Pipeline and Commercial Insight

Publication Date	June 2008
Publisher	Datamonitor
Product Type	Report
Pages	239
ISBN Number	not applicable
Product Code	DAT06315

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Summary

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.

Content

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 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 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-Stage R&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-10 Codes
- Table 28: Datamonitor Drug Assessment Parameters
- List Of Figures
- Figure 1: Forecast Of The Neuropathic Pain Market Value Across The Seven Major Markets, 2008-2017
- 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, 2008
- 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