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
Aarhus University Hospital	PHASE1
Charite University, Berlin, Germany	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	10,016,338	2036-12-20	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,125,189	2035-09-16	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,577,154	2038-12-19	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,912,714	2038-07-09	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	11,298,293	2041-01-15	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	8,101,773	2027-12-20	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	10,016,338	2036-12-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,577,154	2038-12-19	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,912,714	2038-07-09	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	9,554,968	2034-03-11	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	9,662,450	2034-02-28	Patent claims search

International Patents for immune globulin infusion (human)

Country	Patent Number	Estimated Expiration
Denmark	2251454
Canada	2800155
European Patent Office	2971227
Portugal	2445482
Canada	2803613
Australia	2010224461

Market Dynamics and Financial Trajectory for Human Immune Globulin Infusion

Last updated: July 30, 2025

Introduction

Human immune globulin infusion (IGH), a biologic derived from pooled plasma, is a cornerstone therapy in immunodeficiency diseases, autoimmune disorders, and certain neurological conditions. With the global rise in immunological diseases and expanding therapeutic indications, the market for IGH is experiencing significant growth. Understanding the underlying market mechanics and projected financial trajectory is essential for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers aiming to optimize engagement and capitalize on emerging opportunities.

Market Overview and Size

The global immune globulin market was valued at approximately USD 9.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8% to 9% through 2030 [1]. Key drivers include the escalating prevalence of primary and secondary immunodeficiency syndromes, increasing adoption in autoimmune and neurological conditions, and technological advancements yielding higher purity and safer formulations.

In terms of geographical distribution, North America represents the largest market segment, accounting for approximately 45% of global sales, driven by robust healthcare infrastructure and high diagnosis rates of immunodeficiencies (e.g., common variable immunodeficiency). Europe follows closely, with notable growth in the Asia-Pacific region fueled by expanding healthcare access and rising awareness.

Market Drivers

Epidemiological Trends

The proliferation of primary immunodeficiency diseases (PID), now recognized as underdiagnosed in many regions, fosters sustained demand for IGH therapy. Secondary immunodeficiencies, often resultant from chemotherapy, transplantation, or HIV/AIDS, further expand usage. The global prevalence of PID is estimated at 1 in 1,200 to 2,000 live births, with rising diagnosis rates attributable to improved screening [2].

Expanding Therapeutic Indications

Beyond immunodeficiency, IGH demonstrates efficacy in autoimmune conditions like idiopathic thrombocytopenic purpura, Kawasaki disease, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyneuropathy (CIDP). Such applications diversify revenue streams and bolster market resilience.

Technological Advancements

Innovation in purification techniques, viral inactivation processes, and stabilization methods ensures higher safety profiles and broader scalability. The advent of subcutaneous infusion formulations has increased outpatient treatment feasibility, reducing healthcare costs and enhancing patient adherence.

Regulatory and Reimbursement Policies

Regulatory pathways in major markets, including the FDA (U.S.) and EMA (Europe), favor expedited approvals for novel formulations and biosimilars. Reimbursement policies favorable towards premium biologics further accelerate market expansion.

Market Challenges

Supply Chain Constraints

IGH production intrinsically depends on pooled plasma, creating vulnerability to donor variability, plasma shortages, and logistical challenges. The recent COVID-19 pandemic accentuated these issues, leading to supply disruptions and price volatility.

Pricing and Cost-Containment Pressures

Biologic therapies incur substantial manufacturing costs. Payers increasingly scrutinize pricing strategies, demanding value-based reimbursement models. This trend pressures profit margins, especially with the emergence of biosimilar competitors.

Biosimilar and Generic Competition

While biosimilars for IGH are still under development, regulatory approval and market acceptance could lead to price erosion over time, impacting key incumbents.

Financial Trajectory and Future Outlook

Revenue Projections

The market anticipates accelerated revenue growth driven by pipeline expansions and increasing demand. Top pharma players, such as CSL Behring, Grifols, and Takeda, are actively innovating and scaling production capacities to meet rising needs.

In particular, the increased adoption of subcutaneous formulations is expected to contribute to revenue growth. For example, in 2022, subcutaneous IGH accounted for approximately 15% of total IGH sales, with projections indicating a CAGR of around 12% into 2030 [3].

Investment and R&D Focus

Pharmaceutical companies are investing heavily in next-generation formulations, such as recombinant immunoglobulins with improved stability and fewer plasma-derived risks. R&D pipelines include engineered IgG molecules with enhanced half-life or targeted delivery mechanisms, promising higher efficacy and patient convenience.

Pricing Strategies

Innovators are adopting dynamic pricing models, factoring in manufacturing efficiencies and value-added services. Strategic collaborations with healthcare systems aim to optimize utilization and reimbursement.

Emerging Markets

Asian markets present significant growth opportunities due to rising autoimmune disease prevalence, expanding healthcare infrastructure, and increased healthcare expenditure. Market analysts project India and China will account for approximately 20% of global IGH sales by 2030 [4].

Regulatory and Market Access Landscape

Regulatory considerations influence the pace of market penetration. The US market’s accelerated approval pathways, coupled with favorable reimbursement policies, facilitate early commercialization. The EMA emphasizes biosimilar integration post-patent expiries, which may restrain pricing power of originators.

Market access strategies emphasizing value-based care, patient-centric formulations, and disease management programs will be pivotal for maintaining financial momentum.

Conclusion: Strategic Implications

The biologic landscape for immune globulin infusion is robust, with a predictable upward trajectory underpinned by epidemiological trends, therapeutic expansion, and technological innovations. Stakeholders should prioritize capacity expansion, pipeline diversification, and adaptive pricing models to sustain growth. The integration of biosimilars, technological advancements in manufacturing, and entering emerging markets will be crucial in shaping the future financial outlook.

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Key Takeaways

• The global IGH market is expanding rapidly with an expected CAGR of approximately 8-9% through 2030, driven primarily by increased disease prevalence and broader therapeutic indications.
• Technological innovations, such as subcutaneous formulations, are critical to growth, providing higher patient compliance and reduced healthcare costs.
• Supply chain vulnerabilities and pricing pressures pose challenges; strategic investments in manufacturing and value-based pricing strategies are essential.
• Emerging markets present lucrative opportunities, especially in Asia-Pacific, necessitating tailored market access strategies.
• Continued R&D focus on biosimilars and engineered immunoglobulins will influence the competitive landscape and future revenue streams.

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FAQs

1. What are the key factors driving growth in the human immune globulin market?
The primary drivers include rising prevalence of immunodeficiency diseases, expanding indications beyond immunodeficiency (autoimmune and neurological disorders), technological innovations like subcutaneous formulations, and increasing awareness leading to higher diagnosis rates.

2. How does the supply chain impact the financial trajectory of IGH producers?
As IGH is derived from pooled plasma, supply chain constraints—including plasma shortages and logistical disruptions—can restrict production capacity, elevate costs, and influence pricing strategies, impacting profitability and market share.

3. What role do biosimilars play in the future of the IGH market?
Biosimilars could introduce price competition, potentially lowering costs and improving access. While currently limited in the IGH space, regulatory support and market acceptance will determine their impact on revenue and market dynamics.

4. How are emerging markets influencing the global IGH market?
Regions like India and China are experiencing increased demand driven by rising autoimmune diseases and expanding healthcare infrastructure. These markets offer substantial revenue growth potential and strategic opportunities for differentiation.

5. What technological advancements are expected to influence the financial outlook of IGH therapies?
Developments include recombinant immunoglobulins, longer half-life formulations, and more efficient manufacturing processes, all promising higher margins, enhanced safety profiles, and broader patient access, thereby positively impacting the market’s financial trajectory.

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References

[1] MarketsandMarkets. "Immunoglobulin Market by Application, End User and Region." 2022.
[2] Bousfiha, A., et al. "Primary Immunodeficiency Diseases: An Update." The Journal of Allergy and Clinical Immunology, 2020.
[3] Grand View Research. "Immune Globulin Market Size, Share & Trends Analysis." 2022.
[4] Research and Markets. "Healthcare Market Forecast Asia-Pacific." 2021.