NEW YORK, March 9, 2016 /PRNewswire/ -- INTRODUCTION
NASH or Non-Alcoholic Steatohepatitis refers to a chronic liver disorder characterized by accretion of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. In other words, it can be defined as significant steatohepatitis not caused due to alcohol, drugs, toxins, infectious agents or other identifiable exogenous causes. NASH is often accompanied with a high possibility of cirrhosis, a condition in which the liver functions are changed, leading to liver insufficiency. Although NASH has become quite common, there is still no clarity about the underlying cause of the disease. It is currently the third most common factor leading to liver transplants in the US. Estimated to affect around 2-5% of Americans, NASH has been cited as the next hepatitis C.
Given the rising prevalence of NASH, it has become all the more crucial to understand the pathophysiology of NASH in order to develop therapeutic interventions. Several options are being investigated to identify an efficient treatment regimen for NASH; these include lifestyle modifications, off-label therapies, natural products and combinations of these approaches. However, the diagnostic landscape for NASH is quite challenging; majority of the patients are asymptomatic and can only be detected by routine blood tests showing elevations in liver enzymes.At present, liver biopsy is being used as the only reliable way to diagnose NASH and detect the presence of fibrosis; however, very few patients choose to undergo liver biopsy because of its invasive nature.
Recognizing the huge unmet medical need, several companies are striving to establish an early foothold in the area. Investigators are also looking forward to exploiting the approach of personalized medicine in order to identify diagnostic biomarkers, prognostic biomarkers and therapeutic targets for the treatment of NASH on the basis of their pathogenic and clinical traits.
SCOPE OF THE REPORT
The 'NASH Drugs Market, 2015-2025' report provides a comprehensive study on the current landscape and the future outlook of the evolving pipeline of molecules in this area. With an expanding NAFLD and NASH population worldwide, there is a growing need for development of therapeutics in this disease area. NASH is gradually emerging as the leading cause of liver transplants. While the field has garnered interest of several companies, there are no approved therapies till date. It is important to stress that the development pipeline of NASH has several promising candidates that are likely to result in many commercial success stories in the foreseen future.
Amongst other elements, the report elaborates on the new diagnostic solutions being developed and the upcoming opportunities for different stakeholders. As pharmaceutical companies continue to initiate and expand their research programs in this area, one of the key objectives outlined for this report is to understand the future potential of the market. This is done by analyzing:
- The epidemiology, patient population and staging of NASH in different geographies.
- The NASH pipeline in terms of phase of development, type of molecule, route of administration and mechanism of action.
- The likely evolution in the rate of diagnosis, drug treated patient population and the likely price of the drugs.
- The associated constraints, in terms of undefined pathogenesis and the unavailability of non-invasive diagnostic tests, and the initiatives being carried out by the companies to overcome these.
The study provides a detailed scenario analysis to estimate the market forecast for the period till 2025. The research, analysis and insights presented in this report include potential sales of the drugs in late stages of development and expected to launch by 2025. Our opinions and insights, presented in this study, were influenced by the discussions that we conducted with experts in this area. These included senior representatives at BiOrion Technologies, Phenex Pharmaceuticals, Tobira Therapeutics, Verlyx Pharmaceuticals and Connexios.
All actual figures have been sourced and analyzed from publicly available information and discussions with industry experts. The figures mentioned in this report are in USD, unless otherwise specified.
1. During the course of our study, we identified over 50 molecules. Of these, two molecules (Lipaglyn by Zydus Cadila and OCA by Intercept Pharmaceuticals) are in phase 3 clinical studies. Nearly 37% of the pipeline is captured by molecules in phase 2 and 22% in phase 1. Additionally, 35% of the molecules are in preclinical/discovery phase, demonstrating the strong market potential of this field.
2. Amongst several companies expanding in this domain, Intercept Pharmaceuticals is expected to launch INT 747 in the US and EU5 countries in 2017/2018. Subsequently, Genfit (GFT505), Gilead Sciences (GS-6624), Conatus Pharmaceuticals (Emricasan),Galmed Pharmaceuticals (Aramchol) and Raptor Pharmaceuticals (RP103) are expected to complete the clinical trials of their respective molecules in the coming years, sustaining the growth momentum.
3. Lack of competent diagnostic tests has led to a poor diagnosis rate and management of NASH so far. Liver biopsy is currently the gold standard to validate the presence of NASH. We believe that merely 5% - 10% of the total patients suffering from the disease are actually being diagnosed in the US and the EU 5 countries. In addition to developments of tests to diagnose NASH, many small and mid-sized firms are now developing companion diagnostics alongside their NASH drug candidates.
4. The market is fragmented with several start-ups actively involved in this area. Examples (in alphabetical order) include Cerenis Therapeutics, DS Biopharma, Galectin Therapeutics, Immuron, Islet Sciences, Matinas BioPharma, Metabolic Solutions, Naia Pharmaceuticals, Nimbus Therapeutics, Verva Pharmaceuticals, ViroBay and Zafgen.
5. The overall market is likely to be influenced by several parameters such as diagnosis rate, drug penetration and the likely price of the drugs. We expect the market to witness an aggressive growth rate of close to 90%, emerging as a multi-billion dollar market by 2025. However, with successful reimbursement practices and launch in wider markets, the overall opportunity could be much higher.
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