Hepatitis B Vaccine Market is expected to reach US$ 6.1 Billion by 2030 | Major players - Merck & Co., Inc., Sanofi, GlaxoSmithKline plc

Market Size and Growth:

The Hepatitis B Vaccine Market Size reached US$ 4.3 Billion in 2022 and is expected to reach US$ 6.1 Billion by 2030, growing at a CAGR of 4.6% during the forecast period 2024-2031. The Market is growing due to rising global immunization programs, increasing birth-dose vaccination initiatives, and expanding awareness about preventing chronic liver infections. According to DataM Intelligence Report.

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The Hepatitis B Vaccine Market comprises products and immunization solutions designed to prevent hepatitis B virus (HBV) infection across infants, adolescents, and adults. It includes recombinant vaccines, combination vaccines, and innovative formulations driven by growing awareness, national immunization programs, rising disease prevalence, and expanding healthcare infrastructure, with demand influenced by global vaccination policies and technological advancements in vaccine development.

United States: Recent Developments of Hepatitis B Vaccine Market

✅ November 2025: The US vaccine committee, influenced by advisers, voted on proposals to delay hepatitis B shots for most newborns, sparking debate on vaccination timing amid ongoing policy reviews.​

✅ November 2025: A comprehensive review affirmed the effectiveness of the current newborn hepatitis B vaccination policy, highlighting prevention of millions of infections and nearly 1 million related deaths.​

✅ October 2025: The US government expanded its national Hepatitis Elimination Plan with $156 million to subsidize treatments, indirectly supporting vaccine integration for high-risk groups.

Europe: Recent Developments of Hepatitis B Vaccine Market

✅ November 2025: Dynavax Technologies reported increased revenue from its HEPLISAV-B hepatitis B vaccine, reflecting stronger adult market penetration across supplied European regions.​

✅ November 2025: The European Centre for Disease Prevention and Control assessed hepatitis B vaccination policies, noting advances toward WHO 2025 interim targets for coverage in infants and children.​

✅ September 2025: The CDC's updated guidelines on universal HBV boosters gained traction in Europe, boosting uptake by 17% among high-risk populations through aligned regional health initiatives.​

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FDA Approvals / Actions in 2025:

✅ No new FDA approvals for hepatitis B vaccines were announced during Aug-Nov 2025. The FDA's vaccine/CBER product pages and recent guidance listings show no new licensures for HBV vaccines in that window.

✅ Safety/regulatory activity: FDA guidance pages and CBER updates included documents and draft guidances referencing hepatitis B testing and safety topics during 2025 (guidance updates referenced July-Oct 2025), but these were guidance/documents rather than new vaccine approvals.

Regulatory (EMA / Other Regulators) in 2025:

✅ EMA PRAC agenda / review related to HEPLISAV-B (Dynavax): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) agenda and minutes for the 1-4 Sept 2025 meeting included items on HEPLISAV-B (renewal / labelling/PI updates and HBV reactivation wording). The minutes (4 Sept 2025) record discussion of adding HBV reactivation as a warning/undesirable effect and a 5-year renewal item for HEPLISAV-B.

Mergers & Acquisitions, Asset Deals in 2025:

✅ Gilead - completion of Hookipa HBV asset purchase (Oct 30, 2025 press filings/releases): Gilead completed purchase of HBV (and some HIV) assets/programs from HOOKIPA; filings/press releases show the asset purchase closed on/around Oct 30-31, 2025 (this transfers HBV therapeutic vaccine programs such as HB-400 to Gilead). This is the most material deal in the HBV vaccine/therapeutic space during the window.

✅ HOOKIPA corporate actions earlier in 2025 led to the asset sale and voluntary delisting plans; closing & completion notices appeared in Oct 2025. (context for the above transaction). i

✅ Other corporate moves: Dynavax published Q3 2025 results and corporate actions (e.g., share repurchase programs) in Nov 2025 - important for company finances around HEPLISAV-B commercialization but not an M&A/approval.

Major Players:

Key companies in the Hepatitis B Vaccine market include:

Merck & Co., Inc.
Sanofi
GlaxoSmithKline plc
Indian Immunologicals Limited
LG Chem
KM Biologics
Dynavax Technologies
Bharat Biotech
Serum Institute of India Pvt. Ltd
Biological E limited.

Segments Covered in the Hepatitis B Vaccine Market:

By Type: Combination Vaccines, Single Antigen Vaccine.

By End-User: Hospitals, Clinics, Vaccination Centre, Others.

Regional Analysis for Hepatitis B Vaccine Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Hepatitis B Vaccine market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Hepatitis B Vaccine Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Hepatitis B Vaccine market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Hepatitis B Vaccine Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Hepatitis B Vaccine market?

➠ Who are the global key manufacturers of the Hepatitis B Vaccine Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Hepatitis B Vaccine market opportunities and threats faced by the vendors in the global Hepatitis B Vaccine Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Hepatitis B Vaccine market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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