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.
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.
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