Hepatitis B Vaccine Market - By Vaccine Type, By Age Group, By Gender, By End Use - Global Forecast 2025 - 2034

Hepatitis B Vaccine Market Size

The global hepatitis B vaccine market was valued at USD 6.7 billion in 2024. The market is expected to grow from USD 7.3 billion in 2025 to USD 12 billion in 2034, at a CAGR of 5.7%. The market growth is primarily driven by the growing incidence of hepatitis B infections cases coupled with the growing government support and public health initiatives through immunization programs and rapid vaccine development.

According to the World Health Organization (WHO) report, around 254 million individuals were living with chronic hepatitis B infection in 2022. The report indicated that an estimated 1.1 million individuals die each year due to complex complications. Mass immunization programs continue to expand globally, with a strong focus on high-risk groups such as healthcare workers and infants, particularly in developing areas. This market growth is further supported by increased from both public and private sectors, driven by the recognized long-term health and economic benefits of widespread vaccination initiatives.
 

 For instance, in May 2025, Gavi, the Vaccine Alliance, expanded the access for low-income countries to incorporate four vital vaccines into their national immunization programs. These expanded vaccines portfolio includes preventive measures against Ebola virus, meningococcal disease through conjugate vaccines, birth-dose protection against hepatitis B, and post-exposure treatment for human rabies infections. This expansion represents a vital advancement focusing on enhancing immunization coverage and safeguard at-risk populations from severe diseases.
 

Moreover, the growing popularity of combination vaccines to protect patients against multiple diseases through single doses is accelerating vaccines development. These factors collectively contribute to reinforce the market growth in coming years.
 

Hepatitis B vaccines are the biological preparations that protects against hepatitis B virus (HBV) infection that can cause liver damage. It stimulates the immune system to produce antibodies against the HBV surface antigen (HBsAg), which helps prevent chronic liver diseases, cirrhosis and liver cancer. The vaccine is available as single antigen or combination vaccines recommended for infants, children, and adults at high risk of infection.
 

Hepatitis B Vaccine Market Trends

• Advancements in vaccine formulation and production efficiency are driving the global market growth. Ongoing research aimed at developing innovative formulations with enhanced immunogenicity has increased demand for next-generation vaccines that provide stronger protection and a quicker immune response than traditional options, making them more appealing for widespread use.
   
• For instance, an open-label randomized clinical study published in JAMA, demonstrated a significant progress in hepatitis B vaccination for HIV - patients. The Heplisav-B (HepB-CpG vaccine) encompassing a cytosine phosphoguanine adjuvant, exhibited higher effectiveness compared to the traditional Engerix-B (HepB-alum vaccine).
   
• The improved efficacy of HepB-CpG reflected the evolution in vaccine development and adjuvant technology. The availability of these effective vaccines, particularly for immunocompromised patients, is expected to increase market demand and expand immunization coverage globally.
   
• Also, the implementation of enhanced cold-chain logistics, scalable manufacturing processes, and automation has reduced production costs and increased output, improving global vaccine accessibility.
   
• Further, the adoption of new drug mechanisms for vaccine production has offered significant opportunities for companies that are equipped with strong and innovative R&D capabilities to invest heavily in development of novel vaccines. For instance, according to Vir Biotechnology, Inc. report (December 2021), the company invested USD 44.8 billion in the R&D of new vaccines in the pipeline.
   
• Such investments in R&D by key players for new vaccine trials and production across the globe will augment the market growth.
   

Hepatitis B Vaccine Market Analysis

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In 2021, the global market was valued at USD 4.2 billion. The following year, it saw a slight increase to USD 5.4 billion, and in 2023, the market climbed to USD 6.1 billion.
 

Based on vaccine type, the global market is segmented into single antigen vaccine and combination vaccine. The combination vaccine segment dominated the market and was valued at USD 4.5 billion in 2024 and is poised to reach USD 7.8 billion by 2034 at a CAGR of 5.5%.
 

• The combination vaccine segment gained high preference over single antigen vaccines due to its ability to offer broad-spectrum protection in a single dose. These vaccines combine hepatitis B with other immunizing antigens such as diphtheria, tetanus, polio and pertussis.
   
• This combination approach reduces the number of required injections, increasing the patient adherence, and simplifying the vaccination schedules, particularly for pediatrics gaining traction in the market.
   
• In addition, healthcare providers and government prefer for combination vaccines due to their cost-effectiveness, streamlined administration processes, and high vaccination coverage rates, thereby solidify its demand.
   
• Moreover, their widespread implementation across both industrialized and emerging markets has substantially improved hepatitis B vaccination globally.
   

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Based on age group, the global hepatitis B vaccine market is categorized into pediatric and adult. The adult segment accounted for the highest market share of 62.9% in 2024 and is poised to grow at a substantial rate during the analysis period.
 

• Adults, particularly healthcare workers, frequent travelers, those involved in high-risk activities, are at increased risk of hepatitis B virus (HBV) infection, driving the need for targeted immunization initiatives.
   
• Recent advancements in vaccine formulations, focusing on immune response and simplified dosing schedules, have encouraged greater participation in adult vaccination programs. These developments have significantly improved immunization coverage, contributing to overall market expansion.
   
• Additionally, rise in chronic hepatitis B cases among adults, along with the implementation of workplace vaccination policies and public awareness campaigns, continues to propel market growth.
   

Based on the gender, the global hepatitis B vaccine market is categorized into female and male. In 2024, the male segment accounted for the largest share in the market and is projected to account for USD 7.1 billion by 2034.
 

• Biological, immunological, and behavioral differences influencing disease exposure and progression have heightened the need for immunization among the male population.
   
• Studies indicate that men are at a notably higher risk of developing chronic hepatitis B infections compared to women, largely due to sex-based biological factors, particularly the role of hormones like testosterone, which can impact immune responses and facilitate viral replication.
   
• This increased susceptibility to long-term HBV infection and associated liver complications has led to the implementation of targeted vaccination programs for adult males.
   
• Furthermore, the broad availability of adult vaccines and rising health awareness among men continue to strengthen this segment’s contribution to overall market growth.
   

Based on the end use, the global hepatitis B vaccine market is categorized by hospitals, specialty clinics, and other end users. In 2024, the hospitals segment accounted for the largest share of 57.9% in the market and is anticipated to reach USD 6.8 billion by 2034.
 

• The hospitals segment is further categorized into public and private hospitals. Hospitals serve as primary healthcare centers for delivering preventive care and administering scheduled immunization programs.
   
• Equipped with advanced infrastructure, trained medical personnel, and dedicated vaccine storage capabilities, hospitals ensure the safe and effective delivery of immunizations.
   
• They also facilitate large-scale vaccination drives and provide essential medical supervision for vaccines that require professional administration.
   
• Moreover, strategic partnerships between hospitals and pharmaceutical companies help maintain a consistent and reliable vaccine supply. These operational strengths make hospitals the preferred end-user over specialty clinics and other healthcare settings in the global immunization market.
   

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In 2024, the North America region accounted for USD 2.7 billion revenue and is projected to generate USD 4.7 billion by 2034, at a CAGR of 5.4%.
 

• The region maintains a leading position in the global hepatitis B vaccine market, supported by its robust public healthcare infrastructure and widespread awareness about preventive health solutions.
   
• High vaccination coverage across both pediatric and adult populations is driven by accessible immunization programs and government support.
   
• The U.S. and Canada face a significant burden of hepatitis B infection, necessitating comprehensive prevention strategies. According to the Hepatitis B Foundation, approximately 2.4 million individuals in the U.S. were infected with HBV in 2021, contributing to numerous fatalities.
   
• Similarly, Canadian authorities recorded 3,524 cases across all provinces and territories in the same year, highlighting the ongoing need for sustained immunization efforts.
   

In 2024, the U.S. hepatitis B vaccine market accounted for USD 2.5 billion revenue from USD 2.3 billion in 2023.
 

• The U.S. leadership was supported by a well-developed healthcare system, CDC-led immunization protocols, and strong public health campaigns targeting both infants and high-risk adults.
   
• Also, workplace health programs, travel health requirements, and ongoing public awareness campaigns continue to boost vaccine uptake.
   
• Advanced research infrastructure and a growing pharmaceutical pipeline have further led to innovations in vaccine development, improving efficacy and reducing dosing frequency. These factors firmly position the U.S. as the dominant contributor to North America's market growth.
   

Germany is poised to achieve significant growth in the Europe hepatitis B vaccine market.
 

• The country's growth is due to its established pharmaceutical industry, well-supported government vaccination programs, and emphasis on public health education.
   
• Preventive care and early diagnosis are central to the German healthcare system, leading to increased screening and immunization rates. With hepatitis B affecting nearly 1% of the population, demand for effective treatment and vaccination remains strong.
   
• Government initiatives have contributed to a 30% increase in vaccination coverage. Adoption of combination vaccines and patient-tailored approaches has improved treatment adherence and outcomes.
   
• Germany’s ongoing R&D investment and focus on healthcare quality continue to strengthen its position in the European market.
   

Asia Pacific is poised to grow at a significant growth rate in the global hepatitis B vaccine market over the next few years.
 

• The regional growth is driven by a large population base, high HBV prevalence, and increasing government efforts toward preventive care.
   
• China, India, and Japan represent key contributors, with high reported case volumes prompting expanded immunization efforts.
   
• Government partnerships with international health agencies are boosting vaccine coverage, particularly among infants and vulnerable populations.
   
• For instance, in India, the Karnataka Health Department launched a statewide campaign in June 2025 targeting over 56,000 healthcare workers under the National Viral Hepatitis Control Programme (NVHCP). The initiative focused on protecting high-risk groups through a structured three-dose immunization schedule across medical institutions.
   
• Such initiatives not only reinforce infection control within medical settings but also exemplifies the critical role of state-led programs in strengthening public health infrastructure and advancing India's hepatitis B vaccine coverage goals.
   

China is anticipated to grow significantly within the Asia Pacific hepatitis B vaccine market.
 

• China prominence is supported by its large population, established healthcare infrastructure, and effective government policies.
   
• As reported in NIH, China continues to lead regional progress with near-universal newborn vaccination coverage, accounting for 99.6% for the full three-dose schedule and 95.6% for timely birth doses, exceeding WHO benchmarks.
   
• Government-led programs updated clinical guidelines, and targeted antiviral treatment for HBV-positive pregnant women have significantly reduced transmission rates.
   
• The country's investment in local vaccine manufacturing and biotech infrastructure has improved access and affordability, reinforcing China’s leadership in the region.
   

Brazil is projected to witness significant growth in Latin America hepatitis B vaccine market in coming years.
 

• The regional growth is supported by comprehensive public health strategies and consistent healthcare investment. The national immunization schedule includes hepatitis B vaccination for both infants and at-risk adults, backed by public awareness campaigns and international collaborations.
   
• Improved accessibility to healthcare services, especially in rural areas, has enhanced vaccine distribution.
   
• Furthermore, Brazil’s growing pharmaceutical manufacturing capacity and adoption of advanced vaccine technologies support market expansion. This structured approach positions Brazil as a prominent player in Latin America’s hepatitis B vaccine landscape.
   

Saudi Arabia is anticipated to grow in the Middle East and Africa hepatitis B vaccine market.
 

• The country benefits from robust public health policies, government-backed immunization programs, and increasing healthcare infrastructure investments.
   
• Vaccination protocols include mandatory coverage for infants and targeted programs for high-risk adult populations.
   
• Strategic collaborations with global health agencies and the implementation of digital health platforms have improved vaccine delivery and patient tracking. These efforts collectively establish Saudi Arabia as a key contributor to the region’s market growth.
   

Hepatitis B Vaccine Market Share

The top 4 players in the global market accounted for nearly 65 - 70% of the share. The market demonstrates significant competition through rigorous research advancements, collaborations, and widespread immunization initiatives. The key players such as Merck, Sanofi, GSK and Bharat Biotech hold substantial share through their extensive distribution networks and established product portfolios.
 

For example, GSK's Engerix-B and Merck's Recombivax HB remain the primary market offerings. Dynavax Technologies has strengthened the market with its Heplisav-B vaccine featuring enhanced immunogenic properties through CpG adjuvant technology. In addition, the Serum Institute has increased its market presence by developing needle-free delivery systems, particularly benefiting healthcare delivery in developing regions.
 

Furthermore, the market is highly consolidated with pharmaceutical companies focusing on combination vaccines that offer comprehensive protection. The regional players in Asia-Pacific and Latin America continue to expand their operations through government support and strategic partnerships.
 

Hepatitis B Vaccine Market Companies

The company profile section includes both companies that have commercial drug available in the market as well as those that are in to clinical phase development. Prominent players operating in the market are as mentioned below:

• Bharat Biotech
• Biological E
• Dynavax Technologies
• Gilead Sciences
• GSK
• Merck
• Sanofi
• Serum Institute of India
• Shenzhen Kangtai Biological Products
• VBI vaccines
• YS Biopharma

• GSK's Engerix-B hepatitis B vaccine maintains a strong global market position, supported by extensive safety documentation and WHO prequalification. This positions the vaccine as a reliable choice for public immunization programs, supported by the company's robust manufacturing and quality control systems.
   
• Merck's Recombivax HB has built a solid reputation in the vaccines market through proven clinical effectiveness. The company's established biotechnology manufacturing capabilities and distribution infrastructure enable reliable vaccine supply to healthcare providers worldwide.
   
• Sanofi delivers hepatitis B vaccines through its comprehensive global healthcare infrastructure. The company prioritizes vaccine accessibility and develops combination vaccines that enhance immunization programs. Its production facilities support vaccination initiatives in both established and developing markets.
   

Hepatitis B Vaccine Industry News

• In October 2024, ClearB Therapeutics secured a licensing agreement with Adjuvance Technologies for TQL-1055, a saponin-based adjuvant that will enhance its hepatitis B vaccine candidates, CLB-405 and CLB-505. Through this partnership, ClearB Therapeutics moves closer to developing an effective hepatitis B treatment.
   
• In February 2023, Dynavax Technologies received marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for HEPLISAV B, an adjuvanted hepatitis B vaccine for adult use. The approval, granted through the European Commission Decision Reliance Procedure, was supported by safety and immunogenicity data from three Phase 3 clinical trials. This regulatory approval expands Dynavax's vaccine presence in global markets.
   
• In April 2022, Shionogi & Co. and NEC Corporation entered a partnership to develop a hepatitis B therapeutic vaccine. The collaboration leverages Shionogi's expertise in infectious diseases and NEC's biotechnology capabilities. NEC OncoImmunity contributes to the research program. This partnership represents a significant advancement in hepatitis B treatment development.
   

The hepatitis B vaccine market research report includes in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Vaccine Type

• Single antigen vaccine
• Combination vaccine

Market, By Age Group

• Pediatric
• Adult

Market, By Gender

• Female
• Male

Market, By End Use

• Hospitals
  • Public
  • Private 
• Specialty clinics
• Other end use

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea 
• Latin America
  • Brazil
  • Mexico
  • Argentina 
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE