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Reportlinker Adds Forecast Insight: Inflammatory Bowel Disease - New Product Launches Sustain Long-Term Market Growth.

NEW YORK -- Reportlinker.com announces that a new market research report is available in its catalogue.

Reportlinker Adds Forecast Insight: Inflammatory Bowel Disease - New product launches sustain long-term market growth

http://www.reportlinker.com/p0132459/Reportlinker-Adds-Forecast-Insight-Inflammatory-Bowel-Disease---New-product-launches-sustain-long-term-market-growth.html

Introduction

The inflammatory bowel disease market is set to grow from $2.9 billion in 2008 to $4.5 billion in 2018 across the seven major markets. While Datamonitor's updated forecast will parallel its previous forecast up to 2012, several new product launches, regional expansion and upgraded brand forecast will help to sustain growth in the second half of the forecast period.

Scope

*Analysis of the current and future market dynamics in inflammatory bowel disease across the US, France, Germany, Italy, Spain the UK and Japan

*Assessment of over 25 key marketed inflammatory bowel disease brands and late stage pipeline products

*Snapshot of inflammatory bowel disease drug sales outside the seven major markets

*Insight through key opinion leader comments to support conclusions

Highlights

Several events, such as new product launches and regional expansion, will ensure sustained sales growth in the latter part of the forecast period, overcoming biosimilar entry. Datamonitor's updated forecast shows sales in the seven major markets will reach $4.5 billion in 2018.

SONIC trial data shows a u-turn in previous opinion on beginning anti-TNF in combination with immunosuppressant therapy in biologic- or immunosuppressant-naove Crohn's disease patients. Datamonitor expects any impact from SONIC on clinical practice to emerge slowly within the next 2 years, and will impact across the TNF class.

Cimzia (certolizumab) is better able to compete with Abbott's Humira (adalimumab) in Crohn's disease with its new pre-filled syringe formulation. Cimzia's monthly dosing schedule together with its pre-filled syringe and lower cost will enable the drug to capture almost a quarter of the US anti-TNF market, in terms of sales, in 2018.

Reasons to Purchase

*Understand how new brands Lialda and Apriso will fare against established market players, such as Asacol and Pentasa

*Assess the impact of the launch of Cimzia's recent pre-filled syringe and gauge future dynamics within the anti-TNF class

*Quantify the current and future size of the inflammatory bowel disease market

ABOUT DATAMONITOR HEALTHCARE 2

About the Immunology & Inflammation pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Strategic scoping and focus 3

Datamonitor insight into the disease market 3

Related reports 6

Upcoming related reports 6

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8

The inflammatory bowel disease market definition 8

Biologics 8

Tumor necrosis factor (TNF) inhibitors 8

Integrin inhibitor 8

Intestinal anti-inflammatory drugs (5-aminosalicylates) 8

Immunomodulators 9

Corticosteroids 10

ICD-10 codes used to define the inflammatory bowel disease indications 10

Crohn's disease 10

Ulcerative colitis 11

Assumptions and caveats for diagnosis value estimates 12

Diagnosis value based on retail data only 12

Update: Estimation of Remicade's sales in the UK - methodology different than in previous reports 13

Countries and regions included in this report 14

Summary of developments over 2008 and 2009 and their impacts on the forecast 15

Overall seven major market forecast remains largely unchanged 15

Recent events and updated forecast assumptions for Datamonitor's 2009 inflammatory bowel disease forecast 15

Seven major market assessment 17

Current and future market overview 17

Significant inflammatory bowel disease market expansion from 2007-08 17

Inflammatory bowel disease market sales will grow to reach $4.6 billion in 2018 19

The inflammatory bowel disease market volume will experience minimal growth over the next decade 19

Anti-TNFs will remain the largest drug class in terms of sales, but the 5-ASAs will outsize all classes in terms of volume 21

Rest of the world snapshot 23

Current market assessment 23

Rest of the World accounted for only 15% of global inflammatory bowel disease market sales in 2008 23

BRIC and Australia showed highest growth rates in the rest of the world from 2005-08 24

CHAPTER 3 BRAND DYNAMICS 26

Overview of competitive landscape 26

Updated key marketed brand dynamics 28

Remicade (infliximab; Centocor Ortho Biotech/Johnson & Johnson, Schering-Plough and Mitsubishi Tanabe) 28

J&J files for arbitration against Merck Schering-Plough - future marketing rights in the EU uncertain 28

Mitsubishi Tanabe initiated Remicade dose escalation trial in Crohn's disease in Japan - label expansion will boost sales from 2012 29

One-year SONIC trial data presented at DDW 2009 - positive impact on Remicade's forecast from 2010 29

NICE recommended Remicade in acute ulcerative colitis in the UK, but under certain circumstances - small positive impact to Remicade sales 32

Datamonitor revaluated Remicade's ulcerative colitis approval timeline in Japan - approval pushed back to Q4 2012 33

Datamonitor's comment and forecast to 2018 33

Humira (adalimumab; Abbott, Eisai) 35

Eisai/Abbott commence ulcerative colitis trial in Japan 35

Datamonitor expects NICE to recommend Humira in Crohn's disease 35

Humira Japanese Crohn's disease approval timeline reassessed 35

Datamonitor's comment and forecast to 2018 36

Cimzia (certolizumab; UCB, Otsuka Pharmaceuticals) 37

UCB launches pre-filled syringe formulation of Cimzia in the US - Datamonitor upgraded its forecast to 2018 37

Full year 2008 IMS sales marginally ahead of data Datamonitor's 2008 Crohn's disease forecast expectation 39

Cimzia is back in Phase III for Crohn's disease in the EU - Datamonitor updated its forecast to reflect impact of a Cimzia launch 40

Datamonitor's comment and forecast to 2018 40

Simponi (golimumab; Centocor Ortho Biotech/Johnson & Johnson, Schering-Plough, Mitsubishi Tanabe, Janssen Pharmaceutical) 42

Centocor Ortho Biotech/Schering-Plough suspended Phase II/III Simponi IV trial in February 2009 42

Datamonitor's comment and forecast to 2018 42

Tysabri (natalizumab; Biogen Idec, Elan) 43

Further cases of PML since September 2008, Biogen Idec presents Tysabri safety update at DDW 2009 - Datamonitor lowers uptake 43

Datamonitor overestimated Tysabri's full-year 2008 sales for Crohn's disease in the US in its previous forecast 44

Datamonitor's comment and forecast to 2018 46

Asacol (mesalazine, Procter & Gamble) 48

Asacolitin relaunched in Germany as 400mg Asacol 48

Datamonitor assumes 800mg Asacol will launch in the US by Q3 2009 - launch included in updated forecast 49

Datamonitor comments and brand forecast to 2018 51

Pentasa (mesalazine; Shire, Ferring, Nisshin Kyorin) 53

500mg tablet launched and additional regimen approved in Japan 53

Generic competition to Pentasa in Japan from Q3 2008 54

Pentasa generics are nowhere in sight in the US, but Datamonitor upholds genericization risk based on recent Japanese events 54

Datamonitor comments and brand forecast to 2018 55

Lialda/Mezavant XL (MMX mesalazine; Shire, Giuliani, Cosmo) 56

Lialda performed ahead of Datamonitor's expectations in the US and EU in 2008 - continued strong uptake expected during forecast period 56

5EU roll-out slower than Datamonitor predicted 57

Datamonitor launches Lialda in Japan after licensing activity results in agreement between Shire and Mochida Pharmaceuticals 58

Lack of maintenance of remission indication in Lialda's US label not a major downside 58

Datamonitor comments and brand forecast to 2018 59

Apriso/Salofalk (granulated mesalazine; Dr Falk Pharma, Salix Pharmaceuticals, Ajinomoto) 61

Apriso approved in October 2008, but launched in US in February 2009 61

Salix presented Apriso clinical data and promoted its new mesalazine brand to gastroenterologists at DDW 2009 61

Despite the lower cost of Apriso, product familiarity and reduced pill burden means Lialda will win over Apriso 62

Datamonitor pushes back its estimated Japanese launch date for Apriso/Salofalk to Q4 2013 62

Datamonitor's comment and forecast to 2018 63

Budenofalk (budesonide; Dr Falk Pharma, Salix Pharmaceuticals) 64

Datamonitor includes Budenofalk foam in its US forecast 64

Budenofalk formulations are available across the EU, but not in France or Italy - Budenofalk launch excluded in these regions 65

Datamonitor's comment and forecast to 2018 66

Colazal (balsalazide; Salix Pharmaceuticals) 67

Colazal brand erosion rates since December 2007 - higher erosion rates than previously expected 67

1,100mg balsalazide tablets removed from Datamonitor's forecast - Salix turns its attention to Apriso marketing 68

Forecasted promising late-stage pipeline agents 69

Traficet-EN (CCX-282; ChemoCentryx, GlaxoSmithKline) 69

PROTECT-1 trial data presented at DDW 2009 - mixed Phase IIb data leads Datamonitor to downgrade its forecast, but potential remains 69

Datamonitor's comment and forecast to 2018 72

Stelara (Ustekinumab, CNT0-1275; Centocor Ortho Biotech/Johnson & Johnson, Janssen-Cilag) 75

Phase IIb study initiated in TNF-failures ? Datamonitor updated its dosing assumptions for Stelara in Crohn's disease 75

No new clinical data for Stelara in Crohn's disease, but Datamonitor includes in EU forecast based on new multicenter trial 76

Datamonitor's comment and forecast to 2018 77

MMX budesonide (Cosmo Pharmaceuticals, Ferring, Santarus) 79

Santarus acquires exclusive US development and commercialization rights to Cosmo's MMX budesonide 79

Datamonitor reassessed its US/EU launch dates for MMX budesonide - launch now forecast for Q4 2011 79

Datamonitor's comment and forecast to 2018 80

LMW Heparin MMX (Parnaparin Sodium, CB-01-05-MMX; Cosmo Pharmaceuticals) 80

Mixed evidence supporting efficacy of LMW heparins in ulcerative colitis, but LWM heparin MMX Phase IIb data encouraging 80

Phase IIb data presented at DDW 2009 - Datamonitor included LMW heparin MMX in its updated forecast 82

Datamonitor's comment and forecast to 2018 83

BIBLIOGRAPHY 84

Journal papers and Conference proceedings 84

Websites 87

Publications 90

Datamonitor reports 90

APPENDIX A - MARKET ASSUMPTIONS 92

New product launches 92

Patent expiries 92

Brand erosion 92

Colazal case study - Datamonitor revised the rate of US brand erosion for oral small molecules 92

Rowasa case study still holds for rectally administered formulations in the US 94

Patent expiry dates summary 94

Datamonitor's dose and standard unit assumptions 95

Small molecules 95

Biologics 95

Data definitions, limitations and assumptions 96

Standard units 96

Japanese market data 96

Derivation of sales forecasts and pricing trends 97

Forecast methodology 97

APPENDIX B 98

Contributing experts 98

About Datamonitor 99

About Datamonitor Healthcare 99

About the Immunology & Inflammation analysis team 100

Disclaimer 102

List of Tables

Table 1: Datamonitor's definition of Crohn's disease 11

Table 2: Datamonitor's definition of ulcerative colitis 12

Table 3: Gastroenterologist breakdown by region for IMS Prescribing Insight data, 2008 13

Table 4: Leading branded drug sales ($m) for inflammatory bowel disease in the seven major markets, 2008-2018 27

Table 5: Key products in late-stage development for inflammatory bowel disease, 2009 28

Table 6: Datamonitor's standard unit (SU) dose assumptions for Cimzia's formulations in the US, 2009 39

Table 7: Datamonitor's estimated sales of Tysabri for Crohn's disease in the US, 2008 45

Table 8: Price proxy ($ per standard unit) of Lialda/Mezavant in Germany and the UK, 2007-08 58

Table 9: Traficet-EN: Induction of response clinical trial data at Week 12 from Phase II/III PROTECT-1, 2009 70

Table 10: Traficet-EN: Induction of response clinical trial data at Week 4, Week 8 and Week 12 from Phase II/III PROTECT-1, 2009 71

Table 11: Traficet-EN: Remission data at Week 4, Week 8 and Week 12 from Phase II/III PROTECT-1, 2009 71

Table 12: Traficet-EN: Safety data from Phase II/III PROTECT-1, 2009 72

Table 13: Cost per patient per year for anti-TNFs in the US, 2008 74

Table 14: Phase IIb clinical trial data for LMW heparin MMX, May 2009 81

Table 15: Datamonitor's launch dates for inflammatory bowel disease products in the US, 5EU and Japan, 2009-2018 92

Table 16: Patent expiry dates for the approved inflammatory bowel disease drugs in the seven major markets, 2009-2018 94

Table 17: Datamonitor's Standard Unit definitions and dosing assumptions for small molecules in inflammatory bowel disease, 2009 95

Table 18: Datamonitor's Standard Unit definitions and dosing assumptions for biologics in inflammatory bowel disease, 2009 96

List of Figures

Figure 1: Comparison of Datamonitor's 2008 and updated seven major market inflammatory bowel disease forecast ($m), 2008-2018 15

Figure 2: Sales ($m) in the inflammatory bowel disease market, split by region, 2005-2018 19

Figure 3: Volume sales (million standard units) in the inflammatory bowel disease market, split by region, 2005-2018 20

Figure 4: Sales ($m) and volume (million standard units) for inflammatory bowel disease, split by drug class, in the seven major markets 2005-2018 22

Figure 5: Rest of the World versus seven major market sales ($m) and volume (millions standard units) for inflammatory bowel disease, 2008 24

Figure 6: Annual global sales ($m) in the inflammatory bowel disease market, 2005-08 25

Figure 7: Datamonitor's forecast ($m) for Remicade (infliximab) in inflammatory bowel disease in the seven major markets, 2005-2018 34

Figure 8: Datamonitor's forecast ($m) for Humira (adalimumab) in inflammatory bowel disease in the seven major markets, 2005-2018 37

Figure 9: Datamonitor's forecast ($m) for Cimzia (certolizumab) in Crohn's disease in the US and 5EU, 2007-2018 41

Figure 10: Datamonitor's forecast ($m) for Simponi (golimumab) compared with Remicade (infliximab) in ulcerative colitis in the seven major markets, 2008-2018 43

Figure 11: Datamonitor's updated forecast for Tysabri in Crohn's disease in the US, 2008-2018 47

Figure 12: Datamonitor's forecast for Asacol and Asacolitin inflammatory bowel disease in Germany, 2006-2018 49

Figure 13: Datamonitor's forecast for Asacol 400mg and Asacol 800mg in inflammatory bowel disease in the US, 2008-2018 51

Figure 14: Datamonitor's forecast for Asacol in inflammatory bowel disease in the seven major markets, 2008-2018 52

Figure 15: Datamonitor's forecast for Pentasa in inflammatory bowel disease in Japan, 2008-2018 53

Figure 16: Datamonitor's scenario forecast for Pentasa in inflammatory bowel disease in the US, 2008-2018 55

Figure 17: Datamonitor's forecast for Pentasa in inflammatory bowel disease in the US, five major EU and Japan markets, 2008-2018 56

Figure 18: Datamonitor's inflammatory bowel disease forecast ($m) for Lialda (MMX mesalazine) in the seven major markets, 2008-2018 60

Figure 19: Datamonitor's inflammatory bowel disease forecast for Apriso/Salofalk (mesalazine) in the seven major markets, 2008-2018 63

Figure 20: Datamonitor's forecast ($m) for Budenofalk (oral and foam budesonide) in Germany, Spain and the UK, 2008-2018 66

Figure 21: Ulcerative colitis-specific sales of Budenofalk (budesonide foam formulation) and budesonide foam generics in the US, 2008-2018 67

Figure 22: Inflammatory bowel disease-specific sales of Colazal (balsalazide) in the US, 2007-2017 68

Figure 23: Datamonitor's forecast ($m) of Traficet-EN (CCX-282) in the US and 5EU for Crohn's disease, 2008-2018 75

Figure 24: Datamonitor's forecast ($m) of Stelara (ustekinumab) in the US and 5EU, 2008-2018 78

Figure 25: Datamonitor's forecast ($m) of MMX budesonide in the US and 5EU, 2008-2018 80

Figure 26: Datamonitor's forecast ($m) of LMW heparin MMX in ulcerative colitis in the US and 5EU, 2008-2018 83

Figure 27: Brand erosion of Colazal (balsalazide) following first generic entrant in the US 93

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Reportlinker Adds Forecast Insight: Inflammatory Bowel Disease - New product launches sustain long-term market growth

http://www.reportlinker.com/p0132459/Reportlinker-Adds-Forecast-Insight-Inflammatory-Bowel-Disease---New-product-launches-sustain-long-term-market-growth.html

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