Immune globulin intravenous (human) - Biologic Drug Details

Summary for immune globulin intravenous (human)

Tradenames:	8
High Confidence Patents:	0
Applicants:	8
BLAs:	10
Suppliers: see list	8
Recent Clinical Trials:	See clinical trials for immune globulin intravenous (human)
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for immune globulin intravenous (human)

Recent Clinical Trials for immune globulin intravenous (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Washington University School of Medicine	PHASE1
University of Utah	PHASE1
National Heart, Lung, and Blood Institute (NHLBI)	PHASE1

See all immune globulin intravenous (human) clinical trials

Recent Litigation for immune globulin intravenous (human)

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
LIQUIDIA TECHNOLOGIES, INC. v. UNITED THERAPEUTICS CORPORATION	2025-04-21

See all immune globulin intravenous (human) litigation

Pharmacology for immune globulin intravenous (human)

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 intravenous (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin intravenous (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
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	10,640,548	2037-11-06	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	10,646,569	2037-06-20	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	11,191,833	2037-06-12	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	12,233,126	2041-11-04	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for immune globulin intravenous (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
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147	10,016,338	2036-12-20	Patent claims search
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147	10,577,154	2038-12-19	Patent claims search
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147	10,912,714	2038-07-09	Patent claims search
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147	8,703,801	2030-12-07	Patent claims search

International Patents for immune globulin intravenous (human)

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017212067
China	103930595
South Korea	20180100710
Israel	242156

Market and Financial Outlook for Human Immunoglobulin Intravenous (IVIG)

Last updated: February 13, 2026

Immunoglobulin intravenous (human) (IVIG) is a biologic therapy used to treat immunodeficiency disorders, autoimmune diseases, and neurological conditions. Its demand has grown steadily, driven by expanding indications, a shifting demographic profile, and increased global healthcare spending. Market growth is also influenced by pricing dynamics, regulatory landscape, and manufacturing capacity.

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Market Size & Growth Projections

• Global Market Value (2022): Estimated at $10.3 billion, with a compound annual growth rate (CAGR) of approximately 8% from 2017 to 2022 [1].
• Forecast (2027): Expected to reach around $16.5 billion, driven by rising incidence of immunodeficiencies, autoimmune disorders, and expanding approval for new indications [2].
• Key Regions:
  • North America dominates, accounting for roughly 45% of sales.
  • Europe holds about 30%, with growth fueled by aging populations.
  • Asia-Pacific is the fastest-growing segment, with a CAGR of 10% due to increased healthcare access and rising awareness [3].

Market Drivers

• Increased prevalence of primary immunodeficiency (PID), affecting approximately 1 in 25,000 to 50,000 individuals globally.
• Growing autoimmune and neurological indications, such as chronic inflammatory demyelinating polyneuropathy and myasthenia gravis.
• Aging populations in developed markets raise demand, as older patients are more prone to autoimmune conditions.
• Advances in manufacturing technology reduce costs and improve supply consistency.

Key Market Players & Market Share

Major companies include Grifols, CSL Behring, Takeda, and Octapharma, collectively holding over 80% of the market [4].

Company	Market Share (approx.)	Notable Products
Grifols	30%	Gammagard, Flebogamma
CSL Behring	28%	Privigen, Hizentra (subcutaneous)
Takeda	15%	Vivaglobin
Octapharma	10%	Octagam

Growth strategies involve new product approvals, manufacturing capacity expansion, and entering emerging markets.

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Pricing & Reimbursement Dynamics

• Pricing: Retail prices vary by region, with North America averaging $100–$200 per gram, depending on indication and dosage.
• Reimbursement: Broad access facilitated by insurance coverage, Medicare, and Medicaid in the US. Reimbursement policies influence market penetration.
• Pricing Trends: Price increases have persisted annually, reflecting manufacturing complexities, supply chain costs, and regulatory compliance.

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Manufacturing & Supply Chain Trends

• Production relies on pooled plasma from thousands of donors, with strict safety and quality standards.
• Supply constraints include plasma collection bottlenecks and geopolitical factors affecting export/import.
• Enhancements like incremental plasma collection and new manufacturing facilities aim to stabilize supply.

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Regulatory Landscape & Pipeline

• Regulatory bodies (FDA, EMA) maintain rigorous approval standards, impacting development timelines.
• Several biosimilar candidates and new formulations are in pipeline to increase competition.
• Stricter policies on plasma donation and import/export are under review in some regions.

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Financial Trajectory & Investment Considerations

• Revenue growth projected at 7–10% annually over the next five years.
• Operating margins are improving with manufacturing efficiencies but face pressure from pricing pressures and supply constraints.
• R&D investments focus on novel formulations, indication expansion, and biosimilars.
• Mergers and acquisitions are common as firms seek to consolidate plasma resources and expand pipelines, exemplified by CSL Behring’s acquisition of Beijing Tiantan Biological Products in 2021.

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Risks & Challenges

• Regulatory delays or rejections can hinder market expansion.
• Plasma collection bottlenecks threaten supply stability.
• Pricing pressures and reimbursement constraints may decline profitability.
• Competition from biosimilars and alternative therapies could erode market share.

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Key Takeaways

• The IVIG market is expanding, driven initially by immunodeficiency and increasingly by autoimmune and neurological indications.
• North America maintains market dominance, but Asia-Pacific's growth is accelerating.
• Competitive landscape consolidates through mergers, acquisitions, and biosimilar development.
• Supply chain stability remains crucial amid rising demand.
• Pricing and reimbursement strategies significantly influence revenue trajectories.

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FAQs

1. What are the main clinical indications for IVIG?
Immunodeficiency disorders, autoimmune diseases (e.g., Guillain-Barré syndrome), and neurological conditions like myasthenia gravis.

2. How does supply chain constrain IVIG market growth?
Limited plasma donors and geopolitical issues reduce plasma availability, impacting manufacturing capacity.

3. What is the forecasted growth rate for IVIG?
A CAGR of approximately 8% from 2022 to 2027.

4. Who are the leading companies in the IVIG market?
Grifols, CSL Behring, Takeda, and Octapharma.

5. How do biosimilars impact the IVIG market?
They threaten market share by offering lower-cost alternatives, prompting firms to innovate and expand indications.

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Sources:

[1] MarketWatch, "Global Intravenous Immunoglobulin Market," 2022.
[2] Grand View Research, "IVIG Market Analysis," 2022.
[3] IQVIA, "Global Immunoglobulin Market Overview," 2022.
[4] Deloitte, "Biologics and Biosimilars Market Report," 2022.