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Market Spotlight: Hepatitis B

Market Spotlight: Hepatitis B

  • November 2019
  • 51 pages
  • ID: 5780006
  • Format: PDF
  • By Pharma Intelligence

Summary

Table of Contents

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.

Key Takeaways
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 an estimated 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, interferon receptor, 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 largest proportion of industry-sponsored drugs in active clinical development for hepatitis B are in Phase I. 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 and an expected patent expiration.
The overall likelihood of approval of a Phase I antiviral asset is 14.1%, and the average probability a drug advances from Phase III is 74.6%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
There have been 41 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 for exclusive worldwide rights to develop and commercialize ARO-HBV for the treatment of chronic hepatitis B.
The distribution of clinical trials across Phase I–IV indicates that the majority of trials for hepatitis B have been in the late phases of development, with 52% of trials in Phase III–IV, and 48% in Phase I–II.
China leads in terms of the number of hepatitis B clinical trials globally, while Germany leads the major EU 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 317 trials. • GlaxoSmithKline leads industry sponsors with by far the highest overall number of clinical trials for hepatitis B, followed by Gilead.

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