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U.S. Opportunities in Drug Delivery Technologies

814 Pages | 170 Exhibits | Forecasts Through 2008
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Overview

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Table of Contents

EXECUTIVE SUMMARY 

Drug Delivery Markets by Product Approach

Drug Delivery Markets by Clinical Application

Regulatory Factors

Reimbursement Factors 

Assessing Potential Market Opportunities

Suppliers 

 

Summary Exhibit 1: Drug Delivery Markets by Product Approach, 2002-2008

Summary Exhibit 2: Drug Delivery Market by Clinical Application, 2002-2008

Summary Exhibit 3: Factors Impacting Market Opportunities for New Drug Delivery Technologies

 

1.0 DRUG DELIVERY MARKETS BY PRODUCT TYPE 

1.1 Oral Delivery 

1.2 Injection/Infusion Delivery

1.2.1 Syringes

1.2.1.1 Types

1.2.1.1.1 Standard Multipurpose

1.2.1.1.2 Safety Multipurpose

1.2.1.1.3 Insulin 

1.2.1.2 Syringe Market Analysis

1.2.2 Injection Pens

1.2.2.1 Applications 

1.2.2.2 Products and Suppliers

1.2.2.3 Product Trends

1.2.2.4 Market Analysis 

1.2.3 Needleless Jet Injectors

1.2.3.1 Technology 

1.2.3.2 Applications 

1.2.3.3 Product Trends

1.2.3.4 Products and Suppliers

1.2.3.5 Market Analysis 

1.2.4 Infusion Pumps 

1.2.4.1 Volumetric Pumps 

1.2.4.1.1 Medication Safety Software

1.2.4.1.2 Pricing

1.2.4.1.3 Suppliers 

1.2.4.1.4 Market Analysis 

1.2.4.2 Ambulatory Pumps 

1.2.4.2.1 Product Trends

1.2.4.2.2 Suppliers 

1.2.4.2.3 Pricing

1.2.4.2.4 Market Analysis 

1.2.4.3 Syringe Pumps 

1.2.4.3.1 Product Trends

1.2.4.3.2 Applications 

1.2.4.3.3 Suppliers 

1.2.4.3.4 Market Analysis 

1.2.4.4 Disposable Pumps

1.2.4.4.1 Elastomeric Reservoirs 

1.2.4.4.2 Regional Anesthesia Systems 

1.2.4.4.3 Market Analysis 

1.2.4.5 Implantable Pumps

1.2.4.5.1 Products and Suppliers

1.2.4.5.2 Market Analysis 

1.2.4.6 External Insulin Pumps 

1.2.4.6.1 Clinical Advantages

1.2.4.6.2 Drawbacks

1.2.4.6.3 Products and Suppliers

1.2.4.6.4 Product Developments (BioValve Technologies)

1.2.4.6.5 Market Analysis 

1.2.4.7 Enteral Therapy Pumps

1.2.4.7.1 Pump Technology 

1.2.4.7.2 Pump Pricing and Suppliers

1.2.4.7.3 Gravity-Based Enteral Therapy

1.2.4.7.4 Pumps Market Analysis 

1.2.4.8 Gravity Administration Systems

1.2.4.8.1 Product Trends

1.2.4.8.2 Products

1.2.4.8.3 Suppliers 

1.2.4.8.4 Market Analysis 

1.2.4.9 Vascular Access Devices 

1.2.4.9.1 Short Peripheral Catheters 

1.2.4.9.2 Midline Catheters

1.2.4.9.3 Peripherally Inserted Central Catheters (PICCs) 

1.2.4.9.4 Central Venous Catheters 

1.2.4.9.5 Implantable Ports 

1.2.4.9.6 Market Analysis 

1.3 Transdermal Delivery 

1.3.1 Transdermal Approaches 

1.3.1.1 Passive Delivery

1.3.1.2 Active Delivery

1.3.1.2.1 Iontophoresis

1.3.1.2.2 Technologies

1.3.2 Products and Markets

1.3.2.1 Cardiovascular Patches 

1.3.2.2 Hormone-Based Therapy for Women

1.3.2.2.1 Hormone Replacement Therapy 

1.3.2.2.2 Contraceptive Patches

1.3.2.2.3 Market Analysis 

1.3.2.3 Nicotine Replacement Therapy

1.3.2.3.1 Nicotine Replacement Patches

1.3.2.3.2 Market Analysis 

1.3.2.4 Pain Management

1.3.2.4.1 Fentanyl Patch

1.3.2.4.2 Lidocaine Patches 

1.3.2.4.3 Market Analysis 

1.3.2.5 Other Patches 

1.3.2.5.1 TransDermics' Insulin Patch

1.3.2.5.2 Market Analysis 

1.3.2.6 Novel Transdermal Products

1.4 Inhalation Drug Delivery 

1.4.1 Delivery Devices

1.4.1.1 Metered-Dose Inhalers

1.4.1.1.1 Breath-Actuated MDIs

1.4.1.1.2 Chlorofluorocarbon-Free MDIs 

1.4.1.1.3 Spacer Devices

1.4.1.2 Dry Powder Inhalers 

1.4.1.3 Nebulizers 

1.4.1.4 Direct-Haler 

1.4.2 Current and Emerging Respiratory Products 

1.4.2.1 AstraZeneca 

1.4.2.2 Boehringer Ingelheim 

1.4.2.3 Chiron 

1.4.2.4 Forest Laboratories 

1.4.2.5 Genentech 

1.4.2.6 GlaxoSmithKline 

1.4.2.7 Schering-Plough

1.4.3 Inhaled Insulin 

1.4.3.1 Nektar/Pfizer/Aventis 

1.4.3.2 Aradigm 

1.4.3.3 Alkermes/Eli Lilly & Company

1.4.3.4 Aerogen

1.4.3.5 MannKind 

1.4.4 Emerging Specialty Inhaled Drugs 

1.4.5 Market Analysis 

1.4.5.1 Markets by Product Type

1.4.5.2 Supplier Analysis

1.5 Drug Implants 

1.5.1 Injectable Depot Formulations

1.5.1.1 Encapsulation Approaches

1.5.1.2 Biodegradable Polymers 

1.5.1.3 Liposomal Delivery 

1.5.1.4 Depot Products

1.5.1.5 Delivery of Proteins 

1.5.1.6 Market Forecast 

1.5.1.7 Supplier Shares 

1.5.2 Implants

1.5.2.1 Removable Implants 

1.5.2.1.1 ALZA

1.5.2.1.2 Berlex Laboratories

1.5.2.1.3 Debiotech 

1.5.2.1.4 Katholieke Universiteit Leuven

1.5.2.1.5 MicroCHIPS 

1.5.2.1.6 MicroPump 

1.5.2.1.7 Organon International 

1.5.2.1.8 Valera Pharmaceuticals

1.5.2.1.9 Warner Chilcott/Galen 

1.5.2.2 Biodegradable Implants 

1.5.2.2.1 Guilford Pharmaceuticals

1.5.2.2.2 Harmonia Medical Technologies

1.5.2.2.3 Titan Pharmaceuticals

1.5.2.2.4 Vivus

1.5.3 Market Analysis 

1.6 Transmucosal Delivery 

1.6.1 Oral Delivery (Sublingual, Buccal) 

1.6.2 Intranasal Delivery

1.6.3 Other Routes 

1.6.4 Use of Multiple Delivery Modes 

1.6.5 Products and Market Analysis 

 

Exhibit 1-1: Comparison of Injection/Infusion Delivery Routes

Exhibit 1-2: Injection Syringes, Market Forecast, 2002-2008

Exhibit 1-3: Injection Syringes, Supplier Shares, 2003 

Exhibit 1-4: Sample Injection Pen Configurations 

Exhibit 1-5: Selected Injection Pens, 2004 

Exhibit 1-6: Major Injection Pens, 2004 

Exhibit 1-7: Injection Pen Products, Market Forecast, 2002-2008

Exhibit 1-8: Injection Pen Products, Supplier Shares, 2003 

Exhibit 1-9: BioJector 2000 Jet Injector System Components

Exhibit 1-10: Selected Jet Injector Products, 2004 

Exhibit 1-11: Current and Emerging Jet Injectors, 2004 

Exhibit 1-12: Needleless Jet Injectors, Market Forecast, 2002-2008 

Exhibit 1-13: Needleless Jet Injectors, Supplier Shares 2003

Exhibit 1-14: Selected Volumetric Pumps, 2004

Exhibit 1-15: Major Volumetric Pumps, 2004

Exhibit 1-16: Volumetric Pumps and Sets, Market Forecast, 2002-2008

Exhibit 1-17: Volumetric Pumps and Sets, Supplier Shares, 2003

Exhibit 1-18: Selected Ambulatory Infusion Pumps, 2004 

Exhibit 1-19: Major Ambulatory Infusion Pumps, 2004 

Exhibit 1-20: Ambulatory Infusion Pumps and Disposables, Market Forecast, 2002-2008

Exhibit 1-21: Ambulatory Pumps, Supplier Shares 2003 

Exhibit 1-22: Selected Syringe Pumps and Drivers, 2004

Exhibit 1-23: Major Syringe Pumps and Drivers, 2004

Exhibit 1-24: Syringe Infusion Pumps, Drivers and Sets, Market Forecast, 2002-2008 

Exhibit 1-25: Syringe Pumps, Supplier Shares, 2003 

Exhibit 1-26: Selected Disposable Elastomeric and Regional Anesthesia Pumps, 2004 

Exhibit 1-27: Major Disposable Elastomeric and Regional Anesthesia Pumps, 2004 

Exhibit 1-28: Disposable Infusion Pumps, Market Forecast, 2002-2008 

Exhibit 1-29: Disposable Infusion Pumps, Supplier Shares, 2003 

Exhibit 1-30: Selected Implantable Infusion Pumps, 2004

Exhibit 1-31: Medtronic MiniMed 2007 Implantable Insulin Pump System: 

Exhibit 1-32: Implantable Infusion Pumps, Market Forecast, 2002-2008

Exhibit 1-33: Implantable Infusion Pumps, Supplier Shares, 2003 

Exhibit 1-34: Potential Advantages and Drawbacks of Pump-Based Insulin Delivery

Exhibit 1-35: External Insulin Infusion Pump Characteristics 

Exhibit 1-36: Selected External Insulin Infusion Pumps, 2004 

Exhibit 1-37: Major External Insulin Pumps, 2004 

Exhibit 1-38: BioValve Technologies e-Patch

Exhibit 1-39: External Insulin Pumps and Sets, Market Forecast, 2002-2008 

Exhibit 1-40: External Insulin Pumps and Sets, Supplier Shares, 2003 

Exhibit 1-41: Selected Enteral Therapy Pumps, 2004 

Exhibit 1-42: Major Enteral Therapy Pumps, 2004 

Exhibit 1-43: Enteral Nutrition Delivery Products, Market Forecast, 2002-2008

Exhibit 1-44: Enteral Nutrition Delivery Products, Supplier Shares, 2003 

Exhibit 1-45: Mode of Operation of Baxter Clearlink Needle-Free System 

Exhibit 1-46: Selected Gravity Administration Sets, 2004

Exhibit 1-47: Gravity Systems, Market Forecast by Type, 2002-2008 

Exhibit 1-48: Gravity Systems, Supplier Shares, 2003

Exhibit 1-49: Comparison of Major Vascular Access Devices 

Exhibit 1-50: Selected Short Peripheral Catheters, 2004

Exhibit 1-51: Selected Safety Catheters, 2004

Exhibit 1-52: Selected Midline Catheters, 2004 

Exhibit 1-53: Selected Peripherally Inserted Central Catheters, 2004

Exhibit 1-54: Comparison of Chronic versus Acute Central Venous Catheters

Exhibit 1-55: Selected Chronic and Acute Central Venous Catheters, 2004

Exhibit 1-56: Selected Implantable Ports, 2004

Exhibit 1-57: Major Implantable Ports, 2004 

Exhibit 1-58: Vascular Access Devices, Market Forecast, 2002-2008

Exhibit 1-59: Vascular Access Devices, Supplier Shares, 2003

Exhibit 1-60: Short Peripheral Catheters, Market Forecast, 2002-2008

Exhibit 1-61: Short Peripheral Catheters, Supplier Shares, 2004 

Exhibit 1-62: Peripherally Inserted Central Catheters, Market Forecast, 2002-2008

Exhibit 1-63: Peripherally Inserted Central Catheters, Supplier Shares, 2003 

Exhibit 1-64: Central Venous Catheters, Market Forecast by Type, 2002-2008

Exhibit 1-65: Central Venous Catheters, Supplier Shares, 2003 

Exhibit 1-66: Midline Catheters, Market Forecast, 2002-2008 

Exhibit 1-67: Midline Catheters, Supplier Shares, 2003

Exhibit 1-68: Implantable Ports, Market Forecast, 2002-2008

Exhibit 1-69: Implantable Ports, Supplier Shares, 2003 

Exhibit 1-70: Comparison of Active Transdermal Delivery Approaches

Exhibit 1-71: Selected Cardiovascuar Transdermal Patches, 2004 

Exhibit 1-72: Cardiovascular Patches, Market Forecast, 2002-2008

Exhibit 1-73: Transdermal Cardiovascular Patches, Supplier Shares, 2003

Exhibit 1-74: Selected Hormone Replacement Therapy Patches, 2004 

Exhibit 1-75: Transdermal Female Hormone Patches, Market Forecast, 2002-2008

Exhibit 1-76: Hormonal Patches for Women, Supplier Shares, 2003

Exhibit 1-77: Selected Nicotine Replacement Therapy Patches, 2004

Exhibit 1-78: Nicotine Patches, Market Forecast, 2002-2008 

Exhibit 1-79: Nicotine Patches, Supplier Shares, 2003 

Exhibit 1-80: Transdermal Pain Management Patches, Market Forecast, 2002-2008

Exhibit 1-81: Transdermal Pain Management Technologies, Supplier Shares, 2003

Exhibit 1-82: Select Miscellaneous Transdermal Patch Products, 2004

Exhibit 1-83: TransDermics' Transdermal Drug Delivery Technology 

Exhibit 1-84: Other Transdermal Patches, Market Forecast, 2002-2008

Exhibit 1-85: Selected Novel Transdermal Products, 2004 

Exhibit 1-86: Novel Transdermal Products, Market Forecast, 2002-2008 

Exhibit 1-87: Comparison of Inhalation Therapy Delivery Devices 

Exhibit 1-88: Direct-Haler's Pulmonary Delivery Device

Exhibit 1-89: Selected Current Respiratory/Pulmonary Inhalation Products, 2004 

Exhibit 1-90: Selected Emerging Respiratory/Pulmonary Inhalation Products, 2004

Exhibit 1-91: Selected Pulmonary/Respiratory Delivery Technologies Targeting Diabetes, 2004 

Exhibit 1-92: Alkermes' AIR Inhaler 

Exhibit 1-93: Aerogen's Aerodose Inhaler 

Exhibit 1-94: MannKind's MedTone Inhaler 

Exhibit 1-95: Selected Emerging Inhalation Products Targeting Non-Respiratory, Non-Diabetes Applications, 2004

Exhibit 1-96: Inhalation Drug Delivery, Market Forecast, 2002-2008

Exhibit 1-97: Distribution of Inhaled Respiratory Drug Market by Product Type, 2003 

Exhibit 1-98: Inhalation Drug Delivery, Suppliers Shares, 2003 

Exhibit 1-99: Comparison of Drug Delivery Implant Technologies 

Exhibit 1-100: Selected Current and Emerging Depot Formulations, 2004 

Exhibit 1-101: Depot Formulations by Type, Market Forecast, 2002-2008

Exhibit 1-102: Depot Formulations, Supplier Shares, 2003 

Exhibit 1-103: Selected Removable Drug Delivery Implant Technologies, 2004

Exhibit 1-104: Selected Available Removable Implant Technologies, 2004 

Exhibit 1-105: Selected Biodegradable Implant Technologies, 2004

Exhibit 1-106: Drug Delivery Implants, Market Forecast, 2002-2008

Exhibit 1-107: Drug Delivery Implants, Supplier Shares, 2003 

Exhibit 1-108: Overview of Transmucosal Delivery Approaches

Exhibit 1-109: Selected Transmucosal Products, 2004

Exhibit 1-110: Selected Novel Transmucosal Products, Market Forecast, 2002-2008 

 

2.0 MARKETS BY APPLICATION

2.1 Respiratory/Pulmonary Applications

2.1.1 Chronic Obstructive Pulmonary Disease and Asthma

2.1.1.1 Overview of COPD

2.1.1.2 Asthma Overview 

2.1.1.3 Treatment 

2.1.1.3.1 Bronchodilators

2.1.1.3.2 Anti-Inflammatory Agents

2.1.1.3.3 Emphysema Drugs

2.1.1.3.4 Rescue Medications 

2.1.2 Market Analysis 

2.2 Diabetes

2.2.1 Injection Therapy

2.2.2 Infusion Therapy

2.2.3 Inhalation Therapy

2.2.3.1 Nektar Therapeutics/Pfizer/Aventis

2.2.3.2 Aradigm Corporation 

2.2.3.3 Alkermes/Eli Lilly & Company

2.2.3.4 Aerogen

2.2.3.5 MannKind 

2.2.4 Oral Delivery 

2.2.4.1 Oral Enteric Delivery

2.2.4.1.1 Nobex/Glaxo SmithKline

2.2.4.1.2 Emisphere Technologies

2.2.4.2 Transbuccal Delivery 

2.2.5 Transdermal Therapy

2.2.5.1 Altea Therapeutics 

2.2.5.2 TransDermics

2.2.6 Intranasal Insulin

2.2.7 Market Analysis 

2.3 Pain Management

2.3.1 Cancer-Related Pain

2.3.2 Other Chronic Pain 

2.3.2.1 AIDS 

2.3.2.2 Shingles

2.3.3 Acute Pain

2.3.4 Delivery of Pain Medications 

2.3.4.1 Injection Delivery 

2.3.4.2 Infusion Delivery 

2.3.4.3 Oral Delivery 

2.3.4.4 Transbuccal and and Sublingual Delivery 

2.3.4.5 Transrectal Delivery

2.3.4.6 Transdermal Delivery 

2.3.4.6.1 Patches 

2.3.4.6.2 Liquid Transdermal Delivery

2.3.4.6.3 Active Transdermal Delivery

2.3.4.6.4 Emulsions

2.3.4.7 Intranasal Delivery

2.3.4.8 Inhalation Delivery 

2.3.4.9 Depot Delivery

2.3.4.10 Implant-Based Delivery 

2.3.5 Market Analysis 

2.4 Cancer 

2.4.1 Current State of Chemotherapy 

2.4.2 Chemotherapy Drug Delivery

2.4.2.1 Infusion Therapies 

2.4.2.2 Injectable Depots 

2.4.2.3 Implants

2.4.3 Market Analysis 

2.5 Hydration Therapy

2.6 Nutritional Support 

2.6.1 Total Parenteral Nutrition 

2.6.2 Enteral Nutrition 

2.6.3 Market Analysis 

2.7 Anesthesia Delivery

2.8 Antibiotic and Antiviral Therapy

2.9 Compliance Assurance

2.9.1 Oral Antibiotics

2.9.2 Parkinson's Disease 

2.9.3 Addiction

2.9.3.1 Nicotine Addiction

2.9.3.2 Alcohol and Substance Abuse 

2.9.4 Psychotherapeutic Drugs 

2.9.4.1 Depression

2.9.4.1.1 Prevalence and Symptoms 

2.9.4.1.2 Drug Therapy

2.9.4.2 Antipsychotic Therapy

2.9.4.2.1 Schizophrenia

2.9.4.2.2 Other Psychoses

2.9.4.2.3 Global Opportunity 

2.9.4.2.4 Depots 

2.9.4.2.5 Implants

2.9.5 Market Analysis 

2.10 Reproduction

2.10.1 Contraception

2.10.1.1 Ortho McNeil Pharmaceutical 

2.10.1.2 Berlex (Schering)

2.10.1.3 Agile Therapeutics 

2.10.1.4 Organon International 

2.10.1.5 Watson Pharmaceuticals 

2.10.1.6 Pfizer/Pharmacia 

2.10.1.7 Market Analysis 

2.10.2 Infertility 

2.11 Hormone Replacement Therapies

2.11.1 Female Hormone Replacement Therapy 

2.11.1.1 HRT Patches 

2.11.1.2 Transdermal Gels, Emulsions and Sprays 

2.11.1.3 Implants

2.11.1.4 Market Analysis 

2.11.2 Male Hypogonadism

2.11.2.1 Novel Products

2.11.2.2 Market Analysis 

2.11.3 Growth Hormone Deficiency

2.11.3.1 Incidence and Prevalence

2.11.3.2 Treatment 

2.11.3.3 Market Analysis 

2.12 Sexual Dysfunction

2.12.1 Erectile Dysfunction 

2.12.1.1 Treatment 

2.12.1.2 Transdermal Approaches 

2.12.1.3 Biodegradable Implant

2.12.1.4 Inhalation 

2.12.1.5 Intranasal

2.12.2 Female Sexual Dysfunction 

2.12.2.1 Prevalence and Causes

2.12.2.2 Treatment 

2.12.2.3 Emerging Approaches

2.12.2.3.1 Transdermal 

2.12.2.3.2 Intranasal

2.12.2.3.3 Implant 

2.12.3 Market Analysis 

2.13 Cardiovascular 

2.13.1 Cardiovascular Disease Overview 

2.13.2 Drug Delivery in CVD

2.13.2.1 Anticoagulation and Thrombolysis

2.13.2.2 Treatment of Congestive Heart Failure

2.13.2.3 Transdermal Patches 

2.13.2.4 Drug-Eluting Coronary Stents 

2.13.2.5 Liposomal Delivery 

2.13.2.6 Drug Reformulation

2.13.3 Market Analysis 

2.14 Cystic Fibrosis 

2.14.1 Disease Overview 

2.14.2 Treatment 

2.14.2.1 Chiron (TOBI) 

2.14.2.2 Genentech (Pulmozyme)

2.14.3 Market Analysis 

2.15 Other Drug Delivery Applications

2.15.1 Blood Transfusion/Replacement Therapy 

2.15.2 Cytokine Therapy

2.15.3 Bone Marrow and Organ Transplantation 

2.15.3.1 Bone Marrow Transplantation 

2.15.3.2 Organ Transplantation 

2.15.4 Interferon Therapy 

2.15.5 Management of High Risk Pregnancies

 

Exhibit 2-1: COPD and Asthma Drug Delivery, Market Forecast, 2002-2008 

Exhibit 2-2: Selected Inhalation Drug Delivery Targeting Diabetes, 2004 

Exhibit 2-3: Alkermes' AIR Inhaler 

Exhibit 2-4: Aerogen's Aerodose Inhaler 

Exhibit 2-5: MannKind's Technosphere Insulin System 

Exhibit 2-6: TransDermics' Transdermal Drug Delivery Technology 

Exhibit 2-7: Diabetic Population on Insulin Therapy, Patient Forecast, 2002-2008 

Exhibit 2-8: Insulin Drug Delivery, Patients and Markets by Approach, 2002-2008

Exhibit 2-9: Injection Insulin Therapy by Type, Patient and Market Forecast, 2002-2008

Exhibit 2-10: External Insulin Pumps, Patient and Market Forecasts, 2002-2008 

Exhibit 2-11: Emerging Insulin Therapies, Patient and Market Forecast, 2005-2008

Exhibit 2-12: Selected Drug Delivery Targeting Pain Management, 2004 

Exhibit 2-13: Pain Management Drug Delivery Systems, Market Forecast, 2002-2008

Exhibit 2-14: Selected Drug Delivery Targeting Cancer Therapy, 2004

Exhibit 2-15: Cancer Drug Delivery Systems, Market Forecast, 2002-2008 

Exhibit 2-16: Hydration Therapy Delivery Systems, Market Forecast, 2002-2008 

Exhibit 2-17: Nutritional Support Delivery Systems, Market Forecast, 2002-2008

Exhibit 2-18: Antibiotic/Antiviral Therapy Delivery Systems, Market Forecast, 2002-2008

Exhibit 2-19: Key Patents Expiring on Antidepressant and Antipsychotic Drugs 

Exhibit 2-20: Selected Atypical Antipsychotic Drugs, 2004 

Exhibit 2-21: Compliance Enhancement Drug Delivery, Market Forecast, 2002-2008

Exhibit 2-22: Selected Drug Delivery Targeting Contraception, 2004

Exhibit 2-23: Contraceptive Patches, Implants and Depots, Market Forecast, 2002-2008

Exhibit 2-24: Hormone Replacement Therapies, Market Forecast, 2002-2008 

Exhibit 2-25: Selected Drug Delivery Targeting Female Hormone Replacement Therapy, 2004 

Exhibit 2-26: Female Hormone Replacement Therapy, Market Forecast, 2002-2008

Exhibit 2-27: Novel Testosterone Replacement Therapy, Market Forecast, 2002-2008

Exhibit 2-28: Novel Growth Hormone Replacement Therapy, Market Forecast, 2002-2008

Exhibit 2-29: Selected Drug Delivery Targeting Erectile Dysfunction, 2004 

Exhibit 2-30: Selected Drug Delivery Targeting Female Sexual Dysfunction, 2004

Exhibit 2-31: Drug Delivery for Sexual Dysfunction, Market Forecast, 2002-2008

Exhibit 2-32: Selected Cardiovascular Disease Statistics, 2003

Exhibit 2-33: Key Patents Expiring on Cardiovascular Drugs 

Exhibit 2-34: Cardiovascular Drug Delivery Systems, Market Forecast, 2002-2008 

Exhibit 2-35: Drug Delivery Targeting Cystic Fibrosis, Market Forecast, 2002-2008 

 

3.0 ADVANCED DRUG DELIVERY TECHNOLOGIES

3.1 Novel Oral Drug Delivery Systems 

3.2 Implantable Drug Delivery Systems

3.3 Inhalation Technologies

3.4 Transdermal Systems 

3.5 Transmucosal Delivery 

3.6 Other Advanced Drug Delivery Technologies 

3.7 Products and Programs 

3.7.1 3M Drug Delivery Systems 

3.7.1.1 Inhalation 

3.7.1.2 Transdermal 

3.7.2 aaiPharma Inc

3.7.3 Access Pharmaceuticals 

3.7.4 Acrux Group 

3.7.5 Advanced Drug Delivery (ADD) Technologies 

3.7.6 Alkermes 

3.7.6.1 ProLease

3.7.6.2 Medisorb 

3.7.6.3 AIR

3.7.7 AlphaRx

3.7.8 Altea Therapeutics 

3.7.9 ALZA

3.7.9.1 ALZAMER Depot 

3.7.9.2 D-Trans 

3.7.9.3 DUROS

3.7.9.4 E-Trans

3.7.9.5 Macroflux

3.7.9.6 OROS

3.7.9.7 STEALTH

3.7.10 Andrx Pharmaceuticals 

3.7.11 Antares Pharma

3.7.11.1 Transdermal Gels

3.7.11.2 Easy-Tec 

3.7.12 A.P. Pharma 

3.7.12.1 Biochronomer 

3.7.12.2 Bioerodimer 

3.7.12.3 Oral Drug Delivery Systems

3.7.13 Aradigm 

3.7.14 Atrix Laboratories

3.7.14.1 Atrigel 

3.7.14.2 BEMA

3.7.14.3 SMP

3.7.14.4 MCA 

3.7.14.5 BCP

3.7.15 Auxilium Pharmaceuticals 

3.7.16 Bentley Pharmaceuticals

3.7.17 Binghamton University (State University of New York) 

3.7.18 BioChemics

3.7.19 Biocompatibles 

3.7.20 BioSante Pharmaceuticals

3.7.21 Biosyntech

3.7.22 Biovail

3.7.23 BioValve Technologies

3.7.24 Birch Point Medical 

3.7.25 Cardinal Health 

3.7.26 ChipRx

3.7.27 CIMA LABS (Cephalon)

3.7.28 Columbia Laboratories

3.7.29 Control Delivery Systems 

3.7.30 Corium International

3.7.31 Debio R.P

3.7.32 Debiotech 

3.7.33 Dermatrends

3.7.34 DURECT

3.7.34.1 ALZET

3.7.34.2 DURIN

3.7.34.3 DUROS

3.7.34.4 SABER/ORADUR

3.7.35 Elan Drug Delivery 

3.7.35.1 NanoCrystal 

3.7.35.2 SODAS 

3.7.35.3 IPDAS

3.7.35.4 CODAS

3.7.35.5 PRODAS

3.7.36 Emisphere Technologies

3.7.37 EMPI

3.7.38 Encapsulation Systems

3.7.39 Enzon Pharmaceuticals 

3.7.39.1 PEG Technology

3.7.39.2 SCA Technology

3.7.40 Epic Therapeutics (Baxter Healthcare)

3.7.41 Ethypharm SA

3.7.42 Flamel Technologies

3.7.43 Generex Biotechnology 

3.7.44 Genetronics Biomedical

3.7.45 Genzyme Pharmaceuticals 

3.7.46 Guilford Pharmaceuticals

3.7.47 Harmonia Medical Technologies

3.7.48 Helix BioPharma

3.7.49 ID Biomedical

3.7.50 IDEA

3.7.51 ImaRx Therapeutics 

3.7.51.1 Energy Activated Systems 

3.7.51.2 Passive Systems 

3.7.51.3 Gene Delivery 

3.7.52 Intranasal Technology

3.7.53 Iomai 

3.7.54 Katholieke Universiteit Leuven 

3.7.55 Kurve Technology 

3.7.56 Kytogenics Pharmaceuticals 

3.7.57 Labopharm

3.7.58 Lavipharm

3.7.59 LTS Lohmann Therapy Systems 

3.7.60 MacroChem

3.7.61 MacroMed

3.7.62 MaxCyte

3.7.63 MicroCHIPS 

3.7.64 MicroPump 

3.7.65 Mylan Technologies

3.7.66 NanoPass Technologies 

3.7.67 Nastech Pharmaceutical Company 

3.7.68 Nektar Therapeutics 

3.7.69 NexMed

3.7.70 Nitto Denko (Aveva Drug Delivery Systems) 

3.7.71 NjeX Medical Systems 

3.7.72 Norwood Abbey

3.7.73 Novavax

3.7.74 Noven Pharmaceuticals

3.7.75 Novosis 

3.7.76 Oakwood Laboratories

3.7.77 OctoPlus Technologies 

3.7.78 OptiNose 

3.7.79 Organon International 

3.7.80 Penwest Pharmaceuticals

3.7.80.1 TIMERx 

3.7.80.2 Geminex

3.7.80.3 SyncroDose

3.7.81 Phares Drug Delivery

3.7.82 Poly-Med

3.7.83 Praecis Pharmaceuticals

3.7.84 RxKinetix

3.7.85 SkyePharma 

3.7.85.1 Oral 

3.7.85.2 Solubilization 

3.7.85.3 Injection 

3.7.85.4 Inhalation 

3.7.86 Sontra Medical

3.7.87 Sonus Pharmaceuticals

3.7.88 Southern Research Institute 

3.7.89 STS Biopolymers 

3.7.90 Sumitomo Pharmaceuticals Co

3.7.91 Syntonix Pharmaceuticals

3.7.92 Targesome

3.7.93 Therafuse

3.7.94 Therics

3.7.95 Titan Pharmaceuticals

3.7.96 Transdermal Technologies

3.7.97 TransDermics

3.7.98 TransPharma Medical 

3.7.99 Trigenesis Therapeutics (Dr. Reddy's Laboratories)

3.7.100 Ultra-Sonic Technologies 

3.7.101 University of Pennsylvania 

3.7.102 Valera Pharmaceuticals

3.7.103 Valois 

3.7.104 Vectura

3.7.104.1 Inhalation 

3.7.104.2 Oral 

3.7.104.3 Topical 

3.7.105 Ventaira Pharmaceuticals/Zivena 

3.7.106 Vyteris

3.7.107 Warner Chilcott

3.7.108 Watson Pharmaceuticals 

3.7.109 West Pharmaceutical Services 

3.7.110 XenoPort 

3.7.111 ZARS 

 

Exhibit 3-1: Selected Suppliers of Advanced Drug Delivery Systems by Technology Platform 

Exhibit 3-2: Comparison of Major Novel Drug Delivery Approaches

Exhibit 3-3: Selected Oral Drug Delivery Programs

Exhibit 3-4: Selected Implantable Drug Delivery Programs

Exhibit 3-5: Selected Inhalation Drug Delivery Programs 

Exhibit 3-6: Selected Transdermal Drug Delivery Programs 

Exhibit 3-7: Selected Transmucosal Drug Delivery Programs 

Exhibit 3-8: Andrx Pharmaceuticals' Drug Delivery Technologies 

Exhibit 3-9: AERx Drug Delivery Systems 

Exhibit 3-10: BioValve Technologies' Drug Delivery Platforms: 

Exhibit 3-11: LTS Lohmann Therapy Systems Projects Available for License

Exhibit 3-12: MicroCHIPS Technology 

Exhibit 3-13: Atelocollagen Minipellet 

Exhibit 3-14: Targesome Nanoparticle Technology 

Exhibit 3-15: TheraFuse Wearable Drug Infusion System

Exhibit 3-16: West Pharmaceutical Services Instranasal Pipeline

 

4.0 REGULATORY ISSUES

4.1 Drug Delivery Vehicle for Veterinary Medicine 

4.1.1 Device Regulations 

4.1.2 Drug Regulations 

4.2 Infusion Pumps 

4.3 Implantable Programmable Infusion Pump 

4.3.1 Premarket Approval

4.3.2 PMA versus NDA Supplements 

4.3.3 Medical Device Tracking

4.3.4 Products

4.4 Proprietary Drug Delivery Products 

4.4.1 New Drug Approval

4.4.2 Office of Combination Products 

4.5 Recommendations for Non-Traditional Devices 

 

Exhibit 4-1: Comparison of Regulatory Options for Current and Emerging Drug Delivery Devices, 2004

Exhibit 4-2: Likely Need for New Information in New Animal Drug Application

 

5.0 REIMBURSEMENT 

5.1 Background

5.2 Insurance Programs

5.2.1 Medicare 

5.2.2 Medicaid 

5.2.3 Commercial Insurance 

5.3 Coding Systems 

5.4 Recommended Reimbursement Process 

5.5 Reimbursement for Drug Delivery Devices 

5.5.1 External Infusion Pumps

5.5.1.1 Medicare 

5.5.1.2 Commercial Insurance 

5.5.1.2.1 External Infusion Pumps for Insulin Therapy 

5.5.1.2.2 Pump Supplies 

5.5.1.3 Coding and Reimbursement

5.5.2 Implantable Infusion Pumps 

5.5.2.1 Medicare 

5.5.2.2 Commercial Insurance 

5.5.2.3 Codes and Reimbursement 

5.5.3 Disposable Infusion Pumps

5.5.4 Implants

5.5.5 Injectable Delivery Systems 

5.6 Obtaining Coverage for New Devices 

5.6.1 Transitional Pass-Through Codes

5.6.1.1 Timelines

5.6.1.2 Pass-Through Information Requirements 

5.6.2 Application for New Technology APC Code 

5.6.3 Commercial and Medicaid Reimbursement Issues

5.7 Reimbursement Strategies 

5.7.1 External Infusion Devices

5.7.2 Drug Implants 

 

Exhibit 5-1: Selected Reimbursement Coding Systems

Exhibit 5-2: Selected HCPCS Codes Relating to External Infusion Pumps

Exhibit 5-3: HCPCS Codes for Home Infusion Therapy

Exhibit 5-4: HCPCS Codes for Implantable Infusion Pumps

 

6.0 COMPANY PROFILES

6.1 Abbott Laboratories/Hospira, Inc. 

6.2 Alaris Medical Systems, Inc. (Cardinal Health, Inc.) 

6.3 Animas Corporation

6.4 Arrow International, Inc

6.5 AstraZeneca PLC

6.6 Atrix Laboratories, Inc

6.7 C.R. Bard 

6.8 Baxter International, Inc. 

6.9 Becton, Dickinson & Company 

6.10 Boehringer Ingelheim 

6.11 Disetronic Medical Systems (Roche Diagnostics)

6.12 Glaxo SmithKline plc 

6.13 I-Flow Corporation 

6.14 Johnson & Johnson 

6.15 Medex, Inc. 

6.16 Medtronic, Inc

6.17 Nektar Therapeutics 

6.18 Novartis AG

6.19 Pfizer, Inc

6.20 SkyePharma PLC

6.21 Smiths Medical 

6.22 Solvay Group 

6.23 Tyco International, Ltd. 

6.24 Watson Pharmaceuticals, Inc. 

 

APPENDIX: COMPANY LIST

Companies Covered

Abbott Laboratories/Hospira, Inc. 

Alaris Medical Systems, Inc. (Cardinal Health, Inc.) 

Animas Corporation

Arrow International, Inc

AstraZeneca PLC

Atrix Laboratories, Inc

Baxter International, Inc. 

Becton, Dickinson & Company 

Boehringer Ingelheim 

C.R. Bard 

Disetronic Medical Systems (Roche Diagnostics)

Glaxo SmithKline plc 

I-Flow Corporation 

Johnson & Johnson 

Medex, Inc. 

 Medtronic, Inc

Nektar Therapeutics 

Novartis AG

Pfizer, Inc

SkyePharma PLC

Smiths Medical 

Solvay Group 

Tyco International, Ltd. 

Watson Pharmaceuticals, Inc.