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End of Forecast Surge in Sales for NASH from 2012–2017
The Report “OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) – Opportunity Analysis and Forecasts to 2017 – Event-Driven Update″ by GlobalData is now available at RnRMarketResearch.com. Contact [email protected] with “OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) – Opportunity Analysis and Forecasts to 2017 – Event-Driven Update″ in subject line and your contact details to purchase this report or get your questions answered.
This estimates the 2012 off-label sales for nonalcoholic steatohepatitis (NASH) to be approximately $233m across the US and five major European markets of France, Germany, Italy, Spain, and the UK. By forecast end in 2017, it expects sales to grow to about $1.36bn, with a compound annual growth rate (CAGR) of 42.2% across the 6MM. We expect the US to claim the most sales, contributing $1.28bn of global sales and a CAGR of 43.8%.
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Major drivers of growth in the NASH market are attributed to two factors:
- The growing rate of obesity and diabetes globally.
- The launch of Genfit’s GFT505 and Intercept/DSP’s obeticholic acid (OCA) in 2017. In OCA’s favor, its Phase II/IIb trial was stopped early in January 2014, after a planned interim analysis showed that the primary endpoint of the study had been met. While for GFT505, Genfit is aligning itself to register GFT505 among the first approved therapies for NASH and the company received Fast Track designation for the GFT505 NASH program on February 14, 2014.
- We expect the US’ growth will be due in part to the launch of both of these products, while growth in the 5EU will be predominantly driven by GFT505 during the forecast period.
Major barriers to the growth of the NASH market are attributed to:
- Slow development of therapies specific for NASH.
- Unclear understanding of the pathophysiology of NASH.
- Inefficient diagnostic tools for NASH that may lead to delayed diagnosis of NASH.
Emerging Market Players Employing Strategies to Improve Diagnostics and Trial Designs
Complete report is available @ http://www.rnrmarketresearch.com/opportunityanalyzer-nonalcoholic-steatohepatitis-nash-opportunity-analysis-and-forecasts-to-2017-event-driven-update-market-report.html . Read more on “OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) – Opportunity Analysis and Forecasts to 2017 – Event-Driven Update” report below.
The NASH market is virtually vacant aside from off-label therapies that do not provide a “one size fits all” approach. The potential for market leaders to emerge is wide open to all contenders. We expect Gilead and Novo Nordisk to gain market entry after the end of the forecast period in 2017; however, with their market knowledge, their products simtuzumab and liraglutide should do well commercially.
As for newcomers Genfit and Intercept/DSP, fame will be claimed since their products will likely launch at the end of the forecast in Q4 2017, thus giving them an early foothold in the NASH market space.
Since there is no cure or one specific therapy currently available for NASH, R&D strategies in this market space are complicated. Complications range from unraveling the pathophysiology of NASH, to designing diagnostic tools for more accurate diagnosis and staging, to the design of clinical trials. As our expert leaders have agreed, NASH needs an approved therapy that is cost-effective and touts a desirable efficacy and safety profile.
Vast Unmet Needs in the NASH Market
The level of unmet needs for NASH, including both environmental and clinical, is high and includes patient awareness, physician education, and approved therapies specific to NASH. These issues compound the reasons why the NASH market space is very sparse. A series of unknowns exist for the disease, due to its heterogeneous nature, and its slow progression poses problems for drug development. Vitamin E, the current gold-standard therapy, dominates what little drug therapy NASH market there is. We expect both Genfit’s small molecule GFT505 and Intercept Pharmaceuticals/DSP’s small molecule OCA to claim patient share in all subpopulations of NASH.
These products will likely solve the top unmet need – the dire need for an approved therapy for NASH.
Opportunities Will Remain for Tools that Provide Accurate Diagnosis
There is a major opportunity for new entrants to design better biomarkers than the current liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) as non-invasive surrogates for Nonalcoholic Fatty Liver Disease (NAFLD). Testing may also include cytokeratin-18 (CK18), which may provide clues to hepatocyte cell death. In addition, markers that can assess liver stages are needed, since CK18 is also elevated in other liver conditions.
Currently, NASH patients may be diagnosed by chance during routine serological examination, or via invasive liver biopsy. Most NASH patients will be in the mid/late stage of the disease once diagnosed. A more accurate diagnostic tool for determining the extent of fibrosis in NASH patients will also be paramount. That said, we expect these opportunities to remain unmet during the five-year forecast period from 2012–2017.
2017 Launches of Novel Pipeline Products Will Forever Change the Future NASH Treatment Landscape
Twelve molecules of interest across all stages of development make up the pipeline for NASH. However, This believes there are four therapies with the potential to revolutionize the treatment paradigm for NASH in the near term. These four novel, potential first-in-class therapies, which are antifibrotic and antidiabetic by therapeutic class, will target subpopulations (obese, diabetic, and “other” or healthy donors) within NASH.
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The four most promising NASH pipeline products are:
- Genfit’s GFT505: anticipated to launch in Q4 2017 across the 6MM.
- Intercept Pharmaceuticals / Dainippon Sumitomo Pharma’s obeticholic acid (INT-747/DSP-1747): anticipated to launch in Q4 2017 in the US, with an expected launch in the EU after the forecast period of 2012–2017.
- Gilead’s simtuzumab: anticipated to launch after the forecast period of 2012–2017.
- Novo Nordisk’s liraglutide (Victoza): the marketed type 2 diabetes brand is anticipated to launch (with NASH as a new indication) after the forecast period of 2012–2017.
Scope
- Overview of NASH, including epidemiology, etiology, symptoms, diagnosis, pathology and disease management.
- Analysis of the current and future market competition in the global NASH therapeutics market.
- Pipeline analysis: comprehensive data split across Phase II/IIb, emerging trends and mechanisms of action under development, including: oral Proliferator Activated Receptor alpha, delta (PPARa,d) agonist, oral Farnesoid X Receptor (FXR) agonist, subcutaneous Lysyl Oxidase-Like 2 (LOXL2) inhibitor and subcutaneous Glucagon-like Peptide-1 (GLP-1) agonist.
- Annualized NASH therapeutics market forecast, annual cost of therapy and treatment usage pattern data from 2012-2017.
- Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
- Key topics covered include strategic clinical and commercial benchmarking assessment of the pipeline and standard of care, market outlook, R&D strategies, and unmet needs for the NASH therapeutics market.
Reasons to buy
Develop business strategies and perform superior market quantification analysis by -
- Understanding the trends shaping and driving the global NASH Therapeutics market.
- Understanding treatment preferences of physicians in disease state and across treatment flow.
- Accessing market sizing, forecasts and quantified growth opportunities in the global NASH Therapeutics market till 2017.
- Quantifying patient population in the global NASH Therapeutics market to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape by
- Performing benchmarking analysis and growth opportunities against currently marketed products.
- Identifying market entry points based on safety, efficacy, and pricing parameters.
- Assessing competitiveness of products in market by understanding the strength and weakness of current competition.
- Develop and design your in-licensing and out-licensing strategies by
- Taking a comprehensive look of at the disease pipeline and identifying most promising paradigm shifting products.
- Assessing strength of pipeline based on first in class and lifecycle management of products.
- Analyze the potential impact of novel oral therapies such as Genfit’s GFT505 on the NASH treatment paradigm.
- Track drug sales in the global NASH Therapeutics market from 2012 to 2017.
- Identify the emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for consolidation, investments and strategic partnerships.
- What’s the next big thing in the global NASH Therapeutics market landscape? Identify, understand, and capitalize.
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