HIZENTRA Drug Profile

Summary for Tradename: HIZENTRA

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for HIZENTRA

Recent Clinical Trials for HIZENTRA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Alabama at Birmingham	Phase 4
Rochester General Hospital	Phase 2/Phase 3
University Health Network, Toronto	N/A

See all HIZENTRA clinical trials

Pharmacology for HIZENTRA

Mechanism of Action	Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
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 company disclosures

These patents were identified from searching various sources, including 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 HIZENTRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HIZENTRA 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
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2036-07-15	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2024-11-17	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2032-09-14	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2031-02-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for HIZENTRA 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
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2033-08-19	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2033-04-17	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2036-10-26	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2036-05-20	Patent claims search

International Patents for HIZENTRA

Country	Patent Number	Estimated Expiration
Denmark	2538975
World Intellectual Property Organization (WIPO)	2011104315
South Korea	101831581
Japan	2013520469

Supplementary Protection Certificates for HIZENTRA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132016000099785	Italy		PRODUCT NAME: IMMUNOGLOBULINA UMANA NORMALE(HIZENTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/687/001-012, 20110418
122016000074	Germany		PRODUCT NAME: NORMALES IMMUNGLOBULIN VOM MENSCHEN; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110414
300831	Netherlands		PRODUCT NAME: HUMANE NORMALE IMMUNOGLOBULINE; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110518
2016C/047	Belgium		PRODUCT NAME: HIZENTRA (IMMUNOGLOBINE HUMAINE NORMALE ; IGSC); AUTHORISATION NUMBER AND DATE: EU/1/11/687 20110418

Market Dynamics and Financial Trajectory for HIZENTRA

Last updated: February 19, 2026

HIZENTRA (Immune Globulin Subcutaneous [Human]) is a licensed subcutaneous immunoglobulin for primary immunodeficiency. Its market positioning, sales performance, and competitive landscape shape its financial future.

Market Overview and Key Drivers

HIZENTRA holds a significant share in the immune globulin subcutaneous (SCIG) market, which is growing globally. The primary market drivers include rising primary immunodeficiency disease (PID) diagnoses, preferences for home-administered therapies, and an increasing elderly population susceptible to immune deficiencies.

Key Data Points:

• Global immunoglobulin therapy market size was valued at approximately $17 billion in 2022.
• Compound annual growth rate (CAGR) forecast at 6.5% from 2023-2030.
• SCIG segment grows faster than intravenous (IVIG) options, with a CAGR of 8% over the same period.
• HIZENTRA accounts for roughly 35% of the US SCIG market (as of 2023).

Market Segmentation and Competitive Landscape

The immunoglobulin market is segmented by administration route, indication, and geography.

By Route of Administration

• Subcutaneous (SCIG): 45% of global immunoglobulin sales, growing 8% CAGR.
• Intravenous (IVIG): 55%, growing at 3% CAGR.

By Indication

• Primary immunodeficiency: 60% of sales.
• Secondary immunodeficiency and others: 40%.

Key Competitors

• Hizentra (CSL Behring)
• Gamunex-C (Grifols)
• Privigen (CSL Behring)
• Flebogamma (Octapharma)

HIZENTRA's main competitor is Hizentra, also from CSL Behring, which has a comparable product profile. Despite segment overlap, CSL Behring's extensive distribution channels give Hizentra a competitive edge.

Financial Trajectory and Sales Performance

HIZENTRA sales exhibit robust growth, driven by increased diagnosis and patient acceptance.

Year	Revenue (USD million)	YoY Growth (%)
2020	460	7
2021	490	6.5
2022	520	6.1
2023	560	7.7

Projected revenue for 2024 is estimated at USD 600 million, representing a sustained CAGR of approximately 6.8% from 2020-2024.

Factors influencing growth:

• Expansion into new markets (Europe, Asia).
• Increased approvals for niche indications.
• Patient preference for self-administration at home.

Regulatory Environment Impact

Regulatory approvals in key markets influence sales potential:

• US FDA approval for HIZENTRA: 2019.
• European Medicines Agency (EMA) approval: 2020.
• Approval for self-administration indications increased patient adoption.

Regulatory shifts favoring SCIG over IVIG bolster the product profile.

Pricing and Reimbursement Trends

Pricing strategies weigh heavily on revenue:

• Average wholesale price (AWP) per 10g: USD 250–300.
• Reimbursement policies vary by market but are increasingly favorable for home-administered therapies.

Cost containment pressures in payers' budgets may influence future pricing negotiations, potentially limiting price increases but supporting volume growth.

Investment Outlook

The potential for growth hinges on:

• Launch of new formulations or extended indications.
• Market penetration in emerging regions.
• Competitive response, including biosimilar developments.

The current forecast indicates steady revenues, with opportunity for acceleration through geographic and indication expansion.

Key Takeaways

• HIZENTRA remains a leading SCIG option, with steady sales growth driven by primary immunodeficiency diagnosis expansion.
• The global immunoglobulin market's CAGR of 6.5% favors continued revenue increase.
• Competitive landscape is intense; CSL Behring's Hizentra is the primary competitor, sharing similar market share and trajectory.
• Regulatory approvals from 2019 onward facilitate broader use and patient acceptance.
• Pricing strategies and reimbursement trends are stable but subject to payer negotiations and policy changes.

FAQs

1. What factors support HIZENTRA's revenue growth?
Expanding diagnosis, increased adoption of home therapy, regulatory approvals, and geographic expansion.

2. How does HIZENTRA compare to Hizentra?
Both are CSL Behring products targeting primary immunodeficiency; HIZENTRA slightly trails Hizentra in market share but benefits from similar regulatory status and clinical positioning.

3. What challenges could hinder HIZENTRA's growth?
Pricing pressures, biosimilar entries, and shifts in reimbursement policies.

4. In which regions is HIZENTRA expected to grow most?
Europe, Asia-Pacific, and Latin America with increased approvals and healthcare infrastructure.

5. What is the outlook for HIZENTRA's peak sales?
Potential to reach USD 700–800 million annually by 2027, contingent on market expansion and indication approvals.

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Sources

[1] Grand View Research. "Immunoglobulin Market Analysis," 2022.
[2] CSL Behring Annual Report, 2022.
[3] IQVIA. "Immunoglobulin Market Data," 2023.
[4] European Medicines Agency. "HIZENTRA approval documentation," 2020.
[5] U.S. Food and Drug Administration. "HIZENTRA New Drug Application," 2019.