The Functional Cure Frontier: Strategic Outlook fo…

Nucleos(t)ide Analogues (NAs): Agents such as tenofovir alafenamide (VEMLIDY) and entecavir remain the volume leaders. Their role is shifting to become the “backbone” onto which novel agents are added in emerging clinical protocols.
Immune Modulators: While traditional pegylated interferons are still utilized, their use is increasingly reserved for specific patient genotypes or as part of short-course “add-on” strategies to stimulate the host immune response.
Simplified Treatment Access: A major market driver in 2025 is the expansion of treatment eligibility. By lowering the threshold for treatment initiation—moving away from high viral load requirements toward a “treat-all” approach—healthcare systems are expanding the patient pool significantly.

RNA Interference (RNAi) & Antisense Oligonucleotides (ASO): These small nucleic acid drugs are the “vanguard” of the 2025 pipeline. By silencing viral protein production, they aim to lower HBsAg levels, potentially “uncloaking” the virus to the patient’s own immune system.
Capsid Assembly Modulators (CAMs): These agents disrupt the formation of the viral core, preventing the recycling of the viral genome back to the nucleus, a critical step in maintaining chronic infection.
Gene Editing (CRISPR/ARCUS): In 2025, the market saw a historic milestone with the first in vivo gene-editing trials cleared for CHB. These therapies are designed to permanently inactivate the viral reservoir within the liver.

Enhanced Screening & Diagnostics: The deployment of point-of-care (POC) molecular assays and new biomarkers like HBcrAg is improving linkage-to-care rates, especially in underserved regions.
Public-Private Partnerships: Initiatives by organizations like Gavi and the WHO are facilitating pooled procurement, making high-quality antivirals more accessible in low-income markets while sustaining volume growth for manufacturers.
Value-Based Contracts: In North America and Europe, we are seeing the emergence of “pay-for-cure” models, where reimbursement is tied to achieving sustained HBsAg loss, aligning pharmaceutical incentives with long-term patient outcomes.