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Market Spotlight: Hepatitis B

  • ID: 4775323
  • Report
  • 51 pages
  • Datamonitor Healthcare
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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 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.
Note: Product cover images may vary from those shown
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OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT
Nucelos(t)ide analogs
Interferons

EPIDEMIOLOGY
Hepatitis B in the US, China, Japan, and five major EU markets

MARKETED DRUGS

PIPELINE DRUGS

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

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase

BIBLIOGRAPHY
Prescription information

APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of hepatitis B, 2017–26
Figure 2: Overview of pipeline drugs for hepatitis B in the US
Figure 3: Pipeline drugs for hepatitis B, by company
Figure 4: Pipeline drugs for hepatitis B, by drug type
Figure 5: Pipeline drugs for hepatitis B, by classification
Figure 6: ARO-HBV for Hepatitis B (September 6, 2018): Phase I/IIa - AROHBV1001
Figure 7: Inarigivir for Hepatitis B (November 15, 2017): Phase II - ACHIEVE (w/Viread)
Figure 8: Key upcoming events in hepatitis B
Figure 9: Probability of success in the hepatitis B pipeline
Figure 10: Licensing and asset acquisition deals in hepatitis B, 2014–19
Figure 11: Parent patents in hepatitis B
Figure 12: Clinical trials in hepatitis B
Figure 13: Top 10 drugs for clinical trials in hepatitis B
Figure 14: Top 10 companies for clinical trials in hepatitis B
Figure 15: Trial locations in hepatitis B
Figure 16: Hepatitis B trials status
Figure 17: Hepatitis B trials sponsors, by phase

LIST OF TABLES
Table 1: Global prevalent cases of hepatitis B, 2017–26
Table 2: Diagnosed and prevalent cases of hepatitis B, 2017
Table 3: Treatment-eligible and treated prevalent cases of hepatitis B, 2017
Table 4: Total prevalent cases of hepatitis B in the US, China, Japan, and five major EU markets, by country, 2017–26
Table 5: Marketed drugs for hepatitis B
Table 6: Pipeline drugs for hepatitis B in the US
Table 7: ARB-1467 for Hepatitis B (November 7, 2018)
Table 8: ARO-HBV for Hepatitis B (September 6, 2018)
Table 9: Inarigivir for Hepatitis B (November 15, 2017)
Table 10: Historical global sales, by drug ($m), 2013–17
Table 11: Forecasted global sales, by drug ($m), 2019–23
Note: Product cover images may vary from those shown
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