 5.6.3 Strengths of Analysis 59 6 Disease Management 60 6.1 Diagnosis Overview 60 6.2 Treatment Overview 61 6.2.1 Treatment Guidelines and Leading Prescribed Drugs 61 6.2.2 Clinical Practice 62 6.3 US 64 6.4 France 68 6.5 Germany 70 6.6 Italy 73 6.7 Spain 76 6.8 UK 78 6.9 Japan 81 7 Competitive Assessment 84 7.1 Overview 84 7.2 Product Profiles AntiVEGF Therapies 85 7.2.1 Lucentis Ranibizumab 86 7.2.2 Eylea Aflibercept 96 7.2.3 Avastin Bevacizumab 104 7.3 Corticosteroid Implants 110 7.3.1 Ozurdex Dexamethasone Acetate 110
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7.3.2 Iluvien Fluocinolone Acetonide 117 8 Unmet Need and Opportunity 123 8.1 Overview 123 8.2 More Efficacious FirstLine Therapies 123 8.2.1 Unmet Need 123 8.2.2 Gap Analysis 124 8.2.3 Opportunity 126 8.3 Longer Duration of Action 127 8.3.1 Unmet Need 127 8.3.2 Gap Analysis 128 8.3.3 Opportunity 129 8.4 Alternative Route of Administration 129 8.4.1 Unmet Need 129 8.4.2 Gap Analysis 130 8.4.3 Opportunity 131 9 Pipeline Assessment 132 9.1 Overview 132 9.2 Clinical Trial Mapping 134 9.3 Promising Drugs in Clinical Development 135 9.3.1 CLSTA Triamcinolone Acetonide 136 9.3.2 Abicipar Pegol 144 9.3.3 Luminate ALG1001 150 9.3.4 Optina Danazol 157 9.4 Promising Drugs in EarlyStage Development 165 9.4.1 REGN9103 Nesvacumab + Aflibercept 165 9.4.2 RG7716 166 9.4.3 AKB9778 167 9.4.4 Brolucizumab RTH258 170 9.5 Other Drugs in Development 171 9.6 Biosimilars 171 10 Current and Future Players 176 10.1 Overview 176 10.2 Trends in Corporate Strategy 179 10.3 Company Profiles 180 10.3.1 Roche/Genentech 180 10.3.2 Novartis 183 10.3.3 Regeneron 185 10.3.4 Bayer 187 10.3.5 Santen 189 10.3.6 Allergan 190 10.3.7 Alimera Sciences 193 10.3.8 Clearside BioMedical 195 10.3.9 Allegro Ophthalmics 197 11 Market Outlook 199 11.1 Global Market 199 11.1.1 Forecast 199
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11.1.2 Drivers and Barriers Global Issues 204 11.2 US 204 11.2.1 Forecast 204 11.2.2 Key Events 208 11.2.3 Drivers and Barriers 209 11.3 5EU 209 11.3.1 Forecast 209 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 218 12 Appendix 219 12.1 Bibliography 219 12.2 Abbreviations 239 12.3 Methodology 242 12.3.1 Forecasting Methodology 243 12.3.2 Diagnosed Patients 243 12.3.3 Percent DrugTreated Patients 243 12.3.4 Drugs Included in Each Therapeutic Class 243 12.3.5 Launch and Patent Expiry Dates 244 12.3.6 General Pricing Assumptions 244 12.3.7 Individual Drug Assumptions 245 12.3.8 Generic Erosion 250 12.3.9 Pricing of Pipeline Agents 250 12.4 Primary Research KOLs Interviewed for this Report 252 12.5 Primary Research Prescriber Survey 255 12.6 About the Authors 255 12.6.1 Analyst 255 12.6.2 Therapy Area Director 255 12.6.3 Epidemiologist 256 12.6.4 Managing Epidemiologist 256 12.6.5 Global Director of Therapy Analysis and Epidemiology 257 12.6.6 Global Head and EVP of Healthcare Operations and Strategy 257 12.7 About GlobalData 258 12.8 Contact Us 258 12.9 Disclaimer 258
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