Hepatitis B Therapeutics in Major Developed Markets to 2021: JSBMarketResearch

Summary

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.

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 2014-2021 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?

For more information on this report visit – http://www.jsbmarketresearch.com/healthcare-medical/r-hepatitis-b-therapeutics-in-major-developed-markets-203006

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 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.

Table of Contents

1.1 List of Tables 7

 1.2 List of Figures 8

 2 Introduction 9

 2.1 Classification 9

 2.2 Pathophysiology 9

 2.3 Etiology 11

 2.4 Symptoms 12

 2.5 Diagnosis 12

 2.6 Epidemiology 13

 2.7 Treatment and Management 15

 2.8 Prognosis 16

 2.9 Co-infection 17

 2.9.1 HBV-HIV Co-infection 17

 2.9.2 HBV-HDV Co-infection 17

 2.9.3 HBV-HCV Co-infection 17

 
3 Marketed Products 18

 3.1 Viread 18

 3.1.1 Study 0102 18

 3.1.2 Study 0103 18

 3.2 Entecavir 19

 3.2.1 Nucleoside-Inhibitor-Naive Subjects with Compensated Liver Disease (Studies AI463022 and AI463027) 20

 3.2.2 Lamivudine-Refractory Subjects with Compensated Liver Disease (Study AI463026) 21

 3.3 Pegasys (peg interferon α-2a) 23

 3.4 Adefovir dipivoxil 25

 3.4.1 Study 437 (HBeAg-Positive Chronic Hepatitis B Patients) 25

 3.4.2 Study 438 (HBeAg-Negative Chronic Hepatitis B Patients) 25

 3.4.3 Adefovir Treatment beyond 48 Weeks 27

 3.4.4 Study 435 (Pre- and Post-liver Transplantation Subjects) 27

 3.4.5 Study 461 (Clinical Evidence of Lamivudine Resistance Patients) 27

 3.5 Tyzeka per Sebivo 28

 3.5.1 NV-02B-007 GLOBE Trial 28

 3.5.2 HBeAg-Positive Subjects 28

 3.5.3 HBeAg-Negative Subjects 28

 3.6 Comparative Efficacy and Safety 30