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

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

Summary

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.

GI disorders are a large therapy area with 1,241 pipeline products in active development, of which 789 have a disclosed molecular target. Among the 789 pipeline products with a disclosed molecular target, 354 first-in-class products and 252 distinct first-in-class targets have been identified, demonstrating that innovation and diversity within the pipeline is relatively high. Specifically, the number of first-in-class products that have been identified among the CrD, UC, NASH and CeD pipelines is 44, 51, 96 and 13, respectively. Many of the most promising first-in-class targets identified are implicated in immune and inflammatory responses.

Since January 2006, a total of 573 licensing deals have been completed within the GI therapy area. Of these, 207 had a disclosed deal value, and the aggregate disclosed value for these deals was $39.8 billion. Co-development deal activity was considerably lower with 334 deals completed over this time period. Of these, 63 had a disclosed deal value and the aggregate disclosed value of these deals was $17.5 billion. Among the key indications, CrD and UC incurred larger aggregate deal values than NASH and CrD.

Furthermore, among the 354 first-in-class products in the GI disorders pipeline, 99 have previously been involved in licensing deals and 67 have previously been involved in co-development deals. However, 214 first-in-class products have no prior involvement in either licensing or co-development deals and therefore represents potential investment opportunities.

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.


  • Executive Summary
    • Gastrointestinal Disorders Associated with Large Social and Economic Burden
    • Large First-in-Class Pipeline with Many Promising Targets Implicated in Immune and Inflammatory Responses
    • The Majority of First-in-Class Products Have No Prior Involvement in Licensing or Co-development Deals
  • The Case for Innovation
    • Table Figure 1: Gastrointestinal Disorders, US, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987– 2014
    • Growing Opportunities for Biologic Products
    • Diversification of Molecular Targets
    • Innovative First-in-Class Product Developments Remain Attractive
      • Table Figure 2: Gastrointestinal Disorders, US, Post-Marketing-Approval Sales Performance of First-in-Class Products Across the Pharmaceutical Industry ($m), 2006–2013
    • Regulatory and Reimbursement Policy Shifts Favor First-in-Class Innovation
    • Sustained Innovation in Gastrointestinal Disorders
    • Report Guidance
  • Clinical and Commercial Landscape
    • Overview of Gastrointestinal Tract Disorders
      • Crohn's Disease
      • Ulcerative Colitis
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Symptoms
      • Crohn's Disease
      • Ulcerative Colitis
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Diagnosis
      • Crohn's Disease
        • Table Gastrointestinal Disorders, Global, Crohn's Disease Diagnostic Features, 2014
      • Ulcerative Colitis
        • Table Gastrointestinal Disorders, Global, Mayo Score for Ulcerative Colitis, 2017
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Etiology
      • Crohn's Disease
      • Ulcerative Colitis
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Pathophysiology
      • Crohn's Disease
      • Ulcerative Colitis
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Epidemiology
      • Crohn's Disease
      • Ulcerative Colitis
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Co-morbidities and Complications
      • Crohn's Disease
      • Ulcerative Colitis
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Disease Staging
      • Crohn's Disease
        • Table Gastrointestinal Disorders, Global, Summary of Montreal and Paris Classification for Crohn's Disease, 2014
      • Ulcerative Colitis
        • Table Gastrointestinal Disorders, Global, Montreal Classification of Extent and Severity for Ulcerative Colitis, 2005
      • Nonalcoholic Steatohepatitis
        • Table Gastrointestinal Disorders, Global, Categories of Nonalcoholic Fatty Liver Disease, 2019
        • Table Gastrointestinal Disorders, Global, Nonalcoholic Fatty Liver Disease Activity Score (NAS), 2019
      • Celiac Disease
        • Table Gastrointestinal Disorders, Global, Modified Marsh Classification of Histologic Findings in Celiac Disease, 2018
    • Treatment
      • Crohn's Disease
      • Ulcerative Colitis
      • Nonalcoholic Steatohepatitis
      • Celiac Disease
    • Overview of Marketed Products
      • Table Figure 3: Gastrointestinal Disorders, Global, Market by Molecule Type, 2019
      • Table Figure 4: Gastrointestinal Disorders, Global, Market by Molecular Target Class, 2019
  • Assessment of Pipeline Product Innovation
    • Overview
      • Table Figure 5: Gastrointestinal Disorders, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2019
    • Pipeline by Stage of Development and Molecule Type
      • Gastrointestinal Disorders Overall
        • Table Figure 6: Gastrointestinal Disorders, Global, Pipeline by Stage of Development and Molecule Type, 2019
      • Key Gastrointestinal Disorder Indications
        • Table Figure 7: Gastrointestinal Disorders, Global, Pipeline for Key Indications by Stage of Development, 2019
        • Table Figure 8: Gastrointestinal Tract Disorders, Global, Pipeline for Key Indications by Molecule Type, 2019
    • Pipeline by Molecular Target
      • Gastrointestinal Disorders Overall
        • Table Figure 9: Gastrointestinal Disorders, Global, Pipeline by Molecular Target Class and Stage of Development, 2019
        • Table Figure 10: Gastrointestinal Disorders, Global, Breakdown of Cytokine Signaling, GPCR and Transcription Factor and Regulation Molecular Target Classes, 2019
      • Key Gastrointestinal Disorder Indications
        • Table Figure 11: Gastrointestinal Disorders, Global, Pipeline for Key Indications by Molecular Target Class, 2019
    • Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class
      • Table Figure 12: Gastrointestinal Disorders, Global, Pipeline and Marketed Products by Molecular Target Class, 2019
    • First-in-Class Programs Targeting Novel Molecular Targets
      • Table Figure 13: Gastrointestinal Disorders, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2019
      • Table Figure 14: Gastrointestinal Disorders, Global, Pipeline for Key Indications by Molecular Target Class and First-in-Class Status, 2019
      • Table 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
    • Ratio of First-in-Class Products to First-in-Class Targets
      • Table 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
    • List of All Pipeline Products
      • Table Figure 17: Gastrointestinal Disorders, Global, List of All Pipeline Products, 2019
  • Signaling Network, Disease Causation and Innovation Alignment
    • Complexity of Signaling Networks
    • Signaling Pathways and First-in-Class Molecular Target Integration
    • First-in-Class Matrix Assessments
      • Table Figure 30: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Crohn's Disease, 2019
      • Table Figure 32: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Ulcerative Colitis, 2019
      • Table Figure 34: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Nonalcoholic Steatohepatitis, 2019
      • Table Figure 38: Gastrointestinal Disorders, Global, First-in-Class Matrix Assessment for Celiac Disease, 2019
  • First-in-Class Molecular Target Evaluation
    • Pipeline Programs Targeting Non Receptor Tyrosine Protein Kinase TYK2 for Crohn's Disease and Ulcerative Colitis
      • Table Gastrointestinal Disorders, Global, Key Features of Non Receptor Tyrosine Protein Kinase TYK2, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Non Receptor Tyrosine Protein Kinase TYK2, 2019
    • Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5 for Crohn's Disease and Ulcerative Colitis
      • Table Gastrointestinal Disorders, Global, Key Features of Tumor Necrosis Factor Receptor Superfamily Member 5, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5, 2019
    • Pipeline Programs Targeting Interleukin 7 Receptor Subunit Alpha for Crohn's Disease and Ulcerative Colitis
      • Table Gastrointestinal Disorders, Global, Key Features of Interleukin 7 Receptor Subunit Alpha, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Interleukin 7 Receptor Subunit Alpha, 2019
    • Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 for Ulcerative Colitis
      • Table Gastrointestinal Disorders, Global, Key Features of Prostaglandin E2 receptor EP4 subtype, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 Subtype, 2019
    • Pipeline Programs Targeting Adiponectin for Nonalcoholic Steatohepatitis
      • Table Gastrointestinal Disorders, Global, Key Features of Adiponectin, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Adiponectin, 2019
    • Pipeline Programs Targeting Toll-like Receptor 4 for Nonalcoholic Steatohepatitis and Crohn's Disease
      • Table Gastrointestinal Disorders, Global, Key Features of Toll-Like Receptor 4, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Toll-Like Receptor 4, 2019
    • Pipeline Programs Targeting Protease Activated Receptor 2 for Celiac Disease and Nonalcoholic Steatohepatitis
      • Table Gastrointestinal Disorders, Global, Key Features of Proteinase Activated Receptor 2, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Proteinase Activated Receptor 2, 2019
    • Pipeline Programs Targeting Interleukin 2 Receptor Subunit Beta for Celiac Disease
      • Table Gastrointestinal Disorders, Global, Key Features of Interleukin 2 Receptor Subunit Beta, 2019
      • Table Gastrointestinal Disorders, Global, Pipeline Programs Targeting Interleukin 2 Receptor Subunit Beta, 2019
  • Strategic Consolidations
    • Industry-wide First-in-Class Deals
      • Table Figure 39: Gastrointestinal Disorders, Global, Industry-Wide Licensing Deals by First-in-Class Status and Stage of Development, 2006–2014
      • Table 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
    • Licensing Deals
      • Deals by Region, Value and Year
        • Table Figure 41: Gastrointestinal Disorders, Global, Licensing Deals by Region, Value and Year, 2006–2019
      • Deals by Key Indication
        • Table Figure 42: Gastrointestinal Disorders, Global, Licensing Deals by Key Indication, 2006–2019
      • Deals by Stage of Development and Value
        • Table Figure 43: Gastrointestinal Disorders, Global, Licensing Deals by Stage of Development, Deal Value, and Upfront Payment Value ($m), 2006–2019
      • Deals by Molecule Type, Molecular Target and Value
        • Table Figure 44: Gastrointestinal Disorders, Global, Licensing Deals by Molecule Type and Molecular Target Class, 2006–2019
      • List of Deals with Disclosed Deal Values
        • Table Figure 45: Gastrointestinal Disorders, Global, Licensing Deals with Disclosed Deal Values, 2006–2019
    • Co-development Deals
      • Deals by Region, Value and Year
        • Table Figure 49: Gastrointestinal Disorders, Global, Co-development Deals by Region, Value and Year, 2006–2019
      • Deals by Key Indication
        • Table Figure 50: Gastrointestinal Disorders, Global, Co-development Deals by Key Indication, 2006–2019
      • Deals by Stage of Development and Value
        • Table Figure 51: Gastrointestinal Disorders, Global, Co-development Deals by Stage of Development and Deal Value, 2006–2019
      • Deals by Molecule Type, Molecular Target and Value
        • Table Figure 52: Gastrointestinal Disorders, Global, Co-development Deals by Molecule Type and Molecular Target Class, 2006- 2019
      • List of Deals with Disclosed Deal Values
        • Table Figure 53: Gastrointestinal Disorders, Global, Co-development Deals with Disclosed Deal Values, 2006–2019
    • First-in-Class Programs with and without Prior Licensing or Co-development Deal Involvement
      • Table Figure 55: Gastrointestinal Disorders, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2019
  • Appendix
    • References
    • Abbreviations
    • Pipeline Disease List
    • Methodology
      • Data Integrity
      • Innovative and Meaningful Analytical Techniques and Frameworks
      • Evidence Based Analysis and Insight
    • Secondary Research
      • Market Analysis
      • Pipeline Analysis
      • Licensing and Co-development Deals
    • Contact Us
    • Disclaimer

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