Inner Ear Diseases: Novel Drug Delivery Approaches

Categories: Drug Delivery, Pharmaceuticals

Price: $1,899

Description

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.

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.

Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INNER EAR: AN INTRODUCTION
3.1. Chapter Overview
3.2. Structure of the Ear
3.2.1 Outer Ear
3.2.1.1 Auricle
3.2.1.2 Ear Canal
3.2.1.3 Tympanic Membrane
3.2.2 Middle Ear
3.2.3 Inner Ear
3.2.3.1 Semicircular Canal
3.2.3.2 Vestibule
3.2.3.3 Cochlea
3.3. Inner Ear Diseases
3.3.1. Meniere’s Disease
3.3.2. Sensorineural Hearing Loss
3.3.3. Labyrinthitis
3.3.4. Auto-Immune Inner Ear Disease (AIED)
3.3.5. Vestibular Neuritis
3.3.6. Benign Paroxysmal Positional Vertigo (BPPV)
3.3.7. Tinnitus
3.3.8. Ototoxicity
3.3.9. Noise-Induced Hearing Loss
3.4. Inner Ear Drug Delivery
3.4.1. Systemic Drug Delivery
3.4.2. Intratympanic Drug Delivery
3.4.3. Intracochlear Drug Delivery
3.5. Types of Implants
3.5.1. Cochlear Implants
3.5.2. Other Implants

4. INNER EAR DRUG DELIVERY: PIPELINE ANALYSIS
4.1. Chapter Overview
4.2. Industry Sponsored Drugs for Inner Ear Diseases
4.2.1. Drugs for Inner Ear Diseases: Distribution by Phase of Development
4.2.2. Drugs for Inner Ear Diseases: Distribution by Indication
4.2.3. Drugs for Inner Ear Diseases: Distribution by Nature of Drug
4.2.4. Drugs for Inner Ear Diseases: Distribution by Route of Administration
4.3. Academic Research on Inner Ear Diseases
4.3.1. Drugs for Inner Ear Diseases
4.3.2. Nanoparticles for Inner Ear Diseases
4.3.3. Gene Therapy/ Stem Cells for Inner Ear Diseases
4.4. Current Treatment Regimen
4.4.1. Tinnitus
4.4.2. Meniere’s Disease
4.4.3. Sensorineural Hearing Loss

5. DIRECT DRUG DELIVERY TO INNER EAR: INTRATYMPANIC, INTRACOCHLEAR, TRANSTYMPANIC AND INTRALABYRINTHINE ROUTES OF DELIVERY
5.1. Chapter Overview
5.2. Direct Drug Delivery to Inner Ear: Current Pipeline
5.2.1. Two Drugs in Late Stage Development
5.3. Direct Drug Delivery to Inner Ear: Nature of Drugs
5.4. Direct Drug Delivery to Inner Ear: Targeted Indications
5.5. Direct Drug Delivery to Inner Ear: Route of Delivery
5.6. Direct Drug Delivery to Inner Ear: Sales Forecast, 2014 - 2025
5.6.1. Scope and Forecast Methodology
5.6.2. Overall Market Size and Forecast
5.7. Drug Profiles
5.7.1. AM-101, Auris Medical Holding AG
5.7.1.1. Product Specifications
5.7.1.2. History of Development
5.7.1.3. Current Status of Development
5.7.1.3.1. Post Acute Tinnitus
5.7.1.3.2. Acute Tinnitus
5.7.1.4. Phase II Clinical Trial Results
5.7.1.5. Sales Forecast 2014-2025
5.7.2. AM-111, Auris Medical Holding AG
5.7.2.1. Product Specifications
5.7.2.2. History of Development
5.7.2.3. Current Status of Development
5.7.2.4. Phase II Clinical Trial Results
5.7.2.5. Sales Forecast, 2014-2025
5.7.3. Latanoprost, Synphora AB
5.7.3.1. Product Specifications
5.7.3.2. Current Status of Development
5.7.3.3. Phase II Clinical Trial Results
5.7.3.4. Sales Forecast, 2014-2025
5.7.4. OTO-104, Otonomy
5.7.4.1. Product Specifications
5.7.4.2. History and Current Status of Development
5.7.4.3. Phase II Clinical Trial Results
5.7.4.4. Sales Forecast, 2014-2025
5.7.5. CGF166, Novartis and GenVec
5.7.5.1. Product Specifications
5.7.5.2. History and Current Status of Development
5.7.5.3. Preclinical Trial Results
5.7.5.4. Sales Forecast, 2014-2025
5.8. Direct Drug Delivery to Inner Ear: Roots Analysis’ Perspective

6. CASE STUDIES
6.1. Introduction
6.1.1. Orbis Biosciences
6.1.2. Autifony Therapeutics
6.1.3. AudioCure
6.1.4. Sensorion Pharma

7. COCHLEAR IMPLANTS (BIONIC EARS)
7.1. Introduction
7.1.1. History of Cochlear Implants
7.1.2. Working of a Cochlear Implant
7.1.3. Candidacy for a Cochlear Implant
7.2. Cochlear Implants: Current Market Landscape
7.2.1. Comparative Analysis of Cochlear Implants
7.3. Cochlear Implants: Sales Forecast, 2014-2025
7.3.1. Forecast Methodology
7.3.2. Overall Market Size and Forecast
7.4. Key Company Profiles
7.4.1. Cochlear Limited
7.4.1.1. Financial Information
7.4.1.2. Cochlear Implants: Historical Sales
7.4.1.3. Product Portfolio: Nucleus 5, 6, Hybrid and Other Implant Systems
7.4.1.4. Partnerships
7.4.1.5. Manufacturing Facility
7.4.1.6. Future Outlook
7.4.2. Med-El
7.4.2.1. Product Portfolio: EAS, Maestro, Synchrony and Other Implant Systems
7.4.2.2. Partnerships
7.4.2.3. Manufacturing Facilities
7.4.2.4. Future Outlook
7.4.3. Advanced Bionics (Acquired by Sonova Holding Ag)
7.4.3.1. Company Overview
7.4.3.2. Financial Information
7.4.3.3. Product Portfolio: HiRes90K and HiRes90K Advantage
7.4.3.4. Partnerships
7.4.3.5. Manufacturing Facilities
7.4.3.6. Future Outlook
7.4.4. Neurelec SA (Acquired by William Demant Holding)
7.4.4.1. Financial Information
7.4.4.2. Product Portfolio: Digisonic SP and Digisonic SP Binaural
7.4.4.3. Other Products
7.4.4.4. Partnerships
7.4.4.5. Future Outlook
7.4.5. Hangzhou Nurotron Biotechnology
7.4.5.1. Product Portfolio
7.4.5.2. Partnerships
7.4.5.3. Manufacturing Facilities
7.4.5.4. Future Outlook
7.5. Competitive Landscape
7.6. Cochlear Implants: Roots Analysis’ Perspective

8. INTERVIEW TRANSCRIPTS
8.1. Prof. Hans Rommelspacher, CEO, AudioCure Pharma
8.2. Dr. Laurent Nguyen, CEO, Sensorion Pharma
8.3. Maria Flynn, President and CEO& Nathan Dormer, Director of Formulation Sciences, Orbis Biosciences
8.4. Barbara Domayne-Hayman, Chief Business Officer, Autifony Therapeutics

9. CONCLUSION
9.1. Otologic Indications: Drivers for Market Growth
9.2. Intratympanic and Intracochlear Drug Delivery to Play A Key Role in the Future
9.3. Market Landscape will Continue to Evolve
9.4. Emerging Technologies
9.5. Direct Inner Ear Drug Delivery: Overall Opportunity is Big; A Billion Dollar Market Within a Decade

10. APPENDIX 1: TABULATED DATA

11. APPENDIX 2: LIST OF COMPANIES

List of Figures:
Figure 4.1 Industry Sponsored Inner Ear Drugs: Distribution by Phase of Development
Figure 4.2 Industry Sponsored Inner Ear Drugs: Distribution by Target Indication
Figure 4.3 Industry Sponsored Inner Ear Drugs: Distribution by Nature of Drug
Figure 4.4 Industry Sponsored Inner Ear Drugs: Distribution by Route of Administration
Figure 4.5 Academia Sponsored Inner Ear Drugs: Distribution by Route of Administration
Figure 4.6 Academia Sponsored Inner Ear Drugs: Distribution by Target Indication
Figure 5.1 Inner Ear Drug Developers: Number of Drugs Under Development
Figure 5.2 Drugs Directly Delivered Into Inner Ear: Distribution by Phase of Development
Figure 5.3 Drugs Directly Delivered Into Inner Ear: Distribution by Nature of Active Substance
Figure 5.4 Drugs Directly Delivered Into Inner Ear: Distribution by Type of Indication
Figure 5.5 Drugs Directly Delivered Into Inner Ear: Distribution by Route of Administration
Figure 5.6 Inner Ear Direct Drug Delivery Market Forecast, 2014 - 2025: Base Scenario (USD Million)
Figure 5.7 AM-101: Development History
Figure 5.8 AM-101: Sales Forecast, 2014 - 2025: Base Scenario (USD Million)
Figure 5.9 AM-111: Development History
Figure 5.10 AM-111: Sales Forecast, 2014 - 2025: Base Scenario (USD Million)
Figure 5.11 Latanoprost: Sales Forecast, 2014 - 2025: Base Scenario (USD Million)
Figure 5.12 OTO-104: Development History
Figure 5.13 OTO-104: Sales Forecast, 2014 - 2025: Base Scenario (USD Million)
Figure 5.14 CGF166: Development History
Figure 5.15 CGF166: Sales Forecast, 2014 - 2025: Base Scenario (USD Million)
Figure 5.16 Drug Directly Delivered Into Inner Ear: Drivers and Restraints
Figure 7.1 Cochlear Implants: Development History
Figure 7.2 Working of a Cochlear Implant
Figure 7.3 Cochlear Implants: Distribution by Year of Development
Figure 7.4 Cochlear Implants: Comparative Analysis
Figure 7.5 Cochlear Implants: Sales Forecast, 2014 - 2025: Base Scenario (USD Billion)
Figure 7.6 Cochlear Implant Manufacturers: Distribution by Market Share
Figure 7.7 Cochlear Ltd Annual Revenues, 2010-2014 (USD Million)
Figure 7.8 Cochlear Ltd Annual Revenues, 2014: Distribution by Products (USD Million)
Figure 7.9 Cochlear Ltd Annual Revenues: Distribution by Regions (USD Million)
Figure 7.10 Cochlear Ltd: Units of Implants Sold, 2010-2014
Figure 7.11 Number of Cochlear Ltd Implants Implanted Till 2014
Figure 7.12 Nucleus 5 Cochlear Implant: Internal and External Components
Figure 7.13 Sonova Holding Annual Revenues, 2009-2013 (CHF Million)
Figure 7.14 Sonova Holding Annual Revenues, 2013: Distribution by Products (CHF Million)
Figure 7.15 Sonova Holding Cochlear Implant Revenues, 2010-2013 (CHF Million)
Figure 7.16 Sonova Holding Revenues, 2013: Distribution by Operating Regions (CHF Million)
Figure 7.17 William Demant Annual Revenues, 2009-2013 (DKK Million)
Figure 7.18 William Demant Annual Revenues: Distribution by Products, 2013 (DKK Million)
Figure 7.19 Cochlear Implants Market: Drivers and Restraints
Figure 9.1 Direct Inner Ear Drug Delivery Market, 2017, 2021, 2025 (USD Million)

List of Tables:
Table 3.1 Middle Ear: Auditory Ossicles
Table 3.2 Examples of Outer, Middle and Inner Ear Diseases
Table 3.3 Inner Ear Drug Delivery Methods
Table 4.1 Drugs for Inner Ear Diseases: Clinical / Preclinical Pipeline
Table 4.2 Drugs for Inner Ear Diseases: Research Pipeline at Universities
Table 4.3 Nanoparticles for Inner Ear Diseases: Research Pipeline at Universities
Table 4.4 Gene Therapies/ Stem Cells for Inner Ear Diseases: Research Pipeline at Universities
Table 5.1 Drugs Directly Delivered Into Inner Ear: Clinical / Pre-clinical Pipeline
Table 5.2 Current Development Phase and Expected Launch Year of Drugs in Clinical Development
Table 5.3 AM-101: Ongoing Phase III Clinical Trials
Table 5.4 AM-111: Completed/ Planned Clinical Trials
Table 5.5 CGF166: Patent Portfolio
Table 5.6 CGF166: Preclinical Trial Studies
Table 6.1 Case Study: Molecules and their Target Indication
Table 7.1 Degree of Hearing Loss
Table 7.2 Cochlear Implants: Comparative Analysis
Table 7.3 Cochlear Ltd: Marketed Cochlear Implants
Table 7.4 MED-EL: Marketed Cochlear Implant Systems
Table 7.5 MED-EL: Marketed Cochlear Implants
Table 7.6 Advanced Bionics: Product Portfolio
Table 7.7 HiRes 90K: Technical Specifications
Table 7.8 Digisonic SP and Digisonic SP Binaural: Technical Specifications
Table 7.9 Competitive Landscape: Implants and Devices
Table 7.10 Models of Hearing Aids
Table 7.11 Hearing Products: Competitive Analysis
Table 10.1 Industry Sponsored Inner Ear Drugs: Distribution by Phase of Development
Table 10.2 Industry Sponsored Inner Ear Drugs: Distribution by Target Indication
Table 10.3 Industry Sponsored Inner Ear Drugs: Distribution by Nature of Drug
Table 10.4 Industry Sponsored Inner Ear Drugs: Distribution by Route of Administration
Table 10.5 Industry Sponsored Inner Ear Drugs: Distribution by Routes of Delivery
Table 10.6 Academic Research Sponsored Inner Ear Drugs: Distribution by Route of Administration
Table 10.7 Academic Research Sponsored Inner Ear Drugs: Distribution by Target Indication
Table 10.8 Inner Ear Drug Developers: Number of Drugs Under Development
Table 10.9 Drugs Directly Delivered Into Inner Ear: Distribution by Phase of Development
Table 10.10 Drugs Directly Delivered Into Inner Ear: Distribution by Nature of Active Substance
Table 10.11 Drugs Directly Delivered Into Inner Ear: Distribution by Type of Indication
Table 10.12 Drugs Directly Delivered Into Inner Ear: Distribution by Route of Administration
Table 10.13 Inner Ear Direct Drug Delivery: Sales Forecast, 2014 – 2025, Base Scenario (USD Million)
Table 10.14 Inner Ear Direct Drug Delivery: Sales Forecast, 2014 – 2025, Conservative Scenario (USD Million)
Table 10.15 Inner Ear Direct Drug Delivery: Sales Forecast, 2014 – 2025, Optimistic Scenario (USD Million)
Table 10.16 AM-101: Sales Forecast, 2014 – 2025, Base Scenario (USD Million)
Table 10.17 AM-101: Sales Forecast, 2014 – 2025, Conservative Scenario (USD Million)
Table 10.18 AM-101: Sales Forecast, 2014 – 2025, Optimistic Scenario (USD Million)
Table 10.19 AM-111: Sales Forecast, 2014 – 2025, Base Scenario (USD Million)
Table 10.20 AM-111: Sales Forecast, 2014 – 2025, Conservative Scenario (USD Million)
Table 10.21 AM-111: Sales Forecast, 2014 – 2025, Optimistic Scenario (USD Million)
Table 10.22 Latanoprost: Sales Forecast, 2014 – 2025, Base Scenario (USD Million)
Table 10.23 Latanoprost: Sales Forecast, 2014 – 2025, Conservative Scenario (USD Million)
Table 10.24 Latanoprost: Sales Forecast, 2014 – 2025, Optimistic Scenario (USD Million)
Table 10.25 OTO-104: Sales Forecast, 2014 – 2025, Base Scenario (USD Million)
Table 10.26 OTO-104: Sales Forecast, 2014 – 2025, Conservative Scenario (USD Million)
Table 10.27 OTO-104: Sales Forecast, 2014 – 2025, Optimistic Scenario (USD Million)
Table 10.28 CGF166: Sales Forecast, 2014 – 2025, Base Scenario (USD Million)
Table 10.29 CGF166: Sales Forecast, 2014 – 2025, Conservative Scenario (USD Million)
Table 10.30 CGF166: Sales Forecast, 2014 – 2025, Optimistic Scenario (USD Million)
Table 10.31 Cochlear Implants: Sales Forecast, 2014 – 2025, Base Scenario (USD Billion)
Table 10.32 Cochlear Implants: Sales Forecast, 2014 - 2025, Conservative Scenario (USD Billion)
Table 10.33 Cochlear Implants: Sales Forecast, 2014 – 2025, Optimistic Scenario (USD Billion)
Table 10.34 Cochlear Implant Manufacturers: Distribution by Market Share
Table 10.35 Cochlear Ltd Annual Revenues, 2010-2014 (USD Million)
Table 10.36 Cochlear Ltd Annual Revenues, 2014: Distribution by Products (USD Million)
Table 10.37 Cochlear Ltd Annual Revenues: Distribution by Regions (USD Million)
Table 10.38 Cochlear Ltd: Units of Implants Sold, 2010-2014 (USD Million)
Table 10.39 Number of Cochlear Ltd Implants Implanted Till 2014
Table 10.40 Sonova Holding Annual Revenues, 2009-2013 (CHF Million)
Table 10.41 Sonova Holding Annual Revenues, 2013: Distribution by Products (CHF Million)
Table 10.42 Sonova Holding Cochlear Implant Revenues, 2010-2013 (CHF Million)
Table 10.43 Sonova Holding Cochlear Implant Revenues, 2013: Distribution by Operating Regions (CHF Million)
Table 10.44 William Demant Annual Revenues, 2009-2013 (DKK Million)
Table 10.45 William Demant Annual Revenues: Distribution by Products, 2013 (DKK Million)
Table 10.46 Direct Inner Ear Drug Delivery Market, 2017, 2021, 2025 (USD Million)