Hepatitis B Vaccine Market Size, Share & COVID-19 Impact Analysis, By Type (Single Antigen and Combination), By Distribution Channel (Hospital & Retail Pharmacies, Government Suppliers, and Others), and Regional Forecasts, 2022-2029

The hepatitis B vaccine market size was valued at USD 7.53 billion in 2021. The market is projected to grow from USD 7.80 billion in 2022 to USD 10.62 billion by 2029, exhibiting a CAGR of 4.5% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with hepatitis B vaccine experiencing lower than anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global hepatitis B vaccine market exhibited a decline of 11.0% in 2020 as compared to 2019.

The Hepatitis B Virus (HBV) is a serious public health concern worldwide and a major cause of cirrhosis, chronic hepatitis, and hepatocellular carcinoma. There has been a considerable increase in the prevalence of hepatitis B cases due to perinatal 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, in November 2021, the Lancet Global Health published an article stating that in 2019, there were 1.5 million new cases of chronic HBV infection in Africa, among which 90.0% were newborn babies at risk of developing HBV-related liver disease.

Thus, owing to the high prevalence of infection, several international public health agencies have implemented strategies to achieve progress toward global hepatitis B infection elimination goals in countries across the globe.

• 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 hepatitis B vaccine, screening of pregnant women with 90% coverage, and 95% coverage of infants born to infected mothers.

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

COVID-19 IMPACT

Decline in Routine Hepatitis B Immunization amid COVID-19 Pandemic to Hamper Growth

The impact of the COVID-19 pandemic resulted in a decline in the market growth in 2020. Several countries faced challenges in accessing medical care and treatment due to delayed appointments & de-prioritization of routine hepatitis cases and primary care services. It was also challenging for community-based organizations to provide hepatitis B education, screening, preventive vaccinations, and other public health services. Thus, owing to lockdowns imposed by several countries across the globe, the routine immunization programs held by healthcare organizations such as United Nations International Children's Emergency Fund (UNICEF) & World Health Organization (WHO) were hampered.

• According to UNICEF, in May 2020, 99 countries reported a decline in immunization, or terminated mass immunization programs for DTP, measles, and hepatitis B, among others.


• According to OECD estimates in 2020, the percentage of children immunized against hepatitis B in India declined to 85.2% in 2020 from 90.6% in 2019.

However, despite these challenges, the community-based organizations adopted resources through creative strategies such as Hepatitis B United Philadelphia program included contactless hepatitis B lab testing, social media awareness, grants for preventive health programs, and clinical outreach to eliminate hepatitis infection. Such extensive measures by various health awareness programs and rising product approvals augmented the declined vaccination rates post-COVID-19 pandemic.

• In 2021, USD 0.3 million were declared for preventive health grants by the Community Based Organization Program (CBO) in the U.S. for local programs/projects that support and complement the efforts of the country's health.


• In November 2021, CDC Advisory Committee on Immunization Practices (ACIP) guidelines in the U.S. recommended vaccinating all children and adults up to age 60 with FDA approval of a 3-dose hepatitis B vaccine, PreHevbrio, which has higher response rates in adults.

LATEST TRENDS

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 High Adoption of Combination Vaccines to Boost Market Progress

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 the manufacturing cells.

The advantage of using recombinant DNA technology in vaccines is that it can produce an optimal immune response for hepatitis B and is cost-effective if manufactured using yeast-based recombinant proteins, with enhanced safety to the product. However, the traditional single-antigens act only against all known subtypes of HBV with less seroprotection in adults.

• For instance, in November 2021, PreHevbrio, a hepatitis B vaccine manufactured using a recombinant DNA technology, received approval from the FDA to prevent only known subtypes of HBV in adults above 18 years of age.

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 HBV 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.

• For instance, in September 2020, Hepatitis B Foundation published an article stating that Heplisav-B, used for the prevention of hepatitis B, is recommended in the U.S. for use in adults above 18 years of age and can be administered in two doses within one month apart. Similarly, according to the Association of Occupational Health Professionals (AOHP) statistics in 2021, Heplisav-B had a higher efficacy rate of 90.0% than the three-dose vaccine (engerix-B), with 81.3%.

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

DRIVING 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 hepatitis B vaccine trials and production across the globe are further projected to propel the market growth.

• For instance, according to Vir Biotechnology, Inc., annual report statistics, in December 2021, the company invested USD 44.8 billion in the R&D of new candidates in the pipeline. Currently, the company has six candidates in the pipeline for hepatitis B, of which five candidates are in phase II of the clinical trials and 1 candidate is in phase I.

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 hepatitis B vaccine approved in Europe.

Thus, increase in investments in 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 FDA regulation 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, the 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 need 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.

SEGMENTATION

By Type Analysis

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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 2021. The dominance was attributed to potential advantages over 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 November 2021, VBI Vaccines Inc., a biopharmaceutical company driven by immunology, announced the launch of PreHevbrio to prevent infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older in the U.S. Moreover, a pivotal study by ‘The Lancet Infectious Diseases in May 2021’ compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the survey showed that PreHevbrio elicited higher seroprotection rates in all subjects above age 18 (91.4% vs. 76.5%) and adults above age 45 (89.4% vs. 73.1%).

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.

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 2021. 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 in 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

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

The North American market was valued at USD 2.60 billion in 2021 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 B 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 presence across the region further boosted the North America market.

• In June 2021, Merck & Co., Inc. and Sanofi Pasteur, in collaboration, launched Vaxelis in the U.S., the first hexavalent combination vaccine that protects children's and infants against diseases such as diphtheria, tetanus, polio, Haemophilus influenzae type B (Hib), and hepatitis B.

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 hepatitis B birth doses to all newborns.

The Asia Pacific hepatitis b vaccine market share is driven by the rising prevalence of hepatitis B disease, with the focus of the vaccine manufacturing players on raising funds and collaborations for the development of novel hepatitis B 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 hepatitis B vaccine. The collaboration aims to unmet 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.

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

KEY INDUSTRY PLAYERS

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 hepatitis B vaccine market growth.

• 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 across the globe. 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 HBV 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 CORPORATION (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)


• Shenzhen Kangtai Biological Products (China)

KEY INDUSTRY DEVELOPMENTS:

• December 2021 - Sinovac invested USD 155.0 million in research and development programs of the company, 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 R&D facility of the company and improved the productivity of the products in the pipeline.


• May 2021 - Dynavax Technologies entered into a commercialization agreement with Bavarian Nordic, a Germany-based company, for the marketing and distribution of HEPLISAV-B in the country and expects to begin their distribution in 2022.


• 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.


• July 2020 – GSK plc and CureVac AG announced the strategic collaboration for mRNA technology. This collaboration allowed for the manufacturing, commercialization, and R&D of five mRNA-based vaccines and monoclonal antibodies (mAbs) that target infectious disease pathogens.

REPORT COVERAGE

An Infographic Representation of Hepatitis B Vaccine Market

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The research report provides 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 & Segmentation