Recombinant hepatitis B vaccine market is anticipated to grow at a CAGR of 5.6% during the forecast period. The increasing demand for hepatitis B vaccination and the growing prevalence of hepatitis B is the foremost factors driving the market growth. For instance, in 2019, 30.4 million people (10.5% of all people were estimated to be living with hepatitis B) were aware of their infection, while 6.6 million (22%) of the people diagnosed were on treatment. According to the WHO estimates, the proportion of children under five years of age chronically infected with HBV dropped to just under 1% in 2019. The prevalence of HBV infected population is high, especially in the WHO Western Pacific Region. The prevalence of hepatitis B among the general population in the Western Pacific Region was 5.92% in 2019. It is expected that, with further increasing prevalence, the demand for recombinant hepatitis B vaccines is likely to increase more, which in turn will aid in market growth. 

Apart from these, the increasing US FDA approval of new drugs can bring lucrative growth opportunities for the market players targeting the recombinant hepatitis B vaccine market. In December 2021, the PreHevbrio vaccine developed by VBI Vaccines got approval from the US FDA for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults aged 18 years and older. PreHevbrio is the only approved 3-antigen hepatitis B vaccine for adults in the US. Moreover, in December 2018, the USFDA approved VAXELIS and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age. VAXELIS was developed as part of a joint partnership between Merck and Sanofi.  VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B. 

Segmental Outlook  

The global recombinant hepatitis B vaccine market is segmented based on type and application. On the basis of type, the market is bifurcated into 10mcg/ml and 10mcg/0.5ml. Based on application, the market is sub-segmented into newborns/children and adults. Among these, the newborns/children segment is expected to create wide scope for recombinant hepatitis B vaccines. Primary school students especially those are under the age of 10 are at higher risk to get affected by hepatitis. As per the UK Health Security Agency, an increase in the number of acute (sudden onset) hepatitis cases in the UK in children aged 10 and under has been detected. Hepatitis sometimes led to major illnesses and mortality. It also affects liver functioning and sometimes required liver transplants. As per the report released in May 2022 by the US Centers for Disease Control and Prevention (CDC), about 9% of the 180 affected children in the US have required liver transplants due to hepatitis. Moreover, in 2021 WHO estimated that 12% to 25% of people with chronic hepatitis B infection required treatment, depending on the setting and eligibility criteria. This has increased the requirement for recombinant hepatitis B vaccines. 

Regional Outlook 

Geographically, the global recombinant hepatitis B vaccine market is classified into four major regions including North America (the US and Canada), Europe (UK, Germany, France, Italy, Spain, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia-Pacific), and Rest of the World (Latin America and the Middle East and Africa (MEA)). The Asia-Pacific region is likely to show the fastest growth during the forecast period. The presence of a huge population base, integration of the HBV vaccine in pediatric immunization programs in the healthcare sector, significant healthcare investment by the government for vaccine development, and rising awareness programs for hepatitis B are the crucial factors driving the regional market growth.

Global Recombinant Hepatitis B Vaccine Market Growth By Region, 2022-2028

North America Holds the Largest Share in Recombinant Hepatitis B Vaccine Market

Geographically, the North American region held the highest market share in 2021. The region is estimated to dominate by accounting significant share in upcoming years. The region is primarily growing due to an increase in Hepatitis B cases. Hepatitis B is estimated to affect 850,000 people in the US. The increased US FDA approvals for Recombinant Hepatitis B Vaccines in the region have also surged the market growth. For instance, in December 2018, VAXELIS, diphtheria, tetanus, and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus B conjugate, and hepatitis B vaccine has been approved by the US FDA for children aged 6 weeks to 4 years. Furthermore, in July 2017, the US FDA had approved Dynavax Technologies Corporation's HEPLISAV-B to prevent hepatitis B virus infection caused by all known subtypes in adults aged 18 and older. 

Market Players Outlook

The major market players in the global recombinant hepatitis B vaccine market include Merck & Co., Inc., GlaxoSmithKline plc, Sanofi Pasteur, Dalian Hissen Bio-pharm, and Pfizer Inc., among others. The market players are also contributing significantly to the growth of the market by the adoption of various strategies including mergers and acquisitions, geographical expansion, partnerships, collaborations, and new product launches, to stay competitive in the market. 

The Report Covers

• Market value data analysis of 2021 and forecast to 2028.
• Annualized market revenues ($ million) for each market segment.
• Country-wise analysis of major geographical regions.
• Key companies operating in the global recombinant hepatitis B vaccine market. Based on the availability of data, information related to pipeline products, and relevant news is also available in the report.
• Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
• Analysis of market-entry and market expansion strategies.
• Competitive strategies by identifying ‘who-stands-where’ in the market.