U.S. Hepatitis B Vaccine Market Size, Share & Industry Analysis, By Type (Single Antigen and Combination), By Distribution Channel (Hospital & Retail Pharmacies, Government Suppliers, and Others), and Country Forecast, 2024-2032

The U.S. hepatitis B vaccine market size was valued at USD 2.60 billion in 2023 and is projected to grow at a CAGR of 4.3% during the forecast period. 

The prevalence of hepatitis B infection is increasing among adults and children nationwide. The high prevalence is owing to a rise in the spread of the hepatitis B virus through blood, semen, or other body fluids among the population. Thus, the increase in the number of hepatitis B-infected population has led to the enforcement of new strategies by several public health agencies to eliminate the viral infection.

• As per Hepatitis B Foundation data published in April 2022, the U.S. Centers for Disease Control and Prevention (CDC) announced the adoption of universal hepatitis B vaccination for all adults aged 19-59 in the U.S., recommended by its Advisory Committee on Immunization Practices (ACIP).

The rising incidence of hepatitis infection has increased demand for these vaccines nationwide, further propelling the market growth. The impact of the COVID-19 pandemic led to a decline in market growth in 2020. The decline was owing to limited hepatitis B immunizations across the country.

LATEST TRENDS

High Uptake of Hepatitis B Vaccination Among the U.S. Children

The U.S. government is highly emphasizing in public health interventions, such as routine hepatitis vaccination among adults and universal vaccination in hospitals among infants across the nation. Such initiatives increase the uptake of vaccines among the population and support the elimination of the rising incidence of hepatitis B infection, further boosting the market growth.

According to the Organization for Economic Co-operation and Development (OECD) statistics in 2021, the hepatitis B (HepB3) immunization coverage among 1-year-olds was around 92.0% across the U.S.

Thus, rising government initiatives and increasing vaccination uptake among the U.S. population aids market growth.

DRIVING FACTORS

Rising Launch of Advanced Vaccines to Augment Market Growth

The demand for vaccines is increasing in the U.S., to prevent hepatitis B infection among adults and infants. Thus, the industry players are now focusing on strategic initiatives for introducing advanced vaccines across the U.S. Such initiatives increase the presence and adoption of hepatitis B vaccines in the country, further propelling U.S. hepatitis b vaccine market growth.

• In March 2022, VBI Vaccines Inc. announced the launch of PreHevbrio, a 3-antigen hepatitis B vaccine in the U.S. to prevent hepatitis B in Adults.

Thus, rising initiatives of market players to develop a vaccine with an advanced mechanism of action are expected to augment market growth.

The hepatitis B (HepB3) immunization coverage in the U.S. was 92.0% in 2021, lower than other developed nations such as Australia (95%), Japan (95.6%), and the U.K. (92.6%).

RESTRAINING FACTORS

High Costs Associated with Multivalent Vaccines to Limit Market Expansion

The costs of combination vaccines, such as pentavalent and hexavalent vaccines indicated for several diseases, are higher than single antigen vaccines owing to the complex manufacturing process of these vaccines. Such elements have led to a limited sustainable supply and adoption of combination vaccines across the U.S., further limiting market growth.

• As per CDC estimates published in July 2023, the Vaxelis and a hexavalent vaccine cost around USD 146.6 compared to a single valent hepatitis vaccine of USD 25.6.

Thus, soaring costs of combination vaccines limit its adoption nationwide, further hampering the U.S. market growth.

SEGMENTATION

By Type Analysis

By type, the market is segmented into single antigen and combination. The combination segment dominated the market in 2022 owing to extensive advantages over a single antigen vaccine, such as action against several diseases, including hepatitis B, high immunogenicity, improved effectiveness, and lower pain & discomfort.

• According to an article published by MDPI in March 2023, the hexavalent vaccines, compared to conventional hepatitis B vaccines, have benefits, including lowering the risk for infection, reducing the number of clinical visits, better handling, and fewer administration errors.

By Distribution Channel Analysis

Based on distribution channel, the market is segmented into government suppliers, hospitals & retail pharmacies, and others.

The hospitals & retail pharmacies segment held the highest market share in 2022 due to the high volume of first vaccination doses administered among newborn infants in the U.S. hospitals. Moreover, the rising supply of these vaccines from hospitals for public immunization programs across the country is expected to surge the vaccination uptake amongst the population, further propelling market growth.

• According to data published by UNICEF in 2022, about 93.0% of children till 18 months of age received hepatitis b 3 dose vaccination across U.S. hospitals in 2022.

KEY INDUSTRY PLAYERS

Rising Collaborations Among Key Players for New Product Development to Strengthen Their Market Share

The market is primarily consolidated by key manufacturers, such as Sanofi, GSK plc, and others. The prominent players are focusing on facilitating investments in production and R&D centers across the country, to boost vaccine development owing to high demand from government agencies for public immunization programs. These factors are expected to drive the U.S. hepatitis B vaccine market share.  

• In July 2023, GSK plc announced the expansion of its state-of-the-art vaccine facility in Singapore with a USD 343.0 million investment to produce drug substances for Hepatitis B vaccines.

Similarly, other emerging players in the market, including Dynavax Technologies Corporation and VBI Vaccines, Inc., are continuously engaged in strategic collaborations with other industry players to develop advanced vaccines for preventing hepatitis B infection. Such initiatives by new market players are anticipated to drive market growth.

• In July 2023, Biopharmaceutical Company VBI Vaccines Inc., announced the expansion of its hepatitis B virus (HBV) partnership with Brii Biosciences to work on preventing and treating the disease.

LIST OF KEY COMPANIES PROFILED:

• GSK plc (U.K.)


• DYNAVAX TECHNOLOGIES CORPORATION (U.S.)


• VBI Vaccines Inc. (U.S.)


• Sanofi (France)


• Merck & Co., Inc. (U.S.)


• Valneva SE (France)


• Shionogi & Co., Ltd. (Japan)

KEY INDUSTRY DEVELOPMENTS:

• February 2023 - The U.S.-based company, Dynavax Technologies Corporation, announced that the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization for its U.S. FDA-approved HEPLISAV B vaccine in the U.K. The authorization will expand the geographical presence of the vaccine in the Europe region.


• June 2022 - VBI Vaccines Inc. announced the new long-term follow-up clinical data for its 3-antigen adult hepatitis B vaccine presented at the International Liver Congress (LLC) and European Association for the Study of the Liver (EASL) 2022.


• May 2022 - GlaxoSmithKline plc announced the acquisition of Affinivax Inc., a biopharmaceutical company involved in developing a novel class of vaccines, including potent adjuvants. This acquisition strengthens the company’s R&D pipeline and access to potential new technology.

REPORT COVERAGE

The market research report provides a detailed market analysis and focuses on crucial aspects such as leading players, product types, and major indications of the product. Additionally, it offers insights into market trends and key industry developments such as mergers, partnerships, & acquisitions, and the impact of COVID-19 on the market. In addition to the factors mentioned above, the report includes the factors that have contributed to the market's growth in recent years with a regional analysis of different segments.

Report Scope and Segmentation