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TABLE OF CONTENTS
 To request sample pages please contact us at [email protected]  8 EXECUTIVE SUMMARY  9 METHODOLOGY AND MARKET DEFINITION  9 Market definition for inflammatory bowel disease  12 Patient-based forecast methodology  19 Physician sample breakdown  20 Contributing experts  20 Bibliography  22 MARKET FORECAST ANALYSIS  22 Biosimilars to erode biologics' market share and create a highly competitive IBD market  23 Dynamics in the IBD forecast by line of therapy  24 Ulcerative colitis market is forecast to overtake the Crohn’s disease market after 2016  26 High proportion of patients on 5-ASAs and corticosteroids but anti-TNF drive sales  33 US  34 Japan  35 Five major EU markets  37 AJM300  37 Forecast assumptions  37 Bibliography  38 APRISO (MESALAZINE)  38 Forecast assumptions  39 Apriso forecast 2012–21  41 Bibliography  42 ASACOL/ASACOL HD (MESALAZINE)  42 Forecast assumptions  44 Asacol/Asacol HD forecast 2012–21  46 Bibliography  47 BUDENOFALK (BUDESONIDE)  47 Forecast assumptions  49 Budenofalk forecast 2012–21  52 Bibliography  54 CIMZIA (CERTOLIZUMAB)  54 Forecast assumptions  56 Cimzia forecast 2012–21  57 Bibliography  58 ENTOCORT (BUDESONIDE)  58 Forecast assumptions  59 Entocort forecast 2012–21  61 Bibliography  62 HUMIRA (ADALIMUMAB)  62 Forecast assumptions  66 Humira forecast 2012–21  68 Bibliography  70 LIALDA (MESALAZINE MMX)  71 Lialda forecast 2012–21  74 LMW HEPARIN MMX (PARNAPARIN)  74 Forecast assumptions  74 Bibliography  75 REMICADE (INFLIXIMAB)  75 Forecast assumptions  79 Remicade forecast 2012–21  81 Bibliography  82 SIMPONI (GOLIMUMAB)  82 Forecast assumptions  83 Simponi forecast 2012–21  85 Bibliography  86 STELARA (USTEKINUMAB)  87 Stelara forecast 2012–21  89 Bibliography  91 TOFACITINIB (CP-690,550)  91 Forecast assumptions  92 Tofacitinib forecast 2012–21  94 Bibliography  95 TYSABRI (NATALIZUMAB)  95 Forecast assumptions  96 Tysabri forecast 2012–21  99 UCERIS (BUDESONIDE)  99 Forecast assumptions  100 Uceris forecast 2012–21  101 Bibliography  102 VEDOLIZUMAB (MLN0002)  102 Forecast assumptions  103 Vedolizumab forecast 2012–21  105 Bibliography  107 VERCIRNON (GSK1605786, FORMERLY TRAFICET-EN)  107 Forecast assumptions  107 Vercirnon forecast 2012–21  110 APPENDIX  110 Primary research questions  12 Figure 1: Patient-based forecast methodology for inflammatory bowel disease,  22 Figure 2: Inflammatory bowel disease sales of marketed and pipeline biologics across the  23 Figure 3: Inflammatory bowel disease sales ($m) and patient numbers (000s) across the seven major markets, by line of therapy, 2012–21  24 Figure 4: Drivers for increasing ulcerative colitis market relative to Crohn’s disease across  26 Figure 5: Inflammatory bowel disease sales ($m) and patient numbers (000s) across the seven major markets, by class, 2012–21  27 Figure 6: Inflammatory bowel disease market sales across the seven major markets ($m),  28 Figure 7: Inflammatory bowel disease patient numbers across the seven major markets  33 Figure 8: Inflammatory bowel disease-specific sales in the US, by class ($m), 2012–21  35 Figure 9: Inflammatory bowel disease-specific sales in Japan, by class ($m), 2012–21  36 Figure 10: Inflammatory bowel disease sales in the five major EU markets, by class ($m),  39 Figure 11: Apriso (mesalazine; Ajinomoto/Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease across the seven major markets ($m), 2012–21  44 Figure 12: Asacol (mesalazine; Warner Chilcott/Zeria/Kyowa Hakko Kirin) sales forecasts in inflammatory bowel disease across the seven major markets ($m), 2012–21  44 Figure 13: Asacol HD (mesalazine; Warner Chilcott/Zeria/Kyowa Hakko Kirin) sales forecasts in inflammatory bowel disease in the US and the UK ($m), 2012–21  49 Figure 14: Budenofalk foam (budesonide; Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease in the seven major markets ($m), 2012–21  50 Figure 15: Budenofalk capsule (budesonide; Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease in the EU ($m), 2012–21  56 Figure 16: Cimzia (certolizumab; UCB) sales forecasts in Crohn’s disease across the US and five major EU markets, ($m), 2012–21  59 Figure 17: Entocort EC (budesonide; Prometheus/AstraZeneca) sales forecasts in inflammatory bowel disease in the seven major markets ($m), 2012–21  67 Figure 18: Humira (adalimumab; Abbott/Eisai) sales forecasts in inflammatory bowel disease across the seven major markets, ($m), 2012–21  71 Figure 19: Lialda (mesalazine MMX; Cosmo/Giuliani/Mochida/Shire) sales forecasts in inflammatory bowel disease across the seven major markets ($m), 2012–21  79 Figure 20: Remicade (infliximab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) sales forecasts in inflammatory bowel disease across the seven major markets, ($m), 2012–21  83 Figure 21: Simponi (golimumab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) sales forecasts in ulcerative colitis, across the seven major markets, ($m), 2012–21  87 Figure 22: Stelara (ustekinumab; Janssen Biotech/Janssen-Cilag/Johnson & Johnson) sales forecasts in Crohn’s disease, across the US and five major EU markets ($m), 2012–21  92 Figure 23: Tofacitinib (formerly tasocitinib, CP-690,550; Pfizer) sales forecasts in ulcerative colitis across the seven major markets, ($m), 2012–21  96 Figure 24: Tysabri (natalizumab; Biogen Idec/Elan) sales forecasts in Crohn’s disease in  100 Figure 25: Uceris (budesonide MMX; Cosmo/Ferring/Santarus) sales forecasts in ulcerative colitis, across the US and five EU major markets ($m), 2012–21  103 Figure 26: Vedolizumab (MLN0002; Takeda/Millennium Pharmaceuticals) sales forecasts in inflammatory bowel disease, across the US and five major EU markets ($m), 2012–21  108 Figure 27: Vercirnon (GSK1605786, formerly Traficet-EN; ChemoCentryx/GlaxoSmithKline) sales forecasts in Crohn’s disease across the seven major markets ($m), 2012–21  9 Table 1: Summary of drug classes and molecules in Datamonitor’s inflammatory bowel disease patient-based forecast, September 2012  13 Table 2: Price sources and calculations, by country, September 2012  15 Table 3: Exchange rates used for calculating prices, September 2012  16 Table 4: Patent expiry dates for key marketed brands in inflammatory bowel disease across the seven major markets, September 2012  18 Table 5: Estimated launch dates for key late-stage pipeline products and marketed brands in inflammatory bowel disease in the seven major markets, 2012–21  20 Table 6: Physician sample breakdown, 2012  29 Table 7: Inflammatory bowel disease market sales across the seven major markets ($m),  38 Table 8: Datamonitor’s price assumptions for Apriso  40 Table 9: Apriso (mesalazine; Ajinomoto/Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease in the across the seven major markets ($m), 2012–21  42 Table 10: Datamonitor’s price assumptions for Asacol and Asacol HD  45 Table 11: Asacol/Asacol HD (mesalazine; Warner Chilcott/Zeria/Kyowa Hakko Kirin) sales forecasts in inflammatory bowel disease across the seven major markets ($m), 2012–21  47 Table 12: Datamonitor’s price assumptions for Budenofalk (rectal foam and oral capsule)  51 Table 13: Budenofalk foam/Budenofalk oral capsule (budesonide; Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease in the US, ($m), 2012–21  55 Table 14: Datamonitor’s price assumptions for Cimzia  56 Table 15: Cimzia (certolizumab; UCB) sales forecasts in Crohn’s disease across the  58 Table 16: Datamonitor’s price assumptions for Entocort  60 Table 17: Entocort EC (budesonide; Prometheus/AstraZeneca) sales forecasts in inflammatory bowel disease in the US ($m), 2012–21  62 Table 18: Adalimumab biosimilars in clinical development  66 Table 19: Datamonitor’s price assumptions for Humira  67 Table 20: Humira (adalimumab; Abbott/Eisai) sales forecasts in inflammatory bowel disease across the seven major markets, ($m), 2012–21  70 Table 21: Datamonitor’s price assumptions for Lialda  72 Table 22: Lialda (mesalazine MMX; Cosmo/Giuliani/Mochida/Shire) sales forecasts in inflammatory bowel disease across the seven major markets ($m), 2012–21  76 Table 23: Infliximab biosimilars in clinical development  78 Table 24: Datamonitor’s price assumptions for Remicade  80 Table 25: Remicade (infliximab; Janssen Biotech/Johnson & Johnson/Merck &  Tanabe) sales forecasts in inflammatory bowel disease across the seven major markets,  84 Table 26: Simponi (golimumab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) sales forecasts in ulcerative colitis, across the seven major markets ($m), 2012–21  88 Table 27: Stelara (ustekinumab; Janssen Biotech/Janssen-Cilag/Johnson & Johnson) sales forecasts in Crohn’s disease, across the US and five major EU markets ($m), 2012–21  93 Table 28: Tofacitinib (formerly tasocitinib, CP-690,550; Pfizer) sales forecasts in ulcerative colitis across the seven major markets ($m), 2012–21  96 Table 29: Datamonitor’s price assumptions for Tysabri  97 Table 30: Tysabri (natalizumab; Biogen Idec/Elan) sales forecasts in Crohn’s disease in  100 Table 31: Uceris (budesonide MMX; Cosmo/Ferring/Santarus) sales forecasts in ulcerative colitis, across the seven major markets, ($m), 2012–21  104 Table 32: Vedolizumab (MLN0002; Takeda/Millennium Pharmaceuticals) sales forecasts in inflammatory bowel disease, across the seven major markets ($m), 2012–21  108 Table 33: Vercirnon (GSK1605786, formerly Traficet-EN; ChemoCentryx/GlaxoSmithKline) sales forecasts in Crohn’s disease across the seven major markets, ($m), 2012–21

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