Immune globulin intravenous (human), 10% liquid - Biologic Drug Details

Summary for immune globulin intravenous (human), 10% liquid

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

Pharmacology for immune globulin intravenous (human), 10% 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 intravenous (human), 10% liquid Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin intravenous (human), 10% 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	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,434,176	2036-07-15	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	8,715,652	2024-11-17	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	8,906,368	2032-09-14	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	9,422,364	2031-02-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for immune globulin intravenous (human), 10% 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	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,001,489	2033-08-19	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,011,660	2033-04-17	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,144,776	2036-10-26	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,227,383	2036-05-20	Patent claims search

International Patents for immune globulin intravenous (human), 10% liquid

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

Supplementary Protection Certificates for immune globulin intravenous (human), 10% 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 Immune Globulin Intravenous (Human), 10% Liquid

Last updated: August 2, 2025

Introduction

Immune Globulin Intravenous (Human), 10% Liquid (IGIV) represents a pivotal segment within the biopharmaceutical landscape, primarily utilized for immune deficiencies, autoimmune disorders, and secondary immune support in various clinical conditions. As a plasma-derived product, its market dynamics are influenced by regulatory trends, technological advancements, demographic shifts, and competitive forces. Understanding these factors is essential for stakeholders aiming to navigate growth opportunities and mitigate risks effectively.

Market Overview

The global IGIV market has experienced consistent growth, driven primarily by increasing indications, expanding approval scopes, and rising prevalence of immune-related disorders. The global IGIV market was valued at approximately USD 5.8 billion in 2022, with projections indicating a compounded annual growth rate (CAGR) of around 7% to 8% through 2030 (source: MarketsandMarkets). The liquid 10% formulation constitutes the majority of sales due to its ease of administration, stability, and widespread acceptance.

Key Market Drivers

Growing Prevalence of Target Diseases

Autoimmune diseases like chronic inflammatory demyelinating polyneuropathy (CIDP), primary immunodeficiency (PI), and idiopathic thrombocytopenic purpura (ITP) are on the rise globally. The increasing incidence of these conditions bolsters demand for IGIV therapies. For instance, primary immunodeficiency affects approximately 1 in 1,200 to 2,000 live births worldwide, with reports indicating underdiagnosis, suggesting considerable unmet needs [1].

Expanded Therapeutic Indications

Recent approvals and clinical data have broadened IGIV applications to include conditions such as Kawasaki disease, Guillain-Barré syndrome, and certain neurological disorders. This expansion positively influences market growth and encourages R&D investments in novel formulations.

Demographic Shifts

Aging populations in North America, Europe, and Asia-Pacific territories contribute substantially to demand. Elderly populations are more susceptible to autoimmune and immune-deficient states, increasing the utilization of IGIV therapies.

Advancements in Manufacturing Processes

Enhanced plasma fractionation technologies, purification methods, and marketing of high-purity liquid formulations have improved product safety profiles, increased shelf life, and reduced adverse events, fostering clinician confidence and patient compliance.

Market Challenges

Supply Constraints and Plasma Supply

The reliance on human plasma as the raw material introduces variability and challenges in scaling manufacturing. Plasma shortages, particularly in the US and Europe, have periodically constrained supply, impacting availability and pricing.

Cost and Reimbursement

IGIV therapies are costly, often exceeding USD 50,000 per treatment course. Reimbursement policies vary by country, influencing access and market penetration. Cost-containment pressures and payor negotiations have prompted manufacturers to explore biosimilars and alternative formulations.

Regulatory Environment

Regulations governing plasma-derived products are stringent, aiming to ensure safety and efficacy. Navigating different jurisdictional standards adds complexity and can delay product launches, affecting market growth.

Competition from Biologics and Biosimilars

While IGIV remains dominant, emerging biosimilars and recombinant therapies may threaten market share, especially if they demonstrate equivalent efficacy at reduced costs.

Financial Trajectory

Revenue Growth Patterns

The IGIV market is projected to sustain robust growth, buoyed by the expanding patient base and therapeutic indications. Leading players such as CSL Behring, Grifols, and Takeda are expanding sales through geographic penetration and new indication approvals. While prices for liquid 10% formulations have historically increased modestly relative to inflation, the market is beginning to see more aggressive pricing strategies in emerging markets.

Investment in R&D and Manufacturing

Manufacturers are channeling capital into advanced plasma collection centers, novel purification technologies, and development of next-generation immunoglobulin products. These investments aim to optimize yield, enhance safety profiles, and differentiate offerings, potentially leading to higher margins.

Impact of Biosimilars and Competition

Biosimilar entrants have begun to challenge established brands in select markets, exerting downward pressure on prices. However, due to complex manufacturing processes and regulatory hurdles, biosimilar penetration remains limited in certain regions, leaving room for premium pricing on innovative products.

Market Expansion Opportunities

Emerging markets present significant growth potential, driven by rising healthcare infrastructure, increasing awareness, and improving access to plasma therapies. Companies investing in localized manufacturing and tailored reimbursement strategies are poised to capitalize on these dynamics.

Regional Market Perspectives

North America

Dominates the market due to advanced healthcare infrastructure, high diagnosis rates, and early adoption of novel therapies. Medicare and private insurers mainly cover IGIV, although reimbursement policies are always evolving.

Europe

A mature market with steady growth, influenced by regulatory harmonization and increasing prevalence of autoimmune diseases. Countries like Germany, France, and the UK are key contributors.

Asia-Pacific

Expected to experience the highest CAGR owing to rising healthcare expenditure, expanding plasma collection capacities, and increasing awareness. China and India are critical markets, with government initiatives to improve plasma donor pools.

Latin America and Middle East

Growing markets supported by improving healthcare systems and increasing disease awareness, yet facing challenges related to infrastructure and plasma availability.

Future Outlook and Opportunities

Innovative Formulations and Delivery Methods

Research into subcutaneous immunoglobulin (SCIG) alternatives and longer-acting formulations could reshape the competitive landscape, offering convenience and potentially better adherence.

Biosimilar Development

Regulatory pathways are becoming clearer, and biosimilar versions of IGIV could lower costs, expand access, and intensify competitive pressures in mature markets.

Digital and Data-Driven Approaches

Real-world evidence and pharmacovigilance data collection will become critical in demonstrating safety profiles, supporting label expansion, and accelerating approvals.

Potential Disruptors

Advances in recombinant immunoglobulin production or gene therapy could eventually challenge plasma-derived IGIV's dominance, although such technologies remain in early stages.

Conclusion

The IGIV market, particularly the 10% liquid formulation, is poised for sustained growth driven by demographic shifts, expanding indications, and technological innovations. However, it faces notable challenges from plasma supply constraints, regulatory hurdles, and competitive dynamics, including biosimilars. Strategic investments in manufacturing efficiency, pipeline diversification, and market expansion are crucial for maintaining competitive advantage.

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Key Takeaways

• The global IGIV market is expected to grow at a CAGR of approximately 7–8%, with significant contributions from developing regions.
• Increasing prevalence of autoimmune and immunodeficiency disorders fuels ongoing demand.
• Plasma supply limitations and regulatory complexities constrain scalable growth; however, technological advances mitigate some issues.
• Biosimilars and next-generation formulations pose both threats and opportunities for market players.
• Focusing on emerging markets, innovative delivery systems, and streamlined manufacturing will be pivotal to long-term success.

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FAQs

1. What are the primary therapeutic applications of 10% liquid IGIV?
IGIV is mainly used for primary immunodeficiency, autoimmune conditions like ITP and CIDP, and secondary immune support in various clinical scenarios [1].

2. How does plasma supply impact the market for IGIV?
Plasma supply constraints directly affect manufacturing capacity, product availability, and pricing strategies. Limited plasma availability can lead to shortages and impact revenue streams [2].

3. Are biosimilars a significant threat to established IGIV brands?
While biosimilars are emerging in some markets, manufacturing complexity and regulatory challenges limit their current impact. Nonetheless, they pose future competitive threats, especially in cost-sensitive regions [3].

4. Which regions offer the highest growth potential for IGIV?
The Asia-Pacific region, driven by increasing demand, healthcare infrastructure development, and expanding plasma centers, presents the highest growth prospects through 2030 [4].

5. What technological advancements are shaping the future of IGIV?
Innovations include subcutaneous formulations, longer-acting immunoglobulin products, recombinant production methods, and personalized dosing algorithms, all aiming to improve patient convenience and reduce costs [5].

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References

[1] MarketsandMarkets. "Intravenous Immunoglobulin (IVIG) Market by Application, End-use, and Region." 2022.
[2] US FDA. "Plasma-Derived Products: Regulations and Supply Challenges." 2021.
[3] IQVIA. "Impact of Biosimilars in the Immunoglobulin Market." 2022.
[4] WHO. "Global Healthcare Infrastructure Reports." 2022.
[5] BioPharm International. "Innovations in Immunoglobulin Formulations." 2021.