Analyzing the Hepatitis C Market Landscape

After more than a decade of limited treatment options, the hepatitis C (HCV) market is on the cusp of a treatment revolution. In 2011, protease inhibitors-Incivek (telaprevir; Vertex) and Victrelis (boceprevir; Merck)-became the first new drugs approved in the disease in over a decade; however after a bright start sales have plateaued as treatment is held back in less severe populations. Key opinion leaders cite this ‘warehousing’ effect is due to the anticipated arrival of the more convenient, efficacious and safer therapies. Pipeline combinations led by Gilead, Abbott, Bristol-Myers Squibb and Boehringer Ingelheim all have favourable clinical results and notably are not used in conjunction with pegylated-interferon alpha, a key component in the current standard of care but associated with tolerability issues. The battle to be the first will be intense as availability of a non-interferon regimen will transform this potentially lucrative market.

'Therapy Trends: Hepatitis C’ is compiled from exclusive, in-depth interviews with the world’s leading KOLs in HCV. It identifies and analyses the major factors, advances and trends currently influencing the HCV treatment landscape. The report focuses on late-stage pipeline products, and how these could modify future HCV management.
FirstWord selected KOLs to participate in this Therapy Trends research based on their level of engagement and influence within the HCV pharmaceutical industry, and their scientific standing. Our unique KOL scoring system identifies those thought-leaders with the greatest insight into how HCV clinical research will shape the future market.







Key Benefits

Hepatitis C: the race for the first interferon-free regimen examines the most prominent insights gained from the field’s key opinion leaders. The results of FirstWord’s research and analysis will help you to:

Comprehend the current trends driving and shaping the global HCV market
Understand the future landscape and how new classes will fit into the treatment algorithm
Assess the commercial and clinical potential of the pipeline nucs, non-nucs, NS5A inhibitors and next generation protease inhibitors
Develop planning strategies based on insight from the field’s foremost KOLs
Identify the unmet needs and opportunities for disease management
Evaluate the potential of companies with the most promising new product pipelines
Recognise the key factors KOLs predict will drive future treatment trends



Critical Questions Answered
Understand the Global Hepatitis C Market
The hepatitis C (HCV) market is expected to become one of the fastest growing markets in Pharma over the next decade given a sizable 170 million patient population, a significant unmet need and rapid advancements in the clinic. The management of this infectious disease is on the verge of a revolution that will bring considerable changes to the treatment algorithm. KOLs from North America and Europe provide answers to the critical questions regarding the global HCV market, including:

What do KOLs make of the Incivek and Victrelis and their impact on treatment?
What are the current unmet needs and major challenges in HCV treatment?
What are the most promising late-stage classes in development?
Which therapy are KOLs eagerly awaiting?
How will the nucleotide inhibitors, non-nucs, and NS5A inhibitors be positioned in the HCV market?
How do the second generation protease inhibitors differ from their first-generation cousins?
In what ways could eventual biomarkers improve future HCV disease management?
How will treatment of HCV look in the future?
How do KOLs think the pricing environment will shape the uptake of new HCV treatments?
What clinical research trends do KOLs predict for future HCV therapies?


KOL Panel

FirstWord selected the KOLs for this Therapy Trends report based on their level of engagement and influence within the HCV pharmaceutical industry, and their scientific standing. The HCV KOL panel assembled for this Therapy Trends research is drawn from North American and European professionals:

Adult Viral Hepatitis Prevention Coordinator, Bureau of Epidemiology, Pennsylvania Department of Health, Harrisburg, PA, USA
Director of Hepatology, Medicine Service, Massachusetts General Hospital, MA, US
President and Medical Director at Alamo Medical Research, Texas, US
Head, Division of Gastroenterology and Hepatology, Scripps Clinic, CA, US
Chief Medical Officer at Alamo Medical Research Texas, US
Head of the Liver Institute of Virginia, Virginia, US
Department of Hépato-Gastroenterologie, Centre Hospitalier Universitaire de Nancy-Brabois, Vandoeuvre-lès-Nancy, France
Professor of Medicine at the University of Vienna, Vienna General Hospital, Wien, Austria
Professor at Hôpital Saint Eloi, Montpellier, France
Co-lead of HCV Research UK, MRC Virology Unit, Glasgow, Scotland
Professor of Medicine and Chief of the Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany



Event Assessments
Qualitative Analysis Update Within Days of Major Market Events
Stay a step ahead with Therapy Trends Event Assessments. Over the next 12 months, you will receive updated qualitative analysis every time a major market event breaks. Updates will be delivered straight into your inbox within days of each event’s occurrence.
Whether it’s a predicted product approval or an unexpected late stage failure, Therapy Trends has the resources and knowledge to keep you up to date with the latest market analysis.



Methodology
An approach backed by unrivalled knowledge

This report provides a qualitative assessment of the current and future Hepatitis C (HCV) market. Information was gathered from in-depth telephone interviews with twelve key opinion leaders (KOLs), from across the major HCV markets, including France, Germany, Italy, the UK and the US. These regions were selected because they contain many of the largest global markets for the pharmaceutical industry, and also dictate the dynamics of Pharma markets in other countries.

In order to critically select Key Opinion Leaders (KOLs) a number of parameters were considered including their clinical experience, scientific publications, involvement with Pharma, involvement in clinical trials, and record of presenting at high profile international conferences.

Subject matter for discussion in the interviews covered future diagnostic and therapeutic strategies for HCV, the future of HCV drug classes, and new drugs entering the market. These leading KOLs also gave their views on current research, the usefulness of existing HCV drug classes, the cost of newer drugs and other concerns in the therapy area.



Table Of Contents

Current Hepatitis C marketplace

Hepatitis C overview
Current treatment landscape
Reimbursement of key Hepatitis C brands
Unmet needs in Hepatitis C
Current therapies

Pivotal trial data of approved therapies
NS3/NS4A Protease inhibitor overview
Incivek/Incivo (telaprevir; Vertex's/Tibotec/Mitsubishi Tanabe) trends
Victrelis (boceprevir; Merck) trends
Interferon and Ribavirin Overview
Pegylated interferon-alpha (Peg-Intron, PegaSys) and ribavirin trends
Current treatment algorithm
Future Hepatitis C marketplace

Future treatment landscape
NS5B nucleoside (Nuc) inhibitors overview
Sofosbuvir (GS-7977, Gilead) trends
Mericitabine (RO5024048; Roche/Gilead) trends
Mericitabine (RO5024048; Roche/Gilead) trends
NS5B non-nucleoside inhibitor overview
BI-201127 (Boehringer Ingelheim) trends
ABT-333 (Abbott) trends
ABT-072 (Abbott) trends
VX-222 (Vertex) trends
Tegobuvir (GS-9190; Gilead) trends
NS5A replication complex inhibitor overview
Daclatasvir (BMS-790052; Bristol-Myers Squibb) trends
GS-5885 (Gilead Sciences) trends
ABT-267 (Abbott) trends
ACH-3102 (Achillion) trends
NS3/NS4A protease inhibitor overview
Faldaprevir (BI-201335; Boehringer Ingelheim) trends
ABT-450 (Abbott/Enanta) trends
Asunaprevir (BMS-650032; Bristol-Myers Squibb) trends
Simeprevir (TMC435; Medivir/Tibotec) trends
Danoprevir (RO5190591; Roche) trends
Sovaprevir (ACH-1625; Achillion Pharmaceuticals) trends
Vaniprevir (MK-7009; Merck) trends
MK-5172 (Merck) trends
Future treatment algorithm
Future developments in Hepatitis C

Education to raise awareness and improve diagnosis
Clinical trials will evolve in the future
All-oral regimen will be approved by 2014
Constrained pricing environments will reduce market access
Effective shorter treatment regimes will emerge
Eventual development of biomarkers will aid treatment

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