Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Central Nervous System pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the Neuropathic pain market
- Key metrics
- Datamonitor pipeline assessment summary
- Related reports
- CHAPTER 2 NEUROPATHIC PAIN - MARKET OVERVIEW AND POTENTIAL
- Definition of neuropathic pain
- Segmentation of neuropathic pain
- Segmentation of neuropathic pain differs depending on the geographic
market
- General neuropathic pain provides a broader customer base in the EU
- US approval requires evidence in each neuropathic pain subtype
- Major neuropathic pain subtypes
- Diabetic neuropathic pain
- Post-herpetic neuralgia
- HIV neuropathic pain
- Neuropathic low-back pain
- Other subtypes
- Epidemiology
- Diabetic neuropathic pain
- Post-herpetic neuralgia
- HIV neuropathic pain
- Post-operative pain
- Current market overview
- Five treatments are currently marketed for neuropathic pain
- Off-label prescribing
- US dominated market
- Unmet need in neuropathic pain
- Clinical unmet need
- 1. Improved efficacy
- 2. Improved side-effect profile
- 3. Reduced time to onset of action
- 4. Fewer drug-drug interactions
- 5. Pill burden
- Clinical trial design in neuropathic pain
- Choice of endpoint is the key clinical trial design factor in
neuropathic pain
- Head-to-head trials of increasing importance
- Lyrica is the ideal choice of comparator drug for head-to-head
clinical trials
- Length of trial should indicate titration period for physician ease
of use
- The Initiative on Methods, Measurements and Pain Assessments in
Clinical trials (IMMPACT)
- European Federation of Neurological Societies assessment
- Clinical trial end points in neuropathic pain
- 50% reduction in pain is a primary measure of efficacy
- Multiple pain and quality of life assessment questionnaires should be
used in trials
- Clinical trial drop-out as an endpoint
- CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES
- Marketed brands overview
- Lyrica (pregabalin)
- Drug overview
- Forecasts to 2017
- SWOT
- Datamonitor drug assessment summary
- Clinical trial data
- Lyrica clinical trial 1
- Lyrica clinical trial 2
- Lyrica clinical trial 3
- Neurontin (gabapentin)
- Drug overview
- Forecasts to 2017
- SWOT
- Clinical trial data
- Lidoderm (lidocaine)
- Drug overview
- Forecasts to 2017
- Clinical trial data
- Lidoderm clinical trial 1
- Lidoderm clinical trial 2
- Cymbalta (duloxetine)
- Drug overview
- Forecasts to 2017
- SWOT
- Clinical trial data
- Tegretol (carbamazepine)
- CHAPTER 4 FORECAST ANALYSIS
- Key events
- New product launches
- Product launches in Japan
- Patent expiries
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- CHAPTER 5 STRATEGIES FOR SUCCESS
- Key R&D company strategies
- Reformulation strategies: Gabapentin
- Patient subgroups
- CHAPTER 6 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Classification of pipeline products
- Glutamate receptor modulators
- Ion channel modulators
- Sodium channels
- Calcium channels
- GABA modulators
- Others
- SNRIs
- Dopamine modulators
- Cannabinoid agonists
- Vanilloid receptor agonists
- Substance P release modulators
- ACh receptor agonists
- NGF modulators
- TNF alpha antagonists
- Adrenoceptor modulation
- Adenosine A2 agonists
- Free radicals
- Phase II and above
- Key companies involved in the neuropathic pain pipeline
- Discontinued and suspended projects
- Projects recently suspended or discontinued
- ACV-1
- Pristiq
- Radafaxine (353162)
- Lamictal XR
- Namenda (memantine)
- Traxoprodil
- AZD-4282
- CHAPTER 7 LATE-STAGE DRUG ANALYSIS & FORECASTS
- Glutamate receptor modulators
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- Pfizer' s Lyrica is Datamonitor' s comparator therapy
- Lidoderm is the topical comparator therapy
- Zenvia (dextromethorphan & quinidine sulfate)
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Clinical trial data
- NP-1 (ketamine & amitriptyline)
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Clinical trial data
- Other glutamate receptor modulators
- CNS-5161
- V3381
- RGH-896
- EVT 101
- NS-1209
- NGX-426
- Ion channel modulators
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- Vimpat (lacosamide)
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Clinical trial data
- Ralfinamide
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Clinical trial data
- Other ion channel modulators
- Retigabine
- Bupivacaine (Eladur)
- Lidocaine patch KN-48
- Brivaracetam
- GABA receptor modulators
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- XP13512
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors - improved duration of action
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Gabapentin GR
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Clinical trial data
- Other therapies
- Pipeline summary
- Comparative forecasts
- Transacin (NGX-4010)
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Clinical trial data
- Other drugs
- Sativex (GW-1000)
- Fentora (fentanyl buccal transmucosal)
- BVT.115959
- Bicifadine
- NSD-644
- Reboxetine (+)-(S,S)
- F13640
- AS-3201
- KD7040
- Ibudilast (AV411)
- IP 751/CT-3 (ajulemic acid)
- ADL5859
- KDS-2000
- AGN 203818
- 681323
- Liposomal galantamine
- TAK-583
- Botulinum toxin type A-hemagglutinin complex (Dysport)
- Zucapsaicin
- 2PX
- CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS
- Key Phase I and preclinical compounds in neuropathic pain
- Selective sodium channel blockers
- Vanilloid TRPV1 antagonists
- Preclinical trial data
- NGX-1998
- GRC-6211
- SAR-115740
- N-type calcium channel blockers
- Spinal cord and peripheral nerve stimulation
- BIBLIOGRAPHY
- Journals
- Websites
- Datamonitor reports
- APPENDIX A
- Methodology
- Datamonitor forecast methodology
- ICD-10 codes
- Product forecasts
- Definition of a standard unit
- Datamonitor drug assessment summary
- Contributing experts
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Neuropathic pain market size across the seven major markets
($m), 2007 and 2017
- Table 2: Sales forecasts ($m) of key pipeline products in neuropathic
pain, 2007-2017
- Table 3: Abbreviations for neuropathic pain subtypes
- Table 4: Diabetic neuropathic pain patient populations across the seven
major markets, 2008
- Table 5: Post-herpetic neuralgia patient population across the seven
major markets, 2008
- Table 6: HIV neuropathic pain patient population across the seven major
markets, 2008
- Figure 7: Key unmet needs in neuropathic pain, 2008
- Table 7: Recommended core outcomes measures for clinical trials of
chronic pain treatment efficacy
- Table 8: Forecast launch dates for neuropathic pain drugs in the US and
5EU, 2008-2012
- Table 9: Forecast launch dates for neuropathic pain drugs in Japan,
2010-2012
- Table 10: Pivotal patent expiries for key marketed neuropathic pain drugs
in the US and 5EU, 2012-16
- Table 11: Neuropathic pain market sub-type definition by ICD-10 codes
- Table 12: Number of key neuropathic pain drugs by class and phase of
development, 2008
- Table 13: Phase II & III R&D pipeline for neuropathic pain, 2008
- Table 14: Key glutamate receptor modulators in the late-stage R&D
pipeline for neuropathic pain, 2008
- Table 15: Lyrica: key facts
- Table 16: Estimated key events, approvals and launch dates impacting
Zenvia' s revenue forecast, 2008-2017
- Table 17: Estimated key events, approvals and launch dates impacting
NP-1' s revenue forecast, 2008-2017
- Table 18: Key ion channel modulators in the late-stageR&D pipeline
for neuropathic pain, 2008
- Table 19: Estimated key events, approvals and launch dates impacting
Vimpat' s revenue forecast, 2008-2017
- Table 20: Estimated key events, approvals and launch dates impacting
ralfinamide' s revenue forecast, 2008-2017
- Table 21: Key GABA modulators in the late-stage R&D pipeline for
neuropathic pain, 2008
- Table 22: Estimated key events, approvals and launch dates impacting
XP13512' s revenue forecast, 2008-2017
- Table 23: Other drugs in late-stage R&D pipeline for neuropathic
pain, 2008
- Table 24: Estimated key events, approvals and launch dates impacting
Transacin' s revenue forecast, 2008-2017
- Table 25: Key drugs in Phase I development for neuropathic pain, 2008
- Table 26: Key drugs in preclinical development for neuropathic pain, 2008
- Table 27: Neuropathic pain market definition by ICD-10codes
- Table 28: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Forecast of the neuropathic pain market value across the seven
major markets, 2007-2017
- Figure 2: Key neuropathic pain pipeline drug historical sales and
forecasts, 2004-2017
- Figure 3: Datamonitor drug assessment summary of pipeline therapies in
development for neuropathic pain, 2008
- Figure 4: Sales of molecules for neuropathic pain ($m),2007
- Figure 5: Total neuropathic pain sales across the seven major markets by
region, 2004-07
- Figure 6: Total neuropathic pain sales in the six major markets($m), 2007
- Figure 8: Historical and forecast neuropathic pain-specific sales revenue
for key brand and pipeline drugs across the seven major markets, 2004-2017
- Figure 9: Sales forecast for Lyrica in neuropathic pain across the seven
major markets to 2017
- Figure 10: Lyrica SWOT analysis
- Figure 11: Datamonitor' s competitive positioning analysis of Lyrica, 2008
- Figure 12: Historical and forecast sales for Neurontin in neuropathic
pain across the seven major markets, 2004-2017
- Figure 13: Neurontin SWOT analysis
- Figure 14: Historical and forecast sales for Lidoderm in neuropathic pain
across the seven major markets, 2004-2017
- Figure 15: Lidoderm SWOT analysis
- Figure 16: Sales forecast for Cymbalta in neuropathic pain across the
seven major markets, 2004-2017
- Figure 17: Cymbalta SWOT analysis
- Figure 18: Tegretol SWOT analysis
- Figure 19: Impact of each key event on the neuropathic pain market across
the seven major markets, 2008-2017
- Figure 20: Population of neuropathic pain subtypes in the seven major
markets, 2008
- Figure 21: Percentage neuropathic pain sales by subtype,2007
- Figure 22: Drugs in development for neuropathic pain by class and
development stage, 2008
- Figure 23: Pfizer sales by therapeutic area 2006
- Figure 24: Sales of Neurontin, gabapentin and Lyrica for neuropathic pain
($m), 2003-07
- Figure 25: Historical sales of Lyrica, Neurontin,Cymbalta and generic
gabapentin, 2003-07
- Figure 26: Pfizer' s Lyrica and CNS sales 2004-07 ($billion)
- Figure 27: Eli Lilly sales by therapeutic area, 2006
- Figure 28: Cymbalta neuropathic pain specific sales in the seven major
markets, 2003-07 ($m)
- Figure 29: UCB sales by therapeutic area, 2007
- Figure 30: Datamonitor drug assessment summary of key glutamate receptor
modulators in development for neuropathic pain, 2008
- Figure 31: Sales forecasts for glutamate receptor modulators in
neuropathic pain across the seven major markets, 2008-2017
- Figure 32: Sales forecast for Zenvia in neuropathic pain across the seven
major markets, 2009-2017
- Figure 33: Datamonitor' s competitive positioning analysis of Zenvia, 2008
- Figure 34: Sales forecast for NP-1 in neuropathic pain across the seven
major markets, 2008-2017
- Figure 35: Datamonitor' s competitive positioning analysis of NP-1, 2008
- Figure 36: Datamonitor drug assessment summary of pipeline ion channel
modulators in development for neuropathic pain, 2008
- Figure 37: Sales forecasts for ion channel modulators in neuropathic pain
across the seven major markets, 2008-2017
- Figure 38: Sales forecast for Vimpat in neuropathic pain across the seven
major markets, 2008-2017
- Figure 39: Datamonitor' s competitive positioning analysis of Vimpat in
neuropathic pain, 2008
- Figure 40: Sales forecast for ralfinamide in neuropathic pain across the
seven major markets, 2010-2017
- Figure 41: Datamonitor' s competitive positioning analysis of ralfinamide
in neuropathic pain, 2008
- Figure 42: Datamonitor drug assessment summary of pipeline GABA receptor
modulators in development for neuropathic pain,2008
- Figure 43: Sales forecasts for GABA modulators in neuropathic pain across
the seven major markets, 2008-2017
- Figure 44: Sales forecast for XP13512 in neuropathic pain across the
seven major markets, 2008-2017
- Figure 45: Datamonitor' s competitive positioning analysis of XP13512, 2008
- Figure 46: Sales forecast for Gabapentin GR in neuropathic pain across
the seven major markets, 2009-2017
- Figure 47: Datamonitor' s competitive positioning analysis of Gabapentin
GR, 2008
- Figure 48: Datamonitor drug assessment summary other therapies in
development for neuropathic pain, 2008
- Figure 49: Sales forecasts for ' Other' drugs in neuropathic pain across
the seven major markets, 2008-2017
- Figure 50: Sales forecast for Transacin in neuropathic pain across the
seven major markets, 2008-2017
- Figure 51: Datamonitor' s competitive positioning analysis of Transacin in
neuropathic pain, 2008
- Figure 52: Datamonitor drug assessment summary of neuropathic pain
treatments, 2007
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