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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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