Market Report Source

Overview

Introduction

Neurontin (gabapentin) has finally been knocked off the top spot as a result of fierce generic incursion. However, Pfizer’s follow-on Lyrica (pregabalin), Lilly’s Cymbalta (duloxetine) and Endo/Elan’s Lidoderm (lidocaine patch 5%) are re-establishing market growth and laying the groundwork for new entrants.

Scope

*Detailed analysis of key brands, with sales and volume forecasts to 2014 for the neuropathic pain indication alone *Assessment of current and future opportunities and threats in the neuropathic pain market across the seven major pharmaceutical markets *Consideration of key events that may affect revenues in each of the seven major pharmaceutical markets are applied and discussed *Lifecycle management case studies show how previously successful strategies should be applied in today’s market

Highlights

After a brief slump in 2005, the neuropathic pain market is forecast to grow to $5.5 billion by 2015, led by Lyrica and Cymbalta. Pfizer’s commitment to neuropathic pain and Lilly’s targeted approach are both effective strategies that can be utilized by all new entrants.

The presence of generic gabapentin has introduced strong cost competition in the market. Setting a competitive price point for a new product is vital as healthcare payers continue to push for lower drug prices and generic prescribing although innovation is rewarded with a premium price and a high level of reimbursement in most countries.

The current concerns surrounding the use of NSAIDs and opioids will be beneficial to neuropathic pain drug companies as physicians seek alternative analgesics for their patients. However, if they are to realize the full potential of the market, companies need to focus on expanding the patient potential by supporting physician education programs.

Reasons to Purchase

*Quantify the future size of the neuropathic pain market in each of the seven major markets *Understand key product differentiating factors that provide commercial advantages over existing therapies *Compare market penetration and brand positioning strategies to those successfully employed by Pfizer, Endo, and Eli Lilly

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Central Nervous System pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the neuropathic pain market

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Market sizing assumptions and caveats

Five treatments are approved for neuropathic pain in the US and Europe

US and EU markets comprise sales of approved and non-approved products

Japan market value was calculated using sales of popular NSAIDs

Current market situation

During 2005 the global market fell by 23% as US physicians switch from Neurontin to generic gabapentin

US market down but European markets show growth

Cymbalta, Lyrica, and Lidoderm are restoring market value

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Summary of environmental issues affecting the neuropathic pain market

Global opportunities and threats

Opportunities

Physicians are now turning to alternative analgesics amid concerns over NSAID and opioid use

Gain commercial advantage with an improved dosing regimen to gabapentin

A mechanism-based treatment approach would be well received

General neuropathic pain provides a broader customer base in the EU

Subtype-specific labeling provides an opportunity to define and own a market in the US and in Japan

Niche neuropathic pain subtypes can provide orphan drug benefits

Fibromyalgia is an attractive new market

Treatment guidelines say yes to opioids and no to NSAIDs

Journals, medical conferences and CME presentations are effective marketing channels for neuropathic pain products

Maximize market penetration by emphasizing ability to relieve specific symptoms of neuropathic pain

Minimal drug-drug interactions are key in treating HIVNP, DNP, and MSNP patients

European parliament approves pediatric legislation

Threats

Education is needed to improve disease and treatment awareness among PCPs

Generic gabapentin introduces strong cost competition in the EU and the US

Pharmacovigilance is leading to more stringent post-marketing regulations

New EU states may lead to a flood of cheap drug exports

Seeking out additional indications is becoming a less effective generic defense strategy

US: opportunities and threats

Opportunities

US pharmacists to play a greater role in neuropathic pain management

Medicare Part D reforms will provide a short-term boost, but in the longer term the impact is less certain

Threats

Further genericization encouraged by new legislation and public programs

$10 billion cut planned in Medicaid between 2005 and 2010

A high price point can prevent formulary access for drugs that do not have a significant clinical differentiating factor

The Medicare Part D “doughnut hole” could result in a surge in parallel imports

Disclosure of clinical trial results could become mandatory

Japan: opportunities and threats

Opportunities

There is a strong need for regulatory approved medicines

Separation of manufacturing and marketing entities benefits both Japanese and foreign companies

Fewer outsourcing restrictions enhances manufacturing efficiency

Reduced product approval time

Harmonization of approval process

The Internet is an effective means to reach out to patients

Threats

Earnings outlook clouded by lower drug prices and higher R&D costs

Off-label prescribing is uncommon

Generic drug use is expected to increase

Flat-sum reimbursement discourages physicians from prescribing highly priced medicines

France: opportunities and threats

Opportunities

Innovative drug development encouraged by price premium and high-level reimbursement

Consumers in France readily recognize the Internet as a source of high-quality medical information

Threats

Education and strong clinical trial data are needed to promote the use of newer drugs

Slow referrals can delay access to neuropathic pain drugs

French market attractiveness hit by higher taxes, lower prices and a shorter reimbursement

Germany: opportunities and threats

Opportunities

The German Research Network on Neuropathic Pain (GNNP) aims to define a mechanistic approach to diagnosis and treatment

Free pricing system and culture of innovation encourages novel drug development

ePharmacy and mail-order drugs legalized

Threats

National health insurer allowed greater powers to decrease expensive prescribing

Italy: opportunities and threats

Opportunities

Innovative drug development rewarded with premium price and 100% reimbursement

Threats

Education is needed to tackle low awareness of effective therapies

Further pharmaceutical price cuts planned

Spain: opportunities and threats

Opportunities

Planned electronic prescribing will improve access to treatments and promote the rational use of drugs

Threats

Price cuts continue unabated

New medicines bill pushes more price cuts and increases pharmaceutical tax

Government awareness campaign promotes generic use

UK: opportunities and threats

Opportunities

Nurses and pharmacists can now prescribe neuropathic pain drugs

New fast track drug assessment process speeds up time between licensing and NICE recommendations

Threats

Pricing controls dominate budgetary cost containment strategies

The NHS is unreceptive to new treatments compared to the rest of Europe

CHAPTER 4 FORECAST ANALYSIS

Key events

New product launches in the US and EU

Lamictal XR

Neurodex (AVP-923)

Ralfinamide

Transacin (NGX-4010)

Lacosamide

XP13512

Gabapentin GR

Sativex

NP-1

Traxoprodil

Tramadol ER

Brivaracetam (UCB 34714)

New product launches in Japan

Lyrica

Cymbalta

KN-48

Patent expiries

Trileptal

Actiq

Effexor/Effexor XR

Lamictal

Topamax

Lidoderm

Keppra

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Drug pricing and genericization assumptions

Forecasts

Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Market penetration and brand positioning

Case study: Commitment to neuropathic pain is key to Pfizer’s success

The glory days of Neurontin are over but Pfizer will battle on

Lyrica is priced competitively against generics

Pfizer looks set to regrow its neuropathic pain franchise

Pfizer’s legacy benefits other players

Case study: Premium price, brand loyalty and off-label use drives Lidoderm sales growth

Lidoderm follows the Neurontin model of growth

Establish FDA approval before communicating clinical trial data for other pain states

COX-II concerns has benefited Lidoderm

Case study: Cymbalta positioned as the DNP drug of choice

A competitive price point, once daily dosage and simpler titration are key to commercial success

Sponsoring treatment guidelines for specific patient groups will help define the market

Utilize established diabetes resources to reach out to the DNP customer base

APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS

Summary neuropathic pain market data

Anticonvulsant market data

Antidepressant market data

Other drugs market data

APPENDIX B – MARKET FORECAST DATA AND METHODOLOGY

Global market forecasts

5EU market forecasts

US market forecasts

Japan market forecasts

France market forecasts

Germany market forecasts

Italy market forecasts

Spain market forecasts

UK market forecasts

DATAMONITOR FORECAST METHODOLOGY

ICD-10 codes

Sales calculations

APPENDIX C

Contributing experts

Biographies

Bibliography

Clinical trial data

General

Treatment guidelines

Websites

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer

List of Tables

Table 1: Key players in the neuropathic pain market

Table 2: Global sales performance of key brands in the neuropathic pain market, 2004-05

Table 3: Neuropathic pain subtypes and abbreviations

Table 4: First-line recommendations for neuropathic pain, 2004

Table 5: Ex-manufacturer price of Neurontin vs. generic gabapentin in the US

Table 6: Average wholesaler price of Neurontin vs. generic gabapentin in the US, 2006

Table 7: Late stage R&D pipeline for neuropathic pain in Japan

Table 8: Cost comparison of 30 days’ treatment of PHN with generic gabapentin vs. Lyrica in the US, 2005

Table 9: Lidoderm clinical trials

Table 10: Cost comparison of 30 days treatment of DNP with Cymbalta vs. Lyrica in the US, 2006

Table 11: Summary Market Data

Table 12: Neurontin: key facts

Table 13: Lyrica: key facts

Table 14: Topamax: key facts

Table 15: Lamictal: key facts

Table 16: Tegretol: key facts

Table 17: Trileptal: key facts

Table 18: Keppra: key facts

Table 19: Cymbalta: key facts

Table 20: Lidoderm: key facts

Table 21: Oxycontin: key facts

Table 22: Duragesic: key facts

Table 23: Global neuropathic pain drug sales ($m) forecasts, 2005-15

Table 24: 5EU neuropathic pain drug sales ($m) forecasts, 2005-15

Table 25: US neuropathic pain drug sales ($m) forecasts, 2005-15

Table 26: Japan neuropathic pain drug sales ($m) forecasts, 2005-15

Table 27: France neuropathic pain drug sales ($m) forecasts, 2005-15

Table 28: Germany neuropathic pain drug sales ($m) forecasts, 2005-15

Table 29: Italy neuropathic pain drug sales ($m) forecasts, 2005-15

Table 30: Spain neuropathic pain drug sales ($m) forecasts, 2005-15

Table 31: UK neuropathic pain drug sales ($m) forecasts, 2005-15

Table 32: Neuropathic pain market definition by ICD-10 codes

Table 33: Neuropathic pain market definition by ICD-10 codes [continued]

Table 34: Percentage of total value accounted for by neuropathic pain diagnoses, for marketed brands and generics, 2005

List of Figures

Figure 1: Key events impacting the neuropathic pain market, 1999-2006

Figure 2: Global neuropathic pain market value by class, 2002-05

Figure 3: Global neuropathic pain prescription volume by class, 2002-05

Figure 4: Performance of the US, 5EU and Japan neuropathic pain markets, 2004-05

Figure 5: Breakdown of key brands sales by neuropathic pain vs. other indications, 2005

Figure 6: Summary of environmental issues in the global market, 2006

Figure 7: Summary of environmental issues in the US and Japanese markets, 2006

Figure 8: Summary of environmental issues in the 5EU markets, 2006

Figure 9: Pfizer US and 5EU gapapentin sales, 2001-05

Figure 10: Pfizer’s neuropathic pain revenues in the EU and US, 2001-05

Figure 11: 5EU gabapentin sales, 2001-05

Figure 12: SWOT analysis of Lyrica, 2006

Figure 13: Lyrica homepage, 2006

Figure 14: SWOT analysis of Lidoderm, 2006

Figure 15: US sales and key milestones for Lidoderm , 2001-05

Figure 16: Lidoderm US sales split by indication, 2005

Figure 17: SWOT analysis of Cymbalta, 2006

Figure 18: US and 5EU quarterly sales of Cymbalta, 2004-06 97