CLINICAL TRIALS PROFILE FOR GAMMAGARD LIQUID

All Clinical Trials for GAMMAGARD LIQUID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01736579 ↗	Long-Term Study of IGIV, 10% in Alzheimer´s Disease	Terminated	Baxalta now part of Shire	Phase 3	2012-11-29	The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.
NCT01736579 ↗	Long-Term Study of IGIV, 10% in Alzheimer´s Disease	Terminated	Baxalta US Inc.	Phase 3	2012-11-29	The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.
NCT02123615 ↗	ASIS for GAMMAGARD in Primary Immunodeficiency	Unknown status	ASIS Corporation	Phase 1/Phase 2	2016-01-01	ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."

Clinical Trial Conditions for GAMMAGARD LIQUID

Condition Name

Condition Name for GAMMAGARD LIQUID
Intervention	Trials
Alzheimer´s Disease	1
Primary Immunodeficiency	1

Condition MeSH

Condition MeSH for GAMMAGARD LIQUID
Intervention	Trials
Primary Immunodeficiency Diseases	1
Immunologic Deficiency Syndromes	1
Alzheimer Disease	1

Clinical Trial Locations for GAMMAGARD LIQUID

Trials by Country

Trials by Country for GAMMAGARD LIQUID
Location	Trials
United States	2

Trials by US State

Trials by US State for GAMMAGARD LIQUID
Location	Trials
California	1
New York	1

Clinical Trial Progress for GAMMAGARD LIQUID

Clinical Trial Phase

Clinical Trial Phase for GAMMAGARD LIQUID
Clinical Trial Phase	Trials
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for GAMMAGARD LIQUID
Clinical Trial Phase	Trials
Unknown status	1
Terminated	1

Clinical Trial Sponsors for GAMMAGARD LIQUID

Sponsor Name

Sponsor Name for GAMMAGARD LIQUID
Sponsor	Trials
Baxalta now part of Shire	1
Baxalta US Inc.	1
ASIS Corporation	1

Sponsor Type

Sponsor Type for GAMMAGARD LIQUID
Sponsor	Trials
Industry	3

GAMMAGARD LIQUID Market Analysis and Financial Projection

Last updated: February 4, 2026

What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID (immune globulin infusion, human, 10% caprylate/chromatography purified) is a plasma-derived immunoglobulin used to treat primary immunodeficiency diseases (PIDD), ITP, and other immune disorders. It is administered intravenously and provides passive immunity through pooled human plasma antibodies.

What are the recent updates on clinical trials for GAMMAGARD LIQUID?

Recent clinical trial activity for GAMMAGARD LIQUID has focused primarily on expanding indications, improving safety profiles, and optimizing dosing regimens:

• Additional Indications: Trials examining efficacy in autoimmune diseases, such as Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN).
• Safety and Tolerability Studies: Confirming low incidence of adverse events, especially infusion-related reactions.
• Dosing Optimization: Investigations into less frequent dosing schedules and infusion rates to improve patient compliance.
• Pharmacokinetics Studies: Focused on subcutaneous administration as an alternative to intravenous use, potentially broadening therapeutic options.

FDA approval of GAMMAGARD LIQUID for primary immunodeficiency has been reaffirmed; newer data aims to support expanded labeling.

How is the market for GAMMAGARD LIQUID evolving?

The global immunoglobulin market, including GAMMAGARD LIQUID, has experienced steady growth driven by increased prevalence of immunodeficiency disorders and autoimmune diseases, alongside advances in plasma-derived therapeutics.

Market Size & Growth

• 2022 Market Estimate: USD 12.4 billion for the global immunoglobulin market (excluding COVID-19 specific therapies).
• CAGR: 7.2% projected from 2023 to 2028, driven by rising prevalence of PIDD, ITP, and neurological autoimmune conditions.

Key Players & Market Share

• Market Leaders: Takeda Pharmaceutical, CSL Behring, Grifols, and Biotest dominate.
• GAMMAGARD LIQUID’s Position: Competes mainly through Takeda’s portfolio, with approximately 35% of the plasma-derived immunoglobulin market segment.

Geographic Trends

• North America: Largest market, USD 6.5 billion (2022).
• Europe: USD 3.2 billion, growth driven by expanding approved uses.
• Asia-Pacific: Fastest growth (CAGR 9.3%), amid increasing healthcare infrastructure and disease awareness.

Regulatory Environment & Policy Impact

• FDA & EMA Approvals: Reinforcement for primary immunodeficiency use; expansion into other autoimmune conditions pending trial results.
• Pricing & Reimbursement Policies: Vary by country, influence accessibility; US Medicare and private insurers provide coverage, impacting demand.

What are the key market projections?

• 2028 Market Value: Estimated to reach USD 21.7 billion globally.
• Expansion Drivers: Introduction of subcutaneous formulations, wider indications, and increased screening for immunoglobulin deficiencies.
• Product Differentiation: One of the few plasma-derived therapies with a 10% concentration facilitating faster infusion times.

What challenges face GAMMAGARD LIQUID's market?

• Supply Constraints: Plasma availability is finite; centralized collection impacts scalability.
• Pricing Pressures: Healthcare payers seek cost reductions, emphasizing biosimilar development.
• Regulatory Hurdles: Indication expansions require extensive trial data, delaying market entry.

What is the competitive landscape?

Company	Product Portfolio	Market Share	Focus Areas
Takeda	GAMMAGARD LIQUID, BIVIGAM	~35%	PIDD, autoimmune, neurologic disorders
CSL Behring	Privigen, Hizentra	~25%	PIDD, secondary immunodeficiency
Grifols	Flebogamma, Gamunex	~20%	PIDD, autoimmune conditions
Biotest	Plasma-derived and recombinant IG	~10%	Rare diseases, neurology

Key Takeaways

• Clinical trials for GAMMAGARD LIQUID have expanded into new indications, with safety and dosing optimization being priority areas.
• The global immunoglobulin market grows at around 7.2% CAGR, driven by increased demand for plasma-derived therapies.
• Takeda leads the market via GAMMAGARD LIQUID, with significant growth expected through indication expansion and formulation improvements.
• Supply chain constraints and healthcare cost pressures pose ongoing challenges.
• The USD 21.7 billion market projection by 2028 underscores strong demand, with emerging markets offering growth opportunities.

FAQs

1. What are the primary therapeutic indications for GAMMAGARD LIQUID?
Treatment of primary immunodeficiency diseases, ITP, and certain autoimmune neurological conditions.

2. Are there ongoing trials for new indications of GAMMAGARD LIQUID?
Yes, studies focus on autoimmune diseases like Kawasaki disease, CIDP, and expanding into subcutaneous formulations.

3. How does GAMMAGARD LIQUID compare with biosimilars?
No biosimilars currently dominate the market; proprietary formulations retain market share through clinical data and brand recognition.

4. What factors influence the supply of GAMMAGARD LIQUID?
Plasma availability, collection infrastructure, and donor screening processes.

5. What are the main regulatory hurdles for market expansion?
Demonstrating efficacy and safety through comprehensive clinical trials and securing approvals for new indications.

---

References

[1] MarketsandMarkets, "Immunoglobulin Market by Application, End User, and Region," 2022.
[2] Pfizer, "GAMMAGARD LIQUID Prescribing Information," 2023.
[3] FDA, "Biologics License Application," 2022.
[4] EvaluatePharma, "Market Outlook for Plasma Proteins," 2023.