Commercial Insight: Inflammatory Bowel Disease - Convenience and compliance drive market success
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 4
Related reports 6
Upcoming related reports 6
CHAPTER 2 MARKET DEFINITION 8
The inflammatory bowel disease market definition 8
Biologics 8
TNF inhibitors 8
Integrin inhibitor 9
Intestinal anti-inflammatory drugs (5-aminosalicylates) 9
Immunomodulators 10
Corticosteroids 11
ICD-10 codes used to define the inflammatory bowel disease indications 11
Crohn's disease 12
Ulcerative colitis 12
Assumptions and caveats for diagnosis value estimates 13
Diagnosis value based on retail data only 13
CHAPTER 3 PATIENT ACQUISITION PROCESS 15
Introduction 15
Patient care path 15
Points of influence in the patient care path 15
Trigger Point 1: Disease awareness among patients and physicians is critical to
increasing diagnosis rates 17
Trigger Point 2: Tackling patient compliance during maintenance treatment 19
Trigger Point 3: Physician assessment of disease severity influences treatment
choice - using "step-up" or "top-down" strategies 20
Factors that influence patient flow through the healthcare system 21
Increased public awareness leading to early presentation to PCP or a specialist
22
Symptoms of disease can be mild, therefore, patients do not present for
treatment 22
Patients sometimes forget to take medication if they feel symptoms have improved
23
Self-management limits patient follow-up 23
CHAPTER 4 MARKET OVERVIEW 24
Seven major markets 24
Current market assessment 24
Impressive historical growth in inflammatory bowel disease sales from 2004 to
2007 24
Inflammatory bowel disease market volume is increasing, but due to the uptake of
biologics, sales growth is outstripping it 27
Anti-TNFs contributed to half of all sales in the inflammatory bowel disease
market in 2007 29
Spain and France show highest growth in the seven major markets in 2006-07 31
Future market assessment 32
Opportunities and threats 41
Opportunities 41
Threats 46
US 49
Current market assessment 49
The US was the largest of the seven major markets in 2007 49
Anti-TNFs held a 55% share of the US inflammatory bowel disease market in 2007
50
Corticosteroids demonstrated highest CAGR from 2004 to 2007 51
Abbott's Humira experienced strong US uptake from 2006 to 2007 52
Rowasa's US sales continue to decrease in light of generic competition 53
Future market assessment 54
Opportunities and threats 59
Opportunities 59
Threats 59
Japan 61
Current market assessment 61
Japan was the second largest market in terms of sales in 2007 61
Intestinal anti-inflammatory drug class dominates inflammatory bowel disease
market in Japan 62
Nisshin Kyorin's Pentasa is the leading brand for inflammatory bowel disease in
Japan 63
Mitsubishi Tanabe's Remicade experiences low growth from 2006 to 2007 64
Future market assessment 65
Opportunities and threats 69
Opportunities 69
Threats 71
Europe 73
Current market assessment 73
Inflammatory bowel disease sales grew by 28% in the 5EU from 2006 to 2007 73
Anti-TNFs drive growth in the 5EU inflammatory bowel disease market 74
Intestinal anti-inflammatory drug class sales remain ahead of anti-TNFs in 5EU
75
Remicade demonstrated the best performance in the 5EU from 2006 to 2007 75
Future market assessment 76
Opportunities and threats 81
Opportunities 81
Threats 82
France 84
Current market assessment 84
Inflammatory bowel disease market achieved sales of $137m in 2007 84
Future market assessment 85
Germany 90
Current market assessment 90
Germany is the largest inflammatory bowel disease market in the 5EU 90
Future market assessment 91
Italy 96
Current market assessment 96
Second smallest inflammatory bowel disease market behind Spain in 2007 96
Future market assessment 97
Spain 102
Current market assessment 102
Spain showed highest CAGR of all the major markets from 2004 to 2007 102
Future market assessment 103
UK 108
Current market assessment 108
Although anti-TNF class is growing rapidly, intestinal anti-inflammatory agents
retain largest share of the UK market 108
Future market assessment 109
Rest of World snapshot 114
Current market assessment 114
Rest of World accounts for only 13% of global inflammatory bowel disease market
sales 115
Global inflammatory bowel disease market sales increased with a 14.3% CAGR from
2004 to 2007 115
Asia-Pacific, particularly China, is the area of highest growth in the Rest of
World 117
Other regions, such as Russia, show promising growth in the inflammatory bowel
disease market 119
Canada is the largest Rest of World market after the rest of Europe. 120
Remicade is the leading brand in the Rest of World 121
Opportunities and threats 122
Opportunities 122
Threats 123
CHAPTER 5 BRAND DYNAMICS 125
Overview of competitive landscape 125
Drivers of brand choice 126
Factors driving brand choice in the anti-TNF class 128
Patient preference, cost and mode of delivery are among drivers of brand choice
for anti-TNFs 128
US formulary status for leading brands 129
Humira is better positioned than Remicade in most US formularies 130
Asacol has desirable Tier-2 coverage in most plans 131
Remicade (infliximab; Centocor/Johnson & Johnson, Schering-Plough and Mitsubishi
Tanabe) 131
Drug profile 132
Product positioning 133
Remicade is positioned in multiple Crohn's disease patient populations 133
Ulcerative colitis approval expands scope for Remicade product positioning 134
Colectomy avoidance indication will have a small positive impact on Remicade
sales 135
Remicade advances up to second-line therapy for Crohn's disease in the EU 136
SONIC trial directly evaluates Remicade against immunosuppressants 136
Marketing mix 137
Marketing mix for Remicade is varied, but Centocor is promoting the message of
evidence and experience 137
Centocor finds new marketing channel in the form of a documentary 138
Mitsubishi Tanabe's strengthened promotion of Remicade in Japan is a core
marketing strategy 139
Brand forecast to 2017 140
Remicade's sales grow in the near term but then decline amid competition from
new products and biosimilars 140
Japan is the only major market where Remicade will experience overall growth to
2017 142
Infliximab biosimilars will achieve sales of $160m in 2017 145
Strategic recommendations 146
Humira (adalimumab; Abbott, Eisai) 146
Drug profile 147
Product positioning 148
The GAIN trial positioned Humira to capture infliximab-failure patients,
however, competition now comes from Cimzia and Tysabri 148
Abbott now has 2-year data for Humira, which will allow better positioning
against Remicade 148
Humira is building up clinical data beyond remission 149
Remicade will remain choice ahead of Humira for treating fistulizing Crohn's
disease 150
Marketing mix 150
Abbott has relied on heavy marketing of Humira 150
Abbott signs up Eisai to co-promote Humira in Japan 152
Abbott promoted the "sustainable impact" of Humira at the DDW 2008 152
Brand forecast to 2017 153
Humira will experience strong uptake for inflammatory bowel disease in the seven
major markets and will be market leader by 2014 153
Strategic recommendations 157
Cimzia (certolizumab; UCB) 157
Drug profile 159
Product positioning 160
UCB chose a lower price point to position Cimzia in the competitive anti-TNF
market 160
Like Humira, Cimzia will be positioned in the infliximab-failure population, but
as third-line choice 160
Marketing mix 161
UCB must launch a hard-hitting marketing campaign for Cimzia 161
'CIMplicity' includes the home health nurse program for Cimzia administration
161
Crohn's & Me society will increase disease awareness and promote Cimzia 162
UCB and Otsuka will co-promote Cimzia in Japan 163
Brand forecast to 2017 163
Third-line competition will cap Cimzia sales in inflammatory bowel disease 163
Strategic recommendations 166
Tysabri (natalizumab; Biogen Idec, Elan) 166
Drug profile 168
Product positioning 169
Tysabri positioned towards Crohn's disease patients who fail anti-TNF therapy
169
Tysabri reduces hospitalization rates 169
Elan and Biogen Idec funded study shows Tysabri most cost-effective therapy for
anti-TNF-failure patients 170
Marketing mix 170
TOUCH program - newly confirmed cases of PML will limit uptake of Tysabri in
Crohn's disease 171
Brand forecast to 2017 172
Safety concerns dampen Tysabri's sales forecast in Crohn's disease 172
Strategic recommendations 174
Asacol (mesalazine, Procter & Gamble) 175
Drug profile 175
Product positioning 176
Procter & Gamble's strong product positioning facilitates Asacol's market
leadership 176
Asacol looking to compete with Pentasa in Japan 177
Marketing mix 177
Asacol is the most heavily promoted intestinal anti-inflammatory brand, but
Lialda is close behind 177
Brand forecast to 2017 178
Competition from Lialda and Salofalk Granustix will diminish Asacol's US and 5EU
sales 178
Strategic recommendations 181
Pentasa (mesalazine; Shire, Ferring, Nisshin Kyorin) 182
Drug profile 182
Product positioning 183
Pentasa has ulcerative colitis indication, but Crohn's disease generates
majority of sales, especially in the US 183
Pentasa and Lialda co-exist in Shire's gastroenterology franchise without signs
of cannibalization 184
Once-daily Pentasa more effective than twice-daily dosing of Pentasa 185
Marketing mix 185
Pentasa's promotional spend falls behind Asacol and Lialda 185
Brand forecast to 2017 186
Strategic recommendations 188
Lialda/Mezavant (MMX mesalazine; Shire, Giuliani, Cosmo) 189
Target product profile 189
Product positioning 190
Shire will roll-out Lialda across the rest of the EU in 2008 190
Shire markets Lialda as a once-daily tablet in the US, but reduced number of
tablets per day does not equate to lower costs 190
Lialda aims to acquire share from market-leader Asacol 191
Marketing mix 192
Shire and Takeda will co-promote Lialda in the US 192
Drug forecast to 2017 193
Once-daily dosing and reduced pill burden will propel Lialda to become the
market-leading 5-ASA brand 193
Strategic recommendations 197
Golimumab (CNTO-148; Centocor/Johnson & Johnson, Schering-Plough, Mitsubishi
Tanabe, Janssen Pharmaceutical) 197
Target product profile 198
Development overview 199
Product positioning 200
Centocor/Johnson & Johnson and Schering-Plough will position golimumab
(CNTO-148) in the ulcerative colitis population 200
Marketing mix 201
Golimumab's (CNTO-148) marketing will be akin to Remicade's 201
Drug forecast to 2017 201
Strategic recommendations 203
Other marketed brands 204
Salofalk Granustix (mesalazine; Dr Falk Pharma, Salix Pharmaceuticals) 204
Salofalk Granustix is a once-daily granule mesalazine formulation and will
compete with Lialda in the US 205
Salix Pharmaceuticals's experienced sales force an advantage to Salofalk
Granustix 206
Entocort (budesonide; Prometheus Laboratories, AstraZeneca) 207
Entocort patent challenges could result in early generic equivalents in the US
207
Colazal (balsalazide; Salix Pharmaceuticals) 208
Colazal set for significant generic erosion in the US 208
Salix aiming to launch a 1,100mg formulation of Colazal in the US 209
Other promising late-stage pipeline agents 210
CCX-282 (Traficet-EN; ChemoCentryx, GlaxoSmithKline) 211
Ustekinumab (CNT0-1275; Centocor/Johnson & Johnson, Janssen-Cilag) 214
MMX budesonide 217
Orencia (abatacept) 218
CHAPTER 6 KEY DEVELOPERS 220
Strategic overview 220
Trends in corporate strategy 221
Key companies with a biologic have a single marketed drug for inflammatory bowel
disease 221
Collaboration, licensing arrangements and acquisition are the main strategic
trends in the inflammatory bowel disease market 222
Centocor/Johnson & Johnson 223
Corporate strategy 223
Remicade is the only marketed drug in Centocor/Johnson & Johnson's immunology
portfolio 223
Inflammatory bowel disease portfolio assessment 224
Abbott 226
Corporate strategy 226
Humira is at the core of Abbott's business and is the only product in its
immunology franchise 226
Inflammatory bowel disease portfolio assessment 227
Portfolio assessment of other leading companies 228
Schering-Plough 228
Salix 228
Prometheus 228
Shire 229
BIBLIOGRAPHY 231
Journal papers 231
Websites 236
Publications 242
Datamonitor reports 242
APPENDIX A - MARKET ASSUMPTIONS 243
New product launches 243
Patent expiries 244
Brand erosion 244
US brand erosion: Rowasa case study 244
Patent expiry dates summary 244
Data definitions, limitations and assumptions 245
Standard units 245
Japanese market data 245