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
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.
Table of Contents
OVERVIEWKEY TAKEAWAYSDISEASE BACKGROUNDEPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGSKEY UPCOMING EVENTSPROBABILITY OF SUCCESSREVENUE OPPORTUNITYAPPENDIX
TREATMENT
RECENT EVENTS AND ANALYST OPINION
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
BIBLIOGRAPHY
LIST OF FIGURES
LIST OF TABLES
