Summary

Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape. The current Hepatitis C treatment landscape consists of a combination of pegylated interferon, ribavirin and, in patients infected with genotype 1 hepatitis C, one of two direct-acting antiviral agents (DAAs). Products with these mechanisms of action have performed strongly in the commercial setting, with the market leader Incivek (a DAA) having reached blockbuster sales.

However, these products are very poorly tolerated and only moderately efficacious. The approval of the DAA Sovaldi in December 2013 changed this, with a complete viral clearance being achieved in close to 100% of patients and a much improved adverse event profile compared to previous standards of therapy. In patients with genotype 2 and 3 hepatitis C, Sovaldi does not need to be administered with pegylated interferon.

A number of products in the late-stage pipeline, which promise to be even more efficacious and safe are anticipated to enter the market over the forecast period, including several interferon-free therapies for genotype 1-infected patients. As a result of this, as well as an overall increase in the treated population, the authors believe the global market has the potential to grow to a value of $18.6 billion by 2019, more than tripling the 2012 market value of $5.8 billion.


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Scope

- A brief introduction to hepatitis C, including the disease's pathogenesis, risk factors and diagnosis, and detailed analyses of disease epidemiology and treatment algorithms.

- In-depth analysis of the major antiviral drugs used in the treatment of hepatitis C, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map that compares marketed drugs in terms of safety and efficacy.

- A comprehensive review of the pipeline for hepatitis C therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period. The pipeline is analyzed by phase distribution, molecule type and molecular target.

- In-depth clinical trial enrolment, trial duration and program failure rate analyses for each molecule type and mechanism of action. Additionally, clinical trial endpoints and certain selection criteria are analyzed in great depth. This section also includes an additional heat map regarding pipeline products, and a direct cross-analysis against currently marketed products.

- Multi-scenario forecast data of the market to 2019, which takes into account the effects of the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets: US, Canada, Japan, Germany, UK, France, Italy and Spain.

- Discussion of the drivers and barriers for market growth.

- Analysis of licensing and co-development deals occurring in the hepatitis C market.

Reasons to buy

- Understand the different types of hepatitis C therapies and how treatment varies by genotype.

- Understand the treatment algorithms and guidelines related to hepatitis C, how they are anticipated to change during the forecast period and where opportunities and unmet needs lie.

- Understand the vast Scope of the pipeline, including which molecule types and mechanisms of action are most prominent.

- Observe trends in clinical trial duration and size as clinical phase and molecule type varies. Use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for hepatitis C therapeutics.

- Observe the shift in clinical trial endpoints with each clinical Phase, and use this data to potentially influence any future developmental programs. Additionally, understand the trends in enrolment by patient genotype.

- Assess the potential clinical and commercial impact of current late-stage pipeline molecules and the points of opportunity which remain to be capitalized upon.

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Table of Contents:

1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Signs and Symptoms
2.2 Etiology and Risk Factors
2.3 Pathophysiology
2.4 Epidemiology
2.4.1 US and Canada
2.4.2 Europe
2.4.3 Japan
2.4.4 Regional Prevalence of Hepatitis C Genotypes
2.5 Prognosis
2.6 Diagnosis and Screening
2.7 Treatment
2.8 Treatment Algorithms


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