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 Regional Forecast, 2024-2032

The global hepatitis B vaccine market size was valued at USD 8.38 billion in 2023, and is projected to grow from USD 8.85 billion in 2024 to USD 13.31 billion by 2032, exhibiting a CAGR of 5.2% during the forecast period. North America dominated the global market with a share of 33.89% in 2023.

The hepatitis B virus (HBV) is a severe public health concern worldwide and a cause of cirrhosis, chronic hepatitis, and hepatocellular carcinoma. There has been a considerable increase in the prevalence of hepatitis B cases due to prenatal transmission from infected mothers to their newborns at birth or in contact with an infected person's body fluids (such as blood or saliva).

• For instance, as per data published by the World Health Organization (WHO), in 2019, around 296 million people suffered from hepatitis B infection. Moreover, , 1.5 million new cases are observed annually. (2023)

Thus, owing to the high prevalence of infection, several international public health agencies have implemented strategies to achieve progress toward the global elimination goal of this viral infection.

• For instance, in September 2020, the European Centre for Disease Prevention and Control, with the assistance of a regional action plan implemented by the WHO, dropped the estimated hepatitis B infections to 4.7 million cases in Europe. The regional plan covered 95% of infants with a three-dose vaccine, screening of pregnant women with 90% coverage, and 95% coverage of infants born to infected mothers.

Therefore, the rising prevalence of hepatitis infection and initiatives of mass immunization by government bodies to eliminate the disease led to increasing demand for these vaccines across the globe, further propelling the market growth.

During the COVID-19 pandemic in 2020, the market experienced a decline in its market value due to the lockdown restrictions and a limited number of patients visiting doctors’ clinics. However, the market experienced substantial growth in 2021 and 2022 due to the relaxation of lockdown restrictions and a rise in the number of patients visits to physicians’ offices.

Hepatitis B Vaccine Market Trends

High Adoption of Combination Vaccines, especially in Developed Countries

Bacterial or yeast cells are used for manufacturing traditional recombinant vaccines, wherein a piece of DNA is separated from the virus or bacterium and inserted into manufacturing cells.

The use of recombinant DNA technology in vaccines can aid in the production of an optimal immune response for hepatitis B. It can be cost-effective if manufactured using yeast-based recombinant proteins. This also helps in enhancing the safety of the product. However, the traditional single-antigens act only against all known subtypes of the virus with less seroprotection in adults.

• For instance, in February 2023, Dynavax Technologies, a biopharmaceutical company, announced that the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted Marketing Authorization for HEPLISAV B, which is a recombinant hepatitis B vaccine for active immunization in adults in the age group of 18 years and older.

Similarly, the production of combination vaccines uses more than one drug to treat a disease. The use of combination therapy has demonstrated more efficacy in patients suffering from hepatitis B than single antigen vaccines.

• In November 2021, Vir Biotechnology, Inc. announced new clinical data from ongoing trials of VIR-2218 in combination with PEG-IFN-α, which demonstrated substantial reductions of HbsAg compared to VIR-2218 alone.


• For instance, in July 2021, Vir Biotechnology, Inc. initiated the phase 2 clinical trials of the VIR-2218 and VIR-3434, a siRNA combination of vaccines to treat chronic viral hepatitis infection.

Also, the approval of the products that have to be administered in two doses contributes to the faster and higher response rate of these vaccines.

• In January 2021, Gilead Sciences, Inc. collaborated with Vir Biotechnology, Inc. to develop a new combination therapy for treating patients with the hepatitis B virus. The main aim of this collaboration is to evaluate different novel therapeutic combinations for developing a new hepatitis B vaccine.

Thus, the rising approval and adoption of combination vaccines compared to traditional ones aid the growth of the global market.

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Hepatitis B Vaccine Market Growth Factors

Extensive Investments in R&D by Major Industry Players to Boost Market Growth

The introduction of innovative products in the market is increasing owing to the rising adoption of new drug mechanisms for vaccine production. This will further provide opportunities for companies equipped with strong innovative R&D capabilities to invest heavily in developing new products. Therefore, such investments in R&D by key players for new vaccine trials and production across the globe are further projected to propel the market growth.

• For instance, in December 2022, according to Vir Biotechnology, Inc.’s annual report statistics, the company invested USD 474.6 million in the R&D of new candidates in the pipeline. Currently, the company has four candidates in the pipeline for hepatitis B and all are in phase II of the clinical trials.

Also, the companies are focusing on strategic partnerships to launch a product with high market potential, allowing companies to expand their product portfolio with a strategy to market their product globally. These collaborations will also lead to growth in international sales by registering existing products in new countries and developing new products in highly regulated markets.

• For instance, in June 2021, Vaxelis was launched in the U.S. and was the first hexavalent vaccine approved in the country. Vaxelis is a hexavalent combination vaccine that protects against six diseases, diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B, and was developed as part of a U.S.-based partnership between Merck & Co., Inc., and Sanofi Pasteur.


• Similarly, in September 2022, Valneva SE and VBI Vaccines Inc. announced a partnership in selected European markets for the marketing and distribution of PreHevbri, the only 3-antigen vaccine approved in Europe.

Thus, an increase in investments in the R&D of new vaccines and collaborations of different market players to develop a vaccine with an advanced mechanism of action is anticipated to contribute to the market's growth.

RESTRAINING FACTORS

Stringent Regulatory Policies for Vaccine Approval to Hinder Market Growth

Vaccines under the U.S. Food and Drug Administration (FDA) regulations undergo several rigorous review procedures by laboratories to ensure these products' purity, safety, efficacy, and potency. Also, the approved marketing products have to undergo additional studies for evaluation.

For instance, a manufacturer has to file a Biologics License Application (BLA) after the criteria of phase 3 clinical trials are met, which includes submitting thousands of pages of preclinical and clinical data with details of the manufacturing process of the facility.

Also, manufacturing companies must submit requests to the Stringent Regulatory Authority (SRA) for permission to share nonpublic information with the national regulatory authorities.

• According to the 21 CFR 610.1 regulation of the U.S. FDA, the manufacturer has to test each lot of the product to show confirmation of standards applicable to that product. In order to comply with the standard regulation, the company has to do it on a regular basis for each lot.

Thus, developing a vaccine may take around 10 to 15 years to establish its safety and efficacy. Similarly, the factors contributing to such a long process may further arise with complexities at the time of the development process, the clinical trial process, and different regulatory requirements in other regions. Thus, this process with high time consumption will contribute to additional time utilization owing to stringent regulatory policies by various administrative organizations for approval. Therefore, these factors are expected to limit the introduction of new products by advanced technologies, further restraining market growth.

Hepatitis B Vaccine Market Segmentation Analysis

By Type Analysis

High Potential Advantages of Combination Vaccines to Augment Market Growth

The market is segmented by type into single antigen and combination. Among types, the combination segment accounted for the largest market share in 2023. The dominance was attributed to potential advantages over a single vaccine, such as improved cost-effectiveness, high immunogenicity, and protection against five or more diseases, including hepatitis B. Moreover, these vaccines require administering one or two doses, leading to early disease protection compared to single antigens, further increasing their adoption among the population.

• For instance, in February 2023, VBI Vaccines Inc., a biopharmaceutical company, announced interim data from the Phase 2 study evaluating the effect of combining VBI-2601 (BRII-179), VBI Vaccines Inc.’s HBV immunotherapeutic candidate, and BRII-835 (VIR-2218), an HBV-targeting siRNA candidate, in chronically infected HBV patients.

Furthermore, rising strategic initiatives by government health bodies across the globe and expanding the role of combination vaccines in population-based vaccination programs with younger age groups further augment the demand for these products.

Thus, the rising demand for these vaccines owing to better potential advantages over single antigens and increasing combination vaccine-based vaccination programs across the globe propel the segment share in the market.

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By Distribution Channel Analysis

Increasing Immunization Rates will Augment the Hospitals & Retail Pharmacies Segment

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

The hospitals & retail pharmacies segment accounted for the highest market share in 2023. The highest share was attributed to the large volume of product sales owing to the first vaccination dose administered before the discharge of newborn infants from hospitals. Moreover, the extensive supply of vaccines from hospitals is expected to surge the vaccination uptake amongst the population, further propelling the segment share.

The government suppliers segment is expected to grow at a significant CAGR during the forecast period. The higher growth was due to rising strategic initiatives by government bodies, such as the World Health Organization (WHO), PAHO, and Ministry of Health and Family Welfare (MoHFW), among others, to eliminate hepatitis B infection across the globe by introducing national and global health programs providing free-of-cost immunization. Moreover, high procurement of vaccines from key players to boost supply and primary vaccination among the population will further propel the segment growth.

• For instance, the Department of Health & Human Services January 2021 announced the Viral Hepatitis National Strategic Plan for the U.S., “A Roadmap to Elimination” (2021–2025), to eliminate viral hepatitis as a public health threat in the country.

REGIONAL INSIGHTS

On the basis of region, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

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The North America market was valued at USD 2.84 billion in 2023 and is anticipated to continue to dominate the global market during the forecast period. The rising prevalence of hepatitis B diseases and the measures taken by national healthcare organizations for prevention, screening, and reducing the mortality rates caused by viral hepatitis infections have been influential for the highest share of the North American region in the global market. Moreover, increasing collaboration among manufacturing players and rising approvals of new combination vaccines with extensive regional presence further boosted the North American market.

• In February 2024, GSK plc announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB).

Europe is the second most dominated region in terms of revenue and market share. The market in Europe held a significant share due to a number of regional action plans implemented by European government authorities in order to increase the coverage of newborn neonates against hepatitis B infection. For instance, as per World Health Organization estimates, by December 2019, 50 out of 53 countries in Europe provided routine vaccination with hepatitis B to all infants or children aged 1–12 years, including 23 countries that offered doses to all newborns.

The Asia Pacific hepatitis b vaccine market share is driven by the rising prevalence of the disease, with the focus of the vaccine manufacturing players on raising funds and collaborations for the development of novel vaccines, which is anticipated to boost the growth of the region at the highest CAGR over the forecast period. For instance, in April 2022, Shionogi & Co., Ltd., a Japanese research-driven pharmaceutical company, collaborated with NEC Corporation to research and develop a novel vaccine. The collaboration aims to meet the medical needs of the disease condition and to achieve a complete cure for hepatitis B.

On the other side, the Rest of the World (RoW) market, which includes Latin America and the Middle East, is likely to grow at a slower pace. The rising prevalence of hepatitis B infection in the region and the adoption of different strategic frameworks are accelerating the growth of the market in the region.

• For instance, in July 2022, the World Health Organization (WHO) adopted the strategic framework of 2021-2030 in response to the rising prevalence of infection in Africa. The strategy aims to include the birth dose of the hepatitis B vaccine in 35 states of the region.

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List of Key Companies in Hepatitis B Vaccine Market

Robust Investments in New R&D Centers by Key Players to Propel Market

The market is primarily dominated by key manufacturers such as Sanofi and Gilead Sciences, Inc., among others. The top market players are focusing on accelerating investments in vaccine production centers and rising collaborations & acquisitions owing to the high demand for vaccines across the globe. These factors are anticipated to augment the growth of the hepatitis B vaccine market.

• In April 2021, Sanofi declared an investment of USD 476.1 million over five years to create a unique vaccine production site in Singapore, pushing the boundaries of operations through cutting-edge manufacturing and digital technologies.

Similarly, other prominent players in the market, including Dynavax Technologies Corporation and Merck & Co., Inc., are continuously engaged in key developments, such as enhancing their distribution channel across the global market through strategic partnerships and extensive product approvals. Such initiatives by key players are projected to propel the global market and register growth by 2029.

• For instance, in November 2021, PreHevbrio was approved by the U.S. Food and Drug Administration (FDA) and is the only approved three-antigen vaccine for adults manufactured by VBI Vaccines Inc. It is commercially available as Sci-B-Vac in Israel and 14 other countries.

LIST OF KEY COMPANIES PROFILED:

• GSK plc (U.K.)


• DYNAVAX TECHNOLOGIES (U.S.)


• VBI Vaccines Inc. (U.S.)


• Sanofi (France)


• Merck & Co., Inc. (U.S.)


• Beijing Minhai Biological Technology Co., Ltd. (China)


• Gilead Sciences, Inc. (U.S.)


• Beijing Tiantan Biological Products Co., Ltd. (China)


• Amy Vaccine Co., Ltd. (China)


• Biokangtai (China)

KEY INDUSTRY DEVELOPMENTS:

• July 2023 - VBI Vaccines Inc. announced the availability of PreHevbri, a hepatitis B vaccine, in the Netherlands and Belgium for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults.


• September 2022 - Valneva SE. and U.S.-based VBI Vaccines Inc. announced a partnership for the marketing and distribution of the PreHevbri vaccine in selected European markets.


• April 2022 - Shionogi & Co., Ltd. and NEC Corporation announced the execution of a strategic research collaboration agreement to develop a hepatitis B therapeutic vaccine.


• December 2021 - Sinovac invested USD 155.0 million in the company's research and development programs, which was comparatively greater than the previous year, accounting for USD 48.8 million in 2020 and USD 24.3 million in 2019. This strategy will assist the company in ensuring its future growth.


• August 2021 - Sanofi announced the acquisition of Translate Bio Inc. to accelerate the adaptability of mRNA technology for the research and development of new vaccines. This strategic acquisition brought advancement to the company's R&D facility and improved the productivity of the products in the pipeline.

REPORT COVERAGE

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The 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.

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