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The hepatitis B vaccine market size was valued at USD 7.94 billion in 2022 and is projected to grow from USD 8.38 billion in 2023 to USD 12.36 billion by 2030, exhibiting a CAGR of 5.7% during the forecast period.
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 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).
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.
Therefore, the rising prevalence of hepatitis 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.
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 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.
However, despite these challenges, the community-based organizations adopted resources through creative strategies such as Hepatitis B United Philadelphia program included contactless 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.
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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 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 the virus with less seroprotection in adults.
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.
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.
Thus, the rising approval and adoption of combination vaccines compared to traditional ones aid the growth of the global market.
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.
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.
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.
Stringent Regulatory Policies for Vaccine Approval to Hinder Market Growth
Vaccines under the U.S. 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, manufacturing companies must submit requests to the Stringent Regulatory Authority (SRA) for permission to share nonpublic information with the national regulatory authorities.
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.
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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 2022. 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.
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.
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 2022. 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.
North America Hepatitis B Vaccine Market Size, 2022 (USD Billion)
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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 2.72 billion in 2022 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.
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 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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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.
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.
LIST OF KEY COMPANIES PROFILED:
An Infographic Representation of Hepatitis B Vaccine Market
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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.
Value (USD billion)
CAGR of 5.7% from 2023-2030
By Type, Distribution Channel, and Region
By Distribution Channel
Fortune Business Insights says that the global market size was USD 7.94 billion in 2022 and is projected to reach USD 12.36 billion by 2030.
Registering a CAGR of 5.7%, the market will exhibit steady growth in the forecast period (2023-2030).
The combination segment is expected to lead this market during the forecast period.
The rising prevalence of hepatitis B, and the increasing clinical trials for new products across the globe are the key factors driving the market growth.
GSK plc, Sanofi, and Merck & Co., Inc. are the major players in the global market.
High demand for mass immunization and product approvals around the globe are expected to drive the adoption of these products.
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