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, and 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 patent’s history of alcohol use.
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, and up to 90% in obese patients. 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.
FLD is increasingly recognized as a major global health problem. However, despite this the FLD market is still in its infancy, with no FDA-approved drugs for this indication, and only a limited number of generic drugs approved in non-US markets in recent years.
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Due to the increasing health burden of FLD and the lack of therapeutic options, there is a pressing 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, which can lead to liver failure. Due to the pathophysiological complexity of FLD and its diverse population, different therapeutic agents are likely to be needed to tackle the lipotoxicity, inflammation and fibrogenesis that drive FLD progression.
FLD has an active pipeline and first-in-class products account for a considerable proportion, which is very promising considering the level of unmet need and lack of approved treatment options. First-in-class innovation is concentrated heavily at the early drug development stages, and prominent first-in-class molecular targets include nuclear receptors, immune mediators, and molecules involved in lipid synthesis. Additionally, the first-in-class targets identified show considerable diversity, reflecting the multifaceted aspects of FLD pathophysiology.
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?
- 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?
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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."
- 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."
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 5
2.1 Urgent Unmet Need Driven By Rising Prevalence 5
2.2 High Degree of First-in-Class Innovation 5
2.3 Rising Deal Volumes and Considerable Investment Opportunities in First-in-Class Product Development 5
3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Development Remains Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 5
2.1 Urgent Unmet Need Driven By Rising Prevalence 5
2.2 High Degree of First-in-Class Innovation 5
2.3 Rising Deal Volumes and Considerable Investment Opportunities in First-in-Class Product Development 5
3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Development Remains Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
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3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 8
4 Clinical and Commercial Landscape 10
4.1 Disease Overview 10
4.2 Disease Symptoms 11
4.3 Epidemiology 11
4.4 Etiology and Risk Factors 11
4.4.1 Environmental Factors 11
4.4.2 Host Factors 12
4.5 Pathophysiology 13
4.5.1 Steatosis 13
4.5.2 Hepatocellular Injury and Inflammation 14
4.5.3 Fibrosis 15
4.5.4 Conclusion 15
4.6 Co-morbidities and Complications 16
4.7 Diagnosis 16
4.7.1 Diagnosis of Fatty Liver Disease 16
4.7.2 Disease Prognosis 17
4.8 Treatment 17
4.8.1 Lifestyle Intervention 17
4.8.2 Pharmacological Treatment 18
4.8.3 Liver Transplantation 19
5 Assessment of Pipeline Product Innovation 20
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 20
5.2 First-in-Class Programs Targeting Novel Molecular Targets 27
5.3 ASH 33
5.4 AFLD 33
5.5 Steatohepatitis (unspecified) 34
5.6 FLD (unspecified) 34
5.7 Table of All Pipeline Products 35
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 8
4 Clinical and Commercial Landscape 10
4.1 Disease Overview 10
4.2 Disease Symptoms 11
4.3 Epidemiology 11
4.4 Etiology and Risk Factors 11
4.4.1 Environmental Factors 11
4.4.2 Host Factors 12
4.5 Pathophysiology 13
4.5.1 Steatosis 13
4.5.2 Hepatocellular Injury and Inflammation 14
4.5.3 Fibrosis 15
4.5.4 Conclusion 15
4.6 Co-morbidities and Complications 16
4.7 Diagnosis 16
4.7.1 Diagnosis of Fatty Liver Disease 16
4.7.2 Disease Prognosis 17
4.8 Treatment 17
4.8.1 Lifestyle Intervention 17
4.8.2 Pharmacological Treatment 18
4.8.3 Liver Transplantation 19
5 Assessment of Pipeline Product Innovation 20
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 20
5.2 First-in-Class Programs Targeting Novel Molecular Targets 27
5.3 ASH 33
5.4 AFLD 33
5.5 Steatohepatitis (unspecified) 34
5.6 FLD (unspecified) 34
5.7 Table of All Pipeline Products 35
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