Immune globulin subcutaneous (human) - Biologic Drug Details

Summary for immune globulin subcutaneous (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	4
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for immune globulin subcutaneous (human)

Recent Clinical Trials for immune globulin subcutaneous (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	PHASE2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	PHASE2
Institute of Hematology & Blood Diseases Hospital, China	PHASE2

See all immune globulin subcutaneous (human) clinical trials

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 immune globulin subcutaneous (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin subcutaneous (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
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115		2014-07-05	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115		2017-07-28	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115		2018-06-05	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115		2020-01-07	DrugPatentWatch analysis and company disclosures
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

3) Low Certainty: US Patents for immune globulin subcutaneous (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
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668		2033-08-19	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668		2036-03-18	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668		2033-04-17	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668		2035-06-04	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668		2037-05-03	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668		2035-05-15	Patent claims search

Market Dynamics and Financial Trajectory for Immune Globulin Subcutaneous (Human)

Last updated: March 3, 2026

What are the key drivers of demand for immune globulin subcutaneous (Human)?

The demand for immune globulin subcutaneous (SCIG) over the past decade remains driven by its approved indications, cost advantages, and ease of administration compared to intravenous formulations. Primary indications include primary immunodeficiency (PID), chronic inflammatory demyelinating polyneuropathy (CIDP), immune thrombocytopenic purpura (ITP), and other autoimmune conditions.

Market size and volume growth (2020-2025):

• The global immune globulin market was valued at approximately $10.3 billion in 2020.
• Compound annual growth rate (CAGR) projected between 7-9%, driven by increasing prevalence of immunodeficiencies and autoimmune disorders.
• SCIG products constituted roughly 25-30% of total immune globulin sales in 2021, expected to grow to 40% by 2025.

Demand factors:

• Increase in primary immunodeficiency diagnoses, with estimates of 1 in 25,000 to 1 in 50,000 people affected globally.
• Growing preference for subcutaneous over intravenous administration due to reduced infusion times, fewer side effects, and outpatient-friendly protocol.
• Shift toward home-based treatment options to reduce hospital visits, especially exacerbated by COVID-19.

How do regulatory and healthcare policies influence market developments?

Regulatory approvals impact market access, especially variations in approval for different indications and formulations. Key points include:

• The US FDA approved Hizentra (CSL Behring) in 2013 for PID, and it remains a flagship product.
• European Medicines Agency (EMA) approvals support expansion into autoimmune indications.
• Policies favoring outpatient and home-based therapies reduce healthcare system costs, incentivizing development of SCIG products.

Reimbursement policies vary by country, influencing adoption rates. Countries with generous coverage for biologics, including immunoglobulin therapies, promote higher utilization.

Who are the main competitors and market shares?

Leading companies include CSL Behring, Grifols, Takeda Pharmaceuticals, and adoptive biosimilar entrants.

Company	Key Products	Estimated Market Share (2022)	Remarks
CSL Behring	Hizentra, Vivaglobin, Xembify	40-45%	Leader in SCIG segment, extensive global reach
Grifols	Flebogamma DIF, Octagam	25-30%	Focus on European markets, biosimilars emergence
Takeda	Privigen (now phased out in favor of SCIG options)	10-15%	Transitioning toward SCIG product offerings
Others	Biosimilars and regional products	10-20%	Market fragmentation, regional focus

What are the recent R&D and pipeline trends?

R&D focuses on improving formulations, expanding indications, and biosimilar development. Key trends include:

• Development of recombinant immunoglobulins to reduce dependence on plasma sources. While current options are plasma-derived, approvals for biosimilar and recombinant variants could alter supply dynamics.
• Enhanced subcutaneous delivery devices that allow higher infusion rates and volume.
• Exploration of new autoimmune and neurological indications, e.g., multiple sclerosis, with ongoing clinical trials.

Major pipeline candidates encompass next-generation formulations with optimized half-life and reduced immunogenicity.

How do pricing and reimbursement policies influence profitability?

Pricing varies significantly across regions:

Region	Average Wholesale Price (AWP) per gram	Reimbursement policies	Impact
US	$70-$90	Negotiated through Medicare and private insurers	High revenue, complex reimbursement landscape
Europe	€40-€60	National health systems, payment tariffs	Moderate margins, regional variation
Asia-Pacific	$50-$70	Limited reimbursement, out-of-pocket expenses	Lower margins, rapid growth driven by emerging markets

Reimbursement policies heavily influence formulary inclusion, patient access, and ultimately, revenue.

What is the projected financial trajectory?

Revenue projections:

• Expected to reach $12-15 billion globally by 2025, driven by increased adolescent and adult patient populations.
• Median price per gram holds steady, with nominal increases averaging 3-5% annually due to inflation and manufacturing costs.

Margin outlook:

• Companies with proprietary manufacturing processes and high market share target gross margins of 30-50%.
• Biosimilar entrants and generics may pressure prices, compress margins, and accelerate market share shifts.

Market risks:

• Plasma supply constraints could impact production capacity.
• Regulatory delays or restrictions on plasma collection practices may influence supply stability.
• Emerging recombinant technologies, if approved broadly, could disrupt existing product markets.

Key Takeaways

• The immune globulin subcutaneous market advances with a CAGR of approximately 8%, supported by rising immunodeficiency diagnoses and preference for outpatient treatment.
• CSL Behring leads market share, with a broad product portfolio and extensive global footprint.
• Reimbursement policies differentially impact regional market trajectories, with US and Europe representing the largest revenue pools.
• Innovation focuses on biosimilar development and delivery device enhancements to extend market dominance and expand indications.
• Overall market revenue is projected to approach $15 billion by 2025, though pricing pressures and supply constraints present ongoing challenges.

FAQs

1. How does the biosimilar landscape impact the immune globulin subcutaneous market?
Biosimilar development introduces competitive pressure that could lower prices and expand access. Market share for biosimilars is expected to grow, particularly in Europe, where biosimilar adoption is more rapid.

2. What are the main regulatory hurdles for new immune globulin formulations?
Regulatory agencies assess biosimilarity through extensive comparability studies. Approval delays may occur if manufacturing inconsistencies arise or if clinical data are insufficient.

3. How significant is plasma supply for the production of immune globulin?
Plasma supply constitutes the primary raw material. Any constraints could limit production capacity, affecting sales and availability.

4. What are the prospects for recombinant immune globulins?
While current offerings are plasma-derived, recombinant formulations are in early development. Approval and commercial viability could significantly alter the supply chain landscape.

5. How do COVID-19-related disruptions affect the immune globulin market?
Supply chain interruptions impacted plasma collection and distribution channels. The shift toward home-based SCIG therapy mitigates some adverse effects by reducing hospital dependence.

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References

[1] Allied Market Research. (2021). Immune Globulin Market by Type and Application.
[2] BIS Research. (2022). Global Biologic Market Outlook.
[3] FDA. (2013). Approval of Hizentra.
[4] European Medicines Agency. (2022). Biologics approvals overview.
[5] Market Research Future. (2022). Biologics Market Analysis and Forecasts.