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 2030, Exhibiting a CAGR Of 4.5% During The Forecast Period.

Hepatitis B Vaccine Market Overview:

The global COVID-19 pandemic has been unprecedented and shocking. Demand for the hepatitis B vaccine is lower than expected in all areas compared to levels before the pandemic. Based on our research, the global market for hepatitis B vaccines will be 11.0% smaller in 2020 than it was in 2019.

The Hepatitis B Virus (HBV) is a major cause of cirrhosis, chronic hepatitis, and hepatocellular cancer. It is a serious threat to public health all over the world. There have been a lot more cases of hepatitis B because infected mothers pass it on to their babies at birth or because babies come into contact with an infected person's body fluids (such as blood or saliva).

For example, in November 2021, the Lancet Global Health published an article that said there were 1.5 million new cases of chronic HBV infection in Africa in 2019, 90% of which were in newborn babies who could get liver disease from HBV.

Due to the high number of people who are infected, several international public health agencies have put in place plans to help countries around the world reach their goals of eliminating hepatitis B.

For example, in September 2020, the European Center for Disease Prevention and Control and the WHO worked together to bring the number of estimated hepatitis B infections in Europe down to 4.7 million. The regional plan gave a three-dose hepatitis B vaccine to 95% of infants, screened 90% of pregnant women, and gave the vaccine to 95% of babies born to mothers who were infected.

So, the growing number of people with HBV infection and government efforts to get rid of the infection by giving everyone a vaccine led to a rise in demand for these vaccines all over the world, which helped the market grow even more.

Market Dynamics:

Latest Trends:

Traditional recombinant vaccines are made from bacterial or yeast cells. A piece of DNA from the virus or bacterium is taken out and put into the manufacturing cells.

Using recombinant DNA technology in vaccines has the benefit of giving the best immune response to hepatitis B. If the vaccine is made with recombinant proteins made from yeast, it is also cheaper and safer. Traditional single-antigens, on the other hand, only work against all known subtypes of HBV, and adults have less seroprotection from them.

For example, in November 2021, the FDA approved PreHevbrio, a hepatitis B vaccine made with recombinant DNA technology, to protect adults over the age of 18 against only the known subtypes of HBV.

In the same way, when making combination vaccines, more than one drug is used to treat a disease. Patients with hepatitis B who use combination therapy do better than those who only get a single antigen vaccine.

In November 2021, Vir Biotechnology, Inc. released new clinical data from ongoing trials of VIR-2218 in combination with PEG-IFN-. These trials showed that HbsAg was greatly reduced compared to when VIR-2218 was used on its own.

For example, in July 2021, Vir Biotechnology, Inc. began phase 2 clinical trials of the VIR-2218 and VIR-3434 vaccines, which use siRNA to treat chronic HBV infection.

Also, the fact that the products that need to be given in two doses have been approved helps these vaccines work faster and better.

For example, the Hepatitis B Foundation published an article in September 2020 saying that Heplisav-B, which is used to prevent hepatitis B, is recommended for use in the U.S. by adults over 18 and can be given in two doses one month apart. In the same way, the Association of Occupational Health Professionals (AOHP) said that in 2021, Heplisav-B worked better than the three-dose vaccine (engerix-B), which only worked 81.3% of the time.

So, the growth of the global market is helped by the fact that combination vaccines are getting more approval and use than traditional vaccines.

Driving Factors:

Major market players are putting a lot of money into research and development to help the market grow.

More and more new drug mechanisms are being used to make vaccines, which is causing more and more new products to hit the market. This will give companies with strong research and development (R&D) skills more chances to invest heavily in making new products. So, key players' investments in research and development for testing and making new hepatitis B vaccines around the world are expected to keep the market growing.

For example, Vir Biotechnology, Inc.'s annual report says that the company spent USD 44.8 billion on R&D for new candidates in the pipeline in December 2021. At the moment, the company has six possible treatments for hepatitis B in the pipeline. Five of these treatments are in phase II of clinical trials, and one is in phase I.

Also, companies are focusing on strategic partnerships to launch a product with a lot of market potential. This lets companies add more products to their line and plan how to sell them all over the world. By registering existing products in new countries and making new products for markets with a lot of rules, these partnerships will also help international sales grow.

For example, Vaxelis was the first hexavalent vaccine to be approved in the U.S. It came out in June 2021. Vaxelis is a hexavalent combination vaccine that protects against six diseases: diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B. It was made by Merck & Co., Inc. and Sanofi Pasteur in the U.S. as part of a partnership.

In the same way, Valneva SE and VBI Vaccines Inc. announced in September 2022 that they would work together to market and distribute PreHevbri, the only 3-antigen hepatitis B vaccine approved in Europe, in certain European markets.

So, more money will be spent on research and development of new vaccines, and different market players will likely work together to make a vaccine with a more advanced way of working.

Restraining Factors:

Tough rules for approving vaccines will slow down market growth.

Under FDA rules, vaccines go through a number of strict tests in laboratories to make sure they are pure, safe, effective, and strong. Also, the products that are approved for marketing have to go through more studies to be evaluated.

For example, a manufacturer must file a Biologics License Application (BLA) after the criteria of phase 3 clinical trials are met. This includes sending thousands of pages of preclinical and clinical data with details about how the facility makes the drug.

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

The 21 CFR 610.1 rule from the U.S. FDA says that the manufacturer has to test each batch of the product to show that it meets the standards for that batch. In order to follow the standard rule, the company has to do this for each lot on a regular basis.

So, it could take between 10 and 15 years to make a vaccine and prove that it is safe and effective. In the same way, the development process, clinical trial process, and different regulatory requirements in different parts of the world may all add to the length of time it takes to make a drug. So, this process, which takes a lot of time, will take even more time because of the strict rules that different administrative organizations have to follow for approval. So, these factors are likely to make it harder for advanced technologies to create new products, which will slow market growth even more.

Segmentation Analysis:

By Type Analysis:

Combination vaccines have many benefits that could help the market grow.

By type, the market is divided into single antigen and combination segments. In 2021, the segment of the market that was made up of combinations was the largest. People thought that it was better than a single vaccine because it could be more cost-effective, have a high immunogenicity, and protect against five or more diseases, such as hepatitis B. Also, these vaccines only need one or two doses, so they protect against disease faster than single antigens. This makes them even more popular with the public.

For example, in November 2021, VBI Vaccines Inc., a biopharmaceutical company based on immunology, said it would start selling PreHevbrio to protect adults in the U.S. aged 18 and up from getting sick from all known subtypes of the hepatitis B virus. The Lancet Infectious Diseases did a very important study in May 2021 that compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. The survey showed that PreHevbrio had higher seroprotection rates in people over 18 (91.4% vs. 76.5%) and adults over 45 (89.4% vs. 73.1%).

The demand for these products is also boosted by the fact that governments all over the world are taking more strategic steps in health care and that combination vaccines are being used more in population-based vaccination programs for younger age groups.

So, the segment share in the market is driven by the rising demand for these vaccines, which have more potential benefits than single antigens and are used in more vaccination programs around the world.

By Distribution Channel Analysis:

The market is divided into hospitals and retail pharmacies, government supplies, and others based on how the products are sold.

In 2021, the largest portion of the market was made up of hospitals and retail pharmacies. The highest share was due to the fact that a lot of products were sold because babies got their first shot of vaccine before they left the hospital. Also, hospitals' large supply of vaccines is likely to increase the number of people who get vaccinated, which will boost the segment share even more.

During the time frame of the forecast, the government suppliers segment is expected to grow at a high CAGR. The higher growth was caused by more strategic plans by government organisations like the World Health Organization (WHO), the Pan American Health Organization (PAHO), and the Ministry of Health and Family Welfare (MoHFW), among others, to get rid of hepatitis B around the world by starting free national and global health programmes that immunise people. The segment will also grow because of high purchases of vaccines from key players to increase supply and primary vaccinations among the population.

For example, in January 2021, the Department of Health and Human Services released the Viral Hepatitis National Strategic Plan for the U.S., "A Roadmap to Elimination" (2021–2025), which aims to get rid of viral hepatitis as a threat to public health in the country.

Regional Insights:

In 2021, the North American market was worth USD 2.60 billion, and it is expected to continue to be the largest market in the world during the period of the forecast. Hepatitis B diseases are becoming more common, and national health organisations have taken steps to prevent, screen for, and lower the death rates caused by viral hepatitis B infections. This has had the most impact on the North American region, which has the largest share of the global market. North America's market is also growing because more companies are working together and more new combination vaccines are being approved. These vaccines are used widely across the region.

Merck & Co., Inc. and Sanofi Pasteur worked together to launch Vaxelis in the U.S. in June 2021. It was the first hexavalent combination vaccine that protects children and babies from diseases like diphtheria, tetanus, polio, Haemophilus influenzae type B (Hib), and hepatitis B.

In terms of sales and market share, Europe is the second most important region. Due to a number of regional action plans put in place by European government officials to protect more newborn babies against hepatitis B infection, the European market held a large share. For example, the World Health Organization says that by December 2019, 50 out of 53 European countries will offer routine hepatitis B vaccinations to all infants and children ages 1–12, including 23 countries that give all newborns a dose of hepatitis B at birth.

Asia-share Pacific's of the hepatitis B vaccine market is being driven by the growing number of people with hepatitis B disease. At the same time, companies that make vaccines are trying to raise money and work together to make new hepatitis B vaccines, which is expected to help the region grow at the highest CAGR over the next few years. In April 2022, for example, Shionogi & Co., Ltd., a Japanese pharmaceutical company that focuses on research, worked with NEC Corporation to study and create a new hepatitis B vaccine. The goal of the collaboration is to meet all of the medical needs of the disease and find a cure for hepatitis B.

On the other hand, growth is likely to be slower in the Rest of the World (RoW) market, which includes Latin America and the Middle East. The market is growing faster in the region because there are more people with hepatitis B and because different strategic frameworks are being used.

Scope Analysis

Recent Development:

• December 2021 - Sinovac invested US$155 million in the company's research and development programs, which accounted for US$48.8 million in 2020 and US$24.3 million in 2019, up from the previous year. This strategy will help secure the company's 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 advances the company's R&D facilities and improves the productivity of products in the pipeline.
• May 2021 - Dynavax Technologies has entered into a commercialization agreement with Germany-based company Bavarian Nordic for marketing and distribution of HEPLISAV-B in Korea, with distribution expected to begin in 2022.
• January 2021 - Gilead Sciences, Inc. has teamed up with Vir Biotechnology, Inc. to develop a new combination therapy to treat patients with hepatitis B virus. A major goal of this collaboration is to evaluate various novel therapeutic combinations for the development of a new hepatitis B vaccine.
• July 2020 – GSK plc and CureVac AG announce a strategic collaboration for mRNA technology. The collaboration enables manufacturing, commercialization and R&D of five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens.

Market Segmentation

By Type:

• Single Antigen
• Combination
• Others

By Distribution Channel:

• Hospitals
• Government Suppliers
• Others

By Companies:

• 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)
• Others