[英文調查報告書] 神經病理性痛

Abstract

Overview

Introduction

The neuropathic pain market is forecast to almost triple to over $6.3 billion by the end of the forecast period in 2017. The growth in the market is spurred on by the uptake of Pfizer' s Lyrica (pregabalin), forecast to reach almost $3 billion in sales by 2017. Vimpat is the most promising pipeline drug, forecast to take some $480m by 2017.

Scope

Analysis of patient potential, unmet needs and clinical trial design in the neuropathic pain market.
Overview of key marketed brands, late- and early-stage pipeline drugs.
Country-specific sales volume and value forecasts to 2017 of marketed brands, generics, and key late-stage pipeline drugs.
Identification of future market events that are expected to affect neuropathic pain revenues.

Highlights

UCB' s Vimpat (lacosamide) demonstrates the most potential in the pipeline and is well suited to compete in this market. Datamonitor has forecast Vimpat to generate over $480m, over a third of the total pipeline sales by 2017.

Neuropathic pain offers diverse market opportunities, with niche underserved neuropathic pain indications (e.g. HIV associated neuropathic pain) offering a good market entry point.

Following the recent negative FDA advice on Cephalon' s Fentora, Datamonitor has forecast that the drug will not launch for neuropathic pain. This is a blow to the development of a niche breakthrough neuropathic pain market.

Reasons to Purchase

Benchmark key late-stage pipeline neuropathic pain drugs against current market leading brands.
Assess country-specific (US, Japan, France, Germany, Italy, Spain and the UK) sales forecasts of key late-stage pipeline drugs and marketed brands.
Understand unmet needs and opportunities in the neuropathic pain market based on key opinion leader comments.

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)
  - Drug overview
  - SWOT
CHAPTER 4 FORECAST ANALYSIS
- Key events
  - New product launches
  - Product launches in Japan
  - Patent expiries
    - Cymbalta
    - Lidoderm
- 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
    - Gabapentin GR
    - XP13512
  - Patient subgroups
CHAPTER 6 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Classification of pipeline products
  - Glutamate receptor modulators
    - NMDA
    - AMPA
    - Kainate
  - 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
  - Pfizer
    - Neurontin
    - Lyrica
  - Eli Lilly
    - Cymbalta
  - UCB
    - Vimpat
    - Brivaracetam
- 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
  - Biographies
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

神經病理性痛：UCB的Vimpat競爭預測

Pipeline and Commercial Insight: Neuropathic Pain - UCB's Vimpat set to compete with major players

Abstract

Overview

Introduction

Scope

Highlights

Reasons to Purchase

Table of Contents