Forecast Insight: Inflammatory Bowel Disease

New Product Launches Sustain Long-Term Market Growth

Publication Date	June 2009
Publisher	Datamonitor
Product Type	Report
Pages	102
ISBN Number	not applicable
Product Code	DAT13072

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Summary

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-na????????ve 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

Content

about The Immunology & Inflammation Pharmaceutical Analysis Team
Chapter 1 Executive Summary
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
- Upcoming related reports
Chapter 2 Market Definition and Overview
- The inflammatory bowel disease market definition
- Biologics
- Tumor necrosis factor (TNF) inhibitors
- Integrin inhibitor
- Intestinal anti-inflammatory drugs (5-aminosalicylates)
- Immunomodulators
- Corticosteroids
- ICD-10 codes used to define the inflammatory bowel disease indications
- Crohn's disease
- Ulcerative colitis
- Assumptions and caveats for diagnosis value estimates
- Diagnosis value based on retail data only
- Update: Estimation of Remicade's sales in the UK - methodology different than in previous reports
- Countries and regions included in this report
- Summary of developments over 2008 and 2009 and their impacts on the forecast
- Overall seven major market forecast remains largely unchanged
- Recent events and updated forecast assumptions for Datamonitor's 2009 inflammatory bowel disease forecast
- Seven major market assessment
- Current and future market overview
- Significant inflammatory bowel disease market expansion from 2007-08
- Inflammatory bowel disease market sales will grow to reach $4.6 billion in 2018
- The inflammatory bowel disease market volume will experience minimal growth over the next decade
- Anti-TNFs will remain the largest drug class in terms of sales, but the 5-ASAs will outsize all classes in terms of volume
- Rest of the world snapshot
- Current market assessment
- Rest of the World accounted for only 15% of global inflammatory bowel disease market sales in 2008
- BRIC and Australia showed highest growth rates in the rest of the world from 2005-08
Chapter 3 Brand Dynamics
- Overview of competitive landscape
- Updated key marketed brand dynamics
- Remicade (infliximab; Centocor Ortho Biotech/Johnson & Johnson, Schering-Plough and Mitsubishi Tanabe)
- J&J files for arbitration against Merck Schering-Plough - future marketing rights in the EU uncertain
- Mitsubishi Tanabe initiated Remicade dose escalation trial in Crohn's disease in Japan - label expansion will boost sales from 2012
- One-year SONIC trial data presented at DDW 2009 - positive impact on Remicade's forecast from 2010
- NICE recommended Remicade in acute ulcerative colitis in the UK, but under certain circumstances - small positive impact to Remicade sales
- Datamonitor revaluated Remicade's ulcerative colitis approval timeline in Japan - approval pushed back to Q4 2012
- Datamonitor's comment and forecast to 2018
- Humira (adalimumab; Abbott, Eisai)
- Eisai/Abbott commence ulcerative colitis trial in Japan
- Datamonitor expects NICE to recommend Humira in Crohn's disease
- Humira Japanese Crohn's disease approval timeline reassessed
- Datamonitor's comment and forecast to 2018
- Cimzia (certolizumab; UCB, Otsuka Pharmaceuticals)
- UCB launches pre-filled syringe formulation of Cimzia in the US - Datamonitor upgraded its forecast to 2018
- Full year 2008 IMS sales marginally ahead of data Datamonitor's 2008 Crohn's disease forecast expectation
- Cimzia is back in Phase III for Crohn's disease in the EU - Datamonitor updated its forecast to reflect impact of a Cimzia launch
- Datamonitor's comment and forecast to 2018
- Simponi (golimumab; Centocor Ortho Biotech/Johnson & Johnson, Schering-Plough, Mitsubishi Tanabe, Janssen Pharmaceutical)
- Centocor Ortho Biotech/Schering-Plough suspended Phase II/III Simponi IV trial in February 2009
- Datamonitor's comment and forecast to 2018
- Tysabri (natalizumab; Biogen Idec, Elan)
- Further cases of PML since September 2008, Biogen Idec presents Tysabri safety update at DDW 2009 - Datamonitor lowers uptake
- Datamonitor overestimated Tysabri's full-year 2008 sales for Crohn's disease in the US in its previous forecast
- Datamonitor's comment and forecast to 2018
- Asacol (mesalazine, Procter & Gamble)
- Asacolitin relaunched in Germany as 400mg Asacol
- Datamonitor assumes 800mg Asacol will launch in the US by Q3 2009 - launch included in updated forecast
- Datamonitor comments and brand forecast to 2018
- Pentasa (mesalazine; Shire, Ferring, Nisshin Kyorin)
- 500mg tablet launched and additional regimen approved in Japan
- Generic competition to Pentasa in Japan from Q3 2008
- Pentasa generics are nowhere in sight in the US, but Datamonitor upholds genericization risk based on recent Japanese events
- Datamonitor comments and brand forecast to 2018
- Lialda/Mezavant XL (MMX mesalazine; Shire, Giuliani, Cosmo)
- Lialda performed ahead of Datamonitor's expectations in the US and EU in 2008 - continued strong uptake expected during forecast period
- 5EU roll-out slower than Datamonitor predicted
- Datamonitor launches Lialda in Japan after licensing activity results in agreement between Shire and Mochida Pharmaceuticals
- Lack of maintenance of remission indication in Lialda's US label not a major downside
- Datamonitor comments and brand forecast to 2018
- Apriso/Salofalk (granulated mesalazine; Dr Falk Pharma, Salix Pharmaceuticals, Ajinomoto)
- Apriso approved in October 2008, but launched in US in February 2009
- Salix presented Apriso clinical data and promoted its new mesalazine brand to gastroenterologists at DDW 2009
- despite the lower cost of Apriso, product familiarity and reduced pill burden means Lialda will win over Apriso
- Datamonitor pushes back its estimated Japanese launch date for Apriso/Salofalk to Q4 2013
- Datamonitor's comment and forecast to 2018
- Budenofalk (budesonide; Dr Falk Pharma, Salix Pharmaceuticals)
- Datamonitor includes Budenofalk foam in its US forecast
- Budenofalk formulations are available across the EU, but not in France or Italy - Budenofalk launch excluded in these regions
- Datamonitor's comment and forecast to 2018
- Colazal (balsalazide; Salix Pharmaceuticals)
- Colazal brand erosion rates since December 2007 - higher erosion rates than previously expected
- 1,100mg balsalazide tablets removed from Datamonitor's forecast - Salix turns its attention to Apriso marketing
- Forecasted promising late-stage pipeline agents
- Traficet-EN (CCX-282; ChemoCentryx, GlaxoSmithKline)
- PROTECT-1 trial data presented at DDW 2009 - mixed Phase IIb data leads Datamonitor to downgrade its forecast, but potential remains
- Datamonitor's comment and forecast to 2018
- Stelara (Ustekinumab, CNT0-1275; Centocor Ortho Biotech/Johnson & Johnson, Janssen-Cilag)
- Phase IIb study initiated in TNF-failures - Datamonitor updated its dosing assumptions for Stelara in Crohn's disease
- No new clinical data for Stelara in Crohn's disease, but Datamonitor includes in EU forecast based on new multicenter trial
- Datamonitor's comment and forecast to 2018
- MMX budesonide (Cosmo Pharmaceuticals, Ferring, Santarus)
- Santarus acquires exclusive US development and commercialization rights to Cosmo's MMX budesonide
- Datamonitor reassessed its US/EU launch dates for MMX budesonide - launch now forecast for Q4 2011
- Datamonitor's comment and forecast to 2018
- LMW Heparin MMX (Parnaparin Sodium, CB-01-05-MMX; Cosmo Pharmaceuticals)
- Mixed evidence supporting efficacy of LMW heparins in ulcerative colitis, but LWM heparin MMX Phase IIb data encouraging
- Phase IIb data presented at DDW 2009 - Datamonitor included LMW heparin MMX in its updated forecast
- Datamonitor's comment and forecast to 2018
- BIBLIOGRAPHY
- Journal papers and Conference proceedings
- Websites
- Publications
- Datamonitor reports
- APPENDIX A - MARKET ASSUMPTIONS
- New product launches
- Patent expiries
- Brand erosion
- Colazal case study - Datamonitor revised the rate of US brand erosion for oral small molecules
- Rowasa case study still holds for rectally administered formulations in the US
- Patent expiry dates summary
- Datamonitor's dose and standard unit assumptions
- Small molecules
- Biologics
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- APPENDIX B
- Contributing experts
- about Datamonitor
- about Datamonitor Healthcare
- about the Immunology & Inflammation analysis team
- Disclaimer
List of Tables
- Table 1: Datamonitor's definition of Crohn's disease
- Table 2: Datamonitor's definition of ulcerative colitis
- Table 3: Gastroenterologist breakdown by region for IMS Prescribing Insight data, 2008
- Table 4: Leading branded drug sales ($m) for inflammatory bowel disease in the seven major markets, 2008-2018
- Table 5: Key products in late-stage development for inflammatory bowel disease, 2009
- Table 6: Datamonitor's standard unit (SU) dose assumptions for Cimzia's formulations in the US, 2009
- Table 7: Datamonitor's estimated sales of Tysabri for Crohn's disease in the US, 2008
- Table 8: Price proxy ($ per standard unit) of Lialda/Mezavant in Germany and the UK, 2007-08
- Table 9: Traficet-EN: Induction of response clinical trial data at Week 12 from Phase II/III PROTECT-1, 2009
- 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
- Table 11: Traficet-EN: Remission data at Week 4, Week 8 and Week 12 from Phase II/III PROTECT-1, 2009
- Table 12: Traficet-EN: Safety data from Phase II/III PROTECT-1, 2009
- Table 13: Cost per patient per year for anti-TNFs in the US, 2008
- Table 14: Phase IIb clinical trial data for LMW heparin MMX, May 2009
- Table 15: Datamonitor's launch dates for inflammatory bowel disease products in the US, 5EU and Japan, 2009-2018
- Table 16: Patent expiry dates for the approved inflammatory bowel disease drugs in the seven major markets, 2009-2018
- Table 17: Datamonitor's Standard Unit definitions and dosing assumptions for small molecules in inflammatory bowel disease, 2009
- Table 18: Datamonitor's Standard Unit definitions and dosing assumptions for biologics in inflammatory bowel disease, 2009
List of Figures
- Figure 1: Comparison of Datamonitor's 2008 and updated seven major market inflammatory bowel disease forecast ($m), 2008-2018
- Figure 2: Sales ($m) in the inflammatory bowel disease market, split by region, 2005-2018
- Figure 3: Volume sales (million standard units) in the inflammatory bowel disease market, split by region, 2005-2018
- Figure 4: Sales ($m) and volume (million standard units) for inflammatory bowel disease, split by drug class, in the seven major markets 2005-2018
- Figure 5: Rest of the World versus seven major market sales ($m) and volume (millions standard units) for inflammatory bowel disease, 2008
- Figure 6: Annual global sales ($m) in the inflammatory bowel disease market, 2005-08
- Figure 7: Datamonitor's forecast ($m) for Remicade (infliximab) in inflammatory bowel disease in the seven major markets, 2005-2018
- Figure 8: Datamonitor's forecast ($m) for Humira (adalimumab) in inflammatory bowel disease in the seven major markets, 2005-2018
- Figure 9: Datamonitor's forecast ($m) for Cimzia (certolizumab) in Crohn's disease in the US and 5EU, 2007-2018
- Figure 10: Datamonitor's forecast ($m) for Simponi (golimumab) compared with Remicade (infliximab) in ulcerative colitis in the seven major markets, 2008-2018
- Figure 11: Datamonitor's updated forecast for Tysabri in Crohn's disease in the US, 2008-2018
- Figure 12: Datamonitor's forecast for Asacol and Asacolitin inflammatory bowel disease in Germany, 2006-2018
- Figure 13: Datamonitor's forecast for Asacol 400mg and Asacol 800mg in inflammatory bowel disease in the US, 2008-2018
- Figure 14: Datamonitor's forecast for Asacol in inflammatory bowel disease in the seven major markets, 2008-2018
- Figure 15: Datamonitor's forecast for Pentasa in inflammatory bowel disease in Japan, 2008-2018
- Figure 16: Datamonitor's scenario forecast for Pentasa in inflammatory bowel disease in the US, 2008-2018
- Figure 17: Datamonitor's forecast for Pentasa in inflammatory bowel disease in the US, five major EU and Japan markets, 2008-2018
- Figure 18: Datamonitor's inflammatory bowel disease forecast ($m) for Lialda (MMX mesalazine) in the seven major markets, 2008-2018
- Figure 19: Datamonitor's inflammatory bowel disease forecast for Apriso/Salofalk (mesalazine) in the seven major markets, 2008-2018
- Figure 20: Datamonitor's forecast ($m) for Budenofalk (oral and foam budesonide) in Germany, Spain and the UK, 2008-2018
- Figure 21: Ulcerative colitis-specific sales of Budenofalk (budesonide foam formulation) and budesonide foam generics in the US, 2008-2018
- Figure 22: Inflammatory bowel disease-specific sales of Colazal (balsalazide) in the US, 2007-2017
- Figure 23: Datamonitor's forecast ($m) of Traficet-EN (CCX-282) in the US and 5EU for Crohn's disease, 2008-2018
- Figure 24: Datamonitor's forecast ($m) of Stelara (ustekinumab) in the US and 5EU, 2008-2018
- Figure 25: Datamonitor's forecast ($m) of MMX budesonide in the US and 5EU, 2008-2018
- Figure 26: Datamonitor's forecast ($m) of LMW heparin MMX in ulcerative colitis in the US and 5EU, 2008-2018
- Figure 27: Brand erosion of Colazal (balsalazide) following first generic entrant in the US