[英文調查報告書] 神經病變性疼痛治療藥

Abstract

Overview

Introduction

The neuropathic pain market is forecast to double from 2006 to reach over $7 billion by 2016. At this time, the current late-stage neuropathic pain pipeline is forecast to take only 18% of the total market share, highlighting an opportunity for better pipeline drugs that demonstrate improved pain management. The most promising and closest pipeline drug to market is UCB' s Vimpat (lacosamide).

Scope

Analysis of patient potential, unmet needs and clinical trial design in neuropathic pain
Overview of drugs in late- and early-stage clinical development; with analysis of key companies involved in the market
Detailed profiles of key compounds in development for use in neuropathic pain, with indication-specific drug sales forecasts to 2016
Discussion of Pfizer, Eli Lilly and UCB' s market strategies and insight from key opinion leaders

Highlights

UCB' s increasing CNS portfolio is further bolstered by the imminent arrival of Vimpat on the market. CNS is a key area of investigation for UCB, constituting 39% of their sales in 2006. UCB has further expanded its reach by trialling this anticonvulsant not just for epilepsy but also for neuropathic pain, fibromyalgia, migraine and osteoarthritis.

NeurogesX' s Transacin (capsaicin) treatment is set to cause a stir in the topical market, currently dominated by Endo' s Lidoderm (lidocaine 5% patch). The advantageous 3 monthly dosing regimen coupled with a strong efficacy and safety profile, will see Transacin draw favorable returns in its niche market.

Pfizer will continue to be a major contender in neuropathic pain, with the current market leader Lyrica predicted to be an even greater commercial success than its predecessor Neurontin (gabapentin). Pfizer' s branded drugs are forecast to capture a substantial 41% of the neuropathic pain market share in 2016.

Reasons to Purchase

Understand unmet needs in the neuropathic pain market based on key opinion leader insight
Benchmark key late-stage neuropathic pain compounds against current market leaders
Assess the global (US, Japan, five major EU) sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential

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 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Phase II and above
- Discontinued and suspended projects
  - Projects recently suspended or discontinued
    - Pristiq
    - Lamictal XR
    - Gabapentin GR
    - ACV-1
    - Namenda (memantine)
    - Traxoprodil
    - AZD-4282
- Key companies involved in the neuropathic pain pipeline
  - Pfizer
    - Neurontin
    - Lyrica
  - Eli Lilly
    - Cymbalta
  - UCB
    - Vimpat
    - Brivaracetam
- Key R&D company strategies
  - Reformulation strategies: Gabapentin
    - Gabapentin GR
    - XP13512
  - Patient subgroups
CHAPTER 3 NEUROPATHIC PAIN - MARKET OVERVIEW
- 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
CHAPTER 4 R&D APPROACH
- Classification of pipeline products
  - Glutamate receptor modulators
    - NMDA
    - AMPA
    - Kainate
  - Ion channel modulators
    - Sodium channels
    - Calcium channels
  - GABA modulators
  - Monoamine modulators
    - SNRIs
    - Dopamine
  - Others
    - Cannabinoid agonists
    - Vanilloid receptor agonists
    - Substance P release modulators
    - ACh receptor agonists
    - NGF modulators
    - TNF alpha antagonists
    - Adrenoceptor modulation
    - Adenosine A2 agonist
    - Free radicals
- 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 choice of ideal 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 endpoints 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 5 GLUTAMATE RECEPTOR MODULATORS LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview of 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
  - Clinical trial data
    - Phase III trial
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
    - Improved efficacy
    - Improved side effect profile: potential to cause upset
    - Reduced pill burden
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- NP-1 (ketamine & amitriptyline)
  - Drug overview
  - Clinical trial data
    - Phase II trial
  - Patient potential
    - NP-1' s topical use attracts a wide treatment range
    - Potential negative aspects
  - Marketing factors
    - Antidepressant topical mechanism of action
  - Satisfaction of unmet needs
    - Improved efficacy
    - Improved side effect profile
    - Reduced pill burden
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- CNS-5161
  - Drug overview
  - Clinical trial data
    - Phase IIa trial
    - Phase I trial
  - Satisfaction of unmet needs
    - Improved efficacy
    - Improved side effect profile
    - Reduced pill burden
  - Datamonitor comments
- V3381
  - Clinical trial data
    - Phase IIa study
    - Phase I study
    - Preclinical studies:
  - Datamonitor comments
- Other glutamate receptor modulators
  - RGH-896
  - EVT-101
  - NS-1209
  - NGX-426
- Late-stage development compounds recently discontinued
  - AZD-9272
CHAPTER 6 ION CHANNEL MODULATORS LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview of ion channel modulators
  - Pipeline summary
  - Comparative forecasts
  - Definition of current comparator therapy
- Vimpat (lacosamide)
  - Drug overview
  - Clinical trial data
    - Phase III study
    - Phase II study
  - Patient potential
    - Sodium channels have potential to be lucrative market
  - Marketing factors
    - Vimpat is being investigated for epilepsy along with other indications like many neuropathic pain treatments
    - UCB looks set to become a big player in the CNS market
  - Satisfaction of unmet needs
    - Improved efficacy: data promising
    - Improved side-effect profile
    - Fewer drug-drug interactions: add to physician confidence in Vimpat
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Lamictal XR
  - Drug overview
  - Clinical trial data
    - Phase II Lamictal clinical trial
    - Phase III
    - Improved side effect profile: a big problem in neuropathic pain
  - Forecasts to 2016
- Ralfinamide
  - Drug overview
  - Clinical trial data
    - Phase II study results
    - Phase IIa study
  - Patient potential
    - Multiple neuropathic pain indications indicate mechanistic approach
  - Marketing factors
  - Satisfaction of unmet needs
    - Improved efficacy
    - Reduced time to onset of action
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Other ion channel modulators
  - ABT-894
  - Bupivacaine (Eladur)
  - Lidocaine patch KN-48
  - Brivaracetam
- Late-stage development compounds recently discontinued
  - ACV-1
CHAPTER 7 GABA MODULATORS LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview of GABA receptor modulators
  - Pipeline summary
  - Comparative forecasts
  - Definition of current comparator therapy
- Gabapentin GR
  - Drug overview
  - Clinical trial data
    - Phase III study
    - Phase II study
  - A future for Gabapentin GR?
  - Forecasts to 2016
- XP13512 gabapentin (Enacarbil)
  - Clinical trial data
    - Phase IIa
    - Phase I
  - Marketing factors - improved duration of action
  - Patient potential
  - Satisfaction of unmet needs
    - Improved efficacy
    - Reduced pill burden
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Other GABA modulators
  - Retigabine
CHAPTER 8 MONOAMINE MODULATORS LATE-STAGE ANALYSIS AND FORECASTS
- Overview of monoamine receptor modulators
  - Pipeline summary
  - Definition of current comparator therapy
- Pristiq (desvenlafaxine)
  - Drug overview
  - Clinical trial data
    - Ongoing trials: Phase III
    - Phase II Venlafaxine studies
  - Satisfaction of unmet needs
  - Forecasts to 2016
- Other monoamine modulators
  - Bicifadine
  - Reboxetine (+)-(S,S)
  - F13640
- Late-stage development compounds recently discontinued
  - Radafaxine (353162)
CHAPTER 9 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview of other therapies
  - Pipeline summary
  - Comparative forecasts
  - Definition of current comparator therapy
- Fentora (fentanyl buccal transmucosal)
  - Drug overview
  - Clinical trial data
    - Phase III study
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Sativex (GW-1000)
  - Drug overview
  - Clinical trial data
    - Phase III DNP study
    - Phase III Allodynia study
    - Phase II study
    - Ongoing trials
  - Marketing potential
    - Potential for abuse is real but multiple indication use may offset this
  - Patient potential
  - Satisfaction of unmet needs
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Transacin (NGX-4010)
  - Drug overview
  - Clinical trial data
    - Ongoing trials
    - Phase III study
    - Phase III HIV-associated neuralgia
    - Phase II study
  - Patient potential
  - Marketing factors
  - Satisfaction of unmet needs
    - Reduced pill burden
  - Forecasts to 2016
  - Datamonitor drug assessment summary
- Other drugs
  - AS-3201
  - Botulinum toxin type A-hemagglutinin complex (Dysport)
  - Zucapsaicin
  - AGN 203818
  - Ibudilast (AV411)
  - BVT.115959
  - 681323
  - KDS-2000
  - IP 751/CT-3 (ajulemic acid)
  - Liposomal galantamine
  - TAK-583
CHAPTER 10 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
- 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: Size of the neuropathic pain market across the 7MM ($m), 2006-2016
  - Table 2: Sales forecasts ($m) of key pipeline products in neuropathic pain, 2007-2016
  - Table 3: Number of key neuropathic pain drugs by class and phase of development, 2007
  - Table 4: Phase II & III R&D pipeline for neuropathic pain, 2007
  - Table 5: Abbreviations for neuropathic pain subtypes
  - Table 6: The diabetic neuropathic pain patient populations across the 7MMs, 2007
  - Table 7: The post herpetic neuralgia patient population across the 7MMs, 2007
  - Table 8: The HIV neuropathic pain patient population across the 7MMs, 2007
  - Figure 16: Key unmet needs in neuropathic pain, 2007
  - Table 9: Recommended core outcomes measures for clinical trials of chronic pain treatment efficacy
  - Table 10: Key glutamate receptor modulators in the late-stage R&D pipeline for neuropathic pain, 2007
  - Table 11: Lyrica; key facts
  - Table 12: Estimated key events, approvals and launch dates impacting Zenvia' s revenue forecast, 2007-2016
  - Table 13: Estimated key events, approvals and launch dates impacting NP-1' s revenue forecast, 2007-2016
  - Table 14: Key ion channel modulators in the late-stage R&D pipeline for neuropathic pain, 2007
  - Table 15: Estimated key events, approvals and launch dates impacting Vimpat' s revenue forecast, 2007-2016
  - Table 16: Estimated key events, approvals and launch dates impacting ralfinamide' s revenue forecast, 2007-2016
  - Table 17: Key GABA modulators in the late-stage R&D pipeline for neuropathic pain, 2007
  - Table 18: Estimated key events, approvals and launch dates impacting XP13512' s revenue forecast, 2007-2016
  - Table 19: Monoamine modulator in late-stage R&D pipeline for neuropathic pain, 2007
  - Table 20: Other drugs in late-stage R&D pipeline for neuropathic pain, 2007
  - Table 21: Estimated key events, approvals and launch dates impacting Fentora' s revenue forecast, 2007-2016
  - Table 22: Estimated key events, approvals and launch dates impacting Sativex' s revenue forecast, 2007-2016
  - Table 23: Estimated key events, approvals and launch dates impacting Transacin' s revenue forecast, 2007-2016
  - Table 24: Key drugs in Phase I development for neuropathic pain, 2007I
  - Table 25: Key drugs in preclinical development for neuropathic pain, 2007
  - Table 26: Neuropathic pain market definition by ICD-10 codes
  - Table 27: Datamonitor drug assessment parameters
- List of Figures
  - Figure 1: Forecast of the neuropathic pain market value across the 7MM, 2007-2016
  - Figure 2: Key pipeline drug sales forecasts, 2007- 2016
  - Figure 3: Datamonitor drug assessment summary of pipeline therapies in development for neuropathic pain, 2007
  - Figure 4: Drugs in development for neuropathic pain by class and development stage, 2007
  - Figure 5: Pfizer sales by therapeutic area, 2006
  - Figure 6: Sales of Neurontin, gabapentin and Lyrica for neuropathic pain ($m), 2003-06
  - Figure 7: Historical sales of Lyrica, Neurontin, Cymbalta and generic gabapentin, 2003-06
  - Figure 8: Pfizer' s Lyrica and CNS sales 2004-06 ($ billion)
  - Figure 9: Eli Lilly sales by therapeutic area, 2006
  - Figure 10: Cymbalta all indication sales in the 7MMs, 2003-06 ($m)
  - Figure 11: UCB sales by therapeutic area, 2006
  - Figure 12: Population of neuropathic pain subtypes in the 7MMs, 2007
  - Figure 13: Sales of marketed drugs for neuropathic pain, 2006 ($m)
  - Figure 14: Total neuropathic pain sales across the seven major pharmaceutical markets by region, 2003-06
  - Figure 15: Total neuropathic pain sales in the 5EU, 2006 ($m)
  - Figure 17: Datamonitor drug assessment summary of key glutamate receptor modulators in development for neuropathic pain, 2007
  - Figure 18: Sales forecasts for glutamate receptor modulators in neuropathic pain across the 7MMs, 2007-2016
  - Figure 19: Sales forecast for Zenvia in neuropathic pain across the 7MMs to 2016
  - Figure 20: Datamonitor' s competitive positioning analysis of Zenvia, 2007
  - Figure 21: Sales forecast for NP-1 in neuropathic pain to 2016 across the 7MMs
  - Figure 22: Datamonitor' s competitive positioning analysis of NP-1, 2007
  - Figure 23: Datamonitor drug assessment summary of pipeline ion channel modulators in development for neuropathic pain, 2007
  - Figure 24: Sales forecasts for ion channel modulators in neuropathic pain across the 7MMs, 2007-2016
  - Figure 25: Sales forecast for Vimpat in neuropathic pain to 2016 across the 7MMs
  - Figure 26: Datamonitor' s competitive positioning analysis of Vimpat in neuropathic pain, 2007
  - Figure 27: Sales forecast for ralfinamide in neuropathic pain to 2016, in the 7MMs
  - Figure 28: Datamonitor' s competitive positioning analysis of ralfinamide in neuropathic pain, 2007
  - Figure 29: Datamonitor drug assessment summary of pipeline GABA receptor modulators in development for neuropathic pain, 2007
  - Figure 30: Sales forecasts for GABA modulators in neuropathic pain to 2016 in the 7MMs
  - Figure 31: Sales forecast for XP13512 to 2016 in neuropathic pain across the 7MMs
  - Figure 32: Datamonitor' s competitive positioning analysis of XP13512, 2007
  - Figure 33: Datamonitor drug assessment summary other therapies in development for neuropathic pain, 2007
  - Figure 34: Sales forecasts for ' Other' drugs in neuropathic pain to 2016 across the 7MMs
  - Figure 35: Sales forecast for Fentora in neuropathic pain to 2016 in the 7MMs
  - Figure 36: Datamonitor' s competitive positioning analysis of Fentora in neuropathic pain, 2007
  - Figure 37: Sales forecast for Sativex in neuropathic pain to 2016 in the 7MMs
  - Figure 38: Datamonitor' s competitive positioning analysis of Sativex for neuropathic pain, 2007
  - Figure 39: Sales forecast for Transacin in neuropathic pain to 2016 in the 7MMs
  - Figure 40: Datamonitor' s competitive positioning analysis of Transacin in neuropathic pain, 2007
  - Figure 41: Datamonitor drug assessment summary of neuropathic pain treatments, 2007

神經病變性疼痛治療藥市場

Pipeline Insight: Neuropathic Pain - Emerging drugs fail to capitalize in lucrative market

Abstract

Overview

Introduction

Scope

Highlights

Reasons to Purchase

Table of Contents