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, ALN-HBV02, RG7854, and RG7907.
- The overall likelihood of approval of a Phase I antiviral asset is 13.6%, and the average probability a drug advances from Phase III is 69%. Drugs, on average, take 8.5 years from Phase I to approval, compared to 8.9 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)
41 KEY UPCOMING EVENTS
42 PROBABILITY OF SUCCESS
43 LICENSING AND ASSET ACQUISITION DEALS
43 Aligos Deals Separately Target COVID-19, Hepatitis B
43 BeiGene Acquires Rights To Three Assembly HBV Candidates
43 Roche Secures Dicerna RNAi Deal For Hepatitis B
44 REVENUE OPPORTUNITY
46 CLINICAL TRIAL LANDSCAPE
47 Sponsors by status
48 Sponsors by phase
49 Recent events
51 BIBLIOGRAPHY
51 Prescription information
52 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)
41 Figure 9: Key upcoming events in hepatitis B
42 Figure 10: Probability of success in the antiviral pipeline
46 Figure 11: Clinical trials in hepatitis B
46 Figure 12: Top 10 drugs for clinical trials in hepatitis B
47 Figure 13: Top 10 companies for clinical trials in hepatitis B
47 Figure 14: Trial locations in hepatitis B
48 Figure 15: Hepatitis B trials status
49 Figure 16: 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)
44 Table 15: Historical global sales, by drug ($m), 2015–19
45 Table 16: Forecasted global sales, by drug ($m), 2020–24
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