Market Report Source

Overview

Introduction
The current epilepsy market boasts a wide range of treatment options and has recently reached a state of maturity. The market value across the 7MM grew by just 2.3% from 2005 to $3.2 billion in 2006. However, imminent change to the market in the near to mid term will be brought about by the occurrence of key patent expiries and new drugs launches.

Scope

• This report focuses on drugs used to treat epilepsy, with indication- and country-specific sales value and volume forecasts to 2016
• Assessment of current and future opportunities and threats in the epilepsy market across the 7MMs and in individual regions
• Identification of future market events expected to impact epilepsy-specific anticonvulsant drug revenues over the next decade
• Case study analysis of successful lifecycle management strategies and provision of key recommendations to ensure revenue growth

Highlights
Despite advances in epilepsy treatment over the past 15 years, the efficacy of current anticonvulsants remains limited, with approximately 2030% of patients continuing to suffer from refractory seizures. As such, in an increasingly crowded market, targeting refractory epilepsy patients continues to present a potentially lucrative opportunity. Focusing on epilepsy rather than diversifying into other secondary CNS indications has played a pivotal role for UCB in ensuring Keppra’s market leadership and ongoing strong uptake. Demonstrating a solid commitment to the disease will be viewed favorably by neurologists and will promote brand loyalty. This, in turn will provide long-term growth. Keppra’s pediatric epilepsy indication expansions over the past 2 years have served to expand its patient base. In view of the high prevalence of childhood epilepsy and high level of unmet need in this patient group, gaining approval in the pediatric population remains an attractive means of increasing revenue and strengthening brand loyalty.

Reasons to Purchase

• Quantify the future size of the epilepsy market, in terms of prescription volume and value, in each of the seven major markets
• Assess the impact of future events such as patent expiries, indication expansions, and new product launches on the sales of key marketed brands
• Identify key lifecycle management strategies and market opportunities that can ensure growth in the increasingly competitive epilepsy market

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the epilepsy market

Market forecast summary

Contributing experts

Related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current market situation

Growth of the seven major epilepsy market is slowing

The US dominates sales revenue of the total seven major epilepsy market

Germany is the largest epilepsy market in the 5EU

Second-generation anticonvulsants outperform traditional anticonvulsants in terms of value sales

Keppra retains a strong foothold in the epilepsy market

Growth of Topamax outstrips Lamictal due to broader spectrum of approval

Zonegran suffers the steepest decline in sales

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Summary of environmental issues affecting epilepsy market size

Global market opportunities and threats

Opportunities

Treatments for refractory patients remains a significant unmet need

Greater treatment options are required for the growing elderly epilepsy population

Pediatric niche indications represent opportunities to increase market revenue

The under-treatment of epilepsy in developing countries cannot be ignored

High prevalence of co-morbid depression represents a large patient potential for companies marketing antidepressants

Threats

Ethical concerns and regulatory issues make epilepsy monotherapy licenses difficult to obtain

Non-adherence to treatment limits the revenue potential of the epilepsy market

Drive towards generic prescribing

US: opportunities and threats

Opportunities

Advocacy groups drive patient awareness of therapeutic options

Online DTC advertising facilitates patients’ understanding of their condition

Lobbying efforts aim to make generic substitution of anticonvulsants more difficult

Threats

Higher price prices increases the impact of genericization

Proposed cut to Medicare will reduce reimbursement of epilepsy products for elderly patients

Japan: opportunities and threats

Opportunities

Underdeveloped epilepsy market in Japan has scope for growth

Rapidly rising elderly population will boost prevalence of epilepsy in Japan

Governmental funding for clinical trials could benefit research into epilepsy

Threats

Government’s pro-generics strategy aims to double the use of generics by the end of 2012

France: opportunities and threats

Opportunities

Price premiums and high-level reimbursement encourage innovation

Keppra’s non-dominant status reduces competition for potential market entrants

Threats

Take-off of generic sector

Formulary access

Germany: opportunities and threats

Opportunities

Companies can command a higher than average price-point in Germany

Threats

High level of generic incursion set to be exacerbated by introduction of generic incentivization scheme for doctors

Italy: opportunities and threats

Opportunities

Lack of recommendation for generic substitution will ensure generic incursion remains low

A record number of clinical trials were approved in Italy in 2006

Threats

Stringent reference pricing system

Spain: opportunities and threats

Opportunities

Reduced pharmaceutical tax set to save companies selling branded epilepsy treatments over $1.6m per annum

Health ministry introduces ‘Spanish national formulary’

Threats

R&D activity expected to decline

UK: opportunities and threats

Opportunities

Reduced clinical trial times will hasten pipeline epilepsy products to the market

NICE guidelines advocate the use of newer drugs for epilepsy and recommend early specialist consultations

Increased recruitment and training of neurologists will accelerate access to treatments

Threats

Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts

CHAPTER 4 FORECAST ANALYSIS

Key events

New product launches in the US and EU

Rufinamide

Lamictal XR

Vimpat (lacosamide)

Brivaracetam

Retigabine

DP-VPA

New product launches in Japan

Neurontin (gabapentin)

Lamictal (lamotrigine)

Keppra (levetiracetam)

Patent expiries

Cerebyx (fosphenytoin sodium injectable)

Trileptal (oxcarbazepine)

Depakote (valproate semisodium)

Keppra (levetiracetam)

Lamictal (lamotrigine)

Topamax (topiramate)

Felbatol (felbamate)

Carbatrol (carbamazepine sustained release)

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Drug pricing and genericization assumptions

Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Commitment to epilepsy provides long-term growth

Drug innovation provides a firm grounding for growth

Epilepsy-focused brand strategies improve credibility

Post launch clinical studies and indication expansions strengthen brand loyalty

Keppra’s indication expansions have focused on the pediatric population

Seeking regulatory approval in the pediatric population remains a commercially attractive route

Offering a variety of drug delivery formulations provides prescribers with more options

Keppra injectable formulation offers utility in a small proportion of patients

Focus promotional spend on maintaining relationships with prescribers

Continued development of new treatments demonstrates long- term commitment

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS

Summary epilepsy market data

Anticonvulsant market data

APPENDIX B – MARKET FORECAST DATA

Seven major markets

M5EU

US

Japan

France

Germany

Italy

Spain

UK

APPENDIX C

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer

List of Tables

Table 1: Key players in the epilepsy market, 2007

Table 2: Summary of global environmental issues affecting the epilepsy market, 2007

Table 3: Summary of environmental issues in the individual seven major epilepsy markets, 2007

Table 4: Estimated launch dates for new epilepsy drugs in the 5EU and US, 2007-2016

Table 5: Japan launch dates for epilepsy products, 2007-2016

Table 6: Patent expiry dates for the key approved epilepsy brands in the seven major markets, 2007-2016

Table 7: Approved additional therapeutic indications of marketed anticonvulsants, 2007

Table 8: Approved pediatric indications for Topamax, Lamictal and Trileptal

Table 9: UCB/Schwarz’s epilepsy pipeline, 2007

Table 10: Epilepsy summary market data ($m), 2006

Table 11: Keppra: key facts

Table 12: Lamictal: key facts

Table 13: Topamax: key facts

Table 14: Trileptal: key facts

Table 15: Depakine: key facts

Table 16: Tegretol: key facts

Table 17: Dilantin: key facts

Table 18: Carbatrol: key facts

Table 19: Zonegran: key facts

Table 20: Seven major market epilepsy drug sales forecasts ($m), 2007-2016

Table 21: 5EU epilepsy drug sales forecasts ($m), 2007-2016

Table 22: US epilepsy drug sales forecasts ($m), 2007-2016 (New)

Table 23: Japan epilepsy drug sales forecasts ($m), 2007-2016

Table 24: France epilepsy drug sales forecasts ($m), 2007-2016

Table 25: Germany epilepsy drug sales forecasts ($m), 2007-2016

Table 26: Italy epilepsy drug sales forecasts ($m), 2007-2016

Table 27: Spain epilepsy drug sales forecasts ($m), 2007-2016

Table 28: UK epilepsy drug sales forecasts ($m), 2007-2016

Table 29: ICD-10 codes used to size the epilepsy market

List of Figures

Figure 1: Datamonitor’s epilepsy forecast market across the seven major markets, 2007-2016

Figure 2: Epilepsy-specific sales revenue across the seven major markets ($m), 2003-06

Figure 3: Epilepsy-specific sales volume across the seven major markets ($m), 2003-06

Figure 4: Performance of the 5EU epilepsy markets ($m), 2005-06

Figure 5: Key events impacting the epilepsy market, 1995-2007

Figure 6: Sales volume (SU millions) and value ($m) of first- versus second-generation anticonvulsants, 2003-06

Figure 7: Performance of the nine key epilepsy therapies ($m), 2005-06

Figure 8: Population aged over 65 years in the seven major markets, 2007 and 2017

Figure 9: Performance of the key anticonvulsants in the US 2005-06

Figure 10: Average anticonvulsant standard unit price in the US and the other six major markets, 2003-06

Figure 11: Performance of the key anticonvulsants in Japan 2005-06

Figure 12: Population of Japan over the age of 65 (million), 1950-2020

Figure 13: Performance of the key anticonvulsants in France 2005-06

Figure 14: Market share of key epilepsy drugs in France(%), 2006

Figure 15: Generic incursion of epilepsy-specific volume sales of anticonvulsants in the 5EU, 2003-06

Figure 16: Performance of the key anticonvulsants in Germany 2005-06

Figure 17: Average anticonvulsant standard unit price in Germany and the other four EU countries ($), 2003-06

Figure 18: Generic incursion of the 5EU epilepsy markets, 2003-06

Figure 19: Performance of the key anticonvulsants in Italy 2005-06

Figure 20: Performance of the key anticonvulsants in Spain 2005-06

Figure 21: Performance of the key anticonvulsants in the UK 2005-06

Figure 22: Impact of key events on the 7MM epilepsy market

Figure 23: Forecasted UCB epilepsy franchise ($m), 2007-2016

Figure 24: Quarterly value sales of Keppra across the seven major markets ($m), 2003-06

Figure 25: Keppra’s epilepsy indication expansions, 2000-06

Figure 26: Sales of Keppra’s four formulations ($m), 2003-06

Figure 27: Promotional spend on physician detailing for Keppra in the US and 5EU, 2004-06

Figure 28: Promotional spend on journal advertising for Keppra in the US and 5EU, 2004-06