Frontier Pharma: Fatty Liver Disease - High Degree of First-in-Class Innovation, Dominated by Nuclear Receptor-Targeting NASH Products

  • ID: 4225330
  • Report
  • Region: Global
  • 76 Pages
  • GBI Research
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Fatty Liver Disease is the Most Common Chronic Liver Disease in the World

FEATURED COMPANIES

  • BLR Bio
  • Celgene
  • ChemomAb
  • Conatus Pharmaceuticals
  • NGM Biopharmaceuticals
  • Novartis
  • MORE

Summary

Fatty liver disease (FLD) comprises a spectrum of chronic liver disorders characterized by excessive lipid accumulation in the liver (steatosis), which may lead to inflammation (steatohepatitis) and fibrosis. It has the potential to progress to end-stage liver diseases such as cirrhosis, liver cancer and liver failure. It is also associated with numerous complications and co-morbidities, including cardiovascular and metabolic diseases. FLD can be divided into non-alcoholic FLD (NAFLD) and alcoholic FLD (AFLD), depending on the history of alcohol use. Both can also be divided into two subgroups: steatosis and steatohepatitis.

FLD is the most common chronic liver disease in the world, and its global prevalence has increased rapidly in the past several decades. The worldwide prevalence of FLD is estimated at 20-45% in the general population, 70% in diabetic patients, and 50-90% in obese people. There is a broad consensus to describe the condition as the hepatic manifestation of metabolic syndrome, and it is closely associated with obesity, diabetes and dyslipidemia. NAFLD has become the main driver of the rapid growth of FLD prevalence, mainly due to the rising prevalence of obesity.

The FLD pipeline is relatively large, with 173 products in active development, which constitutes almost one fifth of the pipeline for the gastrointestinal therapy area. Many pipeline products for FLD are also in development for other non-hepatic fibrotic diseases or indications from the metabolic disorders therapy area - such as diabetes mellitus and dyslipidemia - reflecting the similarities in the underlying pathophysiology of these indications.

Strategic consolidation activity levels are relatively low in the FLD market, as reflected in the low number of licensing and co-development deals completed since 2006. Analysis of licensing and co-development deals relating to FLD therapeutics since 2006 has identified aggregate deal values of $778m and $1.8 billion, respectively.

Due to the increasing prevalence and the health burden of FLD, and the lack of therapeutic options, there is a high need to develop pharmacological strategies. This is especially the case for patients with steatohepatitis who are at the greatest risk of developing cirrhosis or liver cancer that can lead to liver failure. Due to the pathophysiological complexity of FLD and its diverse population, different therapeutic agents are likely to be needed in order to tackle the lipotoxic, inflammatory and fibrogenic effects seen in FLD.

The report "Frontier Pharma: Fatty Liver Disease - High Degree of First-in-Class Innovation, Dominated by Nuclear Receptor-Targeting NASH Products" helps to understand the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options and algorithms.

In depth, this report provides the following analysis:

  • Provides the composition of the FLD market in terms of dominant classes of therapies. Key unmet needs are identified to allow a competitive understanding of gaps in the market.
  • Allows recognizing innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix tailored to FLD, all first-in-class targets in the pipeline have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.

Companies mentioned in this report: Novartis, Celgene, NGM Biopharmaceuticals, Raptor Pharmaceuticals, chemomAb, Conatus Pharmaceuticals, BLR Bio.

Scope

FLD comprises a diverse patient population with significant unmet needs

  • What is the pathophysiology of FLD?
  • What are the common co-morbidities and complications?
  • What are the most significant unmet needs within the market?

The FLD pipeline is relatively large and has a high degree of first-in-class innovation

  • Which molecule types and molecular targets are most prominent within the pipeline?
  • Which first-in-class targets are most promising?
  • How does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?

The FLD deal landscape shows rising deal volumes and considerable investment opportunities

  • Do FLD products attract high deal values?
  • Which molecule types and molecular targets dominate the deals landscape?
  • Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

This report will allow you to:

  • Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options and algorithms.
  • Visualize the composition of the FLD market in terms of dominant classes of therapies. Key unmet needs are identified to allow a competitive understanding of gaps in the market.
  • Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix tailored to FLD, all first-in-class targets in the pipeline have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
  • Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.
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FEATURED COMPANIES

  • BLR Bio
  • Celgene
  • ChemomAb
  • Conatus Pharmaceuticals
  • NGM Biopharmaceuticals
  • Novartis
  • MORE

1 Table of Contents

2 Executive Summary
2.1 Urgent Unmet Need Driven By Rising Prevalence
2.2 High Degree of First-in-Class Innovation
2.3 Rising Deal Volumes and Considerable Investment Opportunities in First-in-Class Product Development

3 The Case for Innovation
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Development Remains Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 Research Report Guidance

4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Disease Symptoms
4.3 Epidemiology
4.4 Etiology and Risk Factors
4.4.1 Environmental Factors
4.4.2 Host Factors
4.5 Pathophysiology
4.5.1 Steatosis
4.5.2 Hepatocellular Injury and Inflammation
4.5.3 Fibrosis
4.5.4 Conclusion
4.6 Co-morbidities and Complications
4.7 Diagnosis
4.7.1 Diagnosis of Fatty Liver Disease
4.7.2 Disease Prognosis
4.8 Treatment
4.8.1 Lifestyle Intervention
4.8.2 Pharmacological Treatment
4.8.3 Liver Transplantation

5 Assessment of Pipeline Product Innovation
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target
5.2 First-in-Class Programs Targeting Novel Molecular Targets
5.3 ASH
5.4 AFLD
5.5 Steatohepatitis (unspecified)
5.6 FLD (unspecified)
5.7 Table of All Pipeline Products

6 Signaling Network, Disease Causation and Innovation Alignment
6.1 Complexity of Signaling Networks in FLD
6.2 Signaling Pathways and First-in-Class Molecular Target Integration
6.3 First-in-Class Matrix Assessment

7 First-in-Class Target Evaluation
7.1 Pipeline Programs Targeting Connective Tissue Growth Factor
7.2 Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 1 and 2
7.3 Pipeline Programs Targeting Acetyl-CoA Carboxylase 1 and 2
7.4 Pipeline Programs Targeting Galectin 3
7.5 Pipeline Programs Targeting Cathepsin B
7.6 Pipeline Programs Targeting NACHT, KKR and PYD Domains-Containing Protein 3
7.7 Pipeline Programs Targeting P2Y Purinoceptor 13
7.8 Pipeline Programs Targeting Serpin H1
7.9 Conclusion

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 Stage of Development and Value
8.2.3 Deals by Molecule Type, Molecular Target and Value
8.2.4 List of Deals with Disclosed Deal Values
8.3 Codevelopment Deals
8.3.1 Deals by Region, Value and Year
8.3.2 Deals by Stage of Development and Value
8.3.3 Deals by Molecule Type, Molecular Target and Value
8.3.4 List of Deals with Disclosed Deal Values
8.4 First-in-Class Programs with and without Prior Involvement in Licensing and Co-development Deals

9 Appendix
9.1 References
9.2 Abbreviations
9.3 Research Methodology
9.3.1 Data integrity
9.3.2 Innovative and meaningful analytical techniques and frameworks:
9.3.3 Evidence based analysis and insight:
9.4 Secondary Research
9.4.1 Market Analysis
9.4.2 Pipeline Analysis
9.4.3 First-in-Class Matrix Assessment
9.4.4 First-in-Class Target Profiles
9.4.5 Licensing and Co-Development Deals

List of Tables
Table 1: Fatty Liver Disease Therapeutics Market, Survival Rates of Simple Steatosis and NASH/ASH, 2017
Table 2: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Connective Tissue Growth Factor, 2017
Table 3: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting Connective Tissue Growth Factor, 2017
Table 4: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Sterol Regulatory Element-Binding Protein 1, 2017
Table 5: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Sterol Regulatory Element-Binding Protein 2, 2017
Table 6: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 1, 2017
Table 7: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 2, 2017
Table 8: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Acetyl-CoA Carboxylase 1, 2017
Table 9: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Acetyl-CoA Carboxylase 2, 2017
Table 10: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting Acetyl-CoA Carboxylase 1 and 2, 2017
Table 11: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Galectin 3, 2017
Table 12: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting Galectin 3, 2017
Table 13: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Cathepsin B, 2017
Table 14: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting Cathepsin B, 2017
Table 15: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of NACHT, KKR and PYD Domains-Containing Protein 3 Receptor, 2017
Table 16: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting NACHT, KKR and PYD Domains-Containing Protein 3, 2017
Table 17: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of P2Y Purinoceptor 13, 2017
Table 18: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting P2Y Purinoceptor 13, 2017
Table 19: Fatty Liver Disease Therapeutics Market, Global, Key Features and Pipeline Activity of Serpin H1, 2017
Table 20: Fatty Liver Disease Therapeutics Market, Global, Pipeline Programs Targeting Serpin H1, 2017

List of Figures
Figure 1: Fatty Liver Disease Therapeutics Market, US, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Product Approvals, 1987-2014
Figure 2: Fatty Liver Disease Therapeutics Market, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval ($m), 2006-2013
Figure 3: Fatty Liver Disease Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017
Figure 4: Fatty Liver Disease Therapeutics Market, Global, Pipeline by Stage of Development and Molecule Type, 2017
Figure 5: Fatty Liver Disease Therapeutics Market, Global, Non-Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease Pipeline by Stage of Development and Molecule Type, 2017
Figure 6: Fatty Liver Disease Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2017
Figure 7: Fatty Liver Disease Therapeutics Market, Non-Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, Global, Pipeline by Molecular Target and Stage of Development, 2017
Figure 8: Fatty Liver Disease Therapeutics Market, Global, Distribution of Pipeline First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target, 2017
Figure 9: Fatty Liver Disease Therapeutics Market, Global, Non-Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, Distribution of Pipeline First-in-Class and Non-First-in-Class Products by Molecular Target, 2017
Figure 10: Fatty Liver Disease Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development (%), 2017
Figure 11: Fatty Liver Disease Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecular Target (%), 2017
Figure 12: Fatty Liver Disease Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development, 2017
Figure 13: Fatty Liver Disease Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Molecular Target, 2017
Figure 14: Fatty Liver Disease Therapeutics Market, Alcoholic Steatohepatitis, Global, Pipeline Products, 2017
Figure 15: Fatty Liver Disease Therapeutics Market, Alcoholic Fatty Liver Disease, Global, Pipeline Products, 2017
Figure 16: Fatty Liver Disease Therapeutics Market, Steatohepatitis (Unspecified), Global, Pipeline Products, 2017
Figure 17: Fatty Liver Disease Therapeutics Market, Fatty Liver Disease (Unspecified), Global, Pipeline Products, 2017
Figure 18: Fatty Liver Disease Therapeutics Market, Global, Pipeline Products, 2017 (Part 1)
Figure 19: Fatty Liver Disease Therapeutics Market, Global, Pipeline Products, 2017 (Part 2)
Figure 20: Fatty Liver Disease Therapeutics Market, Global, Pipeline Products, 2017 (Part 3)
Figure 21: Fatty Liver Disease Therapeutics Market, Global, Pipeline Products, 2017 (Part 4)
Figure 22: Fatty Liver Disease Therapeutics Market, Global, Pipeline Products, 2017 (Part 5)
Figure 23: Fatty Liver Disease Therapeutics Market, Global, First-in-Class Matrix Assessment, 2017 (Part 1)
Figure 24: Fatty Liver Disease Therapeutics Market, Global, First-in-Class Matrix Assessment, 2017 (Part 2)
Figure 25: Fatty Liver Disease Therapeutics Market, Global, Industry-Wide Deals by Stage of Development and First-in-Class Status, 2006-2014
Figure 26: Fatty Liver Disease Therapeutics Market, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status, 2006-2014
Figure 27: Fatty Liver Disease Therapeutics, Global, Licensing Deals by Region, Value and Year, 2006-2017
Figure 28: Fatty Liver Disease Therapeutics, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2017
Figure 29: Fatty Liver Disease Therapeutics, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type, 2006-2017
Figure 30: Fatty Liver Disease Therapeutics, Global, Number and Aggregate Deal Value of Licensing Deals by Molecular Target, 2006-2017
Figure 31: Fatty Liver Disease Therapeutics, Global, Licensing Deals with Disclosed Deal Values, 2006-2017
Figure 32: Fatty Liver Disease Therapeutics, Global, Co-development Deals by Region, Value and Year, 2006-2017
Figure 33: Fatty Liver Disease Therapeutics, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017
Figure 34: Fatty Liver Disease Therapeutics, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type, 2006-2017
Figure 35: Fatty Liver Disease Therapeutics, Global, Number of Co-development Deals by Molecular Target, 2006-2017
Figure 36: Fatty Liver Disease Therapeutics, Global, Co-development Deals with Disclosed Deal Values, 2006-2017
Figure 37: Fatty Liver Disease Therapeutics Market, Global, First-in-Class Pipeline Products with Prior Involvement in Licensing or Co-development Deals, 2017
Figure 38: Fatty Liver Disease Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals, 2017

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  • BLR Bio
  • Celgene
  • ChemomAb
  • Conatus Pharmaceuticals
  • NGM Biopharmaceuticals
  • Novartis
  • Raptor Pharmaceuticals
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