Executive Summary

This report is about drug delivery systems, what they do for pharmaceutical products, why they are needed, and the extent of this important technology market. The study provides readers with recent information and analysis about key developments driving the industry in 2002. Most people think of drug delivery systems as the added ingredients that go into oral pills that people take for all-day headache pain relief, a patch that helps people stop smoking or an inhaler to help a child with asthma breathe easier. It is this and more. It is an interesting, prospering US industry that is transforming ordinary drugs into drugs optimized for their targeted applications.

Drug delivery is an enabling technology that is helping to expand other pharmaceutical industry sectors such as generic drugs and specialty pharmaceuticals. The technology is being used by some pharmaceutical firms to differentiate their products so that new opportunities can be created. Other companies are adding special drug delivery features to products to extend the marketing life of product lines. The industry definition has expanded to include new, targeted therapies as well as new drug containing implants that were invented by emerging companies. Monoclonal antibodies, gene delivery, MEMS implants and drug-coated stents are examples of emerging drug delivery innovations.

This study has found that the market size for drug delivery systems in 2002 is about $47 billion and is projected to grow to about $67 billion in 2006 with a CAGR of nearly 8%. While the pharmaceutical industry generated about $250 billion in 2001, it faces numerous issues that could be helped with advanced or emerging drug delivery systems. Many of their highly profitable blockbuster drugs will reach patent expiry by 2004-2006 and lose about $37 billion in market value to generic competition. Growing through mergers has not helped much. Optimizing products through drug delivery might be a better strategy.

The report discusses these important issues with interesting and useful findings. This study uses more than 30 figures and tables to illustrate the findings. Detailed information about the activities of companies important to the expanding drug delivery market are profiled.

Table Of Contents

1. Introduction to Drug Delivery Systems   1.1 Overview of Drug Delivery Systems         1.1.1 What Drug Delivery Systems Are         1.1.2 What Drug Delivery Systems Can Do   1.2 Big Picture of Pharma Development Trends Important to Drug Delivery         1.2.1 The Pharmaceutical Industry is Facing a Productivity Gap         1.2.2 Profitable Drugs To Lose Patent Protection and Market Exclusivity         1.2.3 Major Pharma Companies are Using Patent Extension Strategies   1.3 Drug Development Often Requires Using Outsourced Partners         1.3.1 Many New Drugs are Expected to Hit the Market in 3-4 Years         1.3.2 Big Pharmas Cannot Work Alone to Make Drugs   1.4 Goal of Developing Drug Delivery Technologies   1.5 Rationale for Developing Drug Delivery Systems         1.5.1 Commercial Interests         1.5.2 Post-Genomic Advances and Emerging Targeted Therapies         1.5.3 Large Molecule Biopharmaceurticals: Protein and Peptide Drugs         1.5.4 More Knowledge About Disease Mechanisms   1.6 Challenges for Drug Delivery Companies         1.6.1 Market is Fragmented         1.6.2 The Field Has Grown Quickly   1.7 Future Outlook         1.7.1 More Growth Expected in Next Few Years         1.7.2 Drug Delivery Technologies Preferred by the Pharma Industry         1.7.3 Drug Delivery Business Models are Shifting to Self-Marketing. 2. Technologies Developed for Drug Delivery Systems   2.1 Oral Drug Delivery   2.2 Injection Based Drug Delivery   2.3 Transdermal Drug Delivery   2.4 Transmucosal Drug Delivery   2.5 Bone Marrow Infusion   2.6 Organ System Specific Drug Delivery         2.6.1 Pulmonary Drug Delivery         2.6.2 Nasal Delivery to Central Nervous System (CNS)         2.6.3 Cardiovascular System (CV)         2.6.4 Gastro-Intestinal Tract (GI)         2.6.5 Genito-Urinary Tract (GU)         2.6.6 Ocular Drug Delivery   2.7 Controlled Release Systems   2.8 Novel Packaging and Formulations         2.8.1 Fast Dissolving Tablets         2.8.2 Chewable Tablets         2.8.3 Solubility Enhancement   2.9 Highly Targeted Drug Delivery         2.9.1 Polymer and Collagen Systems         2.9.2 Particle-Based Systems               2.9.2.1 Therapeutic Monoclonal Antibodies.               2.9.2.2 Liposomes               2.9.2.3 Microparticles               2.9.2.4 Modified Blood Cells               2.9.2.5 Nanoparticles               2.9.2.6 Viral Assisted Intracellular Gene Delivery               2.9.2.7 Non-Viral Intracellular Gene Delivery 3. Strategic Alliances and M&As by Companies Involved in Drug Delivery Systems 4. Selected Drug Delivery Patent Disputes   4.1 Andrx Corporation Patent Disputes         4.1.1 AstraZenica v. Andrx and Others         4.1.2 Biovail v. Andrx   4.2 Watson Pharmaceuticals v. Bristol Myers-Squibb   4.3 Valentis, Inc. v. Alza Corporation   4.4 Bectin Dickenson v. Tyco Healthcare   4.5 Guidant Corp. v. Boston Scientific 5. Applied and Emerging Technology Status for Drug Delivery 6. The Market for Drug Delivery Systems and Future Outlook   6.1 US Drug Delivery Market Trends         6.1.1 A Significant Market         6.1.2 Solutions for Unmet Medical Needs         6.1.3 Doctors and Patients Prefer No Pain         6.1.4 Drug Delivery Helps Pharmaceutical Firms to Compete   6.2 US Drug Delivery Market Size by Segment 2001-2006         6.2.1 Market Segments         6.2.2 Oral Drug Delivery         6.2.3 Injectable Drug Delivery         6.2.4 Injection Devices         6.2.5 Inhaled Drug Delivery         6.2.6 Inhaler Devices (MDI, DPI, Nebulizer, Liquid)         6.2.7 Transdermal Drug Delivery         6.2.8 Implant Drug Delivery         6.2.9 Transmucosal Drug Delivery         6.2.10 Therapeutic Antibodies         6.2.11 Therapeutic & Cancer Vaccines         6.2.12 Gene Therapy/Delivery         6.2.13 Other Drug Delivery         6.2.14 Market Shares of the US Drug Delivery Market, 2001 and 2006   6.3 Map of New Ventures and Products/Platforms 7. Emerging Nanotechnology and Drug Delivery R&D   7.1 Current Status of Nanotechnology Drug Delivery Market   7.2 Technology to be Developed   7.3 Commercial Implications   7.4 Venture Nanotech R&D Companies' Activities 8. The World Top 50 Drug Delivery Companies 9. Activities of Leading Drug Delivery Firms for R&D   9.1 Big Pharma         9.1.1 Aventis Pasteur SA (Subsidiary of Aventis SA)         9.1.2 GlaxoSmithKline   9.2 Cancer Therapy         9.2.1 Alkermes, Inc.         9.2.2 Antigenics, Inc.   9.3 End-to-End Delivery Platforms         9.3.1 Alza Corporation (subsidiary of Johnson & Johnson)         9.3.2 Elan Corporation         9.3.3 SkyePharma PLC   9.4 Targeted Delivery, Monoclonal Antibodies         9.4.1 Abgenix, Inc.         9.4.2 Medarex, Inc.   9.5 Nanotechnology Drug Delivery         9.5.1 NanoBio Corporation         9.5.2 NanoMed Pharmaceuticals, Inc.         9.5.3 Cima Laboratories   9.6 Inhaled Delivery         9.6.1 Aradigm Corporation         9.6.2 Nektar Therapeutics (previously Inhale)   9.7 Speciality Pharma         9.7.1 Andrx Corporation         9.7.2 Biosyn, Inc.         9.7.3 Watson Pharmaceuticals, Inc.   9.8 Transdermal/Transmucosal         9.8.1 Noven Pharmaceuticals, Inc.         9.8.2 Optime Therapeutics, Inc   9.9 Vaccine Delivery         9.9.1 PowderJect Pharmaceuticals PLC         9.9.2 Wyeth 10. Appendix A: Links to Drug Delivery Websites   10.1 Pharmaceutical Industry Sites   10.2 Government Regulatory Agencies   10.3 Pharmaceutical Industry News Sites 11. Appendix B: Glossary of Drug Delivery Terms List Of Tables Table 1. US Drug Delivery Systems (DDS) Market Size, 2001-2006 Table 2. Analysis of Alliances and M&As of DDS Companies Table 3. Drug Delivery Company Alliances in 2002 Table 4. Drug Delivery Company Alliances in 2001 Table 5. Drug Delivery Company Alliances in 2000 Table 6. Drug Delivery Company Alliances from Mar.- Dec. 1999 Table 7. Summary of Selected Drug Delivery Patent Disputes Table 8. Applied and Emerging Technology Summary Table 9. Emerging Drug Delivery Technology Status in 2002 Table 10. US Drug Delivery Market Size, Revenues by Segments 2001-2006 Table 11. US DDS Market Revenues by Share, 2001 and 2006 Table 12. Map of New Ventures and Products Table 13. C Sixty Inc. Table 14. NTera Ltd. Table 15. MicroCHIPS Inc. Table 16. Molecular Express Inc. Table 17. Capsulution NanoScience AG Table 18. Aphios Corporation Table 19. Nanotherapeutics Inc. Table 20. iMEDD Inc. Table 21. Advectus Life Sciences Inc. Table 22. The World 50 Drug Delivery Companies by Revenues (2001 $M) List Of Illustrations 1. US Drug Delivery Systems (DDS) Market Size, 2001-2006 2. The GI Tract and Oral Drug Delivery Route (by Mouth) 3. Injection Based Drug Delivery Methods 4. Transdermal Patch Drug Delivery 5. Noven Pharmaceuticals' DOT Matrix Patch 6. Intraosseous (Bone Marrow) Infusion 7. Nektar's Inhance(tm) Pulmonary Delivery Solution 8. Pulmonary Delivery 9. Johnson & Johnson's Drug-Coated Stent 10. SkyePharma's Controlled Release Drug 11. US Drug Delivery Market Size, Revenues by Segments 2001-2006 12. US DDS Market Revenues by Share, 2001 and 2006 FOR ORDER OR INQUIRY, PLEASE CLICK "ORDER / INQUIRY FORM"