Inflammatory Bowel Diseases: World Drug Market 2013-2023

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For more information on this report please contact ediz.ibrahim@visiongain.com (+44 (0) 2075499976) or refer to our website

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Inflammatory Bowel Diseases: World Drug Market 2013-2023

  1. 1. www.visiongain.com Contents Fe 1.1 Inflammatory Bowel Disease Market Overview 1.2 Aims, Scope and Format of the Report 1.3 Chapter Outlines 1.4 Research and Analysis Methods 2.1 What is Inflammatory Bowel Disease (IBD)? 2.2 Are There Different Types of IBD? 2.3 Signs, Symptoms and Associated Conditions 2.4 What Causes Inflammatory Bowel Disease? 2.5 How Common is Inflammatory Bowel Disease? 3.1 Can IBD be Cured? 3.2 What Are the Medications Used to Treat IBD? 3.2.1 Aminosalicylates – The Most Common Therapy 3.2.2 Corticosteroids – Limited in the Long-Run? 3.2.3 Immunomodulators – Slow to Act? 3.2.4 Monoclonal Antibodies – The Future? 3.2.5 Antibiotics – Do they Really Help? 3.3 Treatment Protocol 4.1 The Inflammatory Bowel Disease Market in 2012: Domination of Biologics and Aminosalicylates 4.2 Forecast 2013-2023: Any Major Changes Expected? 4.3 Aminosalicylates Forecast 2013-2023: The Work-Horse of IBD Therapy 4.4 Antibiotics Forecast 2013-2023: Will They Still Be Relevant in a Decade? 1. Executive Summary 2. Introduction to the Inflammatory Bowel Disease Market 3. Drug Treatments for Inflammatory Bowel Diseases 4. The World Inflammatory Bowel Disease Market, 2013-2023
  2. 2. www.visiongain.com Contents 4.5 Biologic Therapies Forecast 2013-2023: Main Driver of Growth 4.6 Corticosteroids Forecast 2013-2023: Continued Insignificance? 4.7 Immunomodulators Forecast 2013-2023 5.1 IBD Drugs – Leading National Markets, 2012 5.2 The US IBD Drug Market, Revenues 2013-2023 – Leader of the Pack 5.2.1 Case Study: What is the Relative Contribution of Ulcerative Colitis and Crohn’s Disease to Total IBD Spending in the US? 5.3 The Japanese IBD Drug Market, Revenues 2013-2023 – Tomorrow’s Leader? 5.4 The EU-5 IBD Drug Markets, Revenues 2013-2023 – Europe’s Growth Potential 5.5 IBD Drug Markets in BRIC Countries, Revenues 2013-2023 – Vast Potential for Sales 5.5.1 Brazil: Revenues 2013-2023 5.5.2 Russia: Revenues 2013-2023 5.5.3 India: Revenues 2013-2023 5.5.4 China: Revenues 2013-2023 6.1 Humira (AbbVie) - The Leading Therapy 6.1.1Humira: Forecast and Analysis, 2013-2023 6.2 Remicade (Janssen Biotech) – A Worthy Challenger? 6.2.1Remicade: Forecast and Analysis, 2013-2023 6.3 Asacol (Warner Chilcott) - The Best Mesalazine Formulation? 6.3.1Asacol: Forecast and Analysis, 2013-2023 6.4 Pentasa (Shire USA) – When Will a Generic Substitute Arrive? 6.4.1 Pentasa: Forecast and Analysis, 2013-2023 6.5 Lialda (Shire USA) – What Potential for that Medication? 6.5.1 Lialda: Forecast and Analysis, 2013-2023 6.6 Tysabri (Elan Pharmaceuticals) – Will Side Effects Prove Too Much? 6. Market Prospects for Leading IBD Drugs, 2013-2023 5. Leading National Markets, 2013-2023
  3. 3. www.visiongain.com Contents 6.6.1 Tysabri: Forecast and Analysis, 2013-2023 6.7 Xifaxan (Salix Pharmaceuticals) 6.7.1 Xifaxan: Forecast and Analysis, 2013-2023 6.8 Cimzia (UCB Inc.) – Approved in Only a Handful of Countries 6.8.1 Cimzia: Forecast and Analysis, 2013-2023 6.9 Entocort (AstraZeneca) – Prominent Steroid Treatment 6.9.1 Entocort: Forecast and Analysis, 2013-2023 6.10 Neoral (Novartis) – A Widely Used Immunosuppressant 6.10.1 Neoral: Forecast and Analysis, 2013-2023 6.11 Medrol (Pfizer Inc.) – Another Leading Steroid 6.11.1 Medrol: Forecast and Analysis, 2013-2023 6.12 Canasa/Salofalk (Aptalis Pharmaceuticals) – A Slow Decline 6.12.1 Canasa/Salofalk: Forecast and Analysis, 2013-2023 6.13 Apriso (Salix Pharmaceuticals) – A Serious Challenger to Asacol? 6.13.1 Apriso: Forecast and Analysis, 2013-2023 6.14 Azulfidine (Pfizer Inc.) – What Scope for Revenue Growth? 6.14.1 Azulfidine: Forecast and Analysis, 2013-2023 7.1 Interleukin (IL) Inhibitors – One of the Main Areas of Innovation 7.1.1 Profile: Vidofludimus (4SC) 7.2 Cell-Adhesion Molecule (CAM) Inhibitors – A Promising Avenue 7.2.1 Profile: Etrolizumab (Roche) 7.3 TNF-α Inhibitors – A Tried and Tested Target 7.3.1 Profile: Ozoralizumab (Ablynx) 7.4 Stem Cell Therapies – Basis for a Cure? 7.4.1 Profile: Remestemcel-L (Osiris Therapeutics) 7.5 Janus Kinase (JAK) Inhibitors – More Targets to Hit 7.5.1 Profile: Tasocitinib (Pfizer) 7.6 Immunomodulators – Will They Live Up To the Hype? 7. The R&D Pipeline for Inflammatory Bowel Disease, 2013
  4. 4. www.visiongain.com Contents 7.6.1 Profile: ZP1848 (Zealand Pharma) 7.7 Chemokine Receptors – Potential Exists 7.7.1 Profile: Vercirnon (Chemcentryx/GSK) 7.8 Antioxidants and Barrier Function 7.8.1 Profile: Tetomilast (Otsuka) – The Future of IBD Treatment? 8.1 SWOT and STEP Analysis of the IBD Market 8.2 What Factors Will Drive the IBD Market? 8.2.1 Increasing Disease Incidence 8.2.2 Better Diagnosis 8.2.3 Nature of the Disease 8.2.4 Delivery Systems 8.2.5 Biological Drugs 8.2.6 Socioeconomic Costs of IBD 8.3 What Factors Will Restrain the Market? 8.3.1 Lack of Understanding of Disease Aetiology 8.3.2 Compliance 8.3.3 Limits of Biologics 8.3.4 A Cure or Vaccine 8.3.5 The Possible Development of Alternative Treatments 8.3.6 Surgery – When Other Options Fail 9.1 The Largest Companies by Revenue 9.2 AbbVie – The Leader in a Highly Profitable Area 9.3 Janssen Biotech – Tomorrow’s Powerhouse? 9.4 Warner Chilcott – A Strong Competitor 8. Drivers and Restraints in the Inflammatory Bowel Disease Drug Industry and Market, 2013-2023 9. Leading Companies in the IBD Market, 2013
  5. 5. www.visiongain.com Contents 9.5 Shire Pharmaceuticals – Still a Major Player in the Future? 10.1 Dr Qamar ul Arfin, Gastroenterologist, Aga Khan University Hospital, Karachi, Pakistan 10.1.1 On Antibiotics in Treating IBD 10.1.2 On the Emergence of Biologic Therapies 10.1.3 On IBD in the Pakistani Context 10.1.4 On Any Preventative Measures that Can Be Taken 10.2 Professor John Hermon-Taylor, King’s College London 10.2.1 The Significance of MAP in Crohn’s 10.2.2 Rising Incidence of IBD 10.2.3 Defining IBD 10.2.4 Timeframe of MAP Vaccine 10.2.5 Antibiotic Activity of Other Crohn’s Treatments 10.2.6 Alternative Treatments 10.2.7 Ethics of Crohn’s Drug Development 10.2.8 The Impact of a Vaccine on the Market 10.2.9 On Claims that MAP is Not Implicated in CD 10.3 Professor Thomas Barody, Director, Centre for Digestive Diseases, Sydney 10.3.1 Mycobacterium Avium Paratuberculosis (MAP) Infection and IBD Aetiology 10.3.2 IBD and HIV/AIDS 10.3.3 Monoclonal Antibodies and Immunosuppressant Treatments 10.3.4 Potential Cure? 10.3.5 Remicade and MAP 10.3.6 Genotyping 10.3.7 Crohn’s vs. Colitis 10.3.8 Future Therapies 10.3.9 The Potential and Future of Myoconda 10. Research Interviews
  6. 6. www.visiongain.com Contents 11.1 IBD Market to Expand from 2013 to 2023 11.2 Aminosalicylates and Other Non-Biologic Treatments 11.3 Biologic Treatments 11.4 Improvements Needed in IBD Treatments 11.5 Future IBD Treatments: R&D Efforts Look Promising 11.6 The IBD Sector: Looking to the Future with Confidence 11. Conclusions
  7. 7. www.visiongain.com Contents Table 2.1 World Incidence Rates for IBD, 2013 Table 2.2 Geographical Variations in the Incidence of IBD, 2013 Table 3.1 Other Drug Types Used to Treat IBD, 2013 Table 4.1 Global IBD Drug Sales ($m), Annual Growth Rates (%) and Market Shares (%) by Segment, 2011 and 2012 Table 4.2 Global IBD Drug Market Forecast ($m), 2012-2023 Table 4.3 Global IBD Drug Forecast by Drug Category ($m), 2012-2023 Table 4.4 Global IBD Drug Market Drivers and Restraints, 2012-2023 Table 4.5 Global Aminosalicylates Forecast ($m), 2012-2023 Table 4.6 Global Aminosalicylates Drivers and Restraints, 2012-2023 Table 4.7 Global Antibiotics Forecast ($m), 2012-2023 Table 4.8 Global Antibiotics Drivers and Restraints, 2012-2023 Table 4.9 Global Biologic Therapies Forecast ($m), 2012-2023 Table 4.10 Global Biologic Therapies Drivers and Restraints, 2012-2023 Table 4.11 Global Corticosteroid Forecast ($m), 2012-2023 Table 4.12 Global Corticosteroids Drivers and Restraints, 2012-2023 Table 4.13 Global Immunomodulators Forecast ($m), 2012-2023 Table 4.14 Global Immunomodulators Drivers and Restraints, 2012-2023 Table 5.1 Global IBD Drug Revenues by Geographical Segments ($m), 2012 Table 5.2 Global IBD Drug Market Forecasts by Country ($m), 2012-2023 Table 5.3 US IBD Drug Market Forecast ($m), 2012-2023 Table 5.4 Japanese IBD Drug Market Forecast ($m), 2012-2023 Table 5.5 EU5 IBD Drug Market Forecasts ($m), 2012-2023 Table 5.6 BRIC IBD Drug Market Forecasts ($m), 2012-2023 Table 5.7 Brazilian IBD Drug Market Forecast ($m), 2012-2023 Table 5.8 Russian IBD Drug Market Forecast ($m), 2012-2023 Table 5.9 Indian IBD Drug Market Forecast ($m), 2012-2023 Table 5.10 Chinese IBD Drug Market Forecast ($m), 2012-2023 List of Tables
  8. 8. www.visiongain.com Contents Table 6.1 Leading IBD Treatments by Revenue ($m), 2012 Table 6.2 Leading IBD Medicines: Revenue Forecasts ($m), 2012-2023 Table 6.3 World Humira Revenue Forecast ($m), 2012-2023 Table 6.4 Drivers and Restraints for Humira, 2012-2023 Table 6.5 World Remicade Revenue Forecast ($m), 2012-2023 Table 6.6 Drivers and Restraints for Remicade, 2012-2023 Table 6.7 World Asacol Revenue Forecast ($m), 2012-2023 Table 6.8 Drivers and Restraints for Asacol, 2012-2023 Table 6.9 World Pentasa Revenue Forecast ($m), 2012-2023 Table 6.10 Drivers and Restraints for Pentasa, 2012-2023 Table 6.11 World Lialda Revenue Forecast ($m), 2012-2023 Table 6.12 Drivers and Restraints for Lialda, 2012-2023 Table 6.13 World Tysabri Revenue Forecast ($m), 2012-2023 Table 6.14 Drivers and Restraints for Tysabri, 2012-2023 Table 6.15 World Xifaxan Revenue Forecast ($m), 2012-2023 Table 6.16 Drivers and Restraints for Xifaxan, 2012-2023 Table 6.17 World Cimzia Revenue Forecast ($m), 2012-2023 Table 6.18 Drivers and Restraints for Cimzia, 2012-2023 Table 6.19 World Entocort Revenue Forecast ($m), 2012-2023 Table 6.20 Drivers and Restraints for Entocort, 2012-2023 Table 6.21 World Neoral Revenue Forecast ($m), 2012-2023 Table 6.22 Drivers and Restraints for Neoral, 2012-2023 Table 6.23 World Medrol Revenue Forecast ($m), 2012-2023 Table 6.24 Drivers and Restraints for Medrol, 2012-2023 Table 6.25 World Canasa Revenue Forecast ($m), 2012-2023 Table 6.26 Drivers and Restraints for Canasa, 2012-2023 Table 6.27 World Apriso Revenue Forecast ($m), 2012-2023 Table 6.28 Drivers and Restraints for Apriso, 2012-2023 Table 6.29 World Azulfidine Revenue Forecast ($m), 2012-2023 Table 6.30 Drivers and Restraints for Azulfidine, 2012-2023
  9. 9. www.visiongain.com Contents Table 7.1 Selected IL Inhibitors in Clinical Development, 2013 Table 7.2 Selected CAM Inhibitors in Clinical Development, 2013 Table 7.3 Selected TNF-Alfa Inhibitors in Clinical Development, 2013 Table 7.4 Selected Stem Cell Therapies in Clinical Development, 2013 Table 7.5 Selected Immunomodulators in Clinical Development, 2013 Table 7.6 Selected Chemokine Receptors in Clinical Development, 2013 Table 7.7 Selected Antioxidants and Barrier Function Therapies in Clinical Development, 2013 Table 8.1 SWOT Analysis of the World IBD Drug Market, 2012-2023 Table 8.2 STEP Analysis of the World IBD Drug Market, 2012-2023 Table 9.1 Top 4 Companies for IBD Drugs: Revenues ($m) and Market Shares (%), 2012 Table 9.2 AbbVie Revenues ($m) and Market Share (%), 2012 Table 9.3 Janssen Biotech Revenues ($m) and Market Share (%), 2012 Table 9.4 Warner Chilcott Revenues ($m) and Market Share (%), 2012 Table 9.5 Shire’s Revenues ($m) and Market Share (%), 2012 Table 11.1 Global IBD Revenue Forecasts ($m), CAGR (%) and Market Shares (%) by Product Category, 2013, 2017, 2023 Table 11.2 Global IBD Revenue Forecasts ($m), CAGR (%) and Market Shares (%) by Geographical Regions, 2013, 2017, 2023 Table 11.3 Summary of IBD Market Drivers and Restraints, 2013-2023
  10. 10. www.visiongain.com Contents Figure 3.1 Treatment Protocol for IBD, 2013 Figure 4.1 World IBD Drugs Market Shares by Product Type (%), 2012 Figure 4.2 Global IBD Drug Market Forecast ($m), 2012-2023 Figure 4.3 World IBD Drugs Market Shares by Product Type (%), 2023 Figure 4.4 Global Aminosalicylates Forecast ($m), 2012-2023 Figure 4.5 Global Antibiotics Forecast ($m), 2012-2023 Figure 4.6 Global Biologic Therapies Forecast ($m), 2012-2023 Figure 4.7 Global Corticosteroid Forecast ($m), 2012-2023 Figure 4.8 Global Immunomodulators Forecast ($m), 2012-2023 Figure 5.1 Global IBD Drug Market by Geographical Segments (%), 2012 Figure 5.2 Global IBD Drug Market by Geographical Segments (%), 2023 Figure 5.3 US IBD Drug Market Forecast ($m), 2012-2023 Figure 5.4 Japanese IBD Drug Market Forecast ($m), 2012-2023 Figure 5.5 EU5 IBD Drug Market Forecasts ($m), 2012-2023 Figure 5.6 BRIC IBD Drug Market Forecasts ($m), 2012-2023 Figure 5.7 Brazilian IBD Drug Market Forecast ($m), 2012-2023 Figure 5.8 Russian IBD Drug Market Forecast ($m), 2012-2023 Figure 5.9 Indian IBD Drug Market Forecast ($m), 2012-2023 Figure 5.10 Chinese IBD Drug Market Forecast ($m), 2012-2023 Figure 6.1 World Humira Revenue Forecast ($m), 2012-2023 Figure 6.2 World Remicade Revenue Forecast ($m), 2012-2023 Figure 6.3 World Asacol Revenue Forecast ($m), 2012-2023 Figure 6.4 World Pentasa Revenue Forecast ($m), 2012-2023 Figure 6.5 World Lialda Revenue Forecast ($m), 2012-2023 Figure 6.6 World Tysabri Revenue Forecast ($m), 2012-2023 Figure 6.7 World Xifaxan Revenue Forecast ($m), 2012-2023 Figure 6.8 World Cimzia Revenue Forecast ($m), 2012-2023 Figure 6.9 World Entocort Revenue Forecast ($m), 2012-2023 List of Figures
  11. 11. www.visiongain.com Contents Figure 6.10 World Neoral Revenue Forecast ($m), 2012-2023 Figure 6.11 World Medrol Revenue Forecast ($m), 2012-2023 Figure 6.12 World Canasa Revenue Forecast ($m), 2012-2023 Figure 6.13 World Apriso Revenue Forecast ($m), 2012-2023 Figure 6.14 World Azulfidine Revenue Forecast ($m), 2012-2023 Figure 9.1 Top 4 Companies for IBD Drugs: Market Shares (%), 2012
  12. 12. www.visiongain.com Contents 4SC Abbott Laboratories AbbVie Ablynx Active Biotech Aga Khan University Hospital Ajinomoto Group Amalyte Pharmaceuticals Aptalis Pharmaceuticals ARCA AstraZeneca Athersys Atlantic Pharmaceuticals Biogen Idec Bristol-Myers Squibb Cambridge Antibody Technology Catabasis Pharmaceuticals Celgene Cellular Therapies Celltech Pharmaceuticals Centocor Ortho Biotech Centre for Digestive Diseases, Sydney Centres for Disease Control and Prevention ChemoCentryx China Medical Cosmo Pharmaceuticals Crohn's and Colitis Foundation of America Crohn's and Colitis Foundation of Canada Elan Corporation Organisations Mentioned in This Report
  13. 13. www.visiongain.com Contents European Federation of Crohn's and Ulcerative Colitis Associations European Medicines Agency (EMA) Food and Drug Administration (US FDA) Giaconda Giuliani GlaxoSmithKline (GSK) Harbor BioSciences Hutchison MediPharma InDex Pharmaceuticals Isis Pharmaceuticals Janssen Biotech Johnson & Johnson King's College London Kyorin Pharmaceutical Co. Lipid Therapeutics Medarex Merck & Co. Mylan Pharmaceuticals Neovacs Novartis Nycomed Osiris Therapeutics Otsuka Pharmaceutical Group Palau Pharma PDL BioPharma Pfizer Probiotic Therapy Research Centre, Sydney, Australia Procter & Gamble Pharmaceuticals Prometheus Laboratories Roche
  14. 14. www.visiongain.com Contents Salix Pharmaceuticals Sanofi Shire Pharmaceuticals Group Sigmoid Pharma Takeda Teva Pharmaceutical Industries TxCell UCB Warner Chilcott World Gastroenterology Organisation (WGO) Zealand Pharma
  15. 15. Page 66www.visiongain.com Inflammatory Bowel Diseases: World Drug Market 2013-2023 6.5 Lialda (Shire USA) – What Potential for that Medication? Lialda is a new formulation of mesalazine, and is used to treat inflammation in the colon. Like Asacol, Lialda consists of a pH dependent coating surrounding a core of mesalazine. Lialda's main selling point is that it is a once-daily formulation, in contrast to most other 5-ASA drugs, which require several doses throughout the day. The FDA approved Lialda in the US in 2007. It was released in the UK, as Mezavant, in the same year, and is now available in most of Europe under this name. 6.5.1 Lialda: Forecast and Analysis, 2013-2023 Lialda has achieved impressive growth since its release in 2007. In 2012, it generated revenues of $400m worldwide, which represents a 7.53% increase over the 2011 revenue figure 0f $372m. Visiongain expects this growth to continue, but at a significantly reduced level. By 2017 Lialda will generate sales of $869m, but by 2023 its revenues will have fallen to $750.9m. The CAGR over the forecast period was calculated to be 5.23%. Since Lialda’s patent expires in 2020, visiongain expects it to come under generic competition after this date, and this will cause revenues to begin contracting. Lialda has similar efficacy to Asacol but is more convenient to use because of its once daily dosing. In 2009, Shire presented the results of a 12-month persistency analysis of mesalazine therapies. Lialda patients were twice as likely to refill their prescription within a set period as patients on other mesalazine-based drugs, suggesting increased compliance and satisfaction with the therapy. Lialda acts on colon, just as Asacol does. However, since it is more convenient to use, it may replace Asacol as the gold standard treatment for UC. Visiongain predicts that Lialda will erode Asacol's market share during the forecast period. However, it is worth noting that doctors are unlikely to switch patients to Lialda from other 5-ASAs that are still generating results for their patients, and for this reason, Lialda’s growth will be somewhat slower than otherwise expected. 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Lialda Sales ($m) 372.00 400.00 450.80 534.20 652.26 767.05 869.07 954.24 1005.77 1044.99 988.56 890.70 750.86 Annual Growth Rate (%) 7.53 12.70 18.50 22.10 17.60 13.30 9.80 5.40 3.90 -5.40 -9.90 -15.70 CAGR (% from 2013) 17.83 5.23 Table 6.11 World Lialda Revenue Forecast ($m), 2012-2023 Source: visiongain 2013
  16. 16. Page 67www.visiongain.com Inflammatory Bowel Diseases: World Drug Market 2013-2023 Drivers Restraints • Indicated for the induction and maintenance of remission in UC. The latter indication will ensure long-term revenues • Once daily dosing will improve patient compliance • Several years of patent protection • Will face competition as a maintenance therapy from the newly approved Apriso 6.6 Tysabri (Elan Pharmaceuticals) - Will Its Side Effects Prove Too Much? Tysabri is a monoclonal antibody against α4-integrin, an adhesion molecule found on leukocytes that aids their migration to areas of inflammation. The FDA approved it for treating multiple sclerosis in 2004, but in February 2005, the drug was voluntarily suspended, based on reports of adverse events. These reported events concerned three confirmed cases of progressive multifocal leukoencephalopathy (PML), a rare and often fatal disease of the central nervous system. 0 200 400 600 800 1000 1200 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Sales($m) Years Figure 6.5 World Lialda Revenue Forecast ($m), 2012-2023 Source: visiongain 2013 Table 6.12 Drivers and Restraints for Lialda, 2012-2023 Source: visiongain 2013

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