The Global Hepatitis B Vaccine Market Size was valued at USD 8.1 Billion in 2023 and is anticipated to reach USD 13.2 Billion by 2032 with a CAGR of 5.6% from 2024 to 2032.

Hepatitis B vaccine is intended for the protection against hepatitis B virus also known as HBV. HBV can cause severe liver diseases including hepatitis, cirrhosis, and liver cancer. The vaccine works by exposing the body to a form of the virus that is harmless and causing the body to produce antibodies that will fight off the actual virus. There are many brands of hepatitis B vaccines available such as Engerix-B, Heplisav-B, and Recombivax HB and all are FDA approved. Engerix-B and Recombivax HB are indicated for all age groups, whereas Heplisav-B is recommended for individuals who are 18 years and above.

In immunocompromised individuals including those with HIV, hepatitis B becomes an opportunistic infection (OI). OIs are infections that are usually more common and severe in immunocompromised persons than in immunocompetent persons. HIV positive individuals should consider vaccination against HBV to minimize these complications.

Hepatitis B Vaccine Market Dynamics

Rising knowledge among the populace about the risks and health consequences of hepatitis B infection has enhanced the uptake of vaccines hence boosting the market. Vaccination programs for hepatitis B have been launched in many countries, and regulations have been introduced to prevent the spread of the disease; therefore, the market is growing due to increased vaccination. Given the fact that hepatitis B is very widespread in Asia and Africa, there is a great demand for vaccines in these territories. Also, technological improvement in the production of vaccines and the development of safer and effective vaccines for hepatitis B has also contributed to the growth of the market.

The price of hepatitis B vaccines may be a challenge to mass immunization in developing countries, and therefore vaccination campaigns may be more difficult to organize and launch. Lack of adequate health facilities particularly in the rural areas can also slow down the distribution and administration of vaccines. Another challenge that affects the growth of the market is the vaccine hesitancy and misinformation about the vaccinations which include the hepatitis B vaccines.

Some vaccines such as the hepatitis B vaccines have certain temperature conditions that they should be stored and transported in and this can be very difficult in low income countries. The other major challenge is in guaranteeing a steady source of vaccines and creating the right distribution channels to reach out to the rural areas. The challenge that manufacturers have to overcome is the ability to produce enough hepatitis B vaccines to meet the global demand and at the same time retain production capability.

The high incidence of hepatitis B infection and the gradual enhancement of immunization programs in developing countries are the major growth opportunities for the market. The advances in the technology of combination vaccines that include hepatitis B among other diseases can be used to enhance the vaccination coverage while at the same time reducing the number of injections. Also, programs related to prevention of mother to child transmission of hepatitis B through immunization during pregnancy is another avenue for market development.

Global Hepatitis B Vaccine Market Segment Analysis

Hepatitis B Vaccine Market By Type

·       Single Antigen Hepatitis B Vaccine

·       Combination Vaccines

According to the Hepatitis B Vaccine industry research, the combination vaccine segment holds a market share of more than 65% in 2023 and will have a healthy growth rate in the forecast period. These are vaccines that are developed to target several diseases in one shot in order to reduce the number of shots that an individual has to undertake to be immunized. Hepatitis B combination vaccines contain the hepatitis B antigen together with other antigens for other diseases like diphtheria, tetanus, pertussis and others. These vaccines have advantages of simplicity, better patient compliance and higher overall vaccination rates.

Hepatitis B Vaccine Market By Dose

·       3-Dose Schedule

·       2-Dose Schedule

·       Alternate Schedule

As per the Hepatitis B Vaccine (RGA) market forecast, the 3-dose hepatitis B vaccine schedule has emerged as the most popular one and is expected to remain the market leader from 2024 to 2032. This schedule entails giving doses at 0, 1, and 6 months, which has been the norm for quite some time now. Nonetheless, the 2-dose schedule hepatitis B vaccine is estimated to be the fastest-growing segment during the period between 2019 and 2026. In this case, the two dose regimen with the doses usually administered at 0 and 1 month have a higher probability of giving seroprotective response. The increased compliance due to the fewer number of doses may help increase the vaccination rates hence reducing the infection rates and hence improving the cost effectiveness..

Hepatitis B Vaccine Market By End-Users

·       Hospitals

·       Clinics

·       Others

By the end-user, the hepatitis B vaccine market is classified into hospitals, clinics, and others. Hospitals are expected to reach USD 8 billion by 2032 due to the routine administration of the first dose of the hepatitis B vaccine to newborns before discharge because they are at a high risk of infection. Also, through outpatient services, hospitals ensure that people receive vaccinations during their normal check-up procedures. The developed infrastructure and the enhanced storage facilities in the hospitals also ensure that there is no shortage of vaccines, and that wastage is also low.

Hepatitis B Vaccine Market Regional Analysis                 

North America is expected to account for nearly 40% of the total hepatitis B vaccine market share during the forecast period. The rising cases of hepatitis B infection, and an expanding population at risk of the disease, especially the newborns and healthcare workers are the factors likely to fuel the demand for the product in the region. The efforts to increase R&D spending to improve the efficacy of vaccines, for instance, through the development of vaccines that require fewer doses, will greatly drive the market growth. Also, the government’s efforts in raising awareness on the importance of vaccination will enhance the market’s size in North America by improving on the vaccine coverage.

For instance, the immunization recommendations for hepatitis B in the United States were, in the past, based on risk factors, which are discriminating and ineffective. At present, only 30% of the US population is vaccinated against hepatitis B, and rates of acute hepatitis B have been increasing in the past decade, especially among those aged 40 and older. This points to the need for vaccination campaigns in the general population in order to decrease viral morbidity.

The hepatitis B vaccine market in the Asia-Pacific region is growing due to the increasing incidence of the disease. The vaccine manufacturers are currently majorly concentrating on the funding and partnership to come up with new vaccines and this is likely to take the region to the highest CAGR in the forecast period. For example, in April 2022, the Japanese pharmaceutical company Shionogi & Co., Ltd. and NEC Corporation signed a contract to jointly study a new hepatitis B vaccine to meet medical demand and strive to achieve a cure for the disease.

Hepatitis B Vaccine Market Leading Companies

The Hepatitis B Vaccine market players profiled in the report is GlaxoSmithKline Biologicals, Beijing Minhai Biotechnology, CSL Ltd, Dynavax Technologies, Emergent Biosolutions, Merck & Co., Inc., Pfizer Inc., Novartis AG, Serum Institute of India, Sanofi Pasteur, and Sinovac Biotech.

Hepatitis B Vaccine Market Regions