Hepatitis B Therapeutics in Major Developed Markets Size & Share to 2021

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Hepatitis B Therapeutics in Major Developed
Markets 2015
No. Pages 78
Published on September - 2015
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Report Overview
About Hepatitis B Therapeutics in Major Developed
Markets to 2021 Research Beam added a report
Hepatitis B Therapeutics in Major Developed
Markets to 2021 . Hepatitis B is an infectious
liver disease caused by the Hepatitis B Virus
(HBV) and characterized by acute or chronic
inflammation of the liver. Despite its status as
a vaccine-preventable disease, it remains a
serious global health concern. Incidence tends to
be higher in countries with a significant number
of migrants from medium and high-prevalence
countries. Approximately 350 million people
worldwide are infected with chronic hepatitis B,
which causes significant morbidity and mortality.
Around 780,000 patients die from hepatitis B each
year, of which 650,000 deaths are due to
complications such as cirrhosis and liver cancer.
Despite this, diagnosis and treatment rates are
poor, stemming from its asymptomatic nature.
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Report Overview
Globally, the hepatitis B therapeutics market is
served moderately well by the available products,
of which Baraclude and Viread are the most
frequently prescribed. However, both have
received black-box warnings from the US Food and
Drug Administration (FDA), meaning that the
market has a high level of unmet need. Scope The
current hepatitis B market contains mainly
nucleoside analog reverse transcriptase
inhibitors, nucleotide analogs, and interferons -
- Will these drugs continue to dominate
hepatitis B treatment?With 81 active pipeline
molecules, most of the investigational drug
candidates are small molecules and vaccines,
comprising 64 of the pipeline - - What are the
most prominent small molecules and vaccines in
the pipeline? - Do the pipeline molecules offer
advantages over commercially proven
mechanisms?Analysis of clinical trials since 2006
has identified a high rate of attrition in
hepatitis B products - - How do failure rates
vary by product stage of development, molecule
type, and mechanism of action? - How do other
factors such as average trial duration and trial
size influence the costs and risks associated
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Report Overview
with product development?Over the 20142021
forecast period, the hepatitis B market in the
eight major markets is expected to increase in
value at a CAGR of 2.3 from 2.9 billion to 3.5
billion - - Which markets make the most
significant contribution to the current market
size? - What are the epidemiology trends in
these markets? - Which factors will influence
growth rates in the different major
markets?Despite generic sales erosion resulting
from patent expirations, the uptake of premium
therapies tenofovir and entecavir will contribute
to significant market growth over the forecast
period - - Will patent expirations or emerging
pipeline molecules threaten the commercial
success of existing drugs? - Which patent
expirations will have the most significant impact
on the market? Reasons to buyThis report will
enable you to - - Understand the clinical context
of hepatitis B by considering symptoms, etiology,
pathophysiology, epidemiology, diagnosis, and
treatment options.- Identify the therapeutic
strategies, products, and companies that dominate
the current marketed products landscape and
recognize gaps and areas of unmet need.-
Appreciate key pipeline trends by molecule type,
route of administration, mechanism of action, and
novelty.- Consider market
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Report Overview
opportunities and potential risks by looking at
trends in clinical trial size, duration, and
failure rate by stage of development, molecule
type, and mechanism of action. - Recognize the
late-stage pipeline molecules that have
demonstrated strong therapeutic potential by
examining clinical trial data and multi-scenario
product forecast projections.- Compare treatment
usage patterns, annual therapy costs, and market
growth projections for the US, Canada, the UK,
France, Germany, Italy, Spain, and Japan.-
Discover trends in licensing and co-development
deals concerning hepatitis B products and
identify the major strategic consolidations that
have shaped the commercial landscape.
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Table Of Contents
1 Table of Contents 51.1 List of Tables 71.2
List of Figures 82 Introduction 92.1
Classification 92.2 Pathophysiology 92.3
Etiology 112.4 Symptoms 122.5 Diagnosis 122.6
Epidemiology 132.7 Treatment and Management
152.8 Prognosis 162.9 Co-infection 172.9.1
HBV-HIV Co-infection 17
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Table Of Contents
3 Marketed Products 183.1 Viread 183.1.1 Study
0102 183.1.2 Study 0103 183.2 Entecavir
193.2.1 Nucleoside-Inhibitor-Naive Subjects with
Compensated Liver Disease (Studies AI463022 and
AI463027) 203.2.2 Lamivudine-Refractory Subjects
with Compensated Liver Disease (Study AI463026)
213.3 Pegasys (peg interferon ?-2a) 233.4
Adefovir dipivoxil 253.4.1 Study 437
(HBeAg-Positive Chronic Hepatitis B Patients)
253.4.2 Study 438 (HBeAg-Negative Chronic
Hepatitis B Patients) 253.4.3 Adefovir Treatment
beyond 48 Weeks 273.4.4 Study 435 (Pre- and
Post-liver Transplantation Subjects) 27
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Table Of Contents
4 Pipeline Analysis 324.1 Overall Pipeline
324.2 Pipeline Analysis of Therapeutic Vaccines
334.3 Clinical Trials 354.3.1 Failure Rate
354.3.2 Failure Rate by Molecule Type 354.3.3
Failure Rate by Mechanism of Action 364.3.4
Patient Enrollment and Clinical Trial Size by
Molecule Type 374.3.5 Duration 384.4
Competitive Clinical Trials Metrics Analysis
404.5 Promising Drug Candidates in Pipeline
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