62 HUMIRA (ADALIMUMAB) 62 Forecast assumptions 66 Humira forecast Bibliography 70 LIALDA (MESALAZINE MMX) 71 Lialda forecast

Transcription

1 TABLE OF CONTENTS To request sample pages please contact us at 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 High proportion of patients on 5-ASAs and corticosteroids but anti-tnf drive sales 33 US 34 Japan 35 Five major EU markets 37 AJM Forecast assumptions 37 Bibliography 38 APRISO (MESALAZINE) 38 Forecast assumptions 39 Apriso forecast 41 Bibliography 42 ASACOL/ASACOL HD (MESALAZINE) 42 Forecast assumptions 44 Asacol/Asacol HD forecast 46 Bibliography 47 BUDENOFALK (BUDESONIDE) 47 Forecast assumptions 49 Budenofalk forecast 52 Bibliography 54 CIMZIA (CERTOLIZUMAB) 54 Forecast assumptions 56 Cimzia forecast 57 Bibliography 58 ENTOCORT (BUDESONIDE) 58 Forecast assumptions 59 Entocort forecast 61 Bibliography

2 62 HUMIRA (ADALIMUMAB) 62 Forecast assumptions 66 Humira forecast 68 Bibliography 70 LIALDA (MESALAZINE MMX) 71 Lialda forecast 74 LMW HEPARIN MMX (PARNAPARIN) 74 Forecast assumptions 74 Bibliography 75 REMICADE (INFLIXIMAB) 75 Forecast assumptions 79 Remicade forecast 81 Bibliography 82 SIMPONI (GOLIMUMAB) 82 Forecast assumptions 83 Simponi forecast 85 Bibliography 86 STELARA (USTEKINUMAB) 87 Stelara forecast 89 Bibliography 91 TOFACITINIB (CP-690,550) 91 Forecast assumptions 92 Tofacitinib forecast 94 Bibliography 95 TYSABRI (NATALIZUMAB) 95 Forecast assumptions 96 Tysabri forecast 99 UCERIS (BUDESONIDE) 99 Forecast assumptions 100 Uceris forecast 101 Bibliography 102 VEDOLIZUMAB (MLN0002) 102 Forecast assumptions 103 Vedolizumab forecast 105 Bibliography 107 VERCIRNON (GSK , FORMERLY TRAFICET-EN) 107 Forecast assumptions 107 Vercirnon forecast 110 APPENDIX 110 Primary research questions

3 12 Figure 1: Patient-based forecast methodology for inflammatory bowel disease, September Figure 2: Inflammatory bowel disease sales of marketed and pipeline biologics across the seven major markets ($m), 2012 and Figure 3: Inflammatory bowel disease sales ($m) and patient numbers (000s) across the seven major markets, by line of therapy, 24 Figure 4: Drivers for increasing ulcerative colitis market relative to Crohn s disease across the seven major markets, 26 Figure 5: Inflammatory bowel disease sales ($m) and patient numbers (000s) across the seven major markets, by class, 27 Figure 6: Inflammatory bowel disease market sales across the seven major markets ($m), 28 Figure 7: Inflammatory bowel disease patient numbers across the seven major markets (millions), 33 Figure 8: Inflammatory bowel disease-specific sales in the US, by class ($m), 35 Figure 9: Inflammatory bowel disease-specific sales in Japan, by class ($m), 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), 44 Figure 12: Asacol (mesalazine; Warner Chilcott/Zeria/Kyowa Hakko Kirin) sales forecasts in inflammatory bowel disease across the seven major markets ($m), 44 Figure 13: Asacol HD (mesalazine; Warner Chilcott/Zeria/Kyowa Hakko Kirin) sales forecasts in inflammatory bowel disease in the US and the UK ($m), 49 Figure 14: Budenofalk foam (budesonide; Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease in the seven major markets ($m), 50 Figure 15: Budenofalk capsule (budesonide; Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease in the EU ($m), 56 Figure 16: Cimzia (certolizumab; UCB) sales forecasts in Crohn s disease across the US and five major EU markets, ($m), 59 Figure 17: Entocort EC (budesonide; Prometheus/AstraZeneca) sales forecasts in inflammatory bowel disease in the seven major markets ($m), 67 Figure 18: Humira (adalimumab; Abbott/Eisai) sales forecasts in inflammatory bowel disease across the seven major markets, ($m), 71 Figure 19: Lialda (mesalazine MMX; Cosmo/Giuliani/Mochida/Shire) sales forecasts in inflammatory bowel disease across the seven major markets ($m), 79 Figure 20: Remicade (infliximab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) sales forecasts in inflammatory bowel disease across the seven major markets, ($m), 83 Figure 21: Simponi (golimumab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) sales forecasts in ulcerative colitis, across the seven major markets, ($m), 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 ($m), 92 Figure 23: Tofacitinib (formerly tasocitinib, CP-690,550; Pfizer) sales forecasts in ulcerative colitis across the seven major markets, ($m),

4 96 Figure 24: Tysabri (natalizumab; Biogen Idec/Elan) sales forecasts in Crohn s disease in the US ($m), 100 Figure 25: Uceris (budesonide MMX; Cosmo/Ferring/Santarus) sales forecasts in ulcerative colitis, across the US and five EU major markets ($m), 103 Figure 26: Vedolizumab (MLN0002; Takeda/Millennium Pharmaceuticals) sales forecasts in inflammatory bowel disease, across the US and five major EU markets ($m), 108 Figure 27: Vercirnon (GSK , formerly Traficet-EN; ChemoCentryx/GlaxoSmithKline) sales forecasts in Crohn s disease across the seven major markets ($m), 9 Table 1: Summary of drug classes and molecules in Datamonitor s inflammatory bowel disease patient-based forecast, September Table 2: Price sources and calculations, by country, September Table 3: Exchange rates used for calculating prices, September Table 4: Patent expiry dates for key marketed brands in inflammatory bowel disease across the seven major markets, September Table 5: Estimated launch dates for key late-stage pipeline products and marketed brands in inflammatory bowel disease in the seven major markets, 20 Table 6: Physician sample breakdown, 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), 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 ($m), Table 12: Datamonitor s price assumptions for Budenofalk (rectal foam and oral capsule) 51 Table 13: Budenofalk foam/budenofalk oral capsule (budesonide; Dr Falk Pharma/Salix Pharmaceuticals) sales forecasts in inflammatory bowel disease in the US, ($m), 55 Table 14: Datamonitor s price assumptions for Cimzia 56 Table 15: Cimzia (certolizumab; UCB) sales forecasts in Crohn s disease across the seven major markets, ($m), 58 Table 16: Datamonitor s price assumptions for Entocort 60 Table 17: Entocort EC (budesonide; Prometheus/AstraZeneca) sales forecasts in inflammatory bowel disease in the US ($m), 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, ($m), 70 Table 21: Datamonitor s price assumptions for Lialda 72 Table 22: Lialda (mesalazine MMX; Cosmo/Giuliani/Mochida/Shire) sales forecasts in inflammatory bowel disease across the seven major markets ($m),

5 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 & Co./Mitsubishi Tanabe) sales forecasts in inflammatory bowel disease across the seven major markets, ($m), 84 Table 26: Simponi (golimumab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) sales forecasts in ulcerative colitis, across the seven major markets ($m), 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 ($m), 93 Table 28: Tofacitinib (formerly tasocitinib, CP-690,550; Pfizer) sales forecasts in ulcerative colitis across the seven major markets ($m), 96 Table 29: Datamonitor s price assumptions for Tysabri 97 Table 30: Tysabri (natalizumab; Biogen Idec/Elan) sales forecasts in Crohn s disease in the US ($m), 100 Table 31: Uceris (budesonide MMX; Cosmo/Ferring/Santarus) sales forecasts in ulcerative colitis, across the seven major markets, ($m), 104 Table 32: Vedolizumab (MLN0002; Takeda/Millennium Pharmaceuticals) sales forecasts in inflammatory bowel disease, across the seven major markets ($m), 108 Table 33: Vercirnon (GSK , formerly Traficet-EN; ChemoCentryx/GlaxoSmithKline) sales forecasts in Crohn s disease across the seven major markets, ($m),