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Introduction
New drug launches, combined with the impending impact from the seminal SONIC study, which will result in Crohn's disease patients receiving biologics in combination with immunomodulators earlier in therapy, and increased use of biologics in ulcerative colitis will help to drive sales from $3.5 billion in 2009 to $5.6 billion in 2019 across the seven major markets.
Scope
*In-depth analysis of the current and future inflammatory bowel disease market across the US, 5EU and Japanese markets, and a Rest of World snapshot
*Crohn's disease and ulcerative colitis specific sales forecasts for key brands to 2019, and total brand figure to benchmark indication-specific sales
*Detailed brand dynamics discussion, including analysis of the anti-TNFs Remicade, Humira, Cimzia and 5-aminosalicylates, such as Lialda
*Insight and analysis of the strategies of the key developers in the IBD market
Highlights
Leading on from the SONIC study, experts would like to treat IBD aggressively, but need longer-term safety data and information on which patients will be best to treat with the approach. Clearly, not every patient will be appropriate, with safety and cost and reimbursement coming to the fore.
Datamonitor has always maintained that patient preference, convenience and compliance will help determine the commercial success of marketed products for IBD. In addition, experts interviewed by Datamonitor expect the next 5 to 10 years will revolve around cost and side effects.
Recent data presented at DDW 2010 highlighted Humira's poor efficacy in ulcerative colitis, fuelling concerns over the drug's future potential in this additional indication. Datamonitor, however, remains optimistic that Humira's second Phase III study will generate positive data leading to US and EU approval in 2011.
Reasons to Purchase
*Quantify the current size of IBD sales in the seven major markets and understand trends in the rest of the world
*Understand IBD market trends and assess the impact of events, such as biosimilars entry, on sales of over 30 key brand name products
*Access a case study assessing the likelihood of ulcerative colitis approval for Humira and Simponi with three alternative scenario forecasts
OVERVIEW 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Inflammation & Immunology pharmaceutical analysis team 2
EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the inflammatory bowel disease market 3
Related reports 5
Upcoming related reports 5
TABLE OF CONTENTS 6
1. MARKET DEFINITION 7
Market definition for this report 7
Datamonitor adopts a different drug class definition in its latest 2010 IBD report 7
ICD-10 codes used to define the inflammatory bowel disease indications 8
Crohn's disease 8
Ulcerative colitis 9
IMS assumptions 9
Diagnosis value (DV) 9
US 11
Japan 11
5EU 12
2. MARKET OVERVIEW 14
Seven major markets 15
Current and future market overview 15
Cost and safety will dictate future of the market 15
The US will remain the largest inflammatory bowel disease market in terms of sales to 2019 17
Specific antirheumatic agents sales experienced staggering uptake and will continue to be a growth driver 17
Key impacting events in the seven major inflammatory bowel disease markets from 2010-19 18
Inflammatory bowel disease constitutes up to 30% of total brand sales in the seven major markets 19
Opportunities and threats 25
Opportunities 1: SONIC trial impact 26
Opportunities 2: testing for drug serum and antibody levels in Crohn's disease 27
Opportunities 3: biomarkers to predict response to therapies 29
Opportunities 4: new therapies in development for IBD 30
Threat 1: pricing pressure across the seven major markets 31
Threat 2: biosimilar MAbs looking more certain 31
US 33
Current and future market assessment 33
Opportunities and threats 37
Opportunity 1: US healthcare reform set to boost number of insured IBD patients 37
Opportunity 2: 12-year market exclusivity favors innovator products 38
Threat 1: US healthcare reform brings biologics approval pathway 38
Threat 2: FDA tightens marketing controls in the US 39
Japan 39
Current and future market assessment 39
Impact from exchange rates on US dollar market value in Japan 40
Opportunities and threats 42
Opportunity 1: MHLW approval timelines speeding up significantly 43
Opportunity 2: among the highest inflammatory bowel disease diagnosis rates in the major markets 43
Opportunity 3: novel Japanese provisions protect some drugs from regular price cuts 43
Opportunity 4: Japan's inflammatory bowel disease market has significant room for expansion 44
Threat 1: despite certain protection measures, future Japanese government drug price cuts remain a reality 44
Threat 2: Japan aims to increase generic market's volume share to 30% by 2012 44
Five major European markets (5EU) 45
Current and future market assessment 45
Impact from exchange rates on US dollar market value in the 5EU 46
Opportunities and threats 50
Opportunity 1: 2010 ECCO guidelines include a new section on loss of response to anti-TNFs 51
Opportunity 2: NICE recommends Humira for Crohn's disease 52
Threat 1: drug price cuts across the five major EU markets 52
Threat 2: always a risk that NICE will not recommend biologics in Crohn's disease or ulcerative colitis 53
Threat 3: Europe's biosimilar approval pathway 53
France 53
Current and future market assessment 53
Impact from exchange rates on US dollar market value in France 54
Germany 57
Current and future market assessment 57
Impact from exchange rates on US dollar market value in Germany 58
Italy 62
Current and future market assessment 62
Impact from exchange rates on US dollar market value in Italy 63
Spain 66
Current and future market assessment 66
Impact from exchange rates on US dollar market value in Spain 67
UK 70
Current and future market assessment 70
Impact from exchange rates on US dollar market value in the UK 71
Rest of the world snapshot 74
Current market assessment 75
Exceptional growth in the global inflammatory bowel disease market 75
All other EU countries dominate sales and volume, while Turkey shows impressive growth 78
Notable impact from exchange rates on US dollar market value 80
BRIC shows highest growth from 2008 to 2009 80
3. BRAND DYNAMICS 82
Overview of competitive landscape 82
Patient acquisition process 83
Introduction 83
Patient care path 83
Crohn's disease 83
Ulcerative colitis 85
Drivers of brand choice 87
Patient preference, cost and mode of delivery are among drivers of brand choice for anti-TNFs 88
US formulary tier status for leading brands 88
Notable formulary tier changes since 2008 89
Relative newcomer Cimzia shows moderate formulary advantage in 2010 90
Older 5-aminosalicylate brands show signs of slipping tier status 91
Trends in marketing strategies 91
Centocor Ortho Biotech - promoting experience and the SONIC study 92
Abbott - promoting the Humira pen device and long-term data 93
UCB - despite a low key presence, the major focus was on long-term remission 94
Shire - FDA letter dampens Pentasa and Lialda promotional plans 95
Salix - Apriso loses out to Xifaxan promotion 96
Alaven Pharmaceutical - launch of the Rowasa Kit 97
Rowasa's sales value showed an increase in 2009 after years of generic erosion 97
Rowasa Kit is more expensive than standard Rowasa 99
Anti-tumor necrosis factors (TNFs) 100
Remicade (infliximab; Centocor Ortho Biotech, Merck & Co., Mitsubishi Tanabe) 100
Drug profile 100
Absence of new clinical data for Remicade at DDW 2010, means SONIC gets the most attention 101
Filed for ulcerative colitis in Japan in June 2009 - approved in June 2010 102
SWOT analysis 103
Brand forecast to 2019 103
Humira (adalimumab; Abbott, Eisai) 110
Drug profile 110
Ulcerative colitis data not entirely positive 110
Abbott/Eisai filed Humira for Crohn's disease in Japan in September 2009 113
NICE recommends Humira for Crohn's disease 114
SWOT analysis 115
Brand forecast to 2019 116
Cimzia (certolizumab; UCB, Otsuka Pharmaceuticals) 118
Drug profile 118
Cimzia's major focus on showing long-term maintenance data and mucosal healing at DDW 2010 119
Monthly dosing schedule in Crohn's disease is coming under the spotlight 120
Cimzia out of EU development - removed from our EU forecast 121
Otsuka close to filing Cimzia for Crohn's disease in Japan 121
Early development in ulcerative colitis begins 122
SWOT analysis 123
Brand forecast to 2019 124
Integrin inhibitors 126
Tysabri (natalizumab; Elan, Biogen Idec) 126
Drug profile 126
Crohn's disease-specific sales estimations, 2009 127
Risk stratification could be one way to turn around Tysabri's fortunes in Crohn's disease 127
SWOT analysis 128
Brand forecast to 2019 129
5-aminosalicylates 130
Asacol/Asacol HD (mesalazine; Warner Chilcott, Zeria, Kyowa Hakko Kogyo) 130
Drug profile 130
Impact from competition in the US - increase in price for Asacol 400mg 131
Warner Chilcott receives Paragraph IV from Par Pharmaceuticals - generic impact to Asacol maintained 132
Zeria Pharmaceutical launched Asacol in Japan for ulcerative colitis 133
Some evidence that Asacol 3.6g is superior to Pentasa 2.25g 135
Development in Crohn's disease in Japan pushed back from Phase III to Phase I prompting removal from Datamonitor's Japanese forecast 137
SWOT analysis 137
Brand forecast to 2019 137
Pentasa (mesalazine; Ferring, Shire, Nisshin Kyorin) 138
Drug profile 138
Warning letter from FDA over promotional activity in the US 139
SWOT analysis 141
Brand forecast to 2019 142
Lialda (mesalazine MMX, Cosmo, Giuliani, Mochida, Shire) 144
Drug profile 144
Warning letter from FDA over promotional activity 145
Shire terminated US co-marketing agreement with Takeda in 2009 147
Plenty of data and promotion leads Lialda to outshine Apriso at DDW 2010 147
Paragraph IV filed by Zydus Cadila in May 2010 - potential impact to brand sales from early generics 148
Mochida Pharma put Lialda into Phase I development for ulcerative colitis - Datamonitor removes Lialda from Japanese forecast 149
SWOT analysis 149
Brand forecast to 2019 150
Apriso/Salofalk/Salofalk Granustix/AJG501 (mesalazine; Ajinomoto, Dr Falk Pharma, Salix Pharmaceuticals) 152
Drug profile 152
No substantial data presented for Apriso at the DDW 2010 153
Salix expects similar Apriso uptake to its other ulcerative colitis brand Colazal 153
Ajinomoto progressed Apriso/Salofalk into Phase III 154
SWOT analysis 156
Brand forecast to 2019 157
Other brands 158
Giazo (balsalazide disodium 1.1g tablet; Salix Pharmaceuticals) 158
After a tempestuous regulatory history, Giazo will launch in 2010, but will not exceed sales of $20m 158
Budenofalk (budesonide; Dr Falk Pharma, Salix Pharmaceuticals) 160
Datamonitor forecasts budesonide foam to launch in the US by 2012 160
Datamonitor forecasts Budenofalk's EU sales to reach $30m at the end of the forecast period 161
Entocort EC (budesonide; Prometheus, AstraZeneca) 162
Price per standard unit increase bolsters 2009 sales 162
Teva and AstraZeneca reach deal on generic Entocort EC 164
4. KEY DEVELOPERS 166
Strategic overview 166
Recent strategic partnerships/deals 167
GlaxoSmithKline exercises option to advance ChemoCentryx's Traficet-EN 167
Warner Chilcott acquired P&G pharmaceutical portfolio 167
Santarus and Ferring sign deal to develop Cosmo Pharmaceuticals's budesonide MMX 168
Trends in corporate strategy 168
Collaboration, licensing arrangements and acquisition are the main strategic corporate trends 168
Ajinomoto 168
Centocor Ortho Biotech 169
Salix Pharmaceuticals 171
Shire 172
Cosmo Pharmaceuticals 173
Warner Chilcott 174
US mesalazine market breakdown by company 175
Scenario forecast - impact on Asacol's US sales in absence of generic competition 176
5. CASE STUDIES 178
Biologics in ulcerative colitis - alternative market scenarios 178
Anti-TNF biologics in ulcerative colitis - Remicade is the major player, but competition is on the way 178
Three alternative scenarios tested involving non-approval for either Simponi or Humira, or non-approval for both 181
Conclusion 182
BIBLIOGRAPHY 185
Journal papers 185
Websites 186
Datamonitor reports 190
Other 191
APPENDIX A - MARKET ASSUMPTIONS 192
Forecasting assumptions 192
New product launches 192
Data definitions, limitations and assumptions 192
Standard units 192
Country group definitions 192
Derivation of sales forecasts and pricing trends 192
Exchange rates 192
Forecast methodology 193
APPENDIX B 194
Contributing experts 194
Conferences attended 194
Report methodology 194
About Datamonitor 194
About Datamonitor Healthcare 194
About the Immunology & Inflammation analysis team 195
Disclaimer 196
List of Tables
Table 1: Summary of therapeutic classes in inflammatory bowel disease by Anatomical Therapeutic Chemical (ATC) code, 2009 8
Table 2: Datamonitor's definition of Crohn's disease, 2010 9
Table 3: Datamonitor's definition of ulcerative colitis, 2010 9
Table 4: Gastroenterologist breakdown by region for IMS Prescribing Insights data, 2009 11
Table 5: Key events that will impact inflammatory bowel disease across the seven major markets between 2010 and 2019 19
Table 6: Sales forecasts in inflammatory bowel disease in the seven major markets ($m), split by indication, 2009-2019 21
Table 7: Opportunities and threats in the seven major inflammatory bowel disease markets, 2010 25
Table 8: Estimated patent expiry dates for the key biologics approved for the treatment of inflammatory bowel disease, 2010 32
Table 9: Sales forecasts in inflammatory bowel disease in the US ($m), split by indication, 2009-2019 35
Table 10: Opportunities and threats for inflammatory bowel disease in the US, 2010 37
Table 11: Sales forecasts in inflammatory bowel disease in Japan ($m), split by indication, 2009-2019 42
Table 12: Opportunities and threats for inflammatory bowel disease in Japan, 2010 43
Table 13: Sales forecasts in inflammatory bowel disease in the five major EU markets ($m), split by indication, 2009-2019 48
Table 14: Opportunities and threats for inflammatory bowel disease in the five major EU markets, 2010 51
Table 15: Sales forecasts in inflammatory bowel disease in France ($m), split by indication, 2009-2019 56
Table 16: Sales forecasts in inflammatory bowel disease in Germany ($m), split by indication, 2009-2019 60
Table 17: Sales forecasts in inflammatory bowel disease in Italy ($m), split by indication, 2009-2019 65
Table 18: Sales forecasts in inflammatory bowel disease in Spain ($m), split by indication, 2009-2019 69
Table 19: Sales forecasts in inflammatory bowel disease in the UK ($m), split by indication, 2009-2019 73
Table 20: Key late-stage pipeline products in development for inflammatory bowel disease (IBD), 2010 82
Table 21: Formulary status for leading brands used to treat inflammatory bowel disease in the US, 2010 89
Table 22: Remicade (infliximab) - drug profile, 2010 101
Table 23: Humira (adalimumab) - drug profile, 2010 110
Table 24: Clinical trial data for Humira (adalimumab) in ulcerative colitis, 2010 111
Table 25: Cimzia (certolizumab) - drug profile, 2010 119
Table 26: Tysabri (natalizumab) - drug profile, 2010 127
Table 27: Asacol/Asacol HD(mesalazine) - drug profile, 2010 131
Table 28: Dosing of Asacol and Pentasa tablets in ulcerative colitis in Japan, 2010 136
Table 29: Pentasa (mesalazine) - drug profile, 2010 139
Table 30: Lialda (mesalazine MMX) - drug profile, 2010 145
Table 31: Apriso/Salofalk (mesalazine) - drug profile, 2010 153
Table 32: Leading companies in the inflammatory bowel disease in the seven major markets, 2009-2019 167
Table 33: Centocor Ortho Biotech: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010 170
Table 34: Cosmo Pharmaceuticals: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010 174
Table 35: Comparison between Remicade, Simponi and Humira across characteristics, including efficacy, safety, formulation and cost, in ulcerative colitis, 2010 180
Table 36: Sales ($m) of Remicade (infliximab), Simponi (golimumab) and Humira (adalimumab) in ulcerative colitis in the combined US and five major EU markets, under Datamonitor's base assumption and three alternative scenarios, 2009-2019 184
Table 37: Currency exchange rates, 2010 193
List of Figures
Figure 93: Methodology for forecasting price to remove impact of currency fluctuations on future trend 193
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