Commercial Insight: Anticonvulsants - Non-epilepsy label expansions provide blockbuster potential : Market Research Report

Commercial Insight: Anticonvulsants - Non-epilepsy label expansions provide blockbuster potential

Published by: Datamonitor

Published: Oct. 8, 2009 - 265 Pages

ABOUT DATAMONITOR HEALTHCARE: About the Central Nervous System pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Strategic scoping and focus; Datamonitor insight into the anticonvulsants market; Related reports; Upcoming related reports
CHAPTER 2 MARKET DEFINITION: Market definition for this report
CHAPTER 3 MARKET OVERVIEW: Seven major markets; Current and future market overview; Sales of anticonvulsant drugs across the seven major markets grew to $13.6 billion in 2008; Patent expiries of leading brands will cause the anticonvulsant market to decline to $13.0 billion by 2018; Opportunities and threats; Opportunities; Threats; US; Current and future market assessment; The US was the largest of the seven major markets in 2008; The US will continue to be the largest of the seven major markets for anticonvulsants; Opportunities and threats; Opportunities; Threats; Japan; Current and future market assessment; Japan was the smallest anticonvulsant market in terms of sales in 2008; Launch of two second-generation anticonvulsants leads to strong growth over 2007-08; Zonegran launched for Parkinson's disease in Japan in March 2009; Continued uptake of second-generation anticonvulsants will drive growth to 2018; Opportunities and threats; Opportunities; Threats; Five major European markets (5EU); Current and future market assessment; Anticonvulsant drug sales grew by a CAGR of 14% over 2004-08; Lyrica will remain the greatest growth driver in the 5EU to 2018; Opportunities and threats; Opportunities; Threats; France; Current and future market assessment; Lyrica occupied a 29% share of the anticonvulsants market in France in 2008; Strongest growth of all 5EU countries forecasted for France; Germany; Current and future market assessment; Germany boasts the largest anticonvulsant market in the 5EU region; Anticonvulsants drug class forecast to reach over $1.0 billion by 2014; Italy; Current and future market assessment; Italy has remained the smallest of the 5EU markets for the past 5 years; Anticonvulsants drug class forecast to grow to $462m by 2018; Spain; Current and future market assessment; Spain has demonstrated consistently strong growth over 2004-08; Anticonvulsants drug class forecast to undergo CAGR of 4.4% (2008-18); UK; Current and future market assessment; The UK anticonvulsants market grew by a CAGR of 11.5% over 2004-08; Anticonvulsants drug class forecast to grow to $751m by 2018; Global and rest of the world snapshot; Current market assessment; The global anticonvulsant class market approached $17 billion in 2008; Rest of world anticonvulsant class market has undergone consistently strong growth over 2004-08; Sales volume growth is driven by the rest of the world region; Rest of the world accounts for a greater proportion of global sales volume than the US; Despite forming the smallest region, the MENA nations are demonstrating strong growth; Lyrica was the highest seller in the rest of world region of 2008 and demonstrates the strongest growth; Opportunity within the rest of the world market; The high prevalence of epilepsy in developing countries cannot be ignored
CHAPTER 4 BRAND DYNAMICS: Overview of competitive landscape; Lyrica is set to usurp Topamax's status as market leader; US formulary tier status for leading brands; Availability of generic first-generation anticonvulsants negatively impacts brand tier status; Keppra has desirable Tier-2 coverage in most plans; Trends in marketing strategies; Promotional spend; Lyrica benefits from highest level of non-DTC promotional spend; Sponsorship of patient education/partnerships; Johnson & Johnson sponsors three migraine-education websites; UCB capitalizes on wealth of information stored in online communities; Direct-to-consumer advertising; Websites for three anticonvulsant brands offer savings to patients; Topamax (topiramate; Johnson & Johnson); Drug profile; Topamax has remained the top-selling anticonvulsant for the past 4 years; Product positioning; Topamax is considered a first-line treatment for migraine prophylaxis in the US; Prior to the end of Topamax's lifestyle, Johnson & Johnson had explored additional indication expansions for Topamax; SWOT analysis; Seeking approval of Topamax in the underserved Japanese migraine market is an option open to Johnson & Johnson; Brand forecast to 2018; Generic erosion from 2009 in the US will cause a substantial contraction in sales; Revenue loss will be compounded by lack of opportunity to switch patients from Topamax to carisbamate; Lyrica (pregabalin; Pfizer); Drug profile; Lyrica had a highly successful launch; Product positioning; Lyrica is the leading anticonvulsant product in both the neuropathic pain and fibromyalgia markets; Lyrica receives a substantial proportion of revenues from off-label prescribing; SWOT analysis; Datamonitor forecasts lower US sales than consensus due to Q2 2009 sales dip; Pfizer is seeking to capitalize on Lyrica's long patent life through label expansions in the US; Japanese approval will expand the geographical reach of Lyrica; Lyrica is unlikely to gain EU approval for fibromyalgia over the forecast period; Brand forecast to 2018; Sales of Lyrica are forecast to grow at a CAGR of 4.6% over 2008-2018, aided by the drug's long patent life; Lamictal and Lamictal XR (lamotrigine; GlaxoSmithKline); Drug profile; Seven major market sales of Lamictal declined by 14% over 2007-08; Lamictal XR received FDA approval in June 2009; Product positioning; Lamictal is a leading bipolar disorder treatment in the US; SWOT analysis; Brand forecast to 2018; Generic erosion will cause ongoing decline of GlaxoSmithKline's Lamictal franchise; Datamonitor expects Lamictal to gain approval for bipolar disorder in Japan in Q3 2012; Keppra and Keppra XR (levetiracetam; UCB); Drug profile; Seven major market sales of Keppra grew by 30% between 2007 and 2008; Launch of Keppra XR in September 2008 represents a clear lifecycle management strategy; Product positioning; UCB has focused its Keppra brand strategies exclusively towards the epilepsy population; SWOT analysis; Brand forecast to 2018; Keppra sales will continue to decline sharply following November 2008 US patent expiry; Japanese launch of Keppra for epilepsy is expected in Q2 2010; Keppra XR will not match the commercial success of Keppra; Depakote franchise (valproate semisodium; Abbott); Drug profile; Seven major market sales of Depakote franchise declined by 5% over 2007-08; Product positioning; SWOT analysis; Brand forecast to 2018; Generic competition will cause ongoing contraction of sales; Vimpat (lacosamide; UCB); Drug profile; Vimpat represents the most recent anticonvulsant to enter the market; Product positioning; Vimpat is positioned as a treatment for patients with uncontrolled epilepsy; SWOT analysis; Cannibalization of sales by brivaracetam represents a key threat; Brand forecast to 2018; Patient potential of Vimpat is limited by non-approval in neuropathic pain; Vimpat will struggle to compete with Keppra and generic levetiracetam; Banzel (rufinamide; Eisai); Drug profile; The full commercial potential of Banzel has yet to be seen; Product positioning; Banzel possesses the narrowest approved indication of the key marketed anticonvulsants; Launch of Banzel has expanded Eisai's anticonvulsant portfolio; SWOT analysis; Brand forecast to 2018; Narrow patient potential will limit uptake of Banzel; Datamonitor expects Eisai to launch Banzel in its domestic market of Japan in 2014; Indication expansion in generalized anxiety disorder is on the horizon for rufinamide; Stedesa/Zebinix (eslicarbazepine acetate; Sepracor/Eisai); Drug profile; EU launch is imminent following April 2009 approval; Product positioning; Brand forecast to 2018; Other marketed anticonvulsant drugs; Pipeline anticonvulsants; Carisbamate (Johnson & Johnson); Target product profile; Development overview; Product positioning; Marketing mix; Drug forecast to 2018; Strategic recommendations; Brivaracetam (UCB); Target product profile; Development overview; Product positioning; Marketing mix; Drug forecast to 2018; Strategic recommendations; Retigabine (Valeant/GlaxoSmithKline); Target product profile; Development overview; Product positioning; Marketing mix; Drug forecast to 2018; Strategic recommendations; Perampanel (E2007; Eisai); Target product profile; Development overview; Product positioning; Marketing mix; Drug forecast to 2018; Strategic recommendations
CHAPTER 5 KEY DEVELOPERS: Strategic overview; Leading companies in the branded anticonvulsant class market; Marketers of leading branded anticonvulsants occupy top two positions in 2008; UCB demonstrates strongest growth as Novartis and Eisai succumb to generic competition; Pfizer to occupy prime position in anticonvulsants market from 2009; Trends in corporate strategy; Indication expansion; Pfizer leads the way in maximizing indication expansions; Non-epilepsy indication expansions have provided several brands with their primary revenue source; Development of extended release formulations; Extended release formulations are not expected to be successful in mitigating generic erosion; The US is the target market for extended release formulations; Recent shifts in corporate strategy; Interest in the Japanese market has increased among marketers; Recent strategic partnerships; Key players seek co-promotional deals to expand geographical reach of brands; GlaxoSmithKline seeks to maintain stake in anticonvulsant market through acquiring rights to a novel product; UCB leverages local expertise of Otsuka to ensure successful Japanese launch for Keppra; Eisai; Corporate strategy; In-licensed and acquired products are the cornerstone of Eisai's marketed anticonvulsant portfolio; Eisai is actively building its anticonvulsant portfolio ahead of Aricept's patent expiry; Anticonvulsant portfolio assessment; Eisai's future anticonvulsant portfolio shows a focus on four specific epilepsy indications; UCB; Corporate strategy; Development of a drug with a novel mode of action was a winning strategy for UCB; UCB aims to build on the success of Keppra with three additional products; Anticonvulsant portfolio assessment; Product differentiation is expected to pose a key challenge to UCB
CHAPTER 6 CASE STUDIES: Introduction; Indication expansion strategies; Migraine prophylaxis offers a large patient potential; Topamax indication expansion into migraine prophylaxis has proven highly successful; Fibromyalgia - EMEA thwarts market approval; Branded and unbranded direct-to-consumer campaigns accompanied Lyrica's indication expansion into fibromyalgia; Anxiety disorders - a less profitable indication for anticonvulsant manufacturers despite substantial patient potential; Anxiety indication expansion has proved unsuccessful thus far for Lyrica; Pediatric epilepsy indication expansions generate brand loyalty; Epilepsy indication expansions have contributed to Keppra's leading status in epilepsy
BIBLIOGRAPHY: Journal papers; Publications; Websites; Datamonitor reports
APPENDIX A - MARKET ASSUMPTIONS: New product launches; Patent expiries; Data definitions, limitations and assumptions; Standard units; Country group definitions; Rest of European Union; Middle East and North Africa (MENA); Rest of the world; Derivation of sales forecasts and pricing trends; Forecast methodology
APPENDIX B: Contributing experts; Conferences attended; Report methodology; About Datamonitor; About Datamonitor Healthcare; About the Central Nervous System analysis team; Disclaimer
List of Tables: Table 1: Key events impacting the anticonvulsant class market, 2009-2018; Table 2: Sales and growth of key anticonvulsant brands in the seven major markets, 2008-2018; Table 3: Sales forecasts of key anticonvulsant drugs in the seven major markets ($m), 2008-2018; Table 4: Summary of opportunities and threats in the anticonvulsants market across the seven major markets, 2009-2018; Table 5: Sales and growth of key anticonvulsant brands in the US, 2008-2018; Table 6: US sales forecasts of anticonvulsant drugs ($m), 2008-2018; Table 7: Summary of opportunities and threats in the anticonvulsants market in the US, 2009-2018; Table 8: Sales and growth of anticonvulsant drugs in Japan, 2004-08; Table 9: Sales and growth of key anticonvulsant brands in Japan , 2008-2018; Table 10: Sales forecasts of branded anticonvulsants in Japan ($m), 2008-2018; Table 11: Summary of opportunities and threats in the Japanese anticonvulsants market, 2009-2018; Table 12: Sales and growth of the anticonvulsant drug class in the 5EU, 2004-2018; Table 13: Sales forecasts of branded anticonvulsants in the 5EU ($m), 2008-2018; Table 14: Summary of opportunities and threats in the five major European markets, 2009; Table 15: Sales and growth of key anticonvulsant brands in France , 2008-2018; Table 16: Sales and growth of key anticonvulsant brands in Germany, 2008-2018; Table 17: Sales and growth of key anticonvulsant brands in Italy, 2008-2018; Table 18: Sales and growth of key anticonvulsant brands in Spain, 2008-2018; Table 19: Sales and growth of key anticonvulsant brands in Spain, 2008-2018; Table 20: Global sales ($m) dynamics of the anticonvulsant class market, 2004-08; Table 21: Comparison of leading anticonvulsant brand sales in the seven major markets and the rest of the world, 2004-08; Table 22: Sales of established and recently launched anticonvulsant brands in the seven major markets ($m), 2008-2018; Table 23: Key anticonvulsants in late-stage R&D, 2009; Table 24: Representative formulary tier status in the US for leading anticonvulsant brands, 2009; Table 25: Marketing strategies employed by the companies behind the top five anticonvulsant brands, 2009; Table 26: Topamax (topiramate): key facts, 2009; Table 27: Impacting factors on the revenues of Topamax, 2009-2018; Table 28: Lyrica (pregabalin): key facts, 2009; Table 29: Impacting factors on the revenues of Lyrica, 2009-2018; Table 30: Lamictal (lamotrigine): key facts, 2009; Table 31: Impacting factors on the revenues of Lamictal/Lamictal XR, 2009-2018; Table 32: Keppra (levetiracetam): key facts, 2009; Table 33: Impacting factors on the revenues of Keppra franchise, 2009-2018; Table 34: Depakote (valproate semisodium): key facts, 2009; Table 35: Impacting factors on the revenues of Depakote franchise, 2009-2018; Table 36: Vimpat (lacosamide): key facts, 2009; Table 37: Impacting factors on the revenues of Vimpat, 2009-2018; Table 38: Banzel (rufinamide): key facts, 2009; Table 39: Impacting factors on the revenues of Banzel, 2009-2018; Table 40: Eslicarbazepine acetate (Stedesa/Zebinix): key facts, 2009; Table 41: Summary of all other marketed anticonvulsant drugs, 2009; Table 42: Carisbamate - target product profile, 2009; Table 43: Key facts: Phase II trial of carisbamate in diabetic neuropathic pain; Table 44: Key factors impacting sales of carisbamate, 2009-2018; Table 45: Brivaracetam - target product profile, 2009; Table 46: Ongoing clinical trial summary for UCB's brivaracetam, 2009; Table 47: Key factors impacting sales of brivaracetam, 2009-2018; Table 48: Retigabine - target product profile, 2009; Table 49: Key factors impacting sales of retigabine, 2009-2018; Table 50: Perampanel - target product profile, 2009; Table 51: Development status of Eisai's perampanel, 2009; Table 52: Key factors impacting sales of perampanel, 2009-2018; Table 53: Leading companies in the branded seven major anticonvulsant market by sales value, 2008-2018; Table 54: Key strategic deals and events in the antidepressant market, 2009; Table 55: Eisai portfolio assessment of anticonvulsants, 2009-18; Table 56: UCB's portfolio assessment of anticonvulsants, 2009; Table 57: Product launch and indication expansion dates for anticonvulsants across the seven major markets, 2009-2018; Table 58: Patent expiry dates for marketed anticonvulsant drugs in the seven major markets, 2009-2018
List of Figures: Figure 1: Indexed anticonvulsant drug sales in the seven major markets by region ($m), 2004-08; Figure 2: Key events impacting the anticonvulsants drug class market, 2004-08; Figure 3: Anticonvulsant market forecast across the seven major markets by region ($m), 2008-2018; Figure 4: Primary and secondary indications for anticonvulsants; Figure 5: Topamax (topiramate) total brand sales by indication in the seven major markets ($m), 2004-08; Figure 6: Dynamics of the top five anticonvulsants in the US, 2004-08; Figure 7: US anticonvulsant market forecast, 2008-2018; Figure 8: Epilepsy-specific sales of Trileptal (oxcarbazepine) in the US between Q1 2007 and Q4 2008; Figure 9: Change in Japanese market anticonvulsant class sales value ($), 2004-08; Figure 10: Japanese anticonvulsant market sales forecast, 2008-18; Figure 11: Population of Japan over the age of 65 years (millions), 1950-2020; Figure 12: Dynamics of anticonvulsant drug class markets within the 5EU ($m), 2004-08; Figure 13: 5EU anticonvulsant market sales forecast, split by country, 2008-18; Figure 14: IMS standard unit price point of three leading anticonvulsant brands in the 5EU ($), 2008; Figure 15: Change anticonvulsant market class sales value ($) in France, 2004-08; Figure 16: French anticonvulsant market sales forecast, 2008-18; Figure 17: Change anticonvulsant market class sales value ($) in Germany, 2004-08; Figure 18: German anticonvulsant market sales forecast, 2008-18; Figure 19: Change anticonvulsant market class sales value ($) in Italy, 2004-08; Figure 20: Italian anticonvulsant market sales forecast, 2008-18; Figure 21: Change anticonvulsant market class sales value ($) in Spain, 2004-08; Figure 22: Spanish anticonvulsant market sales forecast, 2008-18; Figure 23: Change anticonvulsant market class sales value ($) in the UK, 2004-08; Figure 24: UK anticonvulsant market sales forecast, 2008-18; Figure 25: Change in global anticonvulsant market sales value by region, 2004-08; Figure 26: Change in global anticonvulsant market sales by value by region, 2004-08; Figure 27: Change in global anticonvulsant market sales volume,( IMS standard units sold, 2004-08; Figure 28: Global anticonvulsant class market sales volume (IMS standard units sold) and sales value ($), by region, 2008; Figure 29: Global anticonvulsant class market sales volume (IMS standard units sold) and sales value ($), by region, 2008; Figure 30: Non-direct consumer promotional spend for four five key anticonvulsant brands in the US and 5EU, Q2 2007-Q2 2008; Figure 31: Screenshot of Johnson & Johnson's promotion of Topamax's coupon card scheme; Figure 32: Screenshot of UCB's patient savings programs for Keppra XR and Vimpat; Figure 33: Screenshot of Eisai's patient assistance program for Banzel; Figure 34: Topamax (topiramate; Johnson & Johnson) sales volume by condition in the seven major markets, 2008; Figure 35: Topamax SWOT analysis, 2009; Figure 36: Topamax sales ($m) forecast across the seven major markets ($m), 2008-2018; Figure 37: Lyrica sales volume split by condition in the US and 5EU, 2008; Figure 38: Lyrica SWOT analysis, 2009; Figure 39: Lyrica sales($m) forecast across the seven major markets ($m), 2008-2018; Figure 40: Lamictal sales volume by condition in the seven major markets, 2008; Figure 41: Lamictal SWOT analysis; Figure 42: Lamictal and Lamictal XR sales across the seven major markets ($m), 2008-2018; Figure 43: Keppra (levetiracetam, UCB) sales volume split by condition in the US and 5EU, 2008; Figure 44: Keppra/Keppra XR SWOT analysis, 2009; Figure 45: Keppra and Keppra XR sales ($m) forecast across the seven major markets ($m), 2008-2018; Figure 46: Indexed seven major market sales of Depakote franchise, 2004-08; Figure 47: Depakote SWOT analysis, 2009; Figure 48: Depakote and Depakote ER sales across the seven major markets ($m), 2008-2018; Figure 49: Vimpat (lacosamide) SWOT analysis, 2009; Figure 50: Vimpat sales by country in the seven major markets ($m), 2008-2018; Figure 51: Banzel SWOT analysis, 2009; Figure 52: Banzel sales ($m) forecast by country in the seven major markets ($m), 2008-2018; Figure 53: Eslicarbazepine acetate (Stedesa/Zebinix) sales by country in the seven major markets ($m), 2008-2018; Figure 54: Carisbamate's epilepsy-specific sales forecast in the US and 5EU, split by country ($m), 2009-2018; Figure 55: Brivaracetam's sales forecast in epilepsy in the US and 5EU, split by country ($m), 2009-2018; Figure 56: Retigabine's epilepsy-specific sales in the US and 5EU, split by country ($m), 2009-2018; Figure 57: Perampanel's sales in epilepsy in the seven major markets split by country ($m), 2009-2018; Figure 58: Sales value dynamics of the top eight branded anticonvulsant class market companies by seven major market revenues ($m), 2004-08; Figure 59: Migraine-specific sales of Topamax across the seven major markets ($m), 2004-08; Figure 60: Fibromyalgia-specific sales of Lyrica across the seven major markets ($m), 2004-08; Figure 61: Keppra's epilepsy indication expansions; Figure 62: Epilepsy-specific sales of Keppra and Lyrica across the seven major markets ($m), 2004-08

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Commercial Insight: Anticonvulsants - Non-epilepsy label expansions provide blockbuster potential

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