神経因性疼痛：UCBのVimpatによる競合見通し

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.

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)
    • 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