Gastrointestinal Disorders: Innovative Pipeline Offers Potential for First Approved Therapies in NASH and Celiac Disease

The burden of disease associated with gastrointestinal disorders is considerable with many of these disorders being highly prevalent. Additionally, many GI disorders are chronic in nature and are associated with significant impairments in quality of life including activity impairment and productivity loss. Despite this, many of these conditions are still incompletely understood and suboptimally managed. Therefore, there is a considerable unmet need for innovative new therapies in this area. This report assesses first-in-class innovation across the gastrointestinal therapy area, with a particular focus on four key indications: Crohn’s disease, ulcerative colitis, nonalcoholic steatohepatitis and celiac disease.

Scope

Many gastrointestinal disorders are highly prevalent. How do epidemiology trends vary for Crohn’s disease, ulcerative colitis, nonalcoholic steatohepatitis and celiac disease? Which drug classes are used to treat these disorders?

There are 1,241 pipeline programs in active development for gastrointestinal disorders. What proportion of these products are first-in-class? How does first-in-class innovation vary by indication, development stage and molecular target class?

First-in-class products within the pipeline most frequently target cytokine signaling. Which other molecular target classes are prominently represented within the first-in-class pipeline? Which first-in-class targets have been identified as most promising for gastrointestinal disorders?

A total of 573 licensing deals and 334 co-development deals have been completed within the gastrointestinal therapy area since 2006. Do products for gastrointestinal products typically attract high deal values? Which first-in-class products have prior deal involvement?

Reasons to buy

Understand the current clinical and commercial landscape. This includes a comprehensive study of symptoms, epidemiology, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment options for the key indications.

Visualize the composition of the gastrointestinal market in terms of dominant molecule types and molecular targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.

Analyze the gastrointestinal pipeline and stratify by stage of development, molecule type and molecular target.

Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products for the key indications have been assessed and ranked according to clinical potential. Promising first-in-class targets have been reviewed in greater detail.

Recognize commercial opportunities in the gastrointestinal deals landscape by analyzing trends in licensing and co-development deals, and identifying gastrointestinal therapies that have not yet been involved in deals and may offer potential investment opportunities.

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Gastrointestinal Disorders Associated with Large Social ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Gastrointestinal Disorders Associated with Large Social and Economic Burden

2.2 Large First-in-Class Pipeline with Many Promising Targets Implicated in Immune and Inflammatory Responses

2.3 The Majority of First-in-Class Products Have No Prior Involvement in Licensing or Co-development Deals

3 The Case for Innovation

3.1 Growing Opportunities for Biologic Products

3.2 Diversification of Molecular Targets

3.3 Innovative First-in-Class Product Developments Remain Attractive

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Innovation

3.5 Sustained Innovation in Gastrointestinal Disorders

3.6 Report Guidance

4 Clinical and Commercial Landscape

4.1 Overview of Gastrointestinal Tract Disorders

4.1.1 Crohn’s Disease

4.1.2 Ulcerative Colitis

4.1.3 Nonalcoholic Steatohepatitis

4.1.4 Celiac Disease

4.2 Symptoms

4.2.1 Crohn’s Disease

4.2.2 Ulcerative Colitis

4.2.3 Nonalcoholic Steatohepatitis

4.2.4 Celiac Disease

4.3 Diagnosis

4.3.1 Crohn’s Disease

4.3.2 Ulcerative Colitis

4.3.3 Nonalcoholic Steatohepatitis

4.3.4 Celiac Disease

4.4 Etiology

4.4.1 Crohn’s Disease

4.4.2 Ulcerative Colitis

4.4.3 Nonalcoholic Steatohepatitis

4.4.4 Celiac Disease

4.5 Pathophysiology

4.5.1 Crohn’s Disease

4.5.2 Ulcerative Colitis

4.5.3 Nonalcoholic Steatohepatitis

4.5.4 Celiac Disease

4.6 Epidemiology

4.6.1 Crohn’s Disease

4.6.2 Ulcerative Colitis

4.6.3 Nonalcoholic Steatohepatitis

4.6.4 Celiac Disease

4.7 Co-morbidities and Complications

4.7.1 Crohn’s Disease

4.7.2 Ulcerative Colitis

4.7.3 Nonalcoholic Steatohepatitis

4.7.4 Celiac Disease

4.8 Disease Staging

4.8.1 Crohn’s Disease

4.8.2 Ulcerative Colitis

4.8.3 Nonalcoholic Steatohepatitis

4.8.4 Celiac Disease

4.9 Treatment

4.9.1 Crohn’s Disease

4.9.2 Ulcerative Colitis

4.9.3 Nonalcoholic Steatohepatitis

4.9.4 Celiac Disease

4.10 Overview of Marketed Products

5 Assessment of Pipeline Product Innovation

5.1 Overview

5.2 Pipeline by Stage of Development and Molecule Type

5.2.1 Gastrointestinal Disorders Overall

5.2.2 Key Gastrointestinal Disorder Indications

5.3 Pipeline by Molecular Target

5.3.1 Gastrointestinal Disorders Overall

5.3.2 Key Gastrointestinal Disorder Indications

5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class

5.5 First-in-Class Programs Targeting Novel Molecular Targets

5.6 Ratio of First-in-Class Products to First-in-Class Targets

5.7 List of All Pipeline Products

6 Signaling Network, Disease Causation and Innovation Alignment

6.1 Complexity of Signaling Networks

6.2 Signaling Pathways and First-in-Class Molecular Target Integration

6.3 First-in-Class Matrix Assessments

7 First-in-Class Molecular Target Evaluation

7.1 Pipeline Programs Targeting [Identified Target #1] for Crohn’s Disease and Ulcerative Colitis

7.2 Pipeline Programs Targeting [Identified Target #2] for Crohn’s Disease and Ulcerative Colitis

7.3 Pipeline Programs Targeting [Identified Target #3] for Crohn’s Disease and Ulcerative Colitis

7.4 Pipeline Programs Targeting [Identified Target #4] for Ulcerative Colitis

7.5 Pipeline Programs Targeting [Identified Target #5] for Nonalcoholic Steatohepatitis

7.6 Pipeline Programs Targeting [Identified Target #6] for Nonalcoholic Steatohepatitis and Crohn’s Disease

7.7 Pipeline Programs Targeting [Identified Target #7] for Celiac Disease and Nonalcoholic Steatohepatitis

7.8 Pipeline Programs Targeting [Identified Target #8] for Celiac Disease

8 Strategic Consolidations

8.1 Industry-wide First-in-Class Deals

8.2 Licensing Deals

8.2.1 Deals by Region, Value and Year

8.2.2 Deals by Key Indication

8.2.3 Deals by Stage of Development and Value

8.2.4 Deals by Molecule Type, Molecular Target and Value

8.2.5 List of Deals with Disclosed Deal Values

8.3 Co-development Deals

8.3.1 Deals by Region, Value and Year

8.3.2 Deals by Key Indication

8.3.3 Deals by Stage of Development and Value

8.3.4 Deals by Molecule Type, Molecular Target and Value

8.3.5 List of Deals with Disclosed Deal Values

8.4 First-in-Class Programs with and without Prior Licensing or Co-development Deal Involvement

9 Appendix

9.1 References

9.2 Abbreviations

9.3 Pipeline Disease List

9.4 Methodology

9.4.1 Data Integrity

9.4.2 Innovative and Meaningful Analytical Techniques and Frameworks

9.4.3 Evidence Based Analysis and Insight

9.5 Secondary Research

9.5.1 Market Analysis

9.5.2 Pipeline Analysis

9.5.3 Licensing and Co-development Deals

9.6 Contact Us

9.7 Disclaimer

List of Tables

Table 1: Gastrointestinal Disorders, Global, Crohn’s Disease Diagnostic Features, 2014

Table 2: Gastrointestinal Disorders, Global, Mayo Score for Ulcerative Colitis, 2017

Table 3: Gastrointestinal ...

Table 1: Gastrointestinal Disorders, Global, Crohn’s Disease Diagnostic Features, 2014

Table 2: Gastrointestinal Disorders, Global, Mayo Score for Ulcerative Colitis, 2017

Table 3: Gastrointestinal Disorders, Global, Summary of Montreal and Paris Classification for Crohn’s Disease, 2014

Table 4: Gastrointestinal Disorders, Global, Montreal Classification of Extent and Severity for Ulcerative Colitis, 2005

Table 5: Gastrointestinal Disorders, Global, Categories of Nonalcoholic Fatty Liver Disease, 2019

Table 6: Gastrointestinal Disorders, Global, Nonalcoholic Fatty Liver Disease Activity Score (NAS), 2019

Table 7: Gastrointestinal Disorders, Global, Modified Marsh Classification of Histologic Findings in Celiac Disease, 2018

Table 8: Gastrointestinal Disorders, Global, Key Features of [Identified Target #1], 2019

Table 9: Gastrointestinal Disorders, Global, Pipeline Programs Targeting [Identified Target #1], 2019

Table 10: Gastrointestinal Disorders, Global, Key Features of [Identified Target #2], 2019

Table 11: Gastrointestinal Disorders, Global, Pipeline Programs Targeting [Identified Target #2], 2019

Table 12: Gastrointestinal Disorders, Global, Key Features of [Identified Target #3], 2019

Table 13: Gastrointestinal Disorders, Global, Key Features of [Identified Target #3], 2019

Table 14: Gastrointestinal Disorders, Global, Key Features of [Identified Target #4], 2019

Table 15: Gastrointestinal Disorders, Global, Pipeline Programs Targeting [Identified Target #4], 2019

Table 16: Gastrointestinal Disorders, Global, Key Features of [Identified Target #5], 2019

Table 17: Gastrointestinal Disorders, Global, Pipeline Programs Targeting [Identified Target #5], 2019

Table 18: Gastrointestinal Disorders, Global, Key Features of [Identified Target #6], 2019

Table 19: Gastrointestinal Disorders, Global, Pipeline Programs Targeting [Identified Target #6], 2019

Table 20: Gastrointestinal Disorders, Global, Key Features of [Identified Target #7], 2019

Table 21: Gastrointestinal Disorders, Global, Pipeline Programs Targeting [Identified Target #7], 2019

Table 22: Gastrointestinal Disorders, Global, Key Features of [Identified Target #8], 2019

Table 23: Gastrointestinal Disorders, Global, Pipeline Programs Targeting [Identified Target #8], 2019

List of Figures

Figure 1: Gastrointestinal Disorders, US, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987–2014

Figure 2: Gastrointestinal Disorders, US, Post-Marketing-Approval Sales Performance of ...

Figure 1: Gastrointestinal Disorders, US, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987–2014

Figure 2: Gastrointestinal Disorders, US, Post-Marketing-Approval Sales Performance of First-in-Class Products Across the Pharmaceutical Industry ($m), 2006–2013

Figure 3: Gastrointestinal Disorders, Global, Market by Molecule Type, 2019

Figure 4: Gastrointestinal Disorders, Global, Market by Molecular Target Class, 2019

Figure 5: Gastrointestinal Disorders, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2019

Figure 6: Gastrointestinal Disorders, Global, Pipeline by Stage of Development and Molecule Type, 2019

Figure 7: Gastrointestinal Disorders, Global, Pipeline for Key Indications by Stage of Development, 2019

Figure 8: Gastrointestinal Tract Disorders, Global, Pipeline for Key Indications by Molecule Type, 2019

Figure 9: Gastrointestinal Disorders, Global, Pipeline by Molecular Target Class and Stage of Development, 2019

Figure 10: Gastrointestinal Disorders, Global, Breakdown of Cytokine Signaling, GPCR and Transcription Factor and Regulation Molecular Target Classes, 2019

Figure 11: Gastrointestinal Disorders, Global, Pipeline for Key Indications by Molecular Target Class, 2019

Figure 12: Gastrointestinal Disorders, Global, Pipeline and Marketed Products by Molecular Target Class, 2019

Figure 13: Gastrointestinal Disorders, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2019

Figure 14: Gastrointestinal Disorders, Global, Pipeline for Key Indications by Molecular Target Class and First-in-Class Status, 2019

Figure 15: Gastrointestinal Disorders, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development and Molecular Target Class (%), 2019

Figure 16: Gastrointestinal Disorders, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2019

Figure 17: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 1)

Figure 18: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 2)

Figure 19: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 3)

Figure 20: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 4)

Figure 21: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 5)

Figure 22: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 6)

Figure 23: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 7)

Figure 24: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 8)

Figure 25: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 9)

Figure 26: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 10)

Figure 27: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 11)

Figure 28: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 12)

Figure 29: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019 (part 13)

Figure 30: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Crohn’s Disease, 2019 (part 1)

Figure 31: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Crohn’s Disease, 2019 (part 2)

Figure 32: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Ulcerative Colitis, 2019 (part 1)

Figure 33: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Ulcerative Colitis, 2019 (part 2)

Figure 34: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Nonalcoholic Steatohepatitis, 2019 (part 1)

Figure 35: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Nonalcoholic Steatohepatitis, 2019 (part 2)

Figure 36: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Nonalcoholic Steatohepatitis, 2019 (part 3)

Figure 37: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Nonalcoholic Steatohepatitis, 2019 (part 4)

Figure 38: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Celiac Disease, 2019

Figure 39: Gastrointestinal Disorders, Global, Industry-Wide Licensing Deals by First-in-Class Status and Stage of Development, 2006–2014

Figure 40: Gastrointestinal Disorders, Global, Industry-Wide Licensing Deals by First-in-Class Status, Deal Value, Upfront Payment Value and Stage of Development, 2006–2014

Figure 41: Gastrointestinal Disorders, Global, Licensing Deals by Region, Value and Year, 2006–2019

Figure 42: Gastrointestinal Disorders, Global, Licensing Deals by Key Indication, 2006–2019

Figure 43: Gastrointestinal Disorders, Global, Licensing Deals by Stage of Development, Deal Value, and Upfront Payment Value ($m), 2006–2019

Figure 44: Gastrointestinal Disorders, Global, Licensing Deals by Molecule Type and Molecular Target Class, 2006–2019

Figure 45: Gastrointestinal Disorders, Global, Licensing Deals with Disclosed Deal Values, 2006–2019 (part 1)

Figure 46: Gastrointestinal Disorders, Global, Licensing Deals with Disclosed Deal Values, 2006–2019 (part 2)

Figure 47: Gastrointestinal Disorders, Global, Licensing Deals with Disclosed Deal Values, 2006–2019 (part 3)

Figure 48: Gastrointestinal Disorders, Global, Licensing Deals with Disclosed Deal Values, 2006–2019 (part 4)

Figure 49: Gastrointestinal Disorders, Global, Co-development Deals by Region, Value and Year, 2006–2019

Figure 50: Gastrointestinal Disorders, Global, Co-development Deals by Key Indication, 2006–2019

Figure 51: Gastrointestinal Disorders, Global, Co-development Deals by Stage of Development and Deal Value, 2006–2019

Figure 52: Gastrointestinal Disorders, Global, Co-development Deals by Molecule Type and Molecular Target Class, 2006-2019

Figure 53: Gastrointestinal Disorders, Global, Co-development Deals with Disclosed Deal Values, 2006–2019 (part 1)

Figure 54: Gastrointestinal Disorders, Global, Co-development Deals with Disclosed Deal Values, 2006–2019 (part 2)

Figure 55: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 1)

Figure 56: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 2)

Figure 57: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 3)

Figure 58: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 4)

Figure 59: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 5)

Figure 60: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 6)

Figure 61: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 7)

Figure 62: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 8)

Figure 63: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 9)

Figure 64: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 10)

Figure 65: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 11)

Figure 66: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 12)

Figure 67: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019 (part 13)

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