The chronic hepatitis B (CHB) therapeutics market across the seven major pharmaceutical markets (7MM*) is forecast to grow at a compound annual growth rate (CAGR) of 7.9% from $1.5 billion in 2024 to $3.2 billion in 2034, forecasts GlobalData, a 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.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “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 late-stage 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 RNA (siRNA), daplusiran + 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 in suppressing HBV viral replication, long-term daily usage 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.

Kurdach continues: “Functional cure drugs are projected to be more expensive than the currently marketed CHB therapeutics, thereby driving the growth of the CHB market. By 2034, the forecasted functional cure drugs will account for over 65% of the CHB market sales. All 7MM are projected to experience growth throughout the forecast period. Spain, the US, and France are projected to have the largest market growth during the forecast period.”

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.

Kurdach concludes: “While the late-stage pipeline does address the need for functional cure drugs, competition from established long-term daily antivirals, in addition to the 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.”

*7MM: The US, France, Germany, Italy, Spain, the UK, and Japan.