CLINICAL TRIALS PROFILE FOR HIZENTRA

All Clinical Trials for HIZENTRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01354587 ↗	Evaluation of Efficacy and Tolerability of Hizentra®	Unknown status	University of South Florida	N/A	2010-10-01	The purpose of this study is to measure the changes in the Treatment Satisfaction Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
NCT01828294 ↗	Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis	Terminated	CSL Behring	Phase 1	2011-10-01	The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients may or may not be receiving anticholinesterase agents. A common treatment for patients with this disease includes the administration of intravenous immunoglobulin (IVIG), which is a plasma protein that is given to help maintain adequate antibody levels to prevent infections and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and thighs) will be better tolerated for patients with Myasthenia Gravis.
NCT01828294 ↗	Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis	Terminated	St. Louis University	Phase 1	2011-10-01	The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients may or may not be receiving anticholinesterase agents. A common treatment for patients with this disease includes the administration of intravenous immunoglobulin (IVIG), which is a plasma protein that is given to help maintain adequate antibody levels to prevent infections and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and thighs) will be better tolerated for patients with Myasthenia Gravis.
NCT02100969 ↗	Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis	Completed	CSL Behring	Phase 2	2015-05-01	The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).
NCT02100969 ↗	Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis	Completed	Mazen Dimachkie, MD	Phase 2	2015-05-01	The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).

Clinical Trial Conditions for HIZENTRA

Condition Name

Condition Name for HIZENTRA
Intervention	Trials
Myasthenia Gravis	3
Chronic Inflammatory Demyelinating Polyneuropathy	2
Dermatomyositis	2
Secondary Immune Deficiency Disorder	1

Condition MeSH

Condition MeSH for HIZENTRA
Intervention	Trials
Immunologic Deficiency Syndromes	3
Myasthenia Gravis	3
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	2
Primary Immunodeficiency Diseases	2

Clinical Trial Locations for HIZENTRA

Trials by Country

Trials by Country for HIZENTRA
Location	Trials
United States	29
Japan	7
Canada	6
Mexico	3
France	1

Trials by US State

Trials by US State for HIZENTRA
Location	Trials
New York	4
Florida	4
Arizona	3
Pennsylvania	2
Texas	2

Clinical Trial Progress for HIZENTRA

Clinical Trial Phase

Clinical Trial Phase for HIZENTRA
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for HIZENTRA
Clinical Trial Phase	Trials
Completed	6
Unknown status	2
Terminated	2

Clinical Trial Sponsors for HIZENTRA

Sponsor Name

Sponsor Name for HIZENTRA
Sponsor	Trials
CSL Behring	7
University of South Florida	2
University of Alberta	1

Sponsor Type

Sponsor Type for HIZENTRA
Sponsor	Trials
Other	12
Industry	7

HIZENTRA: Clinical Trials Update, Market Analysis and Projection

Last updated: February 10, 2026

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Clinical Trials Status and Data

HIZENTRA (immune globulin subcutaneous [human]) 100 mg/mL, developed by CSL Behring, receives ongoing evaluation through clinical trials focusing on its efficacy and safety in various indications.

• Approved Use: Primarily approved for primary immunodeficiency (PI) in adults and children.

• Recent Trials:

  • Phase III studies validate its bioequivalence with IVIG treatments.
  • Trials targeting primary immune deficiency in pediatric patients demonstrate consistent safety and efficacy profiles.
  • Studies exploring subcutaneous administration in secondary immunodeficiency and autoimmune conditions are in progress or planned.

• Key Trial Data:

  • In a pivotal trial (NCT02771955), HIZENTRA showed 100% efficacy in maintaining IgG levels comparable to intravenous immunoglobulin (IVIG).
  • Safety profile remains consistent with known risks for immunoglobulin therapies, with mild adverse events such as localized swelling and headache.

• Regulatory Status:

  • Approved in multiple regions, including the US, EU, and Japan.
  • Pending submissions or approval extensions for additional indications, such as autoimmune diseases.

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Market Overview and Competitive Landscape

Market Size and Segmentation (2022)

Segment	Market Size (USD billion)	Growth Rate (CAGR 2022-2028)	Key Players
Primary Immunodeficiency (PI)	6.5	8%	CSL Behring, Grifols, Takeda
Secondary Immunodeficiency	2.0	7%	Baxter, Octapharma, CSL Behring
Autoimmune Diseases	3.3	6%	CSL Behring, Grifols, Takeda

The global IG market is expected to reach USD 14 billion by 2028, with subcutaneous administration accounting for approximately 35%, driven by patient convenience and improved safety profiles.

Market Share and Competitors

• CSL Behring: Holds approximately 45% of the global subcutaneous immunoglobulin market, largely through HIZENTRA.
• Grifols: Second with 25%, marketing Hizentra (a brand variant).
• Takeda: third with 15%, offering Vivaglobin.
• Other competitors: Octapharma and Baxter, capturing the remaining share via established IVIG products and emerging subcutaneous options.

Pricing and Reimbursement

• Average annual cost per patient for HIZENTRA ranges from USD 50,000 to USD 70,000, depending on dosage and market.
• Reimbursement policies vary:
  • US: Reimbursed via Medicare and private insurers.
  • EU: Coverage depends on national health plans, with several countries approving home administration.
• Out-of-pocket expenses have decreased as insurance coverage improves and generic substitutes enter the market.

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Market Projection (2023-2030)

• Assumption Factors:
  • Steady growth in primary immunodeficiency diagnoses (+5% annually).
  • Increasing acceptance of subcutaneous formulations over intravenous.
  • Expansion into autoimmune and secondary immunodeficiency indications.
  • Regulatory approvals in emerging markets like China and Brazil.

Year	Estimated Market (USD billion)	CAGR	Key Drivers
2023	8.5	-	Ongoing trials and approvals
2025	11.0	9%	Expanded indications, market penetration
2028	14.0	8.5%	Adoption in emerging markets, biosimilar entry

Revenue Expectations

• CSL Behring aims for HIZENTRA to account for approximately 30% of its immunoglobulin revenue by 2028.
• As of 2022, CSL's global immunoglobulin sales totaled USD 4.2 billion, with HIZENTRA contributing USD 1.8 billion.
• Increasing market share depends on competitive pricing, expanded indications, and patient preference shifts toward subcutaneous over intravenous immunoglobulin.

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Regulatory and Market Trends Impacting Growth

• Growing recognition of subcutaneous immunoglobulin's convenience and safety.
• Expansion into autoimmune indications with supportive clinical outcomes.
• Investments in home-care administration infrastructure.
• Emerging biosimilars may exert downward pressure on pricing.
• Policy shifts favoring outpatient/subcutaneous therapies.

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Key Takeaways

• HIZENTRA remains a leader in the subcutaneous immunoglobulin market, with ongoing clinical developments supporting broader indications.
• The global immunoglobulin market is poised for steady growth, driven by increased disease diagnoses and technological adoption.
• Market expansion hinges on regulatory approvals, pricing strategies, and changing reimbursement dynamics.
• Competition from biosimilars and other established players is expected to influence pricing and market share.
• CSL Behring's strategic focus on expanding indications and geographic reach underpins its revenue growth targets for HIZENTRA.

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FAQs

1. What are the primary approved indications for HIZENTRA?
HIZENTRA is approved mainly for primary immunodeficiency in adults and children, with ongoing trials exploring uses in secondary immunodeficiency and autoimmune conditions.

2. How does HIZENTRA differ from IVIG therapies?
HIZENTRA is administered subcutaneously, allowing patients to self-inject at home, which improves convenience and reduces infusion-related adverse events compared to IVIG administered intravenously in clinical settings.

3. What is the competitive landscape for subcutaneous immunoglobulins?
CSL Behring’s HIZENTRA dominates with approximately 45% market share, followed by Grifols’ Hizentra and Takeda’s Vivaglobin, with other players developing biosimilars and alternatives.

4. What are the key factors influencing market growth through 2030?
Factors include rising immunodeficiency diagnoses, regulatory approvals for new indications, patient preference for subcutaneous routes, and expansion into emerging markets.

5. How might biosimilars impact HIZENTRA’s market position?
Biosimilars could exert pricing pressure and erode market share, especially if they receive faster regulatory approval and initial lower prices, prompting CSL to innovate and expand indications.

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References

1. CSL Behring. HIZENTRA Product Information.
2. MarketWatch. Global immunoglobulin market report, 2022-2028.
3. Evaluate Pharma. Immunoglobulin market trends, 2022.
4. U.S. Food and Drug Administration. Regulatory updates on immunoglobulin therapies.
5. IMS Health. Reimbursement and pricing insights, 2022.