The CHB therapeutics market across the 7MM, comprising the US, 5EU, and Japan, is forecast to grow from $1.5bn in 2024 to $3.2bn in 2034 at a compound annual growth rate of 7.9%.
The US represents the largest market for chronic hepatitis B (CHB), with sales of $710.11m in 2024, equating to a market share of 47.5% in the seven major markets (7MM). Japan, which is the second largest market, was valued at $323.83m in 2024, equating to a market share of 21.7%. Leading data and analytics company GlobalData’s report ‘Chronic Hepatitis B Therapeutics: Seven-Market Drug Forecast and Market Analysis’ reveals that market growth will primarily be driven by the highly anticipated arrival of CHB functional cures. The CHB therapeutics market is currently dominated by nucleos(t)ide analogues, specifically entecavir, Vemlidy (tenofovir alafenamide), and tenofovir disoproxil fumarate; however, none of the CHB products currently in late-stage development are nucleos(t)ide analogues, demonstrating a shift among pharmaceutical companies to produce novel CHB therapeutics.
Five pipeline products are currently in late-stage development and are expected to launch by 2034. These include GSK’s toll-like receptor 8 (TLR8) agonist, bepirovirsen; Gilead Sciences’ TLR8 agonist, selgantolimod; GSK’s small interfering ribonucleic acid, daplusiran plus tomligisiran; Aligos Therapeutics’ capsid protein inhibitor, ALG-000184; and Arbutus Biopharma’s hepatitis B virus (HBV) surface antigen inhibitor, imdusiran. Although nucleos(t)ide analogues are effective at suppressing HBV viral replication, long-term daily usage of these drugs can lower patient compliance and lead to prolonged side effects. The late-stage pipeline for CHB therapeutics addresses the critical unmet need to develop a functional cure. The five late-stage pipeline products forecasted in the report are all functional cure components, meaning they will be used either as monotherapy or in combination with existing drugs to achieve a functional cure for patients with CHB. Functional cure drugs are projected to be more expensive than currently marketed CHB therapeutics, thereby driving the growth of the CHB market. By 2034, over 65% of the CHB market will be attributed to sales from these forecasted functional cure drugs. With that being said, all 7MM countries are projected to experience positive growth throughout the forecast period. The countries projected to have the largest market growth during this period include Spain, the US, and France. Despite the anticipated launch of functional cure drugs, generic erosion will represent a barrier to growth over the forecast period, as Vemlidy is set to lose patent protection and become vulnerable to competition from generics during the forecast period.
Likewise, projected reductions in the diagnosed prevalent cases of CHB are expected to curtail market growth. While the late-stage pipeline does address the need for functional cure drugs, competition from established long-term daily antivirals, in addition to commercial barriers such as cost and accessibility, could end up limiting the uptake of these expensive branded products. Nonetheless, there is a clear opportunity for developers to break through clinical and commercial barriers and transform the CHB market.
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