1. Executive Summary
1.1 Macular Degeneration (AMD) and Diabetic Retinopathy (DR): Market Overview
1.2 Contents of this Report
1.3 Research and Analysis Methods
2. AMD and DR: Overview
2.1 The Human Eye
2.1.1 The Retina and the Vision Process
2.2 Age-Related Macular Degeneration (AMD)
2.2.1 Early Stages of AMD
2.2.2 Advanced Dry AMD (Geographic Atrophy)
2.2.3 Wet AMD
2.2.4 Causes and Risk Factors for AMD
2.3 Diabetic Retinopathy (DR)
2.3.1 Causes and Types of DR
2.3.2 Non-Proliferative Diabetic Retinopathy (NPDR)
2.3.3 Diabetic Macular Oedema (DME)
2.3.4 Proliferative Diabetic Retinopathy (PDR)
2.3.5 Risk Factors for DR
2.4 Diagnosis
2.5 Epidemiology
3. The Global AMD and DR Market 2013-2023
3.1 Global AMD and DR Market, 2013-2023
3.2 Segment Analysis, 2013-2023
3.3 Leading Products, 2012
3.4 Leading Companies, 2012
3.4.1 Novartis and Roche, 2012
3.4.2 Regeneron and Bayer, 2012
3.4.3 Pfizer and Other Big Pharma Players, 2012
3.4.4 Ophthalmic Specialists, 2012
3.4.5 Biotech Companies, 2012
3.4.6 Valeant Pharma
3.5 Leading Regional Markets, 2012-2023
3.5.1 The US Market, 2013-2023
3.5.2 The Japanese Market, 2013-2023
3.5.3 The EU5 Market, 2013-2023
3.5.4 The BRIC Nations Market, 2013-2023
4. Currently Approved Products in the AMD and DR World Drug Market, 2013-2023
4.1 Market Forecast for Existing Products, 2013-2023
4.2 Overview: Head-to-Head-to-Head - Lucentis, Eylea and Avastin for the Anti-VEGF Market, 2012
4.3 Lucentis (Roche/Novartis), 2013-2023
4.3.1 Lucentis Indications
4.3.2 Lucentis Market Performance 2011-2012
4.3.3 Drivers and Restraints for Lucentis, 2012
4.3.4 Market Forecast for Lucentis, 2013-2023
4.4 Eylea (Regeneron/Bayer), 2013-2023
4.4.1 Eylea Indications
4.4.2 Eylea Market Performance 2011-2012
4.4.3 Drivers and Restraints for Eylea, 2012
4.4.4 Market Forecast for Eylea, 2013-2023
4.5 Avastin (Roche), 2013-2023
4.5.1 The CATT Study Year Two: The Final Verdict on Avastin vs. Lucentis?
4.5.2 Drivers and Restraints for Avastin, 2012
4.5.3 Market Forecast for Avastin, 2013-2023
4.6 Other Approved Products, 2013-2023
5. Wet AMD Market, 2013-2023
5.1 Wet AMD Market Forecast, 2013-2023
5.2 Wet AMD Overview, 2012
5.3 Expanding the Anti-VEGF Treatment Options
5.3.1 Recombinant Human VEGF Receptor-Fc Fusion Protein (Chengdu Kanghong Biotech)
5.3.2 AGN-150998 DARPin (Allergan): Impressively Extended Half-Life
5.3.3 Squalamine (OHR Pharmaceutical): A Topical Option?
5.3.4 ESBA 1008 (Alcon): Innovative Fragment Technology
5.3.5 PDS 1.0 (ForSight VISION4): New Delivery Options
5.3.6 Pan-90806 (PanOptica): Preclinical Topical Approach
5.4 Treatments Targeting Other Growth Factors
5.4.1 Fovista (Ophthotech): The Next Game-Changer?
5.4.2 iSONEP (Lpath): Targeting S1P
5.5 Gene Therapies: A New Frontier in Wet AMD Treatment?
5.5.1 AVA-101(Avalanche Biotechnologies): Ocular BioFactory Technology
5.5.2 AAV2-sFLT01 (Genzyme): Will Complete Phase I in 2012
5.5.3 RetinoStat (Oxford BioMedica): Delivering Two Anti-Angiogenic Genes to the Retina
5.6 Corticosteroids: Updating an Established Approach
5.6.1 Ozurdex (Allergan): Sustained-Release Implant
5.6.2 IBI-20089 (Icon Bioscience): Clinical Possibilities in 20 Eye Diseases
5.7 Integrin Antagonists: Hitting Endothelial Cell Survival Pathways
5.7.1 Volociximab (Ophthotech): A New Option in Cancer and CNV
5.7.2 JSM6427 (Shire): From the Peptide-to-Drug Platform
5.8 Kinase Inhibitors: Targeting VEGF Upstream
5.8.1 Pazopanib (GlaxoSmithKline): Leading Kinase Inhibitor
5.8.2 AL-39324 (Alcon): Completed WALTZ Trial in 2011
5.8.3 Vatalanib (Novartis): An Angiogenesis Blocker
5.8.4 TG100801 (Sanofi): Topical Kinase Inhibitor
5.9 mTOR Inhibitors: Life After Rapamycin Termination?
5.10 Small Interfering RNAs (siRNAs): Great Promise, Little Clinical Achievement to Date
5.11 Complement Inhibitors: Blocking the Complement Cascade
5.11.1 AL-78898A (Alcon): First Ophthalmic Complement Inhibitor to be Trialled
5.11.2 ARC1905 (Ophthotech): Targeting Factor C5
5.12 Other Potential Wet AMD Treatments: A Variety of Approaches
5.12.1 Ocriplasmin (ThromboGenics): Approved in July 2012
5.12.2 LFG316 (Novartis): Phase II Completion in 2013
5.12.3 Allogeneic Stem Cells (Mesoblast): Singapore Stem Cell Trial
5.12.4 Zybrestat (Oxigene): Pro-drug with New Mechanism of Action
5.12.5 ATG-3 (CoMentis): Nicotine Cholinergic Receptor Antagonist
5.12.6 ORA102 (Ora Bio): Repurposing Old Drugs for AMD and Cancer
5.12.7 GS-101 (Gene Signal): Antisense Approach Based on Gene Discovery Innovations
6. Dry AMD Market, 2013-2023
6.1 Dry AMD Market Forecast, 2013-2023
6.2 Dry AMD Overview, 2012
6.3 Treatment for Vascular Insufficiency: A Universal Approach for Dry AMD?
6.3.1 MC-1101 (MacuCLEAR): In Phase III on Shortened FDA Approval Pathway
6.4 Complement Inhibitors: A Major R&D Approach in Dry AMD
6.4.1 AL-78898A (Alcon): Dry AMD Trial Underway in 2012
6.4.2 Soliris (Alexion): Another Dry AMD Candidate
6.4.3 FCFD4514S (Genentech): Anti-Factor D Fab Fragment
6.4.4 ARC1905 (Ophthotech): Anti-C5 Aptamer to Complete Safety Trial in 2012
6.5 Corticosteroids: Blocking Inflammatory Processes Key to Dry AMD Pathogenesis?
6.5.1 Medidur Fluocinolone Acetonide (Alimera Sciences): Phase II Trial to Conclude in 2014
6.5.2 AGN208397 (Allergan): 200 Times More Potent than Traditional Steroids
6.6 Oxidative Stress Treatments: The Only Verified Approach
6.7 Visual Cycle Modulators: Reducing Metabolic Load
6.7.1 Fenretinide (ReVision Therapeutics): Blocking Vitamin A Toxins
6.7.2 ACU-4429 (Acucela): Possible Better Side-Effect Profile than Other Visual Cycle Options
6.8 Neuroprotectants: A Key Field in R&D
6.8.1 Tandospirone (Alcon): Phase III Trial Completed 2012
6.8.2 NT501 (Neurotech): Using CNTF to Protect Retina
6.8.3 Brimonidine Tartrate (Allergan): Repurposed Glaucoma Drug
6.8.4 RN6G (Pfizer): Binding Amyloid Beta
6.8.5 VAR10200 (Varinel): Preclinical Neuroprotectant
6.9 Regenerative Medicine Treatments: Can Dry AMD be Reversed?
6.9.1 MA09-hRPE Cellular Therapy (Advanced Cell Technology): World-Leading Embryonic Stem Cell Programme
6.9.2 HuCNS-SC (StemCells): Neural Stem Cell Approach
6.9.3 Stemedyne-RPE (Stemedica Cell Technologies): Unique Ischemic-Tolerant Cell Lines
6.9.4 RetroSense Therapeutics: Piloting Optogenetics for Dry AMD
6.10 Other Products in the Dry AMD Pipeline
7. DR Market, 2013-2023
7.1 DR Market Forecast, 2013-2023
7.2 DR Overview, 2012
7.3 Anti-VEGF Treatments: Given Regulatory Approval in 2012
7.4 Corticosteroids: Longer-Acting than VEGF Blockers in DME
7.4.1 Iluvien (Alimera/pSivida): Gaining Approvals in Europe in 2012
7.4.2 Ozurdex (Allergan): Still Being Tested in DME
7.4.3 Betamethasone Microsphere (Santen): Another Novel Delivery System
7.4.4 SK-0503 (Sanwa Kagaku Kenkyusho): Possible DME and RVO Treatment
7.4.5 Cortiject (Novagali Pharma): Eyeject-Delivered Pro-drug
7.5 Integrin Antagonists: Possible DME Approach
7.5.1 SAR1118 (SARcode Bioscience): Blocking T-Cell Mediated Inflammation
7.5.2 ALG-1001 (Allegro Ophthalmics): Peptide Targeting Multiple Integrins
7.6 Angiotensin Receptor Blockers/Angiotensin-Converting Enzyme Inhibitors: Established Off-Label Treatments
7.7 A Range of Other DME Candidates are in Development
7.7.1 Vitreosolve (Innovations in Sight): Hoping to Remount Phase III Test
7.7.2 Choline Fenofibrate (Abbott): Repurposed Cholesterol Drug
7.7.3 iCo-007 Intravitreal Injection (iCo Therapeutics): Second-Generation Antisense Approach
7.7.4 Darapladib (GlaxoSmithKline): DME Applications for Atherosclerosis Candidate?
7.7.5 Bromfenac Ophthalmic Solution (ISTA Pharmaceuticals): Versatile Ophthalmic Product
8. Industry Analysis
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 in the Eye
8.7 Economic: Off-Label Treatment and Reimbursement Issues
8.8 Political: The Demography and Diabetes Time-Bombs
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
9.2.3 Treating the Root Cause of Dry AMD
9.2.4 Phase III: Endpoints and Prospects for MC-1101
9.3 Interview with Sean Ainsworth, RetroSense Therapeutics
9.3.1 The Optogenetic Approach to Vision Restoration
9.3.2 Choosing Disease Targets and Delivery Vectors
9.3.3 The Regulatory Picture
9.3.4 Gene Therapies in AMD and Other Ophthalmic Therapeutic Areas
9.3.5 The Next Ten Years for Gene Therapy
10. Conclusions
10.1 Lucentis and Eylea Will Drive Impressive Growth in the AMD and DR Market to 2023
10.2 The R&D Pipeline is Strong, with Many Novel Candidates
10.3 Dry AMD and DR Treatment Will Become Increasingly Important to the Market
10.4 Bayer Set to Become an Important Market Presence, with China a Key Market
10.5 Global Demography and Diabetes Prevalence Will Drive Market Growth
List of Tables
Table 2.1 Types of CNV in Wet AMD, Description: Approximate Proportion of Cases (%), 2012
Table 2.2 AMD and DR Diagnosis Methods, 2011
Table 2.3 Estimated AMD and DR Prevalence (m), 2010 and 2030
Table 3.1 AMD and DR Market: Revenues ($m), AGR (%), CAGR (%), 2011-2016
Table 3.2 AMD and DR Market: Revenues ($m), AGR (%), CAGR (%), 2017-2023
Table 3.3 AMD and DR Market by Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 3.4 AMD and DR Market by Segment: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 3.5 Novartis AMD and DR Product Pipeline, 2012
Table 3.6 Pfizer AMD and DR Product Pipeline, 2012
Table 3.7 Other Big Pharma Companies: AMD and DR Product Pipeline, 2012
Table 3.8 Leading National Markets in the AMD and DR Market: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 3.9 Leading National Markets in the AMD and DR Market: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 3.10 US Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 3.11 US Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 3.12 Japanese Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 3.13 Japanese Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 3.14 EU5 Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 3.15 EU5 Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 3.16 EU5 Breakdown by Country: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 3.17 EU5 Breakdown by Country: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 3.18 BRIC Nations Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 3.19 BRIC Nations Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 4.1 Leading Products in the AMD and DR Market: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 4.2 Leading Products in the AMD and DR Market: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 4.3 Lucentis, Eylea and Avastin: Comparison of Key Characteristics
Table 4.4 Lucentis Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 4.5 Lucentis Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 4.6 Eylea Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 4.7 Eylea Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 4.8 Avastin Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 4.9 Avastin Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 4.10 Other Products Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 4.11 Other Products Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 5.1 Wet AMD Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 5.2 Wet AMD Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 6.1 Dry AMD Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 6.2 Dry AMD Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
Table 7.1 DR Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2011-2016
Table 7.2 DR Market Forecast: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2017-2023
List of Figures
Figure 2.1 Leading Causes of Blindness Worldwide, Proportion of Total (%), 2010
Figure 2.2 Leading Causes of Visual Impairment (Inclusive of Blindness) Worldwide, Proportion of Total (%), 2010
Figure 2.3 Stages and Progression of AMD
Figure 2.4 Types of CNV in Wet AMD, Approximate Proportion of Cases (%), 2012
Figure 2.5 Estimated AMD and DR Prevalence (m), 2010 and 2030
Figure 2.6 Estimated AMD and DR Disease Subtype Prevalence (m), 2010 and 2030
Figure 3.1 AMD and DR Market: Revenues ($m), 2011-2023
Figure 3.2 AMD and DR Market by Segment: Revenues ($m), Market Share (%), 2011
Figure 3.3 AMD and DR Market by Segment: Revenues ($m), 2011-2016
Figure 3.4 AMD and DR Market by Segment: Revenues ($m), 2017-2023
Figure 3.5 Leading Products in the AMD and DR Market: Revenues ($m), Market Share (%), 2011
Figure 3.6 Leading Products in the AMD and DR Market: Revenues ($m), Market Share (%), 2012
Figure 3.7 Leading Companies in the AMD and DR Market: Revenues ($m), Market Share (%), 2011
Figure 3.8 Leading Companies in the AMD and DR Market: Revenues ($m), Market Share (%), 2012
Figure 3.9 Leading National Markets in the AMD and DR Market: Revenues ($m), Market Share (%), 2011
Figure 3.10 Leading National Markets in the AMD and DR Market: Revenues ($m), 2011-2023
Figure 3.11 US Market Forecast: Revenues ($m), 2011-2023
Figure 3.12 Japanese Market Forecast: Revenues ($m), 2011-2023
Figure 3.13 EU5 Breakdown: Revenues ($m), Market Share (%), 2011
Figure 3.14 EU5 Market Forecast: Revenues ($m), 2011-2023
Figure 3.15 EU5 Breakdown: Revenues ($m), 2011-2023
Figure 3.16 BRIC Nations Breakdown: Revenues ($m), Market Share (%), 2011
Figure 3.17 BRIC Nations Market Forecast: Revenues ($m), 2011-2023
Figure 4.1 Leading Products in the AMD and DR Market: Revenues ($m), 2011-2023
Figure 4.2 Drivers and Restraints for Lucentis, 2012
Figure 4.3 Lucentis Market Forecast: Revenues ($m), 2011-2023
Figure 4.4 Overview of Eylea Launch and Market Penetration, 2011-2015
Figure 4.5 Drivers and Restraints for Eylea, 2012
Figure 4.6 Eylea Market Forecast: Revenues ($m), 2011-2023
Figure 4.7 Drivers and Restraints for Avastin, 2012
Figure 4.8 Avastin Market Forecast: Revenues ($m), 2011-2023
Figure 4.9 Other Products Market Forecast: Revenues ($m), 2011-2023
Figure 5.1 Wet AMD Market Forecast: Revenues ($m), 2011-2023
Figure 6.1 Dry AMD Market Forecast: Revenues ($m), 2011-2023
Figure 7.1 DR Market Forecast: Revenues ($m), 2011-2023