Immune globulin infusion (human) - Biologic Drug Details

Summary for immune globulin infusion (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for immune globulin infusion (human)
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for immune globulin infusion (human)

Recent Clinical Trials for immune globulin infusion (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Charite University, Berlin, Germany	PHASE1
Aarhus University Hospital	PHASE1
Children's Oncology Group	Phase 3

See all immune globulin infusion (human) clinical trials

Recent Litigation for immune globulin infusion (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 infusion (human) litigation

Pharmacology for immune globulin infusion (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 infusion (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin infusion (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
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105		2036-12-20	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105		2035-09-16	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105		2038-12-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for immune globulin infusion (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
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105		2036-12-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105		2038-12-19	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105		2038-07-09	Patent claims search

International Patents for immune globulin infusion (human)

Country	Patent Number	Estimated Expiration
Russian Federation	2523773
Japan	6363676
World Intellectual Property Organization (WIPO)	2021247665

Immune globulin infusion (human) Market Analysis and Financial Projection

Last updated: February 16, 2026

What are the current market dynamics for immune globulin infusion (human)?

The global immune globulin infusion (human) market is expanding, driven by rising prevalence of immune deficiencies, autoimmune disorders, and neurological conditions. The market size was valued at approximately $10.4 billion in 2022 and is projected to reach around $16.8 billion by 2030, increasing at a compound annual growth rate (CAGR) of 6.9%. Uptake is propelled by the growing demand for effective, lifelong treatment options and advancements in manufacturing processes that enhance safety and reduce costs.

Key factors influencing market growth include:

• Rising prevalence of primary immunodeficiency diseases (PIDD): An estimated 1 in 1,200 to 2,000 individuals in developed countries have PIDD, necessitating regular immunoglobulin therapy [1].
• Expansion of autoimmune indications: Conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome, and myasthenia gravis contribute to increased demand.
• Technological advances: Improved purification methods and subcutaneous infusion options (SCIG) enhance patient compliance.
• Market entry barriers: High R&D costs, strict regulatory approval processes, and the need for specialized manufacturing facilities slow new entrant commercialization.

Geographically, North America holds the largest market share (roughly 45%), due to healthcare infrastructure, awareness, and insurance coverage. Europe follows with approximately 30%, with Asia-Pacific rapidly growing due to increasing healthcare access and rising disease prevalence.

How does the financial trajectory look for immune globulin infusion (human)?

Financial projections indicate steady growth driven by expanding indications and innovations. The market is characterized by:

• Revenue growth: Estimated Compound Annual Growth Rate (CAGR) of 6.9% from 2022 to 2030.
• Pricing trends: Average wholesale prices (AWP) per gram in North America ranged from $60 to $80 in 2022. Price increases stem from manufacturing costs and supply chain complexities.
• Market segmentation: The intravenous (IVIG) segment accounted for roughly 70% of revenues in 2022, with subcutaneous (SCIG) capturing increasing market share (around 30%) due to convenience.
• Key players: Major companies include CSL Behring, Grifols, Takeda Pharmaceuticals, and Octapharma. Their revenue from immunoglobulin products extended $7 billion in 2022, with projected growth aligned to overall market expansion.

Investment in infrastructure for plasma collection and fractionation is critical. Companies investing in expanding plasma donor pools and improving process efficiency position themselves for sustained growth.

What are the major drivers and barriers for market growth?

Drivers

• Increased global prevalence of PIDD, autoimmune and neurological disorders.
• Innovations in infusion therapies, including subcutaneous options and faster infusion protocols.
• Aging populations in developed markets increase demand for immunoglobulin therapies.
• Improvements in manufacturing that reduce adverse events and improve supply stability.

Barriers

• High manufacturing and R&D costs, estimated at hundreds of millions of dollars for product development.
• Strict regulatory landscape requires rigorous clinical trials and approval processes.
• Supply shortages, especially during plasma collection disruptions, impact pricing and availability.
• Pricing pressures from healthcare systems and payers, particularly in cost-conscious markets.

How will pricing trends influence the market trajectory?

Pricing remains a critical factor. North American wholesale prices increased approximately 5% annually from 2018-2022. The high cost of plasma collection and manufacturing sustains elevated prices; however, ongoing market competition and biosimilar development could pressure prices downward in the future.

Payers are increasingly scrutinizing the value of immunoglobulin therapies, fostering demand for cost-effective alternatives. The introduction of biosimilars or interchangeable products could disrupt current market leaders, pushing prices further.

What is the outlook for innovation and regulatory pathways?

Regulatory agencies like the FDA and EMA show openness to novel formulations and administration routes. The approval of SCIG products has expanded options for patients, with a preference shift toward subcutaneous infusions in outpatient settings.

Innovations such as plasma exchange optimization and recombinant antibody technologies may eventually lower production costs. Emphasis on demonstrating long-term safety and efficacy remains paramount for approval pathways.

Key takeaways

• The immune globulin infusion (human) market is set to grow annually at roughly 6.9%, driven by rising disease prevalence and technological advances.
• North America dominates the market, but Asia-Pacific exhibits the highest growth potential.
• The IVIG segment continues to generate most revenue but faces increasing competition from SCIG offerings.
• Pricing strategies and manufacturing capacity heavily influence market dynamics and entry barriers.
• Regulatory pathways favor the approval of innovative formulations, which may shape future treatment landscape and pricing.

FAQs

1. What are the main indications for immune globulin infusion (human)?
Immunoglobulin therapy treats primary immunodeficiency diseases, certain autoimmune disorders like CIDP and myasthenia gravis, and specific neurological conditions, with expanding off-label uses.

2. How does biosimilar competition impact the market?
Biosimilars may reduce prices and expand access, but as of 2023, few biosimilar immunoglobulins have received approvals, limiting immediate impact.

3. What manufacturing challenges exist for immunoglobulin products?
Plasma collection logistics, ensuring consistent supply, and maintaining product safety are top challenges. High costs and complex purification processes also pose barriers.

4. How is patient preference evolving?
Preference shifts toward subcutaneous infusions due to fewer systemic side effects and convenience, influencing market share dynamics.

5. What is the regulatory environment’s impact on market growth?
Regulatory agencies prioritize safety and efficacy, requiring extensive data for approval. Streamlined pathways for reformulations accelerate product introduction but require complementary manufacturing investments.

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References

[1] Global Data, Immunoglobulin Market Report 2022.