AUSTIN, Texas and TOKYO, Nov. 19, 2025 /PRNewswire/ -- The Hepatitis B and C Therapeutics Market has entered a renewed growth cycle in 2024, led by innovative antiviral regimens, expanded national vaccination programs, accelerated screening, and renewed investments in long-acting therapies. According to DataM Intelligence, the Hepatitis B and C Therapeutics Market Size reached US$17.02 billion in 2024 and is forecast to grow steadily to US$20.83 billion by 2033, reflecting a CAGR of 3.4% (2025-2033). As the burden of chronic viral hepatitis continues to rise across high-income and emerging economies, pharmaceutical companies are shifting toward potent, shorter-duration therapies, improved compliance models, and immune-targeted drugs designed to deliver functional cures.
Growing disease prevalence-over 296 million people living with chronic Hepatitis B (HBV) and nearly 50 million with Hepatitis C (HCV) worldwide-combined with increased national-level commitments toward elimination by 2030 under WHO guidelines, has created substantial demand for reliable, clinically proven therapeutic options. With expanding access to screening technologies, improved diagnostics, and government-backed reimbursement pathways, the industry is seeing strong uptake of branded and generic therapies across hospital and retail distribution channels.
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Market Dynamics: Strong Push from Antiviral Innovation, Screening Mandates, and Real-World Evidence Programs
The market's expansion is driven by a combination of regulatory reforms, new product approvals, and the shift toward simplified, pan-genotypic therapies. The adoption of tenofovir and entecavir for HBV continues to remain robust, while the transition to direct-acting antivirals (DAAs) has transformed HCV care, reducing treatment durations from 24-48 weeks to as low as 8-12 weeks.
LSI keywords integrated: HBV therapeutics, HCV antivirals, chronic viral hepatitis drugs, DAA market, nucleotide analogues, liver disease burden, screening expansion, immunomodulators.
Key growth factors influencing the 2024-2033 outlook include:
- Expansion of national screening mandates in the U.S., Japan, South Korea, and Europe.
- Strong adoption of pan-genotypic DAAs, improving cure rates across genotypes.
- Government-led vaccination programs are dramatically increasing HBV prevention coverage.
- Emergence of long-acting HBV regimens and immune-active therapeutic candidates.
- Manufacturer partnerships with public health organizations for bulk procurement and cost-sharing models.
Detailed Market Segmentation with 2024 Market Size and Shares
By Indication: Hepatitis B (HBV) vs. Hepatitis C (HCV)
In 2024, the market remained dominated by Hepatitis C therapeutics, supported by the strong commercial performance of direct-acting antivirals. Of the total US$17.02 billion market, HCV therapeutics accounted for approximately US$10.9 billion, representing 64% of global revenues. This dominance is driven by high cure rates, short treatment durations, and aggressive payer funding to eradicate the disease burden.
Meanwhile, Hepatitis B therapeutics generated nearly US$6.12 billion, accounting for 36% of the market in 2024. Despite lower growth relative to HCV, HBV therapeutics benefit from lifelong treatment regimens, rising vaccination uptake, and increasing research activity in functional cure mechanisms such as siRNA-based therapies, capsid assembly modulators, and T-cell immune enhancers.
By Route of Administration: Oral vs. Injectable Therapies
Oral formulations accounted for the largest share of the market in 2024, with revenues reaching US$13.21 billion, equivalent to 77.6% of global market value. The predominance of oral antivirals is linked to their effectiveness, patient convenience, and widespread availability across both retail and hospital channels.
Injectable therapeutics-including interferon-based therapy and novel immune-targeted biologics-represented US$3.81 billion, or 22.4%. Although historically declining, the segment has seen renewed interest in 2024 due to the development of long-acting immunotherapies for HBV functional cure programs.
By Distribution Channel: Hospital vs. Retail Pharmacies
Hospital pharmacies maintained a significant share of the market in 2024, contributing US$ 9.18 billion (54%) of total revenues as complex HCV regimens and high-risk HBV cases necessitated specialist intervention. Retail pharmacies accounted for US$ 7.84 billion (46%), supported by increased availability of DAAs through prescription-based community channels, especially in the U.S., Germany, and Japan.
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Regional Analysis: Strong Momentum in the USA and Japan
United States Market Overview
The U.S. accounted for approximately 41% of the global hepatitis B and C therapeutics market in 2024, representing a market size of US$ 7.0 billion.
Key 2024-2025 quantitative drivers:
- A 12% increase in national HBV vaccinations under CDC's adult immunization schedule.
- A 9% rise in Medicare spending on HCV DAAs, driven by broader reimbursement for simplified treatment pathways.
- 10 new state-level screening mandates implemented between Q2-Q4 2024 for adults aged 18-79, resulting in a measurable surge in newly diagnosed cases entering treatment.
Latest News:
- November 2025: FDA cleared a new post-market real-world evidence protocol requiring manufacturers to submit 12-month treatment outcome data for HBV therapies.
- October 2025: U.S. government expanded its nationwide initiative under the Hepatitis Elimination Plan with a US$ 156 million funding allocation for subsidizing DAA access.
- September 2025: CDC published updated guidance recommending universal HBV booster adoption, increasing booster uptake by 17% across high-risk groups.
Japan Market Overview
Japan represented approximately 12% of the global market, translating to a market size of US$2.04 billion in 2024. The country maintains one of the strongest national commitments to hepatitis elimination globally, reinforced by extensive universal screening and subsidized antiviral access.
Recent quantitative developments:
- 18% YoY increase in HBV screening coverage, driven by the expansion of the national health checkup program.
- Japan's HCV cure rate maintained at 97.5%, among the highest globally, supporting strong DAA uptake.
- Government reimbursement spending for hepatitis drugs increased by 8% between October and December 2024.
Latest News:
- October 2025: Japan's MHLW executed a cost-sharing agreement with leading manufacturers to stabilize DAA prices through 2027.
- November 2025: Approval of a new HBV RNA assay under the national testing program, boosting diagnostic accuracy.
- September 2025: The government issued updated treatment guidelines encouraging earlier antiviral intervention for all viremic HBV adults.
Competitive Landscape: Top Companies Strengthening Their Portfolio
The competitive landscape remains dominated by global pharmaceutical leaders with extensive antiviral portfolios. Companies are investing aggressively in immune-targeting candidates, real-world evidence programs, and pan-genotypic innovation.
Top 5 Companies by 2024 Revenue (Global Revenues Across All Products)
- Johnson & Johnson - US$85.2 billion (2024)
- Merck & Co., Inc. - US$60.1 billion (2024)
- Roche Holding AG - US$58.7 billion (2024)
- AbbVie Inc. - US$54.3 billion (2024)
- Gilead Sciences, Inc. - US$27.1 billion (2024)
Within the hepatitis therapeutics category, Gilead, AbbVie, Merck, and Bristol-Myers Squibb remain highly dominant due to their strong patent portfolios, high cure rates, and extensive distribution networks.
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Future Outlook: Market Transition Toward Functional Cure and Long-Acting Therapies
The next decade will see a clear pivot toward functional cure strategies for HBV, an area where ongoing clinical trials involving siRNA therapies, core protein assembly modulators, and T-cell-directed immunotherapies show promising potential. The success of these new mechanisms could materially reshape the market landscape by reducing the burden of lifelong therapy, increasing compliance, and expanding the addressable patient population.
For HCV, the market will continue to mature with high cure rates, but opportunities remain in improving access across lower-income regions, integrating digital adherence systems, and expanding pan-genotypic RWE datasets.
As the global market approaches US$ 20.83 billion by 2033, companies with strong R&D investment, cost-optimized supply chains, and government-backed procurement agreements will maintain the strongest growth positions.
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