INTRODUCTION A significant proportion of the world’s population is suffering from otologic diseases. Absence of any disease modifying drugs is a big unmet need in the market. The current treatment of inner ear diseases is primarily based on counselling, electric and magnetic nerve stimulations. At the same time, there is a growing off-label use of drugs for symptomatic relief. Cochlear implants, brainstem implants and hearing aids are other commonly available options to the patients to overcome hearing damages. However, these options do suffer from several limitations such as high cost, poor sound quality, and painful surgeries (in case of implants). The widening gap between the demand and supply of drugs is likely to provide a major impetus to the market in the coming decade. The drugs for direct delivery to inner ear are currently under development and, once approved, are likely to gain a major share of the market.
Direct drug delivery to the inner ear is difficult due to the complex labyrinthine structure of the ear. However, with growing advances in technology and the increasing demands for specific drugs, direct inner ear drug delivery has become one of the key focus areas of researchers and companies across the world. The industry and university sponsored research is aimed at improving the current treatment regime and increasing the concentration of the drug in the inner ear for a promising treatment of otologic diseases. Specifically, intratympanic and intracochlear drug delivery routes are being explored by several stakeholders to devise efficient drug delivery strategies.
Cochlear implants (the only robust option currently available for permanent hearing loss) have also garnered increased attention worldwide. There are currently four established players: Cochlear Ltd., MED-EL, Advanced Bionics and Neurelec. However, the market is gradually opening up and newer players such as China‘s Hangzhou Nurotron have made efforts to come up with cost efficient implants. In addition, the industry has witnessed significant technological advancements with the introduction of water proof speech processors, prolonged battery life and compatibility with remote assistant. ‘Bio-Active’ drug eluting cochlear implants are also anticipated to be available in the market in the near future.
SCOPE OF THE REPORT The ‘Inner Ear Diseases: Novel Drug Delivery Approaches, 2014 - 2025’ report provides an extensive study of the emerging market of drugs and cochlear implants for otologic diseases. The focus of this study is primarily on the drugs targeting inner ear diseases delivered through intratympanic and intracochlear routes; these drugs provide improved retention time, increase patient compliance, lower treatment cost and offer numerous other advantages. The report covers various aspects such as research pipeline (both industry and academia), technological improvements, sales potential and competitive landscape to assess new evolving opportunities. The study also identifies cochlear implants which are currently available in the market. We have provided a competitive spider web analysis to compare the various implants based on technical parameters (electrode length, electrode contact points etc.) and their user friendliness.
One of the key objectives of this report is to understand the current and future state of the recent advances in drugs and devices for inner ear diseases market. This is done by analyzing the following: - Drugs for inner ear delivery currently in the pipeline - Size of target consumer segments - Frequency of drug injections per year - Variable price points - Surgical intervention rates
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 base year for the report is 2014. The report provides market forecasts for the period 2014 - 2025. The figures mentioned in this report are in USD, unless otherwise specified.
EXAMPLE HIGHLIGHTS 1. More than 40 drugs are in clinical trials for various inner ear diseases through different routes of administration (both direct and indirect); the companies have now started to realize the potential of this market. 2. Specifically, drugs delivered directly to the inner ear offer sustained release of the drug increasing the overall efficacy. Currently, there are no marketed drugs yet; however, the pipeline is rich with over 20 molecules in various stages of development. 3. The first batch of drugs for direct inner ear delivery are anticipated to be launched in 2017; post this, we expect the market to grow at a healthy annualized rate of 96.7% during 2017 – 2025. 4. Auris Medical is the key leading player, with two of its drugs (AM-101 and AM-111) in late stage clinical trial studies. Other examples include Synphora AB, Orbis Biosciences, O-Ray Pharma, Quark Pharma, Otonomy and Sound Pharmaceuticals. Overall, we have identified 12 companies working in this area. 5. With regards to the cochlear implants, the market is extremely consolidated; in 2013, Cochlear Ltd. captured over 50% of the total market (in terms of number of units sold). We expect the overall market to grow at an annualized rate of 7.49% from 2014-2025.
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. It offers a high level view on the current scenario of the market of inner ear drugs and devices and the likely mid-long term evolution.
Chapter 3 provides a general overview of inner ear diseases such as tinnitus, sensorineural hearing loss, meniere’s disease, drug induced ototoxicity etc. This section also provides an introduction to the implants (middle ear implants, cochlear implants, brainstem implants) currently available in the market. We have also discussed the various routes of administration of the drug to the inner ear; this includes systemic, intratympanic and intracochlear routes of drug delivery.
Chapter 4 offers an extensive pipeline of all the inner ear drugs that are being developed by a number of companies and academic institutions. We have also covered details of the current treatment regime for various inner ear diseases such as tinnitus, meniere’s diseases and sensorineural hearing loss.
Chapter 5covers the drugs which are under development for direct inner ear delivery. The pipeline analysis includes information on the phase of development, nature of drugs, targeted indications etc. The chapter also includes detailed profiles of drugs which are currently in clinical trials; covering information on underlying technology, development history, principal features, current status of development and likely future sales potential.
Chapter 6 provides case studies on four affiliated companies (Orbis Biosciences, Autifony Therapeutics, AudioCure and Sensorion Pharmaceuticals) outlining their current focus and unique technology / platform features.
Chapter 7 focuses on cochlear implants. We have included detailed company profiles of the manufacturers of these implants. These profiles cover the company’s product portfolio, financial information, sales of cochlear implants (wherever available), relevant partnerships, manufacturing facilitiesand respective future outlooks. We have also provided a sales forecast of cochlear implants over the next ten years.
Chapter 8 is a collection of transcripts based on our discussion with some of the upcoming players in the industry such as AudioCure, Orbis Biosciences, Autifony Therapeutics and Sensorion Pharmaceuticals.
Chapter 9 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and a brief description of some of the emerging technologies that are expected to invade the market in future.
Chapters 10 and 11 are appendices, which provide the list of companies and tabulated data for all the figures presented in the report.
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