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Last Updated: April 26, 2025

Hepatitis b vaccine (recombinant) - Biologic Drug Details


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Summary for hepatitis b vaccine (recombinant)
Tradenames:3
High Confidence Patents:0
Applicants:4
BLAs:4
Suppliers: see list6
Recent Clinical Trials: See clinical trials for hepatitis b vaccine (recombinant)
Recent Clinical Trials for hepatitis b vaccine (recombinant)

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)N/A
St George's, University of LondonPhase 1
Malaria Research and Training Center, Bamako, MaliPhase 3

See all hepatitis b vaccine (recombinant) clinical trials

Pharmacology for hepatitis b vaccine (recombinant)
Physiological EffectActively Acquired Immunity
Established Pharmacologic ClassInactivated Hepatitis B Virus Vaccine
Chemical StructureHepatitis B Vaccines
Vaccines, Inactivated
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for hepatitis b vaccine (recombinant) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for hepatitis b vaccine (recombinant) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for hepatitis b vaccine (recombinant) Derived from Patent Text Search

No patents found based on company disclosures

Hepatitis B Vaccine (Recombinant): Market Dynamics and Financial Trajectory

Market Overview

The global Hepatitis B Vaccine (Recombinant) market is experiencing significant growth, driven by increasing awareness of the disease, advancements in vaccine technology, and robust public health initiatives.

Market Size and Growth

As of 2023, the global Hepatitis B Vaccine (Recombinant) market is valued at approximately $6.5 billion and is projected to reach $9.5 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of over 5.6% during the forecast period of 2023-2030[1].

Segmental Analysis

The market is segmented based on type, application, distribution channel, and geography.

Distribution Channel

The hospitals segment holds the highest market share due to the large volume of vaccine sales to these institutions. This segment is expected to continue dominating the market as hospitals remain primary points of vaccination[1].

Application

The newborn/children segment is anticipated to dominate the global market, as the first vaccination dose is typically administered before newborns are discharged from hospitals. This early vaccination is crucial in preventing hepatitis B infections from an early age[1].

Key Market Drivers

Several factors are driving the growth of the Hepatitis B Vaccine (Recombinant) market:

Increasing Awareness and Public Health Initiatives

Growing global awareness of hepatitis B and its prevention techniques has led to an increased demand for vaccines. Public health campaigns and government initiatives to prevent the spread of the disease are significant drivers[1].

Technological Advancements

The development of advanced vaccine technologies, such as recombinant vaccines, has improved the efficacy and safety of hepatitis B vaccinations. For example, the HEPLISAV-B vaccine by Dynavax, which requires only two doses in one month, has seen significant adoption[2].

Expanding Market Access

Vaccines like PreHevbrio by VBI Vaccines, which is now available at several U.S. retail pharmacy chains, are expanding market access and increasing vaccine uptake. This broader availability is expected to further boost market growth[5].

Financial Performance of Key Players

Dynavax Technologies Corporation

Dynavax's HEPLISAV-B vaccine achieved record annual net product revenue of $125.9 million in 2022, representing a 104% growth from 2021. The company anticipates HEPLISAV-B net product revenue to be between $165 million and $185 million in 2023, indicating continued strong growth[2].

VBI Vaccines

VBI Vaccines reported a 234% year-over-year increase in global net revenue for PreHevbrio from 2022 to 2023. The vaccine's availability at multiple retail pharmacy chains and its approval in several regions have significantly contributed to this growth[3].

Market Opportunities and Challenges

Market Opportunities

  • Developing Nations: There is a significant opportunity for growth in developing nations where access to hepatitis B vaccines is still limited.
  • Combination Vaccines: The development of combination vaccines that protect against multiple diseases, including hepatitis B, is another area of potential growth[4].

Market Challenges

  • Competition: The market is highly competitive, with several major players such as GlaxoSmithKline, Merck & Co., Inc., and Sanofi. New entrants and innovative products can pose challenges to existing market leaders.
  • Regulatory Hurdles: Regulatory approvals and compliance can be time-consuming and costly, affecting the launch and distribution of new vaccines[4].

Competitive Landscape

Key Players

The global Hepatitis B Vaccine (Recombinant) market is dominated by several key players, including:

  • Dynavax Technologies Corporation: Known for its HEPLISAV-B vaccine.
  • VBI Vaccines: Developer of the PreHevbrio vaccine.
  • GlaxoSmithKline: A major player with a long-standing presence in the vaccine market.
  • Merck & Co., Inc.: Another significant player with a broad portfolio of vaccines[4].

Strategic Moves

Companies are adopting various strategies to reinforce their market share, such as mergers and acquisitions, partnerships, and product launches. For example, Gilead Sciences, Inc. and Vir Biotechnology Inc. collaborated to develop a new combination medication for treating hepatitis B virus infections[1].

Regional Analysis

The market is analyzed across several regions, including North America, Latin America, Western Europe, Eastern Europe, Middle East & Africa, and Asia Pacific. North America is currently the dominant region, driven by high healthcare spending and advanced healthcare infrastructure[1].

Future Outlook

Long-Term Projections

The global Hepatitis B Vaccine (Recombinant) market is expected to continue growing, driven by increasing demand and advancements in vaccine technology. By 2031, the market is projected to reach approximately $11.84 billion, growing at a CAGR of 4.6% from 2024 to 2031[4].

Emerging Trends

  • Advanced Vaccine Technologies: The development of new vaccine technologies, such as the use of adjuvants like CpG 1018 by Dynavax, is expected to enhance vaccine efficacy and safety.
  • Expanded Access: Efforts to make vaccines more accessible, particularly in developing regions, will be crucial for future market growth[2].

Key Takeaways

  • The global Hepatitis B Vaccine (Recombinant) market is valued at $6.5 billion in 2023 and is expected to reach $9.5 billion by 2030.
  • The market is driven by increasing awareness, public health initiatives, and technological advancements.
  • Key players like Dynavax and VBI Vaccines are experiencing significant revenue growth.
  • The market faces opportunities in developing nations and challenges from competition and regulatory hurdles.
  • North America is the dominant region, but other regions are expected to grow as access to vaccines improves.

FAQs

What is the current market size of the Hepatitis B Vaccine (Recombinant) market?

The global Hepatitis B Vaccine (Recombinant) market is valued at approximately $6.5 billion in 2023[1].

What is the projected growth rate of the Hepatitis B Vaccine (Recombinant) market?

The market is expected to grow at a CAGR of over 5.6% from 2023 to 2030[1].

Which segment dominates the Hepatitis B Vaccine (Recombinant) market in terms of distribution channel?

The hospitals segment holds the highest market share due to the large volume of vaccine sales to these institutions[1].

What are the key drivers of the Hepatitis B Vaccine (Recombinant) market?

Key drivers include increasing awareness of hepatitis B, public health initiatives, and technological advancements in vaccine development[1].

Who are the major players in the Hepatitis B Vaccine (Recombinant) market?

Major players include Dynavax Technologies Corporation, VBI Vaccines, GlaxoSmithKline, Merck & Co., Inc., and Sanofi[4].

Sources

  1. RationalStat: Hepatitis B Vaccine (Recombinant) Market Size, Market Share, Data Analysis and Forecasts 2023-2030[1].
  2. Dynavax: Dynavax Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Full Year 2023 Financial Guidance[2].
  3. VBI Vaccines: VBI Vaccines Reports Full Year 2023 Financial Results[3].
  4. SNS Insider: Hepatitis B Vaccine Market Size, Share & Growth Analysis[4].
  5. VBI Vaccines: VBI Vaccines Reports First Quarter 2023 Financial Results[5].

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