$695 | Single User
$1395 | Global License

Physician Views: With drug developers on the brink of Phase III for NASH, how large is the actual market opportunity?
[Lowest Price Guaranteed: $695]

Published by FirstWord Pharma: 04 Aug 2014 | 143 | In Stock
Related Topics: Pharmaceuticals

Introduction

Scope



While no drugs are approved for non-alcoholic steatohepatitis (NASH), at least eight agents have moved into clinical testing in the setting, including two small molecules on the verge of pivotal trials, making a better understanding of the commercial landscape before them all the more important.


It might seem strange at first blush that so many companies are racing drugs to market for a disease that Deutsche Bank analyst Alethia Young says generated a mere 0 million in off-label sales in 2010.


However, much like what is happening right now in hepatitis C, the advent of effective therapeutics is expected to help expand the NASH market space significantly over the next decade. In fact, Young estimates the total market opportunity could be as large as billion by 2025.


Intercept Pharmaceuticals appears to have pole position among those developing therapeutics for NASH, a severe fibrosis of the liver that exploded into investors' consciousness in earnest only in January when a Phase IIb trial of the company's obeticholic acid (OCA) was stopped early due to efficacy. Detailed results expected at the annual AASLD meeting in November are highly anticipated.


Young believes that Genfit is running a close second with GFT505, which like OCA is intended to clear the inflammation and cell ballooning underlying NASH. She expects initial efficacy data from an ongoing Phase IIb trial of GFT505 should be ready in 1Q15.


Gilead Sciences is taking a slightly different approach with simtuzumab, a mAb against LOXL2 designed to reverse the fibrosis known to play a major role in NASH, though Young suggests that this approach might be complementary to OCA and/or GFT 505. Data from at least one Phase IIb trial of simtuxumab should be available around mid-2015.


These three products alone could generate as much as billion to billion in peak sales each, according to Young's market analysis.


In their wake are a slew of programmes addressing the various underlying inflammation, fibrosis and/or adiposity components of NASH, including those being developed by Galmed Pharmaceuticals, Raptor Pharmaceuticals, Conatus Pharmaceuticals, Novo Nordisk, Takeda, Tobira Therapeutics, Phenex and Galectin Therapeutics.


Puchase Reasons


Thus, to better understand the commercial opportunity represented by NASH, as well as how these agents might end up competing against and with one another for market share, FirstWord is this week polling US and EU5-based gastroenterologists and liver specialists. Specifically we are asking them...


  • How would you describe the level of unmet need in non-alcoholic steatohepatitis (NASH) patients with advanced fibrosis (F2/F3) or cirrhosis?

  • What percentage of total NASH patients do you estimate are currently diagnosed and treated adequately?

  • To what percentage of diagnosed NASH patients would you estimate prescribing a therapy that has been approved on the basis of "reversal of NASH without fibrosis progression"?

  • To what percentage of diagnosed NASH patients would you estimate prescribing a therapy that has been approved on the basis of "reversal of NASH and a statistically significant impact fibrosis progression"?

  • How significant an impact would the development of non-invasive diagnostics (for the identification of NASH patients) have on evolving the market for NASH therapies?
  • Table of Contents
    for Physician Views: With drug developers on the brink of Phase III for NASH, how large is the actual market opportunity?

    Additional Details

    Publisher

    FirstWord Pharma

    Publisher Information

    Reference

    143 |

    Report Format

    PDF

    FirstWord Pharma Reports

    Related Reports

    TitleDate PublishedPrice fromMore Details
    Physician Views: Can the launch of ViiV Healthcare's dolutegravir disrupt Gilead's dominance in the HIV market?
    ScopeBased on current timelines, the FDA is poised to approve the HIV therapy dolutegravir later thi...
    01 Aug 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Will generic Copaxone have traction in the MS market given emergence of oral therapies?
    ScopeA recent ruling by the US Court of Appeals for the Federal Circuit has increased the likelihood...
    01 Aug 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Can GlaxoSmithKline strike early with Anoro? / What role will dosing, inhaler type play in uptake of LAMA/LABA combinations for COPD?
    ScopeThis year looks set to be one of notable evolution for the US chronic obstructive pulmonary dis...
    01 Aug 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Post ADA view on key diabetes market developments
    ScopeLast week’s American Diabetes Association (ADA) meeting provided further evidence that the diab...
    01 Jul 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Biosimilar Remicade poised for approval in Europe – are rheumatologists and gastroenterologists ready?
    ScopeThe recent recommendation to approve a biosimilar version of Merck & Co./Johnson & Johnson's Re...
    01 Jul 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Do EU pulmonologists anticipate rapid uptake for GSK’s Seretide-successor?
    ScopeAs GlaxoSmithKline's Relvar Ellipta – a once-daily successor to its multi-billion dollar Sereti...
    01 Jul 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Key developments in the European diabetes market - will endocrinologists embrace Tresiba and Forxiga? – both rejected by the FDA
    ScopeEuropean-based endocrinologists are currently getting to grips with two new products that have ...
    01 Jul 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Recent developments in US diabetes market – impact of safety concerns & emergence of SGLT-2 drug class
    ScopeWith the diabetes market an important therapeutic area for a host of pharmaceutical manufacture...
    01 Jun 2013 by FirstWord Pharma USD $695 More Info
    Physician Views: Life after Gleevec in the chronic myeloid leukaemia (CML) market?
    ScopeNovartis' Gleevec is widely credited as being one of the most important drug launches of all ti...
    01 Jun 2013 by FirstWord Pharma USD $695 More Info
    Surveying Physician Uptake of Mobile Devices and Apps
    IntroductionThe latest medical application software is increasing physicians’ use of mobile technolo...
    01 Oct 2012 by FirstWord Pharma USD $695 More Info

    This report is published by FirstWord Pharma

    Download Free Report Summary PDF

    Physician Views: With drug developers on the brink of Phase III for NASH, how large is the actual market opportunity? | Download PDF Summary

    Download our FREE report summary PDF. It contains all the information on these web pages, plus a Proforma Invoice request form, should you need it to satisfy your company's internal order procedures.

    Ordering Information

    Orders are processed immediately and you will be notified of the despatch date on confirmation of your order.

    Accepted Card Types

    Payment

    Buy now using our secure payment system.

    We Stock...