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  4. > A Product and Pipeline Analysis of the Global Hepatitis C Virus (HCV) Antiviral Market

All-oral Regimens Revolutionize the Market

This research service focuses on antiviral therapeutics for the treatment of the hepatitis C virus (HCV). A global product and pipeline assessment is provided for marketed and investigational products and combination regimens for the treatment of HCV. Segmentation by drug class is provided, along with supporting information such as clinical trial timelines and results, key market developments, historical and projected launch timelines, and epidemiology. The information contained in this research was derived from published sources, including disease organizations; public health organizations; company publications including annual reports, SEC filings, and press releases; government public sources; and articles in scientific journals.

Key Findings

-Drug development for HCV antivirals has exploded with rising incidence rates (including in developed countries) and the intense need for curative therapy in the absence of a preventative vaccine.
-A treatment revolution is underway as the market moves away from protease inhibitors and interferon regimens and toward highly-effective, easily tolerated interferon-free oral therapies, with Gilead’s sofosbuvir/Sovaldi winning the race to the market and estimating stratospheric numbers in 2014 ($ + billion). Sofosbuvir’s uptake, however, could be slowed by its steep price, which has unleashed a firestorm of criticism from government agencies, patient advocacy groups, and (most importantly) payers. Analysts expect the next-to-market all-orals to compete aggressively on price in an effort to erode Gilead’s share.
-With the introduction of potent all-oral regimens (so-called “terminator” therapies), the treatment paradigm is shifting from disease management to eradication. Nevertheless, there are areas ripe for innovation, notably the development of an all-oral pan-genotypic therapy and a or week treatment regimen.
-The next 3 potential launches for HCV are ABT-450/ABT-267/ABT-333/RBV, GS-7977/GS-5885 FDC, and daclatasvir/asunaprevir.
-While it is unlikely to hit the market before late 2015/early 2016, Merck’s 5172/8142—a single, once-daily tablet—is projected to rival AbbVie’s entry as the 2nd entrant given its dosing advantage and stellar Phase 2 data.

Methodology and Scope

-This research service focuses on antiviral therapeutics for the treatment of infection associated with HCV.
-A product and pipeline assessment is provided for marketed and investigational products and combination regimens for the treatment of HCV infection. Segmentation by drug class is provided, along with supporting information such as clinical trial timelines and results, historical and projected launch timelines, and epidemiology.
-The information contained in this research service was derived from published sources, including disease organization Web sites; public health organization Web sites; company publications including annual reports, SEC filings, and press releases; government public sources; and articles in scientific journals.

HCV Overview

HCV is a bloodborne, infectious disease that presents a global public health issue. Approximatelymillion people are chronically infected globally, and at least die annually from HCV-related liver diseases. According to the World Health Organization (WHO), up to % of those with chronic HCV will develop cirrhosis; and, of those, up to % may progress to liver cancer. The disease has been called a silent killer, as % of people living with HCV are unaware of their infection status. Identification of those with active infection is key to improve health outcomes of those with HCV and prevent transmission.

Potential routes of exposure include needle-stick injuries, needle sharing, blood transfusions, dialysis, tattoos and piercings, mother-to-fetus transmission, and sexual contact. Transmission of HCV occurs mainly via injection drug use in the developed world and blood transfusions from using unsanitary therapeutic injection procedures in the developing world. Persons at higher risk of contracting HCV include those with potential occupational exposure (e.g., healthcare workers, dentists, and first responders), and those who practice high-risk behaviors, such as intravenous drug use and unprotected sex, or who are recipients of invasive therapeutic procedures such as blood transfusions and organ transplants (before 1985 in the United States). Prevalence is highest in Egypt, where the virus affects about% of the population, followed by Pakistan with %, and China with %. There are several different genotypes unique in their global distribution patterns and susceptibility to therapies. Genotype 1 (GT1) is the most common in the developed world and the hardest to treat. Genotypes 1a and 1b are the most common GT1 subtypes globally. There is no vaccine for HCV, increasing the importance of effective antiviral therapy for this condition compared to the hepatitis B virus (HBV). The goal of such antivirals is suppressing viral replication or disease eradication, thereby bringing about remission.

Table Of Contents

A Product and Pipeline Analysis of the Global Hepatitis C Virus (HCV) Antiviral Market
1. EXECUTIVE SUMMARY

Key Market Developments Since Q1 2013
Key Findings
Evolution of Standard of Care for HCV
Key Companies to Watch

2. METHODOLOGY AND SCOPE

Methodology and Scope

3. INTRODUCTION

HCV Overview
Global Prevalence of Chronic HCV Infection by Region
Global HCV Genotype Distribution and Relative Prevalence
HCV Antiviral Market—Segmentation

4. COMPETITIVE ANALYSIS

Competitive Landscape—Marketed Products and Products in Development
Competitive Landscape—All-oral Regimens Late Stage Clinical Data
Competitive Landscape—Projected Launch Timeline for Oral Regimens
Competitive Landscape—Major Phase 3 Trials for All-oral Regimens
Competitive Landscape—Late Stage Assets by Company and Class
Marketed Products Synopsis—Standard of Care
Marketed Products Synopsis—Add-on to Standard of Care
Marketed Products Synopsis—Global Introduction by Region
Pipeline Synopsis—All-oral Regimens in Clinical Development
Pipeline Synopsis—Late Stage Clinical Development Landscape
Pipeline Synopsis—Early Clinical Development Landscape

5. CONCLUSIONS AND RECOMMENDATIONS

Conclusions and Recommendations
Legal Disclaimer

6. APPENDIX

Decision Support Database

7. THE FROST and SULLIVAN STORY

Value Proposition
Global Perspective
Industry Convergence
360º Research Perspective
Implementation Excellence
Our Blue Ocean Strategy

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