Crohn's Disease (Event Driven)

Decision Resources, Inc, January 2012, Pages: 160

Treatment options for Crohn’s disease (CD) include conventional, largely generic small molecules and more-potent biological agents, including tumor necrosis factor-alpha (TNF-a) inhibitors. Despite the clinical and commercial success of the TNF-a inhibitors, opportunity remains for agents that can safely and effectively induce and maintain remission in a significant number of patients with moderate to severe CD.

Emerging therapies with different mechanisms of action—including the interleukin (IL)-12/IL-23 inhibitor ustekinumab (Janssen Biotech/Janssen Cilag’s Stelara), the cell adhesion molecule (CAM) inhibitor vedolizumab (Millennium Pharmaceuticals), and the chemokine receptor inhibitor GSK-1605786 (formerly Traficet-EN or CCX-282B; GlaxoSmithKline/ChemoCentryx)—are in clinical development for CD.

However, interviewed thought leaders do not expect these drugs to displace the TNF-a inhibitors as the dominant drug class for moderate to severe CD. The estimated high pricing of ustekinumab, which is already marketed for psoriasis, and concerns about the risk of progressive multifocal leukoencephalopathy (PML) for vedolizumab will have implications for the CD market.

Executive Summary
What are the key parameters of the Crohn’s disease market?
What factors are driving the market for Crohn’s disease therapies?
What factors are constraining the market for Crohn’s disease therapies?
What are the drug development activities of note in Crohn’s disease?
What do the experts say?
What key challenges and opportunities remain?

1 Etiology and Pathophysiology
Overview
Anatomy
Etiology
Environmental Factors
Microbial Involvement
Genetic Influence
Pathophysiology
Altered Mucosal Immune Response
Intestinal Permeability
Pathogen-Associated Molecular Pattern Recognition
Autophagy
Chronic Inflammation: Inflammatory Mediators and Pathways
Cytokines
Lipid Mediators
Cell Adhesion Molecules
Protein Kinases
Altered T-Cell Apoptosis
Complications of Crohn’s Disease
Local Complications
Systemic Complications
Risk of Colon Cancer

2 Epidemiology and Patient Populations
Overview
Disease Definition
Methods
Subpopulations
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated

3 Current Therapies and Medical Practice
Treatment Providers
Goals of Treatment
Currently Marketed Products
Treatment Guidelines and Factors Influencing Drug Selection
Treatment Algorithm
Country-Specific Prescribing Trends
Country-Specific Reimbursement Issues

4 Unmet Needs
Overview
More-Effective Maintenance Therapies for Crohn’s Disease
Additional Treatment Options for Moderate to Severe Crohn’s Disease Patients Who
Have Failed TNF-Alpha Inhibitors
Novel Oral Therapies for Moderate to Severe Crohn’s Disease
Additional Treatments for Fistulizing Disease
Targeted Therapies for Crohn’s Disease
Improved Methods for Patient Stratification
Improved Noninvasive Tests for Diagnosis and Disease Monitoring

5 Emerging Therapies
Overview
Future Positioning of Key Competitors
Drug Development and Regulatory Hurdles
IL-12/IL-23 Inhibitors
Overview
Mechanism of Action
Ustekinumab
Cell Adhesion Molecule Inhibitors
Overview
Mechanism of Action
Vedolizumab
Chemokine Receptor Antagonists
Overview
Mechanism of Action
GSK-1605786
Stem Cell Therapies
Overview
OTI-010

6 Market Outlook
Overview
Trends in Acute and Maintenance Therapy
Drug-Class-Specific Trends
TNF-Alpha Inhibitors
Oral Aminosalicylates
Immunosuppressants
Corticosteroids
Cell Adhesion Molecule Inhibitors
IL-12/IL-23 Inhibitors
Chemokine Receptor Antagonists
Appendix A Bibliography—Crohn’s Disease

Appendix B Market Forecast Methodology
Bottom-Up Market Forecasting Overview
Patient Populations
Drug-Specific Assumptions
General Sources of Data
Agents Included in Our Market Analysis
Pricing, Dosing, Days of Therapy, and Compliance Assumptions
General Statements About Pricing
Dosing, Days of Therapy, and Compliance
Tumor Necrosis Factor-Alpha Inhibitors
Cell Adhesion Molecule Inhibitors
Oral and Rectal Aminosalicylates
Immunosuppressants
Oral and Rectal Corticosteroids
Antibiotics
Generic Erosion
Emerging Therapy Prices

Appendix C Experts Interviewed—Crohn’s Disease

Appendix D Supplemental Epidemiology Bibliography—Crohn’s Disease

Tables and Figures

Table 1-1 Major Inflammatory Mediators in Crohn’s Disease

Table 2-1 Number of Total Diagnosed and Drug-Treated Prevalent Cases of Crohn’s Disease in the Major Pharmaceutical Markets, 2010-2020 (thousands)

Table 2-2 Number of Diagnosed Prevalent Cases of Crohn’s Disease in the Major Pharmaceutical Markets, by Disease Activity, 2010-2020 (thousands)

Table 2-3 Key Sources for Crohn’s Disease Epidemiology and Model Parameters

Table 3-1 Crohn’s Disease Treatment Providers and Referral Patterns, by Market

Table 3-2 End Points Used in Clinical Trials for Crohn’s Disease

Table 3-3 Current Therapies Used for Crohn’s Disease

Table 3-4 Current Drug Classes Used for Crohn’s Disease—Mechanism of Action

Table 3-5 Comparison of Current Therapies for Crohn’s Disease

Table 3-6 Comparison of Biological Therapies and Placebo in Inducing a Response in Crohn’s Disease

Table 3-7 Comparison of Biological Therapies and Placebo in Inducing Remission in Crohn’s Disease

Table 3-8 Comparison of Biological Therapies and Placebo in Maintaining Response in Crohn’s Disease

Table 3-9 Comparison of Biological Therapies and Placebo in Maintaining Remission in Crohn’s Disease

Table 3-10 Expert Insight: Leading Drugs in Crohn’s Disease

Table 3-11 Crohn’s Disease Treatment Guidelines, by Market

Table 3-12 Factors Influencing Drug Selection in Crohn’s Disease

Table 3-13 The SONIC Study

Table 3-14 Expert Insight on Prescribing Trends by Market

Table 3-15 Reimbursement Trends by Market

Table 5-1 Emerging Therapies in Development for Crohn’s Disease

Table 5-2 Estimated Launch Dates for Key Emerging Therapies for the Treatment of Crohn’s Disease

Table 5-3 Select Therapies in Early-Stage Development for Crohn’s Disease

Table 5-4 Expert Commentary: Emerging Therapies in Crohn’s Disease

Table 6-1 Sales of Drugs to Treat Crohn’s Disease in the Major Pharmaceutical Markets, 2010-2020 (millions of 2010 US dollars)

Table 6-2 Timeline of Key Market Events for Crohn’s Disease

Table B-1 Sources for Drug Prices

Figure 1-1 The Four Layers of the Intestinal Wall

Figure 1-2 Anatomical Distribution Patterns in Crohn’s Disease

Figure 1-3 Regions of the GI Tract Most Commonly Affected by Crohn’s Disease

Figure 1-4 The TH1 Response: Predominant in Crohn’s Disease

Figure 1-5 Key Immune and Inflammatory Responses in Crohn’s Disease

Figure 2-1 Diagnosed Prevalent Cases and Diagnosed Prevalence of Crohn’s Disease in the Major Markets, 2010

Figure 3-1 Algorithm for the Treatment of Crohn’s Disease

Figure 4-1 Unmet Needs: Attainment and Remaining Opportunity in Crohn’s Disease

Figure 6-1 Sales of Crohn’s Disease Therapies, Acute and Maintenance, 2010 and 2020

Figure 6-2 Timeline of Near-Term Events in Crohn’s Disease

Customers who bought this item also bought

• Special Report: Current Treatments, Unmet Needs, and Opportunities in Treating Pediatric Crohn’s Disease
• Crohn’s Disease: Future Treatment Scenarios and Opportunities
• Current Treatments, Unmet Needs, and Opportunities in Treating Pediatric Crohn’s Disease
• Ulcerative Colitis (Event Driven)
• Therapeutic Clinical Intelligence - Inflammatory Bowel Disease
• Thought Leader Insight & Analysis Report - Crohn’s Disease, Ulcerative Colitis Q1 2010
• Key Findings from Treatment Algorithms: Crohn's Disease
• Gastrointestinal Disorder Therapeutics to 2016 - High Unmet Needs Triggering Strong Growth in Crohn's Disease and Irritable Bowel Syndrome Markets
• Crohn's Disease: KOL Insights on Treatment Practices and Unmet Needs
• Anti-TNF Therapies in IBD: Opinion Leader Insight into Current & Future Treatment Practices