Drug Delivery Technologies - Current Market Dynamics, Future Market Opportunities and Lifecycle Strategies

Table of Contents

1 INTRODUCING THE FIELD OF DRUG DELIVERY 15

• 1.1 THE VALUE OF DRUG DELIVERY SYSTEMS 15
• 1.2 DRUG DELIVERY AND PRODUCT DIFFERENTIATION 16
• 1.3 DRUG DELIVERY AND PATENT EXTENSION 17
• 1.4 THE OPTIMAL TIME FOR REFORMULATION 19
• 1.5 OPTIMIZING R&D RETURNS THROUGH DRUG DELIVERY 20
• 1.6 OPPORTUNITIES AND THREATS TO THE DRUG DELIVERY SECTOR 20
• 1.6.1 Opportunities for Growth in the Drug Delivery Sector 21
• 1.6.2 Threats to Additional Growth in the Drug Delivery Sector 24
• 1.7 BUSINESS MODELS OF DRUG DELIVERY COMPANIES 26

2 AN OVERVIEW OF DRUG DELIVERY TECHNOLOGIES 28

• 2.1 ORAL DRUG DELIVERY 28
• 2.1.1 Controlled Release 29
• 2.1.2 Sustained Release 31
• 2.1.3 Chronomodulation 31
• 2.1.4 Rapid Dissolving and Taste-masking Tablets 31
• 2.1.5 Macromolecular Drug Delivery 33
• 2.1.6 Microemulsion 33
• 2.1.7 Pulsatile Drug Delivery 34
• 2.2 INHALABLE DRUG DELIVERY 35
• 2.2.1 Nebulizers 36
• 2.2.2 Metered Dose Inhalers (MDIs) 36
• 2.2.3 Dry Powder Inhalers (DPIs) 37
• 2.2.4 Limitations of Pulmonary Delivery Systems for Systemic Delivery 38
• 2.2.5 Aqueous Systems 39
• 2.2.6 Crystallization Technology 39
• 2.2.7 Electrohydrodynamic (EHD) Aerosol Delivery 40
• 2.2.8 Liposomal Systems 40
• 2.3 INJECTABLE DRUG DELIVERY 41
• 2.3.1 Sustained Release Injectable Systems 42
• 2.3.2 Liposomal Systems 43
• 2.3.3 Needleless Systems 43
• 2.3.4 New Injectable Technologies 44
• 2.4 TRANSMUCOSAL DRUG DELIVERY 44
• 2.4.1 Buccal Delivery 45
• 2.4.2 Nasal 47
• 2.4.3 Rectal 48
• 2.4.4 Vaginal 48
• 2.5 TRANSDERMAL DRUG DELIVERY 49
• 2.5.1 Passive Formulations 51
• 2.5.2 Active Formulations 52
• 2.6 NICHE TECHNOLOGIES 55
• 2.6.1 Topical Systems 56
• 2.6.2 Gene Delivery 58
• 2.6.3 Implantable Systems 60
• 2.6.4 Drug Delivery Microchips 63
• 2.6.5 Nanotechnology 66

3 OVERVIEW OF GLOBAL DRUG DELIVERY MARKET 70

• 3.1 IMPORTANCE OF DRUG DELIVERY 70
• 3.2 GLOBAL DRUG DELIVERY MARKET BY GEOGRAPHIC AREA 71
• 3.3 GLOBAL DRUG DELIVERY MARKET BY SEGMENT 72
• 3.4 GLOBAL DRUG DELIVERY MARKET FORECASTS 74

4 DRUG DELIVERY MARKET ANALYSIS 77

• 4.1 KEY MARKET SEGMENTS 77
• 4.1.1 Oral Drug Delivery 77
• 4.1.1.1 Sales of Products Utilizing Oral Drug Delivery Technology 77
• 4.1.1.2 Key Therapeutic Areas for Oral Drug Delivery 84
• 4.1.1.3 Key Oral Drug Delivery Products Impacting Global Market 86
• 4.1.1.4 The Outlook for Oral Drug Delivery Technology 92
• 4.1.1.5 Drivers and Restraints 93
• 4.1.2 Inhalable Drug Delivery 93
• 4.1.2.1 Sales of Products Utilizing Inhalable Drug Delivery Technology 93
• 4.1.2.2 Key Therapeutic Areas for Inhalable Drug Delivery 96
• 4.1.2.3 Key Inhalable Drug Delivery Products Impacting Global Market 97
• 4.1.2.4 The Outlook for Inhalable Drug Delivery Technology 104
• 4.1.2.5 Drivers and Restraints 105
• 4.1.3 Injectable Drug Delivery 106
• 4.1.3.1 Sales of Products Utilizing Injectable Drug Delivery Technology 106
• 4.1.3.2 Key Therapeutic Areas for Injectable Drug Delivery 110
• 4.1.3.3 Key Injectable Drug Delivery Products Impacting Global Market 113
• 4.1.3.4 The Outlook for Injectable Drug Delivery Technology 116
• 4.1.3.5 Drivers and Restraints 117
• 4.1.4 Transmucosal Drug Delivery 117
• 4.1.4.1 Sales of Products Utilizing Transmucosal Drug Delivery Technology 117
• 4.1.4.2 Key Therapeutic Areas for Transmucosal Delivery 120
• 4.1.4.3 Key Transmucosal Drug Delivery Products Impacting Global Market 121
• 4.1.4.4 The Outlook for Transmucosal Drug Delivery Technology 125
• 4.1.4.5 Drivers and Restraints 126
• 4.1.5 Transdermal Drug Delivery 127
• 4.1.5.1 Sales of Products Utilizing Transdermal Drug Delivery Technology 127
• 4.1.5.2 Key Therapeutic Areas for Transdermal Drug Delivery 131
• 4.1.5.3 Key Transdermal Drug Delivery Products Impacting Global Market 133
• 4.1.5.4 The Outlook for Transdermal Drug Delivery Technology 137
• 4.1.5.5 Drivers and Restraints 137
• 4.1.6 Niche Drug Delivery Technologies 138
• 4.1.6.1 Sales of Products Utilizing Niche Drug Delivery Technologies 138
• 4.1.6.2 Key Niche Drug Delivery Technology Product Impacting Global Market 141
• 4.1.6.3 The Outlook for Niche Drug Delivery Technologies 142
• 4.1.6.4 Drivers and Restraints 143

5 EMERGING DRUG DELIVERY TECHNOLOGIES: ORAL DRUG DELIVERY 144

• 5.1 KEY PRODUCT PROFILES 151
• 5.2 KEY COMPANY INVOLVEMENT IN THE FIELD OF ORAL DRUG DELIVERY 156
• 5.2.1 ALZA 156
• 5.2.2 Biovail 157
• 5.2.3 Cardinal Health 161
• 5.2.4 Depomed 163
• 5.2.5 Emisphere 163
• 5.2.6 Ethypharm 164
• 5.2.7 Penwest 166

6 EMERGING DRUG DELIVERY TECHNOLOGIES: INHALABLE DRUG DELIVERY 167

• 6.1 KEY PRODUCT PROFILES 168
• 6.2 KEY COMPANY INVOLVEMENT IN THE FIELD OF INHALABLE DRUG DELIVERY 171
• 6.2.1 3M 171
• 6.2.2 Alkermes 172
• 6.2.3 Aradigm 172
• 6.2.4 Nektar 173
• 6.2.5 SkyePharma 175

7 EMERGING DRUG DELIVERY TECHNOLOGIES: INJECTABLE DRUG DELIVERY 176

• 7.1 KEY PRODUCT PROFILES 179
• 7.2 KEY COMPANY INVOLVEMENT IN THE FIELD OF INJECTABLE DRUG DELIVERY 182
• 7.2.1 Alkermes 182
• 7.2.2 ALZA 182
• 7.2.3 Enzon 183
• 7.2.4 Ethypharm 184
• 7.2.5 Macromed 185
• 7.2.6 Nektar 185
• 7.2.7 QLT 186

8 EMERGING DRUG DELIVERY TECHNOLOGIES: TRANSMUCOSAL DRUG DELIVERY 188

• 8.1 KEY PRODUCT PROFILES 190
• 8.2 KEY COMPANY INVOLVEMENT IN THE FIELD OF TRANSMUCOSAL DRUG DELIVERY 193
• 8.2.1 Generex 193
• 8.2.2 Nastech 193
• 8.2.3 Pherin 194

9 EMERGING DRUG DELIVERY TECHNOLOGIES: TRANSDERMAL DRUG DELIVERY 197

• 9.1 KEY PRODUCT PROFILES 199
• 9.2 KEY COMPANY INVOLVEMENT IN THE FIELD OF TRANSDERMAL DRUG DELIVERY 202
• 9.2.1 3M 202
• 9.2.2 Altea Therapeutics 203
• 9.2.3 ALZA 204
• 9.2.4 Aradigm 206
• 9.2.5 Noven 207

10 EMERGING DRUG DELIVERY TECHNOLOGIES: NICHE DRUG DELIVERY TECHNOLOGIES 209

• 10.1 KEY PRODUCT PROFILES 212
• 10.2 KEY COMPANY INVOLVEMENT IN NICHE DRUG DELIVERY TECHNOLOGIES 216
• 10.2.1 ALZA 216
• 10.2.2 Connetics (now Stiefel Laboratories) 216
• 10.2.3 Inovio 217
• 10.2.4 MacroChem 218
• 10.2.5 NexMed 218
• 10.2.6 pSivida 219
• 10.2.7 QLT 220
• 10.2.8 SkyePharma 221

11 KEY DRUG DELIVERY COMPANY PROFILES 224

• 11.1 3M PHARMACEUTICALS 224
• 11.2 ALKERMES 226
• 11.3 ALTEA THERAPEUTICS 227
• 11.4 ALZA (JOHNSON & JOHNSON) 229
• 11.5 ARADIGM 231
• 11.6 BIOJECT 232
• 11.7 BIOVAIL 234
• 11.8 CARDINAL HEALTH 236
• 11.9 CIMA LABS (CEPHALON) 237
• 11.10 CONNETICS (STIEFEL LABORATORIES INC.) 239
• 11.11 CYDEX PHARMACEUTICALS 241
• 11.12 DELSITE BIOTECHNOLOGIES (CARRINGTON LABORATORIES) 242
• 11.13 DEPOMED 243
• 11.14 DOR BIOPHARMA 245
• 11.15 DURECT 247
• 11.16 EMISPHERE 249
• 11.17 ENZON 251
• 11.18 ETHYPHARM 253
• 11.19 EURAND 255
• 11.20 GENEREX 256
• 11.21 INOVIO (FORMERLY GENETRONICS) 258
• 11.22 IVAX (PART OF TEVA) 261
• 11.23 MACROCHEM 262
• 11.24 MACROMED (NOW PROTHERICS) 263
• 11.25 NASTECH (NOW MDRNA) 265
• 11.26 NEKTAR 266
• 11.27 NEXMED 269
• 11.28 NOVEN 270
• 11.29 PSIVIDA 272
• 11.30 PENWEST 274
• 11.31 PHERIN PHARMACEUTICALS 276
• 11.32 QLT 277
• 11.33 SKYEPHARMA 279
• 11.34 WATSON PHARMACEUTICALS 281
• 11.35 ZOGENIX 283

Tables

• TABLE 2.1 DRUGS SUITABLE OR UNSUITABLE FOR CONTROLLED RELEASE 30
• TABLE 2.2 ADVANTAGES AND DISADVANTAGES OF TRANSDERMAL DELIVERY 50
• TABLE 3.1 GLOBAL SALES OF DRUG DELIVERY SYSTEMS BY KEY SEGMENTS, 2007 72
• TABLE 3.2 FORECAST GLOBAL SALES OF DRUG DELIVERY SYSTEMS BY SEGMENT, US$ BILLION 75
• TABLE 4.1 KEY ORAL DRUG DELIVERY PRODUCTS, 2004-2007** ($ MN) 78
• TABLE 4.2 LEADING ORAL DRUG DELIVERY COMPANIES 2007, KEY PRODUCTS AND SALES 2007 ($MN) 83
• TABLE 4.3 KEY INHALABLE DRUG DELIVERY PRODUCTS, 2004-2007** ($ MN) 94
• TABLE 4.4 KEY INJECTABLE DRUG DELIVERY PRODUCTS, 2004-2007** ($ MN) 106
• TABLE 4.5 LEADING INJECTABLE DRUG DELIVERY COMPANIES 2007, KEY PRODUCTS AND SALES 2007 ($ MN) 109
• TABLE 4.6 KEY TRANSMUCOSAL DRUG DELIVERY PRODUCTS, 2004-2007** 118 ($ MN) 118
• TABLE 4.7 KEY TRANSDERMAL DRUG DELIVERY PRODUCTS, 2004-2007# 128 ($ MN) 128
• TABLE 4.8 KEY TOPICAL DRUG DELIVERY PRODUCTS, 2007 138
• TABLE 4.9 KEY NICHE DRUG DELIVERY PRODUCTS, 2004-2007 ($ MN) 140
• TABLE 5.1 KEY ORAL DRUG DELIVERY R&D PIPELINE DRUGS, 2008 144
• TABLE 6.1 KEY INHALABLE DRUG DELIVERY R&D PIPELINE DRUGS, 2008 167
• TABLE 7.1 KEY INJECTABLE DRUG DELIVERY R&D PIPELINE DRUGS, 2008 176
• TABLE 8.1 KEY TRANSMUCOSAL DRUG DELIVERY R&D PIPELINE DRUGS, 2008 188
• TABLE 9.1 KEY TRANSDERMAL DRUG DELIVERY R&D PIPELINE DRUGS, 2008 197
• TABLE 10.1 KEY TOPICAL DRUG DELIVERY R&D PIPELINE DRUGS, 2008 209
• TABLE 10.2 KEY NICHE DRUG DELIVERY R&D PIPELINE DRUGS, 2008 210
• TABLE 11.1 3M KEY FINANCIALS, 2003-2007 (US$MN) 224
• TABLE 11.2 3M DRUG DELIVERY PORTFOLIO, 2008 225
• TABLE 11.3 ALKERMES KEY FINANCIALS, 2003-2007 (US$MN) 226
• TABLE 11.4 ALKERMES DRUG DELIVERY PORTFOLIO, 2008 227
• TABLE 11.5 ALTEA THERAPEUTICS DRUG DELIVERY PORTFOLIO, 2008 228
• TABLE 11.6 ALZA DRUG DELIVERY PORTFOLIO, 2008 229
• TABLE 11.7 ARADIGM KEY FINANCIALS, 2003-2007 (US$MN) 231
• TABLE 11.8 ARADIGM DRUG DELIVERY PORTFOLIO, 2008 232
• TABLE 11.9 BIOJECT KEY FINANCIALS, 2003-2007 (US$MN) 233
• TABLE 11.10 BIOJECT DRUG DELIVERY PORTFOLIO, 2008 233
• TABLE 11.11 BIOVAIL KEY FINANCIALS, 2003-2007 (US$MN) 234
• TABLE 11.12 BIOVAIL DRUG DELIVERY PORTFOLIO, 2008 235
• TABLE 11.13 CARDINAL HEALTH KEY FINANCIALS, 2003-2007 (US$MN) 236
• TABLE 11.14 CARDINAL HEALTH DRUG DELIVERY PORTFOLIO, 2008 237
• TABLE 11.15 CEPHALON KEY FINANCIALS, 2003-2007 (US$MN) 238
• TABLE 11.16 CIMA LABS DRUG DELIVERY PORTFOLIO, 2008 238
• TABLE 11.17 CONNETICS KEY FINANCIALS, 2003-2007 (US$MN) 240
• TABLE 11.18 CONNETICS DRUG DELIVERY PORTFOLIO, 2008 240
• TABLE 11.19 CYDEX DRUG DELIVERY PIPELINE, 2008 242
• TABLE 11.20 CARRINGTON LABORATORIES KEY FINANCIALS, 2003-2007 (US$MN) 243
• TABLE 11.21 DEPOMED KEY FINANCIALS, 2003-2007 (US$MN) 244
• TABLE 11.22 DEPOMED DRUG DELIVERY PORTFOLIO, 2008 245
• TABLE 11.23 DOR BIOPHARMA KEY FINANCIALS, 2003-2007 (US$MN) 246
• TABLE 11.24 DOR BIOPHARMA DRUG DELIVERY PORTFOLIO, 2008 246
• TABLE 11.25 DURECT KEY FINANCIALS, 2003-2007 (US$MN) 247
• TABLE 11.26 DURECT DRUG DELIVERY PORTFOLIO, 2008 248
• TABLE 11.27 EMISPHERE KEY FINANCIALS, 2003-2007 (US$MN) 249
• TABLE 11.28 EMISPHERE DRUG DELIVERY PORTFOLIO, 2008 250
• TABLE 11.29 ENZON KEY FINANCIALS, 2003-2007 (US$MN) 251
• TABLE 11.30 ENZON DRUG DELIVERY PORTFOLIO, 2008 252
• TABLE 11.31 ETHYPHARM DRUG DELIVERY PORTFOLIO, 2008 253
• TABLE 11.32 EURAND KEY FINANCIALS, 2003-2007 (US$MN) 255
• TABLE 11.33 EURAND DRUG DELIVERY PORTFOLIO, 2008 256
• TABLE 11.34 GENEREX KEY FINANCIALS, 2003-2007 (US$MN) 257
• TABLE 11.35 GENEREX DRUG DELIVERY PORTFOLIO, 2008 257
• TABLE 11.36 INOVIO KEY FINANCIALS, 2003-2007 (US$MN) 258
• TABLE 11.37 INOVIO DRUG DELIVERY PORTFOLIO, 2008 259
• TABLE 11.38 IVAX KEY FINANCIALS, 2003-2007 (US$MN) 261
• TABLE 11.39 IVAX DRUG DELIVERY PORTFOLIO, 2008 262
• TABLE 11.40 MACROCHEM KEY FINANCIALS, 2003-2007 (US$MN) 263
• TABLE 11.41 MACROCHEM DRUG DELIVERY PORTFOLIO, 2008 263
• TABLE 11.42 MACROMED DRUG DELIVERY PORTFOLIO, 2008 264
• TABLE 11.43 NASTECH KEY FINANCIALS, 2003-2007 (US$MN) 265
• TABLE 11.44 NASTECH DRUG DELIVERY PORTFOLIO, 2008 266
• TABLE 11.45 NEKTAR KEY FINANCIALS, 2003-2007 (US$MN) 267
• TABLE 11.46 NEKTAR DRUG DELIVERY PORTFOLIO, 2008 267
• TABLE 11.47 NEXMED KEY FINANCIALS, 2003-2007 (US$MN) 269
• TABLE 11.48 NEXMED DRUG DELIVERY PORTFOLIO, 2008 270
• TABLE 11.49 NOVEN KEY FINANCIALS, 2003-2007 (US$MN) 271
• TABLE 11.50 NOVEN DRUG DELIVERY PORTFOLIO, 2008 271
• TABLE 11.51 PSIVIDA KEY FINANCIALS, 2003-2007 (US$MN) 273
• TABLE 11.52 PSIVIDA DRUG DELIVERY PORTFOLIO, 2008 273
• TABLE 11.53 PENWEST KEY FINANCIALS, 2003-2007 (US$MN) 274
• TABLE 11.54 PENWEST DRUG DELIVERY PORTFOLIO, 2008 275
• TABLE 11.55 PHERIN PHARMACEUTICALS DRUG DELIVERY PORTFOLIO, 2008 276
• TABLE 11.56 QLT KEY FINANCIALS, 2003-2007 (US$MN) 277
• TABLE 11.57 QLT DRUG DELIVERY PORTFOLIO, 2008 278
• TABLE 11.58 SKYE PHARMA KEY FINANCIALS, 2003-2007 (US$MN) 279
• TABLE 11.59 SKYEPHARMA DRUG DELIVERY PORTFOLIO, 2008 280
• TABLE 11.60 WATSON KEY FINANCIALS, 2003-2007 (US$MN) 281
• TABLE 11.61 WATSON PHARMACEUTICALS DRUG DELIVERY PORTFOLIO, 2008 282
• TABLE 11.62 ZOGENIX PHARMACEUTICALS DRUG DELIVERY PORTFOLIO, 2008 283

Graphs

• GRAPH 3.1 ESTIMATED DRUG DELIVERY MARKET BY MAIN GEOGRAPHIC REGIONS 71
• GRAPH 3.2 GLOBAL SALES OF DRUG DELIVERY SYSTEMS BY KEY SEGMENTS, 2007 73
• GRAPH 3.3 FORECAST GLOBAL SALES OF DRUG DELIVERY MARKET BY SEGMENT, US$ BILLION 75
• GRAPH 3.4 FORECAST 2007-2012 GROWTH OF GLOBAL DRUG DELIVERY MARKET BY SEGMENT 76
• GRAPH 4.1 TOP 5 PRODUCTS UTILIZING ORAL DELIVERY, GLOBAL SALES 2007 ($ MN) 82
• GRAPH 4.2 LEADING ORAL DRUG DELIVERY COMPANIES, COMBINED KEY PRODUCT VALUES 2007 ($ MN) 84
• GRAPH 4.3 KEY THERAPEUTIC AREAS OF EMPHASIS FOR ORAL DRUG DELIVERY, # OF KEY MARKETED PRODUCTS, 2007 85
• GRAPH 4.4 TOP 5 PRODUCTS UTILIZING INHALABLE DELIVERY, GLOBAL SALES 2007 ($ MN) 96
• GRAPH 4.5 INHALABLE DRUG DELIVERY MARKET SHARE, BY TECHNOLOGY 2007 96
• GRAPH 4.6 TOP 5 PRODUCTS UTILIZING INJECTABLE DELIVERY, GLOBAL SALES 2007 ($ MN) 108
• GRAPH 4.7 LEADING INJECTABLE DRUG DELIVERY COMPANIES, COMBINED KEY PRODUCT VALUES 2007 ($ MN) 110
• GRAPH 4.8 TOP 5 PRODUCTS UTILIZING TRANSMUCOSAL DELIVERY, GLOBAL SALES 2007 ($ MN) 119
• GRAPH 4.9 LEADING DEVELOPERS OF TRANSMUCOSAL-BASED THERAPEUTICS 2007 ($ MN) 120
• GRAPH 4.10 LEADING TRANSDERMAL DRUG DELIVERY COMPANIES, BY # OF PRODUCTS ON MARKET 130
• GRAPH 4.11 KEY THERAPEUTIC AREAS OF EMPHASIS FOR TRANSDERMAL DRUG DELIVERY, # OF KEY MARKETED PRODUCTS 131
• GRAPH 5.1 LEADING COMPANIES ACTIVE IN ORAL DRUG DELIVERY DEVELOPMENT 150
• GRAPH 5.2 LEADING INDICATIONS FOR ORAL DRUG DELIVERY PRODUCTS IN DEVELOPMENT 151
• GRAPH 6.1 LEADING COMPANIES ACTIVE IN INHALABLE DRUG DELIVERY DEVELOPMENT 168
• GRAPH 7.1 LEADING COMPANIES ACTIVE IN INJECTABLE DRUG DELIVERY DEVELOPMENT 179
• GRAPH 8.1 LEADING COMPANIES ACTIVE IN INJECTABLE DRUG DELIVERY DEVELOPMENT 189
• GRAPH 9.1 LEADING COMPANIES ACTIVE IN TRANSDERMAL DRUG DELIVERY DEVELOPMENT 198
• GRAPH 10.1 LEADING COMPANIES ACTIVE IN NICHE/TOPICAL DRUG DELIVERY DEVELOPMENT 211

Figures

• FIGURE 1.1 OPTIMAL TIME FOR REFORMULATION 19
• FIGURE 1.2 GROWTH PROSPECTS IN THE DRUG DELIVERY SECTOR 21
• FIGURE 2.1 PULSATILE DRUG RELEASE 34