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
- It is estimated that in 2017, there were approximately 294.5 million prevalent cases of hepatitis B worldwide, with only 9.9% (29.1 million) of those estimated to be diagnosed.
- In the same year, there were an estimated 4.8 million prevalent cases that were treated with an antiviral. In 2017, there were 89.4 million total prevalent cases of hepatitis B in the US, China, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK); 86.0 million of these cases were in China (96.2%).
- Marketed drugs for hepatitis B focus on targets such as DNA polymerase, reverse transcriptase, cell membrane, T lymphocytes, immune system, and interferon receptor. The majority of these drugs are administered via the oral route, with the remainder being intramuscular, subcutaneous, intravenous, intradermal, and topical formulations.
- Half of the industry-sponsored drugs in active clinical development for hepatitis B are in Phase I, with only one drug in Phase III. Therapies in mid- and late-stage development for hepatitis B focus on a wide variety of targets. The largest number of pipeline drugs in mid- and late-stage 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 and Phase III trial results, and an expected patent expiry.
- The overall likelihood of approval of a Phase I antiviral asset is 16.2%, and the average probability a drug advances from Phase III is 75.9%. Drugs, on average, take 8.6 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space.
- There have been 37 licensing and asset acquisition deals involving hepatitis B drugs during 2014-19. The largest deal was the $1,775m licensing agreement signed in 2018 between Janssen and Arrowhead Pharmaceuticals for exclusive worldwide rights to develop and commercialize ARO-HBV for the treatment of chronic hepatitis B.
- The clinical trials distribution across Phase I-IV indicates that the majority of trials for hepatitis B have been in the late phases of development, with 54% of trials in Phase III-IV, and 46% in Phase I-II.
- The US has a slight lead in the number of hepatitis B clinical trials globally. Germany leads the major EU markets, while China has the top spot in Asia.
- Clinical trial activity in the hepatitis B space is dominated by completed trials. GlaxoSmithKline has the highest number of completed trials for hepatitis B, with 286 trials.
- GlaxoSmithKline leads the industry sponsors with by far the highest number of clinical trials for hepatitis B, followed by Gilead.
Key Topics Covered:
Hepatitis B in the US, China, Japan, and five major EU markets
RECENT EVENTS AND ANALYST OPINION
ARB-1467 for hepatitis B (November 7, 2018)
ARO-HBV for hepatitis B (September 6, 2018)
Inarigivir for hepatitis B (November 15, 2017)
KEY UPCOMING EVENTS
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
Ascletis Gains Greater China Rights To Alphamab's HBV Immunotherapy
Brii Builds China Ops With Hep B Assets, New Partnerships
J&J Bets Big On Arrowhead's Early Promise In Hepatitis B
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
For more information about this report visit https://www.researchandmarkets.com/r/ggk9eh