Last Updated 29 December 2014
Hepatitis C virus (HCV) is the leading cause of end-stage liver disease and hepatocellular carcinoma. Treatment of it represents a large untapped market owing to high prevalence, a large pool of previously diagnosed, untreated, “warehoused” patients, and a substantial population of nonresponders who have not achieved sustained virologic response (SVR). The recent and imminent launches of multiple, very tolerable and effective, all-oral, interferon-free regimens will more than triple the number of drug-treated HCV patients in the major pharmaceutical markets under study and cause sales of HCV therapies to soar to nearly $30 billion during the forecast period.

Questions Answered in This Report:

  • The launch of sofosbuvir (Gilead’s Sovaldi) in December 2013 has transformed HCV treatment and heralds the arrival of multiple new direct-acting antivirals (DAAs) over the next several years. How does sofosbuvir stand out from previous treatments in the HCV armamentarium? What other DAAs are following closely behind? Which ones are most likely to prevail?

  • Emerging antiviral therapies in late-stage development have unique efficacy, safety, and dosing profiles that can be combined into all-oral, interferon-free regimens. Which emerging therapies are the most promising candidates for inclusion into all-oral regimens, and how quickly will treatment providers begin using these interferon-free combinations?

  • Despite the launch of multiple more-tolerable regimens for HCV over the next two to three years, significant unmet need remains in the treatment of this disease. What patient subgroups do physicians consider to have remaining unmet need? Which therapies in the HCV pipeline are poised to capitalize on these areas of need?

  • A large proportion of patients infected with HCV remain undiagnosed, and a sizeable population of patients have failed prior therapy and remain viremic (and at risk for developing long-term complications). How will the population of patients eligible for treatment and the drug-treated population change over the next ten years, particularly given the availability of more-effective and tolerable therapies? What will be the key market drivers and constraints over the next decade?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 17 country-specific interviews with thought leaders in HCV treatment.

Epidemiology: Seroprevalence of HCV, prevalence of HCV viremia, and incidence of HCV viremia.

Population segments in market forecast: Treatment-naive and treatment-experienced HCV patients.

Emerging therapies: Phase II: 9 drugs; Phase III: 5 drugs; preregistration: 2 drugs; registered: 3 drugs. Coverage of 4 select preclinical and Phase I products.

Author(s): David W. Holman, Ph.D.
Donal Minihan, M.V.B., Ph.D.