Chronic Hepatitis B – Emerging Therapy, with Unmet Needs and TPP Insights Report – 2025

Chronic Hepatitis B Emerging Therapy and TPP Insights

Thelansis’s “Chronic Hepatitis B Emerging Therapy, with Unmet Needs and TPP Insights Report – 2025″ provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Chronic Hepatitis B Overview

Chronic Hepatitis B (CHB) infection is characterized by the presence of Hepatitis B surface antigen (HBsAg) in the serum for at least six months. Whereas HBsAg indicates the presence of hepatitis B viral infection, the markers HBeAg and HBV DNA, as determined by polymerase chain reaction (PCR) assays, are indicators of viral replication and infectivity. Severe complications associated with chronic infection encompass cirrhosis, liver failure, hepatocellular carcinoma, and mortality. In a minority of cases, HBV DNA can be detected in the serum without concurrent HBeAg presence. This phenomenon is attributed to the “pre-core” mutant, which impedes the production and release of the “e” antigen, despite ongoing HBV DNA replication and is associated with progressive liver disease. Following an acute HBV infection, the risk of developing chronic hepatitis B varies with age; less than 5% of adults develop chronic illnesses, whereas 90% of infants do so. Significant long-term complications like chronic hepatitis, cirrhosis, or hepatocellular carcinoma (HCC) can result from HBV transmission in children aged five and under.

Geography coverage:

G8 (United States, EU5 [France, Germany, Italy, Spain, U.K.], Japan, and China)

Insights driven by surveys* with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs

*Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
  • Pipeline analysis
  • Target patients for emerging therapies
  • Key companies
  • Key mechanism of actions
  • Launch date estimates, etc.
• Clinical trial landscape analysis
  • Target patient segments
  • Trial endpoints
  • Trial design
  • Recruitment criteria, etc.
• Unmet Needs and Opportunities
  • Performance of key current therapies
  • Top areas of unmet needs
  • Opportunity sizing for key unmet needs
• Target Product Profiles
  • Attributes and levels
  • Physician likelihood of prescribing
  • Expected patient shares
• KOL insights on key emerging therapies
  • Level of awareness
  • Expected use / line of therapy
  • Extent to fulfil key unmet needs
  • KOL quotes

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risk,etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets,etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
  • Key takeaways
  • Dx and Tx journey/algorithm
  • Key current therapies – profiles and KOL insights
• Emerging therapies
  • Key takeaways
  • Notable late-phase emerging therapies – profiles, launch expectations, KOL insights
  • Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)