Commercial and Pipeline Insight: Opioids - Short acting and anti-abuse technologies set to fragment
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Contributing experts - page 3
- Datamonitor insight into the opioid market - page 4
- Related reports - page 6
- CHAPTER 2 MARKET OVERVIEW AND POTENTIAL - page 8
- Market overview and pain definition - page 9
- Definition of opioid market - page 9
- Market potential - page 10
- Epidemiology of pain - page 10
- Incidence - page 10
- The burden of pain on every day life - page 10
- Commonly-reported pain conditions - page 10
- Definition of pain - page 11
- Nociceptive pain - page 11
- Neuropathic pain - page 12
- Types of pain treated with opioids - page 13
- Diagnosis of pain - page 14
- Treatment of pain - page 15
- Acute pain and cancer pain - page 15
- Chronic non-cancer pain - page 16
- Unmet need in pain treatment - page 17
- Need to reduce the abuse and overdosing potential of opioids - page 18
- Need to minimize opioid-related adverse events - page 19
- Improved short-acting opioids - page 20
- Epidemiology of pain - page 10
- Current market value and future market forecasts - page 26
- Current market dynamics - page 26
- OxyContin dominates the opioid market - page 26
- The US generated more revenue from opioid therapies than the EU and Japan combined - page 27
- The opioid market is set to grow throughout the forecast period - page 29
- Short-acting opioids-large growth driver - page 30
- Anti-abuse reformulations take share from OxyContin - page 32
- Generics are ever present - page 33
- Current market dynamics - page 26
- Market overview and pain definition - page 9
- CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES - page 34
- Marketed brands overview - page 35
- Short-acting opioid brands - page 36
- Actiq (fentanyl oral transmucosal) - page 36
- Drug overview - page 36
- Forecasts to 2017 - page 36
- SWOT analysis - page 38
- Clinical trial data - page 38
- Fentora - page 40
- Drug overview - page 40
- Forecasts to 2017 - page 40
- SWOT analysis - page 44
- Patient potential - page 44
- Marketing factors - page 44
- Clinical trial data - page 45
- Actiq (fentanyl oral transmucosal) - page 36
- Long-acting opioid brand - page 47
- OxyContin (oxycodone HCl controlled-release) - page 47
- Drug overview - page 47
- Forecasts to 2017 - page 48
- SWOT analysis - page 51
- Clinical trial data - page 51
- Kadian (morphine sulfate XR) - page 55
- Drug overview - page 55
- Forecasts to 2017 - page 55
- SWOT analysis - page 57
- Clinical trial data - page 57
- Avinza (morphine sulfate XR) - page 59
- Drug overview - page 59
- Forecasts to 2017 - page 59
- SWOT analysis - page 61
- Clinical trial data - page 61
- Duragesic (fentanyl transdermal patch) - page 63
- Drug overview - page 63
- Forecasts to 2017 - page 64
- SWOT analysis - page 66
- Clinical trial data - page 66
- Opana - page 68
- Drug overview - page 68
- Forecasts to 2017 - page 69
- SWOT analysis - page 70
- Clinical trial data - page 70
- OxyContin (oxycodone HCl controlled-release) - page 47
- CHAPTER 4 FORECAST ANALYSIS - page 72
- Key events - page 73
- New product launches - page 74
- Key drug launch assumptions - page 74
- Product launches in Japan - page 75
- Patent expiries - page 76
- New product launches - page 74
- Data definitions, limitations and assumptions - page 76
- Standard units - page 76
- Japanese market data - page 76
- Derivation of sales forecasts and pricing trends - page 77
- Forecast methodology - page 77
- Key events - page 73
- CHAPTER 5 STRATEGIES FOR SUCCESS - page 78
- Broaden customer base with key additional indications - page 79
- Back pain - page 80
- Postoperative pain - page 80
- Neuropathic pain - page 81
- Osteoarthritis - page 81
- Refractory migraine - page 82
- Opportunities for specialized niche companies to enter the market - page 82
- Delivery reformulation - page 83
- Anti-abuse technologies - page 86
- Broaden customer base with key additional indications - page 79
- CHAPTER 6 PIPELINE OVERVIEW-R&D DYNAMICS AND APPROACH - page 87
- Pipeline overview - page 88
- Classification of pipeline products - page 91
- Majority of pipeline products are reformulations of existing opioids - page 91
- Short-acting opioids - page 91
- Oral transmucosal opioids - page 91
- Intranasal opioids - page 92
- Oral inhaled opioids - page 92
- Long-acting opioids - page 93
- Oral opioids - page 93
- Subcutaneous opioids - page 93
- Transdermal opioids - page 93
- Clinical trial design - page 94
- Actiq clinical trials set the standard - page 94
- Actiq pivotal trial overview - page 94
- Clinical trial endpoints in pain - page 100
- Primary endpoints: the brief pain inventory is often used to assess pain in cancer patients - page 100
- Secondary endpoints: economic and quality-of-life measures are important - page 100
- CHAPTER 7 SHORT-ACTING OPIOID DRUG ANALYSIS & FORECASTS - page 102
- Late-stage short-acting pipeline overview - page 103
- Fentanyl based formulations - page 105
- Rapinyl (sublingual) - page 106
- Drug overview - page 106
- Forecasts to 2017 - page 106
- Marketing potential - page 109
- Patient potential - page 111
- Satisfaction of unmet needs - page 111
- Clinical trial data - page 112
- BEMA fentanyl (buccal) - page 112
- Drug overview - page 112
- Forecasts to 2017 - page 113
- Marketing factors - page 116
- Patient potential - page 117
- Satisfaction of unmet needs - page 118
- Clinical trial data - page 118
- Instanyl (intranasal) - page 119
- Drug overview - page 119
- Forecasts to 2017 - page 119
- Marketing potential - page 121
- Patient potential - page 122
- Satisfaction of unmet needs - page 122
- Clinical trial data - page 123
- Nasalfent (intranasal) - page 123
- Drug overview - page 123
- Forecasts to 2017 - page 123
- Marketing potential - page 125
- Patient potential - page 126
- Satisfaction of unmet needs - page 126
- Clinical data - page 126
- AD-923 (sublingual spray) - page 127
- Drug overview - page 127
- Ongoing clinical trial program - page 128
- Forecasts to 2017 - page 128
- HFT-290 (transdermal) - page 130
- Rapinyl (sublingual) - page 106
- Morphine-based formulations - page 131
- Rylomine (intranasal) - page 131
- Drug overview - page 131
- Forecasts to 2017 - page 131
- Marketing potential - page 133
- Patient potential - page 134
- Satisfaction of unmet needs - page 134
- Clinical trial data - page 134
- Rylomine (intranasal) - page 131
- Buprenorphine based formulations - page 135
- V1003 (intranasal) - page 135
- Drug overview - page 135
- Forecasts to 2017 - page 136
- Marketing potential - page 138
- Patient potential - page 138
- Clinical trial data - page 139
- BEMA LA (buccal) - page 140
- Drug overview - page 140
- Clinical trial data - page 140
- V1003 (intranasal) - page 135
- Drugs on hold - page 141
- Taifun (inhaled) - page 141
- Drug overview - page 141
- Marketing potential - page 141
- Patient potential - page 142
- Satisfaction of unmet needs - page 143
- Clinical trial data - page 143
- AeroLEF (inhaled) - page 144
- Drug overview - page 144
- Marketing potential - page 145
- Patient potential - page 146
- Satisfaction of unmet needs - page 146
- Clinical trial data - page 147
- Taifun (inhaled) - page 141
- CHAPTER 8 LONG-ACTING OPIOID DRUG ANALYSIS & FORECASTS - page 149
- Late-stage long-acting pipeline overview - page 150
- Oxycodone based formulations - page 153
- Remoxy (oxycodone) - page 153
- Drug overview - page 153
- Forecasts to 2017 - page 154
- Marketing potential - page 156
- Patient potential - page 157
- Satisfaction of unmet needs - page 157
- Clinical trial data - page 157
- Oxytrex (oxycodone and naltrexone) - page 158
- Drug overview - page 158
- Forecasts to 2017 - page 158
- Marketing potential - page 161
- Patient potential - page 161
- Satisfaction of unmet needs - page 162
- Ongoing clinical trial program - page 162
- ELI-216 (naltrexone hydrochloride, oxycodone) - page 162
- Drug overview - page 162
- Marketing potential - page 163
- Patient potential - page 163
- Ongoing clinical trial program - page 163
- Acurox/OxyADF (oxycodone) tablet - page 164
- Drug overview - page 164
- Clinical trial data - page 165
- Remoxy (oxycodone) - page 153
- Morphine-based formulations - page 167
- Embeda (morphine sulfate, naltrexone hydrochloride) - page 167
- Drug overview - page 167
- Forecasts to 2017 - page 167
- Marketing potential - page 170
- Patient potential - page 170
- Satisfaction of unmet needs - page 171
- Clinical trial data - page 171
- Morphine-6-glucuronide (M6G) - page 171
- Drug overview - page 171
- Forecasts to 2017 - page 172
- Marketing potential - page 173
- Patient potential - page 174
- Clinical trial data - page 174
- Egalet morphine (morphine) - page 176
- EpiCept MP/DP (morphine, lidocaine) - page 177
- Drug overview - page 177
- Embeda (morphine sulfate, naltrexone hydrochloride) - page 167
- Tramadol-based formulations - page 177
- Tapentadol - page 177
- Drug overview - page 177
- Forecasts to 2017 - page 178
- Marketing potential - page 180
- Patient potential - page 180
- Clinical trial data - page 181
- Tramadol ER - page 182
- Drug overview - page 182
- Forecasts to 2017 - page 182
- Clinical trial data - page 182
- NS-315 (tramadol hydrochloride) - page 183
- Drug overview - page 183
- BVF-146 (tramadol in combination with NSAID) - page 183
- Tapentadol - page 177
- Other - page 184
- Ionsys (transdermal delivery system) - page 184
- Drug overview - page 184
- Forecasts to 2017 - page 184
- Marketing potential - page 185
- Patient potential - page 185
- Clinical trial data - page 186
- Sufentanil patch - page 188
- Drug overview - page 188
- Forecasts to 2017 - page 188
- Clinical trial data - page 189
- Vicodin CR - page 190
- Drug overview - page 190
- Forecasts to 2017 - page 190
- Hydromorphone nasal spray - page 192
- Drug overview - page 192
- Clinical trial data - page 193
- Q8003IR (morphine and oxycodone) - page 193
- Drug overview - page 193
- Clinical trial data - page 194
- ADL-5859 - page 194
- Drug overview - page 194
- Clinical trial data - page 195
- Nalbuphine ER - page 195
- Drug overview - page 195
- Clinical trial data - page 196
- NRP-290 - page 196
- Drug overview - page 196
- Clinical trial data - page 196
- MGX-001 - page 197
- Drug overview - page 197
- Ionsys (transdermal delivery system) - page 184
- Suspended drugs - page 197
- Titragesia (fentanyl) - page 197
- CHAPTER 9 EARLY-STAGE PROJECTS - page 198
- Key Phase I and earlier opioids in development - page 199
- Phase I overview - page 199
- TPM-01/ Morphine - page 200
- CR665 - page 200
- Clinical trial data - page 200
- Key Phase I and earlier opioids in development - page 199
- BIBLIOGRAPHY - page 202
- Journal papers - page 202
- Websites - page 207
- DM reports - page 215
- APPENDIX - page 216
- Report methodology - page 216
- Contributing experts - page 218
- About Datamonitor - page 218
- About Datamonitor Healthcare - page 218
- About the CNS team - page 219
- Disclaimer - page 220
- Report methodology - page 216
- List of Tables
- Table 1: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain - page 19
- Table 2: Characteristics of immediate-release opioids useful for breakthrough pain - page 21
- Table 3: Side effects experienced in OxyContin clinical trials - page 53
- Table 4: Forecast launch dates in the US and 5EU - page 74
- Table 5: Forecast launch dates in Japan - page 75
- Table 6: Pivotal patent expiries for key marketed drugs in the US and 5EU - page 76
- Table 7: Key pipeline opioids in late-stage development , 2008 - page 89
- Table 8: Characteristics of patients enrolled in the Farrar Actiq trial - page 96
- Table 9: Key short-acting opioids in late-stage development, 2008 - page 105
- Table 10: Key long-acting opioids in late stage development, 2008 - page 152
- Table 11: Opioids in Phase development, 2008 - page 199
- Table 12: Datamonitor drug assessment parameters - page 217
- List of Figures
- Figure 1: Historical (2006) and forecast (2007-17) sales revenue for key marketed and pipeline opioids across the 7MM - page 6
- Figure 2: Key unmet needs in the opioid market - page 17
- Figure 3: The current versus ideal approach to breakthrough pain treatment - page 22
- Figure 4: Onset of action versus duration of action of opioid formulations - page 23
- Figure 5: Opioid sales revenue trend, 7MM, 2004-E2007 - page 26
- Figure 6: Estimated sales revenue generated by opioids per molecule, 2007 - page 27
- Figure 7: Opioid sales by revenue, by region and country, 2006-17 - page 28
- Figure 8: Opioid total market value in the US, Japan and 5EU split by molecule, 2006-17 - page 29
- Figure 9: Opioid total market value in the US, Japan and 5EU, 2006-17 - page 30
- Figure 10: Short-acting opioids sales revenue ($m), 7MM, 2006-17 - page 31
- Figure 11: Sales revenue ($m) of key long-acting opioids, 2006-17 - page 32
- Figure 12: Historical sales revenue (2006-07) and forecast sales revenue (2008-17) for key opioids across the 7MM - page 35
- Figure 13: Actiq sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 37
- Figure 14: Actiq SWOT analysis - page 38
- Figure 15: Fentora sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 42
- Figure 16: Drug assessment summary for Fentora, 2008 - page 43
- Figure 17: Fentora SWOT analysis - page 44
- Figure 18: OxyContin sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 49
- Figure 19: Drug assessment summary for OxyContin, 2008 - page 50
- Figure 20: OxyContin SWOT analysis - page 51
- Figure 21: Kadian sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 56
- Figure 22: Kadian SWOT analysis - page 57
- Figure 23: Avinza sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 60
- Figure 24: Avinza SWOT analysis - page 61
- Figure 25: Duragesic sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 65
- Figure 26: Duragesic SWOT analysis - page 66
- Figure 27: Opana franchise sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 69
- Figure 28: Opana ER SWOT analysis - page 70
- Figure 29: Impact of each key event on the opioid market across the seven major markets, 2007-12 - page 73
- Figure 30: Cephalon's breakthrough pain franchise, 2004-07 - page 84
- Figure 31: Cephalon's franchise as a percentage of Q1 2004 Standard Units - page 85
- Figure 32: Drugs in development by class, 2008+ - page 88
- Figure 33: Actiq study design - page 99
- Figure 34: Historical (2006), estimated (2007) and forecast (2008-17) sales revenue for key short-acting pipeline opioids across the 7MM - page 103
- Figure 35: Drug assessment summary overview of key pipeline short-acting opioids, 2008 - page 104
- Figure 36: Sales forecast for Rapinyl to 2017 in the 7MM - page 108
- Figure 37: Drug assessment summary for Rapinyl, 2008 - page 109
- Figure 38: Sales forecast for BEMA Fentanyl to 2017 in the 7MM - page 115
- Figure 39: Drug assessment summary for BEMA Fentanyl, 2008 - page 116
- Figure 40: Sales forecast for Instanyl to 2017 in the 7MM - page 120
- Figure 41: Drug assessment summary for Instanyl, 2008 - page 121
- Figure 42: Sales forecast for Nasalfent to 2017 in the 7MM - page 124
- Figure 43: Drug assessment summary for Nasalfent, 2008 - page 125
- Figure 44: Sales forecast for sublingual spray to 2017 in the 7MM - page 129
- Figure 45: Drug assessment summary for sublingual spray, 2008 - page 130
- Figure 46: Sales forecast for Rylomine to 2017 in the 7MM - page 132
- Figure 47: Drug assessment summary for Rylomine, 2008 - page 133
- Figure 48: Sales forecast for V1003 to 2017 in the 7MM - page 137
- Figure 49: Drug assessment summary for V1003, 2008 - page 138
- Figure 50: Key long-acting opioid late-stage pipeline overview, 2008 - page 150
- Figure 51: Drug assessment summary overview of key pipeline long-acting opioids, 2008 - page 151
- Figure 52: Sales forecast for Remoxy to 2017 in the 7MM - page 155
- Figure 53: Drug assessment summary for Remoxy, 2008 - page 156
- Figure 54: Sales forecast for Oxytrex to 2017 in the 7MM - page 160
- Figure 55: Drug assessment summary for Oxytrex, 2008 - page 161
- Figure 56: Sales forecast for Embeda to 2017 in the 7MM - page 169
- Figure 57: Drug assessment summary for Embeda, 2008 - page 170
- Figure 58: Sales forecast M6G to 2017 in the 7MM - page 172
- Figure 59: Drug assessment summary for M6G, 2008 - page 173
- Figure 60: Sales forecast for Tapentadol to 2017 in the 7MM - page 179
- Figure 61: Drug assessment summary for Tapentadol, 2008 - page 180
- Figure 62: Sales forecast for Ionsys to 2017 in the 7MM - page 185
- Figure 63: Sales forecast for the Sufentanil patch to 2017 in the 7MM - page 189
- Figure 64: Sales forecast for Vicodin CR to 2017 in the 7MM - page 191
- Figure 65: Drug assessment summary for Vicodin CR, 2008 - page 192
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