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		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 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		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 immune globulin subcutaneous (human), 20% liquid

Country	Patent Number	Estimated Expiration
South Korea	20100090731
Poland	2364730
European Patent Office	1687028
Australia	2011219828

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

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300831	Netherlands		PRODUCT NAME: HUMANE NORMALE IMMUNOGLOBULINE; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110518
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
122016000074	Germany		PRODUCT NAME: NORMALES IMMUNGLOBULIN VOM MENSCHEN; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110414

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

Last updated: August 18, 2025

Introduction

Immune Globulin Subcutaneous (Human), 20% Liquid, represents a significant segment within the biomedical landscape, primarily utilized for immunodeficiency disorders, autoimmune diseases, and certain neurological conditions. Its growth trajectory is shaped by evolving regulatory landscapes, technological innovations, competitive dynamics, and shifting healthcare paradigms. This report analyzes the core market drivers, competitive environment, revenue forecasts, and future growth opportunities, providing insights for stakeholders and investors.

Market Overview

Immune globulin (IG) therapies are intravenous (IV) or subcutaneous (SC) formulations derived from pooled human plasma, offering immunoglobulin G (IgG) to bolster immune function. The subcutaneous 20% liquid formulation has gained prominence due to its ease of administration, reduced systemic reactions, and applicability in outpatient settings. The global IG market was valued at approximately USD 8 billion in 2022 and is projected to reach USD 12 billion by 2028, exhibiting a compound annual growth rate (CAGR) of around 7% (source: MarketsandMarkets).

Key Applications

• Primary immunodeficiency (PID): Covering congenital or acquired IgG deficiencies.
• Secondary immunodeficiency: Resulting from chemotherapy, HIV/AIDS, or transplant-related immunosuppression.
• Autoimmune disorders: Including Kawasaki disease, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyneuropathy (CIDP).
• Neurological conditions: Such as multifocal motor neuropathy (MMN).

The convenience of subcutaneous delivery over IV administration, with reduced infusion times and lower systemic adverse events, has expanded patient acceptance and adherence [1].

Market Drivers

1. Increasing Prevalence of Immunodeficiencies

The rising diagnosis rates of primary and secondary immunodeficiency syndromes, driven by improved screening and awareness, have bolstered demand for IG therapies. The IDEAL and other registries report a steady increase in PID prevalence globally [2].

2. Favorable Route of Administration

The shift from IV to SC formulations signifies a patient-centric move, supported by clinical studies demonstrating comparable efficacy and improved quality of life. The subcutaneous route allows self-administration at home, reducing healthcare visits and costs.

3. Technological Innovations

Advancements in formulation science, such as stabilizing IgG at 20% concentrations, improve shelf life, solubility, and ease of administration. Novel delivery devices facilitate the adoption of SC IG therapies, expanding patient demographics.

4. Regulatory Acceptance and Reimbursement Policies

Stringent regulatory approvals by agencies like the FDA (e.g., BIVIGAM, Gammagard) enhance confidence in SC formulations. Reimbursement frameworks increasingly favor outpatient, self-administered therapies, reducing healthcare system burdens.

5. Aging Population and Emerging Markets

Old age is associated with immune function decline, emphasizing the need for immunoglobulin therapies. Expanding healthcare infrastructure in emerging markets further broadens market access [3].

Market Challenges

Despite positive growth drivers, several factors temper market expansion:

• High Cost and Limited Insurance Coverage: IG therapies remain expensive, limiting access, particularly in lower-income regions.
• Supply Chain and Plasma Availability: Dependence on plasma donations exposes the industry to supply constraints and ethical concerns.
• Serious Adverse Events: Rare but severe reactions necessitate rigorous screening and safety protocols.
• Competitive Landscape: Entry of biosimilar products and alternative therapies pressure pricing and margins.

Competitive Landscape

Leading players delivering immune globulin subcutaneous (human), 20% liquid include CSL Behring, Grifols, Takeda Pharmaceutical, and emerging biosimilar manufacturers. These entities differentiate through manufacturing scale, formulation innovations, delivery devices, and patient support programs.

Recent Innovations

• Extended infusion devices offering improved patient comfort.
• Pre-filled syringes facilitating ease of use.
• Loyalty programs and remote monitoring to enhance adherence.

Market entry barriers are significant owing to plasma sourcing complexities, manufacturing validation, and regulatory hurdles.

Financial Trajectory and Revenue Forecasts

The clinical and commercial momentum supports a robust financial outlook:

• 2022-2028 CAGR: Estimated at 7%, driven primarily by increased adoption and expanding indications.
• Market Segmentation: The subcutaneous segment, especially the 20% liquid formulation, is outpacing intravenous segments owing to convenience and safety profiles.
• Premium Pricing: The biologic nature confers high per-unit costs, although biosimilar entrants threaten margins.

Revenue Projections

Based on current market analyses:

Year	Estimated Market Size (USD Billion)	Growth Rate	Notes
2022	8.0	—	Baseline
2023	8.56	7%	Increased adoption, new approvals
2024	9.15	7%	Regulatory approvals expanding use
2025	9.78	7%	Entry of biosimilars influencing prices
2026	10.45	7%	Market maturation, new markets
2027	11.17	7%	Reimbursement expansion
2028	12.0	7%	Peak growth phase

Profitability Considerations

High manufacturing costs, plasma sourcing, and stringent quality controls limit profit margins, though premium pricing mitigates these effects. Biosimilars' entry could decrease prices, influencing revenue growth and profitability.

Future Opportunities and Outlook

1. Biosimilar Development

Competitors developing biosimilar IgG products will intensify price competition, potentially reducing overall market value but increasing access. Companies investing in biosimilar production must navigate complex patent landscapes and regulatory pathways.

2. Personalized Medicine and Extended Indications

Emerging research suggests expanding indications, including autoimmune neurological conditions, may further boost demand. Personalized dosing regimens and novel formulations will optimize patient outcomes, fostering market growth.

3. Emerging Markets

Growing healthcare infrastructure and plasma donation programs in Asia-Pacific and Latin America offer substantial growth potential. Local manufacturing and partnerships could reduce costs and enhance market penetration.

4. Innovations in Delivery Devices

Smart infusion devices with remote monitoring capabilities can improve patient compliance and safety, creating new revenue streams. Investment in digital health integration is expected to influence the trajectory favorably.

Regulatory and Ethical Considerations

Ensuring plasma safety, rigorous manufacturing standards, and transparent sourcing practices remain central. Regulatory agencies like EMA and FDA continue to streamline approval pathways for new formulations, provided safety benchmarks are met.

Conclusion

The market for immune globulin subcutaneous (human), 20% liquid, is poised for steady growth, driven by increasing demand, technological evolution, and shifting clinician and patient preferences. While challenges such as high costs and biosimilar competition exist, ongoing innovations and expanding indications present lucrative opportunities. Stakeholders investing in or managing such therapies should prioritize technological advances, strategic partnerships, and regulatory compliance to capitalize on this trajectory.

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Key Takeaways

• Growth Drivers: Rising prevalence of immunodeficiency disorders, patient-friendly subcutaneous delivery, and regulatory support underpin market expansion.
• Competitive Environment: Dominated by established biologics manufacturers; biosimilar entrants could reshape pricing and margins.
• Financial Outlook: Compound annual growth rate (~7%) forecasted through 2028, with revenue potential increasing as indications expand.
• Market Challenges: High production costs, plasma supply constraints, and price competition require strategic management.
• Future Focus: Innovation in delivery systems, biosimilar development, and market expansion in emerging economies will shape the industry landscape.

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FAQs

Q1: What are the primary therapeutic indications for immune globulin subcutaneous (human), 20% liquid?
A1: The main indications include primary immunodeficiency disorders, secondary immunodeficiency from chemotherapy or HIV, and autoimmune conditions such as Kawasaki disease and CIDP.

Q2: How does the subcutaneous formulation compare to intravenous in terms of efficacy and safety?
A2: Clinical data demonstrate comparable efficacy, with the added benefits of lower systemic reactions, greater convenience, and increased patient autonomy with SC formulations.

Q3: What are the main factors affecting the pricing of immune globulin therapies?
A3: Costs are influenced by plasma sourcing, manufacturing complexities, regulatory compliance, and market competition, particularly from biosimilars.

Q4: What future trends could influence the market for this biologic?
A4: Expanded indications, innovations in delivery devices, biosimilar competition, and growth in emerging markets are significant trends.

Q5: What risks could impact the financial trajectory of immune globulin subcutaneous products?
A5: Supply chain disruptions, regulatory hurdles, pricing pressures, and safety concerns could alter growth prospects.

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References

[1] MarketsandMarkets. “Immune Globulin Market by Type, Application, End User, and Region – Global Forecast to 2028.” 2022.
[2] Kennedy, K. U., et al. “Advancing Treatment for Primary Immunodeficiencies.” Immunological Reviews, vol. 289, no. 1, 2019, pp. 76-90.
[3] WHO. “Plasma-Derived Medicinal Products: Market and Sourcing.” 2020.