Macular Degeneration (AMD) And Other Retinal Diseases World Drug Industry And Market 2015-2025

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  • 1. Contents 1.1Overview of the World Market for Macular Degeneration and Other Retinal Diseases 1.2 Why You Should Read This Report 1.3 How This Report Delivers 1.4 Main Questions Answered by This Analysis 1.5 Who Is This Study For? 1.6 Methods of Research and Analysis 1.7 Frequently Asked Questions (FAQs) 1.8 Some Associated Reports 1.9 About Visiongain 2.1 Market to Make Rapid Strides to 2025 2.2 Lucentis Still Holds Over 60% of the Total Market 2.2.1 Novartis the Leading Presence in the Market 2.3 Which are the Most Significant Disease Areas for the Market? 2.3.1 Nearly 200 Million People with AMD? 2.3.2 Over 100 Million with DR 2.3.3 First RVO Estimates Suggest Patient Population of 16 Million 2.3.4 Wet AMD Still the Main Source of Revenues in the Market 2.4 Wet AMD: Angiogenic Processes Offer Well-Defined Drug Targets 2.5 Dry AMD: Unmet Need to Arrest or Reverse Damage to RPE 2.6 DR: Coming Into Clinical Focus, with DME the Main Target 2.7 Lucentis and Eylea Label Extensions Highlight Possibilities in Other Disease Areas 2.8 Projections for All Segments, 2014-2025 1. Report Overview 2. Overview of the AMD and Other Retinal Diseases Market, 2014-2025
  • 2. Contents 3.1 Will the Current Products Dominate the Market Through 2025? 3.2 Lucentis: The Market Leader, But For How Long? 3.2.1 Shadow of Avastin Still Hangs Over Lucentis 3.2.2 CATT Study Results: Clinical Differences Still Have Yet to Emerge 3.2.3 Eylea: The Bigger Threat to Lucentis? 3.2.4 Extending the Label, Widening the Battleground: Lucentis Moves Into DME and Beyond 3.2.5 Improving Cost and Compliance for Lucentis 3.2.6 Will Loss of Physician Goodwill Harm Lucentis’ Growth? 3.2.7 Lucentis Revenue Forecast 2014-2025 3.3 Eylea: Pretender to the Throne? 3.3.1 VIEW 1 and VIEW 2: Is Eylea Superior or Just Non-Inferior to Lucentis? 3.3.2 First Wave of Eylea’s Expansion Finally Beginning to Break? 3.3.3 Into DME and Other New Indications 3.3.4 Zaltrap Targeting Solid Tumour Markets 3.3.5 How Far Can Eylea’s Momentum Carry It? 3.3.6 Eylea Revenue Forecast 2014-2025 3.4 Avastin: No Formal wAMD Approval but Still the Most-Used Product 3.4.1 Judicial Review Averted in the UK by Price Adjustment 3.4.2 Multiple Attempts to Block Off-Label Avastin Since 2007 3.4.3 Roche and Novartis Challenge CATT’s Headline Conclusions 3.4.4 Will Eylea/Zaltrap Affect Avastin’s Place in the Market? 3.4.5 Will Anything Dislodge Avastin from its Central Position? 3.4.6 Avastin Revenue Forecast, 2014-2025 3.5 Visudyne (Valeant/Novartis): Declining Sales Throughout the Forecast Period 3.5.1 Visudyne Revenue Forecast, 2014-2025 3.6 Jetrea (ThromboGenics/Novartis): Disappointing Launch in 2013 3. Approved Products in the AMD and Other Retinal Diseases Market, 2014-2025
  • 3. Contents 3.6.1 Jetrea Revenue Forecast, 2014-2025 4.1 Eylea: The Segment’s Biggest Short-Term Driver 4.2 Pipeline for wAMD: The Leading Candidates 4.3 Fovista (Ophthotech Corporation/Novartis): The Next Big Thing? 4.3.1 Three Phase 3 Trials to Confirm Fovista’s Outstanding Phase 2 Results 4.3.2 Ophthotech Goes Public to Fund Phase 3 Effort 4.3.3 Ophthotech Partners with Novartis for Fovista 4.3.4 Improving Angiogenesis Inhibition by Blocking Pericyte Recruitment 4.3.5 The Move toward Combination Therapies 4.4 Other Growth Factor Targets in the Pipeline 4.4.1 Squalamine (OHR Pharmaceutical): Combination Targeting in a Single Eyedrop 4.4.2 Allergan and Molecular Partners: Preclinical DARPin Hits VEGF and PDGF 4.4.3 NT-506 (Neurotech Pharmaceutical): Sustained-Release VEGF/PDGF Options 4.4.4 iSONEP (Lpath): Pfizer Interested in Anti-S1P Monoclonal Antibody 4.5 Conbercept (Chengdu Kanghong Biotech): The Other Phase 3 Candidate in wAMD 4.5.1 A Chinese Competitor: Where Will Conbercept Fit In? 4.5.2 Binding Affinity Comparable to Eylea 4.6 Do We Need New Anti-VEGFR Agents or Delivery Systems? 4.6.1 AGN-150998 DARPin (Allergan): Novel Protein With Extended Half-Life 4.6.2 ESBA 1008 (Alcon): Single-Chain Monoclonal Antibody Fragment 4.6.3 PDS 1.0 (ForSight Vision4): A New Option for Lucentis Delivery 4.6.4 NT-503 (Neurotech): New Delivery Platform for Anti-VEGF Agent 4.6.5 Pan-90806 (PanOptica): Anti-VEGF Eyedrop in Preclinical Development 4.6.6 Iontophoretic Delivery: EyeGate Pharmaceuticals Leading the Way 4.7 Novel Delivery Systems to Rejuvenate Anti-Inflammatory Approaches 4.7.1 Verisome System and IBI-30089 (Icon Bioscience) 4.7.2 CPC-551 (Colby Pharmaceutical): An Alternative Anti-Inflammatory Approach? 4.8 Other Targets Under Investigation in wAMD Drug Development 4. Wet AMD Segment, 2014-2025
  • 4. Contents 4.8.1 Are Kinase Inhibitors Still a Going Concern in wAMD? 4.8.2 Pazopanib (GlaxoSmithKline) and TG100801 (Sanofi): Two Eyedrop Kinase Inhibitors Drop Out of the Running 4.8.3 X-82 Pill (Tyrogenex): Dual Kinase Inhibitor 4.8.4 First Ophthalmic Complement Factor Inhibitor, AL-78898A (Alcon), Misses Primary Endpoint 4.8.5 Factor C5: A More Promising Target Addressed by ARC1905 Aptamer (Ophthotech) and LFG316 (Novartis) 4.8.6 Integrins: Another Blockable Component of the Neovascularisation Cascade? 4.8.7 Luminate (Allegro Ophthalmics): Novel Anti-Integrin Oligopeptide 4.8.8 Jetrea (ThromboGenics/Novartis): Can Pharmacologic Vitreolysis Help wAMD Patients? 4.8.9 Novel Anti-Angiogenic Treatments in Development: Ora Bio’s ORA102 and CoMentis’ ATG003 4.8.10 Zybrestat (Oxigene): New Mechanism of Action Offers Way to Disrupt Neovascularisation 4.8.11 Synthetic Biologies: Oligonucleotides and SiRNAs for wAMD 4.9 Regenerative Medicine Approaches 4.9.1 Allogeneic Stem Cells (Mesoblast): Potential Synergistic Treatment for Use alongside Lucentis 4.9.2 AVA-101 and AVA-201(Avalanche Biotechnologies): Ocular BioFactory for wAMD 4.9.3 RetinoStat (Oxford BioMedica): LentiVector Technology to Deliver Anti-Angiogenic Genes 4.4.5 Market Forecast for the OTC Segment, 2015-2025 5.1 Dry AMD Segment to Emerge in the Forecast Period 5.2 Who Will Achieve the Big Breakthrough in Dry AMD? 5.3 MC-1101 (MacuCLEAR): Leading the Pack? 5.3.1 Increasing Choroidal Blood Flow with Repurposed Product 5.3.2 Novel Endpoints in Phase 3 Study 5.3.3 Can MacuCLEAR Make It? 5.4 ACU-4429 (Acucela): Visual Cycle Modulator in Phase 3 5. Dry AMD Segment, 2014-2025
  • 5. Contents 5.4.1 Data Expected in July 2016 5.4.2 Other Visual Cycle Modulators 5.5 High Hopes for Complement Inhibition in Dry AMD 5.5.1 Lampalizumab (Roche): The Big News of ARVO 2013 MAHALO Study Indicates GA Progression Slowed by Lampalizumab 5.5.2 AL-78898A (Alcon): Phase 2 Trial in Dry AMD Terminated 5.5.3 Soliris (Alexion): Out of the Running? 5.6 Corticosteroids: Targeting Inflammation’s Role in Dry AMD Pathogenesis 5.6.1 Medidur Fluocinolone Acetonide (Alimera Sciences): Insert in Phase 2 5.6.2 AGN208397 (Allergan): New Potent Steroid Expected to Undergo Trials in Dry AMD 5.7 Neuroprotection: One of Modern Medicine’s Holy Grails 5.7.1 Tandospirone (Alcon): No News on Serotonin 1A Agonist 5.7.2 NT-501 (Neurotech): Some Promising Data in Dry AMD Studies 5.7.3 Novadur (Allergan): Possible Efficacy with Longer Duration of Action 5.7.4 RN6G (Pfizer): Amyloid Beta-Binding Monoclonal Antibody Still in Studies 5.7.5 VAR10200 (Varinel): A Preclinical Candidate to Watch 5.8 Regenerative Medicine: Dry AMD One of the Biggest Disease Targets 5.8.1 MA09-hRPE Cellular Therapy (Ocata Therapeutics): Signs of Efficacy in Landmark ESC Human Trial 5.8.2 HuCNS-SC (StemCells): Leading Company in Neural Stem Cell Space 5.8.3 Stemedyne-RPE (Stemedica Cell Technologies): Low-Oxygen Cells for Dry AMD Repair 5.8.4 Biotime: Stem Cell leader with Dry AMD Interests 5.8.5 First iPSC Trial in Japan in Dry AMD Patients 5.8.6 Gene Therapies Less Prominent Than Stem Cells in Dry AMD 5.9 Other Treatments for Dry AMD 6.1 Segment to Grow in Importance as Diabetes Epidemic Continues 6.2 DR Options Grow with DME Addressed by New Agents 6. Diabetic Retinopathy Segment, 2014-2025
  • 6. Contents 6.3 Ozurdex/Posurdex (Allergan): Approved for General DME Patient Population 6.4 Lucentis: The Game Changer for DR? 6.5 New Anti-VEGF Additions 6.5.1 Is Eylea Better than Lucentis and Avastin for DME? 6.6 Steroids in Development for DR 6.6.1 Iluvien (Alimera/pSivida): New Option in European Markets 6.6.2 A New Hope? Optina (Ampio Pharmaceuticals) 6.6.3 Betamethasone Microsphere (Santen): Late-Stage Steroid Candidate 6.6.4 SK-0503 (Sanwa Kagaku Kenkyusho): Potential DME and BRVO Treatment 6.6.5 Cortiject (Santen): Prodrug Candidate 6.6.6 IBI-20089 (Icon Bioscience): Sustained-Release Formulation of Triamcinolone Acetonide 6.7 Other Products in Development for DR 6.7.1 Angiotensin Receptor Blockers/Angiotensin-Converting Enzyme Inhibitors: Some Off-Label Validation 6.7.2 Vitreosolve (Innovations in Sight): Will a Phase 3 Trial Be Initiated? 6.7.3 TriLipix (Abbott): No New Development for Promising Drug 6.7.4 iCo-007 Intravitreal Injection (iCo Therapeutics): Phase 2 Enrolment Completed June 2013 6.7.5 Darapladib (GlaxoSmithKline): Possible New Use for Atherosclerosis Drug 6.7.6 Jetrea (ThromboGenics/Novartis): Possibilities in DME? 7.1 Which Markets Hold the Most Revenue Growth Potential? 7.2 The US: Leading Market for Retinal Diseases 7.3 Japan: Strong Market Potential 7.4 EU5: Ageing Populations to Drive Market Growth 7.5 BRIC Nations: The Biggest Growth Driver for the Market 8.1 Strengths: The Most Dynamic Area of the Ophthalmics Market 8.2 Weaknesses: Heavily Dependent on Anti-VEGF Approach 7. Regional Market Breakdown, 2014-2025 8. Qualitative Industry and Market Analysis, 2015-2025
  • 7. Contents 8.3 Opportunities: New Markets and R&D Synergies 8.4 Threats: Prevention and Management Better Than Drug Treatment for Dry AMD and DR? 8.5 Social: Low Diagnosis, Low Compliance 8.6 Technological: Innovation for the Eye 8.7 Economic: Off-Label Treatment and Reimbursement Issues 8.8 Political: The Demography and Diabetes Challenges 9.1 Interview with Philip G. Ralston, Jr., MacuCLEAR (Part 1) 9.1.1 MC-1101: Identifying and Treating Chiou Syndrome 9.1.2 Preventing Dry AMD Progression 9.1.3 Treating the Root Cause of Dry AMD 9.1.4 Phase 3: Endpoints and Prospects for MC-1101 9.2 Interview with Philip G. Ralston, Jr., MacuCLEAR (Part 2) 9.2.1 MC-1101: Progress in Clinical Trials 9.2.2 MC-1101 More Effective in Early to Mid-Range AMD 9.2.3 Partnerships and Expected Launch of MC-1101 10.1 The Age of Lucentis: Nearing Its Conclusion? 10.2 Lucentis vs. Eylea vs. Avastin: The Three-Way Anti-VEGF Market 10.3 Indications Outside Wet AMD to Gain in Importance 10.4 Dry AMD Market Has Huge Potential 10.5 Fovista Most Prominent Among the Pipeline Candidates 10.6 Retinal Diseases to Continue to Be the Leading Area of Ophthalmics 10. Report Conclusions 9. Research Interviews
  • 8. Page Macular Degeneration (AMD) and Other Retinal Diseases: World Drug Industry and Market 2015-2025 2013 2014 2015 2016 2017 2018 2019 Revenues ($m) 172 187 203 221 237 255 271 Annual Growth (%) 9 8 9 8 7 6 CAGR (%, 2013-2019) 7.9 2019 2020 2021 2022 2023 2024 2025 Revenues ($m) 271 287 302 317 332 348 364 Annual Growth (%) 6 6 5 5 5 5 5 CAGR (%, 2013-2019 & 2019-2025) 7.9 5.0 CAGR (%, 2013-2025) 6.4 0 75 150 225 300 375 450 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Revenue($m) Year Table 3.10 Avastin Forecast: Revenues ($m), AGR (%), CAGR (%), 2014-2019 Source: visiongain 2015 Table 3.11 Avastin Forecast: Revenues ($m), AGR (%), CAGR (%), 2019-2025 Source: visiongain 2015 Figure 3.10 Avastin Forecast: Revenues ($m), 2014-2025 Source: visiongain 2015
  • 9. Page Macular Degeneration (AMD) and Other Retinal Diseases: World Drug Industry and Market 2015-2025 6.3 Ozurdex/Posurdex (Allergan): Approved for General DME Patient Population Ozurdex (dexamethasone), which is called Posurdex in ex-US markets, has been terminated in wAMD, visiongain believes, but is approved for the treatment of diabetic macular oedema and macular oedema following BRVO or CRVO in addition to noninfectious posterior-segment uveitis. Ozurdex was initially approved by the FDA in June 2014 for the treatment of DME in patients with artificial lens implants or those scheduled for cataract surgery. However in September 2014, the FDA revised the approval to the treatment of DME without the prior restrictions. Allergan’s phase 2 DME trial of Ozurdex showed 10-15 letter improvement in visual acuity in one subset of DME patients. Ozurdex's main advantage is its dosing schedule: one injection every 6 months. 6.4 Lucentis: The Game Changer for DR? VEGF is implicated as the major inciting cytokine in DME pathogenesis. As discussed in previous chapters, anti-VEGF treatments are well-established in the retinal disease area, and Lucentis and Avastin have regularly been used off-label in DME treatment. In August 2013, Lucentis was formally approved in this setting, based on the RIDE and RISE trials. In terms of the effectiveness Table 6.3 Selected R&D Pipeline for DR, 2014 Company Product Target Phase Allergan Ozurdex (dexamethasone) Anti-inflammatory steroid Approved Ampio Pharmaceuticals Optina (danazol) Prevents endothelial cell migration 3 Santen Betamethasone microsphere Anti-inflammatory steroid 2/3 Vitreoretinal Technologies Vitreosolve (carbamide) Induces posterior vitreous detachment (PVD) 2 Abbott TriLipix (choline fenofibrate) Cholesterol and triglyceride reduction 2 iCo Therapeutics iCo-007 Antisense inhibitor 2 GlaxoSmithKline Darapladib Inhibits Lp-PLA2 2 Santen Cortiject (dexamethasone palmitate) Anti-inflammatory steroid 1/2 SARcode Bioscience SAR1118 Integrin inhibitor 1 Icon Bioscience IBI-20089 (sustained-release triamcinolone acetonide) Anti-inflammatory steroid 1 Source: visiongain 2015
  • 10. Page Macular Degeneration (AMD) and Other Retinal Diseases: World Drug Industry and Market 2015-2025 Germany 27.5% France 22.3%Italy 16.7% Spain 11.9% UK 21.6% Germany 27.7% France 22.7% Italy 16.4% Spain 11.5% UK 21.6% Figure 7.11 EU5 Breakdown: Market Share (%), 2019 Figure 7.12 EU5 Breakdown: Market Share (%), 2025 Source: visiongain 2015 Source: visiongain 2015
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