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. Half 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 RG7854, RG7907, and IONIS-HBVRx.
• The overall likelihood of approval of a Phase I antiviral asset is 13.1%, and the average probability a drug advances from Phase III is 67.7%. Drugs, on average, take 8.4 years from Phase I to approval, compared to 8.9 years in the overall infectious disease space.
• There have been almost equal proportions of clinical trials for hepatitis B across Phase I–IV, with 51% of trials in Phase I–II, and 49% 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 321 trials.
• GlaxoSmithKline leads industry sponsors with by far the highest overall number of clinical trials for hepatitis B, followed by Gilead