ABOUT DATAMONITOR HEALTHCARE 2
About the CNS pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the epilepsy market 3
Market forecast summary 5
Contributing experts 5
Related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8
Market definition for this report 8
Current market situation 9
Growth of the seven major epilepsy market is slowing 9
The US dominates sales revenue of the total seven major epilepsy market 10
Germany is the largest epilepsy market in the 5EU 11
Second-generation anticonvulsants outperform traditional anticonvulsants in terms of value sales 12
Keppra retains a strong foothold in the epilepsy market 18
Growth of Topamax outstrips Lamictal due to broader spectrum of approval 19
Zonegran suffers the steepest decline in sales 20
Strategic scoping and focus 21
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 22
Summary of environmental issues affecting epilepsy market size 22
Global market opportunities and threats 24
Opportunities 24
Treatments for refractory patients remains a significant unmet need 24
Greater treatment options are required for the growing elderly epilepsy population 26
Pediatric niche indications represent opportunities to increase market revenue 29
The under-treatment of epilepsy in developing countries cannot be ignored 31
High prevalence of co-morbid depression represents a large patient potential for companies marketing antidepressants 32
Threats 34
Ethical concerns and regulatory issues make epilepsy monotherapy licenses difficult to obtain 34
Non-adherence to treatment limits the revenue potential of the epilepsy market 35
Drive towards generic prescribing 36
US: opportunities and threats 38
Opportunities 39
Advocacy groups drive patient awareness of therapeutic options 39
Online DTC advertising facilitates patients' understanding of their condition 40
Lobbying efforts aim to make generic substitution of anticonvulsants more difficult 41
Threats 43
Higher price prices increases the impact of genericization 43
Proposed cut to Medicare will reduce reimbursement of epilepsy products for elderly patients 45
Japan: opportunities and threats 46
Opportunities 46
Underdeveloped epilepsy market in Japan has scope for growth 46
Rapidly rising elderly population will boost prevalence of epilepsy in Japan 47
Governmental funding for clinical trials could benefit research into epilepsy 48
Threats 49
Government's pro-generics strategy aims to double the use of generics by the end of 2012 49
France: opportunities and threats 50
Opportunities 51
Price premiums and high-level reimbursement encourage innovation 51
Keppra's non-dominant status reduces competition for potential market entrants 52
Threats 53
Take-off of generic sector 53
Formulary access 54
Germany: opportunities and threats 54
Opportunities 55
Companies can command a higher than average price-point in Germany 55
Threats 56
High level of generic incursion set to be exacerbated by introduction of generic incentivization scheme for doctors 56
Italy: opportunities and threats 58
Opportunities 58
Lack of recommendation for generic substitution will ensure generic incursion remains low 58
A record number of clinical trials were approved in Italy in 2006 59
Threats 59
Stringent reference pricing system 59
Spain: opportunities and threats 60
Opportunities 60
Reduced pharmaceutical tax set to save companies selling branded epilepsy treatments over $1.6m per annum 60
Health ministry introduces 'Spanish national formulary' 61
Threats 61
R&D activity expected to decline 61
UK: opportunities and threats 62
Opportunities 63
Reduced clinical trial times will hasten pipeline epilepsy products to the market 63
NICE guidelines advocate the use of newer drugs for epilepsy and recommend early specialist consultations 63
Increased recruitment and training of neurologists will accelerate access to treatments 64
Threats 65
Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts 65
CHAPTER 4 FORECAST ANALYSIS 66
Key events 66
New product launches in the US and EU 67
Rufinamide 67
Lamictal XR 68
Vimpat (lacosamide) 70
Brivaracetam 71
Retigabine 73
DP-VPA 74
New product launches in Japan 75
Neurontin (gabapentin) 75
Lamictal (lamotrigine) 76
Keppra (levetiracetam) 76
Patent expiries 77
Cerebyx (fosphenytoin sodium injectable) 77
Trileptal (oxcarbazepine) 78
Depakote (valproate semisodium) 78
Keppra (levetiracetam) 79
Lamictal (lamotrigine) 79
Topamax (topiramate) 80
Felbatol (felbamate) 80
Carbatrol (carbamazepine sustained release) 80
Data definitions, limitations and assumptions 81
Standard units 81
Japanese market data 81
Derivation of sales forecasts and pricing trends 81
Drug pricing and genericization assumptions 81
Forecast methodology 83
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 84
Introduction 84
Commitment to epilepsy provides long-term growth 84
Drug innovation provides a firm grounding for growth 85
Epilepsy-focused brand strategies improve credibility 87
Post launch clinical studies and indication expansions strengthen brand loyalty 88
Keppra's indication expansions have focused on the pediatric population 89
Seeking regulatory approval in the pediatric population remains a commercially attractive route 92
Offering a variety of drug delivery formulations provides prescribers with more options 93
Keppra injectable formulation offers utility in a small proportion of patients 93
Focus promotional spend on maintaining relationships with prescribers 96
Continued development of new treatments demonstrates long- term commitment 98
BIBLIOGRAPHY 100
Journal papers 100
Websites 103
Datamonitor reports 111
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS 112
Summary epilepsy market data 112
Anticonvulsant market data 113
APPENDIX B - MARKET FORECAST DATA 122
Seven major markets 122
M5EU 123
US 124
Japan 125
France 126
Germany 127
Italy 128
Spain 129
UK 130
APPENDIX C 131
Contributing experts 131
Report methodology 134
About Datamonitor 134
About Datamonitor Healthcare 134
About the CNS analysis team 135
Disclaimer 136
List of Tables
Table 1: Key players in the epilepsy market, 2007 15
Table 2: Summary of global environmental issues affecting the epilepsy market, 2007 22
Table 3: Summary of environmental issues in the individual seven major epilepsy markets, 2007 23
Table 4: Estimated launch dates for new epilepsy drugs in the 5EU and US, 2007-2016 67
Table 5: Japan launch dates for epilepsy products, 2007-2016 75
Table 6: Patent expiry dates for the key approved epilepsy brands in the seven major markets, 2007-2016 77
Table 7: Approved additional therapeutic indications of marketed anticonvulsants, 2007 87
Table 8: Approved pediatric indications for Topamax, Lamictal and Trileptal 93
Table 9: UCB/Schwarz's epilepsy pipeline, 2007 98
Table 10: Epilepsy summary market data ($m), 2006 112
Table 11: Keppra: key facts 113
Table 12: Lamictal: key facts 114
Table 13: Topamax: key facts 115
Table 14: Trileptal: key facts 116
Table 15: Depakine: key facts 117
Table 16: Tegretol: key facts 118
Table 17: Dilantin: key facts 119
Table 18: Carbatrol: key facts 120
Table 19: Zonegran: key facts 121
Table 20: Seven major market epilepsy drug sales forecasts ($m), 2007-2016 122
Table 21: 5EU epilepsy drug sales forecasts ($m), 2007-2016 123
Table 22: US epilepsy drug sales forecasts ($m), 2007-2016 (New) 124
Table 23: Japan epilepsy drug sales forecasts ($m), 2007-2016 125
Table 24: France epilepsy drug sales forecasts ($m), 2007-2016 126
Table 25: Germany epilepsy drug sales forecasts ($m), 2007-2016 127
Table 26: Italy epilepsy drug sales forecasts ($m), 2007-2016 128
Table 27: Spain epilepsy drug sales forecasts ($m), 2007-2016 129
Table 28: UK epilepsy drug sales forecasts ($m), 2007-2016 130
Table 29: ICD-10 codes used to size the epilepsy market 133
List of Figures
Figure 1: Datamonitor's epilepsy forecast market across the seven major markets, 2007-2016 5
Figure 2: Epilepsy-specific sales revenue across the seven major markets ($m), 2003-06 10
Figure 3: Epilepsy-specific sales volume across the seven major markets ($m), 2003-06 11
Figure 4: Performance of the 5EU epilepsy markets ($m), 2005-06 12
Figure 5: Key events impacting the epilepsy market, 1995-2007 13
Figure 6: Sales volume (SU millions) and value ($m) of first- versus second-generation anticonvulsants, 2003-06 14
Figure 7: Performance of the nine key epilepsy therapies ($m), 2005-06 18
Figure 8: Population aged over 65 years in the seven major markets, 2007 and 2017 28
Figure 9: Performance of the key anticonvulsants in the US 2005-06 39
Figure 10: Average anticonvulsant standard unit price in the US and the other six major markets, 2003-06 44
Figure 11: Performance of the key anticonvulsants in Japan 2005-06 46
Figure 12: Population of Japan over the age of 65 (million), 1950-2020 48
Figure 13: Performance of the key anticonvulsants in France 2005-06 50
Figure 14: Market share of key epilepsy drugs in France(%), 2006 52
Figure 15: Generic incursion of epilepsy-specific volume sales of anticonvulsants in the 5EU, 2003-06 54
Figure 16: Performance of the key anticonvulsants in Germany 2005-06 55
Figure 17: Average anticonvulsant standard unit price in Germany and the other four EU countries ($), 2003-06 56
Figure 18: Generic incursion of the 5EU epilepsy markets, 2003-06 57
Figure 19: Performance of the key anticonvulsants in Italy 2005-06 58
Figure 20: Performance of the key anticonvulsants in Spain 2005-06 60
Figure 21: Performance of the key anticonvulsants in the UK 2005-06 62
Figure 22: Impact of key events on the 7MM epilepsy market 66
Figure 23: Forecasted UCB epilepsy franchise ($m), 2007-2016 85
Figure 24: Quarterly value sales of Keppra across the seven major markets ($m), 2003-06 86
Figure 25: Keppra's epilepsy indication expansions, 2000-06 89
Figure 26: Sales of Keppra's four formulations ($m), 2003-06 94
Figure 27: Promotional spend on physician detailing for Keppra in the US and 5EU, 2004-06 96
Figure 28: Promotional spend on journal advertising for Keppra in the US and 5EU, 2004-06 97