Hepatitis b vaccine (recombinant) - Biologic Drug Details

Summary for hepatitis b vaccine (recombinant)

Tradenames:	3
High Confidence Patents:	0
Applicants:	4
BLAs:	4
Suppliers: see list	4
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

Sponsor	Phase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	N/A
St George's, University of London	Phase 1
Institut de Recherche en Sciences de la Sante, Burkina Faso	Phase 3

See all hepatitis b vaccine (recombinant) clinical trials

Pharmacology for hepatitis b vaccine (recombinant)

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Hepatitis B Virus Vaccine
Chemical Structure	Hepatitis 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

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.

2. DrugPatentWatch analysis and brand-side disclosures

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.

3. Patents from broad patent text search

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 DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Vbi Vaccines (delaware), Inc.	PREHEVBRIO	hepatitis b vaccine (recombinant)	For Injection	125737	12,128,100	2039-11-13	DrugPatentWatch analysis and company disclosures
Vbi Vaccines (delaware), Inc.	PREHEVBRIO	hepatitis b vaccine (recombinant)	For Injection	125737	9,849,066	2034-04-23	DrugPatentWatch analysis and company disclosures
Dynavax Technologies Corporation	HEPLISAV-B	hepatitis b vaccine (recombinant), adjuvanted	Injection	125428	10,314,907	2038-01-18	DrugPatentWatch analysis and company disclosures
Dynavax Technologies Corporation	HEPLISAV-B	hepatitis b vaccine (recombinant), adjuvanted	Injection	125428	9,452,212	2032-04-16	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	10,537,580	2037-12-20	Patent claims search
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	11,072,615	2039-11-08	Patent claims search
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	9,115,113	2034-11-14	Patent claims search
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	9,169,212	2034-10-10	Patent claims search
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	9,339,510	2035-09-17	Patent claims search
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	9,505,722	2035-04-23	Patent claims search

International Patents for hepatitis b vaccine (recombinant)

Country	Patent Number	Estimated Expiration
Israel	283039
European Patent Office	3880244
China	118987191
Canada	3119581
Israel	314712
China	113423423

Market Dynamics and Financial Trajectory for the Hepatitis B Recombinant Vaccine

Last updated: July 30, 2025

Introduction

The global hepatitis B vaccine market, predominantly composed of recombinant vaccines, remains a critical segment within infectious disease prophylactics. Its landscape is influenced heavily by demographic trends, evolving healthcare policies, technological innovation, and economic factors. Understanding market dynamics and financial trajectories offers vital insights for stakeholders ranging from pharmaceutical firms to investors and healthcare policymakers.

Market Overview

The hepatitis B recombinant vaccine commands a significant and stable position within the vaccine industry. It addresses a substantial unmet medical need, especially in developing regions where hepatitis B virus (HBV) prevalence remains high. The vaccine's success is underpinned by the global disease burden, robust immunization programs, and the vaccine's proven efficacy and safety profile.

The global market was valued at approximately USD 3.8 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4% over the next five years, reaching nearly USD 4.9 billion by 2027 [1].

Market Drivers

1. Burden of Hepatitis B

An estimated 296 million people worldwide live with chronic hepatitis B infection, with Asia-Pacific and Africa bearing the highest burden [2]. The significant morbidity and mortality associated with HBV infections escalate the urgency for expansive vaccination programs, fostering steady demand for recombinant hepatitis B vaccines.

2. Immunization Policies and Public Health Initiatives

Global health organizations, including WHO, recommend universal infant immunization against hepatitis B. Many countries have integrated hepatitis B vaccines into their National Immunization Programs, incentivizing vaccine procurement and deployment [3].

3. Technological Advances

Recombinant DNA technology has improved vaccine safety and efficacy, increasing acceptance and coverage. Efforts to develop thermostable formulations and combination vaccines enhance immunization efficiency, thereby expanding market potential.

4. Expansion into Adult Vaccination

Traditionally targeted at infants, adult vaccination programs are gaining momentum, especially among high-risk groups—healthcare workers, immunocompromised individuals, and populations with high HBV prevalence—opening new revenue streams.

5. Competitive Landscape and Patent Expiry

Leading players like GlaxoSmithKline (Engerix-B), Merck (Recombivax HB), and India-based Bharat Biotech (Sci-Biotech) dominate, though patent expiries and biosimilar entries are anticipated to influence market share and pricing strategies.

Market Challenges

1. Pricing and Reimbursement Pressures

Healthcare systems in emerging markets often face budget constraints, leading to pricing pressures. Reimbursement challenges can limit market access, especially for lower-income populations.

2. Vaccine Hesitancy and Awareness

While generally well-accepted, vaccine hesitancy fueled by misinformation affects coverage rates, particularly in some developed countries.

3. High Costs of Production

Manufacturing recombinant vaccines requires sophisticated technology and stringent quality controls, resulting in high production costs, which can impact profitability margins, especially for biosimilars.

4. Competition from Non-recombinant Alternatives

Although recombinant vaccines are preferred, the emergence of innovative adjuvants and alternative modalities could influence future market shares.

Financial Trajectory

Revenue Streams

The revenue outlook hinges on regional vaccine penetration, pricing policies, and product pipeline expansion. Emerging markets are expected to comprise nearly 40% of revenues by 2027, driven by aggressive immunization campaigns and economic growth frictions.

Profitability Trends

Profitability is moderated by high R&D and manufacturing costs. However, patent protections and brand recognition for top vaccines afford healthier margins. Biosimilars expected to enter the market post-patent expiry could induce pricing pressures but also expand market size through increased access.

Investment and R&D Outlook

Investment in next-generation vaccines—such as thermostable or needle-free formulations—is increasing. R&D expenditure among key players surpasses USD 200 million annually, aiming to optimize cost-efficiency and expand indications [4].

Impact of Public-Private Partnerships

Partnerships with WHO and GAVI expand vaccine reach in low-income countries, ensuring sustained revenues and fostering a positive financial trajectory.

Regional Market Dynamics

North America & Europe

Market growth remains steady due to high vaccination coverage, advanced healthcare infrastructure, and mature regulatory environments. Market players focus on product differentiation and booster shot innovations.

Asia-Pacific

Emerging markets drive growth owing to large population bases, increasing healthcare access, and government-led immunization initiatives. India and China are key in manufacturing and distribution, with local companies gaining market share.

Africa & Latin America

Growth potential is significant, aligned with WHO efforts to eliminate HBV transmission. Cost considerations and vaccine supply chain development are primary focus areas.

Regulatory and Pricing Environment

Regulatory pathways for recombinant hepatitis B vaccines are well-established via agencies like the FDA, EMA, and respective national authorities, facilitating swift approvals. Price controls and reimbursement policies, however, vary widely, affecting market penetration and margins.

Key Players and Competitive Strategies

• GSK: Focuses on expanding immunization programs, developing combination vaccines, and navigating biosimilars' landscape.
• Merck: Invests heavily in research to develop more immunogenic formulations and innovative delivery systems.
• Bharat Biotech and Others: Targetting emerging markets with cost-effective formulations and local manufacturing facilities.

Strategic priorities include:

• Formulation of thermostable vaccines
• Expansion into adult booster markets
• Development of combination vaccines
• Partnership with governments to enhance access

Outlook and Strategic Recommendations

The hepatitis B recombinant vaccine market exhibits a resilient growth trajectory facilitated by ongoing immunization initiatives, technological innovation, and expanding markets. Firms should prioritize R&D investments in vaccine stability and ease of administration, explore biosimilar opportunities post-patent expiry, and deepen collaborations with healthcare authorities for broader adoption.

Emerging markets present both a growth opportunity and a risk landscape requiring tailored pricing and distribution strategies. Market entrants should focus on affordability, supply consistency, and educational campaigns to combat vaccine hesitancy.

Key Takeaways

• The hepatitis B recombinant vaccine market is projected to grow at a CAGR of approximately 4%, driven largely by HBV prevalence and immunization policies.
• Technological innovations—such as thermostability and combination formulations—are critical to expand market reach and enhance consumer compliance.
• Regional disparities, particularly between high-income and emerging markets, influence pricing, access, and revenue streams.
• Patent expiries and biosimilar entries are expected to introduce pricing competition but also create opportunities for increased access and volume sales.
• Public-private partnerships and global health initiatives will remain significant growth catalysts, especially in low-resource settings.

FAQs

1. How do technological innovations influence the financial outlook of hepatitis B vaccines?
Innovations like thermostable formulations reduce logistical costs and expand access in remote areas, increasing market penetration and revenue streams. Additionally, combination vaccines simplify immunization schedules, boosting acceptance and coverage, thereby positively impacting financial performance.

2. What role will biosimilars play in the future of the hepatitis B vaccine market?
Post-patent expiration, biosimilars are poised to lower prices and increase access, especially in emerging markets. They can potentially erode market share of originators but also stimulate overall market growth due to increased affordability.

3. How important are government immunization programs for market sustainability?
Extremely. Government initiatives and international organizations' campaigns sustain demand, ensure steady revenue, and promote product adoption, especially in low-income regions.

4. Which regional markets are expected to dominate growth and why?
Asia-Pacific markets, due to their large populations, high disease burden, and expanding healthcare infrastructure, are expected to lead growth. Africa and Latin America also offer substantial opportunities with targeted initiatives and economic development.

5. What are the biggest challenges facing vaccine manufacturers today?
Key challenges include pricing pressures, vaccine hesitancy, high manufacturing costs, regulatory complexities, and competitive threats posed by biosimilars and emerging technologies.

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References:

[1] Global Market Insights. "Hepatitis B Vaccines Market Size & Forecast," 2022.
[2] World Health Organization. "Hepatitis B Factsheet," 2022.
[3] GAVI Alliance. "Progress Toward Hepatitis B Vaccination," 2022.
[4] Pharmaceutical Technology. "R&D Trends in Vaccine Development," 2023.