Executive Summary

Drug delivery systems have grown to become important technology platforms used by companies in the pharmaceutical, biotechnology and medical device industries in recent years. Drug delivery technology is a resource used by companies to survive in the market. Some companies use it has an enabler of new opportunities in an expanding market. This report takes a broad look at the drug delivery system market, the many technologies, the companies, and the dynamics of this interesting business.

This study is an update to Fuji-Keizai s strong selling report about drug delivery and provides the reader with new technology and business information. The report provides readers with information and analysis about key developments driving the industry in the middle of 2005. People know about drug delivery systems through seeing daily TV commercials promoting the benefits of a new contraceptive patch, the new dry powder inhaler that helps people with allergies breath easier, or the new once a month pill to help with osteoporosis. These TV ads tell us about the benefits of using drug delivery systems.

This report estimates that the US drug delivery market will reach nearly $91 billion by 2009. The US drug delivery industry is prospering and is transforming ordinary drugs into better drugs optimized for a broad range of applications. Drug delivery is helping to expand other pharmaceutical industry sectors such as biotechnology drugs, generic drugs, specialty pharmaceuticals and more. Major pharmaceutical firms use the technology to extend their drug product life cycles.

Drug delivery will help drug companies respond to nearly $80 billion in lost value for drugs with expiring patents during the next few years. More than 21 figures and tables illustrate this report. Detailed information about the activities of twenty-seven companies important to the expanding drug delivery market is profiled. Readers working in healthcare industries including executives, managers, investors, entrepreneurs, consultants and others may find this report of interest.

Fuji - Keizai USA Inc.

Table of Contents

1. The Drug Delivery System Market and Business
  1.1 Key Findings
  1.2 Current and Future DDS Market and Business Potential
    1.2.1 More Growth Expected in Next Few Years
    1.2.2 The Pharmaceutical Industry is Facing a Productivity Gap
    1.2.3 Profitable Drugs To Lose Patent Protection and Market Exclusivity
    1.2.4 Using Patent Extension Strategies for Product Life-Cycle Management
  1.3 Partnership Strategy
    1.3.1 New Drugs Continue to Hit the Market in Near Term
    1.3.2 Big Pharmas Cannot Work Alone to Make Drugs
  1.4 Technology Exposure
    1.4.1 Commercial Interests
    1.4.2 Post-Genomic Advances
    1.4.3 Emerging Targeted Therapies
    1.4.4 Large Molecule Biopharmaceuticals: Protein and Peptide Drugs
    1.4.5 More Knowledge About Disease Mechanisms
  1.5 Drivers and Resistors to DDS Reformulation
    1.5.1 Market is Fragmented
    1.5.2 The Field Continues To Expand
  1.6 Strategic Analysis of key DDS Players
    1.6.1 Drug Delivery Technologies Preferred by the Pharma Industry
    1.6.2 Drug Delivery Business Models Continue Shift to Products

2. Key Drug Delivery Technology & Reformulation and Roadmap
  2.1 Key Technology Findings
  2.2 Oral Drug Delivery
  2.3 Bone Marrow Infusion
    2.3.2 Delivery of Drugs into Bone Marrow
    2.3.3 Delivery of Bone Marrow-based Stem Cells
    2.3.4 Delivery of Other Cell Therapies to Bone Marrow
  2.4 Injectable Drug Delivery (Parenteral)
  2.5 Transdermal Drug Delivery
  2.6 Transmucosal Drug Delivery
  2.7 Organ System Specific Drug Delivery
    2.7.1 Genito-Urinary Tract (GU)
    2.7.2 Nasal Delivery to Central Nervous System (CNS)
    2.7.3 Cardiovascular System (CV)
    2.7.4 Ocular Drug Delivery
    2.7.5 Pulmonary Drug Delivery
    2.7.6 Stomach & Gastrointestinal Tract (GI)
  2.8 Controlled Release Systems
  2.9 Novel Packaging and Formulations
    2.9.1 Orally Disintegrating Tablets (Fast Dissolving)
    2.9.2 Chewable Tablets
    2.9.3 Solubility and Bioavailability Enhancement
  2.10 Highly Targeted Drug Delivery
    2.10.1 Polymer and Collagen Systems
    2.10.2 Particle-Based Systems
      2.10.2.1 Therapeutic Monoclonal Antibodies.
      2.10.2.2 Liposomes
      2.10.2.3 Microparticles
      2.10.2.4 Modified Blood Cells
      2.10.2.5 Nanoparticles
      2.10.2.6 Viral Assisted Intracellular Gene Delivery
      2.10.2.7 Non-Viral Intracellular Gene Delivery

3. Strategic Alliances and M&As
  3.1 Traditional Drug Delivery Licensing Business Model
  3.2 Drug Product Based Drug Delivery Business Model
  3.3 Driving the Need to Partner
  3.4 Alliance Analysis, 2003 to mid-2005

4. Emerging Technology for Drug Delivery
  4.1 Analysis of Emerging Drug Delivery Technologies
  4.2 Nano Drug Delivery
  4.3 Protein Drug Delivery
  4.4 Polymer Development
  4.5 Therapeutic Monoclonal Antibody Development
  4.6 PEGnology Development
  4.7 Inhalation System Development
  4.8 Buccal Delivery Development
  4.9 Ocular Delivery Development
  4.10 Vaccine Delivery Development
  4.11 Other Emerging Technology

5. Market Forecast and Future Outlook
  5.1 US Drug Delivery Market Trends
    5.1.1 A Strong Market
    5.1.2 Solutions for Unmet Medical Needs
    5.1.3 Doctors and Patients Prefer No Pain
    5.1.4 Drug Delivery Helps Pharmaceutical Firms to Compete
  5.2 US Drug Delivery Market Size by Segment 2004-2009
    5.2.1 Market Segments
    5.2.2 Oral Drug Delivery
    5.2.3 Parenteral Drug Delivery
    5.2.4 Injection Devices
    5.2.5 Inhaled Drug Delivery
    5.2.6 Inhaler Devices (Nebulizer, Spacers)
    5.2.7 Transdermal Drug Delivery
    5.2.8 Implant Drug Delivery
    5.2.9 Transmucosal Drug Delivery
    5.2.10 Therapeutic Antibodies
    5.2.11 Therapeutic & Cancer Vaccines
    5.2.12 Gene Therapy/Delivery
    5.2.13 Other Drug Delivery
  5.3 Market Shares of the US Drug Delivery Market, 2004 and 2009
  5.4 Platforms/ Products in the Competitive Vendor Landscape

6. Selected Legal Disputes
  6.1 IVAX, Teva Pharmaceutical Industries Ltd., et al v. Eli Lilly
  6.2 Johnson & Johnson v. Boston Scientific
  6.3 Chiron Corporation v. Corus Pharma, Inc.
  6.4 Novartis Pharmaceuticals Corp., et al v. Sun Pharmaceutical Industries Ltd.
  6.5 GlaxoSmithKline Plc v. Par Pharmaceutical Companies, Inc.
  6.6 Santarus, Inc. v. TAP Pharmaceutical Products, Inc.
  6.7 Travanti Pharma Inc. v. IOMED

7. Activities of Leading Drug Delivery Firms
  Common Research Items
    Company Profile
      - Contact
      - Established Year
      - Revenue
      - # of Employees
    Company Overview, Technology & Products
    Alliances, Mergers and Acquisitions
    Other Finding

  7.1 DNA/RNA Delivery(4)
  7.2 Multiple Delivery Platform(4)
  7.3 Nasal/Lung Delivery(3)
  7.4 Other Drug Delivery(3)
  7.5 Particle Drug Delivery(3)
  7.6 Speciality Pharma(2)
  7.7 Therapeutic MAb Delivery(2)
  7.8 Transdermal/Transmucosal Delivery(4)

8. The Top 50 Drug Delivery Companies

9. Appendix A: Links to Drug Delivery Websites
  9.1 Pharmaceutical and Biotechnology Industry Sites
  9.2 Government Regulatory Agencies
  9.3 Pharmaceutical Industry News Sites

10. Appendix B: Glossary of Drug Delivery Terms

LIST OF TABLES
Table 1. US Drug Delivery Systems (DDS) Market Size, 2004-2009
Table 2. Analysis of Alliances, Mergers and Acquisitions of DDS Companies
Table 3. Selected Drug Delivery Company Alliances in 2005/ (First Half)
Table 4. Selected Drug Delivery Company Alliances in 2004
Table 5. Selected Drug Delivery Company Alliances in 2003
Table 6. Emerging Drug Delivery Technologies
Table 7. US Drug Delivery Market Size, Revenues by Segments, 2004-2009
Table 8. US DDS Market Revenues by Share, 2004 and 2009
Table 9. Leading Drug Delivery Companies Mapped by Competing Platforms/Products
Table 10. Legal Disputes Among Selected Companies Involving Drug Delivery
Table 11. The Top 50 WW Drug Delivery Companies by Total Revenues (2004 $M)

LIST OF ILLUSTRATIONS
Figure 1. US Drug Delivery Systems (DDS) Market Size, 2004-2009
Figure 2. The GI Tract and Oral Drug Delivery Route (by Mouth)
Figure 3. Intraosseous (Bone Marrow) Infusion
Figure 4. Injection Based Drug Delivery Methods
Figure 5. Transdermal Patch Drug Delivery
Figure 6. 3M's Multi-layer Drug-in-Adhesive Transdermal Patch
Figure 7. Johnson & Johnson's Drug-Coated Stent
Figure 8. Pulmonary Delivery Solutions
Figure 9. Penwest's TIMERx(r) Drug Delivery Technology
Figure 10. US Drug Delivery Market Size, Revenues by Segment, 2004-2009
Figure 11. US DDS Market Revenues by Share, 2004 and 2009
 

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