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
National Heart, Lung, and Blood Institute (NHLBI)	PHASE1
Washington University School of Medicine	PHASE1
University of Utah	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		2037-11-06	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062		2037-06-20	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062		2037-06-12	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062		2041-11-04	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2036-12-20	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		2036-12-20	Patent claims search
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147		2038-12-19	Patent claims search
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147		2038-07-09	Patent claims search
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147		2030-12-07	Patent claims search
Grifols Therapeutics Llc	GAMIMUNE	immune globulin intravenous (human)	Injection	101147		2034-03-11	Patent claims search

International Patents for immune globulin intravenous (human)

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011143509
Brazil	112015012470
China	103561758
World Intellectual Property Organization (WIPO)	2018170297
South Korea	102003651

Market Dynamics and Financial Trajectory for the Biologic Drug: Immune Globulin Intravenous (Human)

Last updated: July 27, 2025

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Introduction

Immune globulin intravenous (human), commonly known as IVIG, is a biologic therapy composed of pooled IgG antibodies derived from the plasma of thousands of healthy donors. Its primary applications include treatment for immune deficiencies, autoimmune diseases, and inflammatory disorders. Over the past decade, the IVIG market has experienced exponential growth driven by expanding clinical indications, advancements in manufacturing, and increasing global healthcare infrastructure. This article delineates the current market dynamics and forecasts the financial trajectory of IVIG, providing vital insights for pharmaceutical executives, investors, and stakeholders.

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Market Overview

The IVIG market is characterized by its multi-indication applicability, high product complexity, and significant demand across diverse geographic regions. According to industry reports, the market was valued at approximately USD 9.5 billion in 2021, with projections reaching USD 16.8 billion by 2030, exhibiting a compound annual growth rate (CAGR) of over 7% during this period (Research and Markets, 2022)[1]. The growth is primarily attributed to enhancing diagnosis rates, expanded treatment guidelines, and a growing prevalence of immune-related disorders.

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Key Market Drivers

1. Rising Prevalence of Autoimmune and Immunodeficiency Disorders

The global burden of autoimmune diseases—such as idiopathic thrombocytopenic purpura (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), and Kawasaki disease—continues to rise. Additionally, primary immunodeficiency diseases (PID), including common variable immunodeficiency (CVID), are increasingly diagnosed owing to improved testing standards. The growing patient pool directly fuels IVIG demand, which accounts for approximately 50% of the global immunoglobulin market.

2. Expanding Clinical Indications and Off-Label Use

While FDA approvals secure IVIG's primary indications, off-label use in neurology, infectious disease, and dermatology sustains demand. Notably, recent research underscores IVIG’s efficacy in treating conditions like multiple sclerosis, myocarditis, and COVID-19-related complications—creating short- and long-term revenue streams.

3. Technological and Manufacturing Advancements

Innovations in plasma fractionation, pathogen reduction, and formulation have enhanced product safety and efficacy. Such advancements have enabled production scalability, reduced costs, and improved country-specific supply capacities, especially in emerging markets.

4. Regulatory Landscape and Market Access

Stringent regulations in developed markets (e.g., FDA, EMA) impose high standards for plasma collection and manufacturing due to safety concerns. Conversely, regulatory acceleration in emerging markets like China and India facilitates market entry, boosting global sales potential.

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Market Challenges

1. Supply Constraints

The core raw material—plasma—is limited by donor availability. Plasma collection is both resource- and labor-intensive, with global supply lagging behind soaring demand. Outbreaks of infectious diseases (e.g., COVID-19) have further disrupted collection programs.

2. High Cost and Complex Manufacturing

IVIG’s complex production process and regulatory compliance entail significant capital expenditure, which inflates pricing. High costs restrict accessibility, particularly in low- and middle-income countries, creating socioeconomic disparities in treatment.

3. Competition from Biosimilars and Alternatives

Although biosimilars for IVIG are emerging, their market penetration remains limited due to efficacy and safety concerns, patent protections, and manufacturing complexities. Nevertheless, these alternatives pose potential long-term impact on pricing pressures.

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Financial Trajectory and Revenue Forecast

Market Segmentation and Revenue Streams

The IVIG market is segmented by indication, end-user (hospitals, infusion centers, home care), and geography. North America currently dominates, owing to high diagnosis rates and healthcare expenditure, accounting for approximately 45% of the global market. Europe follows, with rapid adoption in Eastern Europe and the UK. Asia-Pacific presents significant growth opportunities due to expanding healthcare infrastructure and rising disease prevalence.

Projected Growth and Revenue Trends

The market is expected to grow at a CAGR exceeding 7% through 2030. Driven by technological innovations, strategic collaborations, and broadened indications, revenues are anticipated to reach USD 16.8 billion by 2030. Key factors include:

• Increased licensing agreements: Major players like CSL Behring, Grifols, and Takeda are expanding their production capacity and pipeline offerings, facilitating higher revenues.
• Emerging markets: Countries like China and India will witness compounded growth as their healthcare systems modernize.
• Product differentiation: Development of subcutaneous formulations and novel delivery systems can capture market share and command premium prices.

Pricing Trends and Market Saturation

Despite the optimistic growth outlook, pricing pressures stemming from biosimilar competition and procurement negotiations are expected to temper profit margins. Market saturation in established high-income markets might slow growth, shifting focus toward emerging economies.

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Strategic Implications for Stakeholders

• Investment in Plasma Collection Infrastructure: Ensuring sufficient raw material supply will be critical; partnerships with blood banks and plasma centers will mitigate supply risks.
• Innovation in Formulation and Delivery: Developing subcutaneous and more convenient administration methods will boost adherence and expand patient populations.
• Navigating Regulatory Environments: Proactively engaging with regulators and pursuing accelerated approvals will facilitate entry into new markets.
• Cost Optimization: Investing in manufacturing efficiencies and supply chain resilience will improve margins amid competitive pressures.

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Conclusion

The IVIG market stands on a robust growth trajectory, underpinned by expanding indications, technological advancements, and emerging geographic markets. While supply constraints and pricing pressures pose challenges, strategic investments in production capacity, innovation, and regulatory navigation can unlock sustained revenue streams. Stakeholders who adapt to evolving market dynamics and optimize operational efficiencies will capitalize on this lucrative segment of the biologic pharmaceutical landscape.

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Key Takeaways

• The IVIG global market is projected to grow at a CAGR of over 7% through 2030, reaching nearly USD 17 billion.
• Increasing prevalence of autoimmune and immunodeficiency disorders drives sustained demand.
• Supply chain limitations linked to plasma collection remain a critical challenge; innovation and partnerships are key.
• Price competitiveness and biosimilar competition will influence future revenue growth and margins.
• Geographic expansion into emerging markets offers substantial growth opportunities, contingent on regulatory alignment and infrastructure development.

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FAQs

1. What clinical indications are primarily fueling IVIG demand?
Autoimmune diseases like ITP, CIDP, and Kawasaki disease, alongside primary immunodeficiency disorders, are the primary indications driving demand. Emerging evidence is expanding its use into neurology and infectious diseases.

2. How does plasma donation impact the IVIG market?
Plasma donation is essential for IVIG production; supply limitations can restrict market growth. Investments in plasma collection infrastructure and donor recruitment are vital to meet escalating demand.

3. What are the competitive threats facing IVIG manufacturers?
Biosimilar development, pricing pressures, and potential synthetic alternatives pose threats. Regulatory hurdles and safety concerns also influence biosimilar market penetration.

4. How are technological innovations shaping the IVIG market?
Advancements such as pathogen inactivation, affinity chromatography, and subcutaneous formulations improve safety, convenience, and patient adherence, thereby expanding market potential.

5. What are the key considerations for investors in the IVIG market?
Investors should assess manufacturing capacity, pipeline diversity, regulatory landscape, and regional expansion strategies. Understanding supply chain resiliency and competitive positioning is crucial.

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Sources
[1] Research and Markets. (2022). Global Intravenous Immunoglobulin (IVIG) Market Report 2022-2030.