Hepatitis B Vaccines Market Size By Type (Mono Vaccines, Combination Vaccines), By Patient Type (Adult, Pediatric), By Distribution Channel (Hospital, Retail, Online Pharmacies), By Geographic Scope And Forecast

Hepatitis B Vaccines Market Size and Forecast

Hepatitis B Vaccines Market size was valued at USD 8.26 Billion in 2024 and is projected to reach USD 13.31 Billion by 2031, growing at a CAGR of 4.6 % from 2024 to 2031.

• Hepatitis B vaccines are used to prevent infection caused by the hepatitis B virus, which leads to serious liver diseases including cirrhosis and hepatocellular carcinoma.
• These vaccines work by stimulating the body’s immune system to produce antibodies against the hepatitis B virus.
• Furthermore, hepatitis B vaccines are widely used in national immunization programs for newborns and high-risk adult populations and are considered one of the most effective ways to prevent hepatitis B infection and its complications.

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Hepatitis B Vaccines Market Dynamics

The key market dynamics that are shaping the hepatitis B vaccines market include:

Key Market Drivers

• Rising Global Prevalence of Hepatitis B: The rising prevalence of Hepatitis B infections worldwide is a major driver of vaccination demand. According to the World Health Organization (WHO), around 296 million individuals were living with chronic Hepatitis B infection in 2019, with 1.5 million new infections happening annually. The increasing number of cases highlights the need for immunizations to prevent the disease from spreading further.
• Government Immunization Programs: Many nations are extending their immunization programs to combat Hepatitis B infections, considerably increasing the market. For example, the CDC advises that in the United States, Hepatitis B immunization is recommended for all infants, unvaccinated children under the age of 19, and at-risk adults. In 2020, global baby vaccination coverage reached 85%, up from 30% in 2000.?
• Increasing Healthcare Awareness and Initiatives: Increased awareness of Hepatitis B and government-led health programs in emerging nations are promoting vaccination adoption. For example, China’s National Health Commission started an attempt to lower the prevalence of chronic Hepatitis B by boosting immunization. According to 2020 research, more than 90% of children in China have had Hepatitis B vaccinations by the age of one, which is essential for market growth.

Key Challenges:

• Vaccine Hesitancy: Despite the proven efficacy of hepatitis B vaccines, vaccine hesitancy remains a significant challenge in some regions. Misconceptions about vaccine safety and efficacy hinder uptake rates, potentially impacting market growth.
• Cold Chain Management: Hepatitis B vaccines require strict temperature control during storage and transportation. Maintaining the cold chain, especially in resource-limited settings, poses logistical challenges that affect vaccine distribution and availability.
• High Cost of New Vaccine Development: The development of new and improved hepatitis B vaccines involves substantial research and development costs. These high costs are a barrier to market entry for new players and limit innovation in the field.

Key Trends:

• Increasing Focus on Adult Vaccination: While childhood vaccination programs are well-established, there is a growing emphasis on adult hepatitis B vaccination. This trend is driven by the recognition that many adults remain unprotected against hepatitis B, particularly in high-risk groups.
• Development of Therapeutic Vaccines: Research is ongoing into therapeutic hepatitis B vaccines that could potentially treat chronic hepatitis B infections. If successful, these vaccines could significantly expand the market and change the landscape of hepatitis B treatment.
• Expansion of Vaccine Production in Emerging Markets: There is a trend towards increasing vaccine production capabilities in emerging markets, particularly in Asia. This is helping to reduce vaccine costs and improve availability in these regions.

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Hepatitis B Vaccines Market Regional Analysis

The regional analysis of the hepatitis B vaccines market:

North America:

• According to Verified Market Research, North America is estimated to dominate the hepatitis B vaccines market over the forecast period. The North American market benefits from strong governmental efforts to eliminate hepatitis B through comprehensive vaccination programs. For instance, the U.S. Department of Health & Human Services implemented the “Viral Hepatitis National Strategic Plan (2021–2025)” aimed at reducing hepatitis infections as a public health threat. This plan enhances vaccine accessibility and coverage, contributing significantly to the market’s growth. According to the CDC, in 2021, over 90% of U.S. infants received the hepatitis B vaccine by 24 months of age?.
• North America has a notable prevalence of hepatitis B, which drives the demand for vaccination. In the United States alone, approximately 1.2 million people are chronically infected with hepatitis B. The CDC highlights that 22,000 new acute hepatitis B cases were estimated in 2019. This high disease burden prompts increased adoption of vaccines and preventive strategies?.
• Furthermore, the use of combination vaccines that protect against multiple diseases, including hepatitis B, is a key driver in North America. The introduction of vaccines like Pediarix (a 5-in-1 vaccine that includes hepatitis B) has expanded the market share, particularly in pediatric vaccinations. This trend is further supported by government-backed vaccination schedules that emphasize combination vaccines. The CDC notes that combination vaccines are increasingly used to improve adherence to immunization programs?.

Asia Pacific:

• The Asia Pacific region is estimated to exhibit the highest growth during the forecast period. The Asia-Pacific region has one of the highest burdens of Hepatitis B infections globally, driving the demand for vaccines. According to the World Health Organization (WHO), more than 60% of the world’s Hepatitis B carriers live in Asia, with China accounting for a large portion. In China alone, 70 million people are chronically infected, and around 1 million people die each year due to Hepatitis B-related complications. This significant patient population fuels vaccine adoption across the region.
• National immunization programs in Asia-Pacific are strongly supporting the hepatitis B vaccine market. For example, the Chinese government’s immunization program has achieved over 90% Hepatitis B vaccine coverage among children, with a birth dose administered within 24 hours of birth. In 2017, WHO reported that around 85% of countries in the Western Pacific Region implemented universal Hepatitis B immunization, leading to a significant reduction in infection rates.
• Furthermore, ongoing collaborations between pharmaceutical companies and research institutions are driving market growth in Asia-Pacific. In April 2022, Japanese pharmaceutical company Shionogi & Co., Ltd. partnered with NEC Corporation to develop a novel vaccine targeting Hepatitis B, aimed at curing chronic infections. These collaborations, supported by growing R&D investments, are boosting the development of advanced vaccines, contributing to the rapid market expansion in the region.

Hepatitis B Vaccines Market: Segmentation Analysis

The Hepatitis B Vaccines Market is segmented based on Type, Patient Type, Distribution Channel, and Geography.

Hepatitis B Vaccines Market, By Type

• Mono Vaccines
• Combination Vaccines

Based on Type, the market is segmented into Mono Vaccines and Combination Vaccines. The combination vaccines segment is estimated to dominate the hepatitis B vaccines market due to its ability to protect against multiple diseases in a single shot. These vaccines, which typically combine hepatitis B protection with other antigens such as those for diphtheria, tetanus, and pertussis, are increasingly preferred in national immunization programs. The convenience of fewer injections for patients and healthcare providers, along with reduced administration costs, are key factors driving the popularity of combination vaccines. While mono vaccines remain important, particularly for adult vaccination, the efficiency and cost-effectiveness of combination vaccines are cementing their dominant position in the market.

Hepatitis B Vaccines Market, By Patient Type

• Adult
• Pediatric

Based on Patient Type, the market is segmented into Adult and Pediatric. The pediatric segment is estimated to grow at the highest CAGR in the hepatitis B vaccines market. This growth is primarily driven by the widespread implementation of universal hepatitis B vaccination programs for newborns and infants in many countries. These programs, recommended by the World Health Organization, aim to prevent mother-to-child transmission and early childhood infections. The high birth rates in developing countries, coupled with increasing awareness about the importance of early vaccination, are fueling the growth of the pediatric segment. While adult vaccination remains crucial, especially for high-risk groups, the focus on preventing hepatitis B infection from the earliest stages of life is expected to maintain the pediatric segment’s dominant position in the market.

Hepatitis B Vaccines Market, By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

Based on the Distribution Channel, the market is divided into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies. The hospital pharmacies segment is estimated to dominate the market over the forecast period. This dominance is attributed to the fact that a significant portion of hepatitis B vaccinations are administered in hospital settings, particularly for newborns and high-risk patients. Hospitals are often the primary sites for implementing national immunization programs, especially for infant vaccinations. Additionally, hospital pharmacies are well-equipped to handle the storage and distribution requirements of vaccines, including maintaining the cold chain. The trend towards combination vaccines, which are often administered as part of comprehensive immunization schedules in hospital settings, further reinforces the dominance of the hospital pharmacies segment.

Hepatitis B Vaccines Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the world

Based on Geography, the hepatitis B vaccines market is classified into North America, Based on geography, the Hepatitis B Vaccines Market is classified into North America, Europe, Asia-Pacific, and the Rest of the World. The North American region is expected to dominate the market during the forecast period due to several key factors. A high prevalence of hepatitis B in the United States, with approximately 1.2 million people chronically infected, drives a strong demand for vaccines. Additionally, comprehensive immunization programs such as the U.S. Department of Health & Human Services’ “Viral Hepatitis National Strategic Plan (2021–2025)” aim to increase vaccine coverage across all population groups. The region’s strong healthcare infrastructure and significant investments in vaccine development also contribute to this market leadership.

Key Players

The “Hepatitis B Vaccines Market” study report will provide valuable insight with an emphasis on the global market. The major players in the market are GlaxoSmithKline plc, Merck & Co., Inc., Sanofi Pasteur, Dynavax Technologies Corporation, LG Chem, Serum Institute of India, Bharat Biotech, Biological E Limited, Crucell (Johnson & Johnson), and VBI Vaccines Inc.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Hepatitis B Vaccines Market Recent Developments

• In September 2023, Dynavax Technologies Corporation announced that positive Phase 1 clinical trial results had been obtained for its next-generation hepatitis B vaccine candidate. The vaccine demonstrated a favorable safety profile and robust immune responses, potentially offering improved protection against hepatitis B.
• In March 2023, Sanofi Pasteur launched a new hexavalent vaccine in Europe that protects against six diseases, including hepatitis B. This combination vaccine is designed to simplify childhood immunization schedules and improve vaccination coverage.
• In December 2022, the World Health Organization prequalified a new pediatric hepatitis B vaccine developed by LG Chem. This prequalification allows the vaccine to be procured by UN agencies and Gavi, the Vaccine Alliance, for use in global immunization programs.

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