Immune globulin subcutaneous (human), 20% liquid - Biologic Drug Details

Summary for immune globulin subcutaneous (human), 20% liquid

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for immune globulin subcutaneous (human), 20% liquid

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 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), 20% liquid Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin subcutaneous (human), 20% liquid 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	10,434,176	2036-07-15	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	8,715,652	2024-11-17	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	8,906,368	2032-09-14	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	9,422,364	2031-02-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for immune globulin subcutaneous (human), 20% liquid 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	10,001,489	2033-08-19	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	10,011,660	2033-04-17	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	10,144,776	2036-10-26	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	10,227,383	2036-05-20	Patent claims search
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	10,280,208	2035-04-24	Patent claims search

International Patents for immune globulin subcutaneous (human), 20% liquid

Country	Patent Number	Estimated Expiration
Denmark	2538975
World Intellectual Property Organization (WIPO)	2011104315
South Korea	101831581
Japan	2013520469
Poland	2364730

Supplementary Protection Certificates for immune globulin subcutaneous (human), 20% liquid

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
CA 2016 00043	Denmark		PRODUCT NAME: HUMANT NORMALT IMMUNGLOBULIN; REG. NO/DATE: EU/1/11/687/001-012 20110418

Market Dynamics and Financial Trajectory for Immune Globulin Subcutaneous (Human), 20% Liquid

Last updated: March 8, 2026

What is the current market size and growth rate for immune globulin subcutaneous (SCIG) 20% liquid?

The global immunoglobulin market was valued at approximately USD 9.8 billion in 2021 and is projected to reach USD 16.5 billion by 2030, reflecting a compound annual growth rate (CAGR) of around 6.4% from 2022 to 2030 [1]. The SCIG segment accounted for roughly 40% of this market in 2022, driven by ease of administration, reduced infusion times, and outpatient suitability.

The SCIG 20% liquid formulation, designed for convenient subcutaneous administration, is favored in primary immunodeficiency diseases (PIDD) therapy. Its adoption rate increased by approximately 8% annually from 2018 to 2022, with ongoing expansion into autoimmune disease treatments.

What are key factors influencing demand and supply?

Demand Drivers:

• Rising prevalence of primary immunodeficiencies, now estimated at 1 in 25,000 births globally [2].

• Increased use in autoimmune and neurological disorders, including chronic inflammatory demyelinating polyneuropathy (CIDP) and Guillain-Barré syndrome.

• Adoption of home infusion therapy models, favored for SCIG, reduces healthcare costs and patient inconvenience.

• Expanded approvals for new indications, notably in neurology and hematology.

Supply Factors:

• Manufacturing complexities owing to plasma collection dependencies.

• Consolidation among plasma donors and manufacturers leading to supply constraints.

• Competition from recombinant or alternative therapies, though plasma-derived immunoglobulin maintains premier status for certain indications.

What are the leading companies and their market shares?

Company	Market Share (%)	Key Products	Notes
CSL Behring	35	Hizentra (20% liquid SCIG)	Market leader, broad portfolio options
Takeda (formerly Shire)	25	Vivaglobin (subcutaneous)	Focused on autoimmunity indications
Grifols	15	Gammagard (intravenous), Hyqvia (SCIG)	Diversified plasma products portfolio
Octapharma	10	Privigen (IVIG), Nulecit (SCIG)	Emphasizes SCIG for patient convenience
Others	15	Various regional products	Fragmented, emerging players

CSL Behring's Hizentra dominates in SCIG formulations for PIDD, capturing over 40% of the SCIG market share.

What are regulatory trends impacting the market?

• Approval of newer formulations with enhanced stability and tolerability.

• Increasing acceptance of at-home administration protocols by agencies such as the FDA and EMA.

• Expanded use in non-PIDD indications, including neurological and autoimmune diseases, following supportive clinical trial data.

• Accelerated approvals for biosimilar immunoglobulins in select markets, aiming to reduce costs.

What financial considerations are relevant?

Pricing:

• Average annual wholesale acquisition costs (WAC) for SCIG 20% liquid range from USD 150,000 to USD 200,000 per patient, depending on dosage and region.

• Price volatility is influenced by manufacturing costs, supply constraints, and payer negotiations.

Revenue projections:

• Estimated global revenue for SCIG formulations will reach USD 6.4 billion by 2030, representing approximately 39% of total immunoglobulin market value [1].

• Growth in emerging markets will contribute significantly, with CAGR of approximately 7% driven by expanding healthcare infrastructure.

Cost factors:

• Plasma collection costs account for up to 60% of production expenses.

• R&D investments focus on formulations with improved stability and reduced infusion volume.

What risks may impact future market and financial trajectories?

• Potential plasma supply shortages could limit production capacity.

• Increased regulatory scrutiny may slow approval of new or biosimilar products.

• Price containment measures and reimbursement restrictions could pressure margins.

• Competition from recombinant immune globulin molecules remains limited but could intensify with technological advances.

Summary of key market insights:

• The SCIG 20% liquid segment is expanding driven by increased demand in immunodeficiency and autoimmune diseases.

• CSL Behring leads the market, followed by Takeda and Grifols.

• Price levels are high but face pressure from biosimilar entrants and reimbursement policies.

• Supply constraints pose ongoing risks to market growth.

• Regulatory trends favor home-based administration, expanding the application scope.

Key Takeaways

• The global immunoglobulin market grows at a CAGR of approximately 6.4%, with SCIG 20% liquid forms gaining traction due to patient-friendly administration.

• CSL Behring holds the majority share in the SCIG segment, with pricing around USD 150,000–200,000 per year per patient.

• Market expansion is driven by demographic factors, treatment paradigm shifts, and regulatory support for at-home therapy.

• Supply chain limitations and regulatory hurdles remain primary risks.

• The total market for SCIG is projected to reach USD 6.4 billion by 2030, representing a significant portion of the immunoglobulin market.

FAQs

Q1: What distinguishes 20% liquid SCIG from other formulations?

A1: It offers higher concentration, reducing infusion volume and time, enabling home-based administration with less frequent dosing.

Q2: Which indications are driving the most demand?

A2: Primary immunodeficiency disorders, autoimmune diseases like CIDP, and neurological conditions such as Guillain-Barré syndrome.

Q3: How are pricing trends expected to evolve?

A3: Prices are stable but may face downward pressure due to biosimilar competition and reimbursement changes.

Q4: What are the key supply chain challenges?

A4: Limited plasma donors, manufacturing capacity constraints, and logistical hurdles impede consistent supply.

Q5: How is the regulatory environment affecting market prospects?

A5: Supportive policies for home infusion, increased approvals for new indications, and biosimilar pathways boost market potential.

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References

[1] Market Research Future. (2022). Immunoglobulin Market Report.

[2] National Institutes of Health. (2021). Primary Immunodeficiency Diseases.