The market landscape in the nine major markets (9MM*) for chronic hepatitis B (CHB) is expected to see significant change between 2019 and 2029. Projected by GlobalData to grow from $3.8bn in 2019 to $5.16bn in 2029, at a compound annual growth rate (CAGR) of 3.1%, the market will see growth due to the development of drugs with novel mechanisms of action (MOAs) and several intravenous (IV) formulations of drugs with shorter treatment durations, while the barriers include the patent expiry of Gilead’s Vemlidy and low diagnosis rate of CHB.

The latest report by GlobalData, ‘Hepatitis B Virus Infection; Global Drug Forecast and Market Analysis to 2029’, finds that the pipeline holds a number of drugs with novel MOAs, including capsid assembly modulators, antisense nucleotides and toll-like receptor 8 (TLR-8) agonists from Johnson & Johnson and Gilead. These have the potential to achieve viral clearance.

Arafa Salam, PhD, Infectious Diseases Analyst at GlobaData, notes: “Key opinion leaders (KOLs) interviewed by GlobalData stated that, in order to find a functional cure, novel drugs may need to be used in combination with currently available nucleot(s)ide analogues (NAs). GlobalData’s report finds the current standard of care (SOC) for CHB patients across the 9MM are indeed NAs such Vemlidy, Viread and entecavir. Plus, J&J’s JNJ-3989 is expected to reach the highest sales in the 9MM in 2029, and this may be used in combination with current NAs.

However, with the patent expiry of Vemlidy coming up in 2025 for the US and 2026 in the 5EU* and Japan.

Salam continues: “In Japan and Brazil, interferons such as Roche’s Pegasys (peginterferon alfa-2a) were used as SOC for CHB. However, KOLs have indicated that these are used in exceedingly rare cases. Pipeline products contain drugs with IV formulations such as J&J’s JNJ-3989 and Ionis/GSK’s IONIS-HBVRx, which may have significantly shorter treatments durations, and are expected to address the unmet need of reduced treatment exposure.”

*9MM = The US, Germany, France, Italy, Spain, the UK Japan, Brazil and China

*5EU = Germany, France, Italy, Spain and the UK