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, 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 2021, there were approximately 304.6 million prevalent cases of hepatitis B worldwide, with only 10.0% (30.4 million) of those cases estimated to be diagnosed.
• In the same year, there were an estimated 5.0 million prevalent cases globally that were treated with an antiviral. Asia is estimated to have had the largest number of prevalent cases in 2021 (206.6 million cases), with 88.1 million of those cases occurring in China.
• In 2021, Datamonitor Healthcare estimates that there were 91.6 million prevalent cases of hepatitis B across the US, Japan, China, and the five major European markets, and expects that number to increase to 92.8 million prevalent cases by 2030.
• In the same year, the prevalence of hepatitis B was estimated to range from 0.3% in the US and Germany to 6.1% in China. 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, VIR2218, and bepirovirsen; topline Phase IIa trial results for AB-729; and expected NDA as well as MAA filings for RG-6084.
• The overall likelihood of approval of a Phase I antiviral asset is 12.4%, and the average probability a drug advances from Phase III is 64.9%. Drugs, on average, take 8.6 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
• There are approximately equal proportions of clinical trials for hepatitis B across all Phases of development.
• 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. GSK has the highest number of completed clinical trials for hepatitis B, with 184 trials.
• GSK leads industry sponsors with by far the highest overall number of clinical trials for hepatitis B, followed by Gilead