Market Spotlight: Hepatitis B
Market Spotlight: Hepatitis B
$1,318.00
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 2019, there were approximately 297.0 million prevalent cases of hepatitis B worldwide, with only 9.9% (29.4 million) of those cases estimated to be diagnosed.
- In the same year, there were an estimated 4.9 million prevalent cases that were treated with an antiviral. Marketed drugs for hepatitis B focus on targets such as DNA polymerase, reverse transcriptase, cell membrane, T lymphocytes, interferon receptor, interferon-alpha, 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 II. 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 EYP001, VBI-2601, and ALN-HBV02.
- 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 71.3%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
- 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 51% of trials in Phase III–IV, and 49% 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.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
10 TREATMENT
10 Nucleos(t)ide analogs
10 Interferons
11 EPIDEMIOLOGY
18 MARKETED DRUGS
21 PIPELINE DRUGS
28 RECENT EVENTS AND ANALYST OPINION
28 AB-729 for Hepatitis B (May 18, 2020)
29 Inarigivir for Hepatitis B (January 29, 2020)
30 Inarigivir for Hepatitis B (December 26, 2019)
32 ABI-H0731 for Hepatitis B (November 11, 2019)
33 IONIS-HBVRx for Hepatitis B (November 11, 2019)
35 GSK3389404 for Hepatitis B (November 8, 2019)
37 JNJ-3989 for Hepatitis B (November 8, 2019)
38 JNJ-6379 for Hepatitis B (November 8, 2019)
40 HLX10 for Hepatitis B (September 12, 2019)
40 ABI-H0731 for Hepatitis B (April 13, 2019)
43 Vemlidy for Hepatitis B (April 11, 2019)
46 KEY UPCOMING EVENTS
47 PROBABILITY OF SUCCESS
48 LICENSING AND ASSET ACQUISITION DEALS
48 Aligos Deals Separately Target COVID-19, Hepatitis B
48 BeiGene Acquires Rights To Three Assembly HBV Candidates
48 Roche Secures Dicerna RNAi Deal For Hepatitis B
48 GSK Opts In On Ionis’ Antisense Candidates For Hepatitis B
49 Gilead Again Strengthens Antiviral R&D With Durect Deal
50 REVENUE OPPORTUNITY
52 CLINICAL TRIAL LANDSCAPE
53 Sponsors by status
54 Sponsors by phase
55 Recent events
57 BIBLIOGRAPHY
57 Prescription information
58 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of hepatitis B, 2019–28
21 Figure 2: Overview of pipeline drugs for hepatitis B in the US
21 Figure 3: Pipeline drugs for hepatitis B, by company
22 Figure 4: Pipeline drugs for hepatitis B, by drug type
22 Figure 5: Pipeline drugs for hepatitis B, by classification
29 Figure 6: AB-729 for Hepatitis B (May 18, 2020): Phase Ia/Ib – AB-729-001
35 Figure 7: IONIS-HBVRx for Hepatitis B (November 11, 2019): Phase II – Chronic HBV (CS3)
37 Figure 8: GSK3389404 for Hepatitis B (November 8, 2019): Phase II – SAD/MAD (Chronic HBV)
43 Figure 9: ABI-H0731 for Hepatitis B (April 13, 2019): Phase IIa – Viral Antigen (Study 201), Phase IIa – Viral Load (Study 202)
45 Figure 10: Vemlidy for Hepatitis B (April 11, 2019): Phase III – Switching from Tenofovir Disoproxil Fumarate (TDF)
46 Figure 11: Key upcoming events in hepatitis B
47 Figure 12: Probability of success in the hepatitis B pipeline
52 Figure 13: Clinical trials in hepatitis B
52 Figure 14: Top 10 drugs for clinical trials in hepatitis B
53 Figure 15: Top 10 companies for clinical trials in hepatitis B
53 Figure 16: Trial locations in hepatitis B
54 Figure 17: Hepatitis B trials status
55 Figure 18: Hepatitis B trials sponsors, by phase
LIST OF TABLES
12 Table 1: Global prevalent cases of hepatitis B, 2019–28
14 Table 2: Diagnosed prevalent cases of hepatitis B, 2019
16 Table 3: Treatment-eligible and treated prevalent cases of hepatitis B, 2019
19 Table 4: Marketed drugs for hepatitis B
23 Table 5: Pipeline drugs for hepatitis B in the US
28 Table 6: AB-729 for Hepatitis B (May 18, 2020)
30 Table 7: Inarigivir for Hepatitis B (January 29, 2020)
31 Table 8: Inarigivir for Hepatitis B (December 26, 2019)
32 Table 9: ABI-H0731 for Hepatitis B (November 11, 2019)
34 Table 10: IONIS-HBVRx for Hepatitis B (November 11, 2019)
36 Table 11: GSK3389404 for Hepatitis B (November 8, 2019)
37 Table 12: JNJ-3989 for Hepatitis B (November 8, 2019)
39 Table 13: JNJ-6379 for Hepatitis B (November 8, 2019)
40 Table 14: HLX10 for Hepatitis B (September 12, 2019)
41 Table 15: ABI-H0731 for Hepatitis B (April 13, 2019)
44 Table 16: Vemlidy for Hepatitis B (April 11, 2019)
50 Table 17: Historical global sales, by drug ($m), 2015–19
51 Table 18: Forecasted global sales, by drug ($m), 2020–24
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