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Market Spotlight: Hepatitis B

  • ID: 4775323
  • Report
  • February 2021
  • Region: Global
  • 55 pages
  • Datamonitor Healthcare
This Market Spotlight report covers the Hepatitis B market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, key upcoming events, probability of success, 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 majority of industry-sponsored drugs in active clinical development for hepatitis B are in Phase II, with no drugs in Phase III. 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 topline Phase II trial results for EYP001, RG7854, RG7907, and ALN-HBV02.
  • The overall likelihood of approval of a Phase I antiviral asset is 12.9%, and the average probability a drug advances from Phase III is 68.3%. Drugs, on average, take 8.4 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space.
  • There have been equal proportions of clinical trials for hepatitis B across phases of development, with 50% in Phase I–II, and 50% in Phase III–IV.
  • 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.
Note: Product cover images may vary from those shown
OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT
  • Nucleos(t)ide analogs
  • Interferons
EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION
  • Vebicorvir for Hepatitis B (November 5, 2020)
  • AB-729 for Hepatitis B (May 18, 2020)
  • Inarigivir for Hepatitis B (January 29, 2020)
  • Inarigivir for Hepatitis B (December 26, 2019)
  • Vebicorvir 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)
KEY UPCOMING EVENTS

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Gilead Collaborates With Vir On HBV Cure
  • Assembly, Door Join Forces In Hepatitis B
  • Aligos Deals Separately Target COVID-19, Hepatitis B
  • BeiGene Acquires Rights To Three Assembly HBV Candidates
REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of hepatitis B, 2019–28
Figure 2: Overview of pipeline drugs for hepatitis B in the US
Figure 3: Pipeline drugs for hepatitis B, by company
Figure 4: Pipeline drugs for hepatitis B, by drug type
Figure 5: Pipeline drugs for hepatitis B, by classification
Figure 6: Vebicorvir for Hepatitis B (November 5, 2020): Phase II - Study 211
Figure 7: AB-729 for Hepatitis B (May 18, 2020): Phase Ia/Ib - AB-729-001
Figure 8: IONIS-HBVRx for Hepatitis B (November 11, 2019): Phase II - Chronic HBV (CS3)
Figure 9: GSK3389404 for Hepatitis B (November 8, 2019): Phase II - SAD/MAD (Chronic HBV)
Figure 10: Key upcoming events in hepatitis B
Figure 11: Probability of success in the antiviral pipeline
Figure 12: Clinical trials in hepatitis B
Figure 13: Top 10 drugs for clinical trials in hepatitis B
Figure 14: Top 10 companies for clinical trials in hepatitis B
Figure 15: Trial locations in hepatitis B
Figure 16: Hepatitis B trials status
Figure 17: Hepatitis B trials sponsors, by phase

LIST OF TABLES
Table 1: Global prevalent cases of hepatitis B, 2019–28
Table 2: Diagnosed prevalent cases of hepatitis B, 2019
Table 3: Treatment-eligible and treated prevalent cases of hepatitis B, 2019
Table 4: Marketed drugs for hepatitis B
Table 5: Pipeline drugs for hepatitis B in the US
Table 6: Vebicorvir for Hepatitis B (November 5, 2020)
Table 7: AB-729 for Hepatitis B (May 18, 2020)
Table 8: Inarigivir for Hepatitis B (January 29, 2020)
Table 9: Inarigivir for Hepatitis B (December 26, 2019)
Table 10: Vebicorvir for Hepatitis B (November 11, 2019)
Table 11: IONIS-HBVRx for Hepatitis B (November 11, 2019)
Table 12: GSK3389404 for Hepatitis B (November 8, 2019)
Table 13: JNJ-3989 for Hepatitis B (November 8, 2019)
Table 14: JNJ-6379 for Hepatitis B (November 8, 2019)
Table 15: HLX10 for Hepatitis B (September 12, 2019)
Table 16: Historical global sales, by drug ($m), 2015–19
Table 17: Forecasted global sales, by drug ($m), 2021–25
Note: Product cover images may vary from those shown
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