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Market Spotlight: Hepatitis B

  • ID: 4775323
  • Report
  • February 2020
  • Region: Global
  • 60 pages
  • Datamonitor Healthcare
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FEATURED COMPANIES

  • Arrowhead
  • Gilead
  • GlaxoSmithKline
  • Janssen
  • MORE
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 the five major European 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 an expected patent expiration for INTRON A, and topline Phase II trial results for Inarigivir, EYP001, and VBI-2601.

The overall likelihood of approval of a Phase I antiviral asset is 14.3%, and the average probability a drug advances from Phase III is 74.4%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space.

There have been 36 licensing and asset acquisition deals involving hepatitis B drugs during 2015–20. 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 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 319 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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FEATURED COMPANIES

  • Arrowhead
  • Gilead
  • GlaxoSmithKline
  • Janssen
  • MORE
1. OVERVIEW

2. KEY TAKEAWAYS

3. DISEASE BACKGROUND

4. TREATMENT
  • Nucleos(t)ide analogs
  • Interferons
5. EPIDEMIOLOGY
  • Hepatitis B in the US, China, Japan, and five major European markets
6. MARKETED DRUGS

7. PIPELINE DRUGS

8. RECENT EVENTS AND ANALYST OPINION
  • Inarigivir for Hepatitis B (December 26, 2019)
  • ABI-H0731 for Hepatitis B (November 11, 2019)
  • IONIS-HBVRx for Hepatitis B (November 11, 2019)
  • GSK3389404 for Hepatitis B (November 8, 2019)
  • JNJ-3989 for Hepatitis B (November 8, 2019)
  • JNJ-6379 for Hepatitis B (November 8, 2019)
  • ABI-H0731 for Hepatitis B (April 13, 2019)
  • Vemlidy for Hepatitis B (April 11, 2019)
  • ARB-1467 for Hepatitis B (November 7, 2018)
  • JNJ-3989 for Hepatitis B (September 6, 2018)
9. KEY UPCOMING EVENTS

10. PROBABILITY OF SUCCESS

11. LICENSING AND ASSET ACQUISITION DEALS
  • Roche Secures Dicerna RNAi Deal For Hepatitis B
  • GSK Opts In On Ionis’ Antisense Candidates For Hepatitis B
  • Gilead Again Strengthens Antiviral R&D With Durect Deal
  • GSK Divests China Suzhou Site, Antiviral Rights To Fosun
  • Ascletis Gains Greater China Rights To Alphamab’s HBV Immunotherapy
12. PARENT PATENTS

13. REVENUE OPPORTUNITY

14. CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
15. BIBLIOGRAPHY
  • Prescription information
16. 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: IONIS-HBVRx for Hepatitis B (November 11, 2019): Phase II - Chronic HBV (CS3)
Figure 7: GSK3389404 for Hepatitis B (November 8, 2019): Phase II - SAD/MAD (Chronic HBV)
Figure 8: ABI-H0731 for Hepatitis B (April 13, 2019): Phase IIa - Viral Antigen (Study 201), Phase IIa - Viral Load (Study 202)
Figure 9: Vemlidy for Hepatitis B (April 11, 2019): Phase III - Switching from Tenofovir Disoproxil Fumarate (TDF)
Figure 10: JNJ-3989 for Hepatitis B (September 6, 2018): Phase I/IIa - AROHBV1001
Figure 11: Key upcoming events in hepatitis B
Figure 12: Probability of success in the hepatitis B pipeline
Figure 13: Licensing and asset acquisition deals in hepatitis B, 2015–20
Figure 14: Parent patents in hepatitis B
Figure 15: Clinical trials in hepatitis B
Figure 16: Top 10 drugs for clinical trials in hepatitis B
Figure 17: Top 10 companies for clinical trials in hepatitis B
Figure 18: Trial locations in hepatitis B
Figure 19: Hepatitis B trials status
Figure 20: Hepatitis B trials sponsors, by phase

LIST OF TABLES
Table 1: 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 European markets, by country, 2017–26
Table 5: Marketed drugs for hepatitis B
Table 6: Pipeline drugs for hepatitis B in the US
Table 7: Inarigivir for Hepatitis B (December 26, 2019)
Table 8: ABI-H0731 for Hepatitis B (November 11, 2019)
Table 9: IONIS-HBVRx for Hepatitis B (November 11, 2019)
Table 10: GSK3389404 for Hepatitis B (November 8, 2019)
Table 11: JNJ-3989 for Hepatitis B (November 8, 2019)
Table 12: JNJ-6379 for Hepatitis B (November 8, 2019)
Table 13: ABI-H0731 for Hepatitis B (April 13, 2019)
Table 14: Vemlidy for Hepatitis B (April 11, 2019)
Table 15: ARB-1467 for Hepatitis B (November 7, 2018)
Table 16: JNJ-3989 for Hepatitis B (September 6, 2018)
Table 17: Historical global sales, by drug ($m), 2014–18
Table 18: Forecasted global sales, by drug ($m), 2020–24
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  • Gilead
  • GlaxoSmithKline
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