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