Neuropathic Pain - A Plethora of Patient Segmentation and Product Differentiation Opportunities
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Central Nervous System pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the neuropathic pain market - page 3
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 15
- Market definition for this report - page 15
- Market sizing assumptions and caveats - page 15
- Five treatments are approved for neuropathic pain in the US and Europe - page 15
- US and EU markets comprise sales of approved and non-approved products - page 16
- Japan market value was calculated using sales of popular NSAIDs - page 19
- Market sizing assumptions and caveats - page 15
- Current market situation - page 19
- During 2005 the global market fell by 23% as US physicians switch from Neurontin to generic gabapentin - page 19
- US market down but European markets show growth - page 21
- Cymbalta, Lyrica, and Lidoderm are restoring market value - page 22
- Strategic scoping and focus - page 26
- Market definition for this report - page 15
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 27
- Summary of environmental issues affecting the neuropathic pain market - page 27
- Global opportunities and threats - page 31
- Opportunities - page 31
- Physicians are now turning to alternative analgesics amid concerns over NSAID and opioid use - page 31
- Gain commercial advantage with an improved dosing regimen to gabapentin - page 31
- A mechanism-based treatment approach would be well received - page 32
- General neuropathic pain provides a broader customer base in the EU - page 32
- Subtype-specific labeling provides an opportunity to define and own a market in the US and in Japan - page 32
- Niche neuropathic pain subtypes can provide orphan drug benefits - page 34
- Fibromyalgia is an attractive new market - page 35
- Treatment guidelines say yes to opioids and no to NSAIDs - page 35
- Journals, medical conferences and CME presentations are effective marketing channels for neuropathic pain products - page 38
- Maximize market penetration by emphasizing ability to relieve specific symptoms of neuropathic pain - page 39
- Minimal drug-drug interactions are key in treating HIVNP, DNP, and MSNP patients - page 39
- European parliament approves pediatric legislation - page 40
- Threats - page 40
- Education is needed to improve disease and treatment awareness among PCPs - page 40
- Generic gabapentin introduces strong cost competition in the EU and the US - page 41
- Pharmacovigilance is leading to more stringent post-marketing regulations - page 43
- New EU states may lead to a flood of cheap drug exports - page 44
- Seeking out additional indications is becoming a less effective generic defense strategy - page 45
- Opportunities - page 31
- US: opportunities and threats - page 45
- Opportunities - page 45
- US pharmacists to play a greater role in neuropathic pain management - page 45
- Medicare Part D reforms will provide a short-term boost, but in the longer term the impact is less certain - page 46
- Threats - page 47
- Further genericization encouraged by new legislation and public programs - page 47
- $10 billion cut planned in Medicaid between 2005 and 2010 - page 48
- A high price point can prevent formulary access for drugs that do not have a significant clinical differentiating factor - page 48
- The Medicare Part D "doughnut hole" could result in a surge in parallel imports - page 48
- Disclosure of clinical trial results could become mandatory - page 49
- Opportunities - page 45
- Japan: opportunities and threats - page 50
- Opportunities - page 50
- There is a strong need for regulatory approved medicines - page 50
- Separation of manufacturing and marketing entities benefits both Japanese and foreign companies - page 51
- Fewer outsourcing restrictions enhances manufacturing efficiency - page 51
- Reduced product approval time - page 52
- Harmonization of approval process - page 52
- The Internet is an effective means to reach out to patients - page 52
- Threats - page 53
- Earnings outlook clouded by lower drug prices and higher R&D costs - page 53
- Off-label prescribing is uncommon - page 53
- Generic drug use is expected to increase - page 54
- Flat-sum reimbursement discourages physicians from prescribing highly priced medicines - page 54
- Opportunities - page 50
- France: opportunities and threats - page 55
- Opportunities - page 55
- Innovative drug development encouraged by price premium and high-level reimbursement - page 55
- Consumers in France readily recognize the Internet as a source of high-quality medical information - page 56
- Threats - page 56
- Education and strong clinical trial data are needed to promote the use of newer drugs - page 56
- Slow referrals can delay access to neuropathic pain drugs - page 57
- French market attractiveness hit by higher taxes, lower prices and a shorter reimbursement - page 57
- Opportunities - page 55
- Germany: opportunities and threats - page 58
- Opportunities - page 58
- The German Research Network on Neuropathic Pain (GNNP) aims to define a mechanistic approach to diagnosis and treatment - page 58
- Free pricing system and culture of innovation encourages novel drug development - page 60
- ePharmacy and mail-order drugs legalized - page 60
- Threats - page 60
- National health insurer allowed greater powers to decrease expensive prescribing - page 60
- Opportunities - page 58
- Italy: opportunities and threats - page 61
- Opportunities - page 61
- Innovative drug development rewarded with premium price and 100% reimbursement - page 61
- Threats - page 62
- Education is needed to tackle low awareness of effective therapies - page 62
- Further pharmaceutical price cuts planned - page 62
- Opportunities - page 61
- Spain: opportunities and threats - page 63
- Opportunities - page 63
- Planned electronic prescribing will improve access to treatments and promote the rational use of drugs - page 63
- Threats - page 64
- Price cuts continue unabated - page 64
- New medicines bill pushes more price cuts and increases pharmaceutical tax - page 64
- Government awareness campaign promotes generic use - page 65
- Opportunities - page 63
- UK: opportunities and threats - page 65
- Opportunities - page 65
- Nurses and pharmacists can now prescribe neuropathic pain drugs - page 65
- New fast track drug assessment process speeds up time between licensing and NICE recommendations - page 66
- Threats - page 66
- Pricing controls dominate budgetary cost containment strategies - page 66
- The NHS is unreceptive to new treatments compared to the rest of Europe - page 67
- Opportunities - page 65
- CHAPTER 4 FORECAST ANALYSIS - page 68
- Key events - page 68
- New product launches in the US and EU - page 68
- Lamictal XR - page 68
- Neurodex (AVP-923) - page 69
- Ralfinamide - page 70
- Transacin (NGX-4010) - page 71
- Lacosamide - page 72
- XP13512 - page 73
- Gabapentin GR - page 74
- Sativex - page 75
- NP-1 - page 76
- Traxoprodil - page 77
- Tramadol ER - page 78
- Brivaracetam (UCB 34714) - page 78
- New product launches in Japan - page 79
- Lyrica - page 79
- Cymbalta - page 80
- KN-48 - page 80
- Patent expiries - page 80
- Trileptal - page 80
- Actiq - page 81
- Effexor/Effexor XR - page 81
- Lamictal - page 81
- Topamax - page 82
- Lidoderm - page 82
- Keppra - page 82
- New product launches in the US and EU - page 68
- Data definitions, limitations and assumptions - page 82
- Standard units - page 82
- Japanese market data - page 83
- Derivation of sales forecasts and pricing trends - page 83
- Drug pricing and genericization assumptions - page 83
- Forecasts - page 84
- Forecast methodology - page 84
- Key events - page 68
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 85
- Introduction - page 85
- Market penetration and brand positioning - page 85
- Case study: Commitment to neuropathic pain is key to Pfizer's success - page 85
- The glory days of Neurontin are over but Pfizer will battle on - page 86
- Lyrica is priced competitively against generics - page 88
- Pfizer looks set to regrow its neuropathic pain franchise - page 89
- Pfizer's legacy benefits other players - page 90
- Case study: Premium price, brand loyalty and off-label use drives Lidoderm sales growth - page 91
- Lidoderm follows the Neurontin model of growth - page 91
- Establish FDA approval before communicating clinical trial data for other pain states - page 92
- COX-II concerns has benefited Lidoderm - page 95
- Case study: Cymbalta positioned as the DNP drug of choice - page 95
- A competitive price point, once daily dosage and simpler titration are key to commercial success - page 95
- Sponsoring treatment guidelines for specific patient groups will help define the market - page 97
- Utilize established diabetes resources to reach out to the DNP customer base - page 97
- Case study: Commitment to neuropathic pain is key to Pfizer's success - page 85
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 99
- Summary neuropathic pain market data - page 99
- Anticonvulsant market data - page 100
- Antidepressant market data - page 107
- Other drugs market data - page 108
- APPENDIX B - MARKET FORECAST DATA AND METHODOLOGY - page 111
- Global market forecasts - page 111
- 5EU market forecasts - page 112
- US market forecasts - page 113
- Japan market forecasts - page 114
- France market forecasts - page 115
- Germany market forecasts - page 116
- Italy market forecasts - page 117
- Spain market forecasts - page 118
- UK market forecasts - page 119
- DATAMONITOR FORECAST METHODOLOGY - page 119
- ICD-10 codes - page 119
- Sales calculations - page 121
- APPENDIX C - page 123
- Contributing experts - page 123
- Biographies - page 123
- Bibliography - page 124
- Clinical trial data - page 124
- General - page 125
- Treatment guidelines - page 126
- Websites - page 127
- Report methodology - page 128
- About Datamonitor - page 129
- About Datamonitor Healthcare - page 129
- About the CNS analysis team - page 130
- Disclaimer - page 131
- Contributing experts - page 123
- List of Tables
- Table 1: Key players in the neuropathic pain market - page 23
- Table 2: Global sales performance of key brands in the neuropathic pain market, 2004-05 - page 24
- Table 3: Neuropathic pain subtypes and abbreviations - page 33
- Table 4: First-line recommendations for neuropathic pain, 2004 - page 36
- Table 5: Ex-manufacturer price of Neurontin vs. generic gabapentin in the US - page 42
- Table 6: Average wholesaler price of Neurontin vs. generic gabapentin in the US, 2006 - page 43
- Table 7: Late stage R&D pipeline for neuropathic pain in Japan - page 50
- Table 8: Cost comparison of 30 days' treatment of PHN with generic gabapentin vs. Lyrica in the US, 2005 - page 88
- Table 9: Lidoderm clinical trials - page 94
- Table 10: Cost comparison of 30 days treatment of DNP with Cymbalta vs. Lyrica in the US, 2006 - page 96
- Table 11: Summary Market Data - page 99
- Table 12: Neurontin: key facts - page 100
- Table 13: Lyrica: key facts - page 101
- Table 14: Topamax: key facts - page 102
- Table 15: Lamictal: key facts - page 103
- Table 16: Tegretol: key facts - page 104
- Table 17: Trileptal: key facts - page 105
- Table 18: Keppra: key facts - page 106
- Table 19: Cymbalta: key facts - page 107
- Table 20: Lidoderm: key facts - page 108
- Table 21: Oxycontin: key facts - page 109
- Table 22: Duragesic: key facts - page 110
- Table 23: Global neuropathic pain drug sales ($m) forecasts, 2005-15 - page 111
- Table 24: 5EU neuropathic pain drug sales ($m) forecasts, 2005-15 - page 112
- Table 25: US neuropathic pain drug sales ($m) forecasts, 2005-15 - page 113
- Table 26: Japan neuropathic pain drug sales ($m) forecasts, 2005-15 - page 114
- Table 27: France neuropathic pain drug sales ($m) forecasts, 2005-15 - page 115
- Table 28: Germany neuropathic pain drug sales ($m) forecasts, 2005-15 - page 116
- Table 29: Italy neuropathic pain drug sales ($m) forecasts, 2005-15 - page 117
- Table 30: Spain neuropathic pain drug sales ($m) forecasts, 2005-15 - page 118
- Table 31: UK neuropathic pain drug sales ($m) forecasts, 2005-15 - page 119
- Table 32: Neuropathic pain market definition by ICD-10 codes - page 120
- Table 33: Neuropathic pain market definition by ICD-10 codes [continued] - page 121
- Table 34: Percentage of total value accounted for by neuropathic pain diagnoses, for marketed brands and generics, 2005 - page 122
- List of Figures
- Figure 1: Key events impacting the neuropathic pain market, 1999-2006 - page 20
- Figure 2: Global neuropathic pain market value by class, 2002-05 - page 20
- Figure 3: Global neuropathic pain prescription volume by class, 2002-05 - page 21
- Figure 4: Performance of the US, 5EU and Japan neuropathic pain markets, 2004-05 - page 22
- Figure 5: Breakdown of key brands sales by neuropathic pain vs. other indications, 2005 - page 25
- Figure 6: Summary of environmental issues in the global market, 2006 - page 28
- Figure 7: Summary of environmental issues in the US and Japanese markets, 2006 - page 29
- Figure 8: Summary of environmental issues in the 5EU markets, 2006 - page 30
- Figure 9: Pfizer US and 5EU gapapentin sales, 2001-05 - page 86
- Figure 10: Pfizer's neuropathic pain revenues in the EU and US, 2001-05 - page 87
- Figure 11: 5EU gabapentin sales, 2001-05 - page 87
- Figure 12: SWOT analysis of Lyrica, 2006 - page 89
- Figure 13: Lyrica homepage, 2006 - page 90
- Figure 14: SWOT analysis of Lidoderm, 2006 - page 91
- Figure 15: US sales and key milestones for Lidoderm , 2001-05 - page 92
- Figure 16: Lidoderm US sales split by indication, 2005 - page 93
- Figure 17: SWOT analysis of Cymbalta, 2006 - page 96
- Figure 18: US and 5EU quarterly sales of Cymbalta, 2004-06 - page 97
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