Table of Contents
Chapter 1.
- Executive Summary
- 1.1 Aims of the Report
- 1.2 Summary of Contents
- Introduction
Chapter 2.
- 2.1 Introduction to Drug Delivery Technologies (DTT)
- 2.2 Types of Technologies for Drug Delivery
- 2.2.1 Sustained/Controlled Release Systems
- 2.2.2 Injection
- 2.2.3 Needle Free Injection
- 2.2.4 Pulmonary, Buccal and Nasal Delivery
- 2.2.5 Pills and Capsules
- 2.3 The World Biotech Market
- 2.3.1 Summary of The World Biotech Market
- 2.3.2 The Biotech Industry is Strong
- 2.4 Biotech Drugs With Associated Drug Delivery Technologies
- 2.4.1 Pegylated Interferons
- 2.4.2 A Crowded Insulin Market Has Forced Investment in DDT
- 2.5 Exubera - A Case Study for Alternative Biological Delivery Methods
- 2.5.1 Exubera Aims to Meet Unmet Needs
- 2.5.2 Description and Development History
- 2.5.3 Cost, Caution and Complicated Dosing Could Restrict Exubera Sales
- 2.6 The Main Challenges for Biological Drug Delivery
Chapter 3.
- World Market for Biological Drug Delivery
- 3.1 The Controlled Release Market is Well-Established for Biotech Drugs
- 3.1.1 Interferons
- 3.1.2 G-CSF
- 3.1.3 Insulin- An Innovative Market Set to Continue Changing
- 3.2 Potential Markets
- 3.2.1 Human Growth Hormone
- 3.2.2 Vaccines Could Provide Substantial Revenues
- 3.2.3 Monoclonal Antibodies Show Potential
- 3.2.4 RNA/DNA Delivery
- 3.3 New Technology, Old Drugs
- 3.4 Market Forecast Drivers, Restraints and Trends
Chapter 4.
- 4.1 Analysis of Strengths,Weaknesses, Opportunities and Threats (SWOT),
2006-2011
- 4.2 Patent Loss Will Drive Biological Drug Delivery
- 4.2.1 Strict Biogeneric Legislation Encourages Innovation
- 4.2.2 As Patents Expire, Competition Will Increase
- 4.3 A Competitive and Lucrative Monoclonal Antibody Market Will Drive Sales
- 4.4 Biological Drug Delivery is Already Established
- 4.4.1 Controlled Release Technologies Currently Lead the Biological Drug
Delivery Market
- 4.4.2 Exubera Paths the Way for More Innovative Technologies
- 4.4.3 The Emerging Nanotech Industry is Good News For Biological Drug
Delivery
- 4.5 Regulatory Authorities Will Hold Back the Market
- 4.5.1 Risk Adverse FDA/EMEA Will Make Approval Difficult
- 4.5.2 Is it a Choice between New Technology or a New Drug? Or is a
Rethink Required?
- 4.6 New Delivery Methods for Biologicals Must be Cost Effective and
Appropriate
- 4.7 Injection is Still the Major Form of Delivery
- 4.8 Next Generation Drugs May Limit Drug Delivery Revenues
- 4.8.1 Lifecycle Management Via Protein Engineering Blurs Drug Delivery
Lines
- 4.8.2 New Chemical Entities Could Restrict Biotech Growth
- 4.9 The Biological Drug Delivery Market Has Potential But Care Must be
Taken
Chapter 5. Transdermal Delivery Technology
- 5.1 The Search for More Patient Friendly Methods
- 5.2 The Need for Speed - High Doses Are Required For Some Biotech Drugs
- 5.3 Nanotechnology
- 5.3.1 Baxter' s Promaxx Microsphere Technology
- 5.3.2 Camurus Aims to Provide Flexible Solutions
- 5.4 Needle Free Injection Systems
- 5.4.1 Bioject
- 5.4.2 D' Antonio consultants
- 5.4.3 Equidyne Systems
- 5.4.4 Zogenix' s Intraject Technology
- 5.4.5 Biovalve
- 5.4.6 BD Biosciences
Chapter 6. Pipeline: Oral Delivery of Biotech Drugs
- 6.1 Challenges Lie Ahead
- 6.2 Inhaled Vaccines and Hormones are a Real Possibility
- 6.3 A Tricky Challenge - Getting Proteins to the Gut
- 6.4 Leading Companies
- 6.4.1 Nektar Hopes to Build on Success of PEG Technology with Exubera
- 6.4.2 Emisphere Leads the Way for Oral Formulations
- 6.4.3 Merrion Pharmaceutical
- 6.4.4 BioSante
- 6.4.5 Unigene
- 6.4.6 Nastech Pharmaceuticals
- 6.4.7 Aradigm Corporation
- 6.4.8 Generex
- 6.4.9 Bentley Pharmaceuticals
- 6.4.10 Trinity Biosystems
Chapter 7. The Challenge of RNA Delivery
- 7.1 Introduction to RNA Therapeutics
- 7.1.1 Antisense Oligonucleotides and Their Analogues
- 7.1.2 RNA Interference
- 7.1.3 Ribozymes Present a Different Approach
- 7.2 The RNA Pipeline is Wide but not Advanced
- 7.3 Delivery is the Key Problem for Polynucleotides
- 7.4 Developments in the RNA Market
- 7.4.1 Merck' s Acquisition of Sirna Signals Intent
- 7.4.2 Acuity in Clinical Trials
- 7.4.3 Santaris
- 7.4.4 Calando Pharmaceuticals
- 7.4.5 CytRx Corporation
- 7.4.6 Intradigm Corporation
- 7.4.7 Nucleonics Inc.
- 7.4.8 Nastech Pharmaceuticals
- 7.5 RNA Therapies Offer High Potential for Growth
Chapter 8.
- Conclusion: The Market Shows Huge Potential But Many Hurdles Still Remain
- 8.1 Patent Loss Will Drive the Biological Drug Delivery Market
- 8.2 RNA/DNA Therapies Promise Substantial Delivery Revenues - But
Questions Still Remain
- 8.3 Post-Exubera - Safety and Efficacy Concerns Still Present a
Considerable Restriction on Growth
- 8.4 High Competition Will Settle to Establish "Gold Standards"
List of Tables
- Table 2.1, Top Ten Biotech Drugs
- Table 2.2, Pegylated Interferon Drugs 2006
- Table 2.3, Amino Acid Changes for Human Insulin Analogues
- Table 3.1, Revenues for Vaccines
- Table 3.2, Revenue Forecast For Biotech Drugs Using Novel Drug Delivery
Technology 2012
- Table 4.1, SWOT Analysis for the Biological Drug Delivery Market, 2006
- Table 4.2, Possible Biogeneric Targets for Drug Delivery Companies
- Table 4.3, Biotech Drugs Losing Patent Protection 2007-2012
- Table 5.1, Doses for Leading Monoclonal Antibodies
- Table 5.2, Needle-free Injection Devices Developed by Equidyne Systems
- Table 6.1, Biotech Products and Pipeline Drugs Using Nektar' s Technology
Platforms, 2006
- Table 6.2, Partnership Deals in Emisphere' s Pipeline, 2006
- Table 6.3, Proprietary Drug Candidates from Emisphere, 2006
- Table 6.4, Drugs in the Pipeline for Merrion Pharmaceuticals,2006
- Table 6.5, Nastech' s Biotech Pipeline 2006
- Table 7.1, Preclinical/Clinical Development Programs in the Santaris
Pipeline, 2006
- Table 7.2, Preclinical Development Programs in the Nucleonics Pipeline,
2006
List of Figures
- Figure 2.1, World Revenue Forecast for the World Biotech Market
- Figure 3.1, Global Revenues for Pegylated and non-Pegylated Interferons
- Figure 3.2, Historical Sales Figures for Neupogen/Neulasta, 1996-2006
- Figure 3.3, Revenues ($m) for Insulin and Oral Anti-diabetics
- Figure 3.4, Market Share by Brand Name for Somatropin Products
- Figure 3.5, Geographical Breakdown of the World Vaccine Market
- Figure 3.6, Technology Classes in the Biotech Pipeline
- Figure 3.7, World Revenue ($m) Forecast for Monoclonal Antibody Drugs
- Figure 3.8, Revenues ($m) for Off-Patent Biotech Drugs 2012
- Figure 3.9, Revenue Forecast For Biotech Drugs Using Novel Drug Delivery
Technology 2012
- Figure 3.10, Forecast Growth Rates For Biotech Drugs Using Novel Drug
Delivery Technology 2012
- Figure 4.1, Historical Sales Revenues for Pegylated Therapeutic Proteins,
2004-2006
- Figure 4.2, Different Approaches to Biological Drug Delivery
- Figure 8.1, Stages of Development for RNAi based Therapies
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