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Sustained Release Ocular Drug Delivery Systems

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    April 2014

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  1. Vitrasert, launched in 1996, was the first ocular implant. It was, however, taken off the market in 2013. Only three more implants have received regulatory approval since 1996; these are Retisert, Ozurdex and Iluvien.
  2. Out of 42 sustained release ocular drug delivery systems (marketed / under development), 3 are already marketed for specific indications and 14 are in Phase II or Phase III of development.
  3. Diabetic Macular Edema (DME) will provide the much needed boost to the sustained release ocular drug delivery systems market in the short-term. The potential in the market is huge with a high target population, which is growing significantly due to the rise in cases of diabetes.
  4. In the mid to long term, the growth will be boosted by launch of sustained release systems for glaucoma and AMD. At least three companies have sustained release systems delivering prostaglandin analogues in phase II development and one in phase I/II for the treatment of glaucoma and ocular hypertension.
  5. The overall market is likely to be more than USD 1 billion in the coming decade. The opportunity could be much higher in the outer years, especially driven by the regulatory approval of implants for delivery of biologics.

Overview

Given the intricacy of the anatomy and physiology of the eye, it is quite challenging to deliver an ophthalmic drug effectively to a specific ocular site. Several barriers have to be overcome for successful ocular drug delivery. For example, dilution of a drug by tears, clearance of a drug by the lymphatic system of conjunctiva, drug permeation issues with respect to the cornea, sclera, choroid etc. Accordingly, different drug delivery systems have been devised for controlled release of drugs to various parts of the eye. Intravitreal implants for delivery of drugs to the posterior segment of the eye are already commercially available. Moreover, a number of companies are developing injectable particulate systems for controlled drug delivery to treat such diseases. This has been the primary focus for sustained delivery of drugs till date. However, industry and academia are working on novel implants, including drug-eluting contact lenses and punctal plugs, for treatment of anterior segment diseases such as glaucoma and conjunctivitis.

The ‘Sustained Release Ocular Drug Delivery Systems, 2014 - 2024’ report provides an extensive study of the emerging market of implants and particulate drug delivery systems (DDS) for ophthalmic diseases. The focus of this study is on commercial implants and those under development, their applications and the likely mid-term and long-term evolution. It is widely anticipated that the ophthalmic drug delivery systems market has tremendous potential. The sustained drug delivery systems provide improved retention time compared to topical applications and offer convenience over regular intravitreal injections, mainly for posterior eye diseases.

 

Scope of the Report

The report covers various aspects such as technological progress, product pipeline, industry and academic research programs to assess new evolving opportunities.

One of the key objectives of this report is to understand the current and future state of the ophthalmic sustained drug delivery market. This is done by analysing the following:

  • Ophthalmic sustained release drug delivery systems currently available in the market
  • Ophthalmic sustained release drug delivery systems currently in the pipeline
  • Leading technology providers and drug delivery systems developers
  • Most commonly targeted indications and drugs being delivered
  • Size of target consumer segments

The base year for the report is 2013. The report provides market forecasts for the following two time horizons: 2014 - 2019 and 2019 - 2024, respectively. We have discussed, in detail, key drivers behind the likely growth of ophthalmic drug delivery systems market. The research, analysis and insights presented in this report include the sales potential of various marketed and late stage pipeline ocular sustained drug delivery system products based on the current expected launch timelines, adoption rates and the estimated end-use price points. The figures mentioned in this report are in USD, unless otherwise specified.

Contents

Chapter 2  provides an executive summary of the insights captured in our research. The summary offers a high level view on where the ophthalmic drug delivery system market is headed in the mid-long term.

Chapter 3  provides a general introduction to the ophthalmic drug delivery market. We have discussed, in detail, anatomy of the eye, types of ocular drug delivery implants and various ocular diseases being targeted.

Chapter 4  provides an overview of the ophthalmic drug delivery systems market with respect to the available marketed technologies and companies active in the field. The analysis also extends to pipeline analysis with respect to phase of development, system type, indication targeted and drug being eluted.

Chapter 5  presents profiles of eight ophthalmic sustained release drug delivery systems with information on their technology, development history, principal features, current status of development, pricing and sales (for marketed products). We have also presented our sales forecast of each of these systems during short-mid term (2014 - 2019) and long term (2019 - 2024).

Chapter 6  reviews the leading companies which are active in the area of ophthalmology sustained release drug delivery technology. Each company profile includes information such as financial performance, marketed / pipeline ophthalmic products, recent developments and future growth plans.

Chapter 7  provides our analysis of the strengths, weaknesses, opportunities and threats in the ophthalmology drug delivery systems market, capturing the key elements likely to influence future growth.

Chapter 8  is a collection of transcripts based on our discussion with some of the leading players in the industry.

Chapter 9  summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapters 10 and 11  are appendices, which provide tabulated data and a list of companies mentioned in the report.

Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
 
2. EXECUTIVE SUMMARY
 
3. INTRODUCTION
3.1. Structure of the Eye
3.2. Ocular Drug Delivery Systems
3.2.1. Implantable Ocular Drug Delivery Systems
3.2.1.1. Types of Implants Based on Material
3.2.1.2. Types of Implants Based on Site of Implantation
3.2.2. Particulate Drug Delivery Systems
3.3. Ophthalmic Disorders
3.3.1. Age-related Macular Degeneration (AMD)
3.3.2. Cytomegalovirus (CMV) Retinitis
3.3.3. Diabetic Retinopathy
3.3.4. Diabetic Macular Edema (DME)
3.3.5. Glaucoma
3.3.6. Ocular Infection
3.3.7. Uveitis
3.3.8. Retinal Vein Occlusion
 
4. MARKET OVERVIEW
4.1. Scope
4.2. Limited Marketed Ocular Systems for Sustained Drug Delivery
4.3. pSivida is the Key Technology Provider
4.4. Pipeline Analysis
4.4.1. Five Systems in Late Stage Development
4.4.2. Nature of Drug Delivery Systems
4.4.3. Novel Implants for Ocular Drug Delivery
4.4.4. Initial Focus on Anti-Inflammatory Drugs
4.4.5. Anterior Eye Diseases: The New Focus
4.4.6. Glaucoma: The Next Big Opportunity?
4.4.7. Universities’ Interest in Ocular Sustained Drug Delivery Systems Market
4.5. Life Cycle Management Tool
4.6. Gene Therapy
 
5. PRODUCT PROFILES AND SALES FORECAST
5.1. Chapter Overview
5.2. Methodology and Assumptions
5.3. Overall Market Size and Forecast
 
5.4. Vitrasert, Bausch & Lomb, Inc.
5.4.1. Product Overview
5.4.2. Development and Approval History
5.4.3. Product Specifications
5.4.4. Product Advantages
5.4.5. Associated Risks
5.4.6. Price of the Implant
5.4.7. Discontinuation of Vitrasert
 
5.5. Retisert, Bausch & Lomb, Inc.
5.5.1. Product Overview
5.5.2. Development and Approval History
5.5.3. Product Specifications
5.5.4. Manufacturing of Retisert
5.5.5. Product Advantages
5.5.6. Associated Risks
5.5.7. Price of the Implant
5.5.8. Historical Sales
5.5.9. Sales Forecast
 
5.6. Iluvien, Alimera Sciences
5.6.1. Product Overview
5.6.2. Development and Approval History
5.6.3. Product Specifications
5.6.4. Manufacturing of Iluvien
5.6.5. Product Advantages
5.6.6. Associated Risks
5.6.7. Price of the Implant
5.6.8. Current Status of Development
5.6.9. Historical Sales
5.6.10. Competition
5.6.11. Opportunity for Iluvien
5.6.12. Sales Forecast
 
5.7. Ozurdex, Allergan
5.7.1. Product Overview
5.7.2. Development and Approval History
5.7.3. Product Specifications
5.7.4. Associated Risks
5.7.5. Current Status of Development
5.7.6. Historical Sales and Reimbursement
5.7.7. DME to Increase the Market Significantly
5.7.8. Sales Forecast
 
5.8. OTX-DP, Ocular Therapeutix
5.8.1. Product Specifications
5.8.2. Product Advantages
5.8.3. Current Status of Development
5.8.4. Phase II Clinical Trial Results
5.8.5. Competition
5.8.6. Sales Forecast
 
5.9. IBI-10090, Icon Biosciences
5.9.1. Product Specifications
5.9.2. Competition
5.9.3. Current Status of Development
5.9.4. Sales Forecast
 
5.10. DE-102, Santen Pharmaceutical
5.10.1. Product Specifications
5.10.2. Current Status of Development
5.10.3. Sales Forecast
 
5.11. Medidur, pSivida
5.11.1. Product Specifications
5.11.2. Current Status of Development
5.11.3. Competition
5.11.4. Sales Forecast
 
6. COMPANY PROFILES
6.1. Chapter Overview
 
6.2. pSivida
6.2.1. Ocular Delivery Technologies
6.2.2. Marketed and Pipeline Products
6.2.3. Financial Performance
6.2.4. Partnerships
6.2.4.1. Pfizer
6.2.4.2. Alimera Sciences
6.2.4.3. Bausch & Lomb
6.2.4.4. Enigma Therapeutics
6.2.4.5. Intrinsiq
6.2.5. Future Plans
 
6.3. Allergan
6.3.1. Marketed and Pipeline Drugs
6.3.2. Novadur Technology
6.3.3. Financial Performance
6.3.4. Partnerships
6.3.4.1. Oculex Pharmaceuticals
6.3.4.2. Sanwa Kagaku Kenkyusho
6.3.5. Ophthalmic Manufacturing Plant
6.3.6. Future Plans
 
6.4. Icon Biosciences
6.4.1. Verisome Technology
6.4.2. Advantages
6.4.3. Pipeline Products
6.4.4. Funding
6.4.5. Future Plans
 
6.5. Santen Pharmaceutical
6.5.1. Ophthalmology: Leading Marketed Drugs
6.5.2. Pipeline Products
6.5.3. CHRONIJECT Microsphere Technology
6.5.4. Partnerships
6.5.4.1. Oakwood Laboratories
6.5.4.2. Novagali Pharma
6.5.5. Manufacturing Facilities
6.5.6. Financial Performance
 
6.6. Neurotech Pharmaceuticals
6.6.1. Encapsulated Cell Technology
6.6.2. Pipeline Products
6.6.2.1. Evolution of NT-503
6.6.2.2. Development of NT-501
6.6.3. Funding
6.6.4. ECT Manufacturing Facility
6.6.5. Future Plans
 
6.7. Ocular Therapeutix
6.7.1. Hydrogel Technology
6.7.2. Marketed and Pipeline Products
6.7.3. Funding
6.7.4. Future Plans
 
7. SWOT ANALYSIS
7.1. Chapter Overview
7.2. Strengths
7.3. Weaknesses
7.4. Opportunities
7.5. Threats
 
8. INTERVIEW TRANSCRIPTS
8.1. Interview 1: Mati Therapeutics, Bob Butchofsky, Founder and CEO
8.2. Interview 2: On Demand Therapeutics, John Santini, President and CEO
8.3. Other Anonymous Respondents
 
9. CONCLUSION
9.1. Commercial Implants Are Limited; Current Adoption is Low
9.2. Ophthalmic Indications: Short and Long Term Drivers for Market Growth
9.3. Emerging Technologies
9.4. Opportunities Outweigh the Challenges
9.5. A Billion Dollar Market within a Decade
 
10. Appendix 1: Tabulated Data
 
11. Appendix 2: List of Companies and Organizations

List of Figuers

Figure 4.1 Ocular Drug Delivery Implants: Approval Timeline
Figure 4.2 Sustained Release Ocular Drug Delivery Systems: Split by Phase of Development
Figure 4.3 Sustained Release Ocular Drug Delivery System: Split by Nature of System
Figure 4.4 Sustained Release Ocular Drug Delivery Systems: Split by Target Indication
Figure 4.5 Sustained Release Ocular Drug Delivery Systems, University Research: Split by Target Indication
Figure 4.6 Lucentis Sales (USD million), 2010-2013
Figure 5.1 Overall Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Figure 5.2 Retisert Sales (USD million), 2010 - 2012
Figure 5.3 Retisert Sales Forecast: Short-Mid Term, USD Million (Base Scenario)
Figure 5.4 Retisert Sales Forecast: Long Term, USD Million (Base Scenario)
Figure 5.5 Iluvien Sales (USD), Q2 - Q4 2013
Figure 5.6 IVT Treated DME: US Market Share by Leading Drugs (%)
Figure 5.7 Iluvien Sales Forecast: Short-Mid Term, USD Million (Base Scenario)
Figure 5.8 Iluvien Sales Forecast: Long Term, USD Million (Base Scenario)
Figure 5.9 Ozurdex Development Timeline
Figure 5.10 Ozurdex Sales (USD million), 2010 – 2012
Figure 5.11 Ozurdex Sales Forecast: Short-Mid Term, USD Million (Base Scenario)
Figure 5.12 Ozurdex Sales Forecast: Long Term, USD Million (Base Scenario)
Figure 5.13 OTX-DP Sales Forecast: Short-Mid Term, USD Million (Base Scenario)
Figure 5.14 OTX-DP Sales Forecast: Long Term, USD Million (Base Scenario)
Figure 5.15 IBI-10090 Sales Forecast: Short-Mid Term, USD Million (Base Scenario)
Figure 5.16 IBI-10090 Sales Forecast: Long Term, USD Million (Base Scenario)
Figure 5.17 DE-102 Sales Forecast: Short-Mid Term, USD Million (Base Scenario)
Figure 5.18 DE-102 Sales Forecast: Long Term, USD Million (Base Scenario)
Figure 5.19 Retisert, Ozurdex and Iluvien: Percentage Share of Patients Reported to Have Developed IOP
Figure 5.20 Medidur Sales Forecast: Short-Mid Term, USD Million (Base Scenario)
Figure 5.21 Medidur Sales Forecast: Long Term, USD Million (Base Scenario)
Figure 6.1 pSivida Revenues (USD ‘000) - 2011, 2012 and 2013
Figure 6.2 Allergan: Sales for Leading Marketed Ophthalmic Drugs (USD Million), 2012
Figure 6.3 Allergan: Revenue by Business Segment, 2013 (USD Million)
Figure 6.4 Allergan Specialty Pharmaceuticals Revenues, 2013 (USD Million)
Figure 6.5 Icon Biosciences Milestone Chart
Figure 6.6 Santen: Sales of Leading Marketed Ophthalmology Drugs (JPY Million), 2013 and 2012
Figure 6.7 Santen: Revenues by Segment, 2013 (JPY Million)
Figure 6.8 Santen Pharmaceutical: Revenue by Sub-Segments (JPY Million), 2013
Figure 6.9 Neurotech Pharmaceuticals: Timeline
Figure 9.1 Sustained Release Ocular Drug Delivery Systems Market, 2014, 2019, 2024 (USD Million)

List of Tables

Table 3.1 Eye: Description of Tissue Layers
Table 4.1 Availability of Ocular Drug Delivery Implants in the US and Europe
Table 4.2 Sustained Release Ocular Drug Delivery Systems: Pipeline
Table 4.3 Sustained Release Ocular drug delivery system: Research Projects at Universities
Table 4.4 Gene Therapies under Development for Ocular Diseases
Table 5.1 Current Development Phase and Expected Launch Year of Drug Delivery Systems (Phase III and Higher)
Table 5.2 Iluvien: Status of Development
Table 5.3 Comparison of Iluvien with Currently Available Drugs for DME
Table 5.4 Vision Loss Associated with DME, Number of Patients in the US and Major EU Countries, 2012
Table 5.5 Market Potential for Iluvien in the US
Table 5.6 Approval of Ozurdex in different Geographies
Table 5.7 Ozurdex: Current Status of Development
Table 5.8 OTX-DP: Ongoing Clinical Trials
Table 5.9 IBI10090: Competitive Landscape
Table 5.10 IBI-10090 and Marketed Topicals: Comparison of Anterior Chamber Cell Count
Table 5.11 IBI-10090: Current Status of Development
Table 5.12 DE-102: Ongoing Clinical Trials
Table 5.13 Medidur: Status of Development
Table 5.14 Medidur: Competitive Landscape
Table 5.15 Medidur and Available Drugs for Posterior Uveitis: Comparative Analysis
Table 6.1 pSivida: Marketed and Pipeline Ocular Delivery Systems
Table 6.2 Allergan: Marketed and Pipeline Sustained Release Ocular Drug Delivery System
Table 6.3 Icon Biosciences: Clinical Pipeline
Table 6.4 Santen: Pipeline of Ophthalmology Drugs
Table 6.5 Neurotech Pharmaceuticals: Pipeline of Products
Table 6.6 NT-501: Orphan Drug and Fast Track Designations
Table 6.7 Ocular Therapeutix: Marketed and Pipeline Products
Table 7.1 Sustained Release Ocular Drug Delivery Systems: SWOT Analysis
Table 7.2 Development of Sustained Release Ocular Systems: Venture Capital Funding
Table 10.1 Sustained Release Ocular Drug Delivery Systems: Split by Phase of Development
Table 10.2 Sustained Release Ocular Drug Delivery Systems: Split by Nature of System
Table 10.3 Sustained Release Ocular Drug Delivery Systems: Split by Target Indication
Table 10.4 Sustained Release Ocular Drug Delivery Systems, University Research: Split by Target Indication
Table 10.5 Overall Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.6 Overall Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.7 Overall Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.8 Retisert Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.9 Retisert Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.10 Retisert Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.11 IVT Treated DME: US Market Share by Leading Drugs (%)
Table 10.12 Iluvien Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.13 Iluvien Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.14 Iluvien Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.15 Ozurdex Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.16 Ozurdex Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.17 Ozurdex Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.18 OTX-DP Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.19 OTX-DP Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.20 OTX-DP Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.21 IBI-10090 Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.22 IBI-10090 Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.23 IBI-10090 Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.24 DE-102 Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.25 DE-102 Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.26 DE-102 Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.27 Medidur Sales Forecast, 2014 - 2024, USD Million (Base Scenario)
Table 10.28 Medidur Sales Forecast, 2014 - 2024, USD Million (Conservative Scenario)
Table 10.29 Medidur Sales Forecast, 2014 - 2024, USD Million (Optimistic Scenario)
Table 10.30 pSivida Revenues (USD ‘000) - 2011, 2012 and 2013
Table 10.31 Allergan: Revenue by Business Segment (USD Million), 2012 and 2013
Table 10.32 Allergan Specialty Pharmaceuticals Revenues (USD Million), 2013
Table 10.33 Santen: Sales of Leading Marketed Ophthalmology Drugs (JPY Million), 2013 and 2012
Table 10.34 Santen: Revenues by Segment (JPY million), 2012 and 2013
Table 10.35 Santen Pharmaceutical: Revenue by Sub-Segments (JPY million), 2013

Listed Companies

The following companies have been mentioned in the report.

  1. Aciont, Inc.
  2. Alimera Sciences
  3. Allergan
  4. Alliance Medical products Inc. 
  5. Amorphex Therapeutics
  6. Apax Partners
  7. Applied Genetic Technologies Corporation
  8. Ascension Health Ventures
  9. Auritec Pharmaceuticals
  10. Avalanche Biotech
  11. Bausch & Lomb
  12. Baxter Ventures
  13. Ben Venue Laboratories
  14. Biolight Israeli Life Sciences Investments Ltd.
  15. Brandon Capital
  16. Brecon Pharmaceuticals Ltd 
  17. Burrill and Company
  18. Canaan Partners
  19. Ceregene
  20. Duke University Medical Center
  21. Enigma Therapeutics
  22. Envisia Therapeutics
  23. EOS Neuroscience
  24. Euclid Systems Corporation
  25. EVS Glaucoma Therapeutics
  26. FARMABIOS SpA / Byron Chemical Company 
  27. FDA
  28. Flextronics International Ltd 
  29. ForSight VISION 4 
  30. Genable Technologies
  31. Genentech
  32. Genzyme
  33. Graybug
  34. Hemera Biosciences
  35. Hospital Research Center, Linkoping University, 
  36. Icon Biosciences 
  37. IIT Roorkee
  38. Intrinsiq
  39. Johns Hopkins University
  40. Kyoto University, Faculty of Medicine
  41. Lonza
  42. Lux Biosciences
  43. Maryland Venture Fund
  44. Mati Therapeutics 
  45. Medical Research Commercialisation Fund (MRCF) 
  46. Merlin Biosciences
  47. MIT, Boston
  48. Morningside Technology Ventures
  49. National Eye Institute
  50. National Tsing Hua University
  51. Neurotech Pharmaceuticals 
  52. New Enterprise Associates
  53. Nishi Eye Hospital, Osaka, Japan
  54. Novagali Pharma
  55. Novartis
  56. NTU, Singapore
  57. Oakwood Laboratories
  58. OctoPlus
  59. Ocular Therapeutix
  60. Oculex Pharmaceuticals
  61. On Demand Therapeutics
  62. Oxford Biomedica
  63. Pappas Ventures
  64. Pfizer
  65. Polaris Venture Partners
  66. Polyactiva
  67. ProRetina Therapeutics
  68. pSivida
  69. QLT
  70. ReGenX Biosciences
  71. Replenish Inc
  72. RetroSense Therapeutics
  73. Roche
  74. Sanofi Aventis
  75. Santen
  76. Sanwa Kagaku Kenkyusho
  77. Sao Paulo State University
  78. School of Pharmacy, West Virginia University, USA
  79. Signet Healthcare Partners
  80. Singapore Eye Research Institute
  81. Sparta LLC
  82. Specialty Pharmaceuticals 
  83. SV Life Sciences
  84. Taiwan Liposome Company
  85. Tulane University Medical Center
  86. United Centers for Advanced Research and Translational Medicine (ART)
  87. University of California
  88. University of Colorado
  89. University of Florida
  90. University of Miami
  91. University of Nebraska
  92. University of Ottawa, Ottawa
  93. University of Pittsburgh
  94. University of Southern California
  95. University of Waterloo, Canada
  96. Valeant Ophthalmics
  97. Versant Ventures
  98. Wakefield Group
  99. Wayne State University
  100. Wellstat Ophthalmics
  101. Yuuwa Capital

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