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Macular Degeneration AMD and other Retinal Diseases 2014 2024

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For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website …

For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website http://www.visiongain.com/Report/1163/Macular-Degeneration-%28AMD%29-and-Other-Retinal-Diseases-World-Drug-Market-2014-2024

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  • 1. Macular Degeneration (AMD) and Other Retinal Diseases: World Drug Market 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  • 2. Contents 1. Executive Summary 1.1 Overview of Findings 1.2 Chapters in the Report 1.3 Research and Analysis Methods 2. Overview of the AMD and Other Retinal Diseases Market, 2014-2024 2.1 Market to Make Rapid Strides to 2024 2.2 Lucentis Still Holds Over 70% 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, 2014-2024 3. Approved Products in the AMD and Other Retinal Diseases Market, 2014-2024 3.1 Will the Current Products Dominate the Market Through 2024? 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 www.visiongain.com
  • 3. Contents 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 2014-2024 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 2014-2024 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 Market Forecast for Avastin, 2014-2024 4. Wet AMD Segment, 2014-2024 4.1 Eylea The Segment’s Biggest Short-Term Driver 4.2 R&D Pipeline for wAMD: The Leading Candidates 4.3 Fovista (Ophthotech Corporation): 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 Improving Angiogenesis Inhibition by Blocking Pericyte Recruitment 4.3.4 The Move Toward Combination Therapies 4.4 Squalamine (OHR Pharmaceutical): Combination Targeting in a Single Eyedrop 4.4.1 Preclinical DARPin Hits VEGF and PDGF www.visiongain.com
  • 4. Contents 4.4.2 NT-506 (Neurotech Pharmaceutical): Sustained-Release VEGF/PDGF Options 4.4.3 Other Growth Factor Targets in the Pipeline 4.4.4 iSONEP (Lpath): Pfizer Interested in Anti-S1P MAb 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 mAb 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 IBI-20089 (Icon Bioscience): Steroid Gel for Slow Release 4.7.2 OT-551 (Colby Pharmaceutical): An Alternative Anti-Inflammatory Approach? 4.8 Other Targets Under Investigation in wAMD Drug Development 4.8.1 Are Kinase Inhibitors Still a Going Concern in wAMD? 4.8.2 Pazopanib and TG100801: Two Eyedrop Kinase Inhibitors Drop Out of the Running 4.8.3 First Ophthalmic Complement Factor Inhibitor, AL-78898A, Misses Primary Endpoint 4.8.4 Factor C5: A More Promising Target Addressed by LFG316 (Novartis) 4.8.5 Integrins: Another Blockable Component of the Neovascularisation Cascade? 4.8.6 ALG-1001 (Allegro Ophthalmics): Novel Anti-Integrin Oligopeptide 4.8.7 Ocriplasmin (Thrombogenics): Can Pharmacologic Vitreolysis Help wAMD Patients? 4.8.8 Novel Anti-Angiogenic Treatments in Development 4.8.9 Zybrestat (Oxigene): New Mechanism of Action Offers Way to Disrupt Neovascularisation 4.8.10 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 www.visiongain.com
  • 5. Contents 4.9.2 AVA-101(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, 2014-2024 5. Dry AMD Segment, 2014-2024 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 5.4.1 Data Expected in July 2016 5.4.2 Other Visual Cycle Modulators 5.5 Lampalizumab (Roche): The Big News of ARVO 2013 5.5.1 MAHALO Study Indicates GA Progression Slowed by Lampa 5.5.2 High Hopes for Complement Inhibition in Dry AMD 5.5.3 AL-78898A (Alcon): Still Under Investigation in Dry AMD 5.5.4 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 Be Trialled 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 NT501 (Neurotech): Some Promising Data in Dry AMD Studies 5.7.3 Brimonidine Tartrate (Allergan): Possible Efficacy with Longer Duration of Action 5.7.4 RN6G (Pfizer): Amyloid Beta-Binding MAb 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 www.visiongain.com
  • 6. Contents 5.8.1 MA09-hRPE Cellular Therapy (Advanced Cell Technology): 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. Diabetic Retinopathy Segment, 2014-2024 6.1 Segment to Grow in Importance as Diabetes Epidemic Continues 6.2 DR Options Grow with DME Addressed by New Agents 6.3 Lucentis: The Game Changer for DR? 6.3.1 New Anti-VEGF Additions 6.4 A New Hope? Optina (Ampio Pharmaceuticals) 6.4.1 Other Steroids in Development for DR 6.4.2 Iluvien (Alimera/pSivida): New Option in European Markets 6.4.3 Betamethasone Microsphere (Santen): Late-Stage Steroid Candidate 6.4.4 Ozurdex (Allergan): Under Investigation in Several Indications 6.4.5 SK-0503 (Sanwa Kagaku Kenkyusho): Potential DME and BRVO Treatment 6.4.6 Cortiject (Novagali Pharma): Prodrug Candidate 6.5 Other Products in Development for DR 6.5.1 Angiotensin Receptor Blockers/Angiotensin-Converting Enzyme Inhibitors: Some Off-Label Validation 6.5.2 Vitreosolve (Innovations in Sight): Will a Phase 3 Trial Be Initiated? 6.5.3 Choline Fenofibrate (Abbott): No New Development for Promising Drug 6.5.4 iCo-007 Intravitreal Injection (iCo Therapeutics): Phase 2 Enrolment Completed June 2013 6.5.5 Darapladib (GlaxoSmithKline): Possible New Use for Atherosclerosis Drug 6.5.6 Bromfenac Ophthalmic Solution (ISTA Pharmaceuticals): New NSAID Option? www.visiongain.com
  • 7. Contents 6.5.7 Ocriplasmin: Possibilities in DME? 7. Regional Market Breakdown, 2014-2024 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. Qualitative Analysis, 2014-2024 8.1 Strengths: The Most Dynamic Area of the Ophthalmics Market 8.2 Weaknesses: Heavily Dependent on Anti-VEGF Approach 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. Research Interviews from Our Survey 9.1 Interview with Dr Michael Stewart, Mayo Clinic 9.1.1 The Impact of Eylea, 2011-2012 9.1.2 The Comparative Dosing Schedules of Eylea and Lucentis 9.1.3 Patient Transitioning to Eylea: Salvage Switching 9.1.4 Avastin After the CATT Study 9.1.5 Prospects for Eylea in Other Indications and Combinations 9.1.6 Future Possibilities in Wet AMD Treatment 9.2 Interview with Philip G. Ralston, Jr., MacuCLEAR 9.2.1 MC-1101: Identifying and Treating Chiou Syndrome 9.2.2 Preventing Dry AMD Progression www.visiongain.com
  • 8. Contents 9.2.3 Treating the Root Cause of Dry AMD 9.2.4 Phase 3: Endpoints and Prospects for MC-1101 10. Report Conclusions 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 www.visiongain.com
  • 9. Contents List of Tables Table 1.1 Currency Exchange Rates Table 2.1 AMD and Other Retinal Diseases Pharmaceutical Market: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 2.2 AMD and Other Retinal Diseases Pharmaceutical Market: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 2.3 Market Breakdown by Product: Revenues ($m), Market Share (%), 2012 Table 2.4 Market Breakdown by Disease Segment: Revenues ($m), Market Share (%), 2012 Table 2.5 Types of CNV in Wet AMD, Description: Approximate Proportion of Cases (%), 2012 Table 2.6 Retinal Diseases Market Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 2.7 Market Breakdown by Disease Segment: Revenues ($m), Market Share (%), 2017 Table 2.8 Retinal Diseases Market Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 2.9 Market Breakdown by Disease Segment: Revenues ($m), Market Share (%), 2024 Table 3.1 Market Breakdown by Product: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 3.2 Market Breakdown by Product: Revenues ($m), Market Share (%), 2017 Table 3.3 Market Breakdown by Product: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 3.4 Market Breakdown by Product: Revenues ($m), Market Share (%), 2024 Table 3.5 Lucentis, Eylea and Avastin: Comparison of Characteristics Table 3.6 Lucentis: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 3.7 Lucentis: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 3.8 Eylea: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 3.9 Eylea: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 3.10 Avastin: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 3.11 Avastin: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 www.visiongain.com
  • 10. Contents Table 4.1 Wet AMD Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20122017 Table 4.2 Wet AMD Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20182024 Table 4.3 Selected R&D Pipeline for wAMD, 2013 Table 5.1 Dry AMD Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20122017 Table 5.2 Dry AMD Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20182024 Table 5.3 Selected R&D Pipeline for Dry AMD, 2013 Table 6.1 DR Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 6.2 DR Segment: Revenues: ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 6.3 Selected R&D Pipeline for DR, 2013 Table 7.1 Regional Breakdown: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20122017 Table 7.2 Regional Breakdown: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 20182024 Table 7.3 EU5 Breakdown: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 7.4 EU5 Breakdown: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 Table 7.5 BRIC Nations Breakdown: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 7.6 BRIC Nations Breakdown: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 www.visiongain.com
  • 11. Contents List of Figures Figure 2.1 AMD and Other Retinal Diseases Pharmaceutical Market: Revenues ($m), 2012-2024 Figure 2.2 Market Breakdown by Product Revenues ($m), Market Share (%), 2012 Figure 2.3 Market Breakdown by Company: Market Share (%), 2012 Figure 2.4 Leading Causes of Blindness Worldwide, Proportion of Total (%), 2010 Figure 2.5 Leading Causes of Visual Impairment (Inclusive of Blindness) Worldwide, Proportion of Total (%), 2010 Figure 2.6 Global Over-60s Population (m), as Proportion of Total (%), 2012-2024 Figure 2.7 Market Breakdown by Disease Segment: Revenues ($m), 2012 Figure 2.8 Wet AMD Disease Segment: Market Share (%), 2012 Figure 2.9 Dry AMD Disease Segment: Market Share (%), 2012 Figure 2.10 DR Disease Segment: Market Share (%), 2012 Figure 2.11 Other Retinal Diseases Segment: Market Share (%), 2012 Figure 2.12 Market Breakdown by Disease Segment: Revenues ($m), Market Share (%), 2017 Figure 2.13 Market Breakdown by Disease Segment: Revenues ($m), Market Share (%), 2024 Figure 2.14 Retinal Diseases Market Breakdown by Segment: Revenues ($m), 2012-2024 Figure 2.15 Retinal Diseases Market Breakdown by Segment: Revenues ($m), 2012, 2018 and 2024 Figure 3.1 Market Breakdown by Product: Revenues ($m), Market Share (%), 2017 Figure 3.2 Market Breakdown by Product: Revenues ($m), Market Share (%), 2024 Figure 3.3 Market Breakdown by Product: Revenues ($m), 2012-2024 Figure 3.4 Market Breakdown by Product: Revenues ($m), 2012, 2018 and 2024 Figure 3.5 Drivers and Restraints for Lucentis, 2013 Figure 3.6 Lucentis: Revenues ($m), 2012-2024 Figure 3.7 Drivers and Restraints for Eylea, 2013 Figure 3.8 Eylea: Revenues ($m), 2012-2024 Figure 3.9 Drivers and Restraints for Avastin, 2013 Figure 3.10 Avastin: Revenues ($m), 2012-2024 Figure 4.1 Wet AMD Segment: Revenues ($m), 2012-2024 www.visiongain.com
  • 12. Contents Figure 5.1 Dry AMD Segment: Revenues ($m), 2012-2024 Figure 6.1 DR Segment: Revenues ($m), 2012-2024 Figure 7.1 Regional Breakdown: Revenues ($m), 2012-2024 Figure 7.2 Regional Breakdown: Revenues ($m), 2012, 2018 and 2024 Figure 7.3 US Market: Revenues ($m), 2012-2024 Figure 7.4 Japan: Revenues ($m), 2012-2024 Figure 7.5 EU5: Grouped Revenues ($m), 2012-2024 Figure 7.6 EU5 Breakdown: Revenues ($m), 2012-2024 Figure 7.7 EU5 Breakdown: Revenues ($m), 2012, 2018 and 2024 Figure 7.8 BRIC Nations: Grouped Revenues ($m), 2012-2024 Figure 7.9 BRIC Nations Breakdown: Revenues ($m), 2012-2024 Figure 7.10 BRIC Nations Breakdown: Revenues ($m), 2012, 2018 and 2024 www.visiongain.com
  • 13. Contents Organisations Mentioned in Report Abbott Laboratories Abbott Laboratories Acucela Adnexus Advanced Cell Technologies Alcon Alexion Alimera Sciences Alkeus Pharmaceuticals Allegro Ophthalmics Allergan American Academy of Ophthalmology American Society of Retina Specialists Amgen Ampio Pharmaceuticals Applied Genetic Technologies Association for Research in Vision and Ophthalmology (ARVO) AstraZeneca Athenagen Atlantis Pharma ATON Pharma Avalanche Biotechnologies Bausch & Lomb Bayer Bayer Yakuhin (Bayer subsidiary) Biogen Idec Biotime Biovail Corporation Bristol-Myers Squibb www.visiongain.com
  • 14. Contents Casey Eye Institute at Oregon Health and Science University Cell Cure Neurosciences Chengdu Kanghong Biotech Colby Pharmaceutical CoMentis Eli Lilly Emory University ES Cell International ESBATech European Court of Justice European Medicines Agency (EMEA/EMA) EyeGate Pharmaceuticals Eyetech Food and Drug Administration (US FDA) Formatech ForSight Labs ForSight VISION4 Fovea Genaera Gene Signal Genentech General Medical Council (GMC, UK) GenVec Genzyme Geron Gerot Lannach GlaxoSmithKline (GSK) Human Genome Sciences iCo Therapeutics Icon Bioscience www.visiongain.com
  • 15. Contents Innovations in Sight Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG, Germany) International Diabetes Foundation Institute of Ocular Pharmacology ISTA Pharmaceuticals Jerini Kaplan Medical Center Lpath Ludwig-Maximilians - University of Munich MacuCLEAR MacuSight Mayo Clinic MedImmune Merck & Co. Mesoblast Molecular Partners MorphoSys Mystic Pharmaceuticals National Eye Institute (NEI, US) National Health Service (NHS, UK) National Institute for Health and Clinical Excellence (NICE, UK) Natur Produk Neuron Systems Neurotech Novagali Pharma Novartis Novo Nordisk Numoda Capital Innovations Oakwood Laboratories OcuSciences www.visiongain.com
  • 16. Contents Ohr Pharmaceutical Oklahoma Medical Research Foundation Ophthotech Corporation Ora Bio OraPharma Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES, Austria) Othera Pharmaceuticals Otsuka Pharmaceutical Oxford BioMedica Oxigene Paloma Pharmaceuticals Palomid Pharmaceuticals PanOptica PDL BioPharma Pedinol Pharmacal Pele Nova Biotecnologica Pfizer Pieris Potentia Pharmaceuticals Probiotica Laboratorios pSivida Purdue University QLT Quark Regeneron Retina Macula Institute RetroSense Therapeutics ReVision Therapeutics Roche Sanofi www.visiongain.com
  • 17. Contents Santen Pharmaceuticals Sanwa Kagaku Kenkyusho SARcode Bioscience Senju Pharmaceutical Shire Singapore Eye Research Institute Singapore National Eye Centre Sirion Therapeutics StemCells Stemedica Cell Technologies Swissmedic Symphony ViDA Takeda TargeGen Teva Pharmaceutical Industries ThromboGenics UCB University of Kentucky College of Medicine University of Kyoto Valeant Pharma Varinel Vitreoretinal Technologies World Health Organization (WHO) www.visiongain.com
  • 18. Macular Degeneration (AMD) and Other Retinal Diseases: World Drug Market 2014-2024 to prescribe it at the original asking price. In June 2013, the UK’s NICE declined to recommend Zaltrap, also reportedly citing its high cost. 3.3.5 How Far Can Eylea’s Momentum Carry It? See Figure 3.7 for a summary of drivers and restraints for Eylea. The drug has exceeded expectations to date, capturing a large share of the wAMD patient population, rather than merely becoming a salvage/second-line option (as may have been expected for a drug with similar mechanism of action and similar efficacy to the existing standard of care). Eylea’s slightly lower cost and superior label dosing schedule, combined with the apparent ill-will generated by some attempts to protect Lucentis. The relative goodwill of physicians towards the Regeneron product may seem subjective, but visiongain has been informed off the record that this was a strong initial driver for Eylea’s uptake. Eylea’s longer-term growth prospects face the ongoing restraint of Lucentis getting to other retinal disease indications first; and the constant presence of Avastin as a lower-cost off-label option. Eylea’s strong performance against Lucentis in wAMD suggests it has potential to become standard of care in the other retinal disease indications too. Figure 3.7 Drivers and Restraints for Eylea, 2013 Restraints As with Lucentis, Avastin apparently represents a lower-cost alternative to Eylea Relative to Lucentis, Eylea is reportedly slightly cheaper, shows slightly superior VEGF-binding, and has a preferable dosing schedule Has no clear-cut clinical superiority to support its use instead of Lucentis or Avastin where these options are more convenient Rapid expansion shows physicians are willing to switch patients to Eylea, which may also profit from any ill-will to Lucentis Will cede first-to-market advantage to Lucentis in retinal disease indications Expansion opportunities in new markets and indications Drivers Source: visiongain 2013 3.3.6 Eylea Revenue Forecast 2014-2024 Visiongain believes that given the scale of Eylea’s incursion into the wAMD space there is at present no obvious reason that it should not capture the broader retinal disease market from Lucentis. If Eylea achieves the same patient share in RVO, DME and CNV secondary to pathological myopia, it will be a multiple blockbuster product by the end of the forecast period. www.visiongain.com Page 52
  • 19. Macular Degeneration (AMD) and Other Retinal Diseases: World Drug Market 2014-2024 Visiongain anticipates 2013 revenues of $1292m for Eylea, rising to $2079m in 2014 with DME added to the product’s label. Between 2012 and 2017 Eylea will achieve a CAGR of 28%, visiongain believes, with revenues rising to $2891m by the end of that year (Table 3.8). By this point, Eylea will have captured around 29% of the overall retinal diseases market, which visiongain believes is likely to be its high-water-mark as new products and combinations capture market share. Table 3.8 Eylea: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 2012 Revenues ($m) 2013 2014 2015 2016 2017 838 1292 2079 2356 2612 2891 54 61 13 11 11 AGR (%) 28 CAGR (%, 2012-2017) Market share (%) 16 22 29 29 29 29 Source: visiongain 2013 Visiongain predicts that by 2018 Eylea will have exhausted the main avenues for easily expanding its patient base, and will record more gradual growth in the second half of the forecast period in competition with Lucentis and newer approvals. Between 2018 and 2024, visiongain anticipates a CAGR of 6% (15% for the 12-year forecast period overall), with Eylea achieving 2024 revenues of $4475m, and overtaking Lucentis in 2022. By the close of the forecast period, Eylea will hold 27% of the overall market (with Lucentis on 20%). See Table 3.9 and Figure 3.8. Table 3.9 Eylea: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2024 2018 2019 2020 2021 2022 2023 2024 Revenues ($m ) 3156 3417 3617 3852 4077 4261 4475 AGR (%) 9 8 6 6 6 5 5 CAGR (%, 2018-2024) 6 CAGR (%, 2012-2024) 15 Market share (%) 29 28 28 28 28 27 27 Source: visiongain 2013 www.visiongain.com Page 53

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