Commercial Insight: Epilepsy

Companies Committed To The Cause Will Reap The Benefits

Publication Date	September 2007
Publisher	Datamonitor
Product Type	Report
Pages	142
ISBN Number	not applicable
Product Code	DAT08937

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Summary

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.

Content

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