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
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2035-04-24	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2037-04-07	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350		2037-04-07	Patent claims search

International Patents for HIZENTRA

Country	Patent Number	Estimated Expiration
European Patent Office	1532983
Spain	2398241
European Patent Office	2364730
Denmark	2364730
Japan	6170677
Canada	2790978
Poland	1687028

Supplementary Protection Certificates for HIZENTRA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122016000074	Germany		PRODUCT NAME: NORMALES IMMUNGLOBULIN VOM MENSCHEN; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110414
2016C/047	Belgium		PRODUCT NAME: HIZENTRA (IMMUNOGLOBINE HUMAINE NORMALE ; IGSC); AUTHORISATION NUMBER AND DATE: EU/1/11/687 20110418
132016000099785	Italy		PRODUCT NAME: IMMUNOGLOBULINA UMANA NORMALE(HIZENTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/687/001-012, 20110418
CA 2016 00043	Denmark		PRODUCT NAME: HUMANT NORMALT IMMUNGLOBULIN; REG. NO/DATE: EU/1/11/687/001-012 20110418
300831	Netherlands		PRODUCT NAME: HUMANE NORMALE IMMUNOGLOBULINE; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110518

Market Dynamics and Financial Trajectory for the Biologic Drug: HIZENTRA

Last updated: September 25, 2025

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Introduction

HIZENTRA, a plasma-derived intravenous immunoglobulin (IVIG), plays a crucial role in managing primary immunodeficiency diseases (PIDD) and other immune system disorders. As a biologic drug, HIZENTRA's market positioning, growth prospects, and financial trajectory are shaped by a complex interplay of regulatory environments, demographic shifts, technological advancements, and competitive landscapes. This analysis explores the current market dynamics and forecasts the financial trajectory for HIZENTRA, offering insights valuable to industry stakeholders and investors.

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Market Overview and Key Drivers

Market Size and Growth Trends

The global IVIG market, valued at approximately USD 10 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 7-9% over the next five years [1]. HIZENTRA, branded by CSL Behring, accounts for a significant share within this space, particularly in the U.S., Europe, and emerging markets.

Growth drivers include:

• Increasing prevalence of immunodeficiency disorders: Sporadic primary and secondary immunodeficiencies are steadily rising due to aging populations, increased awareness, and diagnostic capabilities.

• Expanding therapeutic indications: Beyond PIDD, IVIG therapies now address autoimmune disorders such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), and Kawasaki disease, expanding market scope.

• Advancements in manufacturing: Innovations in plasma fractionation and purification improve yield, quality, and safety, bolstering confidence and expanding access.

Regulatory Landscape

Regulatory agencies like the FDA and EMA have streamlined approval pathways for plasma-derived products, fostering faster market entry. CSL Behring’s HIZENTRA benefits from pre-established regulatory acceptance, facilitating market expansion [2].

However, upcoming regulations around plasma collection practices and licensing could influence costs and supply stability.

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Competitive Landscape

Major Players and Product Differentiation

The IVIG market is dominated by CSL Behring (HIZENTRA), Grifols (Flebogamma), Octapharma (Octagam), and Takeda (Kedrvia, Bivigam). Differentiation hinges on efficacy, safety profile, formulation, and cost.

HIZENTRA's competitive advantages include:

• Enhanced safety profile: Stringent manufacturing processes reduce infection risk.

• Flexible administration options: HIZENTRA offers both intravenous and subcutaneous formulations.

• Strong clinical data: Backed by robust trials demonstrating efficacy and tolerability [3].

Supply Dynamics

Increased plasma donations—driven by donor incentives, improved collection infrastructure, and plasma fractionation capacity—support supply stability. CSL's efforts to expand plasma collection facilities globally underpin HIZENTRA's supply reliability.

Market Challenges

• Reliance on plasma supply: Limited donors and donor demographics impact availability and costs.

• Pricing pressures: Payers are increasingly scrutinizing biologics pricing, pressuring margins.

• Emergence of biosimilars: Although biosimilars for IVIG are nascent, potential future entrants pose long-term competitive threats [4].

• Manufacturing complexities: The intricate plasma fractionation process requires high capital investment and regulatory compliance, presenting barriers to new entrants.

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Financial Trajectory of HIZENTRA

Revenue Trends

Historical data indicates steady revenue growth driven by increased demand, market expansion, and product portfolio diversification. CSL Behring reported that HIZENTRA contributed significantly to its immunoglobulin sales, which grew approximately 10% annually over the past three years [5].

In the next five years, revenue is projected to increase at a CAGR of 8-10%, fueled by:

• Expanded indications, including potential approval for additional autoimmune conditions.

• Geographic expansion into untapped markets, notably Asia-Pacific and Latin America.

• Continuous improvements in manufacturing throughput and plasma collection capacity.

Profitability and Cost Dynamics

While revenues trend upward, margin preservation faces pressures from:

• Rising plasma procurement costs due to donor scarcity.

• Investment in manufacturing infrastructure and quality assurance.

• Market competition influencing pricing.

Nevertheless, economies of scale and process efficiencies will likely enhance gross margins, assuming steady plasma supply and demand.

Regulatory and Policy Impacts

Regulatory approval of new formulations or indications, as well as adherence to plasma collection standards, may initially incur costs but ultimately strengthen HIZENTRA’s market position.

Policy shifts favoring domestic plasma collection and reducing reliance on imports could reshape supply chains and pricing strategies, influencing profitability.

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Future Outlook and Investment Implications

The future financial trajectory for HIZENTRA appears robust, supported by demographic trends, pipeline developments, and ongoing market expansion. However, risks related to plasma supply constraints, pricing pressures, and regulatory changes necessitate vigilant strategizing.

Investors should monitor CSL Behring’s plasma collection initiatives, pipeline progress for novel indications, and potential biosimilar entrants, which could influence HIZENTRA’s market share and revenue streams.

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Key Takeaways

• Growing Market Demand: The global IVIG market’s steady expansion offers substantial opportunities for HIZENTRA, driven by increased diagnosis of immunodeficiency and autoimmune disorders.

• Supply Chain Optimization: Success hinges on scalable plasma collection infrastructure and manufacturing efficiency to meet rising demand while maintaining high safety standards.

• Competitive Positioning: HIZENTRA’s safety profile, formulation flexibility, and clinical backing provide a competitive edge amidst an evolving landscape with potential biosimilar entrants.

• Pricing and Policy Risks: Market pressures and regulatory frameworks require proactive adaptation to sustain profitability.

• Strategic Growth Opportunities: Geographic expansion into emerging markets and pipeline enhancements (e.g., new indications) can bolster long-term financial performance.

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FAQs

1. What are the primary indications for HIZENTRA?
HIZENTRA is primarily indicated for primary immunodeficiency disorders, including common variable immunodeficiency (CVID), and for patients with secondary immune deficiencies. Its uses extend to autoimmune conditions like Kawasaki disease and idiopathic thrombocytopenic purpura (ITP) [3].

2. How does plasma scarcity impact HIZENTRA’s market?
Plasma scarcity influences pricing, manufacturing capacity, and supply stability. CSL Behring’s investments in plasma collection facilities aim to mitigate these risks, ensuring consistent supply for HIZENTRA.

3. What role do biosimilars play in HIZENTRA’s future?
While biosimilars are emerging in the biologic space, their penetration into the IVIG market remains limited due to manufacturing complexity and safety concerns. Nonetheless, future biosimilar entrants could introduce pricing competition, necessitating strategic differentiation.

4. How are regulatory changes affecting the IVIG market?
Regulatory agencies are enhancing plasma collection standards and product safety requirements, which may increase manufacturing costs but also bolster product trust. Streamlined approval pathways facilitate market access but require compliance.

5. What are growth prospects for HIZENTRA outside traditional markets?
Emerging markets present significant growth opportunities through increased disease awareness and healthcare infrastructure development. CSL Behring’s expansion efforts into Asia-Pacific and Latin America are aligned with these prospects.

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References

[1] Market Research Future, "Global Intravenous Immunoglobulin Market," 2022.
[2] CSL Behring Annual Reports, 2021-2022.
[3] U.S. FDA Label for HIZENTRA.
[4] Pharmaceutical Technology, "The Rise of Biosimilars in the Biologics Market," 2022.
[5] CSL Behring Financial Reports, FY2022.

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In summary, HIZENTRA’s market dynamics are characterized by expanding demand, supply chain evolution, and competitive pressures. Its financial trajectory appears positive, driven by demographic shifts and innovation, albeit intertwined with regulatory and market risks that require strategic navigation. Stakeholders should focus on supply resilience, pipeline development, and market expansion to capitalize on this biologic’s growth potential.