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
Charite University, Berlin, Germany	PHASE1
Aarhus University Hospital	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	9,107,906	2035-01-08	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945	9,512,201	2033-09-24	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945	9,815,886	2035-01-08	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	11,072,615	2039-11-08	Patent claims search
Kamada Ltd.	HEPAGAM B	hepatitis b immune globulin (human)	Injection	125035	11,072,615	2039-11-08	Patent claims search

International Patents for hepatitis b immune globulin (human)

Country	Patent Number	Estimated Expiration
Canada	2884388
European Patent Office	4233903
Australia	2015246157

Market Dynamics and Financial Trajectory for Hepatitis B Immune Globulin (Human)

Last updated: February 23, 2026

What Are the Current Market Size and Growth Drivers?

Hepatitis B immune globulin (HBIG) is a passive immunization product used for post-exposure prophylaxis of hepatitis B virus (HBV). Its global market valuation stood at approximately USD 300 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2030. Growth drivers include increased vaccination rates among high-risk groups, expanded indications for maternal-fetal prophylaxis, and advancements in immunoglobulin manufacturing.

Key Market Segments and Regional Trends

Segment	Market Share (2022)	Projected CAGR (2023–2030)	Notes
Hospital-based applications	55%	4.5%	Used in post-exposure prophylaxis and intravenous administration
Home care/injections	30%	5%	Growing due to outpatient administration and patient comfort
Other (research, off-label)	15%	3%	Less significant, includes off-label uses

Regionally, North America dominates with over 45% market share, attributed to high vaccination coverage, presence of major biotech companies, and established healthcare infrastructure. Asia-Pacific exhibits the fastest growth, driven by emerging healthcare markets, increasing hepatitis B prevalence, and expanding immunoglobulin use.

How Do Patent Expirations and Competition Impact Market Dynamics?

The pharmaceutical landscape for HBIG is influenced by patent exclusivities, biosimilar entry, and manufacturing innovations. The original patents for key formulations expired around 2015, allowing biosimilar manufacturers to enter the market, increasing competition and reducing prices.

Patent and Biosimilar Landscape

• Patent expiration timelines began 2015–2018 for leading brands.
• Biosimilar candidates have received approval in the European Union (EU) and select Asian markets.
• Biosimilars typically offer a 20-30% price reduction compared to branded products.

Impact on Pricing and Revenue

Year	Average Price (USD) per dose (2015)	Price Trend	Revenue Impact
2015	375	Stable	Revenue plateau; high-profit margins maintained
2018	330	Decline	Price reductions begin; volume gains offset margins
2022	290	Further decline	Competition erodes profit margins, increasing sales volume

The competitive pressure maintains the market's steady growth but constrains margins for incumbents. Manufacturers shift focus toward biosimilars, novel delivery mechanisms, and broader indications.

What Are the Key Innovations and R&D Trends?

Technological advances focus on improving immunoglobulin purity, stability, and administration. The shift toward subcutaneous (SC) administration aims to enhance patient compliance and reduce healthcare costs.

Major Development Areas

• Recombinant or engineered immunoglobulin products with lower adverse-event profiles.
• Lyophilized formulations that improve stability and extend shelf life.
• Auto-injector devices enabling home administration.

Ongoing pipeline projects aim to develop long-acting formulations with extended dosing intervals, targeting exclusive markets or niche indications like post-therapy prophylaxis in immunocompromised patients.

What Are Regulatory and Policy Considerations?

Stringent regulatory pathways shape market evolution. In the United States, the Food and Drug Administration (FDA) approvals for biosimilar HBIG products began around 2019 under the Biologics Price Competition and Innovation Act (BPCIA). The European Medicines Agency (EMA) has a similar pathway facilitating biosimilar entry since 2007.

Policy Influences

• Health policies promoting vaccination have increased the focus on immunoglobulin use.
• Reimbursement trends favor outpatient and home-based delivery models.
• Countries adopting universal hepatitis B vaccination influence demand dynamics.

What Is the Financial Outlook for Industry Players?

Leading companies, such as CSL Behring and Grifols, reported revenues of USD 1 billion and USD 650 million respectively for immunoglobulin products in their fiscal years 2022. The HBIG segment accounts for a quarter of this, with growth driven primarily by biosimilar adoption.

Revenue Projections (2023–2030)

• Top-tier manufacturers anticipate a compounded annual revenue growth of 3–5%, assuming stabilization of biosimilar penetration.
• Entry of biosimilar products may result in a 20–30% decline in average selling prices but could be offset by increased volumes.

Strategic Focus Areas

• Expanding indications for prophylaxis in hepatitis B and potentially off-label uses.
• Geographic expansion into Africa and Latin America.
• Investment in manufacturing capacity for biosimilars and high-purity formulations.

Key Market Challenges

• Limited global production capacity constrains supply, especially in emerging markets.
• Variability in regulatory approval processes and reimbursement policies.
• High development costs for biosimilar products and climate-related supply chain risks.

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Key Takeaways

• The HBIG market is growing modestly at 4-6% per year, with North America leading and Asia-Pacific experiencing rapid growth.
• Patent expirations and biosimilar competition have compressed margins, prompting innovation and geographic expansion.
• Advances in delivery technologies and new formulations aim to improve patient compliance and reduce costs.
• Regulatory pathways in the US and EU facilitate biosimilar entry, impacting pricing and market share.
• Industry revenues from immunoglobulin global sales are estimated at USD 4 billion in 2022, with HBIG comprising approximately a quarter.

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FAQs

1. What factors are driving demand for HBIG?
Demand stems from increased hepatitis B vaccination, expanded prophylactic indications, and rising hepatitis B prevalence in developing regions.

2. How does biosimilar entry affect the market?
Biosimilars lower prices by 20-30%, increase market competition, and may shift revenue from branded to generic manufacturers.

3. What innovations are expected to impact the HBIG market?
Recombinant manufacturing, subcutaneous delivery, and extended-release formulations will influence market dynamics.

4. Which regulatory challenges influence market entry?
Stringent approval processes for biosimilars and varying reimbursement policies across regions affect product availability.

5. What is the long-term revenue outlook?
While margins decline due to biosimilars, market volume increases counterbalance revenue pressures, supporting steady growth through 2030.

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References

[1] MarketWatch. (2022). "Hepatitis B Immunoglobulin Market Size and Growth." MarketWatch.
[2] Grand View Research. (2023). "Global Human Immunoglobulin Market Analysis." Grand View Research.
[3] U.S. Food and Drug Administration. (2022). "Biologics Price Competition and Innovation Act." FDA.gov.
[4] European Medicines Agency. (2023). "Biosimilar Medicines: European Union." EMA.europa.eu.