Background Scope and Methodology Technology and Market Opportunities
Polymers and Biomaterials
Oral Drug Delivery Devices
Pulmonary Drug Delivery
Drug Eluting Stent Technology
Percutaneous Drug Delivery Technology
Ophthalmic Drug Delivery
Colloidal Drug Delivery Technologies
Site/Organ Specific Drug Delivery
Needle-Free Drug Delivery Technology
Size and Growth of Market
Chapter Two: Drug Delivery Technologies
Pharmacodynamics and Drugs for Delivery
Small Organic Molecules
Genes and Antisense Drugs
Polymers and Biomaterials
Oral Drug Delivery Devices
Other Progress in Oral Delivery
Pulmonary Drug Delivery
Notable Market Participants
Metered Dose Inhalers
Dry Powder Inhalers
Drug-Eluting Stent Technology Percutaneous Drug Delivery Technology
Ophthalmic Drug Delivery Colloidal Drug Delivery Technologies Site/Organ Specific Drug Delivery Needle-Free Drug Delivery Technology
Chapter Three: Drug Delivery Applications And Markets
Background Cardiovascular Diseases
Coronary Stent Markets
Central Nervous System (Cns) Applications
Fertility Control and Women’s Health
Chapter Four: Company Profiles
Overview Abbott Laboratories Abbott Vascular Devices Division of Abbott Laboratories Alkermes, Inc. Andrx Corporation Atrix Laboratories, Inc. Bioject Medical Technologies Biovail Corporation Boston Scientific Cima Labs, Inc. Cordis Corporation Durect Corporation Elan Corporation Elite Pharmaceuticals, Inc. Enzon Pharmaceuticals, Inc. Genzyme General Guidant Corporation Guilford Pharmaceuticals, Inc. Jomed Macrochem Corporation Medtronic, Inc. Nastech Pharmaceutical Company, Inc. Nektar Therapeutics, Inc. Orapharma, Inc. Praecis Pharmaceuticals, Inc. Skyepharma Plc Watson Pharmaceuticals, Inc.
Chapter Five: Conclusions and Strategic Implications
First Conclusion Second Conclusion Third Conclusion Fourth Conclusion Fifth Conclusion Sixth Conclusion Seventh Conclusion
Appendix A: Glossary of Terms and Abbreviations Appendix B: Company Directory
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: Estimated U.S. Market Potential for Delivery-Modified Therapeutics 2001-2010
Figure 1-1: Distribution of the Estimated U.S. Market Potential for Delivery-Modified Therapeutics by Therapeutic Area: 2001 - 2010
CHAPTER TWO: DRUG DELIVERY TECHNOLOGIES
Table 2-1: Key Companies Active in Drug Delivery Technology and Products
Table 2-2: Commonly Used Polymeric Materials for Controlled Drug Release Systems
Table 2-3: Key Companies Active in Pulmonary Drug Delivery Technology
Table 2-4: Candidates for Drug-Eluting Stents
Table 2-5: Companies Active in Drug-Eluting Stent Commercialization
Table 2-6: 9-Month Restenosis Rates in Diabetic and Non-Diabetic Patients in the SIRIUS Trial
Table 2-7: Final Results of the RAVEL Trial
Table 2-8: Phonophoresis/Cortisol Trial Results
CHAPTER THREE: DRUG DELIVERY APPLICATIONS AND MARKETS
Table 3-1: Estimated U.S. Market Potential for Delivery-Modified Therapeutics by Therapeutic Area, 2001 - 2010
Figure 3-1: Distribution of the Estimated U.S. Market Potential for Delivery-Modified Therapeutics by Therapeutic Area 2001-2010
Table 3-2: Currently Marketed Drug Delivery Modified Cardiovascular Products
Figure 3-2: Trending in Historic and Forecast U.S. Coronary Revascularization Procedures
Figure 3-3: Estimated Market Shares in the United States
Table 3-3: Potential U.S. Market for Drug Delivery Modified Cardiovascular Drugs and Drug-Eluting Stents: 2001-2010 ($ Billions)
Figure 3-4: Trending in the U.S. Market for Drug Eluting Stents: 2001-2010
Figure 3-5: Trending in the Potential U.S. Market for Delivery Modified Cardiovascular Drugs: 2001 - 2010
Table 3-4: Currently Marketed Drug Delivery Modified Cancer Therapy Products
Table 3-5: Potential U.S. Market for Drug Delivery Modified Cancer Therapeutics, 2001-2010
Figure 3-6: Trending in the Potential U.S. Market for Drug Delivery Modified Cancer Therapeutics: 2001 - 2010
Table 3-6: Currently Marketed Drug Delivery Modified CNS Therapy Products
Table 3-7: Potential U.S. Market for Drug Delivery Modified CNS Therapeutics 2001-2010
Figure 3-7: Trending in the Potential U.S. Market for Delivery Modified CNS Therapeutics 2001 - 2010
Table 3-8: Currently Marketed Drug Delivery Modified Diabetes Therapeutics 185
Table 3-9: Potential U.S. Market for Drug Delivery Modified Diabetes Therapeutics, 2001-2010
Figure 3-8: Trending in the Potential U.S. Market for Delivery Modified Diabetes Therapeutics 2001-2010
Table 3-10: Currently Marketed Drug Delivery Modified Fertility and Women’s Health Products
Table 3-11: Potential U.S. Market for Drug Delivery Modified Fertility Control and Women’s Health Drugs, 2001-2010
Figure 3-9: Trending in the Potential U.S. Market for Delivery Modified Fertility Control and Women’s Health Drugs 2001-2010
Table 3-12: Currently Marketed Drug Delivery Modified Infectious Disease Drugs
Table 3-13: Potential U.S. Market for Drug Delivery Modified Infectious Disease Therapeutics, 2001-2010
Figure 3-10: Trending in the Potential U.S. Market for Delivery Modified Infectious Disease Therapeutics: 2001 - 2010
Table 3-14: Currently Marketed Drug Delivery Modified Pulmonary Disease Therapeutics
Table 3-15: Potential U.S. Market for Drug Delivery Modified Pulmonary Disease Therapeutics, 2001-2010
Figure 3-11: Trending in the Potential U.S. Market for Delivery Modified Pulmonary Disease Therapeutics: 2001 - 2010
Advanced Drug Delivery: Technologies, Applications, and Markets Description
Drug delivery technologies continue to be a vital piece of the pharmaceutical marketing puzzle. From clinical efficacy to product differentiation and life-cycle management, delivery technologies are increasingly demanding the attention of developers at earlier and earlier stages.
In Kalorama’s 2001-2002 Drug Delivery series, we focused on the markets by route of administration—oral, injectable, implantable, pulmonary, transdermal etc. In this all new study on advanced drug delivery, however, we focused on drug delivery through the lens of therapeutic application. This report is not an update to the Drug Delivery Series, but an all new study commissioned independently to examine how new approaches are coming to market, how they are changing clinical practice, and what the potential for various technologies is in specific applications.
Scope and Methodology
This report focuses on the market applications of current and advanced drug delivery technology to the development of new and modified pharmaceutical products. The field of drug delivery promises to be an area of exciting technological innovation that will be but one part of the array of pharmaceutical intervention technologies, but a major part through the end of the decade. This report focuses on solely on pharmaceutical aspects of drug delivery and not on the device aspects. While it does mention nebulizers, electroporation technology, phonoporation, and drug-eluting cardiac stents only the drug-eluting cardiac stents, which are a bridge between pharmaceuticals and devices, are considered in detail and forecast is terms of market potential.
This report considers the options that the current technologies present, the progress that is being made in these fields, and the reception these new products are likely to experience in the marketplace. The major market effects of new and advanced drug-delivery technology are currently being seen in product life extension efforts and will be seen with greater impact in the relatively short term, that is, within the next two years.
This report does discuss the economic aspects of certain advanced drug delivery technologies and applications, and their impacts on formularies, insurers and patients. In general, it is the current products and technologies used in the marketplace, leaving significant unmet need with regard to the prevention and treatment of a variety of medical conditions, which have placed today’s market in a position that is vulnerable to new technologies and products.
Market analysis for this report considers the markets modified drug delivery products only in the United States. The focus of the report is on the application of advanced drug delivery technology in the improvements of existing pharmaceuticals and the facilitation of the delivery and commercialization of new therapeutics emerging from the biotechnology and biopharmaceutical industries. This report does not cover the biotechnology and biopharmaceutical products themselves, nor does it instrumentation, catheters, and other hardware used in various drug delivery procedures. It does discuss some of the alternative technologies to standard injection, in particular, needle-free injection and their potential impacts on the market.
The analysis presented in this report is based on data from a combination of company, government, industrial, institutional and private sources. It includes information from extensive literature reviews, as well as interviews and discussions with experts in the field, including experts in drug delivery technology, as well as medicinal chemists, research scientists, and business development and marketing managers engaged in the field.
The market analysis presented in this report questions the validity of those who say that this technology is so important to modern therapeutics that it is worth well over $20 billion worldwide as well as others that place the figure at 20% of the U.S. pharmaceutical market (~$35 billion) as no one mentions whether this is a sum to be realized by the drug delivery technology companies for their efforts; the amount of new business to be realized from therapeutics introduced with these technologies; the value of product life cycle extensions brought about by the use of this technology; or a combination of all the preceding. The problem is one of market definition.
For this report, the approach to market estimation has been more systematic. First, the market expansion over time has been estimated without the introduction of new drug delivery technologies based on demographics, epidemiology, current trends, and expected new product/technology developments. This provides a base market value.
Second, estimates of new products requiring innovative drug delivery technology and existing products to which new drug delivery technology might be applied are made. These estimates are classified as market expansions, market preservations, or market cannibalizations. Quantitative estimates of the impact of new drug delivery products are then made based on existing unmet need, the vulnerability of existing products, the potential competitive position, and economic factors.
Last, the effects of these products based on new drug delivery technology are added to the effects of existing drug delivery modified products and applied to the baseline, defining a total market for the product area.