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Biotech Drug Delivery Systems - Key Company Intelligence & Market Outlook to 2012

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
  • 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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