Market Spotlight: Hepatitis B
Market Spotlight: Hepatitis B
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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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- 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.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
10 TREATMENT
10 Nucleos(t)ide analogs
10 Interferons
11 EPIDEMIOLOGY
17 Hepatitis B in the US, China, Japan, and five major EU markets
20 MARKETED DRUGS
23 PIPELINE DRUGS
30 RECENT EVENTS AND ANALYST OPINION
30 ABI-H0731 for Hepatitis B (April 13, 2019)
32 Vemlidy for Hepatitis B (April 11, 2019)
34 ARB-1467 for Hepatitis B (November 7, 2018)
35 JNJ-3989 for Hepatitis B (September 6, 2018)
38 KEY UPCOMING EVENTS
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 GSK Opts In On Ionis’ Antisense Candidates For Hepatitis B
40 Gilead Again Strengthens Antiviral R&D With Durect Deal
41 GSK Divests China Suzhou Site, Antiviral Rights To Fosun
41 Ascletis Gains Greater China Rights To Alphamab’s HBV Immunotherapy
41 Brii Builds China Ops With Hep B Assets, New Partnerships
41 J&J Bets Big On Arrowhead’s Early Promise In Hepatitis B
43 PARENT PATENTS
44 REVENUE OPPORTUNITY
45 CLINICAL TRIAL LANDSCAPE
46 Sponsors by status
47 Sponsors by phase
49 BIBLIOGRAPHY
49 Prescription information
50 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of hepatitis B, 2017–26
23 Figure 2: Overview of pipeline drugs for hepatitis B in the US
23 Figure 3: Pipeline drugs for hepatitis B, by company
24 Figure 4: Pipeline drugs for hepatitis B, by drug type
24 Figure 5: Pipeline drugs for hepatitis B, by classification
32 Figure 6: ABI-H0731 for Hepatitis B (April 13, 2019): Phase IIa – Viral Antigen (Study 201), Phase IIa – Viral Load (Study 202)
34 Figure 7: Vemlidy for Hepatitis B (April 11, 2019): Phase III – Switching from Tenofovir Disoproxil Fumarate (TDF)
37 Figure 8: JNJ-3989 for Hepatitis B (September 6, 2018): Phase I/IIa – AROHBV1001
38 Figure 9: Key upcoming events in hepatitis B
39 Figure 10: Probability of success in the hepatitis B pipeline
40 Figure 11: Licensing and asset acquisition deals in hepatitis B, 2014–19
43 Figure 12: Parent patents in hepatitis B
45 Figure 13: Clinical trials in hepatitis B
45 Figure 14: Top 10 drugs for clinical trials in hepatitis B
46 Figure 15: Top 10 companies for clinical trials in hepatitis B
46 Figure 16: Trial locations in hepatitis B
47 Figure 17: Hepatitis B trials status
48 Figure 18: Hepatitis B trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of hepatitis B, 2017–26
14 Table 2: Diagnosed and prevalent cases of hepatitis B, 2017
16 Table 3: Treatment-eligible and treated prevalent cases of hepatitis B, 2017
18 Table 4: Total prevalent cases of hepatitis B in the US, China, Japan, and five major EU markets, by country, 2017–26
21 Table 5: Marketed drugs for hepatitis B
25 Table 6: Pipeline drugs for hepatitis B in the US
30 Table 7: ABI-H0731 for Hepatitis B (April 13, 2019)
33 Table 8: Vemlidy for Hepatitis B (April 11, 2019)
35 Table 9: ARB-1467 for Hepatitis B (November 7, 2018)
36 Table 10: JNJ-3989 for Hepatitis B (September 6, 2018)
44 Table 11: Historical global sales, by drug ($m), 2014–18
44 Table 12: Forecasted global sales, by drug ($m), 2019–23
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