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.
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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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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 with product development?
• Over the 2014
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