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Sustained Release Ocular Drug Delivery Systems, 2015 - 2025 (2nd edition)

  • May 2015
  • 275 pages
  • Roots Analysis Private Ltd.
Report ID: 3024711

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INTRODUCTION
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 a successful ocular drug delivery. These include dilution of a drug by tears, clearance of a drug by the lymphatic system of conjunctiva and drug permeation issues with respect to the cornea, sclera and choroid. Approximately 95% of the drug, in topical eye drops, is lost due to the aforementioned barriers.

The widening gap between the demand of novel treatments and supply of drugs/ systems is going to provide a major impetus to the sustained release ocular drug delivery market in the coming decade. Different ocular drug delivery systems have been devised for supplying drugs effectively to various parts of the eye. Contact lenses and punctal plugs are used to deliver drugs to the anterior segment of the eye while intravitreal implants and injectable particulate systems are used for drug delivery into the posterior segment of the eye. There are both advantages and disadvantages of the existing drug delivery systems; advancements are being made to enhance ocular bioavailability and retention time of the drug.

In the past few years, these implants and inserts have become one of the key focus areas of researchers and companies alike. Several venture capital firms have backed the smaller organizations working in this field. In addition, partnerships and collaborations have played a pivotal role in the advancement of the market.

SCOPE OF THE REPORT
The ‘Sustained Release Ocular Drug Delivery Systems, 2015 – 2025 (2nd edition)’ 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 such drug delivery systems have tremendous potential as they provide improved retention time compared to topical applications and offer convenience over regular intravitreal injections, mainly for posterior eye diseases.

The report covers various aspects such as technological progress, product pipeline, target indications, industry and academic research programs to assess new evolving opportunities. We have provided a competitive spider web analysis to compare different implants based on technical parameters (drug elution rate, amount of drug delivered, life of implant etc.) and their likely user friendliness. Our opinion and insights, presented in this study, were influenced by the discussions that we conducted with different ophthalmic implant developers in this industry.

The base year for the report is 2014. The report provides market forecasts for the following two time horizons: 2015 - 2020 and 2020 - 2025. In addition to the above, we have also provided our own independent perspective on the key drivers behind the growth of this market, likely challenges and potential threats. The research, analysis and insights presented in this report include the sales potential of various marketed and late stage pipeline ocular sustained drug delivery systemsbased 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.

RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming nine years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
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 systemsmarket is headed in the short, mid and long term.

Chapter 3 provides a general introduction to the ophthalmic drug delivery market. We have discussed, in detail, the anatomy of the eye. The chapter also outlines details on different types of ocular drug delivery implants. In addition, several ocular indications, which are being targeted by sustained release implants, are also covered in this chapter.

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. We have provided a detailed pipeline of systems that are either marketed or are under clinical/ preclinical development. The chapter includes pipeline analysis by phase of development, system type, and indications targeted. It also covers the sustained release systems that are currently being evaluated by academic researchers and universities. In addition, we have also provided information on gene therapies that are being developed to provide a controlled treatment to several ocular indications.

Chapter 5 provides detailed profiles of 13 systems which are marketed and/ or arein late stages of clinical development (Phase II and Phase III). These profiles cover information on underlying technologies, development history, principal features (size of the implant, drug elution rate, life of the implant, related patents and intellectual property, nature of the insert) and current status of development. For each system, we have also estimated the future sales potential over the next ten years. Given the uncertainty surrounding the adoption rates, we have done a multivariate sensitivity analysis to present different tracks of industry’s evolution.

Chapter 6 reviews the 13 leading companies which are active in the area of ophthalmology sustained release drug delivery technology. Each company profile includes information on the company overview, financial performance, marketed / pipeline systems, fundings, partnerships, and recent developments.

Chapter 7 provides information on several investment instances which have driven research in the area of sustained release ocular drug delivery systems. These investments are a testament to the growing interest of different stakeholders in this industry.

Chapter 8 covers details on the recent partnerships which have taken place in this industry. We have discussed the various partnerships models in existence and the most common forms of deals / agreements which have evolved over time.

Chapter 9 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 10 is a collection of transcripts based on our discussion with some of the leading players in the industry. Examples of companies interviewed include Neurotech Pharmaceuticals, Mati Therapeutics, On Demand Therapeutics and Euclid Systems.

Chapter 11 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 12 and 13 are appendices, which provide tabulated data and a list of companies mentioned in the report.

EXAMPLE HIGHLIGHTS
1. More than 25 companies are currently working on developing sustained release drug delivery systems for the treatment of ocular indications. Examples of some key players include pSivida, Allergan, Ocular Therapeutix, Neurotech Pharmaceuticals, Icon BioScience and GrayBug.
2. 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.
3. Majority of the systems (52%) are in preclinical stage of development. Over 10 systems are currently undergoing late stage clinical trial studies. Once approved, these inserts are likely to provide a major impetus to the overall market.
4. DME and Uveitis will provide the much needed boost to the sustained release ocular drug delivery systems market in the short-term. In the mid to long term, the growth will be fostered by launch of sustained release systems for glaucoma and AMD. In fact, more than 15 sustained release formulations are under development for the treatment of glaucoma.
5. Interest of venture capital firms, licensing/ partnership opportunities will continue to act as key growth drivers of this market. During our research, we identified several instances where venture capitalists and other strategic investors have actively supported the research efforts.
6. The overall market is likely to be more than USD 6.5 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.

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