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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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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- 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 2014–2021 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 Buy
This 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 opportunities and potential risks by looking at trends in clinical trial size, duration, and failure rate by stage of development, molecule type, and echanism 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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