バイオテクノロジーにおけるドラッグデリバリーシステム：主な企業インテリジェンスと2012年までの市場見通し

Abstract

The two major problems for biotech drugs are their mode of delivery and relative instability. The majority of delivery methods for biological drugs involve injection, which is not necessarily ideal for most indications. As the biotech sector starts to heat up, the industry has started to look for new ways of delivering these highly successful drugs.

Two main themes that run through this report: patent loss for leading biotech drugs and the use of technology to enable newer drugs to be more effective. Central to both of these matters is the perception that new drugs rely on old delivery technologies to get past the regulatory authorities, whereas old drugs look to new techniques to survive. This report will examine and challenge that approach; visiongain suggests that pharmaceutical companies should look to new drug delivery systems as they develop new drugs, in order to make the most out of these technologies.

• Revenue forecasts for the biological drug delivery market
• Drivers and restraints of the market are identified and discussed
• An analysis of strengths, weaknesses opportunities and threats (SWOT) for the biological drug delivery market
• Future targets for drug delivery technology
• Summaries and analysis of the leading drug delivery companies and their pipelines
• Special focus on oral drug delivery and injection technologies
• An assessment of potential advances, including the challenge of RNA delivery

In stark contrast to the pharmaceutical market as a whole, which is exhibiting single digit growth, the biotech market is still growing significantly with constantly innovative products. The proven methods, such as intravenous infusion and intra-muscular/subcutaneous injection, have remained the standard mode of administration, whereas the novelty has come from new improved protein therapeutics. This situation may be set to change, however, as key products lose patent protection and the market for some biotech drugs becomes more congested.

The report answers key questions such as:

• Which drug delivery companies are likely to be at the forefront of Biotech launches?
• What will be the revenue impact of altering the drug delivery method of patented drugs?
• What will be the revenue in 2012 for biotech drugs using novel drug delivery methods?
• How will the regulatory rulings involving Biosimilar products effect innovation?
• Understand the effect of nanotechnology on the drug delivery methods of biotech drugs

This report includes visiongain' s predictions of the Top 10 drugs most likely to be targeted for Biogenerics and the impact on revenue to their current manufacturers.

With Wyeth and AstraZeneca this week signing technology deals, this market is hot. This report will keep you up to date and fully informed of the latest developments in your marketplace.

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