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.