Heplisav-B Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

This Heplisav-B market report delivers an in-depth analysis of the market’s key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market.

The growth observed during the historical period can be attributed to several factors, including an increase in government funding, more investments in research and development, a growing global aging population, governmental support for immunization programs, and a rise in healthcare spending.

The growth projected for the forecast period is driven by the rising prevalence of hepatitis B, the increase in chronic diseases, expanding global health initiatives, escalating healthcare costs, and the development of healthcare infrastructure. Key trends in this period include technological innovations, faster vaccination methods, digital health tools, personalized medicine, and the rise of telemedicine.

The growing prevalence of hepatitis B infections is anticipated to drive the expansion of the heplisav-B market in the future. Hepatitis B is a liver disease caused by the hepatitis B virus (HBV), which can result in both acute and chronic conditions, such as cirrhosis and liver cancer. The increasing incidence of hepatitis B is primarily due to factors such as low vaccination rates, transmission within high-risk groups, limited awareness, and inadequate healthcare access. Heplisav-B is a vaccine that works by stimulating the immune system to produce protective antibodies against hepatitis B. According to the World Health Organization (WHO), an estimated 254 million people worldwide were living with chronic hepatitis B in 2022, with 1.2 million new cases reported annually. The disease leads to approximately 1.1 million deaths each year, mainly from complications such as cirrhosis and liver cancer (hepatocellular carcinoma). As such, the rising prevalence of hepatitis B is expected to support the growth of the heplisav-B market.

The increasing prevalence of chronic diseases is projected to contribute to the growth of the heplisav-B market. Chronic diseases are long-term conditions that typically develop gradually, persist for extended periods, and often require continuous medical attention and lifestyle management. This rise is driven by factors including an aging population, changing lifestyles, insufficient healthcare access, and increased environmental factors. Heplisav-B plays a critical role in managing chronic diseases, especially in individuals with weakened immune systems, as it provides a stronger and more durable immune response against hepatitis B infection. For example, the Australian Bureau of Statistics reported in December 2023 that 81.4% of Australians, or 20.7 million people, had at least one long-term health condition lasting six months or more in 2022, and 49.9% (12.6 million) had at least one chronic condition. Women were more likely to experience chronic conditions, with 52.3% of women compared to 47.4% of men. Thus, the rising prevalence of chronic diseases will further drive the growth of the heplisav-B market.

A key trend within the heplisav-B market is the focus on developing innovative products, such as hepatitis B adjuvanted vaccines, which offer stronger and more durable immune responses. These vaccines include an adjuvant to enhance the immune response to the hepatitis B surface antigen, improving vaccine efficacy, particularly in individuals with weaker immune systems. In February 2023, Dynavax Technologies Corporation, a US-based biopharmaceutical company, announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain approved Heplisav-B for marketing. This vaccine, which is intended for adults, is approved for active immunization against all known subtypes of hepatitis B in individuals aged 18 and older. The approval was based on favorable safety and immunogenicity results from three Phase 3 clinical trials. Heplisav-B combines the hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist adjuvant, CpG 1018, to enhance the immune response. Dynavax holds the global commercial rights to heplisav-B.

The key company operating in the heplisav-B market is Dynavax Technologies Corporation.

North America was the largest region in the heplisav-B market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in heplisav-B report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the heplisav-B market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Heplisav-B is a recombinant vaccine designed to protect adults aged 18 and older from hepatitis B. It includes the hepatitis B surface antigen (HBsAg) along with an advanced adjuvant (1018) to boost the immune response. Administered as a two-dose regimen over the span of one month, Heplisav-B provides higher seroprotection rates and offers greater convenience than traditional three-dose vaccines. This makes it especially effective for high-risk groups such as healthcare professionals, individuals with chronic liver disease, and those with diabetes.

The primary forms of Heplisav-B are vaccines and combination vaccines. Vaccines are biological products that help the body develop immunity against specific infectious diseases by stimulating the immune system to recognize and combat pathogens. Heplisav-B is used for preventing adult hepatitis B, particularly for special populations, and is distributed through integrated delivery networks (IDNs), large clinics, retail pharmacies, and hospitals.

The heplisav-B market research report is one of a series of new reports that provides heplisav-B market statistics, including heplisav-B industry global market size, regional shares, competitors with a heplisav-B market share, detailed heplisav-B market segments, market trends and opportunities, and any further data you may need to thrive in the heplisav-B industry. This heplisav-B market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The heplisav-B market consists of sales of adjuvants, immunology products, diagnostic kits, and therapeutic vaccines. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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