Reportlinker Adds Commercial Insight: Inflammatory Bowel Disease Future market prospects rely on addressing cost and safety

NEW YORK, Aug. 25 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Commercial Insight: Inflammatory Bowel Disease Future market prospects rely on addressing cost and safety

http://www.reportlinker.com/p0284516/Commercial-Insight-Inflammatory-Bowel-Disease---Future-market-prospects-rely-on-addressing-cost-and-safety.html

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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Nicolas Bombourg

Reportlinker

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