Global Hepatitis B Market Spotlight 2020: GlaxoSmithKline Leads Industry Sponsors with by Far the Highest Overall Number of Clinical Trials


Dublin, Oct. 05, 2020 (GLOBE NEWSWIRE) -- The "Market Spotlight: Hepatitis B" report has been added to's offering.

This Market Spotlight report covers the Hepatitis B market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • It is estimated that in 2019, there were approximately 297.0 million prevalent cases of hepatitis B worldwide, with only 9.9% (29.4 million) of those cases estimated to be diagnosed.
  • In the same year, there were an estimated 4.9 million prevalent cases that were treated with an antiviral. Marketed drugs for hepatitis B focus on targets such as DNA polymerase, reverse transcriptase, cell membrane, T lymphocytes, interferon receptor, interferon-alpha, and the immune system. The majority of these drugs are administered via the oral route, with the remainder being intramuscular, subcutaneous, intravenous, intradermal, and topical formulations.
  • The largest proportion of industry-sponsored drugs in active clinical development for hepatitis B are in Phase II. Therapies in development for hepatitis B focus on a wide variety of targets. The largest number of pipeline drugs in development are administered orally, with the remainder being intravenous, intramuscular, and subcutaneous formulations.
  • High-impact upcoming events for drugs in the hepatitis B space comprise an expected patent expiration for INTRON A, and topline Phase II trial results for EYP001, VBI-2601, and ALN-HBV02.
  • The overall likelihood of approval of a Phase I antiviral asset is 14.3%, and the average probability a drug advances from Phase III is 71.3%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
  • The distribution of clinical trials across Phase I-IV indicates that the majority of trials for hepatitis B have been in the late phases of development, with 51% of trials in Phase III-IV, and 49% in Phase I-II.
  • China leads in terms of the number of hepatitis B clinical trials globally, while Germany leads the major European markets. Clinical trial activity in the hepatitis B space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for hepatitis B, with 319 trials.
  • GlaxoSmithKline leads industry sponsors with by far the highest overall number of clinical trials for hepatitis B, followed by Gilead.

Key Topics Covered:


Key Takeaways

Disease Background


  • Nucleos(t)ide analogs
  • Interferons


Marketed Drugs

Pipeline Drugs

Recent Events and Analyst Opinion

  • AB-729 for Hepatitis B (May 18, 2020)
  • Inarigivir for Hepatitis B (January 29, 2020)
  • Inarigivir for Hepatitis B (December 26, 2019)
  • ABI-H0731 for Hepatitis B (November 11, 2019)
  • IONIS-HBVRx for Hepatitis B (November 11, 2019)
  • GSK3389404 for Hepatitis B (November 8, 2019)
  • JNJ-3989 for Hepatitis B (November 8, 2019)
  • JNJ-6379 for Hepatitis B (November 8, 2019)
  • HLX10 for Hepatitis B (September 12, 2019)
  • ABI-H0731 for Hepatitis B (April 13, 2019)
  • Vemlidy for Hepatitis B (April 11, 2019)

Key Upcoming Events

Probability of Success

Licensing and Asset Acquisition Deals

  • Aligos Deals Separately Target COVID-19, Hepatitis B
  • BeiGene Acquires Rights To Three Assembly HBV Candidates
  • Roche Secures Dicerna RNAi Deal For Hepatitis B
  • GSK Opts In On Ionis' Antisense Candidates For Hepatitis B
  • Gilead Again Strengthens Antiviral R&D With Durect Deal

Revenue Opportunity

Clinical Trial Landscape

  • Sponsors by status
  • Sponsors by phase
  • Recent events


  • Prescription information


Companies Mentioned

  • Arrowhead
  • Gilead
  • GlaxoSmithKline
  • Janssen

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