Breakthrough Pain - Fast-acting players will capture majority market share
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Central Nervous System pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the breakthrough pain market - page 4
- Summary - page 5
- CHAPTER 2 PATIENT POTENTIAL - page 15
- Definition of breakthrough pain - page 15
- Epidemiology of breakthrough pain - page 16
- Breakthrough cancer pain - page 16
- Breakthrough pain is more prevalent in advanced cancer stages - page 16
- Patients have between four to seven episodes per day - page 17
- Breakthrough pain is a common cause of hospital admissions - page 18
- Breakthrough pain in non-malignant diseases - page 18
- Breakthrough pain also occurs in neuropathic, musculoskeletal, visceral and postoperative pain syndromes - page 18
- Breakthrough cancer pain - page 16
- Market sizing assumptions and caveats - page 19
- Unmet need in breakthrough pain - page 21
- Need for an analgesic that acts rapidly, predictably, and just for the duration of a breakthrough pain episode - page 22
- Need for quick, simple, and safe drug administration - page 26
- Need for improved convenience, cost, and safety of patient-controlled analgesia - page 27
- Need to reduce the abuse and overdosing potential of opioids - page 28
- Need to minimize opioid-related adverse events - page 29
- Need for standardized diagnosis and assessment tools for breakthrough pain - page 30
- CHAPTER 3 R&D APPROACH - page 33
- Classification of pipeline products - page 33
- Majority of pipeline products are reformulations of existing opioids - page 33
- Oral transmucosal opioids - page 33
- Oral inhaled opioids - page 34
- Intranasal opioids - page 34
- Subcutaneous opioids - page 34
- Transdermal opioids - page 35
- Majority of pipeline products are reformulations of existing opioids - page 33
- Clinical trial design in breakthrough pain - page 35
- Actiq clinical trials set the standard - page 35
- Actiq pivotal trial overview - page 36
- Clinical trial endpoints in breakthrough pain - page 41
- Primary endpoints: the Brief Pain Inventory is often used to assess pain in cancer patients - page 41
- Secondary endpoints: economic and quality-of-life measures are important - page 41
- Classification of pipeline products - page 33
- CHAPTER 4 BREAKTHROUGH PAIN PIPELINE ANALYSIS - page 43
- Pipeline overview - page 43
- The success of Actiq and established efficacy make fentanyl a popular target - page 43
- Key companies involved in the breakthrough pain pipeline - page 47
- Cephalon: leading the way in breakthrough pain - page 47
- Strong CNS focus is good for market growth - page 47
- Follow-on drug strategy can offset generic incursion - page 48
- Drug delivery expertise provides positive long term outlook - page 49
- Leverage oncology resource to reach out to key treatment decision makers - page 49
- Cephalon: leading the way in breakthrough pain - page 47
- Strategies for success - page 50
- Broaden customer base with key additional indications - page 51
- Back pain - page 52
- Postoperative pain - page 53
- Neuropathic pain - page 53
- Osteoarthritis - page 53
- Refractory migraine - page 54
- Broaden customer base with key additional indications - page 51
- Pipeline overview - page 43
- CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS - page 56
- Overview - page 56
- Late stage pipeline summary - page 56
- Definition of current comparator therapy - page 57
- Comparison of key compounds - page 60
- Comparative forecasts - page 60
- Fentora - page 61
- Profile - page 61
- Drug overview - page 61
- Clinical trial data - page 62
- Patient potential - page 67
- Marketing factors - page 69
- Satisfaction of unmet needs - page 70
- Forecasts to 2016 - page 71
- Datamonitor drug assessment summary - page 72
- Profile - page 61
- Rapinyl - page 73
- Profile - page 73
- Drug overview - page 73
- Clinical trial data - page 74
- Patient potential - page 74
- Marketing factors - page 75
- Satisfaction of unmet needs - page 77
- Forecasts to 2016 - page 77
- Datamonitor drug assessment summary - page 79
- Profile - page 73
- BEMA Fentanyl - page 79
- Profile - page 79
- Drug overview - page 79
- Clinical trial data - page 80
- Patient potential - page 81
- Marketing factors - page 82
- Satisfaction of unmet needs - page 82
- Forecasts to 2016 - page 83
- Datamonitor drug assessment summary - page 84
- Profile - page 79
- Intranasal morphine gluconate, Nastech - page 85
- Profile - page 85
- Drug overview - page 85
- Clinical trial data - page 86
- Patient potential - page 88
- Marketing factors - page 88
- Satisfaction of unmet needs - page 89
- Forecasts to 2016 - page 89
- Datamonitor drug assessment summary - page 91
- Profile - page 85
- Rylomine (intranasal morphine) - page 91
- Profile - page 91
- Drug overview - page 91
- Clinical trial data - page 92
- Patient potential - page 93
- Marketing factors - page 94
- Satisfaction of unmet needs - page 95
- Forecasts to 2016 - page 95
- Datamonitor drug assessment summary - page 96
- Profile - page 91
- PMI-150 (intranasal ketamine) - page 97
- Profile - page 97
- Drug overview - page 97
- Clinical trial data - page 98
- Patient potential - page 101
- Marketing factors - page 101
- Satisfaction of unmet needs - page 102
- Forecasts to 2016 - page 102
- Datamonitor drug assessment summary - page 103
- Profile - page 97
- Fentanyl Taifun (oral inhaled fentanyl) - page 104
- Profile - page 104
- Drug overview - page 104
- Clinical trial data - page 105
- Patient potential - page 106
- Marketing factors - page 107
- Satisfaction of unmet needs - page 108
- Forecasts to 2016 - page 108
- Datamonitor drug assessment summary - page 110
- Profile - page 104
- AeroLEF (oral inhaled fentanyl) - page 110
- Profile - page 110
- Drug overview - page 110
- Clinical trial data - page 111
- Patient potential - page 113
- Marketing factors - page 114
- Satisfaction of unmet needs - page 114
- Forecasts to 2016 - page 115
- Datamonitor drug assessment summary - page 116
- Profile - page 110
- Other drugs - page 117
- Titragesia (transdermal fentanyl patch) - page 117
- Pain pen (subcutaneous hydromorphone injection) - page 118
- TPM-01 (transdermal morphine cream) - page 119
- AD-923 (sublingual fentanyl) - page 119
- Nasalfent (intranasal fentanyl) - page 120
- Overview - page 56
- BIBLIOGRAPHY - page 121
- Journal articles and conference abstracts - page 121
- Websites - page 129
- APPENDIX A - page 131
- Contributing experts - page 131
- Sales forecasts - page 132
- Competitive positioning analysis of pipeline breakthrough pain drugs - page 133
- Methodology - page 134
- Datamonitor forecast methodology and assumptions - page 134
- Product forecasts - page 134
- Estimation of launch dates - page 134
- Patient expiry and generic assumptions - page 134
- Definition of a standard unit - page 136
- Datamonitor forecast methodology and assumptions - page 134
- APPENDIX B - page 137
- About Datamonitor - page 137
- About Datamonitor Healthcare - page 137
- Datamonitor Healthcare's therapy area capabilities - page 138
- About the CNS analysis team - page 139
- Disclaimer - page 140
- About Datamonitor - page 137
- List of Tables
- Table 1: Prevalence of breakthrough pain across the seven major markets, 2006 - page 16
- Table 2: Estimation of the breakthrough pain market across the seven major markets, 2005 - page 19
- Table 3: Characteristics of immediate-release opioids useful for breakthrough pain - page 23
- Table 4: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain - page 30
- Table 5: Characteristics of patients enrolled in the Farrar et al. (1998) Actiq trial - page 37
- Table 6: Number of R&D projects in each class split by mode of delivery, 2006 - page 43
- Table 7: Clinical R&D pipeline for breakthrough pain drugs, 2006 - page 44
- Table 8: Cephalon's inline and pipeline pain product range, 2006 - page 48
- Table 9: Key products in late-stage R&D pipeline for breakthrough pain, 2006 - page 56
- Table 10: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain - page 58
- Table 11: Pharmacokinetic parameters in adult subjects receiving the various doses of Actiq - page 59
- Table 12: Fentora product claims on www.fentora.com - page 62
- Table 13: Key approval and launch dates impacting Fentora's revenue forecast, 2006-2016 - page 71
- Table 14: Key approval and launch dates impacting Rapinyl's revenue forecast, 2006-2016 - page 78
- Table 15: BEMA technology product claims taken from BioDelivery Sciences's website - page 80
- Table 16: Key approval and launch dates impacting BEMA Fentanyl revenue forecast, 2006-2016 - page 83
- Table 17: Key approval and launch dates impacting intranasal morphine gluconate revenue forecast, 2006-2016 - page 90
- Table 18: Key approval and launch dates impacting Rylomine revenue forecast, 2006-2016 - page 95
- Table 19: Key approval and launch dates impacting PMI-150 revenue forecast, 2006-2016 - page 102
- Table 20: Key approval and launch dates impacting Fentanyl Taifun revenue forecast, 2006-2016 - page 109
- Table 21: Key approval and launch dates impacting AeroLEF revenue forecast, 2006-2016 - page 115
- Table 22: Datamonitor's forecast sales of pipeline breakthrough pain drugs and the total breakthrough pain market across the seven major markets ($m), 2006-2016 - page 132
- Table 23: Summary of commercial and research/clinical attractiveness of late-stage drugs for breakthrough pain - page 133
- Table 24: Estimation of launch dates by phase of development - page 134
- Table 25: Estimated generic discounts by country, 2006* - page 135
- Table 26: Estimates of brand erosion by following patent expiry by country - page 135
- List of Figures
- Figure 1: Datamonitor's breakthrough pain forecast market across the seven major markets, 2006-2016 - page 5
- Figure 2: Datamonitor breakthrough pain drug assessment summary, 2006-2016 - page 6
- Figure 3: The different types of breakthrough pain - page 17
- Figure 4: The current versus ideal approach to breakthrough pain treatment - page 24
- Figure 5: Onset of action versus duration of action of opioid formulations - page 25
- Figure 6: Actiq study design - page 40
- Figure 7: Breakthrough pain drug pipeline by development phase and formulation, 2006 - page 46
- Figure 8: Breakdown of the breakthrough pain pipeline by formulation, 2006 - page 46
- Figure 9: Breakdown of the pipeline by molecule, 2006 - page 47
- Figure 10: Difference in pain intensity between Actiq and placebo (ITT analysis) - page 57
- Figure 11: Pain relief of Actiq versus placebo (ITT analysis) - page 58
- Figure 12: Datamonitor's comparative forecast of sales for key products across the seven major markets ($m), 2006-2016 - page 60
- Figure 13: Pain intensity difference of Fentora versus placebo over time - page 63
- Figure 14: Comparison of pain intensity difference scores of Actiq versus Fentora - page 65
- Figure 15: Datamonitor's forecast of sales for Fentora across the seven major markets ($m), 2006-2016 - page 72
- Figure 16: Datamonitor's competitive positioning analysis for Fentora, 2006-2016 - page 73
- Figure 17: Datamonitor's forecast of sales for Rapinyl across the seven major markets ($m), 2006-2016 - page 78
- Figure 18: Datamonitor's competitive positioning analysis for Rapinyl, 2006-2016 - page 79
- Figure 19: Datamonitor's forecast of sales for BEMA Fentanyl across the seven major markets ($m), 2006-2016 - page 84
- Figure 20: Datamonitor's competitive positioning analysis for BEMA Fentanyl, 2006-2016 - page 85
- Figure 21: Datamonitor's forecast of sales for Intranasal morphine gluconate across the seven major markets ($m), 2006-2016 - page 90
- Figure 22: Datamonitor's competitive positioning analysis for Intranasal morphine gluconate, 2006-2016 - page 91
- Figure 23: Datamonitor's forecast of sales for Rylomine across the seven major markets ($m), 2006-2016 - page 96
- Figure 24: Datamonitor's competitive positioning analysis for Rylomine, 2006-2016 - page 97
- Figure 25: PMI-150 study design - page 99
- Figure 26: Datamonitor's forecast of sales for PMI-150 across the seven major markets ($m), 2006-2016 - page 103
- Figure 27: Datamonitor's competitive positioning analysis for PMI-150, 2006-2016 - page 104
- Figure 28: Datamonitor's forecast of sales for Fentanyl Taifun across the seven major markets ($m), 2006-2016 - page 109
- Figure 29: Datamonitor's competitive positioning analysis for Fentanyl Taifun, 2006-2016 - page 110
- Figure 30: Datamonitor's forecast of sales for AeroLEF across the seven major markets ($m), 2006-2016 - page 116
- Figure 31: Datamonitor's competitive positioning analysis for AeroLEF, 2006-2016 - page 117
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