Pipeline Insight: Depression - Novel therapies key to market penetration
Introduction
With the global antidepressant market valued at $16.6 billion in 2002, drugs for the treatment of depression have historically provided huge returns on investment. However, several of the leading brands are expecting patent expiries over the next five years. New strategies are needed to prevent a decline in the antidepressant market.
Scope
- Detailed coverage of the patient potential, unmet needs, and clinical trial design of antidepressants across the seven major markets
- Overview of the drugs in preregistration, Phase III, II, I and preclinical development, with in-depth profiles of Organon and Dov Pharmaceutical
- Profiles of compounds undergoing development for depression, with sales forecasts to 2011, and insight into innovative early stage products
- Evaluation of key clinical trials in the treatment of depression, with revenue forecasts to 2011
Highlights
Duloxetine, Eli Lilly's follow-up compound to Prozac, is set to become the next drug to enter the antidepressant market. However, convincing physicians that it is superior to Wyeth's Effexor may prove challenging. Lilly needs to position duloxetine as an alternative first-line therapy to selective serotonin reuptake inhibitors (SSRIs).
Merck's NK1 receptor antagonist, aprepitant, is expected to be the first drug from another completely new class of antidepressants to hit the market. Its launch in 2006 will precipitate an influx of similar compounds to the market, presenting a major threat to the leading position of first-line therapy SSRIs.
Why you should buy this report
- Understand the depression market unmet needs to devise market-penetrating strategies
- Analyze the competitive environment at the time of product launch
- Identify in-licensing and co-promotional opportunities
Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the depression market - page 3
- Duloxetine, Eli Lilly’s follow-up compound to Prozac, is set to become the next drug to enter the antidepressant market. However, convincing physicians that it is an improvement on Wyeth’s Effexor may prove challenging. Lilly needs to position duloxetine as an alternative first-line therapy to SSRIs. Datamonitor forecasts revenues of $2.1 billion by 2011. - page 4
- Merck’s aprepitant is expected to be the first drug from the NK receptor antagonists, a completely new class of antidepressants, to hit the market. Its launch, in 2006, will precipitate an influx of similar compounds to the market, presenting a major threat to the leading position of first-line therapy SSRIs - page 5
- Despite the looming patent expiries of several leading antidepressants by 2008, pharmaceutical companies are finding it increasingly difficult to develop novel compounds to replace these products. New strategies are needed to prevent a decline in the antidepressant market. Companies need to begin focusing on the development of compounds with new modes of action and targeting treatment resistant patients. - page 7
- Key metrics - page 9
- CHAPTER 2 PATIENT POTENTIAL - page 11
- Introduction - page 11
- Definition of depression - page 11
- Segmentation of depression - page 12
- Epidemiology of depression - page 13
- MDD prevalence in the major markets - page 13
- Diagnosis and treatment - page 15
- Comorbid disorders - page 15
- Unmet need in depression - page 18
- Introduction - page 18
- Efficacy - page 19
- Improved side-effect profile - page 20
- Onset of action - page 21
- Other unmet needs - page 21
- CHAPTER 3 R&D APPROACH - page 24
- Classification of pipeline products - page 24
- Serotonergics - page 24
- Noradrenergics - page 26
- NK receptor antagonists - page 27
- Reversible monoamine oxidase inhibitors - page 28
- Novel therapies - page 29
- Clinical trial design in depression - page 30
- Patient population - page 30
- Placebo effect - page 31
- Duration - page 32
- Endpoints - page 33
- Clinical trial endpoints in depression - page 34
- Hamilton Rating Scale for Depression - page 34
- Hamilton Rating Scale for Anxiety - page 34
- Montgomery-Asberg Depression Rating Scale - page 34
- Clinical Global Impression Scale - page 35
- The Beck Depression Rating Scale - page 35
- The Zung Self-Rating Depression Scale - page 35
- Classification of pipeline products - page 24
- CHAPTER 4 DEPRESSION PIPELINE ANALYSIS - page 36
- Pipeline overview - page 36
- Preregistration overview - page 36
- Phase III overview - page 37
- Phase II overview - page 38
- Phase I overview - page 40
- Key companies involved in the depression pipeline - page 41
- Organon - page 41
- Dov Pharmaceutical - page 44
- Pipeline overview - page 36
- CHAPTER 5 SEROTONERGIC LATE-STAGE DRUG ANALYSIS & FORECASTS - page 47
- Overview for serotonergics - page 47
- Pipeline summary - page 47
- Definition of current comparator therapy - page 47
- Variza (gepirone) - page 48
- Profile - page 48
- Forecasts to 2011 - page 57
- Other serotonergics - page 59
- Alnespirone (S-20499) - page 59
- Elzasonan (CP 448,187) - page 60
- YKP-10A - page 60
- Late-stage development compounds recently discontinued - page 61
- DU-125530 - page 62
- Flibanserin (Ectris) - page 62
- Robalzotan (NAD 299) - page 63
- Vilazodone (EMD 68843 or SB659746A) - page 63
- Overview for serotonergics - page 47
- CHAPTER 6 NORADRENERGIC LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 64
- Overview for noradrenergics - page 64
- Pipeline summary - page 64
- Definition of current comparator therapy - page 64
- Cymbalta (duloxetine) - page 66
- Profile - page 66
- Forecasts to 2011 - page 76
- Overview for noradrenergics - page 64
- CHAPTER 7 NK RECEPTOR ANTAGONISTS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 80
- Overview for NK receptor antagonists - page 80
- Pipeline summary - page 80
- Aprepitant (MK869) - page 80
- Profile - page 80
- Patient potential - page 84
- Marketing factors - page 84
- Satisfaction of unmet needs - page 85
- Forecasts to 2011 - page 86
- Other NK receptor antagonists - page 88
- GW 597599 - page 88
- R637 - page 89
- TAK637 - page 89
- Saredutant (SR 48968) - page 89
- Osanetant (SR 142801) - page 90
- Late-stage development compounds recently discontinued - page 90
- Compound A - page 91
- CP-122721 - page 91
- Overview for NK receptor antagonists - page 80
- CHAPTER 8 REVERSIBLE MONOAMINE OXIDASE INHIBITORS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 93
- Overview for reversible monoamine oxidase inhibitors - page 93
- Pipeline summary - page 93
- Selegiline (EMSAM) - page 93
- Profile - page 93
- Satisfaction of unmet need - page 97
- Overview for reversible monoamine oxidase inhibitors - page 93
- CHAPTER 9 NOVEL THERAPIES - page 99
- Overview of ‘other’ novel therapies - page 99
- Wellbutrin XL (bupropion) - page 99
- Profile - page 99
- Vagus nerve stimulation (VNS) - page 101
- Profile - page 101
- Patient potential - page 108
- Marketing factors - page 108
- Satisfaction of unmet needs - page 109
- Nemifitide (INN 00835) - page 110
- Profile - page 110
- Satisfaction of unmet needs - page 117
- Forecasts to 2011 - page 118
- OPC-14523 - page 120
- Dov 216,303 - page 121
- AMPAKINE (Org 24448) - page 122
- Org 34517 - page 122
- Triacetyluridine (RG-2133) - page 123
- CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS - page 124
- Key Phase I and preclinical compounds in depression - page 124
- Corticotrophin releasing factors (CRF) - page 125
- Companies developing CRF compounds - page 126
- NB 34041 - page 126
- Potential advantages and disadvantages of CRF - page 126
- Contributing experts - page 128
- List of tables - page 128
- List of figures - page 128
- Bibliography - page 128
- Patient potential - page 128
- R&D approach - page 131
- Clinical trial data - page 133
- Websites - page 138
- R&D research methodology - page 140
- Introduction - page 140
- Hypothesis formulation - page 140
- Hypothesis testing - page 141
- Data verification and quality control - page 142
- Quantification of data reliability - page 142
- Introduction to Datamonitor Healthcare forecasting - page 143
- Methodology - page 143
- Market events - page 144
- Validation - page 145
- Pipeline-drug forecast methodology - page 146
- Predicting initial market share - page 147
- Forecasting future growth - page 148
- Influencing factors - page 148
- About Datamonitor - page 149
- About Datamonitor Healthcare - page 149
- Datamonitor Healthcare’s research and analysis methodologies - page 150
- Datamonitor Healthcare’s therapy area capabilities - page 150
- About Disease analysis team - page 151
- Datamonitor Healthcare’s Consulting expertise - page 152
- Key therapy team members - page 153
- Disclaimer - page 155
- List of Tables
- Table 1: Key parameters of depression - page 9
- Table 2: Forecast key pipeline products in depression in 2011 - page 9
- Table 3: Preregistration antidepressant pipeline, 2003 - page 36
- Table 4: Phase III antidepressant pipeline, 2003 - page 37
- Table 5: Phase II antidepressant pipeline, 2003 - page 39
- Table 6: Phase I and preclinical antidepressant pipeline, 2003 - page 40
- Table 7: Organon’s antidepressant portfolio, 2003 - page 42
- Table 8: Dov’s antidepressant portfolio, 2003 - page 45
- Table 9: Key products in late-stage R&D pipeline for serotonergics, 2003 - page 47
- Table 10: Global sales forecasts for gepirone, 2004–11 - page 57
- Table 11: Impacting factors on the revenues of gepirone, 2004–2011 - page 58
- Table 12: Discontinued R&D projects in serotonergics, 2002–03 - page 61
- Table 13: Key products in late-stage R&D pipeline for noradrenergics, 2003 - page 64
- Table 14: Global sales forecasts for duloxetine, 2004–11 - page 76
- Table 15: Impacting factors on the revenues of duloxetine, 2004–2011 - page 76
- Table 16: Key products in late-stage R&D pipeline for NK receptor antagonists, 2003 - page 80
- Table 17: Global sales forecasts for aprepitant, 2006–11 - page 86
- Table 18: Impacting factors on the revenues of aprepitant, 2006–2011 - page 86
- Table 19: Discontinued R&D projects in NK receptor antagonists, 2002–03 - page 90
- Table 20: Key products in late-stage R&D pipeline for reversible MAOIs, 2003 - page 93
- Table 21: Other key therapies in late-stage development, 2003 - page 99
- Table 22: Global sales forecasts for nemifitide, 2006–11 - page 118
- Table 23: Impacting factors on the revenues of nemifitide, 2006–11 - page 119
- Table 24: Drugs in Phase I and preclinical development for depression, 2003 - page 124
- Table 25: Confidence ratings for R&D pipeline data - page 142
- List of Figures
Figure 1: Unmet needs in depression, 2003 - page 19
- List of Figures
- Figure 2: Variza satisfaction of unmet needs - page 56
- Figure 3: Duloxetine satisfaction of unmet needs - page 74
- Figure 4: Aprepitant satisfaction of unmet needs - page 85
- Figure 5: Nemifitide satisfaction of unmet needs - page 117
- Figure 6: Market events affecting baseline product forecasts - page 144
- Figure 7: Algorithm depicting key constituent variables upon which drug revenues depend - page 145
- Figure 8: Overview of Datamonitor Healthcare’s forecasting approach for pipeline drugs - page 146
- Figure 9: Datamonitor’s Healthcare Consultancy - page 152
- Figure 10: Datamonitor Healthcare’s Therapeutic Consulting capabilities - page 153
Other users found this report page using the following search terms: depression Antidepressants major depression depression pipeline market aprepitant penetration antidepressant novel therapies phase ectris
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.