1. Report Overview

1.1 Why You Should Read This Report

1.2 How This Report Delivers

1.3 Main Questions Answered by This Analysis

1.4 Who Is This Study For?

1.5 Methods of Research and Analysis

1.6 Frequently Asked Questions (FAQs)

1.7 Some Associated Reports

1.8 About Visiongain

2. World AMD and Other Disease Market, 2016

2.1 What are Retinal Diseases?

2.2 Types of Retinal Diseases

2.3 Diagnostics and Treatments for AMD and Other Retinal Diseases

2.4 Nearly 200 Million People with AMD?

2.5 Over 100 Million with DR

2.6 First RVO Estimates Suggest Patient Population of 16 Million

2.7 Market to Make Rapid Pace to 2027

2.8 Eylea Stood as the Leading Drug in the Market

2.9 Regeneron the Leading Presence in the Market

2.10 Which are the Most Significant Disease Areas for the Market?

3. Retinal Disease Market Subsectors, 2016

3.1 Wet AMD Still the Main Source of Revenue in the Market

3.2 Wet AMD: Angiogenic Processes Offer Well-Defined Drug Targets

3.2.1 Revenue Forecasting for Wet AMD segment, 2016-2027

3.3 Dry AMD: Unmet Need to Arrest or Reverse Damage to RPE

3.3.1 Dry AMD Segment to Emerge in the Forecast Period

3.4 DR: Coming Into Clinical Focus, with DME the Main Target

3.4.1 Segment to Grow in Importance as Diabetes Epidemic Continues

3.5 Lucentis and Eylea Label Extensions Highlight Possibilities in Other Disease Areas

3.6 Projections for All Segments, 2016-2027

4. Approved Products in the AMD and Other Retinal Diseases Market, 2016-2027

4.1 Will the Current Products Dominate the Market Through 2027?

4.2 Lucentis: Second Leading Drug in the Market

4.2.1 Positive Revenue Growth Shown in Past: 2012-2016

4.2.2 Shadow of Avastin Still Hangs Over Lucentis

4.2.3 CATT Study Results: Clinical Differences Still Have Yet to Emerge

4.2.4 Eylea: The Bigger Threat to Lucentis?

4.2.5 Extending the Label, Widening the Battleground: Lucentis Moves Into DME and Beyond

4.2.6 Improving Cost and Compliance for Lucentis

4.2.7 Lucentis Revenue Forecast 2016-2027

4.2.8 Will Loss of Physician Goodwill Harm Lucentis’ Growth?

4.3 Eylea: Holds the Throne?

4.3.1 Increasing Revenue Growth in Past: Outside US Sale Amplified

4.3.2 VIEW 1 and VIEW 2: Is Eylea Superior or Just Non-Inferior to Lucentis?

4.3.3 First Wave of Eylea’s Expansion Finally Beginning to Break?

4.3.4 Eylea into DME and Other New Indications

4.3.5 Eylea Revenue Forecast 2016-2027

4.3.6 How Far Can Eylea’s Momentum Carry It?

4.4 Avastin: No Formal wAMD Approval but Still the Most-Used Product

4.4.1 Past Revenue illustrates Increasing Use of Avastin for wetAMD

4.4.2 Judicial Review Averted in the UK by Price Adjustment

4.4.3 Multiple Attempts to Block Off-Label Avastin Since 2007

4.4.4 Roche and Novartis Challenge CATT’s Headline Conclusions

4.4.5 Will Eylea/Zaltrap Affect Avastin’s Place in the Market?

4.4.6 Avastin Revenue Forecast, 2016-2027

4.4.7 Will Anything Dislodge Avastin from its Central Position?

4.5 Visudyne (Valeant/Novartis): Declining Sales throughout the Forecast Period

4.5.1 Visudyne Revenue Forecast, 2016-2027

4.6 Jetrea (ThromboGenics/Novartis): Disappointing Launch in 2013

5. Pipeline for Wet AMD Segment, 2016-2027

5.1 The Leading Pipeline Candidates

5.2 Fovista (Ophthotech Corporation/ Novartis): The Next Big Thing?

5.2.1 Three Phase 3 Trials to Confirm Fovista’s Outstanding Phase 2 Results

5.2.2 Ophthotech Goes Public to Fund Phase 3 Effort

5.2.3 Ophthotech Partners with Novartis for Fovista

5.2.4 Improving Angiogenesis Inhibition by Blocking Pericyte Recruitment

5.2.5 The Move toward Combination Therapies

5.2.6 Biosmiliars of Lucentis: FYB201 & PF-582

5.2.7 TK001/sevacizumab (Jiangsu T-Mab Biopharma)‘s recombinant humanized anti-VEGF monoclonal antibody

5.2.8 Roche’s RG7716 (RO-6867461), an anti- VEGF A monoclonal antibody

5.2.9 Opthea’s OPT-302, a VEGFR inhibitor

5.2.10 Daiichi Sankyo’s DS7080, an angiogenesis inhibitor

5.3 Other Growth Factor Targets in the Pipeline

5.3.1 Squalamine (OHR Pharmaceutical): Combination Targeting in a Single Eyedrop

5.3.2 Allergan and Molecular Partners: Preclinical DARPin Hits VEGF and PDGF

5.3.3 NT-506 (Neurotech Pharmaceutical): Sustained-Release VEGF/PDGF Options

5.3.4 Regeneron’s REGN910-3 (Nesvacumab + Aflibercept) and REGN910 (Nesvacumab)

5.3.5 iSONEP (Lpath): Pfizer Interested in Anti-S1P Monoclonal Antibody

5.4 Conbercept (Chengdu Kanghong Biotech): Launched in China for wAMD

5.4.1 A Chinese Competitor: Where Will Conbercept Fit In?

5.4.2 Binding Affinity Comparable to Eylea

5.5 Do We Need New Anti-VEGFR Agents or Delivery Systems?

5.5.1 Abicipar Pegol (Allergan): Novel Protein with Extended Half-Life

5.5.2 Brolucizumab (Alcon): Single-Chain Monoclonal Antibody Fragment

5.5.3 PDS 1.0 (ForSight Vision4): A New Option for Lucentis Delivery

5.5.4 NT-503 (Neurotech): New Delivery Platform for Anti-VEGF Agent

5.5.5 Pan-90806 (PanOptica): Anti-VEGF Eyedrop

5.5.6 Iontophoretic Delivery: EyeGate Pharmaceuticals Leading the Way

5.6 Novel Delivery Systems to Rejuvenate Anti-Inflammatory Approaches

5.6.1 Verisome System and IBI-30089 (Icon Bioscience)

5.7 Other Targets Under Investigation in wAMD Drug Development

5.7.1 Are Kinase Inhibitors Still a Going Concern in wAMD?

5.7.2 Pazopanib (GlaxoSmithKline) and TG100801 (Sanofi): Two Eyedrop Kinase Inhibitors Drop Out of the Running

5.7.3 X-82 Pill (Tyrogenex): Dual Kinase Inhibitor

5.7.4 Factor C5: A More Promising Target Addressed by Zimura (Ophthotech) and LFG316 (Novartis)

5.7.5 Integrins: Another Blockable Component of the Neovascularisation Cascade?

5.7.6 Luminate (Allegro Ophthalmics): Novel Anti-Integrin Oligopeptide

5.7.7 SF0166 (SciFluor Life Sciences): an integrin αvβ3 inhibitor for Wet AMD

5.7.7 Jetrea (ThromboGenics/Novartis): Can Pharmacologic Vitreolysis Help wAMD Patients?

5.7.8 Novel Anti-Angiogenic Treatments in Development: Ora Bio’s ORA102 and CoMentis’ ATG003

5.7.9 Zybrestat (Mateon Therapeutics Oxigene, formerly OxiGENE): New Mechanism of Action Offers Way to Disrupt Neovascularisation

5.7.10 Alcon’s LMG324 and LHA510 for wAMD

5.7.11 hI-con1 (Iconic Therapeutics), VII-IgGFc chimeric protein targeting tissue factor

5.7.12 Synthetic Biologics: Oligonucleotides and SiRNAs for wAMD

5.8 Regenerative Medicine Approaches

5.8.1 Allogeneic Stem Cells (Mesoblast): Potential Synergistic Treatment for Use alongside Lucentis

5.8.2 AVA-101 and AVA-201(Avalanche Biotechnologies): Ocular BioFactory for wAMD

5.8.3 RetinoStat (Oxford BioMedica): LentiVector Technology to Deliver Anti-Angiogenic Genes

5.8.5 Gene Therapy (RGX-314) for Neovascular AMD

5.8.6 Stem cell therapy with Pfizer’s PF05206388

5.8.7 Diffusion Pharmaceuticals’ Palomid-529

5.8.8 MT-0814 (Mitsubishi Tanabe Pharma), CC chemokine receptor 3 antagonist for AMD

5.8.9 Undisclosed MoA of Boehringer Ingelheim’s BI 144807 for Wet AMD

6. Pipeline for Dry AMD Segment, 2016

6.1 Who Will Achieve the Big Breakthrough in Dry AMD?

6.2 MC-1101 (MacuCLEAR): Leading the Pack?

6.2.1 Increasing Choroidal Blood Flow with Repurposed Product

6.2.2 Novel Endpoints in Phase 3 Study

6.2.3 Can MacuCLEAR Make It?

6.3 ACU-4429 (Acucela): Visual Cycle Modulator in Phase 3

6.3.1 Disappointing results of Phase 2/3 trial

6.4 High Hopes for Complement Inhibition in Dry AMD

6.4.1 Lampalizumab (Roche): The Big News of ARVO 2013

6.4.2 MAHALO Study Indicates GA Progression Slowed by Lampalizumab

6.5 Corticosteroids: Targeting Inflammation’s Role in Dry AMD Pathogenesis

6.5.1 Iluvien (Alimera Sciences): Study terminated

6.5.2 AGN208397 (Allergan): New Potent Steroid Expected to Undergo Trials in Dry AMD

6.6 Neuroprotection: One of Modern Medicine’s Holy Grails

6.6.1 Tandospirone (Alcon): Not effective in GA

6.6.2 Neurotech’s Renexsus: Possibly Promising Data in Dry AMD Studies

6.6.3 Novadur (Allergan): Possible Efficacy with Longer Duration of Action

6.7 Regenerative Medicine: Dry AMD One of the Biggest Disease Targets

6.7.1 MA09-hRPE Cellular Therapy (Ocata Therapeutics): Signs of Efficacy in Landmark ESC Human Trial

6.7.2 HuCNS-SC (StemCells): Leading Company in Neural Stem Cell Space

6.7.3 Stemedyne-RPE (Stemedica Cell Technologies): Low-Oxygen Cells for Dry AMD Repair

6.7.4 OpRegen (Biotime): Stem Cell leader with Dry AMD Interests

6.7.5 First iPSC Trial in Japan in Dry AMD Patients

6.7.6 Ophthotech’s Zimura for Geographic Atrophy

6.7.7 Gene Therapies Less Prominent Than Stem Cells in Dry AMD

6.8 Other Treatments for Dry AMD

7. Pipeline for Diabetic Retinopathy Segment, 2016

7.1 Ozurdex/Posurdex (Allergan): Approved for General DME Patient Population

7.2 Lucentis: The Game Changer for DR?

7.3 New Anti-VEGF Additions

7.3.1 Is Eylea Better than Lucentis and Avastin for DME?

7.4 Steroids in Development for DR

7.4.1 Iluvien (Alimera/pSivida): New Option in European Markets

7.4.2 A New Hope? Optina (Ampio Pharmaceuticals)

7.4.3 Betamethasone Microsphere (Santen): Late-Stage Steroid Candidate

7.4.4 Clearside Biomedical’s CLS-TA/ CLS1004

7.4.5 IBI-20089 (Icon Bioscience): Sustained-Release Formulation of Triamcinolone Acetonide

7.4.6 Kala Pharmaceuticals’ KPI-121

7.5 Other Products in Development for DR

7.5.1 Angiotensin Receptor Blockers/Angiotensin-Converting Enzyme Inhibitors: Some Off-Label Validation

7.5.2 Vitreosolve (Innovations in Sight): Will a Phase 3 Trial Be Initiated?

7.5.3 TriLipix (Abbott): No New Development for Promising Drug

7.5.4 Jetrea (ThromboGenics /Novartis): Possibilities in DME?

7.5.5 SF0166 (SciFluor Life Sciences): an integrin αvβ3 inhibitor for DME

7.5.6 Pan-90806 (PanOptica): Anti-VEGF Eyedrop

7.5.7 Teprotumumab (Horizon Pharma): an insulin-like growth factor-1 receptor antagonist

7.6 Undisclosed MoA of Boehringer Ingelheim’s BI 1026706 for DME

8. Regional Market Breakdown, 2016

8.1 Which Markets Hold the Most Revenue Growth Potential?

8.2 The US: Leading Market for Retinal Diseases

8.3 Japan: Strong Market Potential

8.4 EU5: Ageing Populations to Drive Market Growth

8.5 BRIC Nations: The Biggest Growth Driver for the Market

9. Qualitative Industry and Market Analysis, 2017-2027

9.1 Strengths: The Most Dynamic Area of the Ophthalmics Market

9.2 Weaknesses: Heavily Dependent on Anti-VEGF Approach

9.3 Opportunities: New Markets and R&D Synergies

9.4 Threats: Prevention and Management Better Than Drug Treatment for Dry AMD and DR?

9.5 Social: Low Diagnosis, Low Compliance

9.6 Technological: Innovation for the Eye

9.7 Economic: Off-Label Treatment and Reimbursement Issues

9.8 Political: The Demography and Diabetes Challenges

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

Associated Visiongain Reports

Glossary

Visiongain Report Sales Order Form

About Visiongain

Report Evaluation Form

List of Figures

Figure 2.1 Overall World AMD and Other Retinal Diseases Pharmaceutical Market Forecast: Revenue ($bn), 2016-2027

Figure 2.2 Market Breakdown by Product Revenue ($bn), Market Share (%), 2016

Figure 2.3 Market Breakdown by Company: Market Share (%), 2016

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 3.1 Market Breakdown by Disease Segment: Revenues ($bn), 2016

Figure 3.2 Market Breakdown by Disease Segment: Market Share (%), 2016

Figure 3.3 Wet AMD Segment Forecast: Revenue ($bn), 2016-2027

Figure 3.4 Dry AMD Segment Forecast: Revenue ($bn), 2016-2027

Figure 3.5 DR Segment Forecast: Revenue ($bn), 2016-2027

Figure 3.6 Retinal Diseases Market Breakdown by Segment: Revenue ($bn), 2016-2027

Figure 3.7 Retinal Diseases Market Breakdown by Segment: Revenue ($bn), 2016, 2021 and 2027

Figure 3.8 Market Breakdown by Disease Segment: Market Share (%), 2021

Figure 3.9 Market Breakdown by Disease Segment: Market Share (%), 2027

Figure 4.1 Market Breakdown by Product: Revenue ($bn), Market Share (%), 2021

Figure 4.2 Market Breakdown by Product: Revenue ($bn), Market Share (%), 2027

Figure 4.3 Market Forecast by Product: Revenue ($bn), 2016-2027

Figure 4.4 Market Breakdown by Product: Revenue ($bn), 2016, 2021 and 2027

Figure 4.5 Lucentis: Revenues Forecast ($bn), 2016-2027

Figure 4.6 Drivers and Restraints for Lucentis, 2016

Figure 4.7 Eylea Forecast: Revenue ($bn), 2016-2027

Figure 4.8 Drivers and Restraints for Eylea, 2016

Figure 4.9 Avastin Forecast: Revenue ($bn), 2016-2027

Figure 4.10 Drivers and Restraints for Avastin, 2016

Figure 4.11 Visudyne Forecast: Revenues ($bn), 2016-2027

Figure 8.1 Regional Breakdown: Revenue ($bn), 2016-2027

Figure 8.2 Regional Breakdown: Revenue ($bn), 2016, 2021 and 2027

Figure 8.3 Regional Market Share (%), 2016

Figure 8.4 Regional Market Share (%), 2021

Figure 8.5 Regional Market Share (%), 2027

Figure 8.6 US Market: Revenue ($bn), 2016-2027

Figure 8.7 Japan: Revenue ($bn), 2016-2027

Figure 8.8 EU5: Grouped Revenue ($bn), 2016-2027

Figure 8.9 EU5 Breakdown Forecasts: Revenue ($bn), 2016-2027

Figure 8.10 EU5 Breakdown: Market Share (%), 2016

Figure 8.11 EU5 Breakdown: Market Share (%), 2021

Figure 8.12 EU5 Breakdown: Market Share (%), 2027

Figure 8.13 BRIC Nations Forecast: Grouped Revenue ($bn), 2016-2027

Figure 8.14 BRIC Nations Forecasts: Revenue ($bn), 2016-2027

Figure 8.15 Market Share (%) within BRIC Group by Country, 2016

Figure 8.16 Market Share (%) within BRIC Group by Country, 2021

Figure 8.17 Market Share (%) within BRIC Group by Country, 2027

List of Tables

Table 1.1 Retinal Diseases Market Forecasts by Segment: Revenue ($bn), AGR (%), CAGR (%), 2016-2021

Table 1.2 Retinal Diseases Market Forecasts by Segment: Revenue ($bn), AGR (%), CAGR (%), 2021-2027

Table 2.1 Overall World AMD and Other Retinal Diseases Pharmaceutical Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 2.2 Market Breakdown by Product: Revenue ($bn), Market Share (%), 2016

Table 3.1 Market Breakdown by Disease Segment: Revenue ($bn), Market Share (%), 2016

Table 3.2 Types of CNV in Wet AMD, Description: Approximate Proportion of Cases (%), 2016

Table 3.3 Wet AMD Segment Forecast: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2027

Table 3.4 Dry AMD Segment Forecast: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2027

Table 3.5 DR Segment Forecast: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2027

Table 3.6 Retinal Diseases Market Forecasts by Segment: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 3.7 Retinal Diseases Market Forecasts by Segment: Revenue ($bn), Market Share (%) for 2016, 2021 and 2027

Table 4.1 Major Retinal Drugs Market Forecast: Revenue ($bn), CAGR (%) for 2016-2027

Table 4.10 Avastin Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 4.3 Market Breakdown by Product: Revenue ($bn), Market Share (%), 2027

Table 4.4 Lucentis: Revenue ($bn), AGR (%), 2012-2016

Table 4.5 Lucentis, Eylea and Avastin: Comparison of Reported Characteristics

Table 4.6 Lucentis: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 4.7 Eylea: Revenue ($bn), AGR (%), 2013-2016

Table 4.8 Eylea Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 4.9 Avastin: Revenue ($bn), AGR (%), 2012-2014

Table 4.11 Visudyne Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 4.2 Market Breakdown by Product: Revenue ($bn), Market Share (%), 2021

Table 5.1 Selected R&D Pipeline (Phase 3) for wAMD, 2016

Table 5.2 Selected R&D Pipeline (Phase 2 & 1/2) for wAMD, 2016

Table 5.3 Selected R&D Pipeline (Phase 1) for wAMD, 2016

Table 6.1 Selected R&D Pipeline (Phase 2 & 3) for Dry AMD, 2016

Table 6.2 Selected R&D Pipeline (Phase 2 & 3) for Dry AMD, 2016

Table 7.1 Selected R&D Pipeline (Phase 2 & 3) for Diabetic Retinopathy, 2016

Table 7.2 Selected R&D Pipeline (Phase 1 & !/2) for Diabetic Retinopathy, 2016

Table 8.1 Regional Breakdown: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 8.1 Regional Breakdown: Revenue ($bn), AGR (%), CAGR (%), 2016-2027 (continued)

Table 8.2 US Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 8.3 Japan Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 8.4 EU5 Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 8.5 BRIC Nations Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2027

Table 9.1 Strengths and Weaknesses in the AMD and Other Retinal Diseases Market, 2016

Table 9.2 Opportunities and Threats in the AMD and Other Retinal Diseases Market, 2016

Table 9.3 Social, Technological, Economic and Political Factors Influencing the AMD and Other Retinal Diseases Pharmaceutical Market (STEP Analysis), 2016-2027