Hepatitis b immune globulin (human) - Biologic Drug Details

Summary for hepatitis b immune globulin (human)

Tradenames:	3
High Confidence Patents:	0
Applicants:	3
BLAs:	3
Suppliers: see list	3
Recent Clinical Trials:	See clinical trials for hepatitis b immune globulin (human)

Recent Clinical Trials for hepatitis b immune globulin (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Aarhus University Hospital	PHASE1
Charite University, Berlin, Germany	PHASE1
University of Pennsylvania	Phase 2

See all hepatitis b immune globulin (human) clinical trials

Pharmacology for hepatitis b immune globulin (human)

Mechanism of Action	Virus Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin
Chemical Structure	Immunoglobulins

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 immune globulin (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for hepatitis b immune globulin (human) 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
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945		2035-01-08	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945		2033-09-24	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945		2035-01-08	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	HEPAGAM B	hepatitis b immune globulin (human)	Injection	125035		2018-02-05	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	HEPAGAM B	hepatitis b immune globulin (human)	Injection	125035		2024-11-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for hepatitis b immune globulin (human) 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
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945		2039-11-08	Patent claims search
Kamada Ltd.	HEPAGAM B	hepatitis b immune globulin (human)	Injection	125035		2039-11-08	Patent claims search

International Patents for hepatitis b immune globulin (human)

Country	Patent Number	Estimated Expiration
European Patent Office	4233903
European Patent Office	3026059
Canada	2910491
Hong Kong	1225397
Brazil	102015027387

Market Dynamics and Financial Trajectory for Hepatitis B Immunoglobulin (Human)

Last updated: August 3, 2025

Introduction

Hepatitis B immunoglobulin (HBIG), a human-derived serum antibody, is a pivotal prophylactic agent against hepatitis B virus (HBV) transmission, especially in post-exposure scenarios such as needlestick injuries, and in preventing mother-to-child transmission. With the global burden of hepatitis B remaining high—estimated at over 296 million chronic infections, leading to significant morbidity and mortality—the market landscape for HBIG is shaped by shifting epidemiology, technological advancements, regulatory environments, and competitive dynamics. This analysis examines the current market forces influencing HBIG and projects its financial trajectory within the broader scope of immunoglobulin therapies.

Market Landscape Overview

The global HBIG market, valued at approximately USD 300 million in 2022, is characterized by its niche positioning within the broader immunoglobulin therapeutics segment.[1] Although its specific deployment is limited compared to pooled immunoglobulin products for primary immunodeficiency, HBIG's specialized role sustains steady demand, particularly in high-income countries.

Key drivers include:

• Hepatitis B prevalence and transmission pathways: Despite effective vaccines, vertical mother-to-child transmission remains prevalent in regions with low vaccine coverage, underpinning continued demand for HBIG.[2]

• Regulatory standards and prophylactic protocols: Stringent guidelines from agencies like the FDA and EMA mandate combined use of HBIG and vaccination in certain populations, cementing its clinical importance.[3]

• Advances in hepatitis B vaccination programs: Widespread immunization reduces HBIG demand over the long term; however, gaps persist in developing regions.

• Emerging accessibility and affordability trends: Efforts to lower costs and expand supply are influencing market dynamics, especially in low- and middle-income countries.

Market Dynamics

Epidemiological Influences

Despite global vaccination initiatives, regional disparities in hepatitis B vaccination coverage and healthcare infrastructure maintain a persistent need for HBIG in specific settings. For example, in Sub-Saharan Africa and parts of Southeast Asia, low immunization rates result in higher maternal transmission risks, preserving market demand.[4] Conversely, in high-income nations such as the US and European countries, HBIG's utilization is mainly confined to post-exposure prophylaxis and neonatal management, with declining trends owing to comprehensive vaccination.

Regulatory and Policy Frameworks

Regulatory policies heavily influence market access. The CDC recommends HBIG administration alongside hepatitis B vaccination for infants born to infected mothers, reinforcing demand in developed countries.[5] Additionally, changes in clinical guidelines that endorse alternative or fewer doses streamline the market but also pose challenges for traditional HBIG sales.

Supply Chain and Manufacturing Dynamics

The limited pool of manufacturers—primarily established players such as CSL Behring, Bio Products Laboratory, and Shire—controls supply and influences pricing. Manufacturing complexities involve sourcing plasma donations, purification, and quality assurance, which collectively constrain scalability. Initiatives to develop recombinant or monoclonal antibody alternatives are underway but not yet commercially viable, maintaining reliance on plasma-derived HBIG.

Pricing and Reimbursement Environment

Pricing remains stable in high-income markets due to the critical nature of the prophylactic intervention and regulatory controls. However, in lower-income regions, affordability challenges restrict access, prompting donor-driven supply initiatives or import restrictions. Reimbursement policies favoring vaccination over HBIG could potentially reduce demand over time, especially as vaccine coverage improves.

Emerging Technologies and Competition

While there are no widely adopted recombinant alternatives to HBIG yet, ongoing research explores monoclonal antibodies targeting HBV. These could potentially offer advantages in production, safety, and consistency. However, such innovations are still in clinical development stages and unlikely to disrupt the current market within the next 5–10 years.

Financial Trajectory and Forecast

Short-Term Outlook (2023–2027)

The immediate future anticipates a relatively stable market, supported by existing prophylactic protocols and incremental improvements in supply logistics. With global hepatitis B vaccination coverage gradually improving, especially in developing regions, demand may plateau or marginally decline. Nevertheless, rising awareness, declining plasma donation rates in some areas, and existing infrastructure constraints may stabilize or slightly increase prices, thereby maintaining revenue streams for manufacturers.

Medium to Long-Term Projections (2028–2033)

Projecting a decline in HBIG demand is plausible, driven by:

• Enhanced vaccination programmes: As neonatal immunization coverage reaches >90% globally, the need for HBIG in neonatal prophylaxis could diminish.

• Development of novel therapeutics: Recombinant monoclonal antibodies or synthetic antiviral agents may replace passive immunoglobulin therapy in certain indications.

• Policy shifts: Countries adopting policies favoring vaccination alone for post-exposure prophylaxis could curtail HBIG utilization.

Despite these trends, certain niche sectors—such as managing occupational exposures and high-risk pregnancies—are likely to sustain a baseline demand. Market value might decline to USD 200-250 million by 2030 but will remain significant given the global hepatitis burden.

Factors Supporting Market Resilience

• Persistent unmet needs in low-income regions.
• Demand for prophylaxis in immunocompromised populations.
• Potential for plasma collection expansion through donor incentives.

Risks and Challenges

• Emerging alternatives reducing reliance on HBIG.
• Pricing pressures and reimbursement constraints.
• Regulatory bottlenecks delaying new or biosimilar entries.
• Plasma supply limitations affecting manufacturing scalability.

Implications for Stakeholders

Pharmaceutical companies specializing in plasma-derived products must innovate to retain market share, either by optimizing production efficiency or investing in alternative research pathways. Policymakers should focus on expanding vaccination coverage, reducing reliance on passive immunoglobulin therapy, and ensuring equitable access to prophylactics.

Key Takeaways

• The hepatitis B immunoglobulin market is stabilizing with a projected gradual decline due to improved vaccination coverage and evolving prophylactic strategies.

• Supply constraints and high regulatory standards sustain current pricing, but emerging therapies could threaten future demand.

• Market resilience depends largely on low-income country needs, occupational exposure management, and high-risk pregnancies.

• Strategic investments in manufacturing efficiencies and pipeline diversification are prudent for existing players.

• Policymakers need to balance vaccination programs with strategic planning for prophylactic resource allocation.

Conclusion

While historically a niche product, hepatitis B immunoglobulin remains an essential component of hepatitis B prophylaxis, especially in specific high-risk populations and regions with incomplete vaccination coverage. Its market trajectory reflects a complex interplay of epidemiological, technological, and regulatory factors. Companies and policymakers must navigate these dynamics by fostering innovation, expanding access, and aligning strategies to address the evolving landscape of hepatitis B control.

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FAQs

1. What factors are most likely to influence the decline in HBIG demand over the next decade?
Improvements in global hepatitis B vaccination coverage, especially in neonatal immunization programs, are primary drivers. Additionally, the development of recombinant antibody therapies or potent antiviral agents could replace passive immunoglobulin therapy in some settings, reducing overall demand.

2. Are there any emerging alternatives to plasma-derived HBIG?
Research is ongoing into monoclonal antibodies targeting hepatitis B virus, which could serve as recombinant, standardized alternatives. However, none are currently approved commercially, and their impact on the market remains uncertain.

3. How does plasma supply impact the HBIG market?
Limited plasma donors and complex manufacturing processes constrain supply, affecting product availability and pricing. Enhancing plasma collection and processing efficiencies is vital to meet existing and future demand.

4. How do regulatory policies influence HBIG market growth?
Stringent guidelines mandate the use of HBIG alongside vaccination in specific circumstances, maintaining demand. Conversely, policy shifts favoring vaccination-only strategies could dampen future growth prospects.

5. What role do emerging markets play in shaping the future of HBIG?
Developing regions with low vaccination coverage continue to generate demand, offering growth opportunities for manufacturers willing to invest in supply logistics and pricing strategies tailored to these markets.

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References

1. Market Research Future. (2022). Global Hepatitis B Immunoglobulin Market Report.
2. WHO. (2021). Hepatitis B Fact Sheet.
3. CDC. (2022). Recommendations for the Prevention of Hepatitis B Virus Transmission.
4. Lok, A. S., & McMahon, B. J. (2009). Chronic hepatitis B: update 2009. Hepatology.
5. American Academy of Pediatrics. (2020). Red book: 2021 report of the Committee on Infectious Diseases.