Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the CNS pharmaceutical analysis team
- 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
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